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Studies the frequency of subacute resumption of isthmus conduction after ablation of atrial flutter. Study design and patients; Success of radiofrequency ablation; Resumption of isthmus conduction within the first 24 hours.

The extent to which age, independent of cardiovascular diseases, influences left ventricular (LV) function in adults is uncertain. Echocardiograms and simultaneous arterial pressure in 464 clinically normal adults aged 16 to 88 years were used to measure LV dimensions, endocardial and midwall LV fractional shortening, stroke volume, cardiac output, and circumferential end-systolic stress. The ratios of observed endocardial and midwall shortening to values predicted for observed end-systolic stress were used as measures of chamber and myocardial function. LV endocardial shortening increased slightly with age, as did an index of LV chamber performance, the end-systolic stress/volume index ratio (r = 0.11, p = 0.019, and r = 0.20, p <0.001). However, when age-related increases in LV wall thickness and blood pressure were controlled for by examining afterload-corrected endocardial shortening, no age relation was detected. Weak age-related declines were observed in midwall shortening (r = -0.09, p = 0.043) and afterload-corrected midwall shortening (r = -0.12, p <0.01). Cardiac index decreased slightly with advancing age (r = -0.14, mean -6.7 ml/min/m2/ year, p = 0.003). Total peripheral resistance and the pulse pressure/stroke volume ratio, a measure of arterial stiffness, increased more strongly with age (r = 0.27 and 0.38, both p <0.001). Thus, LV pump performance at rest measured by cardiac index is slightly lower in older than in younger clinically normal adults. Endocardial fractional shortening was slightly higher in older subjects, but the physiologically more appropriate midwall measures of myocardial function decreased slightly. The observed change in LV pump performance was related to smaller LV chamber size and higher total peripheral resistance in older subjects. [ABSTRACT FROM AUTHOR]

