Efficacy and safety of silicone hourglass stent in the treatment of subglottic stenosis: A retrospective study

Background Few studies have explored using hourglass-shaped silicone stents for treating subglottic stenosis despite their potential to reduce complications. This study aims to assess the efficacy and safety of silicone hourglass stents in patients with subglottic stenosis. Methods A retrospective analysis was conducted on 16 cases of subglottic tracheal stenosis, comprising 11 benign and five malignant cases, treated with hourglass-shaped silicone stents placed via rigid tracheoscopy at our centre from August 2020 to April 2024. Patients' modified dyspnea index (mMRC) scores, airway diameters, and complications were assessed following stent placement. Results All patients successfully received hourglass-shaped silicone stents, with dyspnea symptoms alleviated in 14 patients (87.5%). Following stent placement, the upper airway diameter increased from 5.25 ± 0.68 mm to 12.06 ± 1.44 mm (t=-17.49, P = 0.000), while mMRC score decreased from 3.38 ± 0.72 to 1.31 ± 1.30 (Z=-3.43, P = 0.001). Both airway stenosis and dyspnea symptoms significantly improved. No serious complications occurred during the operation. Postoperative complications included vocal fold oedema, necrotic retention, secretion retention, and granulomatous hyperplasia, all of which improved with appropriate treatment. One case of stent displacement, unresolved despite external fixation, required replacement with a Montgomery T-tube. The overall stent placement success rate was 93.75%. Among patients with benign stenosis, three had their stents removed; two successfully underwent removal, while one required reimplantation due to restenosis. Among those with malignant stenosis, three successfully had their stent removed following control of the primary disease, while two died of primary disease. Conclusions Silicone hourglass stents demonstrated feasibility and safety for treating subglottic tracheal stenosis in this study. Trial registration: This study has been registered in the China Clinical Trial Registry, registration number: ChiCTR2500098284,registration date:March 5, 2025(retrospectively registered).