"Tool-in-lesion" Accuracy of Galaxy System-A Robotic Electromagnetic Navigation BroncHoscopy With Integrated Tool-in-lesion-Tomosynthesis Technology: The MATCH Study.

BACKGROUND: The Galaxy System (Noah Medical) is a novel robotic endoluminal platform using electromagnetic navigation combined with integrated tomosynthesis technology and augmented fluoroscopy. It provides intraprocedural imaging to correct computerized tomography (CT) to body divergence and novel confirmation of tool-in-lesion (TIL). The primary aim of this study was to assess the TIL accuracy of the robotic bronchoscope with integrated digital tomosynthesis and augmented fluoroscopy. METHODS: Four operators conducted the experiment using 4 pigs. Each physician performed between 4 and 6 nodule biopsies for 20 simulated lung nodules with purple dye and a radio pacifier. Using Galaxy's "Tool-in-Lesion Tomography (TOMO+)" with augmented fluoroscopy, the physician navigated to the lung nodules, and a tool (needle) was placed into the lesion. TIL was defined by the needle in the lesion determined by cone-beam CT. RESULTS: The lung nodule's average size was 16.3 ± 0.97 mm and was predominantly in the lower lobes (65%). All 4 operators successfully navigated to all (100%) of the lesions in an average of 3 minutes and 39 seconds. The median number of tomosynthesis sweeps was 3 and augmented fluoroscopy was utilized in most cases (17/20 or 85%). TIL after the final TOMO sweep was 95% (19/20) and tool-touch-lesion was 5% (1/20). Biopsy yielding purple pigmentation was also 100% (20/20). CONCLUSION: The Galaxy System demonstrated successful digital TOMO confirmed TIL success in 95% (19/20) of lesions and tool-touch-lesion in 5% (1/20) as confirmed by cone-beam CT. Successful diagnostic yield was achieved in 100% (20/20) of lesions as confirmed by intralesional pigment acquisition.

Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx.

INTRODUCTION: Chronic bronchitis (CB), a phenotype of chronic obstructive pulmonary disease (COPD) characterised by persistent cough and mucus hypersecretion, is associated with poor outcomes despite guideline-based treatment. Bronchial rheoplasty (BR) with the RheOx system delivers non-thermal pulsed electric fields to the lower airway epithelium and submucosa to reduce mucus producing cells. Early phase clinical trials including 1-year follow-up have demonstrated reduction in airway goblet cell hyperplasia and improvement in CB symptoms. METHODS: The current multicentre observational BR study enrolled 21 patients with CB at six centres in the USA, with bilateral treatment and 2-year follow-up. Entry criteria included elevated cough and sputum scores from COPD Assessment Test (CAT) and forced expiratory volume in one second<80% predicted. Safety was assessed by serious adverse event (SAE) incidence through 24 months. Clinical utility was evaluated using changes in the CAT, the St. George's Respiratory Questionnaire (SGRQ) and by comparing exacerbation rates before and following intervention. RESULTS: No procedure-related or device-related SAEs occurred. Mean (SD) changes from baseline in CAT at 12 and 24 months were -9.0 (6.7) (p<0.0001) and -5.6 (7.1) (p<0.0047) and in SGRQ were -16.6 (13.2) (p<0.0001) and -11.8 (19.2) (p<0.0227), respectively. There was a 34% reduction in moderate and a 64% reduction in severe COPD exacerbation events compared with the year prior to treatment. CONCLUSIONS: This study extends the findings from previous feasibility studies, demonstrating that BR can be performed safely and may significantly improve symptoms and health-related quality of life for patients with CB through 24 months. TRAIL REGISTRATION NUMBER: NCT03631472.

Augmented Fluoroscopy: A New and Novel Navigation Platform for Peripheral Bronchoscopy.

