the major costs of minor miracles: technology on the horizon stacy m. borans, md chief medical...

The Major Costs of Minor The Major Costs of Minor Miracles:Miracles:

Technology on the HorizonTechnology on the Horizon

Stacy M. Borans, MDStacy M. Borans, MDChief Medical OfficerChief Medical Officer

Advanced Medical StrategiesAdvanced Medical Strategies

Learning ObjectivesLearning ObjectivesFor Medical DevicesFor Medical Devices

Understand their clinical indicationsUnderstand their clinical indications Know the mechanisms of actionKnow the mechanisms of action Be able to anticipate their costs Be able to anticipate their costs Understand the cost-benefit ratiosUnderstand the cost-benefit ratios Be aware of new(er) technologiesBe aware of new(er) technologies

on the horizonon the horizon

In the News…In the News…

Girl doing well after transplantGirl doing well after transplant

Before finding the donor organ,Before finding the donor organ,a Berlin pump kept her alive.a Berlin pump kept her alive.

The Food and Drug Administration gave The Food and Drug Administration gave emergency approval for the hospital to emergency approval for the hospital to

bring a pump and backup unit from bring a pump and backup unit from Germany.Germany.

IntroductionIntroduction Health care spending consistently Health care spending consistently

increases atincreases ata rate of approximately 7.5%a rate of approximately 7.5%

Health care premiums have also Health care premiums have also increased at the same rateincreased at the same rate

Fifteen medical conditions account for Fifteen medical conditions account for the majority of the growth in the majority of the growth in healthcare spendinghealthcare spending

20-40% of that growth can be 20-40% of that growth can be attributedattributedto new technology developmentsto new technology developments

ObesityObesity

Obesity: Body mass index (BMI)Obesity: Body mass index (BMI)between 30 and 39between 30 and 39

Morbid obesity: BMI greater than 40Morbid obesity: BMI greater than 40 Increased risk of hypertension, diabetes Increased risk of hypertension, diabetes

mellitus, coronary artery disease, breast mellitus, coronary artery disease, breast and colon cancer and gallbladder diseaseand colon cancer and gallbladder disease

Americans classified as such: Americans classified as such: 60 60 millionmillion

Obesity:Obesity: Implantable Gastric StimulatorImplantable Gastric Stimulator

Intended for patients with a BMI Intended for patients with a BMI between 30 and 55 who have failed between 30 and 55 who have failed conventional weight loss treatmentsconventional weight loss treatments

Pacemaker-like device Pacemaker-like device Device induces the feeling of fullness Device induces the feeling of fullness

(satiety)(satiety) Mechanism of action is not well Mechanism of action is not well

understoodunderstood


Implanted under the skin of the abdomenImplanted under the skin of the abdomen Leads and electrodes are inserted into Leads and electrodes are inserted into

the stomach wall and fastened to the the stomach wall and fastened to the musclemuscle

Activated approximately 30 days after Activated approximately 30 days after implantationimplantation

Minimally invasive and can be performed Minimally invasive and can be performed in the outpatient settingin the outpatient setting


Early Results: 30% of baseline weight Early Results: 30% of baseline weight lostlost

Weight loss maintained for 3 yearsWeight loss maintained for 3 years Estimated cost of $10,000Estimated cost of $10,000

•• includes stimulator and leadsincludes stimulator and leads Additional Costs for implantationAdditional Costs for implantation Long term benefits are the reduction of Long term benefits are the reduction of

the comorbid conditionsthe comorbid conditions

Degenerative Disc DiseaseDegenerative Disc Disease Extremely Common Cause ofExtremely Common Cause of

Low Back Pain (LBP)Low Back Pain (LBP) Loss of water content in discs causesLoss of water content in discs causes

two vertebrae to move closer togethertwo vertebrae to move closer together Conservative treatment is first-lineConservative treatment is first-line Severe cases require surgery: spinal Severe cases require surgery: spinal

fusionfusion RodsRods ScrewsScrews Back CagesBack Cages

Degenerative Disc Disease:Degenerative Disc Disease:Charité Artificial DiscCharité Artificial Disc

Patients with only one diseased disc between L4 and L5 or between L5 and S1

Fail six months of conservative treatment

Cannot be used in patients with DDD at more than one level

Patients cannot have osteopenia or osteoporosis


Diseased disc removed and replaced Diseased disc removed and replaced with artificial discwith artificial disc

