Resorbable venous closure system for vascular closure after single shot device by pulmonary vein isolation: The VASC-AF pilot study

Background Vascular access complications are the most common complications following catheter ablation of atrial fibrillation with an incidence ranging from 1 - 4 %. To achieve hemostasis after sheath removal, pressure bandages are usually applied and patients immobilization of 6 - 12 hours is required. A short time to ambulation is critical for high patient`s satisfaction and short hospital stay. For short overnight stay and same discharge PVI which are increasingly performed around the world, low venous access complication rates and short time to ambulation are critical. The VASCADE MVP closure device is approved for venous closure aiming at lower complication rates and faster time to ambulation as compared to manual compression and figure-of-eight suture. Here we assessed safety, efficacy and feasibility of the VASCADE MVP vascular closure device for vascular closure management after single shot system based PVI. Methods The VASC-AF Pilot study is a retrospective, multicentre registry study performed at 3 German EP centres. Patients with single shot system based PVI and 1-2 vascular access sheath were included. After the procedures vascular closure was performed via the VASCADE MVP vascular closure device. Periprocedural data and complications were assessed. Results A total of 75 consecutive patients (mean age 71+/- 11 years, 47% female) were included. In all cases US-guided femoral vein puncture of the groin followed by a single-shot system based PVI (3/75 (4%) Pulse field ablation, 72/75 (96%) Cryoballoon) was performed for AF treatment via 1 (4%) or 2 (96 %) femoral sheaths. Procedural duration was 65 +/-25 minutes). Successful utilization of the VASCADE MVP System without necessity of an additional figure of eight suture was performed in 90.7%. In all patients a pressure bandage was deployed for a mean time of 260+/-114 minutes. Minor vascular access complications occurred in 12/75 pts (16%) while major vascular access complications (prolonged hospital stay, surgery, transfusion) occurred in 0/75 (0%) of patients. No further complications occurred. Conclusion Following single-shot system based AF ablation a relatively high success rate of VASCADE MVP was observed. The rate of major vascular access complications was 0, while the rate of minor complications was 16%. This observation might be due to a certain learning curve utilizing a novel vascular closure system. Further prospective studies need to assess the value of a resorbable vascular closure system.