Optically guided catheter ablation of atrial fibrillation

心房颤动的光导导管消融术

基本信息

批准号：
10457320
负责人：
Christine P Hendon
金额：
$ 68.17万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10457320
关键词：
Ablation Action Potentials Acute Adipose tissue Affect Age Anti-Arrhythmia Agents Atrial Fibrillation Cardiac Electrophysiologic Techniques Cardiac ablation Cardiovascular Pathology Catheters Characteristics Chronic Cicatrix Clinical Clinical Trials Computer software Data Development Diffuse Family suidae Fibrosis Freedom Goals Heart Atrium Histology Human Lesion Maintenance Maps Measures Methods Monitor Myocardial tissue Myocardium Near-Infrared Spectroscopy Optical Coherence Tomography Optics Outcome Patients Population Prevalence Procedures Property Proxy Pulmonary veins Radiofrequency Interstitial Ablation Recovery Recurrence Sinus Technology Temperature Testing Thick Time Tissues Validation Work base classification algorithm electric impedance experimental study human tissue imaging modality improved improved outcome in vivo innovation innovative technologies multidisciplinary necrotic tissue overtreatment radio frequency reduce symptoms standard of care targeted treatment treatment strategy voltage

项目摘要

SUMMARY: Atrial fibrillation (AF) affects approximately 3 million patients and its prevalence is expected to rise as the population ages. Catheter ablation, the preferred treatment strategy for symptomatic patients, creates local regions of tissue necrosis in the atria called lesions that are meant to abolish abnormal electrical activity that causes AF. However, AF recurrence is significant in these patients mostly due to inadequate lesions formed by ablation or by recovery of abnormal electrical activity. Currently, standard-of-care technology to guide lesion formation relies on surrogates for lesion formation that only marginally improve outcomes. Additionally, in some patients with AF the abnormal activity responsible cannot be localized, which then requires adjunctive lesions targeting alternative structural substrates for AF such as fibrosis and scarring. However, alternative AF substrates are currently identified indirectly based substrate proxies rather than the substrate itself, which has yet to be proven effective. Therefore, the main barriers to the successful treatment of AF continue to be: a) creating lesions that completely and permanently block abnormal electrical activity, and b) accurately identifying substrates that are known to cause AF. Optical coherence tomography (OCT) is an imaging method that can monitor lesion formation in real-time, and near-infrared spectroscopy (NIRS) can quantify optical properties from measured diffuse tissue reflectance during RF ablation. When combined, OCT/NIRS can provide direct information on lesion formation, depth, and tissue composition. Based on our previous work and preliminary data we hypothesize that compared to standard-of-care methods, combined OCT/NIRS can be safe and more effective at creating lesions that are complete and durable and for mapping AF structural substrates. To test this hypothesis, we aim to: 1. Develop and validate real-time optically guided atrial ablation lesion formation, and 2. Develop and validate real-time optical mapping of AF structural substrates. For both of these aims, development includes innovative OCT/NIRS software and hardware methods along with validation in vivo and ex vivo in atria from normal pigs and pigs with AF as well as in atrial tissue from humans with or without AF. Then, based on these developments we aim to: 3. Compare real-time optically guided lesion formation and mapping of AF structural substrates against standard-of-care methods. Outcomes will be determined acutely in vivo and verified ex vivo immediately after the procedure and chronically to determine durability of lesions. To achieve these aims, we have assembled a uniquely qualified multi-disciplinary multi-PI team with expertise in OCT (Drs. Rollins and Hendon), NIRS (Dr. Hendon), and basic cardiac electrophysiology (Dr. Laurita), along with Co-I expertise in clinical AF ablation (Dr. Ziv) and cardiovascular pathology (Dr. Marboe). Our team's long-term goal is to develop innovative technologies to improve AF ablation outcomes.

摘要：心房颤动（AF）影响约300万患者，其患病率预计会升高随着人口的年龄。导管消融是有症状患者的首选治疗策略，可创建心房中组织坏死的局部区域称为病变，旨在废除异常电活动导致AF。但是，AF复发在这些患者中很重要，主要是由于病变不足通过消融或恢复异常电活动形成。目前，护理标准技术指导病变的形成依赖于替代物的病变形成，而病变形成只会略微改善预后。另外，在某些AF患者中，负责的异常活动不能被定位，然后需要针对AF的替代结构底物的辅助病变，例如纤维化和疤痕。但是，目前，替代AF基材被间接识别为基于基质的代理底物本身，尚未证明有效。因此，成功治疗的主要障碍 AF继续存在：a）产生完全，永久阻止异常电活动的病变， b）准确识别已知会导致AF的底物。光学相干断层扫描（OCT）为一种可以实时监测病变形成的成像方法，近红外光谱（NIR）可以在RF消融过程中量化测得的弥漫组织反射率的光学特性。当组合时 OCT/NIR可以提供有关病变形成，深度和组织组成的直接信息。基于我们我们假设的先前工作和初步数据与护理标准方法相比 OCT/NIR可以安全，更有效地创建完整且耐用的病变，用于映射 AF结构底物。为了检验这一假设，我们的目标是：1。开发和验证实时光学指导心房消融病变形成和2。开发和验证AF结构的实时光学映射基材。对于这两个目标，开发包括创新的OCT/NIRS软件和硬件方法以及在正常猪和AF和心房的猪中的体内验证和异源验证的方法有或没有AF的人的组织。然后，基于这些发展，我们的目标是：3。比较实时根据护理标准方法的光学引导病变形成和AF结构底物的映射。结果将在手术后立即在体内敏锐地确定，并在体内验证，并且长期以确定病变的耐用性。为了实现这些目标，我们组装了一个独特的资格多学科的多PIP团队在OCT（Rollins和Hendon博士），NIRS（Hendon博士）和Basic 心脏电生理学（Laurita博士），以及临床AF消融（ZIV博士）和心血管病理学（Marboe博士）。我们团队的长期目标是开发创新技术改善AF消融结果。