Early Outcomes of Donation After Circulatory Death Heart Transplantation with Thoracoabdominal Normothermic Regional Perfusion

Abstract

<h3>Purpose</h3> To evaluate the early outcomes of donation after circulatory death (DCD) heart transplantation using thoracoabdominal normothermic regional perfusion (TA-NRP). <h3>Methods</h3> The study is designed as a single center prospective study with single arm. Institutional Review Board approved this pilot for a total number of 60 potential DCD heart recipients using grafts recovered with TA-NRP technique (IRB#460-20-FB). The first patient was enrolled on January 3rd 2021. The anticipated study duration is one year for a total of 10 transplant procedures. Recipient inclusion criteria are age ≥ 19 years, signed informed consent, and eligibility for heart transplantation based on standardized institutional criteria. Patients listed for dual organ transplantation and patients with previous cardiac operation including durable LVAD implantation will also be included. All hearts will be recovered with TA-NRP after no more than 30 minutes of warm ischemia (defined as the time period commencing from SBP < 50 mmHg to in-situ reperfusion). TA-NRP protocol is summarized in Figure 1. Acceptance for transplantation will be based upon the functional assessment with TEE and invasive hemodynamic measurements combined with the visual inspection after separation from mechanical support. Grafts will be recovered using 2,000mL of Celsior® for cardio protection, and transported with colds storage. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. <h3>Endpoints</h3> Primary outcome is 30-day patient survival. Secondary outcomes are primary graft dysfunction and inotropic score at 72 hours, ICU and hospital length of stay, ventilation duration, and the need for renal replacement therapy.