Safety and Efficacy of Two Venous Closure Devices Compared With Manual Compression After Atrial Fibrillation Ablation

Area of Science:

• Cardiovascular Interventions
• Vascular Access Management
• Medical Device Technology

Background:

• Manual compression (MC) for femoral venous closure leads to prolonged bed rest and patient discomfort.
• The Perclose ProGride/ProStyle device reduces bed rest but carries a risk of severe puncture site complications.
• The VASCADE MVP device is a novel femoral venous closure device designed to minimize complications and enable early mobilization.

Purpose of the Study:

• To compare the efficacy and safety of the VASCADE MVP device against manual compression (MC) and the Perclose ProGride/ProStyle device for femoral venous closure after catheter ablation.
• To evaluate the impact of different closure methods on post-procedure time and vascular complication rates.

Main Methods:

• A retrospective study included 858 patients undergoing catheter ablation, categorized into MC (n=196), Perclose (n=547), and VASCADE (n=115) groups.
• Data were collected on compression release times, total post-procedure time, and vascular complications.
• The VASCADE MVP device was introduced in September 2024, following the Perclose device in January 2018.

Main Results:

• VASCADE demonstrated a significantly shorter total post-procedure time (22.6 ± 8.9 min) compared to Perclose (29.6 ± 8.2 min) and MC (30.4 ± 9.3 min) (p < 0.001).
• Re-bleeding rates were comparable between Perclose (11%) and VASCADE (13%) (p = 0.787).
• No serious complications were reported with VASCADE, while the Perclose group experienced three major complications (1%).

Conclusions:

• The VASCADE MVP device safely and effectively reduces total post-procedure time and facilitates early hemostasis.
• Its use is associated with a low incidence of complications, comparable to existing devices.
• VASCADE promotes early patient mobilization without increasing vascular complication risks.