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3. Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2

Author

Valipour A, Shah PL, Herth FJ, Pison C, Schumann C, Hübner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Conway F, Duller M, Mayse M, Norman HS, and Slebos DJ

Subjects
copd exacerbation, targeted lung denervation, bronchoscopy, copd, Diseases of the respiratory system, RC705-779
Abstract

Arschang Valipour,1 Pallav L Shah,2 Felix J Herth,3 Christophe Pison,4 Christian Schumann,5 Ralf-Harto Hübner,6 Peter I Bonta,7 Romain Kessler,8 Wolfgang Gesierich,9 Kaid Darwiche,10 Bernd Lamprecht,11 Thierry Perez,12 Dirk Skowasch,13 Gaetan Deslee,14 Armelle Marceau,15 Frank C Sciurba,16 Reinoud Gosens,17 Jorine E Hartman,18 Francesca Conway,2 Marina Duller,1 Martin Mayse,19 Holly S Norman,19 Dirk-Jan Slebos18 On behalf of the AIRFLOW-2 Trial Study Group1Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria; 2Royal Brompton & Harefield NHS Trust, Chelsea & Westminster Hospital and Imperial College, London, UK; 3Thoraxklinik, Department of Pneumology and Critical Care Medicine and Translational Lung Research Center Heidelberg (TLRCH), University of Heidelberg, Heidelberg, Germany; 4CHU Grenoble Alpes, Service Hospitalier Universitaire Pneumologie Physiologie; Université Grenoble Alpes, Grenoble, France; 5Clinic of Pneumology, Thoracic Oncology, Sleep- and Respiratory Critical Care, Klinikverbund Allgaeu, Kempten and Immenstadt, Germany; 6Charité Universitätsmedizin Berlin, Medizinische Klinik m. Schw. Infektiologie und Pneumologie, Campus Virchow, Berlin, Germany; 7Department of Respiratory Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; 8Service de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France; 9Asklepios-Fachkliniken Munich-Gauting, Comprehensive Pneumology Center Munich, Gauting, Germany; 10Department of Pulmonary Medicine, Section of Interventional Pneumology, Ruhrlandklinik - University Hospital Essen, University of Duisburg-Essen, Essen, Germany; 11Department of Pulmonary Medicine, Kepler Universitatsklinikum GmbH, Linz, Austria; 12CHU de Lille – Hôpital Calmette, Lille, France; 13Department of Internal Medicine II - Cardiology/Pneumology, University of Bonn, Bonn, Germany; 14CHU de Reims, Hôpital Maison Blanche, Service de Pneumologie, Reims, France; 15Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France; 16University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 17Department of Molecular Pharmacology, University of Groningen, Groningen, the Netherlands; 18Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 19Nuvaira, Inc., Minneapolis, MN, USACorrespondence: Dirk-Jan SlebosDepartment of Pulmonary Diseases/Interventional Bronchoscopy AA11, University Medical Center Groningen, PO Box 30001, Groningen, the NetherlandsTel +31 503612357Fax +31503619320Email d.j.slebos@umcg.nlPurpose: COPD exacerbations are associated with worsening clinical outcomes and increased healthcare costs, despite use of optimal medical therapy. A novel bronchoscopic therapy, targeted lung denervation (TLD), which disrupts parasympathetic pulmonary innervation of the lung, has been developed to reduce clinical consequences of cholinergic hyperactivity and its impact on COPD exacerbations. The AIRFLOW-2 study assessed the durability of safety and efficacy of TLD additive to optimal drug therapy compared to sham bronchoscopy and optimal drug therapy alone in subjects with moderate-to-severe, symptomatic COPD two years post randomization.Patients and Methods: TLD was performed in COPD patients (FEV1 30– 60% predicted, CAT≥ 10 or mMRC≥ 2) in a 1:1 randomized, sham-controlled, double-blinded multicenter study (AIRFLOW-2) using a novel lung denervation system (Nuvaira, Inc., USA). Subjects remained blinded until their 12.5-month follow-up visit when control subjects were offered the opportunity to undergo TLD. A time-to-first-event analysis on moderate and severe and severe exacerbations of COPD was performed.Results: Eighty-two subjects (FEV1 41.6± 7.4% predicted, 50.0% male, age 63.7± 6.8 yrs, 24% with prior year respiratory hospitalization) were randomized. Time-to-first severe COPD exacerbation was significantly lengthened in the TLD arm (p=0.04, HR=0.38) at 2 years post-TLD therapy and trended towards similar attenuation for moderate and severe COPD exacerbations (p=0.18, HR=0.71). No significant changes in lung function or SGRQ-C were found 2 years post randomization between groups.Conclusion: In a randomized trial, TLD demonstrated a durable effect of significantly lower risk of severe AECOPD over 2 years. Further, lung function and quality of life remained stable following TLD.Clinical Trial Registration: NCT02058459.Keywords: COPD exacerbation, targeted lung denervation, bronchoscopy, COPD

Published
2020

4. Lungenvolumenreduktion mit Einweg-Ventilen bei fortgeschrittenem Lungenemphysem bei Alpha-1-Antitrypsin-Mangel: Ergebnisse aus dem Lungenemphysemregister e.V.

