Outcomes of Direct Flow Medical vs Sapien 3 Transcatheter Aortic Valve Devices

Abstract

This retrospective study was aimed to compare the safety and efficacy of the Direct Flow Medical (DFM) valve with the more established Sapien 3 (S3) valve in transfemoral TAVI in high-risk aortic stenosis (AS) patients. Between February 2014 and August 2016, 99 and 68 patients had the S3 and DFM valves at our center, respectively. The device success rate was statistically similar among the S3 and DFM groups (p = 0.15). The overall post-procedural complication rate was similar between the two groups (p = 0.4). The procedural time was significantly shorter in the S3 group (p < 0.001) and the post-procedure peak pressure gradient (p < 0.001) was significantly higher in the DFM group. However, the frequency of valvular or paravalvular leaks was similar between both valve groups. We found no significant differences in terms of safety between the DFM and S3 valves. This study confirms the safety and efficacy of the DFM valve in high-risk AS patients.

Keywords: Aortic stenosis; Direct Flow Medical; Sapien 3; TAVI; Transfemoral.