Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic? algorithm

AimsHeart failure (HF) is a chronic disease affecting 64 million people worldwide and places a severe burden on society because of its mortality, numerous re-hospitalizations and associated costs. HeartLogic (TM) is an algorithm programmed into implanted devices incorporating several biometric parameters which aims to predict HF episodes. It provides an index which can be monitored remotely, allowing pre-emptive treatment of congestion to prevent acute decompensation. We aim to assess the impact and security of pre-emptive HF management, guided by the HeartLogic (TM) index.Methods and resultsThe HeartLogic (TM) France Cohort Study is an investigator-initiated, prospective, multi-centre, non-randomized study. Three hundred ten patients with a history of HF (left ventricular ejection fraction <= 40%; or at least one episode of clinical HF with elevated NT-proBNP >= 450 ng/L) and implanted with a cardioverter defibrillator enabling HeartLogic (TM) index calculation will be included across 10 French centres. The HeartLogic (TM) index will be monitored remotely for 12 months and in the event of a HeartLogic (TM) index >= 16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. Secondary endpoints are all-cause mortality, cardiovascular death, HF-related death, unscheduled hospitalizations for ventricular or atrial arrhythmia and HeartLogic (TM) index evolution over time. Blood samples will be collected for biobanking, and quality of life will be assessed. Finally, the safety of a HeartLogic (TM)-triggered strategy for initiating or increasing diuretic therapy will be assessed. A blind and independent committee will adjudicate the events.ConclusionsThe HeartLogic (TM) France Cohort Study will provide robust real-world data in a cohort of HF patients managed with the HeartLogic (TM) algorithm allowing pre-emptive treatment of heart failure exacerbations.