PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

This study will include a prospective cohort of adult patients with persistent air leaks (PALs) undergoing bronchoscopy. The intervention evaluated is a combination approach that includes endobronchial valve placement and instillation of autologous blood with tranexamic acid (TXA), followed by balloon occlusion (referred to as "PATCHVALVE" technique).

Patients will be enrolled and undergo standard imaging and procedural evaluations. For prospective participants, informed consent will be obtained prior to the procedure.

Procedural steps include:

• Identification of the leaking segment using imaging and air leak assessment.
• Instillation of fresh autologous blood (up to 30 mL) followed by TXA (up to 10 mL) via a balloon catheter into the leaking airway segment.
• Balloon occlusion for 3-5 minutes to promote clotting and adherence.
• Deployment of endobronchial valves based on standard criteria.
• Leak reassessment and iterative treatment if necessary.

This study will provide early evidence on the efficacy of this combined approach and help standardize care protocols for managing PALs non-surgically.

{Inclusion Criteria}

• Adult (≥18 years) patients who have been diagnosed with persistent air leaks (PALs) due to conditions such as alveolar-pleural fistulas following pulmonary resections, traumatic injury, or underlying lung disease or other cause.
• PAL patients who are deemed non-candidates for surgical intervention or have declined surgery.

{Exclusion Criteria}

• Patients who have received other experimental or investigational treatments for PALs that could confound the results.
• Patients with contraindications to undergoing bronchoscopy, such as severe cardiovascular instability, or those who cannot tolerate the procedure due to other medical reasons.
• Bronchopleural fistula