ERS Annual Congress Milan September 2017 Skills workshop SW 8, 10, 12 Endoscopy

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ERS Annual Congress Milan 09 13 September 2017 Skills workshop SW 8, 10, 12

1 ERS Annual Congress Milan September 2017 Skills workshop SW 8, 10, 12 Endoscopy Monday, 11 September :00 10:20 10:40 13:00 14:30 16:50 Green 1 (North) MICO

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3 Skills workshop : SW8,10,12 Endoscopy Aims : To provide a comprehensive overview of and provide skills training in different endoscopic procedures. Tags: Clinical Target audience: Clinician - Fellow - Junior member - Oncologist - Pulmonologist - Respiratory physician - Respiratory therapist - Thoracic endoscopist Chairs : Felix J.F. Herth (Heidelberg, Germany), Pallav L. Shah (London, United Kingdom) Introduction Endoscopic lung volume reduction with valves Sebastian Fernandez Bussy (SANTIAGO, Chile), Daniela Gompelmann (Heidelberg, Germany) Targeted lung denervation Dirk-Jan Slebos (Groningen, Netherlands), Arschang Valipour (WIEN, Austria) Stenting Maren Schuhmann (Heidelberg, Germany), Alexander Chen (St. Louis, United States of America) Endobronchial ultrasound Jouke T. Annema (Amsterdam, Netherlands), Lars Konge (Virum, Denmark)

COMING SOON ERS monograph Interventional Pulmonology Edited by Felix Herth, Pallav Shah and Daniela Gompelmann ISBN

training for interventional pulmonology; laryngoscopy; early cancer detection; biopsy techniques; EBUS and EUS;

Interventional Pulmonology will be published in December 2017 and will be available to order from 20 October 2017 at

4 COMING SOON ERS monograph Interventional Pulmonology Edited by Felix Herth, Pallav Shah and Daniela Gompelmann ISBN This Monograph will cover: flexible and rigid bronchoscopy; bronchoscopy in the ICU; imaging and training for interventional pulmonology; laryngoscopy; early cancer detection; biopsy techniques; EBUS and EUS; navigation bronchoscopy; airway stents; airway fistulas; advanced thoracoscopic procedures; and upcoming techniques. Interventional Pulmonology will be published in December 2017 and will be available to order from 20 October 2017 at ersbookshop.com If you re an ERS member, you automatically have full online access to the ERS Monographs. Find out more ERSPUBLICATIONS.COM

5 Thank you for viewing these presentations. We would like to remind you that these materials are the property of the authors. It is provided to you by the ERS for your personal use only, as submitted by the authors by the authors

6 Endoscopic lung volume reduction with valves Skills workshop ERS 2017 Daniela Gompelmann Thoraxklinik am Universitätsklinikum Heidelberg Translational Lung Research Center Heidelberg

7 Conflict of interest Berlin Chemie Olympus Pulmonx Chiesi Astra Zeneca Boehringer Ingelheim Novartis Munidpharma

8 Hyperinflation Casanova et al. Am J Respir Crit Care Med 2005.

9 COPD Hyperinflation Target Lobe Volume Reduction

10 Lung volume reduction Mortality Search for minimally invasive treatment approaches 2017

11 Valve therapy One-way valves Blocking technique allowing air to escape Preventiong air to come in atelectasis lung volume reduction

12 Trial overview RCT Number of patients in the treatment group FEV 1 6-MWT SGRQ Sciurba et al. NEJM 2010 VENT Herth et al. Eur Respir J 2012 Euro-VENT Ninane et al. Eur Respir J 2012 Multicenter European Study Wood et al. J Bronchology Interv Pulmonol 2014 The IBV Valve trial Davey et al. Lancet 2015 BeLieVer Klooster et al. NEJM 2015 STELVIO Valipour et al. Am J Respir Crit Care Med 2016 IMPACT n=214 4,3% 9,3 m -2,8 pts n=111 7 ± 20 % 15 ± 91 m -5 ± 14 pts Complete fissure, complete lobar occlusion (n=20) 26 ± 24% 22 ± 38% -10 ± 15 pts n=37-90 ml 7 m -4 pts n= ml - 24 m n=25 60 ml 25 m -4.4 pts n= ml (20.9%) 60 m n= ± 180 ml 23 ± 67 m -8.6 ± 11,2 pts

Trial overview RCT Number of patients in the treatment group FEV 1 6-MWT SGRQ Sciurba et al. NEJM 2010 VENT Herth et al. Eur Respir J 2012 Euro-VENT Ninane et al.

