Implantable Cardioverter Defibrillator Multisensor Monitoring during Home Confinement Caused by the COVID-19 Pandemic

Ziacchi, Matteo; Calò, Leonardo; D’Onofrio, Antonio; Manzo, Michele; Russo, Antonio Dello; Santini, Luca; Giubilato, Giovanna; Carriere, Cosimo; Santobuono, Vincenzo Ezio; Savarese, Gianluca; Greca, Carmelo La; Arena, Giuseppe; Talarico, Antonello; Pisanó, Ennio; Giammaria, Massimo; Pangallo, Antonio; Campari, Monica; Valsecchi, Sergio; Diemberger, Igor

doi:10.3390/biology11010120

Cited by 5 publications

(5 citation statements)

References 30 publications

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“…This is substantiated by the current low false negative event rate (0.17 per patient year) which is congruent with the previously reported false negative rate of 0.03 per patient year by Calò et al (10). The high negative predictive value and low false negative event rate make the HeartLogic TM algorithm very practical for clinical implementation, especially during the COVID-19 pandemic (21,22). In patients who are not in alert status, the outpatient visits may be converted to digital consults and/or lowered in frequency which is less burdensome for patients while they can rely on the fact that they are continuously monitored.…”

Section: Discussionsupporting

confidence: 89%

“…True positive alerts [42 days ] 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][27][28][29][30][31][32][33][34]] compared to false positive alerts [19][20][21][22][23][24]], p < 0.01. Patients with higher HeartLogic TM indexes required more intense treatment (index height in outpatient setting 25 , day clinic treatment 28 and hospitalized patients 45 , respectively), p < 0.01.…”

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confidence: 99%

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

Feijen

Egorova

Treskes

et al. 2022

Front. Cardiovasc. Med.

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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.

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Section: Discussionsupporting

confidence: 89%

mentioning

confidence: 99%

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

Feijen

Egorova

Treskes

et al. 2022

Front. Cardiovasc. Med.

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“…Ziacchi and colleagues reported a higher rate of alerts, suggesting the worsening of heart failure incidence. The weekly rate of alerts was significantly higher during the lockdown (1.56 alerts/week/100 pts) and after the lockdown (1.37 alerts/week/100 pts) compared to the pre-lockdown period (0.91 alerts/week/100 pts) [25]. In contrast, we found that in-office follow-up visits significantly decreased during the pandemic due to the enactment of the lockdown (p = 0.0077).…”

Section: Discussionmentioning

confidence: 82%

Remote Management of Patients with Cardiac Implantable Electronic Devices during the COVID-19 Pandemic

Nagy,

Pál-Jakab,

Kiss

et al. 2023

JCDD

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Remote monitoring (RM) is the newest function of cardiac implantable electronic devices (CIEDs). In our observational retrospective analysis, we aimed to assess whether telecardiology could be a safe alternative to routine outpatient examinations during the COVID-19 pandemic. The in- and outpatient visits, the number of acute cardiac decompensation episodes, the RM data from CIEDs, and general condition were examined via questionnaires (KCCQ, EQ-5D-5L). Regarding the enrolled 85 patients, the number of personal patient appearances was significantly lower in the year following the pandemic outbreak compared to the previous year (1.4 ± 1.4 and 1.9 ± 1.2, p = 0.0077). The number of acute decompensation events was five before and seven during lockdown (p = 0.6). Based on the RM data, there was no significant difference in heart failure (HF) markers (all related p > 0.05); only patient activity increased after restrictions were lifted compared to that before the lockdown (p = 0.03). During restrictions, patients reported increased anxiety and depression compared to their previous state (p < 0.001). There was no subjective change in the perception of HF symptoms (p = 0.7). Based on the subjective perception and CIED data, the quality of life of patients with CIED did not deteriorate during the pandemic, but their anxiety and depression intensified. Telecardiology may be a safe alternative to routine inpatient examination.

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“…One study used self-reported step-count data from each subject's own, non-standardized smart device-based accelerometer [36]. Four Italian studies (individual sample sizes of 24, 180, 184, and 349 subjects) examining pandemic ICD accelerometry data observed reduced activity levels independent of pre-pandemic activity [56][57][58][59]. Our implantable cardiac device patients demonstrated more sedentary time as a result of the pandemic, mirroring the Italian experience, though they were subject to less strict lockdown mandates in the United States.…”

Section: Discussionmentioning

confidence: 99%

Onset of the COVID-19 pandemic reduced active time in patients with implanted cardiac devices

Sommers

Berger

Rubenstein

et al. 2022

Eur Rev Aging Phys Act

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Background Physical inactivity and sedentary behavior are modifiable risk factors for chronic disease and all-cause mortality that may have been negatively impacted by the COVID-19 shutdowns. Methods Accelerometry data was retrospectively collected from 332 permanent pacemaker (PPM) and 244 implantable cardiac defibrillation (ICD) patients for 6 time points: March 15-May 15, 2020 (pandemic period), January 1-March 14, 2020, October 1-December 31, 2019, March 15-May 15, 2019, January 1-March 14, 2019, and October 1-December 31, 2018. Paired t-tests, with Bonferroni correction, were used to compare time periods. Results Activity significantly decreased during the pandemic period compared to one year prior by an average of 0.53 ± 1.18h/day (P < 0.001) for PPM patients and 0.51 ± 1.2h/day (P < 0.001) for ICD patients. Stratification of subjects by active time (< 2 versus ≥ 2h/day) showed patients with < 2h, particularly those with ICDs, had modestly greater activity reductions with the pandemic onset. Logistical regression analyses suggest a trend toward a greater reduction in active time at the onset of the pandemic and an increased risk of hospital or emergency department (ED) admission for PPM patients, but not ICD patients. Conclusion The onset of the pandemic in the United States was associated with a significant drop in PPM and ICD patient active hours that was modestly more pronounced in less active patients and cannot be explained by one year of aging or seasonal variation. If sustained, these populations may experience excess cardiovascular morbidity.

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Implantable Cardioverter Defibrillator Multisensor Monitoring during Home Confinement Caused by the COVID-19 Pandemic

Cited by 5 publications

References 30 publications

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

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

Remote Management of Patients with Cardiac Implantable Electronic Devices during the COVID-19 Pandemic

Onset of the COVID-19 pandemic reduced active time in patients with implanted cardiac devices

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