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1. Computed tomographic airway morphology after targeted lung denervation treatment in COPD

Author

Jorine E. Hartman, Felix J.F. Herth, Pallav Shah, Christophe Pison, Arschang Valipour, Dirk-Jan Slebos, Christine Abele, Irene Firlinger, Kiran Kothakuzhakal, Marina Duller, Bernd Lamprecht, Roland Kropfmueller, Kornelia Holzmann, Sandra Rathmeier, Ralf Hubner, Leonore Erdmann, Bettina Temmesfeld-Wollbrück, Christoph Ruwwe Glösenkamp, Wolfgang Gesierich, Frank Reichenberger, Christa Niehaus, Felix Herth, Ralf Eberhardt, Daniela Gompelmann, Brigitte Rump, Kaid Darwiche, Stephan Eisenmann, Ulrike Kaiser, Birte Schwarz, Ulrike Sampel, Christian Schumann, Robert Kaiser, Kathryn Schumann-Stoiber, Dirk Skowasch, Sabine Ring, Amandine Briault, Francois Arbib, Marie Jondot, Thierry Perez, Clement Fournier, Regis Matran, Michele Catto, Nathalie Bautin, Virginie De Broucker, Marie Willemin, Anne Prevotat, Ludivine Wemeau, Alice Gicquello, Morgane Foulon, Hasna Camara, Gaetan Deslee, Herve Vallerand, Sandra Dury, Delphine Gras, Margaux Bonnaire-Verdier, Romain Kessler, Sandrine Hirschi, Michele Porzio, Tristan Degot, Mathieu Canuet, Armelle Schuller, Julien Stauder, Sahra Ali Azouaou, Armelle Marceau, Hervé Mal, Yolande Costa, Pallav L. Shah, Justin Garner, Karthi Srikanthan, Cielito Caneja, John Thornton, Nick Ten Hacken, Jorine Hartman, Karin Klooster, Sonja Augustijn, Peter Bonta, Jouke Annema, Marianne van de Pol, Annika Goorsenberg, VU University medical center, Groningen Research Institute for Asthma and COPD (GRIAC), Pulmonology, ACS - Pulmonary hypertension & thrombosis, AII - Infectious diseases, AII - Inflammatory diseases, AII - Cancer immunology, CCA - Cancer biology and immunology, and CCA - Imaging and biomarkers

Subjects
Pulmonary and Respiratory Medicine
Abstract

This post-hoc analysis of the AIRFLOW-2 trial investigated the changes in airway CT-parameters after targeted lung denervation (TLD) and whether these changes are associated with treatment response. In the treatment group (n = 32), an improvement in air trapping was significantly associated with an improvement in residual volume (RV). Furthermore, improvements in Pi10 and airway lumen were significantly associated with an improvement in both RV and FEV1. Our results could suggest that when improving airway characteristics like decreasing airway wall thickness and increasing the airway lumen, this leads to less air trapping and an improvement in clinical outcomes.

Published
2023
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2. Safety of Denervation Following Targeted Lung Denervation Therapy for COPD: AIRFLOW-1 Three-year Outcomes

Author

Christophe Pison, Pallav Shah, Dirk-Jan Slebos, Vincent Ninane, Wim Janssens, Thierry Perez, Romain Kessler, Justin Garner, Jorine Hartman, Gaetan Deslee, Degano Bruno, Anna Mayr, Martin Mayse, Alexander Peterson, and Arschang Valipour

Subjects
respiratory tract diseases
Abstract

Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over three years of follow up.Methods: TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at one, two, and three years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results: Three-year follow-up data were available for 73.9% of patients (n=34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over three years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion: TLD in COPD patients demonstrated a positive safety profile out to three years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over three years of follow up.

Published
2020
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3. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial

Author

Mark T. Dransfield, Justin L. Garner, Surya P. Bhatt, Dirk-Jan Slebos, Karin Klooster, Frank C. Sciurba, Pallav L. Shah, Nathaniel T. Marchetti, Richard D. Sue, Shawn Wright, Hiram Rivas-Perez, Tanya A. Wiese, Momen M. Wahidi, Hugo Goulart de Oliveira, Brian Armstrong, Sri Radhakrishnan, Narinder S. Shargill, Gerard J. Criner, Lewis Katz, Francis Cordova, Parag Desai, Nathaniel Marchetti, Victor Kim, Kartik Shenoy, John Travaline, Jiji Thomas, Lii-Yoong H. Criner, Richard Sue, Aaron Thornburg, Terry Thomas, Mark Dransfield, Surya Bhatt, James Michael Wells, Necole Seabron-Harris, Umair Gauhar, Crissie Despirito, Frank Sciurba, Jessica Bon Field, Divay Chandra, Joseph Leader, Roy Semaan, Christina Ledezma, Pallav Shah, Samuel Kemp, Justin Garner, Arafa Aboelhassan, Karthi Srikanthan, Eric Tenda, Anita Abraham, Cai Sim, Momen Wahidi, Kamran Mahmood, Scott Shofer, Kathleen Coles, Guilherme Augusto Oliveira, Betina Machado, Igor Benedetto, Fabio Svartman, Amarilio de Macedo Neto, Leonardo Schreiner, Taiane Vieira, Brian Morrissey, Ken Yoneda, Tina Tham, Daniel Tompkins, Paulo F. Guerreiro Cardoso, Rodrigo Athanazio, Felipe Nominando, Samia Rached, Luciana Cassimiro, Steven Hays, Eric Seeley, Pavan Shrestha, Gabriela R. Dincheva, Adnan Majid, Daniel Alape-Moya, Mihir Parikh, Alichia Paton, Alexis Agnew, Nicholas Pastis, Charlie Strange, Tatsiana Beiko, Danielle Woodford, Mary Blanton, Lisa Kopas, Timothy Connolly, Jose Fernando Santacruz, Bhavin Shah, Mark Vollenweider, Luis Herrera, Rumi Khan, Kristine Sernulka, P. Michael McFadden, Richard Barbers, Michelle Hernandez, Michael Machuzak, Francisco Almeida, Joseph Cicenia, Thomas Gildea, Atul Mehta, Sonali Sethi, Yvonne Meli, David Hsia, Richard Casaburi, William Stringer, Leticia Diaz, Arthur Sung, Meghan Ramsey, Ryan Van Wert, Karen Morris, Nabil Jarad, Tim Batchelor, Iara Sequeiros, Katy Tucker, Malgorzata Kornaszweska, Hazem Fallouh, Ramsey Sabit, Hatam Naase, Joseph George, Azin Salimian, Helen Dyer, Stephen Hazelrigg, Kristal Adams, Karen Bade, Ganesh Krishna, Bryan S. Benn, Michelle Canfield, Sharmila Vetri Villalan, Travis Stewart, Dirk-Ja n Slebos, Nick H. T. ten Hacken, Jorine Hartman, Sonja Augustijn, and Groningen Research Institute for Asthma and COPD (GRIAC)

Subjects
Male, Exacerbation, medicine.medical_treatment, EMPHYSEMA, Bronchoscopic lung volume reduction, law.invention, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Forced Expiratory Volume, Surveys and Questionnaires, interventional bronchoscopy, Medicine, PREDICTS MORTALITY, 030212 general & internal medicine, LUNG-VOLUME-REDUCTION, Pneumonectomy, Zephyr Valve, Lung function, Original Research, Rehabilitation, Exercise Tolerance, Patient-centered outcomes, Prostheses and Implants, respiratory system, Middle Aged, Treatment Outcome, Pulmonary Emphysema, patient-reported outcomes, Anesthesia, Female, Pulmonary and Respiratory Medicine, REHABILITATION, Adult, Bronchi, Severe copd, OBSTRUCTIVE PULMONARY-DISEASE, CAPACITY, chronic obstructive pulmonary disease, 03 medical and health sciences, severe emphysema, SEVERE COPD, Bronchoscopy, PATIENT-CENTERED OUTCOMES, Humans, Aged, business.industry, respiratory tract diseases, PHYSICAL-ACTIVITY, 030228 respiratory system, EXACERBATION, Quality of Life, business, Adult Pulmonary
Abstract

Rationale: Bronchoscopic lung volume reduction with Zephyr Valves improves lung function, exercise tolerance, and quality of life of patients with hyperinflated emphysema and little to no collateral ventilation. Objectives: Post hoc analysis of patient-reported outcomes (PROs), including multidimensional measures of dyspnea, activity, and quality of life, in the LIBERATE (Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema) study are reported. Methods: A total of 190 patients with severe heterogeneous emphysema and little to no collateral ventilation in the target lobe were randomized 2:1 to the Zephyr Valve or standard of care. Changes in PROs at 12 months in the two groups were compared: dyspnea with the Transitional Dyspnea Index (TDI), focal score; the Chronic Obstructive Pulmonary Disease Assessment Test (CAT; breathlessness on hill/stairs); Borg; the EXAcerbations of Chronic pulmonary disease Tool–PRO, dyspnea domain; activity with the TDI, magnitude of task/effort/functional impairment, CAT (limited activities), and the St. George’s Respiratory Questionnaire (SGRQ), activity domain; and psychosocial status with the SGRQ, impacts domain, and CAT (confidence and energy). Results: At 12 months, patients using the Zephyr Valve achieved statistically significant and clinically meaningful improvements in the SGRQ; CAT; and the TDI, focal score, compared with standard of care. Improvements in the SGRQ were driven by the impacts and activity domains (P

Published
2020

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

Author

Gerard J. Criner, Richard Sue, Shawn Wright, Mark Dransfield, Hiram Rivas-Perez, Tanya Wiese, Frank C. Sciurba, Pallav L. Shah, Momen M. Wahidi, Hugo Goulart de Oliveira, Brian Morrissey, Paulo F. G. Cardoso, Steven Hays, Adnan Majid, Nicholas Pastis, Lisa Kopas, Mark Vollenweider, P. Michael McFadden, Michael Machuzak, David W. Hsia, Arthur Sung, Nabil Jarad, Malgorzata Kornaszewska, Stephen Hazelrigg, Ganesh Krishna, Brian Armstrong, Narinder S. Shargill, Dirk-Jan Slebos, Francis Cordova, Parag Desai, Nathaniel Marchetti, Victor Kim, Kartik Shenoy, John Travaline, Jiji Thomas, Lii-Yoong H. Criner, Aaron Thornburg, Terry Thomas, Surya Bhatt, James Michael Wells, Necole Seabron-Harris, Umair Gauhar, Crissie Despirito, Frank Sciurba, Jessica Bon Field, Divay Chandra, Joseph Leader, Roy Semaan, Christina Ledezma, Pallav Shah, Samuel Kemp, Justin Garner, Arafa Aboelhassan, Karthi Srikanthan, Eric Tenda, Anita Abraham, Cai Sim, Momen Wahidi, Kamran Mahmood, Scott Shofer, Kathleen Coles, Guilherme Augusto Oliveira, Betina Machado, Igor Benedetto, Fabio Svartman, Amarilio de Macedo Neto, Leonardo Schreiner, Taiane Vieira, Ken Yoneda, Tina Tham, Daniel Tompkins, Paulo F. Guerreiro Cardoso, Rodrigo Athanazio, Felipe Nominando, Samia Rached, Luciana Cassimiro, Eric Seeley, Pavan Shrestha, Gabriela R. Dincheva, Daniel Alape-Moya, Mihir Parikh, Alichia Paton, Alexis Agnew, Charlie Strange, Tatsiana Beiko, Danielle Woodford, Mary Blanton, Timothy Connolly, Jose Fernando Santacruz, Bhavin Shah, Luis Herrera, Rumi Khan, Kristine Sernulka, Richard Barbers, Michelle Hernandez, Francisco Almeida, Joseph Cicenia, Thomas Gildea, Atul Mehta, Sonali Sethi, Yvonne Meli, David Hsia, Richard Casaburi, William Stringer, Leticia Diaz, Meghan Ramsey, Ryan Van Wert, Karen Morris, Tim Batchelor, Iara Sequeiros, Katy Tucker, Malgorzata Kornaszweska, Hazem Fallouh, Ramsey Sabit, Hatam Naase, Joseph George, Azin Salimian, Helen Dyer, Kristal Adams, Karen Bade, Bryan S. Benn, Michelle Canfield, Sharmila Vetri Villalan, Travis Stewart, Nick H. T. ten Hacken, Karin Klooster, Jorine Hartman, Sonja Augustijn, and Groningen Research Institute for Asthma and COPD (GRIAC)

