People With Unexplained Fainting Finally Get Some Answers With Take-Home Device

The ASPIRED trial, conducted at 45 hospitals across the U.K., sought to determine the impact of extended ECG monitoring in patients experiencing unexplained fainting episodes. Participants, aged 16 or older and with unexplained syncope after a visit to the emergency department (ED), were randomly assigned to either 14-day cardiac monitoring using the BodyGuardian Mini device or standard care.

At one year follow-up, the frequency of reported syncope episodes was found to be similar between the two groups, with a mean of 1.37 episodes in the intervention group compared to 1.58 episodes in the standard care group. However, immediate 14-day cardiac monitoring was associated with significant benefits. The rate of all-cause death was lower in the intervention group (1.5% vs 2.9%), with an odds ratio of 0.50 (95% confidence interval 0.27-0.93).

Additionally, the device was successful in identifying clinically significant cardiac arrhythmias, with a 22% prevalence in the intervention group compared to 9% in the standard care group (odds ratio 2.95, 95% confidence interval 2.28-3.81). This early detection resulted in a more rapid diagnosis, reducing the time to detection from around 55 days to 22 days.

The investigators believe that the observed reduction in one-year mortality may be due to more thorough investigations following arrhythmia detection rather than a direct causal relationship between arrhythmias and mortality. They suggested that the reduction in mortality could be attributed to more comprehensive patient evaluation following the detection of arrhythmias.

The study was open-label, meaning researchers and participants were aware of the intervention group assignments. Limitations included an open-label design and a lower-than-expected rate of recurrent syncope. The ongoing REMOSYNCED study may provide external validation of these findings in a different care setting.