DOI: 10.1161/jaha.125.048519 ISSN: 2047-9980

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

Jorge Chavez, Gabriela Tirado‐Conte, Yusuke Kobari, Lluis Asmarats, Alberto Berenguer, Alba Abril Molina, Jose Ramón Lopez‐Minguez, Ander Regueiro, Antonio Gomez Menchero, Livia Georghe, Jose A. Baz, Iván Nuñez‐Gil, Ignacio Amat‐Santos, Nieves Gonzalo, Maria Jose Perez‐Vizcayno, Albert Massó van Roessel, Dario Sanmiguel, Mónica Fernández Quero, Juan M. Nogales Asensio, Andrea Ruberti, Elena Izaga, Jose F. Diaz Fernández, Dabit Arzamendi, Pilar Jimenez‐Quevedo, Julian Villacastin, Ole de Backer, Luis Nombela‐Franco
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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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