• Jacob N Schroder, Chetan B Patel, Adam D DeVore, Benjamin S Bryner, Sarah Casalinova, Ashish Shah, Jason W Smith, Amy G Fiedler, Mani Daneshmand, Scott Silvestry, Arnar Geirsson, Victor Pretorius, David L Joyce, John Y Um, Fardad Esmailian, Koji Takeda, Karol Mudy, Yasuhiro Shudo, Christopher T Salerno, Si M Pham, Daniel J Goldstein, Jonathan Philpott, John Dunning, Lucian Lozonschi, Gregory S Couper, Hari Reddy Mallidi, Michael M Givertz, PhamDuc ThinhDTFrom Duke University Medical Center, Durham, NC (J.N.S., C.B.P., A.D.D., S.C., C.A.M.); Northwestern University (B.S.B., D.T.P.) and the University of Chicago (C.T.S.) - both in Chicago; Vanderbilt University Medical Center, Nashville (A.S., Andrew W Shaffer, Masashi Kai, Mohammed A Quader, Tarek Absi, Tamer S Attia, Bassam Shukrallah, Ben C Sun, Maryjane Farr, Mandeep R Mehra, Joren C Madsen, Carmelo A Milano, and David A D'Alessandro.
• From Duke University Medical Center, Durham, NC (J.N.S., C.B.P., A.D.D., S.C., C.A.M.); Northwestern University (B.S.B., D.T.P.) and the University of Chicago (C.T.S.) - both in Chicago; Vanderbilt University Medical Center, Nashville (A.S., T.A.); University of Wisconsin Hospital and Clinics, Madison (J.W.S.), and the Medical College of Wisconsin, Milwaukee (D.L.J.); the University of California, San Francisco, San Francisco (A.G.F.), the University of California, San Diego, La Jolla (V.P.), Cedars-Sinai Medical Center, Los Angeles (F.E.), and Stanford University Medical Center, Stanford (Y.S.) - all in California; Emory University Hospital, Atlanta (M.D., T.S.A.); Advent Health, Orlando (S.S.), Mayo Clinic, Jacksonville (S.M.P.), and Tampa General Hospital, Tampa (J.D., L.L.) - all in Florida; Yale School of Medicine, New Haven, CT (A.G.); Nebraska Medical Center, Omaha (J.Y.U.); Columbia University Medical Center, New York (K.T.), Montefiore Medical Center, Bronx (D.J.G.), and Westchester Medical Center, Valhalla (M.K.) - all in New York; Minneapolis Heart Institute Foundation (K.M., B.S., B.C.S.) and the University of Minnesota Medical Center (A.W.S.) - both in Minneapolis; Sentara Norfolk General Hospital, Norfolk (J.P.), and Virginia Commonwealth University, Richmond (M.A.Q.) - both in Virginia; Tufts Medical Center (G.S.C.), Brigham and Women's Hospital (H.R.M., M.M.G., M.R.M.), and Massachusetts General Hospital (J.C.M., D.A.D.) - all in Boston; and the University of Texas Southwestern Medical Center, Dallas (M.F.).
• N. Engl. J. Med. 2023 Jun 8; 388 (23): 212121312121-2131.

BackgroundData 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.MethodsWe 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.ResultsA 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.ConclusionsIn 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.).Copyright © 2023 Massachusetts Medical Society.

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