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Evaluation of an Integrated Device Diagnostics Algorithm to Risk Stratify Heart Failure Patients - Results From the
Ken Okumura1,2, Shingo Sasaki2, Kengo Kusano3
1Division of Cardiology, Saiseikai Kumamoto Hospital.
Insights
Triage-HF effectively risk stratifies Japanese heart failure patients. This diagnostic tool, used with cardiac resynchronization therapy defibrillators, predicts hospitalization risk, aiding in patient management.
Area of Science:
- Cardiology
- Medical Devices
- Health Informatics
Background:
- Integrated device diagnostics like Triage-HF are valuable for heart failure (HF) risk stratification.
- The efficacy of Triage-HF in Japanese patient populations, particularly those with cardiac resynchronization therapy defibrillators (CRT-D), was previously unknown.
Purpose of the Study:
- To evaluate the performance of Triage-HF in risk stratifying Japanese patients with HF.
- To assess Triage-HF's ability to predict HF-related hospitalizations in CRT-D patients.
Main Methods:
- A prospective study enrolled 320 Japanese CRT-D patients receiving HF treatment.
- Patients were followed for up to 48 months, with Triage-HF risk status assessed every 30 days.
- HF-related hospitalizations within the subsequent 30 days were recorded and analyzed.
Main Results:
- Of 279 patients with complete data, 89 HF-related hospitalizations occurred over 5,977 patient-months.
- Triage-HF identified distinct risk levels: Low (0.7%), Medium (1.6%), and High (4.1%) for HF hospitalization.
- Relative risks for Medium and High risk groups compared to Low were 2.18 and 5.78, respectively.
Conclusions:
- Triage-HF demonstrated effectiveness in stratifying Japanese patients based on HF-related hospitalization risk.
- Key diagnostic factors included decreased activity, OptiVol threshold alerts, and elevated nocturnal heart rate.
Background:
Integrated device diagnostics, Triage-HF, is useful in risk stratifying patients with heart failure (HF), but its performance for Japanese patients remains unknown. This is a prospective study of Japanese patients treated with a cardiac resynchronization therapy defibrillator (CRT-D), with a Medtronic OptiVol 2.0 feature.
Methods And Results:
A total of 320 CRT-D patients were enrolled from 2013 to 2017. All received HF treatment in the prior 12 months. Following enrollment, they were followed every 6 months for 48 months (mean, 22 months). Triage-HF-stratified patients at low, medium and high risk statuses at every 30-day period, and HF-related hospitalization occurring for the subsequent 30 days, were evaluated and repeated. The primary endpoint was to assess Triage-HF performance in predicting HF-related hospitalization risk. All device data were available for 279 of 320 patients (NYHA class II or III in 93%; mean left ventricular ejection fraction, 31%). During a total of 5,977 patient-month follow-ups, 89 HF-related hospitalization occurred in 72 patients. The unadjusted event numbers for Low, Medium and High statuses were 19 (0.7%), 42 (1.6%) and 28 (4.1%), respectively. Relative risk of Medium to Low status was 2.18 (95% CI 1.23-3.85) and 5.78 (95% CI 3.34-10.01) for High to Low status. Common contributing factors among the diagnostics included low activity, OptiVol threshold crossing, and elevated night heart rate.
Conclusions:
Triage-HF effectively stratified Japanese patients at risk of HF-related hospitalization.
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