New Machine Perfusion Technique Expands Pool of Viable Heart Donors
Researchers successfully transplanted hearts into six patients deemed untransplantable using a machine perfusion system that keeps donor organs oxygenated outside the body. The breakthrough could significantly increase heart transplant availability by enabling surgeries with unpredictably long operating times, addressing a critical shortage in a $4+ billion annual transplant market.
Originaltitel: Compassionate Use of Hypothermic Oxygenated Perfusion for Donor Hearts: Extending the Boundaries of Heart Recipient Complexity in Heart Transplantation.
Hypothermic oxygenated machine perfusion (HOPE) möjliggör hjärttransplantation hos patienter som tidigare varit operable på grund av kirurgisk komplexitet. Deutschen Herzzentrum der Charité ansökte om undantag för användning av XVIVO-systemet från Gothenburg för sex patienter med olämplig status enligt standard kyllagring, där risken för utdragen iskemitid hotade graftöverlevnad. Alla sex patienter genomgick kirurgisk dissekering längre än fyra timmar (389–636 minuter), inklusive en patient med medfödda hjärtfel och LVAD-stöd. Bevaringtiderna varierade mellan 286–487 minuter. Ingen svår primär graftdysfunktion observerades. Fem av sex patienter överlevde 30 dagar; en dog av icke-kardial orsak. Resultaten visar att HOPE utökar transplantationskandidaternas komplexitet genom att säkra graftfunktion vid längre ischemi. För regionvård och inköpschefer utgör detta grund för framtida CE-märkning och möjlighet att öka tilgängligheten till hjärttransplantation hos högriskkategorier.
BACKGROUND: Hypothermic oxygenated machine perfusion (HOPE) for ex-vivo non-ischemic heart preservation (NIHP) has been shown to reduce severe primary graft dysfunction (PGD) in human heart transplantation (HTx) compared with standard static cold storage (SCS) and to safely extend preservation time beyond four hours. Patients requiring highly complex surgical site dissection may be deemed unsuitable for HTx under SCS, given the heightened risk of prolonged allograft ischemic time and its well-established association with PGD and adverse post-transplant outcomes. METHODS: Compassionate use of a non-CE-marked Heart Preservation System (XVIVO Group, Gothenburg, Sweden) for HOPE was approved for six patients considered unsuitable for transplantation because of surgical complexity and the risk of graft loss due to unpredictable, prolonged ischemic times. HOPE was performed in accordance with the clinical NIHP trial protocols. Primary outcomes were PGD incidence and 30-day-survival. RESULTS: Total organ preservation time ranged from 286-487 minutes. Pre-implant surgical site dissection times exceeded four hours (389-636 minutes), with the longest in a recipient with congenital heart disease and LVAD support. No PGD was observed. Within 30 days after transplantation five of six patients survived; one died from non-cardiac cause. CONCLUSION: Compassionate use of HOPE facilitated meticulous surgical site dissection in highly complex recipients otherwise unsuitable for HTx with SCS. By safely extending preservation time while providing excellent immediate graft function, HOPE may reduce the overall HTx procedural risk and expand the applicability to the most complex recipients beyond previous limits of SCS. These six cases provide proof-of-concept and demonstrate feasibility of this approach.