Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial.
In: American Heart Journal, Jg. 270 (2024-04-01), S. 13-22
academicJournal
Zugriff:
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. [ABSTRACT FROM AUTHOR]
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Titel: |
Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial.
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Autor/in / Beteiligte Person: | Jammoul, Nidal ; Dupasquier, Valentin ; Akodad, Mariama ; Meunier, Pierre-Alain ; Moulis, Lionel ; Soltani, Sonia ; Macia, Jean-Christophe ; Robert, Pierre ; Schmutz, Laurent ; Steinecker, Matthieu ; Piot, Christophe ; Targosz, Frederic ; Benkemoun, Henri ; Lattuca, Benoît ; Roubille, François ; Cayla, Guillaume ; Leclercq, Florence |
Zeitschrift: | American Heart Journal, Jg. 270 (2024-04-01), S. 13-22 |
Veröffentlichung: | 2024 |
Medientyp: | academicJournal |
ISSN: | 0002-8703 (print) |
DOI: | 10.1016/j.ahj.2024.01.005 |
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