New Approach to the Treatment of Patients in Intermac 1 or 2 Biventricular Failure and on ECMO with the Syncardia Temporary Total Artificial Heart

Abstract

The objective of the present study is to review the clinical experience of 5 North American Centers with the Syncardia (temporary) Total Artificial Heart focusing on the most recent data with patients in biventricular failure and in patients staged to TAH after ECMO or temporary mechanical support devices. Access to transplantation and survival were the two most significant outcomes of the study. Moreover, we sought to determine the effect of end-organ recovery while on TAH on transplant accessibility and outcomes. The rationale for the present study is to understand how patient selection, timing of TAH implantation, the need for ECMO at the time of TAH implantation, the recovery of end-organ function during TAH support affect patient survival, accessibility to and outcomes after heart transplantation. We hypothesized that properly selected patients in Intermacs clinical status 1 and 2 with biventricular failure and patients supported on ECMO have significant survival rate after TAH implantation and after heart transplantation. Moreover, we suggest that renal and hepatic insufficiency developing in patients in Intermacs clinical status I and 2 can recover under TAH support and that these patients can eventually qualify for heart transplantation. We also believe that properly selected patients whom cannot be weaned from ECMO could benefit from TAH implantation and heart transplantation. A registry of all consecutive adult patients who received a TAH from January 2013 to June 2019 from participating centers was established and centralized at the Montreal Heart Institute. More than 200 patients are included in the study population. Descriptive statistics, Cox proportional hazard models and log-rank tests will be used to study the relationship between patient characteristics before TAH implantation and outcomes after TAH surgery and following heart transplantation. Survival to TAH implantation, to heart transplantation and after transplantation. Impact of ECMO support at the time of TAH implantation on survival and access to transplantation. Effects of pre TAH renal and hepatic insufficiency on survival after TAH implantation and after heart transplantation.