Single vs Double ProGlide Devices for Access Site Closure after Transfemoral Aortic Valve Replacement: The SINGLE-CLOSURE Trial.

Authors

Xianbao Liu, Yuchao Guo, Guangyuan Song, Tongfeng Chen, Guipeng An, Lihan Wang, Yansong Guo, Hao Zhou, Lei Jiang, Xiaomin Chen, Biao Cheng, Guannan Niu, Kai Xu, Yibing Shao, Zhikui Chen, Yining Yang, Zhenfei Fang, Jinjun Liu, Jiancheng Xiu, Jianying Chen, Yongping Bai, Xiaodong Zhuang, Zhenfeng Cheng, Lei Wang, Jizhe Xu, Xiangwen Liang, Ke Han, Haochang Hu, Qiong Liu, Martin B Leon, Jian'an Wang

Published in

Journal of the American College of Cardiology. Nov 03, 2026. Epub Nov 03, 2026.

Abstract

Despite advances in transcatheter aortic valve replacement (TAVR), access-site vascular complications remain an important source of procedural morbidity. The conventional double-ProGlide strategy may increase the risk of access-site stenosis and other vascular complications, particularly in patients with challenging iliofemoral anatomy. Retrospective studies have suggested that a single-ProGlide strategy may offer an effective alternative, but this strategy has not yet been evaluated in a randomized trial.
This trial aimed to determine whether a single-ProGlide strategy could offer a simpler alternative to the conventional double-ProGlide strategy without increasing vascular complications.
The SINGLE-CLOSURE trial was a prospective, multicenter, open-label, randomized trial conducted at 25 centers in China. Patients aged ≥65 years scheduled for transfemoral TAVR were assigned 1:1 to single-ProGlide or double-ProGlide closure for the main access site. The primary endpoint was the in-hospital composite of Valve Academic Research Consortium (VARC)-3-defined access-site or access-related major and minor vascular complications.
A total of 876 patients were randomized. In the modified intention-to-treat population, the primary endpoint occurred in 57 of 436 patients (13.1%) in the single-ProGlide group and 65 of 430 patients (15.1%) in the double-ProGlide group, meeting the prespecified criterion for noninferiority (risk difference: -2.2%; 95%: -7.0% to 2.6%; P = 0.013; noninferiority margin: 3.19%). Access-related major vascular complications occurred in 2 patients (0.5%) in the single-ProGlide group and 6 patients (1.4%) in the double-ProGlide group. Among the secondary endpoints, individual components of the primary endpoint, access-related bleeding, time to hemostasis, and all-cause mortality were similar between groups. Access-site stenosis was numerically less frequent with the single-ProGlide strategy (5.0% vs 7.9%), whereas additional closure devices might be used more often (2.5% vs 0.9%).
A single-ProGlide strategy was noninferior to conventional double-ProGlide closure for the composite of VARC-3-defined access-site or access-related vascular complications after transfemoral TAVR. Primary endpoint events were predominantly minor vascular complications.

PMID:
42980634
Bibliographic data and abstract were imported from PubMed on 04 Nov 2026.

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