Clinical Outcomes and Valve Performance of Intra‐Annular Self‐Expanding Transcatheter Aortic Valve in Valve‐in‐Valve Procedures: Insights From the NAViV Registry

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.

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Journal
Journal of the American Heart Association
Published
2026-09-29
DOI
https://doi.org/10.1161/jaha.125.048519
Primary Topic
Cardiac Valve Diseases and Treatments
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article
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article

Clinical Outcomes and Valve Performance of Intra‐Annular Self‐Expanding Transcatheter Aortic Valve in Valve‐in‐Valve Procedures: Insights From the NAViV Registry

Mónica Fernández Quero, Darío Sanmiguel, Jorge Francisco Chávez Solsol, Lluís Asmarats et al.
Journal of the American Heart Association
Cardiac Valve Diseases and Treatments
article

Clinical Outcomes and Valve Performance of Intra‐Annular Self‐Expanding Transcatheter Aortic Valve in Valve‐in‐Valve Procedures: Insights From the NAViV Registry

Mónica Fernández Quero, Darío Sanmiguel, Jorge Francisco Chávez Solsol, Lluís Asmarats, Juan Manuel Nogales‐Asensio, Ole De Backer, Nieves Gonzalo, Elena Izaga Torralba, Livia Luciana Gheorghe, Pilar Jiménez‐Quevedo, José Ramón López-Mínguez, Albert Massó-van Roessel, Ander Regueiro, Antonio Gómez Menchero, Mario García‐Gómez, Ignacio J. Amat‐Santos, Yusuke Kobari, Ivan Javier Nuñez-Gil, Andrea Alberto Ruberti, Alba Abril Molina, Julián Pérez‐Villacastín, Dabit Arzamendi, Luis Nombela-Franco y, José Francisco Díaz Fernández, Gabriela Tirado‐Conte, Alberto Berenguer, Marı́a José Pérez-Vizcayno
article en

Abstract

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.

Journal of the American Heart Association
Hospital de Sant Pau (ES), University Hospital Complex Of Vigo (ES), Copenhagen University Hospital (DK), Hospital Universitario de Torrejón (ES), Centro de Investigación en Red en Enfermedades Cardiovasculares (ES), Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (ES), Hospital General Universitario De Valencia (ES), Hospital Juan Ramón Jiménez (ES), Hospital Universitario Puerta del Mar (ES), Hospital Universitario Virgen del Rocío (ES), Hospital Clínico Universitario de Valladolid (ES), Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES), Universidad de Extremadura (ES), Universidad Europea de Madrid (ES)
Good health and well-being
Openalex Percentile: Top 11%
Cardiac Valve Diseases and Treatments
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