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The Major Costs of Minor Miracles: Technology on the Horizon Stacy M. Borans, MD Chief Medical Officer Advanced Medical Strategies Learning Objectives For 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) technologies on the horizon 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. Introduction Health care spending consistently increases at a 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 attributed to new technology developments 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 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 Obesity: Implantable Gastric Stimulator 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 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 Degenerative Disc Disease Extremely Common Cause of Low Back Pain (LBP) Loss of water content in discs causes two vertebrae to move closer together Conservative treatment is first-line Severe cases require surgery: spinal fusion Rods Screws Back Cages Degenerative Disc Disease: Charité 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: Charité Artificial Disc Degenerative Disc Disease: Charité 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 Degenerative Disc Disease: Charité Artificial Disc Lack of long-term follow up studies Invoice Price for the device is $11,500 Procedure costs for a single disc are $30,000 to $45,000 Long Term Benefits over spinal fusion were primarily greater flexibility Coronary Artery Disease Leading cause of death in both women and men Earlier detection allows for better outcomes Evaluate risk factors and recommend appropriate testing Typically requires invasive methods to get most accurate clinical picture Coronary Artery Disease: 64 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 Coronary Artery Disease: 64 Slice CT scanner Coronary Artery Disease: 64 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 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 Congestive Heart Failure: AbioCor 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 Congestive Heart Failure: AbioCor 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 Congestive Heart Failure: AbioCor Implantable Replacement Heart Congestive Heart Failure: AbioCor Implantable Replacement Heart Inpatient Implantation Patients placed on cardiopulmonary bypass The diseased heart is replaced and the Abiocor is connected to the native blood vessels Implantation of the transcutaneous energy transfer coil, controller, and battery pack. Congestive Heart Failure: AbioCor 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 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 Cerebrovascular Disease: MERCI 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 in the peripheral, coronary, and neuro vasculature Cerebrovascular Disease: MERCI 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 placement of fluids and/or other devices or agents into vessels Balloon provides temporary vascular occlusion during the procedure Cerebrovascular Disease: MERCI Retrieval System Cerebrovascular Disease: MERCI Retrieval System Clot location confirmed by angiography Balloon guide catheter is inserted into the femoral artery and guided via x-ray to 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. Cerebrovascular Disease: MERCI Retrieval System Clinical trial outcomes were good in select 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 on the angiogram Contraindication to intravenous TPA (clot buster) Cerebrovascular Disease: MERCI 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 for the treatment of stroke Prostate Cancer Affects 1:6 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 Prostate Cancer: Robotic 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 Prostate Cancer: Robotic Prostatectomy Prostate Cancer: Robotic 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 Questions/Comments Thank you for attending!