Results:

Baseline characteristics of the study cohort included a mean age of 55.6 ± 11.7 years, 89% male, 48% ischemic etiology, and 70% on inotropes. The majority of patients (66%) were bridge-to-transplantation and 32% were INTERMACS profile 1–2. Six-month survival in this primary implant cohort was 92% (95% confidence interval [CI], 89–94%), with only three patients being transplanted. Age, clinical history, and INTERMACS profile did not predict 6-month survival; however, baseline anemia, renal dysfunction, and long cardiopulmonary bypass time were significant risk factors. In addition, implant volume and previous experience with the HM3 LVAD (participating centers of CE Mark Trial) had no significant impact on the 6-month outcome (high volume 91% [95% CI, 87–93] vs. low/medium volume centers 95% [95% CI, 87–98], p = 0.25). Full cohort survival at 6 months was 82 ± 2% (95% CI, 79–85). In the enrolled primary implant patients, there was no incidence of pump thrombosis, major bleeding was 25%, major infection 35%, and any stroke type was 5%. Functional capacity improved significantly (Δ6MWD 230 ± 191 m; p < 0.001), as did QOL (ΔVAS 31 ± 23; p < 0.001). Freedom from unplanned rehospitalizations at 6 months was 68 ± 2%, and this is slightly lower than seen in previous studies. Main causes for re-hospitalization were infection and bleeding, and only a few admissions (2%) were due to alarms for driveline communication faults or controller errors. The introduction of an artificial pulse (every 2 seconds) in the HM3 has not been associated with lower rates of gastrointestinal bleeding than seen with other continuous flow devices.