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

基本信息

批准号：
8852701
负责人：
James Freeman
金额：
$ 15.7万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-01 至 2016-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8852701
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 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 radiofrequency sex skills treatment strategy

项目摘要

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）：该提案需要一个为期五年的培训计划，重点是为 James V Freeman（医学博士、公共卫生硕士、理学硕士）在以患者为导向的学术心血管医学领域的独立职业做好准备。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（特别是心房颤动）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，完成课程以扩大他对先进方法的理解，培养自主运作所需的管理技能，并撰写一系列工作以使他能够作为独立研究者获得资助。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，他将拥有实现这些目标并过渡到独立的资源和支持。项目描述心房颤动 (AF) 影响美国超过 230 万成年人，预计这一数字将增加至到 2050 年，这一数字将至少达到 560 万。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灶，一种新疗法，目前在美国每年用于治疗 50,000 名患者，在欧洲每年用于治疗 60,000 名患者。随机研究表明 AF 消融可以减轻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，还没有随机研究证明该手术对死亡、缺血性中风、颅内出血和住院治疗的长期影响，而一项正在进行的随机研究包括经过精心挑选的试验人群，并且在患者入组方面遇到了重大挑战。我们建议对现实世界的 AF 患者进行一系列分析，以弥补与 AF 消融相关的一些主要证据差距。拟议项目将使用标准和创新方法来分析 Kaiser Permanente 北加州和南加州（两个医疗保健系统，覆盖超过 650 万人）的临床数据，并进行一项新颖的横断面调查研究，以实现四个具体目标：1）房颤消融是否与房颤患者的长期死亡率、缺血性卒中、颅内出血和住院有关； ) 确定与房颤消融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素以及这些事件后的复发住院率和死亡率； 3) 结合对死亡、缺血性中风、颅内出血和住院治疗的长期估计，估计房颤消融的成本效益； 4）评估以患者为中心的特征，这些特征为接受房颤消融的决定和消融治疗的障碍提供依据。