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.

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.

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.

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.

Ventricular tachycardia in the era of ventricular assist devices.

Sustained ventricular tachycardia (VT) in patients with advanced cardiomyopathy is a potentially life-threatening arrhythmia. Newer treatment strategies have evolved that combine the use of catheter ablation to target the substrate for VT and ventricular assist devices (VADs) to hemodynamically support the failing ventricle. This editorial is targeted to the practicing clinician caring for these difficult patients. The current article reviews the use of percutaneous VADs to support catheter ablation of VT, the use of durable VADs to support the failing heart in patients with recurrent VT, ventricular arrhythmias in patients with durable VADs, and the use of catheter ablation to treat VT in patients with durable VADs.

Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study.

INTRODUCTION: We evaluated the frequency of appropriate and inappropriate shocks and survival in patients using dual-zone programming versus single-zone programming. METHODS AND RESULTS: For the ALTITUDE REDUCES study, patients were followed for 1.6 ± 1.1 years. The 12-month incidence of any shock was lower for dual-versus single-zone programmed detection at rates ≤170 bpm and between 170-200 bpm (P < 0.001). Appropriate shock rates at 1 year were also lower with dual-zone programming in these rate intervals (single zone 9.1%, 5.4%, P < 0.001, dual zone 6.7%, 4.7%, P < 0.02). There were no detectable differences between single- and dual-zone shock incidence at detection rates ≥ 200 bpm (P = 0.14). Inappropriate shock incidence was less with dual- versus single-zone detection at all detect rates <200 bpm, but not at rates ≥200 bpm (P < 0.001, P = 0.37). The lowest risk of appropriate and inappropriate shock was associated with dual-zone programming and detection rates ≥200 bpm (2.1%). Dual-zone detection was associated with more nonsustained and diverted therapy episodes but these patients did not have an increased risk of death compared to patients with single-zone programming. Patients programmed to low detection rate, single-zone detection and shock-only therapy also had the highest preshock mortality risk (P = 0.05). CONCLUSIONS: Shock incidence is lowest with either single- or dual-zone detection ≥200 bpm. For detection rates <200 bpm, dual-zone programming is associated with a reduction in the incidence of total shocks, appropriate shocks, and inappropriate shocks.

Impact of relaxation training on patient-perceived measures of anxiety, pain, and outcomes after interventional electrophysiology procedures.

BACKGROUND: Electrophysiology procedures vary in invasiveness, duration, and anesthesia utilized. While complications are low and efficacy high, cases are elective and patient experiences related to anxiety, pain, and perceived outcomes are not well studied. We sought to determine if a 30-minute audio compact disc (CD) that teaches relaxation techniques and wellness perception prior to an elective procedure impacts validated measures of anxiety, pain, and procedural outcomes. METHODS: Sixty-one patients were randomly assigned to a control group (CG) (N(CG) = 31) or interventional group (IG) (N(IG) = 30). Both groups answered a baseline Hospital Anxiety and Depression Scale (HADS-A) survey consisting only of anxiety assessment questions. The IG listened to the CD the night prior to their procedure. Heart rate and blood pressure were monitored on admission and prior to the procedure. Postprocedure, both groups completed two HADS-A surveys as well as two Patient Experience Surveys (PES). There was no statistical difference in the demographics and the rate of procedural complications between the groups. The statistical significance of our data was determined using a Student's t-test and χ(2) test. RESULTS: At baseline, both groups had equal amounts of anxiety prior to their procedures (P = 0.2). The patients in the IG had lower systolic blood pressures during admission and prior the administration of analgesics in comparison to the CG. Postprocedure, results from administering the HADS-A demonstrated that the IG had 33% lower anxiety (P = 0.02) than CG patients. CONCLUSION: The implementation of basic relaxation teaching techniques prior to planned electrophysiology procedures lowers systolic blood pressure and postprocedural anxiety.

Implantable cardioverter defibrillator electrogram adjudication for device registries: methodology and observations from ALTITUDE.

BACKGROUND: The increasing use of remote monitoring with the associated large retrievable databases provides a unique opportunity to analyze observations on implantable cardioverter-defibrillator (ICD) therapies. Adjudication of a large number of stored ICD electrograms (EGMs) presents a unique challenge. The ALTITUDE study group was designed to use the LATITUDE remote monitoring system to evaluate ICD patient outcomes across the United States. METHODS AND RESULTS: Of 81,081 patients on remote monitoring, a random sample of 2,000 patients having 5,279 shock episodes was selected. The ALTITUDE EGM review committee was comprised of seven electrophysiologists from four institutions. An online EGM adjudication system was designed. Episodes were classified as appropriate (70% of shock episodes) or inappropriate ICD therapies (30%). Light's Kappa was used to assess agreement. Interobserver and intraobserver Kappa scores for dual-chamber ICDs were 0.84 (0.71-0.91) and 0.89 (0.82-0.95), consistent with substantial agreement. Interobserver and intraobserver Kappa scores for single-chamber ICDs were 0.61 (0.54-0.67) and 0.69 (0.59-0.79). The rhythm categories of "nonsustained arrhythmia" and "polymorphic and monomorphic ventricular tachycardia" resulted in the greatest degree of discordant adjudication between reviewers. CONCLUSIONS: This method of adjudication of a large volume of stored EGM data prior to device therapies will allow new observations in regards to device performance and has the potential to improve device programming and design. There was substantial interreviewer agreement for rhythm classification. Agreement was greater for dual-chamber compared to single-chamber devices, indicating the atrial lead adds diagnostic value in rhythm interpretation.

The Addition of a Defibrillator to Resynchronization Therapy Decreases Mortality in Patients With Nonischemic Cardiomyopathy.

OBJECTIVES: The aim of this study was to determine whether patients with heart failure with reduced ejection fraction (HFrEF) due to nonischemic etiology eligible for cardiac resynchronization therapy (CRT) benefit from an implantable cardioverter-defibrillator (ICD). BACKGROUND: It is uncertain whether CRT with an ICD (CRT-D) compared to without an ICD (CRT-P) is associated with a survival benefit in patients with nonischemic etiologies of HFrEF. METHODS: Analyses of the COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure) trial were performed, using Cox proportional hazards modeling stratified by HFrEF etiology of nonischemic cardiomyopathy (NICM) or ischemic cardiomyopathy (ICM). The primary outcome was all-cause mortality (ACM), and secondary outcomes were the combination of cardiovascular mortality or heart failure hospitalization and sudden cardiac death. RESULTS: Among patients randomized to CRT (n = 1,212), 236 (19.5%) died, 131 and 105 in the CRT-P and CRT-D arms, respectively. The unadjusted and adjusted hazard ratios (HRs) for CRT-D versus CRT-P were both 0.84 (95% confidence interval [CI]: 0.65 to 1.09) for ACM, with a significant device-etiology interaction (pinteraction = 0.015 adjusted; pinteraction = 0.040 unadjusted). In patients with NICM (n = 555), CRT-D versus CRT-P was associated with reduced ACM (adjusted HR: 0.54; 95% CI: 0.34 to 0.86), while patients with ICM (n = 657) did not exhibit a between-device reduction in ACM (adjusted HR: 1.05; 95% CI: 0.77 to 1.44). The effects of CRT-D versus CRT-P on sudden cardiac death (advantage CRT-D) and cardiovascular mortality or heart failure hospitalization (no difference between CRT-P and CRT-D) were similar between the 2 HFrEF etiologies. CONCLUSIONS: COMPANION patients with NICM exhibited a decrease in ACM associated with CRT-D but not CRT-P treatment, whereas patients with ICM did not.