PURPOSE: There are two types of stents available for airways obstruction: self expanding metal (SEMS) and silicone. Metal stents can be placed using flexible bronchoscope but are difficult to remove. Silicone stents require rigid bronchoscopy and general anesthesia to place but they are removable. A new hybrid stent, AERO™ stent (Alveolus, Inc. Charlotte, NC), has a completely covered nitinol framework. The potential advantages of a self-expanding hybrid stent (SEHS) include its placement under local anesthesia and easy removability. We report the results of a prospective, multi-center trial using SEHS for treatment of malignant airway obstruction.
METHODS: 56 patients (53% male, 47% female, median age 65.7) with malignant airway obstruction compression underwent SEHS placement at 11 centers between June 2005 and December 2006. Patients were evaluated immediately post procedure and at 7, 30, and 90 days. Ease of deployment was assessed on a 4-point scale. Lumenal patency was assessed pre and post implant by investigators and verified in blinded review. Quality of life was measured using the Baseline and Transitional Dyspnea index (BDI/TDI). Stent complications were documented.
RESULTS: Physicians rated ease of deployment at 3.6 on a 1-4 scale with 1 being poor and 4 being excellent. 88% of patients had a lumenal patency improvement of >50% (P<0.05). Dyspnea indices demonstrated quality of life improvement post implant as compared to baseline values (average improvement of 2.9 at 7 days and 3.2 at 30 days P<0.05) Complications were similar to those reported in historical control trials of stents (1) Stent removal, when clinically indicated, was accomplished without difficulty or complication in 7 patients.
CONCLUSION: SEHS is easy to deploy and remove, improves lumenal patency and quality of life as judged by dyspnea indices and has acceptable rate of complication.
CLINICAL IMPLICATIONS: Further trials are needed to assess the long term outcomes.
DISCLOSURE: Atul Mehta, No Product/Research Disclosure Information; Grant monies (from industry related sources) Alveolus Corporation Provided study related expenses to the Cleveland Clinic on per patient recruited basis; Consultant fee, speaker bureau, advisory committee, etc. I am on the scientific advisory board of the Alveolus Corporation. Over the period of last 5 years I have received no more than $1500 for the services provided.