the december 2011 digital edition of anesthesiology news

Uninformed Consent

Average Study Participant Likely Unaware of Risks

I nformed consent is a must for any clinical researcher, a legacy of Bos-ton anesthesiologist Henry Knowles

Beecher, MD, an early pioneer in the field of medical ethics. Dr. Beecher’s 1966

paper in the New England Journal of Med-icine exposing widespread ethical lapses in clinical research helped lay the foun-dations for the research protections that most investigators now take for granted.

But a new study suggests that even today, a key safeguard against potential abuse—consent forms—is troublingly vulnerable.

Informed consent documents are writ-ten at a reading level too high for the average research participant, accord-ing to an analysis of forms from 15 stud-ies conducted at two tertiary care centers.

Is QT Prolongation A Valid Reason To Abandon Zofran?

A lthough the FDA announced it is con-ducting a safety review

of the antinausea drug Zofran (ondansetron, ondansetron hydrochloride and their gener-ics) because of its potential to increase the risk for cardiac arrhythmias, some experts say the drug is still useful in many patients, provided it is appro-priately monitored.

Zofran, used to prevent nausea and vomiting caused

Opioid Gene Variants Linked To Cancer Survival in Women

M ounting laboratory and epidemi-ologic data have suggested a link between exposure to opioids during

cancer surgery and metastasis of, and eventual death from, the disease. Now, a major genet-ics study has turned up some of the most com-pelling evidence yet for a connection between opioids and malignancy, even beyond the operating room.

The new work, by researchers at the Univer-sity of North Carolina, in Chapel Hill, found that breast cancer patients with variants of the µ-opioid receptor that make their cells less responsive to the analgesic are as much as four-fold less likely to die of their tumors as those with the most widespread form of the receptor.

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see consent page 60

65th PostGraduate Assembly in Anesthesiology meeting issue

see genes page 44see zofran page 58

INsIde08 | Ad LibRobbing the captain’s pantaloons—crime and the history of anesthesia.

10 | COMMENTARYAnesthesia and the Feres Doctrine.

34 | PAiN MEdiCiNEA pair of unusual cases in pain management.

55 | CLiNiCAL ANEsThEsiOLOGYWalking speed pegged to successful surgical recovery.

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—William Tremaine, MD

47 | CME—PREANEsThETiC AssEssMENTLesson 295: PreAnesthetic Assessment of the Patient With Systolic Or Diastolic Heart Failure

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December 2011

Discuss these and other articles @ AnesthesiologyNews.com.

Heard Here First:

See article on page 26.

It seems to be that after a while, the OR personnel no longer

follow the rules.

The five most-viewed articles last month on anesthesiologynews.com

1. “herculean” study of Airway complications finds room for Improvement

2. Nagging Drug shortages Defy easy fixes

3. Tablet Devices get Thumbs-up from Anesthesia residents

4. Dutch researcher poldermans ousted In misconduct Investigation

5. electronic Distraction: An Unmeasured Variable In modern medicine

register for free @ anesthesiologynews.comto read these and other articles.

CorrectionAn·es·the·si·o·gist n. A practitioner of the medical science of anesthesia (November 2011, page 1).

See more common alternative spelling AnesthesiOLogist.

AnesthesiOLogy News regrets the error.

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NIH Study Finds Black Investigators Less Likely To Receive NIH FundingB lack scientists are less likely to

receive research funding from the National Institutes of Health (NIH) than their white counterparts, according to a new study (Science 2011;333:1015-1019).

The study, commissioned by the agency, revealed that black researchers are 13% less likely to receive NIH inves-tigator-initiated research funding com-pared with white researchers, whereas Asians were 4% less likely. After

controlling for applicant education and research experience, the investigators found that blacks are still 10% less likely than whites to receive NIH funding.

However, proposals that received strong priority scores from the NIH dur-ing the review process were equally likely to be funded, regardless of the racial background of the applicants.

“I do not think there’s a policy of exclusion at NIH,” said Donna K. Gin-ther, PhD, director of the Center for

Science, Technology & Economic Pol-icy at the University of Kansas in Law-rence, and lead investigator on the study. “Once a grant receives a com-petitive score, it’s funded regardless of race. Instead, I think it’s probably a lack of effective training and mentoring [at the institutional level].”

Dr. Ginther’s prior research has included analyses of gender differences in scientific careers. She said that “the methods used in those studies apply

equally well to research on race/eth-nicity differences.”

The study analyzed 83,188 appli-cations (representing 40,069 unique investigators) for NIH R01 grants, the oldest and most commonly awarded research funding, sub-mitted between 2000 and 2006. According to Dr. Ginther, as part of the application process, applicants “self-identified” their race and eth-nicity. The study was limited to PhD investigators at U.S. institutions.

Dr. Ginther’s research did not ana-lyze funding applications by NIH departments, so there are no data indicating how the funding trends across individual therapeutic areas, such as pain and pain manage-ment. One reason for this is that rel-atively few black scientists apply for research funding across all NIH departments, an indication that the funding disparity may be the result of failure to develop and groom minority researchers at the academic or institutional level.

The NIH has already announced plans to act on the data revealed in the study. In a statement, the agency called the findings “unac-ceptable.” It has implemented the “Early Career Reviewer” program to encourage junior faculty to par-ticipate in peer-review panels, with the ultimate goal of increasing the diversity (in terms of race and age) among panel membership.

The NIH also has promised to conduct a formal review of its grant review process to identify bias and implement corrective measures. It has formed two advisory “task forces” to solicit expert opinion and recommend steps to improve diver-sity within the grant application process.

“There are actually a lot of good things about this; one is that the NIH had the courage to do the study,” noted Carmen R. Green, MD, pro-fessor of anesthesiology, obstetrics and gynecology, and health manage-ment and policy at the University of Michigan, in Ann Arbor, who was not involved in the project. Dr. Green noted, however, that the study did not “look at MDs or the intersec-tion of race and gender,” and “these aspects should probably be explored further.

“It is also disappointing in the sense that good people are poten-tially not getting funding,” she con-tinued. “We live in an increasingly aging and diverse society and need more voices to help everyone learn about the issues our changing popu-lation faces.”

—Brian P. Dunleavy


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Robbing the Captain’s PantaloonsThis article is the first in a two-part look at crime and the history of anesthesia

I n August 1853, The New York Times ran an arti-cle about a curious caper: In late July of that year, brigands had boarded a ship, “the captain was

put to sleep with chloroform and his pantaloons robbed of $375.”

Remarkably, the article wasn’t describing a single episode but a trend. The paper noted that thieves

“had been boarding and robbing vessels in this port, disguised in masks, and sometimes using chloroform.”

The digitization of newspapers has produced easy access to hundreds of stories about chloroform and other anesthetic agents that were used in criminal activities. A search of the Times archives (1851-1980) for “chloroform thieves” produced about 170 results from 1853 to the 1920s (Figures 1 and 2).

More recently, Casey Anthony is alleged to have searched the Internet for information about chloro-form to use on her young daughter, Caylee. For the last two months of his life, Michael Jackson used propofol to help him sleep. Ketamine and its illegal

“cousins” are widely abused by celebrities and non-celebrities alike. News outlets in the United States and around the world often carry stories in which chloroform apparently has been used on victims of rapes, robberies or murders. Anesthetic agents—old and new—seem to be present outside the operating room as often in real life as in movies and novels.

An Original Indication? The problem has been around as long as anesthesia

itself. In 1847, James Young Simpson described the ease with which chloroform could be used to pro-duce unconsciousness, and criminals took note. Four years later, the British humor magazine Punch pub-lished a cartoon on the subject. Yet in 1850, two arti-cles by John Snow were published that poured cold water on fevered press stories about crime and chlo-roform. His argument has been echoed by many others since then. Attempted use may be common; successful use is much less so.

In 1886, at her trial in London’s Old Bailey, Ade-laide Bartlett (Figure 3) was accused of exactly that kind of success. In the early morning hours of Jan. 1, Adelaide summoned the household maid and asked her to send for Alfred Leach, physician to her hus-band, Edwin. When Dr. Leach arrived, he deter-mined that Edwin was dead and his stomach filled with chloroform.

Thomas Edwin Bartlett was a successful London grocer who met the French-born Adelaide Blanche de la Tremoille in 1875, when she was 19 years old; he was 11 years older. The couple soon married, and to complete her education Edwin sent his young bride first to boarding school in England and then finishing school in Belgium. Adelaide finally moved in with her husband in 1878. After living in a series of residences, they settled into furnished rooms in the Pimlico section of London, in August 1885.

During those seven years, their relationship was marked by various oddities. After Adelaide had com-pleted her schooling, the couple moved into rooms over one of Edwin’s stores. After the death of Edwin’s

mother, his father moved in with the couple. He dis-approved of Adelaide, however, and soon accused her of sleeping with his youngest son, Frederick. Ade-laide denied the affair, and Edwin supported her.

Adelaide would later claim that she had sex with her husband only once, which resulted in a preg-nancy and stillborn child. After another move, the couple met a young Wesleyan minister, George Dyson. Edwin encouraged Dyson’s presence in their home, and after the move to Pimlico, Mr. Dyson began tutoring Adelaide in several subjects, including Latin and mathematics. Of course, rumors developed about the pair’s actual relationship.

In his final months, Edwin suffered from several health problems. Poor dental care had left him with decayed teeth and very bad breath. He also was con-vinced he had syphilis and probably self-adminis-tered mercury as a treatment. After a better dentist improved his teeth, Edwin’s physician, Dr. Leach, concluded that his patient suffered from gastritis and diarrhea. Yet Edwin’s mental state in the weeks before his death indicated depression and hysteria.

On the morning of his death, Edwin’s body was examined first by Frederick Doggett, the Bartletts’ landlord and a registrar of births and deaths. He found various substances in the bedroom, but no evidence of chloroform. Mr. Doggett refused to certify the death without an inquest. Dr. Leach and Adelaide agreed, and the next day five physi-cians conferred but could not establish a natural cause of death. They did find chloroform in Edwin’s stomach and intestines, but no signs of vomit-ing, damage to his trachea or other evidence of its administration.

Adelaide soon admitted that the minister, Mr. Dyson, had obtained chloroform for her, and that she planned to put it on a handkerchief to sub-due Edwin if he attempted sex with her. However, she claimed never to have used it in such a manner.

By mid-April, Adelaide and Mr. Dyson were both on trial for Edwin’s murder. The prosecution’s attempt to prove murder did not succeed because the confusing evidence in the case indicated the possibil-ity of either an accident or suicide. The verdict of not guilty was followed by wild applause from the specta-tors, although many still assumed the pair was guilty. A prominent physician, Sir James Paget, is purported to have said that since Adelaide could not be tried again, she “should tell us, in the interests of science, how she did it.”

The widow and her presumed paramour quickly disappeared from London; nothing is known of their subsequent lives. Little more than rumors have con-tinued through the years —Adelaide’s wealthy royal father took her back to France; she and Mr. Dyson both ended up in America; Adelaide became a nurse in South Africa, and so on. Numerous books and chapters have been devoted to the case over the years, and it also has been fictionalized. The novel Sweet Adelaide (1980) by British writer Julian Symons (Figure 4) and the Jodie Foster film, My Letter to George (1986) were suggested by the case.

—A.J. Wright, MLS

Mr. Wright is an historian in the Anesthesiology Department at the University of Alabama School of Medicine, at Birmingham, and a frequent contributor to Anesthesiology News.


Ad L ib

THIEVES CHLOROFORM AN ENTIRE FAMILY;

W. Sherrard, His Wife, and Four Children Put to Sleep in Roslyn Heights.

servants not disturbed. C.H. Mackay’s Next Door Neighbor Revives in Time to Give an Alarm, but Burglars Escape.

Figure 2. Headline from The New York Times, Sept. 24, 1907.

Figure 3. Adelaide Bartlett.[Source: Wikipedia]

Figure 4. A novel inspired by the story of Adelaide Bartlett. [Source: Amazon]

The British War Steamer Meden at Boston—Desperate Encounter

with River ThievesFigure 1. Headline from The New York Times, Aug. 1, 1853.

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Extubation Case Challenged Long-standing Legal Doctrine

T he practice of anesthesiology does not often come before the U.S. Supreme Court, but the

case of Air Force Staff Sgt. Dean Witt had the potential to radically remake a feature of tort law that has been in effect for more than 60 years.

In October 2003, Sgt. Dean Witt arrived at Travis Air Force Base Med-ical Center with appendicitis. Three months later, following a routine appendectomy complicated by post-extubation laryngospasm, a failed attempt at resuscitation and anoxic brain injury, the family withdrew life support, and Sgt. Witt was dead.

Last June, the Supreme Court declined to hear the case Sgt. Witt’s family brought against the hospital. In doing so, the justices tacitly upheld the Feres Doctrine—a decades-old prohi-bition against allowing the government to be held liable for negligence when military members are injured or killed while on active duty.

Established in 1950 with the deci-sion Feres v. United States, the Feres Doctrine was the result of three sep-arate cases brought before the court: the Feres case, in which a soldier was killed by fire in his barracks because of a defective heating plant; the Jef-ferson case, in which a surgical towel was accidentally left inside a soldier’s abdomen following surgery; and the Griggs case, in which a soldier died at the hands of allegedly remiss Army sur-geons. All three cases had in common negligence by military members that resulted in the death or injury of other military members while they were on active duty. All three asked the justices to determine whether these active-duty military members or their fami-lies were eligible for reparations from the government under the Federal Tort Claims Act (FTCA) of 1948.

Plane Crash Spurred LawCongress passed the FTCA after a

B-25 bomber accidentally crashed into the fog-shrouded Empire State Build-ing in 1945, killing 14 people. The law as it ultimately developed allowed for retroactive provisions so families of the deceased could sue the U.S. govern-ment for monetary restitution.

The FTCA was enacted to allow private parties—civilians—to sue for actionable wrongs committed by agents of the government. The three cases within Feres v. United States

asked whether active-duty military personnel could sue the federal gov-ernment for harm caused by other rep-resentatives of the government. The court said no, and 60 years later, it stands by its initial decision.

By declining to hear Witt v. United States, the Supreme Court effectively decided that only Congress can change the meaning of the FTCA to allow active-duty military members to sue the government. Mike Navarre, a for-mer Navy judge advocate and a mem-ber of the board of advisors for the National Institute of Military Jus-tice, stated, “If you use Congress as a barometer as to the sentiments of the American people, Congress has had 60 years to deal with the Feres Doctrine … and Congress has not dealt with it.”

The Supreme Court reasoned then, as it has ever since, that members of the military have access to remuner-ation through the Veterans Benefits Act (VBA), and thus have no further claim on the public treasury. Indeed, the Congressional Budget Office has reported that if the Supreme Court were to reverse its decision regarding the Feres Doctrine, and active-duty military members could sue the gov-ernment for damages, approximately 750 malpractice lawsuits would be filed each year, resulting in payments of $2.7 billion.

Shortly after Sgt. Witt died, the Air Force barred the nurse anesthetist responsible for his death from practic-ing medicine within a military insti-tution, and the state of California revoked her medical license. Sgt. Witt’s family received $350,000 in repara-tions from the VBA.

Given the state of the nation’s econ-omy and our ever-growing debt, Con-gress appears to be in no hurry to increase the benefits military members killed in the line of duty receive from the VBA, nor do they seem eager to allow them to sue the United States for further monetary gain by revising the FTCA. The Feres Doctrine stands as strongly today as it did when it was first enacted.

—Kristin Adams Forner, MD

Dr. Forner is staff anesthesiologist and medical director for the Department of Anesthesiology at Wright-Patterson Air Force Base, in Dayton, Ohio. You can read more of her writing at www.doc behind thedrapes.com.

1 0 I A n e s t h e s i o l o g y N e w s . c o m D e c e m b e r 2 0 1 1

COMMENTARY

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Pioneering medical technology

SonoLong – The new revo-lutionary echogenic cath-eter kit equipped with “3D Cornerstone” refl ectorsPAJUNK® has, as the fi rst and only manufacturer, initiated a system, by which the catheter is introduced under sterile conditions directly from a cassette through the TRUE echogenic SonoPlex cannula. The SonoPlex cannula is equipped with “3D Cornerstone” refl ectors, which render optimal refl ection properties at steep and shallow punc-ture angles. This SonoLong kit is perfectly suitable for the optimal ultrasound guided continuous nerve block.

The catheter of the SonoLong kit has been provided with a steel stylet, which gives the catheter maximum stability and improves echogenicity. It is removed after catheter insertion.

Maximum stability and improved echoge-nicity – through steel stylet

The distal end of the SonoPlex cannula is equipped with a pattern embossed section over the fi rst 20 mm. This new feature provides optimal visibility of the cannula tip, which can be identifi ed with absolute certainty, regard-less of steep or shallow puncture angles.

Visibility – regardless of the puncture angle

The distal end of the radiopaque catheter is open. This ensures the free fl ow of the anesthetic – particularly in connection with the post-operative injection pump. In addition, the 50 cm long catheter, has been provided with ascending depth graduations at intervals of 5 cm. Therefore its exact position can be determined at any time.

Optimal fl ow and localization – through central opening and depth graduations

Lessons Learned In the Peace Corps

T his summer I went to a reunion in Albuquerque attended by ex-Peace Corps volunteers who

had served in the same country as I had almost 40 years ago.

Our project had been in aquacul-ture and we had dug and stocked fish-ponds in a land-locked country in Equatorial Africa. Although most of us successfully contracted schistosomi-asis and a variety of intestinal parasites, we had more limited success with the fishponds.

Our major stumbling block had been the host country government. Whenever we needed cement, shov-els, nets and more, we would request them from charitable organizations that would donate the material to the host country for our use so that the developing government would learn how to distribute materials to a project. Our problem then was keeping these materials out of the hands of govern-ment officials who were quick to real-ize that the materials could be used in their own homes or could be sold in the marketplace.

The mantra mumbled by everybody in those early days of international development was “planned obsoles-cence,” meaning that all efforts should be made to build the infrastructure of the host country to take over the local projects rather than have the contrac-tors doing the work indefinitely. Once the infrastructure was fully developed, the outside assistance would eventually become unneeded and consequently obsolete. This “top-down” approach still sounds like a good idea because the long-term investment in infrastruc-ture should have a greater effect than the short-term provision of cement and tools.

In our country, the president, his ministers, their assistants and the village chiefs took their cut of the resources and very little ever trickled down to the villagers or local projects where it was needed.

Unfortunately, there was a political coup 10 years into our project and we were forced to leave. A colleague who returned some years later told me that the wonderful fish station on which I had spent so much time building a cement drainage system, keeping the ponds manicured and organizing the tool sheds, was now abandoned and had been reclaimed by the forest. Our project had never received enough of

the trickle-down resources to become fully independent or sustainable. Our planned obsolescence, unfortunately, referred not only to the contractors who are gone but also to the projects that are now abandoned.

This pattern has repeated itself so often and in so many developing coun-tries that the international develop-ment community has changed its strategy. It delivers resources directly to the villages and the local projects where they are needed rather than to the host country’s government. This

“bottom-up” approach may not create a host country infrastructure but it is much more successful in getting wells dug, schools built, fish ponds stocked and the like.

U.S. Health CareSo why am I relating this fish story

to a medical readership? As I was lis-tening to my international develop-ment colleagues talk about their new bottom-up approach, I realized that we should adopt a similar policy in health care.

Typically, what we do in medicine is identify a clinical problem at the bed-side. The problem is communicated up to the hospital administration and, in my circumstance as a federal employee, it then gets communicated to regional and national offices. A committee to study the problem is formed; a policy change is formulated and circulated. Often, a local committee is assigned to design and institute some kind of in-service training.

The changes will sometimes, although not always, improve the bed-side problem. To demonstrate whether the policy change has been effective, we then devote even more resources into doing follow-up studies.

We are learning now that this labor-intensive process does not always have the desired result. It was recently dem-onstrated (and reported in a recent issue of Anesthesiology News) that the Surgical Care Improvement Project (SCIP) measures addressing surgical infections, which have been laboriously collected, collated and reported, have not resulted in a decrease in wound infections. One wonders if those resources would have been better spent on bedside problems, such as outdated equipment or nursing shortages.

Ideally, this process of studying

D e c e m b e r 2 0 1 1 A n e s t h e s i o l o g y N e w s . c o m I 1 1

COMMENTARY

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problems, changing practices and re-evaluating these changes should never end and, theoretically, it makes the system better. It sounds just as good as the inter-national development theories of top-down develop-ment and planned obsolescence.

The problem with the top-down theory in inter-national development is that after 50 years of heavy investment, too few schools had been built, too few fishponds had been dug and too few wells had been drilled. The host country infrastructures that were the beneficiaries of most of this largesse and were supposed to keep up this good work in most cases have become as obsolete as the outside contractors.

My concern for health care is that after we have spent much of our resources on infrastructure such as committees, commissions, workshops, quality assur-ance offices, patient safety committees, patient sat-isfaction questionnaires, and so on, there will not be enough left to deal with the bedside problems, which are usually solved by something as mundane but criti-cally important as equipment or manpower needs.

Quality assurance and patient safety offices do some important work, but as their numbers swell, their policies grow and the in-service training that they require have become more burdensome, their efforts are distracting from the essential mission of direct patient care.

To support their efforts, they have developed a lex-icon of words that get liberally sprinkled throughout any proposals with the thought that this lofty termi-nology lends credence to what they are doing. Prob-lems get “work-shopped,” changes become “paradigm shifts,” training courses or new strategies become

“tools,” evaluating becomes “benchmarking,” prob-lems become “missed opportunities” and people assigned to coordinate these efforts become “cham-pions.” As soon as one of these terms is dragged out, there seems to be a tacit understanding that we are on the right track.

In my role as a department chief, I am continu-ously faced with workforce shortages and outdated equipment. Over the years, we have been trying to address problems at my hospital using the top-down strategy. We hear from those at the bedside that we have a problem and it seems like a reasonable strategy to study the problem, form a committee of interested people, meet, record minutes and then announce that we are addressing the problem. The only problem is that the issue often has not been addressed most of time and resources are spent on data gathering, writ-ing policies and in-service training.

Unfortunately, this is a zero-sum proposition and the creation of this infrastructure requires resources and many man-hours of work, which comes at the expense of needed equipment and time not spent on clinical duties. We have lost many of our talented nurses and physicians to the safety office, quality improvement office, informatics division and a vari-ety of other services that document, measure and report deficiencies in the system, which ironically we can’t adequately address because we don’t have the bedside resources.

I do not mean to denigrate years of work devoted to quality management and patient safety, which is critically important. We as a profession are now

beginning to recognize and address problems, such as the Institute of Medicine’s 100,000 deaths. I just think we have lost our sense of proportion. We seem to be very good at creating the infrastructure (com-mittees, commissions, study groups, etc) but less good at solving the problems. If we spend all of our resources on studying, reporting and formulating strategies to address these problems, we will not have the resources remaining to institute our laboriously crafted solutions.

The last part of any organization to go is the infrastructure. We have recently witnessed the slow deterioration and failure of some of the largest U.S. automobile manufacturers. The earliest signs of deterioration were plant closings, which resulted in workers being laid off and fewer cars being man-ufactured. As the finances got worse, more plants closed and more workers were laid off. By the end, the only thing remaining for these auto giants were their corporate headquarters, replete with water fountains and landscaped gardens.

I get the unsettling feeling that we are witness-ing early signs of deterioration in the health care industry. Compensation for our workforce is being reduced, we are developing labor shortages, and access for our consumers is a growing problem.

We continue, however, to invest heavily in our infrastructure. There are committees and subcom-mittees of patient safety, patient satisfaction, qual-ity assurance, infection control and the like, which seem to spring up almost monthly. Their purpose is unquestionably important but they have had two adverse effects on our patient-care mission. First, they tap off some of the resources that are sorely needed in the clinical realm and, second, they take some of our clinical workforce away from their clinical duties, usually temporarily, but sometimes permanently.

Recently, I sent a surgeon in my department across the country for a two-day meeting on ensuring correct-site surgery. He returned with a

two-hour training module that must be completed by all clinicians in the hospital involving invasive procedures. Operating on the correct site is criti-cally important, but we should question whether this type of reallocation of resources from the bed-side to the conference room is a good way to solve the problem and that it makes sense in an industry that is having such financial difficulties.

Back to AlbuquerqueAs the sun rose on an unseasonably hot day in Albu-

querque, we were clustered under a group of trees that afforded a little shade. I pulled my lawn chair closer to a fellow ex-volunteer who had served in a vil-lage neighboring mine in the Central African Repub-lic. After his service, he had stayed in international development and was now working with the United Nations’ Food and Agriculture Organization (FAO).

As heat rose, the beer was going down easily and we discussed the relative merits of the amber I was drinking, the lager that he had pulled out of the cooler.

Our conversation drifted into a discussion of how his development work was going. He stated that the results were much better since they had abandoned their top-down strategy. He added that they had learned over the years that their limited resources are better used when sent directly to the bare feet on the ground rather than to the wing tips on the 10th floor of the FAO building in Rome. I replied that I hoped my health care industry would learn that they too should direct more of their resources to the rubber soles in the operating rooms and on the wards rather than to the leather soles in the administrative wing of the hospital. He hoisted his beer and said, “Bottoms up.”

— Jon C. White, MD

Dr. White is professor of surgery at George Washington University, in Washington, D.C.


COMMENTARY

Peace corPs continued from page 11The quality assurance and patient safety offices do some important

work, but as their numbers swell, their policies grow and the in-service training that they require have become more burdensome, their efforts

are distracting from the essential mission of direct patient care.

New Treatment Options for C. difficile Raise More Questions

I n the past six months, new surgical and medical options became available to treat patients with Clostridium difficile. As the options for treating

the infection have increased, so too have the ques-tions about who should get what treatments and when.

The ambiguity over how best to treat C. difficile became especially clear after fidaxomicin (Dificid, Optimer Pharmaceuticals Inc.) was FDA-approved in May. Clinicians are now trying to determine whether fidaxomicin is as good or better than the two long-time standards, vancomycin and metro-nidazole. “The answer to that is not clear yet,” said Lawrence Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine of Yeshiva University, in New York City.

An additional two up-and-coming treatments also have been touted as possible game changers in the C. difficile realm. Fecal transplants (FCTs)—a procedure first reported in the medical literature in 1958—have been garnering attention as a highly successful therapy for C. difficile infection. One report published this fall suggests FCTs could be considered a first-line therapy for severe infection (J Clin Gastroenterol 2011;45:655-657). On the surgical front, surgeons are reporting that per-forming a diverting ileostomy with colonic lavage for severe, complicated infections could be used to spare patients from subtotal colec-tomy and may reduce the mortality rate (Ann Surg 2011;254:423-429).

Fidaxomicin on the SceneAlthough patients with C. difficile colitis now

have more treatment possibilities, the developments have revealed new clinical uncertainties about treat-ments. Importantly, how fidaxomicin fits into the

algorithm remains to be seen.This antibiotic is more active in vitro than van-

comycin, by a factor of approximately 8, against clinical isolates of C. difficile, including NAP1/BI/027 strains, according to the researchers. But the long-term risk for resistance with fidaxomicin is unknown. Moreover, fidaxomicin costs significantly more, suggesting it may be best reserved for patients at highest risk for recurrence.

For mild to moderate disease, the guidelines advocate, and experts still support, metronidazole over vancomycin as first-line therapy because of reduced costs, comparable clinical effectiveness and concerns about vancomycin-resistant enterococci; this line of treatment remains unchanged by the approval of fidaxomicin.

“I think we’re comfortable saying that patients with mild to moderate infections should start with oral vancomycin and intravenous metronidazole. But after that point, we’re not sure of the best thing to do when medical therapy starts to fail,” said Peter K. Kim, MD, assistant professor of surgery at Albert Einstein. “There is no evidence one way or the other.”

In the company-sponsored Phase III trial that led to fidaxomicin’s approval by the FDA, fidaxomicin and vancomycin were compared head to head; 548 patients with non–North American pulse-field type

1 (NAP) strains were randomly assigned to fidax-omicin (200 mg twice daily) or vancomycin (125 mg four times daily) orally for 10 days. The analy-sis showed no differences in clinical cure rates but there was a reduced risk for recurrence with fidax-omicin at 13% versus 26.6% (P=0.02) for the intent-to-treat analysis and 11.7% versus 23.2% (P=0.05) for the per-protocol analysis (N Engl J Med 2011;364:422-431).

The lower rate of recurrence was seen in patients with non-NAP1 strains, representing a 69% rel-ative reduction in recurrences with fidaxomicin compared with vancomycin in patients with non-NAP1/BI/027 strains. That’s a tantalizing finding but one that needs confirmation in further trials before clinical practice patterns change, experts said. The researchers also found that in patients with the NAP1/BI/027 strain, the rates of recurrence in the fidaxomicin and vancomycin groups were simi-lar: 24.4% (11 of 45 patients) and 23.6% (13 of 55), respectively (P=0.93).

