Cost effectiveness of bronchial thermoplasty in patients with severe uncontrolled asthma.

RATIONALE: Based on its clinical effectiveness, bronchial thermoplasty (BT) was approved by the Food and Drug Administration in 2010 for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well-controlled with inhaled corticosteroids and long-acting beta-agonist medicines. OBJECTIVE: Assess the 10 year cost-effectiveness of BT for individuals with severe uncontrolled asthma. METHODS: Using a Markov decision analytic model, the cost-effectiveness of BT was estimated. The patient population involved a hypothetical cohort of 41-year-old patients comparing BT to usual care over a 10-year time frame. The main outcome measure was cost in 2013 dollars per additional quality adjusted life year (QALY). RESULTS: Treatment with BT resulted in 6.40 QALYs and $7512 in cost compared to 6.21 QALYs and $2054 for usual care. The incremental cost-effectiveness ratio for BT at 10 years was $29,821/QALY. At a willingness to pay per QALY of $50,000, BT continues to be cost effective unless the probability of severe asthma exacerbation drops below 0.63 exacerbation per year or the cost of BT rises above $10,384 total for all three bronchoscopic procedures needed to perform thermoplasty and to cover the entire bronchial tree (baseline = $6690). CONCLUSIONS: BT is a cost-effective treatment for asthmatics at high risk of exacerbations. Continuing to follow asthmatics treated with BT beyond 5 years will help inform longer efficacy and support its cost-effectiveness.

The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial.

BACKGROUND: Thoracentesis can be accomplished by active aspiration or drainage with gravity. This trial investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration. METHODS: This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergo active aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure. RESULTS: A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P < .001). There were no serious complications. CONCLUSIONS: Thoracentesis via active aspiration and gravity drainage are both safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov.

Clinical Success Stenting Distal Bronchi for "Lobar Salvage" in Bronchial Stenosis.

BACKGROUND: Airway stents are traditionally used in central airway obstructions to maintain airway patency. Historically, distal bronchial stenting within lobar and segmental bronchi has not been amenable to stenting. In addition, there are questionable benefits to stenting small airways. The Atrium iCast stent is a polytetrafluoroethylene covered stainless steel balloon deployed stent which can be deployed through a flexible bronchoscope under direct visualization. The purpose of this study was to assess the feasibility, complications, and long-term impact of using this stent in patients with lobar bronchial stenosis either secondary to malignancy or benign etiologies. METHODS: All records of patients who had the placement of an iCast stent were reviewed over 3.5 years. For each patient the age, sex, location, histology, stent size, duration of stent placement, radiographic improvement, and complications were collected. RESULTS: A total of 122 iCast stents were deployed in 38 patients with lobar bronchial stenosis. The average age was 58 years with 50% male. The etiology included 45% malignant and 55% due to benign conditions. In total, 18.5% patients had stents placed in >1 segment. There was an average of 4 procedures per patient with a mean time to stent revision or removal of 85 days. All patients had symptomatic or radiographic improvement. Common complications included migration (10%), granulation tissue formation (5%), deployment malfunction (2%), stent dislodgement immediately after deployment (2%), mucous plugging (1%), and tumor occlusion (1%). CONCLUSION: Stenting small airways with lobar salvage is feasible and improves symptoms and radiographic outcomes.

Sampling Utility of the Convex Probe Endobronchial Ultrasound Visible Intrapulmonary Lesion.

BACKGROUND: The value of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in the mediastinal staging of lung cancer has been well established. However, data regarding its utility in the diagnosis of intrapulmonary lesions has been sparse. This study assesses the sampling utility of convex probe EBUS-visible intrapulmonary lesions not visualized by the white-light bronchoscopy. METHODS: A retrospective analysis of EBUS-TBNA of EBUS-visible intrapulmonary lesions was performed between January 2010 and March 2015. Patients with visible endobronchial lesions by white-light bronchoscopy were excluded from analysis. RESULTS: Among 108 procedures, the diagnostic yield of EBUS-TBNA for EBUS-visible intrapulmonary lesions was 87%. Following diagnoses were established: lung cancer (73/67.6%), lung metastases (10/9.2%), infection (5/4.6%), lymphoma (1/<1%), sarcoma/spindle cell sarcoma or neoplasm (3/2.8%), unspecified malignancy (1<1%), and hamartoma (1/<1%). EBUS-TBNA was nondiagnostic in 14 (13%); among these, 9 turned out to have benign disease based on additional bronchoscopy samples or other testing and/or follow-up imaging. Five were ultimately diagnosed with a malignant condition: lymphoma (1), epithelioid hemangioendothelioma (1), and non-small cell lung cancer (3). The sensitivity and the negative predicted value of EBUS-TBNA for differentiating malignancy from benign disease was 94.7% and 75%, respectively, while the accuracy for diagnosing the neoplastic disease was 95.3%. There was one major bleeding requiring bronchial artery embolization and 1 pneumothorax requiring chest tube drainage. CONCLUSION: EBUS-TBNA is safe and effective in the diagnosis of EBUS-visible intrapulmonary lesions. It should be considered as the diagnostic test of choice in patients with these lesions undergoing EBUS-TBNA for the staging of suspected lung cancer.