Background: A 2015 expert consensus statement recommended that patients with cardiac implantable electronic devices receive remote monitoring and at least 1 in-office evaluation annually., Objective: The purpose of this study was to examine whether patients who underwent implantation of a new cardiac implantable electronic device received care concordant with consensus statement recommendations., Methods: We examined the rate of follow-up office visits and remote monitoring for 211,346 Medicare beneficiaries with an implantation of a new cardiac implantable electronic device between October 2015 and December 2020. We also assessed the characteristics of patients receiving follow-up care., Results: Within 16 weeks of implantation 77.8% of patients were seen in-office for a postoperative evaluation. The percentage of patients seen in office was 85.9% in the first 12 months, with 64.2% of patients seen in office every 2 years postimplantation, respectively. Following implantation, the percentage of beneficiaries receiving remote monitoring in the first 91 days was 14.7%, with 4.4% patients receiving remote monitoring every 91 days postimplantation within the first year. Patients who were ≥85 years old, nonwhite, or of lower income were less likely to receive office visits postimplantation., Conclusions: Although most Medicare beneficiaries were seen in-office in the year following a new implant, the percentage of beneficiaries with an in-office visit declined in subsequent years. Fewer than 5% of beneficiaries had remote monitoring at the frequency recommended by the expert consensus statement. Patient demographics, including older age, nonwhite race, and lower income were associated with a lower likelihood of receiving care concordant with consensus statement recommendations., Competing Interests: Disclosures Dr Al-Khatib acknowledges research funding from Medtronic and Boston Scientific paid to her institution. Dr Slotwiner and Dr Yu have no affiliation with any organization with a direct or indirect financial interest in the subject matter discussed in the article., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: Atrial fibrillation (AF) symptom relief is a primary indication for catheter ablation, but AF symptom resolution is not well characterized. The study objective was to describe AF symptom documentation in electronic health records (EHRs) pre- and post-ablation and identify correlates of post-ablation symptoms., Methods and Results: We conducted a retrospective cohort study using EHRs of patients with AF (n = 1293), undergoing ablation in a large, urban health system from 2010 to 2020. We extracted symptom data from clinical notes using a natural language processing algorithm (F score: 0.81). We used Cochran's Q tests with post-hoc McNemar's tests to determine differences in symptom prevalence pre- and post-ablation. We used logistic regression models to estimate the adjusted odds of symptom resolution by personal or clinical characteristics at 6 and 12 months post-ablation. In fully adjusted models, at 12 months post-ablation patients, patients with heart failure had significantly lower odds of dyspnoea resolution [odds ratio (OR) 0.38, 95% confidence interval (CI) 0.25-0.57], oedema resolution (OR 0.37, 95% CI 0.25-0.56), and fatigue resolution (OR 0.54, 95% CI 0.34-0.85), but higher odds of palpitations resolution (OR 1.90, 95% CI 1.25-2.89) compared with those without heart failure. Age 65 and older, female sex, Black or African American race, smoking history, and antiarrhythmic use were also associated with lower odds of resolution of specific symptoms at 6 and 12 months., Conclusion: The post-ablation symptom patterns are heterogeneous. Findings warrant confirmation with larger, more representative data sets, which may be informative for patients whose primary goal for undergoing an ablation is symptom relief., Competing Interests: Conflict of interest: M.R.T. and J.P. are affiliated with Iris OB Health LLC (equity). M.R.T. is affiliated with Boston Scientific Corp (consulting). The remaining authors have no disclosures., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: This study aims to leverage natural language processing (NLP) and machine learning clustering analyses to (1) identify co-occurring symptoms of patients undergoing catheter ablation for atrial fibrillation (AF) and (2) describe clinical and sociodemographic correlates of symptom clusters., Methods: We conducted a cross-sectional retrospective analysis using electronic health records data. Adults who underwent AF ablation between 2010 and 2020 were included. Demographic, comorbidity and medication information was extracted using structured queries. Ten AF symptoms were extracted from unstructured clinical notes (n=13 416) using a validated NLP pipeline (F-score=0.81). We used the unsupervised machine learning approach known as Ward's hierarchical agglomerative clustering to characterise and identify subgroups of patients representing different clusters. Fisher's exact tests were used to investigate subgroup differences based on age, gender, race and heart failure (HF) status., Results: A total of 1293 patients were included in our analysis (mean age 65.5 years, 35.2% female, 58% white). The most frequently documented symptoms were dyspnoea (64%), oedema (62%) and palpitations (57%). We identified six symptom clusters: generally symptomatic, dyspnoea and oedema, chest pain, anxiety, fatigue and palpitations, and asymptomatic (reference). The asymptomatic cluster had a significantly higher prevalence of male, white and comorbid HF patients., Conclusions: We applied NLP and machine learning to a large dataset to identify symptom clusters, which may signify latent biological underpinnings of symptom experiences and generate implications for clinical care. AF patients' symptom experiences vary widely. Given prior work showing that AF symptoms predict adverse outcomes, future work should investigate associations between symptom clusters and postablation outcomes., Competing Interests: Competing interests: MRT: Iris OB Health Inc., New York (co-founder/equity); Boston Scientific Corporation (consulting)., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: As a first step in developing a decision aid to support shared decision-making (SDM) for patients with atrial fibrillation (AF) to evaluate treatment options for rhythm and symptom control, we aimed to measure decision quality and describe decision-making processes among patients and clinicians involved in decision-making around catheter ablation for AF., Methods and Results: We conducted a cross-sectional, mixed-methods study guided by an SDM model outlining decision antecedents, processes, and outcomes. Patients and clinicians completed semi-structured interviews about decision-making around ablation, feelings of decision conflict and regret, and preferences for the content, delivery, and format of a hypothetical decision aid for ablation. Patients also completed surveys about AF symptoms and aspects of decision quality. Fifteen patients (mean age 71.1 ± 8.6 years; 27% female) and five clinicians were recruited. For most patients, decisional conflict and regret were low, but they also reported low levels of information and agency in the decision-making process. Most clinicians report routinely providing patients with information and encouraging engagement during consultations. Patients reported preferences for an interactive, web-based decision aid that clearly presents evidence regarding outcomes using data, visualizations, videos, and personalized risk assessments, and is available in multiple languages., Conclusion: Disconnects between clinician efforts to provide information and bolster agency and patient experiences of decision-making suggest decision aids may be needed to improve decision quality in practice. Reported experiences with current decision-making practices and preferences for decision aid content, format, and delivery can support the user-centred design and development of a decision aid., Competing Interests: Conflict of interest: MRT is a consultant for Boston Scientific and is affiliated and has equity ownership in Iris OB Health Inc., New York, a startup company focused on postpartum depression. No other authors have interests to disclose., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

