Dataset Information

Pulsed-field vs. cryoballoon vs. radiofrequency ablation: a propensity score matched comparison of one-year outcomes after pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

ABSTRACT:

Background

Pulsed-field ablation (PFA) has shown favourable data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI). We sought to compare procedural and 1-year follow-up data of patients with paroxysmal atrial fibrillation (AF) undergoing PVI using PFA, cryoballoon ablation (CBA) and radiofrequency ablation (RFA).

Methods

Consecutive patients with paroxysmal AF undergoing a first PVI with PFA at our institution were included. For comparison, patients with paroxysmal AF undergoing a first PVI with CBA and RFA were selected using a 1:2:2 propensity score matching. The PFA group followed the standard 32-applications lesion-set protocol, the CBA group a time-to-effect plus 2-min strategy, and the RFA group the CLOSE protocol. Patients were followed with 7d-Holter ECGs 3, 6, and 12 months after ablation. The primary endpoint was recurrence of atrial tachyarrhythmia (ATa) following a blanking period of 3 months.

Results

A total of 200 patients were included (PFA n = 40; CBA n = 80; RFA n = 80). Median procedure times were shortest with CBA (75 min) followed by PFA (94 min) and RFA (182 min; p < 0.001). Fluoroscopy dose was lowest with RFA (1.6Gycm²) followed by PFA (5.0Gycm²) and CBA (5.7Gycm²; p < 0.001). After a 1-year follow-up, freedom from ATa recurrence was 85.0% with PFA, 66.2% with CBA and 73.8% with RFA (p = 0.12 PFA vs. CBA; p = 0.27 PFA vs. RFA).

Conclusion

In a propensity score matched analysis of patients with paroxysmal AF, freedom from any ATa 1 year after PVI using PFA was favourable and at least as good as for PVI with CBA or RFA.

SUBMITTER: Maurhofer J

PROVIDER: S-EPMC10902096 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Publications

Pulsed-field vs. cryoballoon vs. radiofrequency ablation: a propensity score matched comparison of one-year outcomes after pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

Maurhofer Jens J Kueffer Thomas T Madaffari Antonio A Stettler Robin R Stefanova Anita A Seiler Jens J Thalmann Gregor G Kozhuharov Nikola N Galuszka Oskar O Servatius Helge H Haeberlin Andreas A Noti Fabian F Tanner Hildegard H Roten Laurent L Reichlin Tobias T

Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing 20230930 2

<h4>Background</h4>Pulsed-field ablation (PFA) has shown favourable data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI). We sought to compare procedural and 1-year follow-up data of patients with paroxysmal atrial fibrillation (AF) undergoing PVI using PFA, cryoballoon ablation (CBA) and radiofrequency ablation (RFA).<h4>Methods</h4>Consecutive patients with paroxysmal AF undergoing a first PVI with PFA at our institution were included. For comparison, patients w ...[more]

PMID: 37776355

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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

Pulsed-field vs. cryoballoon vs. radiofrequency ablation: a propensity score matched comparison of one-year outcomes after pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

Background

Methods

Results

Conclusion

Publications

Pulsed-field vs. cryoballoon vs. radiofrequency ablation: a propensity score matched comparison of one-year outcomes after pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

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