A Study of the Use of Chartis* System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects with Heterogeneous Emphysema

Patients with end-stage COPD suffer form severe dyspnea and a poor quality of
life, with no current effective medical treatment. Only for a very small,
highly selective group of COPD patients, very invasive surgical procedures like
lung volume reduction surgery (LVRS) or lungtransplantation are available.
Recently, a non-surgical bronchoscopic treatment modality called bronchoscopic
lungvolume reduction (BVR) using one-way endobronchial valves to achieve lung
volume reduction has come available. BVR is highly effective in a subset of
patients with COPD, with heterogeneous distributed emphysema with intact
intralobular fissures present on CT. However, determining intact intralobular
fissures on CT is very difficult. Therefore we intent to use a balloon catheter
based system that can assess the presence of collateral ventilation. This
assessment of collateral ventilation can significantly increase the succesrate
of bronchosopic lungvolume reduction using one-way valves, and will eliminate
those patient who otherwise would have been treated.

To evaluate the effectiveness of the Chartis System in selecting subjects with
heterogeneous emphysema who will achieve Lung Volume Reduction from
Endobronchial Valve therapy.

A non-randomized, multi-center, prospective feasibility study.

The patients that will be screened for potential participation will receive
pulmonary function testing, thoracic HRCT scanning (both are often already
available) and an outpatient visit. The patients that will be included will
have to come to our outpatient clinic and perform a 6 min walking test. For the
actual treatment an out-patient bronchoscopy with assessment of the collateral
flow using the balloon catheter. If, based on the assessment of the collateral
flow, the patient is a suitable candidate for bronchoscopic lung volume
reduction, a one month follow-up outpatient visit including a HRCT scan,
pulmonary function tests, and a 6 min walking test will be performed. The
included patients will have to put a reasonable effort in the study, and this
seems in balance with the expected outcome. This especially, since the
expectation is that we have a number of patients where we previously (as based
on the CT scan assessment) made the assumption that they were not good
candidates, and vice versa: a number of patients that we previously thought to
be good candidates (based on the CT scan), are now not going to be treated. The
risk to patients for this study is not greater than the risk that anyone with
this disease has on getting side effects of the described investigations (CT,
lung function, walking test, bronchoscopy). Of the assessment of the collateral
flow using the balloon catheter during bronchoscopy are so far in> 60 patients
no side effects described.