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We are currently facing a pandemic of patients with end-stage heart failure (1). Many treatments have been developed for patients with end-stage heart failure, among which orthotopic heart transplantation remains the criterion standard (2). However, the persistent shortage of available donor organs has resulted in an ever-increasing waitlist for transplantation, as well as longer waiting periods before surgery. Although >20,000 patients in the USA may benefit from heart transplantation per year, only 3000 will receive a new heart, with a waitlist mortality of 10.7 deaths per 100,000 waitlist-years (3).
Because of such persistent and worsening shortage of available donor hearts, for the past several decades, there has been scientific and clinical interest in the development of exsitu heart perfusion with oxygenated and nutrient enriched blood to reduce ischemic injury to the donor heart and potentially enable exsitu assessment of metabolic and mechanical function (4). More recently, exsitu heart perfusion has been used to potentially expand the donor pool to include hearts from donation after circulatory death (DCD) (5).
Until recently, beating hearts from donation after brain death (DBD) donors were the only heart donors used for transplantation worldwide. However, during the last 20years, the number of suitable DBD donors has plateaued while the number of patients diagnosed with end-stage organ failure continues to increase. As a result, the waiting list for organ transplantation has grown. To address the organ shortage, DCD donors are being increasingly used to procure donor lungs, livers and kidneys.
However, due to potential damage of warm ischemia in the donor and the functional arrest of the heart that may never recover, DCD donors are not utilized for adult heart transplantation in the USA. In contrast, international transplant centers have been successfully transplanting hearts from DCD donors, using the Organ Care System™ (OCS) Heart System for preservation and assessment of these hearts prior to transplantation (Figure1).
Introduction to the trial
With regard to the challenges posed by DCD donor hearts noted, the OCS Heart System offers the following advantages and capabilities:
- Preservation of the DCD heart into beating physiologic state exsitu to enable for the assessment of the donor heart’s viability;
- Reduction of the time-dependent ischemic injury to the donor hearts during preservation, thus eliminating significant logistical and geographical barriers to...