Transplantation Outcomes with Donor Hearts after Circulatory Death

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; Duc Thinh Pham; 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; David A D'Alessandro

doi:10.1056/NEJMoa2212438

Transplantation Outcomes with Donor Hearts after Circulatory Death

N Engl J Med. 2023 Jun 8;388(23):2121-2131. doi: 10.1056/NEJMoa2212438.

Authors

Jacob N Schroder¹, Chetan B Patel¹, Adam D DeVore¹, Benjamin S Bryner¹, Sarah Casalinova¹, Ashish Shah¹, Jason W Smith¹, Amy G Fiedler¹, Mani Daneshmand¹, Scott Silvestry¹, Arnar Geirsson¹, Victor Pretorius¹, David L Joyce¹, John Y Um¹, Fardad Esmailian¹, Koji Takeda¹, Karol Mudy¹, Yasuhiro Shudo¹, Christopher T Salerno¹, Si M Pham¹, Daniel J Goldstein¹, Jonathan Philpott¹, John Dunning¹, Lucian Lozonschi¹, Gregory S Couper¹, Hari Reddy Mallidi¹, Michael M Givertz¹, Duc Thinh Pham¹, Andrew W Shaffer¹, Masashi Kai¹, Mohammed A Quader¹, Tarek Absi¹, Tamer S Attia¹, Bassam Shukrallah¹, Ben C Sun¹, Maryjane Farr¹, Mandeep R Mehra¹, Joren C Madsen¹, Carmelo A Milano¹, David A D'Alessandro¹

Affiliation

¹ 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.).

PMID: 37285526
DOI: 10.1056/NEJMoa2212438

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.).

Publication types

Equivalence Trial
Randomized Controlled Trial

MeSH terms

Adult
Brain Death*
Death
Graft Survival
Heart Transplantation*
Humans
Organ Preservation
Patient Safety
Tissue Donors
Tissue and Organ Procurement*

Associated data

ClinicalTrials.gov/NCT03831048