Endobronchial Treatment Research Articles

P2.05-04 Development of a New Endobronchial Treatment for Peripheral-Type Lung Cancer

P2.05-04 Development of a New Endobronchial Treatment for Peripheral-Type Lung Cancer

The role of interventional pulmonology in endobronchial metastasis of renal cell carcinoma.

Although metastasis of extrapulmonary solid organ malignant tumors to the lungs is very common, endobronchial metastases are very rare. The most common extrapulmonary tumors that make endobronchial metastases are breast, kidney and colorectal carcinomas. In this study, we retrospectively examined the data of eleven renal cell carcinoma patients who underwent endobronchial metastases in an eight-year period. Ten of the patients were male and the mean age was 55 ± 1 (41-71) years. The most common symptom was cough (45.5%, n= 5), on the other hand 18.2% (n= 2) of the patients had no complaints. Right bronchial system, left bronchial system and tracheal distribution rates of endobronchial lesions were 45.5% (n= 5), 63.6% (n= 7) and 27.3% (n= 3) respectively. The mean time from diagnosis of primary renal cell carcinoma to endobronchial metastases was 47.5 ± 32 (5.2-100.5) months. A total of twenty two interventional procedures were performed. All except one patient underwent endobronchial treatment. Argon plasma coagulation was most commonly used as the endobronchial metastases option (n= 10, 100%). The mechanical resection (n= 6, 60%), laser (n= 5, 50%), cryoextraction (n= 5, 50%) and cryotherapy (n= 4, 40%) methods were used other than argon plasma coagulation. The mean survival time was 19.4 ± 15.7 (3.2-40.5) months after endobronchial metastases and 54.0 ± 40.4 (8.7-107.6) months after renal cell carcinoma diagnosis. Extrathoracic malignancy that most metastasis to the airways is renal cell carcinoma. Endobronchial treatment procedures for endobronchial metastasis of renal cell carcinoma can be performed with low complication rates.

Case of Endobronchial Treatment in the Diagnosis of Neuroendocrine Tumors

Case of Endobronchial Treatment in the Diagnosis of Neuroendocrine Tumors

Endobronchial management of malignant central airway obstruction: the first 6-year single center experience

Objectives: Central airway obstruction (CAO) develops in 20-30% of lung malignancies during the disease. The symptoms related to obstruction often result in poor quality of life and poor prognosis. Interventional bronchoscopic treatments are now recommended in guidelines to improve quality of life and symptom palliation in this patient group. In our study, we aimed to determine the efficacy and safety of our methods in the malignant CAO caused by endobronchial exophytic tumors. Methods: Between May 2012 and August 2018, 432 endobronchial debulking procedures were performed in 388 patients with symptomatic malignant CAO due to endobronchial exophytic or mixed lesions. Results: Primary lung tumors were the most common cause of airway stenosis (84.0%). The most common debulking technique was argon plasma coagulation assisted mechanical debridement (APC+MD) (79.9%). Airway patency was achieved with additional stents (10.2%) in the operations. The success rate of airway patency was 85.5% in APC+MD method, 75.6% in cryorecanalisation method, 91.7% in electrocautery assisted MD method, 100% in MD method and overall success rate was 85.4%. Stent use rate was significantly higher in the stenosis around main carina (42.9%) than in other localizations (p < 0.001). The overall serious complication rate was 2.1%. Procedure-related dead rate was 0.2%. Conclusions: Endobronchial treatment of malignant CAO with interventional bronchoscopic procedures is effective and safe. The first 6 years of experience in our interventional pulmonary clinic show that it has similar characteristics with the world experience in the endobronchial treatment of malignant CAO.

