Thomas R. Gildea

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.

Predictors of Long-term Mortality in Patients With Cirrhosis of the Liver Admitted to a Medical ICU

CONTEXT The long-term survival of patients with cirrhosis of the liver admitted to the ICU has not been described. OBJECTIVE The main objectives were to determine the 1-year and 5-year mortality rates of a cohort of patients admitted to a medical ICU (MICU), and to identify the risk factors that may predict long-term outcomes. DESIGN This is a cohort study. We used a model-building (MB) and model validation (MV) procedure that has previously been described to determine the risk factors for overall mortality. SETTINGS An MICU in a major referral medical center. PATIENTS Four hundred twenty consecutive patients admitted to the ICU from January 1, 1993, through October 31, 1998, met the inclusion criteria of diagnosis of liver failure, cirrhosis, chronic liver disease, variceal bleeding, hepatic encephalopathy, or hepatorenal syndrome. Patients with acute liver failure who had undergone liver transplantation, or candidates for orthotopic liver transplantation were excluded. INTERVENTION None. RESULTS The 1-year mortality rate was 69%, and the 5-year mortality rate was 77%. The median survival time was 1 month. The independent predictors of mortality in patients in the MB group who retained their significance in the MV group were as follows: an acute physiology, age, and chronic health evaluation (APACHE) III score of >/= 90 (hazard ratio [HR], 2.2; 95% confidence interval [CI], 1.6 to 2.8; p < 0.0001), the use of pressors (HR, 2.5; 95% CI, 1.9 to 3.2; p < 0.0001), and jaundice (HR, 1.7; 95% CI, 1.4 to 2.2; p < 0.0001). Patients with all three risk factors (ie, APACHE III score >/= 90, use of pressors, and jaundice) had a 92% 1-month mortality rate compared to 11.2% for patients with no risk factors. CONCLUSIONS Patients admitted to an MICU with underlying cirrhosis who are not eligible for liver transplantation have a poor long-term prognosis, even if they survive the ICU admission, particularly as the number of risk factors increases.

Endobronchial Fungal Disease: An Under-Recognized Entity

Most fungi enter the human body via inhalation; however, endobronchial fungal infection (EBFI) seems to be a rare manifestation compared to pulmonary or systemic disease. This presentation seems to be related to environmental factors as well as to the host status. With the increasing popularity of flexible bronchoscopy, it is being recognized with a higher frequency. Bronchoscopic findings in EBFI vary from mild mucosal inflammation to central airway obstruction. We searched English literature related to the topic and found 228 total cases of EBFI: Aspergillus species (121), Coccidioides immitis (38), Zygomycetes (31), Candida species (14) Cryptococcus neoformans (13), and Histoplasma capsulatum (11). We have also included a single case of endobronchial Pseudallescheria boydii infection in a lung transplant recipient that has not been reported previously. Most patients were immunocompromised, exhibited systemic manifestations of the primary infection, and responded to appropriate therapy. EBFI should be included in the differential diagnosis of any form of airway lesions in immunocompromised patients, especially among residents from the endemic areas.

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. Emphysematous lung sealant therapy is highly efficacious in some patients, but benefits bring significant risks http://ow.ly/JJ2vg

Therapeutic Bronchoscopy for Malignant Central Airway Obstruction: Success Rates and Impact on Dyspnea and Quality of Life

BACKGROUND There is significant variation between physicians in terms of how they perform therapeutic bronchoscopy, but there are few data on whether these differences impact effectiveness. METHODS This was a multicenter registry study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was technical success, defined as reopening the airway lumen to > 50% of normal. Secondary outcomes were dyspnea as measured by the Borg score and health-related quality of life (HRQOL) as measured by the SF-6D. RESULTS Fifteen centers performed 1,115 procedures on 947 patients. Technical success was achieved in 93% of procedures. Center success rates ranged from 90% to 98% (P = .02). Endobronchial obstruction and stent placement were associated with success, whereas American Society of Anesthesiology (ASA) score > 3, renal failure, primary lung cancer, left mainstem disease, and tracheoesophageal fistula were associated with failure. Clinically significant improvements in dyspnea occurred in 90 of 187 patients measured (48%). Greater baseline dyspnea was associated with greater improvements in dyspnea, whereas smoking, having multiple cancers, and lobar obstruction were associated with smaller improvements. Clinically significant improvements in HRQOL occurred in 76 of 183 patients measured (42%). Greater baseline dyspnea was associated with greater improvements in HRQOL, and lobar obstruction was associated with smaller improvements. CONCLUSIONS Technical success rates were high overall, with the highest success rates associated with stent placement and endobronchial obstruction. Therapeutic bronchoscopy should not be withheld from patients based solely on an assessment of risk, since patients with the most dyspnea and lowest functional status benefitted the most.

Complications following therapeutic bronchoscopy for malignant central airway obstruction: Results of the AQuIRE registry

BACKGROUND There are significant variations in how therapeutic bronchoscopy for malignant airway obstruction is performed. Relatively few studies have compared how these approaches affect the incidence of complications. METHODS We used the American College of Chest Physicians (CHEST) Quality Improvement Registry, Evaluation, and Education (AQuIRE) program registry to conduct a multicenter study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was the incidence of complications. Secondary outcomes were incidence of bleeding, hypoxemia, respiratory failure, adverse events, escalation in level of care, and 30-day mortality. RESULTS Fifteen centers performed 1,115 procedures on 947 patients. There were significant differences among centers in the type of anesthesia (moderate vs deep or general anesthesia, P < .001), use of rigid bronchoscopy (P < .001), type of ventilation (jet vs volume cycled, P < .001), and frequency of stent use (P < .001). The overall complication rate was 3.9%, but significant variation was found among centers (range, 0.9%-11.7%; P = .002). Risk factors for complications were urgent and emergent procedures, American Society of Anesthesiologists (ASA) score > 3, redo therapeutic bronchoscopy, and moderate sedation. The 30-day mortality was 14.8%; mortality varied among centers (range, 7.7%-20.2%, P = .02). Risk factors for 30-day mortality included Zubrod score > 1, ASA score > 3, intrinsic or mixed obstruction, and stent placement. CONCLUSIONS Use of moderate sedation and stents varies significantly among centers. These factors are associated with increased complications and 30-day mortality, respectively.

Anastomotic airway complications after lung transplantation.

Purpose of reviewAnastomotic airway complications continue to plague recovery after lung transplantation and serve as a major source of morbidity and mortality. Prevalence has surprisingly remained relatively constant over the last decade, despite improvement in overall transplant survival. Recent findingsAnastomotic airway complications occur in about one-fifth of patients following lung transplantation and are formidable and persistent problems. Technical issues associated with complications are difficult to define, but may include telescoping anastomoses and donor–recipient size mismatch. Endobronchial therapy of complications has reduced early mortality, but may not impact the late deleterious consequences of these complications. A therapeutic algorithm has been developed to assist clinicians. SummaryDespite increasing experience, anastomotic airway complications remain problematic. Continued investigation into this process appears warranted, given the impact and prevalence. Very few risk factors currently appear modifiable, however.

Safety of Diagnostic Bronchoscopy in Patients with Pulmonary Hypertension

Background: Patients with pulmonary hypertension (PH) are considered to be at risk for complications associated with flexible bronchoscopy (FB). Although previous reports suggest that transbronchial biopsies increase the risk for hemorrhage in this population, data are limited to survey analyses and isolated reports. Objectives: It was the aim of this study to describe our experience with FB and to determine if bronchoscopic procedures are associated with adverse events in this population. Methods: We conducted a retrospective review of patients with diagnosis of PH who underwent FB at the Cleveland Clinic between 2002 and 2005. Patients without PH who underwent FB by the same pulmonary physician were used as controls. Results: A total of 90 patients, PH (n = 45) versus controls (n = 45), were included. The mean systolic pulmonary artery pressure in patients with PH was 58 ± 7 mm Hg. Patients with PH had higher oxygen requirements at baseline (FiO2 0.42 vs. 0.3%; p = 0.01). The total number of procedures was similar between the groups (95 vs. 102). Procedures performed were bronchoalveolar lavage (21 vs. 13), transbronchial biopsies (24 vs. 32) and transbronchial needle aspiration (7 vs. 6). There were no hemodynamic complications or episodes of respiratory failure associated with the procedures. None of the patients had significant hemorrhage and only 2 developed mild bleeding which resolved spontaneously. Similarly, none required hospitalization or transfer to an intensive care unit. Conclusions: FB can be performed safely in patients with mild to moderate PH. Transbronchial biopsies are not associated with worsening hypoxemia or an increased risk of hemorrhage. Prospective studies with hemodynamic measurements are necessary to confirm these findings.

Bronchial thermoplasty: A new treatment for severe refractory asthma

Bronchial thermoplasty was recently approved for treating severe refractory asthma that is not well controlled by high-dose inhaled corticosteroids and long-acting bronchodilator therapy. This article reviews its indications, evidence of efficacy, and protocols. Asthma has a new treatment, but it isn’t for everybody. Here, we review its indications, evidence of efficacy, and protocols.

Airway complications after lung transplantation.

Airway complications after lung transplantation present a formidable challenge to the lung transplant team, ranging from mere unusual images to fatal events. The exact incidence of complications is wide-ranging depending on the type of event, and there is still evolution of a universal characterization of the airway findings. Management is also wide-ranging. Simple observation or simple balloon bronchoplasty is sufficient in many cases, but vigilance following more severe necrosis is required for late development of both anastomotic and nonanastomotic airway strictures. Furthermore, the impact of coexisting infection, rejection, and medical disease associated with high-level immunosuppression further complicates care.