Subjects
Male, Pulmonary and Respiratory Medicine, CLINICAL-OUTCOMES, medicine.medical_specialty, Randomization, SURGERY, lung reduction, Bronchi, Critical Care and Intensive Care Medicine, OBSTRUCTIVE PULMONARY-DISEASE, chronic obstructive pulmonary disease, MEDICAL THERAPY, Collateral ventilation, law.invention, 03 medical and health sciences, 0302 clinical medicine, Primary outcome, Randomized controlled trial, law, Forced Expiratory Volume, Surveys and Questionnaires, Internal medicine, Bronchoscopy, Correspondence, Humans, COPD, Medicine, 030212 general & internal medicine, LUNG-VOLUME-REDUCTION, Respiratory system, Exercise Tolerance, IMPORTANT DIFFERENCE, business.industry, Walk distance, OPERATIVE MORTALITY, Endobronchial valve, Equipment Design, Prostheses and Implants, Middle Aged, NATIONAL EMPHYSEMA, medicine.disease, Treatment Outcome, emphysema, Pulmonary Emphysema, 030228 respiratory system, TESTS, Female, business
Abstract

Rationale: This is the first multicenter randomized controlled trial to evaluate the effectiveness and safety of Zephyr Endobronchial Valve (EBV) in patients with little to no collateral ventilation out to 12 months.Objectives: To evaluate the effectiveness and safety of Zephyr EBV in heterogeneous emphysema with little to no collateral ventilation in the treated lobe.Methods: Subjects were enrolled with a 2:1 randomization (EBV/standard of care [SoC]) at 24 sites. Primary outcome at 12 months was the Delta EBV-SoC of subjects with a post-bronchodilator FEV1 improvement from baseline of greater than or equal to 15%. Secondary endpoints included absolute changes in post-bronchodilator FEV1, 6-minute-walk distance, and St. George's Respiratory Questionnaire scores.Measurements and Main Results: A total of 190 subjects (128 EBV and 62 SoC) were randomized. At 12 months, 47.7% EBV and 16.8% SoC subjects had a Delta FEV1 greater than or equal to 15% (P Conclusions: Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea, and quality of life out to at least 12 months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe.

Published
2018
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5. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW) : A Multicenter Randomized Controlled Clinical Trial

