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) 乙醇输注添加到心房颤动 (AF) 导管消融中的治疗价值。房颤是成人最常见的持续性心律失常，是中风、残疾和死亡率增加的主要原因。导管消融术——肺静脉（PV）窦隔离（PVAI）——可以治愈，但最适合阵发性房颤，其中肺静脉产生的异位搏动被证明会引发房颤。 PVAI 在持续性 AF 中的成功率较低，其中心脏自主系统，特别是内在心脏神经节的作用越来越被认识到。扩大消融病灶以包括左心房 (LA) 解剖结构的更大区域，可略微改善结果，但也会导致手术复杂性和持续时间增加、需要重复手术以及心房扑动，特别是二尖瓣周围扑动 (PMF) 等并发症。我们开发了一种在马歇尔静脉 (VOM) 中输注乙醇对 AF 心房组织进行快速消融的技术，并表明： 1) 对 LA 嵴和左下 PV 附近的 LA 组织进行有效、快速和安全的组织消融; 2) 通过到达内在心脏神经节来进行局部 LA 迷走神经去神经支配； 3) 通过消融大部分二尖瓣峡部促进 PMF 的治愈。我们建议评估 VOM 乙醇添加到传统 PVAI 中时产生的结果差异。具体目标是： #1. 评估在持续性房颤的从头导管消融中添加 VOM 乙醇输注对手术成功的影响。我们将接受第一次 AF 消融的持续性 AF 患者随机分为标准 PVAI 和 VOM 乙醇输注加 PVAI (VOM-PV)。 #2.评估消融失败后添加 VOM 乙醇输注对重复导管消融对复发性 AF 的影响。在 PVAI 失败后接受持续性 AF 重复手术的患者将被随机分配至 PVAI 或 VOM-PV 作为重复手术。终点包括 12-15 个月后不再出现症状或心电图 AF。