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

Abstract

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. 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). 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. 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. 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.