RESUMO
BACKGROUND: The National Cardiovascular Data Registry (NCDR) AFib Ablation Registry was created to assess real-world prevalence, demographic characteristics, procedural management, and outcomes of patients undergoing atrial fibrillation (AF) ablation procedures. OBJECTIVES: The goal of this study was to characterize the patient, hospital, and physician characteristics and in-hospital outcomes related to AF ablation in the first 5 years of the registry. METHODS: This paper describes the AFib Ablation Registry structure and governance, outcome assessment processes, data quality, and data collection processes. The characteristics of the patient population, hospitals, and in-hospital outcomes are also described. RESULTS: A total of 76,219 patients were included in the registry between January 2016 and December 2020 (mean age 65.5 ± 10.3 years, 65.2% male, 55.8% paroxysmal AF, mean CHA2DS2-VASc score 2.7 ± 1.6) treated by 708 physicians in 162 hospitals. Successful isolation of all pulmonary veins was achieved in 92.4% of patients. The prevalence of any complication during procedural admission was 2.50% and major complication was 0.9%, including significant bradycardia in 0.47%, heart failure in 0.47%, and pericardial effusion requiring intervention in 0.44%. Hospitalization >1 day occurred in 11.8% of patients, and in-hospital death was rare (n = 41 [0.05%]). CONCLUSIONS: The NCDR AFib Ablation Registry is the largest multicenter, prospective cohort study of patients undergoing catheter ablation worldwide. Results in the first 5 years showed that successful pulmonary vein isolation is achieved in the majority of patients, with a low rate of complications. Future studies from the registry will assess practice trends, evaluate treatment patterns associated with different patient outcomes, and support development of evidence-based guidelines.
Assuntos
Fibrilação Atrial , Sistema Cardiovascular , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Mortalidade Hospitalar , Estudos Prospectivos , Sistema de RegistrosRESUMO
Post-market evaluation is important to ensure the ongoing safety and effectiveness of cardiovascular implantable electronic device (CIED) leads. The Twenty-First Century Cures Act and subsequent Food and Drug Administrative (FDA) Guidance provide an opportunity to leverage real-world data sources for this purpose. The past 4 years have seen the development of EP PASSION: a multi-stakeholder, collaborative effort between the FDA, CIED manufacturers, Heart Rhythm Society, and academics. Using real-world data, EP PASSION enables longitudinal evaluation of the long-term safety of CIED leads, addressing limitations of current approaches to generate evidence that informs regulatory, clinical, and manufacturer decision-making. This state of the art article describes the impetus for and launch of EP PASSION, the lessons learned, its current state, the current analytic approach, and the strengths and limitations of leveraging extant data sources for post-market lead evaluation. We also compare EP PASSION to traditional post-approval studies and describe possible future directions.
Assuntos
Eletrofisiologia Cardíaca , Desfibriladores Implantáveis , Humanos , Pulmão , Sistema de RegistrosRESUMO
BACKGROUND: Current methods to identify cardiovascular implantable electronic device lead failure include postapproval studies, which may be limited in scope, participant numbers, and attrition; studies relying on administrative codes, which lack specificity; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead. OBJECTIVE: The purpose of this study was to determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation. METHODS: Among 48,191 actively monitored patients with a cardiovascular implantable electronic device, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between April 1, 2019, and April 1, 2021. We queried electronic health record and Medicare fee-for-service claims data to determine whether patients had administrative codes for lead failure. We verified lead failure through manual electronic health record review. RESULTS: Of the 48,191 patients, 1170 (2.4%) had incident lead abnormalities detected by RM. Of these, 409 patients had administrative codes for lead failure, and 233 of these 409 patients (57.0%) had structural lead failure verified through chart review. Of the 761 patients without administrative codes, 167 (21.9%) had structural lead failure verified through chart review. Thus, 400 patients with RM transmissions suggestive of lead abnormalities (34.2%) had structural lead failure. In addition, 200 patients without preceding abnormal RM transmissions had leads abandoned or extracted for structural failure, making the total lead failure cohort 600 patients (66.7% with RM abnormalities, 33.3% without). Patients with isolated right atrial or left ventricular lead failure were less likely to have lead replacement and administrative codes reflective of lead failure. CONCLUSION: RM may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.