BACKGROUND: The diagnosis of lung nodules continues to be a challenge. Confirmed diagnosis allows appropriate treatment for cancers and allows avoidance of more invasive procedures for proven noncancers. Currently, available lung biopsy technologies each have their own limitations, which affect the ability to successfully navigate to a suspicious nodule and to collect a diagnostic sample. Additional advancements in endobronchial navigation, localization, and guided biopsy are needed to obtain higher rates of definitive diagnosis for lung nodules. METHODS: This is a prospective, multicenter study that assessed the localization success rate and diagnostic yield of bronchoscopies guided only by the LungVision platform. Physicians navigated to pulmonary nodules according to a proposed pathway and verified nodule location using radial endobronchial ultrasound before the biopsy. RESULTS: Fifty-five patients were enrolled in the study. Two patients had >1 nodule that was evaluated on the day of the procedure. During bronchoscopy, the nodule localization success rate was 93%. The overall diagnostic yield measured the day of the procedure, based on the immediate rapid on-site pathology report, was 75.4%. CONCLUSION: LungVision provides reliable navigation and ability to biopsy pulmonary nodules with an acceptable success rate. The platform demonstrates a high localization rate of pulmonary nodules.

Improving diagnostic yield of navigational bronchoscopy for peripheral pulmonary lesions: a review of advancing technology.

With recommendations for low dose CT scan for lung cancer screening, there has been an increase in the finding of lung nodules and peripheral pulmonary lesions (PPLs). Additionally, when there is concern for malignancy, guidelines have recommended performing the least invasive evaluation. Conventional bronchoscopy diagnostic yields for PPLs have reportedly been quite low and prior electromagnetic navigation bronchoscopy (ENB) studies have reported variable yields. Navigation bronchoscopy in addition to endobronchial ultrasound allows a physician to evaluate peripheral lung lesions along with mediastinal and hilar lymph nodes for the diagnosis and staging of suspected malignancy in one procedure. More recent advances in navigational bronchoscopy including the use of augmented fluoroscopy (AF), cone beam CT, and robotic bronchoscopy have pushed the boundaries of capability in evaluating PPLs. These added bronchoscopic technologies have shown to improve diagnostic yield especially when modalities are used in combination. The ultimate goal of endoscopically localized ablative and therapeutic treatment for peripheral lung lesions will require a high level of physician confidence, accuracy, and precision. This article will review the innovative characteristics and data of some of the more recently available navigational bronchoscopy devices.

A successful bronchial thermoplasty procedure in a "very severe" asthma patient with rare complications: a case report.

Introduction: Bronchial thermoplasty (BT) is a unique bronchoscopic treatment for severe asthma that utilizes radiofrequency ablation to reduce smooth muscle in the bronchial walls. Current studies mainly focused on uncontrolled severe asthma with a forced expiratory volume in 1 second (FEV1) above 60% and associated complications, no human studies have performed on "very severe" asthma as well as its complications. Case study: We present a 60-year-old male with more than 15 years history of very severe asthma, who underwent BT. His FEV1 was only 20.4% predicted, which would have excluded him from all prior clinical trials of BT. The first BT procedure occurred without an issue. After the second BT procedure, he experienced severe dyspnea due to an infection with a non-flu respiratory virus. This illness was complicated by the formation of a pulmonary cyst. During recovering from the third procedure, he developed stomach stones. This is mainly related with taking large amounts of hawthorn previously, also cannot exclude the role of thermal energy injury on gastrointestinal nerve function. Results: Despite these unexpected complications, his quality of life greatly improved after BT, yet his lung function did not improve. Conclusion: This case is the first to describe BT procedures in patient with this level of lung function compromise, although accompanied with rare complications; our report indicates BT may be an opportunity and choice for the "very severe" asthma patients.

Flexible bronchoscopy-guided microwave ablation in peripheral porcine lung: a new minimally-invasive ablation.

