cardiac consult - cleveland clinic · 2013. 12. 20. · cardiac resynchronization optimization p16...

VAD Program Takes a Leap Forward p10

CardiacConsult

Service Spotlight: Blood Management p3

Cardiac Resynchronization Optimization p16

Collaborative Research p8

Inside This Issue

Heart and Vascular News from Cleveland Clinic | Fall 2010 | Vol. XX No. 2

Featured Article

A Branched Endovascular Stentgraft for the Aortic Arch p5

Dear Colleagues,

This issue marks the 20th anniversary of Cardiac Consult. The purpose of this

publication is to keep our colleagues across the nation up-to-date with what our

team is doing here at the Sydell and Arnold Miller Family Heart & Vascular Insti-

tute at Cleveland Clinic and share our insights on cardiac and vascular care. We

are grateful for the many thousands of readers who have enjoyed this publication

over the years and we appreciate your comments and suggestions. Cardiac Con-

sult will continue to be an important part of our physician outreach endeavors.

This year, Cleveland Clinic also celebrates its 16th year in a row

as America’s #1 center for cardiac care in U.S. News & World

Report’s annual “Best Hospitals” survey. We don’t take this honor

for granted. We know we have to earn it, year after year, by focus-

ing on outcomes, patient experience, and attentive collaboration

with our physician partners. Your confidence in us inspires us to

do better every day.

The variety of articles in this issue of Cardiac Consult reflects the broad range

of interests in our field. Our cover story highlights the quiet breakthroughs

being made in the development of stent grafts for aneurysms of the aortic arch.

The story on “bloodless” surgery updates the Miller Family Heart & Vascular

Institute’s continued work in blood conservation, where the push for more

efficient blood use and respect for patient beliefs have resulted in improved

surgical methods. The articles on left-ventricular assist devices and cardiac

resynchronization therapy share useful knowledge on topics where Clevleand

Clinic has particular expertise.

We are proud to be medical editors of this 20th anniversary issue of Cardiac

Consult. We’d like to thank the writers, designers and editors who have

collaborated on this publication over the decades. The pace of innovation at

the Miller Family Heart & Vascular Institute assures us that Cardiac Consult

will have much to communicate in the days and years to come.

Sincerely,

Christopher Bajzer, MD Sean Lyden, MDAssociate Director, Peripheral Intervention Staff Surgeon, Interventional Cardiology Vascular Surgery

A. Marc Gillinov, MDThe Judith Dion Pyle Chair in Heart Valve ResearchThoracic and Cardiovascular Surgery

| Cardiac Consult | Fall 10 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

Cardiac Consult offers updates on state-of-the-art diagnostic and management techniques from Cleveland Clinic heart and vascular specialists. Please direct correspondence to:

Medical Editors

Christopher Bajzer, MDA. Marc Gillinov, MD Sean Lyden, MD [email protected]@[email protected]

Managing Editor

Ann Milanowski

Art Director

Michael Viars

Marketing Manager

Megan Frankel

Marketing Associate

Jason Lansdale

Photographers

Neil Lantzy Russell Lee Steve Travarca

clevelandclinic.org/heart offers informa-tion on new procedures and services, clini-cal trials, and upcoming CME symposia, as well as recent issues of Cardiac Consult.

The Sydell and Arnold Miller Family Heart & Vascular Institute, ranked No. 1 in the nation for cardiac care by U.S.News & World Report every year since 1995, accommodates nearly 300,000 patient visits each year in world-class facilities. Staff are committed to researching and applying state-of-the-art diagnostic and management techniques. Cleveland Clinic is a not-for-profit, multispecialty academic medical center.

Cardiac Consult is written for physicians and should be relied upon for medical education purposes only. It does not provide a complete overview of the topics covered, and should not replace the inde-pendent judgment of a physician about the appropriateness or risks of a procedure for a given patient.

© The Cleveland Clinic Foundation 2010

Service SpotlightBlood

Management

Why blood management?

Blood is a limited resource. While blood transfusion is neces-sary and certainly saves lives in some patients, our research shows that blood also has negative effects, says Colleen Koch, MD, MS, MBA, Professor of Anesthesiology, Vice Chair of Research and Education in Cleveland Clinic’s Department of Cardiothoracic Anesthesiology.

Dr. Koch’s work has found that many problems exist when patients receive blood transfusions. Her 2008 study, which appeared in the New England Journal of Medicine, reported patients who receive transfusions with blood that has been stored more than 14 days are likelier to suffer complications and may face reduced short- and long-term survival.

Prior research by her team has shown that the risk of comp-lications, even death, in heart surgery patients increases with blood transfusions.

“Our findings suggest a need for more studies to examine what level of anemia requires a blood transfusion and the specific changes that take place when blood is stored for increased duration periods,” Dr. Koch says.

Steps for reducing usage

Cleveland Clinic’s Blood Management team develops treat-ment options based on the patient’s specific blood needs. Care plans can help physicians and patients understand the benefits and risks of each option in order to make a well-informed decision.

The patient’s initial complete blood count (CBC) is obtained prior to surgery and used to develop a treatment plan. Options may include: • Vitamin supplements (vitamin B12, folic acid, vitamin C)

• Iron supplementation for repletion (oral or intraveneous)

• Erythopoietic stimulating agents

• Dietary education

The team also works with patients to help them understand why he or she may need a blood transfusion, the risks and benefits, alternatives and making certain the they have enough information to make decisions.

Changes in the OR

Many changes also have taken place in the operating room over the past three years to try to reduce transfusion rates, says Joseph F. Sabik, MD, Chairman of Thoracic and Cardiovascular Surgery.

