SESSION TITLE: Interventional Pulmonology Posters I
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Peripheral pulmonary nodules (PPN) remain a diagnostic challenge for physicians. Minimally invasive biopsy methods for PPN include bronchoscopy with guidance modalities such as fluoroscopy, radial endobronchial ultrasound, navigational bronchoscopy (NB), and trans-thoracic needle aspiration under computer tomography (CT) guidance. Recently, a complete thoracic navigation system (TNS) combining NB and electromagnetic navigational trans-thoracic needle aspiration (N-TTNA) has become available to pulmonologists.The purpose of this study was to investigate the safety and efficacy of this new TNS.
METHODS: This study was a prospective single arm study examining the diagnostic yield, safety and feasibility of a combined diagnostic approach using TNS with NB and N-TTNA in a single procedural setting. Consecutive patients who consented with a PPN undergoing bronchoscopy were enrolled. All patients underwent convex endobronchial ultrasound for full lymph node staging followed by NB and N-TTNA. All non-diagnostic biopsies were followed with radiographic interval imaging revealing a decrease in size or resolution or surgical biopsy. The primary outcome was diagnostic yield with safety and feasibility as secondary endpoints.
RESULTS: Twenty-four subjects were enrolled in this study (9 male and 15 female) with a median age of 70 years (range 52-85). A NB and/or N-TTNA was completed in 24/24 (100%) of the patients. A complete TNS procedure was accomplished in 23/24 (96%). The overall diagnostic yield for the combined TNS procedure was 87% (20/23). N-TTNA was diagnostic in 83%. NB was diagnostic in 72% of subjects when an air bronchus sign was present. When combining convex EBUS with the TNS procedure for complete staging, the diagnostic yield increased further to 92%. No bleeding or hemoptysis events were encountered during the study. There were five (20%) pneumothoraces of which only two (8%) subjects required small bore pigtail catheter placement.
CONCLUSIONS: Results support the safety and feasibility of pulmonologists to perform EBUS, navigational bronchoscopy, and N-TTNA in a single setting. Multicentered prospective studies are needed to confirm these findings.
CLINICAL IMPLICATIONS: This is the first human study demonstrating the high diagnostic yield and acceptable safety profile with a novel complete thoracic navigation system.
DISCLOSURE: Hans Lee: Grant monies (from industry related sources): Study funding from Veran Inc. David Feller-Kopman: Grant monies (from industry related sources): Study funding from Veran Inc. Alexander Chen: Grant monies (from industry related sources): Study funding from Veran Inc. Gerard Silvestri: Grant monies (from industry related sources): Study funding from Veran Inc. Lonny Yarmus: Grant monies (from industry related sources): Study funding from Veran Inc. The following authors have nothing to disclose: Sixto Arias, Roy Semaan, Bernice Frimpong, Karen Oakjones-Burgess, Thompson Richard, Ricardo Ortiz
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