Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation

项目描述(由申请者提供)：该项目的广泛、长期目标是评估马歇尔静脉(VOM)乙醇输注在房颤(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，也是导致中风、残疾和死亡率增加的主要原因。导管消融-肺静脉(PV)窦道隔离(PVAI)-可以治愈，但最适合于阵发性房颤，在阵发性房颤中，来自肺静脉的异位搏动被证明是引发房颤的原因。持续性房颤的PVAI成功率较低，在持续性房颤中，心脏自主神经系统，特别是心脏内神经节的作用日益得到认可。扩大消融范围以包括更大区域的左房(LA)解剖略微改善了结果，但也导致了程序复杂性和持续时间的增加，需要重复程序，以及并发症，如心房扑动，特别是周围扑动(PMF)。我们发展了一种快速消融房颤患者心房组织的技术--马歇尔静脉注射无水乙醇(VOM)，结果表明：1)有效、快速和安全地消融左房隆起和左下肺静脉旁的左房组织；2)通过到达心脏内侧神经节来切断左房迷走神经；3)消融大部分二尖瓣峡部以促进PMF的治愈。我们建议评估VOM乙醇在添加到传统PVAI中时产生的结果差异。具体目标是：#1.评估VOM乙醇输注对持续性房颤新导管消融手术成功的影响。我们将随机将接受第一次房颤消融的持续性房颤患者随机分为标准PVAI组和VOM乙醇输注加PVAI组(VOM-PV组)。#2.评估消融失败后重复导管消融的VOM乙醇输注对复发房颤的影响。在PVAI失败后接受持续性房颤重复手术的患者将被随机分为PVAI或VOM-PV作为他们的重复手术。终点将包括12-15个月后无症状或心电图房颤。

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.