Ten-Year outcomes of transcatheter versus surgical aortic valve replacement: extended follow-up from the OBSERVANT study

Objectives: To compare long-term clinical outcomes of patients undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the Italian clinical practice and enrolled in the multicentre OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) Study. Methods: Propensity score matching was used to compare patients undergoing SAVR or transfemoral (TF) TAVR with similar baseline characteristics. The primary end-points were all-cause mortality and major adverse cardiac and cerebrovascular events (MACCE) at 10 years. Prespecified secondary end-points included cerebrovascular accidents, repeat aortic intervention, repeat hospitalization due to cardiac reasons and heart failure. All outcomes were adjudicated through a linkage with administrative databases. Results: From the entire cohort (n = 5707 SAVR and n = 1911 TAVR treated between December 2010 and June 2012), 650 matched pairs of patients were considered. At 10 years, TF-TAVR was associated with a higher risk of all-cause mortality [Hazard ratio (HR) 1.39, 95% confidence interval (CI) 1.22-1.59; p < 0.001] and MACCE (HR 1.33, 95% CI 1.18-1.51; p < 0.001) compared to SAVR.Secondary end-points did not differ for rehospitalization for heart failure (p = 0.443) or cardiac reasons (p = 0.552), and for cerebrovascular events (p = 0.573), but TAVR had a significantly lower risk of repeat aortic intervention [Sub-distributional HR (SHR), 0.33; 95% CI, 0.12-0.91; p = 0.024] at 10 years. Conclusions: At 10 years, early generation TAVR had significantly higher risk of all-cause mortality and MACCE, but lower risk of repeat aortic intervention in clinical practice.