Réducteur de sinus coronaire : revue de littérature et enjeux autour du registre France Reducer

Abstract

Coronary sinus Reducer implantation is a percutaneous technique used to treat patients suffering from refractory angina pectoris. The device narrows the coronary sinus, increases the back pressure in the myocardial venous system and forces redistribution of coronary blood flow from less ischemic subepicardium to the more ischemic subendocardium. Multiple clinical studies had proven its efficacy to alleviate myocardial ischemia and related symptoms, and to improve the quality of life of patients with refractory symptomatic chronic coronary artery disease for whom coronary revascularization is deemed unsuitable. This literature review aims to expose the device design, its mechanisms of action, and the clinical data supporting its use.Since November 2021 Reducer's reimbursement has been granted in France by the national health authority. It is the first device to be approved under a newly established reimbursement approval process. A transitional coverage is provided with opportunities for renewal before applying for full-time reimbursement. To fulfill the requirements of the National Commission for Evaluation of Medical Devices and Health Technologies, the French Society of Cardiology has been creating the France Reducer registry. This clinical registry has been collecting data from patients undergoing coronary sinus Reducer implantation regarding their clinical situation, periprocedural information, and one-year follow-up. It is crucial for the future of this emerging therapeutic option in France. To date, 215 patients from 28 centers have been included between June 2022 and September 2023.