Comparison of 1-Year Survival and Frequency of Paravalvular Leakage Using the Sapien 3 Versus the Sapien XT for Transcatheter Aortic Valve Implantation for Aortic Stenosis

Abstract

Transcatheter aortic valve implantation shortcomings such as relevant paravalvular leakage (PVL) have been shown to negatively impact survival. The Sapien 3 prosthesis has added features to address these problems. We compared the functional performance of the Sapien 3 (S3) and its predecessor Sapien XT (XT), with a particular focus on PVL. We analyzed 601 patients presenting with severe native aortic valve stenosis treated with either Sapien XT (n = 405, 2011 to 2014, mean STS-PROM [Society of Thoracic Surgeons predicted risk of mortality] 11.0%) or Sapien 3 prosthesis (n = 196, 2014 to 2016, mean STS-PROM 9.2%). Beside a propensity score-based comparison, we modeled the likelihood of PVL as a function of oversizing and prosthesis. Primary end points were 1-year survival, degree of oversizing, and occurrence of PVL. One-year survival (stratified log-rank p = 1.00) and 30-day mortality (S3: 10 of 126 vs XT: 10 of 126, p = 1.00) did not differ. In the matched cohort, oversizing was less common in the S3 group (absolute median difference of 7% in oversizing, interquartile range 1.1% to 12.7%, p = 0.025). PVL > = 1° was similar in both groups (S3: 13 of 126 vs XT: 20 of 126, p = 0.296). Mean gradients were lower in the XT group (median difference 1.0 mm Hg, interquartile range 0.3 to 1.8 mm Hg, p = 0.005). Rate of postdilatation, implantation of a second valve (valve-in-valve), annular rupture, and new pacemaker implantation were similar (all p = 1.00). In conclusion, compared with the Sapien XT, the redesigned Sapien 3 prosthesis offers effective sealing against PVL without grossly compromising hemodynamic performance or increasing the necessity for new pacemaker implantation.