Long-term outcomes after heart transplantation using ex vivo allograft perfusion in standard risk donors: A single-center experience.

heart (allograft) function/dysfunction heart disease organ perfusion and preservation patient survival

Journal

Clinical transplantation
ISSN: 1399-0012
Titre abrégé: Clin Transplant
Pays: Denmark
ID NLM: 8710240

Informations de publication

Date de publication:
05 2022
Historique:
revised: 20 12 2021
received: 01 11 2021
accepted: 10 01 2022
pubmed: 15 1 2022
medline: 14 5 2022
entrez: 14 1 2022
Statut: ppublish

Résumé

The Organ Care System (OCS) is an ex vivo perfusion platform for donor heart preservation. Short/mid-term post-transplant outcomes after its use are comparable to standard cold storage (CS). We evaluated long-term outcomes following its use. Between 2011 and 2013, 38 patients from a single center were randomized as a part of the PROCEED II trial to receive allografts preserved with CS (n = 19) or OCS (n = 19). Endpoints included 8-year survival, survival free from graft-related deaths, freedom from cardiac allograft vasculopathy (CAV), non-fatal major adverse cardiac events (NF-MACE), and rejections. Eight-year survival was 57.9% in the OCS group and 73.7% in the CS group (p = .24). Freedom from CAV was 89.5% in the OCS group and 67.8% in the CS group (p = .13). Freedom from NF-MACE was 89.5% in the OCS group and 67.5% in the CS group (p = .14). Eight-year survival free from graft-related death was equivalent between the two groups (84.2% vs. 84.2%, p = .93). No differences in rejection episodes were observed (all p > .5). In select patients receiving OCS preserved allografts, late post-transplant survival trended lower than those transplanted with an allograft preserved with CS. This is based on a small single-center series, and larger numbers are needed to confirm these findings.

Identifiants

pubmed: 35030278
doi: 10.1111/ctr.14591
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

e14591

Subventions

Organisme : NIH HHS
ID : T32HL116273
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Références

