Treatment of Heterogeneous Emphysema Using the Spiration IBV Valves

Ninety-eight emphysema patients were treated at 13 international sites during a 3-year series of single-arm, open-label studies with the IBV valve and a multi-lobar treatment approach. Fifty six percent of subjects had a clinically meaningful improvement in health-related quality of life, but standard pulmonary function and exercise studies were insensitive effectiveness measures. Quantitative CT analyses of regional lung changes showed lobar volume changes in over 85% of subjects. Lung volume reduction was an uncommon mechanism for a treatment response with bilateral upper lobe treatment. A redirection of inspired air, an interlobar shift to healthier lung tissue, was the most common mechanism for a valve treatment response. © 2009 Elsevier Inc. All rights reserved.Revie

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. Copyright©ERS 2012.SCOPUS: ar.jinfo:eu-repo/semantics/publishe