Ex vivo Normothermic Perfusion in Heart Transplantation: A Review of the TransMedics^® Organ Care System

References

• Bakhtiyar SS , GodfreyEL, AhmedSet al. Survival on the heart transplant waiting list. JAMA Cardiol., 5(11), 1227–1235 (2020).
   PubMed Web of Science ®Google Scholar
• Barnard CN . The operation. A human cardiac transplant: an interim report of a successful operation performed at Groote Schuur Hospital, Cape Town. S. Afr. Med. J., 41(48), 1271–1274 (1967).
   PubMedGoogle Scholar
• Bourge RC , NaftelDC, Costanzo-NordinMRet al. Pretransplantation risk factors for death after heart transplantation: a multiinstitutional study. The Transplant Cardiologists Research Database Group. J. Heart Lung Transplant., 12(4), 549–562 (1993).
   PubMed Web of Science ®Google Scholar
• Stehlik J , EdwardsLB, KucheryavayaAYet al. The Registry of the International Society for Heart and Lung Transplantation: 29th official adult heart transplant report–2012. J. Heart Lung Transplant., 31(10), 1052–1064 (2012).
   PubMed Web of Science ®Google Scholar
• Goldsmith KA , DemirisN, GooiJHet al. Life-years gained by reducing donor heart ischemic times. Transplantation, 87(2), 243–248 (2009).
   PubMed Web of Science ®Google Scholar
• Russo MJ , ChenJM, SorabellaRAet al. The effect of ischemic time on survival after heart transplantation varies by donor age: an analysis of the United Network for Organ Sharing database. J. Thorac. Cardiovasc. Surg., 133(2), 554–559 (2007).
   PubMed Web of Science ®Google Scholar
• Lund LH , KhushKK, CherikhWSet al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-fourth Adult Heart Transplantation Report-2017; Focus Theme: Allograft ischemic time. J. Heart Lung Transplant., 36(10), 1037–1046 (2017).
   PubMedGoogle Scholar
• Khush KK , PotenaL, CherikhWSet 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., 39(10), 1003–1015 (2020).
   PubMedGoogle Scholar
• Yeter R , HublerM, PasicM, HetzerR, KnosallaC. Organ preservation with the organ care system. Applied Cardiopulmonary Pathophysiology, 11, 207–212 (2011).
   Google Scholar
• Michel P , VialR, RodriguezC, FerreraR. A comparative study of the most widely used solutions for cardiac graft preservation during hypothermia. J. Heart Lung Transplant., 21(9), 1030–1039 (2002).
   PubMed Web of Science ®Google Scholar
• TransMedics . https://www.transmedics.com/
   Google Scholar
• Hassanein WH , ZellosL, TyrrellTAet al. Continuous perfusion of donor hearts in the beating state extends preservation time and improves recovery of function. J. Thorac. Cardiovasc. Surg., 116(5), 821–830 (1998).
   PubMed Web of Science ®Google Scholar
• Messer S , ArdehaliA, TsuiS. Normothermic donor heart perfusion: current clinical experience and the future. Transpl. Int., 28(6), 634–642 (2015).
   PubMed Web of Science ®Google Scholar
• Beuth J , FalterF, PintoRibeiro RV, BadiwalaM, MeineriM. New strategies to expand and optimize heart donor pool: ex vivo heart perfusion and donation after circulatory death: a review of current research and future trends. Anesth. Analg., 128(3), 406–413 (2019).
   PubMed Web of Science ®Google Scholar
• Resch T , CardiniB, OberhuberRet al. Transplanting marginal organs in the era of modern machine perfusion and advanced organ monitoring. Front. Immunol., 11, 631 (2020).
   PubMed Web of Science ®Google Scholar
• Tenderich G , ZittermannA, SchulzUet al. Heart transplantation at the Heart Center North Rhine-Westfalia. Clin. Transpl.151–161 (2008).
   PubMedGoogle Scholar
• Tenderich G , El-BanayosyA, RosengardBet 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., 26(2), S64 (2007).
   Web of Science ®Google Scholar
• Tenderich G , TsuiS, El-BanayosyAet al. 293: the 1-year follow-up results of the PROTECT patient population using the organ care system. J. Heart Lung Transplant., 27(Suppl. 2), S166 (2008).
   Web of Science ®Google Scholar
• Ardehali A , EsmailianF, DengMet al. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet, 385(9987), 2577–2584 (2015).
   PubMed Web of Science ®Google Scholar
• Koerner MM , GhodsizadA, SchulzU, ElBanayosy A, KoerferR, TenderichG. Normothermic ex vivo allograft blood perfusion in clinical heart transplantation. Heart Surg. Forum, 17(3), E141–145 (2014).
   PubMed Web of Science ®Google Scholar
• Rojas S , IusF, SchibilskyDet al. Cardiac transplantation in higher risk patients: is ex vivo heart perfusion a safe preservation technique? A two center experience. J. Heart Lung Transplant., 38(4), S43 (2019).
