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）：该提案需要一项为期五年的培训计划，旨在为James V Freeman，医学博士，MPH，MS MS，从事以患者为导向的学术心血管医学的独立职业。该提案旨在赋予申请人所需的技能和知识，以实现其长期目标，即为心律不齐的患者，尤其是心房颤动的患者提供最佳的临床治疗策略的见解。申请人的直接培训目标是掌握基本的临床研究方法，进行课程，以扩大他对高级方法的理解，发展自主运作所需的行政技能，并创作一项工作，使他能够获得独立研究人员的资金。在他的长期导师的指导下，马克·赫拉基（Mark Hlatky）和艾伦·戈（Alan Go）以及精心选择的高级调查人员咨询委员会，他将获得资源和支持，以实现这些目标并过渡到独立。项目描述房颤（AF）在美国影响超过230万成年人，预计该数字将增加到AT 到2050年，至少有560万。用于房颤的导管消融（AF），使用射频能量或冷冻疗法将肺部静脉电气隔离并消除心律不齐的焦点为 一种新的疗法，目前用于每年在美国治疗50,000名患者，欧洲每年60,000名患者。随机研究表明，AF消融可能会减轻心律不齐的负担并改善生活质量，但该过程也与程序并发症发生率相关。迄今为止，尚无随机研究表明该程序对死亡，缺血性中风，颅内出血和住院的长期影响，并且一项正在进行的随机研究包括一个非常选择的试验人群，并且患者的入学挑战很大。我们提出了一系列对AF的现实世界患者的分析，以填补与AF消融有关的一些主要证据差距。拟议的项目将使用标准和创新方法来分析北加州北加州和南加州的临床数据（两个人为超过650万人）和一项新颖的横断面调查研究，以实现四个具体目标：1）以确定心房纤维化是否与长期消融相关，是否与长期的死亡率相关联，缺陷型，内部静脉内化和静脉内化的临床化和治疗习惯，并将其置于静脉内化和治疗。 ）确定与心房纤维消融相关的程序相关的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和死亡率； 3）估计房颤消融的成本效益，结合了死亡，缺血性中风，颅内出血和住院的长期估计； 4）评估以患者为中心的特征，这些特征为决定进行房颤消融和消融治疗障碍的决定提供了信息。