TY - JOUR
T1 - Use and performance of the evolut FX transcatheter aortic valve system
AU - Bajwa, Tanvir
AU - Attizzani, Guilherme F.
AU - Gada, Hemal
AU - Chetcuti, Stanley J.
AU - Williams, Mathew R.
AU - Ahmed, Mustafa
AU - Petrossian, George A.
AU - Saybolt, Matthew D.
AU - Allaqaband, Suhail Q.
AU - Merhi, William M.
AU - Stoler, Robert C.
AU - Bezerra, Hiram
AU - Mahoney, Paul
AU - Wu, Willis
AU - Jumper, Robert
AU - Lambrecht, Larry
AU - Tang, Gilbert H.L.
N1 - Publisher Copyright:
© 2024 Elsevier Inc.
PY - 2024/10
Y1 - 2024/10
N2 - 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.
AB - 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.
KW - Deliverability
KW - Selfexpanding
KW - Supra-annular
KW - Transcatheter aortic valve implantation
KW - Transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85189903389&partnerID=8YFLogxK
U2 - 10.1016/j.carrev.2024.04.002
DO - 10.1016/j.carrev.2024.04.002
M3 - Article
AN - SCOPUS:85189903389
SN - 1553-8389
VL - 67
SP - 1
EP - 7
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
ER -