Arrhythmia Burden and Clinical Responses Under Continuous Monitoring in Heart Failure
Rami KahwashJaved ButlerMuhammad Shahzeb KhanDavid ZhangJonathan DukesMadhu ReddyRachel M. KaplanAnish AminRahul KanwarShantanu SarkarVerla LaagerJennifer WehkingBrian Van DornBart GerritseNirav PatelAimee LaecheltMichael R. ZileDevi NairSunit‐Preet ChaudhryRuple GalaniSteven HeatherlySumit VermaStephen MesterAmbrose PanicoJonathan DukesBarry BertoletMatthew GoldsteinBenjamin RheeElie GharibSelma MohammedHector GarciaGabriel SayerCameron LambertRenee SangrigoliMark MetzlSumant LambaPrasad ChalasaniMichael CammarataJames LyonsAmir MalikGregory JacksonDavid NewtonLaura GravelinEddie BrownChike ObiRobert SanchezKent MorrisJohn RommelAnupam BasurayPatrick GregoryJames AmpaduDeepthi MosaliRita JermynLynne HungDavid ZhangCyrus BuhariErich KiehlIra DauberHal SkopickiJohn MignoneGian Carlo GioveAnkit BhatiaFrank McGrewRaul TorresMadhu ReddyRobert LongIsaac RheaDarius SholevarGeorge Sokos
Key result
ICM-guided congestion management fails to reduce arrhythmias vs usual care, though detected arrhythmias increase hospitalizations ~79%.
- n=711
Why the study?
Arrhythmia burden in ambulatory patients with symptomatic HF without CIEDs is not well defined, and whether device-guided remote congestion management modifies arrhythmia occurrence remains uncertain.
Does ICM-guided congestion management reduce arrhythmia burden in ambulatory patients with symptomatic heart failure without prior CIEDs?
Key Points
- Evaluate arrhythmia burden in heart failure patients under different management strategies and its clinical implications.
- Patients with NYHA class II-III heart failure underwent insertable cardiac monitor (ICM) implantation.
- Patients were randomized to either ICM-guided management or usual care.
- Arrhythmia occurrence was estimated using Kaplan-Meier methods, and associations with interventions analyzed using time-varying Cox models.
- During 13 months, arrhythmia occurrence did not differ between management strategies.
- The 3-year incidence of atrial fibrillation was 66.6%, with new-onset AF at 25.4%; bradyarrhythmia occurred in 47.1%, and VT/VF in 20.1%.
- ICM-recorded arrhythmias were linked to increased risk of hospitalization (HR: 1.79) and heart failure events (HR: 1.69), with therapeutic interventions frequently occurring.
Study Design
Type
RCT (n=711)
Structured PICO
Does ICM-guided congestion management reduce arrhythmia burden in ambulatory patients with symptomatic heart failure without prior CIEDs?
P
Population
711 ambulatory patients with NYHA functional class II-III heart failure (any ejection fraction) and a recent HF event, without prior cardiac implantable electronic devices (CIEDs). Mean age 70.5 ± 10.4 years, 45.7% women, 67.9% had HF with preserved EF, and 60.2% were NYHA functional class II at baseline.
I
Intervention
Insertable cardiac monitor (ICM) implantation with ICM-guided, physician-directed, nurse-facilitated congestion management
C
Comparator
Usual care (both arms underwent ICM implantation, arrhythmia data were accessible to investigators, and arrhythmia-related management was clinician directed)
O
Outcome
Difference in arrhythmia burden between randomized congestion-management strategies during the 13-month randomized phase
Continuous ICM monitoring in heart failure patients reveals a high burden of arrhythmias that predict subsequent clinical events and interventions, although an ICM-guided congestion management strategy did not reduce this arrhythmia burden.
Discussion
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
AJACC Journal Scan
“A key lesson from the ALLEVIATE-HF trial is that alerts are not treatment, and signals without a timely response lose their clinical impact. Future studies should stop treating the alert as the intervention and instead define the alert-to-action pathway as the true intervention.”
“These findings may highlight the diagnostic value of continuous rhythm surveillance in HF, while emphasizing the need for further investigations to determine whether arrhythmia detection-guided interventions improve clinical outcomes in chronic HF.”
DMDr. Mark N. Belkin
“ALLEVIATE-HF provides provocative data on the epidemiology, natural history, and burden of arrhythmias in a diverse HF population. Trials are now needed to address how monitoring improves arrhythmia detection over routine clinical care and, more important, which interventions should be used to prevent rather than treat arrhythmia and lead to improved patient outcomes.”
Implication
ICM-guided management failed to reduce arrhythmia burden in HF; challenges routine ICM use while leaving prognostic implications of detected events open for further study.
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).
Cite This Study
Kahwash et al. (2026) conducted an RCT in symptomatic heart failure (n=711). ICM-guided congestion management vs. usual care was evaluated on arrhythmia burden. ICM-guided congestion management did not modify arrhythmia occurrence compared to usual care, but ICM-detected arrhythmias increased the risk of all-cause hospitalization (HR 1.79; P<0.001).