Journal Article

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

Macia, Jean-Christophe, Meunier, Pierre-Alain, Piot, Christophe, Targosz, Frederic, Leclercq, Florence, Soltani, Sonia, Robert, Pierre, Akodad, Mariama, Moulis, Lionel, Steinecker, Matthieu, Benkemoun, Henri, Dupasquier, Valentin, Cayla, Guillaume, Schmutz, Laurent, Jammoul, Nidal, Lattuca, Benoît, Roubille, François

2024

Overview

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). 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). 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). 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. NCT05140317.

• Publisher: Elsevier Inc,Elsevier Limited,Elsevier
• Subject: Anticoagulants / Aorta / Aortic valve / Balloon treatment / Cardiology / Clinical outcomes / Clinical trials / Congestive heart failure / Feasibility / Heart failure / Heart valves / Hemodynamics / Implantation / Life Sciences / Pacemakers / Patients / Regurgitation / Strategy / Thrombosis / Transplants & implants