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.
CTSNet classification
11
15
Abbreviations and Acronyms
COPD
chronic obstructive pulmonary disease
FEV1, FEV5
forced expiratory volumes in 1 and 5 seconds
FVC
forced vital capacity
6MW
6-minute walk
mMRC
modified Medical Research Council
NETT
National Emphysema Treatment Trial
RV
residual volume
SGRQ
St George’s Respiratory Questionnaire
TLC
total lung capacity
Cited by (0)
Dr Cardoso
Research supported by Broncus Technologies, Inc. Mountain View, Calif.