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).

Radiation dose of cone beam CT combined with shape sensing robotic assisted bronchoscopy for the evaluation of pulmonary lesions: an observational single center study.

Background: Shape sensing robotic-assisted bronchoscopy (ssRAB) combined with radial endobronchial ultrasound (r-EBUS) and cone beam computed tomography (CBCT) is a newer diagnostic modality for the evaluation of pulmonary lesions. There is limited data describing the radiation dose of CBCT combined with ssRAB. The purpose of this study was to describe the technical factors associated with the use of CBCT combined with ssRAB to biopsy pulmonary lesions. Methods: We conducted a single center, prospective observational study of patients undergoing ssRAB combined with fixed CBCT for the pulmonary lesion biopsy. We report our patient demographics, and pulmonary lesion and procedure characteristics. Results: A total of 241 ssRAB procedures were performed to biopsy 269 pulmonary lesions. The mean lesion size was measured in the following dimensions: anteroposterior (18.0±8.8 mm), transverse (17.2±10.5 mm), and craniocaudal (17.7±10.2 mm). A mean of 1.5±0.7 (median: 1, range: 1-4) CBCT spins were performed. The mean total fluoroscopy time (FT) was 5.6±2.9 minutes. The mean radiation dose of cumulative air kerma (CAK) was 63.5±46.7 mGy and the mean cumulative dose area product (DAP) was 22.6±16.0 Gy·cm2. Diagnostic yield calculated based on results at index bronchoscopy was 85.9%. There was a low rate of complications with 8 pneumothoraces (3.3%), 5 (2.1%) of which required chest tube placement. Conclusions: We describe the use of ssRAB combined with CBCT to biopsy pulmonary lesions as a safe diagnostic modality with relatively low radiation dose that is potentially comparable to other image guided sampling modalities. Bronchoscopists should be cognizant of the radiation use during the procedure for both patient and staff safety.

Shape-Sensing Robotic-Assisted Bronchoscopy with Concurrent use of Radial Endobronchial Ultrasound and Cone Beam Computed Tomography in the Evaluation of Pulmonary Lesions.

PURPOSE: Lung nodules are a common radiographic finding. Non-surgical biopsy is recommended in patients with moderate or high pretest probability for malignancy. Shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with radial endobronchial ultrasound (r-EBUS) and cone beam computed tomography (CBCT) is a new approach to sample pulmonary lesions. Limited data are available regarding the diagnostic accuracy of combined ssRAB with r-EBUS and CBCT. METHODS: We conducted a retrospective analysis of the first 200 biopsy procedures of 209 lung lesions using ssRAB, r-EBUS, and CBCT at UT Southwestern Medical Center in Dallas, Texas. Outcomes were based on pathology interpretations of samples taken during ssRAB, clinical and radiographic follow-up, and/or additional sampling. RESULTS: The mean largest lesion dimension was 22.6 ± 13.3 mm with a median of 19 mm (range 7 to 73 mm). The prevalence of malignancy in our data was 64.1%. The diagnostic accuracy of ssRAB combined with advanced imaging was 91.4% (CI 86.7-94.8%). Sensitivity was 87.3% (CI 80.5-92.4%) with a specificity of 98.7% (CI 92.8-100%). The negative and positive predictive values were 81.3% and 99.2%. The rate of non-diagnostic sampling was 11% (23/209 samples). The only complication was pneumothorax in 1% (2/200 procedures), with 0.5% requiring a chest tube. CONCLUSION: Our results of the combined use of ssRAB with r-EBUS and CBCT to sample pulmonary lesions suggest a high diagnostic accuracy for malignant lesions with reasonably high sensitivity and negative predictive values. The procedure is safe with a low rate of complications.

Oxidized Regenerated Cellulose (Surgicel®) on Cytology/Histology.

INTRODUCTION: In patients with a history of malignancy, follow-up surveillance of lymph nodes (LNs) is required to evaluate for potential malignancy or infection. In some cases, the lymphadenopathy may be secondary to an intraprocedural hemostatic agent and/or related granulomatous reaction. CASE PRESENTATION: We present the case of an 80-year-old female with a remote past medical history of breast cancer status post-lumpectomy and chemoradiation. Twenty years later, a 2.4 cm pulmonary right middle lobe nodule was noted on imaging studies. She underwent bronchoscopy, cervical mediastinoscopy, and right middle lobe wedge resection. The final pathologic diagnosis was a pulmonary carcinoid tumor, and the excised mediastinal LN was negative for malignancy. A 10-month surveillance positron emission tomography scan showed new mildly avid mediastinal and right hilar LNs. The following endobronchial ultrasound-guided transbronchial needle aspiration showed unremarkable lymphoid elements in the enlarged 4R LN, while the station 7 LN demonstrated ample dense hyaline-like foreign material. Subsequent review of the cell block/biopsy and communication with the thoracic surgeon revealed that Surgicel® (or oxidized regenerated cellulose) was placed during surgery at the station 7 site. DISCUSSION/CONCLUSION: Assessment of the findings and based on the similar histologic appearance reported in previous cases associated with Surgicel® [Ann Thorac Med. 2017;12(1):55-6, Cancer Cytopathol. 2019;127(12):765-70, and Arch Bronconeumol. 2020;56(7):459-71], the station 7 acellular, amorphous, and hyaline-like exogenous material found in our case was interpreted as hemostatic agent compatible with Surgicel® (or oxidized regenerated cellulose). This case highlights the importance of cytologic/histologic recognition of hemostatic agents, specifically oxidized cellulose mesh.

