Successful support of biventricular heart failure patients by new EXCOR® Adult pumps with bileaflet valves: a prospective study.

Abstract

The Berlin Heart EXCOR® Adult biventricular assist device (BiVAD) is an approved mechanical circulatory support for patients with end-stage biventricular heart failure. In this prospective post-market clinical follow-up study, we present the first clinical experience of the new EXCOR® Adult pump with bileaflet (BL) valves in Europe. After CE-mark approval in August 2014, a total of 12 patients were enrolled with a mean age of 44years ± 11 (range 21-58years). The majority of patients (n = 11) were in INTERMACS level 1 or 2. Eight patients had a median pre-operative extracorporeal life support (ECLS) of 6days (range 1-37days). Primary end point was survival, either to heart transplantation (HTx), recovery or alive at 12months on device, whichever occurred first. Secondary end point was the number of adverse events throughout EXCOR® BiVAD support. Median support time up to last follow-up on EXCOR® BiVAD device was 248days (range 57-381days) and patient survival at 1year was 92%. Half of the EXCOR® BiVAD patients (n = 6) were transplanted and five patients were still on support at 1year post-implantation. Complications during EXCOR® BiVAD support were thoracic bleeding, exit site infection and ischemic cerebrovascular incidents in three cases, respectively. The new EXCOR® Adult pump with BL provides pulsatile high cardiac output with excellent outcome and successful bridging to HTx, particularly in critically ill patients with INTERMACS level 1 or 2at the time of implantation.