Performance Characteristics and 2-Year Outcomes of Digital Tomosynthesis-Assisted Electromagnetic Navigation Bronchoscopy in a Community Hospital.

BACKGROUND: The long-term performance characteristics of digital tomosynthesis-assisted electromagnetic navigation bronchoscopy (DT-ENB) has not been evaluated in the community setting. RESEARCH QUESTION: What is the diagnostic yield and 2-year diagnostic accuracy of DT-ENB in a typical pulmonary practice? STUDY DESIGN AND METHODS: This was a single-center, community hospital-based retrospective observational performance evaluation over 2 years assessing the long-term diagnostic accuracy of DT-ENB using the ILLUMISITE Fluoroscopic Navigation Platform (Medtronic). Other performance characteristics assessed included diagnostic yield, negative predictive value (NPV), and sensitivity. Factors affecting diagnostic yield were analyzed, and subsequent workup for false negatives and outcomes were described. RESULTS: A total of 227 patients underwent DT-ENB, resulting in a specific diagnosis for 175 patients, for a diagnostic yield of 77.1% (95% CI, 71.2-82.1). Of these, 202 patients either had a confirmatory diagnosis or 2 years of CT scan follow-up. Among the 202 patients included in the NPV and sensitivity analysis, 135 (66.8%) were determined to be true positives, 47 (23.3%) were true negatives, 20 (9.9%) were false negatives, and there were no false positives. Overall, 2-year diagnostic accuracy was 71.4% (95% CI, 65.2-76.9). The 2-year NPV was 70.1% (95% CI, 61.0-78.0), and sensitivity was 87.1% (95% CI, 80.8-91.9). Nodule size was associated with higher diagnostic yield (P = .001), with a median nodule size for nondiagnostic procedures of 1.5 cm (95% CI, 1.25-2.15 cm) and a median nodule size for diagnostic procedures of 2.2 cm (95% CI, 1.4-4.0 cm). INTERPRETATION: Our results show that DT-ENB when used in the community setting for lung nodule biopsy resulted in a diagnostic yield of 77.1% and diagnostic accuracy of 71.4% at 2-year follow-up.