Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
Department of Medicine, Université Laval, Quebec City, Quebec, Canada.
JAMA Cardiol. 2021 Nov 1;6(11):1324-1328. doi: 10.1001/jamacardio.2021.3063.
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.
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.
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.
Absolute difference in quality of life from baseline to 12 months postablation.
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.
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.
ClinicalTrials.gov Identifier: NCT01913522.
患有心房颤动 (AF) 的患者主要由于与 AF 发作相关的症状而导致健康相关生活质量受损；然而，生活质量可能受到 AF 治疗、AF 并发症、随访和住院次数、疾病认知以及焦虑或抑郁等患者因素的影响。
确定消融治疗后一年内 AF 负荷变化与生活质量之间的关系。
设计、地点和参与者：本研究是一项前瞻性、平行组、多中心、单盲随机临床试验（冷冻球囊与灌流射频导管消融：双短 vs 标准暴露时间[CIRCA-DOSE]研究）的二次分析，该研究在加拿大的 8 个中心进行。2014 年 9 月至 2017 年 7 月，纳入了 346 名年龄在 18 岁以上、因抗心律失常治疗无效而接受首次导管消融治疗的有症状、主要为低负荷 AF 的患者。所有患者在消融前至少 30 天植入了植入式心脏监测器，并随访至 2018 年 12 月。数据于 2020 年 4 月至 2021 年 6 月进行分析。
患者以 1:1:1 的比例随机分为接触力指导下的射频消融、4 分钟冷冻球囊消融或 2 分钟冷冻球囊消融。本分析中的暴露是通过房颤对生活质量的影响评分（AFEQT 评分）评估的消融前和消融后 12 个月的 AF 负荷绝对值差异。
从基线到消融后 12 个月的生活质量的绝对差异。
在 346 名纳入的患者中，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。消融前的中位（四分位距）AF 负荷为 2.0%（0.1-11.9），消融后 12 个月 AF 负荷降至 0%。在 12 个月时，AFEQT 评分每提高 1 分，与每日 AF 负荷绝对减少 15.8 分钟（95%CI，7.2-24.4；P < .001）或相对 AF 负荷基线时减少 0.63%（95%CI，0.30-0.95；P < .001）相关。
在主要为低负荷阵发性 AF 的患者中，消融后 AF 负荷的降低可能与生活质量的临床显著改善相关。
ClinicalTrials.gov 标识符：NCT01913522。
