Heart failure & cardiomyopathies
Arrhythmia Burden and Clinical Responses Under Continuous Monitoring in Heart Failure: Observations From the ALLEVIATE-HF Trial
Authors' conclusion
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.
Study context
- Population
- Patients with NYHA class II–III heart failure (HF) of any ejection fraction (EF) and a recent HF event, without prior cardiac implantable electronic devices (CIEDs), with an implanted insertable cardiac monitor (ICM)
- Participants
- 711 patients
- Comparison
- ICM-guided congestion management vs usual care
- Primary endpoint
- Arrhythmia occurrence rate by congestion-management strategy
- Follow-up
- 13-month randomized phase
Primary result
As reported in the abstract
Arrhythmia occurrence rate
- Arrhythmia occurrence rate did not differ between study arms
Further findings
| Outcome | HR | P value |
|---|---|---|
| ICM-recorded arrhythmia and subsequent arrhythmia-related interventionsICM-recorded arrhythmia · any arrhythmia-related intervention · time-varying Cox models | 3.81 | P < 0.001 |
| ICM-recorded arrhythmia and subsequent arrhythmia-related interventionsVT/VF · VT/VF-related interventions · time-varying Cox models | 7.04 | P < 0.001 |
| ICM-recorded arrhythmia and subsequent arrhythmia-related interventionsAF · AF-related interventions · time-varying Cox models | 3.28 | P < 0.001 |
| ICM-recorded arrhythmia and subsequent arrhythmia-related interventionsBradyarrhythmia · bradyarrhythmia-related interventions · time-varying Cox models | 7.22 | P < 0.001 |
| ICM-recorded arrhythmia and clinical eventsICM-recorded arrhythmia · all-cause hospitalization | 1.79 | P < 0.001 |
| ICM-recorded arrhythmia and clinical eventsICM-recorded arrhythmia · HF events | 1.69 | P = 0.003 |
Arrhythmia occurrence (overall cohort) · 3 years (atrial fibrillation (AF))
- Overall AF occurrence at 3 years
- 66.6%
- New-onset AF incidence
- 25.4%
- Bradyarrhythmia
- 47.1%
- VT/VF
- 20.1%
Therapeutic interventions
- Therapeutic CIED implantation
- 22.7%
- Ablation
- 26.1%
Arrhythmia by EF
- Bradyarrhythmias more common with EF ≥50%
- VT/VF more frequent with EF <50%
- AF occurrence similar between EF groups
Original publication
Arrhythmia Burden and Clinical Responses Under Continuous Monitoring in Heart Failure: Observations From the ALLEVIATE-HF Trial. J Am Coll Cardiol. Published 27 May 2026. doi:10.
Summarised from the published abstract; every number is checked against it