Results of the National Emphysema Treatment Trial (NETT) demonstrated that patients with advanced, predominant upper lobe emphysema benefit the most from lung volume reduction surgery. Subjective upper lobe predominance and classification of emphysema as heterogeneous or homogeneous was based on scoring done by the designated radiologist at each NETT site. A central core lab was used by NETT for quality control. The purpose of this study was to evaluate if centers participating in a multicenter trial to evaluate the Spiration intrabronchial valve (IBV™) system could correctly select patients with advanced heterogeneous, predominant upper lobe emphysema without the need of a central core lab. NETT radiological criteria and grading was recommended to the sites.
CT-scans corresponding to patients enrolled in the study were evaluated by an independent, Board Certified Radiologist. The radiologist was blinded to patient and clinical site identification. The radiologist provided an independent determination of emphysema severity, predominance and heterogeneity based on a grading scale 0 (no emphysema)to 4 (severe emphysema) using NETT guidelines.
CT-scans corresponding to 27 patients enrolled and treated with IBV valves between January and July 2004 at 5 clinical sites were reviewed and evaluated. Average grading values of 3.11±0.75 and 3.07±0.78 were assigned to the right and left upper zones by the independent radiologist. Values of 1.33±0.55 and 1.33±0.48 were assigned the right and left lower zones.
Radiologist and/or investigators at each clinical site participating in the IBV multicenter trial, correctly selected and enrolled patients with advanced, heterogeneous and upper lobe emphysema. Guidelines established by the NETT study allowed for adequate selection without the need of using a central core lab.
CT-scan based selection of patients with advanced heterogeneous emphysema can be effectively done using appropriate radiological training and guidelines at new clinical sites participating in the IBV trial.
David Ost, Grant monies (from industry related sources) Spiration Inc. is sponsoring clinical trial at my institution; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Intrabronchial Valve IBV being evaluated for the treatment of advanced emphysema.