For individuals visiting emergency departments for unexplained fainting (syncope), a recent study has shown that extended ECG monitoring can facilitate diagnosis even if the frequency of fainting episodes remains unchanged. This was highlighted in the ASPIRED trial.
Involving numerous hospitals across the U.K., individuals with acute unexplained syncope were divided into two groups: one receiving immediate 14-day cardiac monitoring using the BodyGuardian Mini, a compact, waterproof heart monitor, and another receiving standard care.
The primary outcome revealed that after one year, the average number of fainting episodes reported by patients was similar in both groups (1.37 for the intervention group vs. 1.58 for standard care; incidence rate ratio 0.89, 95% CI 0.68-1.18), as reported by Matthew James Reed, MD, from the Usher Institute at Edinburgh University.
Nonetheless, the study showed that immediate 14-day monitoring was linked to significant benefits: a notable decrease in all-cause mortality (1.5% vs 2.9%; OR 0.50, 95% CI 0.27-0.93) and a better identification rate of clinically significant cardiac arrhythmias (22.0% vs 9.0%; OR 2.95, 95% CI 2.28-3.81).
The ASPIRED trial was presented at the European Society of Cardiology (ESC) Congress in Munich and was also published in the New England Journal of Medicine.
According to Reed, the use of a 14-day ambulatory cardiac patch monitoring at the index visit did not effectively reduce the reported syncope episodes over the year. However, it did enhance the detection of arrhythmias, reducing the time to diagnosis from approximately 55 days to 22 days. Also, more patients received timely and targeted treatments such as pacemakers and antiarrhythmic medications.
Diagnosing an underlying cardiac arrhythmia remains a challenge, especially as about half of the patients presenting with syncope leave the emergency department without a clear cause. The difficulty lies in distinguishing between vasovagal syncope, postural hypotension, and severe cardiac issues like structural heart problems or arrhythmias.
The ASPIRED trial reinforces previous evidence indicating that early cardiac monitoring increases the likelihood of detecting arrhythmias in patients with unexplained syncope.
Dr. Michele Brignole, an ESC session discussant, emphasized that while the ASPIRED trial technically falls under negative outcomes, it highlights two critical findings: a higher detection rate of clinically significant arrhythmias in 22% of cases and a 50% reduction in all-cause mortality.
Despite this, Brignole noted that the causal relationship between arrhythmias and overall mortality remains unclear, suggesting the observed reduction in mortality could result from more comprehensive investigations following arrhythmia detection rather than a direct correlation.
Participants of the ASPIRED trial could receive referrals to a syncope specialist and were ideally seen within six weeks following the initial event. Treatment decisions based on the ambulatory heart monitor’s results were at the discretion of the healthcare provider, with local teams notified promptly if significant arrhythmias were detected.
As an open-label trial involving 45 U.K. hospitals, the study included individuals aged 16 and older with unexplained syncope post-emergency department evaluation, randomizing them 1:1 to receive either 14-day ambulatory ECG monitoring or standard care.
Both groups were instructed to document any fainting events in a diary, and the intervention group was provided with the BodyGuardian Mini monitor as soon as feasible.
Out of 2,234 participants randomized (average age 58.3 years, 52.1% male), the main analysis included 1,970 patients, excluding those lost to follow-up.
The monitoring group recorded 49 adverse events, while the control group noted eight. Most events in the intervention group were minor skin irritations.
There were serious adverse events in both groups: one involved an infection of an implantable loop recorder in the extended monitoring group, and the other a hematoma at a pacemaker wound site in the standard care group. Both events were deemed unrelated to the study’s intervention.
Limitations include the trial’s open-label design and a lower occurrence rate of recurrent syncope than expected.
Ongoing research, such as the REMOSYNCED study, aims to validate these findings in different healthcare settings.
Disclaimer: This content is intended for informational purposes only and does not substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
Fuente: https://www.medpagetoday.com/meetingcoverage/esc/122855
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