Ten-year outcomes after transcatheter or surgical aortic valve replacement in low-risk patients: The OBSERVANT study.

Background: The evidence of the long-term advantages of transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement (SAVR) for aortic stenosis (AS) remains scarce.

Methods: Patients with EuroSCORE II < 4 % who underwent TAVR or SAVR for AS from the prospective observational OBSERVANT study were included in this analysis. Ten-year survival was the primary outcome of this analysis. Secondary outcome was repeat procedure on the aortic valve prosthesis.

Results: Propensity score matching resulted in 355 matched pairs of patients who underwent TAVR or SAVR. The mean age of SAVR patients was 80.0 ± 5.1 years and that of TAVR patients 80.1 ± 6.4 years (p = 0.81) and the mean EuroSCORE II was 2.5 ± 0.8 % and 2.6 ± 0.8 % (p = 0.60), respectively. Thirty-day mortality was 2.8 % after SAVR and 2.5 % after TAVR (p = 0.82). At 10-year, survival was 37.0 % (95 %CI 32.2-42.5 %) after SAVR and 18.2 % (95 %CI 14.5-22.8 %) after TAVR (Log-rank test, p < 0.001; HR 1.70, 95 %CI 1.42-2.03). Difference in terms of survival between the propensity matched cohorts became significant 3 years after the procedures. Ten-year cumulative incidences of repeat aortic valve procedure were 2.6 % (95 %CI 1.4-5.0 %) after SAVR and 1.1 % (95 %CI 0.4-3.0 %) after TAVR (p = 0.153; SHR 0.43, 95 %CI 0.13-1.41).

Conclusions: The results of this prospective observational, non-randomized study showed that 10-year survival of low-risk patients who underwent TAVR with early generation prosthesis devices was lower than SAVR.