Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study
Abstract
Background: Today, the main challenge for researchers is to develop new technologies which may help to improve the diagnoses of cardiovascular disease (CVD), thereby reducing healthcare costs and improving the quality of life for patients. This study aims to show the utility of biomedical shirt-based electrocardiography (ECG) monitoring of patients with CVD in different clinical situations using the Nuubo® ECG (nECG) system.
Methods: An investigator-initiated, multicenter, prospective observational study was carried out in a cardiology (adult and pediatric) and cardiac rehabilitation wards. ECG monitoring was used with the biomedical shirt in the following four independent groups of patients: 1) 30 patients after pulmonary vein isolation (PVI), 2) 30 cardiac resynchronization therapy (CRT) recipients, 3) 120 patients during cardiac rehabilitation after myocardial infarction, and 4) 40 pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study. Approval for all study groups was obtained from the institutional review board. The biomedical shirt captures the electrocardiographic signal via textile electrodes integrated into a garment. The software allows the visualization and analysis of data such as ECG, heart rate, arrhythmia detecting algorithm and relative position of the body is captured by an electronic device.
Discussion: The major advantages of the nECG system are continuous ECG monitoring during daily activities, high quality of ECG recordings, as well as assurance of a proper adherence due to adequate comfort while wearing the shirt. There are only a few studies that have examined wearable systems, especially in pediatric populations.
Trial registration: This study is registered in ClinicalTrials.gov: Identifier NCT03068169. (Cardiol J 2018; 25, 1: 52–59)
Keywords: remote electrocardiographyatrial fibrillationcardiac rehabilitationcardiac resynchronization therapyelectrophysiological studymyocardial infarctionmobile healthpulmonary veins isolationsupraventricular tachycardiatelehealthtelemedicine
References
- Gopalsamy C, Park S, Rajamanickam R, et al. The Wearable Motherboard?: The first generation of adaptive and responsive textile structures (ARTS) for medical applications. Virtual Reality. 1999; 4(3): 152–168.
- Despang HG, Netz S, Heinig A, et al. Wireless long-term ECG integrated into clothing. Biomed Tech (Berl). 2008; 53(6): 270–278.
- Perez de Isla L, Lennie V, Quezada M, et al. New generation dynamic, wireless and remote cardiac monitorization platform: a feasibility study. Int J Cardiol. 2011; 153(1): 83–85.
- Curone D, Tognetti A, Secco EL, et al. Heart rate and accelerometer data fusion for activity assessment of rescuers during emergency interventions. IEEE Trans Inf Technol Biomed. 2010; 14(3): 702–710.
- Kwon S, Kim J, Kang S, et al. CardioGuard: a brassiere-based reliable ECG monitoring sensor system for supporting daily smartphone healthcare applications. Telemed J E Health. 2014; 20(12): 1093–1102.
- Bravo-Escobar R, González-Represas A, Gómez-González AM, et al. Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: A randomised, controlled clinical trial. BMC Cardiovasc Disord. 2017; 17(1): 66.
- Chan AW, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 346: e7586.
- Kirchhof P, Benussi S, Kotecha D, et al. Wytyczne ESC dotyczące leczenia migotania przedsionków w 2016 roku, opracowane we współpracy z EACTS. Kardiol Pol. 2016; 74(12): 1359–1469.
- Lodziński P, Kiliszek M, Koźluk E, et al. Does a blanking period after pulmonary vein isolation impact long-term results? Results after 55 months of follow-up. Cardiol J. 2014; 21(4): 384–391.
- Willems S, Khairy P, Andrade JG, et al. Redefining the Blanking Period After Catheter Ablation for Paroxysmal Atrial Fibrillation: Insights From the ADVICE (Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination) Trial. Circ Arrhythm Electrophysiol. 2016; 9(8).
- Andrade JG, Khairy P, Verma A, et al. Early recurrence of atrial tachyarrhythmias following radiofrequency catheter ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2012; 35(1): 106–116.
- McAlister FA, Ezekowitz J, Hooton N, et al. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007; 297(22): 2502–2514.
- Bax J, Bleeker G, Marwick T, et al. Left ventricular dyssynchrony predicts response and prognosis after cardiac resynchronization therapy. J Am Coll Cardiol. 2004; 44(9): 1834–1840.
- Prinzen FW, Vernooy K, Auricchio A. Cardiac Resynchronization Therapy: State-of-the-Art of Current Applications, Guidelines, Ongoing Trials, and Areas of Controversy. Circulation. 2013; 128(22): 2407–2418.
- Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013; 34(29): 2281–2329.
- Lavie CJ, Thomas RJ, Squires RW, et al. Exercise training and cardiac rehabilitation in primary and secondary prevention of coronary heart disease. Mayo Clin Proc. 2009; 84(4): 373–383.
- Piepoli MF, Hoes AW, Agewall S, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016; 37(29): 2315–2381.
- Dylewicz P, Jegier A, Piotrowicz R, et al. Stanowisko Komisji ds. Opracowania Standardów Rehabilitacji Kardiologicznej PTK: Kompleksowa Rehabilitacja Kardiologiczna. Folia Cardiol. 2004.
- Bravata DM, Smith-Spangler C, Sundaram V, et al. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007; 298(19): 2296–2304.
- Pal S, Cheng C, Ho S. The effect of two different health messages on physical activity levels and health in sedentary overweight, middle-aged women. BMC Public Health. 2011; 11: 204.
- Ferdman DJ, Liberman L, Silver ES. A Smartphone Application to Diagnose the Mechanism of Pediatric Supraventricular Tachycardia. Pediatr Cardiol. 2015; 36(7): 1452–1457.
- Jaeggi ET, Gilljam T, Bauersfeld U, et al. Electrocardiographic differentiation of typical atrioventricular node reentrant tachycardia from atrioventricular reciprocating tachycardia mediated by concealed accessory pathway in children. Am J Cardiol. 2003; 91(9): 1084–1089.
- Deutsch K, Stec S, Kukla P, et al. Validation of Standard and New Criteria for the Differential Diagnosis of Narrow QRS Tachycardia in Children and Adolescents. Medicine (Baltimore). 2015; 94(51): e2310.
