The Benefit of a Remotely Monitored Implantable Loop Recorder as a First Line Investigation in Unexplained Syncope: The EaSyAS II Trial
Open accessAbstract
AIMS: This prospective randomized controlled study evaluated the first-line use of a novel remotely monitored implantable loop recorder (ILR) in the initial investigation of unexplained syncope, and compared this to conventional therapy and a dedicated Syncope Clinic (SC). METHODS AND RESULTS: A total of 246 patients (mean age 70.3 years) were randomly allocated to conventional management, SC alone, ILR alone, or SC + ILR. Median follow-up was 20 months (IQR 15-25 months). Time to electrocardiogram (ECG) diagnosis was significantly shorter with ILR alone vs. conventional [hazard ratio (HR) 35.5, P = 0.0004] and with SC vs. conventional (HR 25.6, P = 0.002). Seventy-four per cent of first syncopal events documented in the SC groups occurred during provocative tilt testing. Twenty-two per cent of patients who received an ILR were found to have a bradycardia indication for permanent pacing, compared with 3% of patients who did not. Overall, more investigative tests were undertaken in the conventional group than in any other. Only patients who received an ILR had a significant increase in time to second syncope (P = 0.02), suggesting successful diagnosis and management of treatable causes of syncope. CONCLUSIONS: Implantable loop recorder monitoring achieved a more rapid diagnosis in unexplained syncope than usual care. Conventional management of syncope failed to achieve an ECG diagnosis despite a large number of investigative tests. Syncope Clinic and provocative tilt testing delivered a rapid ECG diagnosis, but did not prevent recurrent syncope. Implantable loop recorders offered rapid diagnosis, increased the likelihood of syncope being reported, demonstrated a high rate of intermittent bradycardia requiring pacing, and reduced recurrent syncope.
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ILR are associated with a shorter time to diagnosis, more frequent treatment initiation, and a positive impact on survival compared to a conventional diagnostic workup.
“with a shorter time to diagnosis, more frequent treatment initiation, and a positive impact on survival compared to a conventional diagnostic workup [13,17,19].”
From Diagnostic Yield and Clinical Implications of Implantable Loop Recorders in Patients with Syncope in Germany: A National Database Analysis (2024) · cites this paper as [17]
The Primary outcome section reports a shorter time to ECG diagnosis with ILR than with conventional management. The Electrocardiogram-directed therapy section reports more pacemaker insertions among ILR recipients (22.4% versus 3.3%), supporting more frequent treatment initiation. The paper reports reduced recurrent syncope, not a positive impact on survival. Page numbers are unavailable in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measuredThe ILR provided a high diagnostic yield in terms of cardiac arrhythmias in patients with syncope, not restricted to arrhythmias directly related to syncope.
“Hence, the ILR provided a high diagnostic yield in terms of cardiac arrhythmias in patients with syncope, not restricted to arrhythmias directly related to syncope [12,13,14,15,17,19,35,36] but including other diagnoses with therapeutic implications such as atrial fibrillation.”
From Diagnostic Yield and Clinical Implications of Implantable Loop Recorders in Patients with Syncope in Germany: A National Database Analysis (2024) · cites this paper as [17]
The Primary outcome section (page unavailable) reports an ECG diagnosis in 50% of ILR recipients, and the Remotely monitored implantable loop recorder section reports a bradycardia pacing indication in 22%. These findings support substantial diagnostic yield in patients with unexplained syncope, but the paper does not establish that the arrhythmias detected were unrelated to syncopal events. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn patients with recurrent syncope of uncertain origin, absence of high-risk criteria and structural heart disease, and in suspected reflex syncope, an asystolic pause was present during syncope in about 50% of patients.
