1. In this randomized controlled trial, compared to heart transplantation from a brain death donor, recipients of hearts from donors following circulatory death had similar six-month survival.
2. There were no significant differences in the number of serious adverse events 30 days post-operatively between standard-care and post-circulatory death transplantation.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Heart transplantation has previously been restricted to hearts obtained from donors after brain death, which allows for in situ assessment of cardiac function and suitability prior to procurement. Due to the disproportionate need for heart transplants relative to availability, the utilization of hearts from donors after circulatory death has been researched. Extracorporeal machine perfusion enables the reanimation of the heart and ex-situ assessment of cardiac function following circulatory death. Evidence supporting this practice is limited. The current study was a multicenter randomized trial where adult heart transplant candidates were assigned to receive either a heart after donor circulatory death or only a heart obtained after donor brain death. In the as-treated primary analysis, compared to recipients of heart after donor brain death, patients who received a heart after circulatory death had a similar six-month risk-adjusted survival rate. The numbers of per-patient serious adverse events were similar across both groups at 30 days. Although these were short-term results, this trial demonstrated the noninferiority of heart transplantation following donor circulatory death compared to standard-care transplantation of the heart after donor brain death.
In-Depth [randomized controlled trial]: The current randomized controlled trial assessed heart transplantation following donor circulatory death compared to standard-care transplantation after donor brain death. Circulatory-death donors were eligible if they were classified as Maastricht category III, between 18 to 49 years of age, and had a functional warm ischemic time of 30 minutes or less. Potential donors were excluded if they had a history of cardiac surgery, coronary artery disease, or severe heart disease. Brain-death donor hearts were screened as per the institutional standard of care. In total, 180 adult heart transplantation candidates on a waiting list were randomized in a 3:1 ratio to receive a heart after donor circulatory death or to receive only a heart after donor brain death. Overall, the as-treated primary analysis assessed 80 patients who received a heart after donor circulatory death and 86 who received a heart after donor brain death. The primary outcome was risk-adjusted survival at six months. The risk-adjusted survival at six months was 94% (95% Confidence Interval [CI], 88 to 99) for patients who had received a heart from a circulatory-death donor and 90% (95% CI, 84 to 97) for patients who had received a heart from a brain-death donor, resulting in a least-squares mean difference of -3 percentage points (90% CI,-10 to 3; p<0.001). The mean number of graft-associated serious adverse events within 30 days was 0.2 among circulatory-death donor heart recipients and 0.1 among brain-death donor heart recipients. In summary, this trial provided early short-term evidence of noninferiority of heart transplantation after donor circulatory death compared to the standard-care approach with hearts from brain-death donors.
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