Early Use of an Implantable Loop Recorder in Syncope Evaluation: A Randomized Study in the Context of the French Healthcare System (FRESH Study)
Open accessAbstract
Background The role of implantable loop recorders (ILRs) in the evaluation strategy for recurrent syncope in France is limited by lack of knowledge of the cost.Aim To compare a conventional evaluation strategy for syncope with the early use of an ILR in low-risk patients, in terms of diagnostic yield, cost and impact on quality of life (QoL).Methods National prospective randomized open-label multicenter study of patients with a single syncope (if severe and recent) or at least two syncopes in the past year.Results Seventy-eight patients (32 men) were randomized to the ILR strategy (ILR group, n=39) or the conventional evaluation strategy (CONV group, n=39): mean age 66.2±14.8 years; 4.3±6.4 previous syncopes. After 14 months of follow-up, a certain cause of syncope was established in 18 (46.2%) patients in the ILR group and two (5%) patients in the CONV group (P<0.001). Advanced cardiological tests were performed less frequently in the ILR group than in the CONV group (0.03±0.2 vs. 0.2±0.5 tests per patient; P=0.05). Patients in the ILR group were hospitalized for a non-significantly shorter period than patients in the CONV group (5.7±3.2 vs. 8.0±1.4 days). There was no difference between the two groups in terms of QoL main composite score.Conclusion In patients with unexplained syncope, the early use of an ILR has a superior diagnostic yield compared with the conventional evaluation strategy, with lower healthcare-related costs.
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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 [175]
The Study design and Follow-up sections describe one randomized trial and report more diagnoses with early ILR implantation than with conventional evaluation (46.2% versus 5% after 14 months). The paper does not report a meta-analysis of five trials or the claimed pooled relative probability of 3.7 (95% CI 2.7–5.0). Page numbers are unavailable in our copy. (LLM, conf=0.88)
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 [16]
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References 11 · Cited by 93
Research works printed but not linked: 2
- [1]1. Moya A, Sutton R, Ammirati F, et al. Guidelines for the diag- nosis and management of syncope (version 2009). Eur Heart J 2009;30:2631-71.
- [3]3. Benditt DG, Brignole M. Syncope: is a diagnosis a diagnosis? J Am Coll Cardiol 2003;41:791-4.
- Authors
- Podoleanu, C., DaCosta, A., Defaye, P., Taieb, J., Galley, D., Bru, P., Maury, P., Mabo, P., Boveda, S., Cellarier, G., Anselme, F., Kouakam, C., Delarche, N., & Deharo, J.-C.
- Affiliations
- Universitatea de Medicină, Farmacie, Științe și Tehnologie „George Emil Palade” din Târgu Mureș (RO)
- Centre Hospitalier Universitaire de Saint-Étienne (FR)
- Centre Hospitalier d'Albi (FR)
- Centre Hospitalier de La Rochelle (FR)
- Hôpital Rangueil (FR)
- Hôpital Pontchaillou (FR)
- Hôpital d'Instruction des Armées Sainte-Anne (FR)
- Hôpital Charles-Nicolle (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- Centre Hospitalier De Pau (FR)
- Assistance Publique Hôpitaux de Marseille (FR)
- Corresponding author
- Deharo, Jean-Claude
- ORCID
- Venue
- Archives of Cardiovascular Diseases
- Publisher
- Elsevier BV
- Published
- 2014-10
- Volume
- 107
- Issue
- 10
- Pages
- 546-552
- ISSN
- 1875-2128 (ISSN-L)
- 1875-2136
- OpenAlex
- W2051860688
- Cited by
- 93
- References
- 11
- Citations by year
- 2026: 9 · 2025: 5 · 2024: 7 · 2023: 3 · 2022: 6 · 2021: 11 · 2020: 7 · 2019: 12 · 2018: 10 · 2017: 14 · 2016: 7 · 2015: 1 · 2013: 1
- FWCI
- 7.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Archives of cardiovascular diseases (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Société française de cardiologie (2003/05)
- Topics
- Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
- Life Sciences › Neuroscience › Neurology › Vestibular and auditory disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
- Keywords
- implantable loop recorder, syncope, recurrent syncope, diagnostic yield, health care costs, quality of life, unexplained syncope, cardiovascular risk, hospitalization, cost-effectiveness, diagnostic strategy comparison, low-risk patients, French health system
- MeSH terms
- Aged, Cost-Benefit Analysis, Delivery of Health Care, Female, Follow-Up Studies, France, Humans, Male, Middle Aged, Prospective Studies, Quality of Life, Syncope, Time Factors, Electrocardiography, Ambulatory, Defibrillators, Implantable, Early Diagnosis
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