In:
Heart, BMJ
Abstract:
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 .
Type of Medium:
Online Resource
ISSN:
1355-6037
,
1468-201X
DOI:
10.1136/heartjnl-2022-321729
Language:
English
Publisher:
BMJ
Publication Date:
2022
detail.hit.zdb_id:
2378689-9
detail.hit.zdb_id:
1475501-4
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