The Major Costs of Minor Miracles: Technology on the Horizon

1
The Major Costs of Minor MiraclesTechnology on
the Horizon

• Stacy M. Borans, MD
• Chief Medical Officer
• Advanced Medical Strategies

2
Learning ObjectivesFor Medical Devices

• Understand their clinical indications
• Know the mechanisms of action
• Be able to anticipate their costs
• Understand the cost-benefit ratios
• Be aware of new(er) technologieson the horizon

3
In the News

• Girl doing well after transplant
• Before finding the donor organ,a Berlin pump
  kept her alive.
• The Food and Drug Administration gave emergency
  approval for the hospital to bring a pump and
  backup unit from Germany.

4
Introduction

• Health care spending consistently increases ata
  rate of approximately 7.5
• Health care premiums have also increased at the
  same rate
• Fifteen medical conditions account for the
  majority of the growth in healthcare spending
• 20-40 of that growth can be attributedto new
  technology developments

5
Obesity

• Obesity Body mass index (BMI)between 30 and 39
• Morbid obesity BMI greater than 40
• Increased risk of hypertension, diabetes
  mellitus, coronary artery disease, breast and
  colon cancer and gallbladder disease
• Americans classified as such 60 million

6
Obesity Implantable Gastric Stimulator

• Intended for patients with a BMI between 30 and
  55 who have failed conventional weight loss
  treatments
• Pacemaker-like device
• Device induces the feeling of fullness (satiety)
• Mechanism of action is not well understood

7
Obesity Implantable Gastric Stimulator
8
Obesity Implantable Gastric Stimulator

• Implanted under the skin of the abdomen
• Leads and electrodes are inserted into the
  stomach wall and fastened to the muscle
• Activated approximately 30 days after
  implantation
• Minimally invasive and can be performed in the
  outpatient setting

9
Obesity Implantable Gastric Stimulator

• Early Results 30 of baseline weight lost
• Weight loss maintained for 3 years
• Estimated cost of 10,000 includes stimulator
  and leads
• Additional Costs for implantation
• Long term benefits are the reduction of the
  comorbid conditions

10
Degenerative Disc Disease

• Extremely Common Cause ofLow Back Pain (LBP)
• Loss of water content in discs causestwo
  vertebrae to move closer together
• Conservative treatment is first-line
• Severe cases require surgery spinal fusion
• Rods
• Screws
• Back Cages

11
Degenerative Disc DiseaseCharité 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

12
Degenerative Disc DiseaseCharité Artificial Disc
13
Degenerative Disc DiseaseCharité Artificial Disc

• Diseased disc removed and replaced with
  artificial disc
• Restore proper disc height between the vertebrae
  above and below the disc
• Maintain motion in the area of the spine where
  the disc is implanted
• Re-establish proper spinal alignment/ curvature
  of the lumbar spine

14
Degenerative Disc DiseaseCharité Artificial Disc

• Lack of long-term follow up studies
• Invoice Price for the device is 11,500
• Procedure costs for a single disc are30,000 to
  45,000
• Long Term Benefits over spinal fusion were
  primarily greater flexibility

15
Coronary Artery Disease

• Leading cause of death in bothwomen and men
• Earlier detection allows forbetter outcomes
• Evaluate risk factors and recommend appropriate
  testing
• Typically requires invasive methods to get most
  accurate clinical picture

16
Coronary Artery Disease64 Slice CT scanner

• FDA Approved in 2004
• Cost to the facility 1.8 million/scanner
• Ability to non-invasively image the heart in
  extreme detail
• Ultrafast
• May be able to use in ER to assess and discharge

17
Coronary Artery Disease64 Slice CT scanner
18
Coronary Artery Disease64 Slice CT scanner

• Patients will still require cardiac cath
• Expense 1000-2000 per scan
• May have other applications
• Inappropriate use risks exposure to substantial
  radiation
• Currently still in clinical trials,but
  anticipate widespread use

19
Congestive Heart Failure

• Five million people in the US suffer from heart
  failure.
• End stage CHF has very limited treatment options
• Only 2,500 cardiac transplants completed per year
  due to organ availability
• Left ventricular assist device used as bridge to
  transplant

