Improved Esophageal Safety in Atrial Fibrillation Elimination

项目摘要 这项SBIR建议的总体目标是开发一种新的设备，以允许更容易的房颤(AF)消融 通过减少食道损伤的风险进行手术。房颤是老年人最常见的慢性疾病。 心律不齐，可应用射频能量或冷冻法消融敏感 通过左心房的部分肺静脉心内膜表面。这件事的复杂性 手术包括损伤位于薄壁左心房后面的食道。伤害 范围从食管腔内无症状的溃疡，到罕见但灾难性的房性食道 瘘管(AEF)继发中风和死亡。目前，避免这些并发症的方法包括 避免在食道1厘米范围内消融，并监测食道温度。然而，大多数 患者的解剖学排除了避免在食道一厘米以内进行消融的可能性。温度 监测和避免超过一定的温度阈值，可以延长程序，减少 程序成功率。事实上，有相当高的程序流产率必须被取消，因为 相对于消融部位的食道造成了不可接受的高伤害风险。在我们的医生身上 合作者的实践2016年，19%(41%)的肺静脉隔离程序不完整 由于靠近食道，至少隔离了一条静脉。很明显，目前保护动物的技术 消融过程中的食道是初级的，没有专门制造的设备获得FDA的认证 批准这一适应症。 BioTex已经从德克萨斯心脏研究所和贝勒医学院获得许可，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 加强体温监测，提高房颤消融的安全性和有效性 程序。此Fast Track提案的目标是构建全功能原型、进行台式计算机 测试，进行先导性动物研究，证明在 射频消融，完成设备的最终设计，完成所有必要的验证，并获得 监管营销许可。我们预计这种新的方法将很容易地取代现有的 食道温度监测方法，对患者的安全有重大影响，并允许 在程序效率和医疗成本节约方面有显著改进。

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.