Cost-effectiveness of routine surveillance endomyocardial biopsy after 12 months post-heart transplantation.

BACKGROUND Despite low risk of late rejection after heart transplant (HT), surveillance endomyocardial biopsies (EMBs) are often continued for years. We assessed the cost-effectiveness of routine EMB after 12 months post-HT. METHODS AND RESULTS Markov model compared the following surveillance EMB strategies to baseline strategy of stopping EMB 12 months post-HT: (1) every 4 months during year 2 post-HT, (2) every 6 months during year 2, (3) every 4 months for years 2 to 3, and (4) every 6 months for years 2 to 3. Patients entered the model 12 months post-HT and were followed until 36 months. In all strategies, patients had EMB with symptoms; in biopsy strategies after 12 months, EMB was also performed as scheduled regardless of symptoms. One-way and Monte Carlo sensitivity analyses were performed. Stopping EMB at 12 months was dominant (more effective, less costly), saving $2884 per patient compared with the next best strategy (every 6 months for year 2) and gaining 0.0011 quality-adjusted life-years. Increasing the annual risk of asymptomatic rejection in years 2 to 3 from previously reported 2.5% to 8.5% resulted in the biopsy every 6 months for year 2 strategy gaining 0.0006 quality-adjusted life-years, but cost $4 913 599 per quality-adjusted life-year gained. EMB for 12 months was also no longer dominant when mortality risk from untreated asymptomatic rejection approached 11%; competing strategies still cost >$200 000 per quality-adjusted life-year as that risk approached 99%. CONCLUSIONS Surveillance EMB for 12 months post-HT is more effective and less costly than EMB performed after 12 months, unless risks of asymptomatic cellular rejection and its mortality are strikingly higher than previously observed.