A recent study, phase 1 of the ALLEVIATE-HF trial, has indicated that a strategy of using cardiac monitoring alerts to guide diuretic therapy is safe for hospitalized patients at risk of worsening heart failure (HF). The trial investigated whether interventions based on high-risk alerts from a subcutaneous insertable cardiac monitor (ICM) could be safely implemented to prevent or resolve HF symptoms. The results suggest a promising approach to proactive HF management.
The ALLEVIATE-HF study involved patients equipped with an ICM, where high-risk alerts triggered physician-prescribed, nurse-implemented uptitration of diuretics for 4 days, repeated if high-risk scores persisted, regardless of symptoms, unless safety rule-out conditions were met. According to Rami Kahwash, MD, of the Ohio State University Wexner Medical Center, and collaborators, the intervention appeared to resolve symptoms in 80% of symptomatic cases and prevented HF symptoms in 93% of asymptomatic patients. Only 7% of asymptomatic people at baseline eventually developed symptoms during a follow-up averaging 11.8 months. These findings were published in the Journal of the American Heart Association.
The study reported 13 adverse events related to the intervention in 59 people, with three related to the Reveal LINQ ICM system, including one device extrusion. However, researchers emphasized the safety of the intervention when administered by trained HF nursing staff. Only eight interventions did not complete the 4-day diuretic intensification due to safety concerns like polyuria, muscle cramps, and palpitations, without acute changes in serum electrolytes or renal function. "Most notably, there were no safety concerns when interventions were applied to patients who were asymptomatic at intervention initiation," the authors noted.
Ting-Tse Lin, MD, PhD, and Jyh-Ming Jimmy Juang, MD, PhD, both of National Taiwan University College of Medicine and Hospital in Taipei, commented in an accompanying editorial that the ALLEVIATE approach "addresses a critical gap in current HF management: connecting remote monitoring data with actionable interventions." They added, "As the field progresses, it will be essential to address the integration of these systems into existing healthcare infrastructures and ensure that they are accessible to a diverse patient population."
Study Design and Patient Population
Phase 1 of ALLEVIATE-HF enrolled patients in New York Heart Association class II/III who had experienced a recent HF event between 2020 and 2021. The 59 patients randomized had a mean age of 68.2 years, with 59.3% being men. Just over two-thirds had a left ventricular ejection fraction of at least 50%. Patients initially randomized to observation had a 7-month observation period before all participants entered the intervention arm.
Device and Monitoring Details
The ALLEVIATE-HF group chose ICMs due to their minimally invasive nature and applicability to a broader range of HF patients compared to cardiac implantable electronic devices or direct pulmonary artery hemodynamic sensors. The ICMs provided continuous ECG, tissue impedance, and 3-axis accelerometry, capturing impedance, respiration rate, atrial fibrillation (Afib) burden, heart rate during Afib, heart rate variability, and activity duration. Based on these variables, 33 ICM patients had 146 high-risk scores recorded, with roughly half meeting safety criteria for nurse-led diuretic intervention.
Limitations and Future Directions
Kahwash and colleagues acknowledged the small sample size and lack of a real control arm as limitations. How effective the intervention really is at improving HF outcomes is currently under further assessment in the larger phase 2 of the ALLEVIATE-HF study. The ultimate goal is to reduce the number of hospitalized HF patients who, after discharge, continue to experience symptoms and are readmitted. Phase 2 of the ALLEVIATE-HF study is currently underway to assess the efficacy of this intervention strategy on a broader scale.
