Single vs Double ProGlide Devices for Access Site Closure after Transfemoral Aortic Valve Replacement

Background 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. Objectives 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. Methods 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. Results 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%). Conclusions 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.