Pharmacokinetics and safety of paclitaxel delivery into porcine airway walls by a new endobronchial drug delivery catheter.

BACKGROUND AND OBJECTIVE: Intratumoral administration of chemotherapeutic agents is a treatment modality that has proven efficacious in reducing the recurrence of tumours and increases specificity of treatment while minimizing systemic side effects. Direct intratumoral injection of malignant airway obstruction has potential therapeutic benefits but tissue drug concentrations and side-effect profiles are poorly understood. METHODS: Bronchial wall injection of generic paclitaxel (PTX) (102 injections of 0.05, 0.5, 1.5 or 2.5 mg/mL in 10 healthy pigs), saline (14 injections in 2 healthy pigs) or Abraxane (ABX) (24 injections of 0.5 mg/mL in 4 healthy pigs) was performed with a microneedle infusion catheter. Local histopathology, plasma and tissue PTX concentrations were evaluated at 7, 20 or 28 days post-injection. RESULTS: Injection of generic PTX directly into the bronchial wall at doses up to 1.5 mg/mL only caused minimal tissue injury. Dose-limiting tissue reaction was observed at 2.5 mg/mL. Plasma PTX was detectable for up to 5 days but not at 28 days, with area under the curve (AUC)(0-5d) 20- to 50-fold lower than the AUC(0-∞) of 6300 ng h/mL for the approved intravenous dose. At 7 and 28 days post-injection, bronchial PTX tissue concentrations were above a 10-nmol/L cancer therapeutic level. PTX was not found in peripheral tissues. Similar results were observed between ABX and generic PTX. CONCLUSION: Results of these studies confirm the administration of PTX directly into the bronchial wall is safe and feasible. PTX was detectable in plasma for <7 days but tissue concentrations remained therapeutic throughout the follow-up period.

Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry.

RATIONALE: Advanced bronchoscopy techniques such as electromagnetic navigation (EMN) have been studied in clinical trials, but there are no randomized studies comparing EMN with standard bronchoscopy. OBJECTIVES: To measure and identify the determinants of diagnostic yield for bronchoscopy in patients with peripheral lung lesions. Secondary outcomes included diagnostic yield of different sampling techniques, complications, and practice pattern variations. METHODS: We used the AQuIRE (ACCP Quality Improvement Registry, Evaluation, and Education) registry to conduct a multicenter study of consecutive patients who underwent transbronchial biopsy (TBBx) for evaluation of peripheral lesions. MEASUREMENTS AND MAIN RESULTS: Fifteen centers with 22 physicians enrolled 581 patients. Of the 581 patients, 312 (53.7%) had a diagnostic bronchoscopy. Unadjusted for other factors, the diagnostic yield was 63.7% when no radial endobronchial ultrasound (r-EBUS) and no EMN were used, 57.0% with r-EBUS alone, 38.5% with EMN alone, and 47.1% with EMN combined with r-EBUS. In multivariate analysis, peripheral transbronchial needle aspiration (TBNA), larger lesion size, nonupper lobe location, and tobacco use were associated with increased diagnostic yield, whereas EMN was associated with lower diagnostic yield. Peripheral TBNA was used in 16.4% of cases. TBNA was diagnostic, whereas TBBx was nondiagnostic in 9.5% of cases in which both were performed. Complications occurred in 13 (2.2%) patients, and pneumothorax occurred in 10 (1.7%) patients. There were significant differences between centers and physicians in terms of case selection, sampling methods, and anesthesia. Medical center diagnostic yields ranged from 33 to 73% (P = 0.16). CONCLUSIONS: Peripheral TBNA improved diagnostic yield for peripheral lesions but was underused. The diagnostic yields of EMN and r-EBUS were lower than expected, even after adjustment.

Experimental Pilot Study of a Novel Endobronchial Drug Delivery Catheter.

BACKGROUND: An endobronchial infusion catheter introduced through a flexible bronchoscope channel has not been previously described. The aim of this study was to evaluate the technical feasibility of a new device. METHODS: Four porcine models underwent bronchoscopy with the infusion catheter. In the first experiment, methylene blue was injected into airway in volumes of 0.1, 0.3, or 1.0 mL into 2 animals. One animal was killed at 1 hour and the other at 24 hours after the procedure and gross dye diffusion was visually assessed. In the second experiment, a mixture of 80% sterile normal saline and 20% contrast media was injected into the airway in volumes of 0.3, 1.0, and 3.0 mL into 2 animals. One animal was killed at 7 days and the other at 20 days. Histologic evaluations were performed according to a bronchial damage scoring system. RESULTS: There was no perioperative morbidity. In the first experiment, infusion volumes of 0.1, 0.3, and 1.0 mL resulted in dye surrounding 67%±29%, 55%±17%, and 80%±20% of the infusion-site circumference, and longitudinal distribution of 4.0±1.7, 8.1±4.1, and 18.0±3.0 mm each, respectively. In the second experiment, infusion of 0.3 to 3.0 mL resulted in mild injury, inflammation, and hemorrhage/fibrin/thrombus at 7 and 20 days after surgery. CONCLUSIONS: Endobronchial infusion of dye and contrast media by the endobronchial drug delivery catheter showed that the media spread in a dose-dependent manner macroscopically and histologically. Further investigation will be required to assess the catheter as a new tool for localized drug delivery into the airway.

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.

Adult Bronchoscopy Training: Current State and Suggestions for the Future: CHEST Expert Panel Report.

BACKGROUND: The determination of competency of trainees in programs performing bronchoscopy is quite variable. Some programs provide didactic lectures with hands-on supervision, other programs incorporate advanced simulation centers, whereas others have a checklist approach. Although no single method has been proven best, the variability alone suggests that outcomes are variable. Program directors and certifying bodies need guidance to create standards for training programs. Little well-developed literature on the topic exists. METHODS: To provide credible and trustworthy guidance, rigorous methodology has been applied to create this bronchoscopy consensus training statement. All panelists were vetted and approved by the CHEST Guidelines Oversight Committee. Each topic group drafted questions in a PICO (population, intervention, comparator, outcome) format. MEDLINE data through PubMed and the Cochrane Library were systematically searched. Manual searches also supplemented the searches. All gathered references were screened for consideration based on inclusion criteria, and all statements were designated as an Ungraded Consensus-Based Statement. RESULTS: We suggest that professional societies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. Bronchoscopy training programs should incorporate multiple tools, including simulation. We suggest that ongoing quality and process improvement systems be introduced and that certifying agencies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. We also suggest that assessment of skill maintenance and improvement in practice be evaluated regularly with ongoing quality and process improvement systems after initial skill acquisition. CONCLUSIONS: The current methods used for bronchoscopy competency in training programs are variable. We suggest that professional societies and certifying agencies move from a volume- based certification system to a standardized skill acquisition and knowledge-based competency assessment for pulmonary and thoracic surgery trainees.

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.

Evaluation of tracheobronchomalacia by dynamic flexible bronchoscopy. A pilot study.

OBJECTIVES: Dynamic flexible bronchoscopy is the "gold standard" for assessing changes in airway luminal size associated with tracheobronchomalacia, but the procedure has not been adequately validated. The present study was designed to test the validity of diagnosing tracheobronchomalacia by dynamic flexible bronchoscopy through assessing inter- and intraobserver agreements in estimating degree of central airway collapse associated with tracheobronchomalacia. METHODS: This prospective observational pilot study enrolled consecutive patients with suspected tracheobronchomalacia scheduled for dynamic flexible bronchoscopy. Images of the airway lumen were obtained at five different sites in the tracheobronchial tree during forced inspiration and expiration and were evaluated by 23 pulmonologists (not involved in the care of study patients) with different levels of training and experience at baseline (interobserver agreement) and 8 days later (intraobserver agreement). The degree of airway collapse was visually estimated by each examiner and expressed as a percentage of narrowing. A multirater generalized kappa-type statistical method was used to calculate the correlation coefficients and to assess reliability of the measurements obtained during dynamic flexible bronchoscopy. MEASUREMENTS AND MAIN RESULTS: Between September 1 and 30, 2009, 10 patients (median age, 65 yr) underwent dynamic flexible bronchoscopy. The correlation coefficients for inter- and intraobserver agreement were favorable and ranged for the five airway sites from 0.68 to 0.92 and from 0.80 to 0.96, respectively. CONCLUSIONS: The favorable inter- and intraobserver agreements among 23 pulmonologists using dynamic flexible bronchoscopy to estimate the degree of dynamic central airway collapse provide additional evidence that dynamic flexible bronchoscopy is a reliable diagnostic tool for tracheobronchomalacia.

Pneumothorax following endobronchial valve therapy and its impact on clinical outcomes in severe emphysema.

BACKGROUND: Patients who achieve significant target lobe volume reduction (TLVR) following endobronchial valve (EBV) treatment may experience substantial improvements in clinical outcome measures. However, in cases of rapid TLVR, the risk of pneumothorax increases due to parenchymal rupture of the adjacent untreated lobe. Target lobe collapse may be more likely in EBV-treated patients who have low collateral ventilation. OBJECTIVES: The aim of this study was to evaluate the impact of pneumothorax on outcome following EBV treatment. METHODS: Data from three prospective clinical trials (the US and European cohorts of VENT and the Multicenter Chartis study) were retrieved for the analysis. All patients had undergone chest X-ray within 24 h of EBV implantation to explore the presence of pneumothorax. TLVR was assessed at either 30 (Chartis study) or 180 days (VENT), and clinical outcome measures (forced expiratory volume in 1 s (FEV1), St. George's Respiratory Questionnaire (SGRQ) and 6-min-walk distance (6-MWD)) were assessed 180 days after implantation. RESULTS: The overall rate of pneumothorax following valve therapy was 5.9% (25/421). Among these patients, 68% had a prolonged air leak for >7 days. However, patients who experienced a pneumothorax benefitted from EBV therapy, with a mean TLVR of 65% (n = 20). The mean percent change in FEV1 was 15 ± 15%, and the mean change in SGRQ was -7 ± 12 points. CONCLUSIONS: Although pneumothorax is a complication of EBV placement, it does not appear to have a negative impact on clinical outcome in terms of FEV1 and health-related quality of life.

Target lobe volume reduction and COPD outcome measures after endobronchial valve therapy.

Endobronchial valve (EBV) therapy may be associated with improvements in chronic obstructive pulmonary disease-related outcomes and may therefore be linked to improvements in the body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index. Data from 416 patients with advanced emphysema and hyperinflation across Europe and USA, who were randomised to EBV (n=284) or conservative therapy (n=132) were analysed. Quantitative image analysis was used to compare the volume of the targeted lobe at baseline and at 6 months to determine target lobe volume reduction (TLVR). 44% of patients receiving EBV therapy (versus 24.7% of controls) had clinically significant improvements in the BODE index (p<0.001). BODE index was significantly reduced by mean ± sd 1.4 ± 1.8, 0.2 ± 1.3 and 0.1 ± 1.3 points in patients with TLVR >50%, 20%-50% and <20%, respectively (intergroup differences p<0.001), but increased by 0.3 ± 1.2 points in controls. Changes in BODE were predicted by baseline BODE and correlated significantly with lobar exclusion and lung volumes at 6 months. A greater proportion of patients in the treatment group than in the control group achieved a clinically meaningful improvement in BODE index; however, the likelihood of benefit was less than half in both groups. Patients in whom TLVR was obtained had greater improvements in clinical outcomes.

The business of interventional pulmonology.

Interventional pulmonologists are regularly asked to perform more complicated and advanced procedures, but reimbursement for the time, effort and skill involved in these procedures has not kept up with other procedural specialties. Further changes in funding and reimbursement are likely under the Affordable Care Act. Understanding and effectively using the current system of funding for interventional pulmonology practices are imperative as we adapt to changing medical needs, legislative mandates, and reimbursement policy. This article reviews the current landscape of insurance and reimbursement in health care and anticipates some changes that might be expected from implementation of the Affordable Care Act.

The localized inflammatory response to bronchoscopic thermal vapor ablation.

BACKGROUND: Bronchoscopic thermal vapor ablation (BTVA) reduces lung volumes in emphysema patients by inducing a localized inflammatory response (LIR) leading to a healing process of fibrosis, but may also increase symptoms. OBJECTIVES: We sought to evaluate whether the clinical manifestation of LIR correlated with patient outcome. METHODS: Respiratory adverse events and inflammatory markers were analyzed from a multicenter trial of BTVA in patients with upper-lobe-predominant emphysema. End points including changes in forced expiratory flow (FEV1), lobar volume, St. George's Respiratory Questionnaire (SGRQ), modified Medical Research Council (mMRC) and 6-minute-walk distance (6-MWD) were analyzed according to the presence or absence of a respiratory adverse event requiring treatment with an antibiotic or steroid. RESULTS: Forty-four patients received BTVA. Increases of inflammatory markers were observed with a peak between the second and fourth week. Eighteen respiratory adverse events occurred in 16 patients within 30 days of BTVA, requiring antibiotics and/or steroids. These patients had significantly greater lobar volume reduction (65.3 vs. 33.4%, p = 0.007) and a change in residual volume at 12 months (-933 vs. 13 ml, p < 0.001) associated with a greater improvement of exercise capacity and health-related quality of life than patients without respiratory adverse events. CONCLUSION: Patients with more prominent respiratory symptoms in the first 30 days following BTVA experience greater efficacy. The clinical manifestations of the LIR are predictive of long-term clinical benefits.

Comparison of 21-gauge and 22-gauge aspiration needle in endobronchial ultrasound-guided transbronchial needle aspiration: results of the American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation Registry.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure originally performed using a 22-gauge (22G) needle. A recently introduced 21-gauge (21G) needle may improve the diagnostic yield and sample adequacy of EBUS-TBNA, but prior smaller studies have shown conflicting results. To our knowledge, this is the largest study undertaken to date to determine whether the 21G needle adds diagnostic benefit. METHODS: We retrospectively evaluated the results of 1,299 patients from the American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation (AQuIRE) Diagnostic Registry who underwent EBUS-TBNA between February 2009 and September 2010 at six centers throughout the United States. Data collection included patient demographics, sample adequacy, and diagnostic yield. Analysis consisted of univariate and multivariate hierarchical logistic regression comparing diagnostic yield and sample adequacy of EBUS-TBNA specimens by needle gauge. RESULTS: A total of 1,235 patients met inclusion criteria. Sample adequacy was obtained in 94.9% of the 22G needle group and in 94.6% of the 21G needle group (P = .81). A diagnosis was made in 51.4% of the 22G and 51.3% of the 21G groups (P = .98). Multivariate hierarchical logistic regression showed no statistical difference in sample adequacy or diagnostic yield between the two groups. The presence of rapid onsite cytologic evaluation was associated with significantly fewer needle passes per procedure when using the 21G needle (P < .001). CONCLUSIONS: There is no difference in specimen adequacy or diagnostic yield between the 21G and 22G needle groups. EBUS-TBNA in conjunction with rapid onsite cytologic evaluation and a 21G needle is associated with fewer needle passes compared with a 22G needle.

Pulmonary function and flow-volume loop patterns in patients with tracheobronchomalacia.

BACKGROUND: Patterns of pulmonary function tests (PFTs) and flow-volume loops among patients with clinically important tracheobronchomalacia (TBM) are not well described. Small studies suggest 4 main flow-volume loop morphologies: low maximum forced expiratory flow, biphasic expiratory curve, flow oscillations, and notching. We studied common PFT and flow-volume loop patterns among the largest prospective series of patients to date, undergoing clinical evaluation for symptomatic moderate to severe TBM. METHODS: We conducted a retrospective analysis of prospectively collected data from patients who were referred to our Chest Disease Center from January 2002 to December 2008, with respiratory symptoms that were attributed primarily to TBM. The PFT results of 90 subjects with symptomatic moderate to severe TBM were evaluated. RESULTS: By PFTs, 40 (44.4%) subjects had an obstructive ventilatory defect, 16 (17.8%) had a definite or highly likely restrictive ventilatory defect, 15 (16.7%) had a mixed defect, and 19 (21.1%) were within normal limits. Among 76 subjects with available flow-volume loops, the most frequent finding was low maximum forced expiratory flow, in 62 (81.6%) subjects, followed by biphasic morphology (15, 19.7%), notched expiratory loop (7, 9.2%), and expiratory oscillations (2, 2.6%). The balance of 13 subjects (17.1%) had no distinctive flow-volume loop abnormality. CONCLUSION: PFTs and flow-volume loops are normal in a substantial number of patients with moderate to severe TBM, and should not be used to decide whether TBM is present or clinically important.

Safety and feasibility of interventional pulmonologists performing bedside percutaneous endoscopic gastrostomy tube placement.

BACKGROUND: Prior to the 1980s, permanent feeding tube placement was limited to an open surgical procedure until Gauderer and colleagues described the safe placement of percutaneous endoscopic gastrostomy (PEG) tubes. This procedure has since expanded beyond the realm of surgeons to include gastroenterologists, thoracic surgeons, and interventional radiologists. In some academic centers, interventional pulmonologists (IPs) also perform this procedure. We describe the safety and feasibility of PEG tube placement by IPs in a critically ill population. METHODS: Prospectively collected data of patients in a medical ICU undergoing PEG tube placement from 2003 to 2007 at a tertiary-care center were reviewed. Inclusion criteria included all PEG tube insertions performed or attempted by the IP team. Data were collected on mortality, PEG tube removal rate, total number of days with PEG tube, and complication rates. Follow-up included hospital length of stay and phone contact after discharge. Procedural and long-term PEG-related complications were recorded. RESULTS: Seventy-two patients were studied. PEG tube insertion was completed successfully in 70 (97.2%), with follow-up data in 69 of these 70. Thirty-day mortality was 11.7%. No deaths or immediate complications were attributed to PEG tube placement. PEG tube removal occurred in 27 patients, with a median time to removal of 76 days. CONCLUSIONS: Bedside PEG tube placement can be performed safely and effectively by trained IPs. Because percutaneous tracheostomy is currently performed by IPs, the ability to place both PEG and tracheostomy tubes at the same time has the potential for decreased costs, anesthesia exposure, procedural times, ventilator times, and ICU days.

Latest advances in advanced diagnostic and therapeutic pulmonary procedures.

Over the past 15 years, patients with a myriad of pulmonary conditions have been diagnosed and treated with new technologies developed for the pulmonary community. Advanced diagnostic and therapeutic procedures once performed in an operating theater under general anesthesia are now routinely performed in a bronchoscopy suite under moderate sedation with clinically meaningful improvements in outcome. With the miniaturization of scopes and instruments, improvements in optics, and creative engineers, a host of new devices has become available for clinical testing and use. A growing community of pulmonologists is doing comparative effectiveness trials that test new technologies against the current standard of care. While more research is needed, it seems reasonable to provide an overview of pulmonary procedures that are in various stages of development, testing, and practice at this time. Five areas are covered: navigational bronchoscopy, endobronchial ultrasound, endoscopic lung volume reduction, bronchial thermoplasty, and pleural procedure. Appropriate training for clinicians who wish to provide these services will become an area of intense scrutiny as new skills will need to be acquired to ensure patient safety and a good clinical result.

Characterization of outcomes 1 year after endoscopic thermal vapor ablation for patients with heterogeneous emphysema.

