Quality of life and perception after pulmonary vein isolation and app-based mental training - Results from the randomized controlled MENTAL AF Trial

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: Foundation. Main funding source(s): German Heart Foundation INTRODUCTION: It was recently shown that app-based mental training (MT) reduces atrial fibrillation (AF) related symptoms as compared to usual care in patients undergoing catheter ablation for AF. We now report the effect of MT on quality of life (QoL) and AF burden. METHODS: MENTAL AF was a RCT with two parallel treatment groups enrolling patients undergoing catheter ablation for symptomatic AF during August 2019 and July 2021. Patients were randomized in a 1:1-ratio to app-based MT or usual care. The MT group gained access to a daily 10-minute app-based breathing, relaxation and meditation training, with a minimum requirement of 2 sessions/week. A total of 183 patients were randomized of which 151 could be included in the final analysis (76 in the MT and 75 in the usual care group). The primary outcome was the intergroup difference of the mean AF6 sum scores during the 3 months study period. Secondary outcomes included web-based QoL measures as assessed by the AF Effect on Quality of Life (AFEQT) and PROMIS Global Health as well as time in AF/atrial tachycardia documented on 7-day Holter. RESULTS: Baseline characteristics were well balanced between the MT vs control group, respectively: mean (SD) age 60.6 (8.7) vs 61.5 (8.7) years, female patients 42 vs 40%, paroxysmal AF 55 vs 55%, and left ventricular ejection fraction 58.0 (7.3) vs 57.5 (7.8) %. The primary outcome of AF6 sum score was 8.9 (6.9) points in the MT and 12.5 (10.1) in the usual care group (P = .011). The median difference of the AFEQT Global Score from baseline to 3 month was 18.3 (IQR 11.7 to 35) in the MT and 10.8 (IQR 1.7 to 31.7) in the usual care group (P = .026). The PROMIS Physical Health domain improved by 4.6 (IQR 0; 7.5) in the MT as compared to 0 (-2.6; 4.7) in the usual care group; P = .000. As for the Mental Health domain there was a trend towards a more pronounced improvement [2.9 (IQR 0 to 5.2) vs 0.8 (IQR -2.6 to 4.7); P = .061]. On 3-month follow-up 7-day-Holter 10 patients (16.9 %) in the MT vs 11 patients (14.3 %) in the usual care group exhibited AF/ atrial tachycardia (P = .67). During the registration period 35 patients (53.8 %) in usual care and 25 patients (35.7 %) in MT reported heart rhythm-related symptoms (P = .034). CONCLUSION: MENTAL AF shows that an app-based mind & body intervention as an adjunctive treatment tool improves QoL despite an equal actual arrhythmia burden on 7-day Holter. These results suggest that mental training unfolds its effect by a modification of disease perception and coping.