LB-8 | Performance and Use of the Evolut FX Transcatheter Aortic Valve System: Updated Results from the Evolut FX Limited Market Release Clinical Survey

Abstract

The next generation supra-annular, self-expanding Evolut FX TAVR system (Medtronic, Minneapolis, MN) has been designed to improve ease of use through enhanced deliverability and trackability. We report FX system procedural outcomes following design enhancements. Physician feedback was obtained (Jun 24–Sept 11, 2022) at 69 US centers with a high level of implant experience (Group 1) and a broader range of implant experience and volume (Group 2). Survey results compared Evolut FX to the predicate PRO+ system using descriptive statistics. 539 surveys (1/case) were collected. Evolut FX valves (23 mm, 7%; 26 mm, 30%; 29 mm, 45%; 34 mm, 19%) were implanted via transfemoral (TF) access in 97% of cases. The cusp-overlap (CO) technique was used in 89% (457/516) of cases. Commissural alignment at the CO view based on TAV marker orientation was achieved in 96% (447/465) of TF cases. Group 2 operators (n=248) reported using the radiopaque commissure markers to assess implant depth in 89% of cases, to visualize pre-deployment commissure alignment in 85% of cases and to remove parallax in the LAO view in 62% of cases. During initial deployment, no noticeable ventricular movement of the Evolut FX device was reported in 79% of cases; 79% of operators rated the FX as having a more predictable deployment. Better deliverability and tracking was noted with Evolut FX compared to the PRO+ system (Figure). Survey results from the first real-world experience using Evolut FX reported improved deliverability, tracking and deployment compared to PRO+. A high (>95%) rate of commissural alignment was achieved, which may facilitate future coronary access.