An understanding of care delays and telehealth experiences during the pandemic among vulnerable patients, such as those with cardiac disease, is needed to inform future telehealth policy. We conducted a cross-sectional survey study with socioeconomically diverse cardiac patients (n=28) and clinicians (n=26). Most patients (89%) preferred to receive some or all of their care in-person during the pandemic and endorsed the lack of in-person visits as the top facilitator to telehealth use. Significantly more clinicians perceived high ease of use of video visits compared to patients (82% vs. 44%). Significantly more patients perceived high ease of learning to use (69% vs. 18%) and using (69% vs. 27%) remote monitoring compared to clinicians. Results suggest that patients are more open to receiving in-person care during the pandemic than clinicians recognize and may need greater support surrounding video visits when in-person care is not feasible or safe., (©2022 AMIA - All rights reserved.)

Background: Cardiac implantable electronic devices (CIEDs) may enable early identification of COVID-19 to facilitate timelier intervention., Objective: To characterize early physiologic changes associated with the onset of acute COVID-19 infection, as well as during and after acute infection, among patients with CIEDs., Methods: CIED sensor data from March 2020 to February 2021 from 286 patients with a CIED were linked to clinical data from electronic health records. Three cohorts were created: known COVID-positive (n = 20), known COVID-negative (n = 166), and a COVID-untested control group (n = 100) included to account for testing bias. Associations between changes in CIED sensors from baseline (including HeartLogic index, a composite index predicting worsening heart failure) and COVID-19 status were evaluated using logistic regression models, Wilcoxon signed rank tests, and Mann-Whitney U tests., Results: Significant differences existed between the cohorts by race, ethnicity, CIED device type, and medical admissions. Several sensors changed earlier for COVID-positive vs COVID-negative patients: HeartLogic index (mean 16.4 vs 9.2 days [ P = .08]), respiratory rate (mean 8.5 vs 3.9 days [ P = .01], and activity (mean 8.2 vs 3.5 days [ P = .008]). Respiratory rate during the 7 days before testing significantly predicted a positive vs negative COVID-19 test, adjusting for age, sex, race, and device type (odds ratio 2.31 [95% confidence interval 1.33-5.13])., Conclusion: Physiologic data from CIEDs could signal early signs of infection that precede clinical symptoms, which may be used to support early detection of infection to prevent decompensation in this at-risk population., (© 2022 Heart Rhythm Society.)

