Early experience with the Evolut FX self-expanding valve vs. Evolut PRO+ for patients with aortic stenosis undergoing TAVR.
Aortic stenosis
Self-expanding valve
Transcatheter aortic valve replacement
Transcatheter heart valve
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
11 2023
11 2023
Historique:
received:
17
05
2023
revised:
03
06
2023
accepted:
03
06
2023
medline:
27
11
2023
pubmed:
16
7
2023
entrez:
15
7
2023
Statut:
ppublish
Résumé
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. 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). 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 37453813
pii: S1553-8389(23)00627-9
doi: 10.1016/j.carrev.2023.06.003
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-6Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Toby Rogers – Consultant: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott; Advisory board: Medtronic, Boston Scientific; Equity: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH. Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors – None.