Confluent tracheal recurrences of head and neck squamous cell carcinoma.

Tracheal head and neck squamous cell cancer recurrence without metastases may be related to physical displacement of cancer cells.

Successful Use of Pulmonary Cryotherapy for Tracheobronchial Thrombus Extraction and Recanalization of the Tracheobronchial Tree During a Pediatric Venovenous Extracorporeal Membrane Oxygenation Run.

Impacted pediatric tracheobronchial thrombus is an uncommon diagnosis. There are no clearly proven therapeutic options for airway casts due to a similar process, plastic bronchitis. Cryotherapy, specifically cryoextraction, has shown potential as a therapeutic option in adults with tracheobronchial thrombus and cast. We describe the novel application of this method in a complex pediatric patient.

Intrabronchial Valves for Air Leaks After Lobectomy, Segmentectomy, and Lung Volume Reduction Surgery.

PURPOSE: Air leaks are common after lobectomy, segmentectomy, and lung volume reduction surgery (LVRS). This can increase post-operative morbidity, cost, and hospital length of stay. The management of post-pulmonary resection air leaks remains challenging. Minimally invasive effective interventions are necessary. The Spiration Valve System (SVS, Olympus/Spiration Inc., Redmond, WA, US) is approved by the FDA under humanitarian use exemption for management of prolonged air leaks. METHODS: This is a prospective multicenter registry of 39 patients with air leaks after lobectomy, segmentectomy, and LVRS managed with an intention to use bronchoscopic SVS to resolve air leaks. RESULTS: Bronchoscopic SVS placement was feasible in 82.1% of patients (32/39 patients) and 90 valves were placed with a median of 2 valves per patient (mean of 2.7 ± 1.5 valves, range of 1 to 7 valves). Positive response to SVS placement was documented in 76.9% of all patients (30/39 patients) and in 93.8% of patients when SVS placement was feasible (30/32 patients). Air leaks ultimately resolved when SVS placement was feasible in 87.5% of patients (28/32 patients), after a median of 2.5 days (mean ± SD of 8.9 ± 12.4 days). Considering all patients with an intention to treat analysis, bronchoscopic SVS procedure likely contributed to resolution of air leaks in 71.8% of patients (28/39 patients). The post-procedure median hospital stay was 4 days (mean 6.0 ± 6.1 days). CONCLUSIONS: This prospective registry adds to the growing body of literature supporting feasible and effective management of air leaks utilizing one-way valves.

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).

Utility of Bronchoalveolar Lavage and Transbronchial Biopsy in Patients with Hypersensitivity Pneumonitis.

INTRODUCTION: Making the diagnosis of HP is challenging due to a lack of consensus criteria and variability of both pathologic and radiographic findings. The purpose of this retrospective study was to determine the diagnostic utility of the combination of BAL lymphocyte count and TBBX in patients with HP. METHODS: We conducted a retrospective cohort study of all patients with a MDD diagnosis of HP at a single center. RESULTS: 155 patients were included in the study. 49% of patients who underwent BAL had a lymphocyte count > 20, 42% had a lymphocyte count > 30, and 34% had lymphocyte count > 40%. The median BAL lymphocyte count was higher in inflammatory HP compared to fibrotic HP. The addition of TBBX to BAL significantly increased the diagnostic yield regardless of the BAL lymphocyte cutoff used. The yield of bronchoscopy with TBBX and BAL when a lymphocyte count > 40% was used as a cutoff was 52%. CONCLUSIONS: Our study suggests that the combination of TBBX with BAL significantly increases the likelihood that the procedure will provide adequate additional information to allow a confident MDD diagnosis of HP and may reduce the need for SLB in the diagnostic workup of HP.

A randomised trial of lung sealant versus medical therapy for advanced emphysema.

Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility.