Author

Thomas, S, additional, Stanzel, F, additional, Grah, C, additional, Holland, A, additional, Gebhardt, A, additional, Ficker, J, additional, Schmidt, B, additional, Andreas, S, additional, Eggeling, S, additional, Franke, K, additional, Eisenmann, S, additional, Gesierich, W, additional, and Hübner, R, additional

Published
2023
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7. COVID-19-disease prevalence and its characteristics among health care workers of specialized respiratory clinics in Germany one year after the start of vaccination campaign

Author

Presotto, M A, primary, Piel, S, additional, Jörres, R A, additional, Karrasch, S, additional, Gesierich, W, additional, Bullwinkel, J, additional, Rabe, K F, additional, Hayden, M, additional, Kaestner, F, additional, Harzheim, D, additional, Joves, B, additional, Kempa, A T, additional, Ghiani, A, additional, Neurohr, C, additional, Kreuter, M, additional, Herth, F J F, additional, and Trudzinski, F C, additional

Published
2022
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8. Risk factors for pandemic-related workplace absenteeism among health care workers and the impact of vaccination

Author

Piel, S, primary, Presotto, M A, additional, Jörres, R A, additional, Karrasch, S, additional, Gesierich, W, additional, Bullwinkel, J, additional, Rabe, K F, additional, Hayden, M, additional, Kaestner, F, additional, Harzheim, D, additional, Joves, B, additional, Kempa, A T, additional, Ghiani, A, additional, Neurohr, C, additional, Kreuter, M, additional, Herth, F J, additional, and Trudzinski, F C, additional

Published
2022
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9. 90P Infrared molecular fingerprinting: A new in vitro diagnostic platform technology for cancer detection in blood-based liquid biopsies

Author

Zigman, M., primary, Huber, M., additional, Kepesidis, K., additional, Voronina, L., additional, Fleischmann, F., additional, Fill, E., additional, Hermann, J., additional, Koch, I., additional, Kolben, T., additional, Schulz, G.B., additional, Jokisch, F., additional, Reinmuth, N., additional, Gesierich, W., additional, Behr, J., additional, Harbeck, N., additional, Reiser, M., additional, Stief, C.G., additional, and Krausz, F., additional

Published
2022
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11. Predicting the effectiveness of high-flow oxygen therapy in COVID-19 patients: a single-centre observational study

Author

Schmidt, F., Nowak, L., Obereisenbuchler, F., Hetrodt, J., Heiß-Neumann, M., Schönlebe, A., Heinig-Menhard, K., Gesierich, W., Behr, J., Hatz, R.A., Dinkel, J., and Stoleriu, M.-G.

Subjects
Oxygen, Anesthesiology and Pain Medicine, Oxygen Inhalation Therapy, COVID-19, Humans, High-flow Therapy, Intensive Care, Sars-cov-2, Covid-19, General Medicine, Prospective Studies, Critical Care and Intensive Care Medicine, Retrospective Studies
Abstract

BACKGROUND: High-flow nasal cannula (HFNC) therapy is a helpful tool in the treatment of hypoxaemic respiratory failure. However, the clinical parameters predicting the effectiveness of HFNC in coronavirus-19 disease (COVID-19) patients remain unclear. METHODS: Sixteen COVID-19 patients undergoing HFNC in the Asklepios Lung Clinic Munich-Gauting, Germany between 16 March and 3 June 2020 were retrospectively included into the study. Seven patients successfully recovered after HFNC (Group 1), while 9 patients required intubation upon HFNC failure (Group 2). Relevant predictors for an effective HFNC therapy were analysed on day 0 and 4 after HFNC initiation via receiver operating characteristics. RESULTS: The groups did not differ significantly in terms of age, sex, body mass index, and comorbidities. Five patients died in Group 2 upon disease progression and HFNC failure. Group 1 required a lower oxygen supplementation (FiO2 0.46 [0.31-0.54] vs. 0.72 [0.54-0.76], P = 0.022) and displayed a higher PaO2/FiO2 ratio (115 [111-201] vs. 93.3 [67.2-145], P = 0.042) on day 0. In Group 2, fever persisted on day 4 (38.5 [38.0-39.4]°C vs. 36.5 [31.1-37.1]°C, P = 0.010). Serum C-reactive protein (CRP) levels > 108 mg L-1 (day 0) and persistent oxygen saturation < 89% and PaO2/FiO2 ratio < 91 (day 4) were identified as significant predictors for HFNC failure (area under curve 0.929, 0.933, and 0.893). CONCLUSIONS: Elevated oxygen saturation, decreased FiO2 and reduced serum CRP on day 4 significantly predict HFNC effectiveness in COVID-19 patients. Based on these parameters, larger prospective studies are necessary to further investigate the effectiveness of HFNC in the treatment of COVID-19-associated hypoxaemic respiratory failure.

