Optimal configuration of adhesive ECG patches suitable for long-term monitoring of a vectorcardiogram

Kabir, Muammar; Alday, Erick Andres Perez; Thomas, J. A. C.; Sedaghat, Golriz; Tereshchenko, Larisa G.

doi:10.1016/j.jelectrocard.2016.12.005

Cited by 14 publications

(9 citation statements)

References 35 publications

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“…Additional independent research with BioStamp technology has looked at ambulatory vectorcardiography [30], spasticity [31], and more granular activities of daily living (unpublished data). This is the first report of clinical validation with the new nPoint system.…”

Section: Discussionmentioning

confidence: 99%

A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments

Sen-Gupta¹,

Wright²,

Caccese³

et al. 2019

Digit Biomark

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Background: Increasingly, drug and device clinical trials are tracking activity levels and other quality of life indices as endpoints for therapeutic efficacy. Trials have traditionally required intermittent subject visits to the clinic that are artificial, activity-intensive, and infrequent, making trend and event detection between visits difficult. Thus, there is an unmet need for wearable sensors that produce clinical quality and medical grade physiological data from subjects in the home. The current study was designed to validate the BioStamp nPoint® system (MC10 Inc., Lexington, MA, USA), a new technology designed to meet this need. Objective: To evaluate the accuracy, performance, and ease of use of an end-to-end system called the BioStamp nPoint. The system consists of an investigator portal for design of trials and data review, conformal, low-profile, wearable biosensors that adhere to the skin, a companion technology for wireless data transfer to a proprietary cloud, and algorithms for analyzing physiological, biometric, and contextual data for clinical research. Methods: A prospective, nonrandomized clinical trial was conducted on 30 healthy adult volunteers over the course of two continuous days and nights. Supervised and unsupervised study activities enabled performance validation in clinical and remote (simulated “at home”) environments. System outputs for heart rate (HR), heart rate variability (HRV) (including root mean square of successive differences [RMSSD] and low frequency/high frequency ratio), activity classification during prescribed activities (lying, sitting, standing, walking, stationary biking, and sleep), step count during walking, posture characterization, and sleep metrics including onset/wake times, sleep duration, and respiration rate (RR) during sleep were evaluated. Outputs were compared to FDA-cleared comparator devices for HR, HRV, and RR and to ground truth investigator observations for activity and posture classifications, step count, and sleep events. Results: Thirty participants (77% male, 23% female; mean age 35.9 ± 10.1 years; mean BMI 28.1 ± 3.6) were enrolled in the study. The BioStamp nPoint system accurately measured HR and HRV (correlations: HR = 0.957, HRV RMSSD = 0.965, HRV ratio = 0.861) when compared to Actiheart^TM. The system accurately monitored RR (mean absolute error [MAE] = 1.3 breaths/min) during sleep when compared to a Capnostream35^TM end-tidal CO₂ monitor. When compared with investigator observations, the system correctly classified activities and posture (agreement = 98.7 and 92.9%, respectively), step count (MAE = 14.7, < 3% of actual steps during a 6-min walk), and sleep events (MAE: sleep onset = 6.8 min, wake = 11.5 min, sleep duration = 13.7 min) with high accuracy. Participants indicated “good” to “excellent” usability (average System Usability Scale score of 81.3) and preferred the BioStamp nPoint system over both the Actiheart (86%) and Capnostream (97%) devices. Conclusions: The present study validated the BioSt...

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Section: Discussionmentioning

confidence: 99%

A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments

Sen-Gupta¹,

Wright²,

Caccese³

et al. 2019

Digit Biomark

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“…A comparison was performed with age‐, sex‐, and race‐matched nonathlete controls from two separate studies. Healthy participants of the OHSU ECG patch study (Kabir, Perez‐Alday, Thomas, Sedaghat, & Tereshchenko, ) who were free from cardiovascular disease and its risk factors were included in this analysis as one source of controls. For the second source of controls, we included digital ECGs of the Intercity Digital Electrocardiogram Alliance (IDEAL) study, which was previously described (Couderc, Xiaojuan, Zareba, & Moss, ; Sur, Han, & Tereshchenko, ).…”

