Chartis Clinical Data

Target. Test. Treat.

Chartis Feasibility Study

Assessment and quantification of collateral ventilation (CV) is critical to predict optimal response to endobronchial lung volume reduction (ELVR) treatment. The feasibility of using the Chartis assessment system to obtain measurements predictive of significant lung volume reduction following EBV treatment was performed in a study by Gompelmann, et al.¹ The results of this study showed that in 18 out of 20, or 90% of analyzable cases, the measurements correlated with the occurrence of significant lung volume reduction after ELVR.

Chartis Multicenter Study

The prospective European Multi-centre Chartis Study enrolled 97 patients between May 2010 and March 2011 to determine whether Chartis System accurately predicts patients who will experience significant lung volume reduction following Zephyr EBV treatment. Patients with low CV in the target lobe were expected to achieve significant lung volume reduction (>350 mL) resulting in clinical improvement with ELVR, while patients with high CV in the target lobe were expected to achieve minimal to no lung volume reduction (<350 mL) resulting in minimal clinical response. 97 patients were enrolled in six centres in Europe. A Chartis assessment was performed on all patients, and valves placed in all patients, regardless of the Chartis result. Patients were followed up at 30 days. Interim results below are analysed by reported CV status.

Interim Results

Final study results will be presented at the European Respiratory Society meeting (Amsterdam, September 2011). Interim data were reported at the American Thoracic Society meeting in May 2011, pending completion of follow-up results. Data shows that the EBV patients with low collateral ventilation (CV-) have achieved high lung volume reduction and also significant clinical benefit in terms of FEV₁, 6MWT and SGRQ.²

Interim Chartis Study results at 30 days post EBV^A

^A Values are mean ± SD, unless noted.

The Role of Chartis in EBV Treatment

In both the US VENT and the EURO-VENT cohorts, a subgroup of patients were identified who achieved very high target lobe volume reduction. Not surprisingly, this group also achieved the most impressive clinical results. Table 7 compares the CV- (predicted responder) group from the Chartis Study against the High TLVR groups from pooled  EURO-VENT and the U.S. cohorts. This table shows that where Chartis is used to determine collateral status, predicted responders (CV- patients) had comparable clinical results to the high TLVR group in the pooled data from the VENT studies.

The lesson is clear: a successful EBV treatment plan should have the goal of achieving as much lung volume reduction as possible, given a specific patient’s anatomy. Using the Chartis system to assess a patient’s target lobes is an essential planning step that enables physicians to make data-driven treatment decisions, and achieve optimal outcomes for each patient.

Table 7. Comparison of Chartis Study CV- cohort results vs.
VENT High TLVR cohort results^A

^A Values are mean ± SD, unless noted.

In the Chartis Multicentre study, there were no adverse events reported to be associated with the use of Chartis balloon catheter and console.

Footnotes

1. Gompelmann D, Eberhardt R, Ernst A, et al. Predicting Atelectasis Using Collateral Ventilation Assessment prior to Endobronchial Lung Volume Reduction – A Feasibility Study. Respiration 2010;80:419-425; doi: 10.1159/000319441.
2. Use of Chartis® Pulmonary Assessment System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR). Chartis Multi-Centre Study, data presented at ATS2011. Data on file with Pulmonx.