INTRODUCTION: Endoscopic lung volume reduction has been developed as a therapeutic option for advanced emphysema. Six-month results following treatment with endoscopic thermal vapor ablation (InterVapor; Uptake Medical, Tustin, CA) were described previously, and here we report observations from the 12-month assessment. METHODS: Two multicenter, international, single-arm trials of InterVapor (unilateral upper lobe treatment) in patients with upper lobe predominant emphysema were conducted. INCLUSION CRITERIA: forced expiratory volume in 1 second (FEV(1)) 15%-45% predicted, residual volume > 150%, total lung capacity > 100%, 6-minute walk distance (6MWD) > 140 m, and diffusing capacity for carbon monoxide > 20% predicted. Efficacy endpoints: spirometry, body plethysmography, lung volumes by high-resolution computed tomography, St George's Respiratory Questionnaire, modified Medical Research Council dyspnea scale, and 6MWD. All adverse events were collected and independently adjudicated. RESULTS: Forty four patients were treated at a mean (standard deviation) age of 63 (5.6) years, FEV(1) 0.86 mL (0.25 mL) (n = 22 men and 22 women). Mean (standard deviation) changes from baseline at 12 months were: FEV(1) 86.2 mL (173.8 mL), St George's Respiratory Questionnaire -11.0 (14.0) units, treated lobar volume from high-resolution computed tomography -751.8 mL (653.9 mL), residual volume -302.8 mL (775.6 mL), 6MWD 18.5 m (63.7 m), and modified Medical Research Council dyspnea scale score -0.83 (0.97) (P < 0.05 for all except 6MWD). Improvements were numerically larger at 6 versus 12 months. GOLD stage III and IV patients had similar outcomes at 6 months; however, improvements relative to baseline were numerically higher in GOLD stage IV patients. Larger improvements were observed in patients with higher heterogeneity. In total, 39 serious adverse events were reported in 23 patients with 10 events in 8 patients between 6 and 12 months. CONCLUSION: Unilateral lobar InterVapor treatment of heterogeneous emphysema improved lung function and health outcomes 1 year following treatment. The magnitude of improvement was larger at 6 months compared to 12 months. Improvements relative to baseline continue to be exhibited at 12 months despite the expected disease related decline over time.

Efficacy of bronchoscopic thermal vapor ablation and lobar fissure completeness in patients with heterogeneous emphysema.

BACKGROUND: Bronchoscopic thermal vapor ablation (BTVA) ablates emphysematous tissue through a localized inflammatory response followed by contractive fibrosis and tissue shrinkage leading to lung volume reduction that should not be influenced by collateral ventilation. OBJECTIVES: To determine the correlation of clinical data from a trial of BTVA with fissure integrity visually assessed by computed tomography (CT). METHODS: We conducted a single-arm study of patients with upper lobe-predominant emphysema (n = 44). Patients received BTVA either to the right upper lobe or left upper lobe, excluding the lingula. Primary efficacy outcomes were forced expiratory volume in 1 s (FEV(1)) and St. George's Respiratory Questionnaire (SGRQ) at 6 months. Lobar volume reduction from CT was another efficacy outcome measurement. The fissure of the treated lobe was analyzed visually on preinterventional CT. Incompleteness of the small fissure, the upper half of the right large fissure and the whole left large fissure were estimated visually in 5% increments, and the relative amount of fissure incompleteness was calculated. Pearson correlation coefficients were calculated for the association between fissure incompleteness and change in efficacy outcomes (baseline to 6 months) of BTVA. RESULTS: A total of 38 out of 44 patients (86%) had incompleteness in the relevant fissure. Calculated relevant fissure incompleteness was a mean of 13% of fissure integrity (range 0-63). Correlation coefficients for the association of incompleteness with outcomes were as follows: FEV(1) = 0.17; lung volume reduction = -0.27; SGRQ score = -0.10; 6-min walk distance = 0.0; residual volume (RV) = -0.18, and RV/total lung capacity = -0.14. CONCLUSIONS: Lobar fissure integrity has no or minimal influence on BTVA-induced lung volume reduction and improvements in clinical outcomes.