A Prospective Randomized Controlled Study Comparing a Collagen‐Based Absorbable Hemostatic Agent Using a Modified Bed Rest Protocol With the Figure‐of‐Eight Suture Technique

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ABSTRACT Background The Vascade MVP Venous Closure System, a collagen‐based absorbable device, enables shorter bed rest while maintaining safety in patients undergoing catheter ablation. Its efficacy and safety compared with the figure‐of‐eight suture technique remain unclear. Methods In this single‐center, prospective, randomized, open‐label trial, 44 patients undergoing femoral venous access for catheter ablation were randomized (1:1) to Vascade ( n = 21) or figure‐of‐eight suture ( n = 23). A modified bed rest protocol with an assisted ambulation phase was applied in the Vascade group. The primary endpoint was strict bed rest duration; secondary endpoints included device deployment success, acute hemostasis time, time to first ambulation, protocol success, patient‐reported outcomes, and access site complications. Results Two patients in the Vascade group were excluded due to intraprocedural femoral artery puncture, leaving 19 Vascade and 23 figure‐of‐eight patients for analysis. Strict bed rest duration was significantly shorter with Vascade (219.5 ± 58.1 vs. 366.3 ± 42.3 min, p < 0.01). Device deployment success was 100%. Time to first ambulation without rebleeding was shorter with Vascade (529.1 ± 238.7 vs. 686.3 ± 264.1 min, p = 0.05). Protocol success tended to be higher with Vascade (89.5% vs. 65.2%, p = 0.08), and patient‐reported outcomes generally favored Vascade. No major access site complications occurred. In the Vascade group, patients with complications had significantly longer acute hemostasis times (6.0 ± 1.4 vs. 3.4 ± 1.3 min, p = 0.02). Conclusions Compared with the figure‐of‐eight suture, Vascade provided significantly shorter strict bed rest, earlier ambulation, and reduced patient discomfort while maintaining a low complication rate.

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