Bronchoscopic placement of custom-made sutured silicone prostheses for refractory tracheal hemoptysis: a retrospective case series

Technical Summary: Bronchoscopic Placement of Custom-Made Sutured Silicone Prostheses for Refractory Tracheal Hemoptysis

Problem Statement
Refractory tracheal hemoptysis represents a critical challenge in respiratory medicine, particularly when standard hemostatic medications and bronchial artery embolization (BAE) fail. Current limitations include the ineffectiveness of vasoactive drugs against non-bronchial arterial bleeding (e.g., from aortic or diaphragmatic arteries) and vascular malformations, as well as the high recurrence rates (10–20%) and risks of ectopic embolism associated with BAE. Furthermore, surgical resection (lobectomy/segmentectomy) is often contraindicated due to high surgical trauma and poor patient tolerance in those with compromised pulmonary function or advanced malignancy. While temporary balloon tamponade offers immediate relief, it lacks long-term efficacy and carries risks of mucosal injury. There is a distinct lack of systematic clinical data regarding minimally invasive, permanent occlusion strategies for these specific refractory cases.

Methodology
This study presents a retrospective case series of four patients with refractory tracheal hemoptysis who failed conventional therapies. The underlying etiologies included lung cancer cavities, aortic malformation with tracheal fistula, and diaphragmatic arterial tracheal fistula.

• Preoperative Planning: Patients underwent enhanced chest CT with three-dimensional airway reconstruction to precisely localize the bleeding segmental bronchus, measure diameters, and assess anatomical relationships with adjacent vessels.
• Prosthesis Fabrication: Custom-made conical occlusive prostheses were fabricated intraoperatively using medical-grade silicone (Model K804ovs-5). The material was tailored to the specific bronchial diameter. To enhance stability and prevent displacement, the prostheses were sutured with Ethicon PROLENE 2-0 non-absorbable polypropylene sutures wrapped around the mid-section to increase friction. A traction loop was sewn at the tail for endoscopic grasping and potential removal.
• Surgical Procedure: Under general anesthesia, rigid or flexible bronchoscopy was employed. After clearing intraluminal blood and clots, the custom prosthesis was delivered via the working channel using biopsy forceps. It was positioned into the bleeding segmental bronchus and gently compressed to ensure tight occlusion.
• Postoperative Management: Patients received standardized antitussive therapy for 72 hours to prevent prosthesis shedding due to coughing. Follow-up included clinical observation and chest CT at 3, 6, and 12 months to monitor prosthesis position, airway morphology, and recurrence.

Key Contributions

• Novel Technique: The study introduces a specific protocol for the bronchoscopic implantation of custom-made, sutured silicone prostheses, distinguishing it from commercial fixed-size devices or temporary balloon tamponades.
• Mechanism of Action: The technique relies on a dual mechanism: physical isolation of the bleeding lesion from the central airway and local hemodynamic regulation (inducing blood stasis to accelerate thrombus formation). The sutured design specifically addresses the common failure mode of prosthesis displacement.
• Applicability to Complex Etiologies: The study demonstrates the feasibility of this approach for bleeding sources that are typically resistant to BAE, including systemic arterial fistulas (aortic/diaphragmatic) and tumor cavities with diffuse neovascularization.
• Resource Accessibility: By utilizing readily available medical silicone and standard sutures, the technique offers a low-cost alternative to expensive imported occlusive devices, making it potentially accessible to primary medical institutions.

Results

• Immediate Efficacy: All four patients achieved complete hemostasis within 24 to 36 hours post-procedure, resulting in a 100% immediate hemostatic success rate.
• Long-term Outcomes: During the 12-month follow-up period, no recurrence of hemoptysis was observed in any patient (0% recurrence rate).
• Safety Profile: No severe intraoperative complications (e.g., airway laceration, massive hemorrhage, asphyxia) occurred. Postoperatively, only one patient experienced transient low-grade fever (peak 38.1°C) within 24 hours, which resolved with symptomatic treatment. There were no cases of prosthesis displacement, airway obstruction, aggravated infection, or pulmonary atelectasis.
• Functional Impact: Ventilatory function remained largely unaffected, and patients reported significant improvements in quality of life, with relief from cough and chest distress.

Significance and Claims
The authors claim that this technique serves as a reliable "salvage therapy" for selected patients with refractory tracheal hemoptysis who are ineligible for or have failed conventional treatments. The study posits that the method offers a favorable balance of minimal invasiveness, high efficacy, and safety, particularly for complex etiologies like vascular fistulas and lung cancer cavities where BAE often fails.

The paper emphasizes that the technique adheres to the principles of precision interventional medicine by utilizing patient-specific anatomical data for device customization. It suggests that this approach fills a critical treatment gap for high-risk patients who cannot tolerate surgical resection. However, the authors maintain a modest tone regarding the study's scope, acknowledging limitations such as the small sample size (n=4), the single-center retrospective design, and the lack of a control group. They conclude that while the preliminary data is promising, further large-scale, multi-center studies with long-term follow-up are necessary to validate the general applicability and long-term safety of the technique.