Live pulmonary endoscopy Emphysema and severe asthma · Live pulmonary endoscopy Emphysema and...
Transcript of Live pulmonary endoscopy Emphysema and severe asthma · Live pulmonary endoscopy Emphysema and...
ERS International Congress Amsterdam
26–30 September 2015
Live pulmonary endoscopy
Emphysema and severe asthma
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Tuesday, 29 September 2015
13:00 – 14:30
Room Auditorium RAI
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Live pulmonary endoscopy
Emphysema and severe asthma
AIMS: Endoscopic lung volume reduction (ELVR) for severe emphysema and bronchial thermoplasty
for severe asthma are new treatment possibilities for patients with obstructive lung diseases. The
techniques that will be demonstrated are endobronchial valve Chartis measurements, endobronchial
coils, and bronchial thermoplasty.
TARGET AUDIENCE: General pulmonologists and residents.
CHAIRS: P. L. Shah (London, United Kingdom), A. Valipour (Vienna, Austria)
SESSION PROGRAMME
13:00 Opening lecture: endoscopic therapies for emphysema and asthma
A. Valipour (Vienna, Austria)
Patient advocate (AMC)
T. Lapperre (Singapore, Singapore)
Patient advocate (UMCG)
N. ten Hacken (Groningen, Netherlands)
Endobronchial coils
D. Slebos (Groningen, Netherlands) F. Sciurba (Pittsburgh, United States of America)
Bronchial thermoplasty
G. Cox (Hamilton, Canada) P. Bonta (Amsterdam, Netherlands)
Endobronchial valves and Chartis measurement
D. Slebos (Groningen, Netherlands) F. Sciurba (Pittsburgh, United States of America)
14:00 Emphysema and severe asthma: question and answer session
A. Valipour (Vienna, Austria) P. Shah (London, United Kingdom)
14:15 Concluding lecture: Which patient should I refer for ELVR/BT?
P. Shah (London, United Kingdom)
BOOKLET CONTENTS PAGE
Endoscopic therapies for asthma and emphysema 4
Which patient should i refer for ELVR/BT 16
Additional resources 42
Faculty disclosures 43
Faculty contact information 44
Endoscopic therapies for emphysema and asthma
Prof. Dr. Arschang Valipour
Department of Respiratory and Critical Care Medicine
Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology
Otto Wagner Hospital
Sanatoriumstr. 2
1140 Vienna
AUSTRIA
4
Endoscopic therapies for asthma and emphysema
Arschang Valipour
Arschang Valipour, MD, FCCP, Assoc. Professor
Ludwig-Boltzmann-Institute for COPD and
Respiratory Epidemiology
Otto-Wagner-Spital
Vienna, Austria
5
Conflict of interest disclosureI have the following, real or perceived direct or indirect conflicts of interest that
relate to this presentation:
Affiliation / financial interest Nature of conflict / commercial company name
Tobacco-industry and tobacco corporate affiliate relatedconflict of interest
N.A.
Grants/research support (to myself, my institution or department):
Boehringer Ingelheim
Honoraria or consultation fees: Pulmonx, PneumRx, Olympus, Boehringer Ingelheim, GSK, Novartis, Astra Zeneca, Chiesi
Participation in a company sponsored bureau: N.A.
Stock shareholder: N.A.
Spouse/partner: N.A.
Other support or other potential conflict of interest: N.A.
This event is accredited for CME credits by EBAP and speakers are required to disclose their potential conflict of interest going back 3 years prior to this presentation. The intent of this disclosure is not to prevent a speaker with a conflict of interest (any significant financial relationship a speaker has with manufacturers or providers of any commercial products or services relevant to the talk) from making a presentation, but rather to provide listeners with information on which they can make their own judgment. It remains for audience members to determine whether the speaker’s interests or relationships may influence the presentation.Drug or device advertisement is strictly forbidden.
6
RATIONALE FOR ENDOSCOPIC
TREATMENT OF EMPHYSEMA
• Lung volume reduction surgery in selected
patients is associated with improvements in
lung function, exercise capacity, QoL, and
survival, but….