Endobronchial Ultrasound-guided Transvascular Needle Aspiration: A Single-Center Experience.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well established for the staging and diagnosis of lung cancer and mediastinal lymphadenopathy. Central mediastinal vascular structures may preclude EBUS-TBNA access to lymph nodes in the aortopulmonary window and certain centrally located parenchymal lesions. Thus, a transvascular approach is necessitated. Few such reports exist in the literature. METHODS: We retrospectively analyzed the results of endobronchial ultrasound-guided transvascular needle aspiration (EBUS-TVNA) performed over 1 year to sample mediastinal lymph nodes (stations: 5) and lung lesions inaccessible by standard bronchoscopy or EBUS-TBNA. Data regarding the indication, location, size, and relationship to adjacent blood vessels, the number of transvascular passes, EBUS-TVNA diagnosis, the final diagnosis, procedural images, and complications were collected. Patients' charts were reviewed for 6 months after the procedure for evidence of late complications, including mediastinitis or mediastinal hemorrhage. RESULTS: Of 865 EBUS-TBNA procedures, 10 were performed by traversing the pulmonary artery or its branches. Nine were for left-sided lesions, 3 for hilar parenchymal nodules, 6 for hilar or mediastinal LN, and the remainder for a right-sided mass. Rapid-onsite evaluation was either diagnostic or positive for lymphoid cells in 9 patients and the final cytopathology was diagnostic in 9 patients: 5 non-small cell lung cancer, 1 small cell cancer, 1 metastatic colon cancer, and 2 normal lymphoid tissue. One patient had necrosis and required video assisted thoracoscopic surgery to diagnose histoplasmosis. Bleeding was insignificant, with no short-term/long-term complications. CONCLUSIONS: From our single-center experience, we conclude that in experienced hands, EBUS-TVNA is feasible, with a high yield, but without complications. Larger prospective trials are warranted to explore its diagnostic potential.

EGFR mutational genotyping of liquid based cytology samples obtained via fine needle aspiration (FNA) at endobronchial ultrasound of non-small cell lung cancer (NSCLC).

OBJECTIVES: Epidermal growth factor receptor (EGFR) gene mutation status should be determined in all patients with advanced, non-squamous non-small cell lung carcinoma (NSCLC) to guide targeted therapy with EGFR tyrosine kinase inhibitors. EGFR mutations are commonly tested by Sanger sequencing or allele specific polymerase chain reaction (ASPCR) on formalin-fixed paraffin-embedded (FFPE) samples including cell blocks (CB) that may fail due to absence of tumor cells. The cell pellet from cytology specimens obtained at the time of endobronchial guided ultrasound fine needle aspiration (EBUS FNA) (EBUS-TBNA, transbronchial needle aspiration) represents an alternative resource for additional tissue. Here we demonstrate the utility of using the FNA cell pellet versus for the detection of EGFR mutations in NSCLC. MATERIALS AND METHODS: For internal validation, 39 cytology samples from patients with NSCLC referred for EGFR testing were analyzed using the EGFR rotor-gene Q (RGQ) PCR assay (Qiagen). Thereafter, a consecutive series of 228 EBUS FNA samples were tested. RESULTS: The ASPCR assay demonstrated acceptable intra-assay, inter-assay and inter-lot reproducibility, sensitivity, and specificity. For the consecutive series, only 6/228 (2.6%) failed analysis (5 due to insufficient DNA yield). Of 228 EBUS FNA cell pellets tested 32 (14.0%) demonstrated clinically relevant mutations. RESULTS AND CONCLUSION: ASPCR can reliably detect EGFR gene mutations in FNA preparations from patients with NSCLC obtained at EBUS.