Bronchoscopic Lung Volume reduction with endobronchial valves using best responder criteria in patients with severe COPD

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. In this grant application we will
investigate the efficacy of BVR in patients with severe heterogeneous emphysema
compared to usual care.

To investigate both the clinical and economical(-healthcare evaluation)
improvement of BVR using best responder criteria in patients with severe COPD.

Prospective, randomized (1:1) clinical intervention trial with a crossover of
the controlgroup to treatment.

Placement of oneway-valves during a bronchoscopy. (Bronchoscopic lungvolume
reduction)

SCREENING: clinic visit; ± 5 hours (including "rest" periods between
examinations): lung function, dynamic hyperinflation testing, 6 min walk test,
record of physical activity, consult anesthesiologist, completing
questionnaires and CT scan of the lungs.

Enrolled patients: Hospital stay :3 days (2 nights) , control X-ray and a
bronchoscopic lung volume reduction under anesthesia.
BVR using EBVs ultimately results in >75% volume loss of the treated lobe,
thereby causing transient symptoms that resolve within 4 weeks after the BVR.
By inducing this significant volume reduction the major risks involved are:
Pneumothorax (1 in 10 patients) for which chest drainage is required, transient
(1-3 days) chestpain (1 in 2 patients), transient (1-7 days) dyspnea (1 in 4
patients). This significant volume loss of the treated lobe results in an
increase in FEV1 and FVC, with decreasing RV, resulting in a significant
reduction in dyspnea and improvement in quality of life (as measured with the
SGRQ) and a better exercise tolerance (as measured with the 6MWT).

FOLLOW-UP: 2 times a visit of ± 3-5 hours, lung function, dynamic
hyperinflation testing, 6 min walk test, chest X, completing questionnaires and
recording of physical activity and CT scan of the lungs

The included COPD patients all have a very serious limitation of their daily
actvities. All included patients have a severe limitation of their activities
of daily living. With the BVR procedure does it seem possible to give -at least
temporarily- relieve of shortness of breath and improvement in expercise
performance.