12 MONTH EFFICACY, SAFETY, SYMPTOMS AND IMPROVED QUALITY OF LIFE POST ARCTIC FRONT ADVANCE CRYOBALLOON ABLATION IN PERSISTENT AF PATIENTS: RESULTS FROM THE GLOBAL PROSPECTIVE MULTICENTER STOP PERSISTENT AF STUDY

The first use of cryoablation in the treatment of arrhythmia has already been described over 40 years ago [1]. Since the introduction of cryoballoon in pulmonary veins isolation in atrial fibrillation treatment, the method has started to attract a lot of interest. Over 350,000 procedures around the word were carried out only by 2018 [2]. Recently, there have been several new publications on the results of second-generation cryoballoon ablation [2, 3, 4]. In view of technology changes, and to summarize years of experience in the treatment of atrial fibrillation, the first Cryousers conference was organized, and held in 2018 in Poland. During this meeting a survey was conducted, obtaining data on the practice of atrial fibrillation treatment in 38 Polish electrophysiological centers performing cryoablation of atrial fibrillation using both balloons, Arctic Front Advance, Medtronic Inc., Minneapolis MN, and radiofrequency point by point ablation. Around 3,745 cryoballoon procedures were performed in the surveyed centers during the year preceding the survey. The survey concerned practical issues related to the qualification and preparation of patients for the procedure, its course, and the results of pulmonary veins isolation in Poland.

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Impact of initial rhythm control with cryoballoon ablation versus drug therapy on atrial fibrillation recurrence and quality of life: results from the Cryo-FIRST study

EP Europace ◽

10.1093/europace/euab116.211 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

N Pavlovic ◽

M Kuniss ◽

V Velagic ◽

JS Hermida ◽

S Healey ◽

...

Keyword(s):

Quality Of Life ◽

Atrial Fibrillation ◽

Summary Score ◽

Group Differences ◽

Cryoballoon Ablation ◽

First Line ◽

Significant Group ◽

Sf 36 ◽

Af Recurrence

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic OnBehalf The Cryo-FIRST Investigators Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial arrhythmia recurrence; however, the impact of first-line CBA specifically on atrial fibrillation (AF) recurrence and quality of life (QoL) has not been well characterized. Purpose To compare AF recurrence and QoL following first-line CBA vs. AAD therapy in patients with paroxysmal AF within the CryoFIRST trial (NCT01803438). Methods Patients with recurrent symptomatic paroxysmal AF who had not been administered class I or III AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. Patients were randomized (1:1) to CBA or AAD treatment (Class I or III). Subjects were followed by 7-day Holter at 1, 3, 6, 9, and 12 months. Time-to-first AF recurrence outside of a 90-day blanking period was estimated by Kaplan-Meier analysis. QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and 36-Item Short Form Health Survey (SF-36) v2 questionnaires. Results Of the 218 randomized subjects, 187 (86%) completed the 12-month follow-up. By intention-to-treat (ITT) analysis, freedom from AF after blanking was achieved in 86.6% in the CBA and 74.5% in the AAD group (p = 0.023). There was no difference in the time-to-first serious adverse event between groups. In total, 84.3% of patients in the CBA vs. 75.0% of patients in the AAD arm had a clinically important improvement (≥5 points) in the AFEQT summary score. The adjusted mean difference in the AFEQT summary score at 12 months was 9.9 points higher in the CBA group (95% CI: 5.5-14.2; P < 0.001). All AFEQT subscale scores were more favorable in the CBA vs. AAD group at 12 months. There were no significant group differences in any of the SF-36 health domain scores at 12 months in the ITT analysis. In the per-protocol analysis, clinically important and significant group differences in favor of CBA were observed at 12 months for 3 of 8 SF-36 health domain scores (physical functioning, general health and social functioning). Conclusion CBA is superior to AAD for preventing AF recurrence and improving AF-specific QoL in patients with paroxysmal AF. AFEQT Scores at Baseline and 12 MonthsAFEQT Score, Mean ± Standard DeviationCBAAADAdjusted Mean Difference at 12 Months (CBA vs. AAD)p-valueBaseline12 MonthsBaseline12 MonthsDaily Activities65.3 ± 25.887.8 ± 17.161.0 ± 27.976.6 ± 25.48.9 (3.2-14.6)0.002Symptoms59.9 ± 24.888.8 ± 15.658.4 ± 25.280.9 ± 22.27.1 (1.5-12.7)0.014Treatment Concern59.9 ± 23.189.8 ± 14.060.4 ± 24.577.7 ± 22.212.7 (7.9-17.5)<0.001AFEQT, Atrial Fibrillation Effect on Quality of Life questionnaire. CBA, cryoballoon ablation. AAD antiarrhythmic drug.Abstract Figure. Freedom From Atrial Fibrillation

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