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.