Natural language processing (NLP) is a set of automated methods to organise and evaluate the information contained in unstructured clinical notes, which are a rich source of real-world data from clinical care that may be used to improve outcomes and understanding of disease in cardiology. The purpose of this systematic review is to provide an understanding of NLP, review how it has been used to date within cardiology and illustrate the opportunities that this approach provides for both research and clinical care. We systematically searched six scholarly databases (ACM Digital Library, Arxiv, Embase, IEEE Explore, PubMed and Scopus) for studies published in 2015-2020 describing the development or application of NLP methods for clinical text focused on cardiac disease. Studies not published in English, lacking a description of NLP methods, non-cardiac focused and duplicates were excluded. Two independent reviewers extracted general study information, clinical details and NLP details and appraised quality using a checklist of quality indicators for NLP studies. We identified 37 studies developing and applying NLP in heart failure, imaging, coronary artery disease, electrophysiology, general cardiology and valvular heart disease. Most studies used NLP to identify patients with a specific diagnosis and extract disease severity using rule-based NLP methods. Some used NLP algorithms to predict clinical outcomes. A major limitation is the inability to aggregate findings across studies due to vastly different NLP methods, evaluation and reporting. This review reveals numerous opportunities for future NLP work in cardiology with more diverse patient samples, cardiac diseases, datasets, methods and applications., Competing Interests: Competing interests: MRT and JP are affiliated with Iris OB Health Inc., New York, a startup company focused on postpartum depression, and have equity ownership. MRT is a consultant for Boston Scientific Corporation., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States., Background: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported., Methods: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates., Results: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA 2 DS 2 -VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure., Conclusions: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute (grants R56HL142765 and R01HL142765). Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Boston Scientific; has received consulting honoraria from W.L. Gore, Baylis Medical, Philips, Biotronik, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; and has equity interest in Indian Wells. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; and has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr Rammohan has received consulting fees from Medtronic and Abbott Vascular. Dr Turi has received honoraria from Coherex for serving on the clinical events committee for the WAVECREST 2 (Wavecrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediated Stroke 2) trial. Dr Varosy has received salary support from the National Heart, Lung, and Blood Institute. Dr Curtis has an institutional contract with the American College of Cardiology for his role as senior scientific adviser of the NCDR; has received salary support from the American College of Cardiology and CMS; and has equity in Medtronic. Dr Masoudi has had an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Introduction: Nearly one-quarter of patients discharged from the hospital with heart failure (HF) are readmitted within 30 days, placing a significant burden on patients, families and health systems. The objective of the 'Using M obile I nte g rated H ealth and T elehealth to support transitions of care among patients with Heart failure ' (MIGHTy-Heart ) study is to compare the effectiveness of two postdischarge interventions on healthcare utilisation, patient-reported outcomes and healthcare quality among patients with HF., Methods and Analysis: The MIGHTy-Heart study is a pragmatic comparative effectiveness trial comparing two interventions demonstrated to improve the hospital to home transition for patients with HF: mobile integrated health (MIH) and transitions of care coordinators (TOCC). The MIH intervention bundles home visits from a community paramedic (CP) with telehealth video visits by emergency medicine physicians to support the management of acute symptoms and postdischarge care coordination. The TOCC intervention consists of follow-up phone calls from a registered nurse within 48-72 hours of discharge to assess a patient's clinical status, identify unmet clinical and social needs and reinforce patient education (eg, medication adherence and lifestyle changes). MIGHTy-Heart is enrolling and randomising (1:1) 2100 patients with HF who are discharged to home following a hospitalisation in two New York City (NY, USA) academic health systems. The coprimary study outcomes are all-cause 30-day hospital readmissions and quality of life measured with the Kansas City Cardiomyopathy Questionnaire 30 days after hospital discharge. The secondary endpoints are days at home, preventable emergency department visits, unplanned hospital admissions and patient-reported symptoms. Data sources for the study outcomes include patient surveys, electronic health records and claims submitted to Medicare and Medicaid., Ethics and Dissemination: All participants provide written or verbal informed consent prior to randomisation in English, Spanish, French, Mandarin or Russian. Study findings are being disseminated to scientific audiences through peer-reviewed publications and presentations at national and international conferences. This study has been approved by: Biomedical Research Alliance of New York (BRANY #20-08-329-380), Weill Cornell Medicine Institutional Review Board (20-08022605) and Mt. Sinai Institutional Review Board (20-01901)., Trial Registration Number: Clinicaltrials.gov, NCT04662541., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing cardiac pacing., Methods and Results: Under the auspice of the Clinical Practice Guideline Quality Indicator Committee of the European Society of Cardiology (ESC), the Working Group for cardiac pacing QIs was formed. The Group comprised Task Force members of the 2021 ESC Clinical Practice Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, members of the European Heart Rhythm Association, international cardiac device experts, and patient representatives. We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care by constructing a conceptual framework of the management of patients receiving cardiac pacing, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. Four domains of care were identified: (i) structural framework, (ii) patient assessment, (iii) pacing strategy, and (iv) clinical outcomes. In total, seven main and four secondary QIs were selected across these domains and were embedded within the 2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization therapy., Conclusion: By way of a standardized process, 11 QIs for cardiac pacing were developed. These indicators may be used to quantify adherence to guideline-recommended clinical practice and have the potential to improve the care and outcomes of patients receiving cardiac pacemakers., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area., (© 2021 Wiley Periodicals LLC.)

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/ Heart Rhythm Society/ European Heart Rhythm Association/ Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored., (This article has been co-published with the permission of Annals of Noninvasive Electrocardiology, Cardiovascular Digital Health Journal, Circulation: Arrhythmia and Electrophysiology, European Heart Journal - Digital Health and Journal of Arrhythmia. All rights reserved. © 2021 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals Inc. on behalf of the International Society for Holter and Noninvasive Electrocardiology / Cardiovascular Digital Health Journal published by Elsevier Inc. on behalf of the Heart Rhythm Society / Circulation: Arrhythmia and Electrophysiology published by Wolters Kluwer Health, Inc. on behalf of the American Heart Association, Inc. / European Heart Journal - Digital Health published by Oxford University Press on behalf of the European Society of Cardiology / Journal of Arrhythmia published by Wiley and Sons Australia Ltd on behalf of the Japanese Heart Rhythm Society and the Asia Pacific Heart Rhythm Society. This article is published under the Creative Commons CC-BY license, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. The articles are identical except for minor stylistic and spelling differences in keeping with each journal’s style. Either citation can be used when citing this article.)