BACKGROUND: Transbronchial lung biopsy is an important approach to diagnose peripheral lung cancer, but bronchoscopy based treatment options are limited and poorly studied. A flexible bronchoscopy-guided water-cooled microwave ablation (MWA) catheter was developed to evaluate the feasibility and safety both in ex vivo and in vivo porcine models. METHODS: Using direct penetration of the catheter through the surface of ex vivo porcine lung, ablations (n=9) were performed at 70, 80, 90 W for 10 minutes. Temperatures of the catheter and 10, 15, 20 mm away from the tip were measured. Under bronchoscopy conditions in porcine lung, ablations (n=18, 6 in ex vivo and 12 in vivo) were performed at 80 W for 5 minutes. Computed tomography (CT) was acquired perioperative, 24 hours, 2 weeks, and 4 weeks post ablation. Ablation zones were excised at 24 hours and 4 weeks respectively. Long-axis diameter (Dl) and short-axis diameter (Ds) were measured and tissues were sectioned for pathological examination. RESULTS: In-ex vivo lung, the temperature at 20 mm removed was over 60 °C at 80 W for 288±26 seconds. The ablations under bronchoscopic conditions were successful in-ex vivo and in vivo lung. No complications occurred during the procedures. Coagulation necrosis was visible at 24 hours, and repaired fibrous tissue was seen at 4 weeks. CONCLUSIONS: The flexible bronchoscopy-guided water-cooled MWA is feasible and safe. This early animal data holds promise of MWA becoming a potential therapeutic tool for Peripheral Lung Cancers.

Mediastinal granuloma: a rare cause of dysphagia.

Dysphagia is commonly attributed to disorders arising from dysfunction of the oesophageal mucosa or oesophageal motility. Mediastinal structures causing compression of the oesophagus remain a rare presenting cause of dysphagia. We report a case of a woman presenting with dysphagia to solid foods and associated symptoms of weight loss. Traditional evaluation for dysphagia was unrevealing until cross-sectional imaging suggested a mediastinal obstructive process. The finding of a mediastinal granuloma, distinct from mediastinal fibrosis, as the aetiology of dysphagia is a rare finding, with specific treatment implications. The patient was treated with itraconazole antifungal therapy with an improvement in her symptoms.

Right Heart Involvement in Patients with Sarcoidosis.

The left ventricle (LV) is affected in 20-25% of patients with sarcoidosis and its involvement is associated with morbidity and mortality. However, effects of sarcoidosis on the right ventricle (RV) are not well documented. Our aims were to investigate the prevalence of RV dysfunction in patients with sarcoidosis and determine whether it is predominantly associated with direct cardiac involvement, severity of lung disease, or pulmonary hypertension (PH). We identified 50 patients with biopsy-proven extra-cardiac sarcoidosis and preserved LV function, who underwent echocardiography, pulmonary function (PF) testing, and cardiovascular magnetic resonance. RV function was quantified by free wall longitudinal strain. Tricuspid valve Doppler and estimated right atrial pressure were used to estimate systolic pulmonary artery pressure. Myocardial late gadolinium enhancement was considered diagnostic for cardiac sarcoidosis and assumed to involve both ventricles. Of the 50 patients, 28 (56%) had RV dysfunction, 4 with poorly defined PF status. Of the remaining 24 patients, 16 (67%) had lung disease, 8 (33%) had PH, and 10 (42%) had LV involvement. Ten patients had greater than one of these findings, and 4 had all 3. In contrast, in 4/24 patients (17%), RV dysfunction could not be explained by these mechanisms, despite severely reduced RV strain. In conclusion, RV dysfunction is common in patients with sarcoidosis and is usually associated with either direct LV involvement, lung disease, or PH, but may occur in the absence of these mechanisms, suggesting the possibility of isolated RV involvement and underscoring the need for imaging protocols that would include RV strain analysis.

The prevalence of alpha-1 antitrypsin deficiency among patients found to have airflow obstruction.

