# Intra-annulaire Navitor-klep biedt veilige en effectieve valve-in-valve TAVR — NAViV-registry

*geplaatst 2026-10-07 · Algemeen · Journal of the American Heart Association · doi 10.1161/JAHA.125.048519 · https://hartvaat.nl/2026/09/29/intra-annulaire-navitor-klep-biedt-veilige-en-effectieve-valve-in-valve-tavr-nav/*

In de retrospectieve NAViV-registry onderzochten onderzoekers de korte- en middentermijnresultaten van de intra-annulaire self-expanding Navitor-klep bij 200 patiënten met een valve-in-valve TAVR-procedure. De technische succesgraad bedroeg 96%, met een lage in-hospital mortaliteit van 2% en een 30-dagen veiligheidsprofiel van 84%. Twee jaar overleving was 85,6%, waarbij hoge residuale gradiënten de belangrijkste oorzaak van device-falen waren. De bevindingen suggereren dat de Navitor-klep een veilige optie is voor complexe valve-in-valve interventies, hoewel grotere vergelijkende studies nodig zijn om de resultaten te bevestigen.

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

The retrospective NAViV registry evaluated short- and midterm outcomes of the intra-annular self-expanding Navitor valve in 200 patients undergoing valve-in-valve TAVR. Technical success reached 96%, with a 2% in-hospital mortality rate and 85.6% two-year survival. High residual gradients were the primary driver of device failure, while low gradients and baseline severe aortic regurgitation independently predicted better survival. These real-world data support the Navitor platform as a safe and effective option for complex valve-in-valve procedures, though larger comparative studies are warranted.

## Abstract (original, from the publication)

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.

Auteurs: 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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Bron: Journal of the American Heart Association, https://doi.org/10.1161/JAHA.125.048519. Bijgewerkt 2026-09-30T01:23:01Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.