Early use of an implantable loop recorder in syncope evaluation: A randomized study in the context of the French healthcare system (FRESH study)

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. (C) 2014 Elsevier Masson SAS. All rights reserved.