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

Syed Zaid; Guilherme F Attizzani; Parasuram Krishnamoorthy; Sung-Han Yoon; Luis A Palma Dallan; Stanley Chetcuti; Shinichi Fukuhara; P Michael Grossman; Sachin S Goel; Marvin D Atkins; Neal S Kleiman; Rishi Puri; Beka Bakhtadze; Timothy Byrne; Akram W Ibrahim; Kendra J Grubb; Andy Tully; Howard C Herrmann; Michela Faggioni; Basel Ramlawi; Sahil Khera; Stamatios Lerakis; George D Dangas; Annapoorna S Kini; Samin K Sharma; Michael J Reardon; Gilbert H L Tang

doi:10.1016/j.jcin.2023.05.004

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

JACC Cardiovasc Interv. 2023 Jul 10;16(13):1626-1635. doi: 10.1016/j.jcin.2023.05.004.

Authors

Syed Zaid¹, Guilherme F Attizzani², Parasuram Krishnamoorthy³, Sung-Han Yoon², Luis A Palma Dallan², Stanley Chetcuti⁴, Shinichi Fukuhara⁴, P Michael Grossman⁴, Sachin S Goel¹, Marvin D Atkins¹, Neal S Kleiman¹, Rishi Puri⁵, Beka Bakhtadze⁵, Timothy Byrne⁶, Akram W Ibrahim⁶, Kendra J Grubb⁷, Andy Tully⁷, Howard C Herrmann⁸, Michela Faggioni⁸, Basel Ramlawi⁹, Sahil Khera³, Stamatios Lerakis³, George D Dangas³, Annapoorna S Kini³, Samin K Sharma³, Michael J Reardon¹, Gilbert H L Tang¹⁰

Affiliations

¹ Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
² University Hospitals of Cleveland, Cleveland, Ohio, USA.
³ Mount Sinai Hospital, New York, New York, USA.
⁴ University of Michigan, Ann Arbor, Michigan, USA.
⁵ Cleveland Clinic, Cleveland, Ohio, USA.
⁶ Abrazo Arizona Heart Hospital, Phoenix, Arizona, USA.
⁷ Emory University, Atlanta, Georgia, USA.
⁸ University of Pennsylvania Perlman School of Medicine, Philadelphia, Pennsylvania, USA.
⁹ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
¹⁰ Mount Sinai Hospital, New York, New York, USA. Electronic address: gilbert.tang@mountsinai.org.

PMID: 37438029
DOI: 10.1016/j.jcin.2023.05.004

Abstract

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.

Keywords: Evolut FX; TAVR; commissural alignment.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aortic Valve Stenosis* / diagnostic imaging
Aortic Valve Stenosis* / surgery
Catheters
Humans
Retrospective Studies
Transcatheter Aortic Valve Replacement* / adverse effects
Treatment Outcome