Robotic bronchoscopy for peripheral pulmonary lesions: A multicenter pilot and feasibility study (BENEFIT)

BACKGROUND: The diagnosis of peripheral pulmonary lesions (PPL) continues to present clinical challenges. Despite extensive experience with guided bronchoscopy, the diagnostic yield has not improved significantly. Robotic-assisted bronchoscopic platforms have been developed potentially to improve the diagnostic yield for PPL. Presently, limited data exist that evaluate the performance of robotic systems in live human subjects. RESEARCH QUESTION: What is the safety and feasibility of robotic-assisted bronchoscopy in patients with PPLs? STUDY DESIGN AND METHODS: This was a prospective, multicenter pilot and feasibility study that used a robotic bronchoscopic system with a mother-daughter configuration in patients with PPL 1 to 5 cm in size. The primary end points were successful lesion localization with the use of radial probe endobronchial ultrasound (R-EBUS) imaging and incidence of procedure related adverse events. Robotic bronchoscopy was performed in patients with the use of direct visualization, electromagnetic navigation, and fluoroscopy. After the use of R-EBUS imaging, transbronchial needle aspiration was performed. Rapid on-site evaluation (ROSE) was used on all cases. Transbronchial needle aspiration alone was sufficient when ROSE was diagnostic; when ROSE was not diagnostic, transbronchial biopsy was performed with the use of the robotic platform, followed by conventional guided bronchoscopic approaches at the discretion of the investigator. RESULTS: Fifty-five patients were enrolled at five centers. One patient withdrew consent, which left 54 patients for data analysis. Median lesion size was 23 mm (interquartile range, 15 to 29 mm). R-EBUS images were available in 53 of 54 cases. Lesion localization was successful in 51 of 53 patients (96.2%). Pneumothorax was reported in two of 54 of the cases (3.7%); tube thoracostomy was required in one of the cases (1.9 %). No additional adverse events occurred. INTERPRETATION: This is the first, prospective, multicenter study of robotic bronchoscopy in patients with PPLs. Successful lesion localization was achieved in 96.2% of cases, with an adverse event rate comparable with conventional bronchoscopic procedures. Additional large prospective studies are warranted to evaluate procedure characteristics, such as diagnostic yield. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT03727425; URL: www.clinicaltrials.gov

Safety and diagnostic performance of pulmonologists performing electromagnetic guided percutaneous lung biopsy (SPiNperc)

Background and objectivePercutaneous lung biopsy for diagnostic sampling of peripheral lung nodules has been widely performed by interventional radiologists under computed tomography (CT) guidance. New technology allows pulmonologists to perform percutaneous lung biopsies using electromagnetic (EM) guided technology. With the adoption of this new technique, the safety, feasibility and diagnostic yield need to be explored. The goal of this study was to determine the safety, feasibility and diagnostic yield of EMâ guided percutaneous lung biopsy performed by pulmonologists.MethodsWe conducted a retrospective, multicentre study of 129 EMâ guided percutaneous lung biopsies that occurred between November 2013 and March 2017. The study consisted of seven academic and three community medical centres.ResultsThe average age of participants was 65.6â years, BMI was 26.3 and 50.4% were females. The majority of lesions were in the right upper lobe (37.2%) and left upper lobe (31.8%). The mean size of the lesions was 27.31â mm and the average distance from the pleura was 13.2â mm. Practitioners averaged two fineâ needle aspirates and five core biopsies per procedure. There were 23 (17.8%) pneumothoraces, of which 16 (12.4%) received smallâ bore chest tube placement. The diagnostic yield of percutaneous lung biopsy was 73.7%. When EMâ guided bronchoscopic sampling was also performed during the same procedural encounter, the overall diagnostic yield increased to 81.1%.ConclusionIn this large multicentred series, the use of EM guidance for percutaneous lung biopsies was safe and feasible, with acceptable diagnostic yield in the hands of pulmonologists. A prospective multicentre trial to validate these findings is currently underway (NCT03338049).Lung cancer screening has led to the discovery of over 1â million pulmonary nodules each year. New technology allows pulmonologists to perform percutaneous lung biopsies using electromagnetic (EM) guided technology. In this retrospective analysis, we demonstrate that EM percutaneous needle biopsy is safe, feasible and provides an acceptable diagnostic yield.See related EditorialPeer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/149341/1/resp13471.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/149341/2/resp13471_am.pd

