RT Journal Article SR Electronic T1 Multicentre European study for the treatment of advanced emphysema with bronchial valves JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 1319 OP 1325 DO 10.1183/09031936.00019711 VO 39 IS 6 A1 Vincent Ninane A1 Christian Geltner A1 Michela Bezzi A1 Pierfranco Foccoli A1 Jens Gottlieb A1 Tobias Welte A1 Luis Seijo A1 Javier J. Zulueta A1 Mohammed Munavvar A1 Antoni Rosell A1 Marta Lopez A1 Paul W. Jones A1 Harvey O. Coxson A1 Steven C. Springmeyer A1 Xavier Gonzalez YR 2012 UL http://erj.ersjournals.com/content/39/6/1319.abstract AB 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.