Aortic Valve (TAVR/TAVI)JACCFriday, August 28, 2026

New-Generation Transcatheter Valves for Extremely Small Aortic Annuli.

1 min read·By E. Nolan Beckett, MD·Source: JACC. Asia

Key Numbers

1.6%

2.0%

2.7%

4.5%

From The Valve Wire

In 385 OCEAN-TAVI registry patients with annular area <314 mm² — the extreme small-annulus population where prosthesis-patient mismatch has historically driven the argument for supra-annular self-expanding designs — balloon-expandable, supra-annular self-expanding, and intra-annular self-expanding valves produced statistically similar rates of severe PPM (1.6% vs 2.0% vs 2.7%, P = 0.85) and mean gradient ≥20 mm Hg (4.5% vs 8.3% vs 2.3%, P = 0.19) after propensity overlap weighting.

Mild-or-greater paravalvular leak was numerically higher with both self-expanding platforms (~27% vs 15.8%, P = 0.09), and 1-year mortality did not differ.

This is registry data, not a randomized comparison, and the effective sample sizes after weighting are modest (85-93 per arm) — underpowered to detect meaningful differences in PPM or mortality.

The PVL signal favoring balloon-expandable valves is directionally consistent with prior work and shouldn't be dismissed just because P = 0.09.

Source Abstract

BACKGROUND: Patients with extremely small aortic annuli are at increased risk of residual gradients and prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). Comparative data on contemporary valve platforms in this subset remain limited. OBJECTIVES: The authors aimed to compare early clinical and hemodynamic outcomes among balloon-expandable valves (BEVs), supra-annular self-expanding valves (SA-SEVs), and intra-annular self-expanding valves (IA-SEVs) in patients with severe aortic stenosis and extremely small annuli. METHODS: Patients with annular area <314 mm2 from the OCEAN-TAVI registry were analyzed using multinomial propensity score overlap weighting. Primary outcomes were severe PPM, mean transvalvular pressure gradient ≥20 mm Hg, and paravalvular leakage (PVL) ≥mild. RESULTS: Among 385 patients, 125, 136, and 124 underwent BEV, SA-SEV, and IA-SEV implantation, respectively. Effective sample sizes after overlap weighting were 92.4, 93.6, and 85.4, with a median follow-up of 358 days. Adjusted probabilities of severe PPM were similarly low (1.6%, 2.0%, and 2.7%; P = 0.85). mean transvalvular pressure gradient ≥20 mm Hg occurred in 4.5%, 8.3%, and 2.3%, respectively (P = 0.19). PVL ≥mild was numerically more frequent with SEV than BEV (15.8%, 27.3%, and 27.0%; P = 0.09), with adjusted odds ratios versus BEV of 1.92 (95% CI: 0.96-3.84) for SA-SEV and 1.83 (95% CI: 0.91-3.70) for IA-SEV. Major complications and 1-year mortality were similar among groups. CONCLUSIONS: Contemporary TAVR platforms showed broadly similar early outcomes, although PVL ≥mild was numerically more frequent with self-expanding valves.

Authors: Shirai S, Hioki H, Yamamoto M, Ishizu K, Hayashi M et al.

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