Long Term Results with Total Artificial Heart: Is It Prime Time for Destination Therapy?

Abstract

Purpose During recent years, mechanical circulatory support (MCS) devices have been increasingly used for long-term support. The Syncardia/CardioWest total artificial heart (TAH) has been implanted in over 1075 patients worldwide as a bridge to transplant. We reviewed data of patients supported more than one year to assess its safety and feasibility as destination therapy device. Methods and Materials 47 patients from 10 centers worldwide have been included in this retrospective study. Clinical data have been collected on survival, infections, thromboembolic and hemorrhagic events, device failure, antithrombotic therapy regimen and outcome. Results The median age was 49 years old, the median support time was 554 days (range 365 – 1373 days). The primary diagnosis was dilatative cardiomiopathy in 23 pts, Ischemic in 15 and other in 9. After at least one year of support patients have been successfully transplanted in 72% of cases, 24% died on device and 4 % are still supported. 4 patients (8%) had a device failure report but only for two patients it was the leading cause of death. Major complications were as follows: sistemic infections (19%; 3% leading death), drive line infections (20%, 0% leading death), ischemic (15%, 6% leading death) and hemorrhagic (23%, 6% leading death) events. Moreover antithrombotic regimen, hospital discharge, post operative rehabilitation period, drugs therapy and follow up management have been carefully investigated among our population of patience. Conclusions Cardiowest (t-TAH) has shown to be a reliable and effective device in replacing the entire heart. Device failure occurred rarely and only in two cases was the leading cause of death. The Syncardia TAH has emerged as a robust form of mechanical circulatory support for biventricular failure patients even in a setting of long term support. The dilemma of destination therapy is more ethical issue up to now considering the major impact in the quality of life of these patients.