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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.

The ability to remotely reprogram a cardiac implantable electronic device (CIED) and the ability to remotely install software or firmware updates would reduce the need for in-office visits and could provide a mechanism to rapidly deploy important software or firmware updates. The challenges of implementing remote reprogramming of cardiac implantable electronic devices are no longer technical. Using asymmetric cryptography, sophisticated end-to-end secure communication protocols and hardware accelerators, the resources required to identify and take advantage of a cybersecurity vulnerability of a single CIED would be very significant and likely well beyond the gain that an intruder would deem worthwhile.

CMS' coverage with evidence development (CED) policy allows Medicare beneficiaries to access promising therapies and services while additional data are collected. CED program characteristics are mostly unreported, and qualities associated with retirement of CED data collection requirements are unknown. We aimed to review and systematically describe CED program history and components and report programmatic elements correlated with retirement of CED data collection requirements, while identifying areas for policy improvement.Systematic review.We extracted CED information from the CMS website, ClinicalTrials.gov, PubMed, internet searches, and communication with CMS.There were 27 CED determinations from 2005 to 2022 in 8 therapeutic areas, with the most for cardiovascular diseases (8/27; 30%). Duration of CED programs (range, 1-16 years) and the number of related registries and clinical trials (range, 0-34) were widely variable. Only 4 CEDs have had data collection requirements with continued National Coverage Determination (NCD); 3 relate to cardiovascular therapies, and all have some public availability of findings resulting from CED-related data collection mechanisms. There were 2 instances of NCD revocation and deferral to local coverage decisions.Changes in the CED program through improving program predictability and transparency with regard to outstanding questions, roles of relevant stakeholders, and requirements for reporting and reevaluation would strengthen the program's effectiveness. Ultimately, these improvements would provide incentives for stakeholder participation in data collection to achieve the goal of increasing access to beneficial therapies and improving clinical outcomes.

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.

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 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. Varma, N (corresponding author), Cleveland Clin, Cleveland, OH 44106 USA. varman@ccf.org

BACKGROUND Cardiac catheterization is among the most performed medical procedures in the modern era. There were sporadic reports indicating that cardiac arrhythmias are common during cardiac catheterization, and there are risks of developing serious and potentially life-threatening arrhythmias, such as sustained ventricular tachycardia (VT), ventricular fibrillation (VF) and high-grade conduction disturbances such as complete heart block (CHB), requiring immediate interventions. However, there is lack of systematic overview of these conditions. AIM To systematically review existing literature and gain better understanding of the incidence of cardiac arrhythmias during cardiac catheterization, and their impact on outcomes, as well as potential approaches to minimize this risk. METHODS We applied a combination of terms potentially used in reports describing various cardiac arrhythmias during common cardiac catheterization procedures to systematically search PubMed, EMBASE and Cochrane databases, as well as references of full-length articles. RESULTS During right heart catheterization (RHC), the incidence of atrial arrhythmias (premature atrial complexes, atrial fibrillation and flutter) was low (< 1%); these arrhythmias were usually transient and self-limited. RHC associated with the development of a new RBBB at a rate of 0.1%-0.3% in individuals with normal conduction system but up to 6.3% in individuals with pre-existing left bundle branch block. These patients may require temporary pacing due to transient CHB. Isolated premature ventricular complexes or non-sustained VT are common during RHC (up to 20% of cases). Sustained ventricular arrhythmias (VT and/or VF) requiring either withdrawal of catheter or cardioversion occurred infrequently (1%-1.3%). During left heart catheterizations (LHC), the incidence of ventricular arrhythmias has declined significantly over the last few decades, from 1.1% historically to 0.1% currently. The overall reported rate of VT/VF in diagnostic LHC and coronary angiography is 0.8%. The risk of VT/VF was higher during percutaneous coronary interventions for stable coronary artery disease (1.1%) and even higher for patients with acute myocardial infarctions (4.1%-4.3%). Intravenous adenosine and papaverine bolus for fractional flow reserve measurement, as well as intracoronary imaging using optical coherence tomography have been reported to induce VF. Although uncommon, LHC and coronary angiography were also reported to induce conduction disturbances including CHB. CONCLUSION Cardiac arrhythmias are common and potentially serious complications of cardiac catheterization procedures, and it demands constant vigilance and readiness to intervene during procedures.