“While we can’t eliminate our need for blood completely, we can reduce it,” Dr. Sabik says. “Blood utilization depends on how ill the patient is, the extensiveness of the operation and whether the patient is anemic or not going into surgery.”

The use of cell savers, or autologous blood salvage systems, is one method of reducing the need for blood products in the OR. Cleveland Clinic also is working to improve heart-lung machine technology to minimize blood loss.

At Cleveland Clinic, a comprehensive Blood Management

program aims to reduce allogenic blood exposure to maximize

patient safety. As a result of these efforts, we have seen a

20 percent decrease in blood transfusions in the past year.

Visit clevelandclinic.org/heart | Cardiac Consult | Fall 10 |

continued on next page ➦


“We are working on designing the circuit to both miniaturize it and make it less harmful to the patient. We have added a leukocyte filter to decrease inflammation, improving the circuit so that it is less harmful that will lead to less bleeding.”

For example, because the circuit used is so small, Dr. Sabik says, the perfusionist is able to decrease the volume of fluids given from the typical liter and a half to between 200 and 250 ccs. “Patients experience less bleeding afterwards because their clotting factors don’t get diluted.”

Negative suction, which was popularized in the 1990s by Cleveland Clinic president and CEO Delos M. Cosgrove, MD, also continues to be utilized to ensure there is adequate

blood return.

“All of these methods, as well as being meticulous as surgeons to eliminate surgical bleeding, go a long way in decreasing our blood utilization,” Dr. Sabik says.

Education and collaboration are key

Another key aspect to reducing blood usage, say Drs. Koch and Sabik, is education.

“To decrease usage, we need to change people’s way of think-ing,” Dr. Koch explains. “We need our staff to stop and think, ‘Do I really need this red cell unit?’ ”

To help educate its staff, Cleveland Clinic hosts an annual Blood Management Summit (see back cover for more details), which invites physicians from different specialties for an inter-disciplinary dialogue to explore avenues for reducing allogeneic transfusion and optimizing the care of anemic patients.

“Our approach to decreasing our usage is multi-faced – includ-ing medical, surgical, research and educational components,” Dr. Sabik concludes.

Agrees Dr. Koch, “We try to apply all evidence-based medicine in terms of blood management to our population. In addition to that, we continue to educate our staff with research that is ongoing here at our own institution.”

Dr. Sabik can be reached at 216.444.6788 or [email protected] and Dr. Koch can be contacted at 216.445.7418 or [email protected].

A Branched Endovascular Stent Graft for the Aortic Arch

| Cardiac Consult | Fall 10 | Visit clevelandclinic.org/heart

continued on next page ➦

Mr. Hanna (a non-smoker) had congestive heart failure, a

coronary stent, pulmonary issues, and few options. Age and

comorbidities blocked his candidacy for open surgical repair

and the site of the lesion seemed to rule out most of the

conventional endovascular repair alternatives.

But, as Mr. Hanna put it, “some guys get all the breaks.”

His local cardiologist referred him to the Miller Family

Heart & Vascular Institute at Cleveland Clinic, where

vascular surgeon Roy Greenberg, MD, has developed

numerous stent grafts for endovascular repair of awkwardly

sited aortic aneurysms. Mr. Hanna, it turned out, was the

perfect candidate for Dr. Greenberg’s most recent design:

a branched endovascular stent graft specifically designed

for the aortic arch.

“Mr. Hanna’s situation highlights our limitations in treating

aneurysms of the aortic arch in older patients with

comorbidities that have contraindications for conventional

surgery,” says Dr. Greenberg. “His was one of the many

cases we see that call for a purely endovascular approach.”

Aneurysm and dissection of the aortic arch can be

clinically challenging. Medical treatment includes beta-

blockade to control heart rate and blood pressure, and

statins to stabilize plaque. When an aneurysm reaches 5.5

cm in diameter, it has an 8 percent annual risk of rupture.

They may progress to dissection or intramural hematomas,

or otherwise manifest acute aortic syndrome. Surgery is

indicated at that point.

In July 2009, 81-year-old David Hanna got sobering news. A CT scan showed a ball-shaped, 6-centimeter aneurysm swelling of his aorta opposite the blood vessels supplying his brain and upper extremities. A swelling of this size was at risk of fatal rupture without intervention.


“Medical management may mitigate risks,” says Dr. Greenberg,

“but it does not prevent or markedly alter the natural history of

the aortic disease to grow, rupture or dissect.”

Mr. Hanna’s CT was first referred to Bruce Lytle, MD, cardiac

surgeon, and chair of the Miller Family Heart & Vascular

Institute. Dr. Lytle reviewed the CT and called in Dr. Greenberg.

“Most cardiothoracic surgeons agree that risks for open

surgery increase markedly when the aneurysms are

extensive, in older patients, in patients with prior open

heart surgery, and in the setting of significant comorbidities

or emergencies,” says Dr. Greenberg. “Median sternotomy,

cardiopulmonary bypass or profound hypthermia all risk

stroke, death or prolonged hospitalization for these patients.”

Working with personnel from Cleveland Clinic’s Department

of Biomedical Engineering and Cook Incorporated, Dr.

Greenberg helped to develop an endovascular stentgraft

with notable features:

• It could bend to accommodate the typical 270 degree

curvature of the aortic arch;

• It had flexible branches to the supra-aortic vessels;

• It could seal within the ascending aorta (unlike existing

stents that sealed within the arch, and can’t be used in

large aneurysms of the mid or proximal arch);

• It came in four sizes off the shelf.

The device is not available for general use, and trials had

not yet been planned or designed, but Mr. Hanna was

eligible for compassionate use through the Food and Drug

Administration program. Only a few devices of this sort had

been implanted, and Dr. Greenberg was present for most of

them. Mr. Hanna’s was to be the first at Cleveland Clinic.

