Publications by authors named "Ralf Eberhardt"

127 Publications

Endobronchial Valve (Zephyr) Treatment in Homogeneous Emphysema: One-Year Results from the IMPACT Randomized Clinical Trial.

Respiration 2021 Jul 23:1-12. Epub 2021 Jul 23.

Department of Respiratory and Critical Care Medicine, Otto-Wagner-Spital, Wien, Austria.

Rationale: The long-term safety and effectiveness of bronchoscopic lung volume reduction with Zephyr endobronchial valves in subjects with severe homogeneous emphysema with little to no collateral ventilation beyond 3 months have yet to be established.

Methods: Ninety-three subjects were randomized to either bronchoscopic lung volume reduction with Zephyr valves or standard of care (SoC) (1:1). Zephyr valve subjects were assessed at 3, 6, and 12 months. SoC subjects were assessed at 3 and 6 months; they were then offered crossover to Zephyr valve treatment.

Results: The mean group difference (Zephyr valve - SoC) for change in FEV1 from baseline to 6 months was 16.3 ± 22.1% (mean ± SD; p < 0.001). Secondary outcomes showed the mean between-group difference for the six-minute walk distance of +28.3 ± 55.3 m (p = 0.016); St. George's Respiratory Questionnaire, -7.51 ± 9.56 points (p < 0.001); modified Medical Research Council, -0.42 ± 0.81 points (p = 0.019); BODE index, -0.85 ± 1.39 points (p = 0.006); and residual volume of -430 ± 830 mL (p = 0.011) in favor of the Zephyr valve group. At 6 months, there were significantly more responders based on the minimal clinically important difference for these same measures in the Zephyr valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of subjects with respiratory serious adverse events was higher in the Zephyr valve group compared to SoC during the first 30 days post-procedure but not statistically different for the Zephyr valve and SoC groups from 31 days to 6 months, and stable in the Zephyr valve group out to 12 months. There were 2 deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr valve group out to 12 months.

Conclusions: Bronchoscopic lung volume reduction with Zephyr valves in subjects with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months, with benefits maintained out to 12 months.
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http://dx.doi.org/10.1159/000517034DOI Listing
July 2021

Bronchoscopic performance of bronchoalveolar lavage in germany - a call for standardization.

Sarcoidosis Vasc Diffuse Lung Dis 2021 31;38(1):e2021003. Epub 2021 Mar 31.

Department of Interventional Pneumology, Ruhrlandklinik - University Medicine, Essen, Germany.

Background: Bronchoalveolar lavage (BAL) is a widely used clinical tool in diagnosing interstitial lung diseases. Although there are recommendations and guidelines, the procedure is not completely standardized. Varying approaches likely influence the conclusiveness of BAL data and may be one reason for the divergent judgement of their value between different centers.

Objectives: To evaluate how BAL is performed in Germany using an electronically based survey.

Methods: We conducted a cross-sectional online survey among all members of the German Respiratory Society.

Results: 608 members responded to the survey and of these 500 perform lavages. Most bronchoscopists (344/500) do not use a tube and have no anesthesiologist present during the procedure (405/500). Propofol is used by 76.8% and midazolam by 67.9% (n = 405), often in combination. A major difference was noted regarding the total volume of instillation. Many respondents use a predefined fixed amount of instilled volume (202/500), whereas an almost equal number use variable volumes based on the recovery (196/500). The minimum recovery volume predefined by 217/499 ranged from 3-150 ml (median 30 ml; mean 42.2 ± 55.1 ml). Most respondents did not transport their samples in special medium (61.5%) or on ice (72.8%). The average time between recovery and arrival at the lab was 115.6±267.0 min (n = 323).

Conclusion: This study shows the broad spectrum of variations in the performance of BAL in Germany, which could have a negative effect on the method's clinical value. There is a need for training and standardization of BAL performance.
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http://dx.doi.org/10.36141/svdld.v38i1.10628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8050621PMC
March 2021

Joint Statement of the German Respiratory Society and German Society of Thoracic Surgery in Cooperation with the German Radiological Society: Structural Prerequisites of Centres for Interventional Treatment of Emphysema.

Respiration 2021;100(1):52-58. Epub 2021 Jan 7.

Division of Thoracic Surgery, Department of Surgery, University Hospital Rechts der Isar, Technical University of Munich, Munich, Germany.

Interventional treatment of emphysema offers a wide range of surgical and endoscopic options for patients with advanced disease. Multidisciplinary collaboration of pulmonology, thoracic surgery, and imaging disciplines in patient selection, therapy, and follow-up ensures treatment quality. The present joint statement describes the required structural and quality prerequisites of treatment centres. This is a translation of the German article "Positionspapier der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin und der Deutschen Gesellschaft für Thoraxchirurgie in Kooperation mit der Deutschen Röntgengesellschaft: Strukturvoraussetzungen von Zentren für die interventionelle Emphysemtherapie" Pneumologie. 2020;74:17-23.
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http://dx.doi.org/10.1159/000511599DOI Listing
January 2021

Endobronchial Ultrasound Elastography for Differentiating Benign and Malignant Lymph Nodes.

Respiration 2020;99(9):779-783. Epub 2020 Oct 7.

Pneumology and Critical Care medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.

Background: Endobronchial ultrasound elastography that provides information on tissue stiffness may help distinguish malignant from benign mediastinal and hilar lymph nodes.

Objectives: In this prospective trial, we assessed the diagnostic value of elastographic images and the interobserver agreement in its evaluation.

Method: Elastographic images from 77 lymph nodes in 65 patients were reviewed by 3 pneumologists. The elastographic image was classified based on the predominant colour: predominantly green, intermediary, and predominantly blue. With 2 or 3 interobserver matches, the corresponding elastographic image was correlated with the pathological result obtained from endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and/or other invasive procedures.

Results: All 3 reviewers had agreement in classifying elastographic images in 45% (35/77). Overall, the interobserver agreement among the 3 readers for classifying elastographic pattern was found to be moderate (Fleiss Kappa index = 0.519; 95% CI = [0.427; 0.611]). On cytological/histological evaluation, 55 lymph nodes were malignant and 22 were benign. In classifying "green" as benign and "blue" as malignant, the sensitivity and specificity were 71% (95% CI = [54%; 85%]) and 67% (95%-CI = [35%; 90%]), respectively.

Conclusions: Elastography will not replace invasive EBUS-TBNA due to a moderate interobserver agreement and insufficient sensitivity and specificity. However, elastography will, maybe, present an additional feature to identify malignant lymph nodes in the context of clinical, radiological, and cytological results.
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http://dx.doi.org/10.1159/000509297DOI Listing
October 2021

Consolidating Lung Volume Reduction Surgery After Endoscopic Lung Volume Reduction Failure.

Ann Thorac Surg 2021 06 28;111(6):1858-1865. Epub 2020 Sep 28.

Translational Lung Research Center (TLRC), Heidelberg, Germany, member of German Center for Lung Research (DZL); Department of Pneumology and Critical Care Medicine, Thoraxklinik, Heidelberg University, Heidelberg, Germany.

Background: 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.

Methods: 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.

Results: 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.).

Conclusions: Consolidating LVRS by lobectomy after failure of a previously successful ELVR is feasible and results in significant symptom relief and improvement of lung function.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.148DOI Listing
June 2021

Comprehensive serial biobanking in advanced NSCLC: feasibility, challenges and perspectives.

Transl Lung Cancer Res 2020 Aug;9(4):1000-1014

Translational Lung Research Center Heidelberg (TLRC), German Center for Lung Research (DZL), Heidelberg, Germany.

Background: Availability of tumor material at baseline and disease progression is increasingly important for patient management in non-small-cell lung cancer (NSCLC), especially for the application of targeted therapies like tyrosine kinase inhibitors and for immune checkpoint inhibitor treatment. Here we report the experience of prospective biomaterial acquisition in advanced NSCLC from a pilot project.

Methods: Main objective was the longitudinal collection of high-quality, cryoconserved biopsies in addition to formalin-fixed paraffin-embedded (FFPE) biopsies required for routine diagnostics, along with blood samples and detailed clinical annotation using standardized questionnaires.

Results: Over five years, 205 patients were enrolled for the project, yielding 387 cryoconserved biopsies and 1,098 serum, plasma and buffy-coat samples. The feasibility of obtaining the cryoconserved biopsies in addition to the FFPE biopsies was 89% for newly diagnosed cases, but dropped down to 56% and 47% at first and second disease progression, respectively. While forceps biopsy was the preferred procedure for tissue acquisition, the highest tissue amounts were received using the cryobiopsy method. Biopsies had a median tumor cellularity of 34% and yielded in median 13.6 µg DNA and 12 µg RNA (median RIN =8). During the five-year project, a maximum of 38 follow-up blood samples per patient were assembled in up to four therapy lines.

Conclusions: Despite the poor condition and limited prognosis of most NSCLC patients, this serial biomaterial acquisition including routine collection of cryoconserved biopsies is feasible to support individualized management. The standardized collection of high-quality material has enabled and enriched several translational research studies that can advance therapeutic options.
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http://dx.doi.org/10.21037/tlcr-20-137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7481602PMC
August 2020

Transbronchial cryobiopsy increases diagnostic confidence in interstitial lung disease: a prospective multicentre trial.

Eur Respir J 2020 12 10;56(6). Epub 2020 Dec 10.

Dept of Medical Oncology and Pneumology, Eberhard Karls University, Tübingen, Germany.

Introduction: The accurate diagnosis of individual interstitial lung diseases (ILD) is often challenging, but is a critical determinant of appropriate management. If a diagnosis cannot be made after multidisciplinary team discussion (MDTD), surgical lung biopsy is the current recommended tissue sampling technique according to the most recent guidelines. Transbronchial lung cryobiopsy (TBLC) has been proposed as an alternative to surgical lung biopsy.

Methods: This prospective, multicentre, international study analysed the impact of TBLC on the diagnostic assessment of 128 patients with suspected idiopathic interstitial pneumonia by a central MDTD board (two clinicians, two radiologists, two pathologists). The level of confidence for the first-choice diagnoses were evaluated in four steps, as follows: 1) clinicoradiological data alone; 2) addition of bronchoalveolar lavage (BAL) findings; 3) addition of TBLC interpretation; and 4) surgical lung biopsy findings (if available). We evaluated the contribution of TBLC to the formulation of a confident first-choice MDTD diagnosis.

Results: TBLC led to a significant increase in the percentage of cases with confident diagnoses or provisional diagnoses with high confidence (likelihood ≥70%) from 60.2% to 81.2%. In 32 out of 52 patients nondiagnostic after BAL, TBLC provided a diagnosis with a likelihood ≥70%. The percentage of confident diagnoses (likelihood ≥90%) increased from 22.7% after BAL to 53.9% after TBLC. Pneumothoraces occurred in 16.4% of patients, and moderate or severe bleeding in 15.7% of patients. No deaths were observed within 30 days.

Interpretation: TBLC increases diagnostic confidence in the majority of ILD patients with an uncertain noninvasive diagnosis, with manageable side-effects. These data support the integration of TBLC into the diagnostic algorithm for ILD.
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http://dx.doi.org/10.1183/13993003.01520-2019DOI Listing
December 2020

Efficacy and Safety of the 9-mm Intrabronchial Valve in Patients with Advanced Emphysema.

Respiration 2020;99(4):333-343. Epub 2020 Apr 20.

Thoraxklinik, University of Heidelberg, Heidelberg, Germany.

Background: Endoscopic valve therapy aims at lung volume reduction that is associated with improved lung function, exercise tolerance and quality of life in emphysema patients. The size of intrabronchial valves of the Spiration® Valve System (SVS) selected to achieve lobar occlusion may have an influence on treatment outcomes.