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia-Pacific Heart Rhythm Society describes the current status of mobile health technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mobile health. The promises of predictive analytics but also operational challenges in embedding mobile health into routine clinical care are explored.

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored., (© 2020 2666-6936/ All rights reserved. \xA9 2021 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals Inc. on behalf of the International Society for Holter and Noninvasive Electrocardiology / Cardiovascular Digital Health Journal published by Elsevier Inc. on behalf of the Heart Rhythm Society / Circulation: Arrhythmia and Electrophysiology published by Wolters Kluwer Health, Inc. on behalf of the American Heart Association, Inc. / European Heart Journal \x96 Digital Health published by Oxford University Press on behalf of the European Society of Cardiology / Journal of Arrhythmia published by Wiley and Sons Australia Ltd on behalf of the Japanese Heart Rhythm Society and the Asia Pacific Heart Rhythm Society. This article is published under the Creative Commons CC-BY license, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. This is an open access article under the CC BY license.)

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology / Heart Rhythm Society / European Heart Rhythm Association / Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited., Objectives: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years., Methods: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates., Results: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA 2 DS 2 -VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare., Conclusions: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Free mobile applications (apps) that use photoplethysmography (PPG) waveforms may extend atrial fibrillation (AF) detection to underserved populations, but they have not been rigorously evaluated., Objective: The purpose of this study was to systematically review and evaluate the quality, functionality, and adherence to self-management behaviors of existing mobile apps for AF., Methods: We systematically searched 3 app stores for apps that were free, available in English, and intended for use by patients to detect and manage AF. A minimum of 2 reviewers evaluated (1) app quality, using the Mobile Application Rating Scale (MARS); (2) functionality using published criteria; and (3) features that support 4 self-management behaviors (including PPG waveform monitoring) identified using evidence-based guidelines. Interrater reliability between the reviewers was calculated., Results: Of 12 included apps, 5 (42%) scored above average for quality (MARS score ≥3.0). App quality was highest for their ease of use, navigation, layout, and visual appeal (eg, functionality and aesthetics) and lowest for their behavioral change support and subjective impressions of quality. The most common app functionalities were capturing and graphically displaying user-entered data (n = 9 [75%]). Nearly all apps (n = 11 [92%]) supported PPG waveform monitoring, but only 2 (17%) supported all 4 self-management behaviors. Interrater reliability was high (0.75-0.83)., Conclusion: The reviewed apps had wide variability in quality, functionality, and adherence to self-management behaviors. Given the accessibility of these apps to underserved populations and the tremendous potential they hold for improving AF detection and management, high priority should be given to improving app quality and functionality.

Pulmonary vein isolation (PVI) has been demonstrated to be a highly effective treatment option for patients with paroxysmal atrial fibrillation (AF), but less effective for patients with persistent AF. The lower efficacy of PVI alone has been attributed to adverse atrial electrical and structural remodelling in the setting of AF. Strategies to improve efficacy of catheter ablation for persistent AF alter these pathophysiological characteristics of atrial tissue remodelling. Here we will review the physiology of atrial electrical remodelling observed during AF and evidence that it is reversible. Further, we will explore its uses to reduce the amount of atrial tissue that needs to be ablated to successfully treat patients with persistent AF.

Early detection of decompensated heart failure enables clinicians to tailor medical therapy to individual patient needs. The utility of transthoracic impedance assessment in the early diagnosis of volume overload has been documented in the literature. We describe the case of a young woman without congestive heart failure who was noted to have cyclical variations of transthoracic impedances that correlated with her menstrual cycle and discuss other factors that may confound proper diagnosis of volume overload in patients with implantable cardioverter-defibrillators., (Copyright © 2013 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

In vitro experiments have shown that the complexity of atrioventricular nodal (AVN) conduction dynamics increases with heart rate. Although complex AVN dynamics (e.g., alternans) have been observed clinically, human AVN dynamics during rapid pacing have not been systematically investigated. We studied such dynamics during ventricular-triggered atrial pacing in 37 patients with normal AVN function (18 patients with dual AVN pathway physiology and 19 patients without). Alternans, which always resulted from single pathway conduction, occurred in 18 patients. In 16 patients (3 of whom also had alternans), quasisinusoidal AVN conduction oscillations occurred (mean frequency 0.02 Hz); such oscillations have not been previously reported. There were no significant differences in the dynamics for patients with or without dual AVN pathways. To illuminate the governing dynamic mechanism, a second atrial pacing trial was performed on 12 patients after autonomic blockade. Blockade facilitated alternans but inhibited oscillations. This study suggests that rapid AVN excitation in vivo can lead to autonomically mediated AVN conduction oscillations or single pathway alternans that are a function of inherent nonlinear dynamic AVN tissue properties.

