PURPOSE: The PolyflexTM (Boston Scientific, Natick, MA) is a silicone covered polyester mesh stent that was introduced as an alternative to existing non-metallic airway stents. Despite its availability for several years there has been very little published clinical experience.
METHODS: A total of 17 stents were placed in 16 patients. 11 (69%) patients had malignant obstruction and 5 (31%) had a benign cause of obstruction. 10 patients had either extrinsic airway compression, endobronchial tumor, or both. Other indications: benign tracheal stenosis (3), post tuberculosis stenosis (1), obstructing granulation tissue (1), and tracheal-esophageal fistula (1). All procedures were performed with rigid bronchoscopy.
RESULTS: Overall, 9 (56%) patients had complications. 2 patients had stent infection with halitosis and positive cultures. Granulation tissue and circumferential stenosis occurred in 2 patients with benign disease and granulation tissue alone in a third patient. Mucous occlusion requiring stent removal or bronchoscopic mucous clearance occurred in 2 patients. Stent rupture and silicone deterioration occurred at 7 months in 1 patient. Migration requiring stent removal was seen in 2 patients. One tracheal stent patient died at home suddenly from an unknown cause. 4/5 (80%) benign patients had some type of complication and the 5th patient died at home as described above. 5/11 (45%) malignant patients had complications. Three patients with malignant disease had the stent removed from 3 - 22 months after placement due to a good response to other systemic therapy.
CONCLUSION: The PolyflexTM stent may offer some advantage over existing silicone airway stents such as a better inner to outer lumen diameter ratio, but there has been very little data published regarding its clinical efficacy and safety. In our experience the PolyflexTM stent has a high complication rate well beyond that of other widely used silicone stents.
CLINICAL IMPLICATIONS: Use of this stent requires cautious consideration and further clinical experience should be reported. There may be a utility in malignant airway obstruction in a mainstem bronchus. Patients who receive these stents may require close bronchoscopic follow-up.
DISCLOSURE: Carla Lamb, None.