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ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths. (423). (224). (137). (32). Months % Survival 1 83 % 3 74 % 6 67 % 12 50 %. Deaths / Month. Percent Survival. Hazard. Event: Death after Implant *. 2005. ISHLT. Months after Device Implant.

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ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths

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  1. ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths (423) (224) (137) (32) Months % Survival 1 83 % 3 74 % 6 67 % 12 50 % Deaths / Month Percent Survival Hazard Event: Death after Implant * 2005 ISHLT Months after Device Implant J Heart Lung Transplant 2005;24:1182-1187 * censored at transplant

  2. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Primary Device Implant: LVAD + RVAD at the same operation (biventricular failure) Predicted % Mortality at 6 months LVAD alone (left ventricular failure) Age (years) at Device Implant

  3. ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 (n=655) 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 Infection Episodes (n=668) 175 Cumulative Events per 100 Patients Bleeding Episodes (n=396) 75 Thromboembolism Episodes (n=86) 18 Months after Device Implant

  4. ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 66 Patients with Major Device Malfunction 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 (410) (212) (122) (38) Months % Survival 1 95 % 3 92 % 6 84 % 12 66 % Percent Freedom from Major Device Malfunction Major Device Adverse Event / Month Hazard Event: Death after Implant * Months after Device Implant * censored at transplant

  5. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Bridge to Transplant Age > = 50 (n=292) Age < 30 (n=52)

  6. Alive (Still waiting) Proportion of Patients 45 % Explanted (recovery) 45 % 37 % 27 % Death (before transplant) 12 % Transplanted 17 % 12 % 5 % 2005 ISHLT Months after Device Implant J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Intent to Treat: Bridge to Recovery (n=35)

  7. ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Intent to Treat: Destination Therapy (n=78) Alive 65 % 55 % Proportion of Patients 33 % 34 % Death 11 % Transplanted 2 % 0 % Explanted (recovery) 0 % 2005 ISHLT Months after Device Implant J Heart Lung Transplant 2005;24:1182-1187

  8. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Destination Therapy Age < 65 (n=37) Age >= 65 (n=41)

  9. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Primary Device Implant n LVAD (alone) 542* Pulsatile flow, chronic device 487 Continuous flow, chronic device 39 LVAD + RVAD Combinations 100 TAH Pulsatile flow, chronic device 13 Total 655 * Type of VAD not specified in 16 patients

  10. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Intention to Treat n % of 655 Bridge to transplant 513 78.3% Bridge to recovery 35 5.3% Destination Therapy 78 11.9% Not specified 29 4.4% Total 655 100%

  11. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

  12. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Risk factors for death* after device implant

  13. ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Summary of Post-Implantation Patient-related Events 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187

  14. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Major Device Malfunctions n Controller 31 Pump/pump drive unit 14 Pump thrombosis 13 Pump inflow 11 Percutaneous lead/drive line 4 Pump outflow 4 Cannula dislodgement 1 Power base electrical malfunction 1 Pump stoppage 1 Other 3 Total Events 83 66 Patients with 83 major device malfunctions

  15. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Intent to Treat: Bridge to Recovery Primary Device Implant n LVAD (alone) 21* Pulsatile flow, chronic device 16 Continuous flow, chronic device 1 LVAD + RVAD Combinations 14 Total 35 * Type of VAD not specified in 4 patients

  16. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Indications for Destination Therapy n % of 78 Advanced age 38 48.7% Co-morbidity 28 35.9% Fixed pulmonary hypertension 8 10.3% Contraindication to immunotherapy 2 2.6% Patient refuses transplant 2 2.6% Total 78 100%

  17. 2005 ISHLT J Heart Lung Transplant 2005;24:1182-1187 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Intent to Treat: Destination Therapy Primary Device Implant n LVAD (alone) 74 Pulsatile flow, chronic device 71 Continuous flow, chronic device 3 LVAD + RVAD Combinations 3 TAH Pulsatile flow, chronic device 1 Total 78

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