Methods: 49 severe emphysema patients (M/F: 24/25, age: 64 ± 7 years), with complete interlobar fissures on the side intended to be treated, underwent treatment with at least one 9-mm intrabronchial valve implantation at 3 centers and were followed up at 30, 90 and 180 days after intervention. Changes in pulmonary function tests (PFT), 6-min walk test (6MWT), modified Medical Research Council (mMRC) dyspnea scale and chronic obstructive pulmonary disease assessment test scores as well as possible complications were recorded.

Results: Forced expiratory volume in 1 s (FEV1) improved significantly over the 6-month period of the study, and the proportion of patients achieving a minimal clinically important difference (MCID) for FEV1 was 46.4% at 6 months. Regarding the remaining PFT values, the changes were not statistically significant at 6 months, but when looking at the MCIDs, 44.4% of the patients achieved the MCID decrease for residual volume. The 6MWT distance also improved statistically significantly, and an MCID increase of ≥26 m was reached by 41.7% of the patients. Furthermore, there was a statistically significant improvement in the mMRC score. The incidence of pneumothoraxes requiring drainage was 26.5% while a valve dislocation rate of 24% was observed but only in the lower lobes.

Conclusions: Endoscopic lung volume reduction with the 9-mm SVS valves was associated with statistically significant but modest improvement of FEV1, mMRC and 6MWT up to 6 months after intervention. These results were accompanied by an anticipated and acceptable risk profile. The relative increased incidence of device dislocation observed needs to be further elucidated.
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http://dx.doi.org/10.1159/000506521DOI Listing
April 2021

Interventional Bronchoscopy.

Am J Respir Crit Care Med 2020 07;202(1):29-50

Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.

For over 150 years, bronchoscopy, especially flexible bronchoscopy, has been a mainstay for airway inspection, the diagnosis of airway lesions, therapeutic aspiration of airway secretions, and transbronchial biopsy to diagnose parenchymal lung disorders. Its utility for the diagnosis of peripheral pulmonary nodules and therapeutic treatments besides aspiration of airway secretions, however, has been limited. Challenges to the wider use of flexible bronchoscopy have included difficulty in navigating to the lung periphery, the avoidance of vasculature structures when performing diagnostic biopsies, and the ability to biopsy a lesion under direct visualization. The last 10-15 years have seen major advances in thoracic imaging, navigational platforms to direct the bronchoscopist to lung lesions, and the ability to visualize lesions during biopsy. Moreover, multiple new techniques have either become recently available or are currently being investigated to treat a broad range of airway and lung parenchymal diseases, such as asthma, emphysema, and chronic bronchitis, or to alleviate recurrent exacerbations. New bronchoscopic therapies are also being investigated to not only diagnose, but possibly treat, malignant peripheral lung nodules. As a result, flexible bronchoscopy is now able to provide a new and expanding armamentarium of diagnostic and therapeutic tools to treat patients with a variety of lung diseases. This State-of-the-Art review succinctly reviews these techniques and provides clinicians an organized approach to their role in the diagnosis and treatment of a range of lung diseases.
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http://dx.doi.org/10.1164/rccm.201907-1292SODOI Listing
July 2020

Quantitative CT detects progression in COPD patients with severe emphysema in a 3-month interval.

Eur Radiol 2020 May 21;30(5):2502-2512. Epub 2020 Jan 21.

Department of Diagnostic and Interventional Radiology, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.

Objectives: Chronic obstructive pulmonary disease (COPD) is characterized by variable contributions of emphysema and airway disease on computed tomography (CT), and still little is known on their temporal evolution. We hypothesized that quantitative CT (QCT) is able to detect short-time changes in a cohort of patients with very severe COPD.

Methods: Two paired in- and expiratory CT each from 70 patients with avg. GOLD stage of 3.6 (mean age = 66 ± 7.5, mean FEV1/FVC = 35.28 ± 7.75) were taken 3 months apart and analyzed by fully automatic software computing emphysema (emphysema index (EI), mean lung density (MLD)), air-trapping (ratio expiration to inspiration of mean lung attenuation (E/I MLA), relative volume change between - 856 HU and - 950 HU (RVC)), and parametric response mapping (PRM) parameters for each lobe separately and the whole lung. Airway metrics measured were wall thickness (WT) and lumen area (LA) for each airway generation and the whole lung.

Results: The average of the emphysema parameters (EI, MLD) increased significantly by 1.5% (p < 0.001) for the whole lung, whereas air-trapping parameters (E/I MLA, RVC) were stable. PRM increased from 34.3 to 35.7% (p < 0.001), whereas PRM decrased from 23.6% to 22.8% (p = 0.012). WT decreased significantly from 1.17 ± 0.18 to 1.14 ± 0.19 mm (p = 0.036) and LA increased significantly from 25.08 ± 4.49 to 25.84 ± 4.87 mm (p = 0.041) for the whole lung. The generation-based analysis showed heterogeneous results.

Conclusion: QCT detects short-time progression of emphysema in severe COPD. The changes were partly different among lung lobes and airway generations, indicating that QCT is useful to address the heterogeneity of COPD progression.

Key Points: • QCT detects short-time progression of emphysema in severe COPD in a 3-month period. • QCT is able to quantify even slight parenchymal changes, which were not detected by spirometry. • QCT is able to address the heterogeneity of COPD, revealing inconsistent changes individual lung lobes and airway generations.
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http://dx.doi.org/10.1007/s00330-019-06577-yDOI Listing
May 2020

Primary pulmonary myxoid sarcoma with an unusual gene fusion between exon 7 of EWSR1 and exon 5 of CREB1.

Virchows Arch 2020 May 27;476(5):787-791. Epub 2019 Nov 27.

Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 69120, Heidelberg, Germany.

Primary pulmonary mesenchymal tumors are rare, yet they compromise a variety of entities. A novel low-grade malignant neoplasm coined primary pulmonary myxoid sarcoma (PPMS) has been introduced in the WHO classification of lung tumors. Molecular analysis in PPMS revealed recurrent gene fusions between EWSR1 and CREB1, a member of the cAMP response element binding protein (CREB) family. However, only 23 PPMS have been reported in the literature reflecting their exceedingly low incidence. Here, we describe the case of a 41-year-old female patient with a lung tumor obstructing the right main bronchus. Histologically, the tumor was composed of spindle-shaped and epithelioid cells exhibiting a reticular growth pattern within a prominent myxoid matrix. Solid areas were also observed. Molecular analysis by next-generation sequencing identified a fusion transcript with an unusual gene fusion involving exon 7 of EWSR1 and exon 5 of CREB1. Together, the diagnosis PPMS was established.
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http://dx.doi.org/10.1007/s00428-019-02716-4DOI Listing
May 2020

Utility of Endobronchial Ultrasound in Assessment of Intrathoracic Lesions in Paediatric Patients.

Respiration 2019;98(4):340-346. Epub 2019 Aug 14.

Department of Respiratory and Sleep Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia.

Introduction: In adults, linear endobronchial ultrasound (EBUS) is the preferred modality to sample intrathoracic adenopathy and radial EBUS is a useful tool to biopsy peripheral pulmonary nodules. Utility in children is less well known.

Objectives: The objective of this study was to review the EBUS experience of two specialist centres to better define the current role of EBUS in paediatric practice.

Methods: A retrospective record review of EBUS procedures undertaken in patients aged 0-17 years at the Royal Children's Hospital (Melbourne, Australia) and Thoraxklinik (Heidelberg, Germany) was performed. Data extracted included patient demographics, clinical presentation, bronchoscope (size and model), EBUS technique used, pathologic results, need for further invasive investigation, and complications.

Results: Between 2008 and 2017, ten EBUS procedures were performed (6 linear EBUS and 4 radial EBUS). No complications were reported. Linear EBUS was performed on subjects who were between 4 and 15 years old, with a 100% diagnostic yield. Radial EBUS was non-diagnostic in three cases of non-malignant disease. In one case, it was used successfully for imaging alone.

Conclusion: Both linear and radial EBUS are safe and feasible in children. Diagnostic yield of linear EBUS was 100%. Radial EBUS did not demonstrate utility, likely reflecting the pathologies of underlying parenchymal masses in paediatric populations.
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http://dx.doi.org/10.1159/000501466DOI Listing
September 2020

Long-term follow up after endoscopic valve therapy in patients with severe emphysema.

Ther Adv Respir Dis 2019 Jan-Dec;13:1753466619866101

Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research, Heidelberg, Germany.

Background And Objective: Endoscopic valve therapy is a treatment modality in patients with advanced emphysema and absent interlobar collateral ventilation (CV). So far, long-term outcome following valve implantation has been insufficiently evaluated. The aim of this study was to investigate the real-world efficacy of this interventional therapy over 3 years.

Methods: From 2006 to 2013, 256 patients with severe emphysema in whom absent CV was confirmed underwent valve therapy. The 3-year effectiveness was evaluated by pulmonary function testing (VC, FEV, RV, TLC), 6-minute-walk test (6-MWT) and dyspnea questionnaire (mMRC). Long-term outcome was also assessed according to the radiological outcome following valve placement.

Results: Of 256 patients treated with valves, 220, 200, 187, 100 and 66 patients completed the 3-month, 6-month, 1-year, 2-year and 3-year follow-up (FU) visit, respectively. All lung function parameters, 6-MWT and mMRC were significantly improved at 3- and 6-month FU. At 1-year FU, patients still experienced a significant improvement of all outcome parameters expect VC (L) and TLC (%). At 2 years, RV (L and %) and TLC (L and %) remained significantly improved compared to baseline. Three years after valve therapy, sustained significant improvement in mMRC was observed and the proportion of patients achieving a minimal clinically important difference from baseline in RV and 6-MWT was still 71% and 46%, respectively. Overall, patients with complete lobar atelectasis exhibited superior treatment outcome with 3-year responder rates to FEV, RV and 6-MWT of 10%, 79% and 53%, respectively.

Conclusions: Patients treated by valves experienced clinical improvement over 1 year following valve therapy. Afterwards, clinical benefit gradually declines more likely due to COPD progression.
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http://dx.doi.org/10.1177/1753466619866101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681249PMC
March 2020

Bleeding risk of transbronchial cryobiopsy compared to transbronchial forceps biopsy in interstitial lung disease - a prospective, randomized, multicentre cross-over trial.

Respir Res 2019 Jul 5;20(1):140. Epub 2019 Jul 5.

Department of Haematology, Oncology, Rheumatology, Immunology and Pulmology, Eberhard Karls University, Otfried-Mueller-Str. 10, 70771, Tübingen, Germany.

Background: Bronchoscopic cryobiopsy is a new method of bronchoscopic tissue sampling in interstitial lung disease. In case of transbronchial biopsies, the resultant tissue samples are of high quality, and the lung parenchyma seen in the samples is adequate for a histological diagnosis in most cases. Bleeding after transbronchial biopsy is the most important procedure- associated complication and may be life threatening. This study addresses the risk of bleeding of transbronchial cryobiopsy.

Methods: In this prospective, randomized, controlled multicentre study 359 patients with interstitial lung disease requiring diagnostic bronchoscopic tissue sampling were included. Both conventional transbronchial forceps biopsy and transbronchial cryobiopsy were undertaken in each patient. The sequence of the procedures was randomized. Bleeding severity was evaluated semi-quantitatively as "no bleeding", "mild" (suction alone), "moderate" (additional intervention) or "severe" (prolonged monitoring necessary or fatal outcome), for each intervention.

Results: In 359 patients atotal of 1160 cryobiopsies and 1302 forceps biopsies were performed. Bleeding was observed after forceps biopsy in 173 patients (48.2%) and after cryobiopsy in 261 patients (72.7%). Bleeding was significantly greater in the cryobiopsy group (cryobiopsy/forceps biopsy: no bleeding 27.3%/51.8%; mild 56.5%/44.0%; moderate 15.0%/4.2%; severe 1.2%/0%; p < 0.001). The rate of clinically relevant bleeding (moderate or severe) was higher after the cryobiopsy procedures compared to the forceps biopsies (16.2% vs. 4.2%, p < 0.05). No fatal bleeding complications occurred.

