Long-term follow-up of patients supported with the HeartWare left ventricular assist system

Abstract

The aim of the present study is to report our long-term experience with the HeartWare Ventricular Assist System (HVAD). Between July 2009 and February 2018, a total of 103 patients (mean age 50.0 ± 14.4, range 28-74 years; 22 females) received HVAD implantation in a single center institution. A total of 26 (25.4%) patients were in cardiogenic shock preoperatively and received extracorporeal life support (ECLS) prior to HVAD implantation. The aim of left ventricular assist device (LVAD) implantation was bridge to transplantation (BT) in 59 (57.3%), destination therapy (DT) in 28 (27.2%), and bridge to decision in 16 (15.5%). There were 211.1 total patient years of support. Mean survival was 2.05 ± 2.14 years. Kaplan-Meier analysis showed an overall survival rate of 69.7%, 56.7%, 46.0%, and 25.0% at 1, 2, 4, and 8 years, respectively. A total of 23 patients (22.3%) died during the hospital stay. Of them 65.2% (15 patients) were preoperatively in cardiogenic shock (INTERMACS 1). Sub-analysis of the BT patients showed a mean survival of 2.45 ± 2.29 years with a survival rate of 85.1%, 75.1%, 67.2%, and 44.8% at 1, 2, 4, and 8 years, respectively. Among them, 20 patients received heart transplantation on follow-up. Mean survival of DT patients was 2.18 ± 1.91 years with a survival rate of 67.9%, 49.0%, and 25.1% at 1, 2, and 4 years, respectively. At latest follow-up in September 2018, 26 patients (25.24%) were still on LVAD. A total of five patients completed 6 years on LVAD, of them two were supported over 8 years. The most common adverse event reported was gastrointestinal bleeding requiring rehospitalization (0.161 EPPY). A total of 19 patients reported disabling stroke. Pump thrombosis was diagnosed in six patients (5.8%) (0.02 EPPY), of them four patients underwent pump exchange. To the best of our knowledge, this is the longest experience with HVAD reported so far. Patients supported with an HVAD show a satisfactory long-term survival. Further multicenter evaluations are needed to confirm these single-center results.

Keywords: ECLS; LVAD; heart failure.