Venous Vascular Closure System Versus Figure-of-Eight Suture Following Atrial Fibrillation Ablation – The STYLE-AF Study

Abstract

Background Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCS) were introduced into clinical practice, aiming to reduce the time of bedrest, to increase the patients’ comfort and to reduce vascular access-related complications. Aims To compare the safety and efficacy of using a VCS to achieve haemostasis following single shot PVI to the actual standard of care (figure-of-eight suture and manual compression (MC)). Methods This is a prospective, multicentre, randomized, controlled, open-label trial performed at 3 German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. Results A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation (109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; p<0.001), shorter time to haemostasis (1 (1, 2) vs. 5 (2, 10) min; p<0.001) and shorter time to discharge eligibility (270 (270, 270) vs. 340 (300, 458) min; p<0.001). No major vascular access related complication was reported in either group. A trend towards a lower incidence of minor vascular access related complications on the day of procedure was observed in the VCS group (7 (11.1%) vs. 15 (24.2%); p=0.063) as compared to the control group. Conclusion Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis and time to discharge eligibility. No major vascular access related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access related complications.