Objectives: This study was designed to determine the incidence and prognostic significance of inducible ventricular fibrillation (VF) in patients with coronary artery disease (CAD) and unexplained syncope., Background: Current American College of Cardiology/American Heart Association practice guidelines recommend implantation of internal cardioverter-defibrillators (ICDs) in patients with unexplained syncope in whom either ventricular tachycardia (VT) or VF is inducible during electrophysiologic (EP) testing. Although the prognostic significance of inducible monomorphic VT is known, the significance of inducible VF remains undefined., Methods: We evaluated 118 consecutive patients with CAD and unexplained syncope who underwent EP testing. Sustained monomorphic VT was inducible in 53 (45%) patients; in 20 (17%) patients, VF was the only inducible arrhythmia; and no sustained ventricular arrhythmia was inducible in the remaining 45 (38%) patients. The latter two groups of 65 (55%) patients make up the study population., Results: There were 16 deaths among the study population during a follow-up period of 25.3 +/- 19.6 months. The overall one- and two-year survival in these patients was 89% and 81%, respectively. No significant difference in survival was observed between patients with and without inducible VF (80% power to detect a fourfold survival difference)., Conclusions: In 17% of patients with CAD and unexplained syncope, VF is the only inducible ventricular arrhythmia. Within the limits of this pilot study, long-term follow-up of patients with and without inducible VF demonstrates no difference in survival between the two groups. Therefore, the practice of ICD implantation in patients with CAD, unexplained syncope and inducible VF, especially with triple ventricular extrastimuli, may merit reconsideration.

Background: CVT-510, N-(3(R)-tetrahydrofuranyl)-6-aminopurine riboside, is a selective A(1)-adenosine receptor agonist with potential potent antiarrhythmic effects in tachycardias involving the atrioventricular (AV) node. This study, the first in humans, was designed to determine the effects of CVT-510 on AV nodal conduction and hemodynamics., Methods and Results: Patients in sinus rhythm with normal AV nodal function at electrophysiologic study (n = 32) received a single intravenous bolus of CVT-510. AH and HV intervals were measured during sinus rhythm and during atrial pacing at 1, 5, 10, 15, 20, 30, 45, and 60 minutes after the bolus. Increasing doses of CVT-510 (0.3 to 10 microg/kg) caused a dose-dependent increase in the AH interval. At 1 minute, a dose of 10 microg/kg increased the AH interval during sinus rhythm from 93 +/- 23 msec to 114 +/- 37 msec, p = 0.01 and from 114 +/- 31 msec to 146 +/- 44 msec during atrial pacing at 600 msec, p = 0.003). The AH interval returned to baseline by 20 minutes. CVT-510 at doses of 0.3 to 10 microg/kg had no effect on sinus rate, HV interval, or systemic blood pressure, and was not associated with serious adverse effects. At doses of 15 and 30 microg/kg, CVT-510 produced transient second/third degree AV heart block in all four patients treated. One of these patients also had a prolonged sedative effect that was reversed with aminophylline., Conclusions: CVT-510 promptly prolongs AV nodal conduction and does not affect sinus rate or blood pressure. Selective stimulation of the A(1)-adenosine receptor by CVT-510 may be useful for immediate control of heart rate in atrial fibrillation/flutter and to convert paroxysmal supraventricular tachycardia to sinus rhythm, while avoiding vasodilatation mediated by the A(2)-adenosine receptor, as well as the vasodepressor and negative inotropic effects associated with beta-adrenergic receptor blockade and/or calcium channel blockers.