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.

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.

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.

Introduction: Catheter ablation is a common treatment for atrial fibrillation (AF) with nuanced risks and benefits. Shared decision-making (SDM) could guide the decision to undergo ablation based on patient values and goals of care. Understanding whether and how SDM about ablation is conducted in clinical practice would allow us to determine how to optimize patient decision making and decision quality. The objective of this study was to investigate decision quality and SDM practices surrounding AF ablation. Methods: We conducted a mixed-methods study guided by Sepucha & Scholl’s (2014) SDM framework which specifies decision antecedents, processes, and outcomes. We recruited a convenience sample of AF ablation patients (n=15) and clinicians (n=5; 3 MDs, 1 PA, 1 NP) from a hospital in Queens, New York. Patients completed the AF Symptom Survey (AFSS), Controls-Preferences scale (CPS), and Decisional Conflict scale (DCS), which were summarized using descriptive statistics (median, interquartile range [IQR], and frequency). Patients and clinicians completed semi-structured interviews, which were analyzed using directed content analysis. Participants received $25 as compensation. The Weill Cornell Medicine IRB approved this study. Results: Patients’ median age was 71.0 years (IQR 69.0-78.5), 27% were female, 67% were White, and 73% spoke English. The median AFSS score was 0 (IQR 0-1.0) out of 35 indicating low symptom burden post-ablation. The median DCS score was 7.0 (IQR 0-16.4) out of 100 indicating low levels of conflict. On the CPS 4 patients (27%) preferred to have some control in decision-making; the remainder preferred to share control or relinquish it to clinicians. Qualitative findings underscore low levels of decisional conflict but limited patient agency (Table) . Conclusion: Findings suggest opportunities to improve decision quality surrounding AF ablation by bolstering patient agency, possibly through educational materials and decision aids.

It is unclear whether physiologic pacing by either cardiac biventricular pacing (BiVP) or His bundle pacing (HisBP) may prevent adverse structural and functional consequences known to occur among some patients who receive right ventricular pacing (RVP).Our analysis sought to review existing literature to determine if BiVP and/or HisBP might prevent adverse remodeling and be associated with structural, functional, and clinical advantages compared with RVP among patients without severe left ventricular dysfunction (35%) who required permanent pacing because of heart block.A literature search was conducted using MEDLINE (through PubMed) and Embase to identify randomized trials and observational studies comparing the effects of BiVP or HisBP versus RVP on measurements of left ventricular dimensions, left ventricular ejection fraction (LVEF), heart failure functional classification, quality of life, 6-minute walk, hospitalizations, and mortality. Data from studies that met the appropriate population, intervention, comparator, and outcomes of interest were abstracted for meta-analysis. Studies that reported pooled outcomes among patients with LVEF both above and below 35% could not be included in the meta-analysis because of strict relationships with industry procedures that preclude retrieval of industry-retained unpublished data on the subset of patients with preserved left ventricular function.Evidence from 8 studies, including a total of 679 patients meeting the prespecified criteria for inclusion, was identified. Results were compared for BiVP versus RVP, HisBP versus RVP, and BiVP+HisBP versus RVP. Among patients who received physiologic pacing with either BiVP or HisBP, the LV end-diastolic and end-systolic volumes were significantly lower (mean duration of follow-up: 1.64 years; -2.77 mL [95% CI -4.37 to -1.1 mL]; p=0.001; and -7.09 mL [95% CI -11.27 to -2.91; p=0.0009) and LVEF remained preserved or increased (mean duration of follow-up: 1.57 years; 5.328% [95% CI: 2.86%-7.8%; p0.0001). Data on clinical impact such as functional status and quality of life were not definitive. Data on hospitalizations were unavailable. There was no effect on mortality. Several studies stratified results by LVEF and found that patients with LVEF35% but ≤52% were more likely to receive benefit from physiologic pacing. Patients with chronic atrial fibrillation who underwent atrioventricular node ablation and pacemaker implant demonstrated clear improvement in LVEF with BiVP or HisBP versus RVP.Among patients with LVEF35%, the LVEF remained preserved or increased with either BiVP or HisBP compared with RVP. However, patient-centered clinical outcome improvement appears to be limited primarily to patients who have chronic atrial fibrillation with rapid ventricular response rates and have undergone atrioventricular node ablation.

