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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)

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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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Author information

Authors and Affiliations

  1. Department of Cardiology, Angiology and Sleep Medicine, Bonifatius Hospital Lingen, Wilhelmstr. 13, 49808, Lingen, Germany

    Jochen Michaelsen & Rainer Hoffmann

  2. Department of Cardiology, Rems-Murr-Klinikum Winnenden, Winnenden, Germany

    Ulli Parade

  3. Department of Cardiology, Klinikum Friedrichshafen, Friedrichshafen, Germany

    Hansjörg Bauerle

  4. Department of Cardiology, Hermann-Josef-Krankenhaus Erkelenz, Erkelenz, Germany

    Klaus-Dieter Winter

  5. Department of Cardiology, Ev. Luth. Diakonissenanstalt Flensburg, Flensburg, Germany

    Ulrich Rauschenbach

  6. Department of Cardiology, Leopoldina Krankenhaus Schweinfurt, Schweinfurt, Germany

    Karl Mischke

  7. Department of Cardiology, Elbe Kliniken Stade-Buxtehude, Buxtehude, Germany

    Carl Schaefer

  8. Department of Cardiology, Klinikum Herford, Herford, Germany

    Klaus-Jürgen Gutleben

  9. Department of Cardiology, Helios St. Marienberg-Klinik Helmstedt, Helmstedt, Germany

    Obaida R. Rana

  10. Kardiologische Gemeinschaftspraxis Brilon, Brilon, Germany

    Tobias Willich

  11. Department of Cardiology, Dreifaltigkeits-Hospital Lippstadt, Lippstadt, Germany

    Marc Schlößer

  12. Department of Cardiology, Medius KLINIK Ostfildern, Ostfildern, Germany

    Alfons Rötzer

  13. Department of Cardiology, Agaplesion Diakonie Kliniken Kassel, Kassel, Germany

    Ole A. Breithardt

  14. Department of Cardiology, Mathias-Spital Rheine, Rheine, Germany

    Stefan Middendorf

  15. Department of Cardiology, St. Josefs-Hospital Cloppenburg, Cloppenburg, Germany

    Rainer Grove

  16. Department of Cardiology, Krankenhaus Freudenstadt, Freudenstadt, Germany

    Jörg Mosa

  17. Department of Cardiology, Klinikum Fulda, Fulda, Germany

    Joachim Krug

  18. Department of Cardiology, Klinikum Osnabrück, Osnabrück, Germany

    Guram Imnadze

  19. Kardio-Diabetes-Zentrum Köln, St. Antonius Krankenhaus, Cologne, Germany

    Erol Saygili

Authors
  1. Jochen Michaelsen
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  2. Ulli Parade
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  20. Rainer Hoffmann
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Corresponding author

Correspondence to Rainer Hoffmann.

Ethics declarations

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 66, 417–425 (2023). https://doi.org/10.1007/s10840-022-01331-9

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  • DOI: https://doi.org/10.1007/s10840-022-01331-9

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