13 Trial overview RCT Number of patients in the treatment group FEV 1 6-MWT SGRQ Sciurba et al. NEJM 2010 VENT Herth et al. Eur Respir J 2012 Euro-VENT Ninane et al. Eur Respir J 2012 Multicenter European Study Wood et al. J Bronchology Interv Pulmonol 2014 The IBV Valve trial Davey et al. Lancet 2015 BeLieVer Klooster et al. NEJM 2015 STELVIO Valipour et al. Am J Respir Crit Care Med 2016 IMPACT n=214 4,3% 9,3 m -2,8 pts n=111 7 ± 20 % 15 ± 91 m -5 ± 14 pts Complete fissure, complete lobar occlusion (n=20) 26 ± 24% 22 ± 38% -10 ± 15 pts n=37-90 ml 7 m -4 pts n= ml - 24 m n=25 60 ml 25 m -4.4 pts n= ml (20.9%) 60 m n= ± 180 ml 23 ± 67 m -8.6 ± 11,2 pts

14 Schuhmann M et al. AJRCCM Gompelmann et al. Respiration Herth et al. Eur Respir J CV Evaluation Fissure analysis Chartis measurement

Patient selection Optimal results are achieved the lower the

6-MWT the higher the LAV of the target lobe to the LAV of

ipsilateral lung lobe Gompelmann*, Hofbauer* et al.

15 Patient selection Optimal results are achieved the lower the vital capacity the higher the residual volume the lower the 6-MWT the higher the LAV of the target lobe to the LAV of the target lung the higher the perfusion in the non-treated ipsilateral lung lobe Gompelmann*, Hofbauer* et al. Respirology Thomson et al. Int J Chron Obstruct Pulmon Dis 2016.

16 Survival ELVR Survival of patients with and without lobar atelectasis Survival of patients with complete and incomplete fissure Hopkinson et al. Eur Respir J 2011 Venuta et al. NEJM 2012

17 Survival atelectasis no atelectasis 4-year survival rate 89.6% (atelectasis) vs. 59.4% (no atelectasis) Baseline characteristics: Atelectasis group: 5.8 points, expected 4-year survival: 57% Non-atelectasis group: 6.1 points, expected 4-year survival: 57% Gompelmann et al. ERS 2016.

18 Valve therapy predictor for succesful LVRS a b Lobectomy c d RCT Number of FEV 1 RV 6-MWT patients in the treatment group Hornemann K et al. Abstract ERS n=6 42% -35% 72m e

19 LTx following lung volume reduction Trials Venuta F et al. Eur J Cardiothoarcic Surg Fuehner T et al. Respiration 2015.

20 Complications

months 7,9% 11,7% 20% 12% 16% 1,9% 3,6% 8% 6% 0,9% 3,6% 3% Respiratory failure 1,4% 3,6% 2% Hypercapnia 0,9% Hemoptysis

21 Complications Complications COPD exacerabtion with hospitalisation Infection, pneumonia Poststenotic pneumonia VENT 2010 n = months Euro- VENT 2012 n = 111 BeLieVe R 2015 n = 25 STELVIO 2015 n = 34 6 months IMPACT 2016 n = 43 3 months 3 months 7,9% 11,7% 20% 12% 16% 1,9% 3,6% 8% 6% 0,9% 3,6% 3% Respiratory failure 1,4% 3,6% 2% Hypercapnia 0,9% Hemoptysis 6,1% 5,4% Pneumothorax 4,2% 4,5% 8% 18% 26% Valve migration, - expectoration 4,7% 20% 6% 5% Bronchus lesion 0,5% Death 0,9% 8% 3%

22 Pneumothorax Pneumothorax rate 18-26% Reason for pneumothorax: volume shift Air leak

23 Success despite pneumothorax? Gompelmann et al. Int J Chron Obstrcuct Pulmon Dis 2016.

24 Pneumothorax

Pneumothorax Asymptomatic, small pneumothorax (to 2 cm) Pneumothorax > 2 cm and/or symptomatic Watch and wait Chest tube insertion Progression of pneumothorax Persistent pneumothorax: Explantation of

25 Pneumothorax Asymptomatic, small pneumothorax (to 2 cm) Pneumothorax > 2 cm and/or symptomatic Watch and wait Chest tube insertion Progression of pneumothorax Persistent pneumothorax: Explantation of one valve After recovering: discuss valve replacement If pneumothorax persists after 2-3 days: remove all valves If pneumothorax still persists after 7 days: discuss with the surgeon Valipour et al. Respiration 2014.

