Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial

Abstract

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.

Symptom Burden of Atrial Fibrillation and Its Relation to Interventions and Outcome in Europe

“…In particular, we observed significant interactions for cardioversion and ablation therapy that were related to a reduced symptom burden. It is well known that AF‐related therapy helps to improve symptom burden 12, 13, 14. In a prior observational study, QoL in patients with newly diagnosed AF reached normal values under pharmacologic therapy and cardioversion 15.…”

Impact of pulmonary vein ostia anatomy on efficacy of cryoballoon ablation for atrial fibrillation

“…It has been shown that the efficacy of this technique is similar to the standard RF-based AF ablation and may be associated with lower hospital readmissions, direct electrical cardioversions and repeated ablations [1,7] . Also the learning curve is much shorter than in the case of RF ablation, which gives a promise for more widespread use of this technique than difficult pointby-point RF ablation [8,9] .…”

Atrial Fibrillation Catheter Ablation: Overcoming Complications and Improving Success

“…32 In a subgroup analysis of the secondary endpoints, such as rehospitalization, a requirement for cardioversion, and repeat PVI, cryoballoon performance appeared to be a slightly better option. 33 Maan et al 34 did an extensive review of AF ablation complications, including of cryoballoon-associated complications, and reported that the most frequent complication was phrenic nerve palsy, which is specifically more likely to occur when a smaller 23 mm (rather than 28 mm) balloon is used to isolate the right superior PV. [35][36][37] …”