Chartis System Study

Understanding emphysema….a new approach to treatment.

A recent prospective study of the Chartis™ System combined with Zephyr^® Endobronchial Valve (EBV) therapy shows promise for the Chartis System as a tool to assist physicians in identifying patients who may benefit most from Endoscopic Lung Volume Reduction (ELVR) using the Zephyr  EBV. The Chartis System can quantify the presence of collateral ventilation, or inter-lobar airflow, which recent research suggests may reduce the effectiveness of lung-volume reduction therapy.^1,2

Details from this study, conducted at the University of Heidelberg in Germany, is outlined below:

Study Design

Patients indicated for ELVR were included in the clinical study prospectively. All investigations were performed under local anesthesia plus moderate sedation under spontaneous breathing. Each lobe targeted for ELVR was blocked via the Chartis Catheter.  Pressures and flows were assessed continuously. A total of 25 patients were enrolled in the study. The primary endpoint of this study was correlation of flow and pressure measurements with the presence of atelectasis following implantation of the Zephyr Endobronchial Valves, as measured by chest x-ray.

Results

25 patients were examined. In all patients the assessment for pressure and flows could be performed without any complications. No adverse events occurred in any of the 25 enrolled patients.

In 5 patients an evaluation of the pressures and flows was not possible due to user error. In 18 patients, the resistance measurements directly correlated with the chest X-ray atelectasis result post-implantation. In only two patients, there was a mismatch between the collateral flow measurement and the incidence of atelectasis after placement of EBV.

In conclusion, in 18 of 20 patients (90%), a correlation could be detected.

Conclusion

Measurement of airway pressures and flows in various lobes were safely and successfully achieved. The clinical impact of these measurements will need to be evaluated in subsequent trials.

Footnotes

1. Aljuri N, Freitag L. Validation and pilot clinical study of a new bronchoscopic method to measure collateral ventilation prior to endobronchial lung volume reduction. J Appl Physiol. 2009;106:774-783.

2. Fessler HE. Collateral damage assessment for endobronchial lung volume reduction. J Appl Physiol. 2009;106:755-756.