TRATTAMENTO
ENDOSCOPICO
dell’ENFISEMA
i dispositivi
Dr.ssa Michela Bezzi
ASPEDALI CIVILI DI BRESCIA
U.O.C. DI ENDOSCOPIA E LASERTERAPIA
DELL’APPARATO RESPIRATORIO
Emphysema causes 3 key patho-physiological problems
 Enlargement of alveolar
airspaces
 Loss of elastic recoil
 Collateral ventilation
BRONCHOSCOPIC TREATMENT OF EMPHYSEMA (BTE)
Interventional Pulmonology – Spedali Civili of Brescia
2008 – Feb 2014
DEVICE
TREATMENT
IBV valves
Bilateral partial
Unilateral complete
IBV+EBV
Airleaks
total
EBV valves
total
EMV valves
total
Coils
total
Aeriseal
Unilateral complete RUL
Airleaks
Unilateral complete LUL
LUL
RUL
BILATERAL
UNILATELAR
BILATERAL (aspire trial)
total
TOTAL
Dr.ssa Michela Bezzi - Endoscopia Respiratoria , Spedali Civili di
Brescia
N. PATIENTS
N. TREATMENTS
13
6
3
10
22+10
66
7
73
1
1
3
5
11
19
2
2
4
13
6
3
15
22+15
80
14
94
1
1
3
5
22
30
2
2
4
129
166
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lung
Scan
+
HRTC
HOMOGENEOUS
Induction of atelectasis (blocking devices)
Endobronchial valves
PULMONX Zephyr EBV
Stent like self-expanding valve,
covered by silicone. It works as
Heimlich valve.
SPIRATION IBV Valve System
Umbrella shaped metallic frame
covered by polyurethane membrane.
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
ENDOSCOPIA RESPIRATORIA
SPEDALI CIVILI - BRESCIA
Spiration – Olympus IBV
Calibration
Valve deployment
IBV Valves: Chest X-Rays
IBV Valves
3 IBV Valves
right hilum
9
Pulmonx® Zephyr endobronchial valve
VENT study: efficacy results
Sciurba FC, Ernst A, Herth FJF, et al.: A Randomized Study of Endobronchial Valves for Advanced Emphysema. N Engl J Med 2010;363:1233-44
30,0%
8
25,6%
7
25,0%
6
20,0%
5
15,2%
15,0%
4
10,6%
10,5%
10,0%
9,6%
8,8%
7,2%
3
2
5,8%
5,0%
1
0,0%
0
Total
H.H. (>10%)
FEV1 % Change
H.H.+ L.E.
H.H.+
L.E.+C.F.
6MWT % Change
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Collateral Ventilation (CV)
Fissure completeness emerged as an
independent predictor of treatment response
• Collateral ventilation is present
in most patients with advanced
emphysema
• Prevents collapse distal to an
endobronchial plugs or valves
• Endobronchial lung volume
reduction
methods
must
address collateral ventilation*
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
The Chartis System
Measurement of Collateral Ventilation (CV)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
The Chartis System
Measurement of Collateral Ventilation (CV +)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
The Chartis System
Measurement of Collateral Ventilation (CV-)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
The Chartis System
Measurement of Collateral Ventilation (CV)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lower/Upper lobes
Chartis
Upper lobes
Lung
Scan
+
HRTC
HOMOGENEOUS
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lower/Upper lobes
Upper lobes
Chartis
CV -
CV +
Lung
Scan
+
HRTC
HOMOGENEOUS
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lower/Upper lobes
Upper lobes
Chartis
CV -
CV +
RV > 225% pred
Most diseased
lobe with
complete
fissure
Permissive
parenchymal
density
Lung
Scan
+
HRTC
HOMOGENEOUS
LVR-COILS Mechanism of Action
Attachments between alveoli
are like springs → elastic recoil
normal
emphysema
With emphysema,
alveolar walls and parenchyma are
destroyed and lungs lose their elastic recoil
“LVRS without Surgery...?”
