ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Cardiac Rhythmology
Optimizing Access: Safety and Efficacy of Venous Closure Devices in Cryoballoon Pulmonary Vein Isolation
Provisionally accepted
Sascha Hatahet1*
Christian Hendrik Heeger1,2,3
Sorin Popescu1Maryuri Delgado1
Hanna Graßhoff4Anna Traub1Samuel Reincke1Behnam Subin1Kohei Ukita1Karl Klotz5Mirco Küchler1Julia Vogler1,6Charlotte Eitel1Julius Nikorowitsch1Jan Per Wenzel1Karl Heinz Kuck1Johanna Meyer-Waeterling1Roland Tilz1,2- 1Department of Rhythmology - University Heart Center Lübeck - University Hospital Schleswig-Holstein - Germany, Lübeck, Germany
- 2German Center for Cardiovascular Research (DZHK) - Partner Site Hamburg/Kiel/Lübeck - Lübeck - Germany., Lübeck, Germany
- 3Department of Rhythmology - Cardiology and Internal medicine - Asklepios Klinik Hamburg Altona - Hamburg - Germany, Hamburg, Germany
- 4Department of Rheumatology and Clinical Immunology - University Hospital Schleswig-Holstein - Lübeck - Germany, Lübeck, Germany
- 5Department of Anesthesiology and Intensive Care Unit - University Hospital Schleswig-Holstein - Lübeck - Germany, Lübeck, Germany
- 6Department of Cardiology and Intensive Care Unit - Asklepios Klinik Hamburg St. Georg - Hamburg - Germany, Hamburg, Germany
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Abstract Background/Objectives: Despite technological progress in atrial fibrillation (AF) ablation, vascular access complications remain common. Venous closure systems (VCS) may reduce these events and improve patient comfort, but data on their safety and e8icacy following cryoballoon-based pulmonary vein isolation (CB-PVI) are limited. This study assessed acute and long-term outcomes of VCS versus manual compression and figure-of-eight suture after CB-PVI. Methods: We conducted a prospective, single-center observational study comparing VCS with figure-of-eight suture plus manual compression post-CB-PVI. VCS patients were enrolled 09/2022 - 08/2023; controls were a 1:1 age-, sex-, and anticoagulation-matched cohort treated 01/2016 - 05/2021. Ultrasound-guided access was used in all VCS cases and routinely from 2018 in controls. Pressure bandage time was ≥60 minutes in VCS vs. ≥4 hours in controls. Vascular complications, emergency department (ED) visits, and readmissions were assessed over 12 months. Results: A total of 280 patients were included (mean age 70; 46.4% female; 38.9% paroxysmal AF). The VCS group had higher rates of hypertension (p=0.036), coronary disease (p=0.026), and BMI (p=0.006). Groin-related periprocedural complications were similar (22.9% vs. 22.1%, p=0.886); all were minor in the VCS group. One major complication occurred in controls. No groin-related ED visits occurred in the VCS group; one in controls. Thirty-day ED visits were lower with VCS (3.6% vs. 15.1%, p<0.001). Follow-up showed a trend
Keywords: venous closure device, Atrial Fibrillation, Pulmonary vein isolation, cryoballoonablation, Venous access
Received: 12 Sep 2025; Accepted: 27 Oct 2025.
Copyright: © 2025 Hatahet, Heeger, Popescu, Delgado, Graßhoff, Traub, Reincke, Subin, Ukita, Klotz, Küchler, Vogler, Eitel, Nikorowitsch, Wenzel, Kuck, Meyer-Waeterling and Tilz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Sascha Hatahet, sascha.hatahet@uksh.de
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