PURPOSE: Collateral ventilation (CV) has been shown to prevent lung volume reduction (LVR) after Endobronchial Valve (EBV) treatment. Direct measurement of CV may predict patients who will achieve significant LVR. The Chartis® Pulmonary Assessment System monitors airflow and pressure within the target lobe and quantifies the average collateral resistance. The purpose of this study is to determine whether Chartis System accurately predicts patients who will experience significant lung volume reduction following EBV treatment.
METHODS: 97 patients with heterogeneous emphysema were enrolled. Following Chartis assessment of the targeted lobe all patients were treated with Zephyr® EBV. Primary endpoint was HRCT-measured LVR in the treated lobe at 30-days. FEV1, SGRQ, and 6MWT were evaluated as secondary endpoints.
RESULTS: To date, outcomes are collected for 57 patients, 27 patients are pending complete follow-up and 13 patients were withdrawn. The interim analysis includes 37 CV- and 20 CV+ patients Chartis accurately predicted the outcome for 30/37 CV- (81%) and 16/20 CV+ (80%) patients. The median LVR reduction was 1031.7 ml (-61.6%) for CV- and -82.0 ml (-3.9%) for CV+. Average FEV1: 19.2% CV-/ 0.9% CV+ Average 6MWT: 15.6% CV-/ 9.8% CV+ Average SGRQ: -11.1 pts CV-/ -4.6 pts CV+
CONCLUSIONS: Chartis System predicts significant LVR after EBV treatment.
CLINICAL IMPLICATIONS: TLVR is demonstrated as an indicator of significant clinical response in lung function, exercise tolerance, and quality of life. Results suggest that expanded patient selection criteria will enable successful treatment for a broader population of emphysema patients.
DISCLOSURE: The following authors have nothing to disclose: Daniela Gompelmann, Ralf Eberhardt, Dirk-Jan Slebos, Joachim Ficker, Frank Reichenberger, Bernd Schmidt, Lars Ek, Felix Herth
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