Target Lobe Volume Reduction Research Articles

Impact of bronchoscopic lung volume reduction with endobronchial valves on dynamic hyperinflation: Results from the PIERCE study.

Dynamic hyperinflation (DH) is a major marker of exertional dyspnoea in severe emphysema. We hypothesized that bronchoscopic lung volume reduction (BLVR) using endobronchial valves (EBVs) decreases DH. In this prospective bi-centre study from both Toulouse and Limoges Hospitals, we assessed DH during an incremental cycle ergometry before and 3months after EBVs treatment. The primary objective was to observe the change in inspiratory capacity (IC) at isotime. Target lobe volume reduction (TLVR) and changes in residual volume (RV), forced expiratory volume in one-second (FEV1 ), mMRC, 6minutes walking distance (6MWD), BODE and other dynamic measures like tele-expiratory volume (EELV) were also analysed. Thirty-nine patients were included, of whom thirty-eight presented DH. IC and EELV at isotime significantly improved (+214 mL, p= 0.004; -713 mL, p˂0.001, respectively). Mean changes were +177 mL for FEV1 (+19%, p< 0.001), -600 mL for RV (p< 0.0001), +33 m for 6MWD (p< 0.0001), respectively. Patients who responded on RV (>430 mL decrease) and FEV1 (>12% gain) had better improvements compared to non-responders (+368 mL vs. +2mL; +398 mL vs. -40 mL IC isotime, respectively). On the opposite, in patients who responded on DH (>200 mL IC isotime increase), changes in TLV (-1216 mL vs. -576 mL), FEV1 (+261 mL vs. +101 mL), FVC (+496 mL vs. +128 mL) and RV (-805 mL vs. -418 mL) were greater compared to non-responders. DH decreases after EBVs treatment, and this improvement is correlated with static changes.

Improved exercise capacity results in a survival benefit after endobronchial valve treatment

BackgroundBronchoscopic lung volume reduction using endobronchial valves (EBV) is a treatment option for selected patients with advanced emphysema. The treatment significantly improves pulmonary function, exercise capacity, quality of life, and potentially improves survival. Our main aim was to assess whether treatment response significantly influences survival time after EBV treatment. MethodsWe evaluated treatment response at 6-week and 1-year follow-up of all patients treated with EBVs between 2008 and 2020. Survival status was retrieved on December 1, 2021. Patients were defined as responders or non-responders based on known minimal important differences for FEV1, residual volume (RV), RV/Total Lung Capacity (TLC) ratio, 6-min walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), target lobe volume reduction (TLVR), and complete lobar atelectasis. Uni- and multivariate cox regression models were used to evaluate the effect of response on survival time. ResultsA total of 428 patients were included. EBV treatment resulted in significant improvements in pulmonary function, exercise capacity and quality of life. Median survival was 8.2 years after treatment. SGRQ and 6MWD response were independent predictors for improved survival time (Hazard Ratio (HR) 0.50 [0.28–0.89], p = .02 and HR 0.54 [0.30–0.94], p = .03, respectively). The presence of a complete lobar atelectasis did not significantly affect survival, neither did pulmonary function improvements. ConclusionsOur results suggest that improvement in exercise capacity and quality of life after EBV treatment are associated with a survival benefit, independent of improvements in pulmonary function, reduction in target lobe volume or the presence of complete lobar atelectasis.

INITIAL EXPERIENCE WITH INTRAPROCEDURAL ELECTRICAL IMPEDANCE TOMOGRAPHY FOR EVALUATING REGIONAL VENTILATION CHANGES DURING BRONCHOSCOPIC LUNG VOLUME REDUCTION

INITIAL EXPERIENCE WITH INTRAPROCEDURAL ELECTRICAL IMPEDANCE TOMOGRAPHY FOR EVALUATING REGIONAL VENTILATION CHANGES DURING BRONCHOSCOPIC LUNG VOLUME REDUCTION

Clinical Impact of Compensatory Hyperinflation of the Nontreated Adjacent Lobe After Bronchoscopic Lung Volume Reduction with Valves.

BackgroundBronchoscopic lung volume reduction (BLVR) with endobronchial valves (EBV) can be a successful treatment for end-stage emphysema patients. The reduction of hyperinflation enhances ventilatory mechanics and diaphragm function. Understanding predictors for treatment success is crucial for further improvements.PurposeThe aim of this study was to assess the effect of the target lobe volume reduction (TLVR) in relation to the ipsilateral lung volume reduction (ILVR), affected by the compensatory expansion of the adjacent lobe, on the outcome after BLVR with valves.Patients and MethodsThe volumetric relationship of ILVR% to TLVR%, addressed as Reduction Ratio (R), was recorded in 82 patients and compared to changes in lung function, physical performance and quality of life. A small value for R implies a relatively low volume reduction of the ipsilateral lung (ILVR) compared to the volume reduction of the target lobe (TLVR). Additionally, the minimal clinically important difference (MCID) for R was calculated.ResultsPatients with a smaller Reduction Ratio (R <0.2) showed minor improvements at the 3 months follow-up compared to patients with R ≥0.2 (mean changes of 39 mL (5.8%), –395 mL (–4.9%) and 96 mL (7.1%) versus 231 mL (33%), –1235 mL (–20%) and 425 mL (29%) in the forced expiratory volume in 1s (FEV1), residual volume (RV) and inspiratory vital capacity (IVC), respectively, and –3 m and 0 points versus 20.4 m and –3.4 points in the 6-minute-walking-distance (6MWD) and COPD assessment test (CAT) score respectively). With a combined value of 0.185, a MCID for R was calculated with established anchors (FEV1, RV, and 6MWD) for emphysema patients.ConclusionExtensive compensatory hyperinflation of the adjacent non-treated lobe after BLVR results in decreased ILVR, which is responsible for a lack of meaningful improvements in ventilatory mechanics and clinical outcome, despite technically successful lobe volume reduction.

Two-Stage Bronchoscopic Endobronchial Valve Treatment Can Lead to Progressive Lung Volume Reduction and May Decrease Pneumothorax Risk.

BackgroundSince successful development of endobronchial valves (EBV) as treatment for severe emphysema, its main complication, pneumothorax, remains an important concern.ObjectiveWe hypothesized that a two-step EBV implantation, during two distinct iterative procedures could lead to a more progressive target lobe volume reduction (TLVR) and thus ipsilateral lobe re-expansion, resulting in a significant decrease in the pneumothorax rate.MethodsThis retrospective bi-center study carried out by Limoges and Toulouse University Hospitals included patients following the inclusion criteria established by the BLVR expert panel. All patients were treated by two distinct procedures: first, EBVs were placed in all but the most proximal segment or sub-segment. The remaining segment was treated subsequently. All patients had a complete evaluation before treatment, and 3 months after the second procedure.ResultsOut of 58 patients included, only 4 pneumothoraxes (7%) occurred during the study. The other complications were pneumonia and severe COPD exacerbation (8.6% and 13.7% of patients, respectively). Significant improvement was found for FEV1 (+19.6 ± 25%), RV (−468 ± 960mL), 6MWD (30 ± 85m), BODE Index (−1.4 ± 1.8 point) and TLVR (50.6 ± 35.1%). Significant TLVR (MCID) was obtained in 74.1% of patients (43/58).ConclusionThis new approach using EBV could reduce the incidence of pneumothorax without increasing other complication rates. Clinical and physiological outcomes are similar to those reported in studies using the conventional single-step treatment.

Use of Ventilation-Perfusion Single-Photon Emission Computed Tomography to Select the Target Lobe for Endobronchial Valve Lung Volume Reduction

Background: Quantitative planar ventilation-perfusion (VQ) has a complementary role in target lobe selection for endobronchial valve lung volume reduction (EBV-LVR), especially in homogenous disease. We investigated a novel method of lung lobar quantitation using VQ single-photon emission computed tomography (SPECT) with computed tomography (CT) to generate a parameter called the ventilation-perfusion differential index (VQDI). Aim: The aim of this study was to validate VQDI as a parameter for target lobe selection in EBV-LVR against the gold standard test of quantitative computed tomography (qCT). Methods: This study was a prospective, multi-centre, single-blinded, observational study of EBV-LVR patients. Baseline and 3-month post intervention VQ SPECT and qCT were performed. The target lobe was chosen using qCT and planar VQ report (CT_TL) whilst blinded to VQDI. Post EBV-LVR, our nuclear physician, blinded to CT_TL, selected a target lobe using deidentified VQDI (VQDI_TL). Inter-rater agreement between CT_TL and VQDI_TL was calculated by Kappa statistic. Treatment outcomes were analysed with a linear mixed-effects model. Results: There was a high concordance between CT_TL and VQDI_TL in 16 patients (89%, Kappa statistic = 0.85). Post EBV-LVR, our subjects showed significant changes in FEV1 (mean difference [MD] +150 mL, p < 0.001), target lobe volume reduction (MD −973 mL, p < 0.001), residual volume (MD −800 mL, p < 0.001), and St. George’s Respiratory Questionnaire score (MD −11, p = 0.001). Improvements in 6-minute walk distances did not reach statistical significance. Conclusion: In this study of treatment responders, EBV-LVR target lobe selection using VQDI concurs with qCT and thus supports its value for this purpose. It complements qCT and may potentially be of synergistic value especially in homogenous emphysema.

Consolidating Lung Volume Reduction Surgery After Endoscopic Lung Volume Reduction Failure

Bronchoscopic valve placement constitutes an effective endoscopic lung volume reduction (ELVR) therapy in patients with severe emphysema and low collateral ventilation. After the most destroyed lobe is occluded with valves, significant target lobe volume reduction leads to improvements in lung function, exercise capacity, and quality of life. The effects are not consistent in some patients, leading to long-term therapy failure. We hypothesized that surgical lung volume reduction (LVRS) would reestablish ELVR short-term clinical improvements after ELVR long-term failure. This retrospective single-center analysis included all patients who underwent consolidating LVRS by lobectomy after long-term failure of valve therapy between 2010 and 2015. Changes in forced expiratory volume in 1 second, residual volume, 6-minute walking distance, and Modified Medical Research Council dyspnea score 90 days after ELVR and LVRS were analyzed, and the outcomes of both procedures were compared. LVRS was performed in 20 patients after ELVR failure. A lower lobectomy was performed in 90%. The 30-day mortality of the cohort was 0% and 90-day mortality was 5% (1 of 20). The remaining 19 patients showed a significant increase in forced expiratory volume in 1 second (+27.5% ± 19.4%) and a reduction in residual volume (-21.0% ± 17.4%) and total lung capacity (-11.1% ± 11.1%). This resulted in significant improvements in exercise tolerance (6-minute walking distance:+56 ± 60 m) and relief of dyspnea (ΔModified Medical Research Council:-1.8 ± 1.4 points.). Consolidating LVRS by lobectomy after failure of a previously successful ELVR is feasible and results in significant symptom relief and improvement of lung function.

Predictive value of Chartis measurement for lung function improvements in bronchoscopic lung volume reduction.

Background:Bronchoscopic lung volume reduction (BLVR) via valve implantation can be achieved by targeting severely hyperinflated and emphysematously destructed lung areas in patients with chronic obstructive lung disease. Lack of collateral ventilation (CV) is important for good outcomes with BLVR. CV can be measured using the catheter-based Chartis system. The aim of this study was to evaluate the correlation between total exhaled volume drained from the target lobe measured by Chartis and clinical outcomes after BLVR in CV-negative patients.Methods:From January 2016 to March 2019, 60 patients were included in this retrospective single-center analysis. Drained volume (TVol) measured by Chartis was recorded and compared with lung function and physical performance parameters. Outcome variables included the percentage change in lung function [forced expiratory volume in 1 s (FEV1), residual volume (RV), and inspiratory vital capacity (IVC)]. Secondary outcomes were the degree of target lobe volume reduction (TLVR), change in 6-min walk distance (6MWD), and change in chronic obstructive pulmonary disease (COPD) assessment test (CAT) score.Results:Drained volume correlated significantly with post-BLVR change in FEV1 (r = 0.663), IVC (r = 0.611), RV (r = −0.368), and TLVR (r = 0.635) (all p < 0.05). In a priori-defined patient subgroups based on drained volume [<100 ml (n = 19), 100−400 ml (n = 33), and >400 ml (n = 8)]; mean changes in FEV1 were 2.6%, 17.4%, and 51.3%; in RV were −3.9%, −10.6%, and −23.8%; in IVC were −4.0%, 10.6%, and 62.4%; and in TLVR were 525 ml (39%), 1375 ml (73%) and 1760 ml (100%), respectively. There were no significant correlations between absolute and percentage changes in 6MWD and the CAT score. Lung volume reduction was diagnosed in 32 (53%) cases.Conclusion:Drained volume measured by the Chartis system correlated with functional improvement in CV-negative patients undergoing BLVR. The reviews of this paper are available via the supplemental material section.

ENDOBRONCHIAL VALVE TREATMENT OF SEVERE EMPHYSEMA IN PATIENTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY

ENDOBRONCHIAL VALVE TREATMENT OF SEVERE EMPHYSEMA IN PATIENTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY

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.

The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema

Background: Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors. Objectives: The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema. Methods: Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone). Results: The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group. Conclusion: The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.

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.

Survival after Endoscopic Valve Therapy in Patients with Severe Emphysema

Background: Endoscopic valve therapy leads to an improvement of lung function, exercise tolerance, and quality of life in a selected cohort of patients with advanced emphysema. So far, only few data exist on the long-term outcome. Objectives: This analysis evaluated the impact of valve therapy on the survival of emphysema patients. Methods: Survival rates of emphysema patients who underwent valve therapy were assessed according to their radiological outcome following valve placement. Results: From 2005 to 2013, 449 emphysema patients (mean age 64 ± 7 years) underwent valve therapy and were followed for a mean time of 37.3 ± 21.3 months. A total of 128 patients (29%) developed complete lobar atelectasis, 34 out of these also experienced a pneumothorax; 50 patients (11%) developed pneumothorax without lobar atelectasis, and 261 patients (58%) target lobe volume reduction or no volume change. Patients with atelectasis showed significantly better baseline forced expiratory volume in 1 second (%), residual volume (L), total lung capacity (L), and transfer factor for carbon monoxide (%; all p < 0.05), but there was no significant difference in the BODE score (p = 0.195). Patients with valve-induced lobar atelectasis had a significant survival benefit compared to patients without atelectasis (p = 0.009; 5-year survival rate 65.3 vs. 43.9%). The advent of pneumothorax in 84 patients did not influence survival (p = 0.52). Conclusions: Lobar atelectasis following endoscopic valve therapy is associated with a survival benefit.

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 minimal important difference for target lobe volume reduction after endoscopic valve therapy.

ObjectiveEndoscopic valve therapy aims at target lobe volume reduction (TLVR) that is associated with improved lung function, exercise tolerance and quality of life in emphysema patients. So far, a TLVR of >350 mL was considered to be indicative of a positive response to treatment. However, it is not really known what amount of TLVR is crucial following valve implantation.Patients and methodsTLVR, forced expiratory volume in 1 second (FEV1), residual volume (RV) and 6-minute walk distance (6-MWD) were assessed before and 3 months after valve implantation in 119 patients. TLVR was calculated based on computed tomography (CT) scan analysis using imaging software (Apollo; VIDA Diagnostics). Minimal important difference estimates were calculated by anchor-based and distribution-based methods.ResultsPatients treated with valves experienced a mean change of 0.11 L in FEV1, −0.51 L in RV, 44 m in 6-MWD and a TLVR of 945 mL. Using a linear regression and receiver operating characteristic analysis based on two of three anchors (ΔFEV1, ΔRV), the estimated minimal important difference for TLVR was between 890 and 1,070 mL (ie, 49%–54% of the baseline TLV).ConclusionIn future, a TLVR between 49% and 54% of the baseline TLV, should be used when interpreting the clinical relevance.

A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM).

Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach. To evaluate the efficacy and safety of Zephyr EBVs in patients with heterogeneous emphysema and absence of collateral ventilation. This was a prospective, multicenter 2:1 randomized controlled trial of EBVs plus standard of care or standard of care alone (SoC). Primary outcome at 3 months post-procedure was the percentage of subjects with FEV1 improvement from baseline of 12% or greater. Changes in FEV1, residual volume, 6-minute-walk distance, St. George's Respiratory Questionnaire score, and modified Medical Research Council score were assessed at 3 and 6 months, and target lobe volume reduction on chest computed tomography at 3 months. Ninety seven subjects were randomized to EBV (n = 65) or SoC (n = 32). At 3 months, 55.4% of EBV and 6.5% of SoC subjects had an FEV1 improvement of 12% or more (P < 0.001). Improvements were maintained at 6 months: EBV 56.3% versus SoC 3.2% (P < 0.001), with a mean ± SD change in FEV1 at 6 months of 20.7 ± 29.6% and -8.6 ± 13.0%, respectively. A total of 89.8% of EBV subjects had target lobe volume reduction greater than or equal to 350 ml, mean 1.09 ± 0.62 L (P < 0.001). Between-group differences for changes at 6 months were statistically and clinically significant: ΔEBV-SoC for residual volume, -700 ml; 6-minute-walk distance, +78.7 m; St. George's Respiratory Questionnaire score, -6.5 points; modified Medical Research Council dyspnea score, -0.6 points; and BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, -1.8 points (all P < 0.05). Pneumothorax was the most common adverse event, occurring in 19 of 65 (29.2%) of EBV subjects. EBV treatment in hyperinflated patients with heterogeneous emphysema without collateral ventilation resulted in clinically meaningful benefits in lung function, dyspnea, exercise tolerance, and quality of life, with an acceptable safety profile. Clinical trial registered with www.clinicaltrials.gov (NCT02022683).

Endoscopic lung volume reduction in chronic obstructive airway disease using one-way valves

Chronic obstructive airway disease (COPD) is a progressive, irreversible and debilitating disease causing lung hyperinflation. Apart from smoking cessation and conventional medical treatment, lung volume reduction surgery (LVRS) has been used for several years but it involves a major thoracic surgery with high incidence of postoperative complications. In the past decade, different approaches of minimally invasive endoscopic lung volume reduction (ELVR) have been developed which differ in indication, mechanism of action, reversibility and are divided into two groups: blocking and non-blocking devices. The endobronchial valves belong to the group of blocking devices available and have the largest series of treated patients. These one way valves are used to occlude the most emphysematous and hence destroyed lobe of the lung. Two different types of valves are available on the market: endobronchial valves (EBV, Zephyr valves) and intrabronchial valves (IBV, Spiration valves). They differ in shape but have a similar mechanism of action. In order to improve the outcome of the ELVR using valves, dedicated screening involving pulmonary function and exercise capacity testing as well as qualitative and quantitative CT analysis and perfusion scan are necessary. Numerous studies in the past years have shown the efficacy and complications following valve therapy. It has been demonstrated that patients with complete fissures show a more pronounced benefit and a significant target lobe volume reduction. Furthermore, unilateral implantation aiming at obtaining complete lobar occlusion has been more effective than the bilateral incomplete treatment. Regarding possible complications, apart from pneumothorax, COPD exacerbations, hemoptysis and valve migrations have been reported. Summarizing, in comparison to LVRS, ELVR using valves is a less invasive alternative with the opportunity to improve shortness of breath, exercise capacity, and quality of life in the patients, who have reached the end of their conventional treatment options.

Clinical and radiological outcome following pneumothorax after endoscopic lung volume reduction with valves.

IntroductionValve implantation has evolved as a therapy for patients with advanced emphysema. Although it is a minimally invasive treatment, it is associated with complications, the most common being pneumothorax. Pneumothorax occurs due to the rapid target lobe volume reduction and may be a predictor of clinical benefit despite this complication.ObjectiveThe objective of this study was to conduct an exploratory data analysis of patients who developed a pneumothorax following endoscopic valve therapy for emphysema.Materials and methodsThis study performed a retrospective evaluation of pneumothorax management and the impact of pneumothorax on clinical outcomes in 70 patients following valve therapy in 381 consecutive patients.ResultsPneumothorax rate following valve therapy was 18%. Pneumothorax management consisted of chest tube insertion, valve removal, and surgical intervention in 87% (61/70), 44% (31/70), and 19% (13/70) of the patients, respectively. Despite pneumothorax, patients experienced modest but significant improvements in lung function parameters (forced expiratory volume in 1 second: 55±148 mL, residual volume: −390±964 mL, total lung capacity: −348±876; all P<0.05). Persistent lobar atelectasis 3 months after recovering from pneumothorax, which was associated with relevant clinical improvement, was observed in only 21% (15/70) of the patients.ConclusionPneumothorax is a frequent severe complication following valve therapy that requires further intervention. Nevertheless, the pneumothorax does not impair the clinical status in the majority of patients. Patients with lobar atelectasis benefit after recovering from pneumothorax in terms of lung function parameters.

Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study.

Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema. To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system. Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George's Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction. Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV1 from baseline was 13.7 ± 28.2% in the EBV group and -3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, -8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. -17.34 ± 52.8 m). Target lobe volume reduction at 3 months was -1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves. EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.

Predicting Lung Volume Reduction after Endobronchial Valve Therapy Is Maximized Using a Combination of Diagnostic Tools

Background: Bronchoscopic lung volume reduction using one-way endobronchial valves (EBVs) has been proven to be effective in patients with severe emphysema. However, the selection of patients without collateral ventilation prior to treatment is critical for procedural success. Collateral ventilation can be assessed directly with the Chartis system or indirectly using computed tomography (CT) fissure analysis. Objectives: We retrospectively evaluated the diagnostic value of a combination of the quantitative CT interlobar fissure completeness score (FCS) and Chartis in predicting responders to EBV therapy. Methods: CT data from four prospective studies were pooled and analyzed using semiautomated software to quantify the completeness of interlobar fissures. These FCSs were compared to a reference standard of achieving ≥350 ml of target lobe volume reduction after EBV treatment. Using a receiver operating characteristic curve, optimal thresholds predictive of complete fissures (responders) and incomplete fissures (non-responders) were determined. A subgroup of patients with partially complete fissures was identified, where software had lower accuracy. The complementary value of Chartis was investigated in this group. Results: A fissure was defined as complete (FCS >95%), incomplete (FCS <80%), or partially complete (80% < FCS < 95%). The positive predictive value (PPV) of complete fissures is 88.1%, and the negative predictive value (NPV) is 92.9%, with an overall accuracy of 89.2%. Chartis was utilized in patients with partially complete fissures, with a PPV of 82.3%, an NPV of 84.6%, and an accuracy of 83.3%. Conclusion: Combining diagnostic tools could reduce the burden on patients and the healthcare system while providing clinicians with a better means for patient selection for EBV therapy.