Sustained Clinical Benefits of Spiration Valve System in Patients with Severe Emphysema: 24-Month Follow-Up of EMPROVE.

Rationale: Follow-up of patients with emphysema treated with endobronchial valves is limited to 3-12 months after treatment in prior reports. To date, no comparative data exist between treatment and control subjects with a longer follow-up. Objectives: To assess the durability of the Spiration Valve System (SVS) in patients with severe heterogeneous emphysema over a 24-month period. Methods: EMPROVE, a multicenter randomized controlled trial, presents a rigorous comparison between treatment and control groups for up to 24 months. Lung function, respiratory symptoms, and quality-of-life (QOL) measures were assessed. Results: A significant improvement in forced expiratory volume in 1 second was maintained at 24 months in the SVS treatment group versus the control group. Similarly, significant improvements were maintained in several QOL measures, including the St. George's Respiratory Questionnaire and the COPD Assessment Test. Patients in the SVS treatment group experienced significantly less dyspnea than those in the control group, as indicated by the modified Medical Research Council dyspnea scale score. Adverse events at 24 months did not significantly differ between the SVS treatment and control groups. Acute chronic obstructive pulmonary disease exacerbation rates in the SVS treatment and control groups were 13.7% (14 of 102) and 15.6% (7 of 45), respectively. Pneumothorax rates in the SVS treatment and control groups were 1.0% (1 of 102) and 0.0% (0 of 45), respectively. Conclusions: SVS treatment resulted in statistically significant and clinically meaningful durable improvements in lung function, respiratory symptoms, and QOL, as well as a statistically significant reduction in dyspnea, for at least 24 months while maintaining an acceptable safety profile. Clinical trial registered with www.clinicaltrials.gov (NCT01812447).

The Utility of EBUS-Guided Transbronchial Forceps Biopsy With or Without an Electrocautery Knife for the Diagnosis of Mediastinal and Hilar Lymphadenopathy.

INTRODUCTION: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has been shown to have a high diagnostic yield for mediastinal and hilar lymph node sampling, particularly in diagnosing and staging non-small cell lung cancer. However, the diagnostic yield is lower in patients with granulomatous and lymphoproliferative disorders. We prospectively compared the feasibility, safety, and diagnostic yield of EBUS-guided lymph node forceps biopsy (EBUS-TBFB) with electrocautery knife compared to EBUS-TBNA of lymph nodes in patients with suspected granulomatous and lymphoproliferative disease. METHODS: Patients over 18 years of age with mediastinal/hilar lymph node >10 mm in size in short axis (on CT chest) who had suspected sarcoidosis/lymphoma radiologically/clinically were included in the study. Patients had EBUS-TBNA first with 21 or 22G needles which were followed by biopsy of the node with small forceps (EBUS-TBFB) through the same aspiration site to obtain samples. Electrocautery knife at 20W was used in patients where mucosal penetration was difficult, followed by passage of forceps through that site. RESULTS: A total of 30 patients were enrolled in the study, of which 25 patients underwent EBUS-TBFB. Eight patients had a history of lymphoma, one patient had history of squamous cell carcinoma, and one patient had history of chronic lymphocytic leukemia. A 22 gauge needle was used for aspiration in all the cases that were performed, and 1.5 mm or 1.8 mm forceps were used for the biopsy. The use of electrocautery knife at 20W (Olympus America Inc.) was required in 10/25 patients. The EC knife allowed all 10 of those to have successful entry of forceps into the lymph node. The cytology (aspiration from EBUS needle) and histopathology (from forceps) were concordant in 17 patients while it was discordant in eight patients. One patient developed pneumomediastinum after needle and forceps biopsy that required no intervention. CONCLUSION: EBUS-guided forceps biopsy is a safe procedure. EC knife did successfully allow forceps entry into the lymph node in all EC knife procedures. The diagnostic yield was 73% (22/30) which improved to 86% (26/30) when both techniques were combined (TBNA and TBFB).

Use of Mitomycin-C in Laryngotracheal Stenosis: A Focused Clinical Review.

