Improved Esophageal Safety in Atrial Fibrillation Elimination

提高消除心房颤动的食道安全性

基本信息

批准号：
9789454
负责人：
Ashok Gowda
金额：
$ 57.39万
依托单位：
BIOTEX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-21 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9789454
关键词：
Ablation Anatomy Animals Area Arrhythmia Atrial Fibrillation Burn injury Cessation of life Chronic Disease Cicatrix Clinical Communication Complication Cost Savings Data Detection Device Designs Device or Instrument Development Devices Ensure Esophageal Esophageal injury Esophagus Family suidae Feedback Fistula Fund Raising Goals Health Care Costs Heart Heart Atrium In Situ Individual Injury Institutes Left Left atrial structure Life Literature Marketing Measurement Measures Medical Device Medicine Methods Modeling Monitor Movement Patients Performance Pharmaceutical Preparations Phase Physicians Positioning Attribute Procedures Publishing Pulmonary veins Radiation exposure Radiofrequency Interstitial Ablation Risk Safety Shapes Site Small Business Innovation Research Grant Stroke Surface Techniques Technology Temperature Testing Texas Thinness Time Tissues Ulcer Validation Veins college commercialization design esophagus ulcer heart rhythm high risk improved mortality novel novel strategies patient safety product development prototype radio frequency seal success verification and validation

项目摘要

Project Summary The overall goal of this SBIR proposal is to develop a novel device to allow easier atrial fibrillation (AF) ablation procedures by mitigating risks for esophageal injury. Atrial fibrillation is the most common chronic disease of heart rhythm, and can be treated with application of radiofrequency energy or cryo to ablate susceptible portions of the endocardial surface of the pulmonary veins through the left atrium. Complications of this procedure include injury to the esophagus, which lies immediately posterior to the thin walled left atrium. Injury can range from asymptomatic ulcerations in the esophageal lumen, to rare, but catastrophic atrioesophageal fistula (AEF) with subsequent stroke and death. Currently, methods to avoid these complications include avoiding ablation within 1cm of the esophagus, and esophageal temperature monitoring. However, most patients’ anatomy precludes avoiding ablation within one centimeter of the esophagus. Temperature monitoring and avoiding exceeding a certain temperature threshold can prolong the procedure and decreases procedural success rates. In fact a significant high rate of procedures must be aborted because the position of the esophagus relative to the ablation site creates unacceptably high risk for injury. In our physician collaborator’s practice in 2016, 19% (41 of 218) of pulmonary vein isolation procedures had incomplete isolation of at least one vein due to proximity of the esophagus. It’s clear that current techniques to protect the esophagus during ablation procedures are rudimentary, and no purpose-built device has received FDA approval for this indication. BioTex has licensed from the Texas Heart Institute and Baylor College of Medicine to create the first ever device designed for controlled deformation of the esophagus away from the left atrium and pulmonary veins as well as enhanced temperature monitoring to improve the safety and efficacy of atrial fibrillation ablation procedures. The objective of this Fast Track proposal is to build fully functional prototypes, conduct benchtop testing, perform pilot animal studies demonstrating reduction of the rate of esophageal injury during radiofrequency ablation, complete a final design of the device, complete all required validations, and obtain regulatory marketing clearances. We anticipate this novel approach will be an easy replacement for existing esophageal temperature monitoring methods, and have a significant impact on patient safety and allow significant improvements in procedure efficiency and health care cost savings.

项目概要该 SBIR 提案的总体目标是开发一种新型设备，以便更轻松地进行心房颤动 (AF) 消融心房颤动是最常见的慢性疾病。心律失常，可以通过应用射频能量或冷冻消融易受影响的方法来治疗肺静脉的部分心内膜表面穿过左心房。手术包括食管损伤，食管位于薄壁左心房损伤的正后方。范围从无症状的食管腔溃疡到罕见但灾难性的心房食管溃疡瘘（AEF）并随后导致中风和死亡。目前，避免这些并发症的方法包括。避免食管1cm内消融，并监测食管温度。患者的解剖结构不允许在食道一厘米内进行消融。监测和避免超过一定的温度阈值可以延长程序并减少事实上，由于位置的原因，必须中止的程序的成功率相当高。食道相对于消融部位造成的伤害风险高得令人无法接受。根据 2016 年合作者的实践，19%（218 人中的 41 人）的肺静脉隔离程序不完整由于靠近食道而隔离至少一根静脉很明显，目前的技术可以保护食道。消融手术期间的食道功能还很初级，并且没有专用设备获得 FDA 批准批准该适应症。 BioTex 已获得德克萨斯心脏研究所和贝勒医学院的许可，创造出有史以来第一个设计用于控制食道变形远离左心房和肺静脉的装置以及加强温度监测以提高房颤消融的安全性和有效性该快速通道提案的目标是构建功能齐全的原型，进行台式测试。测试，进行试点动物研究，证明食管损伤率降低射频消融，完成设备的最终设计，完成所有必需的验证，并获得我们预计这种新颖的方法将很容易取代现有的方法。食管温度监测方法，对患者安全有重大影响并允许显着提高手术效率并节省医疗保健成本。