26 Thank you for your attention!

27 Targeted Lung Denervation A new therapy for COPD Dr. Dirk-Jan Slebos and Dr. Arschang Valipour Disclosure: both are investigators for this therapy/company

29 Targeted Lung Denervation Targeted Anatomically to only the lung To a depth where the nerves are located Lung Decrease smooth muscle tone Decrease mucus production Denervation Disrupt parasympathetic nerves to decrease release of acetylcholine 3

30 The vagal nerve in the Lung Sensory nerve Motor nerve RAR: Rapidly adapting receptors SAR: Slowly adapting receptors Kistemaker and Gosens, Trends Pharmacol Sci(2015) Kistemaker et al

31 The airway cholinergic system

33 Long-acting muscarinic antagonists (LAMA) Tiotropium Aclidinium Glycopyrronium Umeclidinium Compound Dose Frequency Tiotropium 18 µg Once daily Aclidinium 400 µg Twice daily Glycopyrronium 50 µg Once daily Umeclidinium 125 µg Once daily

34 Long-term impact of tiotropium on lung function - Uplift study Tashkin et al. N Engl J Med 2008;359:

35 Long-term impact of tiotropium on on Quality of Life - Uplift study Tashkin et al. N Engl J Med 2008;359:

38 Vagal intervention - Historical data Vagus nerve disruption improves lung function Species (year) Intervention Change Dog (1962) Bilateral cervical vagus cooling - 22% R lung Rabbit (1969) Bilateral cervical vagus cooling + 36% G AW Cat (1979) Unilateral cervical sensory vagotomy - 30% R lung Cat (1979) Bilateral total cervical vagotomy - 34% R lung Sheep (1995) Bilateral vagotomy - 29% R lung Sheep (1999) Bilateral total cervical vagotomy - 54% R lung Human (1957) Bilateral hilar nerve transection + 18% MVV Nadel J. J Physiol 1962; 163: ; Karczewski W. J Physiol 1969; 201: ; Jammes Y. J Physiol 1979; 291: ; Wagner EM. J Appl Physiol 1995; 78: ; Wagner EM. J Appl Physiol 1999; 86: ; Dimitrov-Szokodi D. J Thoracic Surg 1957; 33:

39 Targeted Lung Denervation Treatment Sites

40 TLD - Mechanism of Action Smooth muscle cell relaxation Sustained airway dilation Effect on mucus production?

41 TLD catheter

42 Central protection

43 Depth of TLD effect Depth of Treatment Effect 1 0 Power level (watts) 15W 20W 22W Human Bronchus Sheep Bronchus

44 Treatment assessment Axon Immuno Staining

45 TLD efficacy

airway wall Prompt Screen to control console and guide user Fluid

46 Holaira TM Lung Denervation System Radio-Frequency Generator for ablative therapy Thermoelectric Plate to cool fluid to protect airway wall Prompt Screen to control console and guide user Fluid Pump to circulate chilled fluid through catheter Dual-Cooled Catheter

47 dnerva TM Dual-Cooled Catheter Catheter Shaft Electrode Balloon

48 TLD RF Electrode positioning Electrode fluoroscopic view Electrode bronchoscopic view Slebos, et al. Thorax 2015

49 TLD First in human study Groningen Team Cape Town Team Slebos, et al. Thorax 2015

50 Key Inclusion and Exclusion Inclusion: FEV 1 30% to 60% FEV 1 /FVC <70% FEV 1 change of >15% during ipratropium reversibility testing Non smoking 4 months Exclusion: x<4 weeks since COPD exacerbation or active respiratory infection xpao2 7.3 kpa (55 mm Hg) or PaCO2 > 8.0 kpa (60 mm Hg) xprior major lung surgery xpulmonary nodule requiring surgery; radiation/chemotherapy Slebos, et al. Thorax 2015

