The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure (SINGLE-CLOSURE)

doi:10.1016/j.jacc.2026.10.055

SINGLE-CLOSURE

Patient / Population Intervention / Exposition Vergleich Endpunkt

In patients aged 65 or older undergoing transfemoral TAVR, single-ProGlide closure of the main access site was noninferior for in-hospital VARC-3 access-site or access-related vascular complications compared with double-ProGlide closure.

N

876Patienten

Design

Multicentre (25 Chinese sites; Second Affiliated Hospital of Zhejiang University), open-label randomised trial of one versus two Perclose ProGlide devices for large-bore access closure after transfemoral TAVR

Endpunkt

VARC-3 access-site or access-related major and minor vascular complications during the index hospitalisation

ErgebnisIn the modified intention-to-treat population the primary endpoint occurred in 57 of 436 patients (13.1%) with single-ProGlide vs 65 of 430 patients (15.1%) with double-ProGlide, meeting the prespecified criterion for noninferiority (risk difference -2.2%; 95% CI -7.0% to 2.6%; P = 0.013; noninferiority margin 3.19%). Access-related major vascular complications occurred in 0.5% vs 1.4%. Individual components of the primary endpoint, access-related bleeding, time to haemostasis and all-cause mortality were similar between groups. Access-site stenosis was numerically less frequent with single-ProGlide (5.0% vs 7.9%), whereas additional closure devices were used more often (2.5% vs 0.9%).

Liu X, Guo Y, et al. J Am Coll Cardiol. 2026; published online 3 November. 10.1016/j.jacc.2026.10.055

Diskussion & Kritik

This large multicentre randomised trial shows that a single-ProGlide strategy was noninferior to double-ProGlide closure for in-hospital access-site or access-related vascular complications after transfemoral TAVR, and most primary endpoint events were minor vascular complications. The primary endpoint covers only the index hospitalisation, so the abstract gives no evidence on longer-term access-site outcomes, and major complications were too few to compare the strategies reliably. The trial was open label, which matters for operator-judged complications, and the single-ProGlide arm needed additional closure devices more often (2.5% vs 0.9%). Enrolment was limited to patients aged 65 or older at Chinese centres, and the abstract does not report a trial registration number.