Clinical Outcomes With Normothermic Pulsatile Organ Perfusion in Heart Transplantation: A Report From the OCS Heart Perfusion Registry

Josef Stehlik¹, Maryjane A Farr², Mandeep R Mehra³, Jacob N Schroder⁴, David A D'Alessandro⁵, Jay D Pal⁶, Mauricio A Villavicencio⁷, Peter J Gruber⁸, Gregory S Couper⁹, Yasuhiro Shudo¹⁰, Parag C Patel¹¹, Mani A Daneshmand¹², Liviu Klein¹³, Ashish S Shah¹⁴, Eric R Skipper¹⁵, Fardad Esmailian¹⁶, Daniel Goldstein¹⁷, Suguru Ohira¹⁸, Lucian Lozonschi¹⁹, David J Kaczorowski²⁰, Koji Takeda²¹, Rajasekhar S R Malyala²², Jonathan W Haft²³, Dan M Meyer²⁴, Benjamin C Sun²⁵, Victor Pretorius²⁶, Arman Kilic²⁷, Anelechi C Anyanwu²⁸, Celeste T Williams²⁹, Duc T Pham³⁰, Masashi Kai³¹, Nasir Z Sulemanjee³², Akinobu Itoh³, Masaki Funamoto³³, Christopher T Salerno³⁴, John S Ikonomidis³⁵, Lucian A Durham³⁶, Andrew Shaffer³⁷, Xiang Zhou³⁸, Farhan Zafar³⁸, Sean P Pinney²⁸, Carmelo A Milano⁴

Affiliations

¹ University of Utah, Salt Lake City (J.S.).
² UT Southwestern Medical Center, Dallas, TX (M.A.F.).
³ Brigham and Women's Hospital, Boston, MA (M.R.M., A.I.).
⁴ Duke University Hospital, Durham, NC (J.N.S., C.A.M.).
⁵ Massachusetts General Hospital, Boston (D.A.D.).
⁶ University of Washington Medical Center, Seattle (J.D.P.).
⁷ Mayo Clinic Hospital Minnesota, Rochester (M.A.V.).
⁸ Yale New Haven Hospital, New Haven, CT (P.J.G.).
⁹ Tufts Medical Center, Boston, MA (G.S.C.).
¹⁰ Stanford Health Care, Palo Alto, CA (Y.S.).
¹¹ Mayo Clinic Hospital Florida, Jacksonville (P.C.P.).
¹² Emory University Hospital, Atlanta, GA (M.A.D.).
¹³ University of California San Francisco Medical Center (L.K.).
¹⁴ Vanderbilt University Medical Center, Nashville, TN (A.S.S.).
¹⁵ Carolinas Medical Center, Charlotte, NC (E.R.S.).
¹⁶ Cedars-Sinai Medical Center, Los Angeles, CA (F.E.).
¹⁷ Montefiore Medical Center, Bronx, NY (D.G.).
¹⁸ Westchester Medical Center, Valhalla, NY (S.O.).
¹⁹ Tampa General Hospital, FL (L.L.).
²⁰ University of Pittsburgh Medical Center, PA (D.J.K.).
²¹ NY Presbyterian Hospital/Columbia University Medical Center, New York (K.T.).
²² University of Kentucky Medical Center, Lexington (R.S.R.M.).
²³ University of Michigan Medical Center, Ann Arbor (J.W.H.).
²⁴ Baylor University Medical Center, Dallas, TX (D.M.M.).
²⁵ Abbott Northwestern Hospital, Minneapolis, MN (B.C.S.).
²⁶ University of California San Diego (V.P.).
²⁷ Medical University of South Carolina, Charleston (A.K.).
²⁸ Mount Sinai Medical Center, New York, NY (A.C.A., S.P.P.).
²⁹ Henry Ford Hospital, Detroit, MI (C.T.W.).
³⁰ Northwestern Memorial Hospital, Chicago, IL (D.T.P.).
³¹ Beth Israel Deaconess Medical Center, Boston, MA (M.K.).
³² Aurora St. Luke's Medical Center, Milwaukee, WI (N.Z.S.).
³³ Methodist Specialty and Transplant Hospital, San Antonio, TX (M.F.).
³⁴ University of Chicago Medical Center, IL (C.T.S.).
³⁵ University of North Carolina Hospitals, Chapel Hill (J.S.I.).
³⁶ Froedtert Memorial Lutheran Hospital, Milwaukee, WI (L.A.D.).
³⁷ University of Minnesota Medical Center, Fairview, Minneapolis (A.S.).
³⁸ TransMedics, Inc, andover, MA (X.Z., F.Z.).

