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EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: The EASY AF Trial
JACC: Clinical Electrophysiology ( IF 8.0 ) Pub Date : 2023-10-25 , DOI: 10.1016/j.jacep.2023.09.004 Raul Weiss 1 , Jose Osorio 2 , Devi Nair 3 , Luis Aguinaga 4 , Luis Arabia 4 , Diego Alcivar 5 , Amin Al-Ahmad 6 , Gery Tomassoni 7 , Omar Kahaly 8 , Rohit Mehta 9 , Chad Ward 10 , Benjamin Holmes 10 , Dilesh Patel 11 , Ammar M Killu 12 , Thomas Munger 12 , Michael Essandoh 1 , Mahmoud Houmsse 1 , Anil Rajendra 2 , Gustavo Morales 2 , John D Hummel 1 , Gokulakrishan Balasubramanian 1 , Emile G Daoud 1
JACC: Clinical Electrophysiology ( IF 8.0 ) Pub Date : 2023-10-25 , DOI: 10.1016/j.jacep.2023.09.004 Raul Weiss 1 , Jose Osorio 2 , Devi Nair 3 , Luis Aguinaga 4 , Luis Arabia 4 , Diego Alcivar 5 , Amin Al-Ahmad 6 , Gery Tomassoni 7 , Omar Kahaly 8 , Rohit Mehta 9 , Chad Ward 10 , Benjamin Holmes 10 , Dilesh Patel 11 , Ammar M Killu 12 , Thomas Munger 12 , Michael Essandoh 1 , Mahmoud Houmsse 1 , Anil Rajendra 2 , Gustavo Morales 2 , John D Hummel 1 , Gokulakrishan Balasubramanian 1 , Emile G Daoud 1
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Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF). This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device. This prospective, randomized, multicenter, double-blinded, controlled Food and Drug Administration investigational device exemption trial compared the incidence of ablation-related esophageal lesions, as assessed by endoscopy, in patients undergoing AF ablation assigned to a control group (luminal esophageal temperature [LET] monitoring alone) compared with patients randomized to a deviation group (esophagus deviation device + LET). This novel deviating device uses vacuum suction and mechanical deflection to deviate a segment of the esophagus, including the trailing edge. The data safety and monitoring board recommended stopping the study early after randomizing 120 patients due to deviating device efficacy. The primary study endpoint, ablation injury to the esophageal mucosa, was significantly less in the deviation group (5.7%) in comparison to the control group (35.4%; < 0.0001). Control patients had a significantly higher severity and greater number of ablation lesions per patient. There was no adverse event assigned to the device. By multivariable analysis, the only feature associated with reduced esophageal lesions was randomization to deviating device (OR: 0.13; 95% CI: 0.04-0.46; = 0.001). Among control subjects, there was no difference in esophageal lesions with high power/short duration (31.8%) vs other radiofrequency techniques (37.2%; = 0.79). The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.
中文翻译：
房颤射频消融过程中的食管偏差：简易 AF 试验
据报道，接受心房颤动 (AF) 消融术的患者中，食道损伤的比例很高。本研究评估了接受房颤消融术（使用或不使用食管偏转装置）的患者食管损伤的发生率。这项前瞻性、随机、多中心、双盲、受控的食品和药物管理局研究性设备豁免试验比较了分配到对照组（管腔食管温度[单独使用 LET] 监测）与随机分配到偏离组（食管偏离装置 + LET）的患者进行比较。这种新颖的偏转装置使用真空抽吸和机械偏转来偏转食道的一部分，包括后缘。由于设备功效存在偏差，数据安全和监测委员会建议在对 120 名患者进行随机分组后尽早停止该研究。主要研究终点，即食管粘膜消融损伤，偏离组 (5.7%) 明显低于对照组 (35.4%；< 0.0001)。对照患者的严重程度明显更高，每位患者的消融病变数量也更多。该设备没有发生不良事件。通过多变量分析，与食管病变减少相关的唯一特征是随机化至偏离装置（OR：0.13；95% CI：0.04-0.46；= 0.001）。在对照受试者中，高功率/短持续时间的食管病变（31.8%）与其他射频技术（37.2%；= 0.79）相比没有差异。食管偏转装置的使用显着减少了与消融相关的食管病变，且没有任何不良事件。
更新日期：2023-10-25
中文翻译：
房颤射频消融过程中的食管偏差：简易 AF 试验
据报道，接受心房颤动 (AF) 消融术的患者中，食道损伤的比例很高。本研究评估了接受房颤消融术（使用或不使用食管偏转装置）的患者食管损伤的发生率。这项前瞻性、随机、多中心、双盲、受控的食品和药物管理局研究性设备豁免试验比较了分配到对照组（管腔食管温度[单独使用 LET] 监测）与随机分配到偏离组（食管偏离装置 + LET）的患者进行比较。这种新颖的偏转装置使用真空抽吸和机械偏转来偏转食道的一部分，包括后缘。由于设备功效存在偏差，数据安全和监测委员会建议在对 120 名患者进行随机分组后尽早停止该研究。主要研究终点，即食管粘膜消融损伤，偏离组 (5.7%) 明显低于对照组 (35.4%；< 0.0001)。对照患者的严重程度明显更高，每位患者的消融病变数量也更多。该设备没有发生不良事件。通过多变量分析，与食管病变减少相关的唯一特征是随机化至偏离装置（OR：0.13；95% CI：0.04-0.46；= 0.001）。在对照受试者中，高功率/短持续时间的食管病变（31.8%）与其他射频技术（37.2%；= 0.79）相比没有差异。食管偏转装置的使用显着减少了与消融相关的食管病变，且没有任何不良事件。
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