RESUMEN
Wearable devices are increasingly used by a growing portion of the population to track health and illnesses. The data emerging from these devices can potentially transform health care. This requires an interoperability framework that enables the deployment of platforms, sensors, devices, and software applications within diverse health systems, aiming to facilitate innovation in preventing and treating cardiovascular disease. However, the current data ecosystem includes several noninteroperable systems that inhibit such objectives. The design of clinically meaningful systems for accessing and incorporating these data into clinical workflows requires strategies to ensure the quality of data and clinical content and patient and caregiver accessibility. This scientific statement aims to address the best practices, gaps, and challenges pertaining to data interoperability in this area, with considerations for (1) data integration and the scope of measures, (2) application of these data into clinical approaches/strategies, and (3) regulatory/ethical/legal issues.
Asunto(s)
American Heart Association , Enfermedades Cardiovasculares , Monitoreo Ambulatorio , Humanos , Enfermedades Cardiovasculares/terapia , Enfermedades Cardiovasculares/diagnóstico , Interoperabilidad de la Información en Salud , Monitoreo Ambulatorio/métodos , Monitoreo Ambulatorio/normas , Estados Unidos , Dispositivos Electrónicos VestiblesRESUMEN
Cardiac physiologic pacing (CPP), encompassing cardiac resynchronization therapy (CRT) and conduction system pacing (CSP), has emerged as a pacing therapy strategy that may mitigate or prevent the development of heart failure (HF) in patients with ventricular dyssynchrony or pacing-induced cardiomyopathy. This clinical practice guideline is intended to provide guidance on indications for CRT for HF therapy and CPP in patients with pacemaker indications or HF, patient selection, pre-procedure evaluation and preparation, implant procedure management, follow-up evaluation and optimization of CPP response, and use in pediatric populations. Gaps in knowledge, pointing to new directions for future research, are also identified.
RESUMEN
Cardiac physiologic pacing (CPP), encompassing cardiac resynchronization therapy (CRT) and conduction system pacing (CSP), has emerged as a pacing therapy strategy that may mitigate or prevent the development of heart failure (HF) in patients with ventricular dyssynchrony or pacing-induced cardiomyopathy. This clinical practice guideline is intended to provide guidance on indications for CRT for HF therapy and CPP in patients with pacemaker indications or HF, patient selection, pre-procedure evaluation and preparation, implant procedure management, follow-up evaluation and optimization of CPP response, and use in pediatric populations. Gaps in knowledge, pointing to new directions for future research, are also identified.
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Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca , Niño , Humanos , Fascículo Atrioventricular , Resultado del Tratamiento , Trastorno del Sistema de Conducción Cardíaco , Terapia de Resincronización Cardíaca/métodos , Insuficiencia Cardíaca/terapia , Electrocardiografía/métodosRESUMEN
OBJECTIVES: 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. STUDY DESIGN: Systematic review. METHODS: We extracted CED information from the CMS website, ClinicalTrials.gov, PubMed, internet searches, and communication with CMS. RESULTS: 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. CONCLUSIONS: 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.
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Medicare , Enfermedades no Transmisibles , Anciano , Humanos , Desarrollo de Programa , Sistema de Registros , Estados UnidosRESUMEN
Shared decision-making (SDM) empowers patients and care teams to determine the best treatment plan in alignment with the patient's preferences and goals. Decision aids are proven tools to support high quality SDM. Patients with atrial fibrillation (AF), the most common cardiac arrhythmia, struggle to identify optimal rhythm and symptom management strategies and could benefit from a decision aid. In this Brief Research Report, we describe the development and preliminary evaluation of an interactive decision-making aid for patients with AF. We employed an iterative, user-centered design method to develop prototypes of the decision aid. Here, we describe multiple iterations of the decision aid, informed by the literature, expert feedback, and mixed-methods design sessions with AF patients. Results highlight unique design requirements for this population, but overall indicate that an interactive decision aid with visualizations has the potential to assist patients in making AF treatment decisions. Future work can build upon these design requirements to create and evaluate a decision aid for AF rhythm and symptom management.
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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.
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Desfibriladores Implantables , Marcapaso Artificial , Seguridad Computacional , Electrónica , HumanosRESUMEN
The tools of digital health are facilitating a much-needed paradigm shift to a more patient-centric health care delivery system, yet our health care infrastructure is firmly rooted in a 20th-century model that was not designed to receive medical data from outside the traditional medical environment. COVID-19 has accelerated this adoption and illustrated the challenges that lie ahead as we make this shift. The diverse ecosystem of digital health tools share 1 feature in common: they generate data that must be processed, triaged, acted upon, and incorporated into the longitudinal electronic health record. Critical abnormal findings must be identified and acted upon rapidly, while semi-urgent and noncritical data and trends may be reviewed within a less urgent timeline. Clinically irrelevant findings, which presently comprise a significant percentage of the alerts, ideally would be removed to optimize the high-cost, high-value resource (ie, the clinicians' attention and time). We need to transform our established health care infrastructure, technologies, and workflows to be able to safely, effectively, and efficiently manage the vast quantities of data that these tools will generate. This must include new technologies from industry as well as expert consensus documents from medical specialty societies, including the Heart Rhythm Society. Ultimately, research will be fundamental to inform effective development and implementation of these tools.
