Volume 11
Issue 03
OCTOBER 2023
Inside This Issue
Editorial, 2-5
Technology Corner, 6-8
Tips from the Experts, 9-14
Humanitarian News, 15-20
Best Image Contest, 21
WABIP News, 22-23
Research, 24-25
Links, 26
Gerard J. Criner, M.D.
Professor and Founding Chair, Department of Thoracic Medicine and Surgery,
Lewis Katz School of Medicine at Temple University, Philadelphia PA
Bronchscopic lung volume reduction (BLVR): Past,
Present and Promising Future
WABIP Newsletter
O C T O B E R 2 0 2 3 V O L U M E 1 1 , I S S U E 3
EXECUTIVE BOARD
Stefano Gasparini, MD
Italy, Chair
Pyng Lee, MD, PhD
Singapore, Vice-Chair
Hideo Saka, MD
Japan , Immediate Past-
Chair
Silvia Quadrelli, MD
Membership Commiee
Chair
Jean-Michel Vergnon, MD
Educaon Commiee
Chair
Ali Musani, MD
Finance Commiee Chair
Naofumi Shinagawa, MD
Japan,
Secretary General
Menaldi Rasmin, MD, PhD
Indonesia , President
WCBIP 2024
Rajesh Thomas, MD, PhD
Melbourne , President
WCBIP 2026
STAFF
Michael Mendoza
General Manager
Judy McConnell
Administrator
Kazuhiro Yasufuku
Newsleer Editor-in-chief
P A G E 2
Paents with severe and very severe COPD suer
from hyperinaon, a condion that occurs when
gas volume in the lungs exceeds the normal state at
the end of spontaneous expiraon. The lung can be
hyperinated at rest (stac hyperinaon) and/or
during exercise (dynamic hyperinaon) when ven-
latory demands are increased and expiratory mes
are reduced.
1, 2
Hyperinaon arises due to expirato-
ry ow limitaon
3
that is caused by the dual eects
of emphysematous parenchymal destrucon and
airways abnormalies (e.g., mucus obstrucon, air-
way edema, heightened bronchial tone, airway wall
remodeling). Hyperinaon contributes to dyspnea,
4
5-7
impaired exercise tolerance,
8
9, 10
an increased
number of hospitalizaons,
11
development of respir-
atory failure
12
and increased mortality.
9, 11, 13
In pa-
ents with a predominant emphysema phenotype,
stac and dynamic hyperinaon are commonly
present despite opmal medical management and
signicantly contribute to increased morbidity, mor-
tality and a severely impaired quality of life.
Various intervenons have been tried over the past
century to reduce the size of the lung in paents
with severe hyperinaon due to emphysema.
14
Most failed, or at best had short term success unl
Joel Cooper revised and modernized Oo Branigan’s
technique of bilateral lung volume reducon surgery
(LVRS) and reported remarkable improvements in
lung funcon, quality of life and exercise toler-
ance.
15, 16
Failure of others to duplicate Cooper’s
inial success led to the Center of Medicare and
Medicaid Services to suspend nancial coverage for
the treatment based on an analysis by the Agency
for Healthcare Policy Research (AHRQ) which fos-
tered iniaon of the Naonal Emphysema Treat-
ment Trial (NETT). NETT was a prospecve, randomized and
controlled mulcenter trial of bilateral LVRS plus opmal
medical therapy compared to opmal medical therapy
alone.
17
The coprimary endpoints of NETT were exercise
performance measured by a symptom limited maximal ex-
ercise test and survival with secondary endpoints of chang-
es in lung funcon, quality of life and dyspnea.
NETT demonstrated that LVRS produces stascally signi-
cant and clinically meaningful improvements in exercise
performance, breathlessness, and quality of life and in pa-
ents with upper lobe disease and venlatory limited exer-
cise performance, an improvement in survival.
18
NETT also
demonstrated that hyperinated emphysematous paents
could be sub-phenotyped based on the paern and extent
of emphysema demonstrated on chest CT and post rehabili-
taon exercise performance into subgroups of with dier-
enal magnitudes of improvements in lung funcon, exer-
cise performance quality of life dyspnea and even surviv-
al.
19
High risk for death was inially reported in a subgroup
that had diuse emphysema and FEV
1
< 20 % predicted or
DLCO < 20 % predicted and were further excluded from trial
enrollment.
20
Paents with heterogenous emphysema,
DLCO > 20% predicted and low exercise performance post
rehabilitaon had the largest and most durable improve-
ments in all clinical outcomes.
21
When surgical resecon
was performed in the regions of the lung with the least per-
fusion, paents had the greatest magnitude and durability
of improvement across all clinical outcomes.
22
Cardiopul-
monary morbidity was encountered in ~ 50 % subjects, air
leaks lasng was reported in 90 % (median duraon 7 days)
and mortality at 90 days post LVRS was 4.3% in the non-
high-risk group of paents.
19
CMS approval of LVRS was
announced in 2004, however the uptake of LVRS in the US
has been very low relave to the number of paents with
emphysema and hyperinaon (~140-185 Medicare recipi-
W A B I P N E W S L E T T E R
P A G E 3
paents with homogenous disease. Pneumothorax, COPD
exacerbaons and pneumonia appear are the major compli-
caons with BLVR, however, the morbidity and mortality are
less compared to LVRS.
What does the future hold for this therapy? I propose that
BLVR can be made even safer, more eecve, and durable
by beer paent selecon, enhanced techniques, and de-
vice development. It should be noted that the current EBV
devices are over 2 decades old since their introducon into
the clinical arena. The need for total lobar occlusion with
EBVs placed at the lobar or segmental or subsegmental lev-
els results in an all or none phenomenon- all EBVs must re-
main in place at mulple points to ensure durable success
with BLVR. Over me, displacement of an EBV by granula-
on ssue, cough or cardiorespiratory oscillaon can occur
and the likelihood increases with a greater number of im-
planted EBV devices. Newer devices that have dierent
valve dynamics to allow slower deaon, sizes and shapes
that beer conform to the airway wall to cause less granula-
on ssue development, displacement, or even larger sizes
to treat larger lobar regions with less valves are desirable
features for new EBV products.
Paent selecon is key to the procedure. Paents with dysp-
nea due to emphysema that precipitates stac and/or dy-
namic hyperinaon is the target populaon. As menoned
earlier, airways disorders are common in paents with ad-
vanced emphysema and complicate the clinical picture of
hyperinaon due to air trapping and contribute to poor
outcomes in paents undergoing BLVR with EBV. Evaluang
paents prior to BLVR with chest imaging to assess for air-
way wall thickening, mucus plugging, or airway wall inam-
maon may improve paent selecon and avoid unneces-
sary complicaons. If current ingoing clinical trials demon-
strate success in treang mucus plugging and airway wall
inammaon associated with chronic bronchis, or airways
hyperresponsiveness with targeted lung denervaon, then
perhaps BLVR with EBV as a sequenal, not inial therapy
for these types of paents may show beer outcomes.
Addionally roune assessment of lung perfusion to target
areas for BLVR regardless of the paerns of emphysema
(homogenous or heterogeneous) may improve paents’
outcomes. NETT demonstrated that when the most oligemic
secons of lung ssue were excised those paents had the
greatest magnitude and durability of improvements in lung
funcon, exercise tolerance, quality of life and survival.
22
Not all paents have uniform lobar destrucon with emphy-
sema, removing the funcon of the enre lobe during BLVR
with EBV sacrices viable with the non-viable ssue. Having
ents annually) and limited geographic availability.
23, 24
Explanaons for the poor uptake of LVRS de-
spite being approved therapy include higher than
acceptable morbidity and mortality, lack of region-
al availability, complexity of paent workup, high
procedural costs, need to refer to a specialty cen-
ter and the need for a muldisciplinary team to
evaluate and care for the paents being referred
for this therapy.
25, 26
Based on the above factors, work began on devis-
ing less invasive and costly alternaves that could
use the bronchscopic route of performing lung vol-
ume reducon. Airway plugs or Watanabe spigots
were reported to have some success in inducing
atelectasis of the target lobe.
