Off-label use of intrabronchial valves for persistent air leak is safe and effective: a retrospective case analysis

BACKGROUND: Persistent air leak (PAL) is a challenging clinical problem associated with prolonged hospital stay and increased morbidity. Historically, treatment options were limited to thoracostomy tube drainage, pleurodesis, and surgical repair. The development of one-way airway valves has represented a paradigm shift in PAL management. We present our experience using intrabronchial valves (IBVs) for PAL management looking at both on-label (post-thoracic surgery) and off-label (all other) indications. METHODS: We performed a retrospective review of our single-center experience. Data collected included demographics, primary pathology leading to PAL, comorbidities, time to chest tube removal, complications, mortality, need for any additional procedure, and time to IBV removal. RESULTS: During the study period, 15 patients underwent IBV insertion for PAL. The on-label cohort contained three patients (post lobectomy or segmentectomy). The off-label cohort had 12 patients (6 empyema, 4 secondary spontaneous pneumothorax, 1 penetrating trauma, and 1 post percutaneous lung nodule biopsy). In the on-label cohort, chest tube was removed after a mean duration of 4.0±1.0 days for all patients. In the off-label cohort, 83.3% (10/12) had chest tube removal 16.2±5.7 days (P=0.396) after IBV placement. One patient developed hypoxic respiratory failure shortly after IBV insertion, necessitating removal of 2 out of 5 valves. CONCLUSIONS: IBVs are a minimally invasive, well tolerated treatment modality for patients with PAL and a viable alternative to invasive surgical interventions. Procedure or valve-related complications are uncommon. Valves can be removed and do not preclude surgical intervention. Updated guidelines are necessary to formalize PAL management.