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.

Reports in 2016 that St. Jude implantable defibrillators might be vulnerable to hacking brought to light how unprepared the medical community was to evaluate and manage a potential cybersecurity crisis. In this chapter, we provide an overview of the present cybersecurity landscape, including the existing infrastructure in place to minimize cybersecurity vulnerabilities and the important role that healthcare providers serve both in reducing the risks and advising patients.

The coronavirus disease 2019 crisis is a global pandemic of a novel infectious disease with far-ranging public health implications. With regard to cardiac electrophysiology (EP) services, we discuss the “real-world” challenges and solutions that have been essential for efficient and successful (1) ramping down of standard clinical practice patterns and (2) pivoting of workflow processes to meet the demands of this pandemic. The aims of these recommendations are to outline: (1) essential practical steps to approaching procedures, as well as outpatient and inpatient care of EP patients, with relevant examples, (2) successful strategies to minimize exposure risk to patients and clinical staff while also balancing resource utilization, (3) challenges related to redeployment and restructuring of clinical and support staff, and (4) considerations regarding continued collaboration with clinical and administrative colleagues to implement these changes. While process changes will vary across practices and hospital systems, we believe that these experiences from 4 different EP sections in a large New York City hospital network currently based in the global epicenter of the coronavirus disease 2019 pandemic will prove useful for other EP practices adapting their own practices in preparation for local surges.

Recent data suggest that in patients with advanced heart block and an implanted permanent pacemaker (PPM), permanent His-bundle pacing (PHBP) may reduce deleterious effects of right ventricular pacing. However, PHBP is not without some disadvantages, the most common being increased pacing threshold. We report a case of a patient with increased His-bundle pacing threshold that was associated with the administration of amiodarone.

Objectives To determine, using systematic review of the biomedical literature, whether pacing reduces risk of recurrent syncope and relevant clinical outcomes among adult patients with reflex-mediated syncope. Methods MEDLINE (through PubMed), EMBASE, and the Cochrane Central Register of Controlled Trials (through October 7, 2015) were searched for randomized trials and observational studies examining pacing and syncope, and the bibliographies of known systematic reviews were also examined. Studies were rejected for poor-quality study methods and for the lack of the population, intervention, comparator, or outcome(s) of interest. Results Of 3,188 citations reviewed, 10 studies met the inclusion criteria for systematic review, including a total of 676 patients. These included 9 randomized trials and 1 observational study. Of the 10 studies, 4 addressed patients with carotid sinus hypersensitivity, and the remaining 6 addressed vasovagal syncope. Among the 6 open-label (unblinded) studies, we found that pacing was associated with a 70% reduction in recurrent syncope (relative risk [RR]: 0.30; 95% confidence interval [CI]: 0.15–0.60). When the 2 analyzable studies with double-blinded methodology were considered separately, there was no clear benefit (RR: 0.73; 95% CI: 0.25–2.1), but confidence intervals were wide. The strongest evidence was from the randomized, double-blinded ISSUE-3 (Third International Study on Syncope of Uncertain Etiology) trial, which demonstrated a benefit of pacing among patients with recurrent syncope and asystole documented by implantable loop recorder. Conclusions There are limited data with substantive evidence of outcome ascertainment bias, and only 2 studies with a double-blinded study design have been conducted. The evidence does not support the use of pacing for reflex-mediated syncope beyond patients with recurrent vasovagal syncope and asystole documented by implantable loop recorder.