27
The Zephyr one-
way endobronchial valve was developed by Empha-
sys Medical Inc (Redwood City, CA) to allow target-
ed lobar occlusion with simultaneous egress of
secreons and air through the one-way valve. Early
studies showed success with inducing atelectasis in
paents with severe emphysema and hyperina-
on.
28
The Intrabronchial Valve System was devel-
oped by Spiraon using the airway wall as part of
the valve system. Both endobronchial valves un-
derwent early clinical trials that failed to achieve
clinically meaningful and durable improvements in
lung funcon or radiographic reducon in lung vol-
umes.
29, 30
However, signicant informaon was
gleaned from these inial trials about the essenal
elements of successful endobronchial valve treat-
ment for bronchscopic volume reducon in emphy-
sematous paents. Based on post hoc analysis, the
key elements for successful treatment with endo-
bronchial valves was complete lobar occlusion and
the degree of heterogeneity between the target
lobe and the ipsilateral target lobe. The importance
of lobar occlusion for successful bronchscopic lung
reducon was conrmed in a prospecve and con-
trolled invesgaon.
31
Subsequent mulcentered prospecve randomized
and controlled trials have shown that endobron-
chial valves in hyperinated paents with hetero-
genous and homogenous paerns of emphysema
with intact ssures by chest CT imaging or lack of
collateral venlaon by physiologic assessment
produce clinically meaningful, stascally signi-
cant, and durable improvements in lung funcon,
quality of life and exercise tolerance with accepta-
ble side eects.
32-36
In contrast to LVRS,
bronchscopic lung reducon has similar benets in
paents treated in the upper or lower lobes and in
W A B I P N E W S L E T T E R
P A G E 4
gested that ssure closure with airway delivered sealant may
be successfully followed by EBV treatment, however, follow-
up studies are in progress.
41
Other studies using lung tensing
devices and techniques impervious to ssure integrity or col-
lateral venlaon status are currently underway and hopeful-
ly will successfully produce applicaons to address this unmet
clinical need.
The last 3 decades has shown signicant progress in address-
ing hyperinaon in paents with advanced emphysema and
irreversible airow limitaon who remain symptomac de-
spite opmal medical management. I believe the future is
bright to take a therapy that currently has signicant benet
to paents and make it beer, safer, and more available to
the paents that need it most.
References
1. O'Donnell DE. et al. COPD 2006;3(4):219-232.
2. Gagnon P et al. Int J Chron Obstruct Pulmon Dis 2014;9:187-201.
3. Hya RE J Appl Physiol Respir Environ Exerc Physiol 1983;55(1 Pt
1):1-7.
4. O'Donnell DE et al. Am J Respir Crit Care Med 1999;160(2):542-
549.
5. O'Donnell DE et al. Am Rev Respir Dis 1993;148(5):1351-1357.
6. O'Donnell DE et al. COPD 2007;4(3):225-236.
7. O'Donnell DE et al. J Appl Physiol (1985) 2008;105(2):753-755;
discussion 755-757.
8. O'Donnell DE et al. Am J Respir Crit Care Med 2001;164(5):770-
777.
9. Ozgur ES et al. Respir Care 2012;57(9):1452-1459.
10. Albuquerque AL et al. Eur Respir J 2006;28(5):939-944.
11. Casanova C et al. Am J Respir Crit Care Med 2005;171(6):591-
597.
12. Jubran A et al. Am J Respir Crit Care Med 1997;155(3):906-915.
13. Tantucci C et al. Respir Med 2008;102(4):613-619.
14. Marche N et al. Semin Respir Crit Care Med 2015;36(4):592-
608.
15. Cooper JD et al. J Thorac Cardiovasc Surg 1995;109(1):106-116;
discussion 116-109.
16. Brangan OC et al. Am Rev Respir Dis 1959;80(1, Part 2):194-
206.
17. Fishman A et al. N Engl J Med 2003;348(21):2059-2073.
18. Naunheim KS et al. Ann Thorac Surg 2006;82(2):431-443.
19. Criner GJ et al. Am J Respir Crit Care Med 2011;184(8):881-893.
20. Naonal Emphysema Treatment Trial Research Group, Fishman
A et al. N Engl J Med 2001;345(15):1075-1083.
21. Criner GJ et al. Proc Am Thorac Soc 2008;5(4):393-405.
22. Chandra D et al. Am J Respir Crit Care Med 2010;182(7):937-
946.
23. Stanifer BP et al. J Thorac Dis 2018;10(Suppl 23):S2744-S2747.
24. Abdelsaar ZM et al. Ann Thorac Surg 2021;112(3):952-960.
25. Buery S et al. ERJ Open Res 2017;3(3).
26. Criner GJ et al. Proc Am Thorac Soc 2008;5(4):461-467.
the capability of “sculpng the lung” by just treang
the disease segments may not only produce superior
clinical outcomes in terms of lung funcon and gas
exchange but also decrease the risk of pneumotho-
rax by avoiding the need for total lobar occlusion.
Pneumothorax is the unique complicaon of concern
that occurs ~ 24-34 % of the me in paents who are
collateral venlaon negave or with an intact s-
sure undergoing BLVR with EBV and total lobar oc-
clusion. With targeted lobe collapse, ipsilateral non-
targeted lobe expansion occurs, the rate and extent
of which is dependent upon the elasc recoil of the
treated lobe and the plascity of the nontargeted
lobe to expand. This potenal complicaon requires
a mandatory 72-hour hospitalizaon for observaon
and treatment of a pneumothorax and limits the
availability of BLVR at many community medical cen-
ters. Much more work needs to be done to predict
the development of a pneumothorax based on pre
procedural chest CT imagining by examining emphy-
sema paern and distribuon in the targeted and
ipsilateral nontarget lobe, esmang the potenal
volume shis of the targeted lobe into the non-
targeted lobe, the presence of pleural plaques and
adhesions, and the textural properes of the lung
being treated. Procedural technique such as paern
of mechanical venlaon, eects of high inspired
oxygen inducing reabsorpon atelectasis, choice of
anesthec approach (general vs conscious sedaon)
and procedural me may all contribute to its occur-
rence. Finally, EBV device and its inherent properes
to funcon as a one-way endobronchial valve to fa-
cilitate air egress also needs to be evaluated as a
contribung factor.
The only currently approved BLVR device in the U.S.
and most of the world is the two FDA approved EBV
devices. Only approximately 30% of the hyperinat-
ed emphysematous paent populaon has sucient
ssure intactness or collateral venlaon negave
status to use EBV to perform BLVR. Therefore, most
of the paent populaon who could benet from
lung volume reducon can only be considered for
LVRS or lung transplant- treatments that may not be
feasible for many paents due to age or comorbid
condions. Lung coils, owable adhesives and scle-
rosing agents and thermal ablaon have been stud-
ied but have failed to meet clinical endpoints to al-
low approval or have never been studied in the U.S.,
respecvely.
37-40
Early preliminary studies have sug-
W A B I P N E W S L E T T E R
P A G E 5
27. Watanabe Y MK et al. J Bronchology Interv Pulmonol
2003;10:264-267.
28. Toma TP et al. Lancet 2003;361(9361):931-933.
29. Sciurba FC et al. N Engl J Med 2010;363(13):1233-
1244.
30. Wood DE et al.. J Bronchology Interv Pulmonol
2014;21(4):288-297.
31. Eberhardt R et al. Chest 2012;142(4):900-908.
32. Criner GJ, et al. Am J Respir Crit Care Med 2019.
33. Criner GJ et al. Am J Respir Crit Care Med 2018;198
(9):1151-1164.
34. Kemp SV et al. Am J Respir Crit Care Med 2017;196
(12):1535-1543.
35. Valipour A et al. Am J Respir Crit Care Med 2016;194
(9):1073-1082.
36. Klooster K et al. N Engl J Med 2015;373(24):2325-
2335.
