MA05.02 Electromagnetic Navigation Bronchoscopy: A Prospective, Global, Multicenter Analysis of 1000 Subjects with Lung Lesions

Abstract

Electromagnetic navigation bronchoscopy (ENB) may aid in accessing smaller, more peripheral lesions and hence facilitate earlier diagnosis. ENB may also provide a safer alternative to transthoracic biopsy, and allow adequate tissue capture for molecular testing, diagnosis, staging, and localization for surgery in a single anesthetic event. However, usage patterns, safety, and performance remain largely unexplored in a prospective, multicenter study. NAVIGATE is a global, prospective, multicenter study of ENB using the superDimension™ navigation system (Medtronic, Minneapolis). A pre-specified 1-month interim analysis was conducted on the first 1,000 primary cohort subjects enrolled at 29 centers in the United States and Europe. Enrollment and 2-year follow-up are ongoing. One-month follow-up was completed in 933/1,000 subjects. Of 1,000 procedures, ENB was intended for lung biopsy in 96.4%, to place fiducial markers in 21.0%, and for dye marking in 1.7% (multiple indications in 34.9%). Lymph node biopsies were attempted in 33.4% of procedures (322/334 using linear endobronchial ultrasound [EBUS]). General anesthesia was used in 79.7% and radial EBUS in 54.3%. Among 1,129 lung lesions, fluoroscopy was used in 90.1% and rapid on-site pathology evaluation in 683/1035 (66.0%). Median lesion size was 20.0 mm (interquartile range 16.0 mm). Most lesions were in the peripheral (62.6%) or middle (30.1%) lung thirds. A bronchus sign was present in 48.4% and 6.3% were ground glass. Navigation was subjectively considered successful in 1,036 lesions (91.8%). Site-reported pathology results were read as malignant in 452 lesions (43.6%), including 38.1% with primary lung cancer. Of 247 lesions with adenocarcinoma or unspecified non-small-cell lung cancer, 70 (28.3%) were sent for molecular testing with adequate tissue in 56/70 (80.0%). Primary lung cancer clinical stage was 52.9% I; 10.7% II, 18.9% III, and 17.3% IV. Preliminary non-malignant results were obtained in 444 lesions (42.9%). An additional 140 lesions (13.5%) were read as inconclusive. Longer follow-up is required to calculate the true negative rate and diagnostic yield. ENB-related pneumothorax was 4.9% (49/1,000) overall and 3.2% Grade ≥2 based on the Common Terminology Criteria for Adverse Events scale. The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failures rates were 1.0% and 0.6%. Interim 1-month results suggest a low adverse event rate in the largest prospective, multicenter ENB study conducted to date. Continued enrollment and 2-year follow-up will elucidate the real-world utilization patterns, diagnostic yield, factors contributing to successful diagnosis, and the impact of ENB on lung cancer management.