A New Oxygen Uptake Measurement Supporting Target Selection for Endobronchial Valve Treatment

Background: Adequate target lobe selection for endobronchial valve (EBV) treatment in patients with severe emphysema is essential for treatment success and can be based on emphysema destruction, lobar perfusion, lobar volume, and collateral ventilation. As some patients have >1 target lobe for EBV treatment, we were interested whether we could identify the least functional lobe. Objectives: The objective of this study was to investigate the relationship between endoscopic lobar measurement of oxygen uptake, lobar destruction, and vascular volume, and whether this could help in identifying the least functional lobe and thus optimal target for EBV treatment. Method: We prospectively included patients who were scheduled for EBV treatment in our hospital. A customized gas analysis setup was used to measure lobar O₂ uptake after lobar balloon occlusion. Quantitative CT analysis was performed to assess the degree of emphysematous destruction and lobar arterial and venous volumes. Results: Twenty-one (5 male/16 female) patients with emphysema (median age 63 years, FEV₁ 25% of predicted, residual volume 234% of predicted) were included, and 49 endoscopic lobar measurements were performed. A lower O₂ uptake significantly correlated with a higher degree of emphysematous lobar destruction (Spearman’s ρ: 0.39, p < 0.01), and lower arterial and venous vascular volumes of the lobes (–0.46 and –0.47, respectively; both p < 0.001). Conclusions: Endoscopic measurement of lobar O₂ uptake is feasible in patients with emphysema. Measurement of lobar O₂ uptake helped to identify the least functional lobe and can be used as additional tool for EBV target lobe selection.

Collateral Ventilation Measurement Using Chartis: Procedural Sedation vs General Anesthesia

Absence of interlobar collateral ventilation is key to successful endobronchial valve treatment in patients with severe emphysema and can be functionally assessed by using the Chartis measurement. This system has been validated during spontaneous breathing, undergoing procedural sedation (PS), but can also be performed under general anesthesia. Performing the Chartis measurement under PS is often challenging because of coughing, mucus secretion, and difficulties in maintaining an adequate level of sedation. The objective of this study was to investigate whether there is a difference in Chartis measurement outcomes between PS and general anesthesia. In this prospective study, patients underwent Chartis measurements under both PS and general anesthesia. Study outcomes were Chartis measurement duration, number of measurements, feasibility, and success rate. The study included 30 patients with severe emphysema (mean age, 62 years; median FEV1, 29%of predicted). Chartis measurement duration was significantly longer under PS than under general anesthesia (mean, 20.3 ± 4.2min vs15.1 ± 4.4 min; P< .001). There was no difference in the number (median [range]) of measurements performed (2 [1-3] for PS vs1 [1-3] for general anesthesia; P= 1.00). Chartis measurement was more feasible during general anesthesia (median sum of all feasibility scores, 12 [range, 6-26] for PS vs7 [5-13] for general anesthesia; P< .001). There was no statistical difference in success rate: 77%of PS cases vs97%of general anesthesia cases (P= .07). This study found that Chartis measurement under general anesthesia is faster and more feasible to perform compared with performance with PS, without affecting measurement outcomes. Clinicaltrials.gov; No. NCT03205826; URL: www.clinicaltrials.gov.

Endobronchial treatment of persistent pneumothorax in acute respiratory distress syndrome

Endobronchial treatment of persistent pneumothorax in acute respiratory distress syndrome

Quantitative Evaluation of Lobar Pulmonary Function of Emphysema Patients with Endobronchial Coils

Background: Recent advances in bronchoscopic lung volume reduction offer new therapies for patients with emphysema and hyperinflation. Pulmonary lobe segmentation with quantification of lobar volumes and emphysema severity plays a pivotal role in treatment planning and post-interventional assessment. Computed tomography (CT)-derived lobar volumes could reflect more accurate regional changes in pulmonary function. Objectives: The aim of our study is to validate the reliability of an in-house CT Lung Segmentation software (LungSeg; the Hamlyn Centre, Imperial College London, UK) for lung lobar volume and emphysema quantification for chronic obstructive pulmonary disease (COPD) patients. Methods: A total of 108 CT scans from subjects who participated in an endobronchial coil treatment trial were included. Lobar volume and emphysema quantification were performed using the LungSeg and Syngo CT Pulmo 3D package (Siemens Healthcare GmbH, Germany). The inter-user reliability of the LungSeg program was investigated. Correlation coefficients and Bland-Altman analyses were used to quantify the inter-software variability. The agreement between CT volume analysis and plethysmography analysis was also examined. Results: The high intraclass correlation coefficients (mean ICC = 0.98) of the lobar volumes and emphysema indices measured by LungSeg suggest its excellent reproducibility. The LungSeg and Syngo program have good correlation (rho ≥0.94) and agreement for both lobar volume (median difference = 94 mL and LOA_np = 214.6 mL) and emphysema index (median difference ≤1.5% and LOA_np ≤2.03%) calculations. CT analysis provides a higher estimation of total lung capacity (TLC_CT) than body plethysmography (TLC_pleth), while there is a fair agreement on residual volume (RV_CT) by LungSeg as compared with body plethysmography (RV_pleth). Conclusions: CT-derived lobar volume and emphysema quantification using the LungSeg program is efficient and reliable in allowing lobar volume assessment. LungSeg has low inter-user variability and agrees better with plethysmography for COPD assessment in our study.

Zephyr Endobronchial Valves Improve FEV1 and Quality of Life in Heterogenous Emphysema

Synopsis: In patients with severe heterogenous emphysema and little or no collateral ventilation in target lobes, Zephyr Endobronchial Valve treatment provides statistical and clinical benefits in lung function and quality of life compared with current standard of care therapies over a 12-month period. Source: Criner GJ, Sue R, Wright S, et al. LIBERATE Study Group. A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogenous emphysema (LIBERATE). Am J Respir Crit Care Med 2018;198:1151–1164.

Bronchoscopic Treatment of Benign Endoluminal Lung Tumors.

Background and Aim Endobronchial benign tumors are a rarely seen clinical entity but may cause significant symptoms. Endobronchial treatment has the potential for relieving symptoms while saving the patient from invasive surgical procedures. No trials have been published that present and compare the various endobronchial treatment modalities for endobronchial benign tumors. The aim of the present study is to define safety and efficacy of endobronchial treatment in patients with benign endobronchial tumors from the point of complications and success rate. Methods This study is a retrospective cohort study from a review of medical charts. Eligibility criteria included diagnosis of a benign endobronchial tumor. Our institution's bronchoscopy and pathology database was searched for specific benign tumors, and the results were further detailed based on the endobronchial location. Results Forty-four patients with pathologically confirmed benign endobronchial tumors were included. Tumor regression was achieved in all patients with diode laser and argon plasma coagulation in combination with or without cryotherapy and without any major complication. There were no significant differences between the use of either diode laser or of argon plasma coagulation as a modality with immediate effect from the occurrence of residual tissue that needed cryotherapy (P > 0.05). There were no major complications. Eight patients had minor complications including minor bleeding (6 patients) and hypertension (2 patients) that were controlled medically. Thirty-one patients (70%) had very good response, and 13 patients (30%) had good response as defined in literature before. Conclusion Diode laser and argon plasma coagulation in combination with or without cryotherapy are safe and effective methods for endobronchial treatment of benign endobronchial tumors.

Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema

The Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) trial reported improvements in quality of life, pulmonary function, and exercise performance following endobronchial coil treatment. The purpose of this post hoc analysis was to identify baseline predictors, including quantitative CT measures, that identify patients most likely to significantly benefit from endobronchial coil therapy. Quantitative CT analysis by an independent radiology laboratory and a qualitative evaluation by five blinded experts of the baseline thoracic CT imaging were performed. Univariate and multivariate logistic regression analyses were performed to elucidate characteristics associated with clinical response. In total, 125 patients underwent coil treatment and had evaluable 12-month follow-up results. Of these, 78 patients received treatment of lobes with the highest emphysematous destruction determined by quantitative CT analysis (quantitative visual match [QVM]+), and 47 received treatment in at least one lobe that was not the most destroyed (QVM-). From the 78 patients with QVM+ treatment, a subgroup of 50 patients (64%) was identified with baseline residual volume > 200%predicted, emphysema score > 20%low attenuation area, and absence of airway disease. In this subgroup, greater lobar residual volume reduction in the treated lobes was achieved, which was associated with significant mean ± SE improvement in FEV1 (15.2 ± 3.1%), St. George's Respiratory Questionnaire (-12 ± 2points), and residual volume (-0.57 ± 0.13 L). This post hoc analysis found that both significant hyperinflation (residual volume≥ 200%predicted) and CT analysis are critical for patient selection and treatment planning for endobronchial coil therapy. Quantitative CT analysis is important to identify optimal lobar treatment and to exclude patients with insufficient emphysema (< 20%low attenuation area), whereas visual assessment identifies patients with signs of airway disease associated with worse outcomes. ClinicalTrials.gov; No.: NCT01608490; URL: www.clinicaltrials.gov.

Patients Treated for Central Airway Stenosis After Lung Transplantation Have Persistent Airflow Limitation.

BackgroundAlthough central airway stenosis (CAS) is a common complication after lung transplantation, its consequences have been poorly evaluated. The objective of our study was to evaluate the impact of CAS on lung function after lung transplantation.Material/MethodsAll lung transplant recipients from June 2009 to August 2014 in a single center (Strasbourg, France) were retrospectively reviewed.ResultsA total of 191 lung transplantations were performed: 175 bilateral, 15 single, and 1 heart-lung transplantation. Of the 161 bilateral lung-transplanted patients who survived >3 months, 22 (13.6%) developed CAS requiring endobronchial treatment. All these patients were treated by endoscopic balloon dilatation, and 9 additionally needed endobronchial stents. Respiratory function tests demonstrated persistent obstructive ventilatory pattern despite endoscopic treatment in recipients with CAS compared to those without CAS at 6, 12, and 18 months post-transplant. At 18 months, CAS patients had significantly lower post-transplant FEV1 (1.96±0.60 L versus 2.57±0.76 L, p=0.001) and FEV1/FVC (61±14% versus 81±13%, p<0.001). The percentage of patients hospitalized for respiratory infections and number of hospital days were significantly increased in recipients with CAS (20 [91%] versus 92 [66%] p=0.036, and 144±110 days versus 103±83 days p=0.042, respectively). Survival in transplant recipients did not significantly differ between those with CAS and those without.ConclusionsCAS after lung transplantation was not associated with worse survival, but it did have a significant and persistent effect on lung function, and was associated with increased rate of respiratory infection.

Visual analysis versus quantitative CT analysis of interlobar fissure integrity in selecting emphysematous patients for endobronchial valve treatment.

The aim of this study is to compare the accuracy of the standard visual scoring of computed tomography (CT) scans with a cloud-based quantitative CT analysis that uses the StratX software, to measure collateral ventilation and, thus, predict lobar atelectasis after valve treatment. This is a retrospective, multicentre study of patients who had previously undergone valve treatment for severe heterogeneous emphysema and whose required fissure integrity ≥90% had been qualitatively scored by visual assessment of CT scans. For this study, all preprocedural CT scans were retrospectively analysed using the StratX software to provide quantitative scores of fissure integrity. The diagnostic accuracies of the visual and quantitative scores for predicting a target lobe volume reduction (TLVR) of ≥350 ml were calculated and statistically compared, as this level of volume reduction can be achieved only with sound fissure integrity. The clinical outcome of TLVR was also evaluated according to the minimal clinically important difference criteria. Eighty-three patients were included in the analysis. Of them, 65 of 83 (78%) patients presented with TLVR ≥350 ml. Visual scoring correctly identified the absence of collateral ventilation in 65 of 83 (78%) cases but failed in 18 of 83 (22%) cases. Of these 18 patients, quantitative analysis showed that 16 of 18 (89%) patients did not present completeness of the fissure. The diagnostic accuracy of the quantitative analysis was better than that of the visual analysis (96.4% vs 78.3%; P = 0.0003). Only patients having TLVR ≥350 ml met or exceeded the minimal clinically important difference criteria. The quantitative analysis using the StratX software contributed a more objective and efficient evaluation of collateral ventilation that would have improved the selection of emphysematous patients for endobronchial valve treatment in the study population.

Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency.

Endobronchial coil treatment (ECT) is a minimally invasive procedure developed for palliative care of patients with severe emphysema. ECT has demonstrated a decrease in hyperinflation, an improvement in quality of life, and an acceptable safety profile in randomized controlled trials (RCTs). Because alpha-1 antitrypsin deficiency (AATD) is a classical exclusion criterion in RCTs, there is no available data for ECT in AATD. In this post hoc analysis of the REVOLENS study (Réduction volumique endobronchique par spirales; ClinicalTrials.gov Identifier: NCT01822795), a multicenter 1:1 RCT which compared bilateral ECT with usual care in severe emphysema, we analyzed the efficacy and safety results at 1 year in six patients with AATD (five males, one female; mean age: 52±9 years) who underwent ECT. A significant decrease in hyperinflation (0.35 L decrease in residual volume [RV]) was observed in four out of six patients at 6 months and three out of six patients at 12 months, and an improvement in quality of life (improvement of 4 points in the St George’s Respiratory Questionnaire [SGRQ]) was observed in four out of six patients at both 6 and 12 months. Efficacy results at 6 and 12 months from the six AATD patients were compared with 84 non-AATD patients who underwent ECT, and no statistically significant differences were found for FEV1, RV, 6MWT score and SGRQ score. Respiratory-related serious adverse event was limited to pneumonia in one AATD patient at 1 year post-ECT. This post hoc study suggests that AATD patients may have similar efficacy and safety outcomes at 1 year as non-AATD patients. Because of the paucity of available data, appropriately powered studies are needed to determine the effects of ECT in AATD.

Complications related to endoscopic lung volume reduction for emphysema with endobronchial valves: results of a multicenter study.

Despite bronchoscopic lung volume reduction (BLVR) with valves is a minimally invasive treatment for emphysema, it can associate with some complications. We aimed at evaluating the rate and type of complications related to valve treatment and their impact on clinical outcomes. It is a retrospective multicenter study including all consecutive patients with severe heterogeneous emphysema undergoing BLVR with endobronchial valve treatment and developed any complications related to this procedure. The type of complication, the time of onset, the treatment required and the out-come were evaluated. Response to treatment was assessed according to the minimal clinically important difference (MCID) as follows: an improvement of ≥15% in forced expiratory volume in one second (FEV1); of -8% in residual volume (RV); of ≥26 m in 6-minnute walking distance (6MWD); and of ≥4 points on the St. George's Respiratory Questionnaire (SGRQ). Target lobe volume reduction (TLVR) ≥350 mL was considered significant. One hundred and seven out of 423 (25.3%) treated patients had complications related to valve treatment including pneumothorax (17.3%); pneumonia (1.7%), chronic obstructive pulmonary disease (COPD) exacerbation (0.9%), respiratory failure (1.4%), valve migration (2.1%), and hemoptysis (1.9%). In all cases complications resolved with appropriate treatment including removal of valves in 21/107 cases (19.6%). Patients with TLVR ≥350 mL (n=64) vs. those <350 mL (n=43) had a statistically significant higher improvement in FEV1 (19.0%±3.9% vs. 3.0%±0.9%; P=0.0003); in RV (-10.0%±4.8% vs. -4.0%±2.9%; P=0.002); in 6MWD (33.0±19.0 vs. 12.0±6.3 metres; P=0.001); and in SGRQ (-15.0±2.9 vs. -8.0±3.5 points; P=0.01). Only patients with TLVR ≥350 mL met or exceeded the MCID cut-off criteria for FEV1 (19.0%±3.9%), RV (-10.0%±4.8%), 6MWT (33.0±19.0 metres), and SGQR (-15.0±2.9 points). Five patients (1.2%) died during follow-up for causes not related to valves treatment neither to any of the complications described. Valve treatment is a safe and reversible procedure. The presence of complications seems not to have a significant impact on clinical outcome in patients with lobar atelectasis. Due to poor clinical conditions and possible complications, BLVR should be performed in high volume centers with a multidisciplinary approach.

