American Heart Association

American Heart Association

Source:

Marcus GM, et al. LBS.04. Information Overload? Striving to Improve Care Delivery Through Digital Health and Automated Data. Presented at: American Heart Association Scientific Sessions; Nov. 13-15, 2021 (virtual meeting).

Disclosures: The I-STOP-AFIB trial was funded by the Patient-Centered Outcomes Research Institute (PCORI), which also participated in trial design. Marcus reports receiving research funding from Baylis Medical, California Tobacco-Related Disease Research Program, Eight Sleep, Medtronic, NIH and PCORI; receiving consultant fees from InCarda Therapeutics and Johnson & Johnson; and holding equity as co-founder of InCarda Therapeutics.
November 14, 2021
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I-STOP-AFIB: No effect of trigger testing on AF-related quality of life, but fewer events

Source:

Marcus GM, et al. LBS.04. Information Overload? Striving to Improve Care Delivery Through Digital Health and Automated Data. Presented at: American Heart Association Scientific Sessions; Nov. 13-15, 2021 (virtual meeting).

Disclosures: The I-STOP-AFIB trial was funded by the Patient-Centered Outcomes Research Institute (PCORI), which also participated in trial design. Marcus reports receiving research funding from Baylis Medical, California Tobacco-Related Disease Research Program, Eight Sleep, Medtronic, NIH and PCORI; receiving consultant fees from InCarda Therapeutics and Johnson & Johnson; and holding equity as co-founder of InCarda Therapeutics.
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Patient-selected trigger testing for paroxysmal atrial fibrillation did not improve AF-related quality of life, but the process was tied to fewer self-reported AF events in the weeks after trial participation, a speaker reported.

According to results presented at the American Heart Association Scientific Sessions, patients were able to select which AF triggers to test, and although caffeine was the most commonly selected exposure, alcohol was the only exposure with a strong association with AF events.

Atrial fibrillation smartphone
Source: Adobe Stock

A total of 446 participants with paroxysmal AF who were interested in choosing and testing their own idiosyncratic AF triggers were enrolled into the I-STOP-AFIB trial (mean age, 58 years; 58% men; 92% white). Participants were recruited from the worldwide Health eHeart Study, StopAfib.org and social media.

For the program of 10 weeks or more, participants were instructed to expose themselves to or avoid self-selected AF triggers for random 1-week intervals. Researchers then communicated to the participants the probability of their trigger influencing AF risk.

Self-reported incident AF was assessed daily using a smartphone-based ECG monitoring device (KardiaMobile, AliveCor). Patients in a control group were assigned to monitor their AF during the same period.

The primary outcome was Atrial Fibrillation Effect on Quality of Life (AFEQT) score at 10 weeks among trigger groups compared with controls.

The list of self-selected triggers included exposure to caffeine, alcohol, reduced sleep, exercise, lying on left side, dehydration, large meals, cold food or drink, specific diets and other customized triggers. Caffeine was the most common self-selected trigger for testing.

Seventy-two percent of the cohort completed all study activities.

According to the presentation, there was no difference in the primary outcome among the group testing their AF triggers and controls.

Participants in the trigger testing group reported 40% fewer AF events in the subsequent 4 weeks compared with the monitoring-only group after receiving a communication from the researchers on the likelihood of their selected trigger causing an AF event (adjusted RR = 0.6; 95% CI, 0.43-0.83; P < .0001), according to the presentation.

Gregory M. Marcus

“Randomized assignment to individual trigger testing did not result in overall improved AF-related quality of life,” Gregory M. Marcus, MD, MAS, associate chief of cardiology for research and endowed professor of atrial fibrillation research at the University of California, San Francisco, said during a press conference. “However, those randomized to trigger testing subsequently reported less AF episodes. Maybe the AFEQT is a little more prone to recall bias. On the other hand, the AFEQT may better reflect the broad experience pertinent to AF severity.”

Moreover, alcohol was significantly associated with self-reported AF events compared with no exposure (OR = 2.15; 95% CI, 1.27-3.16).

“After that initial 10-week period, everyone was thanked for their participation and they were given an option to either test another trigger, if they were initially randomized to trigger testing, or if they had initially been randomized to just monitor their AF, they were given an opportunity to test their trigger,” Marcus said during the presentation. “We brought all of those together in a meta-analysis ... and alcohol was the only trigger that came out consistently associated with AF. We didn't find anything in terms of intention-to-treat; this was only per protocol, meaning when people did expose themselves to alcohol, that was associated with a highly statistically significant greater odds of a near-term AF event. Notably, caffeine, which was the most selected trigger for testing, did not reveal any significant relationships with AF.”

Biykem Bozkurt

In a discussion at the press conference, Biykem Bozkurt, MD, PhD, FHFSA, FACC, FAHA, FESC, Mary and Gordon Cain Chair and Professor of Medicine, director of the Winters Center for HF Research and associate director of the Cardiovascular Research Institute at Baylor College of Medicine, the W.A. “Tex” and Deborah Moncrief Jr., Chair and medicine chief at DeBakey VA Medical Center and immediate past president of the Heart Failure Society of America, in discussing the trial, said: “Patients were able to characterize what their triggers were, be it exercise, diet, caffeine and alcohol. Of those, the fascinating result was the validation of the ‘holiday heart,’ meaning alcohol is associated with increased atrial fibrillation risk.

“The others not resulting in a major association with AF risk in the meta-analysis is not surprising because, on an individual level, it may be a trigger for an individual, and if with autoregulation and control, this individual changes their behavior and/or exposure may affect the rate of AF,” Bozkurt said. “The lack of findings regarding quality of life is not that surprising. Quality of life is a measure that is difficult to change, especially with the interventions being very limited. But I think it has to be further followed up with other methodology.”

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