Prospective evaluation of integrated device diagnostics for heart failure management: results of the TRIAGE‐HF study

Aims The primary aim of the TRIAGE‐HF trial was to correlate cardiac implantable electronic device‐generated heart failure risk status (HFRS) with signs, symptoms, and patient behaviours classically associated with worsening heart failure (HF). Methods and results TRIAGE‐HF enrolled 100 subjects with systolic HF implanted with a Medtronic high‐performance device and followed up at three Canadian HF centres. Study follow‐up was up to 8 months. The HFRS assigned each subject's overall risk of HF hospitalization in the next 30 days and also highlighted abnormal device parameters contributing to a patient's risk status at the time of remote data transmission. Subjects with a high HFRS were contacted by telephone to assess symptoms, and compliance with prescribed therapies, nutrition, and exercise. Clinician‐assessed risk and HFRS‐calculated risk were correlated at both study baseline and exit. Twenty‐four high HFRS occurrences were observed among 100 subjects. Device parameters associated with increased risk of HF hospitalization included OptiVol index ( n  = 20), followed by low patient activity ( n  = 18) and elevated night heart rate ( n  = 12). High HFRS was associated with symptoms of worsening HF in 63% of cases ( n  = 15) increasing to 83% of cases ( n  = 20) when non‐compliance with pharmacological therapies and lifestyle was considered. Conclusions TRIAGE‐HF is the first study to provide prospective data on the distribution of abnormal device parameters contributing to high HFRS. High HFRS has good predictive accuracy for patient‐reported signs, symptoms, and behaviours associated with worsening HF status. As such, HFRS may be a useful tool for ambulatory HF monitoring to improve both patient‐centred and health system level outcomes.