J Heart Lung Transplant 2004; 23: Continuous Patient Characteristics at Hospital Admission MeasurementMeanMinimumMaximumStd. Error Age at admission Weight (kg) at admission BSA at admission Table I BSA, body surface area

J Heart Lung Transplant 2004; 23: Primary Device Implant LVAD (alone)339 Pulsatile flow, chronic device303 Continuous flow, chronic device27 Not specified9 LVAD + RVAD74 LVAD: Pulsatile flow, chronic device69 LVAD: Continuous flow, chronic device1 LVAD: Not specified4 RVAD: Pulsatile flow, chronic device44 RVAD: Pulsatile flow, temporary device21 RVAD: Continuous flow, temporary device8 RVAD: Not specified1 Total413 Table III

J Heart Lung Transplant 2004; 23: Intention to Treat Category # of patients % of all patients Bridge to transplant % Bridge to recovery245.8% Destination Therapy, Advanced age194.6% Destination Therapy, Co-morbidity122.9% Destination Therapy, Fixed Pulmonary Hypertension30.7% Destination Therapy, Contraindication to Transplant10.2% Not specified71.7% Table IV

J Heart Lung Transplant 2004; 23: Major Causes of Death Causen% of 105 Multiple organ failure2827% Hemorrhage1716% Cardiovascular1110% Stroke1010% Infection77% Other2322% Unspecified99% Total105100% Table VI

J Heart Lung Transplant 2004; 23: Risk Factors for Death after Device Implant Risk FactorRelative RiskP-value EARLY PHASE OF HAZARD Blood type: AB Diagnosis other than Cardiomyopathy BUN at implant1.9 (20 vs 120).04 Concurrent placement of RVAD7.4<.0001 CONSTANT PHASE OF HAZARD Older age2.7 (30 vs 60).02 Gender: female *Patients are censored at transplant BUN, Blood Urea Nitrogen Table VII

J Heart Lung Transplant 2004; 23: Death before transplant TransplantExplant-recovery Reason for Implant nn%n%n% Bridge to transplant %14546%86% Bridge to recovery 24729%28%866% Destination351029%26%0- Other7229%0-2 Unknown35720%1543%0- Total %16440%184% Table VIII ISHLT/MCSD Registry January 2002 – May 2004, n=413

J Heart Lung Transplant 2004; 23: 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% Table IX

J Heart Lung Transplant 2004; 23: Device Malfunction Event# of Events Controller16 Pump/pump drive unit7 Conduit/graft inflow5 Conduit/graft outflow2 Valve/valved conduit inflow2 Battery1 Implanted battery1 Percutaneous lead/drive line1 Other 19 Total54 Table X

J Heart Lung Transplant 2004; 23: ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413, 105 deaths Percent Survival Months after Device Implant Deaths / Month Event: Death after Implant * * censored at transplant Hazard Months % Survival 184 % 376 % 668 % 1255 % (279) (140) (78) (33) Figure 1

J Heart Lung Transplant 2004; 23: p <.0001 Percent Survival Months after Device Implant LVAD only (n=339) LVAD + RVAD at the same operation (n=74) ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413, 105 deaths Primary Device Implant: Event: Death after Implant Figure 2

J Heart Lung Transplant 2004; 23: ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413 BUN at Implant Predicted % Mortality at 3 months LVAD + RVAD at the same operation LVAD (alone) Primary Device Implant: Figure 3

J Heart Lung Transplant 2004; 23: Percent freedom from Explant (due to recovery) Months after Device Implant Explant due to recovery / Month ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413, 18 Explants due to recovery Event: Device Explant due to Recovery Hazard (285) (150) (81) (21) Figure 4

J Heart Lung Transplant 2004; 23: Percent freedom from Transplantation Months after Device Implant Transplants / Month ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413, 164 transplants Event: Transplantation Hazard Months % Freedom 190 % 367 % 643 % 1222 % (279) (140) (72) (18) Figure 5

J Heart Lung Transplant 2004; 23: Instantaneous Event Rates: Events / Month Months after Device Implant Death * Transplantation Explant due to recovery * Censored at transplant ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413, Death, Transplant, Recovery Figure 6

J Heart Lung Transplant 2004; 23: Months after Device Implant Proportion of Patients MCSD Study: Jan 2002 – May 2004 Competing Outcomes Analysis (n=339) Primary Implant: LVAD only Alive (Still waiting) Death (before transplant) Explanted (recovery) Transplanted 30 % 44 % 23 % 3 % 11 % 59 % 26 % 4 % Figure 7

J Heart Lung Transplant 2004; 23: MCSD Study: Jan 2002 – May 2004 Competing Outcomes Analysis (n=74) Primary Implant: LVAD + RVAD at the same operation Months after Device Implant Proportion of Patients Alive (Still waiting) Death (before transplant) Explanted (recovery) Transplanted 14 % 33 % 43 % 10 % 3 % 36 % 48 % 13 % Figure 8

J Heart Lung Transplant 2004; 23: Months after Device Implant Cumulative Events per Patient ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413 Bleeding events (n=282) Infection events (n=304) Thromboembolism (n=59) Figure 9

J Heart Lung Transplant 2004; 23: ISHLT/MCSD Analysis: Jan 2002 – May 2004 n=413 Percent Freedom from Device Malfunction Months after Device Implant Months % Freedom 195 % 389 % 679 % 1260 % Hazard Device Adverse Events / Month (285) (132) (70) (30) Figure 10