1Universitätsklinikum Schleswig-Holstein Klinik für Rhythmologie Lübeck, Deutschland; 2Universitätsklinikum Schleswig-Holstein Med. Klinik II / Kardiologie, Elektrophysiologie Lübeck, Deutschland; 3Universitätsklinikum Schleswig-Holstein Anästhesiologie und Intensivmedizin Lübeck, Deutschland
Background: The safety and efficacy of cryoballoon (CB)-based pulmonary vein isolation (PVI) was demonstrated in clinical studies. Time to ambulation is crucial for patient satisfaction and lab efficacy. Vascular access complications remain the most frequent complications following catheter-based atrial fibrillation (AF) ablation procedures.
A venous closure device (VCD) was recently introduced aiming a faster time to ambulation, higher patient satisfaction, and reduction of vascular access complication rate. Currently, data on VCD for electrophysiological procedures is sparse. The aim of this study is to investigate the safety and efficacy of VCDs.
Methods: We conducted a prospective, monocentric, observational study of patients receiving CB-based PVI and haemostasis by means of VCDs between September 2022 and March 2023 at the University Heart Center of Lübeck. All femoral vein vascular accesses were ultrasound-guided. A pressure bandage was applied for a minimum of 60 minutes and serial puncture site assessments were used before the ambulation was allowed. For every patient the database of the hospital was searched for haemostasis success, adverse events, emergency department (ED) presentations, unplanned medical visits and readmissions for 30 days postprocedural.
Results: A total of 100 patients (45% female); median age 70 (62; 77) years, median BMI 29.03 (+/- 4.81) kg/m2) underwent a CB-based PVI and VCD aided haemostasis. The majority of patients had persistent AF (63%), while only 5% of them had longstanding persistent AF. The median CHA2DS2-VASc-Score was 3 (2; 4). At the time of procedure, 95 (95%) patients were on oral anticoagulation.
Two venous punctures were routinely performed in all but one patient. In this patient undergoing AF ablation and cavotricuspid isthmus ablation a third puncture was performed. A successful haemostasis was achieved in 97 (97%) procedures using the VCD, while in 3 patients the second VCD failed to achieve haemostasis. Six (6%) patients were discharged after 4-6 hours on the same day.
A total of 11 (11%) minor procedural complications occurred. During hospitalisation, 26 (26%) patients showed minor postprocedural complications, 25 (25%) being puncture related complications (Figure 1). When analysing the puncture related complications, 64% of them occurred on the day of procedure, while 36% on the first postprocedural day (Figure 2). No major complications were observed.
Within 30 days following the procedure, 6 patients presented to the emergency room, none of which were procedure related. Three patients had unplanned ambulatory visits and 6 patients were readmitted within 30 days after the procedure. Only one unplanned ambulatory visit might be considered as procedure related (vagal reaction post-ablation). All the other events were classified as non-procedure-related.
Conclusion: The use of VCD in CB-based PVI was safe and efficient in this single centre study. No major vascular access related adverse events occurred during the first 30 days after the procedure. The use of VCD-aided haemostasis has the potential to reduce vascular complications following catheter-ablation and to increase patient satisfaction and lab efficacy by increasing the time to ambulation.