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ESC Heart Fail. 2018 Oct;5(5):809-817. doi: 10.1002/ehf2.12309. Epub 2018 Jun 22.

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

Author information

1
University of British Columbia, 9th Floor-Cardiology, 2775 Laurel Street, Vancouver, BC, V5Z 1M9, Canada.
2
Medtronic Plc., Minneapolis, MN, USA.
3
Southlake Regional Health Centre, Newmarket, ON, Canada.
4
University of Manitoba, Winnipeg, MB, Canada.

Abstract

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.

KEYWORDS:

Heart failure; Implantable device diagnostics; Remote monitoring; Risk scores

PMID:
29934976
PMCID:
PMC6165932
DOI:
10.1002/ehf2.12309
[Indexed for MEDLINE]
Free PMC Article

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