Intra-annulaire Navitor-klep biedt veilige en effectieve valve-in-valve TAVR — 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.