Fidaxomicin’s approval could “potentially be an important change” in C. difficile treatment, given the decreased risk for recurrent infection in patients with non-NAP1 strains but that must be balanced against the cost, said Darrell Pardi, MD, associate professor


PRN

see C. diff page 16”We believe that the current

classification schema

understages the severity of

illness in many patients.”

—Brian Zuckerbraun, MD

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of medicine at Mayo Clinic, in Rochester, Minn.The price of fidaxomicin is set at $2,800 for a

10-day course, about double that of vancomycin. That price drops more when vancomycin is com-pounded into a powder, further widening the differ-ential cost.

So far, the cost of fidaxomicin has limited insur-ance company approval and most patients cannot afford to pay for it out of pocket, Dr. Pardi said. That has slowed the adoption of fidaxomicin. “Despite the impressive results from the clinical trial, this drug is not being used all that often yet,” he said.

Many hospital formularies are considering cer-tain restrictions on fidaxomicin use, reserving it for patients with multiple recurrences or predicted severe infections. However, these indications were not studied in the trials for fidaxomicin, “so we don’t know for sure if its benefit over vancomycin applies to these patient groups,” Dr. Pardi said.

More trials will be needed to tease out the health benefits and cost issues for each antibiotic, Dr. Brandt said.

Beyond AntibioticsAdding to the murkiness of clinical decision mak-

ing for C. difficile infections is the growing list of options besides antibiotic regimens. Treatments such as FCTs and vancomycin enemas also are increasing in popularity. The evidence for FCTs

is growing with results from more than 300 FCTs published worldwide with cure rates close to 90%.

In the September edition of the Journal of Clinical Gastroenterology, Dr. Brandt and colleagues argued that endoscopic fecal microbiota transplants should be elevated to first-line treatment of patients with deteriorating and severe infection and its complica-tions at the earliest possible time (2011;45:655-657). The authors noted that FCTs are low-tech, cost-effective and require no additional training. The cure rate is “unparalleled, with 90% to 100% of reported patients achieving cure.” Moreover, FCTs are the only treatment that can restore the underlying flora defi-ciency, “changing the composition of the recipient’s intestinal microbiota in a durable manner.”

The investigators concluded that “as the risks of FCT are minimal and the potential gain in criti-cally ill patients is great, we believe the use of FCT in this patient population is rational and clinically well grounded.”

For vancomycin enemas, fewer cases have been reported and they are limited to patients with severe, fulminant C. difficile colitis. In a series of 47 consecutive patients treated at an American hospi-tal from January 2007 to October 2009, 37 (79%) survived and 33 (70%) had complete resolution of colitis, Dr. Kim and his associates reported in a poster at the 2010 annual meeting of the Surgical Infection Society.

Dr. Kim said that vancomycin enemas are an option for some very ill patients who have failed medical therapy and are being considered for sur-gery. However, with only limited retrospective data available, a trial is necessary to show where this treatment fits into the spectrum of options for patients with severe infections.

“Unfortunately, it’s very hard to develop a trial because these are very, very sick patients, and ethi-cally it’s difficult to justify some of these things in this population,” he said.

A group from the University of Pittsburgh recently described another new surgical therapy that might help fill the gap between medical failure and total abdominal colectomy in patients with severe, complicated C. difficile-associated disease (Ann Surg 2011;254:423-429).

Brian Zuckerbraun, MD, and colleagues at Pitt perform a diverting loop ileostomy and intraoper-atively lavage the colon with warmed polyethylene glycol 3350/electrolyte solution via the ileostomy. After the operation, they do antegrade colonic ene-mas with 500 mg of vancomycin in 500 mL three times daily for 10 days, also via the ileostomy. The procedure, they hope, will improve on the poor out-comes associated with total abdominal colectomy with end ileostomy. The traditional procedure has reported mortality rates ranging from 35% to 80%.

In a study comparing 42 patients who underwent diverting ileostomy with historical controls, inves-tigators reported reduced mortality—19% versus 50% (odds ratio, 0.24; P=0.006). Of the 42 patients, 39 had preservation of the colon (93%) and 35 were treated laparoscopically.

“In a critically ill and complex patient population, we can successfully avoid the need for colectomy in severe, complicated [C. difficile-associated disease] by performing a diverting ileostomy with colonic

lavage,” Dr. Zuckerbraun said.He cautioned that the success of any surgi-

cal therapy depends on timing. Surgical therapies, including ileostomy and colonic lavage or total abdominal colectomy, should be considered earlier in the course of patients with severe, complicated disease than what has been practiced over the past several decades, he said.

At Pitt, Dr. Zuckerbraun’s team set a low thresh-old for instituting surgical therapy. A surgical consultation is called for any patient requiring vaso-pressors or intubation or who has a white blood cell count greater than 20,000 or less than 3,000/mm2. The surgeons consider each patient’s case individ-ually, he stressed, but “as soon as they cross that threshold of signs in their illness, we institute surgi-cal therapy.”

Future of C. difficile TreatmentOne of the challenges of treating C. difficile

patients is the lack of a prognostic scoring system to help clinicians differentiate early which patients are likely to fail medical therapy. There is no clear stage between moderate and severe disease, according to guidelines.

“We believe that the current classification schema understages the severity of illness in many patients and fails to adequately identify patients who are likely to become critically ill,” Dr. Zuckerbraun said. As a result, surgeons often are not called in until patients are very ill and their risk for dying during or after surgery is extremely high.

What is required now is that specialists from gas-troenterology, surgery and infectious disease meet to discuss the treatment options. Dr. Kim said he would like to see a symposium in 2012 where cli-nicians and researchers begin to develop a risk stratification strategy, a treatment algorithm and multicenter trials.

“There are many questions that we just do not know the answers to,” Dr. Kim said. “When med-ical therapy fails, what do we try next? Is it fecal transplant, vancomycin enemas, ileostomy with washout? It’s great that there are more options, but we simply do not know [the best course of action].”

—Christina Frangou


PRN

c. diff continued from page 15

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CONTINUING MEDICAL EDUCATIONANESTHESIOLOGY NEWS • DECEMBER 2011 17

Malignant Hyperthermia Diagnosis, Treatment, and PreventionRELEASE DATE: December 1, 2011EXPIRATION DATE: December 1, 2013

CHAIR

Cynthia A. Wong, MDProfessor of AnesthesiologyNorthwestern University Feinberg School of MedicineChicago, Illinois

FACULTY

Bonnie Denholm, MS, BSN, RN, CNORPerioperative Nursing SpecialistCenter for Nursing PracticeAssociation of periOperative Registered Nurses, Inc.Denver, Colorado

GOALThe goal of this educational activity is to provide anesthesiologists, perioperative nurses, and other health care professionals with current, clinically useful information on malignant hyperthermia (MH).

LEARNING OBJECTIVESAt the completion of this activity, participants should be better prepared to:1. Discuss the pathophysiology of MH.2. Describe the characteristic clinical findings that identify an MH crisis.3. Identify all supplies required to manage an MH crisis.4. Discuss, in order, the appropriate steps that must be taken to manage an MH crisis.5. Discuss preventive measures required to provide safe care to patients who are susceptible

to MH.

INTENDED AUDIENCEThis activity is intended for physicians, perioperative nurses, and other health care professionals responsible for managing MH.

STATEMENT OF NEEDMalignant hyperthermia (MH) is a life-threatening pharmacogenetic disorder triggered by the admin-istration of volatile anesthetics, succinylcholine, or both. It manifests in a hypermetabolic crisis that is likely to be fatal if left untreated. Because MH is rare, clinicians may lack awareness of it, may not rec-ognize it, and may not be prepared to treat it. Important steps in the treatment protocol may be omit-ted, with potentially lethal results, when clinicians rely on unaided memory alone to treat MH. In addi-tion, stocks of dantrolene or other supplies may be inadequate or not readily accessible in the event of an MH crisis, particularly in non-hospital surgical settings. Finally, preoperative and post-episode evaluation of patients often is inadequate. Clinical education is necessary to close these practice gaps.

ACCREDITATION STATEMENTSPhysicians: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare and Applied Clinical Education (ACE). AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this enduring monograph educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their par-ticipation in the activity.Perioperative nurses: This continuing nursing education activity was approved by the Association of periOperative Registered Nurses, Inc., an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. AORN recognized this activity as continuing education for registered nurses. This recognition did not imply that AORN or the ANCC Commission on Accreditation approved or endorsed any product included in the presentation.

CONFLICT OF INTEREST STATEMENTIt is the policy of AKH Inc. and the AORN to ensure independence, balance, objectivity, scientific rigor, and integrity in all continuing education activities. The faculty and planning committee must disclose any significant relationship with a commercial interest whose product or device may be mentioned in the activity or with the commercial supporter of this activity. Identified conflicts of interest are resolved by AKH Inc. and the AORN prior to accreditation of the activity.

FINANCIAL DISCLOSURESCynthia A. Wong, MD: Nothing to discloseBonnie Denholm, MS, BSN, RN, CNOR: Nothing to discloseOren Traub, MD, PhD (medical writer): Nothing to discloseAKH planners and reviewers: Nothing to disclose

DISCLOSURE OF UNLABELED USEThis educational activity may contain discussion of products or procedures that have been studied but are not FDA-approved for MH. Please refer to all official product information for approved indi-cations, contraindications, and warnings.

ESTIMATED TIME OF COMPLETION60 minutes

METHOD OF PARTICIPATIONThere are no fees for participating in and receiving credit for this activity. The participant should, in order, read the objectives and monograph and complete the multiple-choice post-test. Participation is available online at CMEZone.com. Enter IP112 in the keyword field to access this activity directly. Or, complete the answer sheet with registration and evaluation on page 22 and mail to: AKH Inc., PO Box 2187, Orange Park, FL 32067-2187; or fax to (904) 683-3803. Statements of participation will be mailed/emailed approximately 6 to 8 weeks after receipt of mailed or faxed submissions. A score of at least 70% is required to complete this program successfully. One retake is allowed. Credit is available through December 1, 2013. For questions regarding this CME/CE activity, please contact AKH Inc. at [email protected].

DISCLAIMERThis course is designed solely to provide the health care professional with information to assist in his or her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the health care professional, and therefore, cannot be considered as giving legal, nursing, medical, or other profes-sional advice in specific cases. AKH Inc., ACE, the AORN, the authors, and the publisher specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from informa-tion in the course, for undetected error, or through the reader’s misunderstanding of the content.Copyright © 2011 AKH Inc. and Applied Clinical Education.

SPONSORED BY

SUPPORTED BY EDUCATIONAL GRANTS FROM

DISTRIBUTED VIA

IntroductionMalignant hyperthermia (MH) is a serious and potentially life-threatening hypermeta-

bolic skeletal muscle disorder induced in response to certain anesthetics in genetically sus-ceptible individuals.1-5 Because the condition is relatively uncommon, most clinicians may not have extensive firsthand experience with its diagnosis and clinical management and thus may not be prepared to act quickly and appropriately in an MH crisis. Indeed, a recent study reported that operating room personnel are not prepared to detect and manage episodes of MH sufficiently.6 These limitations may be magnified in ambulatory surgery settings, which have relatively fewer resources for the management of complex patients.7,8

This activity provides an overview of the pathophysiology, epidemiology, clinical pre-sentation, diagnosis, management, and prevention of MH. It also discusses recent changes in the formulation of the major treatment agent, dantrolene, as well as evolving guidelines for the transfer of affected patients to appropriate treatment facilities.

CONTINUINGMEDICAL EDUCATION 18 ANESTHESIOLOGY NEWS • DECEMBER 2011

Why wait? Access this program and post-test @ CMEZone.com

Pathophysiology and Epidemiology

The level of calcium in the cytoplasm of skeletal mus-cle cells is the primary determinant of muscular contrac-tion. In the baseline relaxed state, intracellular calcium is sequestered within a specialized organelle, the sarcoplas-mic reticulum (SR). Upon stimulation of skeletal muscle at the neuromuscular junction, membrane depolarization leads to activation of dihydropyridine receptors on the skeletal muscle cell membrane, which subsequently acti-vate ryanodine-sensitive calcium channels on the SR.2-4 This results in the release of calcium from the SR into the intracellular cytoplasm, thereby activating actin and myo-sin and producing skeletal muscle cell contraction. When the neuromuscular stimulus is terminated, the ryanodine-sensitive calcium channel closes, and calcium is reseques-tered into the SR via specialized calcium pumps, resulting in cessation of muscular contraction.2-4

In some individuals, inherited or spontaneous muta-tion of genes associated with the dihydropyridine recep-tor, ryanodine-sensitive calcium channel receptor (RYR1) or possibly other proteins lead to excess and/or sus-tained release of calcium from the SR, resulting in per-sistent skeletal muscle contraction.2-4 The sustained contraction leads to a hypermetabolic state represented by excess production of lactate, carbon dioxide (CO2), and heat, as well as excess consumption of adenosine triphosphate (ATP) and oxygen. Ultimately, ATP deple-tion causes the failure of cellular homeostatic mech-anisms and the release of potassium, creatine kinase (CK), and myoglobin from skeletal muscle cells into the bloodstream, resulting in hyperkalemia, rhabdomyolysis, arrhythmias, end-organ damage, and death.2-4 Individu-als who possess these genetic mutations are designated as “MH-susceptible” or as having “MH susceptibility.” Numerous genetic mutations associated with MH sus-ceptibility, mostly in the RYR1, have been identified.2-5

An episode of MH typically requires underlying MH genetic susceptibility and the presence of a triggering agent, the most common being volatile inhalational anesthetic agents (eg, halothane, sevoflurane, or desflu-rane), the depolarizing muscle relaxant succinylcholine, and rarely (in humans), stresses such as vigorous exercise and heat (Table 1).2-4 Very little is known about the spe-cific mechanisms by which anesthetics interact with these abnormal receptors to trigger an MH crisis.

The estimated prevalence of abnormalities in gene coding for RYR1 may be as great as 1 in 3,000 individu-als.5 The incidence of MH episodes is lower (between 1 in 5,000 and 1 in 50,000 to 100,000 anesthetics), due to the variable penetrance of genetic abnormalities and the requirement for a triggering factor.5,9 Further, an MH crisis may develop at first exposure to anesthesia with trigger-ing agents or patients may experience multiple unevent-ful anesthetics before having an episode.5 Reactions occur more commonly in younger patients and in males, but there is no ethnic or geographic predominance.5,10

Clinical Presentation and Consequences

Clinical manifestations of MH may vary, and not all of the classic symptoms associated with MH may occur. The most reliable initial clinical sign heralding the develop-ment of acute MH is an increase in end-tidal CO2 (ETCO2)that is resistant to increasing the patient’s minute ven-tilation.2 The increase in exhaled CO2 may heat the CO2 absorbent in the circle system and exhaust the absorbant rapidly.11 Other early signs may include sinus tachycardia and masseter muscle spasm (or tension) and/or general-ized muscle rigidity.1-5

Contrary to its nomenclature, hyperthermia often is a later sign of MH and may be absent when the diagnosis is suspected initially.12 Sustained muscle contraction from unregulated calcium release generates more heat than the

body is able to dissipate. The resulting hyperthermia can occur minutes to hours following the initial onset of symp-toms.1-5 Severe hyperthermia is associated with develop-ment of disseminated intravascular coagulation (DIC), a poor prognostic indicator and often terminal event.13

The severity and timing of other signs of MH can vary and may depend on the degree of muscle mass.1-5,14 They include electrocardiographic (ECG) changes and arrhyth-mias (eg, peaked T-waves, premature ventricular con-tractions, ventricular tachycardia, ventricular fibrillation) caused by elevated potassium levels from muscle break-down. Rhabdomyolysis also can occur, with plasma CK and urine myoglobin levels peaking hours to days after an acute MH episode.14 In muscular patients, plasma CK lev-els may exceed 100,000 units/L.15 Brownish or tea-colored urine may indicate the presence of myoglobinuria.16

Time of initial symptom onset can vary as well. Most cases occur intraoperatively, within 1 hour of anesthetic induction.1-4,7,14 Following successful treatment, approxi-mately 20% of patients can experience recurrence, usually within the first 24 hours, which may be more common in those with greater muscle mass.14

MH crisis is likely to be fatal if left untreated. Even in non-fatal cases, morbidity can be serious; a North American MH Registry study of reports from 1987 to 2006 showed that nonfatal complications occurred in 35% of patients.12 These complications included cardiac, renal, or hepatic dysfunc-tion; coma or change in consciousness level; pulmonary edema; and DIC. In recent years, the MH-related mortality rate has decreased from an estimated 70% to less than 10% as a result of the availability of an effective treatment and an improved understanding of the clinical manifestation and pathophysiology of the condition.17 One study found that the nationwide mortality rate from MH had fallen fur-ther to 6.5% in 2005.17 Although previously controversial, “awake” MH events have been confirmed in individuals found to have mutations in the RYR1 gene.18,19

Diagnosis

The signs and symptoms of MH episodes can be variable and nonspecific, making diagnosis difficult.1-5 In addition, risk factors that can predict MH have not been identified. Although specific operative procedures and diseases have been associated with MH, the positive predictive value is extremely low.20 The consequences of difficult diagnosis are magnified by the fact that early detection and treatment of MH are required in order to avoid catastrophic outcomes. Thus, successful diagnosis requires a thorough knowledge of the constellations of possible clinical manifestations and variable time course, in combination with a high degree of clinical suspicion.21

During an acute event, diagnosis of MH is based on clin-ical signs and symptoms as well as laboratory tests in the appropriate context (ie, recent administration of a trigger-ing agent). The most important indicator of MH is the pres-ence of respiratory acidosis, manifested as increased ETCO2. Muscle rigidity, metabolic acidosis, and hyperthermia may be present.12 In a patient anesthetized with volatile agents, MH should be suspected strongly when there is a signifi-cant increase (>55 mm Hg) in ETCO2 that does not respond readily to large increases in minute ventilation. How-ever, increased ETCO2 can be caused by technical factors (eg, malfunction of the circle breathing system, ventilator, monitor), decreased CO2 elimination (eg, hypoventilation, bronchial obstruction, pneumothorax), or increased CO2

production or retention (eg, CO2 insufflation during lapa-roscopic procedures; reperfusion after prolonged vascu-lar occlusion, thyrotoxicosis, or pheochromocytoma).1-5 During general anesthesia or sedation, the most com-mon cause of sudden or gradual hypercapnia is hypoven-tilation. Increasing minute ventilation with supplemental ventilation or correcting ventilator settings should correct the ETCO2. Ventilating with a bag mask valve attached to a

Table 1. Anesthetic Drugs and Malignant Hyperthermia Susceptibility

Triggering Agents

Unsafe for Use in MH-susceptible Patients

Inhaled general anesthetics

Desflurane

Isoflurane

Halothane

Sevoflurane

Depolarizing muscle relaxants

Succinylcholine

Nontriggering Agents

Safe for Use in MH-susceptible Patients

Sedative-hypnotics

Diazepam

Etomidate

Ketamine

Methohexital

Midazolam

Pentobarbital

Propofol

Thiopental

Inhaled nonvolatile general anesthetic

Nitrous oxide

Local anesthetics (all local anesthetics)

Bupivacaine

Chloroprocaine

Levobupivacaine

Lidocaine

Mepivacaine

Prilocaine

Procaine

Ropivacaine

Opioids (all opioids)

Alfentanil

Codeine

Diamorphine

Fentanyl

Hydromorphone

Meperidine

Methadone

Morphine

Naloxone

Oxycodone

Remifentanil

Sufentanil

Muscle relaxants (all nondepolarizing)

Atracurium

Cisatracurium

Pancuronium

Rocuronium

Vecuronium

Anxiolytics (all benzodiazepines)

Diazepam

Lorazepam

Midazolam

Adapted from: http://wp2.mhaus.org/anesthetics.


supplemental oxygen source should correct the ETCO2 in the setting of breathing circuit malfunction.

A diagnosis of MH can be supported further by venous or arterial blood gas analysis, which demonstrates a mixed metabolic and respiratory acidosis.22 In the very early stages of acute MH, the metabolic component of the acidosis may be mild. The presence of hyperkale-mia, indicating significant muscle breakdown, further strengthens the diagnosis.1-5

Masseter muscle tension normally increases after the administration of succinylcholine, but typically lasts only a few seconds; if it persists, it may indicate MH.23 Generalized muscle rigidity in the presence of neuromuscular block-ade is considered pathognomonic for MH in the presence of other signs of hypermetabolism. The CK level may or may not be elevated in the initial stages of acute MH and, like potassium, increases greatly due to lysis of muscle cell membranes. Detection of urine myoglobin during the clin-ical course also supports a diagnosis of MH.1-5 A rapid test for urine myoglobin is the presence of heme on the dip-stick with lack of red blood cells on the urinalysis.

Tachycardia often occurs during the early course of MH but is relatively nonspecific. Other causes of tachycar-dia that must be distinguished from MH include inade-quate depth of anesthesia and sympathomimetic toxicity, among a multitude of others.2

Timely detection of an MH event is aided by core tem-perature monitoring. Skin temperature does not reflect MH adequately in a swine model, therefore, core (esoph-ageal, nasopharyngeal, tympanic, pulmonary artery) or near-core (oral, bladder, axillary) temperature monitoring is recommended.24 Experts recommend temperature mon-itoring for general anesthetics longer than 30 minutes in duration.24 Hyperthermia may be hard to distinguish from causes of perioperative fever, including transient bacte-remia, endothelial cell disruption, and drug effects (recre-ational drug overdose, serotonin syndrome).2 Sepsis may be accompanied by fever, metabolic acidosis, and elevated CK, making it difficult to distinguish from MH.

Because of the catastrophic consequences associated with delayed therapy, exploration of the differential diag-nosis of a potential MH episode should not delay initiation of therapy if MH cannot be excluded rapidly.

Management

Early identification of MH and initiation of treatment is the main factor determining success in rescue from an MH event (Figure 1).7 The Malignant Hyperthermia Asso-ciation of the United States (MHAUS) provides clinicians with emergency consultation to help guide management of an MH episode via a hotline telephone number: (800) 644-9737 (outside the United States: 001-303-389-1647).

Acute TreatmentOnce an episode of MH is recognized, anesthetic trig-

gering agents should be discontinued immediately, the patient’s inspired oxygen concentration should be increased to 100%, and ventilation should be increased with high oxygen flows to prevent rebreathing.1- 5,25 Sur-gery should be aborted if the procedure is elective and at a point when it can be stopped. Otherwise, the patient should continue to receive general anesthesia with non-triggering agents (eg, propofol, ketamine, opioids, or ben-zodiazepines).1-5,25 If the patient’s trachea is not intubated, ETT placement should be performed simultaneously with the remainder of the protocol. Additional person-nel should be summoned to assist with drug preparation and administration, as well as other aspects of patient management.1-5,25

Dantrolene, the only known antidote for MH, should be administered immediately. Dantrolene binds to ryanodine receptors (RYR1) and inhibits SR calcium release, thereby reversing skeletal muscle hypermetabolism.1-5 Dantrolene is

administered as a loading bolus of 2.5 mg/kg intravenously via large-bore IV access. If the patient does not respond to the first dose within minutes, subsequent bolus doses of 2.5 mg/kg should be administered until the signs of acute MH have abated.25 Some patients, especially muscular males, may require initial dantrolene doses approaching 10 mg/kg, and some case reports have described necessary doses of approximately 40 mg/kg.26 If a response does not occur after repeated dantrolene administration, alternative diagnoses should be considered.

Dantrolene is supplied as a lyophilized powder (20 mg) in a vial that also contains 3 g of mannitol and sodium hydroxide to maintain pH of 9.0 to 10. The powder should be mixed with sterile water. The older formulation of dan-trolene did not dissolve readily27; a newer, rapidly mixing formulation that solubilizes much more readily (reconsti-tution time of 20 seconds) is available currently.28

Dantrolene generally is safe when administered at recommended dosages.29 It has no effect on cardiac or smooth muscle. Side effects include nausea, malaise, light-headedness, muscle weakness, and irritation and thrombosis at the IV site due to the high pH of the drug.30 Limb muscle weakness usually occurs. Respiratory muscle weakness may occur when large doses are used or when administered to patients with an underlying debility. Pul-monary edema has been described.30

Additional TreatmentSimultaneous to dantrolene administration, treatment

to address the metabolic effects of MH should be initi-ated.1-5,25 The patient’s temperature should be monitored, and blood should be collected for assessment of elec-trolytes, acid–base status, CK, and coagulation parame-ters. Arterial or venous blood gases should be collected as needed until pH and potassium levels trend toward nor-mal values. An indwelling urinary catheter should be used to monitor urine color and volume.

Hyperkalemia is treated via standard measures (ie, cal-cium, bicarbonate, and insulin-glucose); lacking labora-tory confirmation, treatment should be initiated based on the presence of abnormal ECG waveforms (ie, peaked T-waves) to prevent the development of life-threatening arrhythmias or cardiac arrest.1-5,18 Persistent metabolic aci-dosis can be treated with repeated doses of sodium bicar-bonate, 1 to 2 mEq/kg.1-5,25

Cooling measures should be instituted to maintain patient temperature at below approximately 38.5ºC (101.3ºF).1-5,25 This can be achieved by uncovering the patient; decreasing ambient temperature; using cool-ing blankets, ice packs, IV infusion of cooled saline or ice saline lavage via nasogastric tube; or wound irrigation. Care should be taken not to overcool the patient.

Although cardiac arrhythmia generally abates when acidosis and hyperkalemia are brought under control, it may persist. In such cases, standard antiarrhythmic agents can be used, but calcium channel blockers are contraindi-cated because they can worsen the hyperkalemic condi-tion and lead to cardiac collapse.1-5,25

Transfer to an acute care facility should be initiated at any point at which these recommended interventions exceed the capacity of the treatment facility (eg, ambu-latory surgical center).7 Patient comfort should be main-tained with the administration of sedative–hypnotics.

Ongoing CareFollowing initial control of the hypermetabolic event,

the patient should be transferred to the intensive care unit (or to an acute care facility if not already done) for ongoing monitoring, mechanical ventilation, and treat-ment.7 Because the anesthesiologist may have the most experience and training with the treatment of MH, his or her ongoing participation in the care of the patient is recommended.

CK and renal function (serum creatine) should be mon-itored, and urine output maintained at 1 to 2 mL/kg per hour until the urine color returns to normal and CK begins to decrease. Peak CK levels occur 14 to 48 hours after the MH crisis. Diuretics and IV bicarbonate may be used to reduce the risk for myoglobin-induced renal failure; consul-tation with a nephrologist may be helpful.1-5,25

Because recurrence occurs in up to 20% of patients after initial treatment,12 maintenance doses of dantrolene (1 mg/kg every 6 hours) should continue for 24 to 48 hours after the last observed sign of acute MH.1-5,25 If recurrent signs appear despite ongoing treatment, additional dan-trolene boluses may be required. Alternatively, a dantrolene infusion (0.25 mg/kg per hour) can be used.25

Post-Recovery ManagementFollowing recovery from an acute MH event, patients

should be advised to avoid MH-triggering agents and inform future anesthesia providers and emergency response personnel of their susceptibility.1-5,25 A letter from the anesthesia professional who supervised the initial inci-dent should be sent to the patient, and the patient should be instructed to give a copy to all future anesthesia provid-ers. An additional copy should be placed in the patient’s medical record for future reference. A medical alert brace-let, which can be obtained through MHAUS, also may be indicated. Because MH susceptibility is genetic, health care professionals should inform family members of the event to allow them to seek advice from their personal physicians regarding further evaluation or the potential need to avoid triggering agents.

• Notify surgeon, get help, get dantrolene

• Discontinue triggering agents • Hyperventilate with 100% oxygen

• Dantrolene sodium for injection 2.5 mg/kg, rapid IV

• Repeat if necessary

• Treat metabolic acidosis, hyperkalemia: insulin, glucose, bicarbonate, calcium (arrhythmia usually responds to treatment of acidosis, hyperkalemia)

Cool the patient Follow: ETCO2, electrolytes, blood gases, CK, serum myoglobin, core temperature, urine output, coagulation studies

Figure 1. Emergency therapy for malignant hyperthermia.

CK, creatine kinase; ETCO2, end-tidal carbon dioxide; IV, intravenousAdapted from reference 25.



All patients with a clinical event suspicious for MH should be referred to a Malignant Hyperthermia Testing Center for further evaluation and consult the MHAUS Web site for additional information. The testing center may recommend testing the patient and family members for MH susceptibil-ity. The gold standard is the caffeine-halothane contracture test, which requires a muscle biopsy.2-5 However, in North America, testing is performed only at a few centers and is expensive. In lieu of contracture testing, some patients with suspected MH susceptibility opt for molecular genetic test-ing or simply consider themselves (and their family mem-bers) MH-susceptible. However, because current genetic testing evaluates only a relatively small percentage of pos-sible mutations, its overall sensitivity is low, and a negative genetic test does not rule out underlying MH susceptibility.

Transfer of Care ConsiderationsMHAUS recently issued recommendations for the trans-

fer of a patient with suspected MH from an ambulatory sur-gery center (ASC) to an acute care facility (Figure 2).7,8 This

is critical for the patient’s well-being. In general, decisions about the timing and mode of transport should be made by ASC clinicians and take into account the patient’s condition, capabilities of the ASC, capabilities of the transport services, and time needed to arrive at an acute care facility.