The treatment began in March 2010, with a bypass

placed to connect the left common carotid artery with

the subclavian artery. This is a simple procedure with a

brief hospital stay and minimal risks. After the device was

manufactured specifically for Mr. Hanna’s anatomy, he was

taken to one of the hybrid operating rooms at the Miller

Engineering a Stentgraft

Biomedical engineers in the Cleveland Clinic

Lerner Research Institute work closely with

vascular surgeon Roy Greenberg, MD, to design

new endograft devices for specific arteries. Once

the specifics of the device are determined, the

scientists make sure the materials and design will

function well in the intravascular environment.

Using CT data, they help determine where the

branches and fenestrations should be located

on the endograft to make them serviceable to

the largest number of patients through a variety

| Cardiac Consult | Summer 10 | Visit clevelandclinic.org/heart

Family Pavilion on June 3, 2010. The device was inserted

through a groin artery and deployed while his heart was

stopped briefly (less than one minute) using a pacemaker

set at a rapid beat. Dr. Greenberg used other adjuncts

to help with the positioning of the device specifically by

overlaying the preoperative CT scan with the fluoroscopic

image, minimizing the need for contrast, and shortening

the overall procedure time.

The patient went home about four days after the operation

and is doing well. “If this were a conventional surgery,” says

Dr. Greenberg, “he might have been in the hospital 10 days

to two weeks.”

Dr. Greenberg hopes that his device will become a versatile,

easy-to-use stentgraft that can be mated with customized

grafts and used off the shelf in an emergency.

Dr. Greenberg can be reached at 216.444.4508 or

[email protected].

of positions. “The goal,” says Dr. Greenberg

“is to create a standardized device that will

accommodate as many patients as possible.”

When a “standard” design has been determined,

a prototype is developed on the computers and

built with the specified materials. Dr. Greenberg

approves the prototype, and sends it to Cook

Medical, Australia, where it is built. Each design

modification is submitted for approval by the FDA

under investigational device exemption.

Endovascular stentgrafts need to be anchored

and sealed in healthy tissue. That means the

surgeon needs to find a certain length of healthy

tissue to either side of the aneurysm – a “landing

zone” – to maneuver the device during placement,

and anchor and seal the distal and proximal

ends. Finding a suitable landing zone can be a

challenge in the presence of tortuous anomalies

or certain population characteristics. Asians

and women, for instance, often have common

iliac arteries that are frequently shorter and

wider than non-Asian populations. This makes it

particularly difficult to find a suitable landing zone

for stentgrafts meant to repair abdominal aortic

aneurysms involving the common iliac arteries in

Asians. (Writing in the Journal of Endovascular

Therapy, Stephen W.K. Cheng, MS, FRCS, et al,

of the University of Hong Kong Medical Center,

notes “the application of stent-grafts in Asians

poses additional challenges unique to their

smaller body build.”)

Roy Greenberg, MD, a vascular surgeon in

the Miller Family Heart & Vascular Institute,

has designed an endovascular stentgraft that

addresses this anomaly – which applies to some

non-Asians as well.

It is termed a bifurcated-bifurcated internal

branch device. The main body of the device

fits in the abominal aorta. It has a branch going

down into the common iliac artery with an

additional side-branch that allows for access

into the involved internal iliac artery.

Dr. Greenberg expects that there will be some

demand for this device. Smoking is the leading

risk factor for aortic aneurysms of all types,

and East Asia (according to the World Health

Organization) has the highest smoking rate in

the world.

Aneurysm Repair for Asian Morphology


Cleveland Clinic is among 10 major medical centers in the U.S. and Canada participating in the Cardiothoracic Surgical Trials Network (CTSN), which facilitates the development and coordination of collaborative research studies and interventional protocols to improve cardiovascular disease treatment outcomes.

Specifically, CTSN enables leading cardiac surgeons and car-diologists to evaluate the efficacy of newer surgical techniques and devices, as well as innovative pharmaceutical and bioen-gineered products. The Cleveland Clinic effort is being led by Eugene Blackstone, MD, (PI) head of Clinical Investigations at the Miller Family Heart & Vascular Institute, and cardiac surgeon A. Marc Gillinov, MD, (co-PI), with highly capable re-search coordinators within the framework of Cleveland Clinic’s clinical trials organization, the Cleveland Clinic Cardiovascular Coordinating Center (C5).

“CTSN is currently engaged in critically important random-ized controlled clinical trials in cardiac surgery,” explains Dr. Gillinov, MD. “Well conducted randomized controlled clinical trials in cardiac surgery are extremely rare, and their perfor-mance is very challenging. However, CTSN has accepted this challenge and it is thriving.”

The clinical trials currently underway are:

• Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgita-tion (SMR) – The SMR study will determine whether it is bet-ter to repair or replace the mitral valve of patients with severe mitral valve regurgitation from coronary artery disease.

• Surgical Interventions for Moderate Ischemic Mitral Re-gurgitation (MMR) – The MMR study will evaluate whether repairing a mitral valve with moderate leakage at the time of planned coronary artery bypass graft surgery will improve health outcomes of those who received it compared to those who have bypass surgery alone.

• Surgical Ablation versus No Surgical Ablation for Patients with Persistent or Longstanding Persistent Atrial Fibril-lation Undergoing Mitral Valve Surgery – The AF trial will explore whether surgical atrial fibrillation ablation performed during scheduled mitral valve surgery is better than mitral valve surgery by itself without surgical ablation.

• Management Practices and the Risk of Infection Following Cardiac Surgery – This observational study will determine the best ways to prevent infections after heart surgery.