37. Sciurba FC et al. JAMA 2016;315(20):2178-2189.
38. Herth FJ et al. Lancet Respir Med 2016;4(3):185-193.
39. Herth FJ et al. Respiraon 2011;82(1):36-45.
40. Come CE et al. Eur Respir J 2015;46(3):651-662.
41. Ing AJ et al. Respirology 2022;27(12):1064-1072.
W A B I P N E W S L E T T E R
P A G E 6
Technology Corner
Quantave Computed Tomography of Emphysema
Introducon
Paents with advanced emphysema oen suer from breathlessness despite opmal medical treatment. When pulmonary funcon
test in these paents indicates signicant hyperinaon, lung volume reducon (LVR) by bronchoscopy or surgery may be consid-
ered to improve the paent´s quality of life. Prior to such an invasive treatment modality, accurate paent selecon is crucial to en-
sure opmal clinical outcomes. Besides pulmonary funcon tests, exercise tests, and echocardiography, mul-detector computed
tomography (CT) is an essenal diagnosc tool that conrms the presence of the emphysema, reveals emphysema extent and distri-
buon, and detects the interlobar ssures and thus the interlobar collateral venlaon (CV). Depending on these results, a decision
can be made whether a paent is likely to benet from one of the lung volume reducon procedures and from which one, or wheth-
er the paent should be excluded from these invasive treatment modalies.
Background
Nowadays, various soware techniques are available that support the CT emphysema evaluaon referred to as quantave comput-
ed tomography (QCT) [1]. One soware technology is StratX, a cloud based QCT provided by PulmonX Inc. For StratX evaluaon, the
non-contrast, inspiratory CT scan should full the following criteria: (a) all les in standard DICOM format, (b) supine posion chest
CT scans with arms posioned above the head, (c) slice thickness <1.5 mm or less and (d) slice pacing less than or equal to slice thick-
ness [2].
StratX quanes the inspiratory lobar volumes and emphysema extent and calculates the ssure integrity between the dierent
lung lobes (Figure 1). Emphysematous parenchyma is evaluated for each lung lobe by applying a density threshold of -910 Hounseld
units (HU) and -950 HU. The best correlaon between pathologically conrmed emphysema and CT measurements were shown for
a voxel density less than -950 HU, so the -950 HU threshold seems to be the opmal cut-o. The dierence between the lobar em-
physema quancaon scores indicates the emphysema distribuon. Heterogeneity is the percentage dierence in the emphysema
Prof. Dr. me. Daniela Gompelmann
Division of Pulmonology
Department of Internal Medicine II
Medical University of Vienna
Austria
W A B I P N E W S L E T T E R
P A G E 7
scores between ipsilateral lobes. Although there is no clear denion for heterogeneity, a > 10–20% dierence in the proporon of
pixels of less than −910 HUs or a > 10% dierence in the proporon of pixels of less than –950 HU is used as the criterion for hetero-
geneity [4]. Moreover, the ssure completeness will be given in % between the adjacent lung lobes which is a surrogate for the inter-
lobar CV.
The emphysema extent and the ssure integrity are also displayed graphically (gure 1): If the emphysema index (voxel density less
than -910 HU) is ≥70%, 60-70%, 50-60% and <50%, the lung lobe is colored black, dark grey, light grey and white respecvely. A s-
sure integrity ≥95; 80-90% and <8% are represented by a black solid line, a grey solid line, and a doed light grey line respecvely.
This allows the physician to see at rst glance whether there is a target lobe for a volume reducon treatment modality.
Clinical Applicaon
For each paent with symptomac advanced emphysema despite opmal medical treatment, a forced expiratory volume in 1 second
(FEV
1
) <50% and a residual volume >175% should be considered for an addional therapeuc modality that aims at LVR [4]. Thereby,
a QCT analysis of an inspiratory slice thickness CT scan is an elementary part of the preceding diagnoscs for paent selecon prior to
a lung volume reducon procedure. StratX provides the idencaon of the most emphysematous lung lobe that presents the target
lobe for volume reducon and ssure integrity. Studies have shown that the quantave analysis using the StratX soware contribut-
ed to a more objecve and ecient evaluaon of collateral venlaon compared to a visual ssure analysis [5]. Overall, a ssure with
>95%, 80-95%, and 80% completeness is dened as complete, parally complete, and incomplete, respecvely [4; 6]. Paents with a
target lung lobe, that is separated by a complete ssure from the adjacent lung lobes, will most likely benet from endoscopic valve
treatment. Paents with ssure integrity between 80 and 95% should undergo an invasive catheter-based measurement of the CV
and should be treated by valve implantaon in case of absent signicant CV. Paents with a signicant CV in the catheter-based
measurement or ssure integrity <80% should be evaluated for alternave treatment approaches such as bronchoscopic thermal
vapor ablaon or lung volume reducon surgery.
Conclusion
Paent selecon is crucial for benecial outcomes following LVR procedures. QCT by using StratX or comparable soware techniques
provides emphysema quancaon and automated ssure analysis that is superior to visual CT assessment. Therefore, QCT is recom-
mended prior to LVR procedures to select paents who will benet and to decide which LVR technique to use.
W A B I P N E W S L E T T E R
P A G E 8
References
1. Tenda ED et al. Respiraon. 2019;98(1):86-94.
2. hps://pulmonx.com/stratx-ct-parameters/. 27.08.203
3. Madani A et al. Radiology. 2006 Mar;238(3):1036-43.
4. Herth FJF et al. Respiraon. 2019;97(6):548-557. doi: 10.1159/000496122.
5. Fiorelli A et al. Interact Cardiovasc Thorac Surg. 2019 May 1;28(5):751-759.
6. Koster TD et al.. Respiraon. 2016;92(3):150-7.
Figure 1. StratX analysis of a paent with lower lobe predominant emphysema. The right lower lobe is the most emphysematous lung lobe and
thus target lobe for LVR. The ssure between the right lower lobe and the middle lobe/right upper lobe is 93.6%. The next step would be an inva-
sive catheter-based measurement of CV. In case of an absent CV, the paent would most likely benet from endoscopic valve implantaon in the
right lower lobe.
Tips from the Experts
P A G E 9 V O L U M E 1 1 , I S S U E 3
Introducon:
High complicaons of surgical lung volume reducon have led to mulple iteraons (bypass stents, thermal vapor, sealants, coils, valves,
etc.) of bronchoscopic lung volume reducon (BLVR). BLVR has been proven in clinical trials to benet quality of life and improve lung func-
on (FEV1, TLC, RV, 6-minute walk). These potenal gains in paents with severe emphysema should be weighed with the potenal for com-
plicaons, and strict paent selecon should be adhered to. Complicaons generally seen post-BLVR are acute, chronic obstrucve pulmo-
nary disease (COPD) exacerbaon/respiratory failure, pneumonia, and pneumothorax.
We present a few unusual cases of BLVR endobronchial valve (EBV) complicaons to help pulmonologists elucidate the risk/benet of BLVR
in their paents.
Case 1: Pneumothorax gone WILD:
A 59-year-old female prior smoker with severe COPD on maximum medical therapy, on 3 liters of oxygen at rest/5, liters of oxygen on exer-
on, severe dyspnea with minimal exeron, without any thoracic surgeries/radiaon, and no recent COPD exacerbaons was evaluated for
Bronchoscopic Lung Volume Reducon (BLVR). Her FEV1 was 33%, TLC 145%, RV 209%, DLCO 56%, 6MWT 265m, CT-chest without any nod-
ules or bullae. StratX and V/Q scan with le upper lobe target. Chars balloon occlusion/collateral venlaon evaluaon in the le upper
lobe/lingula showed no evidence of collateral venlaon. Zephyr valves were placed in the le upper lobe and lingula. Post-procedure chest
x-ray showed atelectasis of the le upper lobe, elevaon of le hemidiaphragm, and no pneumothorax.
One hour post-BLVR, the paent began to have chest ghtness and dyspnea. Chest x-ray revealed a large le pneumothorax. Percutaneous
le mid-axillary 14Fr chest tube placed with improvement in pneumothorax. She connued to have persistent bronchopulmonary stula
aer mulple chest tubes. She had a CT chest with large le mideld bullae, severe generalized subcutaneous emphysema, and unclear po-
sioning of the chest tube. She connued to have slowly progressive generalized subcutaneous emphysema without any change in oxygena-
on or dyspnea over two weeks. Thoracic surgery was consulted, and on post-BLVR day 18, our paent had le video-assisted thoracoscopic
surgery with lelower lobe bullectomy/wedge resecon and talc pleurodesis. Her chest tubes were removed in the following days, and she
was discharged home. She returned for her 1-month follow-up in the oce. She improved much from the pre-BLVR baseline with less dysp-
nea, improvement in exeronal capacity, and decreased oxygen requirement. Her repeat pulmonary funcon tests are pending.