Because successful treatment for MH requires imme-diate action, it is preferable that immediate treatment and control of the hypermetabolic event be achieved on-site (eg, ETCO2 declining or normal, heart rate stable or decreasing, no ominous cardiac dysrhythmias, IV dan-trolene administration begun, temperature declining, muscular rigidity resolving). However, it will not always be possible for all the indicators of stability to be pres-ent before transfer. For the rapidly deteriorating patient, immediate transfer to a sophisticated facility that is pre-pared to treat MH may be the wisest course of action.

The anesthesiologist may have the most experience and training with the treatment of MH and should continue to participate in care of the patient in the ASC, during trans-port, and/or at the receiving facility. Procedures for transfer

should be formulated ahead of time (eg, admission to the emergency department or direct admission to the ICU); physician-to-physician communication is optimal. The nurse may play an important role by facilitating the trans-fer and supporting family members.

ReportingAll MH events or suspected MH events should be

reported to the North American Malignant Hyperthermia Registry (http://www.mhaus.org/malignant-hyperthermia-registry) which was established to acquire, analyze, and disseminate patient-specific clinical and laboratory infor-mation to scientific investigators and physicians caring for MH-susceptible patients. Data also are used in research on the epidemiology, diagnosis, and treatment of MH.

Prevention and Preparedness

An y facility that uses MH-triggering agents should be prepared to detect and manage an episode of MH. This includes established protocols for treatment and/or trans-fer, availability of appropriate drugs and equipment (MH kits, emergency carts), and the presence of personnel who are educated and trained in the detection, treatment, and prevention of MH episodes. MHAUS provides resources for such training, including brochures, posters, and multime-dia resources for training and drills (Table 2).31

Prevention of MH episodes also is critical. It is not practi-cal or feasible to screen for MH susceptibility using biopsy or genetic testing in an individual without a personal or family history of MH susceptibility or a previous MH epi-sode, but the preanesthesia evaluation and preoperative nursing assessment should assess for a personal or family history of MH susceptibility.4,5,32 Most patients with under-lying MH susceptibility will not be aware of it, however; because MH has variable penetrance, previous uneventful anesthesia does not exclude MH susceptibility.

Patients with known or suspected MH should not receive triggering agents but instead should be safely anesthetized using nontriggering agents or local or regional anesthe-sia.4,5,32 Pretreatment with dantrolene is not recommended. In addition, the anesthesia provider should prepare the anesthesia machine and ensure that the patient will not be exposed to trace anesthetic gases. Measures include flush-ing the anesthesia machine with high-flow oxygen (at least 10 L per minute) for 20 minutes, and removing or placing tape over the vaporizer canisters to avoid accidental admin-istration.4,5,32 For older machines with copper tubing, the reservoir bag should be attached to the distal end of the ventilator circuit Y-piece with at least 5 ventilator cycles per minute during the 20-minute flushing. Newer anesthesia workstations with plastic components may require more than 60 minutes to purge residual gases.4,5,32,33 Charcoal fil-ters inserted in the breathing circuit have been shown to reduce the residual anesthetic concentration in the breath-ing circuit quickly.33 Practitioners should consult manu-facturer information in regard to the optimal manner for preparing specific equipment.

All facilities at which general anesthesia is administered should have adequate stocks of dantrolene in the event that MH occurs. Because of the increasing prevalence of obesity and uncertainty regarding the required dosing (actual body weight vs ideal body weight) for effective relief of MH, MHAUS recommends that at least 36 vials be available at all times.25,31 However, it should be noted that 75 vials (20 mg per vial) would be required in the theoreti-cal instance of an obese patient (150 kg) requiring a dan-trolene dose of 10 mg/kg.

Conclusions

MH is a serious and potentially life-threatening hyper-metabolic condition involving abnormal release of calcium within skeletal muscle cells in response to a

Table 2. Components of MH Treatment Kit/Emergency Cart

Drugs • Dantrolene, 36 vials• Sterile water for injection USP, without bacteriostatic agent, stored in glass vials (not bags)

to avoid accidental IV administration - Reconstitute each vial of dantrolene by adding 60 mL, shake until solution is clear - Drug must reach skeletal muscle

• Sodium bicarbonate 8.4%, 50 mL × 5• Furosemide 40 mg × 4• Dextrose 50%, 50-mL vials × 2• Calcium chloride 10%, 10 mL × 2• Regular insulin 100 units/mL × 1, refrigerated• Lidocaine for injection, 100 mg/5 mL or 100 mg/10 mL in preloaded syringes × 3

- Amiodarone also acceptable - Do not give lidocaine or procainamide if wide-QRS complex arrhythmia likely due to hyperkalemia; may result in asystole

General equipment

• Syringes 60 mL × 5 to dilute dantrolene• Mini-Spike® IV additive pins × 2, Multi-Ad fluid transfer sets × 2 to reconstitute dantrolene• IV catheters for venous and arterial access• NG tubes• Toomy irrigation syringes 60 mL × 2 with adapter for NG irrigation• IV pump tubing

Monitoring equipment

• Esophageal or other core temperature probes - Nasopharyngeal, tympanic membrane, rectal, bladder, pulmonary artery catheter

• CVP kits• Transducer kits for arterial and central venous cannulation

Nursing supplies • ≥3,000 mL refrigerated cold saline solution for IV cooling• Large sterile steri-drape• Urine meter × 1• Irrigation tray with piston syringe, 60 mL, for irrigation• Large clear plastic bags for ice × 4• Small plastic bags for ice × 4• Bucket for ice• Test strips for urine analysis

Laboratory test-ing supplies

• Syringes or kits for blood gas analysis × 6• Blood specimen tubes × 2 per test

- CK, myoglobin, electrolytes, chemistries (LDH, thyroid) - PT/PTT, fibrinogen, D-Dimer - CBC, platelets - Blood gas syringe (lactic acid level)

› If no immediate laboratory analysis available, keep samples on ice for later analysis; may prove useful on retrospective review, diagnosis

› Include blood cultures to rule out bacteremia• Urine collection container for urine myoglobin level.

CBC, complete blood count; CK, creatine kinase; CVP, central venous pressure; IV, intravenous; LDH, lactate dehydrogenase; NG, nasogastric; PT, prothrombin time; PTT, partial thromboplastin timeAdapted from reference 31.


triggering agent. It occurs in genetically susceptible indi-viduals. Successful diagnosis requires recognition of the constellation of symptoms in the right clinical con-text, and avoidance of catastrophic outcomes requires prompt discontinuation of triggering agents, adminis-tration of dantrolene, and therapy directed against the metabolic complications of the disorder. Transfer-of-care protocols are critical for patients who experience an MH episode in an ASC. A rapidly mixing formulation of dan-trolene became available in 2009. It is easier to prepare than the older formulation and should facilitate the care of patients with an MH episode.

References1. Collins CP, Beirne OR. J Oral Maxillofac Surg. 2003; 61(11): 1340-1305.

2. McCarthy EJ. AACN Clin Issues. 2004;15(2):231-237.

3. Litman RS, Rosenberg H. JAMA. 2005;293(23):2918-2924.

4. Hopkins PM. Curr Anaes Crit Care. 2008;19(1):22-33.

5. Rosenberg H, et al. In Pagon RA, et al, eds. GeneReviews [Inter-net]. Seattle, WA: University of Washington; 1993-2003, updated Jan 19,2010. http://www.ncbi.nlm.nih.gov/books/NBK1146. Accessed October 26, 2011.

6. Burden A, et al. Presented at: Annual Meeting of the American Society of Anesthesiologists; October 16-20, 2010; San Diego, CA. Abstract A384.

7. MHAUS. MHAUS transfer of care guidelines. http://medical.mhaus.org. Accessed October 1, 2011.

8. MHAUS. Malignant hyperthermia: new transfer guidelines. http://www.ascassociation.org/MHAUSTransferStory.pdf. Accessed October 1, 2011.

9. Brady JE, et al. Anesth Analg. 2009;109(4):1162-1166.

10. Brady JE, et al. Presented at: Annual Meeting of the American Society of Anesthesiologists; October 17-21, 2009; New Orleans, LA. Abstract A1521.

11. Denborough M. Lancet. 1998;352(9134):1131-1136.

12. Larach MG, et al. Anesth Analg. 2010;110(2):498-507.

13. Larach MG, et al. Anesthesiology. 2008;108(4):603-611.

14. Burkman JM, et al. Anesthesiology. 2007;106(5):901-906.

15. Denborough MA, et al. Br Med J (Clin Res Ed). 1984;288(6434):1878.

16. Huerta-Alardín AL, et al. Crit Care. 2005;9(2):158-169.

17. Rosero EB, et al. Anesthesiology. 2009;110(1):89-94.

18. Groom L, et al. Anesthesiology. 2011;115(5):938-945.

19. Tobin JR, et al. JAMA. 2001;286:168-169.

20. Li G, et al. Ped Anesth. 2011;21:958-963.

21. MHAUS. www.mhaus.org. Accessed October 21, 2011.

22. Glahn KP, et al. Br J Anaesth. 2010;105(4):417-420.

23. van der Spek AF, et al. Anesthesiology. 1987;67:459-465.

24. Sessler D. Anesthesiology. 2008;109(2):318-338.

25. MHAUS. Emergency therapy for MH. http://www.mhaus.org/malignant-hyperthermia-healthcare-professionals. Accessed October 1, 2011.

26. Blank JW, et al. J Clin Anesth. 1993;5(1):69-72.

27. Mitchell LW, et al. Can J Anaesth. 2003;50(2):127-130.

28. JHP Pharmaceuticals. Dantrium IV Frequently asked questions. http://www.dantrium.com/faq.php. Accessed October 1, 2011.

29. Dantrium (dantrolene sodium for injection) [prescribing informa-tion]. Rochester, MN: JHP Pharmaceuticals; 2008.

30. Brandom BW, et al. Anesth Analg. 2011;112(5):1115-1123.

31. MHAUS. Stocking the MH cart. http://www.mhaus.org/ malignant-hyperthermia-healthcare-professionals/mhaus-faqs-healthcare-professionals/stocking-mh-cart/. Accessed October 1, 2011.

32. Wappler F. Curr Opin Anaesthesiol. 2010;23(3):417-422.

33. Gunter JB. Anesth Analg. 2008;107(6):1936-1945.

ResourcesAssociation of pero-Operative Nurses: http://www.aorn.org/Education/ConfidenceBasedLearning/MalignantHyperthermia/

American Association of Nurse Anesthetists: http://www.aana.com/uploadedfiles/resources/practice_documents/stds_officebasedanesth.pdf

American Society of Anesthesiologists: http://www.asahq.org/Knowledge-Base/Diseases-and-Conditions/ASA/Malignant-Hyperthermia-Syndrome-From-Barnyard-to-Molecular-Genetics-Laboratory.aspx

CME Post-Test1. Which of the following therapeutic agents is

contraindicated in the context of an acute episode of malignant hyperthermia (MH)?a. Amiodaroneb. Verapamilc. Furosemided. Sodium bicarbonate

2. Which of the following is the earliest and most reliable sign of an acute episode of MH?a. Hyperthermiab. Elevation in end-tidal CO2 (ETCO2)c. Increased serum creatine kinased. Cardiac arrhythmias

3. Which of the following agents represents a potential triggering agent in patients with susceptibility to MH?a. Sevofluraneb. Midazolamc. Fentanyld. Propofol

4. Which of the following tissues is involved in the pathophysiology of MH?a. Smooth muscleb. Cardiac musclec. Skeletal muscled. Endothelial cells

5. Which of the following is most likely a potential complication of an episode of MH?a. Peripheral neuropathyb. Central pontine myelinolysisc. Pericarditisd. Rhabdomyolysis

6. How many vials of dantrolene does the Malignant Hypothermia Association of the United States recommend should be readily available?a. 3b. 10c. 16d. 36

7. Which of the following represents a major advantage of a newer formulation of dantrolene over the previous formulation?a. Easier to reconstituteb. More potentc. Less expensived. Longer shelf-life

8. MH-triggering agents are contraindicated in which of the following patients?a. Patients with a personal history of an MH episodeb. Patients with a history of MH in a first-degree relativec. Patients with a positive halothane-caffeine contracture

studyd. All of the above

9. Which of the following preventative measures is recommended in an MH-susceptible patient who requires general anesthesia?a. Purging equipment and breathing circuit of volatile

anestheticsb. Prophylactic dantrolene administrationc. Induction of intraoperative hypothermiad. Prophylactic administration of potassium-binding resins

10. Which of the following is true regarding MH-susceptibility testing?a. All patients anticipating surgery with general anesthesia

should undergo susceptibility testingb. The caffeine-halothane contracture test is expensive and

available only at certain centersc. Negative genetic testing essentially rules out a diagnosis

of MH susceptibilityd. All of the above

1 Recognize suspected MH• Discontinue

triggering agents, begin treatment

• Initiate established emergency MH transfer plan

4 Debrief, evaluate transfer plan

3 Implement transfer plan• Notify receiving

health care facility

• Establish continu-ous communication among transfer team members, receiving health care facility, MH hotline

• Nursing profession-als facilitate commu-nication with family, support system

2 Adapt established transfer plan based on real-time assessment• Capabilities of

available profes-sionals at receiving health care facility

• Clinical information, best interests of patient

• Transfer team capabilities

Figure 2. MHAUS recommendations for transfer of care in MH.

MH, malignant hyperthermia; MHAUS, Malignant Hyperthermia Association of the United StatesAdapted from references 7 and 8.



Answer Sheet and Evaluation Form

Malignant Hyperthermia: Diagnosis, Treatment, and Prevention

Release Date: December 1, 2011 Expiration Date: December 1, 2013

Participate online at: CMEZone.com Type IP112 in the keyword field (availability may be delayed from print date).Or fax to: (904) 683-3803

Or mail to: AKH Inc. Advancing Knowledge in HealthcarePO Box 2187 Orange Park, FL 32067-2187

Participant Information (please print) First Name: Last Name: Degree:

Address:

City: State: ZIP:

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License #: State of Licensure:

� Physician I am claiming AMA PRA Category 1 Credit™

� Other (specify):

Post-Test Answer Section

Please circle the correct answer for each question. (A score of at least 70% is required to receive credit.)

1. a b c d 6. a b c d

2. a b c d 7. a b c d

3. a b c d 8. a b c d

4. a b c d 9. a b c d

5. a b c d 10. a b c d

Evaluation QuestionsPlease answer the following questions by circling the appropriate rating. Strongly Agree Agree Disagree Strongly Disagree

1. After participating in this activity, I am better prepared to:

a. Discuss the pathophysiology of MH. 4 3 2 1

b. Describe the characteristic clinical findings that identify an MH crisis. 4 3 2 1

c. Identify all supplies required to manage an MH crisis. 4 3 2 1

d. Discuss, in order, the appropriate steps that must be taken to manage an MH crisis. 4 3 2 1

e. Discuss preventive measures required to provide safe care to patients who are susceptible to MH. 4 3 2 1

2. The activity met my educational needs. 4 3 2 1

3. The faculty were knowledgeable and effective in the presentation of content. 4 3 2 1

4. The teaching method and educational materials were effective. 4 3 2 1

5. The learning activities were effective and incorporated active learning methods. 4 3 2 1

6. The post-test accurately assessed learning. 4 3 2 1

7. The content was objective, current, scientifically based, and free of commercial bias.

� Yes � No (please explain):

8. Based on the information presented in this activity, I will � do nothing, as the content was not convincing. � seek additional information on this topic. � change my practice. � do nothing, as current practice reflects the program’s recommendations.

9. The most important concept learned during this activity that may effect a change in patient care is:

10. What issue(s) related to the therapeutic area discussed in this activity, or other topics, would you like addressed in future continuing education?

11. Additional comments:

IP11

2


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The SmartBlock Pain Pump, From AmbuQ: What are the expected consistency rates of the SmartBlock pain pump?

A: The unique design of the Ambu SmartReg allows the SmartBlock pain pump to deliver medication to the patient at a consistent rate of at least 5%. The smart pump relies on an active restriction of pressure, unlike the market standard, which relies on the passive restriction of the pressure created by the reser-voir. The flow rates of the Smart-Block pain pump are among the most consistent for any disposable elastomeric pump. Because of the consistency of the pump, clinicians may require less interaction, such as the need for a bolus shot, with patients.

Q: What safety features separate the SmartBlock pain pump from other products in this market?

A: All Ambu SmartBlock pumps include, as a standard feature, a locking carrying bag and combina-tion lock to restrict patients from tampering with the pump. The SmartReg also has a permanent locking feature to create a fixed flow rate. However, our unique locking key feature, the LockGuard, enables the flow rate to be secured in place or adjusted to meet the patient’s pain needs.

Q: Can the SmartBlock pump save money?

A: A unique feature of the Ambu SmartBlock pump is that the reser-voir can be filled to any volume from 50 to 650 mL. Also, the SmartBlock is available with a variable rate reg-ulator of 1 to 6 mL per hour or 5 to 15 mL per hour. With the combina-tion of this built-in customization, along with a consistent flow rate of at least 5%, the Ambu SmartBlock offers better control of medication delivery and reduces the amount of inventory and skews needed by your facility.

Q: Is the SmartBlock pain pump latex- and silicon-free?

A: Ambu SmartBlock pain pumps are completely latex- and silicon-free. The Ambu SmartBlock pump does not rely on elastomeric rubber to control the flow rate of the med-ication to the patient. Instead, the SmartBlock uses a patented dual-chamber regulating device to offer

the most consistent flow rates in a disposable pump.

Q: Why is it important that the flow rates not be controlled by pressure from the elastomeric reservoir?A: Other pumps are affected by external forces such as volume changes in the reservoir, additional

pressure being applied on the res-ervoir or improperly filled reservoirs. Because our flow rates are regu-lated by the SmartReg and not the reservoir, pressure generated by a patient rolling onto the bag or sud-den changes to reservoir volumes will not affect flow rates. Even under such conditions, the Ambu Smart-Block pump will continue to deliver at a rate of within 5%.

Case Study: Anesthetic Implications in the Management Of a Patient With Cowden Syndrome

A 39-year-old woman pre-sented for reconstructive sur-gery of her left breast. The

patient had a medical history signifi-cant for Cowden syndrome, obesity (body mass index, 48.3 kg/m2), poly-cystic ovary syndrome, thyroid carci-noma, and depression. Past surgeries included a thyroidectomy and multiple procedures on her breasts. She had a Mallampati score of 3, intact craniocer-vical movement, and adequate mouth opening with history of wide range of intubations.

PathologyCowden syndrome, or multiple

hamartoma syndrome, is a rare autoso-mal dominant condition from a muta-tion in the PTEN tumor suppressor gene. Cowden syndrome causes muco-cutaneous lesions and neoplasms in the mucosa of the gastrointestinal tract, central nervous system and genitouri-nary system. Nearly all patients have hamartomas of the skin. Although most features of Cowden syndrome are physical, some patients also experience autism and mental retardation.

Anesthetic ConcernsThe anesthetic management of a

patient with Cowden syndrome pres-ents many potential challenges. Men-tal retardation can affect patient cooperation, and anxiolytics are used during induction. Airway manage-ment is of vital importance in these patients, as they often can have mac-rocephaly, hypoplastic maxilla with a high arched palate, hypoplastic man-dible and thyroid tumors. Clinicians also must be careful with papilloma-tosis at the base of the tongue that warrants an awake fiber-optic intu-bation. Avoidance of neuromuscular

blockade until the airway has been secured is advisable, especially in patients with dysmorphism in the maxilla and mandible. Thyroid dys-function is common in patients with Cowden syndrome; thus, thyroid function tests should be obtained before surgery.

SurgeryFollowing intubation, surgery lasted

approximately five hours with no com-plications. The left breast was recon-structed with a latissimus dorsi flap.

tAfter proper positioning and IV access were secured, 4 mg of mid-azolam was administered. Rapid

sequence induction was initiated with propofol (1.2 mg/kg) and succinyl-choline (0.7 mg/kg). Video-assisted laryngoscopy was accomplished with a grade II view, and a 7.0-mm standard endotracheal tube (ETT) was placed without difficulty.


PRN

see Cowden page 27

Figure. Hamartomas characteristic of Cowden syndrome.

Source: Marcio A Oliveira et al.

©2011 Centurion Medical Products Corporation 800-248-4058 | www.cvcbundle.com

Institute for Healthcare Improvement, 5 Million LivesCampaign, “Prevent Central Line Infections: How-to Guide”

Centers for Disease Control and Prevention, “Guidelinesfor the Prevention of Intravascular Catheter-RelatedInfections, 2011”

The Joint Commission, “Accreditation Program: Hospital National Patient Safety Goals,” Effective January 1, 2011

CENTRAL LINE BLOODSTREAM INFECTIONS ARE PREVENTABLERecent studies have concluded proper techniques,protocol and bundling can successfully prevent Central Line Associated Bloodstream Infections (CLABSIs).

A major part of this success lies in the componentsand structure of the Bundle. As a nationally-recognized provider of custom trays, Centurion is uniquely qualifi edto supply every component your team may needto help you implement a CLABSI prevention strategy.

No other company can offer you as many choices forfull-body drapes, gowns and masks. We will customizeyour checklist to your exact protocol. We offer a uniquepre-fi lled sterile-fi eld-ready syringe as well as ourpatented SorbaView® Dressings and Shield Securement. And we can wrap the entire kit around your choice ofVantex or Multi-Med central line catheters, or AVAHigh Flow Introducers by Edwards LifeSciences.

Centurion Medical Products is the only CVCprovider that can build you a COMPLETE Bundle.

CENTURION® CENTRAL LINE BUNDLE SOLUTION – EVERYTHING YOU NEED TO STOP CLABSIs


Centurion The following advertorial is provided as a service to our valued advertisers.It is designed to support the advertisement presented below.

©2011 Centurion Medical Products Corporation 800-248-4058 | www.cvcbundle.com

Institute for Healthcare Improvement, 5 Million LivesCampaign, “Prevent Central Line Infections: How-to Guide”

Centers for Disease Control and Prevention, “Guidelinesfor the Prevention of Intravascular Catheter-RelatedInfections, 2011”

The Joint Commission, “Accreditation Program: Hospital National Patient Safety Goals,” Effective January 1, 2011

CENTRAL LINE BLOODSTREAM INFECTIONS ARE PREVENTABLERecent studies have concluded proper techniques,protocol and bundling can successfully prevent Central Line Associated Bloodstream Infections (CLABSIs).

A major part of this success lies in the componentsand structure of the Bundle. As a nationally-recognized provider of custom trays, Centurion is uniquely qualifi edto supply every component your team may needto help you implement a CLABSI prevention strategy.

No other company can offer you as many choices forfull-body drapes, gowns and masks. We will customizeyour checklist to your exact protocol. We offer a uniquepre-fi lled sterile-fi eld-ready syringe as well as ourpatented SorbaView® Dressings and Shield Securement. And we can wrap the entire kit around your choice ofVantex or Multi-Med central line catheters, or AVAHigh Flow Introducers by Edwards LifeSciences.

Centurion Medical Products is the only CVCprovider that can build you a COMPLETE Bundle.

CENTURION® CENTRAL LINE BUNDLE SOLUTION – EVERYTHING YOU NEED TO STOP CLABSIs


Centurion CVC Bundle Q: What is a central-line bloodstream infection?A: In the United States, an estimated 248,000 central line–associated bloodstream infections (CLABSIs) occur each year. CLABSIs are associ-ated with high mortality rates (12%-25%) and extended hospital stays, requiring patients to spend an estimated nine to 12 additional days in a hospital. According to the Centers for Disease Control and Prevention (CDC), the cost of treat-ing a single episode of CLABSI can range from $34,500 to $56,000.

Q: Are CLABSIs preventable?A: CLABSIs are preventable; in fact, they are called “never events” precisely because they are avoidable complications of patient care. Recent studies have concluded proper techniques, proto-col and bundling can successfully prevent CLAB-SIs. Bundling is the key. According to every major agency—the CDC, the Joint Commission, the Occupational Safety and Health Administration and the Institute for Healthcare Improvement—following a comprehensive prevention strategy reduces CLABSIs.

Q: What are the basic interventions of the bundle?A: According to the CDC, “Guidelines for the Pre-vention of Intravascular Catheter-Related Infec-tions, 2011,” a bundle includes:

Hand hygiene; maximal barrier precautions at insertion, including cap, mask, gloves and full-body sterile drape; chlorhexidine skin asep-sis; optimal catheter site selection; daily review of the necessity of a line with prompt removal of unnecessary lines; and a checklist to support the standardized protocol.

Q: What are the differences between your CVC kit and a Centurion CVC bundle?A: A kit includes items for certain aspects of a procedure such as site preparation, line inser-tion or site protection. A bundle contains every-thing needed for the entire procedure, from “prep to dressing.” That’s why Centurion’s CVC bundle saves time, minimizes waste, maximizes savings and ensures procedural excellence.

Q: Why is Centurion’s CVC bundle the ultimate central-line bundle solution?A: Centurion Medical Products is uniquely qual-ified to help you implement a prevention strat-egy by constructing a customized CVC bundle to match your team’s needs exactly, with every com-ponent needed to maximize efficiency and effec-tiveness in reducing CLABSIs.

Q: What components are available in a Centurion CVC bundle?A: The components are: • Protective gear—Centurion offers a full line

of maximum barrier protective gear for one or more users from gown, gloves and masks to bouffants and caps.

• Full-body drapes—Using full-body drapes is key to creating maximal sterile barrier pro-tection. In addition to a large variety of stock drapes, Centurion can customize a drape to suit your specific procedure.

• Edwards catheters—Choose from pressure injectable, anti-microbial, multi-lumen Van-tex and Multi-Med catheters or IntroFlex and High-Flow advanced venous access introducer catheters.

• Prefilled syringes—Exclusively from Centurion, sodium chloride in sterilized, prefilled syringes packaged within your procedure tray. Choose from single, double or triple syringe foil packs to meet your specific needs.

• SorbaView shield—The patented SorbaView® SHIELD is a one-step catheter securement sys-tem that combines the features and benefits of a SorbaView® dressing with SHIELD Technol-ogy that eliminates the need for a secondary securement device.

• SorbaView Ultimate IJ dressing system—Par-ticularly suited for multi-lumen and introducer catheters placed on the neck, the SorbaView Ultimate IJ dressing system with tubing anchor stays intact and stable for extended periods.

• SnagFree needle holders—Centurion Snag-Free® instruments feature a patented hinge design that prevents sutures from catching.

• Hospital forms and patient/family education materials—Customized procedural checklists, labels, signs and forms can be built into trays to meet Joint Commission goals for patient safety and ensure proper protocol.

• Additional items—Safety components, Chlora-Prep applicators, Biopatch, sterile labels, ultra-sound gel and probe covers, needle-free valves and saline/heparin/lidocaine solutions.

Centurion Medical Products 301 Catrell Dr.Howell, MI 48843800-248-4058www.centurionmp.com

ECG Cables Are Common Source of Contaminants in OR

C urrent sterilization protocols may be ineffective in eliminat-ing pathogenic microorgan-

isms from operating room equipment, French researchers have found.

Investigators found that 34% of the 50 sets of electrocardiograph (ECG) cables they examined tested positive for a host of bacteria and fungi. The results were presented at the 2011

annual meeting of the American Soci-ety of Anesthesiologists (abstract 1111).

The findings are consistent with other research suggesting that some nosocomial infections can be traced back to contaminated OR equipment, said Nancy Nussmeier, MD, profes-sor of anesthesiology at the State Uni-versity of New York Upstate Medical

University, in Syracuse, who was not involved in the study. “There is a grow-ing concern that resistant organisms are emerging in the OR, and these authors should be congratulated for pointing out important—and often overlooked—potential sources of patient infection,” Dr. Nussmeier told Anesthesiology News. “This study sup-ports other literature suggesting the

need for more rigorous decon-tamination of reus-able equipment that comes into direct con-tact with patients in every oper-ating room.”

In previous research, up to 75% of laryngoscope handles were found to be con-taminated with bacteria (e.g., Anesth Analg 2009;109:479-483). However, the full extent of cross-contamination of OR equipment is not known.

In the current study, lead investi-gator Brice Samyn, MD, staff anes-thesiologist at Strasbourg University Hospital, and several colleagues preop-eratively collected swab samples from ECG cables used during 50 procedures in the OR. The cables were swabbed after ostensibly having been disinfected with a 0.25% quaternary ammonium solution, according to protocol. Each set of swab samples was tested for both bacterial and mycological contami-nants. The OR staff was unaware that the ECG cables were being tested for potential contaminants.

Seventeen of the 50 sets of cables tested positive for bacteria or fungi (Table). The microorganisms most commonly found were coagulase-neg-ative Staphylococcus aureus, methicil-lin-sensitive S. aureus, Staphylococcus epidermis, several species of the genus Bacillus, Aspergillus fumigatus and, in some cases, Enterococcus faecalis. Con-taminated cables largely originated from ORs where gastrointestinal and gynecologic surgeries had been performed.