“Similar findings were subsequently observed with ILR use expanded in an early phase of evaluation in patients with recurrent syncope of uncertain origin, in the absence of highrisk criteria and structural heart disease, 176,180-183 and in suspected reflex syncope. 184-186 In particular, an asystolic pause was present during syncope in about 50% of these patients.”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [176]
The Discussion (page unavailable) identifies the trial as an evaluation of ILRs in recurrent unexplained syncope, supporting that part of the citation. The Primary outcome section reports that 50% of ILR recipients achieved an ECG diagnosis, not that 50% had an asystolic pause during syncope. The paper does not establish the claimed absence of structural heart disease for the study population. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn a meta-analysis of five randomized controlled trials, initial implantation of an ILR in the workup provided a 3.7 (95% CI 2.7-5.0) increased relative probability of a diagnosis compared with the conventional strategy.
“The results showed that initial implantation of an ILR in the workup provided a 3.7 [95% confidence interval (CI) 2.7-5.0] increased relative probability of a diagnosis compared with the conventional strategy (see Supplementary Data Table 5 ).”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [176]
The Primary outcome section reports that ILR patients reached an ECG diagnosis sooner than conventionally managed patients. But this paper reports one randomized trial, not a meta-analysis of five trials, and it does not report the claimed relative probability of 3.7 (95% CI 2.7–5.0). (LLM, conf=0.89)
Experimental — accuracy not yet measuredILR are used to confirm the etiology of syncope.
“Next to noninvasive monitoring strategies, implantable loop recorders (ILR) are used to confirm the etiology of syncope [2,12,13,14,15,16,17,18]”
From Diagnostic Yield and Clinical Implications of Implantable Loop Recorders in Patients with Syncope in Germany: A National Database Analysis (2024) · cites this paper as [17]
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Cites
Developed in collaboration with, European Heart Rhythm Association (EHRA), Heart Failure Association (HFA), and Heart Rhythm Society (HRS), societies, E. B. T. F., European Society of Emergency Medicine (EuSEM), European Federation of Internal Medicine (EFIM), European Union Geriatric Medicine Society (EUGMS), American Geriatrics Society (AGS), European Neurological Society (ENS), et al. (2009) · European Heart Journal · doi:10.1093/eurheartj/ehp298 · Cited by 2,040 · see citing works
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“Formally, the ICD-10-GM code R55 includes syncope as well as collapse, which may have led to the inclusion of patients without actual syncope.”
BackgroundMethodIndikationen Zur Loop-Rekorder-Implantation Bei Synkope
Schuchert, A. (2018) · Herzschrittmachertherapie + Elektrophysiologie · doi:10.1007/s00399-018-0571-1 · Cited by 2 · see citing works
- Authors
- Sulke, N., Sugihara, C., Hong, P., Patel, N., & Freemantle, N.
- Affiliations
- Eastbourne District General Hospital (GB)
- University College London (GB)
- Corresponding author
- Sulke, Neil
- ORCID
- Freemantle, Nick
- Venue
- Europace
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-10-12
- Volume
- 18
- Issue
- 6
- Pages
- 912-918
- ISSN
- 1099-5129 (ISSN-L)
- 1532-2092
- OpenAlex
- W2237521376
- Cited by
- 95
- References
- 14
- Citations by year
- 2026: 13 · 2025: 6 · 2024: 8 · 2023: 10 · 2022: 6 · 2021: 12 · 2020: 4 · 2019: 7 · 2018: 11 · 2017: 12 · 2016: 6
- FWCI
- 9.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- EP Europace (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Transoma Medical Inc
- Eastbourne Cardiology Research Charity Fund
- Topics
- Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Keywords
- unexplained syncope, implantable loop recorder, remote monitoring, electrocardiographic diagnosis, permanent cardiac pacing, recurrent syncope
- MeSH terms
- Adult, Aged, Aged, 80 and over, Bradycardia, Electrodes, Implanted, Female, United Kingdom, Humans, Male, Middle Aged, Pacemaker, Artificial, Prospective Studies, Recurrence, Syncope, Electrocardiography, Ambulatory, Proportional Hazards Models, Tilt-Table Test
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