Section: Methodsmentioning

confidence: 99%

“…Athletes underwent a 10‐s resting, supine, 12‐lead ECG recorded using a MAC 5,500 HD ECG machine (General Electric Healthcare, Milwaukee, WI, USA). Athlete ECG recordings were performed during the winter ski season at an elevation of 1,800 m. In healthy nonathlete controls, modified (5th intercostal space) Frank XYZ ECGs were recorded at rest, as previously described (Kabir et al, ; Sur et al, ). Digital ECG files (sampling rate 500 Hz; amplitude resolution 1 µV) were exported for VCG analysis.…”

Section: Methodsmentioning

confidence: 99%

Vectorcardiogram in athletes: The Sun Valley Ski Study

Thomas

Alday

Junell

et al. 2018

Noninvasive Electrocardiol

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Background Global electrical heterogeneity (GEH) is associated with sudden cardiac death (SCD) in adults of 45 years and above. However, GEH has not been previously measured in young athletes. The goal of this study was to establish a reference for vectorcardiograpic (VCG) metrics in male and female athletes. Methods Skiers (n = 140; mean age 19.2 ± 3.5 years; 66% male, 94% white; 53% professional athletes) were enrolled in a prospective cohort. Resting 12‐lead ECGs were interpreted per the International ECG criteria. Associations of age, sex, and athletic performance with GEH were studied. Results In age and training level‐adjusted analyses, male sex was associated with a larger T vector [T peak magnitude +186 (95% CI 106–266) µV] and a wider spatial QRS‐T angle [+28.2 (17.3–39.2)°] as compared to women. Spatial QRS‐T angle in the ECG left ventricular hypertrophy (LVH) voltage group (n = 21; 15%) and normal ECG group did not differ (67.7 ± 25.0 vs. 66.8 ± 28.2; p = 0.914), suggesting that ECG LVH voltage in athletes reflects physiological remodeling. In contrast, skiers with right ventricular hypertrophy (RVH) voltage (n = 26, 18.6%) had wider QRS‐T angle (92.7 ± 29.6 vs. 66.8 ± 28.2°; p = 0.001), larger SAI QRST (194.9 ± 30.2 vs. 157.8 ± 42.6 mV × ms; p < 0.0001), but similar peak SVG vector magnitude (1976 ± 548 vs. 1939 ± 395 µV; p = 0.775) as compared to the normal ECG group. Better athletic performance was associated with the narrower QRS‐T angle. Each 10% worsening in an athlete's Federation Internationale de’ Ski downhill ranking percentile was associated with an increase in spatial QRS‐T angle by 2.1 (95% CI 0.3–3.9) degrees (p = 0.013). Conclusion Vectorcardiograpic adds nuances to ECG phenomena in athletes.

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“…Kabir et al utilized the MC10 Biostamp to develop an optimal configuration of the sensors, which would provide the best agreement with the Frank orthogonal ECGs for long-term monitoring of a vectorcardiogram (VCG). 105 A VCG represents the movement of the heart vector in three orthogonal dimensions and provides information complementary to that of a 12-lead ECG. 106 Analysis of VCGs has been demonstrated to help define abnormal electrophysiological substrate in patients with life-threatening ventricular arrhythmias and sudden cardiac death (SCD).…”

Section: Physiological Status Of the Athlete To Optimize On-field Permentioning

confidence: 99%

Wearable sensors for monitoring the internal and external workload of the athlete

et al. 2019

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The convergence of semiconductor technology, physiology, and predictive health analytics from wearable devices has advanced its clinical and translational utility for sports. The detection and subsequent application of metrics pertinent to and indicative of the physical performance, physiological status, biochemical composition, and mental alertness of the athlete has been shown to reduce the risk of injuries and improve performance and has enabled the development of athlete-centered protocols and treatment plans by team physicians and trainers. Our discussions in this review include commercially available devices, as well as those described in scientific literature to provide an understanding of wearable sensors for sports medicine. The primary objective of this paper is to provide a comprehensive review of the applications of wearable technology for assessing the biomechanical and physiological parameters of the athlete. A secondary objective of this paper is to identify collaborative research opportunities among academic research groups, sports medicine health clinics, and sports team performance programs to further the utility of this technology to assist in the return-to-play for athletes across various sporting domains. A companion paper discusses the use of wearables to monitor the biochemical profile and mental acuity of the athlete.

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Optimal configuration of adhesive ECG patches suitable for long-term monitoring of a vectorcardiogram

Cited by 14 publications

References 35 publications

A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments

A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments

Vectorcardiogram in athletes: The Sun Valley Ski Study

Wearable sensors for monitoring the internal and external workload of the athlete

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