The transfemoral approach is the predominant strategy for transcatheter aortic valve implantation (TAVI). Although vascular complications are currently less frequent, they remain relevant determinants of procedural success.
The TAVI-CLOSE study evaluated the efficacy and safety of two femoral access closure strategies after TAVI: closure with a dual suture device (dual Perclose ProGlide) vs a hybrid strategy consisting of a single suture plus a vascular plug (Perclose + Angio-Seal).
This was a prospective, randomized, single-center study conducted in the United States, in which patients were assigned in a 1:1 ratio to one of the two vascular closure strategies. Clinical follow-up extended to 30 days.
The primary endpoint (PE) was a composite of major access-site related bleeding and major vascular complications according to VARC-3 definitions. Secondary endpoints included minor vascular complications and total hospitalization costs.
The incidence of the primary endpoint was 2.1% in the dual suture group vs 7.1% in the suture + plug group. The absolute risk difference was 5% (95% CI −3.8% to 13.8%), exceeding the predefined non-inferiority margin.
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No serious events such as death, limb ischemia, embolization, or vascular perforation were reported. Procedural duration, fluoroscopy time, contrast volume, and length of hospital stay (approximately 1.1 days in both groups) were similar between strategies. Likewise, no differences were observed in total hospitalization costs, with a mean cost of approximately $42,000.
TAVI-CLOSE is the first randomized study conducted in the United States comparing vascular closure strategies after TAVI. The study demonstrated a low overall complication rate, with dual suture device closure emerging as the reference strategy.
Presented by Imran Baig at Late Breaking Clinical Trials, CRT 2026, Washington, USA.
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