Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study.

BACKGROUND: Morbidity from undiagnosed atrial fibrillation (AF) may be preventable with early detection. Many consumer wearables contain optical photoplethysmography (PPG) sensors to measure pulse rate. PPG-based software algorithms that detect irregular heart rhythms may identify undiagnosed AF in large populations using wearables, but minimizing false-positive detections is essential. METHODS: We performed a prospective remote clinical trial to examine a novel PPG-based algorithm for detecting undiagnosed AF from a range of wrist-worn devices. Adults aged ≥22 years in the United States without AF, using compatible wearable Fitbit devices and Android or iOS smartphones, were included. PPG data were analyzed using a novel algorithm that examines overlapping 5-minute pulse windows (tachograms). Eligible participants with an irregular heart rhythm detection (IHRD), defined as 11 consecutive irregular tachograms, were invited to schedule a telehealth visit and were mailed a 1-week ambulatory ECG patch monitor. The primary outcome was the positive predictive value of the first IHRD during ECG patch monitoring for concurrent AF. RESULTS: A total of 455 699 participants enrolled (median age 47 years, 71% female, 73% White) between May 6 and October 1, 2020. IHRDs occurred for 4728 (1%) participants, and 2070 (4%) participants aged ≥65 years during a median of 122 (interquartile range, 110-134) days at risk for an IHRD. Among 1057 participants with an IHRD notification and subsequent analyzable ECG patch monitor, AF was present in 340 (32.2%). Of the 225 participants with another IHRD during ECG patch monitoring, 221 had concurrent AF on the ECG and 4 did not, resulting in an IHRD positive predictive value of 98.2% (95% CI, 95.5%-99.5%). For participants aged ≥65 years, the IHRD positive predictive value was 97.0% (95% CI, 91.4%-99.4%). CONCLUSIONS: A novel PPG software algorithm for wearable Fitbit devices exhibited a high positive predictive value for concurrent AF and identified participants likely to have AF on subsequent ECG patch monitoring. Wearable devices may facilitate identifying individuals with undiagnosed AF. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04380415.

Rationale and design of a large population study to validate software for the assessment of atrial fibrillation from data acquired by a consumer tracker or smartwatch: The Fitbit heart study.

BACKGROUND: Early detection of atrial fibrillation or flutter (AF) may enable prevention of downstream morbidity. Consumer wrist-worn wearable technology is capable of detecting AF by identifying irregular pulse waveforms using photoplethysmography (PPG). The validity of PPG-based software algorithms for AF detection requires prospective assessment. METHODS: The Fitbit Heart Study (NCT04380415) is a single-arm remote clinical trial examining the validity of a novel PPG-based software algorithm for detecting AF. The proprietary Fitbit algorithm examines pulse waveform intervals during analyzable periods in which participants are sufficiently stationary. Fitbit consumers with compatible wrist-worn trackers or smartwatches were invited to participate. Enrollment began May 6, 2020 and as of October 1, 2020, 455,699 participants enrolled. Participants in whom an irregular heart rhythm was detected were invited to attend a telehealth visit and eligible participants were then mailed a one-week single lead electrocardiographic (ECG) patch monitor. The primary study objective is to assess the positive predictive value of an irregular heart rhythm detection for AF during the ECG patch monitor period. Additional objectives will examine the validity of irregular pulse tachograms during subsequent heart rhythm detections, self-reported AF diagnoses and treatments, and relations between irregular heart rhythm detections and AF episode duration and time spent in AF. CONCLUSIONS: The Fitbit Heart Study is a large-scale remote clinical trial comprising a unique software algorithm for detection of AF. The study results will provide critical insights into the use of consumer wearable technology for AF detection, and for characterizing the nature of AF episodes detected using consumer-based PPG technology.

Heart rate variability with photoplethysmography in 8 million individuals: a cross-sectional study.

BACKGROUND: Heart rate variability, or the variation in the time interval between consecutive heart beats, is a non-invasive dynamic metric of the autonomic nervous system and an independent risk factor for cardiovascular death. Consumer wrist-worn tracking devices using photoplethysmography, such as Fitbit, now provide the unique potential of continuously measuring surrogates of sympathetic and parasympathetic nervous system activity through the analysis of interbeat intervals. We aimed to leverage wrist-worn trackers to derive and describe diverse measures of cardiac autonomic function among Fitbit device users. METHODS: In this cross-sectional study, we collected interbeat interval data that are sent to a central database from Fitbit devices during a randomly selected 24 h period. Age, sex, body-mass index, and steps per day in the 90 days preceding the measurement were extracted. Interbeat interval data were cleaned and heart rate variability features were computed. We analysed heart rate variability metrics across the time (measured via the root mean square of successive RR interval differences [RMSSD] and SD of the RR interval [SDRR]), frequency (measured by high-frequency and low-frequency power), and graphical (measured by Poincare plots) domains. We considered 5 min windows for the time and frequency domain metrics and 60 min measurements for graphical domain metrics. Data from participants were analysed to establish the correlation between heart rate variability metrics and age, sex, time of day, and physical activity. We also determined benchmarks for heart rate variability (HRV) metrics among the users. FINDINGS: We included data from 8 203 261 Fitbit users, collected on Sept 1, 2018. HRV metrics decrease with age, and parasympathetic function declines faster than sympathetic function. We observe a strong diurnal variation in the heart rate variability. SDRR, low-frequency power, and Poincare S2 show a significant variation with sex, whereas such a difference is not seen with RMSSD, high-frequency power, and Poincare S1. For males, when measured from 0600 h to 0700 h, the mean low-frequency power decreased by a factor of 66·5% and high-frequency power decreased by a factor of 82·0% from the age of 20 years to 60 years. For females, the equivalent factors were 69·3% and 80·9%, respectively. Comparing low-frequency power between males and females at the ages of 40-41 years, measured from 0600 h to 0700 h, we found excess power in males, with a Cohen's d effect size of 0·33. For high-frequency power, the equivalent effect size was -0·04. Increased daily physical activity, across age and sex, was highly correlated with improvement in diverse measures of heart rate variability in a dose-dependent manner. We provide benchmark tables for RMSSD, SDRR, high and low frequency powers, and Poincare S1 and S2, separately for different ages and sex and computed at two times of the day. INTERPRETATION: Diverse metrics of cardiac autonomic health can be derived from wrist-worn trackers. Empirical distributions of heart rate variability can potentially be used as a framework for individual-level interpretation. Increased physical activity might yield improvement in heart rate variability and requires prospective trials for confirmation. FUNDING: Fitbit.

A wireless modular multi-modal multi-node patch platform for robust biosignal monitoring.

In this paper a wireless modular, multi-modal, multi-node patch platform is described. The platform comprises low-cost semi-disposable patch design aiming at unobtrusive ambulatory monitoring of multiple physiological parameters. Owing to its modular design it can be interfaced with various low-power RF communication and data storage technologies, while the data fusion of multi-modal and multi-node features facilitates measurement of several biosignals from multiple on-body locations for robust feature extraction. Preliminary results of the patch platform are presented which illustrate the capability to extract respiration rate from three different independent metrics, which combined together can give a more robust estimate of the actual respiratory rate.

Prognosis-a wearable health-monitoring system for people at risk: methodology and modeling.

Wearable health-monitoring systems (WHMSs) represent the new generation of healthcare by providing real-time unobtrusive monitoring of patients' physiological parameters through the deployment of several on-body and even intrabody biosensors. Although several technological issues regarding WHMS still need to be resolved in order to become more applicable in real-life scenarios, it is expected that continuous ambulatory monitoring of vital signs will enable proactive personal health management and better treatment of patients suffering from chronic diseases, of the elderly population, and of emergency situations. In this paper, we present a physiological data fusion model for multisensor WHMS called Prognosis. The proposed methodology is based on a fuzzy regular language for the generation of the prognoses of the health conditions of the patient, whereby the current state of the corresponding fuzzy finite-state machine signifies the current estimated health state and context of the patient. The operation of the proposed scheme is explained via detailed examples in hypothetical scenarios. Finally, a stochastic Petri net model of the human-device interaction is presented, which illustrates how additional health status feedback can be obtained from the WHMS' user.

SPN-model based simulation of a wearable health monitoring system.

The deployment of Wearable Health Monitoring Systems (WHMS) can potentially enable ubiquitous and continuous monitoring of a patient's physiological parameters. Moreover by incorporating multiple biosensors in such a system a comprehensive estimation of the user's health condition can possibly be derived. In this paper we present a Stochastic Petri Net (SPN) model of a multi-sensor WHMS along with a corresponding simulation framework implemented in Java. The proposed model is built on top of a previously published multisensor data fusion strategy, which has been expanded in this work to take into account synchronization issues and temporal dependencies between the measured bio-signals.

A survey on wearable biosensor systems for health monitoring.

Wearable biosensor systems for health monitoring are an emerging trend and are expected to enable proactive personal health management and better treatment of various medical conditions. These systems, comprising various types of small physiological sensors, transmission modules and processing capabilities, promise to change the future of health care, by providing low-cost wearable unobtrusive solutions for continuous all-day and any-place health, mental and activity status monitoring. This paper presents a comprehensive survey on the research and development done so far on wearable biosensor systems for health-monitoring, by comparing a variety of current system implementations and approaches and identifying their technological shortcomings. A set of significant features, that best describe the functionality and the characteristics of wearable biosensor systems, has been selected to derive a thorough study. The aim of this survey is not to criticize, but to serve as a reference for current achievements and their maturity level and to provide direction for future research improvements.