Performance of a HeartLogicTM Based Care Path in the Management of a Real-World Chronic Heart Failure Population

Abstract

AimEarly detection of impending fluid retention and timely adjustment of (medical) therapy can prevent heart failure related hospitalizations. The multisensory cardiac implantable electronic device (CIED) based algorithm HeartLogicTM aims to alert in case of impending fluid retention. The aim of the current analysis is to evaluate the performance of the HeartLogicTM guided heart failure care path in a real-world heart failure population and to investigate whether the height of the index and the duration of the alert state are indicative of the degree of fluid retention.MethodsConsecutive adult heart failure patients with a CIED and an activated HeartLogicTM algorithm were eligible for inclusion. Patients were followed up according to the hospital's heart failure care path. The device technician reviewed alerts for a technical CIED checkup. Afterwards, the heart failure nurse contacted the patient to identify impending fluid retention. An alert was either true positive or false positive. Without an alert a patient was true negative or false negative.ResultsAmong 107 patients, [82 male, 70 (IQR 60–77) years, left ventricular ejection fraction 37 ± 11%] 130 HeartLogicTM alerts were available for analysis. Median follow up was 14 months [IQR 8–23]. The sensitivity to detect impending fluid retention was 79%, the specificity 88%. The positive predictive was value 71% and the negative predictive value 91%. The unexplained alert rate was 0.23 alerts/patient year and the false negative rate 0.17 alerts/patient year. True positive alerts [42 days (IQR 28–63)] lasted longer than false positive alerts [28 days (IQR 21–44)], p = 0.02. The maximal HeartLogicTM index was higher in true positive alerts [26 (IQR 21–34)] compared to false positive alerts [19 (IQR 17–24)], p < 0.01. Patients with higher HeartLogicTM indexes required more intense treatment (index height in outpatient setting 25 [IQR 20–32], day clinic treatment 28 [IQR 24–36] and hospitalized patients 45 [IQR 35–58], respectively), p < 0.01.ConclusionThe CIED-based HeartLogicTM algorithm facilitates early detection of impending fluid retention and thereby enables clinical action to prevent this at early stage. The current analysis illustrates that higher and persistent alerts are indicative for true positive alerts and higher index values are indicative for more severe fluid retention.

Reduction in long-term mortality using remote device monitoring in a large real-world population of patients with implantable defibrillators

“…These findings may have implications for the strategies for patient enrolment in RM programs, where current RM systems are mainly targeted at early detection of heart failure exacerbation. 22 , 23 Prospective trials including patients regardless of ICD indications are required to confirm these findings. Moreover, the IN-TIME trial demonstrated heart failure patients with a history of atrial fibrillation (AF) to be more likely to benefit from RM than were patients without a history of AF.…”

The Effects of a Therapeutic Strategy Guided by Lung Ultrasound on 6-Month Outcomes in Patients with Heart Failure: Results from the EPICC Randomized Controlled Trial

“…In this sense, in addition to the use of LUS, pro-BNP and clinical evaluation, a multisensory cardiac implantable electronic device (CIED)-based algorithm, HeartLogicTM, was created to alert in case of impending fluid retention. Felten et al demonstrated through this method that higher and persistent alerts are indicative for true positive alerts and higher index values are indicative for more severe fluid retention [ 33 ].…”

Clinical Pathways Guided by Remotely Monitoring Cardiac Device Data: The Future of Device Heart Failure Management?

“…69 Feijen et al reported on the integration of the HeartLogic with an HF care pathway using telephone-based clinical assessments (107 participants, 136 alerts over a median 14-month study period). 6 Alerts were true positives in 71% of cases, with a sensitivity and specificity of 0.79 (95% CI [0.68-0.86]) and 0.88 (95% CI [0.08-0.15]), respectively. 6 The MANAGE-HF randomised trial comparing HeartLogic 'on' versus 'off' is ongoing and due to complete in 2025 (NCT03237858).…”

“…6 Alerts were true positives in 71% of cases, with a sensitivity and specificity of 0.79 (95% CI [0.68-0.86]) and 0.88 (95% CI [0.08-0.15]), respectively. 6 The MANAGE-HF randomised trial comparing HeartLogic 'on' versus 'off' is ongoing and due to complete in 2025 (NCT03237858).…”

“…[2][3][4][5] However, recent studies have produced promising results that, alongside radical changes to the delivery of care during the COVID-19 pandemic, have reignited interest in RM platforms. 5,6 There has also been an observed shift in focus towards the applied utility of device diagnostics to augment clinical pathways rather than standalone diagnostic tools. 7 This narrative review focuses on cardiac device HF RM tools currently available in the UK, provides an overview of the current research evidence and discusses the ways in which these RM tools have been integrated into clinical pathways to improve the care of device patients with HF.…”