Background: The survival benefit of heart transplantation (HT) compared with optimal medical therapy (OMT) has never been tested.
Methods and results: We created a decision analytic model that simulates a randomized clinical trial of OMT versus HT for each New York Heart Association (NYHA) class. The simulation calculates average life expectancy. The following assumptions were made for OMT annual mortality: class I no excess mortality from HF; class II and III based on MERIT-HF are 5.3% and 8.1%. Class IV is 12.8%, based on COPERNICUS. HT mortality rates were based on survival curves for HT 1982 to 2001. For classes I, II, and III, OMT demonstrated a life expectancy gain of 113 months (232+/-2.2 versus 119+/-2.1), 38 months (152+/-2.1 versus 114+/-2.1), and 6 months (117+/-1.8 versus 111+/-2.2), respectively, over HT. Class IV favored HT with a life expectancy gain of 26 months (107+/-2.1 versus 81+/-1.4) over OMT. Sensitivity analysis revealed if improvement in OMT decreased mortality by 38% for class IV patients, OMT and HT would have equivalent life expectancies. If improvement in HT resulted in a 7% increase in post-HT survival, OMT and HT would be equivalent for class III patients. If improvement in HT resulted in a 30% increase in post-HT survival, OMT and HT would be equivalent for class II patients.
Conclusions: Our model predicts that currently, OMT is superior to HT for classes I, II, and III, but HT is superior for class IV. However, future advances in OMT or HT may change the relative benefits of these treatment modalities.