First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System.

Background: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited.
Objectives: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience.
Methods: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported.
Results: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001).
Conclusions: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.
Competing Interests: Funding Support and Author Disclosures Dr Attizzani is a consultant for Medtronic and Abbott Vascular; and serves as a proctor and is on the advisory board for Medtronic. Dr Chetcuti has received personal fees from Medtronic for proctoring and consulting; institutional grants from Edwards Lifesciences, Boston Scientific, and Jena during the conduct of the study; and serves on advisory boards for JenaValve without remuneration. Dr Fukuhara is a consultant for Medtronic, Terumo Aortic, and Artivion. Dr Grossman is a physician proctor for Medtronic; and receives research support from Medtronic, Edwards Lifesciences, Abbott, Cardiovascular Systems, Inc., and Boston Scientific. Dr Goel is a consultant for Medtronic and W. L. Gore & Associates; and is on the Speakers Bureau for Abbott Structural Heart. Dr Kleiman is a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Puri is a speaker and proctor for Medtronic; is a consultant for Medtronic, Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, and Protembis; and has equity interest in Centerline Biomedical, VahatiCor, and NuevoSono. Dr Byrne is a physician proctor for Abbott Structural Heart and Medtronic; a consultant for Medtronic and Abiomed; and has received speakers honoraria from Abbott Structural Heart and Abiomed. Dr Grubb is a physician proctor for Medtronic and Edwards Lifesciences; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, BioVentrics, 4C Medical, W.L. Gore, and Abbott Vascular. Dr Herrmann has received institutional research funding from Boston Scientific, Abbott Structural Heart, Edwards Lifesciences, and Medtronic; and has received consultant fees and speaking honoraria from Medtronic. Dr Ramlawi is a consultant for Boston Scientific, Medtronic, Liva Nova, and Atricure. Dr Khera is a speaker for Medtronic and Zoll Medical; a proctor for Medtronic; and a consultant for Terumo, Medtronic, Abbott, and Boston Scientific. Dr Reardon is a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Tang is a physician proctor for Medtronic; a consultant for Medtronic, Abbott Structural Heart, and NeoChord; a physician advisory board member for Abbott Structural Heart, Boston Scientific, and JenaValve; and receives speakers honoraria from Siemens Healthineers and East End Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)