Assuntos
Desfibriladores Implantáveis , Insuficiência Cardíaca , Idoso , Humanos , Estados Unidos/epidemiologia , Desfibriladores Implantáveis/efeitos adversos , Medicare , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Monitorização Fisiológica/métodosRESUMO
Almost all electrophysiology (EP) devices need to obtain premarket approval before they can be commercially sold and available for use in the community. The US Food and Drug Administration (FDA) has different paths to market approval depending on the intended use and the associated risks of the device. The European Union and Japan have device approval processes that have many similarities as well as differences to the US regulatory system. This paper describes some of the history and background of the US device approval process with an emphasis on EP devices. It provides an overview of the different regulatory pathways in the USA that are currently being utilized and contrasts them to the procedures often used in the European Union and in Japan. It also touches on the impact of the twenty-first Century Cures Act and how the balance between premarket and postmarket regulatory oversight is continually being examined and refined.
Assuntos
Eletrofisiologia Cardíaca/instrumentação , Aprovação de Equipamentos , Segurança de Equipamentos , União Europeia , Humanos , Japão , Vigilância de Produtos Comercializados , Estados Unidos , United States Food and Drug AdministrationRESUMO
A survey found that of cardiology services were widely available at facilities across the US Department of Veterans Affairs, but the types of services varied considerably based on facility complexity.
Assuntos
Bradicardia/diagnóstico , Doença do Sistema de Condução Cardíaco/diagnóstico , Agonistas Adrenérgicos beta/uso terapêutico , Algoritmos , Bradicardia/genética , Bradicardia/terapia , Broncodilatadores/uso terapêutico , Bloqueadores dos Canais de Cálcio/uso terapêutico , Doença do Sistema de Condução Cardíaco/genética , Doença do Sistema de Condução Cardíaco/terapia , Cardiotônicos/uso terapêutico , Eletrocardiografia/métodos , Testes Genéticos/métodos , HumanosAssuntos
Bradicardia/diagnóstico , Doença do Sistema de Condução Cardíaco/diagnóstico , Antagonistas Adrenérgicos beta/uso terapêutico , Arritmias Cardíacas/etiologia , Bradicardia/complicações , Bradicardia/epidemiologia , Bradicardia/terapia , Doença do Sistema de Condução Cardíaco/complicações , Doença do Sistema de Condução Cardíaco/epidemiologia , Doença do Sistema de Condução Cardíaco/terapia , Eletrocardiografia , Fenômenos Eletrofisiológicos , Epilepsia/complicações , Cardiopatias/complicações , Cardiopatias/congênito , Humanos , Infarto do Miocárdio/complicações , Qualidade de VidaAssuntos
Bradicardia/terapia , Doença do Sistema de Condução Cardíaco/terapia , Estimulação Cardíaca Artificial , Bradicardia/diagnóstico , Doença do Sistema de Condução Cardíaco/diagnóstico , Doença do Sistema de Condução Cardíaco/etiologia , Gerenciamento Clínico , Humanos , Síndromes da Apneia do Sono/complicaçõesAssuntos
American Heart Association , Cardiologia , Comitês Consultivos , Bradicardia , Humanos , Sociedades , Estados UnidosAssuntos
Bradicardia , Doença do Sistema de Condução Cardíaco , Terapia de Ressincronização Cardíaca/métodos , Procedimentos Cirúrgicos Cardíacos , Fármacos Cardiovasculares/farmacologia , Técnicas Eletrofisiológicas Cardíacas/métodos , Qualidade de Vida , American Heart Association , Bradicardia/etiologia , Bradicardia/fisiopatologia , Bradicardia/terapia , Doença do Sistema de Condução Cardíaco/etiologia , Doença do Sistema de Condução Cardíaco/fisiopatologia , Doença do Sistema de Condução Cardíaco/terapia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/métodos , Frequência Cardíaca/efeitos dos fármacos , Frequência Cardíaca/fisiologia , Humanos , Administração dos Cuidados ao Paciente/métodos , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Estados UnidosAssuntos
Bradicardia , Doença do Sistema de Condução Cardíaco , Terapia de Ressincronização Cardíaca/métodos , Procedimentos Cirúrgicos Cardíacos , Fármacos Cardiovasculares/farmacologia , Técnicas Eletrofisiológicas Cardíacas/métodos , Qualidade de Vida , American Heart Association , Bradicardia/etiologia , Bradicardia/fisiopatologia , Bradicardia/terapia , Doença do Sistema de Condução Cardíaco/etiologia , Doença do Sistema de Condução Cardíaco/fisiopatologia , Doença do Sistema de Condução Cardíaco/terapia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/métodos , Frequência Cardíaca/efeitos dos fármacos , Frequência Cardíaca/fisiologia , Humanos , Administração dos Cuidados ao Paciente/métodos , Seleção de Pacientes , Estados UnidosRESUMO
The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.