Bronchoscopic Lung Volume Reducon: Complicaons Happen!
Ali Musani MD
Professor of Medicine and Surgery
Division of Pulmonary Sciences &
Crical Care Medicine
University of Colorado School of
Medicine, Denver
Nishil Dalsania MD
Intervenonal Pulmonologist,
AtlanCare Regional Medical
Center, New Jersey
Tips from the Experts
P A G E 10 V O L U M E 1 1 , I S S U E 3
Tips from the Experts
P A G E 11 V O L U M E 1 1 , I S S U E 3
Tips from the Experts
P A G E 12 V O L U M E 1 1 , I S S U E 3
Commentary:
The causes of pneumothorax in post-BLVR paents include pleural adhesions, blebs, pleural scarring, and severely damaged/fragile lung s-
sue in the treated and untreated lobes. Expansion of ny blebs into large bullae in the remaining (untreated) lobe is oen noted due to the
expansion of the lobe once the target lobe undergoes atelectasis. Persistent air leaks (Bronchopleural stula) aer BLVR requires careful
management. We usually follow conservave management with small pigtail catheters and low sucon. A muldisciplinary approach is war-
ranted in the event of failure aer a week. A CT chest and discussion with CT surgery is crical. In the presence of large bullae (not before the
BLVR) and signicant subcutaneous emphysema, the decision to remove the valves or do bullectomy with pleurodesis is considered. The nal
decision should be individualized with paents' input since some may vehemently oppose valve removal. In contrast, others would want to
remove the valves immediately, cing the valve as the problem.
The management of post-BLVR pneumothorax is oen stepwise, including removing just one valve rst and observing for resoluon of pneu-
mothorax and re-expansion of the lung. But in case of failure, all the valves can be removed. The paents should be reassured that, in most
cases, valves can be tried again. Below is an algorithm to guide the management of post-post-BLVR pneumothorax management.
Our paent had a pneumothorax, mulple chest tubes, and large bullae formed aer the valve placement and atelectasis of the le upper
lobe and lingula. With signicant persistent bronchopleural stula, unclear placement of chest tube, and large bullae, a successful VATS bul-
lectomy and pleurodesis were performed. On follow-up, the paent received all the benets from BLVR as expected.
Figure Reference: van Dijk, M et al. Respiraon. DOI: 10.1159/000516326
Case 2: Get them OUT
81-year-old male with a history of prior smoking and severe COPD was on maximum medical therapy. He also had obstrucve sleep apnea,
coronary artery disease, heart failure with preserved ejecon fracon, on 2 liters of oxygen at rest, and severe dyspnea with minimal exer-
on. He had no thoracic surgeries/radiaon history and no recent COPD exacerbaons. His FEV1 was 45%, TLC 157%, RV 194%, DLCO 60%,
Tips from the Experts
P A G E 13 V O L U M E 1 1 , I S S U E 3
6MWT 202m, CT-chest without any nodules or bullae. StratX showed the le upper lobe as the best target. Pulmonx Zephyr valves were
placed in the le upper lobe and lingula. Post-procedure chest x-ray showed atelectasis of the le upper lobe and elevaon of the le hemi-
diaphragm without pneumothorax. He was discharged without any immediate complicaons from the hospital on post-BLVR day 4.
He returned for a roune clinic follow-up at one month and three months post-BLVR with worsening dyspnea and oxygen requirements com-
pared to pre-BLVR. His pulmonary funcon tests from pre-BLVR to 1-month post-BLVR and 3-month post-BLVR, respecvely had consistent
improvements in RV (194% → 153% → 151%) and TLC (157% → 111% → 117%), although worsening of FEV1 (45% → 37% → 39%), FVC (108%
→ 71% → 75%), DLCO (80% → 58% → 57%), and 6MWT (440m → 396m → 396m). CT-chest was completed, which showed atelectasis of the
le upper lobe and lingula along with a ny bulla. During this me, he had been given mulple courses of prednisone and anbiocs for pos-
sible COPD exacerbaons without any improvement. He subsequently had all valves removed four months post-BLVR, with reinaon of his
le upper lobe/lingula, and on a 1-month follow-up visit, he returned to his pre-BLVR baseline respiratory symptoms and PFTs and 6MW.
Tips from the Experts
P A G E 14 V O L U M E 1 1 , I S S U E 3
Commentary:
Our second case delineates the importance of a perfusion scan in BLVR. We now get perfusion scans in almost all cases to ensure that our
target lobe has the lowest perfusion and that the lung le behind has good perfusion. This issue is even more crical in homogenous emphy-
sema. Our paent most likely had good perfusion to the lobes, collapsed with valves, and suered respiratory decline due to a decrease in
venlaon perfusion. By understanding the lung volumes, perfusion, and physiologic principles of BLVR, we can avoid some of the complica-
ons, and if they do occur, we can reverse them, as in this case.
Conclusion:
The goal of endobronchial valve placement is atelectasis of the target lobe(s) in ancipaon of allowing the remaining lung parenchyma to
expand and provide objecve and symptomac benets. With this goal, there can be repercussions; some unusual ones are described in the
above cases. These complicaons are typically due to lung adhesions, rapid expansion of remaining lobes, rupture of bullae or blebs, and
poor lung parenchyma. The complicaons can be devastang and should be clearly weighed with paent discussion before the valve place-
ment. If these complicaons arise, contemplaon of lung physiology and all possible treatment opons should be reviewed. Having a strong
suspicion of complicaons, thinking outside the box, and having muldisciplinary resources to deal with possible devastang complicaons
are necessary for bronchoscopic lung volume reducon.
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W A B I P N E W S L E T T E R P A G E 15
STRIKING A BALANCE: ADDRESSING INEQUITY IN THE FACE OF RISING DRUG
COSTS AND BIG PHARMA'S COMMERCIAL INTERESTS
Healthcare providers are bound to make subopmal treatment judgements. Healthcare professionals in most countries work
within intricate and fragmented systems that oen lack sucient evidence. While it is true that every paent is unique, it is
important to note that the majority of current research tends to concentrate on paent groups that share similar character-
iscs. The enhancement of the connuum of drug development, approval, funding, and prescripon is crucial for medical
researchers, regulatory bodies, insurance providers, and accountable care organizaons, despite the challenges posed by
these disncons. The importance of this is especially signicant when considering costly medicaons that have proven to
be ineecve. In order to sustain the healthcare system in the long term, it is necessary to establish a thorough framework
that supports fair and ecient therapeuc choices.
The increasing costs pose a challenge for funding innovave medicaons in this situaon. One aspect to consider is the ac-
quision of sucient nancial resources to meet the increasing demand for drugs. Addionally, it is important to implement
strategies that will improve the process of introducing new drugs. According to data from 2015, the total expenditure on
pharmaceucals by OECD countries exceeded $800 billion. The signicant rise in spending on new hepas C and oncology
drugs is the main factor behind this upward trend. The allocaon of health expenditures to pharmaceucals varies signi-
cantly between developing and transioning naons, ranging from 20 to 60 percent. In comparison, OECD countries allocate
a lower proporon of 18 percent towards pharmaceucals. In low-income countries, a signicant poron of the populaon,
up to 90 percent, relies on personal funds to purchase medicaons. This implies that medicines rank as the second-largest
household expense, following food. As a result, a considerable number of people around the globe face dicules when it
comes to obtaining aordable medicaons.
Over the course of the last decade, there has been a signicant increase in the cost of novel cancer drugs, with prices mul-
plying by up to ten mes their original value. The observed trend has played a signicant role in the overall rise in the cost of
cancer medicaons. Cancer therapies have become the primary focus of pharmaceucal spending in developed markets. The
global sales of cancer medicaons in 2015 were $107 billion, which represented a signicant increase of 11.4% compared to
the previous year. The increase in queson can be aributed to two main factors: the growing occurrence of cancer and the
increasing expenses associated with pharmaceucals. Projecons indicate that there will be a signicant rise in new cancer
cases, reaching 21.4 million annually by 2030. This increase is expected to have a notable impact on the nancial burden
associated with cancer-related healthcare. The high costs of premium-priced medicines, especially in the eld of oncology,
are worrisome due to a lack in many new drugs of clear therapeuc benets. According to independent drug informaon
journals, the majority of new drugs are found to have limited or nonexistent health benets compared to exisng therapies.
