Results:

Median (range) patient age was 49 (20-75) years, 86% were male, 92% were INTERMACS profiles 2 or 3, and 100% were on preoperative inotropes. The median duration of support was 322 (12-847) days. There were 41 survivors (82%) at study completion and nine deaths (18%), which occurred after a median 94 (13-515) days of support. Of the survivors, cardiac transplant occurred in 40% (n = 20), 8% (n = 4) had pump explantation for myocardial recovery, and 34% (17) remained on support at 2 years. Actuarial survival at 6, 12, and 24 months after device implant was 90%, 84%, and 79%, respectively, compared with Seattle Heart Failure Model (SHFM) predicted survivals of 73%, 58%, and 40% with continued medical therapy. The hazard ratio for HVAD therapy at 1 year using the SHFM predictions as a hypothetical control was 0.29 (p < 0.001). The average readmission rate following HVAD implant was 1.2 admissions/patient-year, which was a 74% reduction when compared to the year prior to device implant. The adverse event rate was 1.9 events/patient-year and included surgical bleeding (0.23 events/patient-year), device replacement (0.15 events/patient-year), right heart failure (0.06 events/patient-year), and driveline infection (0.20 events/patient-year). Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire significantly improved in all areas from baseline by 6 months postoperative.