   PubMed Web of Science ®Google Scholar
• Kaliyev R , LesbekovT, BekbossynovSet al. Heart transplantation of patients with ventricular assist devices: impact of normothermic ex-vivo preservation using organ care system compared with cold storage. J. Cardiothorac. Surg., 15(1), 323 (2020).
   PubMed Web of Science ®Google Scholar
• Sáez DG , ZychB, MohitePet al. LVAD bridging to heart transplantation with ex vivo allograft preservation shows significantly improved: outcomes: a new standard of care? J. Heart Lung Transplant., 34(4), S95 (2015).
   Web of Science ®Google Scholar
• García Sáez D , ZychB, SabashnikovAet al. Evaluation of the organ care system in heart transplantation with an adverse donor/recipient profile. Ann. Thorac. Surg., 98(6), 2099–2105 (2014).
   PubMed Web of Science ®Google Scholar
• Sponga S , BonettiA, FerraraVet al. Preservation by cold storage vs ex vivo normothermic perfusion of marginal donor hearts: clinical, histopathologic, and ultrastructural features. J. Heart Lung Transplant., 39(12), 1408–1416 (2020).
   PubMed Web of Science ®Google Scholar
• Schroder J , D’AlessandroD, EsmailianFet 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., 38(4), S42 (2019).
   Web of Science ®Google Scholar
• Dhital K , LudhaniP, ScheuerS, ConnellanM, MacdonaldP. DCD donations and outcomes of heart transplantation: the Australian experience. Indian J. Thorac Cardiovasc. Surg., 36(Suppl. 2), 224–232 (2020).
   PubMed Web of Science ®Google Scholar
• Messer S , PageA, BermanMet al. First to 50: early outcomes following heart transplantation at Royal Papworth Hospital from donation after circulatory determined death (DCD) donors. J. Heart Lung Transplant., 38(4), S43 (2019).
   PubMed Web of Science ®Google Scholar
• Garcia Saez D , ZychB, SabashnikovAet al. Evaluation of the organ care system in heart transplantation with an adverse donor/recipient profile. Ann. Thorac. Surg., 98(6), 2099–2105 (2014).
   PubMed Web of Science ®Google Scholar
• Chan JL , KobashigawaJA, ReichHJet al. Intermediate outcomes with ex-vivo allograft perfusion for heart transplantation. J. Heart Lung Transplant., 36(3), 258–263 (2017).
   PubMed Web of Science ®Google Scholar
• Sato T , AzarbalB, ChengRet al. Does ex vivo perfusion lead to more or less intimal thickening in the first-year post-heart transplantation? Clin. Transplant., 33(8), e13648 (2019).
   PubMed Web of Science ®Google Scholar
• Wentz CP . TransMedics® Organ Care System™ (OCS) Heart System FDA Presentation for the April 6, 2021 Cardiovascular Devices Advisory Panel Meeting. (2021). https://www.fda.gov/media/147299/download
   Google Scholar
• Wittwer T , WahlersT. Marginal donor grafts in heart transplantation: lessons learned from 25 years of experience. Transpl. Int., 21(2), 113–125 (2008).
   PubMed Web of Science ®Google Scholar
• Massad MG . Current trends in heart transplantation. Cardiology, 101(1–3), 79–92 (2004).
   PubMed Web of Science ®Google Scholar
• Heart EXPAND Continued Access Protocol. https://clinicaltrials.gov/ct2/show/NCT03835754?term=transmedics&draw=4%29
   Google Scholar
• Donors After Circulatory Death Heart Trial. https://clinicaltrials.gov/ct2/show/NCT03831048
   Google Scholar
• White CW , MesserSJ, LargeSRet al. Transplantation of hearts donated after circulatory death. Front Cardiovasc Med, 5, 8 (2018).
   PubMed Web of Science ®Google Scholar
• Thuong M , RuizA, EvrardPet al. New classification of donation after circulatory death donors definitions and terminology. Transpl. Int., 29(7), 749–759 (2016).
   PubMed Web of Science ®Google Scholar
• Mehta V , TaylorM, HasanJet al. Establishing a heart transplant programme using donation after circulatory-determined death donors: a United Kingdom based single-centre experience. Interact Cardiovasc. Thorac. Surg., 29(3), 422–429 (2019).
   PubMed Web of Science ®Google Scholar
• Noterdaeme T , DetryO, HansMFet al. What is the potential increase in the heart graft pool by cardiac donation after circulatory death? Transpl. Int., 26(1), 61–66 (2013).
   PubMed Web of Science ®Google Scholar
• Iyer A , GaoL, DoyleAet al. Normothermic ex vivo perfusion provides superior organ preservation and enables viability assessment of hearts from DCD donors. Am. J. Transplant., 15(2), 371–380 (2015).
   PubMed Web of Science ®Google Scholar
• Garcia Saez D , ElbetanonyA, LezbergPet al. Ex vivo heart perfusion after cardiocirculatory death; a porcine model. J. Surg. Res., 195(1), 311–314 (2015).
   PubMed Web of Science ®Google Scholar
• Dhital KK , IyerA, ConnellanMet al. Adult heart transplantation with distant procurement and ex-vivo preservation of donor hearts after circulatory death: a case series. Lancet, 385(9987), 2585–2591 (2015).