7
Naunheim KS et al., J Thorac Cardiovasc Surg 2006
• Tracheostomy
• Weaning Failure
• Reintubation
• Pneumonia
• Myocardial Infarct
• Pulmonary Embolism
• Arrythmias
• Ventilation > 3 days
MORBIDITY AND MORTALITY
ASSOCIATED WITH LVRS
8
Naunheim KS et al., J Thorac Cardiovasc Surg 2006
There is a need for
minimal invasive alternatives
to surgical LVR!
MORBIDITY AND MORTALITY
ASSOCIATED WITH LVRS
9
RATIONALE FOR ENDOSCOPIC
TREATMENT OF SEVERE ASTHMA
1FitzGerald JM, et al. Can Respir J. 2006;13:253-259.
CACG, Canadian Asthma Consensus Guidelines; GP, General Practitioner 10
RATIONALE FOR ENDOSCOPIC
TREATMENT OF SEVERE ASTHMA
Dockrell M, et al. Allergy. 2007;62(2):134-141.
• In a phone survey of 1300 patients from the UK, France, Germany, Spain and Sweden, many patients with severe asthma reported that their normal daily activities were restricted as a result of their condition
11
ENDOSCOPIC TREATMENTOF OBSTRUCTIVE AIRWAYS DISEASE
• Endoscopic Valve Therapy
• RECOIL Procedure
• Bronchial Thermoplasty
• Polymeric Lung Volume Reduction
• Bronchoscopic Thermal Vapor Ablation
• Airway Bypass
• Targeted Lung Denervation Therapy
• Pneumostoma
• BioLVR, Endobronchial Cryotherapy,...12
13
PATIENT SELECTION IS CRUCIAL FOROPTIMAL RISK-BENEFIT
14
AIMS OF THE SESSION
• To understand patient selection, the procedure related set-up,
and the technique of interventional procedures to treat severe
asthma and emphysema.
• To see how procedures are being performed in real-life.
• To have the opportunity to interact with top international
experts in the field of interventional pulmonology.
15
Endoscopic therapies for emphysema and asthma
Dr Pallav L Shah
Royal Brompton Hospital
Sydney Str.
SW3 6NP London
United Kingdom
16
WHICH PATIENT SHOULD I REFER
FOR ELVR/BT
Pallav Shah
Royal Brompton Hospital
Chelsea & Westminster Hospital
Imperial College
17
Conflict of Interest Disclosure
❑I have the following, real or perceived direct or indirect conflicts of interest that
relate to this presentation:
Affiliation / financial interest Nature of conflict / commercial company name
Tobacco-industry and tobacco corporate affiliate
related conflict of interestNONE
Grants/research support (to myself, my institution
or department):
PneumRx, Holariio, Uptake and Pulmonx reimbursed the Royal
Brompton Hospital and Chelsea & Westminster Hospital for clinical
trial expenses (RENEW trial, RESET coil randomised trial)
Honoraria or consultation fees: Olympus, Medtronic, BTG, PneumRx, Pulmonx, CSA Medical
Participation in a company sponsored bureau: PneumRx, Boston Scientific, Pulmonx
Stock shareholder: NONE
Spouse/partner: NONE
Other support or other potential conflict of
interest:
Boston Scientific, Erbe, Olympus/Keymed, Cook Medical, PneumRx,
Medtronic, Immotech, Pulmonx sponsorship to Imperial College for an
annual interventional bronchoscopy course
This event is accredited for CME credits by EBAP and speakers are required to disclose their potential conflict of interest going back 3 years prior to this presentation. The intent of this disclosure is not to prevent a speaker with a conflict of interest (any significant financial relationship a speaker has with manufacturers or providers of any commercial products or services relevant to the talk) from making a presentation, but rather to provide listeners with information on which they can make their own judgment. It remains for audience members to determine whether the speaker’s interests or relationships may influence the presentation.Drug or device advertisement is strictly forbidden.
18
•PneumRx reimbursed the Royal Brompton Hospital and Chelsea &
Westminster Hospital for clinical trial expenses (RENEW trial,
RESET coil randomised trial)
•Holario reimbursed the Royal Brompton Hospital and Chelsea &
Westminster Hospital for clinical trial expenses (Airflow trial)
•Uptake medical reimbursed the Royal Brompton Hospital for clinical
trial expenses (Step Up trial)
•Pulmonx reimbursed the Royal Brompton Hospital for clinical trial
expenses (Liberate trial)
•Boston Scientific, Erbe, Olympus/Keymed, Cook Medical, PneumRx,
Medtronic, Immotech, Pulmonx sponsorship to Imperial College for
an annual interventional bronchoscopy course
•Consultancy Activity for Olympus/Keymed, PneumRx, Medtronic,
Broncus, CSA Medical & Pulmonx sponsorship
Conflict of Interest Disclosure
19
Introduction
AIMS
• Understand which patients should be considered for endoscopic
lung volume reduction
• Key investigations that assist in selection of optimal patients for
endoscopic lung volume reduction
• Understand which patients should be considered for bronchial
thermoplasty
• Understand key contra-indications for bronchial thermoplasty
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Established diagnosis of emphysema and on Optimal Medical
Treatment
• Stopped smoking
• Long acting anticholinergics (LAMA)
• Combination inhaled steroids and long acting beta agonists
(LABA)
• Completed pulmonary rehabilitation & on maintenance regime
(PR)
Patient Selection for Lung Volume
Reduction Therapies
Clinical Characteristics
21
• Evidence of moderate to severe airflow obstruction FEV1< 50%
predicted ie GOLD stage 3/4 (D)
• FEV1:FVC ratio < 0.6
• Hyperinflation: residual volume >175% predicted or RV/TLC ratio
of >0.58
• Transfer factor >20% predicted (>15% for selected therapies)
• Exercise limitation (6MWT 150 to 400m)
Patient Selection for Lung Volume
Reduction Therapies
Physiological Characteristics
22
• Hypoxia PaO2 < 6.0 kPA (45mmHg)
• Hypoxia PaCO2 > 8.0 kPA (60mmHg)
• Transfer factor <20% predicted (<15% for selected therapies)
• FEV1< <20% predicted (<15% for selected therapies)
• No Exercise limitation (6MWT >400m)
Patient Selection for Lung Volume
Reduction Therapies
Physiological Characteristics which exclude LVR Therapies
23
Exclude significant co-morbidity
• bronchiectasis
• new pulmonary nodules/suspected lung cancer
• irreversible unstable conditions eg cerebro-vascular disease
• pulmonary hypertension (echocardiography measurements of
PAP >50mmHg
Patient Selection for Lung Volume
Reduction Therapies
Co-morbidity
24
• Fissure Integrity
• Heterogenity
• Severity
• presence of significant
co-morbidity ie
bronchiectasis
Patient Selection for Lung Volume
Reduction Therapies
Radiological Characteristics
25
Patient Selection for Lung Volume
Reduction Therapies
Radio-nuclide scintigraphy
26
Lobe Right§Lung
LeftLung
Upper 3 2
Middle 2 n/a
Lower 2 2
Defining Homogenous /Heterogenous
Disease
Protocol grades: % emphysema
(low attenuation % voxels ≤-910)
0:no destruction;
1: 1-25%
2: 26-50%;
3:51-75%
4:76-100%
CT scores
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CT Post Processing
Case
PH
Distance
Transformation
Features
28
CT Post Processing
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Centrilobular Pattern
Phenotypes of Emphysema
30
Panacinar Pattern
Phenotypes of Emphysema
31
Paraseptal Pattern
Phenotypes of Emphysema
32
Poor Patient Selection:expensive mistake & poor
outcomes
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Strategy
• Unilateral occlusion
Selection
• intact fissure or absent collateral ventilation
• heterogenity (greater than 15% difference in degree
of destruction between upper & lower lobes
Survival
• atelectasis of target lobe indicative of response &
long term survival
Summary: Endobronchial Valves
34
• Strategy
• insertion of 8-12 coils per lung
• staged procedure unilateral then treat contra-lateral
side when required
• Selection
• broad patient selection
• homogenous to heterogenous disease
• avoid very bullous disease
• Survival
• long term effect on coil tension is unclear (longest
follow up about 72 months
Summary: RePneu Coils
35
LVR Algorithm
Clinical TrialsCoils
Sealants
Steam
Emphysema optimal medical RX
FEV1<50% and RV>175% , RV/TLC>0.58, 6MWT 150-400m
Severe Co-morbidity
- bronchiectasis
-suspected cancer
-PHT
-PaO2<7.0kPa
-PaCO2>7.0 kPa
Homogenous
LVRS
Severe hyperinflation
TLCO>20%
FEV1>20%
Clinical TrialsLVRS
Coils
Valves
Sealants
Emphysema
optimal pharmacological & non pharmacological treatments
-smoking cessation
-optimal diet
-pulmonary rehabilitation
-consider oxygen therapy
-vaccination
-consider all patients for lung transplant
consider
Lung Transplant
CT Features
Heterogenous
No Collateral Ventilation Collateral Ventilation
Valves LVRS
ANY
MDT & PATIENT CONSENSUS
36
Mild Moderate Severe
BT Studies in Asthma
Feasibilityn = 16
AIRn = 109
AIR2n = 297
RISAn = 32
37
Feasibility(n = 16)
AIR(RCT; n = 108)
RISA(RCT; n = 32)
AJRCCM, v176, Sep 2007 AJRCCM, v173, May 2006 NEJM, v356, Mar 2007
All of the above were shown to be significant (p < 0.05), except where noted.
AIR 2(RCT; n = 297)
AJRCCM v181 Jan 2010
■ Well Tolerated
■ Lung Function
■ Symptom Free Days
■ Persistent Effect
■ AQLQ
■ Exacerbations
■ Rescue Medications
■ Symptom Free Days
■ AQLQ
■ ACQ
■ Rescue Medications
■ Oral Steroids
(p=0.12)
■ AQLQ
■ Severe Exacerbations
■ ER visits
■ Days lost work/school
BT Studies in Asthma
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Indications for Bronchial Thermoplasty
• FDA license: Alair Bronchial thermoplasty device is approved for the
treatment of adult patients (18 years of age) with severe persistent asthma that
is not controlled on combination of high dose inhaled corticosteroids (ICS)
and long acting bronchodilators (LABA)
• The European Respiratory Society/American Thoracic Society (ERS/ATS) task
force in 2014 strongly recommended consideration of bronchial thermoplasty
in adults with severe asthma in a context of institutional review board (IRB)-
approved systematic registry or as part of a clinical study
• The American College of Chest Physicians (ACCP/CHEST 2014) that “all public
and private insurers provide coverage and payment for bronchial
thermoplasty ..... for those adult patients with severe persistent,
poorly‐controlled asthma who continue to experience asthma exacerbations,
emergency department visits and hospitalizations despite maximal medical
treatment”
39
Patient Selection
• Adults with severe persistent asthma
• Symptomatic despite treatment with combination of high dose
inhaled corticosteroids (ICS) and long acting bronchodilators
(LABA)
• Patients requiring maintenance oral steroids
• Patients on STEP 4/5 of GINA guidelines
40
Main Contraindications
• Significant Respiratory co-morbidity: Bronchiectasis, ABPA, Vocal
cord dysfunction, Churg-Strauss syndrome, drug reactions,
congestive heart failure, bronchiolitis obliterans, chronic sinus
problems, severe GERD, excessive dynamic airway collapse, and
tracheobronchomalacia
• Pacemaker, Implanted Defibrillator, other implanted electronic device
• sensitivity to drugs required to perform the bronchoscopy e.g.
