title: Early use of an implantable loop recorder in syncope evaluation: a randomized study in the context of the French healthcare system (FRESH study).
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Medicine and Pharmacy, Târgu Mures, Romania.
authors.forename: Cristian
authors.initials: C
authors.lastname: Podoleanu
authors.affiliation: CHU Nord, Saint-Étienne, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: DaCosta
authors.affiliation: CHU La Tronche, Grenoble, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Defaye
authors.affiliation: Centre hospitalier Aix-en-Provence, Aix-en-Provence, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Taieb
authors.affiliation: Centre hospitalier Albi, Albi, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Galley
authors.affiliation: Centre hospitalier La Rochelle, La Rochelle, France.
authors.forename: Paul
authors.initials: P
authors.lastname: Bru
authors.affiliation: CHU Rangueil, Toulouse, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Maury
authors.affiliation: CHU Pontchaillou, Rennes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Mabo
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Serge
authors.initials: S
authors.lastname: Boveda
authors.affiliation: HIA Sainte-Anne, Toulon, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Cellarier
authors.affiliation: CHU Charles-Nicolle, Rouen, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Anselme
authors.affiliation: CHRU de Lille, Lille, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Kouakam
authors.affiliation: Centre hospitalier Pau, Pau, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Delarche
authors.affiliation: Cardiologie 9(e) étage, CHU La Timone, 263, rue Saint-Pierre, 13385 Marseille cedex 5, France. Electronic address: jean-claude.deharo@ap-hm.fr.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Deharo
mesh_terms: D000368:Aged; D003362:Cost-Benefit Analysis; D017147:Defibrillators, Implantable; D003695:Delivery of Health Care / Q000191:economics / Q000379:methods*; D042241:Early Diagnosis; D015716:Electrocardiography, Ambulatory; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D013575:Syncope / Q000175:diagnosis / Q000191:economics / Q000628:therapy*; D013997:Time Factors
keywords: Cost; Coût; Enregisteur électrocardiographique implantable; Implantable loop recorder; Syncope