BACKGROUND: Therapeutic options for managing laryngotracheal stenosis (LTS) are limited. Endoscopy is a minimally invasive approach to treating LTS, but carries a high risk of stenosis recurrence. Mitomycin C (MMC) is often used as an adjunct therapy to delay the time to symptomatic recurrence of LTS. This review synthesizes the current literature on the topic of MMC as an adjunct treatment strategy for LTS. METHODS: A focused literature search was carried out from PubMed on June 12, 2022 using the terms "mitomycin c AND stenosis" in all fields with no date limitations. Evidence-based recommendations relevant to the clinical application of MMC as an adjunct therapy for LTS were formulated. Three questions were addressed: 1) efficacy of MMC, 2) single versus multiple application(s) of MMC, and 3) safety of MMC. The evidence rating and recommendation strength were guided by the GRADE system. RESULTS: Twenty-nine studies were reviewed. The efficacy of MMC as an adjunct therapy for LTS varied across studies. Randomized controlled trials have not shown an outcome difference with MMC use, although methodologic flaws including underpowering were noted. A meta-analysis of observational studies with a comparator arm found the unadjusted probability of remaining symptom-free for > 1 year is greater with versus without MMC application (73% vs. 35%). Single versus multiple application(s) of MMC resulted in similar restenosis rates at long-term follow-up. Complications related to MMC use are rarely reported using conventional doses (0.4 mg/mL). Overall, the quality of evidence was low and the recommendation for intervention was weak. CONCLUSION: The role for MMC as an adjunct therapy in LTS is uncertain. While safe in its application, the efficacy of MMC in reducing stenosis recurrence remains a matter of debate. Large, prospective studies are needed to inform future recommendations.

Effect of Bronchoscopic Spray Cryotherapy and Ultra-low Temperature on Physical Properties of Metallic and Silicone Airway Stents.

BACKGROUND: Bronchoscopic spray cryotherapy (SCT) is utilized in the field of interventional pulmonology for treating benign and malignant airway stenosis as a standard tool to maintain airway patency. Stent-related complications include tumor overgrowth, granulation tissue, and epithelialization. Thermal ablation can have a limited role in such scenarios due to the risk of airway fire and damage to the existing stent. SCT is a potential therapy using ultra-low temperatures that can allow stents to remain in place during treatment. However, there has been no study demonstrating the safety of SCT on the integrity and physical properties of tracheobronchial stents. We report the results of the first study demonstrating the safety of SCT utilized to treat stent-associated granulation or malignant airway disease. The aim of this study was to demonstrate the effects of SCT on the physical properties of airway stents in an ex vivo environment. METHODS: Various types of airway stents were subjected to multiple intervals of SCT for up to 30 seconds, and then the cycle was repeated 3 times. After every cycle, we compressed the stents to 60% of their original size, and compression and expansion force data was collected immediately after, at 3-minute and 5-minute intervals, and compared with the baseline readings. RESULTS: There was no significant change in the association between diameter and compression/expansion force, including any derangement in returning to the original diameter or any physical damage to any of the stents even after 3 prolonged SCT sessions of 30 seconds. CONCLUSION: Our study provides the first evidence that the use of SCT in conjunction with existing silicone/metal stents is feasible and does not cause any physical damage to the stents or alters their ability to maintain the original diameter.

The Impact of Thoracentesis On Postprocedure Pulse Oximetry.