• Non-resectional, non-surgical (i.e., bronchoscopic) LVR is
possible through
 Creation of extra-anatomical tracts
 Induction of atelectasis (blocking devices)
Endobronchial occluders and valves
 Non blocking devices (Implants or Coils)
 Irreversible non-blocking techniques (bronchoscopic thermal
vapor ablation, polymeric lung volume reduction)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lower/Upper lobes
Upper lobes
ASPIRE trial
Chartis
CV -
Lung
Scan
+
HRTC
CV +
Aeriseal
RV > 200% pred
Most diseased
lobe with
complete
fissure
Permissive
parenchymal
density
HOMOGENEOUS
Polimeric Lung Volume Reduction
PLVR is designed to produce lung volume reduction nonsurgically using a hydrogel foam
that flows into the damaged alveoli, adheres to the tissues, and produces lung volume
reduction as the gas within the foam is absorbed, and the foam collapses. This reduces the
size of hyperinflated regions of lung to produce therapeutic benefit.
PLVR is designed to produce lung volume reduction nonsurgically using a hydrogel foam
that flows into the damaged alveoli, adheres to the tissues, and produces lung volume
reduction as the gas within the foam is absorbed, and the foam collapses. This reduces the
size of hyperinflated regions of lung to produce therapeutic benefit.
“LVRS without Surgery...?”
• Non-resectional, non-surgical (i.e., bronchoscopic) LVR is
possible through
 Creation of extra-anatomical tracts
 Induction of atelectasis (blocking devices)
Endobronchial occluders and valves
 Non blocking devices (Implants or Coils)
 Irreversible non-blocking techniques (bronchoscopic thermal
vapor ablation, polymeric lung volume reduction)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
AeriSeal System therapy
Radiographic Changes Post AeriSeal
•
Radiographic changes include:
–
–
–
–
“scar-like” lesions
“mass-like” lesions
diffuse infiltrates
benign “cavities” that collapse over time
AeriSeal System therapy
Radiographic Changes Post AeriSeal
“Scar-like” Lesion
Baseline
Week 12
Week 48
Signs/symptoms of pathology:
None
Response to treatment:
DFEV1 = +55% DFEV1= +41%
DSGRQ= -0.3 DSGRQ= -10.1
AeriSeal System therapy
Radiographic Changes Post AeriSeal
“Mass-like” Lesion
Baseline
Signs/symptoms of pathology:
Response to treatment:
Week 12
None
DFEV1 = +54%
DSGRQ= -26.9
AeriSeal System therapy
Radiographic Changes Post AeriSeal
“Diffuse Infiltrates”
Baseline
Week 12
Signs/symptoms of pathology:
None
Response to treatment:
DFEV1 = +46% DFEV1= +49%
DSGRQ= -2.6 DSGRQ= -14.2
Week 48
AeriSeal System therapy
Radiographic Changes Post AeriSeal
“Benign Cavities” that collapse
Baseline
Week 12
Signs/symptoms of pathology:
None
Response to treatment:
DFEV1 = +1% DFEV1= +9%
DSGRQ= +3.4 DSGRQ= -6.2
Week 48
Conclusions
• Medical management is an important component of AeriSeal System
therapy
(combined medical/interventional treatment)
• Prophylaxis significantly reduces post treatment (expected) side effects
• Strict patient selection and patient information are crucial
• SAEs are not common
• Radiographic changes are an expected part of the response and do not
indicate pathology
• Treatment of COPD exacerbations and infections follow standard protocols
and should be initiated based on clinical signs and symptoms
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lower/Upper lobes
ASPIRE trial
CV +
Aeriseal
RV > 200% pred
Most diseased
lobe with
complete
fissure
HOMOGENEOUS
Upper lobes
Chartis
CV -
Lung
Scan
+
HRTC
Permissive
parenchymal
density
One lobe
with
perfusion
<30%
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lower/Upper lobes
ASPIRE trial
CV +
Aeriseal
RV > 200% pred
Most diseased
lobe with
complete
fissure
HOMOGENEOUS
Upper lobes
Chartis
CV -
Lung
Scan
+
HRTC
Permissive
parenchymal
density
One lobe
with
perfusion
<30%
Airway
bypass
“LVRS without Surgery...?”