The evidence suggests that in the pharmaceucal industry, increases in prices do not always correspond directly to the level
of benets provided. The signicant rise in oncology drug prices over the past decade serves as a notable example within the
eld of cancer research. The rise in costs, combined with the observaon that a signicant poron of new drugs oer mini-
mal or no extra advantages, raises concerns about the sustainability and ecacy of exisng pharmaceucal pracces.
But not only cancer drugs have outraging prices. In the new scenario, the issue of funding for medicaons for orphan diseas-
es is challenging due to the increasing costs involved and the lack of sucient and trustworthy data in many diseases. The
presence of emoonal complexity within these disorders adds a layer of complicaon to the situaon. Taking into account
the proliferaon of new costly drugs for low prevalence diseases, according to projecons, the global expenditure on orphan
pharmaceucals was expected to reach $178 billion by 2020, which is equivalent to the amount spent on cancer treatment.
That potenal impact of orphan drugs worsens the current dicult situaon.
A deliberate balance is needed due to price and nancial constraints. The possible downsides of these issues in light of their
benets to pharmaceucal rms in smulang the development of new treatments to sasfy unmet medical needs must be
considered. Sovaldi and Harvoni, two hepas C drugs, have also garnered aenon. Sovaldi costs $84,000 and Harvoni
$95,000 for a 12-week course. Although they may cure Hepas C, their total impact is hard to assess. Since these therapies
can avoid liver cancer, liver failure, transplants, and disease spread, their advantages are clear. Hepas C killed 20,000 peo-
ple in 2013. Like the cancer medicaons discussed previously, paents who cannot pay or qualify for discounts face a di-
cult situaon. Sofosbuvir, known as Sovaldi in the US, was once priced at $1,000 per tablet, making it expensive even for
robust economies. Pharmaceucal rm Gilead charges £35,000 for a 12-week UK treatment cycle. Some people need a 24-
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W A B I P N E W S L E T T E R P A G E 16
week therapy schedule. The persistent danger of hepas C and the transforming power of these drugs make universal ac-
cess crucial. It became evident that no government had enough money to help everyone. The UK Naonal Instute for
Health and Care Excellence (NICE) authorized hepas C medicaons if Gilead oered a discount. Despite the potenal cost
savings from eliminang expensive Naonal Health Service (NHS) operaons like liver transplants, the UK government has
been reluctant to cover 160,000 aected people. The NHS has tried an innovave approach by phasing in medicines. This
method priorizes the sickest and delays adopon for others. This remarkable move represents a new healthcare delivery
model. The decision to delay NICE-approved medicine implementaon is a major deviaon from standards. The authories'
decision underlines the complexity of balancing healthcare goals with naonal healthcare systems' nancial limits.
The annual growth rate of new medicine introducons from 2008 to 2021 was 20%. In 2020-2021, the market acquired 47%
of the innovave medicines that had inial costs exceeding $150,000. Despite ancipated manufacturer discounts and alter-
aons in drug characteriscs, such as cancer and specialty drugs like injectables and biologics, the upward trend persisted
with an annual growth rate of 11%. The cost of these newly developed drugs, which are safeguarded by 20-year patents, can
amount to hundreds or even thousands of pounds per package. But government may implement strategies to decrease the
impact. In 2015, the UK implemented the breast cancer medicaon Kadcyla, which had a price tag of £90,000 per paent
annually. The outcome of the negoaons led to a substanal reducon in the NHS.
The challenge of escalang drug prices extends beyond newly developed medicaons, indicang a pervasive trend that sur-
passes the rate of price hikes observed in other healthcare services. A staggering 71% of pharmaceucals acquired through
Medicaid have witnessed price increases, highlighng a prevalent and persistent issue. Global healthcare systems are grap-
pling with an escalang burden. According to NHS England, the esmated annual spending on pharmaceucals in 2017 was
£16 billion, with £9 billion specically earmarked for general praconers' prescripons. Furthermore, this expenditure has
been increasing at a rate of 7% per year, outpacing the overall growth rate of the NHS budget and signicantly dispropor-
onate to inaon.
Manufacturers commonly implement price hikes aer the launch of pharmaceucal products, resulng in an average annual
increase of 4.5% in net pricing from 2007 to 2018. A noteworthy case is the substanal price surge of Mylan's EpiPen, sky-
rockeng by over 500% from 2007 to 2016, escalang from just under $100 to over $600. AbbVie's rheumatoid-arthris
medicine Humira also experienced a signicant price hike from $19,000 to $60,000 per year between 2012 and 2019, even
with discounts factored in. Another distressing example is the threefold increase in insulin costs from 2002 to 2013. This
surge in insulin prices has severe nancial implicaons, leading to instances of self-raoning among certain paents, posing
signicant risks, some of which can be life-threatening. It is uerly unacceptable that a life-saving drug remains inaccessible
to individuals in need. This example underscores the crical need to address the systemic issue of escalang medicaon
costs, parcularly for essenal medicaons.
The inuence of pharmaceucal pricing and regulaons extends signicantly to both paents and physicians. The imposion
of prior authorizaon requirements not only hinders and delays access to healthcare but also results in adverse clinical out-
comes. As indicated by a recent survey, a substanal 75% of physicians have reported instances where paents disconnued
their treatment due to the onerous demands of prior authorizaon. Furthermore, 28% of physicians observed severe ad-
verse events directly linked to these prior authorizaon requirements and the resulng unavailability of essenal medica-
ons. Notably, 25% of diabec paents chose to reduce their insulin intake below the prescribed amount in a cost-cung
eort, and approximately one-third of these paents opted not to disclose this informaon to their healthcare providers.
Exorbitant drug prices have not only aected paent care but have also added an extra burden on physicians. Physicians
invest a signicant amount of me, averaging 14.9 hours per week, in administrave tasks such as compleng prior-
authorizaon paperwork, making phone calls, and fullling procedural dues. Within this meframe, physicians typically
submit an average of 31 prior authorizaon requests. Physicians and their sta play a crucial role in interpreng coverage
regulaons and conveying them to paents, serving as the primary source of informaon as paents navigate their treat-
ment choices within coverage plans.
What factors contribute to the determinaon of drug prices? How can we dene is the price of a medicaon is fair?
The escalang and considerable costs of medicaons have sparked public apprehension across a spectrum of naons. A sur-
vey involving 1500 paent groups in 78 countries revealed that merely 9% considered pharmaceucal companies to possess
"excellent or good" fair pricing policies. This percentage has uctuated between 11% and 15% since the survey's iniaon in
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W A B I P N E W S L E T T E R P A G E 17
2011.1 A heated discourse among policians, experts, physicians, paents, and pharmaceucal execuves has ensued, re-
volving around the equitable pricing of medicines, yet consensus on the denion of "fairness" remains elusive. The drug
pricing debates revolve around the intricate calculaons of costs and the inclusion of various factors.
Pharmaceucal corporaons argue that the cost of a medicine includes expenses related to research and development
(R&D), even for drugs that do not ulmately make it to market. Clinical trials, which are conducted to ensure the safety and
eecveness of medical intervenons, require signicant nancial resources, oen amounng to millions of dollars. The
process of drug development is characterized by its unpredictability, as a signicant number of potenal candidates ul-
mately fail or exhibit adverse eects in human trials, despite inially showing promise in laboratory or animal studies. This
inherent uncertainty in drug development poses a considerable nancial burden. Pharmaceucal companies argue that in-
corporang the expenses of unsuccessful medicaons is essenal for funding connuous research. The Tus Centre for the
Study of Medicaon Development in Boston agrees with this statement, highlighng the signicant me and nancial invest-
ments required for medicaon development.
But many disagree with its logic. Olivier Wouters, PhD, associate professor of economics and polics at the London School of
Economics and Polical Science, quesons the idea that high R&D expenditures jusfy high medicine prices. Wouters and
colleagues from UC San Diego's Skaggs School of Pharmacy and Pharmaceucal Sciences studied 60 new FDA-approved med-
icaons from 2009 to 2018. R&D costs did not aect medicine pricing, contrary to forecasts. The sciensts also discovered
no associaon between price and therapeuc value. These data challenge the idea that increasing R&D spending raise medi-
cine pricing. “Our ndings show that drug companies do not set prices based on R&D spending or drug quality. Instead, they
charge what the market will bear”.
