Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study.

BACKGROUND: The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown. METHODS: Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch irregular rhythm notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naïve" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary end point is time from randomization to clinical diagnosis of AF, with confirmation by health care claims. Key secondary endpoint are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, DOAC medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study. CONCLUSION: The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04276441.

Diverse predictors of early attrition in an elite Marine training school.

Reconnaissance Marine training is deliberately difficult, to assure that graduates have the capabilities required to function successfully in the high-risk military occupational specialty. The majority of training attrition is due to voluntary withdrawal and previous research has identified certain predictive factors such as demographics, mental status, and physical performance. While some characteristics of training attrition have been identified, there is still a lack of understanding related to an individual's profile that is more apt to complete Recon training. Retrospective survey data was analyzed from 3,438 trainees within the Reconnaissance Training Company. Surveys were related to trainees' military recruitment history and other military experience, prior life experience, athletic experience, self-identified personality characteristics and motivations, and reasons for voluntary withdrawal if applicable, as well as physical performance metrics. Various demographic factors, self-reported hobbies, motivations, aquatic experience, and physical performance were associated with success in Recon Marine training courses. Subjects who voluntarily withdrew from training most commonly cited mental stress and aquatic rigor as the reason and less commonly cited reasons were physical and family reasons. These results could potentially increase training success, but more research is needed to understand the relationships between the observed trainee characteristics and success in elite warfighter training.

Player Tracking Technology and Data for Injury Prevention in the National Football League.

ABSTRACT: The recent partnership of NFL's Next Gen Stats with Amazon Web Services has created a buzz among media and fans, yet the full scope and utility of digital biosensors has yet to be determined. We review current uses of Global Positioning System technology and digital biosensors in the NFL and discuss the future role of this technology in injury prevention. A complete literature review was conducted, along with review of the NFL web site and news outlet articles, to obtain a comprehensive assessment of all prior and current uses of biosensor technology in the NFL. Limited data exist on successful injury prevention and return to play, and utilization of this emerging technology has mostly been for fan experience. While ethical and legal challenges exist, the integration of digital biosensor and GPS technology in the NFL has enormous potential and is an invaluable tool in the comprehensive assessment of player health.

Home Monitoring of Cardiac Devices in the Era of COVID-19.

PURPOSE OF REVIEW: Despite the promise of remote patient monitoring (RPM), this technology remained underutilized secondary to a lack of data transparency and systems issues until the COVID-19 pandemic ushered in a new era of telehealth and virtual solutions out of necessity. This review will explore the data supporting the use of RPM via both implantable and wearable devices in the field of cardiology and the role of home monitoring using RPM in the era of COVID-19. RECENT FINDINGS: RPM using implantable cardiac devices is a safe alternative to in-person only visits which leads to enhanced patient satisfaction and improved clinical outcomes. Consumer-grade wearable sensors have drastically expanded RPM capabilities from just the sickest cardiac patients to the entire population aiding in early diagnosis and real-time disease management. Home monitoring enabled by automated alert systems tailored specifically to the needs of the patient by the provider will be the cornerstone of a more continuous, patent-centric healthcare model.

2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry.

Ambulatory ECG (AECG) is very commonly employed in a variety of clinical contexts to detect cardiac arrhythmias and/or arrhythmia patterns which are not readily obtained from the standard ECG. Accurate and timely characterization of arrhythmias is crucial to direct therapies that can have an important impact on diagnosis, prognosis or patient symptom status. The rhythm information derived from the large variety of AECG recording systems can often lead to appropriate and patient-specific medical and interventional management. The details in this document provide background and framework from which to apply AECG techniques in clinical practice, as well as clinical research.

Implantable Cardioverter Defibrillator Programming Characteristics, Shocked Rhythms, and Survival Among Patients Under Thirty Years of Age.

