Ancillary Comparative Effectiveness of Atrial Fibrillation Ablation Surgery

房颤消融手术的辅助比较疗效

• 批准号: 8669806
• 负责人: Eugene Hubert Blackstone
• 金额: $ 38.89万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-10 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8669806
• 关键词: Ablation; Affect; Agreement; American; Ancillary Study; Atrial Fibrillation; Cardiac; Clinic; Clinical; Clinical Trials; Complex; Data; Data Aggregation; Data Analyses; Data Coordinating Center; Development; Devices; Discipline; Effectiveness; Elderly; FDA approved; Frequencies; Funding; Future; Guidelines; Heart Atrium; Heart Valve Diseases; Holter Electrocardiography; Hour; Housing; Implant; Individual; Institute of Medicine (U.S.); Intramural Research Program; Knowledge; Lead; Logistic Regressions; Machine Learning; Methodology; Methods; Mitral Valve; Modeling; Monitor; National Heart, Lung, and Blood Institute; Ohio; Operative Surgical Procedures; Outcome; Pacemakers; Parents; Patients; Pattern; Physicians; Population; Prevalence; Principal Investigator; Procedures; Prognostic Factor; Recurrence; Research Infrastructure; Research Methodology; Risk; Risk Factors; Sample Size; Science; Series; Specificity; Statistical Methods; Stroke; Structure; Surgeon; Techniques; Technology; Testing; Time; Tissues; United States National Institutes of Health; abstracting; analytical tool; base; comparative effectiveness; compare effectiveness; design; effectiveness trial; experience; follow-up; heart rhythm; innovation; monitoring device; novel; programs; protocol development; randomized trial; success; tool; transmission process

DESCRIPTION (provided by applicant): This proposal describes an ancillary study to a recently initiated comparative effectiveness trial "Surgical Ablation versus No Surgical Ablation for Patients with Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery" (NCT00903370), which is part of the NHLBI-sponsored Cardiothoracic Surgery Network (CTSN). Its aims are to perform a time-sensitive substudy of continuous heart rhythm monitoring and to develop and apply novel statistical tools to assess ablation effectiveness in groups of patients. As such, it will provide critical new knowledge to support a secondary objective of the parent trial: to inform rhythm monitoring and analysis strategies for future trials of rhythm control in atrial fibrillation (AF). Great enthusiasm for innovative tissue-destroying (ablation) procedures to treat AF has led to technology outstripping science. Mechanisms of AF (which afflicts >3 million Americans) remain poorly understood, methods to assess its cure are primitive, and guidelines for analyzing rhythm outcomes are flawed due to lack of appropriate statistical methodology. Why? After ablation procedures, AF may recur in episodes of varying duration. Yet current monitoring consists of "snapshots" of semiannual rhythm recording (Holter), or more frequent-but short-transtelephonic monitoring (TTM). Ideally, an implantable monitoring device could detect all these episodes over a patient's lifetime; however, even if this were possible, statistical methods to analyze this series of occurrences in groups of patients for comparative effectiveness of AF therapies or to identify risk factors are poorly developed. Right now a window of opportunity exists to make important strides in more thorough AF assessment and proper data analysis because the CTSN has just launched a randomized trial of surgical AF therapies that includes weekly TTM of atrial rhythm as well as traditional 6- and 12-month Holter assessment. We propose a time-sensitive substudy of implanting an FDA-approved miniature loop recorder to capture AF episodes continuously. These data will be used in the development of a suite of new analytic methods for aggregating data such as these across time and across patients to characterize time course and identify modulating factors. They will then be used to assess the trial's rhythm endpoints and suggest designs for more informative future trials with substantially reduced sample size. We have assembled a team of clinicians and statisticians, including individuals who designed the parent trial, who are experienced in implanting the monitoring device, and who are experts in analytic methods research, to develop and apply novel methods to these several types of rhythm data. We will leverage developments from an intramural NHLBI machine learning program at Cleveland Clinic and State of Ohio-funded Atrial Fibrillation Innovation Center. The analytic methods have wide applicability to the important field of longitudinal data analysis.

