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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, MD
Chief 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
Obesity:Obesity: Implantable Gastric StimulatorImplantable Gastric Stimulator
Obesity:Obesity: Implantable Gastric StimulatorImplantable Gastric Stimulator
Implanted under the skin of the abdomenImplanted under the skin of the abdomen Leads and electrodes are inserted into the Leads and electrodes are inserted into the
stomach wall and fastened to the musclestomach wall and fastened to the muscle 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
Obesity:Obesity: Implantable Gastric StimulatorImplantable Gastric Stimulator
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 Long term benefits are the reduction
of the comorbid conditionsof the comorbid conditions
Degenerative Disc DiseaseDegenerative Disc Disease
Extremely Common Cause ofExtremely Common Cause ofLow Back Pain (LBP)Low Back Pain (LBP)
Loss of water content in discs causesLoss of water content in discs causestwo 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
Degenerative Disc Disease:Degenerative Disc Disease:Charité Artificial DiscCharité Artificial Disc
Degenerative Disc Disease:Degenerative Disc Disease:Charité Artificial DiscCharité Artificial Disc
Diseased disc removed and replaced Diseased disc removed and replaced with artificial discwith artificial disc
Restore proper disc height between Restore proper disc height between the vertebrae above and below the the vertebrae above and below the disc 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
Degenerative Disc Disease:Degenerative Disc Disease:Charité Artificial DiscCharité Artificial Disc
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 bothwomen and menwomen and men
Earlier detection allows forEarlier detection allows forbetter 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 Cost to the facility: $1.8
million/scannermillion/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
Coronary Artery Disease:Coronary Artery Disease:64 Slice CT scanner64 Slice CT scanner
Coronary Artery Disease:Coronary Artery Disease:64 Slice CT scanner64 Slice CT scanner
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 or will not benefit from LVAD insertioninsertion
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
Congestive Heart Failure:Congestive Heart Failure:AbioCor Implantable Replacement AbioCor Implantable Replacement
HeartHeart
Congestive Heart Failure:Congestive Heart Failure: AbioCor Implantable Replacement AbioCor Implantable Replacement
HeartHeart
Congestive Heart Failure:Congestive Heart Failure:AbioCor Implantable Replacement AbioCor Implantable Replacement
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.
Congestive Heart Failure:Congestive Heart Failure:AbioCor Implantable Replacement AbioCor Implantable Replacement
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 FDA Advisory Panel rejected application to widen use in 2005application to widen use in 2005
Cost estimates are $200,000-Cost estimates are $200,000-$250,000 for the total implantation$250,000 for 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 80% of ischemic infarcts are due to
large vessel occlusion by atherosclerosislarge vessel 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
Cerebrovascular Disease:Cerebrovascular Disease:MERCI Retrieval SystemMERCI Retrieval System
System consists of Merci Retriever, System consists of Merci Retriever, microcatheter and balloon guide microcatheter and balloon guide cathetercatheter
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
Cerebrovascular Disease:Cerebrovascular Disease:MERCI Retrieval SystemMERCI Retrieval System
Cerebrovascular Disease:Cerebrovascular Disease:MERCI Retrieval SystemMERCI Retrieval System
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.
Cerebrovascular Disease:Cerebrovascular Disease:MERCI Retrieval SystemMERCI Retrieval System
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)
Cerebrovascular Disease:Cerebrovascular Disease:MERCI Retrieval SystemMERCI Retrieval System
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
Prostate Cancer:Prostate Cancer:Robotic ProstatectomyRobotic Prostatectomy
Prostate Cancer:Prostate Cancer:Robotic ProstatectomyRobotic Prostatectomy
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
Questions/CommentsQuestions/Comments
Thank you for attending!Thank you for attending!