Khush KK, Potena L, Cherikh WS, et al. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: 37th adult heart transplantation report-2020; focus on deceased donor characteristics. J Heart Lung Transplant. 2020;39(10):1003-1015.
Colvin M, Smith JM, Ahn Y, et al. OPTN/SRTR 2019 Annual Data Report: heart. Am J Transplant. 2021;21(Suppl 2):356-440.
Buckberg GD, Brazier JR, Nelson RL, Myron Goldstein S, McConnell DH, Cooper N. Studies of the effects of hypothermia on regional myocardial blood flow and metabolism during cardiopulmonary bypass: I. The adequately perfused beating, fibrillating, and arrested heart. J Thorac Cardiovasc Surg. 1977;73(1):87-94.
Chambers DC, Yusen RD, Cherikh WS, et al. The Registry of the International Society for Heart and Lung Transplantation: thirty-fourth Adult Lung And Heart-Lung Transplantation Report-2017; focus theme: allograft ischemic time. J Heart Lung Transplant. 2017;36(10):1047-1059.
Tenderich G, El-Banayosy A, Rosengard B, et al. 10: prospective multi-center European trial to evaluate the safety and performance of the Organ Care System for heart transplants (PROTECT). J Heart Lung Transplant. 2007;26(2):S64.
McCurry K, Jeevanandam V, Mihaljevic T, et al. 294: prospective multi-center safety and effectiveness evaluation of the Organ Care System device for cardiac use (PROCEED). J Heart Lung Transplant. 2008;27(2):S166.
Ardehali A, Esmailian F, Deng M, et al. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet. 2015;385(9987):2577-2584.
Billingham ME, Cary NR, Hammond ME, et al. A working formulation for the standardization of nomenclature in the diagnosis of heart and lung rejection: Heart Rejection Study Group. The International Society for Heart Transplantation. J Heart Transplant. 1990;9(6):587-593.
Stewart S, Winters GL, Fishbein MC, et al. Revision of the 1990 working formulation for the standardization of nomenclature in the diagnosis of heart rejection. J Heart Lung Transplant. 2005;24(11):1710-1720.
Kobashigawa J, Crespo-Leiro MG, Ensminger SM, et al. Report from a consensus conference on antibody-mediated rejection in heart transplantation. J Heart Lung Transplant. 2011;30(3):252-269.
Chang DH, Youn JC, Dilibero D, Patel JK, Kobashigawa JA. Heart transplant immunosuppression strategies at Cedars-Sinai Medical Center. Int J Heart Fail. 2021;3(1):15. https://doi.org/10.36628/ijhf.2020.0034
Ozeki T, Kwon MH, Gu J, et al. Heart preservation using continuous ex vivo perfusion improves viability and functional recovery. Circ J. 2007;71(1):153-159.
Koerner MM, Ghodsizad A, Schulz U, El Banayosy A, Koerfer R, Tenderich G. Normothermic ex vivo allograft blood perfusion in clinical heart transplantation. Heart Surg Forum. 2014;17(3):E141-E145.
Chan JL, Kobashigawa JA, Reich HJ, et al. Intermediate outcomes with ex-vivo allograft perfusion for heart transplantation. J Heart Lung Transplant. 2017;36(3):258-263.
Ramzy D, Rao V, Brahm J, Miriuka S, Delgado D, Ross HJ. Cardiac allograft vasculopathy: a review. Can J Surg. 2005;48(4):319-327.
Kevelaitis E, Nyborg NC, Menasché P. Coronary endothelial dysfunction of isolated hearts subjected to prolonged cold storage: patterns and contributing factors. J Heart Lung Transplant. 1999;18(3):239-247.
Lim JY, Jung SH, Kim MS, et al. Cardiac allograft vasculopathy after heart transplantation: is it really ominous? Clin Transplant. 2017;31(2):e12883.
Mehra MR, Crespo-Leiro MG, Dipchand A, et al. International Society for Heart and Lung Transplantation working formulation of a standardized nomenclature for cardiac allograft vasculopathy-2010. J Heart Lung Transplant. 2010;29(7):717-727.
Schroder JN, D'Alessandro D, Esmailian F, et al. Successful utilization of extended criteria donor (ECD) hearts for transplantation - results of the OCS™ heart EXPAND trial to evaluate the effectiveness and safety of the OCS heart system to preserve and assess ECD hearts for transplantation. J Heart Lung Transplant. 2019;38(4):S42.
García Sáez D, Zych B, Sabashnikov A, et al. Evaluation of the organ care system in heart transplantation with an adverse donor/recipient profile. Ann Thorac Surg. 2014;98(6):2099-2105. discussion 2105-2106.
Sáez DG, Bowles CT, Maunz OK, et al. Donor circulatory death heart transplantation with adverse donor and recipient risk profile. J Heart Lung Transplant. 2017;36(4):S16.
Sponga S, Ferrara V, Beltrami AP, et al. Ex-vivo perfusion on marginal donors in heart transplantation: clinical results and pathological findings. J Heart Lung Transplant. 2019;38(4):S42-S43.
Iyer A, Gao L, Doyle A, et al. Normothermic ex vivo perfusion provides superior organ preservation and enables viability assessment of hearts from DCD donors. Am J Transplant. 2015;15(2):371-380.
Dhital KK, Iyer A, Connellan M, et al. Adult heart transplantation with distant procurement and ex-vivo preservation of donor hearts after circulatory death: a case series. Lancet. 2015;385(9987):2585-2591.
TransMedics Clinical trial to evaluate the safety and effectiveness of the portable Organ Care System (OCSTM) heart for resuscitation, preservation and assessment of hearts from donors after circulatory death (DCD heart trial). clinicaltrials.gov; 2020. Accessed August 9, 2021. https://clinicaltrials.gov/ct2/show/NCT03831048

Auteurs

Qiudong Chen (Q)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Tahli Singer-Englar (T)

Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Jon A Kobashigawa (JA)

Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Amy Roach (A)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Dominic Emerson (D)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Dominick Megna (D)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Danny Ramzy (D)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Pedro Catarino (P)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Jignesh K Patel (JK)

Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Michelle Kittleson (M)

Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Lawrence Czer (L)

Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Joanna Chikwe (J)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Fardad Esmailian (F)

Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH