Momen M. Wahidi

A Multicenter Pilot Study of a Bronchial Valve for the Treatment of Severe Emphysema

Background: Chronic obstructive pulmonary disease (COPD) affects millions of people and has limited treatment options. Surgical treatments for severe COPD with emphysema are effective for highly selected patients. A minimally invasive method for treating emphysema could decrease morbidity and increase acceptance by patients. Objective: To study the safety and effectiveness of the IBV® Valve for the treatment of severe emphysema. Methods: A multicenter study treated 91 patients with severe obstruction, hyperinflation and upper lobe (UL)-predominant emphysema with 609 bronchial valves placed bilaterally into ULs. Results: Valves were placed in desired airways with 99.7% technical success and no migration or erosion. There were no procedure-related deaths and 30-day morbidity and mortality were 5.5 and 1.1%, respectively. Pneumothorax was the most frequent serious device-related complication and primarily occurred when all segments of a lobe, especially the left UL, were occluded. Highly significant health-related quality of life (HRQL) improvement (–8.2 ± 16.2, mean ± SD change at 6 months) was observed. HRQL improvement was associated with a decreased volume (mean –294 ± 427 ml, p = 0.007) in the treated lobes without visible atelectasis. FEV1, exercise tests, and total lung volume were not changed but there was a proportional shift, a redirection of inspired volume to the untreated lobes. Combined with perfusion scan changes, this suggests that there is improved ventilation and perfusion matching in non-UL lung parenchyma. Conclusion: Bronchial valve treatment of emphysema has multiple mechanisms of action and acceptable safety, and significantly improves quality of life for the majority of patients.

American College of Chest Physicians Consensus Statement on the Use of Topical Anesthesia, Analgesia, and Sedation During Flexible Bronchoscopy in Adult Patients

BACKGROUND Optimal performance of bronchoscopy requires patients comfort, physicians ease of execution, and minimal risk. There is currently a wide variation in the use of topical anesthesia, analgesia, and sedation during bronchoscopy. METHODS A panel of experts was convened by the American College of Chest Physicians Interventional/Chest Diagnostic Network. A literature search was conducted on MEDLINE from 1969 to 2009, and consensus was reached by the panel members after a comprehensive review of the data. Randomized controlled trials and prospective studies were given highest priority in building the consensus. RESULTS In the absence of contraindications, topical anesthesia, analgesia, and sedation are suggested in all patients undergoing bronchoscopy because of enhanced patient tolerance and satisfaction. Robust data suggest that anticholinergic agents, when administered prebronchoscopy, do not produce a clinically meaningful effect, and their use is discouraged. Lidocaine is the preferred topical anesthetic for bronchoscopy, given its short half life and wide margin of safety. The use of a combination of benzodiazepines and opiates is suggested because of their synergistic effects on patient tolerance during the procedure and the added antitussive properties of opioids. Propofol is an effective agent for sedation in bronchoscopy and can achieve similar sedation, amnesia, and patient tolerance when compared with the combined administration of benzodiazepines and opiates. CONCLUSIONS We suggest that all physicians performing bronchoscopy consider using topical anesthesia, analgesic and sedative agents, when feasible. The existing body of literature supports the safety and effectiveness of this approach when the proper agents are used in an appropriately selected patient population.

A Phase 3, Randomized, Double-Blind Study To Assess the Efficacy and Safety of Fospropofol Disodium Injection for Moderate Sedation in Patients Undergoing Flexible Bronchoscopy

