Journal of the American Heart Association · 2026
Clinical Outcomes and Valve Performance of Intra-Annular Self-Expanding Transcatheter Aortic Valve in Valve-in-Valve Procedures: Insights From the NAViV Registry.
СтатьяНазвание и аннотация: Перевод в очереди
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Chavez Jorge, Tirado-Conte Gabriela, Kobari Yusuke, Asmarats Lluis, Berenguer Alberto, Molina Alba Abril, Lopez-Minguez Jose Ramón, Regueiro Ander, Menchero Antonio Gomez, Georghe Livia, Baz Jose A, Nuñez-Gil Iván, Amat-Santos Ignacio, Gonzalo Nieves, Perez-Vizcayno Maria Jose, van Roessel Albert Massó, Sanmiguel Dario, Quero Mónica Fernández, Nogales Asensio Juan M, Ruberti Andrea, Izaga Elena, Diaz Fernández Jose F, Arzamendi Dabit, Jimenez-Quevedo Pilar, Villacastin Julian, de Backer Ole, Nombela-Franco Luis
Аннотация
BACKGROUND: Most evidence for transcatheter aortic valve replacement (TAVR) for valve-in-valve procedures comes from balloon-expandable and supra-annular self-expanding valves. However, data on intra-annular self-expanding valves remain limited. The objectives of this registry were to evaluate the short- and midterm outcomes of ViV-TAVR using the intra-annular self-expanding valve Navitor platform in a real-world setting.
METHODS: The NAViV (Navitor Valve-in-Valve) registry is a retrospective, multicenter study that included 200 patients who underwent valve-in-valve TAVR with the Portico/Navitor systems. The primary end point was 30-day device success. Secondary outcomes included intraprocedural technical success, early safety, and all-cause death and major adverse events at 2 years.
RESULTS: The cohort had a high-risk profile and a high prevalence of small surgical bioprostheses (internal diameter ≤21 mm in 86% of the patients). Technical success was achieved in 96%, with an in-hospital mortality rate of 2% and early safety at 30 days of 84%. Mean residual gradients after TAVR were low (14 [interquartile range, 10-20] mm Hg), and residual significant aortic regurgitation was rare (1%). Device success was 73.5%, with high residual gradients (≥20 mm Hg) being the main reason for device failure. Two-year survival and major adverse events were 85.6% and 69.8%, respectively; with low residual gradients and baseline significant AR being independently associated with higher survival.
CONCLUSIONS: Valve-in-valve TAVR using the Portico/Navitor intra-annular self-expanding valve demonstrates a favorable procedural safety profile, sustained valve performance, and encouraging midterm survival in intermediate- and high-risk populations. Larger and comparative studies are warranted to confirm these findings.
METHODS: The NAViV (Navitor Valve-in-Valve) registry is a retrospective, multicenter study that included 200 patients who underwent valve-in-valve TAVR with the Portico/Navitor systems. The primary end point was 30-day device success. Secondary outcomes included intraprocedural technical success, early safety, and all-cause death and major adverse events at 2 years.
RESULTS: The cohort had a high-risk profile and a high prevalence of small surgical bioprostheses (internal diameter ≤21 mm in 86% of the patients). Technical success was achieved in 96%, with an in-hospital mortality rate of 2% and early safety at 30 days of 84%. Mean residual gradients after TAVR were low (14 [interquartile range, 10-20] mm Hg), and residual significant aortic regurgitation was rare (1%). Device success was 73.5%, with high residual gradients (≥20 mm Hg) being the main reason for device failure. Two-year survival and major adverse events were 85.6% and 69.8%, respectively; with low residual gradients and baseline significant AR being independently associated with higher survival.
CONCLUSIONS: Valve-in-valve TAVR using the Portico/Navitor intra-annular self-expanding valve demonstrates a favorable procedural safety profile, sustained valve performance, and encouraging midterm survival in intermediate- and high-risk populations. Larger and comparative studies are warranted to confirm these findings.