Qualitative and quantitative evaluation of a new wearable device for ECG and respiratory Holter monitoring

TY - JOUR

T1 - Qualitative and quantitative evaluation of a new wearable device for ECG and respiratory Holter monitoring

AU - Sarmento, A.

AU - Vignati, C.

AU - Paolillo, S.

AU - Lombardi, C.

AU - Scoccia, A.

AU - Nicoli, F.

AU - Mapelli, M.

AU - Leonardi, A.

AU - Ossola, D.

AU - Rigoni, R.

AU - Agostoni, P.

AU - Aliverti, A.

N1 - Cited By :1 Export Date: 1 February 2019 CODEN: IJCDD Correspondence Address: Agostoni, P.; Centro Cardiologico Monzino, IRCCS, Dept. of Clinical Sciences and Community Health, Cardiovascular Section, University of Milano, Milano, Via Parea, Italy; email: piergiuseppe.agostoni@unimi.it Manufacturers: Sensormedics, United States References: Piotrowicz, E., Jasionowska, A., Banaszak-Bednarczyk, M., Gwilkowska, J., Piotrowicz, R., ECG telemonitoring during home-based cardiac rehabilitation in heart failure patients (2012) J. Telemed. Telecare, 18, pp. 193-197; Goudis, C.A., Ketikoglou, D.G., Obstructive sleep and atrial fibrillation: pathophysiological mechanisms and therapeutic implications (2017) Int. J. Cardiol., 230, pp. 293-300; Steinberg, J.S., Varma, N., Cygankiewicz, I., Aziz, P., Balsam, P., Baranchuk, A., 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry (2017) Heart Rhythm., 14; Berry, R.B., Budhiraja, R., Gottlieb, D.J., Gozal, D., Iber, C., Kapur, V.K., Rules for scoring respiratory events in sleep: update of the 2007 AASM manual for the scoring of sleep and associated events. Deliberations of the sleep apnea definitions task force of the American Academy of sleep medicine (2012) J. Clin. Sleep Med., 8, pp. 597-619; Kapur, V.K., Auckley, D.H., Chowdhuri, S., Kuhlmann, D.C., Mehra, R., Ramar, K., Clinical practice guideline for diagnostic testing for adult obstructive sleep apnea: an American Academy of sleep medicine clinical practice guideline (2017) J. Clin. Sleep Med., 13, pp. 479-504; May, A.M., Van Wagoner, D.R., Mehra, R., OSA and cardiac arrhythmogenesis: mechanistic insights (2017) Chest, 151, pp. 225-241; Parati, G., Lombardi, C., Castagna, F., Mattaliano, P., Filardi, P.P., Agostoni, P., Heart failure and sleep disorders (2016) Nat. Rev. Cardiol., 13, pp. 389-403; Parati, G., Lombardi, C., Narkiewicz, K., Sleep apnea: epidemiology, pathophysiology, and relation to cardiovascular risk (2007) Am. J. Phys. Regul. Integr. Comp. Phys., 293, pp. R1671-R1683; Landis, J.R., Koch, G.G., The measurement of observer agreement for categorical data (1977) Biometrics, 33, p. 159e174; Aliverti, A., Wearable technology: role in respiratory health and disease (2017) Breathe, 13

PY - 2018

Y1 - 2018

N2 - Background: Recent advances in wearable technology make continuous cardiorespiratory monitoring possible, with potential applications in assessment of cardiopulmonary patients, healthy subjects and athletes. The aim of the present study was to qualitatively and quantitatively evaluate a new wearable device (Learn Inspire Free Entertain = L.I.F.E.) by embedding in a compression shirt a 12‑lead ECG system and 5 respiratory sensors. Methods: Thirty cardiorespiratory patients and ten healthy subjects were studied for 24 h during their usual life activities. In 8 healthy subjects, simultaneous measurements of the device and of an ergo-spirometer were performed during different levels of ventilation in five different body positions. The quality of ECG signals in terms of measurability of heart rate, P wave, QRS complex and ST segment, was analyzed by four expert cardiologists/respiratory physiologists using an arbitrary 1–5 scale. The sum of the respiratory signals was used to calculate the respiratory rate, inspiratory time and relative changes of tidal volume. These parameters were compared to ergo-spirometer measurements. Results: Median quality value was >3 for heart rate, QRS complex, ST segment and P wave (except in L3, aVL, aVF, V1 and V2 leads). Median quality of respiratory traces was >4 in patients and between 3 and 4 in healthy subjects. The respiratory monitoring of respiratory rate and inspiratory time was accurate in all body positions. Tidal volumes were underestimated due to a high level of ventilation. Conclusions: The L.I.F.E. device provides an accurate continuous monitoring of cardiorespiratory signals during the 24 h both in normal subjects and cardiorespiratory patients. © 2018 Elsevier B.V.

AB - Background: Recent advances in wearable technology make continuous cardiorespiratory monitoring possible, with potential applications in assessment of cardiopulmonary patients, healthy subjects and athletes. The aim of the present study was to qualitatively and quantitatively evaluate a new wearable device (Learn Inspire Free Entertain = L.I.F.E.) by embedding in a compression shirt a 12‑lead ECG system and 5 respiratory sensors. Methods: Thirty cardiorespiratory patients and ten healthy subjects were studied for 24 h during their usual life activities. In 8 healthy subjects, simultaneous measurements of the device and of an ergo-spirometer were performed during different levels of ventilation in five different body positions. The quality of ECG signals in terms of measurability of heart rate, P wave, QRS complex and ST segment, was analyzed by four expert cardiologists/respiratory physiologists using an arbitrary 1–5 scale. The sum of the respiratory signals was used to calculate the respiratory rate, inspiratory time and relative changes of tidal volume. These parameters were compared to ergo-spirometer measurements. Results: Median quality value was >3 for heart rate, QRS complex, ST segment and P wave (except in L3, aVL, aVF, V1 and V2 leads). Median quality of respiratory traces was >4 in patients and between 3 and 4 in healthy subjects. The respiratory monitoring of respiratory rate and inspiratory time was accurate in all body positions. Tidal volumes were underestimated due to a high level of ventilation. Conclusions: The L.I.F.E. device provides an accurate continuous monitoring of cardiorespiratory signals during the 24 h both in normal subjects and cardiorespiratory patients. © 2018 Elsevier B.V.

KW - Apnea

KW - ECG monitoring

KW - Respiratory monitoring, wearable device

KW - adult

KW - aged

KW - Article

KW - body position

KW - breathing rate

KW - clinical article

KW - clinical evaluation

KW - controlled study

KW - cross-sectional study

KW - daily life activity

KW - electrocardiogram

KW - female

KW - heart rate measurement

KW - Holter monitoring

KW - human

KW - hyperpnea

KW - lung ventilation

KW - male

KW - middle aged

KW - P wave

KW - priority journal

KW - QRS complex

KW - quality control

KW - ST segment

KW - tidal volume

KW - validation study

KW - very elderly

U2 - 10.1016/j.ijcard.2018.06.044

DO - 10.1016/j.ijcard.2018.06.044

M3 - Article

VL - 272

SP - 231

EP - 237

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -