Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement.

Importance: Atrial fibrillation (AF) is the most common cardiac arrhythmia. The prevalence of AF increases with age, from less than 0.2% in adults younger than 55 years to about 10% in those 85 years or older, with a higher prevalence in men than in women. It is uncertain whether the prevalence of AF differs by race and ethnicity. Atrial fibrillation is a major risk factor for ischemic stroke and is associated with a substantial increase in the risk of stroke. Approximately 20% of patients who have a stroke associated with AF are first diagnosed with AF at the time of the stroke or shortly thereafter. Objective: To update its 2018 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on the benefits and harms of screening for AF in older adults, the accuracy of screening tests, the effectiveness of screening tests to detect previously undiagnosed AF compared with usual care, and the benefits and harms of anticoagulant therapy for the treatment of screen-detected AF in older adults. Population: Adults 50 years or older without a diagnosis or symptoms of AF and without a history of transient ischemic attack or stroke. Evidence Assessment: The USPSTF concludes that evidence is lacking, and the balance of benefits and harms of screening for AF in asymptomatic adults cannot be determined. Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AF. (I statement).

Screening for Atrial Fibrillation: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Atrial fibrillation (AF), the most common arrhythmia, increases the risk of stroke. Objective: To review the evidence on screening for AF in adults without prior stroke to inform the US Preventive Services Task Force. Data Sources: PubMed, Cochrane Library, and trial registries through October 5, 2020; references, experts, and literature surveillance through October 31, 2021. Study Selection: Randomized clinical trials (RCTs) of screening among asymptomatic persons without known AF or prior stroke; test accuracy studies; RCTs of anticoagulation among persons with AF; systematic reviews; and observational studies reporting harms. Data Extraction and Synthesis: Two reviewers assessed titles/abstracts, full-text articles, and study quality and extracted data; when at least 3 similar studies were available, meta-analyses were conducted. Main Outcomes and Measures: Detection of undiagnosed AF, test accuracy, mortality, stroke, stroke-related morbidity, and harms. Results: Twenty-six studies (N = 113 784) were included. In 1 RCT (n = 28 768) of twice-daily electrocardiography (ECG) screening for 2 weeks, the likelihood of a composite end point (ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause mortality, and hospitalization for bleeding) was lower in the screened group over 6.9 years (hazard ratio, 0.96 [95% CI, 0.92-1.00]; P = .045), but that study had numerous limitations. In 4 RCTs (n = 32 491), significantly more AF was detected with intermittent and continuous ECG screening compared with no screening (risk difference range, 1.0%-4.8%). Treatment with warfarin over a mean of 1.5 years in populations with clinical, mostly persistent AF was associated with fewer ischemic strokes (pooled risk ratio [RR], 0.32 [95% CI, 0.20-0.51]; 5 RCTs; n = 2415) and lower all-cause mortality (pooled RR, 0.68 [95% CI, 0.50-0.93]) compared with placebo. Treatment with direct oral anticoagulants was also associated with lower incidence of stroke (adjusted odds ratios range, 0.32-0.44) in indirect comparisons with placebo. The pooled RR for major bleeding for warfarin compared with placebo was 1.8 (95% CI, 0.85-3.7; 5 RCTs; n = 2415), and the adjusted odds ratio for major bleeding for direct oral anticoagulants compared with placebo or no treatment ranged from 1.38 to 2.21, but CIs did not exclude a null effect. Conclusions and Relevance: Although screening can detect more cases of unknown AF, evidence regarding effects on health outcomes is limited. Anticoagulation was associated with lower risk of first stroke and mortality but with increased risk of major bleeding, although estimates for this harm are imprecise; no trials assessed benefits and harms of anticoagulation among screen-detected populations.

The New S7B/E14 Question and Answer Draft Guidance for Industry: Contents and Commentary.

In August 2020, the International Council on Harmonisation (ICH) released a new draft document, which for the first time combined nonclinical (S7B) and clinical (E14) Questions and Answers (Q&As) into 1 document. FDA describes the revision as a "value proposition": if the human ether-à-go-go assay and the in vivo study are performed in a standardized way, the number of dedicated thorough QT (TQT) studies can be reduced. In this article, we describe and discuss the Q&As that relate to clinical ECG evaluation. If supported by negative standardized nonclinical assays, Q&A 5.1 will obviate the need for a TQT study in the case that a >2-fold exposure margin vs high clinical scenario cannot be obtained. Q&A 6.1 addresses drugs that are poorly tolerated in healthy subjects and cannot be studied at high doses or in placebo-controlled studies; it therefore mainly applies to oncology drugs. It will enable sponsors to claim that a new drug has a "low likelihood of proarrhythmic effects" in the case that the mean corrected QT effect is <10 milliseconds at the time of market application. The E14 2015 revision allowed application of concentration-corrected QT analysis on data from routinely performed clinical pharmacology studies, for example, the first-in-human study and the proportion of dedicated TQT studies has since steadily decreased. It can be foreseen that the proposed new revision will further reduce the number of TQT studies. To achieve harmonization across regulatory regions, it seems important to reach consensus within the International Council on Harmonisation group on the new threshold proposed in 6.1. For this purpose, the Implementation Working Group has asked for public comments.

Population-Based Screening for Atrial Fibrillation.

Atrial fibrillation (AF) is a common and morbid arrhythmia. Stroke is a major hazard of AF and may be preventable with oral anticoagulation. Yet since AF is often asymptomatic, many individuals with AF may be unaware and do not receive treatment that could prevent a stroke. Screening for AF has gained substantial attention in recent years as several studies have demonstrated that screening is feasible. Advances in technology have enabled a variety of approaches to facilitate screening for AF using both medical-prescribed devices as well as consumer electronic devices capable of detecting AF. Yet controversy about the utility of AF screening remains owing to concerns about potential harms resulting from screening in the absence of randomized data demonstrating effectiveness of screening on outcomes such as stroke and bleeding. In this review, we summarize current literature, present technology, population-based screening considerations, and consensus guidelines addressing the role of AF screening in practice.

Accuracy of the 2017 international recommendations for clinicians who interpret adolescent athletes' ECGs: a cohort study of 11 168 British white and black soccer players.

AIM: To investigate the accuracy of the recently published international recommendations for ECG interpretation in young athletes in a large cohort of white and black adolescent soccer players. METHODS: 11 168 soccer players (mean age 16.4±1.2 years) were evaluated with a health questionnaire, ECG and echocardiogram; 10 581 (95%) of the players were male and 10 163 (91%) were white. ECGs were retrospectively analysed according to (1) the 2010 European Society of Cardiology (ESC) recommendations, (2) Seattle criteria, (3) refined criteria and (4) the international recommendations for ECG interpretation in young athletes. RESULTS: The ESC recommendations resulted in a higher number of abnormal ECGs compared with the Seattle, refined and international criteria (13.2%, 4.3%, 2.9% and 1.8%, respectively). All four criteria were associated with a higher prevalence of abnormal ECGs in black athletes compared with white athletes (ESC: 16.2% vs 12.9%; Seattle: 5.9% vs 4.2%; refined: 3.8% vs 2.8%; international 3.6% vs 1.6%; p<0.001 each). Compared with ESC recommendations, the Seattle, refined and international criteria identified a lower number of abnormal ECGs-by 67%, 78% and 86%, respectively. All four criteria identified 36 (86%) of 42 athletes with serious cardiac pathology. Compared with ESC recommendations, the Seattle criteria improved specificity from 87% to 96% in white athletes and 84% to 94% in black athletes. The international recommendations demonstrated the highest specificity for white (99%) and black (97%) athletes and a sensitivity of 86%. CONCLUSIONS: The 2017 international recommendations for ECG interpretation in young athletes can be applied to adolescent athletes to detect serious cardiac disease. These recommendations perform more effectively than previous ECG criteria in both white and black adolescent soccer players.

Volume variation may be a relevant metric in the study of aneurysm pulsatility: a study using ECG-gated 4D-CTA (PULSAN).

​BACKGROUND AND PURPOSE: Intracranial aneurysms are a frequently occurring disease, with an estimated prevalence of 2-5% in the general population. They usually remain silent until rupture occurs, with a mortality rate of 35-50% and a high rate of morbidity, including long-term disability. However, preventative treatments have their own risk of complications and morbi-mortality rates, including stroke and hemorrhage. ECG-gated four-dimensional CT angiography (4D-CTA) allows the acquisition of time-resolved three-dimensional reconstructions. The aim of our study was to evaluate different intracranial aneurysm metrics over the cardiac cycle using ECG-gated 4D-CTA. ​MATERIALS AND METHODS: ECG-gated 4D-CTA datasets were acquired in patients presenting with intracranial aneurysms. Seven aneurysm metrics, including aneurysm height, aneurysm length, ostium width, aspect ratio, ostium area, volume, and volume-to-ostium ratio, were analysed over different cardiac phases. Intra-reader agreement, inter-reader agreement, and inter-cycle agreement were calculated through the intraclass correlation coefficient. ​RESULTS: Twenty-one aneurysms from 11 patients were considered for inclusion. Post-processing failed for three aneurysms, and 18 aneurysms were finally analysed. There was good intra-reader agreement for each metric (ICC >0.9). Agreements among three consecutive cardiac cycles were calculated for six aneurysms and were especially good for the volume metric (ICC >0.9). Volume variation appears to be the most relevant metric and seems especially perceptible for aneurysms larger than 5 mm. ​CONCLUSIONS: Quantification of aneurysm volume changes during the cardiac cycle seems quantitatively possible and reproducible, especially for aneurysms larger than 5 mm. Further studies need to be conducted to validate this parameter for intracranial aneurysm assessment.

Conventional and new electrocardiographic criteria for hypertension-mediated cardiac organ damage: A narrative review.

Hypertension-mediated organ damage (HMOD) is frequently observed in hypertensive patients at different cardiovascular (CV) risk profile. This may have both diagnostic and therapeutic implications for the choice of the most appropriate therapies. Among different markers of HMOD, the most frequent functional and structural adaptations can be observed at cardiac level, including left ventricular hypertrophy (LVH), diastolic dysfunction, aortic root dilatation, and left atrial enlargement. In particular, LVH was shown to be a strong and independent risk factor for major CV events, namely myocardial infarction, stroke, congestive heart failure, CV death. Thus, early identification of LVH is a key element for preventing CV events in hypertension. Although echocardiographic assessment of LVH represents the gold standard technique, this is not cost-effective and cannot be adopted in routine clinical practice of hypertension. On the other hand, electrocardiographic (ECG) assessment of HMOD relative to the heart is a simple, reproducible, widely available and cost-effective method to assess the presence of LVH, and could be preferred in large scale screening tests. Several new indicators have been proposed and tested in observational studies and clinical trials of hypertension, in order to improve the relatively low sensitivity of the conventional ECG criteria for LVH, despite high specificity. This article reviews the differences in the use of the main conventional and the new 12 lead ECG criteria of LVH for early assessment of asymptomatic, subclinical cardiac HMOD in a setting of clinical practice of hypertension.

[ECG in sportsmen: Distinguishing the normal from the pathological]. / ECG du sportif : distinguer le normal du pathologique.

An ECG is recommended by the French Society of Cardiology in the screening of a competitive athlete. An intense and prolonged physical activity (>4 hours of intense sport/week) can lead to a physiological electric remodeling. In addition to physical activity (type, intensity, duration), the ECG should be interpreted according to the athlete's ethnicity and age. It is necessary to know the physiological modifications related to sport practice to avoid either false reassurances or the realization of unjustified additional examinations because of a wrong interpretation. The latest athlete ECG classification published in 2017 can be used to identify in which athlete additional tests are recommended (figure 1).

Individualized parameterization of multiparametric monitors alarms in infarcted patients / Parametrización individualizada de alarmas de monitores multiparamétricos en pacientes infartados / Parametrização individualizada de alarmes de monitores multiparamétricos em pacientes infartados

ABSTRACT Objective: To measure the magnitude of the effect of an individualized parameterization protocol for hemodynamic alarms in patients with acute myocardial infarction. Method: Pragmatic clinical trial, open label and single arm, whose intervention was performed through a protocol validated and tested in 32 patients using multiparametric monitors. The heart rate, blood pressure, respiratory rate, oxygen saturation and ST segment-monitoring were measured and classified for clinical consistency one hour before and after the intervention, for 64 hours. Results: The protocol obtained Content Validity Index of 0.92. Of the 460 registered alarms, 261 were considered inconsistent before the intervention and 47 after it. The Relative Risk of inconsistent alarms after the protocol was 0.32 (95% CI 0.23-0.43, p <0.0001). Conclusion: The protocol proved to be a protective factor to the appearance of inconsistent clinical alarms of multiparametric monitors.

RESUMEN Objetivo: Medir la magnitud del efecto de un protocolo de parametrización individualizada de alarmas hemodinámicas en pacientes con infarto agudo de miocardio. Método: Ensayo clínico pragmático, open label y single arm cuya intervención ocurrió por medio de un protocolo validado y testado en 32 pacientes, utilizándose monitores multiparamétricos. Las alarmas de frecuencia cardíaca, presión arterial, frecuencia respiratoria, saturación de oxígeno y segmento ST fueron valorados y clasificados según su consistencia clínica, una hora antes y después de la intervención, durante 64 horas. Resultados: El protocolo obtuvo un índice de Validez de Contenido de 0,92. De las 460 alarmas registradas, 261 fueron consideradas inconsistentes antes de la intervención y 47 después. El Riesgo Relativo de las alarmas incoherentes después del protocolo fue de 0,32 (IC 95% 0.23-0.43, p <0,0001). Conclusión: El protocolo se mostró un factor protector al surgimiento de alarmas clínicas inconsistentes de monitores multiparamétricos.

RESUMO Objetivo: Medir a magnitude do efeito de um protocolo de parametrização individualizada de alarmes hemodinâmicos em pacientes com infarto agudo do miocárdio. Método: Ensaio clínico pragmático, open label e single arm, cuja intervenção ocorreu por meio de um protocolo validado e testado em 32 pacientes usando monitores multiparamétricos. Os alarmes de frequência cardíaca, pressão arterial, frequência respiratória, saturação de oxigênio e segmento ST foram mensurados e classificados quanto à consistência clínica uma hora antes e após a intervenção, durante 64 horas. Resultados: O protocolo obteve Índice de Validade de Conteúdo de 0,92. Dos 460 alarmes registrados, 261 foram considerados inconsistentes antes da intervenção e 47 após. O Risco Relativo de alarmes inconsistentes após o protocolo foi de 0,32 (IC 95% 0.23-0.43, p<0,0001). Conclusão: O protocolo mostrou-se um fator protetor ao surgimento de alarmes clínicos inconsistentes de monitores multiparamétricos.

Diagnostic Performance of a Smart Device With Photoplethysmography Technology for Atrial Fibrillation Detection: Pilot Study (Pre-mAFA II Registry).

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The asymptomatic nature and paroxysmal frequency of AF lead to suboptimal early detection. A novel technology, photoplethysmography (PPG), has been developed for AF screening. However, there has been limited validation of mobile phone and smart band apps with PPG compared to 12-lead electrocardiograms (ECG). OBJECTIVE: We investigated the feasibility and accuracy of a mobile phone and smart band for AF detection using pulse data measured by PPG. METHODS: A total of 112 consecutive inpatients were recruited from the Chinese PLA General Hospital from March 15 to April 1, 2018. Participants were simultaneously tested with mobile phones (HUAWEI Mate 9, HUAWEI Honor 7X), smart bands (HUAWEI Band 2), and 12-lead ECG for 3 minutes. RESULTS: In all, 108 patients (56 with normal sinus rhythm, 52 with persistent AF) were enrolled in the final analysis after excluding four patients with unclear cardiac rhythms. The corresponding sensitivity and specificity of the smart band PPG were 95.36% (95% CI 92.00%-97.40%) and 99.70% (95% CI 98.08%-99.98%), respectively. The positive predictive value of the smart band PPG was 99.63% (95% CI 97.61%-99.98%), the negative predictive value was 96.24% (95% CI 93.50%-97.90%), and the accuracy was 97.72% (95% CI 96.11%-98.70%). Moreover, the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of mobile phones with PPG for AF detection were over 94%. There was no significant difference after further statistical analysis of the results from the different smart devices compared with the gold-standard ECG (P>.99). CONCLUSIONS: The algorithm based on mobile phones and smart bands with PPG demonstrated good performance in detecting AF and may represent a convenient tool for AF detection in at-risk individuals, allowing widespread screening of AF in the population. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-OOC-17014138; http://www.chictr.org.cn/showproj.aspx?proj=24191 (Archived by WebCite at http://www.webcitation/76WXknvE6).

Implementing Practice Standards for Inpatient Electrocardiographic Monitoring.

BACKGROUND: Although electrocardiographic monitoring is common in hospitalized patients, many patients receive unnecessary monitoring, contributing to patients' inconvenience, clinicians' alarm fatigue, and delayed admissions. OBJECTIVE: To evaluate the impact of implementation of an electronic order set based on the American Heart Association practice standards for electrocardiographic monitoring on the occurrence of appropriate monitoring. METHODS: The sample for this preintervention-to-postintervention quasi-experimental study consisted of 297 adult patients on medical, surgical, neurological, oncological, and orthopedic patient care units that used remote electrocardiographic monitoring in a 627-bed hospital in Minneapolis, Minnesota. The intervention was the introduction into the electronic health record of order sets prompting physicians to order electrocardiographic monitoring per the American Heart Association practice standards. Indications for monitoring according to the practice standards and adverse outcomes (unexpected transfer to intensive care unit, death, code blue events, and call for the rapid response team) were compared before and after implementation of the order set. RESULTS: Implementation of the order set was associated with an increase in appropriate monitoring (48.0% to 61.2%; P = .03); the largest increase was in ordering by medical residents (30.8% to 76.5%; P = .001). No significant increase in adverse patient outcomes was noted. CONCLUSIONS: Implementation of the practice standards via an electronic order set was associated with a statistically significant increase in appropriate monitoring, with no increase in adverse events. Use of electronic order sets is an effective and safe way to enhance appropriate electrocardiographic monitoring.

Evaluation of the impact of treatment with hematopoietic stem cells transplantation (HSCT) on biochemical markers of heart function and novel electrocardiographic markers of repolarization in patients with hematological malignancies.

High-dose chemotherapy (HDC) followed by stem cell transplantation (HSCT) is a well-established method in patients with hematological malignancies, and for last few years, many efforts have been made to estimate short- and long-term efficacy of this method, as well as early and late complications. The present study concentrates on cardiotoxic effects, mainly early changes using biochemical markers such as N-terminal natriuretic peptide type B (NT-proBNP) and cardiac troponins (cTn). Simultaneously, the analysis of 12-lead ECG was done before and after the procedure in which the novel repolarization markers: Tp-e and Tp-e/QT ratio were measured, together with standard markers: QT, QTc. It was found that NT-pro BNP was significantly increased after HSCT in comparison to results before it, and no significant changes were present in Troponin levels. Simultaneously, Tp-e interval and Tp-e/QT ratio were significantly higher after HSCT. The use of cyclophosphamide, advanced age, and higher level of blood cholesterol concentration were risk factors for the increase in NT-proBNP and treatment with cyclophosphamide as well as fludarabine and higher creatinine levels were risk factors for the increase in Tp-e/QT ratio. In conclusion, in the early term evaluation after HSCT in patients with no previously diagnosed heart disease, the mild changes in markers of heart overload and repolarization were noted. The observations suggest that in all patients undergoing HSCT, even the ones without pre-existing cardiovascular disease, the evaluation, and monitoring of heart function should be considered.

Evaluation of a novel automatic screening tool for determining eligibility for a subcutaneous implantable cardioverter-defibrillator.

BACKGROUND: The manufacturer has developed a new ECG screening tool to determine eligibility for the subcutaneous ICD (S-ICD), the "automatic screening tool" (AST), which may render manual ECG-screening unnecessary. The aim of the study was to determine the eligibility for the S-ICD using two methods (manual ECG-screening versus AST) in different patient categories including patients with cardiomyopathy, congenital heart disease and inherited primary arrhythmia syndrome. METHODS: We prospectively evaluated the ECG suitability for an S-ICD in consecutive patients at our outpatient clinic between February and June 2017. The primary endpoint of the study was ECG eligibility defined as at least 1 successful vector in both supine and sitting postures. RESULTS: A total of 254 patients (167 men; mean age 45 ±â€¯16 years) were screened using both methods. Overall, there was a high ECG eligibility using either method (93% versus 92%, P = 0.45). Overall agreement between both methods was 94%. Patients with hypertrophic cardiomyopathy (HCM) more often had a failed screening test using either test in comparison to the patients without HCM (manual: odds ratio [OR] 3.3, 95% confidence interval [CI] 1.2-9.3, P = 0.02; AST: OR 3.0, 95% CI 1.2-7.6, P = 0.02). CONCLUSION: AST showed a high agreement with manual ECG-screening for S-ICD. Overall there was a high ECG eligibility for S-ICD, although patients with HCM had a lower passing rate irrespective of the screening method.

Automated Method for Discrimination of Arrhythmias Using Time, Frequency, and Nonlinear Features of Electrocardiogram Signals.

We developed an automated approach to differentiate between different types of arrhythmic episodes in electrocardiogram (ECG) signals, because, in real-life scenarios, a software application does not know in advance the type of arrhythmia a patient experiences. Our approach has four main stages: (1) Classification of ventricular fibrillation (VF) versus non-VF segments—including atrial fibrillation (AF), ventricular tachycardia (VT), normal sinus rhythm (NSR), and sinus arrhythmias, such as bigeminy, trigeminy, quadrigeminy, couplet, triplet—using four image-based phase plot features, one frequency domain feature, and the Shannon entropy index. (2) Classification of AF versus non-AF segments. (3) Premature ventricular contraction (PVC) detection on every non-AF segment, using a time domain feature, a frequency domain feature, and two features that characterize the nonlinearity of the data. (4) Determination of the PVC patterns, if present, to categorize distinct types of sinus arrhythmias and NSR. We used the Massachusetts Institute of Technology-Beth Israel Hospital (MIT-BIH) arrhythmia database, Creighton University’s VT arrhythmia database, the MIT-BIH atrial fibrillation database, and the MIT-BIH malignant ventricular arrhythmia database to test our algorithm. Binary decision tree (BDT) and support vector machine (SVM) classifiers were used in both stage 1 and stage 3. We also compared our proposed algorithm’s performance to other published algorithms. Our VF detection algorithm was accurate, as in balanced datasets (and unbalanced, in parentheses) it provided an accuracy of 95.1% (97.1%), sensitivity of 94.5% (91.1%), and specificity of 94.2% (98.2%). The AF detection was accurate, as the sensitivity and specificity in balanced datasets (and unbalanced, in parentheses) were found to be 97.8% (98.6%) and 97.21% (97.1%), respectively. Our PVC detection algorithm was also robust, as the accuracy, sensitivity, and specificity were found to be 99% (98.1%), 98.0% (96.2%), and 98.4% (99.4%), respectively, for balanced and (unbalanced) datasets.

Direct comparison of the novel automated screening tool (AST) versus the manual screening tool (MST) in patients with already implanted subcutaneous ICD.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has evolved as a valuable alternative to the transvenous ICD, especially in young patients. Unfortunately, some of these patients are ineligible for S-ICD implantation due to specific electrocardiographic features. So far, these patients were identified by mandatory pre-implantation screening using the manual screening tool (MST), which lacks objective value. Therefore, a novel automated screening tool (AST) has been introduced recently for objective screening, which has not been evaluated yet. METHODS/RESULTS: We here first investigate the novel AST, in direct comparison to MST, in 33 consecutive patients with already implanted S-ICD system to compare predicted eligibility by screening tools with true sensing of the S-ICD system. Both screening tools reliably predicted true ineligible single vectors, but also suggested overall ineligibility in a similar fraction of patients (MST: 3.0%; AST: 6.1%), albeit the implanted S-ICD worked flawlessly in these patients. AST did not predict the finally selected sensing vector better than MST. There was a surprising mismatch between AST and MST for the predicted eligibility of single vectors; only in 49% of patients did both screening tools predict eligibility for the same vectors. CONCLUSIONS: The novel AST predicted overall eligibility approximately similar to MST. Both tools predicted ineligibility in a few patients, who were actually eligible. There was a striking mismatch between both screening tools when eligibility of single vectors was predicted. Thus, the AST seems to be a valuable advance, due to its standardized and objective process, but it still lacks specificity.

Diagnosing ARVC in Pediatric Patients Applying the Revised Task Force Criteria: Importance of Imaging, 12-Lead ECG, and Genetics.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a potentially lethal disease that is well described in adults. In pediatric patients, however, identification of patients at risk of adverse events of ARVC remains a challenge. We aimed to determine which criteria of the revised Task Force Criteria (rTFC), alone or combined, have an impact on diagnosis of ARVC when compared to disease-specific genetic mutations in pediatric patients ≤ 18 years. Between September 2010 and December 2013, 48 consecutive young patients ≤ 18 years of age (mean 14, range of 12.9-15.1 years) underwent contrast-enhanced magnetic resonance imaging (CMR), genetic testing, and comprehensive clinical work-up for ARVC criteria to test for clinically suspected ARVC. As specified by the rTFC, patients were grouped into four categories: "definite," "borderline," "possible," and "none" ARVC. Of the 48 patients, 12 were found to have gene mutations of either the desmoplakin (9/12) or plakophilin (3/12) locus. According to rTFC 12/48 patients were considered as "definite" ARVC (25%), while 10/12 (83.3%) had an ARVC-specific gene mutation. Of the remaining 36 patients, 6 (12.5%) were grouped as "borderline" ARVC, 7 (14.6%) as "possible" ARVC (including the remaining two genetic mutations), and 22 (45.8%) as "none" ARVC, respectively. Statistical analysis of ARVC criteria in patients diagnosed with "definite" ARVC revealed high prevalence of positive findings by imaging (CMR and echocardiography) and positive genetics. The positive predictive value to detect "definite" ARVC by genotyping was 83.3%, while the negative predictive value was 94%. Logistic regression analyses for different criteria combinations revealed that imaging modalities (echo and CMR combined) and abnormalities of 12-lead ECG were significant markers (p < 0.01). Positive results of endomyocardial biopsies or arrhythmia on ECG or Holter as defined by the rTFC were not significant in this analysis. The rTFC for ARVC should be used with caution in children and adolescents suspected for ARVC. 12-Lead ECG and imaging modalities (CMR and echo) were of major value, positive results should prompt genetic testing.

Cardiovascular Screening Practices and Attitudes From the NCAA Autonomous "Power" 5 Conferences.

BACKGROUND:: The development of athlete-specific electrocardiogram (ECG) interpretation standards, along with recent rates of sudden cardiac death (SCD) in athletes being higher than previously estimated, has heightened the debate in the sports medicine community regarding cardiovascular screening of the college athlete, including whether certain high-risk subsets, such as male basketball athletes, should undergo more intensive screening. HYPOTHESIS:: ECG and/or echocardiography screening in National Collegiate Athletic Association Autonomous 5 Division I (A5DI) schools will be more common than previous reports, and there will be more frequent use of noninvasive cardiac screening for men's basketball players than the general athlete population. STUDY DESIGN:: Cross-sectional, quantitative study. LEVEL OF EVIDENCE:: Level 4. METHODS:: The head team physician for each of the 65 schools in the A5DI conferences was contacted to complete an anonymous survey regarding cardiovascular screening practices at their institution. The survey inquired about current screening protocols, whether SCD epidemiology (SCD-E) was considered in establishing those practices, and whether awareness of present epidemiology altered physician attitudes toward screening. RESULTS:: A total of 45 of the 65 team physicians (69%) responded. All schools reported performing history and a physical evaluation. While 17 (38%) perform only history and physical, 26 (58%) also include an ECG, and 12 (27%) include echocardiography for all student-athletes. Specifically for male basketball athletes, 10 (22%) schools perform only history and physical, 32 (71%) include ECG, and 20 (45%) include echocardiography. Additionally, 64% reported using SCD-E in developing their screening protocol. Those that had not considered SCD-E indicated they were unlikely to change their screening protocol when presented with current SCD-E. CONCLUSION:: The majority (62%) of A5DI institutions include ECG and/or echocardiography as part of their cardiovascular screening of all athletes, increasing to 78% when specifically analyzing male basketball athletes. CLINICAL RELEVANCE:: A5DI institutions, presumably with greater resources, have largely implemented more intensive cardiovascular screening than just history and physical for all student-athletes and specifically for men's basketball-the athlete group at greatest risk.

Comparison of one- and three-lead ECG to measure cardiac intervals and differentiate drug-induced multi-channel block.

INTRODUCTION: FDA has established initiatives to characterize clinical and non-clinical biomarkers to enable more precise prediction of proarrhythmia risk based upon knowledge of drug effect on multiple cardiac ion channels (Colatsky et al., 2016). The FDA has recently demonstrated superiority of early ventricular repolarization interval (JTp) in differentiating pure hERG block from multi-channel block in human subjects. Preclinical studies often acquire a single lead ECG, whereas FDA measurements of JTp were derived ​from a spatial vectorcardiogram computed using multiple leads. This study compares QT subintervals derived from single lead vs. spatial magnitude (SM) ECG and contrasts information obtained from multilead and single lead ECGs in the canine model. METHODS: Four beagle dogs were instrumented with 3-lead Holter monitors to acquire continuous surface ECG recordings for three consecutive days. A 24-h baseline recording was obtained on day 1 followed by administration of dofetilide on day 2 and atropine and dofetilide on day 3. Lead II and SM ECGs were automatically analyzed using the AE-1010 Rhythm Express™ (RE) software (VivaQuant, St. Paul, MN USA) without manual intervention or editing of the results (auto). Five-minute averages of beat-to-beat intervals measured on each lead were compared for agreement assessed by Bland-Altman (BA) statistics and consistency measured as the repeatability standard deviation (SD) from 5-min intervals. The fully automated results were screened by an operator (semi-automated) and compared to automated results. RESULTS: JTp and TpTe measured using SM lead are less sensitive to changes in posture and respiration related changes in T-wave morphology. The 24-h repeatability SD of 5-min subintervals for JTp and TpTe over the three days was improved by 15.4% and 15.5% respectively with the highest improvements of 23.3% for JTp on day 2 and 25.3% for TpTe on day 3. Drug induced changes in QTcV, QRS, RR, and PR intervals were qualitatively similar between the SM lead and Lead II and in close agreement based on BA statistics. Semi-automated and automated measurements from SM Lead were in close agreement based on BA statistics. DISCUSSION: Single lead ECG is adequate for PR, RR, QRS, and QT, but produces different and more variable results when assessing QT subintervals relative to the SM lead. Close agreement between automated and semi-automated measurements demonstrates Rhythm Express accuracy and the potential to streamline interval analysis.