Restore proper disc height between the Restore proper disc height between the vertebrae above and below the disc vertebrae above and below the disc

Maintain motion in the area of the Maintain motion in the area of the spine where the disc is implanted spine where the disc is implanted

Re-establish proper spinal alignment/ Re-establish proper spinal alignment/ curvature of the lumbar spinecurvature of the lumbar spine


Lack of long-term follow up studiesLack of long-term follow up studies Invoice Price for the device is $11,500Invoice Price for the device is $11,500 Procedure costs for a single disc areProcedure costs for a single disc are

$30,000 to $45,000$30,000 to $45,000 Long Term Benefits over spinal fusion Long Term Benefits over spinal fusion

were primarily greater flexibility were primarily greater flexibility

Coronary Artery DiseaseCoronary Artery Disease Leading cause of death in bothLeading cause of death in both

women and menwomen and men Earlier detection allows forEarlier detection allows for

better outcomesbetter outcomes Evaluate risk factors and recommend Evaluate risk factors and recommend

appropriate testingappropriate testing Typically requires invasive methods Typically requires invasive methods

to get most accurate clinical pictureto get most accurate clinical picture

Coronary Artery Disease:Coronary Artery Disease:64 Slice CT scanner64 Slice CT scanner

FDA Approved in 2004FDA Approved in 2004 Cost to the facility: $1.8 million/scannerCost to the facility: $1.8 million/scanner Ability to non-invasively image the Ability to non-invasively image the

heart in extreme detailheart in extreme detail UltrafastUltrafast May be able to use in ER to assess and May be able to use in ER to assess and

dischargedischarge


Patients will still require cardiac cathPatients will still require cardiac cath Expense: $1000-$2000 per scanExpense: $1000-$2000 per scan May have other applicationsMay have other applications Inappropriate use risks exposure to Inappropriate use risks exposure to

substantial radiationsubstantial radiation Currently still in clinical trials,Currently still in clinical trials,

but anticipate widespread usebut anticipate widespread use

Congestive Heart FailureCongestive Heart Failure Five million people in the US suffer Five million people in the US suffer

from heart failure. from heart failure. End stage CHF has very limited End stage CHF has very limited

treatment optionstreatment options Only 2,500 cardiac transplants Only 2,500 cardiac transplants

completed per year due to organ completed per year due to organ availabilityavailability

Left ventricular assist device used as Left ventricular assist device used as bridge to transplantbridge to transplant

Congestive Heart Failure:Congestive Heart Failure:AbioCor Implantable Replacement AbioCor Implantable Replacement

HeartHeart Strict Patient CriteriaStrict Patient Criteria

End stage heart failureEnd stage heart failure Life-expectancy of less than 30 days Life-expectancy of less than 30 days Not heart transplant candidatesNot heart transplant candidates Have no other viable treatment optionsHave no other viable treatment options

Patients are not candidates for LVAD Patients are not candidates for LVAD or will not benefit from LVAD insertionor will not benefit from LVAD insertion

Multiple Components of deviceMultiple Components of device Internal Components: artificial Internal Components: artificial

ventricles, hydraulic pumping ventricles, hydraulic pumping system, rechargeable battery and system, rechargeable battery and electronics packageelectronics package

External Components: external External Components: external console or battery packs console or battery packs


HeartHeart

Congestive Heart Failure:Congestive Heart Failure: AbioCor Implantable Replacement AbioCor Implantable Replacement

HeartHeart


HeartHeart Inpatient ImplantationInpatient Implantation Patients placed on cardiopulmonary Patients placed on cardiopulmonary

bypassbypass The diseased heart is replaced andThe diseased heart is replaced and

the Abiocor is connected to the native the Abiocor is connected to the native blood vesselsblood vessels

Implantation of the transcutaneous Implantation of the transcutaneous energy transfer coil, controller, and energy transfer coil, controller, and battery pack. battery pack.