BACKGROUND Fospropofol disodium is a water-soluble prodrug of propofol with unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, multicenter study evaluated the use of fospropofol in patients undergoing flexible bronchoscopy. METHODS Patients >or= 18 years of age were randomized (2:3) to receive fospropofol, 2 mg/kg or 6.5 mg/kg, after pretreatment with fentanyl, 50 microg. Supplemental doses of each were given per protocol. The primary end point was sedation success, which was defined as follows: three consecutive Modified Observers Assessment of Alertness/Sedation scores of <or= 4 plus procedure completion without alternative sedative medication and/or mechanical ventilation. Other end points included treatment success, patient/physician satisfaction, and safety. RESULTS Of 252 patients, 150 were randomized to receive 6.5 mg/kg fospropofol; 102 were randomized to receive 2 mg/kg fospropofol. Sedation success rates were 88.7% and 27.5%, respectively (p < 0.0001). Treatment successes (91.3% vs 41.2%, respectively; p < 0.001), willingness to be treated again (94.6% vs 78.2%, respectively; p < 0.001), and absence of procedural recall (83.3% vs 55.4%, respectively; p < 0.001) were significantly better with the administration of 6.5 mg/kg fospropofol. The median time to full alertness was slightly longer for the 6.5 mg/kg dose (5.5 vs 3.0 min, respectively). The proportion of patients requiring supplemental therapy with analgesics (16.7% vs 37.3%, respectively) and the use of alternative sedative medications (8.0% vs 58.8%, respectively) were lower for patients in the 6.5 mg/kg dose group (all comparisons, p < 0.001). The most frequent adverse events (AEs) were transient and self-limited paresthesias and pruritus of mild-to-moderate severity. Hypoxemia (predominantly mild-to-moderate) was the most common sedation-related AE, and occurred in 15.4% and 12.6% of patients, respectively, in the 6.5 and 2 mg/kg fospropofol dose groups. CONCLUSIONS Fospropofol provided safe and effective sedation for patients undergoing flexible bronchoscopy. TRIAL REGISTRATION Clinical Trials.gov Identifier: NCT00306722.

A Prospective Multicenter Study of Competency Metrics and Educational Interventions in the Learning of Bronchoscopy Among New Pulmonary Fellows

BACKGROUND Learning medical procedures relies predominantly on the apprenticeship model, and competency is established based on the number of performed procedures. Our study aimed to establish bronchoscopy competency metrics based on performance and enhanced learning with educational interventions. METHODS We conducted a prospective study of the acquisition of bronchoscopy skills and cognitive knowledge in two successive cohorts of new pulmonary fellows between July 5, 2006, and June 30, 2008. At prespecified milestones, validated tools were used for testing: the Bronchoscopy Skills and Tasks Assessment Tool (BSTAT), an objective evaluation of bronchoscopy skills with scores ranging from 0 to 24, and written multiple-choice questions examinations. The first cohort received training in bronchoscopy as per the standards set by each institution, whereas the second cohort received educational interventions, including training in simulation bronchoscopy and an online bronchoscopy curriculum. RESULTS There was significant variation among study participants in bronchoscopy skills at their 50th bronchoscopy, the minimum number previously set to achieve competency in bronchoscopy. An educational intervention of incorporating simulation bronchoscopy enhanced the speed of acquisition of bronchoscopy skills, as shown by the statistically significant improvement in mean BSTAT scores for seven of the eight milestone bronchoscopies (P < .05). The online curriculum did not improve the performance on the written tests; however, compliance of the learners with the curriculum was low. CONCLUSIONS Performance-based competency metrics can be used to evaluate bronchoscopy skills. Educational interventions, such as simulation-based training, accelerated the acquisition of bronchoscopy skills among first-year pulmonary fellows as assessed by a validated objective assessment tool.

Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial

IMPORTANCE Preliminary clinical trials have demonstrated that endobronchial coils compress emphysematous lung tissue and may improve lung function, exercise tolerance, and symptoms in patients with emphysema and severe lung hyperinflation. OBJECTIVE To determine the effectiveness and safety of endobronchial coil treatment. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted among 315 patients with emphysema and severe air trapping recruited from 21 North American and 5 European sites from December 2012 through November 2015. INTERVENTIONS Participants were randomly assigned to continue usual care alone (guideline based, including pulmonary rehabilitation and bronchodilators; n = 157) vs usual care plus bilateral coil treatment (n = 158) involving 2 sequential procedures 4 months apart in which 10 to 14 coils were bronchoscopically placed in a single lobe of each lung. MAIN OUTCOMES AND MEASURES The primary effectiveness outcome was difference in absolute change in 6-minute-walk distance between baseline and 12 months (minimal clinically important difference [MCID], 25 m). Secondary end points included the difference between groups in 6-minute walk distance responder rate, absolute change in quality of life using the St Georges Respiratory Questionnaire (MCID, 4) and change in forced expiratory volume in the first second (FEV1; MCID, 10%). The primary safety analysis compared the proportion of participants experiencing at least 1 of 7 prespecified major complications. RESULTS Among 315 participants (mean age, 64 years; 52% women), 90% completed the 12-month follow-up. Median change in 6-minute walk distance at 12 months was 10.3 m with coil treatment vs -7.6 m with usual care, with a between-group difference of 14.6 m (Hodges-Lehmann 97.5% CI, 0.4 m to ∞; 1-sided P = .02). Improvement of at least 25 m occurred in 40.0% of patients in the coil group vs 26.9% with usual care (odds ratio, 1.8 [97.5% CI, 1.1 to ∞]; unadjusted between-group difference, 11.8% [97.5% CI, 1.0% to ∞]; 1-sided P = .01). The between-group difference in median change in FEV1 was 7.0% (97.5% CI, 3.4% to ∞; 1-sided P < .001), and the between-group St Georges Respiratory Questionnaire score improved -8.9 points (97.5% CI, -∞ to -6.3 points; 1-sided P < .001), each favoring the coil group. Major complications (including pneumonia requiring hospitalization and other potentially life-threatening or fatal events) occurred in 34.8% of coil participants vs 19.1% of usual care (P = .002). Other serious adverse events including pneumonia (20% coil vs 4.5% usual care) and pneumothorax (9.7% vs 0.6%, respectively) occurred more frequently in the coil group. CONCLUSIONS AND RELEVANCE Among patients with emphysema and severe hyperinflation treated for 12 months, the use of endobronchial coils compared with usual care resulted in an improvement in median exercise tolerance that was modest and of uncertain clinical importance, with a higher likelihood of major complications. Further follow-up is needed to assess long-term effects on health outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01608490.

Symptom Management in Patients With Lung Cancer : Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines

BACKGROUND Many patients with lung cancer will develop symptoms related to their disease process or the treatment they are receiving. These symptoms can be as debilitating as the disease progression itself. To many physicians these problems can be the most difficult to manage. METHODS A detailed review of the literature using strict methodologic review of article quality was used in the development of this article. MEDLINE literature reviews, in addition to Cochrane reviews and other databases, were used for this review. The resulting article lists were then reviewed by experts in each area for quality and finally interpreted for content. RESULTS We have developed recommendations for the management of many of the symptom complexes that patients with lung cancer may experience: pain, dyspnea, airway obstruction, cough, bone metastasis, brain metastasis, spinal cord metastasis, superior vena cava syndrome, hemoptysis, tracheoesophageal fistula, pleural effusions, venous thromboembolic disease, depression, fatigue, anorexia, and insomnia. Some areas, such as dyspnea, are covered in considerable detail in previously created high-quality evidence-based guidelines and are identified as excellent sources of reference. The goal of this guideline is to provide the reader recommendations based on evidence supported by scientific study. CONCLUSIONS Improved understanding and recognition of cancer-related symptoms can improve management strategies, patient compliance, and quality of life for all patients with lung cancer.

Technical aspects of endobronchial ultrasound-guided transbronchial needle aspiration CHEST guideline and expert panel report

BACKGROUND Endobronchial ultrasound (EBUS) was introduced in the last decade, enabling real-time guidance of transbronchial needle aspiration (TBNA) of mediastinal and hilar structures and parabronchial lung masses. The many publications produced about EBUS-TBNA have led to a better understanding of the performance characteristics of this procedure. The goal of this document was to examine the current literature on the technical aspects of EBUS-TBNA as they relate to patient, technology, and proceduralist factors to provide evidence-based and expert guidance to clinicians. METHODS Rigorous methodology has been applied to provide a trustworthy evidence-based guideline and expert panel report. A group of approved panelists developed key clinical questions by using the PICO (population, intervention, comparator, and outcome) format that addressed specific topics on the technical aspects of EBUS-TBNA. MEDLINE (via PubMed) and the Cochrane Library were systematically searched for relevant literature, which was supplemented by manual searches. References were screened for inclusion, and well-recognized document evaluation tools were used to assess the quality of included studies, to extract meaningful data, and to grade the level of evidence to support each recommendation or suggestion. RESULTS Our systematic review and critical analysis of the literature on 15 PICO questions related to the technical aspects of EBUS-TBNA resulted in 12 statements: 7 evidence-based graded recommendations and 5 ungraded consensus-based statements. Three questions did not have sufficient evidence to generate a statement. CONCLUSIONS Evidence on the technical aspects of EBUS-TBNA varies in strength but is satisfactory in certain areas to guide clinicians on the best conditions to perform EBUS-guided tissue sampling. Additional research is needed to enhance our knowledge regarding the optimal performance of this effective procedure.