DESCRIPTION (provided by applicant): This proposal describes an ancillary study to a recently initiated comparative effectiveness trial "Surgical Ablation versus No Surgical Ablation for Patients with Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery" (NCT00903370), which is part of the NHLBI-sponsored Cardiothoracic Surgery Network (CTSN).其目的是执行连续心律监测的时间敏感性，并开发和应用新颖的统计工具来评估患者组的消融效率。因此，它将提供关键的新知识，以支持父母试验的次要目标：为心房颤动中节奏控制的未来试验（AF）提供节奏监测和分析策略。 对毁灭性组织（消融）治疗AF的极大热情，导致技术超越了科学。 AF的机制（苦难> 300万美国人）的理解仍然很少，评估其治疗方法是原始的，并且由于缺乏适当的统计方法，分析节奏结局的指南存在缺陷。为什么？消融程序后，AF可能会在不同持续时间的发作中复发。然而，当前的监视包括半年度节奏记录的“快照”（Holter），或更频繁的频率，但短传输频率监测（TTM）。理想情况下，可植入的监测装置可以在患者的一生中检测到所有这些发作。但是，即使这是可能的，也可以分析患者组中的这一系列发生的统计方法，以了解AF疗法的比较有效性或鉴定危险因素的相对有效性。目前，在更彻底的AF评估和适当的数据分析中，存在一个机会窗口，因为CTSN刚刚开始了手术AF疗法的随机试验，其中包括每周一次的心房节律TTM以及传统的6个和12个月的Holter评估。我们提出了植入FDA批准的微型环记录器的时间敏感的子宫，以连续捕获AF发作。这些数据将用于开发一系列新的分析方法，以跨时间和整个患者汇总这些数据，以表征时间过程并确定调节因素。然后，它们将用于评估试验的节奏终点，并建议设计的设计大幅减少。我们组建了一个由临床医生和统计学家组成的团队，包括设计父母试验的个人，在植入监测设备方面经验丰富，并且是分析方法研究专家，以开发和将新方法应用于这几种类型的节奏数据。我们将利用克利夫兰诊所的壁内NHLBI机器学习计划和俄亥俄州资助的房颤创新中心的发展。分析方法对纵向数据分析的重要领域具有广泛的适用性。

项目成果

A multiphase non-linear mixed effects model: An application to spirometry after lung transplantation.

• DOI: 10.1177/0962280214537255
• 发表时间: 2017-02
• 期刊: Statistical methods in medical research
• 影响因子: 2.3
• 作者: Rajeswaran J;Blackstone EH
• 通讯作者: Blackstone EH

Evolution of association between renal and liver functions while awaiting heart transplant: An application using a bivariate multiphase nonlinear mixed effects model.

• DOI: 10.1177/0962280216678022
• 发表时间: 2018-07
• 期刊: Statistical methods in medical research
• 影响因子: 2.3
• 作者: Rajeswaran J;Blackstone EH;Barnard J
• 通讯作者: Barnard J

Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants.

• DOI: 10.1016/j.athoracsur.2014.10.070
• 发表时间: 2015-04
• 期刊: ANNALS OF THORACIC SURGERY
• 影响因子: 4.6
• 作者: Johnston, Douglas R.;Soltesz, Edward G.;Vakil, Nakul;Rajeswaran, Jeevanantham;Roselli, Eric E.;Sabik, Joseph F., III;Smedira, Nicholas G.;Svensson, Lars G.;Lytle, Bruce W.;Blackstone, Eugene H.
• 通讯作者: Blackstone, Eugene H.

Tricuspid regurgitation and right ventricular function after mitral valve surgery with or without concomitant tricuspid valve procedure.

• DOI: 10.1016/j.jtcvs.2012.08.061
• 发表时间: 2013-11
• 期刊: JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
• 影响因子: 6
• 作者: Desai, Ravi R.;Abello, Lina Maria Vargas;Klein, Allan L.;Marwick, Thomas H.;Krasuski, Richard A.;Ye, Ying;Nowicki, Edward R.;Rajeswaran, Jeevanantham;Blackstone, Eugene H.;Pettersson, Goesta B.
• 通讯作者: Pettersson, Goesta B.

Estimating the prevalence of atrial fibrillation from a three-class mixture model for repeated diagnoses.

从重复诊断的三类混合模型中估计心房颤动的患病率。

• DOI: 10.1002/bimj.201600098
• 发表时间: 2017
• 期刊: Biometrical journal. Biometrische Zeitschrift
• 作者: Li,Liang;Mao,Huzhang;Ishwaran,Hemant;Rajeswaran,Jeevanantham;Ehrlinger,John;Blackstone,EugeneH
• 通讯作者: Blackstone,EugeneH