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

摘要 心房颤动（AF）是最常见的心律失常类型;据估计， 美国已被诊断为AF，预计这一数字将增加。心脏导管消融 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 关注是存在的。内镜检查发现的食管病变（EDEL）发生在15 - 40%的病例中， 严重的创伤，包括心房食管瘘（AEF），这在大多数情况下是致命的。电流 预防策略包括减少应用于左心房的消融能量，监测食管 温度，并机械地移位食道。这些方法都没有证明 预防或减少重度EDEL或AEF的临床有效性可重现。先前的研究 表明主动冷却可减少食管热损伤，但临床实施中的挑战有限 这种商业化的做法。ensoETM最初设计并成功商业化， Attune Medical利用SBIR种子资金进行的全身温度调节提供了第一个可扩展的 用于心脏消融期间主动食管冷却的解决方案。ensoETM器械是FDA- 允许使用放置在食管中的多腔硅胶管进行核心温度调节，以冷却或 温暖病人。在射频（RF）消融手术期间，ensoETM器械用作散热器， 射频能量无意中输送到食管，从而最大限度地减少不必要的组织损伤。试点 随机对照研究显示了一个大的和一致的效应量，并建议在效率和 透视复位，扩大多部位检查范围。该项目的具体目标是： 1)确定食管热损伤的发生率并比较食管损伤的严重程度 2）测量ensoETM对手术效率的影响， X线透视使用; 3）确定特定的ensoETM设计变更和冷却方案变更， 优化.这些目标的证明将为这种创新方法的商业化铺平道路 食管保护，并支持扩大的FDA标签声明，使导管消融术更安全， 目前每年有数十万人接受房颤消融术，并扩大了替代方案， 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.