n-of-1 testing of self-selected AF triggers did not improve quality of life compared to monitoring alone, but reduced daily AF episodes (RR 0.60; 95% CI 0.43-0.83; P<0.001).
RCT (n=446)
random 1-week blocks
Does n-of-1 testing of self-selected AF triggers improve Atrial Fibrillation Effect on Quality-of-Life (AFEQT) scores in symptomatic patients with paroxysmal AF?
Individualized n-of-1 testing of AF triggers did not improve quality of life but was associated with a reduction in subsequent AF events, identifying alcohol as the only consistent trigger.
Importance: Atrial fibrillation (AF) is the most common arrhythmia. Although patients have reported that various exposures determine when and if an AF event will occur, a prospective evaluation of patient-selected triggers has not been conducted, and the utility of characterizing presumed AF-related triggers for individual patients remains unknown. Objective: To test the hypothesis that n-of-1 trials of self-selected AF triggers would enhance AF-related quality of life. Design, Setting, and Participants: A randomized clinical trial lasting a minimum of 10 weeks tested a smartphone mobile application used by symptomatic patients with paroxysmal AF who owned a smartphone and were interested in testing a presumed AF trigger. Participants were screened between December 22, 2018, and March 29, 2020. Interventions: n-of-1 Participants received instructions to expose or avoid self-selected triggers in random 1-week blocks for 6 weeks, and the probability their trigger influenced AF risk was then communicated. Controls monitored their AF over the same time period. Main Outcomes and Measures: AF was assessed daily by self-report and using a smartphone-based electrocardiogram recording device. The primary outcome comparing n-of-1 and control groups was the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score at 10 weeks. All participants could subsequently opt for additional trigger testing. Results: Of 446 participants who initiated (mean SD age, 58 14 years; 289 men 58%; 461 White 92%), 320 (72%) completed all study activities. Self-selected triggers included caffeine (n = 53), alcohol (n = 43), reduced sleep (n = 31), exercise (n = 30), lying on left side (n = 17), dehydration (n = 10), large meals (n = 7), cold food or drink (n = 5), specific diets (n = 6), and other customized triggers (n = 4). No significant differences in AFEQT scores were observed between the n-of-1 vs AF monitoring-only groups. In the 4-week postintervention follow-up period, significantly fewer daily AF episodes were reported after trigger testing compared with controls over the same time period (adjusted relative risk, 0.60; 95% CI, 0.43- 0.83; P < .001). In a meta-analysis of the individualized trials, only exposure to alcohol was associated with significantly heightened risks of AF events. Conclusions and Relevance: n-of-1 Testing of AF triggers did not improve AF-associated quality of life but was associated with a reduction in AF events. Acute exposure to alcohol increased AF risk, with no evidence that other exposures, including caffeine, more commonly triggered AF. Trial Registration: ClinicalTrials.gov Identifier: NCT03323099.
Marcus et al. (Sun,) conducted a rct in Paroxysmal atrial fibrillation (n=446). n-of-1 testing of self-selected AF triggers via smartphone app vs. AF monitoring only was evaluated on Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score at 10 weeks. n-of-1 testing of self-selected AF triggers did not improve quality of life compared to monitoring alone, but reduced daily AF episodes (RR 0.60; 95% CI 0.43-0.83; P<0.001).
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