INTRODUCTION: Indications for implantable cardioverter defibrillators (ICDs) in young patients have expanded and differ from those in older adults. We sought to provide descriptive characteristics and data regarding ICD therapy and outcomes among younger and older ICD recipients. METHODS AND RESULTS: Demographics, device type and programming, remotely transmitted data, shock events, and survival were compared among younger (≤30 years) and older (>30 years) cohorts with ICDs from a single manufacturer followed on a remote network. The younger cohort included 904 patients (1.6% of all implants). This group had more females (46% vs. 25%; P < 0.01), single-coil leads (21% vs. 4%; P < 0.01), and single-chamber devices (46% vs. 34%; P < 0.01). Shock incidence was higher (40% younger vs. 32% older at 4 years; P < 0.01) and survival was better over comparable follow-up (88% vs. 72%; P < 0.01). Remote monitoring was associated with improved survival in both groups (93% vs. 86% ≤ 30 years, P < 0.01; 73% vs. 66% > 30 years, P < 0.01). Shock for polymorphic ventricular tachycardia/fibrillation (VT/VF) was more frequent in younger patients (12% vs. 5%; P < 0.01); 39% of all shocks were inappropriate. A 10-fold increased risk of mortality was seen among young patients with shocks for atrial fibrillation/flutter (AF/AFL). CONCLUSIONS: Differences in survival, shock incidence, and prognostic significance of VT/VF and AF/AFL exist between younger and older ICD recipients. These suggest distinct differences in myocardial substrates and diseases that ultimately impact ICD management.

Wireless Smartphone ECG Enables Large-Scale Screening in Diverse Populations.

BACKGROUND: The ubiquitous presence of internet-connected phones and tablets presents a new opportunity for cost-effective and efficient electrocardiogram (ECG) screening and on-demand diagnosis. Wireless, single-lead real-time ECG monitoring supported by iOS and android devices can be obtained quickly and on-demand. ECGs can be immediately downloaded and reviewed using any internet browser. OBJECTIVE: We compared the standard 12-lead ECG to the smartphone ECG in healthy young adults, elite athletes, and cardiology clinic patients. Accuracy for determining baseline ECG intervals and rate and rhythm was assessed. METHODS: In 381 participants, 30-second lead I ECG waveforms were obtained using an iPhone case or iPad. Standard 12-lead ECGs were acquired immediately after the smartphone tracing was obtained. De-identified ECGs were interpreted by automated algorithms and adjudicated by two board-certified electrophysiologists. RESULTS: Both smartphone and standard ECGs detected atrial rate and rhythm, AV block, and QRS delay with equal accuracy. Sensitivities ranged from 72% (QRS delay) to 94% (atrial fibrillation). Specificities were all above 94% for both modalities. CONCLUSION: Smartphone ECG accurately detects baseline intervals, atrial rate, and rhythm and enables screening in diverse populations. Efficient ECG analysis using automated discrimination and an enhanced smartphone application with notification capabilities are features that can be easily incorporated into the acquisition process.

Rationale and Design of the Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study (LAPTOP-HF).

BACKGROUND: Daily measurements of left atrial pressure (LAP) may be useful for guiding adjustments in medical therapy that prevent clinical decompensation in patients with severe heart failure (HF). STUDY DESIGN: LAPTOP-HF is a prospective, multicenter, randomized, controlled clinical trial in ambulatory patients with advanced heart failure in which the safety and clinical effectiveness of a physician-directed patient self-management therapeutic strategy based on LAP measured twice daily by means of an implantable sensor will be compared with a control group receiving optimal medical therapy. The trial will enroll up to 730 patients with New York Heart Association functional class III symptoms and either a hospitalization for HF during the previous 12 months or an elevated B-type natriuretic peptide level, regardless of ejection fraction, at up to 75 investigational centers. Randomization to the treatment group or control group will be at a 1:1 ratio in 3 strata based on the ejection fraction (EF > or ≤35%) and the presence of a de novo CRT device indication. SUMMARY: LAPTOP-HF will provide essential information about the role of implantable LAP monitoring in conjunction with a new HF treatment paradigm across the spectrum of HF patients.

Use of remote monitoring of newly implanted cardioverter-defibrillators: insights from the patient related determinants of ICD remote monitoring (PREDICT RM) study.

BACKGROUND: Current guidelines recommend using remote patient monitoring (RPM) for implantable cardioverter-defibrillators, but the patterns of adoption of this technology have not been described. Successful use of RPM depends on (1) the enrollment of the patient into an RPM system and (2) subsequent activation of RPM by the enrolled patient. We examined RPM enrollment and activation rates and the patient, physician, and institutional determinants of RPM use. METHODS AND RESULTS: Information about the use of RPM-capable devices was obtained from the Boston Scientific Corporation ALTITUDE program and linked to the National Cardiovascular Data Registry ICD Registry. Patients were first categorized as RPM-enrolled and RPM-not enrolled, and the RPM-enrolled patients were further categorized into RPM-active and RPM-inactive groups based on whether they transmitted RPM data. Variables associated with RPM enrollment and activation were identified with the use of multivariable logistic regression. Among 39 158 patients with newly implanted RPM-capable devices, 62% (n=24 113) were RPM-enrolled. Of those enrolled, 76% (n=18 289, or 47% of the entire cohort) activated their device. RPM enrollment was highly variable among institutions. The hospital-specific median odds ratio for RPM enrollment was 3.43, signifying that physician or institutional factors are associated with RPM enrollment. In contrast, the hospital-specific median odds ratio for RPM activation was 1.69. Age, race, health insurance, geographic location, and health-related factors were similarly associated with both RPM enrollment and activation. CONCLUSIONS: RPM technology is used in less than half of eligible patients. Lack of enrollment into RPM systems is the major cause of underutilization, and this primarily relates to the local practice environment.

Performance of an automatic arrhythmia classification algorithm: comparison to the ALTITUDE electrophysiologist panel adjudications.

INTRODUCTION: Adjudication of thousands of implantable cardioverter defibrillator (ICD)-treated arrhythmia episodes is labor intensive and, as a result, is most often left undone. The objective of this study was to evaluate an automatic classification algorithm for adjudication of ICD-treated arrhythmia episodes. METHODS: The algorithm uses a machine learning algorithm and was developed using 776 arrhythmia episodes. The algorithm was validated on 131 dual-chamber ICD shock episodes from 127 patients adjudicated by seven electrophysiologists (EPs). Episodes were classified by panel consensus as ventricular tachycardia/ventricular fibrillation (VT/VF) or non-VT/VF, with the resulting classifications used as the reference. Subsequently, each episode electrogram (EGM) data was randomly assigned to three EPs without the atrial lead information, and to three EPs with the atrial lead information. Those episodes were also classified by the automatic algorithm with and without atrial information. Agreement with the reference was compared between the three EPs consensus group and the algorithm. RESULTS: The overall agreement with the reference was similar between three-EP consensus and the algorithm for both with atrial EGM (94% vs 95%, P = 0.87) and without atrial EGM (90% vs 91%, P = 0.91). The odds of accurate adjudication, after adjusting for covariates, did not significantly differ between the algorithm and EP consensus (odds ratio 1.02, 95% confidence interval: 0.97-1.06). CONCLUSIONS: This algorithm performs at a level comparable to an EP panel in the adjudication of arrhythmia episodes treated by both dual- and single-chamber ICDs. This type of algorithm has the potential for automated analysis of clinical ICD episodes, and adjudication of EGMs for research studies and quality analyses.

Continuous Assessment of Active-Duty Army Special Operations and Reconnaissance Marines Using Digital Devices and Custom Software: The Digital Comprehensive Operator Readiness Assessment (DcORA) Study.

BACKGROUND: Continuous exposure to extreme and chronic stress from uncontrollable events has been linked to increased psychological and physiological reactivity. Prolonged, frequent deployments may test coping skills over time, ultimately rendering Servicemembers vulnerable to mental health problems and suicide. This study develops a methodology for accurately collecting holistic health measures from Servicemembers using digital tools, including custom-built phone software and body-worn sensors. METHODS: The secure research platform and mobile app continuously collect multiple health measures and, after data analysis, deliver continuously updated summary data back to the Servicemember. This system provides novel insights into the relationships between the measures while helping individuals track their progress toward self-established goals. Participants were given an iPhone (including the study app) and an Apple Watch. Participants tracked their data for more than 6 months and responded to baseline, daily, and weekly questions and assessments. Physiologic, psychologic, and cognitive assessment data across the Preservation of the Force and Family program (POTFF) domains were collected, displayed to the individual, and analyzed in aggregate. RESULTS: When coupled with custom-built software, this hardware can be elevated from a fitness tracker to a user-facing health monitoring, educational, and delivery system. CONCLUSION: This wearable system measured vital factors associated with the health and human performance of Servicemembers. In real-time, it engaged Servicemembers in health and human performance optimization practices to achieve a goal of prevention of physical or mental injury.

Force plate assessments in reconnaissance marine training company.

The ability to obtain dynamic movement assessments using force plate technology holds the promise of providing more detailed knowledge of the strength, balance and forces generated by active-duty military personnel. To date, there are not well-defined use cases for implementation of force plate assessments in military training environments. We sought to determine if force plate technology assessments could provide additional insights, related to the likelihood of graduation, beyond that provided by traditional physical fitness tests (PFT's), in an elite Marine training school. Serial force plate measures were also obtained on those Marines successfully completing training to determine if consistent measures reflecting the effects of training on muscle skeletal load-over-time could be accurately measured. A pre-training force plate assessment performed in 112 Marines did not predict graduation rates. For Marines who successfully completed the course, serial measures obtained throughout training were highly variable for each individual and no firm conclusions could be drawn related to load imposed or the fitness attained during training.

Ubiquitous wireless ECG recording: a powerful tool physicians should embrace.

The use of smart phones has increased dramatically and there are nearly a billion users on 3G and 4G networks worldwide. Nearly 60% of the U.S. population uses smart phones to access the internet, and smart phone sales now surpass those of desktop and laptop computers. The speed of wireless communication technology on 3G and 4G networks and the widespread adoption and use of iOS equipped smart phones (Apple Inc., Cupertino, CA, USA) provide infrastructure for the transmission of wireless biomedical data, including ECG data. These technologies provide an unprecedented opportunity for physicians to continually access data that can be used to detect issues before symptoms occur or to have definitive data when symptoms are present. The technology also greatly empowers and enables the possibility for unprecedented patient participation in their own medical education and health status as well as that of their social network. As patient advocates, physicians and particularly cardiac electrophysiologists should embrace the future and promise of wireless ECG recording, a technology solution that can truly scale across the global population.

CRT or CRT-D devices? The case for 'high energy' devices.

The decision to implant a CRT or CRT-D device is an important one that requires a careful look at the patient and discussion with the patient as to the benefits and risks associated with each approach. The good news is that CRT provided in any device is a robust therapy that improves many measures of heart failure outcome in very high-risk patients. We argue that in most circumstances, it is much easier to turn a tachycardia device off than not to have the benefit of prompt defibrillation should a tachycardia event occur. While cost is always a consideration, the responsibility of the physician is to individualize patient care and advocate for each patient, based upon the best available therapies.

Noise, artifact, and oversensing related inappropriate ICD shock evaluation: ALTITUDE noise study.

BACKGROUND: Approximately 12-21% of implantable cardioverter defibrillator (ICD) patients receive inappropriate shocks. We sought to determine the incidence and causes of noise/artifact and oversensing (NAO) resulting in ICD shocks. METHODS: A random sample of 2,000 patients who received ICD and cardiac resynchronization therapy defibrillator shocks and were followed by a remote monitoring system was included. Seven electrophysiologists analyzed stored electrograms from the 5,279 shock episodes. Episodes were adjudicated as appropriate or inappropriate shocks. RESULTS: Of the 5,248 shock episodes with complete adjudication, 1,570 (30%) were judged to be inappropriate shocks. Of these 1,570, 134 (8.5%) were a result of NAO. The 134 NAO episodes were determined to be due to external noise in 76 (57%), lead connector-related in 37 (28%), muscle noise in 11 (8%), oversensing of atrium in seven (5%), T-wave oversensing in two (2%), and other noise in one (1%). The ICD shock itself resulted in a marked decrease in the level of noise in 60 of 134 (45%) NAO episodes, and the magnitude of this effect varied with the type of NAO (58% for external noise, 35% for muscle, 27% for lead/connector, and 0% for oversensing; P = 0.03). There was no significant difference in NAO likelihood based on type of lead (integrated bipolar 89/1,802 vs dedicated bipolar 9/140, P = 0.67). CONCLUSIONS: External noise and lead/connector noise were the primary causes, while T-wave oversensing was the least common cause of NAO resulting in ICD shock. Noise/artifact decreased immediately after a shock in nearly half of episodes. The specific ICD lead type did not impact the likelihood of NAO.

A Novel Digital Research Methodology for Continuous Health Assessment of the Special Operations Warfighter: The Digital cORA Study.

