The goal of this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs).
The main question it aims to answer is:
· Does selecting the target lobe based on the lowest VQDI (indicating the worst functional mismatch) lead to a higher rate of successful treatment response at 6 months compared to selecting the lobe based on the worst destruction on CT scan?
If there is a comparison group: Researchers will compare the VQDI-guided selection group to the conventional CT/Chartis-guided selection group to see which strategy results in more patients achieving significant improvement in both lung function and reduction in the size of the treated lobe.
Participants will:
* Undergo standard clinical assessments (lung function tests, CT scan, exercise test) and an additional V/Q SPECT/CT scan to calculate the VQDI. * Have their collateral ventilation status checked using the Chartis system during bronchoscopy. * Be randomly assigned to one of the two target lobe selection strategies. * Receive EBV placement in the selected lobe. * Attend follow-up visits at 1, 3, 6, and 12 months after the procedure for check-ups, repeated lung function tests, questionnaires, and CT scans to assess their response to treatment.
Clinical and radiological evidence of emphysema
Nonsmoking for 4 months prior to screening interview
BMI less than 35 kg/m2
Stable on current medication regimen
Had two or more hospitalizations over the last year for a COPD exacerbation
Had two or more hospitalizations over the last year for pneumonia
Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
Had a heart attack or congestive heart failure within the last 6 months
Parallel
VQDI-assisted target lung lobe selection strategy
Procedure/SurgeryParticipants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected specifically based on functional imaging. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the lowest Ventilation-Perfusion Discrepancy Index (VQDI) - indicating the most severe mismatch between air flow and blood flow - is chosen for treatment. All other procedural aspects, screening assessments, and follow-up are identical to the comparator arm.
Conventional target lung lobe selection strategy
Procedure/SurgeryParticipants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected based on standard anatomical criteria. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the highest CT destruction score - indicating the most severe anatomical emphysema - is chosen for treatment. This reflects current standard-of-care practice. All other procedural aspects, screening assessments, and follow-up are identical to the experimental arm.
Ventilation-Perfusion Discrepancy Index (VQDI)
The absolute change in the target lobe's VQDI from baseline to 6 months post-procedure.
St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
FEV1 Post-bronchodilator Absolute Change
Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).
6-minute Walk Distance
Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).
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