Answering important questions

“These are the sorts of large trials that require participation of multiple institutions. No single program could complete these studies,” says Dr. Gillinov. “This multi-institutional collabora-tive initiative will answer important questions that have been lingering within cardiothoracic circles for three decades.”

For example, with one-year mortality rates as high as 40 percent among SMR patients, guidelines recommend surgical intervention even though there is a lack of conclusive evidence supporting the long-term comparative benefits of repairing or replacing a patient’s mitral valve. According to CTSN, sur-geons must weigh the trade-off between the reduced operative morbidity and mortality associated with repair versus the better long-term correction of mitral insufficiency with replacement. Its SMR study, which recently enrolled its 100th patient, is expected to recruit 250 patients by spring 2011.

Likewise, it is not clear whether routine mitral valve repair, in addition to revascularization, is a beneficial treatment for MMR patients. Nearly 90 patients have been randomized to date for CTSN’s MMR trial.

Collaborative ResearchCardiothoracic network studies expected to answer longstanding questions about cardiac surgery interventions


Improving care and outcomes

“Cleveland Clinic is participating in these trials at a high level across the board as we are working closely with our internal cardiologists and referring cardiologists to optimize enrollment. These studies, and future ones, will increase our knowledge and ultimately enhance patient care and outcomes,” says Dr. Gillinov. Results from these trials are expected within two to three years.

In addition to Cleveland Clinic, the participating CTSN clinical centers include Columbia University, Duke University, East Carolina Heart Institute, Emory University, Montefiore Einstein Heart Center, Montreal Heart Institute, NIH Heart Center at Suburban Hospital, University of Pennsylvania and University of Virginia.

The CTSN already is considering the next round of trials, which may include hybrid revascularizations, Dr. Gillinov says. “Other studies may examine the effects of stem cells

Producing the next generation of clinical researchers

As part of the CTSN, Cleveland Clinic and Duke University are the two designated centers selected to train surgeon-inves-tigators to become clinical researchers. This training is headed by Edward Nowicki, MD, and involves an intensive formal education program at Case Western Reserve University, mentored research, and career development.

The National Heart, Lung and Blood Institute, the National Institute of Neurological Disorders and Stroke at the National Institutes of Health, and the Canadian Institutes of Health Research support CTSN.

Contact Dr. Gillinov at 216.445.8841 or [email protected]. Contact Dr. Blackstone at 216.444.6712 or [email protected].

CTSN designed and initiated its AF study with Dr. Gillinov as the head of the protocol development group, as a comparative effectiveness randomized trial of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with persistent AF undergoing mitral valve surgery. Nested within this trial is a further randomized comparison of two different lesions sets, pulmonary vein isolation and the full Maze lesion. Recently opened for enrollment, the trial has randomized about 30 patients.

Although prior studies have evaluated the relationship be-tween patient baseline characteristics and infections following cardiac surgery, CTSN’s trial, led by Dr. Blackstone, will as-sess the relationship between routine practices (i.e. line and ventilator management, etc.) and postoperative infection risk. More than 4,000 patients have been enrolled in this prospec-tive cohort study.

to improve cardiac function in patients with moderate to severe heart failure, or pharmaceutical trials to look at the impact of different antiplatlet agents for patients undergoing cardiac bypass surgery.”

In the interest of fostering collaborative interaction with the broader surgical community, CTSN will consider clinical research ideas from colleagues in the surgical community, allied health specialties and academic areas who are not part of the network. For more information, please visit www.ctsurgerynet.org.


Country’s Oldest and Largest VAD Program Takes a Leap Forward

Cleveland Clinic now offers mechanical circulatory support as a routine treatment option for NYHA class IV heart failure. The development results from the confluence of two critical factors: experience and expertise gained from two decades of working with ventricular assist devices (VADs), and FDA approval of Tho-ratec’s HeartMate II, a VAD with an excellent record of extending survival and improving quality of life.

“We are able to treat patients who come to us in need of a VAD and also offer VADs to patients who are extremely ill in order to help them recover,” says Cleveland Clinic cardiac surgeon Gonzo Gonzalez-Stawinski, MD.

Although heart transplantation remains the gold standard for end-stage heart failure, the number of donor hearts has remained stable while the number of patients with advanced heart failure has continued to grow. Recent advances in VAD technology enable new devices to bridge the gap. As a result, in 2009 Cleveland Clinic implanted more VADs (81) than performed heart transplants (57).

“VADs provide an exciting new option for these extremely ill patients. Results have been excellent, with a consistent 90 percent in-hospital survival rate and low rates of stroke and infection,” says Dr. Gonzalez-Stawinski.

Improving outcomes

Cleveland Clinic has extensive experience with clinical trials of mechanical circulatory support systems, including the Heart-Mate II, a non-pulsatile, continuous flow pump. In January 2010, the FDA approved the HeartMate II as destination ther-apy. The device had been approved as a bridge to transplant in April 2008. Dual approval enables all patients with advanced heart failure to be considered for destination therapy.

“We have made a conscientious effort to use only one pump. Developing a familiarity with it enables us to identify problems and intervene early,” Dr. Gonzalez-Stawinski explains.

In addition, the device offers many benefits.

“Ease of implantation and low morbidity and mortality speak volumes about how the technology has moved forward. Its biocompatible design reduces the risk of emboli, infection and stroke. Once implanted, the pump requires little care. In fact, most people forget they have it,” he says.

Assessment of candidacy

The evaluation process for a VAD is similar to that for heart transplantation. Candidates are evaluated by a cardiologist, cardiac surgeon, social worker, VAD nurse, psychologist and bioethicist.

The program has no upper age limit. Rather, careful consider-ation is given to appropriate use of available resources.

