Multicentre European study for the treatment of advanced emphysema with bronchial valves.
This multicentre, blinded, sham-controlled study was performed to assess the safety and effectiveness of bronchial valve therapy using a bilateral upper lobe treatment approach without the goal of lobar atelectasis. Patients with upper lobe predominant severe emphysema were randomised to bronchoscopy with (n = 37) or without (n = 36) IBV Valves for a 3-month blinded phase. A positive responder was defined as having both a ≥ 4-point improvement in St George's Respiratory Questionnaire (SGRQ) and a lobar volume shift as measured by quantitative computed tomography. At 3 months, there were eight (24%) positive responders in the treated group versus none (0%) in the control group (p = 0.002). Also, there was a significant shift in volume in the treated group from the upper lobes (mean ± SD -7.3 ± 9.0%) to the non-treated lobes (6.7 ± 14.5%), with minimal change in the control group (p<0.05). Mean SGRQ total score improved in both groups (treatment: -4.3 ± 16.2; control: -3.6 ± 10.7). The procedure and devices were well tolerated and there were no differences in adverse events reported in the treatment and control groups. Treatment with bronchial valves without complete lobar occlusion in both upper lobes was safe, but not effective in the majority of patients.
CHU St Pierre Hospital, Brussels, Belgium. Vincent_NINANE@stpierre-bru.be
Vincent
V
Ninane
Christian
C
Geltner
Michela
M
Bezzi
Pierfranco
P
Foccoli
Jens
J
Gottlieb
Tobias
T
Welte
Luis
L
Seijo
Javier J
JJ
Zulueta
Mohammed
M
Munavvar
Antoni
A
Rosell
Marta
M
Lopez
Paul W
PW
Jones
Harvey O
HO
Coxson
Steven C
SC
Springmeyer
Xavier
X
Gonzalez
D000368:Aged; D001999:Bronchoscopy / Q000009:adverse effects / Q000379:methods*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011656:Pulmonary Emphysema / Q000628:therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome