Use and performance of the evolut FX transcatheter aortic valve system


Tanvir Bajwa, Advocate Health - MidwestFollow
Guilherme F. Attizzani, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, United States of America. Electronic address:
Hemal Gada, University of Pittsburgh-Pinnacle, 1000 N Front Street, Wormleysburg, PA 17043, United States of America.
Stanley J. Chetcuti, University of Michigan, 1500 E Medical Center Drive, Ann Arbor, MI 48109, United States of America. Electronic address:
Mathew R. Williams, New York University - Langone Health, 530 1st Ave. Suite 9V, New York, NY 10016, United States of America. Electronic address:
Mustafa Ahmed, University of Alabama Medicine, 2000 6th Avenue South, Floor 4, Birmingham, AL 35233, United States of America. Electronic address:
George A. Petrossian, Saint Francis Hospital, Vizza Pavilion, 100 Port Washington Blvd Ste G04, Roslyn, NY 11576, United States of America.
Matthew D. Saybolt, Jersey Shore University Medical Center, 1945 NJ-33, Neptune Township, NJ 07753, United States of America.
Suhail Q. Allaqaband, Advocate Health - MidwestFollow
William M. Merhi, Spectrum Health Hospitals, 743 E Beltline Ave NE, Grand Rapids, MI 49525, United States of America. Electronic address:
Robert C. Stoler, Baylor Scott & White Heart and Vascular Hospital at Baylor Scott & White University Medical Center, 621 N Hall St #500, Dallas, TX 75226, United States of America. Electronic address:
Hiram Bezerra, Tampa General Hospital, University of South Florida; 2 Tampa General Circle, Tampa, FL 33606, United States of America. Electronic address:
Paul Mahoney, Sentara Norfolk General Hospital, 600 Gresham Dr Ste 8630A, Norfolk, VA 23507, United States of America.
Willis Wu, Rex Hospital, 2800 Blue Ridge Rd Suite 201, Raleigh, NC 27607, United States of America. Electronic address:
Robert Jumper, St. Vincent's Medical Center, 115 Technology Dr UNIT C300, Trumbull, CT 06611, United States of America. Electronic address:
Larry Lambrecht, Medtronic, 8200 Coral Sea St., Mounds View, MN 55112, United States of America. Electronic address:
Gilbert H. Tang, Mount Sinai Health System, 1190 5th Ave, New York, NY 10029, United States of America.


Background:The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated.

Methods:Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience. Operators were to compare the experience with the Evolut FX to the predicate Evolut PRO+ system.

Results:There were 285 cases during Stage I from June 24 to August 12, 2022, and 254 cases during Stage II from August 15 to September 11, 2022. Overall, the cusp overlap technique was used in 88.6 %, and commissural alignment was achieved in 96.1 % of these cases. Compared to implanter's previous experience with the Evolut PRO+ system, less resistance was noted with the Evolut FX system: in 83.0 % of cases during vascular insertion, in 84.7 % of cases while tracking through the vasculature, in 84.4 % of cases while traversing over the arch, and 76.1 % of cases in advancing across the valve. Better symmetry of valve depth was observed in 423 of 525 cases (80.6 %).

Conclusion:Evolut FX system design modifications translated into improvements in catheter deliverability, deployment symmetry and stability, and commissural alignment as assessed by experienced self-expanding and balloon expandable operators.



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