“Donor hearts are limited, so we reserve transplantation for patients who are otherwise healthy, except for their heart. I would consider anyone else for a VAD,” says Cleveland Clinic cardiologist Maria Mountis, DO.

Mechanical circulatory support now a mainstay of heart failure therapy


The ideal VAD candidate is NYHA class III or IV, experiencing frequent heart failure hospitalizations, requiring escalating diuretic doses, with lab values indicative of chronic heart failure and intolerance to their heart failure medical regimen. The patients must be compliant, able to care for the mechanical device and its drive line and have a strong support system.

“When a physician has nothing else to offer these patients, they may be candidates for a VAD,” says Dr. Mountis. “We would prefer that referring physicians not wait until they are too sick to send them for evaluation.”

Contraindications include biven-tricular heart failure, psychological problems, extreme neurological dis-ability, poor family support or limited financial resources.

According to the doctors, some bridge-to-transplant patients are so satisfied with their VAD they decide not to proceed with transplantation.

“We are usually successful in getting patients back to NYHA class I. Many are able to return to school or to work, travel and enjoy life again,” says Dr. Mountis.

The HeartMate II has a life expectancy of five to 10 years. If a technical or mechanical issue occurs, replacement may be considered.

Immunosuppressants are not needed. Patients are maintained on heart failure medications and require frequent checkups. Most patients experience a dramatic improvement in health

and quality of life.

Future plans

Although Cleveland Clinic is delighted with the results obtained with the HeartMate II, the researchers

continue to investigate other forms of mechanical circulatory support. They are currently participating

in clinical trials of the HeartWare VAD and Syncardia’s Total Artificial Heart (TAH) as

bridge to transplant.

A third-generation VAD, HeartWare has a single moving part, an impeller, which

is suspended by magnets. The rotating turbine propels blood through the body. No friction is generated, so the device contains no parts to wear out.

“We are looking closely at the HeartWare VAD. It is small,

and its components are easy to work with. The drive line is extremely small. No pump pocket required; it is implanted directly into the chest,” says Dr. Gonzalez-Stawinski.

FDA approval is expected by 2012.

“A fully implantable VAD is being researched and is not far in the future,” says Dr. Mountis.

Contact Dr. Gonzalez-Stawinski at 216.444.6708 or [email protected]. Contact Dr. Mountis at 216.636.6101 or [email protected]


BriefIn

Socioeconomic position, not race, is linked to death after cardiac surgery

Lower socioeconomic position (SEP), but not race, is

associated with a notably increased risk of mortality

following cardiac surgery, according to a study by

Cleveland Clinic researchers that appeared in the

May 1 issue of Circulation: Cardiovascular Quality

and Outcomes.

The study, by Colleen G. Koch, MD, MS, MBA,

Cardiothoracic Anesthesiology, examined 23,330

patients who underwent isolated coronary artery

bypass grafting, valve, or combined coronary artery

bypass grafting and valve procedures from Jan. 1,

1995 through Dec. 30, 2005.

It concluded that disparities in SEP are present

and significantly affect health outcomes. Although

race per se was not the driver for reduced survival,

patients of low SEP were predominantly represented

by blacks and women. Socioeconomically

disadvantaged patients had significantly higher

risk-adjusted mortality after surgery. The authors say

further investigation and targeted intervention should

focus specifically on patients of low SEP, their health

behaviors, and secondary prevention efforts.

Genetic test can help heart transplant patients

A genetic test can help some heart transplant

patients avoid frequent biopsies, a new study says.

The study, published in the New England Journal

of Medicine, examined 602 patients who had

undergone cardiac transplantation six months to five

years previously to be monitored for rejection with

the use of gene-expression profiling or with the use

of routine endomyocardial biopsies, in addition to

clinical and echocardiographic assessment of graft

function. The authors performed a noninferiority

comparison of the two approaches with respect to

the composite primary outcome of rejection with

hemodynamic compromise, graft dysfunction due to

other causes, death or retransplantation.

Randall Starling, MD, MPH, Section Head, Heart

Failure & Cardiac Transplant Medicine, and co-author

of the study, says the findings suggest that whether

a gene test is used or not, doctors perform too many

biopsies in monitoring low-risk patients for rejection.

Study to examine how genes and diet affect heart disease development

Stanley Hazen, MD, PhD, Section Head, Preventive

Cardiology, has received a $3.8 million federal grant

to study how an individual’s genes and diet interact

in the development of heart disease.

The five-year, NIH-sponsored study will focus on

whether gut flora metabolism of dietary lipids is

linked to cardiovascular disease. Dr. Hazen, who

serves as PI on the grant, and his colleagues, Joseph

DiDonato, PhD, Cell Biology; W.H. Wilson Tang, MD,

Cardiovascular Medicine and Cell Biology; Zeneng

Wang, PhD; Stephen J. Nicholls, MD, PhD; and

Steven Nissen, MD, hope the work can create new

treatments to prevent heart disease.

Even small amounts of coronary atherosclerosis leads to poor outcomes

A study led by Stephen J. Nicholls, MD, PhD,

Cardiovascular Medicine, appearing in the May

25, 2010 issue of the Journal of the American


College of Cardiology, reports a direct relationship

between the burden of coronary atherosclerosis, its

progression and adverse cardiovascular events.

The team examined coronary plaque progression

in more than 4,000 patients in six clinical trials

that used serial intravascular ultrasound. It found

plaque growth of less than 1 percent over an 18- to

24-month period predicted poor outcomes, including

heart attack, bypass or angioplasty surgery, or death.

The authors say the data supports the use of

atherosclerosis imaging with IVUS in the evaluation

of novel antiatherosclerotic therapies.