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. ispartof: EP-Europace vol:22 issue:11 pages:1742-+ ispartof: location:England status: Published online

Background: It is unclear whether physiologic pacing by either cardiac biventricular pacing (BiVP) or His bundle pacing (HisBP) may prevent adverse structural and functional consequences known to occur among some patients who receive right ventricular pacing (RVP). Aim: Our analysis sought to review existing literature to determine if BiVP and/or HisBP might prevent adverse remodeling and be associated with structural, functional, and clinical advantages compared with RVP among patients without severe left ventricular dysfunction (>35%) who required permanent pacing because of heart block. Methods: A literature search was conducted using MEDLINE (through PubMed) and Embase to identify randomized trials and observational studies comparing the effects of BiVP or HisBP versus RVP on measurements of left ventricular dimensions, left ventricular ejection fraction (LVEF), heart failure functional classification, quality of life, 6-minute walk, hospitalizations, and mortality. Data from studies that met the appropriate population, intervention, comparator, and outcomes of interest were abstracted for meta-analysis. Studies that reported pooled outcomes among patients with LVEF both above and below 35% could not be included in the meta-analysis because of strict relationships with industry procedures that preclude retrieval of industry-retained unpublished data on the subset of patients with preserved left ventricular function. Results: Evidence from 8 studies, including a total of 679 patients meeting the prespecified criteria for inclusion, was identified. Results were compared for BiVP versus RVP, HisBP versus RVP, and BiVP+HisBP versus RVP. Among patients who received physiologic pacing with either BiVP or HisBP, the LV end-diastolic and end-systolic volumes were significantly lower (mean duration of follow-up: 1.64 years; –2.77 mL [95% CI –4.37 to –1.1 mL]; P =0.001; and –7.09 mL [95% CI –11.27 to –2.91; P =0.0009) and LVEF remained preserved or increased (mean duration of follow-up: 1.57 years; 5.328% [95% CI: 2.86%–7.8%; P 35% but ≤52% were more likely to receive benefit from physiologic pacing. Patients with chronic atrial fibrillation who underwent atrioventricular node ablation and pacemaker implant demonstrated clear improvement in LVEF with BiVP or HisBP versus RVP. Conclusion: Among patients with LVEF >35%, the LVEF remained preserved or increased with either BiVP or HisBP compared with RVP. However, patient-centered clinical outcome improvement appears to be limited primarily to patients who have chronic atrial fibrillation with rapid ventricular response rates and have undergone atrioventricular node ablation.

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 CHA2DS2-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: 4 to 56) and for physicians was 12 (interquartile range: 0 to 14). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with 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.

The anticipated advantages of electronic health records (EHRs)-improved efficiency and the ability to share information across the healthcare enterprise-have so far failed to materialize. There is growing recognition that interoperability holds the key to unlocking the greatest value of EHRs. Health information technology (HIT) systems including EHRs must be able to share data and be able to interpret the shared data. This requires a controlled vocabulary with explicit definitions (data elements) as well as protocols to communicate the context in which each data element is being used (syntactic structure). Cardiac implantable electronic devices (CIEDs) provide a clear example of the challenges faced by clinicians when data is not interoperable. The proprietary data formats created by each CIED manufacturer, as well as the multiple sources of data generated by CIEDs (hospital, office, remote monitoring, acute care setting), make it challenging to aggregate even a single patient's data into an EHR. The Heart Rhythm Society and CIED manufacturers have collaborated to develop and implement international standard-based specifications for interoperability that provide an end-to-end solution, enabling structured data to be communicated from CIED to a report generation system, EHR, research database, referring physician, registry, patient portal, and beyond. EHR and other health information technology vendors have been slow to implement these tools, in large part, because there have been no financial incentives for them to do so. It is incumbent upon us, as clinicians, to insist that the tools of interoperability be a prerequisite for the purchase of any and all health information technology systems.

Supplemental Digital Content is available in the text., 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.

