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Twelve-month efficacy of second-generation cryoballoon ablation for atrial fibrillation performed at community hospitals: results of the German register on cryoballoon ablation in local hospitals (regional)

Abstract

Background

The 12-month follow-up (F/U) efficacy of CBA PVI performed at community hospitals for treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF) is unknown. This study determined the 12-month efficacy of pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) performed at community hospitals with limited annual case numbers.

Methods

This registry study included 983 consecutive patients (pts) from 19 hospitals, each with an annual procedural volume of < 100 PVI procedures/year. Pts underwent CBA PVI for paroxysmal AF (n = 520), persistent AF (n = 423), or redo PVI (n = 40). The primary endpoint was frequency of documented recurrent AF, the occurrence of atrial flutter or tachycardia following a 90-day period after the index ablation and up to 12 months. The frequency of repeat ablation was determined.

Results

Isolation of all PVs was documented in 98% of pts at the end of the procedure. Twelve-month F/U data could be obtained in 916 pts. A 24-h ECG registration was performed in 641 pts (70.0%); in 107 pts (16.7%) of them, recurrent AF was documented. The primary endpoint was met in 193 F/U pts (21.1%). It occurred in 80/486 F/U pts with paroxysmal AF (16.4%), and in 107/390 F/U pts with persistent AF (27.4%). Redo PVI was performed in 71 pts (7.8%), and atrial flutter ablation was performed in 12 pts (1.4%).

Conclusions

CBA PVI for paroxysmal or persistent AF can be performed at community hospitals with adequate rates of 12-month symptom freedom and arrhythmia recurrence. The study was registered at the German register of clinical studies (DRKS00016504).

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Correspondence to Rainer Hoffmann.

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Ethics approval

Ethical approval was obtained by the Ärztekammer Niedersachsen and subsequently by the local ethical committees of each federal state that participated in the study.

Conflict of interest

Dr. Bauerle reports speaker fees and consulting fees by Medtronic and Boston Scientific, both companies providing medical supply for pulmonary vein ablation procedures. All other authors do not have any conflicts of interest to be disclosed.

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Michaelsen, J., Parade, U., Bauerle, H. et al. Twelve-month efficacy of second-generation cryoballoon ablation for atrial fibrillation performed at community hospitals: results of the German register on cryoballoon ablation in local hospitals (regional). J Interv Card Electrophysiol (2022). https://doi.org/10.1007/s10840-022-01331-9

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Keywords

  • Atrial fibrillation
  • Cryoballoon ablation
  • Outcomes
  • Pulmonary vein isolation