AtriClip for left atrial appendage occlusion approved in U.S.

The AtriClip Gillinov-Cosgrove Left Atrial

Appendage (LAA) Exclusion system

(AtriCure, West Chester, Ohio) has been

approved by the FDA for occlusion of

the LAA, under direct visualization, in

conjunction with other open cardiac

surgical procedures.

The device, co-developed by Delos

Cosgrove, MD, President and CEO of

Cleveland Clinic, and A. Marc Gillinov, MD, Surgical

Director of the Center for Atrial Fibrillation, is

designed to be implanted from outside of the

heart, avoiding contact with circulating blood

and eliminating blood flow between the left atrial

appendage and the atria. The device can help

eliminate blood clots that could lead to strokes in

patients with atrial fibrillation. Cleveland Clinic has

a financial interest in AtriCure.

Compliance high among patients with wearable cardioverter defibrillator

A study by Cleveland Clinic researchers finds that

survival and mortality rates were similar among

patients with a wearable cardioverter defibrillator and

those with an implantable cardioverter defibrillator.

The study by Mina K. Chung, MD, Cardiovascular

Medicine, which appeared in the Journal of the

American College of Cardiology, examined more

than 3,500 patients to determine patient compliance

and effectiveness of antiarrhythmic treatment by

the wearable cardioverter-defibrillator (WCD).

The study found that compliance was satisfactory

with 90 percent wear time in greater than 50

percent of patients and low sudden death mortality

during use. The authors say survival was comparable

to that of ICD patients. However, they note, asystole

was an important cause of mortality in sudden

cardiac arrest events.


Cardiovascular Medicine

Cardiac Imaging

Deborah Kwon, MD, has joined the

Cardiac Imaging section at the Miller

Family Heart & Vascular Institute.

Dr. Kwon received her medical degree

from the University of Michigan

Medical School. She completed

her residency at the Hospital of

the University of Pennsylvania and her fellowship at

Cleveland Clinic. Her specialty interests include cardiac MRI/

CT, ischemic cardiomyopathy, valve disease, hypertrophic

cardiomyopathy, and women and heart disease.

Juan Carlos Plana, MD, has joined

Cleveland Clinic’s Cardiac Imaging

section. Dr. Plana received his

medical degree from Pontificia

Universidad Javeriana School of

Medicine, Bogota, Columbia. He

completed both his residency and

fellowship at Baylor College of Medicine Affiliated Hospitals,

Houston, Texas.

Zoran Popovic, MD, PhD, has joined the Cardiac Imaging

section at Cleveland Clinic. Dr. Popovic received his medical

degree from Belgrade University Medical School, Yugoslavia,

where he also completed his residency and a fellowship. He

also completed a fellowship at Cleveland Clinic. His specialty

interests include echocardiography and ventricular function.

Sagar Kalahasti, MD, has joined Cleveland Clinic’s Cardiac

Imaging section. He has received his medical degree

from Sri Venkatesvara University Medical College-Tirupati,

Tirupati, India. He completed his residency and fellowship

at Cleveland Clinic.

Wael Al Jaroudi, MD, has joined the Cardiac Imaging

section. Dr. AlJaroudi received his medical degree from the

American University of Beirut, Lebanon. He completed his

internal medicine residency and a cardiac MRI fellowship

at Duke Medical Center, Durham, N.C., and a general

cardiology fellowship at the University of Alabama.

Bilaji Tamarappoo, MD, PhD, is

new to Cleveland Clinic’s Cardiac

Imaging section. Dr. Tamarappoo

received his medical degree from

MCP Hahnemann University School

of Medicine, Philadelphia. He

completed his specialty training at

Cedars-Sinai Medical Center in Los Angeles and Oregon

Health Sciences University Hospital.

Rory Hachamovitch, MD, has joined

the Cardiac Imaging section. Dr.

Hachamovitch received his medical

degree from Albert Einstein College

of Medicine, New York, N.Y. He

completed his residency at Cedars-

Sinai Medical Center and fellowships

at both Cedars-Sinai and Beth Israel Hospital, Boston. He

will be heavily involved in outcomes research.

Congenital Heart Disease

David Majdalany, MD, has joined the Cardiovascular

Medicine staff to be involved in our congenital clinic.

Dr. Majdalany received his medical degree from Marshall

University School of Medicine Huntington, W.V. He com-

pleted his residency at Mount Sinai Medical Center, New

York, N.Y. and fellowships at Columbia University Medical

Center, New York, N.Y.; Mayo Clinic, Rochester, Minn.;

and the University of Louisville Hospital, Louisville, Ky.

StaffNew


Syria. He completed residencies at Fairview Hospital and

the Medical College of Ohio, followed by a fellowship in

peripheral vascular surgery at Baptist Memorial Hospital

in Memphis, Tenn.

Ramandeep Sidhu, MD, recently

joined the Miller Family Heart &

Vascular Institute’s Vascular Surgery

Department from the Jobst Vascular

Center, Promedica Health System,

Toledo, Ohio. Dr. Sidhu received

his medical degree from Topiwala

National Medical College in Mumbai, India. He completed

his residency at Fairview Hospital and a vascular surgery

fellowship at Jobst Vascular Center.

James R. Bekeny, MD, has joined

the Miller Family Heart & Vascular

Institute’s Vascular Surgery

Department. Dr. Bekeny has been

in private practice in Cleveland for

nearly 30 years, recently serving as

President-elect of Cleveland Clinic

Lakewood Hospital and President of its medical staff. He

received his medical degree from Case Western Reserve

University. He completed his general surgery residency at

University Hospitals of Cleveland, followed by a vascular

residency fellowship at Lutheran Medical Center of Cleveland.

