Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study

Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study

The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:

Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?

Participants will:

undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.

receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.

Inclusion Criteria:

• 1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
• 2. Age range from 40 to 85 years old (including 40 and 85 years old);
• 3. BMI ≤ 35kg/m2;
• 4. 15% ≤ FEV1% pred ≤ 45%;
• 5. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;
• 6. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
• 7. Quit smoking for more than 4 months;
• 8. The evaluation result of pulmonary bypass ventilation function is negative;
• 9. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.

Exclusion Criteria:

• 1. Being pregnant or breastfeeding;
• 2. PaCO2>50mmHg and/or PaO2<45mmHg;
• 3. Obvious bronchiectasis or other infectious lung diseases;
• 4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
• 5. Coagulation dysfunction, platelet count<60e+09/L;
• 6. Myocardial infarction or congestive heart failure within the past 24 weeks;
• 7. Previous lobectomy, LVRS or lung transplantation;
• 8. Anticoagulant therapy that cannot be stopped before surgery;
• 9. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
• 10. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
• 11. Pulmonary nodules that require intervention;
• 12. Patients participating in other clinical trials;
• 13. Individuals with other contraindications to bronchial operations;
• 14. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.