RESUMEN
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.
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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.
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Atención Ambulatoria/tendencias , Electrofisiología Cardíaca , Infecciones por Coronavirus , Reestructuración Hospitalaria , Control de Infecciones , Pandemias , Manejo de Atención al Paciente , Neumonía Viral , Telemedicina/tendencias , Betacoronavirus/aislamiento & purificación , COVID-19 , Electrofisiología Cardíaca/métodos , Electrofisiología Cardíaca/organización & administración , Electrofisiología Cardíaca/tendencias , Gestión del Cambio , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/terapia , Vías Clínicas/tendencias , Reestructuración Hospitalaria/métodos , Reestructuración Hospitalaria/organización & administración , Hospitalización/tendencias , Hospitales Urbanos/organización & administración , Humanos , Control de Infecciones/métodos , Control de Infecciones/organización & administración , Ciudad de Nueva York , Manejo de Atención al Paciente/métodos , Manejo de Atención al Paciente/organización & administración , Manejo de Atención al Paciente/tendencias , Neumonía Viral/epidemiología , Neumonía Viral/terapia , SARS-CoV-2Asunto(s)
Arritmias Cardíacas/terapia , Electrofisiología Cardíaca , Desfibriladores Implantables , Registros Electrónicos de Salud/normas , Colaboración Intersectorial , Marcapaso Artificial , American Heart Association , Electrofisiología Cardíaca/instrumentación , Electrofisiología Cardíaca/métodos , Electrofisiología Cardíaca/tendencias , Exactitud de los Datos , Humanos , Difusión de la Información/métodos , Registro Médico Coordinado/métodos , Evaluación de Necesidades , Estados UnidosAsunto(s)
Electrofisiología Cardíaca , Enfermedades Cardiovasculares , Difusión de la Información/ética , Telemedicina , Dispositivos Electrónicos Vestibles/ética , Acceso a la Información , Electrofisiología Cardíaca/ética , Electrofisiología Cardíaca/instrumentación , Electrofisiología Cardíaca/métodos , Electrofisiología Cardíaca/tendencias , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/terapia , Confidencialidad/ética , Necesidades y Demandas de Servicios de Salud , Humanos , Legislación de Dispositivos Médicos , Registro Médico Coordinado/métodos , Monitoreo Ambulatorio/métodos , Participación de los Interesados , Telemedicina/ética , Telemedicina/instrumentación , Telemedicina/legislación & jurisprudencia , Telemedicina/normasRESUMEN
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<0.0001). 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 LVEF >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.
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Bradicardia/patología , Trastorno del Sistema de Conducción Cardíaco/patología , Estimulación Cardíaca Artificial/métodos , Función Ventricular Izquierda/fisiología , Fibrilación Atrial/complicaciones , Bradicardia/complicaciones , Bradicardia/terapia , Trastorno del Sistema de Conducción Cardíaco/complicaciones , Trastorno del Sistema de Conducción Cardíaco/terapia , Humanos , Guías de Práctica Clínica como Asunto , Calidad de Vida , Volumen SistólicoRESUMEN
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<0.0001). 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 LVEF >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.
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Estimulación Cardíaca Artificial/métodos , Bloqueo Cardíaco/terapia , Estimulación Cardíaca Artificial/efectos adversos , Humanos , Volumen Sistólico , Remodelación VentricularRESUMEN
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<0.0001). 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 LVEF >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.
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Bradicardia , Trastorno del Sistema de Conducción Cardíaco , Terapia de Resincronización Cardíaca , Sistema de Conducción Cardíaco/fisiopatología , Volumen Sistólico , American Heart Association , Bradicardia/fisiopatología , Bradicardia/terapia , Trastorno del Sistema de Conducción Cardíaco/fisiopatología , Trastorno del Sistema de Conducción Cardíaco/terapia , Terapia de Resincronización Cardíaca/efectos adversos , Terapia de Resincronización Cardíaca/métodos , Ventrículos Cardíacos/fisiopatología , Humanos , Guías de Práctica Clínica como Asunto , Resultado del Tratamiento , Estados Unidos , Remodelación VentricularRESUMEN
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.