midazolam, lidocaine,
• Known problems with coagulopathy
• Active respiratory infection within 14 days of the procedure
• Unstable asthma within 14 days of the procedure
• contra-indications to bronchoscopy
41
Additional course resources
Readings, guidelines and E-learning resources
1. Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette
M; RISA Trial Study Group., Safety and efficacy of bronchial thermoplasty in symptomatic,
severe asthma, Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. Epub 2007 Sep 27
2. Kaukel P, Herth FJ, Schuhmann M., Bronchial thermoplasty: interventional therapy in asthma,
Ther Adv Respir Dis. 2014 Feb; 8(1):22-9. doi: 10.1177/1753465813509302. Epub 2013 Dec 10
3. Pavord ID1, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill
NS, Laviolette M; Research in Severe Asthma Trial Study Group. et al., Safety of bronchial
thermoplasty in patients with severe refractory asthma, Ann Allergy Asthma Immunol. 2013 Nov;
111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13
4. Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein
R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB,McEvoy C, Slebos DJ, Holmes
M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth
K, Kline JN, Mansur AH, Louie BE,Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring
J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. et al., Bronchial
thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma, J
Allergy Clin Immunol. 2013 Dec; 132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013
Aug 30
5. Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss
E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy
C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn
W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study
Group., Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a
multicenter, randomized, double-blind, sham-controlled clinical trial, Am J Respir Crit Care
Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8
42
Faculty disclosures
Dr Peter I. Bonta work benefited from the research grants provided by Boston Scientific and St Jude.
Dr Gerard P. Cox is an investigator in clinical trials of Bronchial Thermoplasty with funding from
Asthmatx Inc. (now part of Boston Scientific). He has also received speaker's fees from Boston
Scientific for talks on management of severe asthma including the role of Bronchial Thermoplasty.
Dr Frank Sciurba has received research support from PneumRx and Pulmonx.
Dr Pallav L. Shah has received personal fees from Broncus, Olympus, PneumRX and Pulmonx as
consultant on scientific advisory board. His work benefited from sponsorship for a bronchoscopy
course from ERBE, Cook medical, Superdimension, Boston Scientific, Aquilant, Broncus, Pulmonx,
Olympus and PneumRX. His institutions has received also a research funding from PneumRX
Dr Dirk-Jan Slebos performed several clinical trials using the coil technology, is advisor to PneumRx
Inc, as well as received travel grants and speakers fees for scientific presentations and educational
activities for PneumRx Inc.
Prof. Dr Arschang Valipour has received grants or research support from Boehringer Ingelheim, as
well as Honoraria or consultation fees from Pulmonx, PneumRx, Olympus, Boehringer Ingelheim,
GSK, Novartis, Astra Zeneca, Chiesi
43
Faculty contact information
Dr Peter I. Bonta
Academic Medical Center Amsterdam
Meibergdreef 9
1105 AZ Amsterdam Zuid-Oost,
NETHERLANDS
Dr Gerard P. Cox
FIRH T2123
St.Josephs' Healthcare
McMaster University
50 Charlton Ave East
L8N 4A6 ON Hamilton
CANADA
Dr Therese Lapperre
Department of Respiratory and Critical care
Medicine
Singapore General Hospital
Outram Rd
Singapore 169608
SINGAPORE
Dr Frank Sciurba
UPMC Montefiore Hospital - NW628
3459 Fifth Avenue
Pittsburgh, PA 15213
UNITED STATES OF AMERICA
Dr Pallav L Shah
Royal Brompton Hospital
Sydney Str.
SW3 6NP London
United Kingdom
Dr Dirk-Jan Slebos
Dept of Pulmonary Diseases
University Medical Center of Groningen
P.O. Box 30001
9700 RB Groningen
NETHERLANDS
Prof. Dr Arschang Valipour
Department of Respiratory and Critical Care
Medicine
Ludwig-Boltzmann-Institute for COPD and
Respiratory Epidemiology
Otto Wagner Hospital
Sanatoriumstr. 2
1140 Vienna
AUSTRIA
Dr Nicolaas H.T. ten Hacken
Pulmonary Department
University Medical Center Groningen
P.O. Box 30001
9700 RB Groningen
NETHERLAND
44