Substantial data have been accumulated and indications have been well delineated for pacemaker implantation in the treatment of sinus node dysfunction and heart block. However, many other indications have been proposed for pacemaker implantation. In this review, the authors examine available data regarding pacemaker implantation for new indications: neurally mediated syncope, hypertrophic obstructive cardiomyopathy, congestive heart failure, prevention of atrial fibrillation, and the relative merits of single-chamber and dual-chamber pacemakers.

Nonlinear-dynamical control techniques, also known as chaos control, have been used with great success to control a wide range of physical systems. Such techniques have been used to control the behavior of in vitro excitable biological tissue, suggesting their potential for clinical utility. However, the feasibility of using such techniques to control physiological processes has not been demonstrated in humans. Here we show that nonlinear-dynamical control can modulate human cardiac electrophysiological dynamics by rapidly stabilizing an unstable target rhythm. Specifically, in 52/54 control attempts in five patients, we successfully terminated pacing-induced period-2 atrioventricular-nodal conduction alternans by stabilizing the underlying unstable steady-state conduction. This proof-of-concept demonstration shows that nonlinear-dynamical control techniques are clinically feasible and provides a foundation for developing such techniques for more complex forms of clinical arrhythmia.

Background: Although tilt testing has emerged as the test of choice for assessing patients with suspected neurally mediated syncope, the optimum duration of tilt testing is poorly defined. This in part relates to the absence of a gold standard to assess test performance., Objective: Our purpose was to formally estimate the effects of varying duration of drug-free tilt testing on test performance in diagnosing neurally mediated syncope., Design: If a test's specificity is known, then in the absence of a gold standard an imputed (estimated) sensitivity may be calculated on the basis of the observed diagnostic yield in a given population as a function of assumed population prevalence. We determined the relationship of specificity to drug-free tilt test duration by use of data from 11 previous studies reporting the results of drug-free tilt testing in a total of 435 control subjects (60 to 80 degrees of tilt, footboard support, 15- to 60-minute duration). Data (weighted for study size) were fit to an exponential function relating specificity to tilt duration. Test yield was evaluated as a function of tilt duration in 213 consecutive patients referred to our laboratory for the evaluation of suspected neurally mediated syncope who underwent passive tilt testing for up to 30 to 60 minutes., Results: The estimated specificity of tilt testing was 94% at 30 minutes, 92% at 40 minutes, and 88% after 60 minutes of passive tilt. The cumulative yield of tilt testing was only 17% at 30 minutes, 22% at 40 minutes, and 28% after 60 minutes. On the basis of an estimated population prevalence of 25% to 50% in this referral population, imputed sensitivity is 27% to 48% at 30 minutes, 36% to 64% at 40 minutes, and 43% to 74% after 60 minutes of passive tilt. The overall diagnostic accuracy was not strongly influenced by tilt duration beyond 30 minutes and ranged from 60% to 84%., Conclusions: Passive tilt testing (ie, tilt testing without pharmacologic provocation) for durations of up to 60 minutes has limited sensitivity for diagnosing neurally mediated syncope. For populations with a pretest likelihood of 25% to 50%, test results are inaccurate in one to two fifths of patients.

Idiopathic ventricular tachycardia (VT) is characterized by two predominant forms. The most common form originates from the right ventricular outflow tract and presents as repetitive monomorphic VT or exercise-induced VT. The tachycardia is adenosine sensitive and is thought to be because of cAMP-mediated triggered activity. The other major form of idiopathic VT is owing to verapamil-sensitive intrafascicular re-entrant tachycardia, which most often originates in the region of the left posterior fascicle. Both forms of idiopathic VT can be readily treated with radiofrequency catheter ablation.

