Comparative effectiveness of catheter ablation vs medical therapy for atrial fibr

导管消融与药物治疗对心房纤维的疗效比较

• 批准号: 8487609
• 负责人: James Freeman
• 金额: $ 15.9万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8487609
• 关键词: Ablation; Accounting; Acute; Adherence; Adult; Adverse event; Advisory Committees; Affect; Age; Alcohol abuse; Arrhythmia; Atrial Fibrillation; Attitude to Health; California; Cardiac Tamponade; Cardiac ablation; Cardiovascular system; Caring; Cessation of life; Characteristics; Clinical Data; Clinical Research; Clinical Treatment; Clinical Trials; Clinics and Hospitals; Cold Therapy; Congestive Heart Failure; Cross-Sectional Studies; Data; Decision Making; Enrollment; Esophageal Fistula; Europe; Event; Funding; Goals; Health behavior; Healthcare Systems; Heart Atrium; Hemorrhage; Hospitalization; Incidence; Intracranial Hemorrhages; Ischemic Stroke; Knowledge; Left; Left Ventricular Ejection Fraction; Medical; Medical History; Medicine; Mentors; Methods; Outcome; Paralysed; Patient Self-Report; Patients; Pharmaceutical Preparations; Pneumothorax; Population; Procedures; Pulmonary veins; Quality of life; Randomized; Recording of previous events; Recurrence; Research Methodology; Research Personnel; Resources; Risk; Safety; Series; Socioeconomic Status; Stroke; Structural Models; Structure of phrenic nerve; Subgroup; Tobacco use; Training; Training Programs; Transient Ischemic Attack; United States; base; career; comparative effectiveness; cost effective; cost effectiveness; density; high risk; hospital readmission; improved; innovation; insight; mortality; novel; patient oriented; public health relevance; radiofrequency; sex; skills; treatment strategy

DESCRIPTION (provided by applicant): This proposal entails a five-year training program focused on preparing James V Freeman, MD, MPH, MS, for an independent career in patient-oriented academic cardiovascular medicine. This proposal aims to impart the skills and knowledge required for the applicant to achieve his long-term goal of contributing insights into the best clinical treatment strategies for patients with cardiac arrhythmias, and particularly atril fibrillation. The applicant's immediate training objectives are to master fundamental clinical research methods, perform coursework that will expand his understanding of advanced methods, develop administrative skills required to function autonomously, and compose a body of work that will enable him to obtain funding as an independent investigator. Under the guidance of his long-term mentors, Mark Hlatky and Alan Go, as well as a carefully selected advisory committee of senior investigators, he will have the resources and support to achieve these goals and transition to independence. PROJECT DESCRIPTION Atrial fibrillation (AF) affects over 2.3 million adults in the United States and this number is projected to increase to at least 5.6 million by 2050. Catheter ablation for atrial fibrillation (AF), using radiofrequency energy or cryotherapy to electrically isolate the pulmonary veins and eliminate arrhythmia foci, is a new therapy that is currently used to treat 50,000 patients per year in the United States and 60,000 patients per year in Europe. Randomized studies suggest that AF ablation may decrease arrhythmia burden and improve quality of life, but the procedure has also been associated with a 1-10% rate of procedural complications. No randomized studies to date have demonstrated the long term impact of the procedure on death, ischemic stroke, intracranial hemorrhage and hospitalization and the one ongoing randomized study includes a very selected trial population and has had significant patient enrollment challenges. We propose a series of analyses in real- world patients with AF, to close some of the major evidence gaps related to AF ablation. The proposed project will use standard and innovative methods to analyze clinical data from Kaiser Permanente Northern California and Southern California (two health care systems for over 6.5 million people) and a novel cross-sectional survey study to achieve four specific aims: 1) to establish whether atrial fibrillation ablation is associated with long-term mortality, ischemic stroke, intracranial hemorrhage and hospitalization in patients with atrial fibrillation; ) to determine the risk of procedure-related adverse safety events associated with atrial fibrillatio ablation, the predictors of these adverse events, and the rate of recurrent hospitalization and death after these events; 3) to estimate the cost-effectiveness of atrial fibrillation ablation incorporating long-term estimates of death, ischemic stroke, intracranial hemorrhage and hospitalization; 4) to assess patient-centered characteristics which inform the decision to undergo atrial fibrillation ablation and barriers to treatment with ablation.

描述（由申请人提供）：这项建议需要一个为期五年的培训计划，重点是准备詹姆斯V弗里曼，医学博士，公共卫生硕士，MS，在以患者为导向的学术心血管医学的独立职业生涯。该提案旨在传授申请人所需的技能和知识，以实现其长期目标，即为心律失常患者（特别是房颤患者）的最佳临床治疗策略提供见解。申请人的直接培训目标是掌握基本的临床研究方法，执行课程，这将扩大他对先进方法的理解，发展自主运作所需的管理技能，并组成一个工作机构，使他能够获得资金作为一个独立的研究者。在他的长期导师Mark Hlatky和Alan Go以及精心挑选的高级调查员咨询委员会的指导下，他将获得实现这些目标并向独立过渡的资源和支持。房颤（AF）影响了美国230多万成年人，预计这一数字将增加到 到2050年至少有560万人。心房颤动（AF）的导管消融术，使用射频能量或冷冻疗法电隔离肺静脉并消除心律失常病灶， 这种新疗法目前在美国每年治疗5万名患者，在欧洲每年治疗6万名患者。随机研究表明，房颤消融术可减少心律失常负担并改善生活质量，但该手术也与1-10%的手术并发症发生率相关。迄今为止，尚无随机研究证明该手术对死亡、缺血性卒中、颅内出血和住院的长期影响，一项正在进行的随机研究包括一个非常选定的试验人群，并且存在显著的患者招募挑战。我们建议对真实的房颤患者进行一系列分析，以弥补与房颤消融相关的一些主要证据缺口。拟议的项目将使用标准和创新的方法来分析来自凯萨医疗机构北方加州和南加州的临床数据（两个医疗保健系统，超过650万人）和一项新的横断面调查研究，以实现四个具体目标：1）确定房颤消融术是否与长期死亡率、缺血性卒中、确定与心房颤动消融术相关的手术相关不良安全事件的风险、这些不良事件的预测因子以及这些事件后的复发住院率和死亡率; 3）估计房颤消融术的成本效益，包括死亡、缺血性卒中、颅内出血和住院的长期估计; 4）评估以患者为中心的特征，这些特征为决定接受房颤消融术和消融治疗的障碍提供信息。