There is increasing demand for transcatheter aortic valve replacement (TAVR) as the primary treatment option for patients with severe aortic stenosis (AS) who are high risk surgical candidates or inoperable. TAVR is typically limited to centers of excellence with restricted capacity, thereby causing prolonged wait-times. Our objective was to use mathematical simulation models to estimate the hypothetical effectiveness of TAVR with increasing wait-times, when compared to either conservative medical therapy in inoperable candidates or conventional surgical aortic valve surgery in high risk candidates.
Methods:
We developed a fully probabilistic discrete event model, using input data from the randomized controlled Placement of Aortic Transcatheter Valves (PARTNER) trials. We evaluated two populations separately: a) in the high risk surgical cohort, we compared TAVR to conventional aortic valve surgery; b) in the inoperable cohort, we compared TAVR to conservative medical therapy. We evaluated 7 scenarios with hypothetical TAVR wait-times ranging from 10 days to 180 days. The main outcome was 1-year mortality and wait-time deaths.
Results:
In the inoperable cohort, the mean 1-year mortality for the conservative medical therapy arm was approximately 50%. When the TAVR wait-time was 10 days, the mean TAVR wait-time mortality was 1.9% with a 1 year mortality of 31.5%. Mean TAVR wait-time deaths increased to 28.9% with a 180-day wait, with a corresponding mean 1-year mortality of 41.4%.
In the high risk cohort, the wait-time deaths and mean 1-year mortality for the surgical patients were 2.5% and 27% respectively in all scenarios. The TAVR wait-time deaths increased from 2.2% at a 10-day wait to 22.4% at a 180-day wait, with a corresponding increase in 1-year mortality from 24.5% to 32.6%. The 1-year mortality in the TAVR group exceeded that in the surgical group at wait-times greater than 60 days.
Conclusion:
We found that modest increases in TAVR wait-times would have substantial impact on the effectiveness of TAVR in both inoperable patients and high risk surgical candidates. In the high-risk surgical candidates, at wait-times beyond 60 days, TAVR was less effective on average compared to conventional surgery. Our results highlight the importance of aggressive wait-time management for TAVR in severe AS.
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