To refer a patient to any staff at the Miller Family Heart & Vascular Institute, please call 800.553.5056.

Heart Failure

Eiran Gorodeski, MD, MPH, has

joined the Heart Failure Section at


Institute. Dr. Gorodeski received his

medical degree from Case Western

Reserve University School of

Medicine. He completed a residency

in internal medicine at Massachusetts General Hospital,

followed by fellowships in cardiovascular medicine and

heart failure/transplantation medicine at Cleveland Clinic.

He earned his MPH at Harvard University. His research

interests include cardiovascular epidemiology, cardiovascular

risk modeling, and heart failure outcomes.

Electrophysiology and Pacing

Przemyslaw Borek, MD, is the newest

addition to the Electrophysiology and

Pacing Section at Cleveland Clinic.

Dr. Borek received his medical degree

from the University of Connecticut

School of Medicine. He completed his

internal medicine residency at Johns

Hopkins Hospital, Baltimore, and fellowships in cardiovascular

medicine and cardiac electrophysiology at Cleveland Clinic.

Vascular Surgery

Basem Droubi, MD, has joined


Institute’s Vascular Surgery

Department. Dr. Droubi has been

in private practice, recently serving

as Chief of Vascular Surgery at

Cleveland Clinic Fairview and

Lutheran hospitals. Dr. Droubi received his medical degree

from Damascus University-Faculty of Medicine in Damascus,


Cardiac Resynchronization Optimization

Research indicates a systematic protocol-driven approach may help a significant percentage of patients with suboptimal response to CRT

Up to two-thirds of patients with advanced heart failure respond positively to cardiac resynchronization therapy (CRT) following the implantation of a biventricular pacemaker, (BiV). However, one-third of patients with severe heart failure do not respond favorably to CRT, and a small percentage may even worsen after a BiV implant.

“For a significant percentage of patients with a suboptimal re-sponse to CRT, we are able to improve their condition utilizing a systematic protocol-driven approach, which includes using Dop-pler echocardiography,” says Richard A. Grimm, DO, Director of the Echocardiography within the Section of Cardiovascular Imaging, who has extensively researched CRT. Cleveland Clinic’s Cardiac Resynchronization Optimization Clinic has been providing CRT optimization since 2001.

Optimization Begins with Comprehensive Evaluation

Helping these patients must begin with a comprehensive evaluation of their cardiac function. Using Doppler echocar-diography, cardiologists can view the impact of CRT on cardiac function, including interventricular, intraventricular and atrio-ventricular (AV) mechanical synchrony.

Previous research by Dr. Grimm, published in the September 15, 2006 edition of The American Journal of Cardiology, evalu-ated the utility of AV optimization using Doppler echocardiogra-phy in patients who undergo CRT. The study included data col-lected from 215 patients in New York Heart Association class III or IV heart failure (66 percent ischemic) who underwent AV optimization <30 days after implantation from 1999 to 2003.

According to the study, all patients arrived to the lab with an AV delay programmed at the time of their CRT procedures (100 to 120 ms). AV delay was optimized using Doppler mitral inflow data to target stage l diastolic filling. The study concluded AV optimization in patients who underwent CRT resulted in a final AV delay setting of > 140 ms in 40 percent of patients, and that AV delay optimization based on Doppler echocardiographic determination of optimal diastolic filling is useful and safe in patients who undergo CRT.

Reviewing patient data

In addition to routine utilization of Doppler echocardiography to optimize AV timing in these patients, those patients considered non-responders to CRT (up to 1/3 of those treated) also are evalu-ated in a CRT non-responder clinic, part of the Cardiac Resyn-chronization Optimization Clinic. This evaluation is performed using a protocol-driven, comprehensive, multi-disciplinary (including heart failure specialists, electrophysiologists and imag-ing specialists) clinical and hemodynamic assessment that utilizes echocardiography to assess the impact of cardiac resynchroniza-tion pacing therapy on the failing heart. This is a “problem solv-ing” investigation. This evaluation, among other factors, includes the patient’s symptom status, medications, lead location, pacing configurations as well as degree of baseline left ventricle (LV)


dysfunction, the presence and degree of intraventricular mechani-cal delay and QRS duration before the implant.

Dr. Grimm says it is not uncommon to encounter patients who may have been borderline candidates for CRT relative to baseline left ventricle function, QRS duration as well as QRS morphol-ogy. However, studies indicate these patients may be less likely to respond favorably to CRT compared with patients with non-isch-emic cardiomyopathies, LVEF of less than 35 percent, a QRS of more than 150 ms and left bundle branch block (LBBB).

“Precise knowledge of this information may be able to provide insights into why a patient may have realized a suboptimal response,” Dr. Grimm notes in the paper, “Nonresponsders and Patient Selection from an Echocardiographic Perspective,” pub-lished in the first edition of Cardiac Resynchronization Therapy in 2007. “Non-responders often present with either symptoms or worsening LV dysfunction, or both. Classifying these cases as they present may be helpful in determining an etiology and generating a management plan and adjusting therapy.”

Optimizing CRT response

Indeed, managing therapy based on a protocol-driven and multidisciplinary approach appears to help improve the condi-tion of patients with advanced heart failure who do not respond favorably to CRT, according a research study co-authored by Dr. Grimm and published in the Journal of the American College of Cardiology last year.

The Image: Pacemaker Optimization

This image reflects a pacemaker optimization, before (left)

and after (right).

The left image shows the upper (atrium) and lower chamber

(ventricle) of the heart. Two cardiac cycles (heartbeats) are

represented. In the left image, blood flow moves from the

upper to the lower chamber producing a positive signal.