Conclusions: Compared to transbronchial forceps biopsy, transbronchial cryobiopsy was associated with an increased risk of bleeding which is of clinical relevance. Therefore training and additional precautions for bleeding control should be considered.

Trial Registration: The study was registered with clinicaltrials.gov ( NCT01894113 ).
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http://dx.doi.org/10.1186/s12931-019-1091-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612220PMC
July 2019

Interventional therapy in patients with severe emphysema: evaluation of contraindications and their incidence.

Ther Adv Respir Dis 2019 Jan-Dec;13:1753466619835494

Pneumology and Critical Care Medicine, Thoraxklinik at University of Heidelberg, Heidelberg, Germany, and Translational Lung Research Center Heidelberg (TLRCH, German Center for Lung Research), Heidelberg, Germany.

Background: Endoscopic and surgical interventions may be beneficial for selected patients with emphysema. Rates of treatment failure decrease when the predictors for successful therapy are known. The aim of the study was to evaluate the number of patients with severe emphysema who were not eligible for any intervention, and the reasons for their exclusion.

Methods: The study was a retrospective analysis of 231 consecutive patients with advanced emphysema who were considered for interventional therapy in 2016 at the Thoraxklinik, Heidelberg, Germany. The reasons for not receiving valve or coil therapy were assessed for all patients who did not receive any therapy.

Results: Of the 231 patients, 50% received an interventional therapy for lung volume reduction (LVR) (82% valve therapy, 6% coil therapy, 4.3% polymeric LVR or bronchial thermal vapour ablation, 4.3% total lung denervation, and 3.4% lung volume reduction surgery [LVRS]). A total of 115 patients did not undergo LVR. Out of these, valve or coil therapy was not performed due to one or more of the following reasons: incomplete fissure in 37% and 0%; missing target lobe in 31% and 30%; personal decision in 18% and 28%; pulmonary function test results in 8% and 15%; ventilatory failure in 4% and 4%; missing optimal standard medical care and/or continued nicotine abuse in 4% and 3%; general condition too good in less than 1% and 3%; cardiovascular comorbidities in 0% and 3%; age of patient in 0% and less than 1%. Both techniques were not performed due to one or more of the following reasons: solitary pulmonary nodule(s)/consolidation in 27%; bronchopathy in 7%; neoplasia in 2%; destroyed lung in 2%; prior LVRS in less than 1%.

Conclusions: The main reason for not placing valves was an incomplete fissure and for coils a missing target lobe. Numerous additional contraindications that may exclude a patient from interventional emphysema therapy should be respected.
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http://dx.doi.org/10.1177/1753466619835494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6421604PMC
August 2019

Transbronchial Cryobiopsies for Diagnosing Interstitial Lung Disease: Real-Life Experience from a Tertiary Referral Center for Interstitial Lung Disease.

Respiration 2019;97(4):348-354. Epub 2018 Dec 14.

Center for Interstitial and Rare Lung Diseases, Thoraxklinik, University of Heidelberg, Heidelberg, Germany,

Background: Transbronchial cryobiopsy (cTBB) may offer an alternative to surgical lung biopsy (SLB) for histopathological diagnosis of interstitial lung diseases (ILDs). However, real-life experience is limited, although case series are increasingly reported.

Objectives: We aimed to evaluate the value of cTBB performed under real-life conditions in a tertiary care center for ILDs.

Methods: Data on all patients undergoing a cTBB for evaluation of suspected ILD between October 2015 and January 2017 were included in this retrospective case series. Procedure details, complication rates, histopathological results, and diagnostic consensus reached by a multidisciplinary team (MDT) discussion were collated and evaluated.

Results: A total of 109 patients (mean age 64 years, range 19-85; 66% male, 38% never smokers) referred to our center with features suggestive of ILD underwent cTBB. The mean FVC% predicted was 77% (range 41-131), with a mean DLCO of 51% (range 20-86), and a 6-min walking test (6MWT) of 402 m (range 100-642). On average, 4 samples were taken from each patient (range 1-8), with a mean biopsy diameter of 5 mm (range 2-12). Complications included pneumothorax (11.9%), all treated with chest drain. Moderate bleeding occurred in 28.4% (all resolved without active measures). No acute disease exacerbations and no deaths occurred. A histopathological pattern diagnosis was possible in 80 cases (73.4%), and 26.6% of cases were considered nonspecific. An MDT consensus diagnosis was reached in 83.5% of cases. Subsequent SLB was proposed in 13 cases and performed in 8 cases.

Conclusions: In the real-world setting, cTBB has a meaningful diagnostic value in the context of a MDT approach and may enable histopathological assessment even in patients with more advanced disease unsuitable for SLB.
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http://dx.doi.org/10.1159/000493428DOI Listing
August 2020

Glycodelin as a Serum and Tissue Biomarker for Metastatic and Advanced NSCLC.

Cancers (Basel) 2018 Dec 4;10(12). Epub 2018 Dec 4.

Translational Research Unit, Thoraxklinik at University Hospital Heidelberg, D-69126 Heidelberg, Germany.

A major part of non-small cell lung cancer (NSCLC) patients treated with mono- or multimodal concept develop therapy resistance. Despite the abundance of biomarkers investigated in the past, there is still a need for valid NSCLC biomarkers. Glycodelin, an immunosuppressive endometrial protein, has been shown to be also expressed in NSCLC. Here, we investigated its potential as a biomarker in metastatic and advanced stage NSCLC. Glycodelin gene and protein expression were measured in 28 therapy-naïve resected tumors as well as in corresponding brain ( = 16) and adrenal gland ( = 12) metastasis by qPCR and IHC. Moreover, we correlated glycodelin gene expression of cryoconserved therapy-naïve biopsies ( = 55) of advanced stage patients with glycodelin serum concentrations and patient survival. Using follow-up samples of the patients, we monitored glycodelin serum concentrations during therapy. Glycodelin expression correlated between primary tumor and distant metastases within the same patients. The gene expression of glycodelin in therapy-naïve biopsies also correlated with the serum concentrations of the patients (r = 0.60). Patients with elevated serum concentrations showed a tendency in lower overall survival ( = 0.088) and measuring of glycodelin indicated a progression of the disease earlier compared to clinical diagnostic. Taken together, we demonstrate that glycodelin is a promising prognostic and follow-up biomarker for metastatic and advanced NSCLC.
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http://dx.doi.org/10.3390/cancers10120486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6315759PMC
December 2018

Quantitative CT detects changes in airway dimensions and air-trapping after bronchial thermoplasty for severe asthma.