Linear probe endobronchial ultrasound bronchoscopy with guided transbronchial needle aspiration (EBUS-TBNA) in the evaluation of mediastinal and hilar pathology: introducing the procedure to a teaching institution.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an important tool in the diagnosis of mediastinal and hilar pathology. We describe our experience with EBUS-TBNA performed in a teaching institution primarily under conscious sedation. METHODS: Patients who underwent EBUS-TBNA were included in this retrospective review. We focused on the diagnostic yield of EBUS-TBNA in relationship to the nature of the mediastinal or hilar lesions (suspected malignancy vs. benign disease), incremental 25 procedures aliquots, lymph node (LN) station, LN size, and the number of needle aspirations per LN station. RESULTS: Of the 212 patients who underwent EBUS-TBNA, 200 patients had adequate follow-up information and were included in this analysis. The procedure was performed under conscious sedation in 97 % of patients and 133 patients (67 %) were suspected to have malignancy before the procedure. A total of 690 TBNAs were performed from 294 LN stations. The mean number of LN stations sampled per procedure was 1.47 ± 0.6. The mean number of TBNAs per LN station was 2.35 ± 0.91. The mean number of TBNAs per procedure was 3.45 ± 1.2. The overall sensitivity, specificity, negative predictive value (NPV), and diagnostic accuracy for all procedures were 87.41 % (CI 80.76-91.99), 100 % (CI 93.12-100), 75.36 % (CI 64.04-84.01), and 90.91 % (CI 85.92-94.25), respectively. The NPV increased significantly after the initial 25 procedures and remained high thereafter. EBUS-TBNA was more accurate (96.12 % (CI 91.25-98.33)) with higher NPV (90.74 % (CI 80.09-95.98)) in patients with suspected malignancy compared with patients with suspected benign disease (79.31 % (CI 67.23-87.75), 20 % (7.05-45.19)). Samples from relatively smaller LN (>5 to ≤20 mm) and from all analyzed LN stations were similarly accurate with high sensitivity and NPV. CONCLUSIONS: EBUS-TBNA allows safe real-time sampling of mediastinal and hilar lesions under conscious sedation with high diagnostic accuracy. The NPV is high and increased significantly after the initial 25-50 procedures. This is comparable to available surgical techniques, including mediastinoscopy, when malignancy is suspected. The NPV for specific benign disease remains low in our experience. The diagnostic yield is not affected by the LN station, size, or the number of passes per LN station.

Cryptogenic and secondary organizing pneumonia: clinical presentation, radiographic findings, treatment response, and prognosis.

BACKGROUND: Organizing pneumonia (OP) is a distinct clinical and pathologic entity. This condition can be cryptogenic (COP) or secondary to other known causes (secondary OP). In the present study, we reviewed the features associated with COP and secondary OP in patients from two teaching hospitals. METHODS: The medical records of 61 patients with biopsy-proven OP were retrospectively reviewed. Forty patients were diagnosed with COP and 21 patients with secondary OP. The clinical presentation, radiographic studies, pulmonary function tests (PFTs), laboratory data, BAL findings, treatment, and outcome were analyzed. RESULTS: The mean age at presentation was 60.46 ± 13.57 years. Malaise, cough, fever, dyspnea, bilateral alveolar infiltrates, and a restrictive pattern were the most common symptoms and findings. BAL lymphocytosis was observed in 43.8% of patients with OP. The relapse rate and mortality rate after 1 year of follow-up were 37.8% and 9.4%, respectively. The in-hospital mortality was 5.7%. The clinical presentation and radiographic findings did not differ significantly between patients with COP and secondary OP. A mixed PFT pattern (obstructive and restrictive physiology) and lower blood levels of serum sodium, serum potassium, platelets, albumin, protein, and pH were observed among patients with secondary OP. Higher blood levels of creatinine, bilirubin, Paco2, and BAL lymphocytes were also more common among patients with secondary OP. There were no differences in the relapse rate or mortality between patients with COP and secondary OP. The 1-year mortality correlated with an elevated erythrocyte sedimentation rate, low albumin, and low hemoglobin levels. CONCLUSIONS: The clinical and radiographic findings in patients with COP and secondary OP are similar and nonspecific. Although certain laboratory abnormalities are more common in secondary OP and can be associated with worse prognosis, they are likely due to the underlying disease. COP and secondary OP have similar treatment response, relapse rates, and mortality.

Pleuropericarditis in a patient with inflammatory bowel disease: a case presentation and review of the literature.

Inflammatory bowel disease (IBD) can affect the lung parenchyma and airways. Rarely it involves the pleural space and pericardium, causing inflammatory exudative pleural and/or pericardial effusions. In this report, we describe a 76-year-old patient with recurrent sterile exudative pleuropericarditis that gradually responded to treatment with steroids, and we review the relevant literature. Thoracic serositis in patients with IBD can cause pleuritis, pericarditis, pleuropericarditis, or myopericarditis. This is a relatively rare presentation of the uncommon and probably underreported and underrecognized pulmonary extraintestinal manifestations of IBD. Pleuropericardial inflammatory disease and effusion can be directly related to IBD, its complications, associated infections, or the medications used to treat it. Serositis directly related to IBD is a diagnosis of exclusion. It is important to evaluate the pleural effusion and rule out other etiologies before making this diagnosis. Pleural or pericardial biopsies are rarely necessary, and probably show nonspecific acute and chronic inflammatory changes. Although the specific pathophysiology of pleuropericardial disease in patients with IBD remains unclear, the response to systemic steroids is usually adequate.