International approaches to regulation and outcome monitoring in heart transplantation.

Heart transplantation improves the prognosis and quality of life in carefully selected patients with advanced heart failure. Outcomes depend on a multitude of donor, operative, and recipient factors. There is a high opportunity cost because the number of suitable donor hearts is limited. Many countries regulate their heart transplant programs, but differences in regulatory systems are not well described. We identified 39 nations that performed >20 transplants annually between 2015 and 2024. We invited transplant professionals in each nation to complete a survey on regulation in their country. Professionals from 32 nations responded, of which 28 had mandatory outcome reporting to a national registry. Outcome measures included survival (n = 26), primary graft dysfunction (n = 15), and quality of life (n = 5). Only 6 countries had a pre-specified definition of unacceptable outcomes after heart transplantation. Future studies might investigate the effectiveness of regulatory strategies in heart transplantation.