Safety and Efficacy of Two Venous Closure Devices Compared With Manual Compression After Atrial Fibrillation Ablation
Satoko Shiomi, Kenichi Tokutake, Ui Takato, Ryutaro Sakurai, Yoshito Yamazaki, Takuya Matsumoto, Hidenori Sato, Hirotsuna Oseto, Masaaki Yokoyama, Seigo Yamashita, Teiichi Yamane, Michifumi TokudaABSTRACT
Background
VASCADE MVP device has garnered attention as a novel femoral venous closure device. Manual compression (MC) is associated with prolonged bed rest and significant patient discomfort. Although Perclose ProGride/ProStyle device reduces bed rest duration, it can result in severe puncture site complications. The adoption of VASCADE MVP is anticipated to reduce the incidence of puncture site complications and facilitate early patient mobilization.
Methods
A total of 858 patients undergoing catheter ablation were included in this study (MC: n = 196; Perclose: n = 547; VASCADE: n = 115). Perclose device was introduced in January 2018, and VASCADE device in September 2024. Venous closure devices were employed for all suitable femoral puncture sheaths. In the MC group, compression was released after 7 h or the following morning; in the Perclose group after 4 h and in the VASCADE group after three or 4 h. Total post‐procedure time and vascular complications were compared among the groups.
Results
The total post‐procedure time was significantly shorter with VASCADE compared to Perclose and MC (22.6 ± 8.9 min vs. 29.6 ± 8.2 min and 30.4 ± 9.3 min, p < 0.001). The incidence of re‐bleeding was comparable between Perclose and VASCADE (11% vs. 13%, p = 0.787). No serious complications were observed in VASCADE group, whereas three patients (1%) in Perclose group experienced major complications.
Conclusion
The use of VASCADE devices safely reduced both total post‐procedure time and bedrest times for complete hemostasis, without an associated increase in complications.