Introduction: Endoscopic lung volume reduction with endobronchial valves has been widely recognized for treating hyperinflation in advanced chronic obstructive pulmonary disease and emphysema patients. The main challenges include the technical complexity of upper lobe implantation and the number of endobronchial valves required. These issues might be addressed by placing larger diameter valves in the lobar bronchus. This study evaluated the feasibility, efficiency, and safety of the new valve PulmValve (model PV-13) in porcine models. Methods: Six PV-13 valves were bronchoscopically implanted into the caudal lobe bronchus of six healthy pigs. The procedure time, valve deployment, and removability were recorded. Follow-up examinations included blood tests, chest CT scans, and bronchoscopy at 30 min, 14 days, 28 days, and 84 days post-procedure, with necropsy and pathological evaluations after the final follow-up examination. Results: The successful in vivo deployment and removal of PV-13 valves was established, with a median procedure time of 6.5 min. The distal lung volume reduction was evident at 30 min post-operation and was persistently monitored on day 84. No migration or malfunction of any PV-13 valves was detected, but a mild angle deviation was found in 3 cases. Coughing was observed in four pigs within the first 7 days and localized granulation tissue was observed in all pigs. No cases of pneumothorax, diffuse pneumonia, or hemoptysis were detected. Conclusions: In this study, we report the successful implantation and removal of a new valve PulmValve in a short operation time. Complete lobar atelectasis was induced without device migration, malfunction, or severe complications. Further studies are warranted to evaluate the long-term, sustained effects and potential benefits in human patients.

Endoscopic lung volume reduction with endobronchial valves has been widely recognized as a treatment for advanced emphysema and chronic obstructive pulmonary disease. The main challenges include the technical complexity of implanting valves in the upper lobes and the number of valves required. These issues may be addressed by using larger diameter endobronchial valves in the lobar bronchi. The newly developed PulmValve System offers five variants of valves designed to accommodate airways with diameters ranging from 7.0 to 15.0 mm. The system is specifically designed for lobar bronchial implantation, with valve diameters within the range of 10.5–16.5 mm. Our study reports the successful implantation and subsequent removal post-placement of the PulmValve (PV-13) within a short operative time in healthy porcine models. During an 84-day follow-up period, significant atelectasis was induced in the distal lung without evidence of device migration, malfunction, or severe complications.

1.
Adeloye
D
,
Song
P
,
Zhu
Y
,
Campbell
H
,
Sheikh
A
,
Rudan
I
, et al
.
Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis
.
Lancet Respir Med
.
2022
;
10
(
5
):
447
58
.
2.
Organization WH
.
Chronic obstructive pulmonary disease (COPD)
;
2023
.
3.
Collaborators GL
.
Age-sex differences in the global burden of lower respiratory infections and risk factors, 1990-2019: results from the Global Burden of Disease Study 2019
.
Lancet Infect Dis
.
2022
;
22
(
11
):
1626
47
.
4.
Snider
GL
.
Chronic obstructive pulmonary disease: a definition and implications of structural determinants of airflow obstruction for epidemiology
.
Am Rev Respir Dis
.
1989
;
140
(
3 Pt 2
):
S3
8
.
5.
Harkin
TJ
,
Pawlowski
J
, editors.
Endoscopic treatment of chronic obstructive pulmonary disease
;
2022
.
6.
Association AL
.
Endobronchial valve (EBV) therapy
.
2023
.
7.
van Geffen
WH
,
Slebos
DJ
,
Herth
FJ
,
Kemp
SV
,
Weder
W
,
Shah
PL
.
Surgical and endoscopic interventions that reduce lung volume for emphysema: a systemic review and meta-analysis
.
Lancet Respir Med
.
2019
;
7
(
4
):
313
24
.
8.
Strange
C
,
Herth
FJ
,
Kovitz
KL
,
McLennan
G
,
Ernst
A
,
Goldin
J
, et al
.
Design of the endobronchial valve for emphysema palliation trial (VENT): a non-surgical method of lung volume reduction
.
BMC Pulm Med
.
2007
;
7
:
10
.
9.
Wood
DE
,
Nader
DA
,
Springmeyer
SC
,
Elstad
MR
,
Coxson
HO
,
Chan
A
, et al
.
The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema
.
J Bronchology Interv Pulmonol
.
2014
;
21
(
4
):
288
97
.
10.
Davey
C
,
Zoumot
Z
,
Jordan
S
,
McNulty
WH
,
Carr
DH
,
Hind
MD
, et al
.
Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial
.
Lancet
.
2015
;
386
(
9998
):
1066
73
.
11.
Kemp
SV
,
Slebos
DJ
,
Kirk
A
,
Kornaszewska
M
,
Carron
K
,
Ek
L
, et al
.
