Assist Devices in the New Decade: From Technical Developments to Political Decisions

This editorial refers to the paper entitled ‘Extracorporeal membrane oxygenation as a rescue of intractable ventricular fibrillation and bridge to heart transplantation’ by T. Fux et al., on page 301. Although assist devices have successfully been used for 20 years as a bridge to heart transplantation, there is still an ongoing debate about the use of long-term mechanical circulatory support as an alternative to transplantation. Since the publication of the REMATCH study in 2001,1 there have been extensive discussions about the optimal treatment of end-stage heart failure. The REMATCH study is still unsurpassed in which patients, non-eligible for heart transplantation, were randomly assigned to optimal medical therapy or mechanical circulatory support with a pusher-plate type of left ventricular assist device (LVAD), the HeartMate XVE (Thoratec, Inc., Pleasanton, CA, USA). After 1 year of follow-up, survival in the LVAD group was about twice that in the conservatively treated patients (52 vs. 25%). For the first time, it had been shown that long-term mechanical support was feasible and better than optimal medical treatment. This has led to FDA approval and reimbursement of the HeartMate XVE as a treatment option for end-stage heart failure. Despite high expectations, the number of implants, however, did not grow excessively. Part of this lack of widespread enthusiasm was certainly related to the bulky size of the device, and the very characteristic hissing noise from the device, hampering normal social contacts. Another major problem became evident in the 2-year follow-up, when almost all patients had died in both arms (survival 23% vs. 8%), the major problems in the LVAD group being device failure and device-related infections. None of the study patients lived for more than 3.5 years with their device.