PT  - JOURNAL ARTICLE
AU  - Gupta, Dhiraj
AU  - Ding, Wern Yew
AU  - Calvert, Peter
AU  - Williams, Emmanuel
AU  - Das, Moloy
AU  - Tovmassian, Lilith
AU  - Tayebjee, Muzahir H
AU  - Haywood, Guy
AU  - Martin, Claire A
AU  - Rajappan, Kim
AU  - Bates, Matthew G D
AU  - Temple, Ian Peter
AU  - Reichlin, Tobias
AU  - Chen, Zhong
AU  - Balasubramaniam, Richard N
AU  - Ronayne, Christina
AU  - Clarkson, Nichola
AU  - Morgan, Maureen
AU  - Barton, Janet
AU  - Kemp, Ian
AU  - Mahida, Saagar
AU  - Sticherling, Christian
TI  - Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter
AID  - 10.1136/heartjnl-2022-321729
DP  - 2023 Mar 01
TA  - Heart
PG  - 364--371
VI  - 109
IP  - 5
4099  - http://heart.bmj.com/content/109/5/364.short
4100  - http://heart.bmj.com/content/109/5/364.full
SO  - Heart2023 Mar 01; 109
AB  - 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.Data are available upon reasonable request. Data are available upon reasonable request from the corresponding author.