DUOTAP: Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses

doi:10.1001/jamacardio.2026.5260

DUOTAP

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In patients undergoing balloon-expandable TAVI, routine post-dilatation with the original delivery balloon reduced transcatheter valve asymmetry compared with a sham procedure.

N

148patients

Schéma

Single-centre (Medical University of Vienna), double-blind randomised trial of routine nominal post-dilatation with the original delivery balloon versus none after balloon-expandable TAVR

Critère

Transcatheter heart valve asymmetry index (peri-procedural)

RésultatTHV asymmetry index was 70% lower with post-dilatation than with control (median 1.2% vs 2.8%; geometric mean ratio 0.30; 95% CI 0.18-0.47; P < .001), with consistent effects across prespecified subgroups. THV diameters on fluoroscopy were numerically larger and THV areas at the inflow, midframe and outflow level on CT significantly larger with post-dilatation. HALT and mild or worse paravalvular leak were significantly less frequent and the Doppler Velocity Index significantly higher in the intervention group. Procedure-related adverse events did not differ between groups (P = .36).

Autherith M, Singer K, et al. JAMA Cardiol. 2026; published online 3 November. 10.1001/jamacardio.2026.5260

Discussion et critique

This randomised, sham-controlled trial shows that a second nominal inflation of the delivery balloon makes balloon-expandable valves more symmetrical, with larger CT valve areas, less HALT and less paravalvular leak. The primary endpoint is an imaging measure of valve geometry, and the trial was not designed to show effects on clinical outcomes or long-term valve durability. It was a single-centre study of 148 patients with single blinding, so the procedural safety comparison is underpowered for rare complications. The abstract gives no event rates for adverse events and no information beyond the early follow-up.