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

描述(由申请人提供)：本申请涉及房颤的广泛挑战领域(05)比较有效性研究和特殊挑战05-HL-101*治疗。心房颤动(房颤)是最常见的心律失常，影响着超过250万美国人，仅医疗保险每年就造成超过70亿美元的损失。重要的是，15%的卒中归因于心房颤动，在这些患者中，心耳可能是血栓的来源。近年来的文献表明，心房颤动通常是由肺静脉中的异位病灶引起的，因此，出现了大量基于导管的微创手术方法，以隔离肺静脉触发因素并消融导致房颤的左心房内的病灶。有一些证据表明，微创手术方法比基于导管的方法具有更大的初步疗效，并提供了额外的优势，因为它允许结扎心耳--房颤中导致中风的主要栓子来源。有中风和房颤的患者，即使采用包括抗凝和心率控制在内的最佳治疗措施，也有10%的中风复发风险。该应用专门针对伴有房颤的中风患者，通过比较最佳的药物治疗和一种新的外科消融程序来恢复窦性心律并结扎心耳。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，其中包括：生活质量评估；基线和6个月时的大脑MRI成像，以及对复发中风、出血和其他不良事件的严格随访。该方案的独特之处在于，它结合了连续的远程7天遥测，以确定患者处于房颤(他们的“房颤负担”)的时间的真实百分比，因为以前的房颤干预研究依赖于患者报告的症状、临床就诊或间歇性电话随访的EKG。重要的是，房颤可以是无症状的，但无论症状如何，中风的风险都是相同的。这项研究还得益于我们中心在检查房颤患者的生活质量方面的经验，以及他们在先前的植入式心房除颤器研究中对患者感知的成功。佛罗里达大学拥有一支经验丰富的研究团队，为这一项目提供了理想的协作环境，调查团队包括：一名具有丰富临床试验经验的心胸外科医生，一名担任佛罗里达大学中风中心主任的神经科医生，一名具有多年消融经验的佛罗里达大学电生理学主任，一名曾参与过心脏搭桥手术后核磁共振检查的临床试验的神经放射科医生，以及一名在心脏手术后预后和脑血管疾病方面具有专业知识的有经验的神经心理学家。目前的应用是对NIH挑战赛05-HL-101*治疗房颤的理想回应，因为它提供了一个机会，将一种新的房颤微创外科疗法的有效性与目前的医疗管理进行比较。如果微创外科房颤消融术被发现优于药物治疗，它不仅可以使患有房颤的中风患者受益，而且可以使目前患有房颤的250万美国人受益。佛罗里达大学为当地和地区经济做出了巨大贡献。2008年，UF创造了2525个就业机会，最近的研究表明，UF每年为佛罗里达州的经济贡献近60亿美元。该大学直接在主校区雇佣了约3.4万人，并通过UF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。目前的应用程序将创造或保留7个工作岗位，如果该项目的试点数据转化为多中心临床试验，可能会创造更多工作岗位。 与公共卫生相关：房颤(AF)是最常见的心律失常，影响着超过250万美国人，仅医疗保险每年就造成超过70亿美元的损失。重要的是，15%的卒中归因于心房颤动，在这些患者中，心耳可能是血栓的来源。该应用专门针对伴有房颤的中风患者，通过比较最佳的药物治疗和一种新的外科消融程序来恢复窦性心律并结扎心耳。

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.