PURPOSE: To evaluate the technical success and initial clinical safety and effectiveness of the use of a Y-shaped metallic stent for complex stenoses involving the carina. MATERIALS AND METHODS: Thirty-five consecutive patients with complex tracheobronchial stenoses involving the carina were treated with an integrated self-expandable inverted Y-shaped metallic stent and delivery system. The Y-shaped metallic stents were placed in the tracheobronchial tree with fluoroscopic guidance. Technical success, clinical success, Hugh-Jones classification, and complications were assessed during follow-up. RESULTS: The delivery of the integrated self-expandable Y-shaped metallic stent in the carinal areas was technically successful and well-tolerated in all patients. Clinical success was achieved in 31 patients (89%) 1-7 days after stent placement; the procedure failed in four patients (11%). The improvement between pre- and postoperative Hugh-Jones classification grade was statistically significant (P<.001). During follow-up (mean follow-up, 192 days+/-169), all stenoses were resolved, and general physical examination of the 31 patents showed improvement with no obvious dyspnea or bleeding. Twenty-one patients were healthy without evidence of dyspnea, and the remaining 14 patients died (mean survival, 189 days+/-172) at the time of this report. The mean and median survival periods were 217 days+/-30 and 215 days+/-108, respectively. The mean and median stent patency periods were 216 days+/-30 and 215 days+/-119, respectively. CONCLUSIONS: Deployment of an integrated, self-expandable inverted Y-shaped metallic stent with the delivery system was a safe and effective procedure for the treatment of complex tracheobronchial stenoses involving the carina.
PURPOSE: To evaluate the technical success and initial clinical safety and effectiveness of the use of a Y-shaped metallic stent for complex stenoses involving the carina. MATERIALS AND METHODS: Thirty-five consecutive patients with complex tracheobronchial stenoses involving the carina were treated with an integrated self-expandable inverted Y-shaped metallic stent and delivery system. The Y-shaped metallic stents were placed in the tracheobronchial tree with fluoroscopic guidance. Technical success, clinical success, Hugh-Jones classification, and complications were assessed during follow-up. RESULTS: The delivery of the integrated self-expandable Y-shaped metallic stent in the carinal areas was technically successful and well-tolerated in all patients. Clinical success was achieved in 31 patients (89%) 1-7 days after stent placement; the procedure failed in four patients (11%). The improvement between pre- and postoperative Hugh-Jones classification grade was statistically significant (P<.001). During follow-up (mean follow-up, 192 days+/-169), all stenoses were resolved, and general physical examination of the 31 patents showed improvement with no obvious dyspnea or bleeding. Twenty-one patients were healthy without evidence of dyspnea, and the remaining 14 patients died (mean survival, 189 days+/-172) at the time of this report. The mean and median survival periods were 217 days+/-30 and 215 days+/-108, respectively. The mean and median stent patency periods were 216 days+/-30 and 215 days+/-119, respectively. CONCLUSIONS: Deployment of an integrated, self-expandable inverted Y-shaped metallic stent with the delivery system was a safe and effective procedure for the treatment of complex tracheobronchial stenoses involving the carina.