Retrospective evaluation of the prostyle vascular closure device in patients undergoing atrial fibrillation ablation: effects on hemostasis and hospital stay
I Bax, N F T Keijzer, M Van Der Graaf, M De Lange, M Liebregts, L V A BoersmaAbstract
Background
Pulmonary vein isolation (PVI) for atrial fibrillation (AF) is associated with a considerable incidence of bleeding complications and a subsequent long bed rest duration. Vascular closure devices (VCDs) offer a potential alternative to reduce bleeding and enable faster mobilization, but real-world data are still limited.
Objective
To evaluate the optimal strategy to minimalize in-hospital access site bleeding complications and achieving shorter hospitalization by using different vascular closure techniques in patients undergoing PVI.
Method
This single-center registry included patients with atrial fibrillation undergoing a primary PVI or redo catheter ablation between April 3rd and October 28th, 2025, at a Hospital in the Netherlands. The registry consisted of three consecutive phases. In phase one, femoral access sites ≥8F (outer diameter 12-17F) were closed using a VCD followed by four hours of bed rest. In phase two, the same VCD technique was applied with a shortened bedrest of two hours followed by two hours seated. In phase three, a combination of the VCD and additional figure-of-eight suture was used, followed by two hours of bed rest and one hour seated or a semi-upright position. Outcomes included access-site bleeding complications, categorized as major type 1 (requiring surgical or endovascular intervention), major type 2 (hemoglobin drop > 2 g/dL and/or requiring blood transfusion), minor type 1 (managed conservatively, e.g., local pressure or bed rest < 4 h), and minor type 2 (requiring additional measures such as ultrasound evaluation, bed rest ≥ 4 h, or unplanned overnight stay). Additional outcomes included (planned) same-day discharge (SDD) and post procedure length of stay.
Results
A total of 461 patients were included (phase 1: 170; phase 2: 240; phase 3: 51). The mean age was 63.7 ± 9.7 years, and 35.4% were female. Baseline characteristics were comparable across the three phases. In phase 3, no redo procedures were performed, consequently, no double VCDs were observed. No major bleeding complications occurred with any strategy. Minor bleeding was observed in 33 patients (19.4%) in phase 1, 49 (20.4%) in phase 2, and 4 (7.8%) in phase 3, with no statistically significant difference (p = 0.106). Multivariable logistic regression showed a protective effect of protamine on bleeding. Prolonged bed rest occurred in 29 (17.2%), 103 (42.9%), and 10 (19.6%) patients in phases 1, 2, and 3, respectively. Unplanned overnight stay due to bleeding was required in 0 (0%), 6 (2.5%), and 0 (0%) patients, respectively.
Conclusion
Implementation of a VCD allowed for a reduction in bed rest duration following PVI from 4 to 2 hours, although this was associated with a slight increase in minor bleeding, likely due to the shorter rest period and unclosed smaller puncture sites. The addition of a figure-of-eight suture largely resolved this issue, supporting higher same-day discharge rates and fewer unplanned overnight stays.