The electrocardiogram in patients with pacemakers

A study of the pacemaker-induced ventricular complexes can be of help in determining the site of stimulation. The first step consists in separating the stimulus artefacts from the QRS complexes. Right ventricular pacing usually produces a complete left bundle branch block (CLBBB) morphology. The electrical axis can be left, normal or even right, as pacing is performed from the apex to the outflow tract. Rarely an S1-S2-S3 pattern (with negative deflection in V1 and V2) appears during right ventricular apical pacing. Left ventricular stimulation usually produces a right bundle branch block pattern with inferior and rightwards deviation of the AQRS, although a superior axis is rarely seen with inferior stimulation. In the absence of pacer failure the basic QRS morphology produced by late diastolic stimuli can change if: (a) there are significant respiratory movements; (b) stimulation occurs during the relative refractory period; and (c) fusion beats occur. The classical Wolff-Parkinson-White beat was interpreted as a fusion beat, as long as exclusive Kent bundle conduction was not present. In the latter instances pacing from the preexcited area appeared to have produced similar QRS complexes

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT)

BACKGROUND: The diagnosis of peripheral pulmonary lesions (PPL) continues to present clinical challenges. Despite extensive experience with guided bronchoscopy, the diagnostic yield has not significantly improved. Robotic assisted bronchoscopic platforms have been developed to potentially improve the diagnostic yield for PPL. Presently, limited data exists evaluating the performance of robotic systems in live human subjects. RESEARCH QUESTION: What is the safety and feasibility of robotic assisted bronchoscopy in patients with peripheral pulmonary lesions? STUDY DESIGN AND METHODS: This was a prospective, multicenter pilot and feasibility study using a robotic bronchoscopic system with a mother-daughter configuration in patients with PPL 1-5cm in size. The primary endpoints were successful lesion localization using radial probe endobronchial ultrasound (R-EBUS) and incidence of procedure related adverse events. Robotic bronchoscopy was performed in patients using direct visualization, electromagnetic navigation and fluoroscopy. Following utilization of R-EBUS, transbronchial needle aspiration (TBNA) was performed. Rapid on-site evaluation (ROSE) was utilized on all cases. TBNA alone was sufficient when ROSE was diagnostic; when ROSE was non-diagnostic, transbronchial biopsy was performed using the robotic platform followed by conventional guided bronchoscopic approaches at the discretion of the investigator. RESULTS: Fifty-five patients were enrolled at five centers. One patient withdrew consent, leaving 54 patients for data analysis. Median lesion size was 23mm (IQR 15mm to 29mm). R-EBUS was available in 53/54 cases. Lesion localization was successful in 51/53 (96.2%) patients. Pneumothorax was reported in 2/54 (3.7%) of cases, requiring tube thoracostomy in 1/54 (1.9 %) case. No additional adverse events occurred. INTERPRETATION: This is the first, prospective, multicenter study of robotic bronchoscopy in patients with peripheral pulmonary lesions. Successful lesion localization was achieved in 96.2% of cases with an adverse event rate comparable to conventional bronchoscopic procedures. Additional large prospective studies are warranted to evaluate procedure characteristics such as diagnostic yield

Accuracy of a Robotic Endoscopic System in Cadaver Models with Simulated Tumor Targets: ACCESS Study

BACKGROUND: Bronchoscopy for the diagnosis of peripheral pulmonary lesions continues to present clinical challenges, despite increasing experience using newer guided techniques. Robotic bronchoscopic platforms have been developed to potentially improve diagnostic yields. Previous studies in cadaver models have demonstrated increased reach into the lung periphery using robotic systems compared to similarly sized conventional bronchoscopes, although the clinical impact of additional reach is unclear. OBJECTIVES: This study was performed to evaluate the performance of a robotic bronchoscopic system\u27s ability to reach and access artificial tumor targets simulating peripheral nodules in human cadaveric lungs. METHODS: Artificial tumor targets sized 10-30 mm in axial diameter were implanted into 8 human cadavers. CT scans were performed prior to procedures and all cadavers were intubated and mechanically ventilated. Electromagnetic navigation, radial probe endobronchial ultrasound, and fluoroscopy were used for all procedures. Robotic-assisted bronchoscopy was performed on each cadaver by an individual bronchoscopist to localize and biopsy peripheral lesions. RESULTS: Sixty-seven nodules were evaluated in 8 cadavers. The mean nodule size was 20.4 mm. The overall diagnostic yield was 65/67 (97%) and there was no statistical difference in diagnostic yield for lesionsmm, the presence of a concentric or eccentric radial ultrasound image, or relative distance from the pleura. CONCLUSIONS: The robotic bronchoscopic system was successful at biopsying 97% of peripheral pulmonary lesions 10-30 mm in size in human cadavers. These findings support further exploration of this technology in prospective clinical trials in live human subjects