Fenestrated vs. Conventional Silicone Stents in Benign Central Airway Stenosis: Clinical Outcomes and Biomechanical Validation

Silicone stents are the gold standard for inoperable benign central airway stenosis but are often limited by complications. This study developed a self-made fenestrated silicone stent by perforating conventional stents and compared its efficacy with conventional stents. This retrospective study included 118 patients with benign central airway stenosis treated with fenestrated (n = 53) or conventional (n = 65) silicone stents between 2019 and 2023. Technical success, complication rate, patency time, and removal rate were compared between fenestrated and conventional cohorts using propensity score matching. Finite element analysis and computational fluid dynamics simulations were conducted to evaluate the equivalent stress, total deformation, static pressure, and turbulent intensity of fenestrated and conventional stents. The PSM analysis included 35 patients with fenestrated stents and 35 with conventional stents. Stent insertion was successful in all cases. The cumulative incidence of overall complications (log-rank test p < 0.001), migration (log-rank test p = 0.006), granulation (log-rank test p = 0.006), and mucus retention (log-rank test p = 0.007) in the fenestrated group was significantly lower than in the conventional group. Fenestrated silicone stent was independently associated with a lower incidence of overall complications (adjusted hazard ratio (aHR) 0.23 [0.11-0.48]; p < 0.001), migration (aHR 0.15 [0.03-0.68]; p = 0.013), granulation (aHR 0.29 [0.13-0.63]; p = 0.002), and mucus retention (aHR 0.44 [0.20-0.94]; p = 0.034). Biomechanical analysis showed comparable equivalent stress and static pressure between fenestrated and conventional stents, while fenestrated stents exhibited increased localised flexibility and slightly higher turbulent intensity. Compared to conventional silicone stents, fenestrated stents offer longer patency, fewer complications, and improved biomechanical performance, without compromising the stent's structural integrity.