Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor:...

Area of Science:

• Cardiology
• Biomedical Engineering
• Digital Health

Background:

• Insertable cardiac monitors (ICMs) offer valuable diagnostic data for identifying patients at high risk of heart failure (HF) events.
• Effective management of HF requires timely interventions triggered by high-risk alerts from ICMs.

Purpose of the Study:

• To evaluate the safety and efficacy of a protocolized intervention pathway activated by high-risk alerts from ICMs in patients with HF.
• To assess the impact of personalized, data-driven interventions on patient outcomes.

Main Methods:

• The ALLEVIATE-HF Phase 1 study randomized 59 patients with NYHA class II/III HF and recent events.
• A HF risk score incorporating impedance, respiration rate, AF burden, and heart rate variability was calculated.
• A protocolized pathway involved nurse-implemented diuretic uptitration for high-risk alerts, unless safety criteria were unmet.

Main Results:

• 146 high-risk scores were noted in 33 patients, leading to 118 interventions in 75 alerts.
• No serious adverse events occurred; 13 minor adverse events were linked to interventions.
• Symptom resolution was achieved in 80% of interventions for symptomatic patients and 7% of interventions for asymptomatic patients.

Conclusions:

• A personalized medication intervention strategy, guided by ICM-derived HF risk scores, can be safely implemented in HF patients.
• This approach is effective regardless of the patient's symptomatic status at the time of intervention.