Frontiers in cardiovascular medicine · 2025
Optimising access: safety and efficacy of venous closure devices in cryoballoon pulmonary vein isolation.
СтатьяНазвание и аннотация: Перевод в очереди
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Hatahet S, Heeger C H, Popescu S S, Delgado M, Grasshoff H, Traub A, Reincke S, Subin B, Ukita K, Klotz K, Küchler M, Vogler J, Eitel C, Nikorowitsch J, Wenzel J P, Kuck K H, Meyer-Waeterling J, Tilz R R
Аннотация
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 efficacy following cryoballoon-based pulmonary vein isolation (CB-PVI) are limited. This study assessed acute and long-term outcomes of VCS vs. manual compression and figure-of-eight suture after CB-PVI.
METHODS: We conducted a prospective, single-centre observational study comparing VCS with figure-of-eight suture plus manual compression post-CB-PVI. VCS patients who underwent CB-PVI between September 2022 and August 2023 were enrolled; controls were a 1:1 age-, sex-, and anticoagulation-matched cohort treated between January 2016 and May 2021. Ultrasound-guided access was used in all VCS cases and routinely from 2018 in controls. Pressure bandage time was ≥60 min in VCS vs. ≥4 h 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 body mass index (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 occurred in controls. Thirty-day ED visits were lower with VCS (3.6% vs. 15.1%, p < 0.001). Follow-up showed a trend toward fewer complications (2.5% vs. 8.5%, p = 0.053). Subgroup analysis (ultrasound-guidance only) confirmed these findings.
CONCLUSION: VCS following CB-PVI is safe and feasible. No significant difference regarding acute, mid-term, and long-term groin complications was observed.
METHODS: We conducted a prospective, single-centre observational study comparing VCS with figure-of-eight suture plus manual compression post-CB-PVI. VCS patients who underwent CB-PVI between September 2022 and August 2023 were enrolled; controls were a 1:1 age-, sex-, and anticoagulation-matched cohort treated between January 2016 and May 2021. Ultrasound-guided access was used in all VCS cases and routinely from 2018 in controls. Pressure bandage time was ≥60 min in VCS vs. ≥4 h 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 body mass index (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 occurred in controls. Thirty-day ED visits were lower with VCS (3.6% vs. 15.1%, p < 0.001). Follow-up showed a trend toward fewer complications (2.5% vs. 8.5%, p = 0.053). Subgroup analysis (ultrasound-guidance only) confirmed these findings.
CONCLUSION: VCS following CB-PVI is safe and feasible. No significant difference regarding acute, mid-term, and long-term groin complications was observed.