PMID: 40052272
DOI: 10.1161/CIRCULATIONAHA.124.071743

Multicenter Study

Clinical Outcomes With Normothermic Pulsatile Organ Perfusion in Heart Transplantation: A Report From the OCS Heart Perfusion Registry

Josef Stehlik et al. Circulation. 2025 Apr.

. 2025 Apr;151(13):896-909.

doi: 10.1161/CIRCULATIONAHA.124.071743. Epub 2025 Mar 7.

Authors

Affiliations

¹ University of Utah, Salt Lake City (J.S.).
² UT Southwestern Medical Center, Dallas, TX (M.A.F.).
³ Brigham and Women's Hospital, Boston, MA (M.R.M., A.I.).
⁴ Duke University Hospital, Durham, NC (J.N.S., C.A.M.).
⁵ Massachusetts General Hospital, Boston (D.A.D.).
⁶ University of Washington Medical Center, Seattle (J.D.P.).
⁷ Mayo Clinic Hospital Minnesota, Rochester (M.A.V.).
⁸ Yale New Haven Hospital, New Haven, CT (P.J.G.).
⁹ Tufts Medical Center, Boston, MA (G.S.C.).
¹⁰ Stanford Health Care, Palo Alto, CA (Y.S.).
¹¹ Mayo Clinic Hospital Florida, Jacksonville (P.C.P.).
¹² Emory University Hospital, Atlanta, GA (M.A.D.).
¹³ University of California San Francisco Medical Center (L.K.).
¹⁴ Vanderbilt University Medical Center, Nashville, TN (A.S.S.).
¹⁵ Carolinas Medical Center, Charlotte, NC (E.R.S.).
¹⁶ Cedars-Sinai Medical Center, Los Angeles, CA (F.E.).
¹⁷ Montefiore Medical Center, Bronx, NY (D.G.).
¹⁸ Westchester Medical Center, Valhalla, NY (S.O.).
¹⁹ Tampa General Hospital, FL (L.L.).
²⁰ University of Pittsburgh Medical Center, PA (D.J.K.).
²¹ NY Presbyterian Hospital/Columbia University Medical Center, New York (K.T.).
²² University of Kentucky Medical Center, Lexington (R.S.R.M.).
²³ University of Michigan Medical Center, Ann Arbor (J.W.H.).
²⁴ Baylor University Medical Center, Dallas, TX (D.M.M.).
²⁵ Abbott Northwestern Hospital, Minneapolis, MN (B.C.S.).
²⁶ University of California San Diego (V.P.).
²⁷ Medical University of South Carolina, Charleston (A.K.).
²⁸ Mount Sinai Medical Center, New York, NY (A.C.A., S.P.P.).
²⁹ Henry Ford Hospital, Detroit, MI (C.T.W.).
³⁰ Northwestern Memorial Hospital, Chicago, IL (D.T.P.).
³¹ Beth Israel Deaconess Medical Center, Boston, MA (M.K.).
³² Aurora St. Luke's Medical Center, Milwaukee, WI (N.Z.S.).
³³ Methodist Specialty and Transplant Hospital, San Antonio, TX (M.F.).
³⁴ University of Chicago Medical Center, IL (C.T.S.).
³⁵ University of North Carolina Hospitals, Chapel Hill (J.S.I.).
³⁶ Froedtert Memorial Lutheran Hospital, Milwaukee, WI (L.A.D.).
³⁷ University of Minnesota Medical Center, Fairview, Minneapolis (A.S.).
³⁸ TransMedics, Inc, andover, MA (X.Z., F.Z.).

PMID: 40052272
DOI: 10.1161/CIRCULATIONAHA.124.071743

Abstract

Background: A preservation system, the Organ Care System (OCS; TransMedics) uses normothermic pulsatile perfusion during organ transport for heart transplantation. This system has demonstrated favorable outcomes in hearts recovered from extended-criteria donors after brain death (DBD) and donors after circulatory death (DCD).

Methods: The OCS Heart Perfusion Registry collects data on US heart transplantations using the OCS, static cold storage (SCS), or thoracoabdominal normothermic regional perfusion (NRP) and donor hearts recovered from DBD or DCD donors. We analyzed donor and recipient characteristics and posttransplantation outcomes in patients transplanted with OCS donor hearts (either DBD or DCD) compared with SCS hearts, and with OCS hearts from DCD donors compared with those recovered with NRP followed by SCS. Propensity score matching was used in survival analyses to adjust for differences among recipient characteristics.

