0373 : Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN 3 versus SAPIEN XT prostheses

Abstract

The new balloon-expandable valve SAPIEN 3 provide a superiority over previous device, in a broader range of patients, with better accuracy in valve positioning and less paravalvular regurgitation. We aimed to evaluate periprocedural and short-term outcomes using the Edwards SAPIEN 3-S3 compared with the earlier generation SAPIEN XTSXT prosthesis. A single center prospective study included all patients who underwent TAVR with SAPIEN device between January 2013 and March 2015. Valve Academic Research Consortium endpoints were used. 142 consecutive patients who underwent TAVR using SAPIEN device were included (n=76 SXT and n=66 S3).S3 patients had a higher prevalence of peripheral arterial disease (65.2 vs. 36.8%, p=0.001) and ilio-femoral axis calcifications on scanner (47.9 vs; 26.5%, p=0.008). TAVR was performed through transfemoral access in 96% in both groups. Device implantation success rate was higher (100% vs. 90%, p=0.002) in the S 3.The prevalence of moderate to severe paravalvular leak was lower in S3 patients (0% vs 9.2%, p=0.01). We observed fewer hemorrhagic events in the S 3, as assessed by the lower incidence of life-threatening and major bleeding events (1,5% vs 13,1%, p=0.02). There was no difference regarding the 30-days rate of MACCE between patients, including death (3% vs. 5%), stroke (3% vs. 2.6%) and major vascular complications (6% vs. 8%). Finally, the rate of permanent pacemaker implantation was comparable in both groups (10.6 vs. 14.5%, p=0.49). SAPIEN 3 allows TAVR in patients with more severe peripheral artery disease with lower rate of paravalvular regurgitations and major bleeding compared with SAPIEN XT. The author hereby declares no conflict of interest