51 Post Enrollment Patient Flow Day -14 OFF drug baseline assessment Day -7 ON drug baseline testing Day 0 TLD Treatment Procedure 1 & 2 Day 30, 90, 180, 365 OFF drug testing Slebos, et al. Thorax 2015

52 Baseline Characteristics 20 watt cohort (n=12) 15 watt cohort (n=10) Age (years) (11 37) (8 87) Male (n, %) 7 (58%) 4 (40%) History of Smoking (n, %) 12 (100%) 10 (100%) Pack-Years 38 6 (19 9) 40 4 (29 0) Wash-out Pre-bronchodilator FEV 1 (L) 0 90 (0 28) 0 84 (0 15) Wash-out Pre-bronchodilator FVC (L) 2 56 (0 59) 2 45 (0 60) Reversibility peak relative change in FEV 1 (%) (7 60) (1 91) Data are mean (SD) unless stated otherwise. FEV1=forced expiratory volume in 1 s. FVC=forced vital capacity. Slebos, et al. Thorax 2015

53 First TLD Procedure Rigid bronchoscope + HF-JET Olympus BF XT160 / 3.2mm ID 1 st generation catheter Slebos, et al. Thorax 2015

54 Safety Airway Effects Slebos, et al. Thorax 2015

55 Safety Airway Effects TLD - Left main bronchus Pre Tx TLD PostTX 90days Slebos, et al. Thorax 2015

56 Safety Airway Effects Slebos, et al. Thorax 2015

57 Safety Severe Adverse Events 0-30 Days (3) COPD exacerbations (1) Drug reaction (1) Coronary bypass (1) Chest pain (1) Gastroparesis Days (5) COPD exacerbations (2) Pneumonia (1) Influenza, H1N1 (1) Stomach cancer Slebos, et al. Thorax 2015

58 Efficacy: FEV 1 Pre-TLD on drug Post-TLD, off drug compared to baseline Data presented as mean (SEM), * indicates p<0.05 vs. baseline Slebos, et al. Thorax 2015

59 Efficacy: SGRQ Pre-TLD on drug Post-TLD, off drug compared to baseline Data presented as mean (SEM), * indicates p<0.05 vs. baseline Slebos, et al. Thorax 2015

60 Efficacy Cycle Endurance Post-TLD, off drug compared to baseline Data presented as mean (SEM), * indicates p<0.05 vs. baseline Slebos, et al. Thorax 2015

61 Efficacy TLD + Ipratropium Pre-TLD on drug Post-TLD, off drug compared to baseline Data presented as mean (SEM), * indicates p<0.05 vs. baseline Slebos, et al. Thorax 2015

68 TLD Effects on Airway Inflammation Kistemaker et al., Eur Respir J 2015

69 TLD - Conclusions First-in-human clinical trial TLD was safe in these 22 patients during 1-year of follow-up TLD showed improvements in the 20W group at 1-year TLD + Ipratropium appear synergistic at 1-year Benefit tended to be greater in the 20W vs. 15W group Potential anti-inflammatory effects

70 Next stepts

71 TLD Clinical COPD Program Optimization Pivotal 3 JP1 Feasibility IPS-I / IPS-II Safety Efficacy Safety Feasibility Dose Ranging Key Areas to Optimize Protocol Dose Procedure Device

72 Dia 45 JP1 Can LMR get me a cool #3 logo? Jim Pavliska;

73 From Rigid to Flexible procedure

74 New generation balloon catheter - 5mm (folded) - 45 angle - 8 rotations - 3mm (folded) - 90 angle - 4 rotations

75 New generation console

77 TLD Procedural Evolution Device Attributes Procedural optimization during AIRFLOW-1 Version #1 n=13 Procedure Version #2 n=17 Version #3 n=15* Electrode contact Cooling/ surface protection Esophageal Protection Carinal Protection *active enrollment

78 Esophageal Protection

79 Esophageal Protection Bronchoscope Electrode > 2 scopes Esophageal balloon

82 Targeted Lung Denervation Parasympathetic nerves can be targeted using TLD First in human study was safe during 1-year of follow-up Effects seems dose-dependent New generation catheter allows easier procedures AIRFLOW 1: Further procedure optimization AIRFLOW 2: Sham controlled RCT

