In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.).

AimsThe primary safety and efficacy endpoints of the randomized FIRE AND ICE trial have recently demonstrated non-inferiority of cryoballoon vs. radiofrequency current (RFC) catheter ablation in patients with drug-refractory symptomatic paroxysmal atrial fibrillation (AF). The aim of the current study was to assess outcome parameters that are important for the daily clinical management of patients using key secondary analyses. Specifically, reinterventions, rehospitalizations, and quality-of-life were examined in this randomized trial of cryoballoon vs. RFC catheter ablation.Methods and resultsPatients (374 subjects in the cryoballoon group and 376 subjects in the RFC group) were evaluated in the modified intention-to-treat cohort. After the index ablation, log-rank testing over 1000 days of follow-up demonstrated that there were statistically significant differences in favour of cryoballoon ablation with respect to repeat ablations (11.8% cryoballoon vs. 17.6% RFC; P = 0.03), direct-current cardioversions (3.2% cryoballoon vs. 6.4% RFC; P = 0.04), all-cause rehospitalizations (32.6% cryoballoon vs. 41.5% RFC; P = 0.01), and cardiovascular rehospitalizations (23.8% cryoballoon vs. 35.9% RFC; P < 0.01). There were no statistical differences between groups in the quality-of-life surveys (both mental and physical) as measured by the Short Form-12 health survey and the EuroQol five-dimension questionnaire. There was an improvement in both mental and physical quality-of-life in all patients that began at 6 months after the index ablation and was maintained throughout the 30 months of follow-up.ConclusionPatients treated with cryoballoon as opposed to RFC ablation had significantly fewer repeat ablations, direct-current cardioversions, all-cause rehospitalizations, and cardiovascular rehospitalizations during follow-up. Both patient groups improved in quality-of-life scores after AF ablation.Clinical trial registrationClinicalTrials.gov identifier: NCT01490814.

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URL: https://www.clinicaltrials.gov. Unique identifier: NCT01490814.

Background Radiofrequency high‐power ablation appears to be a novel concept for atrial fibrillation (AF). The ablation index (AI) value has been associated with durability of pulmonary vein isolation (PVI). Objectives This study aimed to report the procedural data and initial results of a combined ablation technique using AI‐guided high‐power (AI‐HP; 50 W) ablation for PVI. Methods Symptomatic AF patients were consecutively enrolled and underwent wide‐area contiguous circumferential PVI. Contact‐force catheters were used, ablation power was set to 50 W targeting AI values (550 anterior and 400 posterior). Esophageal temperature was monitored during procedure, all patients underwent postablation esophageal endoscopy. Results PVI was achieved in all (n = 50, mean age: 68 ± 9 years, female: 60%) patients, rate of first‐round PVI was 92%. A total of N = 2105 AI‐guided ablation lesions were analyzed. Comparing left anterior wall vs left posterior wall and right anterior wall vs right posterior wall, mean ablation time (s) per lesion was 20.5 ± 8 vs 8.6 ± 3 and 12.2 ± 4 vs 9.3 ± 3; mean contact force (g): 17.1 ± 12 vs 25.4 ± 14 and 33.7 ± 13 vs 21.0 ± 11; mean AI: 547 ± 48 vs 445 ± 55 and 555 ± 56 vs 440 ± 47 (all P < .0001). Procedure and fluoroscopy time (minute) were 55.6 ± 6.6 and 6 ± 1.7, respectively. Only one (2%) patient had a minimal esophageal lesion. During In‐hospital and 1‐month follow‐up no major complications such as death, stroke, tamponade, or atriaesophageal fistula (AE) occurred. Preliminary 6‐month follow‐up showed 48 of 50 (96%) patients were free from clinical AF/atrial tachycardia recurrence. Conclusion AI‐HP (50 W) ablation appears to be a feasible, safe, fast, and effective ablation technique for PVI.