BACKGROUND: Although thoracentesis can offer considerable symptomatic relief to the patient, its physiologic impact on oxygen saturation has not been well established in the literature. This study aimed to evaluate the impact of thoracentesis on postprocedure pulse oximetry (SpO2) in an inpatient population. METHODS: A retrospective study of patients undergoing thoracentesis from January 2012 to November 2017 was performed. Inclusion criteria were age above 18 and thoracentesis performed in an inpatient setting. Records were reviewed for patient demographics, procedure reports, and laboratory values. SpO2 and FiO2 values were collected before and 6 and 24 hours postprocedure. Multivariable linear regression models were used to evaluate for changes in SpO2 and SpO2/FiO2. Analyses were adjusted for age, sex, serum hemoglobin, effusion etiology, volume removed, nonexpandable lung physiology and procedural complications and FiO2. RESULTS: A total of 502 patients were included. The mean (SD) age was 60 (14) years, and 53.4% of the patients were male. The most common cause of pleural effusion was malignant effusion (37%). The median (interquartile range) volume of fluid removed was 1400 (1000 to 2000) mL and nonexpandable lung physiology was noted in 35%. There was no significant within-subject difference in 24 hours postprocedure SpO2 compared with preprocedure SpO2. In multivariable analysis, there was a small increase in 24-hour postprocedure SpO2 [ß=0.31, 95% confidence interval (0.22, 0.41), P<0.01] and a similar small increase in 24-hour postprocedure SpO2/FiO2 [ß=0.84, 95% confidence interval: (0.68, 1.01), P<0.01). CONCLUSION: Among inpatients undergoing thoracentesis, there is no clinically significant change in SpO2 or SpO2/FiO2 at 24-hours post-procedure compared to pre-procedural SpO2 or SpO2/FiO2.

Bronchoscopic ablation techniques in the management of lung cancer.

Central airway involvement is a common manifestation of lung cancer during the disease course. Some patients will require bronchoscopic therapeutic interventions to palliate symptoms, or less commonly to provide more definitive therapy of airway involvement. We describe an overview specifically of bronchoscopic ablative techniques that are available for use in malignant airway obstruction. Techniques that are more commonly used include bronchoscopic application of laser, electrocautery, argon plasma coagulation (APC), cryotherapy and mechanical debulking techniques. Less commonly employed are brachytherapy and photodynamic therapy. These techniques may be applied via flexible or rigid bronchoscopy depending upon the clinical scenario. The choice of technique depends on available tools and expertise, the urgency of the clinical scenario, and whether the lesion is predominately endobronchial, extrinsic compression, or a combination of both. Malignant airway obstruction is a common finding in lung cancer and there are a number of effective bronchoscopic ablative techniques that may be employed safely to palliate patients with a significant symptom burden.

Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial.

Rationale: Less invasive, nonsurgical approaches are needed to treat severe emphysema.Objectives: To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management.Methods: In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control).Measurements and Main Results: The primary efficacy outcome was the difference in mean FEV1 from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV1 responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The primary safety outcome was the incidence of composite thoracic serious adverse events. All analyses were conducted by determining the 95% Bayesian credible intervals (BCIs) for the difference between treatment and control arms. Between October 2013 and May 2017, 172 participants (53.5% male; mean age, 67.4 yr) were randomized to treatment (n = 113) or control (n = 59). Mean FEV1 showed statistically significant improvements between the treatment and control groups-between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060-0.141) and 0.099 L (95% BCI, 0.048-0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints except 6-minute-walk distance. Composite thoracic serious adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax.Conclusions: In patients with severe heterogeneous emphysema, the SVS shows significant improvement in multiple efficacy outcomes, with an acceptable safety profile.Clinical trial registered with www.clinicaltrials.gov (NCT01812447).

Safety and Feasibility of Pleural Cryobiopsy Compared to Forceps Biopsy During Semi-rigid Pleuroscopy.

BACKGROUND: Pleural biopsy is often obtained in patients with undiagnosed exudative pleural effusion during pleuroscopy. Standard forceps have been traditionally used for the biopsy. Cryoprobes are being increasingly used for transbronchial lung biopsy as they obtain larger specimens and have less crush artifact. However, the safety and feasibility of cryoprobe biopsy compared to standard forceps for pleural biopsy has not been fully assessed. OBJECTIVES: The objective of this study was to demonstrate the safety and feasibility of cryoprobe biopsy in the pleural space using semi-rigid pleuroscopy. METHODS: Patients with idiopathic exudative pleural effusions underwent pleuroscopy. The procedure was done in the endoscopy suite with full barrier precautions and moderate sedation. Pleural biopsies were initially taken with a 2.0-mm saw-toothed forceps followed by a 2.4-mm cryoprobe (ERBECRYO, ERBE, US). The freeze time for each biopsy was 3 s. RESULTS: There were a total of ten patients, five males and five females. The mean age was 69 years (SD ± 11 years). The mean number of biopsies taken from the parietal pleura using forceps was 4.5 (SD ± 1.5) vs. 3.7 (SD ± 1.4) using cryoprobe. The mean cumulative tissue volume with forceps biopsy was 80 cu. mm; the mean cumulative tissue volume with cryobiopsy was 320 cu. mm, p = 0.007. The diagnostic yields were similar in both the groups. There was no increased incidence of bleeding, chest wall injury, or pain using cryoprobe in any of the patients. CONCLUSION: The use of cryoprobe for parietal pleural biopsy via semi-rigid pleuroscopy was feasible and safe in this small pilot study.

