Remote multiparametric monitoring and management of heart failure patients through cardiac implantable electronic devices

Boriani, Giuseppe; Imberti, Jacopo Francesco; Bonini, Niccolò; Carriere, Cosimo; Mei, Davide; Zecchin, Massimo; Piccinin, Francesca; Vitolo, Marco; Sinagra, Gianfranco

doi:10.1016/j.ejim.2023.04.011

Cited by 12 publications

(3 citation statements)

References 70 publications

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“…With regard to guidelines, it has not been appropriately defined what clinical decisions are indicated in response to specific alarms related to preclinical changes in health status detected by implanted device diagnostics, such as may occur in heart failure [ 49 ]. Indeed, there is a need for more high-quality clinical studies to validate specific clinical pathways in response to the information provided by devices to be implemented in guidance documents for appropriate clinical decision-making in different settings.…”

Section: Resultsmentioning

confidence: 99%

Cardiology in a Digital Age: Opportunities and Challenges for e-Health: A Literature Review

Pegoraro

Bidoli

Mas

et al. 2023

JCM

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To date, mortality rates associated with heart diseases are dangerously increasing, making them the leading cause of death globally. From this point of view, digital technologies can provide health systems with the necessary support to increase prevention and monitoring, and improve care delivery. The present study proposes a review of the literature to understand the state of the art and the outcomes of international experiences. A reference framework is defined to develop reflections to optimize the use of resources and technologies, favoring the development of new organizational models and intervention strategies. Findings highlight the potential significance of e-health and telemedicine in supporting novel solutions and organizational models for cardiac illnesses as a response to the requirements and restrictions of patients and health systems. While privacy concerns and technology-acceptance-related issues arise, new avenues for research and clinical practice emerge, with the need to study ad hoc managerial models according to the type of patient and disease.

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Section: Resultsmentioning

confidence: 99%

Cardiology in a Digital Age: Opportunities and Challenges for e-Health: A Literature Review

Pegoraro

Bidoli

Mas

et al. 2023

JCM

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“… 10 Another ICD monitoring system is based on the combination of multiple heart rate-derived variables (AHRE burden, ventricular rate during AF, night heart rate, heart rate variability, percentage of CRT pacing) and a few other rate-independent variables (thoracic impedance, patient activity, treated ventricular arrhythmias). 8 , 32 The fact that most components of these HF scores are derived from heart rate assessment suggests that they could be less robust in the presence of long-lasting AF. Indeed, the validation study of the first of the two algorithms mentioned above 10 excluded patients with permanent AF, and its commercial diagnostic function is contra-indicated for patients in permanent AF or with no atrial lead implanted.…”

Section: Discussionmentioning

confidence: 99%

Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation

Boriani,

Bertini,

Manzo

et al. 2023

Europace

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Aims The HeartLogic Index combines data from multiple implantable cardioverter defibrillators (ICD) sensors and has been shown to accurately stratify patients at risk of heart failure (HF) events. We evaluated and compared the performance of this algorithm during sinus rhythm and during long-lasting atrial fibrillation (AF). Methods and Results HeartLogic was activated in 568 ICD patients from 26 centers. We found periods of ≥30 consecutive days with an atrial high-rate episode (AHRE)-burden <1 hour/day, and periods with an AHRE-burden ≥20 hours/day. We then identified patients who met both criteria during follow-up (AHRE group, N = 53), to allow pairwise comparison of periods. For control purposes, we identified patients with an AHRE-burden <1 h throughout their follow-up and implemented 2:1 propensity score matching versus the AHRE group (Matched non-AHRE group, N = 106). In the AHRE group, the rate of alerts was 1.2 (95%CI:1.0-1.5)/patient-year during periods with an AHRE-burden <1 hour/day and 2.0 (95%CI:1.5-2.6)/patient-year during periods with an AHRE-burden ≥20 hours/day (p = 0.004). The rate of HF hospitalizations was 0.34 (95%CI:0.15-0.69)/patient-year during IN-alert periods and 0.06 (95%CI:0.02-0.14)/patient-year during OUT-of-alert periods (p < 0.001). The IN/OUT-of-alert state incidence rate ratio of HF hospitalizations was 8.59 (95%CI:1.67-55.31) during periods with an AHRE-burden <1 hour/day and 2.70 (95%CI:1.01-28.33) during periods with an AHRE-burden ≥20 hours/day. In the Matched non-AHRE group, the rate of HF hospitalizations was 0.29 (95%CI:0.12-0.60)/patient-year during IN-alert periods, and 0.04 (95%CI:0.02-0.08)/patient-year during OUT-of-alert periods (p < 0.001). The incidence rate ratio was 7.11 (95%CI:2.19-22.44). Conclusions Patients received more alerts during periods of AF. The ability of the algorithm to identify increased risk of HF events was confirmed during AF, despite a lower IN/OUT-of-alert incidence rate ratio in comparison with non-AF periods and non-AF patients.

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“…Accordingly, worsening HF is frequently detected relatively late in the course. Remote 2 of 10 cardiac monitoring is a promising approach to detect worsening HF at early stage, allowing intervention before congestion becomes symptomatic [3]. The multisensory HeartLogic TM algorithm is incorporated in implantable cardiac defibrillators (ICD) and can accurately detect impending congestion in ambulatory HF patients [4][5][6][7].…”

Section: Introductionmentioning

confidence: 99%

The Potential of the HeartLogicTM Algorithm in Patients with a Left Ventricular Assist Device, an Initial Report

Feijen,

Egorova,

Tops

et al. 2024

JCDD

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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 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 HeartLogicTM algorithm accurately detected impending congestion in ambulant heart failure patients. The aim of the current study is to investigate the feasibility of HeartLogicTM-driven care in LVAD patients. Methods: Consecutive LVAD destination therapy patients were followed-up according the structured HeartLogicTM-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: HeartLogicTM-driven care with continuous monitoring to detect impending fluid retention in LVAD patients was feasible and deserves further prospective validation.

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Remote multiparametric monitoring and management of heart failure patients through cardiac implantable electronic devices

Cited by 12 publications

References 70 publications

Cardiology in a Digital Age: Opportunities and Challenges for e-Health: A Literature Review

Cardiology in a Digital Age: Opportunities and Challenges for e-Health: A Literature Review

Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation

The Potential of the HeartLogicTM Algorithm in Patients with a Left Ventricular Assist Device, an Initial Report

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