Eur J Radiol 2018 Oct 9;107:33-38. Epub 2018 Aug 9.

Translational Lung Research Center Heidelberg (TLRC), German Center for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany; Department of Respiratory and Critical Care Medicine, Thoraxklinik at University of Heidelberg, Röntgenstraße 1, 69126 Heidelberg, Germany.

Objectives: Bronchial thermoplasty (BT) can be considered in the treatment of severe asthma to reduce airway smooth muscle mass and bronchoconstriction. We hypothesized that BT may thus have long-term effects on airway dimensions and air-trapping detectable by quantitative computed tomography (QCT).

Methods: Paired in- and expiratory CT and inspiratory CT were acquired in 17 patients with severe asthma before and up to two years after bronchial thermoplasty and in 11 additional conservatively treated patients with serve asthma, respectively. A fully automatic software calculated the airways metrics for wall thickness (WT), wall percentage (WP), lumen area (LA) and total diameter (TD). Furthermore, lung air-trapping was quantified by determining the quotient of mean lung attenuation in expiration vs. inspiration (E/I MLA) and relative volume change in the Hounsfield interval -950 to -856 in expiration to inspiration (RVC) in a generation- and lobe-based approach, respectively.

Results: BT reduced WT for the combined analysis of the 2nd-7th airway generation significantly by 0.06 mm (p = 0.026) and WP by 2.05% (p < 0.001), whereas LA and TD did not change significantly (p = 0.147, p = 0.706). No significant changes were found in the control group. Furthermore, E/I MLA and RVC decreased significantly after BT by 12.65% and 1.77% (p < 0.001), respectively.

Conclusion: BT significantly reduced airway narrowing and air-trapping in patients with severe asthma. This can be interpreted as direct therapeutic effects caused by a reduction in airway-smooth muscle mass and changes in innervation. A reduction in air-trapping indicates an influence on more peripheral airways not directly treated by the BT procedure.
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http://dx.doi.org/10.1016/j.ejrad.2018.08.007DOI Listing
October 2018

Survival after Endoscopic Valve Therapy in Patients with Severe Emphysema.

Respiration 2019;97(2):145-152. Epub 2018 Sep 18.

Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.

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.
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http://dx.doi.org/10.1159/000492274DOI Listing
April 2020

Clinical and quantitative computed tomography predictors of response to endobronchial lung volume reduction therapy using coils.

Int J Chron Obstruct Pulmon Dis 2018 20;13:2215-2223. Epub 2018 Jul 20.

Department of Pulmonology and Respiratory Care Medicine, Thoraxklinik at the University of Heidelberg, Heidelberg, Germany,

Objectives: Bronchoscopic lung volume reduction using coils (LVRC) is a well-known treatment option for severe emphysema. The purpose of this study was to identify quantitative computed tomography (QCT) and clinical parameters associated with positive treatment outcome.

Patients And Methods: The CT scans, pulmonary function tests (PFT), and 6-minute walk test (6-MWT) data were collected from 72 patients with advanced emphysema prior to and at 3 months after LVRC treatment. The procedure involved placing 10 coils unilaterally. Various QCT parameters were derived using Apollo imaging software (VIDA). Independent predictors of clinically relevant outcome (Δ6-MWT ≥ 26 m, ΔFEV ≥ 12%, ΔRV ≥ 10%) were identified through stepwise linear regression analysis.

Results: The response outcome for Δ6-MWT, for ΔFEV and for ΔRV was met by 55%, 32% and 42%, respectively. For Δ6-MWT ≥ 26 m a lower baseline 6-MWT ( = 0.0003) and a larger standard deviation (SD) of low attenuation cluster (LAC) sizes in peripheral regions of treated lung ( = 0.0037) were significantly associated with positive outcome. For ΔFEV ≥ 12%, lower baseline FEV ( = 0.02) and larger median LAC sizes in the central regions of treated lobe ( = 0.0018) were significant predictors of good response. For ΔRV ≥ 10% a greater baseline TLC ( = 0.0014) and a larger SD of LAC sizes in peripheral regions of treated lung ( = 0.007) tended to respond better.

Conclusion: Patients with lower FEV and 6-MWT, with higher TLC and specific QCT characteristics responded more positively to LVRC treatment, suggesting a more targeted CT-based approach to patient selection could lead to greater efficacy in treatment response.
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http://dx.doi.org/10.2147/COPD.S159355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055902PMC
January 2019

Endoscopic Valve Removal >180 Days since Implantation in Patients with Severe Emphysema.

Respiration 2018;96(4):348-354. Epub 2018 Jul 24.

Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.

Background: Valve implantation provides a reversible effective therapy in a selected group of emphysema patients. Knowing predictors for successful therapy, the rate of treatment failure has decreased. Some patients, however, do not benefit, so that the valves may have to be removed.

Objectives: To assess implant-related events, complications during valve removal, and clinical outcome after endoscopic procedure.

Methods: The data of 76 consecutive emphysema patients who underwent valve removal > 6 months since implantation were collected.

Results: Seventy-six patients (mean age 62 years, 54% male) underwent removal of all valves after a mean time of 624 days (193-3,043 days) since implantation. Granulation tissue was observed in 39.5% (30/76) and significant secretion in 34.2% (26/76). In 5.3% (4/76), valve removal was complicated requiring another bronchoscopy in 2 of them. In 5.3% (4/76) of the patients, one valve could not be removed and remained in situ. Bleeding requiring intervention occurred in 3.9% (3/76) during valve removal. Following bronchoscopy, there was a need for antibiotics in 34.2% (26/76), glucocorticosteroids in 1.3% (1/76), and both in 6.6% (5/76) due to productive cough or chronic obstructive pulmonary disease (COPD) exacerbation. Due to respiratory failure, invasive ventilation or noninvasive ventilation was necessary in 2.6% (2/76) and 6.6% (5/76), respectively, following procedure. No statistical significant change in lung function was observed following valve removal.