The role of US Special Operations Forces (SOF) globally has expanded greatly in the past 20 years, leaving SOF serving multiple deployments with little time or ability to recover in between. Currently, assessments of the health and human performance capabilities of these individuals are episodic, precluding an accurate assessment of physical and mental load over time, and leading to high rates of acute and chronic injury to the mind and body. The collection of personal health-related continuous datasets has recently been made feasible with the advancement of digital technologies. These comprehensive data allow for improved assessment, and consequently better results, partly due to the warfighters' real-time access to their data. Such information allows Soldiers to engage in their own health optimization. This article describes a research platform that allows for collection of data via a custom-made secure mobile application that extends the type, scope, and frequency of data collection beyond what is feasible during an in-person encounter. By digitizing existing assessments and by incorporating additional physical, neurocognitive, psychological, and lifestyle assessments, the platform provides individuals with the ability to better understand their mental and physical load, as well as reserve. The results of this interactive exchange may help to preserve the health of users as well as the stability and readiness of units.

The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF.

AIMS: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality for patients with heart failure, reduced left ventricular ejection fraction, QRS duration >130 ms and in sinus rhythm. The aim of this study was to identify patient characteristics that predict the effect, specifically, of CRT pacemakers (CRT-P) on all-cause mortality or the composite of hospitalization for heart failure or all-cause mortality. METHODS AND RESULTS: We conducted an individual patient data meta-analysis of the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) and Cardiac Resynchronization-Heart Failure (CARE-HF) trials. Only patients assigned to CRT-P or control (n = 1738) were included in order to avoid confounding from concomitant defibrillator therapy. The influence of baseline characteristics on treatment effects was investigated. Median age was 67 (59-73) years, most patients were men (70%), 68% had a QRS duration of 150-199 ms and 80% had left bundle branch block. Patients assigned to CRT-P had lower rates for all-cause mortality (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.56-0.81; p < 0.0001) and the composite outcome (HR 0.67, 95% CI 0.58-0.78; p < 0.0001). No pre-specified characteristic, including sex, aetiology of ventricular dysfunction, QRS duration (within the studied range) or morphology or PR interval significantly influenced the effect of CRT-P on all-cause mortality or the composite outcome. However, CRT-P had a greater effect on the composite outcome for patients with lower body surface area and those prescribed beta-blockers. CONCLUSIONS: Cardiac resynchronization therapy-pacemaker reduces morbidity and mortality in appropriately selected patients with heart failure. Benefits may be greater in smaller patients and in those receiving beta-blockers. Neither QRS duration nor morphology independently predicted the benefit of CRT-P. CLINICAL TRIAL REGISTRATION: COMPANION, NCT00180258; CARE-HF, NCT00170300.

Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study.

BACKGROUND: Outcome data for patients receiving implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices treated outside of clinical trials are lacking. No clinical trial has evaluated mortality after device implantation or after shock therapy in large numbers of patients with implanted devices that regularly transmit device data over a network. METHODS AND RESULTS: Survival status in patients implanted with ICD and CRT devices across the United States from a single manufacturer was assessed. Outcomes were compared between patients followed in device clinic settings and those who regularly transmit remote data collected from the device an average of 4 times monthly. Shock delivery and electrogram analysis could be ascertained from patients followed on the network, enabling survival after ICD shock to be evaluated. One- and 5-year survival rates in 185,778 patients after ICD implantation were 92% and 68% and were 88% and 54% for CRT-D device recipients. In 8228 patients implanted with CRT-only devices, survival was 82% and 48% at 1 and 5 years, respectively. For the 69,556 ICD and CRT-D patients receiving remote follow-up on the network, 1- and 5-year survival rates were higher compared with those in the 116,222 patients who received device follow-up in device clinics only (50% reduction; P<0.0001). There were no differences between patients followed on or off the remote network for the characteristics of age, gender, implanted device year or type, and economic or educational status. Shock therapy was associated with subsequent mortality risk for both ICD and CRT-D recipients. CONCLUSIONS: Survival after ICD and CRT-D implantation in patients treated in naturalistic practice compares favorably with survival rates observed in clinical trials. Remote follow-up of device data is associated with excellent survival, but arrhythmias that result in device therapy in this population are associated with a higher mortality risk compared with patients who do not require shock therapy.