• Non-resectional, non-surgical (i.e., bronchoscopic) LVR is
possible through
 Creation of extra-anatomical tracts (Airway bypass system)
 Induction of atelectasis (blocking devices)
Endobronchial occluders and valves
 Non blocking devices (Implants or Coils)
 Irreversible non-blocking techniques (bronchoscopic thermal
vapor ablation, polymeric lung volume reduction)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
HETEROGENEOUS
Lower/Upper lobes
ASPIRE trial
CV +
Aeriseal
RV > 200% pred
Most diseased
lobe with
complete
fissure
HOMOGENEOUS
Upper lobes
Chartis
CV -
Lung
Scan
+
HRTC
Permissive
parenchymal
density
One lobe
with
perfusion
<30%
Airway
bypass
“LVRS without Surgery...?”
• Non-resectional, non-surgical (i.e., bronchoscopic) LVR is possible
through
 Creation of extra-anatomical tracts
 Induction of atelectasis (blocking devices)
Endobronchial occluders and valves
 Non blocking devices (Implants or Coils)
 Irreversible non-blocking techniques (bronchoscopic thermal vapor
ablation, polymeric lung volume reduction)
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Bronchoscopic treatment of emphysema
COPD with severe EMPHYSEMA
MRC > 2
FEV1 < 50% pred
TLC > 100% pred
RV > 150% pred
Blocking devices
HETEROGENEOUS
Lower/Upper lobes
ASPIRE trial
CV +
Aeriseal
RV > 200% pred
Most diseased
lobe with
complete
fissure
HOMOGENEOUS
Upper lobes
Chartis
CV -
Lung
Scan
+
HRTC
Non-Blocking devices
Permissive
parenchymal
density
One lobe
with
perfusion
<30%
Airway
bypass
What’s going on…..
• IBV vs EBV in inducing atelectasis
• CHARTIS vs CT for CV +/-
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
What’s going on…..
First Results of the Italian National Registry for the
endoscopic treatment of pulmonary emphysema by Lung
Volume Reduction Coils
• COILS REGISTRO
Bezzi M, Failla G, Zuccatosta L, Novali M, Bonifazi M, Foccoli PF, Giustolisi M and S
Gasparini
Methods n the setting of a national registry (in three different
hospitals in Italy)
• patients with severe, heterogeneous emphysema
(FEV1<45%, TLC>100%, RV>150%)
• COILS RETRO’
• unilateral or bilateral LVR-coil Bronchoscopic
Treatment for Emphysema (BTE)
• baseline and follow-up tests: PFTs and 6MWT.
• COILS PROSPETTICO
Results over a period of 18 months
• 18 procedures in 17 patients (baseline FEV1 22.18
±5.5% predicted)
• 158 coils used, 8.8 (±1) per lobe
• 16 unilateral (15 upper lobe, 1 lower lobe) and 1 bilateral
• average procedure time 45 (36-80) minutes
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Placebo effect: The joke
Sometimes we think of a
placebo effect as
something shallow,
something that only works
for stupid people, or
something that is a joke.
How powerful are our expectations?
“for there is nothing either good
or bad, but thinking makes it so”
William Shakespeare
Hamlet, Act II, scene ii (1600)
Placebo effect with surgery
“Whatever the mind of a man can
conceive and believe, it can
achieve”
Napolean Hill
Think and Grow Rich (1937)
“A man is but the product of
his thoughts. What he thinks, he becomes.” Mahatma Gandhi
BLVR by
Lung Volume Reduction Coils
Complications
•
Mild or severe (requiring hembolization) hemoptysis
•
Pneumothorax
•
Pneumonia
•
COPD exacerbation
•
Chest pain
BLVR by
Endobronchial Valves
Complications
•
Valve migration
•
Pneumothorax
•
Pneumonia
•
COPD exacerbation
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Endobronchial valves
Complications - migration
Endobronchial valves
Complications - pneumothorax
Day after
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Endobronchial valves
Complications - pneumothorax
Dr.ssa Michela Bezzi - Endoscopia
Respiratoria , Spedali Civili di Brescia
Grazie per
l’attenzione
Michela Bezzi
Interventional Pulmonology
Spedali Civili - Brescia
Italy
michela.bezzi@spedalicivili.brescia.it