Background: Clinical studies have shown that biphasic shocks are more effective than monophasic shocks for ventricular defibrillation. The purpose of this study was to compare the efficacy of a rectilinear biphasic waveform with a standard damped sine wave monophasic waveform for the transthoracic cardioversion of atrial fibrillation., Methods and Results: In this prospective, randomized, multicenter trial, patients undergoing transthoracic cardioversion of atrial fibrillation were randomized to receive either damped sine wave monophasic or rectilinear biphasic shocks. Patients randomized to the monophasic protocol (n=77) received sequential shocks of 100, 200, 300, and 360 J. Patients randomized to the biphasic protocol (n=88) received sequential shocks of 70, 120, 150, and 170 J. First-shock efficacy with the 70-J biphasic waveform (60 of 88 patients, 68%) was significantly greater than that with the 100-J monophasic waveform (16 of 77 patients, 21%, P<0.0001), and it was achieved with 50% less delivered current (11+/-1 versus 22+/-4 A, P<0.0001). Similarly, the cumulative efficacy with the biphasic waveform (83 of 88 patients, 94%) was significantly greater than that with the monophasic waveform (61 of 77 patients, 79%; P=0.005). The following 3 variables were independently associated with successful cardioversion: use of a biphasic waveform (relative risk, 4.2; 95% confidence intervals, 1.3 to 13.9; P=0.02), transthoracic impedance (relative risk, 0.64 per 10-Omega increase in impedance; 95% confidence intervals, 0.46 to 0.90; P=0.005), and duration of atrial fibrillation (relative risk, 0.97 per 30 days of atrial fibrillation; 95% confidence intervals, 0.96 to 0.99; P=0.02)., Conclusions: For transthoracic cardioversion of atrial fibrillation, rectilinear biphasic shocks have greater efficacy (and require less energy) than damped sine wave monophasic shocks.

Objectives: We compared the efficacy of a novel rectilinear biphasic waveform, consisting of a constant current first phase, with a damped sine wave monophasic waveform during transthoracic defibrillation., Background: Multiple studies have shown that for endocardial defibrillation, biphasic waveforms have a greater efficacy than monophasic waveforms. More recently, a 130-J truncated exponential biphasic waveform was shown to have equivalent efficacy to a 200-J damped sine wave monophasic waveform for transthoracic ventricular defibrillation. However, the optimal type of biphasic waveform is unknown., Methods: In this prospective, randomized, multicenter trial, 184 patients who underwent ventricular defibrillation were randomized to receive a 200-J damped sine wave monophasic or 120-J rectilinear biphasic shock., Results: First-shock efficacy of the biphasic waveform was significantly greater than that of the monophasic waveform (99% vs. 93%, p = 0.05) and was achieved with nearly 60% less delivered current (14 +/- 1 vs. 33 +/- 7 A, p < 0.0001). Although the efficacy of the biphasic and monophasic waveforms was comparable in patients with an impedance < 70 ohms (100% [biphasic] vs. 95% [monophasic], p = NS), the biphasic waveform was significantly more effective in patients with an impedance > or = 70 ohms (99% [biphasic] vs. 86% [monophasic], p = 0.02)., Conclusions: This study demonstrates a superior efficacy of rectilinear biphasic shocks as compared with monophasic shocks for transthoracic ventricular defibrillation, particularly in patients with a high transthoracic impedance. More important, biphasic shocks defibrillated with nearly 60% less current. The combination of increased efficacy and decreased current requirements suggests that biphasic shocks as compared with monophasic shocks are advantageous for transthoracic ventricular defibrillation.

Objectives: We evaluated the long-term outcome of patients with coronary artery disease and unexplained syncope who were treated with an electrophysiologic (EP)-guided approach., Background: Electrophysiologic studies are frequently performed to evaluate unexplained syncope in patients with coronary artery disease. Patients with this profile who have inducible ventricular tachycardia are considered at high risk for sudden death and increased overall mortality, and therefore are often treated with an implantable cardioverter-defibrillator (ICD). The impact of this EP-guided strategy is unknown because there are no data comparing the long-term outcome of ICD recipients with that of noninducible patients., Methods: We evaluated 67 consecutive patients with coronary artery disease and unexplained syncope. All patients were treated with an EP-guided approach that included ICD implantation in patients with inducible ventricular tachycardia., Results: Electrophysiologic testing suggested a plausible diagnosis in 32 (48%) of these patients. Inducible monomorphic ventricular tachycardia was the most common abnormality. Despite frequent appropriate therapy with ICDs, the total mortality for patients with inducible monomorphic ventricular tachycardia was significantly higher than for noninducible patients. The respective one- and two-year survival rates were 94% and 84% in noninducible patients and 77% and 45% in inducible patients (p = 0.02)., Conclusions: Electrophysiologic testing suggests an etiology for unexplained syncope in approximately 50% of patients and risk stratifies these patients with regard to long-term outcome. Patients who receive an ICD for the management of inducible ventricular tachycardia have a high incidence of spontaneous ventricular arrhythmias requiring ICD therapy. However, despite ICD implantation and frequent appropriate delivery of ICD therapies, patients with inducible ventricular tachycardia have a significantly worse prognosis than do those who are noninducible.