UK: The ASPIRED trial has found that immediate 14-day continuous ECG monitoring in patients presenting to emergency departments with acute unexplained syncope increased the likelihood of obtaining an eventual diagnosis compared with standard care. However, extended monitoring did not reduce the subsequent frequency of fainting episodes.

The study, conducted across multiple hospitals in the U.K., used the BodyGuardian Mini, a small, adhesive, waterproof continuous cardiac monitor, highlighting the potential value of prolonged ECG monitoring in improving diagnostic evaluation of unexplained syncope.

The findings, published in The New England Journal of Medicine, were reported by Matthew J. Reed, M.D., of the Usher Institute, School of Population Health Sciences, Acute Care Edinburgh, University of Edinburgh, Edinburgh, and colleagues. The researchers noted that identifying an underlying cardiac arrhythmia can be challenging when patients present with syncope and no clear cause is established during their emergency department assessment.

The open-label, randomized, controlled trial was conducted across 45 hospitals in the United Kingdom. It enrolled adults whose syncope remained unexplained following emergency department evaluation. Participants were randomly assigned to either immediate 14-day ambulatory ECG monitoring or standard care according to the usual practice at participating hospitals.

A total of 2,234 patients were randomized, with 1,123 allocated to the monitoring group and 1,111 to standard care. The mean age was 58.3 years, and 52.1% were male. After excluding patients who did not complete any follow-up, 1,970 participants were included in the primary analysis.

The main outcome was the average number of patient-reported syncope episodes during the first year after enrollment.   

The trial revealed the following findings:

  • At 1 year, the mean number of syncope episodes was 1.37 with immediate ECG monitoring versus 1.58 with standard care.
  • Immediate 14-day ECG monitoring did not significantly reduce recurrent syncope, with an incidence rate ratio of 0.89.
  • Despite no significant reduction in fainting episodes, prolonged ECG monitoring improved diagnostic evaluation by providing a longer period to detect intermittent cardiac arrhythmias.
  • Adverse events were more frequently reported with ambulatory ECG monitoring, occurring in 49 patients versus 8 patients receiving standard care; one serious adverse event occurred in each group.

The researchers concluded that 14-day ambulatory ECG monitoring initiated after an unexplained syncope episode did not significantly reduce the number of patient-reported fainting episodes at 1 year compared with standard care. Nevertheless, the findings support its potential role in improving diagnostic assessment, particularly when intermittent arrhythmias are suspected but difficult to identify through conventional evaluation.

Reference:

DOI: 10.1056/NEJMoa2605812

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Article Source : The New England Journal of Medicine

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