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 immobilization of 6 - 12 hours is required. A short time to ambulation is critical for high patient`s satisfaction and short hospital stay. For 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 (Haemonetics) 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. However, randomized controlled data are needed to prove the feasibility, safety and efficacy of vascular closure devices (VCD) following catheter ablations in daily clinical practice.
Methods:
Here we assessed safety, efficacy and feasibility of the VASCADE MVP vascular closure device for vascular closure management after single shot system based PVI. For this purpose a prospective randomized multicenter study (n=3 centers) of 100 patients with single short PVI based catheter ablation (VASC-AF) was conducted (Group 1: Vascular closure device (VCD). Group 2 figure of eight suture (Fo8). The primary efficacy endpoint was time to ambulation after sheath removal. The primary safety endpoint is the incidence of major periprocedural adverse events defined as adverse events until hospital discharge requiring medical intervention.
Results:
A total of 100 patients (age median (Q1/Q3): 70 (59, 77) years; female 44%) were included. In all cases US-guided femoral vein puncture of the groin followed by a single-shot system based PVI (24%) Pulse field ablation, 76 Cryoballoon) was performed for AF treatment via 1 (26%) or 2 (74 %) femoral sheaths. Procedural duration was 60 (25, 72 minutes). Successful utilization of the VASCADE MVP System without necessity of an additional figure of eight suture was performed in 96%. The primary efficacy endpoint: time to ambulation was assessed: VSD: 120 (120, 150) minutes vs. Fo8: (180 (180, 240) minutes, p=0.015). The primary safety endpoint was VSD: 0 (0%) vs. Fo8 2 (4%), p=0.153). Major vascular access complications occured in VCD: 0 (0%) vs. Fo8: 2 (4%) patients, p=0.153. Any vascular access complications occurred in VCD: 2 (4%) vs. Fo8: 12 (24%) patients, p<0.001). Groin pain were reported by the patients in VCD: 1 (2%) vs. Fo8 19 (38%) patients, p<0.001).
Conclusion:
In this randomized multicenter study a shorter time to ambulation was observed for patients with VCD after single shot based PVI. Concerning the primary safety endpoint a trend to lower rate of complications in the VCD group was observed. For any vascular complications and patients pain at the puncture site signifcantly significantly higher rates were obsered for the Fo8 group.
