Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation

摘要 房颤(房颤)是最常见的心律失常类型；据估计，全世界有270万至610万人 美国已经被诊断出患有房颤，这个数字预计还会增加。心导管消融术 是一种有效的房颤治疗方法，在美国每年进行多达25万次；然而，安全性 令人担忧的是。内窥镜检测到的食道病变(EDELs)发生在15%-40%的病例中，并且可以 进展为严重损伤，包括房性食管瘘(AEF)，这在大多数情况下是致命的。当前 预防策略包括减少应用于左心房的消融能量，监测食道 温度，以及机械移位食道。这些方法都没有证明 在预防或减少严重的Edels或AEF方面具有可重复性的临床效果。之前的研究已经 显示主动降温可减少热性食道损伤，但临床应用的挑战有限 这种方法的商业化。EnsoETM最初设计并成功商业化用于 Attune Medical使用SBIR种子资金进行的全身温度调制提供了第一个可扩展的 心脏消融术中主动食道降温的解决方案。EnsoETM器件是一种新型器件FDA- 允许使用放置在食道中的多腔硅胶管进行核心温度调节 给病人取暖。在射频(RF)消融过程中，EnsoETM设备充当散热器 射频能量无意中传递到食道，从而将不必要的组织损伤降至最低。引航员 随机对照研究显示出大而一致的效应大小，并表明在效率和 透视减少也是必要的，需要进行更大规模的多部位检查。该项目的具体目标是： 1)确定食道热损伤发生率，比较食道损伤的严重程度 在使用和不使用ensoETM的小组之间；2)测量ensoETM对程序效率和 透视使用；3)确定特定的EnsoETM设计更改和必要的冷却方案更改 优化。这些目标的展示将为这一创新方法的商业化铺平道路 到食道保护，并支持FDA扩展的标签声明，使导管消融对 目前每年有数十万人接受房颤消融，并扩大了替代房颤的方法 昂贵的终身药物治疗。

ABSTRACT Atrial fibrillation (AF) is the most common type of heart arrhythmia; an estimated 2.7 to 6.1 million people in the United States have been diagnosed with AF and this number is expected to increase. Cardiac catheter ablation is an effective AF treatment and is performed up to a quarter million times per year in the US; however, safety concerns exist. Endoscopically detected esophageal lesions (EDELs) occur in 15-40% of cases and can progress into serious injuries, including atrioesophageal fistula (AEF), which is fatal in most cases. Current prevention strategies include reducing ablation energy applied to the left atrium, monitoring esophageal temperature, and mechanically displacing the esophagus. None of these methods have demonstrated reproducible clinical effectiveness in preventing or reducing severe EDELs or AEF. Previous studies have shown that active cooling reduces thermal esophageal injury but challenges in clinical implementation limited commercialization of this approach. The ensoETM, originally designed and successfully commercialized for whole-body temperature modulation by Attune Medical using SBIR seed funding provides the first scalable solution for active esophageal cooling during cardiac ablation. The ensoETM device is a novel device FDA- cleared for core temperature modulation using a multi-lumen silicone tube placed in the esophagus to cool or warm a patient. During radiofrequency (RF) ablation procedures, the ensoETM device acts as a heat sink for RF energy inadvertently delivered to the esophagus, thus minimizing unwanted tissue damage. Pilot randomized, controlled studies show a large and consistent effect size, and suggest benefits in efficiency and fluoroscopy reduction as well, warranting larger, multi-site investigation. The Specific Aims of this project are: 1) Determine the occurrence rate of esophageal thermal injury and compare the severity of esophageal injury between groups with and without ensoETM; 2) Measure the impact of ensoETM on procedural efficiency and fluoroscopy use; 3) Determine specific ensoETM design changes and cooling protocol changes necessary for optimization. Demonstration of these aims will pave the way for commercialization of this innovative approach to esophageal protection, and support an expanded FDA label claim, making catheter ablation safer for the hundreds of thousands of people who currently undergo AF ablation per year, and expanding an alternative to expensive and life-long pharmaceutical treatment.