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Unformatted text preview: Implantable Artificial Hearts and Ventricular Assist Devices George M. Pantalos, Ph.D.
Department of Surgery and Cardiovascular Innovation Institute University of Louisville and the Jewish Hospital Heart and Lung Institute Hearts in Space 1. To provide an adequate amount of blood flow to the body at an adequate pressure for an indefinite period of time 2. To deliver the blood with minimal adverse effect to the body 3. To provide the recipient with an adequate quality of life TAH = Total Artificial Heart LVAD = Left Ventricular Assist Device RVAD = Right Ventricular Assist Device Heart Disease in the United States
(deaths by age group in 1987)
1-14 15-34 35-54 55-74 75 + 287 2,758 40,848 190,298 161,719 Female
266 1,392 12,853 100,700 221,309 Quality of Fit Adequate Design + Good Positioning = A Good Fit Inadequate Design and/or Poor Positioning = A Poor Fit AbioCor Heart Fit Program Biomaterials in Total Artificial Hearts Polyurethanes (Biomer, Pellethane, Isoplast): blood chamber housing, flexing diaphragms, drive lines, quick-connects, air chamber base, valve holders, valves Polycarbonate: valve holders, air chamber base PVC: drive lines, VAD cannulae Polypropylene: suture material Woven Dacron: outflow grafts Dacron Velcro: ventricular anchor Dacron Velour: skin buttons, atrial sewing cuffs, driveline sleeves Biomaterials in Total Artificial Hearts
(continued) Dacron Felt: skin button Silastic: skin button Woven Silk: aspiration port sealing tie Pyrolytic Carbon: valve rings, valve leaflets & discs Marine Aluminum: air chamber base Stainless Steel: base retaining wire, drive line connectors, connector rings Satellite: valve rings Titanium: valve rings, blood chamber housings TAH Hematology
SKADI King Lear % HCT PFHb (mg %) Serum LDH (U/ml) Actuarial Survival
100 80 60 40 20 0 % Surviving
Thoratec VAD patients 74% Conventional Transplantation (ISHT Registry) 0 1 2 3 4 5 6 7 8 Predicted vs Actual Survival AbioCor Recipients
ABIOCOR PATIENT SURVIVAL
17 March 2004
Includes THI#5 (ongoing) 100 90 80 AbioScore Predicted Mortality SURVIVAL (%) 70 60 50 40 30 20 10 0 0 100 200 300 400 Actual AbioCor Patient Survival 500 600 DAYS Pediatric Circulatory Support Systems Pediatric Ventricular Assist Device University of Pittsburgh Harvey Borovetz, Ph.D. PediPump Cleveland Clinic Lerner College of Medicine-CWRU Brian Duncan, M.D. Pediatric Cardiopulmonary Assist System Ension, Inc. Mark Gartner, M.S. Child-size and Infant-size Jarvik 2000 LVADs Jarvik Heart, Inc. Robert Jarvik, M.D. Pulsatile Pediatric Ventricular Assist Devices Penn State University Bill Weiss, Ph.D. Bioactivity
1.6 1.4 IU IIa Deactivated /cm2 1.2 1 0.8 0.6 0.4 0.2 0 Carmedalike Rev. 1 Rev. 2 Rev. 3
Initial Post EtO Different Assessments and Criteria FDA: Are medical products SAFE and EFFECTIVE? CMS: Are medical products REASONABLE and NECESSARY? "But the driving force behind these and all other factors is one that politicians refuse to recognize: Washington's blind obsession with market-based health care, the notion that competition is always good and can never have a bad result." In a third-party payor system, unhappiness is maximized and conflict is guaranteed. .. As long as people lack the power and responsibility to choose, it will be extraordinarily difficult to get people to take primary responsibility of their own health. Where Ford pioneered the lowcost production run, Sloan pioneered the customer-defined manufacturing process Artificial Heart... ...Real Hope ...
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