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Randomized Controlled Trial
. 2023 Feb 14;109(5):364-371.
doi: 10.1136/heartjnl-2022-321729.

Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter

Dhiraj Gupta  1   2   3 , Wern Yew Ding  4   2   3 , Peter Calvert  4   2   3 , Emmanuel Williams  4   2   3 , Moloy Das  5 , Lilith Tovmassian  4 , Muzahir H Tayebjee  6 , Guy Haywood  7 , Claire A Martin  8 , Kim Rajappan  9 , Matthew G D Bates  10 , Ian Peter Temple  11 , Tobias Reichlin  12 , Zhong Chen  13 , Richard N Balasubramaniam  14 , Christina Ronayne  4 , Nichola Clarkson  4 , Maureen Morgan  4 , Janet Barton  4 , Ian Kemp  4 , Saagar Mahida  4 , Christian Sticherling  15
Affiliations
Randomized Controlled Trial

Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter

Dhiraj Gupta et al. Heart. .

Abstract

Objective: We aimed to compare cryoballoon pulmonary vein isolation (PVI) with standard radiofrequency cavotricuspid isthmus (CTI) ablation as first-line treatment for typical atrial flutter (AFL).

Methods: Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter was an international, multicentre, open with blinded assessment trial. Patients with CTI-dependent AFL and no documented atrial fibrillation (AF) were randomised to either cryoballoon PVI alone or radiofrequency CTI ablation. Primary efficacy outcome was time to first recurrence of sustained (>30 s) symptomatic atrial arrhythmia (AF/AFL/atrial tachycardia) at 12 months as assessed by continuous monitoring with an implantable loop recorder. Primary safety outcome was a composite of death, stroke, tamponade requiring drainage, atrio-oesophageal fistula, pacemaker implantation, serious vascular complications or persistent phrenic nerve palsy.

Results: Trial recruitment was halted at 113 of the target 130 patients because of the SARS-CoV-2 pandemic (PVI, n=59; CTI ablation, n=54). Median age was 66 (IQR 61-71) years, with 98 (86.7%) men. At 12 months, the primary outcome occurred in 11 (18.6%) patients in the PVI group and 9 (16.7%) patients in the CTI group. There was no significant difference in the primary efficacy outcome between the groups (HR 1.11, 95% CI 0.46 to 2.67). AFL recurred in six (10.2%) patients in the PVI arm and one (1.9%) patient in the CTI arm (p=0.116). Time to occurrence of AF of ≥2 min was significantly reduced with cryoballoon PVI (HR 0.46, 95% CI 0.25 to 0.85). The composite safety outcome occurred in four patients in the PVI arm and three patients in the CTI arm (p=1.000).

Conclusion: Cryoballoon PVI as first-line treatment for AFL is equally effective compared with standard CTI ablation for preventing recurrence of atrial arrhythmia and better at preventing new-onset AF.

Trial registration number: NCT03401099.

Keywords: Ablation Techniques; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Catheter Ablation.

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Conflict of interest statement

Competing interests: DG was a speaker for Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Biosense Webster and Boston Scientific and a proctor for Abbott, and received research grants from Medtronic, Biosense Webster and Boston Scientific. MD received fellowship funding from Biosense and speaker fees from Boston-Scientific. CAM received speaker fees and research grants from BSCI and Medtronic and speaker fees from Biosense Webster for work outside the submitted study, TR received research grants from the Goldschmidt-Jacobson Foundation, the Swiss National Science Foundation, the Swiss Heart Foundation, the European Union (Eurostars 9799–ALVALE), the Professor Max Cloëtta Foundation, the Cardiovascular Research Foundation Basel, the University of Basel and the University Hospital Basel; speaker/consulting honoraria or travel support from Abbott/SJM, Astra Zeneca, Brahms, Bayer, Biosense-Webster, Biotronik, Boston-Scientific, Daiichi Sankyo, Medtronic, Pfizer-BMS and Roche; and support for his institution’s fellowship programme from Abbott/SJM, Biosense-Webster, Biotronik, Boston-Scientific and Medtronic. CS reported grants and lecture fees from Biosense Webster and Medtronic and served as a proctor for Biosense Webster and Medtronic. Other authors have no relevant disclosures to declare.

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