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Association of Atrial Fibrillation Burden With Health-Related Quality of Life After Atrial Fibrillation Ablation: Substudy of the Cryoballoon vs Contact-Force Atrial Fibrillation Ablation (CIRCA-DOSE) Randomized Clinical Trial
JAMA Cardiology ( IF 24.0 ) Pub Date : 2021-11-01 , DOI: 10.1001/jamacardio.2021.3063
Michelle Samuel 1 , Paul Khairy 1 , Jean Champagne 2 , Marc W Deyell 3 , Laurent Macle 1 , Peter Leong-Sit 4 , Paul Novak 5 , Mariano Badra-Verdu 6 , John Sapp 7 , Jean-Claude Tardif 1 , Jason G Andrade 1, 3
Affiliation  

Importance Patients with atrial fibrillation (AF) have impaired health-related quality of life primarily owing to symptoms related to AF episodes; however, quality of life can be influenced by AF therapies, AF complications, the frequency of follow-up visits and hospitalizations, illness perceptions, and patient factors, such as anxiety or depression.

Objective To determine the association between change in AF burden and quality of life in the year following ablation.

Design, Setting, and Participants The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic, primarily low-burden AF refractory to antiarrhythmic therapy referred for first catheter ablation were enrolled. All patients received an implantable cardiac monitor at least 30 days before ablation and were followed up with up to December 2018. Data were analyzed from April 2020 to June 2021.

Interventions Patients were randomized 1:1:1 to contact force–guided radiofrequency ablation, 4-minute cryoballoon ablation, or 2-minute cryoballoon ablation. The exposure in the present analysis is the absolute difference in AF burden prior to ablation and 12 months following ablation, as evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) Score.

Main Outcomes and Measures Absolute difference in quality of life from baseline to 12 months postablation.

Results Of 346 included patients, 231 (66.7%) were male, and the median (interquartile range) age was 60 (52-66) years. A total of 328 patients (94.8%) had paroxysmal AF. The median (interquartile range) preablation AF burden was 2.0% (0.1-11.9), and the AF burden decreased to 0% at 12 months postablation. At 12 months, a 1-point improvement in AFEQT score was observed for every absolute reduction in daily AF burden of 15.8 minutes (95% CI, 7.2-24.4; P < .001), or every 0.63% (95% CI, 0.30-0.95; P < .001) reduction in relative AF burden from baseline.

Conclusions and Relevance In patients with primarily low-burden paroxysmal AF, the reduction in AF burden following ablation may be associated with a clinically meaningful improvement in quality of life.

Trial Registration ClinicalTrials.gov Identifier: NCT01913522



中文翻译:

心房颤动消融后心房颤动负担与健康相关生活质量的关联:冷冻球囊与接触力心房颤动消融 (CIRCA-DOSE) 随机临床试验的子研究

重要性 心房颤动 (AF) 患者的健康相关生活质量受损,主要是由于与 AF 发作相关的症状;然而,生活质量会受到 AF 治疗、AF 并发症、随访和住院频率、疾病认知和患者因素(如焦虑或抑郁)的影响。

目的 确定消融后一年内 AF 负担的变化与生活质量之间的关联。

设计、设置和参与者 当前研究是对一项前瞻性、平行组、多中心、单盲随机临床试验(冷冻球囊与灌注射频导管消融:双短与标准暴露持续时间 [CIRCA-DOSE] 研究)的二次分析,这发生在 8 个加拿大中心。在 2014 年 9 月至 2017 年 7 月期间,纳入了 346 名 18 岁以上的有症状、主要是低负担 AF 抗心律失常治疗难治性房颤患者,转诊为首次导管消融。所有患者在消融前至少 30 天接受了植入式心脏监护仪,并随访至 2018 年 12 月。数据分析时间为 2020 年 4 月至 2021 年 6 月。

干预 患者按 1:1:1 随机分配接受接触力引导射频消融、4 分钟冷冻球囊消融或 2 分钟冷冻球囊消融。本分析中的暴露是消融前和消融后 12 个月 AF 负担的绝对差异,通过心房颤动对生活质量的影响 (AFEQT) 评分进行评估。

主要结果和措施 从基线到消融后 12 个月的生活质量的绝对差异。

结果 346 名患者中,231 名(66.7%)为男性,中位(四分位距)年龄为 60(52-66)岁。共有 328 名患者 (94.8%) 患有阵发性 AF。消融前房颤负担中位数(四分位距)为 2.0% (0.1-11.9),消融后 12 个月房颤负担降至 0%。在 12 个月时,观察到每日 AF 负担每绝对减少 15.8 分钟(95% CI,7.2-24.4;P  < .001)或每 0.63%(95% CI,0.30), AFEQT 评分提高 1 分-0.95;P  < .001) 相对于基线的 AF 负担减少。

结论和相关性 在以低负荷阵发性 AF 为主的患者中,消融后 AF 负担的减轻可能与临床上有意义的生活质量改善有关。

试验注册 ClinicalTrials.gov 标识符:NCT01913522

更新日期:2021-11-08
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