Co-investigator Pierre Diemunsch, MD, PhD, chief of the Department of Anesthesia at Strasbourg University

Table. ECG Cable Contamination Findings by Specialty

Samples by OR Specialty, n=50

Negative Samples, n=33 (68%) Positive Samples, n=17 (34%)

Digestive, n=34 20 1 methicillin-sensitive Staphylococcus aureus8 coagulase-negative staphylococci2 coagulase-negative staphylococci + Bacillus sp.2 Bacillus sp.1 Aspergillus fumigatus

Gynecologic, n=12 10 2 coagulase-negative staphylococci

ENT, n=1 – 1 coagulase-negative staphylococci

Other, n=3 3 –

ECG, electrocardiograph; ENT, ear, nose and throat; OR, operating room


PRN

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Hospital, said it is not clear whether the pathogens they found are affect-

ing patient safety. “Fortunately, none of our patients has developed infec-tions that can clearly be related to this cross-contamination issue,” Dr. Diemunsch told Anesthesiol-ogy News. “However, we also did not look for this etiology.”

Dr. Diemunsch suspected one rea-son for the high contamination rates might be poor adherence to oth-erwise effective decontamination protocols.

“It seems to be that after a while, the OR personnel no longer follow the rules,” he said. However, he stopped short of attributing the problem of contaminated equipment entirely to poor protocol adherence, adding that cables that had been in use for more than six months tended to be more contaminated than newer cables. He speculated that equipment becomes more porous over time and surfaces therefore become more adherent.

Dr. Diemunsch’s group currently is examining rates of cross-contamina-tion in finger pulse oximeter sensors and noninvasive blood pressure cuffs in the OR.

—David Wild

An arterial line was placed on the patient’s right radial position. The patient was maintained on desflurane and an infusion of remi-fentanil (0.1 mcg/kg per minute) for the case. Reversal of neuromus-cular blockade was achieved with neostigmine (3 mg) and glycopyr-rolate (0.6 mg), and the ETT was removed following extubation cri-teria. The patient was discharged

with an uneventful postoperative period and returned subsequently for additional planned procedures.

Suggested Reading1. Lloyd KM II, Dennis M. Cowden’s disease. A

possible new symptoms complex with multiple involvement. Ann Intern Med. 1963;58:136-142.

2. Shiraishi N, Nakamura T, Saito H, Ogawa S, Suzuki H. Anesthetic management of a patient with Cowden syndrome. Masui. 1995;44(2):282-285.

3. Pilarski R. Cowden syndrome: a critical review of the clinical literature. J Genet Couns. 2009;18(1):13-27.

4. To EW, Tsang WM, Pak MW, Cheng JH, Tse GM, van Hasselt CA. Cowden’s disease with vocal fold involvement. Ear Nose Throat J. 2001;80(10)754-756.

5. Omote K, Kawamata T, Imaizumi H, Namiki A. Case of Cowden’s disease that caused airway obstruction during induction of anesthesia. Anesthesiology. 1999;91(5):1537-1540.

Anoushka Afonso, MD Larry Hausman, MD

Department of Anesthesia Mount Sinai School of Medicine

New York, New York

Table. ECG Cable Contamination Findings by Specialty

Samples by OR Specialty, n=50

Negative Samples, n=33 (68%) Positive Samples, n=17 (34%)

Digestive, n=34 20 1 methicillin-sensitive Staphylococcus aureus8 coagulase-negative staphylococci2 coagulase-negative staphylococci + Bacillus sp.2 Bacillus sp.1 Aspergillus fumigatus

Gynecologic, n=12 10 2 coagulase-negative staphylococci

ENT, n=1 – 1 coagulase-negative staphylococci

Other, n=3 3 –

ECG, electrocardiograph; ENT, ear, nose and throat; OR, operating room


‘There is a growing concern

that resistant organisms are

emerging in the OR, and

these authors should be

congratulated for pointing

out important—and often

overlooked—potential

sources of patient infection.’

—Nancy Nussmeier, MD

PRN

cowden continued from page 24

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shiraishi N%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nakamura T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Saito H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ogawa S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Suzuki H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22To EW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tsang WM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Pak MW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Cheng JH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tse GM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22van Hasselt CA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Omote K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kawamata T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Imaizumi H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Namiki A%22%5BAuthor%5D

Prostate Cases Taking More of the Anesthesia WorkdayI f you feel like you’re spending more time on pros-

tate surgery cases, there’s a reason: Diagnosis of prostate cancer has surged in recent years, as has the number of prostatectomy procedures to remove the diseased glands, new research shows. Steven Roth, MD, professor of anesthesia and critical care at the University of Chicago, used diagnostic coding to chart the trends (Figures 1 and 2), which he said likely reflect the growing acceptance of robotic-assisted surgery in prostate cancer cases.

“Laparoscopic techniques offer faster recovery at lower cost and anesthesiologists can expect to be performing more of these procedures in the future,” stated Dr. Roth, who presented his findings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 715).

Survey: Multimodal Analgesia UnderusedD espite 2004 recommendations from the Amer-

ican Society of Anesthesiologists, clinicians haven’t fully embraced multimodal analgesia for the management of perioperative pain. That’s accord-ing to a recent survey by researchers at Thomas

Jefferson University, who queried anesthesiologists, nurse anesthetists and other OR-based providers and administrators about the use of multimodal analge-sia at their institutions. Fewer than 25% of physicians surveyed said they used more than two nonopioid

drugs to control pain perioperatively, the researchers found, while 75% said they administered acetamin-ophen preoperatively in less than 25% of cases. For the full range of responses, see the Table below. The findings were presented at the 2011 annual meet-ing of the American Society of Anesthesiologists (abstract 1178).

—AN StaffTable. Behavioral Patterns Among Anesthesia Providers

Question Answer Anesthesiologist CRNA Other P value

1. Who in your facility makes the decision to use nonopioids/multimodal therapy to treat perioperative pain?

Anesthesiologist/CRNA 82.9% 90% 81% 0.063

Surgeon 17.1% 10% 19%

2. When you use a multimodal agent, how many nonopioid analgesics do you include?

1 43.9% 35% 47.6% 0.0432 34.1% 65% 47.6%>2 22% 0% 4.8%

3. How often do you administer nonopioids/multimodal therapy preoperatively?

<25% 41.5% 36.8% 68.2% 0.18325-50% 19.5% 26.3% 4.5%50-75% 24.4% 10.5% 13.6%>75% 14.6% 26.3% 13.6%

4. How often do you administer nonopioids/multimodal therapy postoperatively?

<25% 12.8% 20% 45.5% 0.06325-50% 30.8% 15% 27.3%50-75% 30.8% 30% 9.1%>75% 25.6% 35% 18.2%

5. How often do surgeons oppose the use of nonsteroidal anti-inflammatory drugs in your patients?

<25% 56.1% 68.4% 70% 0.34925-50% 36.6% 21.1% 25%50-75% 7.3% 10.5% 0%>75% 0% 0% 5%

6. How often do you administer nonsteroidal anti-inflammatory drugs preoperatively?

<25% 70.7% 65% 85.7% 0.31225-50% 14.6% 30% 4.8%50-75% 12.2% 5% 4.8%>75% 2.4% 0% 4.8%

7. How often do you administer gabapentinoids preoperatively?

<25% 82.9% 95% 88.2% 0.68125-50% 12.2% 5% 5.9%50-75% 4.9% 0% 5.9%>75% 0% 0% 0%

8. How often do you administer acetaminophen preoperatively?

<25% 75% 55% 88.2% 0.22725-50% 10% 25% 5.9%50-75% 12.5% 10% 0%>75% 2.5% 10% 5.9%

9. What is the most significant benefit that you achieve from employing a nonopioid/multimodal therapy?

Reduced opioid use 46.3% 40% 19% 0.484Decreased length of stay 9.8% 15% 19%Decreased postoperative nausea/vomiting 17.1% 20% 33.3%Increased patient satisfaction 26.8% 25% 28.6%

CRNA, certified registered nurse anesthetist


PRN

Figure 2. Total number of discharges for radical prostatectomy.(ICD-9-CM all-listed procedure code 60.5)

Figure 1. Total number of discharges for diagnosis of prostate cancer.(ICD-9-CM all-listed diagnosis code 185, malignant neoplastic prostate)

300

290

280

270

260

250

240

230

220

210

200

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

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l dis

char

ges,

thou

sand

s

90

80

70

60

50

40

30

20

10

0

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

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MCAN2022.indd 1 9/19/11 3:46 PM

30 ANESTHESIOLOGY NEWS • DECEMBER 2011

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Goal-directed Therapies for Positive Patient Outcomes:

Monitoring and Volume Replacement With 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride for Injection

IntroductionGoal-directed strategies for optimal patient assessment

and treatment are facilitated when practitioners use mini-mally invasive technologies, such as arterial pressure contour wave analysis and esophageal Doppler flow measurement, to assess perioperative fluid responsiveness in the hypoten-sive patient. Additionally, a more balanced approach to vol-ume replacement for patients undergoing surgeries with the potential for large intraoperative fluid shifts and blood loss—one that incorporates colloids for intravascular vol-ume expansion—has been advocated.1 Typically, colloid selection is based on multiple factors including availability, clinical experience, and cost. Albumin, a human-derived pro-tein, is commonly available and has been used as an effec-tive volume expander; however, albumin is more expensive when compared with crystalloid solutions.2 Its use also may be associated with a higher mortality rate in certain patient populations, such as traumatic brain injury, and it has been shown to be no more effective than less expensive colloids (eg, hydroxyethyl starch [HES] solutions).3,4

Use of HES solutions has increased during the last decade and represents an important addition to resusci-tation fluid management strategy. HES solutions carry the risk of anaphylactoid or hypersensitivity reactions with the most common adverse reactions including pruritus, elevated serum amylase, and hemodilution.5 Six percent HES 130/0.4 in 0.9% sodium chloride for injection has been accepted as an alternative to earlier HES solutions Hespan® (6% HES 600/0.75 in 0.9% sodium chloride for injection; B. Braun) and Hextend® (6% HES 670/0.75 in lactated electrolyte for injection; Hospira). Compared with earlier HES solutions, HES 130/0.4 offers a lower mean molec-ular weight and molar substitution along with a higher C2/C6 ratio, allowing for similar intravascular expansion time with less plasma accumulation. Lower plasma accu-mulation is associated with less effect on coagulation and renal dysfunction. Lower molecular weight and lower molar substitution decrease the potential for coagulo-pathic side effects,6 due to reduced influence on factor VIII, von Willebrand factor, and ristocetin cofactor.7

A reduction in coagulopathic side effects is of particular importance for trauma patients as well as patients receiving larger total volumes of colloids. HES 130/0.4 is similar to the other starches in that it is contraindicated in patients receiv-ing dialysis treatment or in patients who have renal failure with oliguria or anuria not related to hypovolemia. In addi-tion, it should not be used in patients with intracranial bleed-ing.5 HES 130/0.4 also possesses a higher plasma clearance and lower elimination half-life when compared with older HES solutions.8 Even after repetitive doses, HES 130/0.4 accu-mulates less in plasma and tissues than older starches.7,9 HES 130/0.4 has 0.9% sodium chloride as the diluent solution and as such, it is contraindicated in patients with severe hyperna-tremia or severe hyperchloremia.5 These enhanced qualities increasingly have led practitioners to use HES 130/0.4 when volume expansion is necessary for a variety of surgical proce-dures or if immediate fluid responses are required.

Case Study 1: Use of HES 130/0.4 in a Colloid-Based, Goal-directed Approach to Volume Management in a Major Orthopedic Procedure

A 53-year-old woman with a history of osteoarthritis was scheduled for bilateral total hip replacements. The patient also had a history of myalgia/myositis and depression. Her prescription medications included clonazepam 2 mg, duloxetine 30 mg, and oxaprozin 1,200 mg each daily, as well as hydrocodone 10 mg/acetaminophen 325 mg (1 to 2 tablets every 6 hours) and morphine 60 mg every 8 hours. Additionally, she admitted daily marijuana use. She denied any drug allergies or complications from previous anes-thetic use for a cesarean delivery and tubal ligation per-formed in the 1980s. Her height and weight were 157 cm and 63 kg, respectively, with a body mass index of 26.

The patient was brought to the operating room (OR) after receiving IV midazolam 2 mg for preoperative anx-iolysis. Standard monitors were applied and general

anesthesia was induced with propofol 2.5 mg/kg. Rocuronium 0.8 mg/kg was administered for muscle relaxation. Mainte-nance of anesthesia was achieved with sevoflurane 0.8-1.2 minimum alveolar concentration in addition to fentanyl and hydromorphone. A dexmedetomidine bolus (0.5 mcg/kg) and infusion (0.2-0.6 mcg/kg per hour) were used during the procedure as an adjunct to her intraoperative and post-operative pain medication needs. After the placement of an additional large-bore IV, an esophageal Doppler monitoring probe (CardioQ-ODM™, Deltex Medical) was inserted follow-ing the manufacturer’s recommended technique in order to guide a goal-directed strategy for fluid optimization.

The cardiac output (CO), cardiac index (CI), and stroke volume (SV) were monitored throughout the procedure (Table 1). Then, the patient was placed in the right lat-eral position for a left total hip replacement. Blood pres-sure (BP) was kept to within 20% of the patient’s baseline, and fluid optimization was guided using the esophageal Doppler. A fluid strategy was developed using HES 130/0.4 (colloid) and Lactated Ringer’s (LR) solution (crystalloid). Serial venous hematocrit evaluation allowed for red cell mass assessment with a transfusion trigger of 25%. Begin-ning with a hematocrit of 30%, CO, CI, and SV were evalu-ated. SV change of greater than 10% was an indication of potential fluid responsiveness.

After positioning and equilibration time, the ini-tial CO, CI, and SV were 4.8 L/min, 2.6 L/min/m2 and 71 mL, respectively. Approximately 60 minutes into the procedure, estimated blood loss (EBL) was 500 mL. CO, CI, and SV were recorded at 4.2 L/min, 2.3 L/min/m2, and 68 mL, respectively; hematocrit was 29%. With 1,000 mL of LR already infused, HES 130/0.4 500 mL was given over the next 30 minutes, which led to an increase in CO to 4.8 L/min, CI to 2.5 L/min/m2, and SV to 78 mL. At the completion of the first hip replacement, EBL was 900 mL, and CO, CI, and SV were noted to be 5 L/min, 2.8 L/min/m2, and 83 mL, respectively. Urine

Faculty

David D. Rose, CRNA, PhDStaff Anesthetist/Volunteer Assistant Clinical ProfessorDepartment of Anesthesiology and Pain MedicineUC Davis School of MedicineSacramento, California

Neal W. Fleming, MD, PhDProfessor of Clinical AnesthesiaDirector, Cardiovascular and Thoracic AnesthesiaUC Davis School of MedicineSacramento, California

Rainer Kentner, MD, PhDAssistant Professor of AnesthesiologyDepartment of Anesthesiology/Trauma SectionWashington University School of MedicineSt. Louis, Missouri

Table 1. Vitals During Surgery

Time 8 AM 8:30 9:00 9:30 10:00 10:30 11:00 11:30 12 PM 12:30 1:00 1:30 2:00

SBP (mm Hg) 98 113 104 96 90 88 100 100 101 105 104 98 100

DBP (mm Hg) 56 64 63 50 50 51 58 64 63 62 66 60 64

HR (beats per min) 61 64 52 51 51 62 61 58 58 62 59 62 63

CO (L/min) 4.8 5.0 5.5 4.2 4.8 5.0 4.5 4.2 4.8 5.1 5.5 5.6 5.6

CI (L/min/m2) 2.6 3.2 3.0 2.3 2.5 2.8 2.3 2.1 2.4 2.8 2.9 2.9 2.8

SV (mL) 71 89 88 68 78 83 69 66 71 84 90 92 91

UOP (mL/kg/h) 280 340 410 480

EBL (mL) 500 900 1,100 1,800 1,900

Crystalloid 1,000 1,600 2,000 2,500

HES 130/0.4 (mL) 500/ 500

500/ 1,000

HCT (%) 29 30 25 31

PRBC (# of units) 1 2 3

CI, cardiac index; CO, cardiac output; DBP, diastolic blood pressure; EBL, estimated blood loss; HCT, hematocrit; HES 130/0.4, 6% HES 130/0.4 in 0.9% sodium chloride for injection; HR, heart rate; PRBC, packed red blood cells; SBP, systolic blood pressure; SV, stroke volume; UOP, urinary output

ANESTHESIOLOGY NEWS • DECEMBER 2011 31

Supported by

output remained stable and was measured at 280 mL at this point of the procedure.

Approximately 30 minutes into the second hip replace-ment, EBL was 1,100 mL. CO, CI, and SV were measured at 4.2 mL/min, 2.1 L/min/m2, and 66 mL, respectively. A venous hematocrit was measured at 25%. Packed red blood cells (PRBC) were ordered and the infusion started. An additional 500 mL of HES 130/0.4 was given during this time, and a total of 3 PRBC units were infused during the second procedure. Urine output was maintained at greater than 0.5 mL/kg per hour throughout the procedure, with a total output of 480 mL. Along with 3 PRBC units, the final fluid totals were: HES 130/0.4, 1,000 mL; LR solution, 2,500 mL; and EBL, 1,900 mL. Final hematocrit after the blood transfusion was 31%, and final Doppler readings were CO, 5.6 mL/min; CI, 2.9 L/min/m2; and SV, 92 mL.

Case Study 2: Use of HES 130/0.4 in the Management of Massive Blood Loss in a Patient With Penetrating Abdominal Injury

A 32-year-old woman (estimated height 165 cm, weight 70 kg) with a stab wound to the upper abdomen was brought to the emergency room. No other injuries were noted. Her vitals were initially stable (heart rate [HR], 90 beats per minute; BP, 125/90 mm Hg), with normal lab val-ues (hematocrit, 40%; platelets, 290 000/mcL; prothrombin time, 12.1 seconds; partial thromboplastin time, 22 seconds; international normalized ratio, 0.95; creatinine, 1.2 mg/dL).

A FAST (Focused Assessment with Sonography in Trauma) procedure revealed free fluid in her abdomen. She quickly became hypotensive despite a fluid challenge of 2 L of crys-talloids. A large-bore cordis line (8.5 French) was placed in the left subclavian vein and a blood transfusion was initi-ated (emergency release, uncrossmatched). The patient was rushed to the OR for an emergency exploratory laparotomy. Upon arrival in the OR, patient BP was 80/35 mm Hg and HR was 95 beats per minute. One liter of HES 130/0.4 was started to stabilize BP and to bridge the time until more blood

products became available. The massive transfusion proto-col was activated, and anesthesia was induced using etomi-date, fentanyl, midazolam, rocuronium, and sevoflurane. Despite surgical efforts to control bleeding, EBL was massive (ie, greater than 6 L per hour), thus requiring the infusion of large amounts of blood products, including crystalloids and colloids. After 3 hours into ongoing fluid resuscitation, the blood bank could not maintain the timely delivery of blood products, which resulted in a significant compromise of hemodynamics (BP, 45/22 mm Hg; HR, 120 beats per minute).

At this time, 2.5 L of HES 130/0.4 along with 500 mL of 5% human albumin were administered as the maximum daily dose of HES 130/0.4 had been reached, and crystalloids (2 L of normal saline [NS]) were given until blood prod-ucts became available. As the bleeding could not be con-trolled surgically, the liver/abdomen was packed and the patient was ordered to be transferred to the Interven-tional Radiology Suite. Before the patient left the OR, re-bleeding occurred, which led to immediate abdominal re-exploration and re-packing. Under massive fluid resusci-tation with PRBC, fresh frozen plasma (FFP), platelets, HES, and crystalloids, the patient became more stable and then was transferred to Interventional Radiology. One bleeding vessel could be identified (right hepatic artery) and was successfully embolized. About 6 hours after admission to the ER, the patient became hemodynamically more stable and was transferred to the intensive care unit (ICU).

EBL was approximately 37 L. Intraoperative fluid resusci-tation included 53 units of PRBC, 33 units of FFP, 6 units of platelets, 20 units of cryoprecipitate, 3.5 L of HES 130/0.4, 5.5 L of 5% human albumin, and 6 L of crystalloids (NS) [Table 2]. Despite the massive blood loss and fluid resusci-tation with blood products and large amounts of crystal-loids and colloids, lab values of coagulation showed close to normal values after admission to the ICU. No re-bleeding occurred. The patient returned to the OR for abdomi-nal washout the following day. The abdominal cavity was surgically closed 3 days later and the patient was extu-bated on postsurgery day 5. The postoperative course was

complicated by renal impairment and reduced liver func-tion. The patient was transferred to the floor on postopera-tive day 21 and discharged at postoperative day 35.

This case is presented as a fictitious report. Any similari-ties to an original case would be coincidental.

ConclusionClinical application of current concepts in goal-directed

therapy have been facilitated by the development of novel, minimally invasive technologies for the assessment of CO, intravascular volume, and preload responsiveness. Esoph-ageal Doppler flow monitoring of the descending thoracic aorta is one of several modalities currently available to the anesthesia practitioner. This method of functional hemo-dynamic monitoring allows for real-time intravascular vol-ume assessment of fluid challenges in order to estimate if the patient is fluid responsive and functioning on the steep portion of the Frank-Starling curve.10,11

Colloids have been advocated because of their ability to expand and remain in the intravascular space for a pro-longed period of time.1 The safety profile of HES 130/0.4, characterized by a similar duration of volume expansion and decreased plasma accumulation, allows for the administra-tion of larger volumes than previously used with older HES solutions with fewer side effects.7 HES 130/0.4 should not be used in patients with fluid overload, for example patients with pulmonary edema and congestive heart failure. Cau-tion should also be observed in patients with severe liver disease or bleeding disorders.5 Since the introduction of HES 130/0.4 to our institution, practitioners have selected it over other available colloid solutions. Because of the differ-ent pharmacokinetic properties of HES 130/0.4, our practi-tioners have reported more confidence both in its safety and efficacy to correct intravascular volume deficits.

References1. Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational

approach to perioperative fluid management. Anesthesiology. 2008; 109(4):723-740.

2. Rizoli SB. Crystalloids and colloids in trauma resuscitation: a brief over-view of the current debate. J Trauma. 2003;54(5 suppl):S82-S88.

3. Finfer S, Bellomo R, Boyce N, et al, and the SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004;350(22):2247-2256.

4. Choi YS, Shim JK, Hong SW, Kim JC, Kwak YL. Comparing the effects of 5% albumin and 6% hydroxyethyl starch 130/0.4 on coagulation and inflammatory response when used as priming solutions for cardiopul-monary bypass. Minerva Anestesiol. 2010;76(8):584-591.

5. Voluven™ prescribing information. www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/ NewDrugApplicationsNDAs/UCM083138.pdf. Accessed November 9, 2011.

6. Jungheinrich C, Sauermann W, Bepperling F, Vogt NH. Volume efficacy and reduced influence on measures of coagulation using hydroxyethyl starch 130/0.4 (6%) with an optimised in vivo molecular weight in orthopaedic surgery: a randomised, double-blind study. Drugs R D. 2004;5(1):1-9.

7. Neff TA, Doelberg M, Jungheinrich C, Sauerland A, Spahn DR, Stocker R. Repetitive large-dose infusion of the novel hydroxyethyl starch 130/0.4 in patients with severe head injury. Anesth Analg. 2003;96(5):1453-1459.

8. James MF, Latoo MY, Mythen MG, et al. Plasma volume changes associ-ated with two hydroxyethyl starch colloids following acute hypovolae-mia in volunteers. Anaesthesia. 2004;59(8):738-742.

9. Waitzinger J, Bepperling F, Pabst G, Opitz J, Muller M, Baron JF. Pharma-cokinetics and tolerability of a new hydroxyethyl startch (HES) 130/0.4 specification: [HES (130/0.4)] after single-dose infusion of 6% or 10% solutions in healthy volunteers. Clin Drug Invest. 1998;16(2):151-160.

10. Noblett SE, Snowden CP, Shenton BK, Horgan AF. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection. Br J Surg. 2006;93(9):1069-1076.

11. Chatti R, de Rudniki S, Marqué S, et al. Comparison of two versions of the Vigileo-FloTrac system (1.03 and 1.07) for stroke volume estimation: a multicentre, blinded comparison with oesophageal Doppler measure-ments. Br J Anaesth. 2009;102(4):463-469. BB

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Table 2. Labs During Trauma Fluid Resuscitation

OR Time Start 1 h 2 h 3 h 4 h 5 h 6 hPostop

6 hPostop

12 hPostop

24 h

pHa 7.09 7.22 7.38 7.32 7.35

paCO2 (mm Hg) 43 48 41 46 37

paO2 (mm Hg) 154 500 440 281 110

HCO3 14 21 28 27 24

artBE (mmol/L) -15 -7 2 2 -1

HCT (%) 30 21 20 31 19 25 30 31 32

Platelets (000/mcL) 105 51 65 50 42 49 51 110 99 103

PT (sec) 15.1 18.6 17 18.5 16.4 15.2 13.9 17.1

PTT (sec) 37.7 44.3 46.2 58.1 47.5 44.2 49.0 38.7 33.0

INR 1.2 1.6 1.6 1.4 1.4 1.1 1.2 1.2 1.5 1.3

PRBC (# of units) 2 9 18 13 5 6 2 1

FFP (# of units) 6 10 4 8 3 2 2

Platelets (# of units) 1 1 2 2 1

HES 130/0.4 (mL) 1,000 2,500

5% Human albumin (mL) 500 2,000 1,500 1,500

Crystalloids (mL) 1,000 2,000 1,000 1,000 1,000 1,000 1,000 2,000

artBE, arterial base excess; FFP, fresh frozen plasma; HCO3, bicarbonate; HCT, hematocrit; HES 130/0.4, 6% HES 130/0.4 in 0.9% sodium chloride for injection; INR, international normalized ratio; paCO2, arterial pCO2; paO2, arterial pO2; pHa, arterial pH; PRBC, packed red blood cells; PT, prothrombin time; PTT, partial thromboplastin time

Are People Still the Weak Link in Drug Safety?Pittsburgh—Human failures rather than technology flaws were the cause of most technology-associated medica-tion errors reported last year at a large Illinois hospital, according to a study presented at the annual meeting of the American College of Clinical Phar-macy (ACCP; abstract 338E).

The retrospective analysis of 703 reported medication errors at

Chicago’s Advocate Lutheran General Hospital in 2010, showed that 88% of those associated with technology were human errors and 12% were the result of system malfunctions. The research-ers defined technology-related errors as those caused by programming flaws or system breakdowns. All other events were counted as human errors.

“We were not surprised to find that

most were human errors and not sys-tem errors,” said lead author Jennifer Phillips, PharmD, BCPS, assistant pro-fessor of pharmacy practice at Mid-western University Chicago College of Pharmacy. That just meant that a technology worked as programmed, but was used incorrectly or built-in safety nets were bypassed, she said. “It could be a training issue, or maybe

there are too many alerts and we need to reduce them to prevent alert fatigue,” Dr. Phillips said.

The study’s main objective, however, was not to determine a human-versus-technology error ratio, but to see if one type of technology was more prone to errors than others. The researchers found that the answer was yes. Errors associated with computerized physi-cian order entry (CPOE) led all other types with 30% of 303 reported tech-nology-associated errors. The phar-macy information system (PIS) ranked second with 20% of reported errors.

Dr. Phillips said one factor in the higher proportion of CPOE errors might be the large number of resident physicians at the 654-bed teaching hos-pital. An institution that has a smaller resident staff might have fewer CPOE-related medication errors because of a more stable cadre of physicians bet-ter trained in technology system use, she said.

Digging DeeperA second goal was to determine

at which points in the medication use process various types of errors were mostly likely to occur. The results showed that much depended on whether or not errors were asso-ciated with technology. If they were, errors were more likely to happen during prescribing (35% of reported


TEChNOLOGY

BRIEF SUMMARYCONSULT PACKAGE FOR FULL PRESCRIBING INFORMATION

VOLUVEN®(6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION)

1 INDICATIONS AND USAGEVoluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia.

It is not a substitute for red blood cells or coagulation factors in plasma.

4 CONTRAINDICATIONSThe use of Voluven® is contraindicated in the following conditions:

• known hypersensitivity to hydroxyethyl starch [see General Warnings and Precautions (5.1)]

• fl uid overload (hyperhydration) and especially in cases of pulmonary edema and congestive heart failure

• renal failure with oliguria or anuria not related to hypovolemia• patients receiving dialysis treatment• severe hypernatremia or severe hyperchloremia• intracranial bleeding.

5 WARNINGS AND PRECAUTIONS

5.1 General Warnings and PrecautionsAnaphylactoid reactions (mild infl uenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved. [see Adverse Reactions (6)]

Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insuffi ciency or severe kidney dysfunction.

In cases of severe dehydration, a crystalloid solution should be given fi rst. Generally, suffi cient fl uid should be administered in order to avoid dehydration.