Bronchoscopic pursuit of the peripheral pulmonary lesion: navigational bronchoscopy, radial endobronchial ultrasound, and ultrathin bronchoscopy.

PURPOSE OF REVIEW: Peripheral pulmonary lesions (PPL) are being diagnosed with increasing frequency, especially with the increased use of chest computed tomography (CT). Depending on the location and size, these lesions often present a diagnostic challenge in terms of the low yield of traditional bronchoscopic biopsy techniques or the risks of a percutaneous biopsy approach. RECENT FINDINGS: Over the last several years, several different image-guided bronchoscopy techniques have emerged, including virtual bronchoscopic navigation, electromagnetic navigation bronchoscopy, radial endobronchial ultrasound, and ultrathin bronchoscopy. These technologies seek to improve both access and the diagnostic yield of PPL compared with traditional bronchoscopy and to perform with a lower complication rate than percutaneous techniques such as CT-guided trans-thoracic needle aspiration. SUMMARY: These advanced bronchoscopic techniques play an increasingly common role in the evaluation and biopsy of PPL. Electromagnetic navigation bronchoscopy and radial endobronchial ultrasound are the most commonly used guided techniques either in isolation or in combination and have the most published data regarding clinical experience and diagnostic yield; however, none of the techniques have consistently matched the yield of CT-guided trans-thoracic needle biopsy for PPL. Overall the complication rate of image-guided bronchoscopy techniques is low with pneumothorax being the most common adverse event.

Tracheobronchial tuberculosis.

Tracheobronchial tuberculosis (TBTB) is reported in approximately 10% to 39% of the patients with pulmonary tuberculosis. It is defined as the tubercle infection of the trachea and or bronchi. Due to its non-specific presentation, insidious onset and normal chest radiography in about 10-20% of the patients, the diagnosis is delayed. Bronchoscopy is the most definite method of diagnosis which provides adequate specimens for microbiological and histopathological diagnosis. Tracheobronchial stenosis is one of the most common long term complications of TBTB resulting in significant morbidity. It is estimated that 90% of patients with TBTB have some degree of tracheal and or bronchial stenosis. In this review article, we will discuss the pathogenesis, symptoms, imaging, bronchoscopic findings, and treatment of TBTB and management of tracheobronchial stenosis.

Lung cancer screening with low-dose computed tomography: an analysis of the MEDCAC decision.

Lung cancer is the leading cause of cancer death in the United States and worldwide. However, among the top 4 deadliest cancers, lung cancer is the only one not subject to routine screening. Optimism for an effective lung cancer-screening examination soared after the release of the National Lung Screening Trial results in November 2011. Since then, nearly 40 major medical societies and organizations have endorsed low-dose computed tomography (LDCT) screening. In December 2013, the United States Preventive Services Task Force also endorsed LDCT. However, the momentum for LDCT screening slowed in April 2014 when the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel concluded that there was not enough evidence to justify the annual use of LDCT scans for the detection of early lung cancer. This article briefly reviews the epidemiology of lung cancer, the National Lung Screening Trial study results, and the growing national endorsement of LDCT from a variety of key stakeholder organizations. We subsequently analyze and offer our evidence-based counterpoints to the major assumptions underlying the MEDCAC decision.

Construct validity of the Simbionix bronch mentor simulator for essential bronchoscopic skills.

