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.