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

描述（由申请人提供）：本申请涉及广泛的挑战领域（05）比较有效性研究和特定挑战05- hl -101*心房颤动的治疗。房颤（AF）是最常见的心律失常，影响超过250万美国人，每年仅医疗保险就花费超过70亿美元。重要的是，15%的中风归因于心房颤动，心房附件可能是这些患者栓塞的来源。近年来的文献表明房颤通常由肺静脉异位灶引起，因此，近年来，基于导管和微创的手术入路出现了爆炸式增长，以隔离导致房颤的肺静脉“触发点”和左心房消融灶。有证据表明，微创手术入路比基于导管的入路具有更高的初级疗效，并且具有额外的优势，因为它可以结扎心房附件——心房附件是导致房颤中风的主要栓塞来源。卒中和房颤患者的结扎率为10%即使有最佳的医疗管理，包括抗凝和心率控制，卒中复发的风险。本应用程序通过比较最佳药物治疗与一种新的外科消融手术，恢复窦性心律并结扎心房附件，专门针对中风合并房颤患者。该项目包括几个重要的结果变量，以衡量大规模多中心临床试验的可行性，包括：生活质量评估；在基线和6个月时进行脑MRI成像，并对复发性卒中、出血和其他不良事件进行严格随访。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的真实时间百分比（他们的“房颤负担”），因为以前的房颤干预研究依赖于患者报告的症状、门诊就诊的心电图或间歇性电话随访。重要的是，房颤可以是无症状的，但卒中的风险是相同的，无论症状如何。本研究也受益于我们中心在检查房颤患者的生活质量和患者在之前的植入式心房除颤器研究中感知的成功方面的经验。佛罗里达大学为该项目提供了理想的合作环境，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，佛罗里达大学中风中心主任的神经学家；佛罗里达大学电生理学主任，有多年消融术经验；他是一位神经放射学家，曾从事心脏搭桥手术后核磁共振成像的临床试验，也是一位经验丰富的神经心理学家，在心脏手术后的结果和脑血管疾病方面具有专业知识。目前的应用是对NIH Challenge 05-HL-101*房颤治疗的理想响应，因为它提供了一个比较新型微创房颤手术治疗与当前医疗管理有效性的机会。如果发现微创手术心房消融优于药物治疗，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重大贡献。2008年，佛罗里达大学创造了2525个工作岗位，最近的研究表明，佛罗里达大学每年为佛罗里达经济贡献近60亿美元。该大学在其主校区直接雇用了约34,000人，并通过佛罗里达大学组织，如食品和农业科学研究所，负责在全州创造74,894个工作岗位。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，则有可能创造更多的工作岗位。

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.