Published
2022

16. Vergleich von transbronchialer Zangen- und Kryobiopsie bei Patienten mit histologischem Nachweis Sarkoidose-typischer Granulome

Author

Häntschel, M, additional, Eberhardt, R, additional, Petermann, C, additional, Gesierich, W, additional, Darwiche, K, additional, Hagmeyer, L, additional, Colby, T V, additional, Fend, F, additional, Theegarten, D, additional, Wintzer, H O, additional, Kreuter, M, additional, Spengler, W, additional, Behrens-Zemek, A F, additional, Lewis, R A, additional, Evrard, H, additional, Ehab, A, additional, Böckeler, M, additional, and Hetzel, J, additional

Published
2022
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18. Diagnostic Yield of Transbronchial Lung Cryobiopsy Compared to Transbronchial Forceps Biopsy in Patients with Sarcoidosis in a Prospective, Randomized, Multicentre Cross-Over Trial

Author

Häntschel, M., Eberhardt, R., Petermann, C., Gesierich, W., Darwiche, K., Hagmeyer, L., Colby, T.V., Fend, F., Theegarten, D., Wintzer, H., Kreuter, M., Spengler, W., Behrens-Zemek, A.F., Lewis, Richard A., Evrard, H.C., Ehab, A., Böckeler, M., and Hetzel, J.

Subjects
transbronchial biopsy, bronchoscopy, Medizin, cryobiopsy, Medicine, sarcoidosis, Article
Abstract

Background: Transbronchial lung forceps biopsy (TBLF) is of limited value for the diagnosis of interstitial lung disease (ILD). However, in cases with predominantly peribronchial pathology, such as sarcoidosis, TBLF is considered to be diagnostic in most cases. The present study examines whether transbronchial lung cryobiopsy (TBLC) is superior to TBLF in terms of diagnostic yield in cases of sarcoidosis. Methods: In this post hoc analysis of a prospective, randomized, controlled, multicentre study, 359 patients with ILD requiring diagnostic bronchoscopic tissue sampling were included. TBLF and TBLC were both used for each patient in a randomized order. Histological assessment was undertaken on each biopsy and determined whether sarcoid was a consideration. Results: A histological diagnosis of sarcoidosis was established in 17 of 272 cases for which histopathology was available. In 6 out of 17 patients, compatible findings were seen with both TBLC and TBLF. In 10 patients, where the diagnosis of sarcoidosis was confirmed by TBLC, TBLF did not provide a diagnosis. In one patient, TBLF but not TBLC confirmed the diagnosis of sarcoidosis. Conclusions: In this post hoc analysis, the histological diagnosis of sarcoidosis was made significantly more often by TBLC than by TBLF. As in other idiopathic interstitial pneumonias (IIPs), the use of TBLC should be considered when sarcoidosis is suspected. CA extern

Published
2021

21. Bronchoscopic Probe-Based Confocal Laser Endomicroscopy to Diagnose Diffuse Parenchymal Lung Diseases

Author

Silbernagel, E., Stacher-Priehse, E., Dinkel, J., Stepp, H., Gesierich, W., Lindner, M., Behr, J., and Reichenberger, F.

Subjects
Bronchoscopy, Diffuse Parenchymal Lung Disease, Imaging, Interstitial Lung Disease, Probe-based Confocal Laser Endomicroscopy, Original Article
Abstract