Caution should be observed before administering Voluven® to patients with severe liver disease or severe bleeding disorders (e.g., severe cases of von Willebrand´s disease).

5.2 Monitoring: Laboratory TestsClinical evaluation and periodic laboratory determinations are necessary to monitor fl uid balance, electrolyte concentrations, kidney function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or whenever the patient’s condition warrants such evaluation.

5.3 Interference with Laboratory TestsElevated serum amylase levels may be observed temporarily following administration of the product and can interfere with the diagnosis of pancreatitis.

At high dosages the dilutional eff ects may result in decreased levels of coagulation factors and other plasma proteins and a decrease in hematocrit.

6 ADVERSE REACTIONS

6.1 Overall Adverse Reaction Profi leFrom the accumulated clinical development experience, expected adverse reactions after administration of Voluven® occurring in less than 10% of patients are as follows:

Immune system disorders (Rare, >0.01% to <0.1%): Products containing hydroxyethyl starch may lead to anaphylactoid reactions (hypersensitivity, mild infl uenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema). In the event of an intolerance reaction, the infusion should be discontinued immediately and the appropriate emergency medical treatment initiated. [see General Warnings and Precautions (5.1)]

Skin and subcutaneous tissue disorders (Common, >1 to <10%, dose dependent): Prolonged administration of high dosages of hydroxyethyl starch may cause pruritus (itching) which is an undesirable eff ect observed with all hydroxyethyl starches.

Investigations (Common, >1% to <10%, dose dependent): The concentration of serum amylase can rise during administration of hydroxyethyl starch and can confound the diagnosis of pancreatitis. At high doses the dilutional eff ects may result in decreased levels of coagulation factors and other plasma proteins and in a decrease of hematocrit. [see Interference with Laboratory Tests (5.3)]

6.2 Adverse Reactions in Clinical TrialsBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug may not refl ect the rates observed in practice.

During clinical development, 471 patients were exposed to Voluven®, and a total of 768 patients received the hydroxyethyl starch 130/0.4 drug substance contained in Voluven® at diff erent concentrations (2%, 4%, 6%, or 10%) and at cumulative doses of several mL up to 66 L1). The mean duration of treatment with hydroxyethyl starch 130/0.4 was 3.9 ± 3.3 days, mean cumulative doses were 3338 ± 3695 mL, and the longest follow-up period was 90 days.

In the US trial, 100 patients undergoing elective orthopedic surgery were treated either with Voluven® (N=49) or hetastarch (6% hydroxyethyl starch in 0.9% sodium chloride injection) (N=51) for intraoperative volume replacement. Mean infusion volumes were 1613 ± 778 mL for Voluven® and 1584 ± 958 mL for hetastarch.

Adverse reactions observed in at least 1% of patients: In the US trial comparing Voluven® with hetastarch, a possible relationship to Voluven® was reported in fi ve cases in a total of three patients (aPTT elevated, PT prolonged, wound hemorrhage, anemia, pruritus). A possible relationship to hetastarch was reported in fi ve patients (three cases of coagulopathy; two cases of pruritus). The three coagulopathy cases in the hetastarch group were serious and occurred in patients receiving more than the labeled ceiling dose (20 mL/kg), whereas no serious coagulopathy occurred in the Voluven® group.

6.3 Postmarketing ExperienceThe following adverse reactions have been identifi ed during the post-approval use of Voluven® and other types of hydroxyethyl starch solutions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The safety profi le from postmarketing experience of Voluven® is not diff erent from the profi le obtained from clinical trials performed using the product.

Based on spontaneous reporting of hypersensitivity reactions, urticaria, bronchospasm, or hypotension were the most frequently reported serious adverse drug reactions for patients treated with Voluven®.

With the administration of hydroxyethyl starch solutions, disturbances of blood coagulation can occur depending on the dosage2).

10 OVERDOSAGEAs with all plasma volume substitutes, overdosage can lead to overloading of the circulatory system (e.g. pulmonary edema). In this case, the infusion should be stopped immediately and if necessary, a diuretic should be administered. [see General Warnings and Precautions (5.1)]

16 HOW SUPPLIED/STORAGE AND HANDLINGVoluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) for intravenous infusion is supplied in the following primary container and carton sizes:

Polyolefi n bag (freefl ex®) with overwrap: 500 mLCarton of 15 x 500 mLNDC 0409-1029-01

Store at 15° to 25°C (59° to 77°F). Do not freeze.

Manufactured by: Fresenius Kabi Norge AS,P.O. Box 430,NO-1753 Halden, Norway

Distributed by: Hospira, Inc.275 North Field DriveLake Forest, Illinois 60045 USA

Made in Norway

technology-related errors vs. 16% of non–technology-related ones). In con-trast, the highest proportion of non–technology-related errors occurred during administration (34% of non–technology-related errors vs. 13% of technology-related ones).

In addition, the research showed that technology-related errors were more likely than non–technology-related errors to be near misses (59% vs. 51%, respectively), and non–tech-nology-related errors were more apt to reach patients than technology-related errors (45% vs. 35%, respectively), although these errors did not result in harm.

To Dr. Phillips, these findings made sense because the largest percentage of technology-related errors occurred dur-ing prescribing, where the errors were most likely to be caught in downstream safety nets. Conversely, the large pro-portion of non–technology-related errors occurring in the final stage meant a lower likelihood of detection

before reaching the patient. The num-ber of errors resulting in harm was too small to draw any conclusions, she said.

The next phase of the investiga-tion, Dr. Phillips said, will be to look at the top two or three technology-related errors and see what can be done to prevent them and also improve performance.

ISMP’s Take on ResultsStuart Levine, PharmD, informat-

ics specialist at the Institute for Safe

Medication Practices (ISMP), in reviewing the study, noted that “just because you have technology doesn’t mean it’s safer. Certainly, there are unintended consequences of all the new technologies that we have to try to address.”

But overall, Dr. Levine added, tech-nology has been “very beneficial” to pharmacy. “Certainly having com-mon databases has been a big plus,” he said, and so have “clinical decision sup-port systems that provide information

to pharmacists as to when they should contact the physician when doses are out of range.”

Dr. Levine took issue with the focus on human activity as the source of a high proportion of the medication errors reported in the study. “Rather than human errors, these may be sys-tem flaws and deficiencies that lead people down the wrong path,” he said.

—Bruce Buckley


‘[Tech-related errors]

could be a training issue,

or maybe there are too

many alerts and we

need to reduce them to

prevent alert fatigue.’

—Jennifer Phillips, PharmD, BCPS

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Managing the Difficult Pain Case

Case Study 1: Spinal Cord Stimulation as Treatment for Neuropathic Pruritus

Sanjay S. SaStry, MDDirector, Lake Mary Pain Relief CenterLake Mary, FloridaKristina H. Berger, MDFamily Practice PhysicianOviedo, Florida

Case DescriptionThe patient was a 44-year-old white woman who

was a homemaker from Florida. She was referred by her neurologist and presented with complaints of daily severe itching discomfort in the plantar aspect of the left foot for approximately 1 year. The symp-tom was reported as deep within the sole of her foot. The itching was so severe that the patient scratched incessantly at night. When scratching would not relieve the itching, the patient stated she took a kitchen knife or fork and “carved into” her foot for relief. Her primary care provider, dermatologist, allergist, and physiatrist could not determine the eti-ology of her symptom. She had tried different shoes, various skin creams, and medications including pre-gabalin and loratadine, all without improvement in her symptom. She reported several surgeries for left ankle fractures secondary to injuries sustained 30 years ago when she was a gymnast.

Diagnosis and TreatmentAfter evaluating the patient, the physician

deemed she was within normal limits except for the plantar aspect of the left foot. The top half of the sole of the foot demonstrated open wounds in various stages of healing. The patient stated this was due to her scratching her foot with a kitch-en utensil to relieve the itching. Magnetic res-onance imaging (MRI) of the left foot and ankle showed no obvious abnormality. Electromyogra-phy (EMG) with nerve conduction velocities dem-onstrated findings consistent with left tarsal tunnel syndrome. The patient subsequently was referred for psychiatric evaluation to rule out psycholog-ical disorders. She also was referred to podiatry for further foot care. Three nerve blocks were per-formed at 2-week intervals toward the posterior tarsal tunnel. This treatment alleviated her itching

for 5 days after each block was done. Peripheral nerve blocks at the foot and ankle levels did not result in prolonged relief of pruritus. Her podia-trist reported that the patient was at high risk for amputation because of chronic infections of the left foot. Her psychiatrist and neurologist said the patient exhibited no psychological impairment, but recommended long-term relief of her symp-toms. At this point, the potential benefits of spi-nal cord stimulation (SCS) were discussed with the patient and she consented to a trial.

Treatment was initiated by fluoroscopically guided trial placement of dual percutaneous spi-nal cord stimulator cylindrical octrode leads in the lumbar epidural space. This procedure was per-formed in the office under mild sedation with 5 mg of oral diazepam 30 minutes prior to the proce-dure. Using retrograde technique, after injecting


PAiN MEdiCiNE

local anesthesia, access was gained to the L2-3 epidural space. The first octrode lead was placed left paramedian to the L4-5 region from lateral to medial. The second lead was placed through the L3-4 epidural space as well as crossing the prima-ry octrode lead and left paramedian to the spi-nous process of L4-5 epidural space region. The distal end of the second lead was focused toward stimulating the left L4-5 nerve root (Figure 1). The patient reported paresthesia covering the left foot. The best coverage was with the octrode lead, which was most lateral. The patient subsequently returned after 3 days of the trial period, at which time the trial leads were removed. The patient stat-ed that she had 80% to 90% relief of her pruritus. A month later, she had permanent implant of spi-nal cord stimulator using dual cylindrical octrode leads in the L4-5 region with retrograde placement (Figure 2). The patient had excellent stimulation, which provided effective relief. At 1-month follow-up, the patient’s left foot wounds had completely healed. At 1-year follow-up, the patient continued to be symptom-free.

Discussion

SCS has been used to treat many pain syn-dromes, but there are very few cases involving treatment for non–pain-related syndromes. This patient had intractable pruritus, which endangered not only her left foot, but also her overall health. SCS evidently provided relief from pruritus. The rarity of this syndrome makes it difficult to con-duct a large-scale assessment of the effectiveness of SCS. SCS for lower-extremity pain takes place usually in the low thoracic, high lumbar region.

The difficulty lies in creating substantial paresthe-sia, which is stimulation for pain relief in the soles of the feet not easily covered by the usual antero-grade thoracolumbar approach. Therefore, a retro-grade approach creating stimulation close to the L4-5 nerve root is indicated for a patient such as this one.

Now, 2.5 years after the procedure, the patient has continuing relief from her symptom. Thus, SCS may be a viable treatment option for patients with continuous intractable neuropathic pruritus, and further studies are warranted.

Case Study 2:The Addicted Patient in Acute Careyvonne D’arcy, MSPain Management and Palliative Care Nurse PractitionerSuburban Hospital-Johns Hopkins MedicineBethesda, Maryland

Case DescriptionCindy C. was a 46-year-old patient admitted to

the hospital emergency room with right thigh pain. She rated her pain at 10/10 and reported the pain as constant on the anterior aspect of her thigh. She said she had started having the discomfort 2 days before and it was getting worse. She request-ed intravenous hydromorphone to relieve her pain.

In her history, she revealed no major health problems but had pollen allergy and asthma. Cindy said the pain started a day after she injected hero-in into a vein in her thigh.

On examination, the area was tender but not red or warm. A Doppler study revealed a signif-icant blood clot in a thigh vessel, for which the patient needed surgery.

In her pain history, Cindy said she not only used heroin, but chewed 6 to 8 tablets of 80 mg extended-release oxycodone and used 30 mg of oxycodone several times per day between her extended-release doses. She said she enjoyed the way oxycodone made her feel, but she did not have pain diagnoses. Her heroin use was report-ed as infrequent but her legs had depressed circu-lar scars indicating subcutaneous injections called “skin popping”—a route used by addicts when they have damaged their veins beyond repair.

After the surgery, Cindy was placed in the post-anesthesia care unit. Again, she said her pain was severe and she needed something to manage it. She was put on a hydromorphone patient-con-trolled analgesia (PCA) pump with a baseline

infusion of 1 mg per hour and a frequent bolus dose. She also was offered extended-release mor-phine 45 mg twice per day to supplement the intravenous medications. Within 24 hours, Cindy refused the morphine, stating it caused head-ache and nausea. She requested extended-release oxycodone.

The postoperative course was complicated by an infection that required incision and drainage. The postoperative pain relief was provided by PCA for the first 3 days along with low-dose extended-release oxycodone, then a conversion was made to oral extended-release oxycodone 80 mg 3 times per day with oxycodone 20 mg every 3 hours as needed. Cindy became oversedated on the drugs


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see difficult pain page 36

Figure 1. Figure 2.

when the dose was increased to 4 times per day, so the dose was decreased to 3 times per day. At best, her pain was rated 5/10, which she deemed acceptable. She also had intravenous hydromor-phone available for dressing changes. In addi-tion to the opioids, she received pregabalin 75 mg twice per day, off-label, to help reduce opioid use and address any neuropathic elements of the pain.1

On discharge, the patient was grateful for the help she received with her pain management. She never revealed the source of her prescription med-ications, and she did not wish to enter an outpa-tient treatment program. But she realized that her drug injecting was beginning to present seri-ous health problems for her; however, this realiza-tion was not enough to motivate her to change her lifestyle.

Discussion

This patient presented with several interesting issues. She was an addict but she had also just had a painful surgery. She not only used illicit drugs but she also used prescription drugs for plea-sure. Treating an addicted patient such as this one means using opioids in some form.

In the acute care setting, a physician’s focus after surgery is on treating the pain and moving the addicted patient to discharge. Trying to with-hold pain medication or switch to a nonopioid drug will leave the patient with uncontrolled pain and withdrawal. Using standard techniques, such as PCA, also can present a problem for some pre-scribers who believe that an IV drug abuser will just escalate medication use once it begins. Dose control and frequent use monitoring will deter-mine how the medication is being used and the

effect it produces. The addicted patient may never reach a pain level below 5/10 but it should be pos-sible to move the pain intensity score 2 points to make a clinically significant pain reduction.2

Also problematic are which drug and the route to use. The patient is an admitted IV drug injec-tor and abuses prescription medications. Her drug source is unknown so drug quality is questionable. Using a PCA will help establish what the patient needs to control pain at a reasonable level. This patient needs to understand that the medication is not being used to further her addiction, but to control her pain. Close monitoring of PCA use along with the extended-release medication can help determine what the real need is for adequate pain control.

This particular patient also used oral medica-tion. The trial of moving to another extended-release oral medication was not successful, but switching to extended-release oxycodone provid-ed adequate pain relief and allowed the patient to be discharged in a timely fashion. This was not the first choice, but helped improve the level of pain relief and allowed the patient to work toward dis-charge. Even though not opioid-naive, it is pos-sible for that patient to become oversedated if enough medication is taken.

As health care providers in acute care, we need to treat all patients who are admitted to the facil-ity. This means, in some cases, we have to treat patients who are addicted to illicit drugs or who are abusing prescription drugs. We may be seeing more addicted patients because prescription drug abuse is currently increasing. One estimate puts the national rate of sales in the United States at 710 mg of prescription opioids per person.3 Addi-tionally, increased access to these drugs is attrib-utable to “pill mills” or illegitimate pain clinics,

where prescriptions are provided to almost any patient who complains of pain.3

Cindy was an honest patient. She was able to provide a good report of what she was doing with drugs so we could move her toward better pain relief. Patients who continue to report unrelieved pain may be abusing opioids or illicit drugs and their cases may require further investigation. Most case reports of unrelieved pain may be resolved with dose or medication adjustments, but in other cases, addiction may be a factor. Signs of addic-tion such as track marks, irritated nasal mucosa, or skin popping scars will signal that the patient either is actively using illicit drugs or has a history of illicit drug use. For those health care providers who feel reluctant or unsure of how to best treat these individuals, consulting professionals such as pain management specialists or behavioral health specialists can provide direction and support for treatment decisions.

References1. Tippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical

patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007;104(6):1545-1556.

2. Farrar JT, Young JP, Lamoreaux L, Werth JL, Poole R. Clinical importance of changes in chronic pain intensity measured on an 11 point numerical pain rating scale. Pain. 2001;94:149-158.

3. Fiore K. Deaths for OD of RX pain killers triple in 10 years. 2011; Health News from Medpage Today. Available at www.everydayhealth.com/printview.

Additional informationAmerican Academy of Pain Medicine, American Pain Soci-ety, and American Society of Addiction Medicine Public Policy Statement on the Rights and Responsibilities of Health Care Professionals in the Use of Opioids for the Treatment of Pain (2004). Available at www.ampainsoc.org.

D’Arcy Y. How to manage pain in addicted patients. Nursing. 2010;40(8):60-64.


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difficult Pain continued from page 35

ClipCHart

Boston: In Africa, roughly 75% of patients do not have access to a pulse oximeter. In Latin America, the figure is 41%; in southern Asia, 49%. All told, 77,000 operating rooms worldwide do not have the devices—considered one of the most important monitors in the hospital by the World Health Organization. The nonprofit group Lifebox (www.lifebox.org) hopes to change those statistics.

Led by Atul Gawande, MD, the Harvard surgeon and OR checklist advocate, Lifebox has launched a campaign to close what it calls the “pulse oximetry gap.” Working with Acare Technology Co., a Taiwan-based device maker, the group promises to provide the instruments to operating rooms in need for a donation of $250.

Lifebox is a collaboration of the Harvard School of Public Health, the Association of Anaesthetists of Great Britain and Ireland and the World Federation of Societies of Anaesthesiologists.

Madison, Wis: After the long, northern winters here, more than six in 10 anesthesia providers at the University of Wisconsin have inadequate blood levels of vitamin D, a critical nutrient for healthy bones, researchers have found.

The study, of 124 anesthesi-ologists, residents and other anesthesia caregivers, found that 25% had vitamin D levels below 20 ng/dL, 61% had levels below 30 ng/dL and 6% had levels con-sidered deficient—putting them at increased risk for fractures. Madison is at the 43rd parallel north, approxi-mately the same latitude as Boston.

MCAN1859.indd 1 3/9/11 9:02:13 PM

Former Smokers Report Less Chronic Pain Than Current SmokersChicago—For smokers with chronic pain, kicking the habit may do more than simply reduce the risk for cancer and other health problems associated with tobacco use—it may also ease their discomfort.

A new study presented at the 2011 annual meeting of the American Soci-ety of Anesthesiologists (ASA; abstract 462) found that current smokers had

significantly more intense and impair-ing pain, as well as more anxiety and depression than people who never smoked; however, former smokers and never-smokers scored the same in these areas.

According to Michael Hooten, MD, associate professor of anesthesiology at Mayo Clinic, in Rochester, Minn., the results help confirm a link between

smoking and pain severity suggested by previous research, including his own. However, the nature of that link is not fully understood, said Dr. Hooten, an expert on smoking and pain who was not involved in the current study.

“This is an evolving area of research and, at the moment, we don’t really know exactly how smoking impacts pain severity,” Dr. Hooten told

Anesthesiology News. “For example, it may be that quitting smoking improves depression, a factor known to affect pain. Less depression might in turn reduce pain.”

Lead investigator Jenna Goes-ling, PhD, a postdoctoral fellow in the Department of Anesthesiology at the University of Michigan Medi-cal School, in Ann Arbor, noted the importance of elucidating the relation-ships among smoking, pain and mood disorders. “Approximately 23% of the general population are smokers, com-pared with as many as 40% of chronic pain patients,” Dr. Goesling said. “At our center, about 30% of patients are current smokers and another 30% are former smokers, so this is a very rele-vant focus of research interest.”

Dr. Goesling and her team analyzed data from 321 consecutive chronic pain patients treated at the Univer-sity of Michigan’s Back & Pain Center, including 88 current smokers, 97 for-mer smokers and 136 never-smokers.

Blocking Morphine’s Itchy

Side Effect I tching is one of the most prevalent side

effects of opioids like morphine. But until now, researchers have been stumped as to why these effective pain suppressors cause the irritation.

New research shows that a particular variant of the µ-opioid receptor (MOR) in the spinal cord, called MOR1D, controls itch. Investigators from Washington Uni-versity in St. Louis found that blocking MOR1D in the spinal cord of mice halted morphine-induced itching without inter-fering with the drug’s ability to relieve pain (Cell 2011;147:447-458).

“It is exciting to know that MOR1D actu-ally functions as an itch-specific receptor,” said principal investigator Zhou-Feng Chen, PhD, director of Washington University’s Center for the Study of Itch, a new mul-tidisciplinary center aimed at translating basic itch research into novel treatments.


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The researchers conducted statisti-cal analyses to determine any corre-lation between smoking status and pain severity, which they measured using the 11-point Brief Pain Inven-tory. They also examined scores on the Hospital Anxiety and Depression Scale (HADS), which includes two 21-point anxiety and depression subscales. The investigators controlled for the poten-tial confounding effects of depression, age, sex and education.

The team found that smokers had significantly higher average scores on all of the measures than never-smok-ers (Table). In contrast, former smok-ers and chronic pain patients who had never smoked had nearly identical scores. The analysis also revealed no dose–response relationship between the amount of cigarette consumption and the severity of pain.

But controlling for depres-sion reduced the statistical dif-ference in scores between current smokers and never-smokers, supporting

Dr. Hooten’s suspicion that improved mood can partly explain why quitting smoking may improve pain symptoms. Giving up cigarettes has “important tangible benefits in [the chronic pain] population” and clinicians should include smoking cessation as an ele-ment of care for the growing number of chronic pain patients, he said.

“These results are very hopeful in that they demonstrate a significant potential benefit of quitting smoking on the severity and impact of chronic

pain,” Dr. Goesling said. She urged cli-nicians to address comorbid mood dis-orders in chronic pain patients who smoke, but also emphasized the impor-tance of using “caution when interpret-ing these results as our understanding of the relationship between quitting smoking and pain is still preliminary.”

The ASA has made smoking cessa-tion a priority. For more on the group’s antismoking initiative, visit www.asahq.org/stopsmoking.

—David Wild

More specifically, Dr. Chen explained, opioids such as morphine first activate MOR1D, which subsequently connects to an itch-specific receptor in the spinal cord called gastrin-releasing peptide receptor (GRPR). GRPR specifically transmits itch but does not carry pain information.

The researchers also found that another variant of the µ-opioid recep-tor called MOR1 exclusively mediates morphine’s analgesic effects in the spi-nal cord but does not prevent itch; when blocking MOR1, the mice no longer received the drug’s pain-killing benefits, but continued to scratch.

Based on the results of the current study, Dr. Chen suspects that additional variants of the receptor may be related to nausea, respiratory depression, constipa-tion or other common side effects asso-ciated with the use of pain-killing drugs. This discovery raises the hope of generat-ing new treatments to eliminate itch, and potentially other side effects, in patients who rely on opioids to relieve chronic and severe pain, the researchers said.

—Victoria Stern

Table. Pain, Depression and Anxiety Among Current, Former And Never-Smokers

Cu

rren

t S

mo

kers

(n

=88)

Form

er

Sm

oke

rs (

n=9

7)

Nev

er-S

mo

kers

(n

=136

)

Cu

rren

t vs

. N

ever

-Sm

oke

rs

(P v

alu

e)

Form

er v

s.

Nev

er-S

mo

kers

(P

val

ue)

BPI Pain Intensity subscale 6.95 6.16 6.28 0.001 NS

BPI Pain Interference subscale 7.56 6.59 6.43 0.000 NS

HADS - Depression subscalea 11.64 8.17 8.11 0.000 NS

HADS - Anxiety subscalea 10.70 7.48 7.84 0.000 NS

BPI, Brief Pain Inventory; HADS, Hospital Anxiety and Depression Scale; NS, not significanta A score of 11 to 21 on the HADS for depression or anxiety indicates need for psychiatric treatment.


PAiN MEdiCiNE

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Simulated Patient Assessment Powerful Tool In Pain Medicine EducationLas Vegas—The Pain Paradox, an hour-long continuing medical edu-cation program, has the potential to significantly boost pain clinicians’ comfort and competence with pre-scribing opioids, according to a study presented at PAINWeek 2011.

The program significantly increased

the percentage of clinicians who said they were “comfortable” or “very com-fortable” prescribing controlled sub-stances, and clinicians were better able to assess the potential of pain patients to become addicted to opioids, the investigators said.

“There is a compelling need to

improve the competencies of clini-cians who undertake the management of long-term opioid therapy,” said Russell K. Portenoy, MD, the Ger-ald J. Friedman Chair in Pain Medi-cine and Palliative Care at Beth Israel Medical Center, in New York City, who was not involved in the Pain

Paradox program. “This early experi-ence is encouraging and supports the value of additional work using the sim-ulated patient strategy to teach safe opioid prescribing.”

The investigators collected data dur-ing the Pain Paradox activities held at five medical meetings over two years: PAINWeek 2009 and 2010, American Pain Society 2009 and 2010 and the American Academy of Pain Medicine 2010. Physicians, nurses, pharmacists and psychologists viewed a number of educational posters using an audio guide, and then participated in a simu-lated assessment with a live patient led by an experienced pain physician. Sim-ulated patient scenarios included an elderly woman who runs out of pre-scriptions early and a middle-aged woman with an inappropriate result on a urine drug test (UDT).

Before and after the assessment, par-ticipants responded to multiple-choice questions regarding risk factors associ-ated with addiction, UDT, treatment agreements, legal requirements for pre-scribing controlled substances and dif-ferential diagnoses related to aberrant behaviors.

These questions were designed to showcase any gaps in knowledge, such as the subtle but significant differences between addiction, pseudoaddiction, physical dependence and medication intolerance. For example, participants


Clinicians’ comfort

level prescribing

controlled substances

significantly improved.

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had to answer several true or false statements such as “It is easy to deter-mine who will become a problematic user of opioids” and “A patient who escalates his dose and returns early for a refill is probably developing an addic-tion.” Both statements are false.

The investigators found that clinicians’ comfort level prescribing controlled substances significantly improved from 67% at baseline to 87% after the activ-ity (P<0.01). Furthermore, 86% of clini-cians reported comfort with prescribing controlled substances three months after the program.

“The participants were very posi-tive—they found this [program] inno-vative and unique, and could go back to their practices on Monday and make positive changes, feel more com-fortable and give their patients better care,” said Howard Heit, MD, a pain specialist at Georgetown University’s School of Medicine, in Washington, D.C. Dr. Heit was one of the program’s creators along with Douglas Gourlay, MD, MSc, of the Wasser Pain Manage-ment Centre, at Mount Sinai Hospi-tal, in Toronto, Canada; John Peppin, MD, of The Pain Treatment Center of the Bluegrass, in Lexington, Ky.; and Paul Arnstein, RN, PhD, of Massachu-setts General Hospital, in Boston. The program was funded by unrestricted educational grants from Cephalon, Mallinckrodt and Purdue.

More Education NeededThe study, however, also exposed

gaps in knowledge that persisted after the program. At baseline, 56% of cli-nicians considered unexpected UDT results for prescribed medications as definitive evidence of diversion rather than a broad differential that included diversion. When educated on the com-plexities of UDT, including variable metabolism and the possibility of lab-oratory error, 32% of participants still interpreted the lack of an opioid in a

UDT as definite diversion. After the simulation, clinicians con-

tinued to struggle to differentiate between pseudoaddiction (50%), med-ication tolerance (60%) and physical dependence (51%), and still showed significant deficiencies about current legal obligations for prescribing con-trolled substances.

“There is a need for future program-ming, as demonstrated by the fact that we identified some large knowl-edge gaps,” said James Miller, MD, of

Educational Awareness Solutions in Norwalk, Conn., who helped design the Pain Paradox program and tabulating answers to the pre- and post-program test questions. “We were trying to move [pain clinicians] a little bit outside their comfort zone, to be able to make quick judgments, such as ‘I need to get more information before I make a decision, ask the patient some more questions or get some more testing done.’”

—Rosemary Frei, MSc


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Results for Glucose Control in Cardiac ICU Not All Sweet

Two different critical care teams are reporting mixed results meeting infection prevention

goals set forth by the Surgical Care Improvement Project (SCIP).

For investigators at the University of Chicago, the problematic goal was SCIP INF-4, which specifies keep-ing blood glucose levels in cardiac sur-gery patients to less than 200 mg/dL

at 6 a.m. on the first and second days after surgery. Clinicians at the univer-sity’s medical center routinely failed to hit the goal, they reported at the 2011 annual meeting of the American Soci-ety of Anesthesiologists (ASA; abstract 1372). However, missing the goal had no demonstrable effect on infection rates or hospital length of stay (LOS).

In the second study (abstract 1706),

by researchers at Maimonides Medi-cal Center, in New York City, compli-ance with some of the SCIP modules increased significantly over the study period. And they documented shorter hospital LOS, as well as a trend toward decreased mortality. But the team was unable to show a significant reduction in rates of infection as a result of the SCIP compliance efforts.