HeartHeart Currently in trials at selected centersCurrently in trials at selected centers No long term studies available to No long term studies available to

assess either safety or efficacy of the assess either safety or efficacy of the devicedevice

FDA Advisory Panel rejected application FDA Advisory Panel rejected application to widen use in 2005to widen use in 2005

Cost estimates are $200,000-$250,000 Cost estimates are $200,000-$250,000 for the total implantationfor the total implantation

Cerebrovascular DiseaseCerebrovascular Disease Strokes have an annual incidence of Strokes have an annual incidence of

700,000 700,000 75% of strokes are due to ischemic 75% of strokes are due to ischemic

infarcts infarcts 80% of ischemic infarcts are due to large 80% of ischemic infarcts are due to large

vessel occlusion by atherosclerosisvessel occlusion by atherosclerosis Time to treatment is critical in Time to treatment is critical in

preventing significant disability for preventing significant disability for affected patientsaffected patients

Cerebrovascular Disease:Cerebrovascular Disease:MERCI Retrieval SystemMERCI Retrieval System

FDA Approved in 2004FDA Approved in 2004 Indicated for removal of blood clots Indicated for removal of blood clots

from patients experiencing an from patients experiencing an ischemic strokeischemic stroke

Late Onset Presenters Late Onset Presenters Also used to remove foreign bodies inAlso used to remove foreign bodies in

the peripheral, coronary, andthe peripheral, coronary, andneuro vasculature neuro vasculature


System consists of Merci Retriever, System consists of Merci Retriever, microcatheter and balloon guide cathetermicrocatheter and balloon guide catheter

Retriever is designed to engage and Retriever is designed to engage and capture the occlusive thrombus (clot)capture the occlusive thrombus (clot)

Microcatheter is designed for placementMicrocatheter is designed for placementof fluids and/or other devices or agents of fluids and/or other devices or agents into vessels into vessels

Balloon provides temporary vascular Balloon provides temporary vascular occlusion during the procedure occlusion during the procedure


Clot location confirmed by angiographyClot location confirmed by angiography Balloon guide catheter is inserted intoBalloon guide catheter is inserted into

the femoral artery and guided via x-raythe femoral artery and guided via x-rayto the carotid artery. to the carotid artery.

Retriever ensnares the clot, balloon Retriever ensnares the clot, balloon guide catheter is temporarily inflated guide catheter is temporarily inflated and the clot is withdrawnand the clot is withdrawn

Main goal is to reopen the artery before Main goal is to reopen the artery before there is permanent neurologic damage.there is permanent neurologic damage.


Clinical trial outcomes were good inClinical trial outcomes were good inselect patientsselect patients

National Institutes of Health Stroke Scale National Institutes of Health Stroke Scale score (NIHSS) greater than or equal to 10score (NIHSS) greater than or equal to 10

Treatment performed within 8 hours from Treatment performed within 8 hours from symptoms’ onset symptoms’ onset

Occlusion of a major cerebral artery onOcclusion of a major cerebral artery onthe angiogram the angiogram

Contraindication to intravenous TPA (clot Contraindication to intravenous TPA (clot buster)buster)


Further studies in larger patient Further studies in larger patient populations are neededpopulations are needed

No reports of device related No reports of device related complications complications

Personnel training is neededPersonnel training is needed Estimated cost of the device is $9,000Estimated cost of the device is $9,000 Other devices being evaluated forOther devices being evaluated for

the treatment of stroke the treatment of stroke

Prostate CancerProstate Cancer

Affects 1:6 menAffects 1:6 men Predominantly a disease of older Predominantly a disease of older

menmen African American men are 61% more African American men are 61% more

likely to develop prostate cancer likely to develop prostate cancer 2.5 times more likely to die of the disease2.5 times more likely to die of the disease

Family history contributes to riskFamily history contributes to risk Early Stage disease can be curedEarly Stage disease can be cured

Prostate Cancer:Prostate Cancer:Robotic ProstatectomyRobotic Prostatectomy

Minimally invasive surgeryMinimally invasive surgery Performed from a computerized

workstation Robotic arms perform the necessary

movements including: Hold and position an endoscope Grasp, cut, dissect and cauterize Suture tissue


Computer-enhanced system provide:Computer-enhanced system provide: 3-D view of the surgical field, including depth of 3-D view of the surgical field, including depth of

field, magnification and high resolutionfield, magnification and high resolution Instruments that are designed to mimic the Instruments that are designed to mimic the

movement of the human hands, wrists and fingersmovement of the human hands, wrists and fingers Master controls that allow the surgeon to Master controls that allow the surgeon to

manipulate the instrumentsmanipulate the instruments Magnifies the surgical field up to 15 timesMagnifies the surgical field up to 15 times Shorter hospital stay and less Shorter hospital stay and less

postoperative painpostoperative pain

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the major costs of minor miracles: technology on the horizon stacy m. borans, md chief medical...

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