INTRODUCTION: Alpha-1 antitrypsin deficiency (AATD) is a genetic disease that may be manifested by chronic obstructive pulmonary disease. Despite professional society guidelines that recommend broad testing of at-risk individuals, fewer than 10% of affected individuals have been identified. The goals of this study were to estimate the frequency of abnormal AAT genotypes among patients found to have fixed airflow obstruction and to assess the feasibility of having Pulmonary Function Laboratory personnel administer the study. METHODS: Nineteen medical centers in the United States participated in the study. Eligible patients (> GOLD II, FEV(1)/FVC ratio < 0.7, with post-bronchodilator FEV(1)<80% predicted) were offered testing for AATD by the Pulmonary Function Laboratory personnel at the time of pulmonary function testing. RESULTS: A total of 3,457 patients were tested, of whom 3152 were eligible. Deficient patients (ZZ, SZ) constituted 0.63% of subjects, while 10.88% were carriers (MS, MZ). Neither demographic (except African-American race) nor post-bronchodilator pulmonary function variables (FEV(1), FVC, FEV(1)/FVC ratio, TLC, and FEV(1)/FVC) allowed us to predict AAT heterozygote or deficiency status. CONCLUSIONS: The prevalence of AATD among patients undergoing pulmonary function tests with fixed airflow obstruction was 0.63%. Pulmonary Function Laboratory personnel effectively conducted the study.

Electromagnetic navigational bronchoscopy: an effective and safe approach to diagnose peripheral lung lesions unreachable by conventional bronchoscopy in high-risk patients.

PURPOSE: The purpose of this study was to investigate the diagnostic yield and safety of electromagnetic navigation bronchoscopy (ENB) on peripheral lung lesions deemed otherwise unreachable using conventional bronchoscopy in high-risk patients. METHODS: This was a retrospective chart review involving adults (age, 18 y and older) who underwent ENB for pulmonary lesions located at the fourth order of bronchi or beyond, including subpleural lesions, at the University of Chicago Medical Center. Forty-eight patients underwent ENB by 3 different trained operators from January 2006 to September 2008. There was a short period of inactivity when the device was withdrawn from the market. ENB was reserved for use only in lesions at the fourth order of bronchi or beyond, including subpleural lesions, in patients who are considered high risk for other invasive procedures. Pathologic, cytologic, and microbiologic studies were carried out on recovered samples. Postprocedural chest radiographs were obtained on all patients to detect the presence of procedure-associated complications. RESULTS: ENB led to the diagnosis of 37 of 48 (77%) lesions not amenable to conventional bronchoscopic biopsy in high-risk patients. Of the 37 successful procedures, malignancy was identified in 18 patients (49%). Nonsmall cell lung cancer (NSCLC) was diagnosed 16 times, whereas both small cell lung cancer and carcinoid tumor were diagnosed once. In addition, 4 lesions (11%) were found to be infectious, 1 lesion (3%) was found to be granulomatous (noncaseating), and 1 lesion (3%) was diagnosed as organizing pneumonia. Of the 37 successful diagnoses, 13 lesions (35%) were determined to be nonpathologic, benign lesions. Eleven procedures (22%) were unsuccessful in yielding the correct pathologic diagnosis. Nine of the 11 unsuccessful ENB cases (82%) were found to be malignant, 9 of which were identified as NSCLC. Other than NSCLC, 1 neuroendocrine tumor (9%) and 1 metastatic transitional cell carcinoma of the kidney (9%) were identified by alternative, invasive testing methods. The 2 other lesions unsuccessfully diagnosed by ENB were not malignant. One was determined to be infection (histoplasmosis) and the other was diagnosed as an organizing pneumonia. The most common complication noted by all modalities was pneumothorax. ENB carried a pneumothorax rate of 5 of 49 (10%), 2 of which required chest tube insertion for treatment. In the ENB success group, 4 cases (11%) were complicated by pneumothoraces. In the ENB failure group, 1 case (9%) was complicated by a pneumothorax. CONCLUSIONS: ENB is an effective and low-risk modality for diagnosing pulmonary lesions that are difficult to reach in patients deemed to be at high risk for invasive procedures. Although no clear criteria for the use of ENB currently exist, our study shows that diagnostic sampling can be obtained in 77% of lesions at the fourth order of bronchi or beyond, including subpleural lesions. CLINICAL IMPLICATIONS: ENB is an effective, minimally invasive method for the diagnosis of pulmonary nodules previously deemed unreachable by conventional bronchoscopy in high-risk patients and harbors a low complication rate.