BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Inclusion Criteria:

• Age: ≥ 40 years and ≤ 75 years

• Written informed consent obtained from the patient

• Severe emphysema with indication for BTVA:

• bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3/4 and

• evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and

• functional evidence of severe pulmonary hyperinflation and

• FEV1 post lysis between 20% and < 45% (calculated) and

• Total lung capacity (TLC) ≥ 100% (calculated) and

• Residual volume (RV) > 175% (calculated) and

• arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 > 50 mmHg on room air and

• marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC) and

• 6-minute walk test > 140 metres

• Patient-specific, pre-interventional exhaustion of conservative treatment options

• optimised medical therapy (according to the GOLD guidelines) and

• Non-smoker for 6 months prior to inclusion

• Evidence of completed pulmonary and geriatric rehabilitation in the last 4 years

• ≥ 6 weeks outpatient or

• ≥ 3 weeks inpatient or

• Individual Participation in regular physical activities that go beyond theactivities of daily living (e.g. a walking programme)

• According to the investigator's assessment mentally and physically able toparticipate in the study procedures and visits

• Indication within the framework of an interdisciplinary case conference withspecialists in pneumology, radiology and thoracic surgery in accordance with §3 ofthe guideline on quality assurance measures in accordance with § 136 Paragraph 1Sentence 1 Number 2 SGB V for inpatient care with bronchoscopic lung volumereduction procedures for severe emphysema (QS-RL BLVR).

Exclusion Criteria:

• Any condition that would interfere with the conduct of the clinical trial follow-upor bronchoscopy or affect the outcome of the clinical trial

• DLCO < 20% (calculated)

• Body mass index (BMI) < 18 kg/m2 or > 32 kg/m2

• Pulmonary hypertension

• Peak systolic PAP > 45 mmHg or mean PAP > 25 mmHg

• Right heart catheter measurements are considered authoritative over echocardiogrammeasurements

• Clinically significant bronchiectasis

• Pneumothorax or pleural effusions within the last 6 months

• Heart and/or lung transplantation, surgical lung volume reduction (LVRS),bullectomy, lobectomy or pneumonectomy, pleurodesis or any surgery in the targetlobes (upper lobes).

• Recent respiratory infection or COPD exacerbation in the last 6 weeks

• Unstable COPD (any of the following conditions):

• >3 COPD-related hospitalisations requiring antibiotics in the last 12 months

• COPD-related hospital stay in the last 3 months

• daily use of systemic steroids, > 5 mg prednisolone

• Single large bulla (defined as > 1/3 of the volume of the lobe) in the upper lobe orparaseptal emphysema distribution in the lobe being treated

• Coagulopathy or current use of anticoagulants

• Patients with current endobronchial valves or with valves explanted less than 6months ago in the target lobe in a segment to be treated with InterVapor®.

• Patients with implanted, endobronchial coils (coils)

• Patients with previous endobronchial polymer/adhesive treatment

• Patients with immune system disorders or concomitant diseases that necessitate theuse of immunosuppressants of clinical relevance

• History of any of the following conditions:

• Myocardial infarction or acute coronary syndrome in the previous year

• Hospitalisation for left heart failure in the last year

• clinically leading asthma disease or alpha-1-antitrypsin deficiency

• Known sensitivity to medications required to perform bronchoscopy

• Life expectancy < 12 months

• Newly prescribed morphine derivatives within the last 4 weeks

• Pregnancy at the time of inclusion