Minimally Invasive Surgical Pulmonary Vein Insolation vs. Medical Management in P

描述（由申请人提供）：本申请涉及广泛挑战领域（05）比较有效性研究和特定挑战05-HL-101* 房颤治疗。心房颤动（AF）是最常见的心律失常，影响超过250万美国人，仅医疗保险每年的费用就超过70亿美元。重要的是，所有卒中中有15%归因于房颤，其中心耳可能是这些患者的栓塞源。近年来的文献表明，房颤常由肺静脉异位病灶引发，因此，有大量基于导管的微创外科手术方法来隔离肺静脉“触发点”并消融左心房中引起AF的病灶。有证据表明微创外科手术方法比导管具有更大的主要疗效。基于方法，并提供了额外的优势，因为它允许结扎心房附件-房颤中引起中风的栓塞的主要来源。中风和房颤患者有10%的中风复发风险，即使采用最佳的医疗管理，包括抗凝和心率控制。本申请通过比较最佳药物治疗与恢复窦性心律并结扎心耳的新型外科消融术，专门针对房颤卒中患者。该项目包括几个重要的结果变量，以衡量更大规模多中心临床试验的可行性，包括：生活质量评估;基线和6个月时的脑部MRI成像，以及对复发性卒中、出血和其他不良事件的严格随访。该方案的独特之处在于，它结合了连续7天的远程遥测，以确定患者处于房颤（其“房颤负荷”）的真实时间百分比，因为之前的房颤干预研究依赖于患者报告的症状、来自诊所访视或间歇性电话随访的EKG。重要的是，AF可能无症状，但无论症状如何，中风的风险都是相同的。本研究还受益于我们中心在检查房颤患者生活质量方面的经验，以及患者在既往植入式心房颤动器研究中感知的成功。佛罗里达大学为该项目提供了一个理想的合作环境，拥有经验丰富的研究团队，包括：具有丰富临床试验经验的心胸外科医生，佛罗里达大学卒中中心主任神经科医生;具有多年消融经验的佛罗里达大学电生理学主任;一位神经放射科医生曾参与过一项临床试验，检查搭桥手术后的MRI，另一位是经验丰富的神经心理学家，擅长心脏手术后的结果和脑血管疾病。目前的应用是对NIH挑战05-HL-101* 房颤治疗的理想回应，因为它提供了一个机会，可以比较房颤的新型微创手术治疗与当前医疗管理的有效性。如果微创外科心房消融术被发现是上级的药物治疗，它可以受益不仅中风患者AF-但目前患有AF的250万美国人的整个人口。佛罗里达大学的贡献，大大提高了当地和地区的经济。在2008年，UF创造了2,525个工作岗位，最近的研究表明，UF每年为佛罗里达的经济贡献近60亿美元。该大学直接在其主校区雇用约34，000人，并通过用友组织，如食品和农业科学研究所，负责在全州范围内创造74，894个就业机会。当前的应用程序将创建或保留7个工作岗位，如果将该项目的试点数据转化为多中心临床试验，则可能会创建更多工作岗位。 公共卫生相关性：心房颤动（AF）是最常见的心律失常，影响超过250万美国人，仅医疗保险每年的费用就超过70亿美元。重要的是，所有卒中中有15%归因于房颤，其中心耳可能是这些患者的栓塞源。本申请通过比较最佳药物治疗与恢复窦性心律并结扎心耳的新型外科消融术，专门针对房颤卒中患者。

DESCRIPTION (provided by applicant): This application addresses Broad challenge area (05) Comparative Effectiveness Research and specific Challenge 05-HL-101* Treatment of Atrial Fibrillation. Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting over 2.5 million Americans at a cost of over 7 billion dollars per year to Medicare alone. Importantly, 15% of all strokes are attributed to atrial fibrillation with the atrial appendage implicated as the likely source of emboli in these patients. Literature in recent years has shown atrial fibrillation is often initiated by ectopic foci in the pulmonary veins and accordingly, there has been an explosion of catheter- based and minimally invasive surgical approaches to isolate the pulmonary vein "triggers" and ablate foci in the left atrium responsible for AF. There is some evidence that the minimally invasive surgical approach has greater primary efficacy than the catheter-based approaches and offers an added advantage in that it allows ligation of the atrial appendage -- the predominant source of emboli causing stroke in AF. Patients with strokes and AF have a 10% risk of recurrent stroke even with optimal medical management that includes anticoagulation and rate control. This application specifically addresses stroke patients with AF by comparing optimal medical therapy with a novel surgical ablative procedure that restores sinus rhythm and ligates the atrial appendage. This project includes several important outcome variables to gauge the feasibility of a larger scale multi-center clinical trial including: quality of life assessment; MRI imaging of the brain at baseline and 6 months and rigorous follow-up for recurrent stroke, bleeding and other adverse events. This protocol is unique in that it incorporates continuous remote 7 day telemetry to identify the true percentage of time patients are in atrial fibrillation (their "atrial fibrillation burden") as previous studies of AF intervention have relied on patient reported symptoms, EKGs from clinic visits or intermittent telephone follow-up. Importantly, AF can be asymptomatic but the risk for stroke is the same regardless of symptoms. This study also benefits from our center's experience in examining the quality of life patients with AF and their patient perceived success in a previous study of implantable atrial defibrillators. The University of Florida offers an ideal collaborative environment for this project with an experienced team of investigators including: a cardiothoracic surgeon with extensive clinical trial experience, a neurologist who is director of The University of Florida stroke center; the chief of electrophysiology at The University of Florida with years of ablation experience; a neuroradiologist who has previously worked on a clinical trial examining MRIs after bypass surgery and an experienced neuropsychologist with expertise in post cardiac surgery outcome and cerebrovascular disease. The current application is an ideal response to NIH Challenge 05-HL-101* treatment of atrial fibrillation because it presents an opportunity to compare the effectiveness of a novel minimally invasive surgical therapy for atrial fibrillation to current medical management. If minimally invasive surgical atrial ablation is found to be superior to medical therapy it could benefit not only stroke patients with AF -- but the entire population of 2.5 million Americans currently suffering from AF. The University of Florida contributes substantially to the local and regional economy. In 2008, UF created 2,525 jobs and recent studies have shown that UF contributes nearly $6 billion annually to Florida's economy. The university employs about 34,000 people directly on its main campus and via UF organizations, such as the Institute of Food and Agricultural Sciences, is responsible for the creation of 74,894 jobs statewide. The current application will create or retain 7 jobs with the potential to create many more if pilot data from this project is translated into a multicenter clinical trial. PUBLIC HEALTH RELEVANCE: Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting over 2.5 million Americans at a cost of over 7 billion dollars per year to Medicare alone. Importantly, 15% of all strokes are attributed to atrial fibrillation with the atrial appendage implicated as the likely source of emboli in these patients. This application specifically addresses stroke patients with AF by comparing optimal medical therapy with a novel surgical ablative procedure that restores sinus rhythm and ligates the atrial appendage.