As an example the price of Zolgensma has sparked debate and disagreement. Pharmaceucal companies argue that the im-
plementaon of high prices is essenal in order to recover the costs incurred during research and development. In 2019,
Novars introduced Zolgensma, a gene-altering injectable medicaon that is considered the most expensive in the world. It
is priced at $2.1 million for a single treatment, targeng an uncommon genec condion that is fatal for children. Crics ar-
gue that Novars, the drug's marketer, should not be credited with the research and development of Zolgensma. In addion,
the company strategically acquired AveXis, the developer of Zolgensma, with the expectaon of achieving swi cost recov-
ery. There is disagreement among parents of children who have beneted from Zolgensma. The cost of $2,100,000 is jus-
ed by their belief that it can potenally save their future generaons. According to these parents, the expenses associated
with in-home care, venlators, and frequent hospitalizaons could potenally surpass the overall cost of Zolgensma treat-
ment over a person's lifeme.
Companies' claim that high medicaon prices are due to a compeve market is untrue since drug pricing does not follow
free market principles. Medicine prices are higher in some naons due to monopoly-like safeguards. Patents protect against
compeon and encourage bargaining, extending market exclusivity. In the meanwhile, the secrecy of drug pricing is main-
tained. In order to share informaon relevant to the transparency of health product markets, including investments, incen-
ves, and subsidies, WHO would need to "evaluate the feasibility and potenal value of establishing a web-based tool." At
the moment, manufacturers' prices are enrely subjecve, opaque, and discreonary, with lile accountability.
Commercial organizaons, including BigPharma, are primarily driven by the desire to maximize their prots. But the accepta-
bility of high prot margins, especially for necessies, raises a crucial moral queson. Mulple studies have provided evi-
dence of the impact of a nancialized business model on pharmaceucal companies. These studies highlight the shi in pri-
ories, where these companies have moved away from making investments that benet a larger populaon and instead
priorize maximizing prots for their shareholders. The nancial stability of a company can be assessed by analyzing various
indicators such as the size of its balance sheet, the amount of dividends paid to shareholders, and the proporon of valuable
assets held by the company. When these events take place, a company's approach shis from focusing on manufacturing
goods and providing services to priorizing the generaon of revenue. The negave impact of this situaon can be observed
in the hindered growth of producvity, investments in xed capital, research and development (R&D), and labor force parc-
ipaon. The cash reserves of 27 companies experienced a signicant increase over the span of 18 years, rising from US$83
billion in 2000 to US$219 billion in 2018. The allocaon of funds to shareholders has experienced a signicant increase over
the years, rising from 88% of total R&D expenditure in 2000 to 123% in 2018, amounng to a substanal sum of US$146 bil-
lion. This growth can be aributed to dividends and share buybacks. The use of drugs is crucial for the well-being of individu-
als, and their availability directly impacts human lives. It is doubul that pharmaceucal companies can sustain their pursuit
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W A B I P N E W S L E T T E R P A G E 18
of prots, as they oen rely on low-cost borrowing and monopolisc income from intangible assets. While some argue that
high drug prices are necessary to oset research and development expenses, studies suggest that the signicant price dier-
ence between the United States and other naons would enable companies to not only cover their R&D costs but also gen-
erate substanal prots.
Pharmaceucal corporaons, like other businesses, priorize shareholder prot while following laws. But priorizing private
prots over public well-being, especially when it threatens a fundamental human right like healthcare, raises grave ethical
concerns. Turing Pharmaceucals, founded by former hedge fund manager Marn Shkreli, was notorious for drascally rais-
ing Daraprim prices from $13.50 to $750 per pill. The annual treatment costs somemes exceeded hundreds of thousands of
dollars. The company's juscaon that the price raise was to fund toxoplasmosis therapeuc research and development
has been cricized for hiding pharmaceucal greed. Daraprim's eecveness and low side eects exacerbate this response.
Shkreli's forthright statement at the Forbes Healthcare Summit that prot maximizaon took the topic to scandalous propor-
ons. While Valeant and Rodelis Therapeucs have used similar pricing strategies to acquire specic medicaons, Shkreli's
acons sparked widespread public outcry and heightened scruny on this issue, and his transparency in revealing the under-
lying objecves, pricing strategies, and operaonal mechanisms of a healthcare system oen shielded from such candid dis-
cussions was notable. He proved that Turing Pharmaceucals raised Daraprim's price from $18 to $750 per pill just because
they could.
During his keynote address at the Medicine X conference, Peter Bach, MD, the director of Memorial Sloan Keering's Centre
for Health Policy and Outcomes, expressed concerns about the acons of pharmaceucal companies. According to Peter B.
Bach, there is a general consensus that drug pricing in the United States lacks raonality, with the pharmaceucal industry
having complete control over prices. This reects a widespread appreciaon of the issue. Pharmaceucal companies oen
establish prices and try to discourage discussions about costs by emphasizing the importance of innovaon. This implies that
any measures to restrict prots could potenally hinder the progress of creang life-saving medicaons. Implemenng the
framework for decision-making necessitates access to typically condenal informaon regarding research and development
(R&D), manufacturing, and distribuon costs. The absence of cost transparency impedes aempts to assess the reasonable-
ness of drug prices and exacerbates the informaon asymmetry in favour of sellers. Nonetheless, disclosure may be mandat-
ed by law, regulaon, judicial acon, or as a condion for receiving public research funds, tax benets, regulatory approval,
or reimbursement formulary inclusion. In the absence of such disclosure, decision-makers may rely on publicly available in-
formaon to make reasonable esmates. At least as ordinary cizens, physicians should advocate for greater cost structure
transparency with their elected ocials.-
Big Pharma has spent $2.5 billion lobbying for medicaon pricing policies over the previous decade (OpenSecrets, 2018).
Pharmaceucal trade organizaons like PhRMA and BIO spent $277 million on federal government lobbying in 2017. Accord-
ing to CREW, 153 rms lobbied on medicine prices in 2017, a fourfold rise from previous years, 22 of these companies were
among Forbes' top 25 worldwide pharma/biotech corporaons, demonstrang sector dominance. On the other hand, re-
markably, pharmaceucal companies wield substanal inuence over paent advocacy groups. For instance, the Leukemia
and Lymphoma Society receives a staggering $50 million annually from drug makers, constung approximately 16 percent
of their funding. The Naonal Paent Advocate Foundaon relies on the pharmaceucal industry for 60 percent of its $2
million budget. This inuence has the potenal to se crucial voices in the policy discourse on escalang drug prices, parc-
ularly in the context of cancer or childhood potenally fatal diseases. Paents and their advocates are more concerned
about the prospect of curing diseases than the specic costs associated with individual drugs, regardless of their nancial
implicaons, and their voice is a powerful one because the emoonal impact of personal histories..
The expiraon of drug patents can lead to the availability of inexpensive generic copies, which has the potenal to reduce
healthcare costs. In recent years, advancements in technology have made it possible to produce cheap copies even of com-
plex biologics, which have demonstrated their eecveness in various cases. For instance, the Royal Marsden cancer hospital
in London saved £80 million in one year by using a biosimilar of rituximab for lymphoma treatment. Similarly, the NHS could
potenally save £200 million to £300 million annually by ulizing a biosimilar version of trastuzumab (Hercepn). However,
concerns arise for paents with life-threatening diseases who cannot aord to wait for patents to expire.
Organizaons like Médecins Sans Fronères and the UN have been advocang for fair access to vital medicines, arguing that
they should not be considered a luxury but a basic right. The World Health Organizaon (WHO) supports the idea of univer-
sal medicaon access and maintains a list of crical drugs that all countries should have in stock.
