The main objective of PEGASE is to validate the recovery of a satisfactory cardiac function of a transplanted heart after a prolonged period of preservation by an ex-vivo perfusion device. This recovery of cardiac function will have to happen within 15 days after transplantation.
Heart transplantation is a scarce resource, only 1 patient among 2 had the opportunity to be grafted in France in 2022. Despite the shortage of organs, some potential heart transplants are currently not recovered because the ischemia duration anticipated before being grafted (from donor to recipient) is too long and not compatible with transplantation, actually limited to 4h, max. Innovation in ex-vivo hypothermic perfusion allows to consider the extension of the graft viability time, thus offering the possibility of extending the pool of heart grafts available to the patients, The study aims to demonstrate the feasibility of taking heart grafts from donors in Martinique and Guadeloupe, transferring them via air transport and then successfully transplanting them to patients hospitalized in France, up to 14 hours later, using an ex-vivo cold perfusion device to protect the heart during transport. Patients involved in this study will be patients in desperate need of transplantation, with no chance of receiving it, due to the French transplant allocation policy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Heart transplantation in patients who have obtained a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière
Pitié-Salpêtrière Hospital
Paris, France
Short term recovery of Cardiac function
Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography
Time frame: Within 15 days after transplantation
Survival
Time frame: 15 days, 30 days, 9 months, 6 months and 12 months
Absence of cardiac deaths
Patient who survived or died for a reason other than failure of cardiac function
Time frame: 15 days, 30 days, 3 months, 6 months and 12 months
Cardiac function recovery
Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography
Time frame: 30 days, 3months, 6 months and 12 months
Adverse events after transplant
* moderate or severe primary graft dysfunction (according to ISHLT consensus), * acute cell rejection \>2R, VAD \>1, * long-term circulatory support (LVAD, BiVAD, TAH)
Time frame: 15 days and 12 months
Myocardial preservation
Absence of significant edema (pre- and post-preservation graft weight)
Time frame: during the procedure/surgery
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