Abstract 2457: Left Ventricular Assist Device Therapy with the HeartMate II Continuous Flow Rotary Pump as a Bridge to Heart Transplantation
Background: The HeartMate (HM) II continuous flow rotary pump represents a new generation of implantable left ventricular assist device (LVAD) that has recently completed clinical evaluation in an FDA-approved study for bridge to transplantation (BTT). Through a continued access protocol (CAP), an additional cohort of patients has undergone implantation of the HMI II device. We report on a comparative analysis of outcomes from both the primary and CAP cohorts.
Methods: In a prospective, multi-center study, 297 patients with refractory heart failure and on intravenous inotrope therapy underwent implantation of the HM II to evaluate safety and efficacy as a BTT (n=133 patients-primary study cohort; n=164 patients-CAP; 61 patients in the CAP cohort completed 6 mo followup).
Results: Baseline demographics, hemodynamics, renal and hepatic function were not significant between groups (Table 1⇓). Number of patients with positive outcomes at 6 mo (transplant, cardiac recovery, alive on LVAD) were similar between cohorts (79% vs 80%). HM II therapy improved 6 minute walk distance at 3 month followup (by 250±232 m vs 226±180 m), and quality of life (Minnesota Living with Heart Failure; by 37% vs. 41%) to similar degrees for each cohort. The incidence of significant adverse events (pump replacements, 5 vs. 1; postoperative bleeding requiring surgery, 31% vs 23%; ischemic and hemorrhagic stroke, 8.0% vs 9.8%; need for RVAD, 4% vs 8%) were not significant between groups.
Conclusions: Outcomes from patients implanted with the HMII device during CAP were similar to outcomes of patients implanted in the primary cohort. These analyses validate the original findings regarding efficacy and risk profile of the HM II continuous flow LVAD in this patient population as a BTT.