Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema

Inclusion Criteria:

• Patients suffering from emphysema (all morphologies, uni- or bilateral distribution)potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusionscintigraphy within < 6 month of screening, CT scan within < 4 months of screening)
• Age ≥ 30 and ≤ 80 years
• Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2
• Non-smoking for 3 months prior to screening interview
• Patient is able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• FEV1 more than 50% predicted
• TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58%predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% inheterogeneous emphysema, respectively
• PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)
• PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)
• Patients with incomplete interlobar fissures as revealed by quantitative computedtomography analysis with StratX® (fissure completeness ≤ 80%)
• Patients with collateral ventilation as evidenced by bronchoscopic Chartis®measurement (only performed if fissure completeness according to StratX® is < 95%)
• 6-minute walking distance ≥ 470m
• More than two COPD exacerbation episodes requiring hospitalization in the last year
• More than two instances of pneumonia episodes in the last year
• Unplanned weight loss ≥ 10% within 90 days prior to enrollment
• Pulmonary hypertension as evidenced by Delta Psyst RV-RA > 35 mmHg on recentechocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35mmHg) and signs of moderate to severe RV dysfunction.
• Evidence of left ventricular ejection fraction (LVEF) less than 45% on recentechocardiography (within 3 months prior to screening)
• History of exercise-related syncope
• Myocardial infarction or congestive heart failure within 6 months of screening
• Clinically significant arrhythmias that might put the patient at risk in regard to theinterventions
• Prior LVR (any method), bullectomy, or lobectomy
• Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons/day.
• Pulmonary nodule requiring surgery
• Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days
• Patients with a life expectancy of less than one year