The University of Chicago Experience

In the University of Chicago study, the investigators conducted an eight-month retrospective review of patients who had undergone cardiac surgery. The researchers examined patient charts and ICD-9 codes to determine the type of surgery the patients had and the presence of diabetes, conges-tive heart failure, hypertension and ischemic heart disease. They also mea-sured ICU duration, hospital LOS and infection rates. Of the 188 patients who had undergone cardiac surgery during the study period, 165 passed the blood glucose control measure and 23 did not.

Although patients who did not meet the required level had a significantly higher incidence of diabetes (52% vs. 29%; P<0.03), those who passed and those who failed had similar outcomes with regard to ICU duration (median, 60.43 vs. 72.6 hours; P=0.928), hos-pital LOS (median, 171.83 vs. 211.25 hours; P=0.328) and infection rates (15.15% vs. 13.04%; P=1.00), the investigators reported.

“In our small population, we found no real difference between the two groups,” said Avery Tung, MD, pro-fessor and quality chief for anesthesia in the University of Chicago’s Depart-ment of Anesthesia and Critical Care, who led the study. “Looking at our out-comes, it’s not apparent what the risk factors are for infection. In this case, it may not be just glucose.”

Whatever the explanation may be for the disconnection between SCIP and noncompliance, the implications are clear, Dr. Tung said. “Our data clearly suggest that complying with SCIP INF-4 may not improve outcomes, and it also raises the possibility that the benefits of glucose control in cardiac surgery patients may be overstated.”

Study co-author Katherine D. Mieure, PharmD, a clinical pharmacy resident specializing in cardiothoracic surgery, noted that although there is evidence to support the requirements for people with diabetes, the breadth of the SCIP glucose control module may be problematic.

“One study in patients with diabe-tes showed an association between blood glucose over 200 mg/dL and deep tissue infections, but we are obli-gated to follow these measures for all patients, not only those with diabetes,” she said. “The [ideal blood glucose goal] may differ depending on pre-op


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risk, including whether patients have diabetes.” In other words, she said, patients who don’t have diabe-tes may have more leeway, and higher blood glucose levels may not present as much risk for them as for their diabetic counterparts.

Dr. Mieure stressed that variables affecting blood glu-cose need to be considered in this clinical setting. “A proto-col would help as would find-ing a systematic way to affect patient outcomes, but as all pharmacists and physicians know, the variables for blood glucose control are many. There may

not be just one stan-dard that will work.”

At Maimonides, A Bit More Success

The team at Maimonides Medical Center tracked out-

comes related to several SCIP infection prevention measures,

including prophylactic adminis-tration of antibiotics, perioperative glucose control and intraoperative use of insulin. Mortality and hospi-tal LOS also were assessed.

The study was based on a review of 460 cardiac surgeries performed at the hospital in 2006 (n=227) and 2009 (n=233; the SCIP national campaign began in 2005). Overall, 179 patients had diabetes and 284 were using insulin.

The intraoperative use of insu-lin was significantly higher in 2009 than in 2006 (66.7% vs. 57.3%;

P=0.043), indicating a growing awareness of the SCIP INF-4 qual-

ity measure, the team reported. How-ever, despite increased use of insulin, compliance with intraoperative blood glucose goals—a precursor to meeting

the 200 mg/dL postsurgical blood glu-cose target set forth by SCIP INF-4—was not significantly different (22.3% of patients in 2006 vs. 15.6% in 2009; P=0.17). Possible contributing fac-tors included higher body mass index of patients in 2009 vs. 2006 (30.75 vs. 29.12 kg/m2; P=0.024) and inadequate efforts to optimize serum glucose pre-operatively, the investigators suggested.

As far as other SCIP quality control measures, the study showed that com-pliance with antibiotic prophylaxis was significantly increased in 2009 com-pared with 2006 (93.2% vs. 88.75%, respectively; P<0.001).

Altogether, the infection control measures had some impact: Patients in 2009 had a significantly shorter hospi-tal LOS (7.71 vs. 8.4 days; P<0.001) and slightly lower mortality (3.16% vs. 5.6%; P<0.1) than 2006 patients, the team reported. However, rates of ster-nal wound infection did not differ sig-nificantly between the two groups (0.63% in 2009 vs. 1.53% in 2006; P<0.2).

More Questions Than Answers?

For Dr. Tung, these types of stud-ies may raise more questions than answers, especially in the assessment of the impact of blood glucose on post-operative infection. “It comes down to the risk-and-gain argument,” he said.

“What are you risking by tighter con-trol, and what do you have to gain by meeting these requirements? And is there any way we can predict risks asso-ciated with not meeting the require-ments? A larger study might help us get a better grip on that. But right now, the answers are not clear.”

—Terri D’Arrigo



‘Looking at our outcomes,

it’s not apparent what

the risk factors are for

infection. In this case, it

may not be just glucose.’

—Avery Tung, MD

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The findings, presented at the 2011 annual meeting of the American Soci-ety of Anesthesiologists (ASA; abstract JS05), came as “pretty much of a sur-prise” to the investigators, said study leader Andrey Bortsov, MD, PhD, assistant professor of anesthesiology at UNC. “We think this is a very strong association.”

Dr. Bortsov and colleagues analyzed the genetic makeup of 2,039 women diagnosed with breast cancer, who had participated in the Carolina Breast Can-cer Study—a longitudinal, population analysis of the disease that began in 1993.

Opioid GeneticsThe researchers wanted to see if vari-

ations in the G allele of the µ-opioid receptor gene, OPRM1 A118G, affected a woman’s risk for death from breast cancer. In particular, because the 118G form of the allele ratchets down the receptor’s responsiveness to opioids, the UNC team hypothesized that women with one or more of these variants would be more likely to survive their cancer.

The results of the study sup-ported that hypothesis. According to Dr. Bortsov’s group, women who had at least one variant copy of the allele were half as likely to die of breast cancer by 2006 as those with the typical form. Women with two copies of the 118G variant were four times as likely to sur-vive the disease (Table).

Samuel McLean, MD, said OPRM1 is the best understood opioid gene. “We know that if you have a G allele, you respond less well” to the drugs. “If you have cancer, you will need more opi-oids over time if you have a G allele. If it takes more opioids, that’s bad for you for controlling your pain, but it may be good because of the other effect,” he said.

Most Americans of European and African ancestry have an A allele of the OPRM1 gene, Dr. McLean noted. The G allele is less common, appear-ing in about 30% of European Amer-icans, but only about 7% of African Americans. That difference might help explain why black women are signifi-cantly more likely to die of breast can-cer than women from other racial and ethnic groups with the malignancy, the researchers suggested.

Dr. McLean cautioned that although opioids appear to play an important role in the growth and spread of can-cer, how they do so remains unclear. Indeed, it’s not even known if the opi-oids that patients take for cancer pain have an effect on cancer cells beyond that of the endogenous opioids that the body already produces. “We’re a long way from having any evidence that opioids patients take for cancer pain are harming them,” Dr. McLean said. “There is animal data that’s pro-vocative, but obviously we can’t take humans and not give them opioids if they have cancer. That’s the last thing we want to do.”

Mouse Data Bolster LinkNew cellular evidence backs the

UNC findings. In an unrelated study also presented at the ASA meeting (abstract JS08), researchers from the University of Chicago showed that cancer cells modified to overexpress the µ-opioid receptor are far more likely to grow and spread than those with normal levels of the protein.

Using a line of human lung can-cer cells that they transplanted into nude mice, the researchers found that overexpression of the opioid receptor caused the growth rate of the tumors to rise 2.5-fold. Metastasis of the tumors spiked by a factor of 20.

Jonathan Moss, MD, PhD, profes-sor of anesthesia and critical care at the University of Chicago, said the North Carolina work “confirms a growing body of in vitro and animal data from several laboratories, including our own, suggesting a role of the µ-opioid recep-tor in cancer progression.”

However, Dr. Moss said, too many questions remain to consider alter-ing clinical practice. “We don’t want to scare patients,” Dr. Moss said. “Our paper and theirs did not address giv-ing opioids and may relate to endoge-nous opioids. While I may personally believe there could be effects which would change practice, there are no randomized, double-blind studies on this. There are no direct, prospective, randomized controlled [trial] data suggesting that opioids influence can-cer progression in humans, but several studies contribute to the debate.”

Jeffrey L. Apfelbaum, MD, profes-sor of anesthesia at the University of Chicago, who was not involved in the studies, agreed. “They need some prospective studies to clearly delin-eate what major practice changes might need to take place,” said Dr. Apfelbaum, a member of the edito-rial board of Anesthesiology News. “But they’re working on that.”

—Adam Marcus

Table. The Double-A Genotype Was Strongly Associated With Cancer Deaths

A118G GenotypeNumber of Participants

Breast Cancer Deaths

% of Breast Cancer Deaths P Value

All cases

A/A 1,682 296 17.6 0.0001

A/G 323 28 8.7

G/G 22 1 4.6

Invasive cases

A/A 1,332 290 21.8 0.0006

A/G 233 28 12

G/G 13 0 0


‘We’re a long way from having any evidence that

opioids patients take for cancer pain are harming them.

There is animal data that’s provocative, but obviously

we can’t take humans and not give them opioids if

they have cancer. That’s the last thing we want to do.’

—Samuel McLean, MD


Genes continued from page 1

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Heart Health Strongly Linked to Outcomes After Neurosurgery

Patients with heart failure are nearly five times more likely to die after neurosur-

gery than patients without the con-dition, according to new research from the University of Virginia in Charlottesville.

The investigators reviewed the records of all neurosurgical patients at UVA between 1994 and 2008. Patients were divided into those with congestive heart failure (CHF; n=906) and those without the con-dition (n=20,968), which affects roughly 20% of the population.

The investigators took data from the first neurosurgery in patients who had multiple surgeries during the study period. They also performed statistical analyses to evaluate the impact of CHF and other comorbid-ities on mortality after neurosurgery, hospital length of stay (LOS) and hos-pitalization costs.

Approximately 4% of patients who underwent neurosurgery had CHF. Patients with CHF had a mortal-ity rate of 14.7%, compared with 3.2% in patients without the illness (P<0.001). CHF was found to be an independent factor in determining mortality. CHF also was shown to increase hospital LOS by 8.2 days and the adjusted cost of hospitalization by $20,096 per patient.

“It’s kind of obvious that folks who are sicker will do worse,” said study co-author Narayana Varhabhatla, MD, an anesthesiology resident at UVA, whose group reported its find-ings at the 2011 annual meeting of the American Society of Anesthesi-ologists (abstract 1021). “But the sig-nificant increase in mortality was the most surprising finding. It’s important to optimize patients with CHF before any surgery. What’s special about neu-rosurgery needs to be teased out.”

“Like any good study, this raised more questions,” said study senior author Zhiyi Zuo, MD, PhD, pro-fessor of anesthesiology at UVA. These include whether physicians can improve heart function—through the use of diuretics, digoxin and cardiac rehabilitation—to reduce mortality and LOS.

The authors said they hope to study these associations in a larger database of patients.

The current study is a follow-up to work showing that patients with chronic pulmonary disease under-going neurosurgery had statistically

significant increases in hospital LOS and costs. Those results were pub-lished earlier this year in the Journal of Neurosurgery (2011;115:375-379).

George Williams II, MD, assistant professor of anesthesiology and neu-rosurgery at the University of Texas Medical School at Houston, said he would have liked more informa-tion about the severity of patients’

heart failure, as CHF is a broad term encompassing illness of varying degrees.

“Without knowing the types of heart failure and types of neurosur-gery that these patients had, it’s hard to tell what to conclude from this,” he said. “But it is very interesting, and perhaps we can draw something useful from this study.”

One mechanism that could explain the higher mortality is that patients with CHF have less perfusion to the end organs, he said. It could be that they need better perfusion to heal well. “Heart failure patients would do worse secondary to reduced perfusion, fluid retention and a diminished tolerance to surgical stress,” Dr. Williams added.

—Karen Blum



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1 Anesthesia Oral Board Review: Knocking Out the BoardsJessica A. Lovich-Sapola

Cambridge University Press, October 30, 2009

This book is specially designed for the American Board of Anesthesiol-ogy Oral Examination. The evidence-based approach is presented in a concise outline-oriented format. More than 100 topics have already been board review–tested by residents who have passed the oral board exam.

2 Anesthesiology Oral Board Flash CardsJeff Gadsden; Dean Jones

McGraw-Hill, August 25, 2011

The cards are designed to impart best patient care for a specific disease/condition or surgical procedure. Great for studying alone or with a part-ner, these cards teach residents how to think through an unexpected operating scenario.

3 Atlas of Airway Management: Techniques and ToolsSteven Orebaugh

Lippincott Williams & Wilkins, October 10, 2011

Clinical applications in airway management are dependent on both the anatomy of the individual and the individual’s comorbidities, with dif-ferent tools available for different patient presentations. New sections have been created on pediatric applications, bronchoscopy, special air-way considerations in the emergency room and the ICU, and post- intubation care issues.

4 Atlas of Image-Guided Intervention in Regional Anesthesia and Pain Medicine

James RathmellLippincott Williams & Wilkins, November 7, 2011

This atlas is a practical guide for practitioners who perform interventional procedures with radiographic guidance to alleviate acute or chronic pain. The author provides an overview of each technique, with detailed illus-trations of the relevant anatomy, technical aspects of each treatment, and a description of potential complications. The author also discusses medical evidence on the technique’s applicability.

5 Diagnosis, Management, and Treatment of Discogenic Pain: Volume 3: A Volume in the Interventional and

Neuromodulatory Techniques for Pain Management SeriesLeonardo Kapural; Philip KimElsevier/Saunders, September 29, 2011 This book presents state-of-the-art guidance on the full range of disco-genic pain relief techniques performed today. The authors offer expert advice on a variety of procedures to manage and treat discogenic pain.

6 Intrathecal Drug Delivery for Pain and Spasticity: Volume 2: A Volume in the Interventional and

Neuromodulatory Techniques for Pain Management SeriesAsokumar Buvanendran; Sudhir DiwanElsevier/Saunders, September 29, 2011 This book presents state-of-the-art guidance on the full range of intrathe-cal drug delivery techniques performed today. The authors offer expert advice on a variety of procedures to treat chronic non-malignant pain, cancer pain, and spasticity.

7 Spinal Injections & Peripheral Nerve Blocks: Volume 4: A Volume in the Interventional and

Neuromodulatory Techniques for Pain Management SeriesMarc Huntoon; Honorio Benzon; Samer NaurozeElsevier/Saunders, September 29, 2011 This book presents state-of-the-art guidance on when and why these proce-dures should be performed, the mechanisms of action on pain and current guidelines for practice. The authors offer expert advice and scientific evi-dence supporting the use of spinal injections and sympathetic nerve blocks.

8 Understanding Pain Anatomical ChartLippincott Williams & Wilkins

Lippincott Williams & Wilkins, November 8, 2006 This visual and textual overview of pain provides an easy-to-understand tool for patient interaction with health professionals. A pain scale and a sample human figure are provided so patients can give their health pro-fessionals information about the level and location of pain.

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For pricing, a more complete review and easy ordering with a credit card, go to McMahonMedicalBooks.com.

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CONTINUING MEDICAL EDUCATIONdeCeMBer 2011 4 7

Lesson 295: PreAnesthetic Assessment of the Patient With Systolic or Diastolic Heart Failure WRITTEN BY:Megan Lanigan, MD,a and Richa Dhawan, MDb

a Resident, Department of Anesthesia and Critical Care, University of Chicago Medical Center, Chicago, Illinois b Assistant professor, Department of Anesthesia and Critical Care, University of Chicago Medical Center, Chicago, Illinois

REVIEWED BY:Mark Chaney, MDProfessor, Department of Anesthesia and Critical Care, University of Chicago Medical Center, Chicago, Illinois

DATE REVIEWED: November 2011

DISCLOSURESThe authors and the reviewer have no relationships with pharmaceutical companies or man-ufacturers of products to disclose. This educational activity may contain discussion of pub-lished and/or investigational uses of agents for the treatment of disease. The FDA has not approved some uses of these agents. Please refer to the official prescribing information for each product for approved indications, contraindications, and warnings.

NEEDS STATEMENTDiagnosing congestive heart failure (CHF) may be difficult in the elderly or obese patient. Complications during anesthesia can lead to increased morbidity and mortality. Recognizing this common condition has been identified by committee as required knowledge for anesthesiologists.

TARGET AUDIENCEAnesthesiologists

CALL FOR WRITERSIf you would like to write a CME lesson for An esthesiology News, please send an email to Eliz a beth A.M. Frost, MD, at [email protected].

LEARNING OBJECTIVES At the end of this activity, the participant should be able to:1. List the diagnostic criteria for CHF with preserved ejection fraction (EF).2. Differentiate the diagnostic criteria between CHF with, and without, preserved EF.3. Define the American College of Cardiology/American Heart Association and New York

Heart Association classifications for CHF.4. Identify differences in ventricular structural abnormalities in CHF with and without

preserved EF.5. Quote the prevalence and demographics of CHF.6. Outline the pathophysiology leading to CHF.7. Discuss the treatment options for patients with CHF.8. Evaluate the patient with acute decompensated heart failure.9. Explain the anesthetic implications for CHF.10. Establish hemodynamic goals for patients with CHF.

CASE HISTORYA 55-year-old woman presented for ventral hernia repair. Her medical history included sev-eral hospitalizations during the past 5 years for shortness of breath and chest pain. The most recent occurrence was 9 months previously, at which time changes were made to her medica-tions. A recent cardiac catheterization revealed nonobstructive coronary artery disease; stress echocardiography revealed an EF of 68%. The patient had a history of long-standing hyper-tension—poorly controlled as a result of sporadic compliance with medication regimens. Physical examination findings were unremarkable. Her medications included lisinopril, meto-prolol, and aspirin. Her blood pressure was 165/85 mm Hg, and heart rate was 70 beats per minute.

PREANESTHETIC ASSESSMENTDr. Elizabeth A.M. Frost, who is the editor of this continuing

medical education series, is clinical professor of an esthes iology at the Mount Sinai School of Medicine in New York City. She is the author of Clinical Anesthesia in Neu rosur gery (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthe siologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Asses-s ment, Volumes 1 through 3 (Birkhäuser, Bos ton) and 4 through 6 (McMahon Publishing, New York City).

A COURSE OF STUDY FOR AMA/PRA CATEGORY 1 CREDIT

Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson post-test and course evaluation before December 31, 2012. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit.TIME TO COMPLETE ACTIVITY: 2 hoursRELEASE DATE: December 2011TERMINATION DATE: December 31, 2012

ACCREDITATION STATEMENT

The Mount Sinai School of Medicine is accredited by the Accred-itation Council for Con tinuing Medical Education (ACCME) to pro-vide continuing medical education for phy sicians.

CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine designates this educational

activity for a maximum of 2 AMA PRA Category 1 Credits.™ Physicians should only claim credit commensurate with the extent of their participation in the activity.

It is the policy of Mount Sinai School of Medicine to ensure objectivity, balance, independence, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices.

H eart failure (HF) is a complex syndrome that can be defined hemodynamically as an inabil-ity to provide adequate cardiac output to sup-

port the metabolic demands of the body, or to do so only at elevated filling pressures. Clinically, it is characterized by signs and symptoms of dyspnea on exertion, fatigue, orthopnea, edema, and rales. Congestive heart failure (CHF) typically has been subdivided into systolic heart fail-ure (SHF) and diastolic heart failure (DHF). The ejection fraction (EF) is normal or near normal in almost 50% of patients diagnosed with HF.1

Numerous underlying alterations in cardiovascular physiology lead to HF, including myocardial ischemia, congenital anomalies, valvular disease, and pericar-dial disease; all result in a constellation of similar clinical signs and symptoms. HF continues to be a major health problem in the United States with nearly 5 million peo-ple affected.2 As the management of HF improves, the

CONTINUINGMEDICAL EDUCATION 4 8 This lesson is available online at www.mssm.procampus.net deCeMBer 2011

number of individuals living with the disease increases. As a result, more patients admitted for surgery have HF.

Prevalence and Demographics

The prevalence of HF has been increasing both within the United States and worldwide. In the United States, about 500,000 new cases are diagnosed annually. Approx-imately 1 in every 5 people aged 40 in the United States will develop HF in his or her lifetime, with the prevalence increasing with increasing age. Approximately 6% to 10% of people older than 65 years have HF.

The prevalence of DHF is estimated to be 15%, 33%, and 50% at ages less than 50 years, 50 to 70 years, and more than 70 years, respectively.1,3,4 Patients with DHF are more likely to be older, women, and hypertensive, and less likely to have had previous myocardial infarction or coronary artery disease (CAD) than patients with SHF.2

Clinical Manifestations

The symptoms are similar between SHF and DHF. Typi-cally, patients have poor exercise tolerance, dyspnea on exertion, fatigue, orthopnea, paroxysmal nocturnal dys-pnea, or chest pain. Accompanying signs indicating fluid overload include peripheral edema, an S3 or S4 heart sound on auscultation, pulmonary crackles, and jugular venous distention.2 Some patients predominantly experience dys-pnea and intolerance to activity, whereas others may have signs of fluid overload exclusively, without dyspnea.5

Patients with DHF typically have exercise intolerance secondary to an elevation in left atrial and pulmonary venous pressures that occur with worsening left ventricu-lar (LV) relaxation. Under normal circumstances, exercise results in an increased heart rate that reduces diastolic fill-ing time and may result in pulmonary edema and wors-ened cardiac output in patients with impaired ventricular relaxation.6

Classifications of Heart Failure

The American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the assessment of chronic HF classifies patients based on 4 stages of symp-toms (Table 1). The New York Heart Association (NYHA) categorizes HF based on levels of physical exertion required to illicit symptoms (Table 2).4,7

In addition to various methods for classifying chronic HF, it has been divided classically into 2 distinct pheno-types: HF with reduced ejection fraction (HFrEF) or SHF

and HF with preserved ejection fraction (HFpEF) or DHF (Table 3).

HFrEF or SHF is a pathologic state in which abnor-mal cardiac function results in an inability of the heart to pump adequate blood at a rate required to meet the metabolic demands of the body. The principal derange-ment in SHF is impaired contractile function leading to a decreased EF.

HFpEF or DHF is a pathologic state in which impaired relaxation or resistance to LV filling results in congestion, or in filling of the ventricular chamber only at elevated pres-sures to maintain sufficient stroke volume.5 DHF affects approximately 50% of patients with chronic HF.

Whether SHF and DHF are 2 distinct forms of HF, or instead are extremes in a spectrum of overlapping phe-notypes remains controversial. Those who support the spectrum hypothesis claim that HF is a complex multi-factorial disease, and similar to other complex diseases, it has a broad linear distribution with varying phenotypes at opposite ends of a bell-shaped spectrum. The distribu-tion of EFs in HF falls along a bell-shaped curve, and under this hypothesis, DHF and SHF fall at opposite ends of the spectrum. It is for this reason, proponents argue, that the 2 forms of HF have different characteristics and clinical responses to therapy. They note that systolic dysfunction is not unique to HFrEF, as aspects of systolic dysfunction can be found in HFpEF.8

Proponents of the theory that SHF and DHF are 2 sep-arate phenotypes within a spectrum of HF argue that the distribution of EFs seen in HF actually is bimodal, not uni-modal. They also point out that the ventricular and cellu-lar remodeling patterns seen in SHF and DHF are distinct from one another, that SHF and DHF tend to develop in different patient populations, and that the progression and pathogenesis of the disease are distinct.2

Pathophysiology

The syndrome of HF can progress from a number of chronic cardiovascular conditions, including hypertension, ischemic myocardial disease, myocarditis, valvular disease, disorders of the pericardium, and other cardiomyopathies ultimately leading to the expression of similar signs and symptoms in the spectrum of HF. The underlying patho-genesis of HF is widespread. Hypertension and advanc-ing age are the greatest risk factors for the development of DHF. By contrast, CAD causes about two-thirds of SHF cases; other nonischemic causes include myocarditis, thy-roid disease, alcohol use, and other behaviors inflicted on the myocardium.2,4

Adequate peripheral circulation in HF is maintained by compensatory mechanisms that include hypertrophy, stimulation of the renin–angiotensin–aldosterone sys-tem, and retention of salt and water. Myocardial remodel-ing and conversion from compensated hypertrophy to HF involve complex molecular and cellular changes, includ-ing myocyte growth and death, as well as changes in the extracellular matrix. These alterations result in changes to myocardial structure and function that impair sys-tolic function, diastolic function, or both. Stimuli for these changes include mechanical strain on myocytes, neuro-hormones (eg, norepinephrine and angiotensin), inflam-matory cytokines, and other growth factors.9

Increased LV mass is seen in most forms of HF; however, the patterns of ventricular remodeling differ between SHF and DHF. The ventricular chamber often is dilated in HFrEF, but less so in HFpEF.2 In HFpEF, the ventricular cavity size often remains the same or decreases, and end-diastolic and end-systolic volumes remain normal or decrease. In HFpEF, there is an increase in wall thickness, mass, and the ratio of mass-to-chamber volume.5

In HFrEF, the cardiomyocyte is narrow and elon-gated with reduced myofibrillar density. By contrast, in HFpEF the myocyte diameter and resting tension are both increased. There also are differences in the bal-ance between matrix metalloproteinases (enzymes that play a role in cell proliferation and apoptosis) and their inhibitors in HFrEF and HFpEF.2 In animal models of HFrEF, fibrillar collagen is degraded. This differs from the pressure-overloaded hypertrophy seen in HFpEF, a result of increased collagen and collagen crosslinks.5

The resulting hemodynamic profile may be simi-lar between SHF and DHF. In SHF, a reduced EF leads to decreased cardiac output, increased LV end-diastolic vol-umes, and a passive increase in left atrial and pulmonary venous pressures. In DHF, there also is an increase in left atrial and pulmonary venous pressures resulting from the increase in LV diastolic pressure. Thus, both forms may lead to pulmonary congestion, and chronically can lead to increased pulmonary vascular resistance.5

Normal diastolic function involves a process of active myocardial relaxation, which occurs early in diastole. It results in a rapid decline in pressure causing a suc-tion effect that helps LV filling, as well as passive disten-tion of the LV that occurs in late diastole. During this later phase of diastole, atrial contraction contributes approx-imately 20% to 30% of the total LV filling volume at low pressures. In diastolic dysfunction, loss of normal LV relax-ation and distensibility from either structural or functional abnormalities results in impaired ventricular filling and

Table 1. ACC/AHA Classification of Chronic Heart Failure

Stage Description

A: High-risk for HF HTN, DM, CAD, family history of CHF

B: Asymptomatic HF Valve disease, previous MI, LV dysfunction

C: Symptomatic HF Dyspnea, fatigue, exercise intolerance

D: Refractory end-stage HF Marked symptoms of HF despite optimal medical management

ACC, American College of Cardiology; AHA, American Heart Association; CAD, coronary artery disease; CHF, congestive heart failure; DM, diabetes mellitus; HF, heart failure; HTN, hypertension; LV, left ventricle; MI, myocardial infarction

Table 2. New York Heart Association Classification System

Stage Description

I Asymptomatic with normal physical activity

II Symptomatic with moderate exertion

III Symptomatic with minimal exertion

IV Symptomatic at rest


elevated filling pressures. LV filling shifts from predomi-nantly occurring in early diastole to more later-phase dias-tole due to an inability of the ventricle to actively relax. Atrial contraction in turn contributes more to diastolic fill-ing under these conditions.10

Diagnosis

The signs and symptoms of HF often are nonspecific and include dyspnea, exercise intolerance, weakness, and fatigue; these also can be present in other disease states—including non-cardiac–mediated diseases such as thyroid abnormalities, pulmonary disease, obesity, and anemia. There is no officially established set of diagnostic criteria for HF; however, there are a number of commonly used systems including the Framingham criteria, Boston criteria, and Duke criteria.

In the commonly used Framingham criteria, the diag-nosis of HF requires the simultaneous presence of 2 major criteria, or 1 major and 2 minor criteria (Figure 1).11

It is difficult to distinguish between SHF and DHF based on clinical signs and symptoms. An elevated level of brain natriuretic peptide is a reliable means of diagnosing HF, but does not help distinguish between SHF and DHF. A brain natriuretic peptide level greater than 100 pg/mL has been shown to be 95% sensitive for the diagnosis of HF, but only 14% specific for detecting systolic failure.12 Non-specific tests—such as chest x-ray that reveals cardiomeg-aly and electrocardiography (ECG) that reveals signs of LV hypertrophy or ischemia—can be used as diagnostic aids. Overall, the diagnosis of SHF involves assessing vari-ous clinical signs and symptoms from the patient’s medi-cal history, in addition to echocardiographic evidence of decreased EF.