Atrial fibrillation (AF) is the most common arrhythmia in patients with acute myocardial infarction (AMI) and is associated with additional morbidity and mortality. While AMI outcomes have significantly improved in recent decades, AF remains a significant comorbidity. We analyzed the impact of

TABLE OF CONTENTS Preamble2 1. Introduction2 1.1. Key Questions3 2. Stroke Prevention in AF: Current Evidence and Guidelines3 3. Literature Review4 3.1. Background4 3.2. WATCHMAN4 3.3. Amplatzer Cardiac Plug7 3.4. LARIAT7 3.5. Other Percutaneous Devices and Surgical Approaches8 4. Care Team and Facilities8 4.1. Multidisciplinary Heart Team8 4.2. General Requirements9 4.3. Facilities9 5. Operator Training10 6. Protocols for Care10 7. Assessment of Patient Selection and Outcomes10 Appendix 1. Relevant Author Relationships With Industry and Other Entities–ACC/HRS/SCAI Left Atrial Appendage Occlusion Device Societal Overview14 Appendix 2. Reviewer Relationships With Industry And Other Entities–2015 ACC/HRS/SCAI Left Atrial Appendage Occlusion Device Societal Overview15

Objectives: To determine, using systematic review of the biomedical literature, whether pacing reduces risk of recurrent syncope and relevant clinical outcomes among adult patients with reflex-mediated syncope. Methods: MEDLINE (through PubMed), EMBASE, and the Cochrane Central Register of Controlled Trials (through October 7, 2015) were searched for randomized trials and observational studies examining pacing and syncope, and the bibliographies of known systematic reviews were also examined. Studies were rejected for poor-quality study methods and for the lack of the population, intervention, comparator, or outcome(s) of interest. Results: Of 3188 citations reviewed, 10 studies met the inclusion criteria for systematic review, including a total of 676 patients. These included 9 randomized trials and 1 observational study. Of the 10 studies, 4 addressed patients with carotid sinus hypersensitivity, and the remaining 6 addressed vasovagal syncope. Among the 6 open-label (unblinded) studies, we found that pacing was associated with a 70% reduction in recurrent syncope (relative risk [RR]: 0.30; 95% confidence interval [CI]: 0.15–0.60). When the 2 analyzable studies with double-blinded methodology were considered separately, there was no clear benefit (RR: 0.73; 95% CI: 0.25–2.1), but confidence intervals were wide. The strongest evidence was from the randomized, double-blinded ISSUE-3 (Third International Study on Syncope of Uncertain Etiology) trial, which demonstrated a benefit of pacing among patients with recurrent syncope and asystole documented by implantable loop recorder. Conclusions: There are limited data with substantive evidence of outcome ascertainment bias, and only 2 studies with a double-blinded study design have been conducted. The evidence does not support the use of pacing for reflex-mediated syncope beyond patients with recurrent vasovagal syncope and asystole documented by implantable loop recorder.

1. Introduction 95 2. Current Guidelines that Address ICD Use 95 3. Randomized Controlled Trials of ICD Therapy for Primary Prevention of Sudden Cardiac Death 96 4. ICD Implantation in the Context of an Abnormal Troponin that Is Not Due to a Myocardial Infarction 100 5. ICD Implantation Within 40 Days of a Myocardial Infarction 101 6. ICD Implantation Within 90 Days of Revascularization 105 7. ICD Implantation < 9 Months from the Initial Diagnosis of Nonischemic Cardiomyopathy 110 8. Dual-Chamber vs Single-Chamber ICD Recommendations 114 9. Documentation of Clinical Decisions 116 10. Future Research and Directions 117 The implantable cardioverter defibrillator (ICD) has emerged as an important treatment option for selected patients who are at risk of sudden cardiac death. Randomized trials have consistently shown that ICD implantation reduces mortality in patients with heart failure and reduced left ventricular function, as well as in patients who have suffered a cardiac arrest.1–3 Recommendations on the use of the ICD in clinical practice have been provided in four important guideline documents sponsored by the American College of Cardiology (ACC), the American Heart Association (AHA), Heart Rhythm Society (HRS), and the European Society of Cardiology (ESC).4–7 For each indication for ICD therapy, both a Class of indication (I, II, or III) and level of evidence for the indication (A, B, or C) are provided. To ensure that recommendations are evidence-based, Class I recommendations are typically based on the results of prospective randomized clinical trials. For example, in the ACC/AHA/HRS 2012 Focused Update of the …

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.

