ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n= Deaths * censored at transplant Percent Survival Months after Device Implant Deaths / Month Event: Death after Implant * Months % Survival 183 % 374 % 667 % 1250 % (423) (224) (137) (32) Hazard ISHLT 2005 J Heart Lung Transplant 2005;24:

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

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

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n= Patients with Major Device Malfunction Percent Freedom from Major Device Malfunction Months after Device Implant Major Device Adverse Event / Month Event: Death after Implant * * censored at transplant Months % Survival 195 % 392 % 684 % 1266 % (410) (212) (122) (38) Hazard ISHLT 2005 J Heart Lung Transplant 2005;24:

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

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

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

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

* Type of VAD not specified in 16 patients Primary Device Implantn LVAD (alone)542* Pulsatile flow, chronic device487 Continuous flow, chronic device 39 LVAD + RVAD Combinations100 TAH Pulsatile flow, chronic device 13 Total655 ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 ISHLT 2005 J Heart Lung Transplant 2005;24:

Intention to Treatn % of 655 Bridge to transplant % Bridge to recovery % Destination Therapy % Not specified % Total % ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 ISHLT 2005 J Heart Lung Transplant 2005;24:

Major Causes of Deathn% of 178 Multiple organ failure6234.8% Hemorrhage2715.2% Cardiovascular2212.4% Stroke1810.1% Infection147.9% Pulmonary95.1% Other2413.5% Unspecified21.1% Total178100% ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 ISHLT 2005 J Heart Lung Transplant 2005;24:

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Risk factors for death* after device implant Risk FactorRelative RiskP-value EARLY PHASE OF HAZARD Concurrent placement of RVAD4.89<.0001 Age (older)3.13<.0001 Female Platelet count (lower) WBC count (higher) Blood type A CONSTANT PHASE OF HAZARD Diabetes Ventilator (pre-implant) Creatinine (higher) *Patients are censored at time of transplant. ISHLT 2005 J Heart Lung Transplant 2005;24:

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Summary of Post-Implantation Patient-related Events Event# of Patients% of all Patients Infection % Bleeding % Arrhythmia % Renal dysfunction8520.6% Respiratory dysfunction6616.0% Neurological dysfunction5814.0% Right ventricular dysfunction4410.7% Hepatic dysfunction307.2% Cardiac tamponade225.3% Thrombotic vascular complication184.4% Hematoma102.4% Pleural effusion92.2% Internal organ compromise51.2% Pacemaker implanted20.5% ISHLT 2005 J Heart Lung Transplant 2005;24:

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Major Device Malfunctionsn 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 Patients with 83 major device malfunctions ISHLT 2005 J Heart Lung Transplant 2005;24:

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Intent to Treat: Bridge to Recovery * Type of VAD not specified in 4 patients Primary Device Implantn LVAD (alone)21* Pulsatile flow, chronic device16 Continuous flow, chronic device 1 LVAD + RVAD Combinations14 Total35 ISHLT 2005 J Heart Lung Transplant 2005;24:

Indications for Destination Therapyn% of 78 Advanced age3848.7% Co-morbidity2835.9% Fixed pulmonary hypertension 810.3% Contraindication to immunotherapy 2 2.6% Patient refuses transplant 2 2.6% Total % ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 ISHLT 2005 J Heart Lung Transplant 2005;24:

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Intent to Treat: Destination Therapy Primary Device Implantn LVAD (alone)74 Pulsatile flow, chronic device71 Continuous flow, chronic device 3 LVAD + RVAD Combinations 3 TAH Pulsatile flow, chronic device 1 Total 78 ISHLT 2005 J Heart Lung Transplant 2005;24: