Clinical Impact of the Implantable Loop Recorder in Patients with Isolated Syncope, Bundle Branch Block and Negative Workup: A Randomized Multicentre Prospective Study
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Background Few studies have compared conventional testing with prolonged monitoring using an implantable loop recorder (ILR) following the first syncope episode in patients with bundle branch block (BBB) and negative workup.Objectives To compare two syncope evaluation strategies-primary use of an ILR (Group 1) versus conventional testing (Group 2)-and to estimate the prevalence of significant arrhythmias in the ILR patient subset.Methods From January 2005 to December 2010, 78 patients admitted after one syncope episode were randomized to ILR (n=41) or conventional follow-up (n=37). Mean follow-up was 27 ± 12 months.Results Mean age was 76 ± 8 years and 30 patients were women (38.5%); 18 presented cardiomyopathy (23%) and 12 had a history of atrial fibrillation (15.4%). Mean left ventricular ejection fraction was 56.5 ± 11% and mean His-to-ventricle interval was 55 ± 6ms based on negative electrophysiological study (EPS). Electrocardiogram abnormalities involved: 34 left bundle branch blocks (BBBs); 11 right BBBs; and 33 bifascicular blocks. Overall, 21 patients (27%) developed significant arrhythmic events: ventricular tachycardia (n=1; 1.3%); sudden death (n=2; 2.6%); third-degree atrioventricular (AV) block (n=14; 18%); sick sinus syndrome (n=4; 5.1%). In 19 (24.4%) patients, relevant arrhythmias were detected, with a significant difference between the ILR group (n=15/41; 36.6%) and the conventional follow-up group (n=4/37; 10.8%) (P=0.02). Eighteen patients were implanted with pacemakers; one received an implantable defibrillator. No predictors of AV block were identified in the ILR group.Conclusions In this randomized prospective study, the ILR strategy proved largely superior to conventional follow-up in detecting recurrent events, with a potential impact on therapeutic management. This observation highlights the usefulness of early monitoring in patients with BBB and negative EPS even after the first syncope episode but an empiric pacemaker strategy remains to be validated in this selected population.
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In 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 [174]
The Follow-up and Conclusions sections report that ILR detected more arrhythmic events than conventional follow-up in this randomized trial (15/41 versus 4/37). The paper does not report a meta-analysis of five trials or the claimed 3.7 relative probability with a 95% CI of 2.7–5.0; its Table 3 instead gives an events hazard ratio of 3.4 (95% CI 1.2–9.5). Page numbers were not available in our copy. (LLM, conf=0.89)
Experimental — accuracy not yet measuredIn patients with bundle branch block in whom paroxysmal AV block is likely despite negative complete EPS, an arrhythmia was observed in 41% under ILR observation, being paroxysmal AV block in 70%.
“Patients with bundle branch block (BBB) in whom paroxysmal atrioventricular (AV) block is likely despite negative complete EPS: an arrhythmia was observed in 41% of these patients (being paroxysmal AV block in 70%) under ILR observation, based on pooled data from three studies 174,187,188”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [174]
The Follow-up section (page not provided) reports ILR-documented arrhythmias in 15 of 41 patients (36.6%), including third-degree AV block in 11 of the 15 (about 73%). This supports the general pattern, but the paper does not report the cited pooled estimates of 41% and 70% from three studies. (LLM, conf=0.86)
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 [15]
The 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 [15]
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Experiencia clínica con el uso del monitor cardiaco implantable
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Etiology of syncope in patients with preexisting atrioventricular conduction disorders
Mitro, P., Šimurda, M., Lazúrová, Z., & Jakubová, M. (2020) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.14064 · Cited by 3 · see citing works
Bradycardia risk stratification with implantable loop recorder after unexplained syncope
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Advanced Cardiac Signal Recording
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Electrophysiological study as a predictor of mortality in unexplained syncope
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Management del paziente con cefalea, vertigine e sincope: dalle evidenze alla pratica clinica
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Use of Implantable Monitors for Arrhythmia Detection
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- Authors
- Da Costa, A., Defaye, P., Romeyer-Bouchard, C., Roche, F., Dauphinot, V., Deharo, J.-C., Jacon, P., Lamaison, D., Bathélemy, J.-C., Isaaz, K., & Laurent, G.
- Affiliations
- Université Grenoble Alpes (FR)
- Université Jean Monnet (FR)
- Hôpital Pierre Wertheimer (FR)
- Aix-Marseille Université (FR)
- ORCID
- Venue
- Archives of Cardiovascular Diseases
- Publisher
- Elsevier BV
- Published
- 2013-03
- Volume
- 106
- Issue
- 3
- Pages
- 146-154
- ISSN
- 1875-2128 (ISSN-L)
- 1875-2136
- OpenAlex
- W2038141101
- Cited by
- 63
- References
- 35
- Citations by year
- 2026: 4 · 2025: 2 · 2024: 3 · 2023: 9 · 2022: 8 · 2021: 5 · 2020: 5 · 2019: 5 · 2018: 5 · 2017: 9 · 2016: 7 · 2014: 1
- FWCI
- 2.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (vor, 365 d)
- doi.org/10.15223/policy-017 (stm-asf)
- doi.org/10.15223/policy-037 (stm-asf)
- doi.org/10.15223/policy-012 (stm-asf)
- doi.org/10.15223/policy-029 (stm-asf)
- doi.org/10.15223/policy-004 (stm-asf)
- Locations
- Archives of cardiovascular diseases (publishedVersion)
- PubMed (publishedVersion)
- 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
- implantable loop recorder, syncope, bundle branch block, prolonged cardiac monitoring, complete heart block, sick sinus syndrome, sudden cardiac death, ventricular tachycardia, arrhythmia detection, pacemaker implantation, implantable cardioverter-defibrillator, elderly patients, cardiomyopathy, atrial fibrillation
- MeSH terms
- Aged, Aged, 80 and over, Bundle-Branch Block, Cardiac Pacing, Artificial, Electric Countershock, Equipment Design, Female, France, Heart Conduction System, Humans, Male, Pacemaker, Artificial, Predictive Value of Tests, Prognosis, Prospective Studies, Recurrence, Syncope, Time Factors, Electrocardiography, Ambulatory, Prevalence, Proportional Hazards Models, Defibrillators, Implantable, Electrophysiologic Techniques, Cardiac, Kaplan-Meier Estimate
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