Conclusions: Valve removal after > 6 months since implantation is feasible and associated with an acceptable safety profile. However, close monitoring of these patients with limited pulmonary reserve is recommended with particular attention to COPD exacerbations and respiratory failure.
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http://dx.doi.org/10.1159/000489887DOI Listing
October 2019

Endoscopic approaches for treating emphysema.

Expert Rev Respir Med 2018 08 4;12(8):641-650. Epub 2018 Jul 4.

a Department of Pneumology and Critical Care Medicine , Thoraxklinik at University of Heidelberg , Heidelberg , Germany.

Introduction: Surgical treatment of severe pulmonary emphysema has so far been associated with relatively high perioperative morbidity and mortality. In the past two decades, novel approaches to lung volume reduction and alternative minimally invasive endoscopic techniques have been developed. This review presents the different techniques (blocking and nonblocking) available until present as well as the appropriate patient selection and possible complications. Areas covered: All available randomized controlled trials (RCTs) have been evaluated. The only blocking technique is the reversible valve implantation. It results in lobar volume reduction and clinical benefit in emphysema patients with absent interlobar collateral ventilation and its efficacy has been confirmed in various RCTs. Non-blocking techniques that are independent of collateral ventilation include the partially irreversible coil implantation leading to parenchymal compression, the irreversible bronchoscopic thermal vapor ablation, and the polymeric lung volume reduction both inducing inflammatory reaction. These methods have been up to date examined in a few RCTs only. Finally, the targeted lung denervation aims at sustainable bronchodilation by ablation of parasympathetic pulmonary nerves. Expert commentary: Future studies must address the predictors of clinical outcome as well as the reduction of complications to improve both outcome and safety.
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http://dx.doi.org/10.1080/17476348.2018.1491794DOI Listing
August 2018

New bacterial growth in bronchial secretions after bronchoscopic valve implantation.

Int J Chron Obstruct Pulmon Dis 2018 8;13:565-570. Epub 2018 Feb 8.

Department of Pulmonology and Respiratory Care Medicine, Thoraxklinik, at the University of Heidelberg, Heidelberg.

Background: Bronchoscopic valve implantation is an established treatment in selected patients with severe lung emphysema. There is evidence in literature of increased bacterial colonization of various implants. So far, it is unclear if an increased bacterial colonization can also be observed after endoscopic valve therapy.

Methods: Retrospective analysis of patients with examination of the bronchial secretions for presence or change of bacterial growth before and after valve implantation.

Results: Overall, 144 patients who underwent bronchoscopic follow-up after valve implantation were included in this analysis. Prior to valve placement, only 7 out of 144 consecutive emphysema patients (5%) presented with evidence of bacterial colonization, whereas 137 patients (95%) showed no bacterial growth prior to valve placement. One hundred seven out of the 137 patients (78%) showed new bacterial growth after valve implantation. Almost 38% of the patients who presented with a new bacterial growth had evidence of , and species simultaneously, as bacterial colonization. Pathogenic bacterial growth was recorded for (18%), (13%) and (9%) microorganisms. There was also a significant bacterial growth by (26%) and anaerobic bacteria (23%), especially in patients with complete atelectasis after successful endoscopic lung volume reduction. For all of the 7 patients, the presented initial bacterial colonization showed a change in the flora after bronchoscopy valve implantation.

Conclusion: In this study we observed an increased bacterial colonization in the long term after valve implantation. This finding needs further evaluation regarding its possible clinical relevance but should be taken into consideration in the follow-up of these patients.
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http://dx.doi.org/10.2147/COPD.S148196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5810521PMC
September 2018

Transbronchial Cryobiopsies for the Diagnosis of Diffuse Parenchymal Lung Diseases: Expert Statement from the Cryobiopsy Working Group on Safety and Utility and a Call for Standardization of the Procedure.

Respiration 2018;95(3):188-200. Epub 2018 Jan 9.

Department of Diseases of the Thorax, Ospedale GB Morgagni, Forlì, Italy.

Transbronchial cryobiopsies (TBCB) have recently been introduced as a promising and safer alternative to surgical lung biopsy in the diagnostic approach to diffuse parenchymal lung diseases (DPLD). Despite a substantial and expanding body of literature, the technique has not yet been standardized and its place in the diagnostic algorithm of DPLD remains to be defined. In part, this reflects concerns over the diagnostic yield and safety of the procedure, together with the rapid spread of the technique without competency and safety standards; furthermore, there is a substantial procedural variability among centers and interventional pulmonologists. We report this expert statement proposed during the third international conference on "Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Disease" (Ravenna, October 27-28, 2016), which formulates evidence- and expert-based suggestions on the indications, contraindications, patient selection, and procedural aspects of the procedure. The following 5 domains were reviewed: (1) what is the role of TBCB in the diagnostic evaluation of DPLD: patient selection; (2) pathological considerations; (3) contraindications and safety considerations; (4) how should TBCB be performed and in what procedural environment; and (5) who should perform TBCB. Finally, the existence of white paper recommendations may also reassure local hospital credentialing committees tasked with endorsing an adoption of the technique.
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http://dx.doi.org/10.1159/000484055DOI Listing
October 2018

Endobronchial valve placement in emphysema: When is it lung volume reduction?

Authors:
Ralf Eberhardt

Respirology 2018 03 5;23(3):242-243. Epub 2017 Nov 5.

Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.

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http://dx.doi.org/10.1111/resp.13217DOI Listing
March 2018

Influence of fissure integrity on quantitative CT and emphysema distribution in emphysema-type COPD using a dedicated COPD software.

Eur J Radiol 2017 Oct 19;95:293-299. Epub 2017 Aug 19.