A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM)
.
Am J Respir Crit Care Med
.
2017
;
196
(
12
):
1535
43
.
12.
Valipour
A
,
Slebos
DJ
,
Herth
F
,
Darwiche
K
,
Wagner
M
,
Ficker
JH
, et al
.
Endobronchial valve therapy in patients with homogeneous emphysema. Results from the IMPACT study
.
Am J Respir Crit Care Med
.
2016
;
194
(
9
):
1073
82
.
13.
Criner
GJ
,
Sue
R
,
Wright
S
,
Dransfield
M
,
Rivas-Perez
H
,
Wiese
T
, et al
.
A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (LIBERATE)
.
Am J Respir Crit Care Med
.
2018
;
198
(
9
):
1151
64
.
14.
Criner
GJ
,
Delage
A
,
Voelker
K
,
Hogarth
DK
,
Majid
A
,
Zgoda
M
, et al
.
Improving lung function in severe heterogenous emphysema with the spiration valve system (EMPROVE). A multicenter, open-label randomized controlled clinical trial
.
Am J Respir Crit Care Med
.
2019
;
200
(
11
):
1354
62
.
15.
Klooster
K
,
van Dijk
M
,
Koster
TD
,
Slebos
DJ
.
First in human experience of the performance of the new 5.5-LP size Zephyr endobronchial valve
.
Respiration
.
2020
;
99
(
1
):
50
5
.
16.
Nada
KM
,
Nishi
S
.
Endoscopic lung volume reduction: review of the EMPROVE and LIBERATE trials
.
Mayo Clin Proc Innov Qual Outcomes
.
2021
;
5
(
1
):
177
86
.
17.
Ernst
A
,
Anantham
D
.
Bronchoscopic lung volume reduction
.
Pulm Med
.
2011
;
2011
:
610802
.
18.
Chang
AB
,
Gaffney
JT
,
Eastburn
MM
,
Faoagali
J
,
Cox
NC
,
Masters
IB
.
Cough quality in children: a comparison of subjective vs. bronchoscopic findings
.
Respir Res
.
2005
;
6
(
1
):
3
.
19.
Coxson
HO
,
Nasute Fauerbach
PV
,
Storness-Bliss
C
,
Muller
NL
,
Cogswell
S
,
Dillard
DH
, et al
.
Computed tomography assessment of lung volume changes after bronchial valve treatment
.
Eur Respir J
.
2008
;
32
(
6
):
1443
50
.
20.
Kontogianni
K
,
Gompelmann
D
,
Valipour
A
,
Gerovasili
V
,
Schuhmann
M
,
Stanzel
F
, et al
.
Efficacy and safety of the 9-mm intrabronchial valve in patients with advanced emphysema
.
Respiration
.
2020
;
99
(
4
):
333
43
.
21.
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
.
2015
;
373
(
24
):
2325
35
.
22.
Ninane
V
,
Geltner
C
,
Bezzi
M
,
Foccoli
P
,
Gottlieb
J
,
Welte
T
, et al
.
Multicentre European study for the treatment of advanced emphysema with bronchial valves
.
Eur Respir J
.
2012
;
39
(
6
):
1319
25
.
23.
Van Der Molen
MC
,
Klooster
K
,
Hartman
JE
,
Slebos
DJ
.
Lung volume reduction with endobronchial valves in patients with emphysema
.
Expert Rev Med Devices
.
2018
;
15
(
11
):
847
57
.
24.
Park
EA
,
Goo
JM
,
Park
SJ
,
Lee
CH
,
Park
CM
.
Collateral ventilation quantification using xenon-enhanced dynamic dual-energy CT: differences between canine and swine models of bronchial occlusion
.
Korean J Radiol
.
2015
;
16
(
3
):
648
56
.
25.
Lashari
BH
,
Criner
GJ
.
Advances in surgical and mechanical management of chronic obstructive pulmonary disease
.
Med Clin North Am
.
2022
;
106
(
6
):
1013
25
.
26.
Fiorelli
A
,
D’Andrilli
A
,
Bezzi
M
,
Ibrahim
M
,
Anile
M
,
Diso
D
, et al
.
Complications related to endoscopic lung volume reduction for emphysema with endobronchial valves: results of a multicenter study
.
J Thorac Dis
.
2018
;
10
(
Suppl 27
):
S3315
25
.
27.
Koster
TD
,
Klooster
K
,
Ten Hacken
NHT
,
van Dijk
M
,
Slebos
DJ
.
Endobronchial valve therapy for severe emphysema: an overview of valve-related complications and its management
.
Expert Rev Respir Med
.
2020
;
14
(
12
):
1235
47
.
You do not currently have access to this content.