Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial

Jason G. Andrade; Jean Champagne; Marc Dubuc; Marc W. Deyell; Atul Verma; Laurent Macle; Peter Leong-Sit; Paul Novak; Mariano Badra-Verdu; John Sapp; Iqwal Mangat; Clarence Khoo; Christian Steinberg; Matthew T. Bennett; Anthony S.L. Tang; Paul Khairy

doi:10.1161/CIRCULATIONAHA.119.042622

Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial

Jason G. Andrade, Jean Champagne, Marc Dubuc, Marc W. Deyell, Atul Verma, Laurent Macle, Peter Leong-Sit, Paul Novak, Mariano Badra-Verdu, John Sapp, Iqwal Mangat, Clarence Khoo, Christian Steinberg, Matthew T. Bennett, Anthony S.L. Tang, Paul Khairy

Medicine

Résultat de recherche: Article › examen par les pairs

435 Citations (Scopus)

Résumé

Background: Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation. Methods: We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder. Results: One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 (P=0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups (P=0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs cryoballoon groups). Conclusions: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522.

Langue d'origine	English
Pages (de-à)	1779-1788
Nombre de pages	10
Journal	Circulation
Volume	140
Numéro de publication	22
DOI	https://doi.org/10.1161/CIRCULATIONAHA.119.042622
Statut de publication	Published - nov. 26 2019

Note bibliographique

Funding Information:
Dr Andrade reports grants and personal fees from Medtronic, grants from Baylis, and personal fees from Biosense Webster. Dr Verma reports grants and personal fees from Medtronic and Biosense Webster. Dr Deyell reports grants from Biosense Webster. Dr Tang reports grants from Medtronic. Dr Leong-Sit reports personal fees from Medtronic and Biosense Webster. Dr Dubuc reports grants and personal fees from Medtronic. Dr Sapp reports grants and personal fees from Biosense Webster and St Jude Medical/Abbott and personal fees from Medtronic. Dr Macle reports personal fees from Medtronic and grants and personal fees from St Jude Medical/Abbott and Biosense Webster. Drs Bennett, Khoo, Steinberg, Mangat, Badra, Novak, Champagne, and Khairy have nothing to disclose.

Funding Information:
The trial was funded by a peer-reviewed grant from the Heart and Stroke Foundation of Canada (grant G-13-0003121) with additional financial support from Medtronic and the University of British Columbia. The funding sources were not involved in the study design, in the writing of the article, or in the decision to submit the article for publication. The data that support the findings of this study are available from the corresponding author upon reasonable request.

Funding Information:
The CIRCA-DOSE study was funded by a peer-reviewed grant from the Heart and Stroke Foundation of Canada (grant number G-13-0003121), with additional financial support from Medtronic. Drs Andrade and Deyell are supported by a Michael Smith Foundation for Health Research Scholar Award. Dr Khairy is supported by the André Chagnon research chair in electrophysiology and congenital heart disease. The funding sources had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

Publisher Copyright:
© 2019 American Heart Association, Inc.

ASJC Scopus Subject Areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

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10.1161/CIRCULATIONAHA.119.042622

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Andrade, J. G., Champagne, J., Dubuc, M., Deyell, M. W., Verma, A., Macle, L., Leong-Sit, P., Novak, P., Badra-Verdu, M., Sapp, J., Mangat, I., Khoo, C., Steinberg, C., Bennett, M. T., Tang, A. S. L., & Khairy, P. (2019). Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial. Circulation, 140(22), 1779-1788. https://doi.org/10.1161/CIRCULATIONAHA.119.042622

Andrade, JG, Champagne, J, Dubuc, M, Deyell, MW, Verma, A, Macle, L, Leong-Sit, P, Novak, P, Badra-Verdu, M, Sapp, J, Mangat, I, Khoo, C, Steinberg, C, Bennett, MT, Tang, ASL & Khairy, P 2019, 'Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial', Circulation, vol. 140, n° 22, pp. 1779-1788. https://doi.org/10.1161/CIRCULATIONAHA.119.042622

