Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial.

Autor: Jammoul N; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France., Dupasquier V; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France., Akodad M; Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques-Cartier, Massy, France., Meunier PA; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France., Moulis L; Epidemiological and Clinical Research Unit, CHU Montpellier, Montpellier, France. Electronic address: l-moulis@chu-montpellier.fr., Soltani S; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France., Macia JC; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France., Robert P; Department of cardiology, CHU Nimes, Montpellier University, Nimes, France., Schmutz L; Department of cardiology, CHU Nimes, Montpellier University, Nimes, France., Steinecker M; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France., Piot C; Millenaire Clinic, Montpellier, France., Targosz F; Perpignan hospital, Perpignan, France., Benkemoun H; St Pierre Clinic, Perpignan, France., Lattuca B; Department of cardiology, CHU Nimes, Montpellier University, Nimes, France., Roubille F; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France; PhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France., Cayla G; Department of cardiology, CHU Nimes, Montpellier University, Nimes, France., Leclercq F; Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France. Electronic address: f-leclercq@chu-montpellier.fr.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2024 Apr; Vol. 270, pp. 13-22. Date of Electronic Publication: 2024 Jan 20.
DOI: 10.1016/j.ahj.2024.01.005
Abstrakt: Background: Safety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR vs BAV pre-TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519).
Methods: Clinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n = 228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation).
Results: Median follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ± 6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, P = 0.6). Prevalence of predicted prothesis-patient mismatch was low (n = 13 [11.4%] in the direct TAVR group vs n = 15 [13.2%] in BAV group) and similar between both groups (P = .7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (P = .4, P = .7, P = .3, and P = .3 respectively).
Conclusion: Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible.
Clinical Trials Registration Number: NCT05140317.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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