Introduction: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single‐center studies; thus, the diagnostic yield in a generalizable setting is unknown. Methods: NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016. Results: The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB‐specific procedure time was 25 minutes. Among 1157 subjects undergoing ENB‐guided biopsy, 94% (1092 of 1157) had navigation completed and tissue obtained. Follow‐up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12‐month diagnostic yield was 73%. Pathology results of the ENB‐aided tissue samples showed malignancy in 44% (484 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB‐related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB‐related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. Conclusions: NAVIGATE shows that an ENB‐aided diagnosis can be obtained in approximately three‐quarters of evaluable patients across a generalizable cohort based on prospective 12‐month follow‐up in a pragmatic setting with a low procedural complication rate.

中文翻译：

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电磁导航支气管镜检查周围肺部病变：前瞻性、多中心 NAVIGATE 研究的一年结果

简介：电磁导航支气管镜（ENB）是一种引导内窥镜工具检查肺部病变的微创技术。ENB 主要在小型单中心研究中进行评估；因此，在一般情况下的诊断率是未知的。方法：NAVIGATE 是一项前瞻性、多中心、队列研究，使用 superDimension 导航系统（明尼苏达州明尼阿波利斯的美敦力公司）评估 ENB。在这项美国队列分析中，2015 年 4 月至 2016 年 8 月期间，在 29 个学术和社区场所连续招募了 1215 名受试者。 结果：病变中位尺寸为 20.0 毫米。91% 的病例使用了透视检查（60% 的病例可见病变），57% 的病例使用了径向支气管内超声检查。ENB 计划时间中位数为 5 分钟；ENB 特定手术时间为 25 分钟。在接受 ENB 引导活检的 1157 名受试者中，94%（1157 名受试者中的 1092 名）完成了导航并获取了组织。99% 的受试者在 1 个月时完成随访，80% 的受试者在 12 个月时完成。12 个月的诊断率为 73%。ENB 辅助组织样本的病理学结果显示，44% 的患者为恶性肿瘤（1092 例中有 484 例）。恶性肿瘤的敏感性、特异性、阳性预测值和阴性预测值分别为 69%、100%、100% 和 56%。ENB 相关不良事件通用术语标准 2 级或以上气胸（需要入院或放置胸管）的发生率为 2.9%。ENB 相关的 2 级或以上支气管肺出血不良事件和 4 级或以上呼吸衰竭发生率的通用术语标准分别为 1.5% 和 0.7%。结论：