   PubMed Web of Science ®Google Scholar
• Messer SJ , AxellRG, ColahSet al. Functional assessment and transplantation of the donor heart after circulatory death. J. Heart Lung Transplant., 35(12), 1443–1452 (2016).
   PubMed Web of Science ®Google Scholar
• Shudo Y , Benjamin-AddyR, KoyanoTK, HiesingerW, MacArthurJW, WooYJ. Donors after circulatory death heart trial. Future Cardiol., 17, 11–17 (2021).
   PubMedGoogle Scholar
• Monteagudo Vela M , GarciaSaez D, SimonAR. Current approaches in retrieval and heart preservation. Ann. Cardiothorac. Surg., 7(1), 67–74 (2018).
   PubMed Web of Science ®Google Scholar
• Watson DC , ReitzBA, BaumgartnerWAet al. Distant heart procurement for transplantation. Surgery, 86(1), 56–59 (1979).
   PubMed Web of Science ®Google Scholar
• Stamp NL , ShahA, VincentVet al. Successful heart transplant after ten hours out-of-body time using the TransMedics organ care system. Heart Lung Circ., 24(6), 611–613 (2015).
   PubMed Web of Science ®Google Scholar
• Kaliyev R , BekbossynovS, NurmykhametovaZ. Sixteen-hour ex vivo donor heart perfusion during long-distance transportation for heart transplantation. Artif. Organs, 43(3), 319–320 (2019).
   PubMed Web of Science ®Google Scholar
• Ghodsizad A , BordelV, UngererM, KarckM, BekeredjianR, RuhparwarA. Ex vivo coronary angiography of a donor heart in the organ care system. Heart Surg. Forum, 15(3), E161–163 (2012).
   PubMed Web of Science ®Google Scholar
• Hassanein A , ElbatanonyA, AbdelaziemA, SolomonS. 241: the organ care system (OCS) enables ex-vivo assessment of donor heart coronary perfusion using contrast echocardiography. J. Heart Lung Transplant., 28(2), S150 (2009).
   Web of Science ®Google Scholar
• Tsui S , DhitalK, EisenringC, ArdehaliA. 387: ex-vivo assessment of donor hearts with the OCS to detect hidden pathologies. J. Heart Lung Transplant., 27(2), S200 (2008).
   Web of Science ®Google Scholar
• Hamed A , TsuiS, HuberJ, LinR, PoggioE, ArdehaliA. 19: serum lactate is a highly sensitive and specific predictor of post cardiac transplant outcomes using the organ care system. J. Heart Lung Transplant., 28(2), S71 (2009).
   Web of Science ®Google Scholar
• Sponga S , NapgalD, BeltramiAPet al. Coronary dissection discovered during ex vivo organ preservation: avoiding a fatal complication. Ann. Thorac. Surg., 104(5), e383–e384 (2017).
   PubMed Web of Science ®Google Scholar
• Summary Minutes Center for Devices and Radiological Health. In: FDA Circulatory Devices Panel. (2021). https://www.fda.gov/media/148330/download
   Google Scholar
• Sandha JK , WhiteCW, MullerAet al. Steroids limit myocardial edema during ex vivo perfusion of hearts donated after circulatory Death. Ann. Thorac. Surg., 105(6), 1763–1770 (2018).
   PubMed Web of Science ®Google Scholar
• TransMedics OCS Lung System O160013/S002 (2019). https://www.fda.gov/medical-devices/recently-approved-devices/transmedics-ocs-lung-system-p160013s002
   Google Scholar
• Nakajima D , WatanabeY, OhsumiAet al. Mesenchymal stromal cell therapy during ex vivo lung perfusion ameliorates ischemia-reperfusion injury in lung transplantation. J. Heart Lung Transplant., 38(11), 1214–1223 (2019).
   PubMed Web of Science ®Google Scholar
• Martens A , OrdiesS, VanaudenaerdeBMet al. Immunoregulatory effects of multipotent adult progenitor cells in a porcine ex vivo lung perfusion model. Stem Cell Res. Ther., 8(1), 159 (2017).
   PubMed Web of Science ®Google Scholar
• Bishawi M , RoanJN, MilanoCAet al. A normothermic ex vivo organ perfusion delivery method for cardiac transplantation gene therapy. Sci. Rep., 9(1), 8029 (2019).
   PubMedGoogle Scholar
• Chew HC , MacdonaldPS, DhitalKK. The donor heart and organ perfusion technology. J. Thorac. Dis., 11(Suppl. 6), S938–S945 (2019).
   PubMedGoogle Scholar
• Macdonald PS , ChewHC, ConnellanM, DhitalK. Extracorporeal heart perfusion before heart transplantation: the heart in a box. Curr. Opin. Organ Transplant., 21(3), 336–342 (2016).
   PubMed Web of Science ®Google Scholar
• Nilsson J , JernrydV, QinGet al. A nonrandomized open-label Phase II trial of nonischemic heart preservation for human heart transplantation. Nat. Commun., 11(1), 2976 (2020).
   PubMed Web of Science ®Google Scholar