Objectives Diagnosing underlying arrhythmia in ED syncope patients remains problematic. This study investigates diagnostic yield, event prevalence, patient satisfaction and compliance, and influence on resource utilisation of an ambulatory patch monitor in unexplained ED syncope patients.
Methods Prospective pilot study conducted in a single tertiary ED in Scotland between 17 November 2015 and 16 June 2017 with a historical unmatched comparator group. Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days. Patients with an obvious underlying cause were excluded. An unmatched historical group of 603 syncope patients with no obvious diagnosis in ED, recruited to a prior cohort study (2007–2008), were used as a comparator. Primary endpoint was symptomatic significant arrhythmia at 90-day follow-up.
Results During the prospective study period, 86 patients were recruited. 90-day diagnostic yield for symptomatic significant arrhythmia was 10.5% (95% CI 4.0 to 16.9; 9 of 86) versus 2.0% (95% CI 0.9 to 3.1; 12 of 603) in the comparator group. 24 patients (27.9%) had a significant arrhythmia (five serious); 26 patients (30.2%) had serious outcomes (major adverse cardiac event and/or death). Blinded patch report review suggested the patch would significantly reduce requirement for standard outpatient ambulatory ECG monitoring. 56 of 76 returned patches had a diagnostic finding within±45 s of a triggered/diary event (73.7% diagnostic utility; 95% CI 63.7 to 83.6); 34 of 56 (61%) for sinus rhythm or ectopic beats only.
Conclusions Routine, early ambulatory ECG monitoring in ED patients with unexplained syncope is probably warranted. A large-scale trial comparing this approach to standard care with cost-effectiveness and safety analysis is now required.
Trial registration NCT02683174.
- cardiac care, arrythmia
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Contributors MJR, NRG, AJG, CCL and KS were responsible for the conception and design of the study; KS and AM were responsible for acquisition of data; MJR, AM and CJW were involved in data analysis; and all authors were involved in drafting the article and revising it critically for important intellectual content. All authors approve the manuscript.
Funding This study was funded by a minor research award from Chest, Heart and Stroke Scotland (£4950). MJR was supported by an NHS Research Scotland Career Researcher Clinician award. iRhythm Technologies, Inc. provided the Zio XT monitors and ECG analysis service free of charge. CJW was supported in this work by NHS Lothian via the Edinburgh Clinical Trials Unit.
Disclaimer iRhythm Technologies, Inc. and the funder had no involvement in the design, conduct, analysis or reporting of the study.
Competing interests None declared.
Patient consent Not required.
Ethics approval The study was granted ethical approval by the South East Scotland Research Ethical Committee (15/SS/0072).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data are available on request.
Presented at This work was presented at the European Heart Rhythm Association Congress on 18–20 March 2018.