Patients with heart failure and reduced ejection fraction (HFrEF) suffer from a relapsing and remitting disease, where early treatment changes may improve outcomes. We assessed the clinical integration and safety of the HeartLogic multi-sensor index and alerts in heart failure care.
The Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) study enrolled 200 patients with HFrEF (< 35%), NYHA class II-III symptoms, implanted with a CRT-D or ICD, who had either a hospitalization for HF within 12 months or unscheduled visit for HF exacerbation within 90 days or an elevated natriuretic peptide concentration (BNP≥150 pg/mL or NT-proBNP≥600 pg/mL). This phase included development of an alert management guide and evaluated changes in medical treatment, natriuretic peptide levels, and safety.
Mean age of participants was 67 years, 68% were men, 81% were white, and 61% had a HF hospitalization in prior 12 months. During follow-up there were 585 alert cases with an average of 1.76 alert cases/pt-yr. HF medications were augmented during 74% of the alert cases. HF treatment augmentation within 2 weeks from an initial alert was associated with more rapid recovery of the HeartLogic Index. Five SAEs (0.015 per pt-year) occurred in relation to alert-prompted medication change. NTproBNP levels decreased from median of 1316 pg/mL at baseline to 743 pg/mL at 12 months (p<0.001).
HeartLogic alert management was safely implemented in HF care and may optimize HF management. This phase supports further evaluation in larger studies.
ClinicalTrials.gov (NCT03237858).
Copyright © 2022. Published by Elsevier Inc.
Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) – Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure.
