Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation

马歇尔静脉注射乙醇治疗持续性心房颤动

• 批准号: 8506825
• 负责人: Miguel Valderrabano
• 金额: $ 75.73万
• 依托单位: METHODIST HOSPITAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-23 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8506825
• 关键词: 3-Dimensional; Abbreviations; Ablation; Address; Adult; Alcohol consumption; Anatomy; Anti-Arrhythmia Agents; Antral; Area; Arrhythmia; Atrial Fibrillation; Atrial Flutter; Cardiac; Cardiac ablation; Catheters; Complex; Coronary sinus structure; Data; Death Rate; Denervation; Ectopic beats; Electrocardiogram; Ethanol; Failure; Freedom; Ganglia; Heart Atrium; Inferior; Infusion procedures; Lead; Left; Lesion; Life; Ligaments; Marshal; Monitor; Nerve; Operative Surgical Procedures; Outcome; Patients; Physiology; Prevalence; Procedures; Publishing; Pulmonary veins; Quality of life; Randomized; Recurrence; Role; Route; Safety; Stroke; Superior vena cava structure; System; Techniques; Therapeutic; Tissues; Veins; abstracting; auricular appendage; disability; heart rhythm; human data; improved; intravenous drip; mortality; public health relevance; radiofrequency; success

DESCRIPTION (provided by applicant): Project Abstract The broad, long-term objective of this project is to evaluate the therapeutic value of vein of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation (AF). AF is the most common sustained arrhythmia in adults, and it is a leading cause of stroke, disability and increased mortality. Catheter ablatin - pulmonary vein (PV) antral isolation (PVAI)- can lead to cure, but is best suited for paroxysmal AF, in which ectopic beats arising from the pulmonary veins were shown to initiate AF. PVAI success is lower in persistent AF, in which the role of the cardiac autonomic system, particularly the intrinsic cardiac ganglia, is being increasingly recognized. Expanding the ablation lesions to include greater areas the left atrial (LA) anatomy marginally improves outcomes, but also leads to increases in procedural complexity and duration, need of repeat procedures, and complications such as atrial flutters, particularly perimitral flutter (PMF). We have developed a technique to perform rapid ablation of atrial tissues in AF using ethanol infusion in the vein of Marshall (VOM), and have shown: 1) Effective, rapid and safe tissue ablation of LA tissue neighboring the LA ridge and left inferior PV; 2) Regional LA vagal denervation by reaching the intrinsic cardiac ganglia; and 3) Facilitation of cure of PMF by ablating most of the mitral isthmus. We propose to evaluate outcomes differences yielded by VOM ethanol when added to conventional PVAI. The specific aims are: #1.To assess the impact of VOM ethanol infusion in procedure success when added to de novo catheter ablation of persistent AF. We will randomize patients with persistent AF undergoing a first AF ablation to standard PVAI vs a combined VOM ethanol infusion plus PVAI (VOM-PV). #2. To assess the impact of VOM ethanol infusion added to repeat catheter ablation of recurrent AF after a failed ablation. Patients undergoing a repeat procedure for persistent AF after a failed PVAI will be randomized to either PVAI or VOM-PV as their repeat procedure. End points will include freedom from symptomatic or electrocardiographic AF after 12-15 months.

描述（由申请人提供）：项目摘要该项目的广泛，长期目标是评估马歇尔静脉（VOM）乙醇输液的治疗价值，当添加到心房颤动（AF）的导管消融中时。 AF是成年人最常见的持续性心律失常，它是中风，残疾和死亡率增加的主要原因。导管阿布拉丁 - 肺静脉（PV）闭合分离（PVAI）可以导致治疗，但最适合于阵发性AF，其中显示由肺静脉引起的异位跳动可启动AF。 PVAI的持续性AF成功较低，其中心脏自主神经系统的作用，尤其是内在的心脏神经节，越来越多地得到认可。扩大消融病变以包括更大的区域，左心房（LA）解剖结构略有改善，但也会导致程序复杂性和持续时间增加，重复程序的需求以及诸如心房fl弹，尤其是腹膜外围（PMF）等并发症。我们已经开发了一种技术，可以使用马歇尔（VOM）静脉输注乙醇在AF中快速消融，并显示了：1）有效，快速且安全的组织消融在La Ridge附近的LA组织和左PV下； 2）通过到达固有的心脏神经节来区域性的迷走神经神经神经节； 3）通过消融大部分二尖瓣促进PMF的治疗。我们建议评估添加到常规PVAI中时VOM乙醇产生的结果差异。具体目的是：＃1。当添加到从头导管的持续性AF中，评估呕吐物输注对程序成功的影响。我们将对持续AF的患者随机进行第一次AF消融，以与标准PVAI与组合的VOM乙醇输注加PVAI（VOM-PV）。 ＃2。为了评估在消融失败后，添加到重复导管消融中的VOM乙醇输注的影响。在失败的PVAI后接受重复程序的患者将被随机分为PVAI或VOM-PV作为重复程序。终点将包括在12-15个月后摆脱有症状或心电图AF的自由。