Document Type
Article
Publication Title
Journal of the American College of Cardiology
Abstract
BACKGROUND: Arrhythmia burden in ambulatory patients with symptomatic heart failure (HF) without cardiac implantable electronic devices (CIEDs) is not well defined, and it remains uncertain whether device-guided remote congestion management modifies arrhythmia occurrence.
OBJECTIVES: The goal was to assess whether arrhythmia burden differed between randomized congestion-management strategies and characterize the occurrences and associations of insertable cardiac monitor (ICM)-detected arrhythmias with therapeutic actions and clinical events.
METHODS: In ALLEVIATE-HF, patients with NYHA functional class II-III HF with any ejection fraction (EF) and a recent HF event, without prior CIEDs, underwent ICM implantation and were randomized to ICM-guided, physician-directed, nurse-facilitated congestion management or usual care. In both arms, arrhythmia data were accessible to investigators, and arrhythmia-related management was clinician directed. Arrythmia occurrence was estimated using Kaplan-Meier methods. Associations with therapeutic interventions and clinical events were evaluated using time-varying Cox models.
RESULTS: The analysis included 711 patients (mean age 70.5 ± 10.4 years; 45.7% women; mean follow-up 17.3 ± 8.9 months); 67.9% had HF with preserved EF, and 60.2% were NYHA functional class II at baseline. During the 13-month randomized phase, arrhythmia occurrence rate did not differ between the study arms. The 3-year overall occurrence of atrial fibrillation (AF) was 66.6%, with an incidence of new-onset AF of 25.4%. Bradyarrhythmia occurred in 47.1% of patients, and ventricular tachycardia or fibrillation (VT/VF) in 20.1%. ICM-recorded arrhythmia was associated with subsequent increase in arrhythmia-related interventions (HR: 3.81; VT/VF and VT/VF-related interventions, HR: 7.04; AF and AF-related interventions, HR: 3.28; bradyarrhythmia and bradyarrhythmia-related interventions, HR: 7.22; all P < 0.001). ICM-recorded arrhythmia was associated with increased risk of all-cause hospitalization (HR: 1.79; P < 0.001) and HF events (HR: 1.69; P = 0.003). Therapeutic CIED implantation and ablation occurred in 22.7% and 26.1%, respectively. Bradyarrhythmias were more common in patients with EF ≥50%, whereas VT/VF occurred more frequently in EF < 50%; AF occurrence was similar between EF groups.
CONCLUSIONS: In ambulatory patients with recent symptomatic HF events, arrhythmia burden was not modified by the study protocol-directed, congestion-management strategy. Continuous ICM monitoring revealed a high burden of clinically meaningful arrhythmias that were associated with clinical events and therapeutic interventions. (Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure [ALLEVIATE-HF]; NCT04452149).
First Page
3611
Last Page
3628
DOI
10.1016/j.jacc.2026.03.174
Publication Date
6-30-2026
Recommended Citation
Kahwash R, Butler J, Khan MS, Zhang D, Dukes J, Reddy M, Kaplan RM, Amin A, Kanwar R, Sarkar S, Laager V, Wehking J, Van Dorn B, Gerritse B, Patel N, Laechelt A, Zile MR; ALLEVIATE-HF Investigators. Arrhythmia Burden and Clinical Responses Under Continuous Monitoring in Heart Failure: Observations From the ALLEVIATE-HF Trial. J Am Coll Cardiol. 2026 Jun 30;87(25):3611-3628. doi: 10.1016/j.jacc.2026.03.174. Epub 2026 May 27. PMID: 42201276.