Assessing a biomarker's ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study.

A blood-based integrated classifier (IC) has been clinically validated to improve accuracy in assessing probability of cancer risk (pCA) for pulmonary nodules (PN). This study evaluated the clinical utility of this biomarker for its ability to reduce invasive procedures in patients with pre-test pCA ≤ 50%. This was a propensity score matching (PSM) cohort study comparing patients in the ORACLE prospective, multicenter, observational registry to control patients treated with usual care.

Assessment of Plasma Proteomics Biomarker's Ability to Distinguish Benign From Malignant Lung Nodules: Results of the PANOPTIC (Pulmonary Nodule Plasma Proteomic Classifier) Trial.

Background: Lung nodules are a diagnostic challenge, with an estimated yearly incidence of 1.6 million in the United States. This study evaluated the accuracy of an integrated proteomic classifier in identifying benign nodules in patients with a pretest probability of cancer (pCA) ≤ 50%.

The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema.

Background: Lung volume reduction surgery improves quality of life, exercise capacity, and survival in selected patients but is accompanied by significant morbidity. Bronchoscopic approaches may provide similar benefits with less morbidity.

Methods: In a randomized, sham procedure controlled, double-blind trial, 277 subjects were enrolled at 36 centers.

Endoscopic treatment of native lung hyperinflation using endobronchial valves in single-lung transplant patients: a multinational experience.

Background: Hyperinflation of the native lung (NLH) is a known complication to single-lung transplantation for emphysema. The hyperinflation can lead to compression of the graft and cause respiratory failure. Endobronchial valves have been used to block airflow in specific parts of the native lung, reducing the native lung volume and relieving the graft.

Multicentre European study for the treatment of advanced emphysema with bronchial valves.

This multicentre, blinded, sham-controlled study was performed to assess the safety and effectiveness of bronchial valve therapy using a bilateral upper lobe treatment approach without the goal of lobar atelectasis. Patients with upper lobe predominant severe emphysema were randomised to bronchoscopy with (n = 37) or without (n = 36) IBV Valves for a 3-month blinded phase. A positive responder was defined as having both a ≥ 4-point improvement in St George's Respiratory Questionnaire (SGRQ) and a lobar volume shift as measured by quantitative computed tomography.

Endobronchial valve treatment for prolonged air leaks of the lung: a case series.

Purpose: An endobronchial valve developed for treatment of severe emphysema has characteristics favorable for bronchoscopic treatment of air leaks. We present the results of a consecutive case series treating complex alveolopleural fistula with valves.

Description: Patients with air leaks that persisted after treatment gave consent and compassionate use approval was obtained.

Bronchoscopic management of prolonged air leak.

Prolonged pulmonary parenchymal air leaks are an important clinical problem. Standard treatment of prolonged air leaks include continued chest tube drainage, pleural sclerosis, or surgery. Approaches that are less invasive than bedside sclerosis or surgery are desirable but bronchoscopy approaches tried over the years have had limited success.

Treatment of heterogeneous emphysema using the spiration IBV valves.

Ninety-eight emphysema patients were treated at 13 international sites during a 3-year series of single-arm, open-label studies with the IBV valve and a multi-lobar treatment approach. Fifty six percent of subjects had a clinically meaningful improvement in health-related quality of life, but standard pulmonary function and exercise studies were insensitive effectiveness measures. Quantitative CT analyses of regional lung changes showed lobar volume changes in over 85% of subjects.

Pulmonary rehabilitation and clinical trial design in patients with severe COPD.

Pulmonary rehabilitation confers significant benefit to patients with COPD. The beneficial effects are seen in dyspnea and health-related quality of life. These measures are often considered in clinical trials as study endpoints.

A multicenter trial of an intrabronchial valve for treatment of severe emphysema.

Objectives: Minimally invasive endoscopic treatment of emphysema could provide palliation with less risk than lung volume reduction surgery and offer therapy to patients currently not considered for lung volume reduction surgery. The Intrabronchial Valve is used to block bronchial airflow in the most emphysematous areas of lung.

Methods: Patients with severe chronic obstructive pulmonary disease and heterogeneous upper lobe-predominant emphysema were eligible.

Lung volume reduction surgery: a meta-analysis of randomized clinical trials.

Background: Observational studies have suggested that lung volume reduction surgery (LVRS) is superior to optimal medical therapy for selected subsets of patients with advanced emphysema. Randomized clinical trials (RCTs) with the exception of the National Emphysema Treatment Trial (NETT), failed to enroll a sufficient number of patients to provide clinicians and patients with convincing outcome data on the usefulness of LVRS. It was postulated that a meta-analysis of these RCTs (3-12 months' follow up) may provide more compelling information on the value of LVRS in patients with emphysema.

Novel surgical system for reducing lung tissue and preventing air leaks.

Purpose: This study assessed the feasibility of using the VALR surgical system (Spiration Inc, Redmond, WA), limited by federal law to investigational use, for capturing and reducing a selected portion of affected lobes in patients undergoing lobectomy.

Description: The tested system consists of a hand-held vacuum-regulated introducer loaded with a flexible, silicone sleeve. Targeted tissue is drawn into the introducer and the silicone sleeve is deployed and sutured in place.