Transplantation Outcomes with Donor Hearts after Circulatory Death
Jacob N. Schroder, Chetan B. Patel, Adam D. DeVore, Benjamin S. Bryner, Sarah Casalinova, Ashish S. Shah, Jason W. Smith, Amy G. Fiedler, Mani A. Daneshmand, Scott Silvestry, Arnar Geirsson, Victor Pretorius, David L. Joyce, John Um, F. Esmailian, Koji Takeda, Karol Mudy, Yasuhiro Shudo, Christopher T. Salerno, Si M. Pham, Daniel J. Goldstein, Jonathan M. Philpott, John Dunning, Lucian Lozonschi, Gregory S. Couper, Hari R. Mallidi, Michael M. Givertz, Duc Thinh Pham, Andrew Shaffer, Masashi Kai, Mohammed Quader, Tarek Absi, Tamer Attia, Bassam Shukrallah, Ben C. Sun, Maryjane Farr, Mandeep R. Mehra, Joren C. Madsen, Carmelo A. Milano, David A. D’Alessandro
Abstract
BACKGROUND: Data showing the efficacy and safety of the transplantation of hearts obtained from donors after circulatory death as compared with hearts obtained from donors after brain death are limited. METHODS: We conducted a randomized, noninferiority trial in which adult candidates for heart transplantation were assigned in a 3:1 ratio to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group). The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation. RESULTS: A total of 180 patients underwent transplantation; 90 (assigned to the circulatory-death group) received a heart donated after circulatory death and 90 (regardless of group assignment) received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor). The risk-adjusted 6-month survival in the as-treated population was 94% (95% confidence interval [CI], 88 to 99) among recipients of a heart from a circulatory-death donor, as compared with 90% (95% CI, 84 to 97) among recipients of a heart from a brain-death donor (least-squares mean difference, -3 percentage points; 90% CI, -10 to 3; P<0.001 for noninferiority [margin, 20 percentage points]). There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation. CONCLUSIONS: In this trial, risk-adjusted survival at 6 months after transplantation with a donor heart that had been reanimated and assessed with the use of extracorporeal nonischemic perfusion after circulatory death was not inferior to that after standard-care transplantation with a donor heart that had been preserved with the use of cold storage after brain death. (Funded by TransMedics; ClinicalTrials.gov number, NCT03831048.).