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Extracorporeal Perfusion for Extended Criteria Donor Hearts
Quick Takes
- In this study using a portable extracorporeal perfusion system during heart procurement, utilization of extended criteria donor hearts was high at 86.7%.
- In this setting, 30-day post-transplant survival and freedom from severe primary graft dysfunction was 92.0%. Survival outcomes were comparable to standard heart transplant approaches.
Study Questions:
For extended criteria donor (ECD) hearts in donation after brain death (DBD), what is the impact of the use of portable extracorporeal perfusion on donor heart utilization and post-transplant outcomes?
Methods:
This was a prospective, multicenter, single-arm study, including data from the EXPAND and EXPAND-Continued Access Protocol (CAP) trials. Included were adult heart transplant recipients that received ECD DBD hearts (not meeting current standard donor heart criteria due to risk factors) via an extracorporeal perfusion system. Excluded were recipients with a prior solid organ or bone marrow transplant, multiorgan transplant, or diagnosis of chronic kidney disease requiring renal replacement therapy.
The primary outcome of the study was a composite of 30-day post-transplant survival and absence of severe primary graft dysfunction (PGD). Key secondary outcomes were donor heart utilization rate, 30-day post-transplant survival, and incidence of severe PGD. The safety outcome was the mean number of heart graft-related serious adverse events at 30 days post-transplant (including moderate or severe PGD, primary graft failure requiring re-transplantation).
Results:
In this study, a total of 173 ECD DBD hearts were perfused with the extracorporeal perfusion system from January 2015–August 2021 (93 in EXPAND, 80 in EXPAND-CAP). Of these, 150 hearts (86.7%) were utilized and successfully transplanted.
For the primary outcome, 30-day post-transplant survival and absence of severe PGD was 92.0% (95% confidence interval [CI], 86.4%-95.8%; p < 0.001). For the secondary outcomes, 30-day post-transplant survival was 96.6% and the incidence of severe PGD was 6.7%. Post-transplant survival was also assessed at additional time intervals. Survival was 92.6%, 89.3%, and 86.0% at 6, 12, and 24 months, respectively. These survival outcomes were comparable to heart transplantation with standard criteria hearts using traditional cold storage. For the safety outcome, the mean number of heart graft-related serious adverse events at 30 days was 0.17 (95% CI, 0.11-0.23).
Conclusions:
For ECD DBD hearts, the use of portable extracorporeal perfusion systems resulted in high donor heart utilization and excellent 30-day post-transplant survival and freedom from severe PGD.
Perspective:
While heart transplantation is a lifesaving therapy for patients with advanced heart failure, there are not enough available donor organs to meet the needs of this patient population. Compounding the problem is the underutilization of donor organs, leading to increased waitlist times and mortality. A factor that may contribute to underutilization is the limitations associated with traditional cold storage organ preservation (time-dependent ischemic injury creating geographic limitations, no ability to assess/optimize allografts). This may lead to turning down donor organs not meeting standard criteria due to risk factors (ECD hearts).
This study addressed these limitations with the use of a portable extracorporeal perfusion system that limits that ischemic injury to donor hearts and allows for ex-situ assessment and optimization of allograft function, providing reassurance that a ECD DBD heart may be suitable for transplant. Results of this approach demonstrated high organ utilization rates with promising outcomes comparable to standard criteria heart transplantation. This has the potential to significantly increase the size of the donor heart pool and the number of heart transplants performed.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Heart Transplant
Keywords: Heart Transplantation, Organ Preservation
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