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Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry

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Abstract

Background

Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA.

Methods

AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients’ reporting of symptoms.

Results

Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HRunadj 0.64 (95% CI 0.47–0.88); p < 0.01) regardless of the centers’ CBA experience; when controlling for baseline characteristics, the difference was not significant (HRadj 0.87 (95% CI 0.56–1.37); p = 0.55). No difference was observed in repeat ablations and hospitalizations between cohorts. First-line patients experienced a larger mean reduction in symptoms and were prescribed AADs at a lower rate at 12-month follow-up (9.7 vs. 29.9%). QOL improved in both cohorts from baseline to 12 months with no significant difference between groups (p = 0.29).

Conclusions

In this global real-world experience, first-line CBA in patients with symptomatic AF is effective, with a larger symptom reduction compared with CBA after AAD failure and without a difference in healthcare utilization at mid-term follow-up.

Clinical trial registration

https://clinicaltrials.gov/ct2/show/NCT02752737

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Abbreviations

AAD:

Antiarrhythmic drug

AF:

Atrial fibrillation

AFL:

Atrial flutter

AT:

Atrial tachycardia

CBA:

Cryoballoon ablation

LA:

Left atrium

PAF:

Paroxysmal AF

PsAF:

Persistent AF

PV:

Pulmonary vein

PVI:

Pulmonary vein isolation

References

  1. Kirchhof P, Camm AJ, Goette A, et al. Early rhythm-control therapy in patients with atrial fibrillation. N Engl J Med. 2020;383:1305–16. https://doi.org/10.1056/NEJMoa2019422.

    Article  PubMed  Google Scholar 

  2. Zhang YY, Qiu C, Davis PJ, et al. Predictors of progression of recently diagnosed atrial fibrillation in REgistry on Cardiac Rhythm DisORDers Assessing the Control of Atrial Fibrillation (RecordAF)-United States cohort. Am J Cardiol. 2013;112:79–84. https://doi.org/10.1016/j.amjcard.2013.02.056.

    Article  PubMed  Google Scholar 

  3. Hindricks G, Potpara T, Dagres N, et al. ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2020;42:373–498.

    Article  Google Scholar 

  4. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace. 2018;20(1):e1–160. https://doi.org/10.1093/europace/eux274.

    Article  PubMed  Google Scholar 

  5. Wazni OM, Dandamudi G, Sood N, et al. Cryoballoon ablation as initial therapy for atrial fibrillation. N Engl J Med. 2021;384:316–24. https://doi.org/10.1056/NEJMoa2029554.

    Article  CAS  PubMed  Google Scholar 

  6. Kuniss M, Pavlovic N, Velagic V, et al. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. EP Europace. 2021;23(7):1033–41. https://doi.org/10.1093/europace/euab029.

    Article  Google Scholar 

  7. Andrade JG, Wells GA, Deyell MW, et al. Cryoablation or drug therapy for initial treatment of atrial fibrillation. N Engl J Med. 2020;384:305–15. https://doi.org/10.1056/NEJMoa2029980.

    Article  PubMed  Google Scholar 

  8. Cosedis Nielsen J, Johannessen A, Raatikainen P, et al. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012;367:1587–95. https://doi.org/10.1056/NEJMoa1113566.

    Article  CAS  PubMed  Google Scholar 

  9. Morillo CA, Verma A, Connolly SJ, et al. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial. JAMA. 2014;311:692–700. https://doi.org/10.1001/jama.2014.467.

    Article  CAS  PubMed  Google Scholar 

  10. Wazni OM, Marrouche NF, Martin DO, et al. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005;293(21):2634–40. https://doi.org/10.1001/jama.293.21.2634.

    Article  CAS  PubMed  Google Scholar 

  11. Chun KRJ, Okumura K, Scazzuso F, et al. Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real-world global setting: results from the Cryo AF Global Registry. J of Arrhythmia. 2021;37(2):356–67. https://doi.org/10.1002/joa3.12504.

    Article  Google Scholar 

  12. Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374(23):2235–45. https://doi.org/10.1056/NEJMoa1602014.

    Article  PubMed  Google Scholar 

  13. Kuck KH, Fürnkranz A, Chun KR, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016;37(38):2858–65. https://doi.org/10.1093/eurheartj/ehw285.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Kuck KH, Albenque JP, Chun KJ, et al. Repeat ablation for atrial fibrillation recurrence post cryoballoon or radiofrequency ablation in the FIRE AND ICE Trial. Circ Arrhythm Electrophysiol. 2019;12(6):e007247. https://doi.org/10.1161/CIRCEP.119.007247.

