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SINGLE-CLOSURE: Single-ProGlide Strategy Noninferior to Double-ProGlide For Post-TAVR Access Site Closure

A single-ProGlide strategy may be noninferior for a composite of access-site or access-related vascular complications compared to conventional double-ProGlide closure following transfemoral TAVR, according to results of the SINGLE-CLOSURE trial presented at TCT 2026 and simultaneously published in JACC.

Jian'an Wang, MD, PhD, FACC, et al., conducted a prospective, multicenter, open-label trial that randomized 876 patients (aged ≥65 years; 45% women) across 25 Chinese centers with severe aortic stenosis scheduled for transfemoral TAVR 1:1 to either single-ProGlide or double-ProGlide closure for the main access site. Among patients, median age was 74 years, median Society of Thoracic Surgeons risk score was 2.9%, and median common femoral artery diameter was 8.3 mm on the right and 8.2 mm on the left.

Results showed that the primary endpoint, an in-hospital composite of Valve Academic Research Consortium-3-defined access-site or access-related major and minor vascular complications, occurred in 57 of 436 patients (13.1%) in the single-ProGlide group vs. 65 of 430 patients (15.1%) in the double-ProGlide group within the modified intention-to-treat population. The single-ProGlide strategy met the prespecified criterion for noninferiority (risk difference, –2.2%; p=0.013; noninferiority margin, 3.19%) but not superiority (p=0.365).

Most of the composite endpoint was driven by minor vascular complications; only two patients (0.5%) in the single-ProGlide group and six patients (1.4%) in the double-ProGlide group experienced major access-related complications.

Between the single and double-ProGlide groups, access-related bleeding (7.3% vs. 8.8%), time to hemostasis (9.3 vs. 8.7 min.) and all-cause mortality at 30 days (2.1% vs. 2.3%) were similar. Access-site stenosis was numerically less frequent (5.0% vs. 7.9%) and additional closure devices were more often used (2.5% vs. 0.9%) with the single-ProGlide strategy.

"This approach may simplify femoral access closure and reduce routine closure-device use, although additional bailout closure devices might be required more frequently," write the study authors.
"These findings should be interpreted in the context of the trial population, which was characterized by predominant use of self-expanding valves and frequent use of 20F sheaths," they add. "Generalizability to populations with more prevalent peripheral vascular disease or smaller femoral arteries, and to settings with predominant use of balloon-expandable valves and 14F-16F delivery systems, requires further investigation."

Explore more simultaneously published research through JACC Journals' TCT 2026 Coverage, and visit ACC's TCT Meeting Coverage for additional studies, clinical insights and news from the meeting.

Resources

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Interventions and Vascular Medicine

Keywords: Transcatheter Cardiovascular Therapeutics, TCT26, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Peripheral Vascular Diseases