Humanitarian News
W A B I P N E W S L E T T E R P A G E 19
Pharmaceucal corporaons are prot-driven, only one aspect of the problem. Drug price is systemic, and payers and pro-
viders share responsibility. The government is crucial in ensuring access to expensive drugs that increase survival or quality
of life. This obligaon arises from the government's commitment to public health, cizen rights, and fair and equal access to
crical healthcare. The degree of regulaon imposed by the laws and the proporon of the naonal budget allocated to
health care are also government prerogaves (at least in middle or high income countries). The accessibility of new pharma-
ceucals and technologies is directly impacted by decisions regarding the level of taxes levied on exceedingly high income or
non-producve acvies (such as the nancial sector) and whether tax payers' money will primarily fund armed conicts or
social security. As regular people, physicians should include as a reason for their polical elecons their policies on the
maer.
Eorts to address exorbitant drug prices have given rise to numerous policy soluons, a detailed analysis of which goes be-
yond the scope of this column. Mulple factors contribute to the problem of (excessively) high prices, which can only be re-
solved through a combinaon of targeted policies, regulatory measures, and stakeholder cooperaon. Achieving substanal
change is undeniably challenging. Meanwhile, physicians grapple with a fundamental ethical dilemma: nding a balance be-
tween advocang for cancer or orphan disease paents and responsibly managing social resources. While ethical scholars
are divided on whether physicians should always priorize their paents, considering the direct impact on paent care
prompts reecon on how to make conscienous and responsible decisions.
Physicians may have limited polical inuence, but professional organizaons have the ability to eect change. Pharmaceu-
cal companies that engage in price proteering should be held accountable. Ignoring the cost of cancer or rare diseases care
may ease the consciences of medical professionals, but it would be unethical and scally irresponsible, potenally burdening
taxpayers or other insured individuals. Since the majority of new targeted cancer medicines are only marginally eecve, the
cost-benet rao of drugs is substanal. Dierent payers and mainly health care authories could negoate substanal re-
ducons, so healthcare systems, governments, and medical sociees should advocate to inuence legislaon and regula-
ons. When exisng laws limit such consideraons, advocacy and policy changes are necessary. To ensure equity, allocaon,
and paent welfare, scienc sociees should establish benchmarks for cost-eecve benets, such as requiring expensive
pharmaceucals to increase life expectancy. Doctors must collaborate with professional associaons and provide individual-
ized paent counselling in order to full their moral obligaons and protect paents from preventable medical and nancial
damage.
The Hippocrac Oath binds physicians as advocates for their paents' health, but their economic role is frequently over-
looked. Doctors are responsible for controlling prices and helping paents aord treatments. Due to their ignorance of drug
costs, physicians' economic contribuons are undervalued. Physicians frequently misesmate prescripon costs due to a lack
of communicaon between healthcare enes. Oncologists and specialists in uncommon diseases may be incenvized to
recommend parcular treatments, jeopardizing their dual role as paent advocates and healthcare organizaon representa-
ves. Capitated payment systems may force physicians to juggle paent and organizaon obligaons. Because physicians
regulate demand, pharmaceucal corporaons target them for promoonal expenditure. Promoon that is persuasive ra-
ther than informave increases prices, prescribing frequency, and quality decline. The lack of cost knowledge among physi-
cians, parcularly for insured paents, impedes prudent paent expenditure. System-level reforms to opaque medicaon
pricing, coverage decisions, and challenging prescripon coverage are needed to enhance paent care in the healthcare sys-
tem. It can be argued that physicians are oen inuenced by pharmaceucal corporaons' persuasive promoons that in-
crease prices and prescribing frequency. Physicians must engage in crical thinking and make well-informed decisions, fol-
lowed by appropriate acons. Ignoring the current topic is not a viable strategy as they are urged to fulll their moral obliga-
ons by protecng paents from both unnecessary medical and nancial harms, necessitang collaboraon with profession-
al organizaons and individualized paent guidance.
The research conducted in Norway reveals that there is widespread support for explicit criteria-based priority seng, which
aligns with the country's legal framework that guarantees access to essenal healthcare. The parcipants in the study recog-
nized the signicance of priorizaon and understood the need to allocate resources carefully. But the discussions surround-
ing the role of physicians as paent advocates and gatekeepers raised concerns about potenal conicts of interest. The lack
of trust in the raoning process can be aributed to various factors, including limited involvement, inconsistencies in raon-
ing standards, and doubts about the transparency and eecveness of dispute resoluon mechanisms. In general, physicians
do not wish to be involved in the design of health care policy, cost-controlling strategies, or raoning discussions. But they
Humanitarian News
W A B I P N E W S L E T T E R P A G E 20
must acknowledge that de facto raoning is already widespread and decisions are being made by people who do not neces-
sarily priorize the benet of the paents. Teen suicide rates exceed the combined age-related fatalies of main health con-
dions, however, the majority countries do not invest signicantly in mental health coverage or programs. Millions of chil-
dren are aected by adverse emoonal or physical traumac childhood events, and it has been known for a decade that
mulple adverse childhood events increase mortality risk. Even when childhood trauma shortens a vicm's life and aects
future generaons, few naons allocate a poron of their health care budget to prevenng these events or their conse-
quences. Overall, the obesity epidemic, which kills 300,000 people yearly, is a signicant public health issue, predominantly
(although not only) in highly developed countries . Not surprisingly, there are few programs and no large-scale iniaves to
make a dierence. These pressing concerns at hand require prompt intervenon, although they are mostly overlooked,
along with the majority of prevenve acons, due to a lack of comparable lobbying as compared to expensive pharmaceu-
cal intervenons.
Healthcare and pharmaceucal manufacture are complex and expensive dicules, creang moral quandaries for govern-
ments entrusted with providing healthcare to their inhabitants. Coverage systems dier between naons due to dierences
in historical circumstances, ethical beliefs, and priority classicaons. While praccally every country recognizes healthcare
as a core human right, medical treatment cost and aordability vary. Globally, physicians agree that it is unacceptable that
paents risk terrible consequences, including death, owing to the inability to buy crical prescripons such as insulin. Insulin,
which was designed to be widely available, has regreably become a tragic symbol of a system in which business oen takes
precedent above human wellbeing.
Physicians have the ethical obligaon to ensure that their paents have access to safe and eecve medicaons that can
improve their lives. It is our responsibility as members of a professional community to advocate for the formulaon and exe-
cuon of naonal policies in our naons that improve the availability and cost of vital medicaons. Furthermore, we should
urge medical associaons to implement strict ethical norms for scienc informaon sharing, ensuring that pricey medica-
ons provide meaningful advantages that jusfy their revoluonary prices. Most importantly, as individual praconers, we
must make educated and responsible judgements that priorize paent well-being over possible unspoken gains linked with
choosing more expensive pharmaceucals or overusing therapies with minor benets. Physicians act as demand gatekeep-
ers, they must use their power to protect their paents' rights while minimizing harm to the healthcare system's sustainabil-
ity and prevent the amplicaon of unacceptable inequies in healthcare access.
References:
1. Brennan T et al. JAMA, 2014; 312(6): 593.
2. Cameron A et al. The Lancet. 2019; 373(9659): 240–249.
3. Fleck L et al. AMA Journal of Ethics. 2017; 19(2): 147–156.
4. Reynolds E. L. et al. Neurology. 2020; 94(13): e1415–e1426.
5. Rome B. N et al. JAMA. 2022; 327(21): 2145.
6. Rosenthal E. JAMA Internal Medicine. 2019; 179(1): 114.
7. Simoens S et al. Appl. Health Econ. Health Policy. 2012; 11(1): 1–3.
8. Tsou A. Y et al. Neurology. 2021; 97(14): 685–692.
9. Wouters O. J et al. JAMA Network Open. 2022; 5(9), e2218623.
*The views expressed in this arcle are those of the author (Silvia Quadrelli) and do not necessarily reect the ocial posi-
ons of the Execuve Board or Internaonal Board of Regents of the WABIP.
Best Image Contest 2023 (3 of 3)
Descripon: ENDOBRONCHIAL TB - TUMOR TYPE
Central Airway Obstrucon due to endobronchial tumorous type of tuberculosis
A. CT scan showing RMB polypoid mass with extraluminal extension
B. Mobile large growth in the distal trachea on the right side causing ball valve eect at the carinal level . The
histopathology suggesve of Granulomatous inammaon with necrosis
Submier(s): Harikishan Gonuguntla, Pree Vidyasagar, Sai Samrat
Best Image Contest
P A G E 21
This image is 1 of 3 selected among 100+ submissions to our Best Image Contest held in late 2022. Our next
Image Contest will open later this year. We look forward to receiving your image submissions.
