Abstract

Abstract Background/introduction Previous studies examining the utility of cardiac implantable electronic devices (CIEDs) to remotely monitor heart failure patients for decompensation have not demonstrated an impact on hard end-points. However, a key limitation of these prior studies (REM-HF and MORE-CARE) has been the failure to stratify patients according to their risk of worsening heart failure (WHF) prior to randomization (usual care vs active monitoring). We examined a different approach, using a single manufacturer’s remote monitoring platform, whereby only patients with CIED-derived data indicating the highest risk of WHF are contacted for assessment. The validated ‘Triage Heart Failure Risk Score’ (Triage-HFRS) is a medical algorithm within Medtronic CIEDs that can risk-stratify patients as low-, medium- or high-risk of WHF in the next 30 days based on integrated monitoring of physiological parameters. Purpose This study is the largest prospective evaluation of the Triage-HFRS, and examines the additional role of contacting those patients with a ‘High-Risk’ Triage-HFRS alert by telephone (Triage-HF Plus pathway). Methods Prospective, real-world evaluation of the Triage-HF Plus pathway undertaken between June 2016 and September 2019. 326 high-risk Triage-HFRS transmissions were contacted for telephone triage assessment. Screening questions were designed to identify episodes of WHF and non-heart failure events. Interventions were at the discretion of the clinical practitioner and in line with guideline-directed practice. An additional 3-month consecutive sample of low and medium Triage-HFRS transmissions (control group) were also contacted for telephone triage assessment (n= 98). Results Successful telephone contact was made following 245 high-risk Triage-HFRS alerts. Following contact, 194 (79.1%) patients reported an acute medical issue: 137 (70.6%) reported symptoms consistent with worsening heart failure (WHF) requiring intervention; and 57 (29.4%) had an alternative acute medical problem. 51 (26.2%) had no apparent reason for the high score. The sensitivity and specificity of CIED-based remote monitoring to identify any HF and non-HF events requiring intervention was 99.5% (97.2-99.9%) and 65.5% (57.3-73.2%) respectively; positive predictive value was 79.2%. The negative predictive value of a non-high risk score to rule out an acute event was 98.9%. Overall accuracy of the pathway to identify an acute issue (HF or non-HF related) was 84.8%. Conclusion The Triage-HF Plus clinical pathway is a potentially useful remote monitoring tool for patients with heart failure. The pathway has high diagnostic accuracy to identify patients with WHF and a wide range of non-HF issues which are just as relevant in a population who often have multiple complex co-morbidities and are known for their high health care utilisation.

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