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

Summary 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 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.