The diagnosis of DHF is more controversial and can include a number of diagnostic methods. In the Euro-pean Society of Cardiology guidelines, 3 conditions must be met concurrently for a diagnosis of DHF (Figure 2).13 There are a number of methods for evaluating impaired relaxation, the third parameter. Cardiac catheterization is the gold standard because it directly measures ventric-ular diastolic pressure, particularly the rate of decline in

LV pressure in early diastole, and end-diastolic pressure. The procedure involves the use of fluid-filled catheters or micromanometer catheters. Doppler ECG is less invasive, however, and is now the primary way to noninvasively assess diastolic function.12

Blood inflow velocity in the transmitral valve is evalu-ated by Doppler ECG. Peak velocities of blood flow dur-ing early diastolic filling (E-wave) and atrial contraction (A-wave) are measured and the ratio calculated. Under normal conditions, E-wave velocity is greater than A-wave velocity because atrial contraction contributes little to dia-stolic filling. The E-to-A ratio is approximately 1.5.

In early diastolic dysfunction due to a slower relaxation time secondary to ventricular stiffness, atrial contrac-tion contributes more to filling; the relationship reverses and the E-to-A wave ratio is less than 1—which is typical of grade I diastolic dysfunction. In grade II diastolic dys-function due to increasing left atrial pressures, early dia-stolic velocities are elevated. This causes an increase in the E-wave, and the E-to-A ratio increases again to “normal” or pseudonormal levels.

With further worsening of diastolic dysfunction, LV diastolic pressure rises considerably. Atrial contraction contributes less to ventricular filling because of high end-diastolic pressures; thus, the E-to-A wave ratio rises signifi-cantly due to the drop in A- wave pressure. The ratio often goes above 2, which is seen in grades III and IV diastolic dysfunction.

E-to-A wave ratios are affected by mitral valve anatomy, blood volumes, and abnormal cardiac rhythms including atrial fibrillation. Therefore, in these settings the ratios are of limited use for diagnosing diastolic abnormalities.12 In clinical practice, a diagnosis of DHF is usually one of exclu-sion in symptomatic patients who have documented pre-served EF.

Evaluating Acute Decompensated Heart Failure

In patients with a history of HF, acute decompensation can commonly present as respiratory failure. It is impor-tant for the anesthesiologist to recognize the signs and

symptoms of this hemodynamic state because it presents a significant risk to the patient for complications. Elective surgery should be avoided until the condition is stabilized.

Acute decompensated HF typically results from SHF or DHF with a number of different stimulating factors. The clinical presentation commonly includes significant dys-pnea because of a rapid accumulation of fluid in intersti-tial lung spaces that typically results from acutely elevated cardiac filling pressures. Patients characteristically present with cough, dyspnea, fatigue, and occasionally chest pain.

Major Criteria

Paroxysmal nocturnal dyspnea

Neck vein distension

Rales

Radiographic cardiomegaly

Acute pulmonary edema

S3 gallop

Increased central venous pressure (>16 cm H2O at right atrium)

Hepatojugular reflux

Weight loss >4.5 kg in 5 days in response to treatment

Minor Criteria

Ankle edema, bilaterally

Nocturnal cough

Dyspnea on ordinary exertion

Hepatomegaly

Pleural effusion

Decrease in vital capacity by one-third from maxi-mum recorded

Tachycardia (heart rate >120 bpm)

Figure 1. In the commonly used Framingham criteria, the diagnosis of heart failure requires the simultaneous presence of 2 major criteria, or 1 major and 2 minor criteria.

Table 3. Comparison of Systolic and Diastolic Heart Failure

SHF DHF

Demographics Younger, male, CAD/history of MI Older, female, hypertensive

Pathophysiology Impaired contractile function, decreased EF Impaired myocardial relaxation, normal EF

Chamber/cellular remodeling

Ventricular chamber dilation, elongated/narrow myocytes, reduced myofibrillar density, degradation of fibrillar collagen

Normal or decreased ventricular chamber size, increased ventricular wall thickness, increased ratio of mass-to-chamber volume, increased myocyte diameter, increased col-lagen and collagen crosslinks

Treatment β-blockers, ACEIs/ARBs, diuretics, CRT β-blockers, ACEIs/ARBs, aldosterone antag-onists (lack of significant evidence for sur-vival benefit), dihydropyridine CCBNote: sensitive to preload reduction; cau-tion with nitrates, diuretics, ACEIs

ACEIs, angiotensin-converting enzyme inhibitors; ARBs, angiotensin receptor blockers; CAD, coronary artery disease; CCB, calcium chan-nel blocker; CRT, cardiac resynchronization therapy; DHF, diastolic heart failure; EF, ejection fraction; MI, myocardial infarction; SHF, systolic heart failure

The presence of signs and symptoms of CHF (eg, see Figure 1)

The presence of normal or mildly abnormal LV sys-tolic function

Documented impairment of relaxation, filling, or diastolic compliance

Figure 2. In the European Society of Cardiology guidelines for diagnosing DHF, 3 conditions must be met simultaneously.

CHF, congestive heart failure, DHF, diastolic heart failure; LV, left ventricular

CONTINUINGMEDICAL EDUCATION 5 0 This lesson is available online at www.mssm.procampus.net deCeMBer 2011

Tachypnea, tachycardia, and either hypertension or hypo-tension may develop. Classical physical findings include crackles or wheezing on auscultation (indicating signifi-cant pulmonary edema), S3 or S4 heart sound on cardiac examination, and elevated jugular venous pressures (indi-cating elevated right-sided filling pressures).13

The patient should be evaluated for precipitating fac-tors. Common causes include myocardial infarction or ischemia, severe hypertension, atrial fibrillation or other arrhythmias, and acute valvular abnormalities such as mitral or aortic regurgitation. The diagnosis of acute decompensated HF is based on a typical clinical presen-tation. Supporting tests to confirm the diagnosis include ECG for signs of ischemia, chest radiography for signs of pulmonary edema, brain natriuretic peptide levels that can be significantly elevated, and echocardiography to assess valvular abnormalities and overall cardiac function.

Treatment

Based on a number of randomized controlled trials, drug therapy has been the primary treatment for SHF. Sur-gical therapy makes use of several devices as well as trans-plantation. Diuretics are a key component of drug therapy for symptomatic relief of water retention in patients with SHF. The dose is titrated by monitoring weight and elec-trolyte status with the goal of maintaining euvolemia. Diuretics, however, have not been shown to prolong survival.

By inhibiting the renin–angiotensin–aldosterone sys-tem (which often is abnormally activated in the progres-sion of HF), angiotensin-converting enzyme inhibitors (ACEIs) have significantly benefited patients, including fewer symptoms of HF and hospital admissions, and pro-longed survival.

Angiotensin receptor blockers (ARBs) are an alternative therapy in patients with ACEI intolerance. Multiple ran-domized trials of various ARBs found beneficial effects, including decreased hospitalizations. Spironolactone, an aldosterone receptor antagonist, has been found to increase survival in patients with HF, in addition to ACEIs. A key component of drug therapy for HF is the use of β-blockers to decrease chronic sympathetic activation.3

Cardiac transplantation remains the definitive treat-ment for HF, although there is an overall lack of available transplant organs in the United States. A number of alter-native surgical treatment options exist, however, includ-ing coronary revascularization for ischemic causes of HF, valve replacements, and LV reconstruction for pathologic remodeling.

Cardiac resynchronization therapy, which involves the use of biventricular pacing in a synchronized mode, has been used in patients in whom EF is less than 35% and QRS duration is greater than 0.12 seconds (ie, patients with abnormal conduction and possible ventricular con-traction dyssynchrony). Cardiac resynchronization therapy in combination with optimal medical management has been shown to improve functional class, exercise capacity, and EF, and reduce mortality in patients with SHF.

Increasingly, LV-assist devices (LVADs) are used because many patients develop refractory HF despite medical management. The REMATCH (Randomized Evaluation of Mechanical Assistance in the Treatment of Congestive Heart Failure) trial, in which patients were randomized to receive optimal medical management, or LVAD plus

optimal medical management, found that the LVAD group had better 1- and 2-year survival rates than patients in the medical management alone group.3

The goals in treating patients with DHF include relief of symptoms, elimination of exacerbations, and reduced mortality; however, the mainstay drugs used in treat-ing SHF—including ACEIs, ARBs, β-blockers, and aldoste-rone antagonists—have not been shown to be as effective against DHF in multiple studies. According to the ACC/AHA guidelines, the management of DHF should include treatment of hypertension, maintenance of sinus rhythm, prevention of tachycardia and ischemia, and reduction of venous pressure.6

Blood pressure control reduces LV end-diastolic pres-sure, improves relaxation of the ventricle leading to improved early filling, decreases ischemia, and reduces LV hypertrophy, thus inhibiting further diastolic dysfunction. ACEIs have been shown to increase exercise capacity and possibly reduce the risk for hospitalization of patients with DHF; however, ACEIs have not been shown to improve overall prognosis in a number of studies evaluating these drugs for treatment of hypertension in HFpEF. Despite a lack of data on overall decrease in mortality, ACEIs, ARBs, and aldosterone antagonists are the recommended drugs for treating hypertension in diastolic failure.

Maintenance of sinus rhythm or avoidance of tachycar-dia improves relaxation and increases diastolic filling time. If conversion to sinus rhythm is not possible, rate control is important. Calcium channel blockers or β-blockers are rec-ommended. Specifically, dihydropyridine calcium channel blockers have been shown to be beneficial in the treat-ment of diastolic dysfunction, in contrast to SHF.6 Patients with DHF who have a small, stiff left ventricle are particu-larly sensitive to decreases in preload; this can result in a significant fall in cardiac output. Therefore, these patients may not tolerate diuretics, venodilators such as nitrates, ACEIs, or calcium channel blockers.

Implications and Goals for AnesthesiaCHF has important implications for surgery and anes-

thesia. A number of studies have demonstrated significant risks for morbidity and mortality after noncardiac sur-gery in patients with HF. A study by Hammill et al14 looked at 159,327 patients with HF undergoing noncardiac sur-gery and found an 8.0% incidence of operative mortal-ity—more than double the incidence among patients with CAD and more than triple the incidence in the con-trol group. After controlling for comorbidities, there was a 63% higher incidence of operative mortality among patients with HF compared with controls; the rate for all causes of 30-day readmission also was significantly higher.

Perioperatively, a number of hemodynamic changes can occur that affect both systolic and diastolic functions. A thorough preoperative evaluation of the patient’s HF symptoms and exercise tolerance should be obtained. Patients with HF are particularly sensitive to changes in volume status, as well as increases in afterload. Given that there are many different underlying causes of HF, anes-thetic and hemodynamic management of these patients may vary depending on the primary pathology. Valvular pathology leading to HF should be treated based on the specific valve affected and the appropriate hemodynamic goals associated with those lesions. In patients with isch-emic cardiomyopathies, anesthetic management to opti-mize myocardial oxygen supply and demand is essential.

For the surgical patient with DHF, several hemodynamic changes during the perioperative period exert adverse effects on diastolic filling, including tachycardia, abnor-mal cardiac rhythm, or myocardial ischemia. Tachycardia decreases the late phase of diastole and reduces cardiac filling, LV end-diastolic volumes, and cardiac output. Atrial fibrillation is not tolerated because optimal cardiac function relies on atrial contraction for LV filling and stroke volume.

Acute, severe elevations in systemic blood pressure worsen LV wall stress and can impair myocardial relax-ation. Additionally, patients with DHF can be extremely sensitive to decreases in preload, and venodilators should be used with caution. Volume status should be closely monitored, and hypovolemia or volume overload should be avoided. In addition to the negative effects of ischemia on the myocardium, ischemia itself can cause reversible impairment in myocyte relaxation, which further worsens diastolic function.

Myocardial ischemia is one of the main mechanisms of LV diastolic dysfunction postoperatively. Factors including pain, shivering, tachycardia, hypertension, and hypoxia increase myocardial oxygen demand and cause isch-emia.15 Volatile agents as well as opioids and muscle relax-ants do not appear to worsen diastolic dysfunction alone.

No studies have demonstrated improved outcomes with certain anesthetic techniques over others, including regional or general anesthesia; however, the anesthesi-ologist must keep in mind that hemodynamic effects can vary depending on the anesthetic method.

Management of the Case Presented

After the patient completed a physical examination and provided her medical history, it was determined that her episodes of HF had been medically optimized. The echo-cardiogram indicated preserved EF and abnormal relax-ation of the left ventricle. Thus, the patient met criteria for diastolic heart dysfunction with episodes of DHF.


Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evalua-tion form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the Web site, call toll-free customer service at (888) 345-6788 or send an email to [email protected].

For inquiries about course content only, send an email to [email protected]. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Mount Sinai School of Medicine, New York, NY.

Post-Test

1. The American College of Cardiology/American Heart Association guidelines for assessing chronic heart failure:a. classify patients according to severity of symptomsb. classify patients based on the stage of symptomsc. include 5 levels of severity d. are the same as the New York Heart Association classification system

2. The principle derangement in diastolic heart failure (DHF) is:a. impaired contractilityb. reduced ejection fractionc. impaired ventricular relaxation and complianced. preserved left ventricular (LV) diastolic pressure

3. Which of the following is not a ventricular compensatory mechanism to offset stress on cardiac performance?a. Hypertrophyb. Salt and water retentionc. Stimulation of the renin–angiotensin–aldosterone systemd. Regional wall motion abnormalities

4. Risk factors for the development of DHF include:a. hypertension and advancing ageb. high-fat dietc. coronary artery diseased. end-stage renal disease

5. Using the Framingham criteria, a diagnosis of heart failure requires:a. 4 major criteriab. 2 major, or 1 major and 2 minor criteriac. echocardiographic evaluationd. correlation with another system for an accurate diagnosis

6. The European Society of Cardiology recommends the use of all of the following criteria to diagnose DHF, except:a. presence of symptoms of congestive heart failure (CHF)b. normal LV systolic functionc. hypertensiond. documented impairment of LV compliance

7. The management of patients with DHF should include:a. treatment of hypertensionb. cardiac resynchronization therapyc. aggressive diuresisd. inotropic agents

8. The incidence of operative mortality for patients with CHF undergoing noncardiac surgery has been reported to be:a. 1%b. 3%c. 8%d. 15%

9. Hemodynamic goals during the perioperative period include the following, except:a. maintaining normal sinus rhythmb. avoiding tachycardiac. avoiding hypertensiond. avoiding volatile anesthetics because of possible worse outcome

10. In DHF, angiotensin-converting enzyme inhibitors have been shown to:a. improve exercise capacityb. increase the risk for hospitalizationc. improve overall prognosisd. lower overall mortality

Because this was a laparoscopic repair, general endo-tracheal anesthesia was chosen. Lidocaine, fentanyl, mid-azolam, propofol, and vecuronium were administered for induction. Large fluctuations in blood pressure and heart rate were avoided on direct laryngoscopy by adminis-tration of 75 mcg of fentanyl before intubation. Routine monitors were used and fluid management was directed at maintaining euvolemia. Small doses of labetalol were administered during emergence and extubation to con-trol heart rate and blood pressure. IV morphine in 5-mg doses was given postoperatively for pain management.

References1. Zile MR, Brutsaert DL. New concepts in diastolic dysfunction and

diastolic heart failure; part I: diagnosis, prognosis, and measure-ments of diastolic function. Circulation. 2002;105(11):1387-1393.

2. Borlaug BA, Redfield MM. Diastolic and systolic heart failure are distinct phenotypes within the heart failure spectrum. Circula-tion. 2011;123(18):2006-2014.

3. Yuzefpolskaya M, Weinberg C, Kukin M. Advances in systolic heart failure. F1000 Med Rep. 2010;2:31.

4. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult; executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Prac-tice Guidelines (committee to revise the 1995 guidelines for the evaluation and management of heart failure). J Am Coll Cardiol. 2001;38(7):2101-2113.

5. Chatterjee K, Massie B. Systolic and diastolic heart failure: differ-ences and similarities. J Card Fail. 2007;13(7):569-576.

6. Kazik A, Wilczek K, Poloński L. Management of diastolic heart fail-ure. Cardiol J. 2010;17(6):558-565.

7. Criteria Committee of the New York Heart Association. Nomencla-ture and criteria for diagnosis of diseases of the heart and great ves-sels. 9th ed. Boston, MA: Little, Brown & Co; 1994:253-256.

8. De Keulenaer GW, Brutsaert DL. Systolic and diastolic heart fail-ure are overlapping phenotypes within the heart failure spec-trum. Circulation. 2011;123(18):1996-2005.

9. Oka T, Komuro I. Molecular mechanisms underlying the transi-tion of cardiac hypertrophy to heart failure. Circ J. 2008;72(suppl A):A13-A16.

10. Aurigemma GP, Gaasch WH. Clinical practice: diastolic heart fail-ure. N Engl J Med. 2004;351(11):1097-1105.

11. McKee PA, Castelli WP, McNamara PM, Kannel WB. The natural his-tory of congestive heart failure: the Framingham study. N Engl J Med. 1971;285(26):1441-1446.

12. Gutierrez C, Blanchard DG. Diastolic heart failure: chal-lenges of diagnosis and treatment. Am Fam Physician. 2004;69(11):2609-2616.

13. Ware LB, Matthay MA. Clinical practice: acute pulmonary edema. N Engl J Med. 2005;353(26):2788-2796.

14. Hammill BG, Curtis LH, Bennett-Guerrero E, et al. Impact of heart failure on patients undergoing major noncardiac surgery. Anes-thesiology. 2008;108(4):559-567.

15. Pirracchio R, Cholley B, De Hert S, Solal AC, Mebazaa A. Dia-stolic heart failure in anaesthesia and critical care. Br J Anaesth. 2007;98(6):707-721.

For US-Guided Interscalene Blocks, Close Is Good EnoughLas Vegas—Horseshoes, hand gre-nades, nuclear warfare—and now, it seems, interscalene blocks: four things for which being near the target is basi-cally as good as being smack on it.

Needle placement and the distribu-tion of local anesthetics do not seem to affect the characteristics of ultrasound-guided interscalene block after shoulder arthroscopy, according to the results of

a new study by investigators at the Uni-versity of Pittsburgh Medical Center.

Neither variable was associated with significant differences in block setup times, incision pain in the postanesthe-sia care unit or the duration of analge-sia, the researchers reported at the 2011 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 107).

“There can be some variation in terms of what anesthesiologists recommend for interscalene block,” said Steven L. Orebaugh, MD, associate professor of anesthesiology and critical care med-icine at Pittsburgh, and leader of the study. “Some [clinicians] have put their needle next to each visible fascicle and injected local anesthetic around them. Others pop into the space near any

of the fascicles and inject there, wait to see if it surrounds the fascicle, and then adjust the needle position accord-ingly. Finally, some clinicians simply get a twitch to make sure their needle is in the groove, and inject everything into it.”

Dr. Orebaugh and his colleagues sought to determine what happens to the local anesthetic if the needle is inserted in a conventional manner and anesthetic is injected after a twitch is observed. “Where does the local anes-thetic go?” he asked. “And does it make a difference in terms of block setup, duration or the success of the block depending on those distribution characteristics?”

To help answer these questions, the researchers enrolled 32 patients under-going shoulder arthroscopy into the trial, all of who received ultrasound-guided anesthesia and nerve stimulation (Table 1).

After the brachial plexus was imaged in the interscalene groove, a 5-cm, 22-gauge stimulating needle was inserted and advanced toward visible nerve fascicles. Once any brachial plexus motor stimulation occurred, a solu-tion of 20 mL of 0.75% ropivacaine was injected.

The Pittsburgh researchers used a three-point scale for both motor and

Table 1. Patient Demographics

Age, y 49.12

Height, in 69.78

Weight, lb 190.03

GenderMale 22

Female 10

Side of surgeryRight 22

Left 10

Type of surgerySubacromial decompression 30

Rotator cuff repair 23

Labral repair 4

Capsule 3

AC 4

Motor response to stimulationDeltoid 21

Brachioradialis 2

Biceps 4

Pectoralis 1

Deltoid/biceps 5

AC, acromioclavicular


‘These investigators

have demonstrated

what we long

suspected during

the era of nerve

stimulation: As long as

your needle tip is close

to the brachial plexus

at the interscalene

groove, injection of a

sufficient volume will

ensure a good block,

regardless of where

the injectate spreads.’

—Jeffrey Gadsden, MD


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sensory blockade to evaluate the degree of anesthesia after five, 10 and 20 min-utes had elapsed. After surgery, an anes-thesiologist blinded to the procedures evaluated ultrasound video and used a six-point quantitative score to rate the degree of distribution around visible nerves.

“We found that in about one-third of the blocks, the local anesthetic was com-pletely around and in between the nerve fascicles,” Dr. Orebaugh told Anesthe-siology News. “In the other two-thirds, the local anesthetic didn’t completely surround the nerve. In other words, it did not appear to have moved around the nerves to involve the entire medial side as well.”

The researchers also reported that when evaluated according to the nature of injectate distribution, no differ-ences were found between patients with early (<5 minutes), intermediate (5-10 minutes) or late block setup time (20 minutes). Similarly, no significant relationship was found between the duration of analgesia and injectate dis-tribution; the typical block lasted 17.6 hours (±4.8 hours; Table 2).

“There was a small tendency for those with complete surrounding of the nerves to have a faster setup, but it did not reach statistical significance,” Dr. Orebaugh added. The research-ers are planning to enroll more patients into the trial to tease out this finding.

The findings indicate that intersca-lene blocks for shoulder arthroscopy will have a high degree of success regard-less of the approach, Dr. Orebaugh said. “For the average shoulder proce-dure, I think that putting the needle in the groove and making certain that local

anesthetic is flowing into the groove, with visible spread adjacent to the nerves, is going to provide an adequate interscalene block,” he said. “You don’t necessarily need to go around each vis-ible fascicle and deliver local anesthetic to each one.”

Jeffrey Gadsden, MD, assistant pro-fessor of clinical anesthesiology at Columbia University College of Phy-sicians and Surgeons in New York City, said the study had important implica-tions for patient safety.

“With ultrasound guidance, many of us try to achieve circumferential spread around one or more trunks dur-ing interscalene block, often requiring multiple needle passes and increasing the risk for mechanical nerve injury,” Dr. Gadsden said. “These investigators have demonstrated what we long sus-pected during the era of nerve stim-ulation: As long as your needle tip is close to the brachial plexus at the interscalene groove, injection of a suf-ficient volume will ensure a good

block, regardless of where the injectate spreads.”

It remains to be seen, he added, if this relationship holds true with smaller vol-umes. “Is unilateral spread around a trunk sufficient if only 5 or 10 mL are used, or do we indeed need to strive for circumferential spread in these cases?” Dr. Gadsden asked. “Since many cen-ters are reducing their local anesthetic volumes substantially, this would be an interesting follow-up study.”

—Michael Vlessides

Table 2. Block Characteristics

Distribution Score 1-2

(n=1

0)

3-4

(n=1

0)

5-6

(n=1

2)

Setup TimeEarly (5 min) 0 0 3Intermediate (10 min) 4 6 5Late (20 min) 6 4 4

Mean duration, h 17.4 18.7 17Incision pain in PACU 0 0 1PACU, postanesthesia care unit



30

25

20

15

10

5

00 1 2 3 4 5 6 7

Dur

atio

n of

Blo

ck, h

Distribution Score

Figure. variation in distribution of anesthetic did not appear to affect block duration.


Laryngeal Mask Safety in Major Surgery Points to Wider Use

L aryngeal masks may be as safe as endotracheal tubes (ETs) for use in surgical procedures last-

ing more than three hours, a recent study has found.

The randomized, prospective trial, presented at the 2011 annual meet-ing of the American Society of Anes-thesiologists (ASA; abstract 1059), comprised 100 patients undergoing

radical retropubic prostatectomy. During procedures averaging nearly four hours, there were no cases of aspiration associated with laryngeal mask airways and fewer cases of intra-operative coughing, compared with the ET group. The study was funded by an unrestricted grant from LMA Deutschland GmbH.

“The use of LMAs appears to be

safe and a valuable alternative to ETs for this kind of major surgery in a selected group of patients,” primary investigator Daniel Reuter, MD, PhD, told Anesthesiology News. Dr. Reuter is vice chair of anesthesiology at the University Medical Center Hamburg-Eppendorf, in Germany.

Older laryngeal masks are jus-tifiably contraindicated in longer

procedures because of the risk for aspiration. Newer models that allow for gastric access and can drain gas-tric contents are likely associated with a lower risk for aspiration—or so hypothesized Dr. Reuter and his colleagues.

To test their theory, the research-ers randomly assigned the patients to receive airway management with either an LMA (LMA Supreme; LMA North America, Inc.) or endotracheal intubation. Both groups (50 patients each) were similar for premedication, use of spinal anesthesia and respirator settings. The mean age of the patients was 66 years and mean body mass index was 26.9 kg/m2; average ASA physical status was II.

The mean length of procedure was 230 minutes (±40 minutes). Dr. Reuter said no patient in either group experienced aspiration; how-ever, four patients in the LMA group and six in the ET group experienced postoperative nausea and vomiting. Seven patients in the ET group expe-rienced intraoperative coughing or choking, compared with none in the LMA group (P<0.01). Although the degree of impairment in lung func-tion was similar between groups immediately after surgery, spirom-etry testing at 24 hours revealed greater impairment in the ET group (P<0.05).

Dr. Reuter said that the only research to examine the safety of LMAs in surgical procedures lasting more than three hours was retrospec-tive and observational, and the results were not conclusive (e.g., Anaesthe-sia 2009;64:1289-1294). “The fact that ours is the first prospective study looking at this subject strengthens the importance of our results,” Dr. Reuter said.

However, Richard Galgon, MD, MS, assistant professor of anesthesi-ology at the University of Wiscon-sin School of Medicine and Public Health, in Madison, who was not involved in the trial, said method-ological weaknesses limit the ability to draw conclusions from the study.

“The most striking design limitation is the size of the study,” Dr. Galgon said. “The aspiration rate in adults is generally about four in 10,000, so it is not surprising that the researchers did not observe any aspirations in either group.”

—David Wild



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Walking Speed Good Marker For Surgical RecoverySan Francisco—An elderly per-son’s walking speed can predict how well he or she will fare after an opera-tion, according to a report at the 2011 annual clinical congress of the Ameri-can College of Surgeons.

Researchers from the University of Colorado, in Denver, reported that a simple walking test performed before surgery is a powerful tool for deter-mining the extent to which seniors will recover after heart or colorectal procedures.

“Our study showed that this timed up-and-go test is a very sharp predic-tor of complications and mortality,” said Daniel Wu, MD, study co-author and chief surgical resident at the Den-ver Veterans Affairs Medical Cen-ter, in a press release. “It’s a cheap and simple test that may eventually lead to a change in preoperative care. You really only need a stop watch to per-form this test, and the implications are huge.”

The findings come from a study of 195 patients aged 65 years and older who were scheduled for heart or colorectal surgery. Before surgery, the researchers gave the patients a short, timed walking test. Patients were asked to stand up from a chair, walk 10 feet, turn around, return to the chair and sit down. After completing the test, the patients were classified as fast (10 seconds or fewer), intermedi-ate (between 11 and 14 seconds) or slow (15 seconds or more).

Results showed that slower walking speed was associated with increased risk for complications, longer length of stay and higher rates of discharge to a medical institution after both cardiac and colorectal procedures. Among the 65 colorectal patients, the patients classified as slow spent more than twice as many days in the hos-pital as fast patients (14.4±12.4 vs. 6.3±4.1 days; P=0.009), and they were 10 times more likely to be dis-charged to an institution than home (59% vs. 5%; P=0.007). These patients also had significantly higher rates of complications (56% vs. 20%; P=0.0424). Similar differences were shown in patients undergoing heart procedures.

Walking speed is a good marker of physical frailty, the investigators said. A walking speed test may distinguish physiologically weak patients in a way that preoperative assessments of heart,

lung or kidney function might not.The simple walking test is a use-

ful tool that surgeons now can add to their preoperative evaluations of geri-atric patients, said Emily Finlayson, MD, assistant professor of surgery, University of California, San Fran-cisco. “It’s something that can be done fairly easily in the clinic. It just takes a minute, and this one simple measure really has a powerful ability to tell us whether patients are going to have complications, whether they are going to have prolonged hospital stays and where they are going to be going after surgery,” she said. Many of the other tests for frailty are cumbersome, she said. This one is not, and the results, although preliminary, are compelling.

“With this, we can have really informed discussions with our patients about what the expected out-comes are after their operations and also help with planning afterward. For instance, if you are somebody who is going to require acute rehabilitation after surgery, you can start organizing that even before surgery.”

Study co-author Thomas Robinson, MD, associate professor of surgery at Colorado, said he hopes this approach could lead to a more individualized way of deciding who should undergo surgery.

“We are designing tests to get away from chronologic age, and instead are now focusing on physiologic age,” Dr. Robinson said. “Ultimately, what we are trying to do is establish very simple tools that the average surgeon can use to determine who is going to fare poorly after an operation.”

The research is a proof-of-concept study, and more work is needed to develop an accurate tool for assess-ing geriatric patients, he added. The investigators are currently organiz-ing a multi-institution trial to confirm the results.



‘You really only need a

stop watch to perform

this test, and the

implications are huge.’

