Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: Difference of valve selection in the real world

Abstract

Background: The SAPIEN 3 (S3; Edwards Lifescience, Irvine, CA, USA) is a new-generation percutaneous aortic valve with better profile, more precise handling and positioning, designed to reduce the risk of post-procedural paravalvular aortic leak (PVL). The aim of this study was to compare the S3 valve and SAPIEN XT valve (SXT).

Methods: The last 89 transfemoral transcatheter aortic valve implantation (TAVI) cases using SXT were compared to the first 111 cases using the S3.

Results: Patient age and logistic EuroSCORE were similar (83.1 years vs 83.0 years and 18.2% vs 16.6%) in the S3 and SXT groups, respectively as were other baseline characteristics. The ratio of valve diameter/calculated annulus average diameter (CAAD) by multi-detector row computed tomography was significantly lower in the S3 group (1.06 vs 1.09, p<0.001) as was the annular area oversizing percentage (11.3% vs 20.5%, p<0.001). Furthermore, a smaller valve was selected in S3 cases with borderline CAAD compared to SXT cases. Nevertheless, the frequency of paravalvular aortic leakage (PVL) ≥2 tended to be reduced in the S3 group (5% vs 9%, p=0.339). The rate of major vascular complications was significantly lower with S3 (3% vs 12%, p=0.013). In addition, 30-day mortality was significantly lower in the S3 group (0% vs 5%, p=0.044).

Conclusions: Although TAVI using S3 tended to be carried out with a less oversized valve compared to TAVI using SXT, the frequency of post-procedural PVL ≥2 tended to be lower in the S3 group. The outcomes including vascular complications and 30-day mortality showed a trend in favor of the S3 group.

Keywords: SAPIEN 3; SAPIEN XT; Severe symptomatic aortic stenosis; Transcatheter aortic valve implantation.