Related Experiment Video
Updated: Jul 23, 2025

Transcatheter Pulmonary Valve Replacement from Autologous Pericardium with a Self-Expandable Nitinol Stent in an Adult Sheep Model
Published on: June 8, 2022
Early experience with the Evolut FX self-expanding valve vs. Evolut PRO+ for patients with aortic stenosis undergoing
Ilan Merdler1, Brian Case1, Sukhdeep Bhogal1
1MedStar Heart & Vascular Institute, MedStar Washington Hospital Center, Washington, DC, United States of America; MedStar Georgetown University Hospital, Washington, DC, United States of America.
Background:
The Evolut FX system is the most recent generation of self-expandable transcatheter heart valve (THV) technology. This study aims to report the early experience and outcomes associated with this system.
Methods:
Our analysis included 200 consecutive patients who underwent transcatheter aortic valve replacement at our center from 2022 to 2023. The first cohort comprised the last 100 patients who received the Evolut PRO+ THV, while the second cohort included the first 100 patients who received the Evolut FX THV. The primary endpoints of the study were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria, which included technical success (at exit from procedure), device success (at discharge or at 30 days), and early safety (at 30 days).
Results:
The study groups demonstrated no significant differences in baseline characteristics, including co-morbidities, pre-procedural imaging, and echocardiography. VARC-3 technical success rate was 99 % for both valves. The VARC-3 device success rate for the Evolut FX was 92 % compared to 97 % for the Evolut PRO+ (p = 0.12), and VARC-3 early safety rate was 80.1 % for the Evolut PRO+ vs. 81.5 % for the Evolut FX (p = 0.82). The in-hospital permanent pacemaker implantation rate for the Evolut FX was 12 % compared to 9 % for the Evolut PRO+ (p = 0.21). There were no differences in clinical outcomes, such as mortality or stroke, between the two groups.
Conclusions:
The Evolut FX THV performed well when used for patients with severe aortic stenosis, demonstrating high success with low complication rates when compared to an earlier generation of self-expanding THV.
Related Concept Videos
Aortic Regurgitation I: Introduction
Aortic Regurgitation III: Medical Management
Mitral Stenosis I: Introduction
Mitral Valve Prolapse I: Introduction
Mitral Valve Prolapse II: Assessment and Management
Mitral Stenosis III: Medical Management

