ISHLT MCSD Analysis Jan 2002 Dec 2004 n 655

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths (224) (137) Months 1 3 6 12 % Survival 83 % 74 % 67 % 50 % (32) Hazard Event: Death after Implant * * censored at transplant ISHLT Months after Device Implant 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187 Deaths / Month Percent Survival (423)

Predicted % Mortality at 6 months ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Primary Device Implant: LVAD + RVAD at the same operation (biventricular failure) LVAD alone (left ventricular failure) Age (years) at Device Implant ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

Cumulative Events per 100 Patients ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 (n=655) 175 Infection Episodes (n=668) 75 Bleeding Episodes (n=396) 18 Thromboembolism Episodes (n=86) Months after Device Implant ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

(410) (212) (122) Months 1 3 6 12 (38) % Survival 95 % 92 % 84 % 66 % Hazard Event: Death after Implant * Months after Device Implant * censored at transplant ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187 Major Device Adverse Event / Month Percent Freedom from Major Device Malfunction ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 66 Patients with Major Device Malfunction

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Bridge to Transplant Age > = 50 (n=292) ISHLT Age < 30 (n=52) 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

Proportion of Patients ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Intent to Treat: Bridge to Recovery (n=35) Alive (Still waiting) 45 % Explanted (recovery) 27 % Death (before transplant) 17 % 12 % Transplanted Months after Device Implant ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187 45 % 37 % 12 % 5%

Proportion of Patients ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Intent to Treat: Destination Therapy (n=78) Alive 65 % 55 % 33 % Death Explanted (recovery) 0 % 2 % Transplanted Months after Device Implant ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187 34 % 11 % 0%

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Destination Therapy Age < 65 (n=37) ISHLT Age >= 65 (n=41) 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Primary Device Implant n LVAD (alone) Pulsatile flow, chronic device Continuous flow, chronic device 542* LVAD + RVAD Combinations 100 TAH Pulsatile flow, chronic device 13 Total 655 * Type of VAD not specified in 16 patients ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187 487 39

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Intention to Treat n Bridge to transplant Bridge to recovery Destination Therapy Not specified 513 35 78 29 78. 3% 5. 3% 11. 9% 4. 4% Total 655 100% ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187 % of 655

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Major Causes of Death n % of 178 Multiple organ failure 62 34. 8% Hemorrhage 27 15. 2% Cardiovascular 22 12. 4% Stroke 18 10. 1% Infection 14 7. 9% 9 5. 1% 24 13. 5% 2 1. 1% 178 100% Pulmonary Other Unspecified Total ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Risk factors for death* after device implant Risk Factor Relative Risk P-value Concurrent placement of RVAD 4. 89 <. 0001 Age (older) 3. 13 <. 0001 Female 2. 53 . 0003 Platelet count (lower) 2. 13 . 02 WBC count (higher) 2. 01 . 008 Blood type A 1. 89 . 008 Diabetes 2. 01 Ventilator (pre-implant) 1. 84 . 03 Creatinine (higher) 1. 64 . 05 EARLY PHASE OF HAZARD CONSTANT PHASE OF HAZARD *Patients are censored at time of transplant. ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Summary of Post-Implantation Patient-related Events Event # of Patients 134 115 100 85 66 58 44 30 22 18 10 9 5 2 Infection Bleeding Arrhythmia Renal dysfunction Respiratory dysfunction Neurological dysfunction Right ventricular dysfunction Hepatic dysfunction Cardiac tamponade Thrombotic vascular complication Hematoma Pleural effusion Internal organ compromise Pacemaker implanted ISHLT 200 5 % of all Patients 32. 5% 27. 8% 24. 2% 20. 6% 16. 0% 14. 0% 10. 7% 7. 2% 5. 3% 4. 4% 2. 2% 1. 2% 0. 5% J Heart Lung Transplant 2005; 24: 1182 -1187

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Major Device Malfunctions n Controller Pump/pump drive unit Pump thrombosis Pump inflow Percutaneous lead/drive line Pump outflow Cannula dislodgement Power base electrical malfunction Pump stoppage Other 31 14 13 11 4 4 1 1 1 3 Total Events 83 66 Patients with 83 major device malfunctions ISHLT 200 5 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) Pulsatile flow, chronic device Continuous flow, chronic device 21* LVAD + RVAD Combinations 14 Total 35 * Type of VAD not specified in 4 patients ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187 16 1

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 Indications for Destination Therapy n % of 78 Advanced age Co-morbidity Fixed pulmonary hypertension Contraindication to immunotherapy Patient refuses transplant 38 28 8 2 2 48. 7% 35. 9% 10. 3% 2. 6% Total 78 100% ISHLT 200 5 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) Pulsatile flow, chronic device Continuous flow, chronic device 74 71 3 LVAD + RVAD Combinations 3 TAH Pulsatile flow, chronic device 1 Total 78 ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

Centers Contributing to the ISHLT MCSD Database COUNTRY CENTER AUSTRIA Universitätsklinik für Chirurgie, Wien BELGIUM Cliniques Universitaires St. Luc Universitair Ziekenhuis Antwerpen, Edegem University Hospital Gasthuisberg/Catholic Univ. of Leuven CANADA Ottawa Heart Institute Quebec Heart Institute – Laval Hospital The Toronto General Hospital St Paul’s Hospital FRANCE C. H. U. Henri Mondor – Univ Paris XII Hopital La Pitie – Salpetriere GERMANY Universitätsklinikum Erlangen Herz-& Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen Chirurgische. Universitaetsklinik/University of Freiburg ISRAEL Sheba Medical Center ITALY Istituto Clinico Humanitas Niguarda CA Granda Hospital SINGAPORE National Heart Centre ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

Centers Contributing to the ISHLT MCSD Database COUNTRY CENTER UNITED STATES University of Alabama Hospital University Medical Center, University of Arizona California Pacific Medical Center Washington Hospital Center St. Luke’s Hospital (Jacksonville) University of Iowa Hospitals and Clinics Rush-Presbyterian/St. Luke’s Med. Center OSF St Francis Medical Center Advocate Christ Medical Center Lutheran Heart Center St Vincent Hospital and Health Care Center Jewish Hospital Oschner Medical Institutes New England Medical Center Massachusetts General Hospital Johns Hopkins Hospital University of Michigan Medical Center Fairview University Medical Center St Mary’s Hospital, Mayo Clinic Barnes Jewish Hospital Carolinas Medical Center Duke University Medical Center Bryan LGH Medical Center East Newark Beth Israel Medical Center ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187

Centers Contributing to the ISHLT MCSD Database COUNTRY CENTER UNITED STATES (continued) Montefiore Medical Center Columbia Presbyterian Medical Center Westchester Medical Center Ohio State University Hospital University of Cincinnati Medical Center University Hospital Cleveland Clinic Foundation St Francis Hospital Oregon Health Sciences & University Hospital Providence Portland Medical Center Hershey Medical Center Temple University Hospital University of Pittsburgh Medical Center Baptist Memorial Hospital Vanderbilt Transplant Center Seton Medical Center Medical City Dallas Hospital Baylor University Medical Center The Methodist Hospital (Houston) LDS Hospital University of Utah Medical Center Inova Fairfax Hospital MCV Hospitals Sacred Heart Medical Center University of Wisconsin Hospital St. Luke’s Medical Center (Milwaukee) ISHLT 200 5 J Heart Lung Transplant 2005; 24: 1182 -1187