P A G E 22
WABIP News
Inving you to Bali Indonesia for WCBIP 2024
Dear Colleagues,
On behalf of the World Congress of Bronchology and Intervenonal Pulmonology (WCBIP) in Conjuncon with
Naonal Congress of Indonesian Society of Respirology (ISR), it is my great pleasure to invite you to join us in Bali,
Indonesia for the upcoming the 23rd Congress of the WCBIP, October 23rd – 27th, 2024 organized by WABIP, In-
donesia Society of Bronchoscopy, and Indonesian Society of Respirology.
World Congress of Bronchology and Intervenonal Pulmonology (WCBIP) in Conjuncon with Naonal Congress
of Indonesian Society of Respirology will convene about 500 parcipants from Indonesia and 1000 parcipants
from all around the world. This meeng will be aended by the expert in the eld of Bronchology and Interven-
onal Pulmonology. Furthermore, in Naonal Congress of Indonesian Society of Respirology will be aended by
the expert in pulmonology infecon, thoracic oncology, asthma and chronic obstrucve pulmonary disease, and
also intersal lung diseases. In this meeng, we are developing an aracve programme with enhanced scien-
c and educaonal sessions to explore the latest developments, medical advances and breakthrough in the
management of pulmonology and respiratory illness. Recognizing the value of closer industry cooperaon, this
congress will also provide opportunies for meaningful engagements between you and key opinion leaders, high
prescribers, and other respiratory medicine professionals.
WCBIP and ISR Naonal Congress 2024 thus represents an opportunity to share your products and services with a
capve medical community. As a congress sponsor, you not only have the chance to broaden your reach, but you
also will nd more informaon on strategic opportunies to gain valuable faceme with your target audience and
to achieve the depth of scienc exchange that we aim to achieve.
We look forward to partnering with you in our endeavors to promote clinical excellence in the eld of respiratory
medicine. Visit the congress website at hps://www.WCBIP.org for more details.
Yours Sincerely,
Menaldi Rasmin
Congress President
WCBIP-ISR Naonal Congress 2024
hps://www.WCBIP.org
P A G E 23
WABIP News
The Bronchoscopic Revoluon Connues!
Bronchoscopic Treatment of Emphysema
Emphysema, a debilitang and oen life-threatening condion, has long challenged the medical community. For decades, paents with upper lobe
dominant emphysema and low exercise tolerance found a glimmer of hope in Lung Volume Reducon Surgery (LVRS), as shown by the Naonal
Emphysema Treatment Trial (NETT), a procedure that promised improved mortality and quality of life. However, the widespread applicaon of
LVRS has been hampered by its high morbidity and mortality rates. In the United States, less than 150 paents receive LVRS annually, leaving mil-
lions of emphysema suerers without eecve treatment opons. Globally, the situaon is even more dire due to connued smoking and limited
access to transplantaon and alternave treatments.
Over the past two decades, the pulmonary community has dedicated signicant eorts to developing minimally invasive Bronchoscopic Lung Vol-
ume Reducon (BLVR) techniques. BLVR operates on a concept akin to surgical lung volume reducon but achieves the damaged lobe's atelectasis
(lung collapse) by blocking its airway. This process redirects air to relavely healthier lung regions, enhancing gas exchange and reversing the debil-
itang symptoms of Chronic Obstrucve Pulmonary Disease (COPD).
Tradionally, LVRS has held the "Gold Standard" status for emphysema treatment despite mounng evidence suggesng otherwise. BLVR has
emerged as a less morbid and mortal alternave, with shorter hospital stays and conceivably reduced costs. Moreover, BLVR is oen reversible
when conducted with valves, a feature that adds to its appeal. It is not uncommon for the medical community to take me to embrace paradigm-
shiing modalies, even when the evidence clearly supports their ecacy.
One approach to demonstrang the eecveness of a new treatment modality is to conduct a head-to-head comparison with the established
"Gold Standard." Such a study was undertaken by Buery SC et al. in the UK (1). This mulcenter, single-blind, parallel-group study involved pa-
ents eligible for both LVRS and BLVR. The study aimed to compare outcomes at the one-year mark using the i-BODE (body mass index, airow
obstrucon, dyspnea, and exercise capacity) score.
Editor-in-Chief: Dr. Kazuhiro Yasufuku
Research
Primary Business Address:
Kazuhiro Yasufuku, Editor-in-Chief WABIP
Newsleer
c/o Judy McConnell
200 Elizabeth St, 9N-957
Toronto, ON M5G 2C4 Canada
E-mail: newsleer@wabip.com
P A G E 24
Associate editor:
Dr. Ali Musani
Associate editor:
Dr. Sepmiu Murgu
Ali I. Musani MD, FCCP
University of Colorado School of Medicine,
Denver
Eighty-eight parcipants (48% female, age 64.6±7.7 years, FEV1 predicted 31.0±7.9%) were recruited at ve specialist centers and random-
ized to either LVRS (n=41) or BLVR (n=47). At 12 months follow-up, the complete i-BODE was available in 49 parcipants (21 LVRS/28 BLVR).
Neither improvement in the i-BODE score (LVRS −1.10±1.44 versus BLVR −0.82±1.61; p=0.54) nor its individual components diered between
groups. Both treatments produced similar improvements in gas trapping (residual volume percent predicted: LVRS −36.1% (95% CI −54.6–
−10%) versus BLVR −30.1% (95% CI −53.7– −9%); p=0.81). There was one death in each treatment arm.
The study conducted by Buery SC et al. underscores no signicant dierence in the outcomes of LVRS and BLVR aer one year of follow-up
in paents eligible for both procedures. BLVR, in this study conducted with endobronchial Zephyr valves from Pulmonx, CA USA, demon-
strates its eecveness as a treatment opon for emphysema, challenging the tradional "Gold Standard" of LVRS.
However, it is essenal to acknowledge that BLVR may not be suitable for all paents, parcularly those with posive collateral venlaon.
In such cases, alternave BLVR modalies or LVRS may be more appropriate.
The benets of BLVR, including lower morbidity and mortality, shorter hospital stays, and reversibility (in cases using valves), posion it as
the preferred opon for many paents. Moreover, the potenal for paents to remain on the lung transplant candidacy list aer BLVR oers
them an improved quality of life while potenally delaying the need for transplantaon.
In conclusion, Bronchoscopic Lung Volume Reducon has the potenal to revoluonize the treatment of emphysema, oering hope and
relief to millions of paents who have long suered from this debilitang condion. As more studies and clinical experience accumulate,
BLVR will likely connue to gain recognion as a viable alternave to the tradional surgical approach, ulmately reshaping the landscape of
emphysema treatment.
Reference:
1. Buery SC et al. Eur Respir J 2023; 61: 2202063 [DOI: 10.1183/13993003.02063-2022].
Research
P A G E 25
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26
WABIP ACADEMY- WEBCASTS
The WABIP has started a new educaon project recently: THE WABIP ACADEMY. The WABIP Academy will pro-
vide free online webcasts with new and hot topics that will interest pulmonologists and intervenonalists.
Current webcast topic: Tissue acquision for biomarker directed therapy of NSCLC
You can reach these webcasts by using this link: hp://www.wabipacademy.com/webcast/
www.bronchology.com Home of the Journal of Bronchology
www.bronchoscopy.org Internaonal educaonal website for
bronchoscopy training with u-tube and
facebook interfaces, numerous teachiing
videos, and step by step tesng and assess
ment tools
www.aabronchology.org American Associaon for Bronchology and I
ntervenonal Pulmonology (AABIP)
www.eabip.org European Associaon for Bronchology and
Intervenonal Pulmonology
W A B I P N E W S L E T T E R
Links
www.chestnet.org Intervenonal Chest/Diagnosc Procedures (IC/DP)
NetWork
www.thoracic.org American Thoracic Society
www.ctsnet.org The leading online resource of educaonal and
scienc research informaon for cardiothoracic
surgeons.
www.jrs.or.jp The Japanese Respirology Society
sites.google.com/site/asendoscopiarespiratoria/
Asociación Sudamericana de Endoscopía Respiratoria
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