Quality of Life and Safety Outcomes after First-Line Treatment of Symptomatic AF with Cryoablation or Drug Therapy: A Meta-Analysis of Randomized Controlled Trials

Qingchun Song, Haoyu Tan, Benli Yang, Hongduan Liu, Chengming Fan
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Abstract

Background : Cryoablation has emerged as a recognized interventional strategy for the treatment of atrial fibrillation (AF). Numerous trials have investigated cryoablation as a first-line therapy for AF. This meta-analysis aimed to evaluate the impact of cryoablation on quality of life (QoL) and safety outcomes compared to antiarrhythmic drugs (AADs) in patients with symptomatic AF. Methods : A comprehensive search of the PubMed, EMBASE, and Cochrane Library databases was conducted for randomized controlled trials (RCTs) comparing cryoablation and AADs as first-line treatments for AF until May 2023. Continuous outcome data were analyzed using mean differences (MDs) with 95% confidence intervals (CIs), and dichotomous outcome data were analyzed using relative risks (RRs) with 95% CIs. The primary outcomes assessed were QoL and serious adverse events. Results : Our analysis included four RCTs involving 928 patients. Cryoablation was associated with a significant improvement in the AF Effect on Quality of Life (AFEQT) score (3 trials; MD 7.46, 95% CI 2.50 to 12.42; p = 0.003; I 2 = 79%) and EQ-VAS score (2 trials; MD 1.49, 95% CI 1.13 to 1.86; p < 0.001; I 2 = 0%) compared to AAD therapy. Additionally, cryoablation demonstrated a modest increase in EQ-5D score from baseline compared to AAD therapy, with no statistically significance (2 trials; MD 0.03, 95% CI –0.01 to 0.07; p = 0.07; I 2 = 79%). Furthermore, the rate of serious adverse events was significantly lower with cryoablation compared to AAD therapy (4 trials; 11.8% vs. 16.3%; RR, 0.73; 95% CI, 0.54–1.00; p = 0.05; I 2 = 0%). Cryoablation was also associated with a reduction in overall adverse events, incidence of persistent AF, hospitalizations, and additional ablation. However, there was no significant difference in major adverse cardiovascular events and emergency department visits between the two treatment groups. Conclusions : Cryoablation, as a first-line treatment for symptomatic AF patients, significantly improved AF-specific quality of life and reduced serious adverse events, as well as overall adverse events, persistent AF, hospitalizations, and additional ablation compared to AADs.
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冷冻消融或药物治疗一线治疗症状性房颤后的生活质量和安全性结果:随机对照试验的元分析
背景:冷冻消融术已成为治疗心房颤动(房颤)的公认介入策略。许多试验都将冷冻消融作为房颤的一线疗法进行了研究。本荟萃分析旨在评估与抗心律失常药物(AADs)相比,冷冻消融术对无症状房颤患者生活质量(QoL)和安全性的影响。方法:对 PubMed、EMBASE 和 Cochrane Library 数据库进行了全面检索,以寻找 2023 年 5 月之前将冷冻消融与 AADs 作为房颤一线治疗方法进行比较的随机对照试验 (RCT)。连续性结果数据采用平均差 (MD) 和 95% 置信区间 (CI) 进行分析,二分法结果数据采用相对风险 (RR) 和 95% CI 进行分析。评估的主要结果是 QoL 和严重不良事件。结果:我们的分析包括四项研究,涉及 928 名患者。与 AAD 治疗相比,低温消融术显著改善了房颤对生活质量的影响 (AFEQT) 评分(3 项试验;MD 7.46,95% CI 2.50 至 12.42;p = 0.003;I 2 = 79%)和 EQ-VAS 评分(2 项试验;MD 1.49,95% CI 1.13 至 1.86;p < 0.001;I 2 = 0%)。此外,与AAD疗法相比,冷冻消融术的EQ-5D评分较基线略有增加,但无统计学意义(2项试验;MD 0.03,95% CI -0.01至0.07;P = 0.07;I 2 = 79%)。此外,与AAD疗法相比,冷冻消融术的严重不良事件发生率明显较低(4项试验;11.8% vs. 16.3%;RR,0.73;95% CI,0.54-1.00;P = 0.05;I 2 = 0%)。低温消融也与总体不良事件、持续房颤发生率、住院率和额外消融率的降低有关。然而,两个治疗组在主要心血管不良事件和急诊就诊方面没有明显差异。结论 :冷冻消融作为无症状房颤患者的一线治疗方法,与AADs相比,能显著改善房颤患者的生活质量,减少严重不良事件、总体不良事件、持续性房颤、住院和额外消融。
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