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Prospective Evaluation of Integrated Device Diagnostics for Heart Failure Management: Results of the TRIAGE-HF Study

作者:Sean Virani, Vinod Sharma, Mary Ellen McCann, Jodi Koehler, Bernice Tsang, Shelley Zieroth · 发表于:ESC Heart Failure · 年份:2018 · DOI:10.1002/ehf2.12309 · 被引用次数:70 · 研究领域:Cardiac pacing and defibrillation studies、Heart Failure Treatment and Management、Transplantation: Methods and Outcomes

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 HFR...