MA13.11 Photodynamic Therapy for Peripheral-Type Lung Cancer in a Multi-Center Clinical Trial

Photodynanic therapy (PDT), is a treatment modality for many cancers, and uses a tumor-specific photosensitizer and laser irradiation. Recently, we have developed a new minimally invasive laser device using a 1.0 mm in diameter composite-type optical fiberscope (COF), which could transmit laser energy and images for observation in parallel.In this study, we aimed to develop a new endobronchial treatment for peripheral cancer using PDT and a COF, and we evaluated the feasibility of PDT using COF for peripheral lung cancer. This phase I study enrolled 3 patients with peripheral lung cancers (primary tumor< 20 mm, stage IA), which were definitively diagnosed by bronchoscopic modalities such as EBUS-GS and brocnhoscopic navigation system. We conducted irradiation using a diode laser (664 nm) and a COF 4 hours after the administration of NPe6 40 mg/m2. We evaluated the tumor lesions using EBUS, and then we introduced the COF into the peripheral lung cancer, and irradiated of red light 664 nm (120 mW, 50 J/cm2 or 100J/cm2). We performed PDT for 3 patients with c-stage IA peripheral lung cancer, using a laser dose (120mW, 50J/cm2), and confirmed the feasibility of the dose. We escalated the laser dose and performed 4 patients using a laser dose (120mW, 100J/cm2). Seven patients met our criteria, and 5 cases were adenocarcinoma and 2 case squamous cell carcinoma. We were able to observe the cancer lesions at the peripheral lung by the COF, and feasibly irradiated. Two weeks and 3 months after NPe6-PDT, complications such as pneumonia and pneumothorax were not found, but one mildly found light skin-photosensitivity. Six months later, we found CR in 3 cases and SD in 4 cases. The 1.0 mm COF was a very useful device of NPe6-PDT for peripheral lung cancers, and PDT was a feasible and non-invasive treatment for a peripheral type early lung cancer. In the future, for non-invasive adenocarcinoma such as AIS, NPe6-PDT will become a treatment modality.

Updates on bronchoscopic management of airway disease

Tracheobronchial surgery is one of the most challenging fields in thoracic surgery. Tremendous effort has been made to ensure that surgical resection and reconstruction of the tracheobronchial tree can be performed safely, and minimally‐invasive video assisted thoracoscopic surgery pioneers have recently pushed the limit for certain airway procedures. However, surgical resection of the diseased airway is often not feasible or contraindicated due to the nature of the disease or advanced malignancies. In the present, we focus on the endobronchial treatment of adult airway diseases and the latest updates.

Chartis Measurement of Collateral Ventilation: Conscious Sedation versus General Anesthesia – A Retrospective Comparison

