A Prospective Multicenter Trial of a Self-expanding Hybrid Stent in Malignant Airway Obstruction

Introduction There are 2 general classes of stents available for airway obstruction: self-expanding metal and silicone. Metal stents can be placed using flexible bronchoscopy under local anesthesia but may be difficult to remove. Silicone stents require rigid bronchoscopy and general anesthesia to place but they are relatively easy to remove. A new hybrid stent, the AERO stent (Alveolus Inc, Charlotte, NC), has a completely covered nitinol framework. The purpose of this study was to evaluate the efficacy and safety of this new hybrid stent for the treatment of malignant airway obstruction. Methods This was a prospective multicenter intention to treat study. Eligible patients with malignant airway obstruction underwent self-expanding hybrid stent placement at 11 centers between June 2005 and December 2006. Patients were evaluated immediately postprocedure and at 7, 30, and 90 days postprocedure. Ease of deployment was assessed on a 4-point Likert scale. Luminal patency was visually assessed preimplant and postimplant by investigators and verified in blinded review of photographs taken during the procedure. Quality of life was measured using the Baseline Dyspnea Index and Transitional Dyspnea Index. Results Fifty-six patients (53% male, 47% female, median age 65.7) underwent stent placement. Physicians rated ease of deployment at 3.6 on a 1 to 4 scale with 1 being poor and 4 being excellent. Eighty-eight percent of patients had a lumen patency improvement of >50% (P&<0.05). Dyspnea indices demonstrated quality of life improvement postimplant as compared with baseline values (average improvement in Transitional Dyspnea Index of 2.9 at 7 d and 3.2 at 30 d, P<0.05) Complications included hemoptysis, infection, granulation tissue formation, stent migration, and pain at rates comparable with previously published studies. Stent removal, when clinically indicated, was accomplished without difficulty or complication in 7 patients. Conclusions In patients with malignant airway obstruction, self-expanding hybrid stent were easy to deploy and remove and improved luminal patency and quality of life with an acceptable complication rate. Further trials are needed to assess the long-term outcomes of this new stent technology.