20
Congestive Heart FailureAbioCor Implantable
Replacement Heart

• Strict Patient Criteria
• End stage heart failure
• Life-expectancy of less than 30 days
• Not heart transplant candidates
• Have no other viable treatment options
• Patients are not candidates for LVAD or will not
  benefit from LVAD insertion

21
Congestive Heart FailureAbioCor Implantable
Replacement Heart

• Multiple Components of device
• Internal Components artificial ventricles,
  hydraulic pumping system, rechargeable battery
  and electronics package
• External Components external console or battery
  packs

22
Congestive Heart Failure AbioCor Implantable
Replacement Heart
23
Congestive Heart FailureAbioCor Implantable
Replacement Heart

• Inpatient Implantation
• Patients placed on cardiopulmonary bypass
• The diseased heart is replaced andthe Abiocor is
  connected to the native blood vessels
• Implantation of the transcutaneous energy
  transfer coil, controller, and battery pack.

24
Congestive Heart FailureAbioCor Implantable
Replacement Heart

• Currently in trials at selected centers
• No long term studies available to assess either
  safety or efficacy of the device
• FDA Advisory Panel rejected application to widen
  use in 2005
• Cost estimates are 200,000-250,000 for the
  total implantation

25
Cerebrovascular Disease

• Strokes have an annual incidence of 700,000
• 75 of strokes are due to ischemic infarcts
• 80 of ischemic infarcts are due to large vessel
  occlusion by atherosclerosis
• Time to treatment is critical in preventing
  significant disability for affected patients

26
Cerebrovascular DiseaseMERCI Retrieval System

• FDA Approved in 2004
• Indicated for removal of blood clots from
  patients experiencing an ischemic stroke
• Late Onset Presenters
• Also used to remove foreign bodies inthe
  peripheral, coronary, andneuro vasculature

27
Cerebrovascular DiseaseMERCI Retrieval System

• System consists of Merci Retriever, microcatheter
  and balloon guide catheter
• Retriever is designed to engage and capture the
  occlusive thrombus (clot)
• Microcatheter is designed for placementof fluids
  and/or other devices or agents into vessels
• Balloon provides temporary vascular occlusion
  during the procedure

28
Cerebrovascular DiseaseMERCI Retrieval System
29
Cerebrovascular DiseaseMERCI Retrieval System

• Clot location confirmed by angiography
• Balloon guide catheter is inserted intothe
  femoral artery and guided via x-rayto the
  carotid artery.
• Retriever ensnares the clot, balloon guide
  catheter is temporarily inflated and the clot is
  withdrawn
• Main goal is to reopen the artery before there is
  permanent neurologic damage.

30
Cerebrovascular DiseaseMERCI Retrieval System

• Clinical trial outcomes were good inselect
  patients
• National Institutes of Health Stroke Scale score
  (NIHSS) greater than or equal to 10
• Treatment performed within 8 hours from symptoms
  onset
• Occlusion of a major cerebral artery onthe
  angiogram
• Contraindication to intravenous TPA (clot buster)

31
Cerebrovascular DiseaseMERCI Retrieval System

• Further studies in larger patient populations are
  needed
• No reports of device related complications
• Personnel training is needed
• Estimated cost of the device is 9,000
• Other devices being evaluated forthe treatment
  of stroke

32
Prostate Cancer

• Affects 16 men
• Predominantly a disease of older men
• African American men are 61 more likely to
  develop prostate cancer
• 2.5 times more likely to die of the disease
• Family history contributes to risk
• Early Stage disease can be cured

33
Prostate CancerRobotic Prostatectomy

• Minimally 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

34
Prostate CancerRobotic Prostatectomy
35
Prostate CancerRobotic Prostatectomy

• Computer-enhanced system provide
• 3-D view of the surgical field, including depth
  of field, magnification and high resolution
• Instruments that are designed to mimic the
  movement of the human hands, wrists and fingers
• Master controls that allow the surgeon to
  manipulate the instruments
• Magnifies the surgical field up to 15 times
• Shorter hospital stay and less postoperative pain

36
Questions/Comments
Thank you for attending!