Results: Between 2021 and 2023, 3225 consecutive heart transplantations enrolled from 56 centers were analyzed in the Heart Perfusion Registry. The OCS was used in 854 of 3225 heart transplantations (26.4%), among which 340 (39.8%) were DBD and 514 (60.2%) were DCD donors, whereas 2174 DBD donors were recovered with SCS and another 197 DCD donors with NRP techniques. The OCS-DBD group experienced a greater number of organ offer refusals before final acceptance (13 versus 6; Wilcoxon rank sum, P<0.001) and a longer transport distance (667 miles versus 232 miles; Wilcoxon rank sum, P<0.001) compared with SCS-DBD. Survival at 12 months was similar between the 2 groups (89.9% for OCS-DBD versus 90.6% for SCS-DBD; marginal Cox model, P=0.54). Among the OCS-DCD and SCS-DBD groups, survival at 12 months was also similar (91.0% versus 92.5%, respectively; marginal Cox model, P=0.32). The OCS-DCD and NRP-DCD groups demonstrated similar survival (91.0% versus 91.7%, respectively; log rank, P=0.63), although the transport distance was longer in OCS-DCD compared with DCD with NRP followed by SCS (400 miles versus 223 miles; Wilcoxon rank sum, P<0.001). By 2023, 90% of all OCS donor management and recovery was performed with dedicated organ recovery teams.

Conclusions: We demonstrate that real-world implementation of the OCS for DBD donors (using predominantly a dedicated recovery team) is associated with expanded donor criteria, longer transport distance, and excellent posttransplantation outcomes. In OCS-DCD donors, outcomes parallel those of donors recovered with NRP-DCD and compare favorably with DBD donor organs.

Keywords: heart transplantation; organ preservation; perfusion; survival.

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Conflict of interest statement

Drs Stehlik, Farr, Pinney and Milano received equity compensation by TransMedics for their consulting role as OHP Registry Steering Committee members. Dr Stehlik reports research support from Natera and Merck and consulting fees from Natera, and Medtronic. Dr Farr reports consulting for Natera. Dr Pinney reports consulting for Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, and Valgen Medtech. Dr Mehra reported receiving consulting fees paid to Brigham and Women’s Hospital from Abbott during the conduct of the study and personal fees from Moderna, Natera, TransMedics, Cadrenal, Second Heart Assist, Paragonix, NupulseCV, FineHeart, and Leviticus outside the submitted work. Dr Schroder was a speaker/consultant to Abbott and Abiomed. Dr D’Alessandro reports consulting for Abiomed (ongoing) and receiving speaker honorarium from Paragonix (ended). Dr Daneshmand is a TransMedics consulting National OCS Program procurement surgeon. Dr Skipper has been a speaker/consultant for Abbott, Abiomed, Boston Scientific, and Edwards Lifesciences. Dr Goldstein has been an Abbott consultant, Abiomed consultant, speaker, and national co-primary investigator for the IMPACT trial. Dr Kaczorowski reports research support from TransMedics, XVIVO, and Abiomed and speaking/consulting fees from Abiomed. Dr Sun has been a consultant for Abbott Vascular. Dr Kilic has been a consultant/speaker for Abbott, Abiomed, 3ive, and LivaNova. Dr Pham has been a speaker/consultant for Abbott, AbioMEd, and Medtronic. Dr Itoh has been a speaker for Abbott and Abiomed, Dr Salerno has been a speaker/consultant for Abbott. Dr Shaffer consulted on new product development for Abbott Medical. Dr Shudo received honoraria for participating in an industry-sponsored educational webinar titled Long Distance Organ Recovery, organized by ISHLTv in 2022. Drs Zhou and Zafar are TransMedics employees. The other authors report no conflicts.

Comment in

The Future Is Now: Paradigm Shifts in Heart Transplantation in the United States.
Yau TM, Verma S. Yau TM, et al. Circulation. 2025 Apr;151(13):910-912. doi: 10.1161/CIRCULATIONAHA.125.073544. Epub 2025 Mar 31. Circulation. 2025. PMID: 40163564 No abstract available.

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Clinical Outcomes With Normothermic Pulsatile Organ Perfusion in Heart Transplantation: A Report From the OCS Heart Perfusion Registry

Affiliations

Clinical Outcomes With Normothermic Pulsatile Organ Perfusion in Heart Transplantation: A Report From the OCS Heart Perfusion Registry

Authors

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Abstract

Conflict of interest statement

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