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title = "Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial",

abstract = "Background: Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation. Methods: We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder. Results: One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 (P=0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups (P=0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs cryoballoon groups). Conclusions: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522.",

author = "Andrade, {Jason G.} and Jean Champagne and Marc Dubuc and Deyell, {Marc W.} and Atul Verma and Laurent Macle and Peter Leong-Sit and Paul Novak and Mariano Badra-Verdu and John Sapp and Iqwal Mangat and Clarence Khoo and Christian Steinberg and Bennett, {Matthew T.} and Tang, {Anthony S.L.} and Paul Khairy",

note = "Funding Information: Dr Andrade reports grants and personal fees from Medtronic, grants from Baylis, and personal fees from Biosense Webster. Dr Verma reports grants and personal fees from Medtronic and Biosense Webster. Dr Deyell reports grants from Biosense Webster. Dr Tang reports grants from Medtronic. Dr Leong-Sit reports personal fees from Medtronic and Biosense Webster. Dr Dubuc reports grants and personal fees from Medtronic. Dr Sapp reports grants and personal fees from Biosense Webster and St Jude Medical/Abbott and personal fees from Medtronic. Dr Macle reports personal fees from Medtronic and grants and personal fees from St Jude Medical/Abbott and Biosense Webster. Drs Bennett, Khoo, Steinberg, Mangat, Badra, Novak, Champagne, and Khairy have nothing to disclose. Funding Information: The trial was funded by a peer-reviewed grant from the Heart and Stroke Foundation of Canada (grant G-13-0003121) with additional financial support from Medtronic and the University of British Columbia. The funding sources were not involved in the study design, in the writing of the article, or in the decision to submit the article for publication. The data that support the findings of this study are available from the corresponding author upon reasonable request. Funding Information: The CIRCA-DOSE study was funded by a peer-reviewed grant from the Heart and Stroke Foundation of Canada (grant number G-13-0003121), with additional financial support from Medtronic. Drs Andrade and Deyell are supported by a Michael Smith Foundation for Health Research Scholar Award. Dr Khairy is supported by the Andr{\'e} Chagnon research chair in electrophysiology and congenital heart disease. The funding sources had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Publisher Copyright: {\textcopyright} 2019 American Heart Association, Inc.",

year = "2019",

month = nov,

day = "26",

doi = "10.1161/CIRCULATIONAHA.119.042622",

language = "English",

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pages = "1779--1788",

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TY - JOUR

T1 - Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring

T2 - A Randomized Clinical Trial

AU - Andrade, Jason G.

AU - Champagne, Jean

AU - Dubuc, Marc

AU - Deyell, Marc W.

AU - Verma, Atul

AU - Macle, Laurent

AU - Leong-Sit, Peter

AU - Novak, Paul

AU - Badra-Verdu, Mariano

AU - Sapp, John

AU - Mangat, Iqwal

AU - Khoo, Clarence

AU - Steinberg, Christian

AU - Bennett, Matthew T.

AU - Tang, Anthony S.L.

AU - Khairy, Paul

N1 - Funding Information: Dr Andrade reports grants and personal fees from Medtronic, grants from Baylis, and personal fees from Biosense Webster. Dr Verma reports grants and personal fees from Medtronic and Biosense Webster. Dr Deyell reports grants from Biosense Webster. Dr Tang reports grants from Medtronic. Dr Leong-Sit reports personal fees from Medtronic and Biosense Webster. Dr Dubuc reports grants and personal fees from Medtronic. Dr Sapp reports grants and personal fees from Biosense Webster and St Jude Medical/Abbott and personal fees from Medtronic. Dr Macle reports personal fees from Medtronic and grants and personal fees from St Jude Medical/Abbott and Biosense Webster. Drs Bennett, Khoo, Steinberg, Mangat, Badra, Novak, Champagne, and Khairy have nothing to disclose. Funding Information: The trial was funded by a peer-reviewed grant from the Heart and Stroke Foundation of Canada (grant G-13-0003121) with additional financial support from Medtronic and the University of British Columbia. The funding sources were not involved in the study design, in the writing of the article, or in the decision to submit the article for publication. The data that support the findings of this study are available from the corresponding author upon reasonable request. Funding Information: The CIRCA-DOSE study was funded by a peer-reviewed grant from the Heart and Stroke Foundation of Canada (grant number G-13-0003121), with additional financial support from Medtronic. Drs Andrade and Deyell are supported by a Michael Smith Foundation for Health Research Scholar Award. Dr Khairy is supported by the André Chagnon research chair in electrophysiology and congenital heart disease. The funding sources had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Publisher Copyright: © 2019 American Heart Association, Inc.

PY - 2019/11/26

Y1 - 2019/11/26

N2 - Background: Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation. Methods: We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder. Results: One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 (P=0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups (P=0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs cryoballoon groups). Conclusions: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522.

AB - Background: Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation. Methods: We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder. Results: One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively (P=0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 (P=0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups (P=0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs cryoballoon groups). Conclusions: In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522.

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Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial

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