Transplantation Outcomes with Donor Hearts after Circulatory Death

被引：126

作者：

Schroder, J. N. ^{[1
]}

Patel, C. B. ^{[1
]}

DeVore, A. D. ^{[1
]}

Bryner, B. S. ^{[2
]}

Casalinova, S. ^{[1
]}

Shah, A. ^{[4
]}

Smith, J. W. ^{[5
]}

Fiedler, A. G. ^{[7
]}

Daneshmand, M. ^{[11
]}

Silvestry, S. ^{[12
]}

Geirsson, A. ^{[15
]}

Pretorius, V. ^{[8
]}

Joyce, D. L. ^{[6
]}

Um, J. Y. ^{[16
]}

Esmailian, F. ^{[9
]}

Takeda, K. ^{[17
]}

Mudy, K. ^{[20
]}

Shudo, Y. ^{[10
]}

Salerno, C. T. ^{[3
]}

Pham, S. M. ^{[13
]}

Goldstein, D. J. ^{[18
]}

Philpott, J. ^{[22
]}

Dunning, J. ^{[14
]}

Lozonschi, L. ^{[14
]}

Couper, G. S. ^{[24
]}

Mallidi, H. R. ^{[25
]}

Givertz, M. M. ^{[25
]}

Pham, D. T. ^{[2
]}

Shaffer, A. W. ^{[21
]}

Kai, M. ^{[19
]}

Quader, M. A. ^{[23
]}

Absi, T. ^{[4
]}

Attia, T. S. ^{[11
]}

Shukrallah, B. ^{[20
]}

Sun, B. C. ^{[20
]}

Farr, M. ^{[27
]}

Mehra, M. R. ^{[25
]}

Madsen, J. C. ^{[26
]}

Milano, C. A. ^{[1
]}

D'Alessandro, D. A. ^{[26
]}

机构：

[1] Duke Univ, Med Ctr, Durham, NC USA

[2] Northwestern Univ, Chicago, IL USA

[3] Univ Chicago, Chicago, IL USA

[4] Vanderbilt Univ, Med Ctr, Nashville, TN USA

[5] Univ Wisconsin Hosp & Clin, Madison, WI USA

[6] Med Coll Wisconsin, Milwaukee, WI USA

[7] Univ Calif San Francisco, San Francisco, CA USA

[8] Univ Calif San Diego, San Diego, CA USA

[9] Cedars Sinai Med Ctr, Los Angeles, CA USA

[10] Stanford Univ, Med Ctr, Stanford, CA USA

[11] Emory Univ Hosp, Atlanta, GA USA

[12] Advent Hlth, Orlando, FL USA

[13] Mayo Clin, Jacksonville, FL USA

[14] Tampa Gen Hosp Tampa, Tampa, FL USA

[15] Yale Sch Med, New Haven, CT USA

[16] Nebraska Med Ctr, Omaha, NE USA

[17] Columbia Univ, Med Ctr, New York, NY USA

[18] Montefiore Med Ctr, Bronx, NY USA

[19] Westchester Med Ctr, Valhalla, NY USA

[20] Minneapolis Heart Inst Fdn, Minneapolis, MN USA

[21] Univ Minnesota, Med Ctr, Minneapolis, MN USA

[22] Sentara Norfolk Gen Hosp, Norfolk, VA USA

[23] Virginia Commonwealth Univ, Richmond, VA USA

[24] Tufts Med Ctr, Boston, MA USA

[25] Brigham & Womens Hosp, Boston, MA USA

[26] Massachusetts Gen Hosp, Boston, MA USA

[27] Univ Texas Southwestern Med Ctr, Dallas, TX USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2023年 / 388卷 / 23期

关键词：

PRIMARY GRAFT DYSFUNCTION; DONATION;

D O I：

10.1056/NEJMoa2212438

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 braindeath 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 circulatorydeath 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 standardcare 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.)

引用

页码：2121 / 2131

页数：11

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