—Daniel Wu, MD


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“Med Marijuana” Fizzles in PONV TrialSide effects of injected THC halt study early, but expert sees reason for optimism

Chicago—Intravenous tetrahydro-cannabinol (THC), the active ingre-dient in marijuana, does not prevent postoperative nausea and vomiting in high-risk patients undergoing elec-tive surgery under general anesthesia, researchers have found. To the contrary, patients in the study group experienced

more sedation, confusion and anxi-ety than did controls, which led to the trial being stopped after 40 patients participated.

“Despite advances in medical research, we still see a lot of postoper-ative nausea and vomiting,” said Maren Kleine-Brueggeney, MD, senior fellow

at the University of Washington, in Seattle, who led the research. “Oral THC has been shown to prevent nau-sea and vomiting in cancer patients who receive chemotherapy, and anec-dotal evidence suggests that oral THC may prevent PONV. So we decided to perform our double-blind, randomized

controlled trial with intravenous THC.”

The investigators planned on enroll-ing 320 patients into the study; only 40 (39 women) participated before the trial was stopped. After accounting for smoking status and history of PONV, the patients were randomly assigned to receive either placebo or one dose of THC (0.125 mg/kg) IV 15 minutes before the end of surgery.

The incidence of postoperative nau-sea was similar for the study and con-trol groups (Table). Moreover, no differences were found with respect to vomiting in the first two hours (26% of patients receiving THC vs. 26% receiv-ing placebo), between two and six hours after surgery (0% for THC vs. 5% for placebo; P=0.35) or between six and 24 hours after surgery (13% for THC vs. 6% for placebo; P=0.44). Retching in the first two hours after surgery proved to be significantly more common in patients who received THC than in those who received pla-cebo (53% vs. 21%; P=0.04).

The time to extubation after sur-gery was longer for patients given THC than for controls (20±16 vs. 12±6 minutes; P=0.04). Patients in the THC group also had higher scores for confusion (P<0.01), anxiety (P=0.03), change of perception (P<0.01) and sedation (P<0.01) at admission to the postoperative care unit (PACU). These scores became equal at all time points between 30 minutes and 24 hours after admission to the PACU.

Patients who received THC also consumed significantly less fentanyl in the first two hours after surgery than those in the placebo group (P=0.03). One patient given THC experienced

Table. Incidence of Nausea

THC (n=19) Placebo (n=21) P value

Overall nausea 11/19 (58%) 14/21 (67%) 0.57

Early nausea (first two hours postoperative)

9/19 (47%) 10/21 (48%) 0.99

Nausea 2-6 hours postoperative

4/19 (21%) 6/21 (29%) 0.58

Late nausea (6-24 hours postoperative)

1/18a (6%) 3/21 (14%) 0.37

Highest nausea score (vAS)-10

3.7±3.5 4.1±3.2 0.65

THC, tetrahydrocannabinol; VAS, visual analog scale a Data missing for one patient.



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extensive mood swings during the first 24 hours after surgery. No signif-icant cardiovascular or respiratory side effects were observed, according to the researchers, who presented their find-ings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 834).

Despite the disappointing results, Dr. Kleine-Brueggeney said she is not ready to give up on the possibility that THC may prove to be an effec-tive postoperative antiemetic. “We were really positive about the effects of THC prior to the study because of the knowledge we had from chemotherapy patients, but it really seems to be differ-ent in this patient population.

“So perhaps in a different setting with a different dosage or a different form of administration it might work, but there is certainly not enough evi-dence to recommend THC for the prevention of PONV.”

Daniel I. Sessler, MD, chair of the Department of Outcomes Research at Cleveland Clinic, in Ohio, said the study was stopped too soon.

“PONV studies need hundreds of patients,” Dr. Sessler told Anesthesiol-ogy News. “The reported results are perfectly consistent with the 25% rela-tive risk reduction provided by ondan-setron, dexamethasone and droperidol. The investigators can’t rule out the expected effect. This is not a negative trial; it’s underpowered.”

In a related study (abstract 815), Dr. Kleine-Brueggeney’s group and col-leagues from the University of Miami Miller School of Medicine found evi-dence of a genetic effect on the metab-olism of THC.

“There is some evidence that cer-tain polymorphisms of the cytochrome P450 enzyme might have an effect on the pharmacodynamics and pharma-cokinetics of THC,” she said. “So we studied healthy volunteers [n=40] to

evaluate the effects of those polymor-phisms on the metabolism of THC.” The healthy, nonsmoking participants were screened for CYP2C9 polymor-phisms on chromosomal location 10q24; interim data are available for 16 patients to date.

The researchers found that a person’s CYP2C9*3 status significantly affected how much of the COOH-THC metabolite they produced—leading them to conclude that there is a slow metabolizer phenotype for CYP2C9*3.

In other words, genetic variation deter-mines the pharmacokinetics of THC and may impact vital signs and psycho-tropic side effects, thereby influencing clinical anesthesiology and potentially explaining the varied results noted in the Seattle group’s study.

“We observed very different effects between individual patients,” Dr. Kleine-Brueggeney added. “We had some patients who had had PONV previously, received THC and did not experience PONV

thereafter. We had patients who were very sedated and confused. And we also had patients who described it as an extremely positive experience. So even though there was a trend for an antiemetic effect of THC in our PONV trial, the psychotropic side effects were too pronounced and common to make the drug a suitable adjunct in the setting we chose for the study.”

—Michael Vlessides

Table. Incidence of Nausea

THC (n=19) Placebo (n=21) P value

Overall nausea 11/19 (58%) 14/21 (67%) 0.57

Early nausea (first two hours postoperative)

9/19 (47%) 10/21 (48%) 0.99

Nausea 2-6 hours postoperative

4/19 (21%) 6/21 (29%) 0.58

Late nausea (6-24 hours postoperative)

1/18a (6%) 3/21 (14%) 0.37

Highest nausea score (vAS)-10

3.7±3.5 4.1±3.2 0.65

THC, tetrahydrocannabinol; VAS, visual analog scale a Data missing for one patient.



You know ONLY capnography measures real-time adequacy of ventilation.

Only capnography measures adequacy of ventilation

as recommended by patient safety standards (ASA,

APSF, Joint Commission).1,2,3 No matter how you

measure respiratory rate, it gives you only a partial

picture of ventilation.

1 ASA Standards for Basic Anesthetic Monitoring, Committee of Origin: Standards and Practice Parameters (Approved by the ASA House of Del egates on October 21, 1986, and last amended on October 20, 2010 with an effective date of July 1, 2011) - Viewed 3-21-11 at ww.asahq.org/.../Standards%20Guidelines%20Stmts/Basic%20Anesthetic%20Monitor ing%202011.ashx

2 Stoelting R and Overdyk F. Anesthesia Patient Safety Foundation, Conclusions and Recommendations from June 08, 2011 Conference on Electronic Monitoring Strategies to Detect Drug-Induced Postopera-tive Respiratory Depression. Accessed August 25, 2011 at http://www.apsf.org/announcements.php?id=7.

3 Standards for Basic Anesthetic Monitoring. American Society of Anesthesiologists. Accessed 6/20/11 at http://www.asahq.org/For-Healthcare-Professionals/~/media/For%20Members/documents/Stan-dards%20Guidelines%20Stmts/Basic%20Anesthetic%20Monitoring%202005.ashx

But did you know Oridion Capnography

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by surgery, cancer chemotherapy and radiation ther-apy, is a serotonin type 3-receptor (5-HT3) antagonist. The FDA previously noted cardiovascular safety concerns indicating Zofran could pro-long the QT interval of the elec-trocardiogram, which can lead to the potentially fatal heart rhythm known as tors-ades de pointes.

In September, the agency announced it had reviewed all available infor-mation and added a new warning that Zofran should not be used in patients with congenital long QT syndrome because these patients are at particular risk for developing tor-sades de pointes. (Previous versions of the labels for ondansetron included a warning about QT inter-val prolongation.) The FDA also added recommen-dations for electrocardiogram monitoring in patients with electrolyte abnormalities, congestive heart fail-ure and brady-arrhythmias, or in patients taking other medications that can lead to QT prolongation.

Furthermore, the FDA is requiring drug manufac-turer GlaxoSmithKline to conduct a study to deter-mine the extent to which Zofran may cause QT interval prolongation.

The FDA action is a déjà vu moment for the anesthesia community, coming a decade after the agency in 2001 pushed for a black-box warning on another anti-emetic, droperidol. Many anesthesi-ologists felt then that the label change, which effec-tively removed droperidol from the armamentarium of drugs for postoperative nausea and vomiting, was an over-reaction.

How Much Concern Warranted?Despite all the concern, some clinicians said there’s

no reason to be nervous, in part because the relation-ship between 5-HT3 antagonists and QT prolonga-tion has been well known for years.

Last December, the FDA issued a warning about the use of the injection form of Anzemet (dolasetron mesylate) in pediatric and adult cancer patients with underlying heart conditions or heart rate abnormalities. The previous October, the agency changed the label for Kytril (granisetron hydrochloride) to state that the drug should be used with caution in patients with pre-existing arrhythmias or cardiac conduction disorders.

The anesthesiology literature also has documented QT prolongation as a potential side effect of onsanse-tron therapy. In fact, two studies published in the jour-nal Anesthesiology helped prompt the FDA review of Zoftran. The first study, by Charbit et al at Beaujon University Hospital in Paris, showed that onsansetron and droperidol increased the QT interval by 17 to 20 milliseconds in patients with postoperative nausea and vomiting (2008;109:206-212). The second study, also by Charbit et al, showed that the drug combination increased QT prolongation in healthy volunteers by an average of 28 milliseconds (2005;102:1094-1100).

“As anesthesiologists we see QTc prolongations in the range of 20 to 30 milliseconds with virtually

every anesthetic we provide,” said Christian C. Apfel, MD, PhD, associate profes-sor of anesthesia, epidemi-

ology and biostatistics at the University of California, San

Francisco, an an expert in postop-erative nausea and vomiting. “And

since anesthesia-related complications in otherwise healthy individuals are

exceptionally rare—on the order of 1 in every 300,000 cases—it is hard for us to

imagine that the use of ondansetron or droperidol, both which have a

much smaller effect on the QTc interval, as Dr. [Paul] White et al. have demonstrated for droperidol

in a well-designed randomized controlled trial, can lead to any meaningful cardiac outcomes.”

However, Dr. Apfel added, the challenge for cli-nicians is that even young and healthy-looking indi-viduals may have mutations on the HERG receptor, a potassium receptor in the cardiac rhythmogenic circuitry, and thus be at considerably higher risk for severe arrhythmias or cardiac arrest than the average population.

“This may be the tip of the iceberg we are seeing and why alternatives like palonosetron [Aloxi, Eisai], which does not possess the class-specific QTc prolon-gation effect, may be safer,” he said. “And this might be even more relevant for chemotherapy where higher doses are used.”

The fact that multiple 5-HT3 agents have been implicated has caused some experts, like Dr. Apfel, who has consulted for Eisai, to suggest QT prolonga-tion is a class effect; others still claim it is agent-spe-cific. (Earlier this year, a medical officer at the FDA chimed in by stating in a clinical review that QT pro-longation and other electrocardiographic changes are indeed “class effects” of 5-HT3 antagonists.)

James Kalus, PharmD, senior manager for patient care services in the Department of Pharmacy Services at Henry Ford Hospital in Detroit, said he and oth-ers continue to use Zofran, although they monitor for heart arrhythmias in specific patient populations, such as those with low potassium and magnesium or those who take other medications that cause QT prolongation.

Many antiemetics have similar risks, Dr. Kalus said, and some of the newer ones could be considerably more expensive. “At this point, I don’t have a sense of

the magnitude of the QT interval increase,” he noted. “An increase of 30 is worrisome; an increase of 60 is bad; but for a 10-millisecond increase, it may not be a big deal.

“Should [the FDA warning] be taken seriously? Yes, but I don’t think we should throw [ondanse-tron] away since we don’t know the magnitude of the problem. About 20% of drugs we use regularly have similar risks.”

Strength of Data QuestionedCynthia Sanoski, PharmD, chair of the Department

of Pharmacy Practice at the Jefferson School of Phar-macy at Thomas Jefferson University, in Philadelphia, said the data on QT prolongation from Zofran “is not the strongest evidence in the world. But if you use it in the wrong type of patient—someone with heart issues or on other drugs causing QT prolongation—it could result in a life-threatening emergency.” Physicians had been “giving out Zofran like water,” she added, but the FDA warning gives a reason to pause and take steps like checking patients’ magnesium and potassium lev-els before administering the medicine.

Ali McBride, PharmD, clinical pharmacy special-ist at Barnes-Jewish Hospital in St. Louis, said clini-cians may be liable if they don’t take steps to monitor patients on 5-HT3 drugs for QT prolongation. “The problem is that nobody has determined, with any degree of scientific rationale, just how much monitor-ing is required; how often it should be performed; and by whom,” he said. “I can tell you that there is a lot of concern and confusion on this issue among hematol-ogy/oncology pharmacists, and I’m not sure we know where to turn for answers.”

Dr. McBride also echoed Dr. Kalus’ point that there could be considerable financial fallout if clini-cians switch from ondansetron to a branded drug such as Aloxi that reportedly does not cause heart-rhythm abnormalities. Such a switch “could be a pharmacy budget buster, especially on the inpatient side,” he said.

Could the switching strategy ultimately be a cost saver, by reducing Zofran-induced rehospitalizations and lawsuits? “That argument could be made,” Dr. Mc Bride said. “But there is still a large ‘silo’ mentality in health systems. Those drug budgets are often viewed in a vacuum. If there is a big uptick in drug spending, eyebrows will definitely be raised, and not everyone will have the patience to wait for downstream savings to accrue.”

Risk Not Limited 5-HT3 DrugsOther types of drugs also can cause QT prolonga-

tion, Dr. Sanoski said, including Celexa (citalopram hydrobromide). In August, the FDA announced that Celexas no longer should be given at daily doses of more than 40 mg because of the side effect. But with antidepressants, she pointed out, there are so many options that a different drug can easily be selected. With nausea and vomiting, in contrast, “there are not a lot of great alternatives to the 5-HT3 receptor antag-onists such as Zofran. In most cases you are probably still going give the drug and document accordingly. I don’t see this as being any different from other drugs in this class of medications that have gotten the same warnings with regard to QT prolongation.”

—Karen Blum


‘Should [the FDA warning] be taken

seriously? Yes, but I don’t think we

should throw [ondansetron] away

since we don’t know the magnitude

of the problem. About 20% of drugs

we use regularly have similar risks.’

—James Kalus, PharmD


Zofran continued from page 1

ASCs Need Safety Protocols for Better Patient Transitions

A mbulatory surgery centers should implement protocols to transfer elderly patients

between care settings before and after surgery, according to a report in the October issue of the Journal of the Association of Peri-Operative Nurses (2011;94:348-361).

The number of surgical procedures performed annually in ambulatory sur-gery centers (ASCs) has risen dramati-cally over the past decade, surpassing the number of operations done in tra-ditional hospitals. At the same time, the patient population has become increasingly complex. ASCs now treat a greater number of older adults than in the past, and these patients are more likely to have multiple care provid-ers, comorbidities and a higher risk for complications related to transition of care, the authors of the report wrote.

Despite the changing patient pop-ulation, ASCs have been overlooked in health care organizations’ push to improve safety when moving patients from one health care setting to another. Transition protocols so far have focused on hospitals, but ASCs could incorporate some of these best prac-tices, which outline safety measures for transition between hospitals, according to the report.

“The ambulatory setting serves an increasingly complex patient popula-tion and provides the majority of elec-tive surgeries, and adapting some of the transition tools that have been tested in other settings will benefit health care providers and patients in the ambulatory setting,” the authors wrote.

The report detailed the few studies that looked at best practices for tran-sitions of care for ASC settings. In one study, researchers identified many gaps in transition processes as critical

safety issues, especially in the preop-erative period; these included gaps in communication between providers and between providers and patients, poor coordination of paperwork, lack of timing of instructions and an absence of standards of care (Ergonomics 2006;49:470-485). At least one other study came to similar conclusions (Cogn Tech Work 2007;9:219-231).

The authors also described several real-life cases in which poor transi-tions compromised patient safety and increased the cost of care. In one case, a 68-year-old man had to be trans-ferred to a hospital as an inpatient after experiencing airway compromise dur-ing his orthopedic surgery at an ASC. The center’s staff received only par-tial records that did not mention his

obstructive sleep apnea. In another sit-uation, a 68-year-old woman returned to her assisted-living facility after a radius repair, along with a filled pre-scription for narcotic analgesics. The nursing staff members were unable to allow her to take the medications or administer them without an order from her primary care provider.


‘The most important

thing an ambulatory

surgical center can do

is to appropriately select

a patient who should

be treated at one and

not at a tertiary care

or other facility.’

—Keith Metz, MD

POLiCY & MANAGEMENT

see AsC page 62

Bair Hugger® linked to implant infections

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“Disruption [by Bair Hugger®] in the ventilation of the surgical site was associated with significantly higher risks of joint sepsis...”

“Excess heat from forced-air warming resulted in [hot air convection currents] that transported floor-level air upwards and into the surgical

site. In contrast, conductive fabric warming did not release sufficient excess heat to establish these convection currents.”

“Air-free warming, therefore, is recommended over forced-air warming for orthopedic proce-dures.”

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Researchers told attendees at the 2011 annual meeting of the American Soci-ety of Anesthesiologists (abstract 710) that the consent forms they exam-ined were written at a grade-11 read-ing level, a full three levels higher than the grade-8 standard recommended by institutional review boards (IRBs).

The findings come as no surprise to William Tremaine, MD, direc-tor of the Office of Human Research

Protection at Mayo Clinic, in Roch-ester, Minn., who was not involved in the study. “Everyone knows research consent forms are too long and com-plicated,” Dr. Tremaine told Anesthesi-ology News. “These results underscore the importance of using consent forms as only one part of the informed con-sent process for research.”

Dr. Tremaine said that team mem-bers obtaining consent for stud-ies must go beyond what is written.

“Potential participants need to have an

opportunity to ask ques-tions, including ques-tions about the meaning of words and phrases in the written consent documents. They need to get answers in lay language they can understand so that they are fully informed about the details of the study.”

Templates for consent forms have been tested for readability, according

to the primary investi-gator Madhav Swami-nathan, MD. However, forms that are used rarely undergo scrutiny, he said. Dr. Swaminathan, associate professor of anesthesiology and director of periopera-tive echocardiography in the Division of Cardiotho-racic Anesthesiology and Critical Care Medicine at Duke University School

of Medicine, in Durham, N.C., along with his team, including high school student Param Sidhu, analyzed a ran-dom sample of IRB-approved consent forms. The investigators used five val-idated, standardized readability tests to analyze the consent forms that rep-resented 15 studies—some of which were ongoing at the time and the remainder completed at Duke or the University of California, Los Ange-les. Included in the analysis were four observational-noninterventional stud-ies, five observational-interventional studies, three evaluation studies and three randomized controlled trials (RCTs).

Dr. Swaminathan’s team found that the average reading level of the consent forms was grade 11, with the observa-tional-noninterventional studies rated at the highest reading level (grade 11.7; Figure). RCTs and evaluation studies were written at a mean reading level of grade 10.7. Although the RCT consent forms were more readable, they also included the most sentences and words, as well as the most complex words.


POLiCY & MANAGEMENT

consent continued from page 1

RandomizedControlled Trial

Observational-Nonintervention

Observational-Intervention

Evaluation

14.0

13.0

12.0

11.0

10.0

9.0

8.0

Gra

de R

eadi

ng L

evel

Flesch–Kincaid Grade Level ARI (Automated Readability Index) Coleman–Liau Index Gunning Fog Score SMOG Index Mean

Figure. Grade reading level by study type.

Henry Knowles Beecher, MD

Dr. Swaminathan said the findings have implications for the smooth con-duct of research. By ensuring that sub-jects have a firm understanding of the risks and benefits of involvement at the outset of their participation, the exe-cution of the study can improve. “Sub-jects who do not fully understand a consent form,” he said, “may initially consent to participate, but withdraw after realizing they are receiving an intervention or procedure they did not understand or agree with at the outset of the study.”

Although the grade-11 reading level is too complex for the average reader, it may be acceptable for research con-ducted in more educated populations, such as participants living in urban areas with more educational institu-tions, according to Dr. Swaminathan. In fact, he said, “that we manage to keep complex research worded at an 11th-grade level is itself an achievement.”

Adhering to a grade-8 reading level, however, is necessary for subjects with lower socioeconomic status and less education, Dr. Swaminathan said. “It may be prudent for IRBs and investi-gators to consider tailoring the reading level to the population served.”

The National Institutes of Health and the Department of Health and Human Services’ Office of Human Research Protection are soliciting com-ments to help improve the readabil-ity and usefulness of consent forms. Readers can submit comments to the Department of Health and Human Services at www.regulations.gov; enter docket identification number HHS-OPHS-2011-0005.

—David Wild


‘Everyone knows research

consent forms are too

long and complicated.’


‘Everyone knows

research consent

forms are too long

and complicated.’


POLiCY & MANAGEMENT

Contact the editor of Anesthesiology News

[email protected]

RandomizedControlled Trial

Observational-Nonintervention

Observational-Intervention

Evaluation

14.0

13.0

12.0

11.0

10.0

9.0

8.0

Gra

de R

eadi

ng L

evel

Flesch–Kincaid Grade Level ARI (Automated Readability Index) Coleman–Liau Index Gunning Fog Score SMOG Index Mean

Figure. Grade reading level by study type.

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“Postsurgical transitions can be com-plicated for the older adult with multi-ple caregivers,” the authors concluded.

“Poor communications between the primary caregiver, the ASC staff mem-bers and the specialist resulted in pain and suffering for the patient and increased the cost of care.”

The authors advised ASCs and their staff to consider using “transition tools” that have been tested in other settings.

The article identified several vali-dated forms and checklists that can be employed at each stage of the transi-tion process. The recommended tools come from groups such as the Cen-ters for Medicare & Medicaid Ser-vices, the Society of Hospital Medicine, The Hartford Institute for Geriatric Nursing, The Institute for Healthcare Improvement, The Care Transitions Program, Boston University and the International Anesthesia Research Society.

The authors recommended individ-ual ASCs develop protocols for mov-ing patients to the center, within it and from it to the patient’s home, assisted-living facility or other institutional setting. The authors suggested imple-menting electronic health records that cover patients through all phases of care, “especially during care transitions, to enhance communication and patient care and reduce error-related costs.”

The article highlighted an important issue for ASCs but did not provide

solid evidence that transitions pre-sented problems at these centers, said Keith Metz, MD, an anesthesiologist and medical director of Great Lakes Surgical Center, in Southfield, Mich.

“It’s an overview of potential concerns.”Most ASCs do have clear protocols

for transitioning patients, he added. “It’s an important issue that all ambu-latory surgical centers face. It’s some-thing that we talk about a great deal at our institution, where we do about 7,000 cases a year, including elderly patients.”

The real key to safe transitions is a careful selection process when evaluat-ing patients for surgery, Dr. Metz said.

“The most important thing an ambula-tory surgical center can do is to appro-priately select a patient who should be treated at one and not at a tertiary care or other facility.”

Dr. Metz questioned whether an electronic health record could play a role because privacy regulations restrict access to electronic medical records and make it impossible for one care center to access another’s computer system. However, he recommended incorporating a detailed discharge plan and thorough physician-to-physician communication throughout the care process involving ASCs.



POLiCY & MANAGEMENT

asc continued from page 59

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To the Editor:

I n the April 2007 issue of Anesthesiology News, we reported a simple technique for performing an interscalene block, based on a loss-of-resistance

(LOR) approach directly analogous to that in wide-spread use for epidural injections and catheters.

Since that time, we have refined this technique. In addition, we have performed several other blocks suc-cessfully using the LOR approach. We wish to report these developments here.

Refinements to the Interscalene Technique

The most important change in the technique is a shorter needle. Instead of the 2 1/8-inch Braun cathe-ter assembly (no longer in production), we have substi-tuted a 1.5-inch, 22-gauge needle with a short B-bevel.

The needle is placed with the bevel parallel to the skin, so that the mouth of the bevel comes into con-tact with the brachial plexus sheath all at once. This approach makes the resistance, and LOR, markedly easier to feel. We also have found that the advantages of a continuous technique are offset by the tendency of the catheter to kink, especially intraoperatively, when it is not easily reached under the drapes.

These considerations, plus the long duration of a bupivacaine/epinephrine block, prompted us to change to a single-shot method. It should be noted that the change to a shorter needle was caused by a case of pneu-mothorax referable to the longer catheter assembly.

With regard to other blocks, they are discussed below in order of number performed.

Caudal Epidural Block (n>800)

To identify the sacral hiatus, with the patient prone, lay the index finger of the left hand in the midline of the upper sacrum, flat and pointing cau-dad. Slide the finger to the right (caudad) until a gen-tle downward (ventral) inflection of the spine is felt. The distal phalanx of the finger comes to lie inside a shallow cup, which marks the sacral hiatus. The skin is prepped and a local wheal is placed slightly above the midpoint of the hiatus.

A full-thickness nick in the skin is made using a 1.5-inch, 18-gauge long-bevel needle. A two-inch, 21-gauge long-bevel needle attached to a 3 cc syringe of saline is introduced through this opening at a 30-degree angle, with the bevel facing downward. The tough sacrococcygeal ligament will be encoun-tered within a half to one inch, depending on the thickness of the adipose pad.

Advance the needle using firm pressure until a “give” is felt. At this point, test the resistance by push-ing the plunger of the syringe. If injection is easy, the tip of the needle will be in the caudal epidural space. If not, the needle should be advanced further until LOR is found. (In this block alone, a long-bevel needle is used because pushing a short-bevel needle through the tough sacrococcygeal ligament requires an uncomfortable amount of force.) The two-inch needle is long enough for all but the most obese patients.

Dosing for epidural steroid injections is about 18 cc of total volume. For operative cases (e.g., hemor-rhoidectomy), 12 cc of a more concentrated solution, such as lidocaine/bupivacaine, works well.

Ilioinguinal Nerve Block (n>150) Several conventional landmarks can be used. The

point 2 cm rostral and 2 cm medial to the anterior superior iliac spine is commonly employed. Prep and locally anesthetize the skin. Make a full-thick-ness skin nick using an 18-gauge, long-bevel nee-dle. Introduce a two-inch, 22-gauge short-bevel needle attached to a 3 cc syringe of saline at a 30-degree angle, with the bevel facing downward. A tough membrane will be present at a depth of about one inch (in a thin patient); this is the aponeuro-sis of the external oblique muscle. Advance the nee-dle slowly until the membrane “gives”—whereupon

injection should be easy. Depending on the strength of the solution, 20 to 60 cc may be injected. In obese patients, a longer needle (3.5–inch, short-bevel, 22 or 20 gauge spinal) may be necessary.

Popliteal (Sciatic) Block (n=10)Standard landmarks for the popliteal fossa may be

used. Perform the injection between the medial and lateral heads of the biceps femoris muscle, slightly above the equator of the space. Prep the skin and place a local anesthetic wheal. Make a full-thickness nick with an 18-gauge, long-bevel needle. Place a 22-gauge, 1.5-inch needle attached to a 3 cc syringe of saline into the opening at a 30-degree angle to the skin, aimed rostrally (for convenience). A thin mem-brane will be present at a depth of about 0.5 cm. Gentle pressure advances the needle easily through this membrane. Injection is easy, and 20 cc of local anesthetic may be administered with good effect. (Our attempts at continuous techniques here were not fully satisfactory because of leaking around the catheter, resulting from the thin surrounding tissue.)

Femoral Nerve Block (n=6)Use the standard landmark immediately lateral to

the femoral arterial pulse. In a thin patient, use a two-inch, 22–gauge, short-bevel needle. For a large patient, a longer needle, such as a 3.5-inch, 22-gauge Quincke spinal, may be necessary. In this procedure, the first resistance encountered is the fascia lata. This should not create ambiguity, because no LOR is found upon piercing this membrane. The second membrane encountered is the sheath of the femoral neurovas-cular bundle. Use a 3 cc syringe of saline to identify the LOR, followed by the injection of at least 40 cc of local anesthetic. (As an alternative, an 18-gauge, B-bevel introducer for a 22-gauge continuous block catheter may be used. With the bevel of the intro-ducer pointing downward, an excellent LOR is felt.)

All of the above blocks were performed by the author from 2006 to 2010, in the setting of a free-standing pain clinic located in Fall River, Mass. The author would like to acknowledge the encourage-ment of Henry Crowley, DO, in the development and application of these techniques.

—Edward Koh, MD, PhD Worcester Surgical Center

Worcester, Mass.


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Figure. Schematic of a loss-of-resistance (LOR) block using a B-bevel needle. The bevel faces the skin. Advancing the 20 degree tip at a 30 degree approach yields a 10 degree angle of incidence at the nerve sheath. This is nearly flush to the sheath, and produces a pronounced sensation of LOR.

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the december 2011 digital edition of anesthesiology news

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