However, there is just one positive signal in each cardiac

cycle. This single signal signifies that the filling pressures

are abnormally increased in the heart, and increased filling

pressures equate to congestion. There is also evidence that

the electrical and mechanical timing between the atrium

and ventricle is not optimized.

The right image demonstrates the each cardiac cycle now

shows with two humps, or flows. This signifies that heart

function has improved, thanks to pacemaker optimization.

As a result the filling pressures in the heart are lower. Also,

the timing of electrical and mechanical events in the heart

is optimized. All of this is good news.


The study involved 75 consecutive ambulatory patients with persistent advanced heart failure symptoms and/or adverse reverse remodeling. All patients, (mean left ventricular [LV] ejection fraction 23 +/-9 percent, LV en-diastolic volume 275 +/-127 ml) who had their BiV implanted for longer than six months, underwent a comprehensive protocol-driven evalua-tion to determine the reasons for their suboptimal response to pacing therapy. Recommendations were made to maximize the potential of CRT, and adverse events were documented.

According to the study’s results, 88 percent of patients had significantly better echocardiographic indices of LV filling and LV ejection with optimal setting of their CRT compared to temporary WI back-up pacing.

Additionally, most patients had identifiable reasons for subop-timal response, including inadequate device settings (47 per-cent), suboptimal medical treatment (32 percent), arrhythmias (32 percent), inappropriate lead position (21 percent), or lack of baseline dyssynchrony (9 percent).

The study reported that multidisciplinary recommendations led to changes in device settings and/or other therapy modifica-tions in 74 percent of patients and were associated with fewer adverse events (13 percent vs. 50 percent, odds ratio: 0.2 [95 percent confidence interval: 0.07 to 0.56], p=0.002) com-pared with those in which no recommendation could be made.

In a small percentage of patients, however, there are no iden-tifiable reasons for their suboptimal response to CRT. In these cases, the pacemaker therapy is discontinued and patients may be referred for ventricular assist device therapy and/or cardiac transplantation

Contact Dr. Grimm at 216.445.4636 or [email protected].

“For a significant percentage of patients with a suboptimal response to CRT, we are able to improve their condition and their quality of life…” – Richard A. Grimm, DO

Visit clevelandclinic.org/heart | Cardiac Consult | Fall 10 |

DrConnect Make Your Next Report Electronic

DrConnect is an Internet-based service developed to provide our community physician colleagues real-time electronic medical record information about the treatment their patients receive at Cleveland Clinic.

After establishing a DrConnect account with a secure log-in name and password, referring physicians may identify office personnel to receive security rights, allowing DrConnect patient updates to be immediately integrated into a busy medical practice’s daily activities and workflow.

A single daily email notification containing the DrConnect Web address (URL) gives you one-click access to all newly released patient-related information, which is presented in easy-to-navigate “What’s New” screens for quick access and effective case and time management.

Establishing your own DrConnect account is easy. 1) Log onto drconnect.clevelandclinic.org. 2) Click on the OnLine Signup button. 3) Simply fill out your physician participant information, including choosing a secure password, and submit.

Medical Concierge Complimentary assistance for out-of-state patients

and families 800.223.2273, ext. 55580, or email

[email protected]

Global Patient ServicesComplimentary assistance for national and international

patients and families 001.216.444.8184 or visit

clevelandclinic.org/ic

HVI ReferralsTo refer patients to a Cleveland Clinic heart and vascular specialist please call:

Cardiovascular Medicine 216.444.6697

Thoracic and Cardiovascular Surgery 877.843.2781

Vascular Surgery 216.444.4508

New patients, in most cases, can be seen within one week of calling for an appointment.

Same-day Visits Now AvailableThe Miller Family Heart & Vascular Institute now offers same-day appointments for new

patients and follow-up visits. Patients who want or need to be seen immediately will be

scheduled with a HVI Cardiovascular Medicine staff member.

All same-day visits will be coordinated through our appointment office. To arrange an

appointment, call 216.444.6697 or 800.659.7822.

C L E V E L A N D C L I N I C A C C E S S G u I D E

The Cleveland Clinic Foundation9500 Euclid Avenue/AC311Cleveland, OH 44195

Heart-Brain Summit 2010 Sept. 23-24 Ruvo Brain Institute Las Vegas, Nevada

Preceptorship in Carotid Ultrasound Interpretation February 7-11, 2011 June 20-24, 2011 Cleveland Clinic, Miller Family Heart & Vascular Institute, Noninvasive Vascular Laboratory, Cleveland, Ohio

21st Century Treatment of Heart Failure 2010 Oct. 21-22 Intercontinental Hotel & Bank of America Conference Center Cleveland, Ohio

2010 Medical Innovation Summit: Obesity, Diabetes & the Metabolic Crisis November 1-3, 2010 Cleveland Clinic, Cleveland, Ohio

For more information about the above events, call the Cleveland Clinic Department of Continuing Education at 216.444.5696 or 800.762.8173, or visit ccfcme.org.

CME Calendar | Medical professionals are invited to attend the following upcoming symposia:

Blood Management Summit

Saturday, Nov. 13, 2010

Dedicated to improving performance

Cleveland Clinic uses more blood than anyone

else in the country due to its high volumes and

patient acuity levels.

CardiacConsult

Save

the

Dat

e!

A blood management team was created, led by Medicine Institute

hospitalist Ajay Kumar, MD, and orthopaedic surgeon Mark Froim-

son, MD, during 2007. This multidisciplinary team’s objective is to

find effective alternatives to blood transfusions at Cleveland Clinic

and create metrics to assist physicians in improving performance.

cardiac consult - cleveland clinic · 2013. 12. 20. · cardiac resynchronization optimization p16...

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