BACKGROUND: Although simulation-based bronchoscopy has been shown to be an effective training modality, formal assessment should still be performed as new technology emerges. We sought to validate a simulator in essential bronchoscopic tasks, and survey perceptions of bronchoscopists on simulation. METHODS: A cohort study at 2 medical centers used 3 groups to assess construct validity of the Simbionix Bronchoscopy Simulator: 7 first-year fellows with <10 bronchoscopies each (novice), 6 pulmonologists with 200 to 1000 bronchoscopies each (experienced), and 7 pulmonologists with >1000 bronchoscopies each (expert). Participants were tested in 4 tasks (1: scope manipulation, 2: guided anatomic navigation, 3: airway anatomy, and 4: lymph node anatomy). Participants were scored and surveyed on their impressions of simulation. The means and Kruskal-Wallis test among groups were compared by task item (P<0.05). RESULTS: There were statistically significant differences in mean ranks among groups for tasks 1 and 3. For task 1, final score, time, mid-lumen time, and wall hits were discriminative (P=0.006, 0.006, 0.012, and 0.014, respectively). For task 3, time, bronchial segments identified, bronchial segments incorrectly identified, and bronchial segments skipped were discriminative (P=0.04, 0.012, 0.013, and 0.013, respectively). There was no statistically significant difference for task 2 and task 4. All participants agreed that simulation training is helpful and should be incorporated into bronchoscopic training. CONCLUSIONS: The simulator demonstrated validity in differentiating skill in scope manipulation and airway anatomy, but did not discriminate skill levels in anatomic orientation or identification of lymph nodes. Bronchoscopy simulation was viewed as helpful by all levels and should be considered before performance on patients.

Palliative interventional pulmonology procedures in the incarcerated population with cancer: a case series.

RATIONALE: Cancer is the second most common cause of death in incarcerated population and lung cancer is the most common cause of cancer death in this group. Inmates are excluded from most published surveys and research,thus the effectiveness of lung cancer palliation in this population is not known. OBJECTIVE: To report the feasibility and safety of palliative interventional pulmonary procedures in inmates with cancer. STUDY DESIGN: Retrospective review of registry data from a single center. MATERIALS AND METHODS: Inmate data on prospectively enrolled data registry (2009­2012) from the interventional pulmonology procedural registry at Virginia Commonwealth University was extracted and analyzed for safety and efficacy. Inmates with lung cancer and advanced malignancies with pleural or airway metastasis requiring airway debulking (mechanical/thermal), airway stenting, and tunneled pleural catheter (TPC) placement were included in the analysis. RESULTS: A total of 16 procedures were performed in 12 incarcerated patients. These included six TPC placements in six patients. Ten procedures were performed in seven patients with airway obstruction. These procedures included rigid and flexible bronchoscopy with mechanical (rigid and balloon dilation) and thermal (laser, argon plasma coagulation, and cautery) tumor debulking and dilation,airway stenting, and tracheostomy in one case. All six TPCpatients had immediate symptomatic relief and improved lung aeration on chest radiograph. Three of six patients had successful auto-pleurodesis. In the seven patients with airway obstruction, three patients reported symptomatic relief and one had resolution of post-obstructive pneumonia. No immediate- or long-term procedure-related complications were reported. CONCLUSION: Incarcerated patients with advanced malignancy may benefit from interventional pulmonology procedures with low complications. Palliative interventional pulmonology procedures in inmates should not be withheld solely on their incarceration status.

The use of octreotide to manage symptoms of bronchorrhea: a case report.

Octreotide, a synthetic analogue of the hormone somatostatin, is primarily used in palliative medicine because of its antisecretory effect and has been shown to be effective in the management of bowel obstruction, nausea, and diarrhea. Octreotide also has been successfully used for the management of bronchorrhea in both inpatient and outpatient settings. We report the case of a 47-year-old female with a history of bronchioloalveolar cell carcinoma whose copious bronchial secretions were controlled with octreotide. Octreotide should be further evaluated as a first-line treatment for bronchorrhea.