83 Suggested reading Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax May;70(5): Koegelenberg CF, Theron J, Slebos DJ, Klooster K, Mayse M, Gosens R. Antimuscarinic Bronchodilator Response Retained after Bronchoscopic Vagal Denervation in Chronic Obstructive Pulmonary Disease Patients. Respiration. 2016;92(1): Kistemaker LE, Slebos DJ, Meurs H, Kerstjens HA, Gosens R. Anti-inflammatory effects of targeted lung denervation in patients with COPD. Eur Respir J Nov;46(5): Kistemaker LE, Oenema TA, Meurs H, Gosens R. Regulation of airway inflammation and remodeling by muscarinic receptors: perspectives on anticholinergic therapy in asthma and COPD. Life Sci Nov 27;91(21-22): ERS 2016 presentation video s:

ERS International Congress 2017 Milan, Italy 09-13 September SW 8,10,12 Endoscopy Date: 11.09.2017 WORKSHOP PREPARATION Readings, guidelines and E-learning resources Endoscopic valve therapy 1.

84 ERS International Congress 2017 Milan, Italy September SW 8,10,12 Endoscopy Date: WORKSHOP PREPARATION Readings, guidelines and E-learning resources Endoscopic valve therapy 1. Valipour A, Slebos DJ, Herth F, Darwiche K, Wagner M, Ficker JH, Petermann C, Hubner RH, Stanzel F, Eberhardt R; IMPACT Study Team. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med : Klooster K, ten Hacken NH, Hartman JE, Kerstjens HA, van Rikxoort EM, Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med : Davey C, Zoumut Z, Jordan S, McNulty WH, Carr DH, Hind MD, Hansell DM, Rubens MB, Banya W, Polkey MI, Shah PL, Hopkinson NS. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BelLieVeR-HIFi study): a randomised controlled trial. Lancet : Herzog D, Poellinger A, Doellinger F, et al. Modifying Post-Operative Medical Care after EBV Implant May Reduce Pneumothorax Incidence. PLoS One :e Schuhmann M, Raffy P, Yin Y, et al. Computed tomography predictors of response to endobronchial valve lung reduction treatment. Comparison with Chartis. Am J Respir Crit Care Med 2015; 191: Gompelmann D, Eberhardt R, Slebos DJ, et al. Diagnostic performance comparison of the Chartis System and high-resolution computerized tomography fissure analysis for planning endoscopic lung volume reduction. Respirology 2014; 19: Gompelmann D, Herth FJF, Slebos DJ, et al. Pneumothorax following Endobronchial Valve Therapy and Its Impact on Clinical Outcomes in Severe Emphysema. Respiration 2014; 87: Valipour A, Slebos DJ, de Oliveira HG et al. Expert statement: pneumothorax associated with endoscopic valve therapy for emphysema potential mechanism, treatment algorithm, and case examples. Respiration : Valipour A, Herth FJ, Burghuber OC et al. Target lobe volume reduction and COPD outcomes meaures after endobronchial valve therapy. Eur Respir J : Herth FJ, Eberhardt R, Gompelmann D, et al. Radiological and clinical outcomes of using chartis to plan endobronchial valve treatment. Eur Respir J 2012; 41: Herth FJ, Noppen M, Valipor A et al. International VENT Study Group. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J 2012; 39: Eberhardt R, Gompelmann D, Schuhmann M, et al.complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012;142: Venuta F, Anile M, Diso D, et al. Long-term follow-up after bronchoscopic lung volume reduction in patients with emphysema. Eur Respir J 2012; 39: Hopkinson NS, Kemp SV, Toma TP, et al. Atelectasis and survival after bronchoscopic lung volume reduction for COPD. Eur Respir J 2011; 37: Sciurba FC, Ernst A, Herth FJF et al. VENT Study Research Group. A Randomized Study of Endobronchial Valves for Advanced Emphysema. N Engl J Med 2010; 363:

85 Skills workshop Endoscopy Monday, 11 September 2017 Following companies support this workshop with equipment:

Journal of the COPD Foundation. Journal Club - Endobronchial Valve Bronchoscopic Lung Volume Reduction Ron Balkissoon, MD, MSc, DIH, FRCPC 1

118 Journal Club: Endobronchial Valve Lung Volume Reduction Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation Journal Club Journal Club - Endobronchial Valve Bronchoscopic Lung Volume