Medtronic. Dr. Nead has received personal fees from Medtronic. Dr. Bowling has received personal fees from Medtronic. Dr. Murgu has received personal fees from Medtronic, Boston Scientific, Pinnacle Biologics, Olympus, Cook, Auris Robotics, and Elsevier; and has stock ownership in Concordia, Boston Scientific, and Merck. Dr. Krimsky has received personal fees from Medtronic, Innovital Systems, Gala Therapeutic, SOC, and Peytant; has stock ownership with Innovital Systems and CSA Medical; and has patents pending with Medtronic and Merit. Dr. Murillo has received support from Medtronic. Dr. LeMense has received personal fees from Medtronic. Dr. Minnich has received personal fees from Medtronic. Dr. Bansal has received personal fees from Medtronic, Pinnacle Biologics, Sunovion, and Veran Medical. Dr. Ellis has received support from Medtronic. Dr. Mahajan has received personal fees from Medtronic. Dr. Gildea has received personal fees from Medtronic. Dr. Bechara has received support from Medtronic. Dr. Sztejman has received support from Medtronic. Dr. Flandes has received grants from BTG-PneumRx and Ambu; and personal fees from Medtronic, BTG-PneumRx, Olympus, Ambu, PulmonX, and Boston Scientific. Dr. Rickman has received personal fees from Medtronic, Veran Medical, BD, Olympus, and Abbvie. Dr. Benzaquen has received support from Medtronic. Dr. Hogarth has received personal fees from Medtronic, Auris Surgical Robotics, Boston Scientific, Grifols, Shire, and CSL; and has stock ownership with Auris Surgical Robotics. Dr. Linden has received support from Medtronic. Dr. Wahidi has received personal fees from Medtronic and Veran Medical. Dr. Mattingley has received personal fees from Medtronic and is current employee of Medtronic (employment began after completion of enrollment). Dr. Hood is an employee with stock ownership at Medtronic; and has stock ownership with Boston Scientific. Ms. Lin and Ms. Wolvers are employees with stock ownership at Medtronic. Dr. Khandar has received personal fees from Medtronic.

ClinicalTrials.gov; No.: NCT01752114; URL: www.clinicaltrials.gov).

BackgroundElectromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.MethodsNAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing.ResultsENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively.ConclusionsOne-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield.Trial registrationClinicalTrials.gov NCT02410837. Registered 31 March 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-017-0403-9) contains supplementary material, which is available to authorized users.

BackgroundThe annual incidence of a small indeterminate pulmonary nodule (IPN) on computed tomography (CT) scan remains high. While traditional paradigms exist, the integration of new technologies into these diagnostic and treatment algorithms can result in alternative, potentially more efficient methods of managing these findings.MethodsWe report on an alternative diagnostic and therapeutic strategy for the management of an IPN. This approach combines electromagnetic navigational bronchoscopy (ENB) with an updated approach to placement of a pleural dye marker. This technique lends itself to a minimally invasive wedge resection via either video-assisted thoracoscopic surgery (VATS) or a robotic approach.ResultsSubsequent to alterations in the procedure, a cohort of 22 patients with an IPN was reviewed. Navigation was possible in 21 out of 22 patients with one patient excluded based on airway anatomy. The remaining 21 patients underwent ENB with pleural dye marking followed by minimally invasive wedge resection. The median size of the nodules was 13.4 mm (range: 7–29). There were no complications from the ENB procedure. Indigo carmine dye was used in ten patients. Methylene blue was used in the remaining 11 patients. In 81% of cases, the visceral pleural marker was visible at the time of surgery. In one patient, there was diffuse staining of the parietal pleura. In three additional patients, no dye was identified within the hemithorax. In all cases where dye marker was present on the visceral pleural surface, it was in proximity to the IPN and part of the excised specimen.ConclusionsENB with pleural dye marking can provide a safe and effective method to localize an IPN and can allow for subsequent minimally invasive resection. Depending on the characteristics and location of the nodule, this method may allow more rapid identification intraoperatively.

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Traditional approaches to managing occluded airways include surgery, mechanical debulking, brachytherapy, stents, photodynamic therapy, and thermal modalities, such as electrocautery, laser, argon plasma coagulation, and cryotherapy. Although cryotherapy with cryoprobes has been used safely for over a decade in airways management, it is often tedious and time-consuming because of surface area limitations of the probes, which must be inserted into or come in contact with the surface of the targeted lesion. Newer cryotherapy devices obviate the need for contact with the target tissue. Reports of promising results from use of low-pressure spray cryotherapy for ablation of esophageal lesions 1-2 have led to the experience reported here, in which spray cryotherapy with low-pressure liquid nitrogen was used for the first time to treat human airways.

Rationale: Chronic bronchitis (CB) is characterized by productive cough with excessive mucus production, resulting in quality-of-life impairment and increased exacerbation risk. Bronchial rheoplasty uses an endobronchial catheter to apply nonthermal pulsed electrical fields to the airways. Preclinical studies have demonstrated epithelial ablation followed by regeneration of normalized epithelium. Objectives: To evaluate the feasibility, safety, and initial outcomes of bronchial rheoplasty in patients with CB. Methods: Pooled analysis of two separate studies enrolling 30 patients undergoing bilateral bronchial rheoplasty was conducted. Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology, and changes in symptoms using the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test and St. George’s Respiratory Questionnaire (SGRQ). Measurements and Main Results: Bronchial rheoplasty was performed in all 30 patients (63% male; mean [SD] age, 67 [7.4]; mean [SD] postbronchodilator FEV 1 , 65% [21%]; mean [SD] COPD Assessment Test score 25.6 [7.1]; mean [SD] SGRQ score, 59.6 [15.3]). There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months. The most frequent nonserious, device- and/or procedure-related event through 6 months was mild hemoptysis in 47% (14 of 30) patients. Histologically, the mean goblet cell hyperplasia score was reduced by a statistically significant amount ( P < 0.001). Significant changes from baseline to 6 months in COPD Assessment Test (mean, −7.9; median, −8.0; P = 0.0002) and SGRQ (mean, −14.6; median, −7.2; P = 0.0002) scores were observed, with similar observations through 12 months. Conclusions: This study provides the first clinical evidence of the feasibility, safety, and initial outcomes of bronchial rheoplasty in symptomatic patients with CB. Clinical trial registered with www.anzctr.org.au (ACTRN 12617000330347) and clinicaltrials.gov (NCT 03107494).

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