BACKGROUND: Diagnosis of diffuse parenchymal lung disease (DPLD) is based on clinical evaluation, radiological imaging and histology. However, additional techniques are warranted to improve diagnosis. AIMS AND OBJECTIVE: Probe based confocal laser endomicroscopy (pCLE) allows real time in vivo visualisation of the alveolar compartment during bronchoscopy based on autofluorescence of elastic fibres. We used pCLE (Cellvizio®, Mauna Kea Technology. Inc, Paris, France) to characterise alveolar patterns in patients with different types of DPLD. METHODS: In this pilot study we included 42 therapy naive patients (13 female, age 72.6 +/- 2.3 years), who underwent bronchoscopy for workup of DPLD. pCLE images were obtained during rigid bronchoscopy in affected lung segments according to HR-CT scan, followed by cryobiopsies in the identical area. Diagnoses were made by a multidisciplinary panel. The description of pCLE patterns was based on the degree of distortion of the hexagonal alveolar pattern, the density of alveolar structures, the presence of consolidations or loaded alveolar macrophages (AM). The assessment was performed by 2 investigators blinded for the final diagnosis. RESULTS: The normal lung showed a typical alveolar loop pattern. In amiodarone lung disease loaded AM were predominant. COP showed characteristic focal consolidations. IPF was characterized by significant distortion and destruction, NSIP showed significant increase in density, and chronic HP presented with consolidations, mild distortion and density. CONCLUSION: pCLE shows potential as an adjunctive bronchoscopic imaging technique in the differential diagnosis of DPLD. Structured and quantitative analysis of the images is required.

Published
2021

26. Empfehlungen zur Durchführung einer Bronchoskopie in Zeiten der COVID-19-Pandemie: Update 12/2020

Author

Darwiche, K., additional, Ross, B., additional, Gesierich, W., additional, Petermann, C., additional, Huebner, R.-H., additional, Grah, C., additional, Gompelmann, D., additional, Hetzel, J., additional, Holland, A., additional, Eisenmann, S., additional, Stanzel, F., additional, Kempa, A., additional, Conrad, K., additional, Hagmeyer, L., additional, and Eberhardt, R., additional

Published
2020
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28. A Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: Airflow-2 Two Year Outcomes

Author

Valipour, A., primary, Shah, P.L., additional, Herth, F.J., additional, Pison, C., additional, Schumann, C., additional, Hubner, R.-H., additional, Bonta, P.I., additional, Kessler, R., additional, Gesierich, W., additional, Darwiche, K., additional, Lamprecht, B., additional, Perez, T., additional, Skowasch, D., additional, Deslee, G., additional, Marceau, A., additional, Sciurba, F.C., additional, Gosens, R., additional, Hartman, J.E., additional, Sirkanthan, K., additional, Duller, M., additional, and Slebos, D.-J., additional

Published
2020
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35. 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

Author

Gesierich, W., Darwiche, K., Döllinger, F., Eberhardt, R., Eisenmann, S., Grah, C., Heußel, C.-P., Hübner, R.-H., Ley-Zaporozhan, J., Stanzel, F., Welter, S., and Hoffmann, H.

Published
2020
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50. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial

Author

Deslee, G., Klooster, K., Hetzel, M., Stanzel, F., Kessler, R., Marquette, C.-H., Witt, C., Blaas, S., Gesierich, W., Herth, F.J., Hetzel, J., Rikxoort, E.M. van, Slebos, D.-J., Deslee, G., Klooster, K., Hetzel, M., Stanzel, F., Kessler, R., Marquette, C.-H., Witt, C., Blaas, S., Gesierich, W., Herth, F.J., Hetzel, J., Rikxoort, E.M. van, and Slebos, D.-J.

Abstract

Item does not contain fulltext, The lung volume reduction ({LVR}) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of {LVR} coil treatment in a prospective multicentre cohort trial in patients with severe emphysema.Patients were treated in 11 centres. Safety was evaluated by recording all adverse events, efficacy by the St George's Respiratory Questionnaire ({SGRQ}) as primary endpoint, and pulmonary function testing, modified Medical Research Council dyspnoea score ({mMRC}) and 6-min walk distance ({6MWD}) up to 12 months after the final treatment.Sixty patients (60.9 ± 7.5 years, forced expiratory volume in 1 s ({FEV1}) 30.2 ± 6.3\% pred) were bronchoscopically treated with coils (55 bilateral, 5 unilateral), with a median of 10 (range 5-15) coils per lobe. Within 30 days post-treatment, seven chronic obstructive pulmonary disease exacerbations (6.1\%), six pneumonias (5.2\%), four pneumothoraces (3.5\%) and one haemoptysis (0.9\%) occurred as serious adverse events. At 6 and 12 months, respectively, {ΔSGRQ} was -12.1±12.9 and -11.1±13.3 points, {Δ6MWD} was +29.7±74.1 m and +51.4±76 m, {ΔFEV1} was +0.11±0.20 {L} and +0.11±0.30 {L}, and {ΔRV} (residual volume) was -0.65±0.90 {L} and -0.71±0.81 {L} (all p<0.01). Post hoc analyses showed significant responses for {SGRQ}, {6MWD} and {RV} in patients with both heterogeneous and homogeneous emphysema.{LVR} coil treatment results in significant clinical improvements in patients with severe emphysema, with a good safety profile and sustained results for up to 1 year.{NCT01328899.}

Published
2014

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