Contraindications and safety of transbronchial lung biopsy via flexible bronchoscopy. A survey of pulmonologists and review of the literature.

Background: Transbronchial lung biopsy (TBLB) via flexible bronchoscopy is a common procedure performed by pulmonologists. Limited scientific data exist concerning the risk of this procedure in patients with conditions that may adversely affect the rate of procedural complications. Objectives: To evaluate the current practice pattern and attitude of pulmonologists toward the performance of TBLB in the presence of high-risk conditions. Methods: A survey was constructed and distributed at the American College of Chest Physicians annual meeting, held in Philadelphia, USA, in November of 2001. Results: A total of 227 surveys were distributed with a return of 158 (69.6%). Anticoagulation medications are temporarily held prior to TBLB by the majority of our survey respondents (98.7% for intravenous heparin, 90.5% for warfarin, and 87.3% for low-molecular-weight heparin). Medications with effect on platelet function are held by fewer pulmonologists. There is a wide variation in the pulmonologists’ perception of the risk of performing TBLB when certain medical conditions coexist: pulmonary hypertension [absolute contraindication (AC), 28.7%; relative contraindication (RC) 58.6%], superior vena cava syndrome (AC 19.6%, RC 51%), mechanical ventilation (AC 17.8%, RC 58.6%) and lung cavity/abscess (AC 7%, RC 44.9%). A significant percentage of pulmonologists (55%) do not regard an elevated serum creatinine at any level as AC to TBLB. Thirty-eight percent of the survey participants administer desmopressin prior to TBLB in uremic patients to prevent excessive bleeding. Conclusions: Prior to performing bronchoscopic TBLB, the majority of pulmonologists temporarily holds anticoagulation medications. However, there is a lack of agreement in relation to perceived contraindications and safety of TBLB.

The Montgomery T-tube tracheal stent

The Montgomery T-tube is a valuable tracheal stent that provides a functional airway while supporting the tracheal mucosa. It is used in benign and malignant tracheal diseases and provides symptomatic relief to the majority of the patients. T-tubes are simple to insert and rarely cause serious complications. The use of T-tubes continues to gain popularity with the increasing incidence of benign trachea stenosis following the use of artificial airways. Physicians dealing with diseases of the airways should be familiar with the indications, contraindication, complications, and care of the Montgomery T-tubes.

Bronchial Thermoplasty for Severe Asthma

Bronchial thermoplasty (BT) is a novel treatment of patients with severe asthma who continue to be symptomatic despite maximal medical treatment. It aims to reduce the smooth muscle mass in the airways by delivering controlled thermal energy to the airway walls during a series of three bronchoscopies. Randomized controlled clinical trials of BT in severe asthma have not been able to show a reduction in airway hyperresponsiveness or change in FEV(1) but have suggested an improvement in quality of life, as well as a reduction in the rate of severe exacerbations, emergency department visits, and days lost from school or work. Strict inclusion and exclusion criteria of these trials resulted in the elimination of patients with severe asthma who experienced more than three exacerbations per year. Therefore, the generalizability of this treatment to the broader severe asthma population still needs to be determined. The short-term adverse events consist primarily of airway inflammation and occasionally more severe events requiring hospitalization. Long-term safety data are evolving and have shown thus far clinical and functional stability up to 5 years after BT treatment. Additional studies on BT are needed to establish accurate phenotyping of positive responders, durability of effect, and long-term safety.