Author

Dirk-Jan Slebos, Pallav L. Shah, Felix J. F. Herth, Christophe Pison, Christian Schumann, Ralf-Harto Hübner, Peter I. Bonta, Romain Kessler, Wolfgang Gesierich, Kaid Darwiche, Bernd Lamprecht, Thierry Perez, Dirk Skowasch, Gaetan Deslee, Armelle Marceau, Frank C. Sciurba, Reinoud Gosens, Jorine E. Hartman, Karthi Srikanthan, Marina Duller, Arschang Valipour, Christine Abele, Irene Firlinger, Kiran Kothakuzhakal, Roland Kropfmueller, Kornelia Holzmann, Sandra Rathmeier, Ralf Hubner, Leonore Erdmann, Bettina Temmesfeld-Wollbrück, Christoph Ruwwe Glösenkamp, Frank Reichenberger, Christa Niehaus, Felix Herth, Ralf Eberhardt, Daniela Gompelmann, Brigitte Rump, Stephan Eisenmann, Ulrike Kaiser, Birte Schwarz, Ulrike Sampel, Robert Kaiser, Kathryn Schumann-Stoiber, Sabine Ring, Amandine Briault, Francois Arbib, Marie Jondot, Clement Fournier, Regis Matran, Michele Catto, Nathalie Bautin, Virginie De Broucker, Marie Willemin, Anne Prevotat, Ludivine Wemeau, Alice Gicquello, Morgane Foulon, Hasna Camara, Herve Vallerand, Sandra Dury, Delphine Gras, Margaux Bonnaire-Verdier, Sandrine Hirschi, Michele Porzio, Tristan Degot, Mathieu Canuet, Armelle Schuller, Julien Stauder, Sahra Ali Azouaou, Hervé Mal, Yolande Costa, Justin Garner, Cielito Caneja, John Thornton, Nick Ten Hacken, Jorine Hartman, Karin Klooster, Sonja Augustijn, Peter Bonta, Jouke Annema, Marianne van de Pol, Annika Goorsenberg, CCA - Imaging and biomarkers, AII - Inflammatory diseases, and Pulmonology

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, Radiofrequency ablation, medicine.drug_class, Medizin, Critical Care and Intensive Care Medicine, law.invention, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Bronchoscopy, Double-Blind Method, law, Internal medicine, Forced Expiratory Volume, medicine, Anticholinergic, Humans, 030212 general & internal medicine, Adverse effect, Aged, Denervation, COPD, Radiofrequency Ablation, Lung, medicine.diagnostic_test, business.industry, Editorials, Middle Aged, medicine.disease, 3. Good health, Bronchodilator Agents, respiratory tract diseases, Clinical trial, medicine.anatomical_structure, Treatment Outcome, 030228 respiratory system, Cardiology, Female, business
Abstract

Rationale: Targeted lung denervation (TLD) is a bronchoscopic radiofrequency ablation therapy for chronic obstructive pulmonary disease (COPD), which durably disrupts parasympathetic pulmonary nerves to decrease airway resistance and mucus hypersecretion.Objectives: To determine the safety and impact of TLD on respiratory adverse events.Methods: We conducted a multicenter, randomized, sham bronchoscopy-controlled, double-blind trial in patients with symptomatic (modified Medical Research Council dyspnea scale score, ≥2; or COPD Assessment Test score, ≥10) COPD (FEV1, 30-60% predicted). The primary endpoint was the rate of respiratory adverse events between 3 and 6.5 months after randomization (defined as COPD exacerbation, tachypnea, wheezing, worsening bronchitis, worsening dyspnea, influenza, pneumonia, other respiratory infections, respiratory failure, or airway effects requiring therapeutic intervention). Blinding was maintained through 12.5 months.Measurements and Main Results: Eighty-two patients (50% female; mean ± SD: age, 63.7 ± 6.8 yr; FEV1, 41.6 ± 7.3% predicted; modified Medical Research Council dyspnea scale score, 2.2 ± 0.7; COPD Assessment Test score, 18.4 ± 6.1) were randomized 1:1. During the predefined 3- to 6.5-month window, patients in the TLD group experienced significantly fewer respiratory adverse events than those in the sham group (32% vs. 71%, P = 0.008; odds ratio, 0.19; 95% confidence interval, 0.0750-0.4923, P = 0.0006). Between 0 and 12.5 months, these findings were not different (83% vs. 90%; P = 0.52). The risk of COPD exacerbation requiring hospitalization in the 0- to 12.5-month window was significantly lower in the TLD group than in the sham group (hazard ratio, 0.35; 95% confidence interval, 0.13-0.99; P = 0.039). There was no statistical difference in the time to first moderate or severe COPD exacerbation, patient-reported symptoms, or other physiologic measures over the 12.5 months of follow-up.Conclusions: Patients with symptomatic COPD treated with TLD combined with optimal pharmacotherapy had fewer study-defined respiratory adverse events, including hospitalizations for COPD exacerbation.Clinical trial registered with www.clinicaltrials.gov (NCT02058459).

Published
2019

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