Safety and efficacy of venous closure systems in cryoballoon ablation procedures

Background: The safety and efficacy of cryoballoon (CB)-based pulmonary vein isolation (PVI) have been demonstrated previously. Vascular access complications remain the most frequent complications following CB-based atrial fibrillation (AF) ablation procedures. Venous closure systems (VCS) were recently introduced facilitating faster ambulation, enhancing patient satisfaction and reducing vascular access complications. Data on VCS for electrophysiological procedures remains sparse. 

Aim: To investigate the safety and efficacy of VCS for haemostasis following CB-based PVI. 

Methods: We conducted a prospective, monocentric, observational study comparing patients achieving haemostasis by VCS with those achieving haemostasis by manual compression and/or figure-of-eight suture following CB based PVI. Consecutive patients were enrolled in the study group and compared to a 1:1 matched population regarding age, gender and oral anticoagulation. All patients received a pressure bandage and serial puncture site assessments prior to ambulation. Baseline characteristics, procedural data, adverse events, emergency department (ED) presentations, unplanned visits, and readmissions within 30 days were analysed.

Results: A total of 140 patients (46% female, median age 71 (63; 77)) were matched to 140 patients (46% female, median age 70 (62; 77)). All patients underwent a CB-based PVI between January 2016 and August 2023 in a tertiary electrophysiological center. In 4 (2.9%) patients in the VCS group the second VCS failed to achieve haemostasis. In the VCS group 11 (7.9%) patients were discharged on the same day, in the No-VCS group none. 

Procedural and postprocedural complications occurred in both groups, with one fatality in the No-VCS group due to procedural and postprocedural complications. Postprocedural vascular access-related groin complications were observed in 32 patients (22.9%) in the VCS group and in 31 patients (22.1%) in the No-VCS group, though they were more severe in the No-VCS group (figure 1).

Within 30 days post-procedure, 34 ED presentations, ambulatory visits, or readmissions in the VCS group occurred, two of which were procedure-related, but none to vascular access. In the No-VCS group, there were 49 such presentations, including three procedure-related events. One patient in the No-VCS group presented to the ED and was readmitted due to a vascular access-related complication (actively bleeding pseudoaneurysm). 

Conclusion: VCS use in CB-based PVI was safe and feasable in this single-center study. Complication severity was lower in the VCS group. In the first 30 days post-procedure, no vascular access-related adverse events occurred in the VCS group, while one No-VCS patient required readmission. VCS-aided haemostasis may reduce major vascular complications after catheter ablation and increase patient satisfaction and procedural efficiency through faster ambulation.