A dual-phase study of a bioabsorbable venous vascular closure system: identifying predictors of failure and ensuring long-term safety in over 1,000 procedures
TL;DR
A dual-phase evaluation confirms that the bioabsorbable VVCS is highly effective, although its efficacy is influenced by BMI and sheath size.
Abstract
As the volume of catheter ablation for arrhythmias increases, optimizing post-procedural hemostasis is essential for clinical workflow and patient comfort. The VASCADE MVP is an extravascular, bioabsorbable collagen-based venous vascular closure system (VVCS). We conducted a dual-phase study to identify predictors of procedural failure and evaluate long-term safety, specifically focusing on the management of rare infectious complications. This study, conducted at our hospital, utilized a two-phase design. Phase 1 involved a mechanistic analysis of 203 consecutive venous access sites (70 patients) to identify predictors of hemostatic failure. Phase 2 consisted of an expanded safety evaluation of 1,162 consecutive procedures through October 2025. For atrial fibrillation ablation, an uninterrupted DOAC protocol was used with ACT targets of >300s (RF/cryoballoon) or >350s (pulsed-field ablation). Post-deployment, institutional protocol required 3–4 hours of gauze compression before ambulation. In Phase 1, the procedural success rate in the initial cohort was 94%. Multivariate analysis identified female sex (P=0.04), lower BMI (22.7 ± 3.5 vs. 25.0 ± 3.6 kg/m², P=0.02), and large-bore sheaths (10.4 ± 1.8 vs. 8.9 ± 1.2 Fr, P=0.01) as significant predictors of failure. In Phase 2, the safety cohort (n=1,162), delayed access-site cellulitis occurred in 0.6% (7/1,162) approximately one-month post-procedure. Management of these infections was limited to oral antibiotics and minor local management (incision, irrigation, and local debridement). Crucially, no patient required major surgical intervention, such as vascular reconstruction or bypass grafting, which are sometimes reported with suture-mediated closure devices. This dual-phase evaluation confirms that the bioabsorbable VVCS is highly effective, although its efficacy is influenced by BMI and sheath size. The system’s primary safety advantage is its bioabsorbable nature, which allows rare infectious complications to be managed conservatively, thereby avoiding the invasive surgical interventions associated with permanent suture-based devices.Table