Endobronchial valves (EBV) are investigational devices for bronchoscopic treatment of emphysema and bronchopleural fistula (BPF) or lung hyperinflation. They selectively block inspiratory airflow and allow drainage in expiration. We describe a patient series with a compassionate use protocol of EBV for which no other options were available.
Prospective compassionate use study performed at a tertiary center. Events were reviewed from June 2006 and July 2008. Patients did not qualify for multicenter trials or other standard therapy. The “Zephyr” EBV (Emphasys Medical, Inc., Redwood City, CA) were used.
Five patients received valves in a compassionate/urgent protocol. Three were females mean age 57 years (range 51–74). Indications were: Persistent bronchopleural fistula (BPF) despite multiple prior surgical interventions (n=3); severe native lung hyperinflation after single lung transplant for lymphangioleiomyomatosis (n=1); and severe upper lobe emphysema who was not a study candidate. The emphysema and the lung transplant patients were not surgical candidates. 80% (4/5) died within 40 days after EBV placement (range 11–40). There were no complications at implantation. However, most valves either failed or required removal. The emphysema patient died from septic shock following a 50% pneumothorax and pseudomonas infection. In the patient with native lung hyperinflation, the valves required removal for infection and hemoptysis, and progressive respiratory failure. Both patients died 11 days after EBV placement. Among the patients with BPF, the EBV failed in 2 patients in whom persistent pneumothoraces were seen. One patient died from septic shock and acute coronary syndrome; and the other died from pseudomonas infection and progressive respiratory failure. The third patient noted improvement of symptoms and air leak after 23 months with no reported complications.
The complications of compassionate use EBV include major infections, life threatening pneumothorax and respiratory failure in high risk individuals.
Extending this safe procedure to high risk individuals does not preclude fatal medical complications.
Jose Santacruz, No Financial Disclosure Information; No Product/Research Disclosure Information