Lurz JA, et al. Late-breaking clinical trials: randomized clinical trials. Presented at: Heart Rhythm 2022; April 29-May 1, 2022; San Francisco (hybrid meeting).
Lurz does not report any relevant financial information.
An app-based mind-body intervention significantly reduced atrial fibrillation-related symptom burden in the 3 months following catheter ablation compared with usual care, according to results of a controlled trial randomized.
Catheter ablation offers an effective treatment option for AF; however, AF-related symptoms and recurrences, especially in the first 3 months after ablation, are common. Julia A. Lurz, MD, said a cardiac electrophysiologist at the Heart Center Leipzig of the University of Leipzig during a press conference at Heart Rhythm 2022.
“AF, as everyone knows, causes a variety of symptoms, which means stress for the patient as well as a limited quality of life,” Lurz said. “We have catheter ablation as an effective treatment option, but recurrences, especially within 3 months of ablation, are common.”
Mindfulness exercises and symptoms of AF
For the single-center MENTAL AF study, Lurz and colleagues analyzed data from 183 patients with paroxysmal and symptomatic persistent AF with a compatible smartphone and internet access who were scheduled to undergo catheter ablation. Researchers randomly assigned patients to 3 months of mental training (n=91) using the MINDANCE app, an audio-guided multimodule program, or usual care (n=92). The app included a 6-week relaxation module which consisted of breathing, imagination and self-talk techniques to induce relaxation and relieve physical and mental discomfort, followed by a mindfulness module of 6 weeks which included body acceptance and sensual meditation. The mean age of the patients was 61 years old and 41% were women; 45% had persistent AF.
The primary endpoint was per-protocol analysis of mean monthly summary scores of AF6, a six-item questionnaire assessing symptoms of AF, over the 3-month study period. AF6 scores were reported weekly online; measures included breathing difficulty at rest, breathing difficulty on exertion, limitations in daily living, feeling of discomfort, fatigue, and worry/anxiety due to AF.
At 3 months, researchers found that patients assigned to the mental training app had an average reduction of 29% in AF-related symptom burden based on the AF6 score; mean scores over 3 months were 8.9 for the intervention group and 12.5 for the usual care group (P= .011).
“Compared to baseline, both groups showed a decrease [AF6] scores during the 3 months; however, the mental training group had significantly lower AF6 scores at months 2 and 3, suggesting that mental training effects appear over time,” Lurz said. The difference in AF6 scores was not significant at 1 month (P = .13), but it was at 2 months and 3 months (P for both = 0.006), according to the researchers.
Quality of life improvements
In the subgroup analysis, the benefit of mental training was consistent across all subgroups, Lurz said. Assessing quality of life measures, Lurz said there was a significant improvement for intervention patients in the AFEQT score, an AF-related quality of life questionnaire. The mean change in global score from baseline to 3 months was 22.6 in the mental training group and 15.7 in the usual care group (P for intergroup changes = 0.026).
“Both groups benefited, but the improvement was significantly more pronounced in the mental training group,” Lurz said. “App-based mental training was well received by patients, was feasible, and was able to reduce AF symptoms for 3 months after catheter ablation, with consistent effects across all subgroups .”