Background: Survival and quality-of-life of left ventricular assist device (LVAD) recipients improved significantly because of growing experience and technological advances. However, LVAD-related... Show moreBackground: Survival and quality-of-life of left ventricular assist device (LVAD) recipients improved significantly because of growing experience and technological advances. However, LVAD-related complication rates, including recurrent episodes of congestion, remain high. Early detection of fluid retention to provide a time-window for medical intervention is the pillar in preventing hospitalizations. The multisensory HeartLogic (TM) algorithm accurately detected impending congestion in ambulant heart failure patients. The aim of the current study is to investigate the feasibility of HeartLogic (TM)-driven care in LVAD patients. Methods: Consecutive LVAD destination therapy patients were followed-up according the structured HeartLogic (TM)-based heart failure carepath. An alert triggered a device check-up, and the heart failure team contacted the patient to evaluate for signs and symptoms of impending congestion. An alert was adjudicated as true positive or unexplained. An episode of congestion not preceded by an alert was deemed as a false negative. Results: Data from 7 patients were included: the median age was 67 years [IQR 61-71], 71% were male and 71% had a non-ischemic aetiology. Total follow-up entailed 12 patient-years. All patients experienced at least one alert. In total, 33 alerts were observed. Majority of alerts (70%, n = 23) were driven by congestion and one alerts (15%) were clinically meaningful but not primarily fluid-retention-related (e.g., altered hemodynamic triggered by a pump thrombosis). Of all the alerts, five (15%) were classified as an unexplained alert, and during follow-up, four false negative episodes were documented. Conclusions: HeartLogic (TM)-driven care with continuous monitoring to detect impending fluid retention in LVAD patients was feasible and deserves further prospective validation. Show less
Aim: Early detection of impending fluid retention and timely adjustment of (medical) therapy can prevent heart failure related hospitalizations. The multisensory cardiac implantable electronic... Show moreAim: Early 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 HeartLogic (TM) aims to alert in case of impending fluid retention. The aim of the current analysis is to evaluate the performance of the HeartLogic (TM) 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.Methods: Consecutive adult heart failure patients with a CIED and an activated HeartLogic (TM) 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. Results: Among 107 patients, [82 male, 70 (IQR 60-77) years, left ventricular ejection fraction 37 +/- 11%] 130 HeartLogic (TM) 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 HeartLogic (TM) 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 HeartLogic (TM) 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. Conclusion: The CIED-based HeartLogic (TM) 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. Show less
