Department of Electrophysiology Heart Center Leipzig at University Leipzig Leipzig Germany.
Department of Cardiology University Medical Center of the Johannes Gutenberg University Mainz Mainz Germany.
J Am Heart Assoc. 2024 Jun 4;13(11):e033500. doi: 10.1161/JAHA.123.033500. Epub 2024 May 23.
Even after atrial fibrillation (AF) catheter ablation, many patients still experience relevant symptom burden. The objective of the MENTAL AF trial was to determine whether app-based mental training (MT) during the 3 months following pulmonary vein isolation reduces AF-related symptoms.
Patients scheduled for pulmonary vein isolation were enrolled and randomized 1:1 to either app-based MT or usual care. Of 174 patients, 76 in the MT and 75 in the usual care group were included in the final analysis. The intervention was delivered by a daily 10-minute app-based MT. The primary outcome was the intergroup difference of the mean AF6 sum score, an AF-specific questionnaire, during the 3-month study period. Secondary outcomes included quality-of-life measures such as the AFEQT (Atrial Fibrillation Effect on Quality of Life). Mean age (SD) was 61 (8.7) years and 61 (41%) were women. The mean AF6 sum score over the study period was 8.9 (6.9) points in the MT group and 12.5 (10.1) in the usual care group (=0.011). This referred to a reduction in the AF6 sum score compared with baseline of 75% in MT and 52% for usual care (<0.001). The change in the AFEQT Global Score was 22.6 (16.3) and 15.7 (22.1), respectively; =0.026.
MENTAL AF showed that app-based MT as an adjunctive treatment tool following pulmonary vein isolation was feasible. App-based MT was found to be superior to standard care in reducing AF-related symptom burden and improving health-related quality of life.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04067427.
即使在心房颤动(AF)导管消融后,许多患者仍经历相关症状负担。MENTAL AF 试验的目的是确定在肺静脉隔离后 3 个月内基于应用程序的心理训练(MT)是否能减轻与 AF 相关的症状。
招募了计划进行肺静脉隔离的患者,并以 1:1 的比例随机分为基于应用程序的 MT 组或常规护理组。在 174 名患者中,MT 组 76 例,常规护理组 75 例纳入最终分析。干预措施通过每日 10 分钟的基于应用程序的 MT 提供。主要结局是在 3 个月研究期间,AF6 总分的组间差异,这是一种特定于 AF 的问卷。次要结局包括生活质量测量,如 AFEQT(心房颤动对生活质量的影响)。平均年龄(标准差)为 61(8.7)岁,61(41%)为女性。在研究期间,MT 组的平均 AF6 总分(6.9)为 8.9(6.9)分,常规护理组为 12.5(10.1)分(=0.011)。这意味着与基线相比,MT 组的 AF6 总分降低了 75%,而常规护理组降低了 52%(<0.001)。AFEQT 全球评分的变化分别为 22.6(16.3)和 15.7(22.1);=0.026。
MENTAL AF 表明,肺静脉隔离后作为辅助治疗工具的基于应用程序的 MT 是可行的。基于应用程序的 MT 在减轻与 AF 相关的症状负担和改善健康相关生活质量方面优于常规护理。