Richard J. Kovacs, MD, FACC, Chair Deepak Bhatt, MD, FACC Ralph Brindis, MD, MPH, MACC Paul N. Casale, MD, MPH, FACC Edward T.A. Fry, MD, FACC Paul A. Heidenreich, MD, FACC Jeffrey P. Jacobs, MD, FACC James L. Januzzi, Jr, MD, FACC Amy L. Miller, MD, PhD, FACC Athena Poppas, MD, FACC

Physicians are in an excellent position to significantly contribute to medical device innovation, but the process of bringing an idea to the bedside is complex. To begin to address these perceived barriers, the Heart Rhythm Society convened a forum of stakeholders in medical device innovation in conjunction with the 2015 Heart Rhythm Society Annual Scientific Sessions. The forum facilitated open discussion on medical device innovation, including obstacles to physician involvement and possible solutions. This report is based on the themes that emerged. First, physician innovators must take an organized approach to identifying unmet clinical needs and potential solutions. Second, extensive funds, usually secured through solicitation for investment, are often required to achieve meaningful progress, developing an idea into a device. Third, planning for regulatory requirements of the US Food and Drug Administration and Centers for Medicare & Medicaid Services is essential. In addition to these issues, intellectual property and overall trends in health care, including international markets, are critically relevant considerations for the physician innovator. Importantly, there are a number of ways in which professional societies can assist physician innovators to navigate the complex medical device innovation landscape, bring clinically meaningful devices to market more quickly, and ultimately improve patient care. These efforts include facilitating interaction between potential collaborators through scientific meetings and other gatherings; collecting, evaluating, and disseminating state-of-the-art scientific information; and representing the interests of members in interactions with regulators and policymakers.

Background— The Sprint Fidelis implantable cardioverter-defibrillator lead was recalled in 2007 because of an elevated risk of lead fracture. Several studies have demonstrated an accelerating risk of lead failure over time. We sought to identify predictors and characterize trends of Fidelis lead failure. Methods and Results— We evaluated 604 Fidelis leads with ≥90 days of follow-up implanted at our institution. Fidelis lead survival was analyzed by the Kaplan-Meier method. Analysis of log-log plots of cumulative hazard plots was performed to assess changes in lead failure rate over time. During follow-up of 3.3±1.7 years, 51 (8.4%) Fidelis lead failures were identified. The 3-year and 5-year Fidelis lead survival rates were 93.5% and 85.3%, respectively. Female sex was the only significant predictor of lead failure (heart rate, 2.1; 95% CI, 1.1–3.9; P P Conclusions— After 3 years, failure rates of Fidelis leads stabilize but at a significantly elevated rate. Female sex is associated with a doubling of the risk of Fidelis lead failure. These findings have implications for Fidelis lead management decisions that are based on the prediction of lead failure risk.

2011;57;1330-1337; originally published online Feb 14, 2011; J. Am. Coll. Cardiol. Richard L. Page, David J. Slotwiner, William G. Stevenson, and Cynthia M. Tracy Michael D. Ezekowitz, Warren M. Jackman, Craig T. January, James E. Lowe, L. Samuel Wann, Anne B. Curtis, Kenneth A. Ellenbogen, N.A. Mark Estes, III, on Practice Guidelines of Cardiology Foundation Foundation/American Heart Association Task Force Atrial Fibrillation (Update on Dabigatran): A Report of the American College 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With This information is current as of March 11, 2012 http://content.onlinejacc.org/cgi/content/full/57/11/1330 located on the World Wide Web at: The online version of this article, along with updated information and services, is

Valentin Fuster, MD, PhD, FACC, FAHA, FESC, Co-Chair; Lars E. Ryden, MD, PhD, FACC, FESC, FAHA, Co-Chair; David S. Cannom, MD, FACC; Harry J. Crijns, MD, FACC, FESC; Anne B. Curtis, MD, FACC, FAHA; Kenneth A. Ellenbogen, MD, FACC, FHRS† Jonathan L. Halperin, MD, FACC, FAHA; G. Neal Kay, MD, FACC