Objective: To assess the safety and early clinical results of a multicenter evaluation of airway bypass with paclitaxel-eluting stents for selected patients with severe emphysema.
Methods: Airway bypass was performed with a fiberoptic bronchoscope in three steps: identification of a blood vessel-free location with a Doppler probe at the level of segmental bronchi, fenestration of the bronchial wall, and placement of a paclitaxel-eluting stent to expand and maintain the new passage between the airway and adjacent lung tissue. All adverse events were recorded, as well as 1- and 6-month pulmonary function tests and dyspnea index.
Results: Thirty-five patients received the airway bypass procedure with a median of 8 stents implanted per patient. At 1-month follow-up, statistically significant differences in residual volume, total lung capacity, forced vital capacity, forced expiratory volume, modified Medical Research Council scale, 6-minute walk, and St George's Respiratory Questionnaire were observed. At the 6-month follow-up, statistically significant improvements in residual volume and dyspnea were demonstrated. One death occurred after bleeding during the procedure. Retrospective analysis revealed that the degree of pretreatment hyperinflation may be an important indicator of which patients achieve the best short- and long-term results.
Conclusions: The airway bypass procedure reduces hyperinflation and improves pulmonary function and dyspnea in selected patients with severe emphysema. Duration of benefit appears to correlate with the degree of pretreatment hyperinflation. These preliminary clinical results support further evaluation of the procedure.