Department of Diagnostic and Interventional Radiology, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany; Translational Lung Research Center Heidelberg (TLRC), Member of the German Center for Lung Research (DZL), Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Diagnostic and Interventional Radiology with Nuclear Medicine, Thoraxklinik at University of Heidelberg, Amalienstr. 5, 69126 Heidelberg, Germany.

Objectives: Fissure integrity (FI) plays a key role in selecting patients for interventional emphysema therapy. We investigated its interference with automated lobar segmentation in quantitative computed tomography (CT) and emphysema distribution.

Methods: CT was available for 50 patients with chronic obstructive pulmonary disease (COPD). Lobe segmentation was performed fully automated by software and corrected manually. FI was evaluated visually using a %-scale. The influence of FI on emphysema ratio (ER=percentage of lung volume with density values<-950 HU), mean lung density (MLD), emphysema and total volume of adjacent lobes was analyzed. Lobe-based results were compared with respect to FI.

Results: Differences in ER in adjacent lobes for complete vs. incomplete fissures were 12.4% for the right horizontal, 0.2% and 3% for the right oblique and 4.4% for the left oblique fissure (all p>0.05). Results for emphysema comparing automated vs. manually corrected segmentation exceeded clinically acceptable values, but were not significantly affected by FI (p>0.05). The widest limits of agreement for ER and MLD were noted in the right middle lobe ([-14, 17.4%], [-22.4, 32.4 Hounsfield Units]).

Conclusions: Automated lobe segmentation and emphysema distribution are not significantly affected by FI. Manual correction of automated lobar segmentation is still recommended in severe emphysema.
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http://dx.doi.org/10.1016/j.ejrad.2017.08.015DOI Listing
October 2017

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

Am J Respir Crit Care Med 2017 12;196(12):1535-1543

17 Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, FHU OncoAge, Service de Pneumologie, Nice, France.

Rationale: 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.

Objectives: To evaluate the efficacy and safety of Zephyr EBVs in patients with heterogeneous emphysema and absence of collateral ventilation.

Methods: 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 FEV improvement from baseline of 12% or greater. Changes in FEV, 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.

Measurements And Main Results: 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 FEV 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 FEV 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.

Conclusions: 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).
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http://dx.doi.org/10.1164/rccm.201707-1327OCDOI Listing
December 2017

Current Practice of Airway Stenting in the Adult Population in Europe: A Survey of the European Association of Bronchology and Interventional Pulmonology (EABIP).

Respiration 2018;95(1):44-54. Epub 2017 Sep 8.

Department of Thoracic Oncology, Pleural Diseases and Interventional Pulmonology, North Hospital of Marseille, Aix-Marseille University, Marseille, France.

Background: Airway stenting (AS) commenced in Europe circa 1987 with the first placement of a dedicated silicone airway stent. Subsequently, over the last 3 decades, AS was spread throughout Europe, using different insertion techniques and different types of stents.

Objectives: This study is an international survey conducted by the European Association of Bronchology and Interventional Pulmonology (EABIP) focusing on AS practice within 26 European countries.

Methods: A questionnaire was sent to all EABIP National Delegates in February 2015. National delegates were responsible for obtaining precise and objective data regarding the current AS practice in their country. The deadline for data collection was February 2016.

Results: France, Germany, and the UK are the 3 leading countries in terms of number of centres performing AS. These 3 nations represent the highest ranked nations within Europe in terms of gross national income. Overall, pulmonologists perform AS exclusively in 5 countries and predominately in 12. AS is performed almost exclusively in public hospitals. AS performed under general anaesthesia is the rule for the majority of institutions, and local anaesthesia is an alternative in 9 countries. Rigid bronchoscopy techniques are predominant in 20 countries. Amongst commercially available stents, both Dumon and Ultraflex are by far the most commonly deployed. Finally, 11 countries reported that AS is an economically viable activity, while 10 claimed that it is not.

Conclusion: This EABIP survey demonstrates that there is significant heterogeneity in AS practice within Europe. Therapeutic bronchoscopy training and economic issues/reimbursement for procedures are likely to be the primary reasons explaining these findings.
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http://dx.doi.org/10.1159/000480152DOI Listing
October 2018

Flexible 19-Gauge Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Needle: First Experience.

Respiration 2017 17;94(1):52-57. Epub 2017 May 17.

Division of Thoracic Surgery, Toronto General Hospital, University Health Network, Toronto, ON, Canada.

Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a well-established first-line invasive modality for mediastinal lymph node staging in lung cancer patients and in the diagnostic workup of patients with mediastinal adenopathy. With the current 21- and 22-gauge (G) EBUS-TBNA needles, the procedure can be limited by the degree of flexibility in the needle and the size of the lumen in tissue acquisition.

Objective: We report our initial experience with a first-generation flexible 19-G EBUS-TBNA (Flex 19G; Olympus Respiratory America, Redmond, WA, USA) needle with regards to efficacy and safety.

Methods: The Flex 19G EBUS-TBNA needle was used in 47 selected patients with enlarged hilar and/or mediastinal lymphadenopathy at 3 centers. The standard Olympus EBUS scope with a 2.2-mm working channel was used in all cases.

Results: The diagnostic yield of the Flex 19G needle according to clinical cytopathology reports was 89% (42/47). The diagnosis and their respective diagnostic yield with the Flex 19G EBUS-TBNA needle were malignancy 24/27 (89%), sarcoidosis 13/14 (93%), and reactive lymph node hyperplasia 5/6 (83%). The mean short axis of the sampled lymph nodes was 19 ± 9 mm. No complications occurred except for 1 instance of moderate bleeding, which did not require intervention beyond suctioning and subsequently resolved. All 13 patients diagnosed with adenocarcinoma by the 19-G needle had sufficient tissue for genetic testing.

Conclusion: EBUS-TBNA using the first-generation Flex 19G needle is feasible and safe with promising diagnostic yield while providing a greater degree of flexion with the Olympus EBUS scope. Additional clinical evaluations are warranted.
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http://dx.doi.org/10.1159/000475504DOI Listing
May 2018
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