Background: Absence of interlobar collateral ventilation using the Chartis measurement is the key predictor for successful endobronchial valve treatment in severe emphysema. Chartis was originally validated in spontaneous breathing patients under conscious sedation (CS); however, this can be challenging due to cough, mucus secretion, mucosal swelling, and bronchoconstriction. Performing Chartis under general anesthesia (GA) avoids these problems and may result in an easier procedure with a higher success rate. However, using Chartis under GA with positive pressure ventilation has not been validated. Objectives: In this study we investigated the impact of anesthesia technique, CS versus GA, on the feasibility and outcomes of Chartis measurement. Methods: We retrospectively analyzed all Chartis measurements performed at our hospital from October 2010 until December 2017. Results: We analyzed 250 emphysema patients (median forced expiratory volume in 1 s 26%, range 12–52% predicted). In 121 patients (48%) the measurement was performed using CS, in 124 (50%) using GA, and in 5 (2%) both anesthesia techniques were used. In total, 746 Chartis readings were analyzed (432 CS, 277 GA, and 37 combination). Testing under CS took significantly longer than GA (median 19 min [range 5—65] vs. 11 min [3–35], p < 0.001) and required more measurements (3 [1–13] vs. 2 [1–6], p < 0.001). There was no significant difference in target lobe volume reduction after treatment (–1,123 mL [–3,604 to 332] in CS vs. –1,251 mL [–3,333 to –1] in GA, p = 0.35). Conclusions: In conclusion, Chartis measurement under CS took significantly longer and required more measurements than under GA, without a difference in treatment outcome. We recommend a prospective trial comparing both techniques within the same patients to validate this approach.

The safety and efficacy of endobronchialvalve therapy in patients with advanced heterogeneous emphysema versus standard medical care: A meta-analysis.

BackgroundEndobronchial valves had been utilized for many years to treat patients with advanced emphysema, despite unfavorable results. In this meta-analysis, we aimed to assess the efficacy and safety of the use of endobronchial valves in patients with heterogeneous advanced emphysema.MethodsWe performed systematic database searches to identify clinical trials that met all our inclusion criteria. Direct-comparison and mixed-treatment-comparison (MTC) meta-analyses were conducted to estimate the mean difference or odds ratio of outcomes. Each outcome was analyzed with Review Manager 5 statistical software.ResultsEight prospective clinical trials assessing this therapy were retrieved, with a total of 744 patients. Outcomes, including the forced expiratory volume in 1 second (FEV1), 6-minute walk test (6MWT), and St. George's Respiratory Questionnaire (SGRQ), were analyzed, and the odds ratio of reported complications related to endobronchial valve therapy was calculated. Significant improvement in the mean difference of FEV1 (5.61 [4.42, 6.80]), 6MWT (25.75 [12.30, 39.20]), and SGRQ (−10.96 [−13.88, −8.05]) was observed after endobronchial valve treatment. Moreover, the rate of adverse events related to endobronchial valves was low.ConclusionsEndobronchial valve treatment offers benefits in terms of lung function and quality of life. Endobronchial valve treatment is feasible and safe for patients with advanced heterogeneous emphysema, especially those with no evidence of collateral ventilation.

Quantifying patient centered outcomes associated with the use of bilateral endobronchial coil treatment in patients with severe emphysema

Objective: To determine the impact of endobronchial coils on health-related quality-of-life (HRQoL). This paper utilizes trial data to identify the predictors of HRQoL in patients with severe emphysema, and subsequently estimates the impact of a new treatment on HRQoL (measured by utilities). These utility estimates are used to generate indicative long-term QALY estimates for a range of clinically plausible scenarios as a precursor to cost-effectiveness analyses.Methods: Patient level HRQoL data from RENEW and the National Emphysema Treatment Trial (NETT) were combined and mapped to generic EuroQol 5-dimension health utility questionnaire (EQ-5D) values using a published algorithm. Multilevel statistical models were developed using treatment, time, response, and baseline characteristics (EQ-5D, age, gender, FEV1, lung RV) to predict EQ-5D over time. Lifetime QALY estimates were generated using published survival data from NETT (assuming no impact of treatment on mortality) and four clinically plausible response profiles. Each response profile was combined with assumptions around treatment impact (constant or time varying).Results: After controlling for baseline characteristics, both treatment and response had a statistically significant impact (p < .001) on utility (+0.101 and +0.061, respectively). When combined with selected baseline characteristics and time, Coils and Standard of Care (SoC) generated more QALYs than SoC alone in all scenarios, with incremental lifetime benefit ranging from 0.29–0.55 QALYs.Conclusions: Coils and SoC resulted in statistically significant improvements in HRQoL compared to SoC alone in patients with severe emphysema.