Background: The comparative mid and long-term durability, including the rates of bioprosthetic valve failure (BVF) of the Sapien XT® and Sapien 3® transcatheter heart valve (THV) in patients with intermediate surgical risk has not been reported.
Methods: Consecutive intermediate-risk patients with severe aortic stenosis from the Mexican registry of transcatheter aortic valve replacement (TAVR) with Sapien® THVs were included. The primary endpoint was to compare the BVF rate between THVs at 2 years of follow-up. Secondary endpoints were comparisons of the composite of global mortality, cardiovascular mortality, and neurological events at 30 d and 24 months of follow-up.
Results: During 2014-2019, 115 (60 Sapien XT® and 55 Sapien 3®) patients met the inclusion criteria in five medical centres. The mean age was 77.3 ± 8.4 years. The average Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) was 5.6 ± 2.9. There was no statistically significant difference between the groups in BVF rate. At 30 d, overall, cardiovascular and non-cardiovascular mortality was 4.3%, 2.6%, and 1.7%, respectively. Neurological events rate was 1.73%. The mean long-term follow-up was 25.3 ± 14.2 months with an overall mortality of 9.56% but lower for the Sapien 3® group (15% vs. 3.6%, p=.037). The only independent predictor of composite mortality and neurological events that occurred in the long term was using a Sapien XT® [OR 1.6, CI 95%, 1.0-24.9; p=.049].
Conclusions: The BVF rate at 25 months of follow-up was similar with the XT and S3 systems. During this follow-up period, the major composite events of death from any cause and neurological events were significantly lower with the S3 system.
Keywords: Severe aortic stenosis; balloon-expandable transcatheter heart valve; bioprosthetic valve failure; structural heart interventions; transcatheter aortic valve implantation.