Dataset Information

Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes.

ABSTRACT: Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications.Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group.The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure.ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.

SUBMITTER: Luik A

PROVIDER: S-EPMC5445510 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes.

Luik Armin A Kunzmann Kevin K Hörmann Patrick P Schmidt Kerstin K Radzewitz Andrea A Bramlage Peter P Bramlage Peter P Schenk Thomas T Schymik Gerhard G Merkel Matthias M Kieser Meinhard M Schmitt Claus C

BMC cardiovascular disorders 20170525 1

<h4>Background</h4>Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.<h4>Methods</h4>FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the tr ...[more]

PMID: 28545407

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Project description:AimsThe current challenge in atrial fibrillation (AF) treatment is to develop effective, efficient, and safe ablation strategies. This randomized controlled trial assesses the medium-term efficacy of duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (PVAC) vs. conventional electro-anatomically guided wide-area circumferential ablation (WACA).Methods and resultsOne hundred and eighty-eight patients (mean age 62 ± 12 years, 116 M : 72 F) with paroxysmal AF were prospectively randomized to PVAC or WACA strategies and sequentially followed for 12 months. The primary endpoint was freedom from symptomatic or documented >30 s AF off medications for 7 days at 12 months post-procedure. One hundred and eighty-three patients completed 12 m follow-up. Ninety-four patients underwent PVAC PV isolation with 372 of 376 pulmonary veins (PVs) successfully isolated and all PVs isolated in 92 WACA patients. Three WACA and no PVAC patients developed tamponade. Fifty-six percent of WACA and 60% of PVAC patients were free of AF at 12 months post-procedure (P = ns) with a significant attrition rate from 77 to 78%, respectively, at 6 months. The mean procedure (140 ± 43 vs. 167 ± 42 min, P<0.0001), fluoroscopy (35 ± 16 vs. 42 ± 20 min, P<0.05) times were significantly shorter for PVAC than for WACA. Two patients developed strokes within 72 h of the procedure in the PVAC group, one possibly related directly to PVAC ablation in a high-risk patient and none in the WACA group (P = ns). Two of the 47 patients in the PVAC group who underwent repeat ablation had sub-clinical mild PV stenoses of 25-50% and 1 WACA patient developed delayed severe PV stenosis requiring venoplasty.ConclusionThe pulmonary vein ablation catheter is equivalent in efficacy to WACA with reduced procedural and fluoroscopy times. However, there is a risk of thrombo-embolic and pulmonary stenosis complications which needs to be addressed and prospectively monitored.Clinicaltrialsgov identifierNCT00678340.

Project description:Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia (Calkins H, et al. 2012). There are various methods to treat AF of which Ablation is one of the most effective. We aimed to assess the cost-utility of Cryoballoon ablation (CBA) compared to Radiofrequency ablation (RFA) to treat patients with paroxysmal AF in Iran. A cost-utility analysis was done using a decision-analytic model based on a lifetime Markov structure which was drawn considering the nature of interventions and the natural progress of the disease. Costs data were extracted from medical records of 47 patients of Shahid Rajaie Cardiovascular Medical Center in Tehran in 2019. Parameters and variables such as transition probabilities, risks related to side effects, mortality rates, and utility values were extracted from the available evidence. Deterministic and probabilistic sensitivity analysis was also done. TreeAge pro-2020 software was used in all stages of analysis. In the base case analysis, the CBA strategy was associated with higher cost and effectiveness than RFA, and the incremental cost-effectiveness ratio was $11,223 per Quality-adjusted life year (QALY), which compared to Iran's GDP per capita as Willingness to pay threshold, CBA was not cost-effective. On the other hand, considering twice the GDP per capita as a threshold, CBA was cost-effective. Probabilistic sensitivity analysis confirmed the findings of base case analysis, showed that RFA was cost-effective and the probability of cost-effectiveness was 59%. One-way sensitivity analysis showed that the results of the study have the highest sensitivity to changes in the RFA cost variable. Results of sensitivity analysis showed that the cost-effectiveness results were not robust and are sensitive to changes in variables changes. Primary results showed that CBA compared to RFA is not cost-effective in the treatment of AF considering one GDP per capita. But the sensitivity analysis results showed considerable sensitivity to changes of the ablation costs variable.

Dataset Information

Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes.

Publications

Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes.

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