    Article  CAS  PubMed  Google Scholar 

  15. Baysal E, Okşul M, Burak C, et al. Decreasing time between first diagnosis of paroxysmal atrial fibrillation and cryoballoon ablation positively affects long-term consequences. J Interv Card Electrophysiol. 2022. https://doi.org/10.1007/s10840-022-01167-3.

    Article  PubMed  Google Scholar 

  16. Kuck K-H, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). EP Europace. 2021;23(3):362–369a. https://doi.org/10.1093/europace/euaa298.

    Article  Google Scholar 

  17. Bavishi AA, Kaplan RM, Peigh G, et al. Patient characteristics as predictors of recurrence of atrial fibrillation following cryoballoon ablation. Pacing Clin Electrophysiol. 2019;42(6):694–704. https://doi.org/10.1111/pace.13669.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Aksu T, Baysal E, Guler TE, Golcuk SE, Erden İ, Ozcan KS. Predictors of atrial fibrillation recurrence after cryoballoon ablation. J Blood Med. 2015;29(6):211–7. https://doi.org/10.2147/JBM.S81551.

    Article  Google Scholar 

  19. Chew DS, Black-Maier E, Loring Z, et al. Diagnosis-to-ablation time and recurrence of atrial fibrillation following catheter ablation: a systematic review and meta-analysis of observational studies. Circ Arrhythm Electrophysiol. 2020;13(4):e008128. https://doi.org/10.1161/CIRCEP.119.008128.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Moltrasio M, Iacopino S, Arena G, et al. First-line therapy: insights from a real-world analysis of cryoablation in patients with atrial fibrillation. J Cardiovasc Med. 2021;22:000–000. https://doi.org/10.2459/JCM.0000000000001176.

    Article  CAS  Google Scholar 

  21. Straube F, Dorwarth U, Ammar-Busch S, et al. First-line catheter ablation of paroxysmal atrial fibrillation: outcome of radiofrequency vs. cryoballoon pulmonary vein isolation. Europace. 2016;18:368–75. https://doi.org/10.1093/europace/euv271.

    Article  PubMed  Google Scholar 

  22. Akkaya E, Berkowitsch A, Zaltsberg S, et al. Second-generation cryoballoon ablation as a first-line treatment of symptomatic atrial fibrillation: two-year outcome and predictors of recurrence after a single procedure. Int J Cardiol. 2018;259:76–81. https://doi.org/10.1016/j.ijcard.2017.11.011.

    Article  PubMed  Google Scholar 

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Acknowledgements

The authors sincerely thank the Cryo Global Registry global sites and staff for their commitment and contributions to the study. The authors also thank Troy Penz, Jada Selma, Hae Lim, Bob Hokanson, and Valentine Obidigbo from Medtronic for their support of the trial and generation of this manuscript.

Author information

Authors and Affiliations

  1. Second Division of Cardiology, Azienda Ospedaliero Universitaria Pisana, Via Roma, 67, 56126, Pisa, Italy

    Giulio Zucchelli

  2. Cardioangiologisches Centrum Bethanien, Frankfurt, Germany

    K. R. Julian Chun

  3. Institut Jantung Negara, National Heart Institute, Kuala Lumpur, Malaysia

    Surinder Kaur Khelae

  4. Gottsegen György Országos Kardiovaszkuláris Intézet, Budapest, Hungary

    Csaba Földesi

  5. Medtronic, Inc, Minneapolis, MN, USA

    Fred J. Kueffer & Kelly A. van Bragt

  6. Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina

    Fernando Scazzuso

  7. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Young-Keun On

  8. Chest Disease Hospital, Kuwait City, Kuwait

    Fawzia Al-Kandari

  9. Saiseikai Kumamoto Hospital, Kumamoto, Japan

    Ken Okumura

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  1. Giulio Zucchelli
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the Cryo Global Registry Investigators

Corresponding author

Correspondence to Giulio Zucchelli.

Ethics declarations

Ethics approval

Data collection adhered to the principles outlined in the Declaration of Helsinki and Good Clinical Practices. The study was approved by local institutional review boards and ethics committees at each center.

Informed concent

Patients provided written informed consent prior to participation in the study.

Conflict of interest

FJ Kueffer and KA van Bragt are employees of Medtronic.

Dr. Földesi has received compensation for teaching and proctoring from Medtronic, The Johnson & Johnson Co., Abbott Laboratories, and Biotronik SE & Co. Dr. Okumura has received compensation from Medtronic and compensation from Johnson and Johnson outside the submitted work. The remaining authors have no conflicts of interest pertaining to this manuscript to declare.

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Zucchelli, G., Chun, K.R.J., Khelae, S.K. et al. Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry. J Interv Card Electrophysiol 66, 711–722 (2023). https://doi.org/10.1007/s10840-022-01388-6

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