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: 8894564
• 负责人: Miguel Valderrabano
• 金额: $ 73.51万
• 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 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8894564
• 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; Health; 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; 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）：项目摘要本项目的广泛、长期目标是评价马歇尔静脉（VOM）乙醇输注在房颤（AF）导管消融术中的治疗价值。AF是成人中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-肺静脉（PV）窦隔离（PVAI）-可导致治愈，但最适合阵发性房颤，其中肺静脉引起的异位搏动被证明会引发房颤。PVAI成功率在持续性房颤中较低，其中心脏自主神经系统，特别是心脏固有神经节的作用越来越受到认可。扩大消融损伤以包括左心房（LA）解剖结构的更大区域可略微改善结局，但也会导致手术复杂性和持续时间增加，需要重复手术，以及并发症，如房扑，特别是二尖瓣周围房扑（PMF）。我们开发了一种通过马歇尔静脉（VOM）注入乙醇快速消融房颤心房组织的技术，并证明：1）有效、快速和安全地消融邻近左心房嵴和左下肺静脉的左心房组织; 2）通过到达心内神经节进行局部左心房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治愈。我们建议评价VOM乙醇添加到传统PVAI中时产生的结局差异。具体目标是：#1.评估VOM乙醇输注在持续性房颤的原发导管消融术中对手术成功的影响。我们将接受首次房颤消融术的持续性房颤患者随机分为标准PVAI组和VOM乙醇输注+PVAI联合组（VOM-PV）。#2.评估消融失败后，再次导管消融复发性房颤时添加VOM乙醇输注的影响。在PVAI失败后接受持续性AF重复手术的患者将随机接受PVAI或VOM-PV作为重复手术。终点将包括12-15个月后无症状性或心电图房颤。