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The New England Journal of Medicine Nov 2019Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is...
BACKGROUND
Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown.
METHODS
Participants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10.
RESULTS
We recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events.
CONCLUSIONS
The probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).
Topics: Adult; Aged; Algorithms; Atrial Fibrillation; Confidentiality; Electrocardiography; Female; Humans; Male; Middle Aged; Mobile Applications; Predictive Value of Tests; Prospective Studies; Telemedicine; Wearable Electronic Devices
PubMed: 31722151
DOI: 10.1056/NEJMoa1901183 -
Biomedicines Dec 2021The patient presenting with stroke often has cardiac-related risk factors which may be involved in the mechanism of the stroke. The diagnostic assessment is predicated... (Review)
Review
The patient presenting with stroke often has cardiac-related risk factors which may be involved in the mechanism of the stroke. The diagnostic assessment is predicated on recognition of this potential relationship. Naturally, an accurate history is of utmost importance in discerning a possible cause and effect relationship. The EKG is obviously an important clue as well as it allows immediate assessment for possible cardiac arrhythmia, such as atrial fibrillation, for possible acute ischemic changes reflective of myocardial ischemia, or there may be indirect factors such as the presence of left ventricular hypertrophy, typically seen with longstanding hypertension, which could be indicative of a hypertensive mechanism for a patient presenting with intracerebral hemorrhage. For all presentations in the emergency room, the vital signs are important. An elevated body temperature in a patient presenting with acute stroke raises concern about possible infective endocarditis. An irregular-irregular pulse is an indicator of atrial fibrillation. A markedly elevated blood pressure is not uncommon in both the acute ischemic and acute hemorrhagic stroke setting. One tends to focus on possible cardioembolic stroke if there is the sudden onset of maximum neurological deficit versus the stepwise progression more characteristic of thrombotic stroke. Because of the more sudden loss of vascular supply with embolic occlusion, seizure or syncope at onset tends to be supportive of this mechanism. Different vascular territory involvement on neuroimaging is also a potential indicator of cardioembolic stroke. Identification of a cardiogenic source of embolus in such a setting certainly elevates this mechanism in the differential. There have been major advances in management of acute cerebrovascular disease in recent decades, such as thrombolytic therapy and endovascular thrombectomy, which have somewhat paralleled the advances made in cardiovascular disease. Unfortunately, the successful limitation of myocardial damage in acute coronary syndrome, with intervention, does not necessarily mirror a similar salutary effect on functional outcome with cerebral infarction. The heart can also affect the brain from a cerebral perfusion standpoint. Transient arrhythmias can result in syncope, while cardiac arrest can result in hypoxic-ischemic encephalopathy. Cardiogenic dementia has been identified as a mechanism of cognitive impairment associated with severe cardiac failure. Structural cardiac abnormalities can also play a role in brain insult, and this can include tumors, such as atrial myxoma, patent foramen ovale, with the potential for paradoxical cerebral embolism, and cardiomyopathies, such as Takotsubo, can be associated with precipitous cardioembolic events.
PubMed: 34944651
DOI: 10.3390/biomedicines9121835 -
Trends in Cardiovascular Medicine Oct 2020Apple launched a novel feature of the Apple Watch (Apple Inc.) series 4 that enables consumers to record a rhythm strip and assist with self-diagnosis of atrial... (Review)
Review
Apple launched a novel feature of the Apple Watch (Apple Inc.) series 4 that enables consumers to record a rhythm strip and assist with self-diagnosis of atrial fibrillation (AF). The watch is paired with an app that provides automatic classification of the rhythm. Ability of the algorithm to identify AF has received Food and Drug Administration clearance. Given increasing use of direct-to-consumer devices, important questions regarding the utilization of such devices and their features in clinical practice arise. It is unclear how the data obtained from these devices can be optimally incorporated in patient care and what it means for patients. Safety and security of using wearables are also of concern. Furthermore, whether data generated from the Electrocardiogram (ECG) feature will be beneficial to public health is to be determined. We discuss possible uses and challenges of Apple's (Apple Inc.) newly launched ECG feature and review an upcoming trial looking at clinical applications and outcomes using this technology. We also review the literature on the Kardia (AliveCor Inc.) mobile and smartwatch ECG technology and briefly discuss Apple Watch irregular heartbeat notifications along with the Apple Heart Study.
