Study objective: To assess the uncovered Ultraflex nitinol stent (Boston Scientific; Natick, MA) for its efficacy and safety.
Design, setting, and patients: Between October 1997 and October 1998, we carried out a prospective multicenter study at six hospitals in Japan. Fifty-four Ultraflex stents were inserted in 34 patients with inoperable malignant airway stenosis using a flexible and/or a rigid bronchoscope under fluoroscopic and endoscopic visualization.
Measurements and results: Clinical, endoscopic examination, and pulmonary function on days 1, 30, and 60 after stent implantation showed improvement. In 19 patients (56%), stent implantation was performed as an emergency procedure because of life-threatening tracheobronchial obstruction. Immediate relief of dyspnea was achieved in 82% of the patients. The dyspnea index improved significantly after implantation (before vs. days 1, 30, and 60; p<0.001). Significant improvements were observed in obstruction of airway diameter (81+/-15% before vs. 14+/-17% on day 1, 12+/-12% on day 30, and 22+/-28% on day 60; p<0.001). Vital capacity (VC), FEV(1), and peak expiratory flow (PEF) increased significantly after stent implantation: before vs immediately after VC (p<0.01), FEV(1) (p<0.001), and PEF (p<0.05). The main complications were tumor ingrowth (24%) and tumor overgrowth (21%). After coagulation with an Nd-YAG laser or argon plasma coagulation, mechanical coring out using the bevel of a rigid bronchoscope was necessary in patients showing tumor ingrowth or overgrowth. Removal and reposition were possible in case of misplacement. There were no problems with migration and retained secretions. The median survival time of patients was 3 months. The 1-year survival rate was 25.4%.
Conclusions: In this study of the Ultraflex nitinol stent, we have demonstrated that patients were relieved from dyspnea, which contributed to improved quality of life, with minimal complications. This stent can be used safely, even in the subglottic region. Owing to its excellent flexibility and biocompatibility, the stent is also indicated in certain complicated situations, eg, narrow stenosis, hourglass stenosis, curvilinear stenosis, bilateral mainstem bronchial stenoses, and long stenosis of varying diameters.