Topics: Action Potentials; Atrial Fibrillation; Computers, Handheld; Electrocardiography; Heart Rate; Humans; Mobile Applications; Predictive Value of Tests; Prognosis; Reproducibility of Results; Signal Processing, Computer-Assisted; Telemedicine; Telemetry; Time Factors
PubMed: 31706789
DOI: 10.1016/j.tcm.2019.10.010 -
Annals of Translational Medicine Sep 2019Atrial fibrillation (AF) poses a major health concern in the United States by affecting over 5 million people accounting for at least 15% to 25% of strokes. It can be... (Review)
Review
Atrial fibrillation (AF) poses a major health concern in the United States by affecting over 5 million people accounting for at least 15% to 25% of strokes. It can be asymptomatic or subclinical with its first presentation being stroke in 18%, and AF being only detected at the time of stroke. With evidence of subclinical AF associated with increased risk of ischemic stroke, recent developments indeed point towards wearables, especially smart watches, being quite effective and representing a novel method for screening for silent AF in the general population, and thereby reducing mortality and morbidity associated with it. This manuscript aims to review whether the photoplethysmography (PPG) technology, employed in the wearables to monitor heart rate, is accurate enough to aid in the diagnosis of AF that may remain asymptomatic or paroxysmal. It also explores the option of actually employing this method in the general population, the feasibility of this mode of diagnosis, sensitivity and specificity of this method compared to the conventional electrocardiogram (EKG), and the actual follow up with a practitioner and subsequent treatment of AF, if diagnosed. We conducted a Medline search using various combinations of "smart watch" "atrial fibrillation" "wearables", and "Kardia" to identify pivotal randomized trials published before June 1, 2019, for inclusion in this review. Concurrently, major practice guidelines, trial bibliographies, and pertinent reviews were examined to ensure inclusion of relevant trials. A consensus among the authors was used to choose items for narrative inclusion. The following section reviews data from pivotal trials to determine the effectiveness of smart watch technology in detecting AF in the general population. Trials reviewed evaluated apple watch, Kardia, Samsung wearables in diagnosis of AF. The fact that there is an increase in consumer use of wearables, smart devices, which can serve as health monitoring devices that can be used as a non-invasive, ambulatory assessment of heart rate and rhythm, is definitely novel. Intermittent short EKG recordings repeated over a longer-term period produced significantly better sensitivity for AF detection, with 4 times as many cases diagnosed compared with a single time-point measurement. Since there are limitations and further research into this new field is required, the wearable technology may not serve as the ultimate tool for diagnosis of AF, rather a nidus for the general population to seek medical advice for confirmation on being notified of having an irregular rhythm leading to prevention of morbidity and mortality associated with it.
PubMed: 31660316
DOI: 10.21037/atm.2019.06.79 -
American Heart Journal Jan 2019Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse...
BACKGROUND
Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse irregularity or variability from these data has the potential to identify atrial fibrillation or atrial flutter (AF, collectively). The rapidly expanding consumer base of these devices allows for detection of undiagnosed AF at scale.
METHODS
The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants (NCT03335800). The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc, Cupertino, CA) with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1) characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2) estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants.
CONCLUSIONS
The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The Apple Heart Study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening.
Topics: Algorithms; Atrial Fibrillation; Atrial Flutter; Electrocardiography, Ambulatory; Humans; Mobile Applications; Patient Acceptance of Health Care; Patient Reported Outcome Measures; Prospective Studies; Smartphone; Telemedicine; Time Factors; Wearable Electronic Devices
PubMed: 30392584
DOI: 10.1016/j.ahj.2018.09.002 -
Circulation Nov 2022Morbidity from undiagnosed atrial fibrillation (AF) may be preventable with early detection. Many consumer wearables contain optical photoplethysmography (PPG) sensors...
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.
Topics: Adult; Female; Humans; Middle Aged; Male; Atrial Fibrillation; Prospective Studies; Photoplethysmography; Electrocardiography, Ambulatory; Electrocardiography; Wearable Electronic Devices
PubMed: 36148649
DOI: 10.1161/CIRCULATIONAHA.122.060291 -
Cureus Oct 2022Since the first pacemaker was implanted, nearly 60 years have passed. Since then, pacemaker technology has made major advancements that have increased both its safety... (Review)
Review
Since the first pacemaker was implanted, nearly 60 years have passed. Since then, pacemaker technology has made major advancements that have increased both its safety and effectiveness in treating people with bradyarrhythmias. The repeated stimulation of cells in specialized "pacemaker" regions of the mammalian heart and the transmission of stimulus via the ventricles serve as evidence that the electrical function of the mammalian heart is necessary for a regular mechanical (pump) role. The development of action potentials in individual cardiac cells is linked to myocardial electrical activity and the heart's regular cooperative electrical functioning. A container or pulse initiator that houses the battery and electronics, as well as lines that connect to the myocardium to deliver a depolarizing pulse and detect intrinsic cardiac stimulation, are all parts of a pacemaker. Defibrillators could be used with artificial hearts that have electrical pacemakers integrated into them in order to treat arrhythmia, heart failure, and cardiac arrest. Modern pacemakers have units for supporting patients with other disorders like "heart failure," which happens when the heart does not pump as forcefully as it should. While many pacemakers are effective in treating different types of arrhythmias (irregular heartbeats), they also have units for treating them.
PubMed: 36348845
DOI: 10.7759/cureus.30027