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Clinical experience with the silicone tracheal prosthesis

Macroscopically, the tracheo-prosthetic junctions were difficult to identify; no loosening of the prosthesis was visible. None of the prostheses showed signs of fracture. The prostheses were surrounded by a tissue matrix, with the thickness of the tissue around the prostheses corresponding to about 50 percent of their diameter. A growth of newly formed fibroepithelial tissue opposite the juxtaprosthetic endoluminal surface created a partial stenosis without clinical consequence for animals 2 and 3. By contrast, no sign of stenosis on any section was detected in animals 4 and 5.

Clinical experience with the silicone tracheal pros

In IM3 ( = 2), we implanted prostheses by replacing a tracheal segment without the silicone tube after conditioning the prostheses in the infrahyoid muscles for 25 days. The animals used in this procedure died prematurely (days 27 and 29). The low survival rate of the sheep was directly linked to endoprosthetic stenosis or to necrotic junction zones. Furthermore, the bodies of the prostheses were covered with endoluminal mucus without colonization. No stenosis at the level of the prosthesis body was documented; only the tracheo-prosthetic anastomoses were involved. The prior conditioning and colonization of prostheses did not warrant bypassing the use of a stent. These results support the hypothesis that the silicone tube is necessary to protect the respiratory lumen and to stent the junction zones. The role of the silicone tube as a splint is essential, even with the improved impermeability of the conditioned prosthesis.

Success with a silicone tracheal prosthesis

Clinical experience with the silicone ..

AB - The Dumon stent (or Endoxane), designed in 1987, is a flexible, multisized, studded, silicone prosthesis. This report describes the combined results of Dumon stent placement in Marseille, France (J.F.D.), Brescia, Italy (S.C.), Saint-Etienne, France (J.M.V.), and Barcelona, Spain (P.D.). The four teams had placed 1,574 stents in 1,058 patients through September 1994. All cases involved high-grade stenosis of the tracheobronchial tree resulting from extrinsic compression or wall collapse due to loss of cartilaginous support. The locations were the trachea (54%), the left main stem bronchus (21%), the right main stem bronchus (18%), and miscellaneous (8%). The main indications were malignant tumors (677 patients, 926 stents), benign tracheal stenosis (263 patients, 419 stents), postsurgical bronchial stenosis after lung transplantation (15 patients, 36 stents), low-grade malignant tumors (21 patients, 50 stents), and miscellaneous benign stenosis lesions (82 patients, 143 stents). All stents were placed via the rigid bronchoscope. The mean number of stents per patient was 1.5 overall, 1.4 in patients with malignant lesions, and 1.6 in patients with benign tracheal stenosis. The mean duration of stenting was 14 months for benign tracheal disease (longest, 6.2 years) and 4 months for malignancy (longest, 4.7 years). Complications were uncommon, usually easily managed, and rarely life threatening. The main complications were migration (9.5%), obstruction by secretions (3.6%), and granulation (7.9%). Rare complications included airway ulceration, infection, septic shock, and aphonia. Secondary obstruction due to extrinsic compression of the prosthesis was never observed. Routine yearly evaluations are recommended, with other evaluations based on clinical indications. Based on our 7-year experience, we conclude that the Dumon stent represents an effective way to reestablish a viable airway in patients with benign and malignant tracheobronchial disease.

These findings led us to research an optimal operative protocol to improve the impermeability and endoluminal colonization of the prostheses. To this end, we implanted the prostheses in sheep using five different methods (described in the next section) and compared their survival rates and histological results. We analyzed the colonization of porous titanium prostheses with and without conditioning (placing the prosthesis in muscle for colonization before implantation) and the use of a sili-cone tube for endoprosthetic calibration. We also assessed the improvement in the prostheses' endoluminal epithelialization via the application of an endoprosthetic mucous graft. This study compares and analyzes the clinical and histological results of these five surgical techniques. Our aim was to determine the ideal surgical procedure for replacing a tracheal segment with a porous titanium prosthesis in large animals before the procedure is potentially translated to humans.

experience with the silicone tracheal pros ..

Clinical experience with the silicone tracheal ..

We performed a daily clinical follow-up. We recorded data regarding the general well-being of the animals and their weight throughout the experiment. We performed endoscopic follow-up (with archival films and photographs) under general anesthesia weekly during the first month after tracheal-segment prosthesis implantation, then every 2 weeks, to evaluate the endoluminal diameter of the prosthesis and the colonization tissue. Endoscopic evaluations were also performed in cases of dyspnea and before scheduled euthanasia.

After 21 days (day 81), we reopened the cervical cutaneous incision and laterally transposed the prosthesis, with its endoluminal surface covered with buccal epithelium, to replace a 5 cm tracheal segment (6-7 rings), which we resected during the same operation. We removed the solid titanium tube and replaced it with a silicone tube (placed inside the porous titanium prosthesis) that was sutured to the prosthesis with one proximal and one distal stitch (vicryl 2.0). Before closing the skin and subcutaneous tissue, we performed a myoplasty to improve coverage and limit future leakage.

Photograph of the tracheal prosthesis with a silicone ..
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This study compares and analyzes the clinical and histological ..

N2 - The Dumon stent (or Endoxane), designed in 1987, is a flexible, multisized, studded, silicone prosthesis. This report describes the combined results of Dumon stent placement in Marseille, France (J.F.D.), Brescia, Italy (S.C.), Saint-Etienne, France (J.M.V.), and Barcelona, Spain (P.D.). The four teams had placed 1,574 stents in 1,058 patients through September 1994. All cases involved high-grade stenosis of the tracheobronchial tree resulting from extrinsic compression or wall collapse due to loss of cartilaginous support. The locations were the trachea (54%), the left main stem bronchus (21%), the right main stem bronchus (18%), and miscellaneous (8%). The main indications were malignant tumors (677 patients, 926 stents), benign tracheal stenosis (263 patients, 419 stents), postsurgical bronchial stenosis after lung transplantation (15 patients, 36 stents), low-grade malignant tumors (21 patients, 50 stents), and miscellaneous benign stenosis lesions (82 patients, 143 stents). All stents were placed via the rigid bronchoscope. The mean number of stents per patient was 1.5 overall, 1.4 in patients with malignant lesions, and 1.6 in patients with benign tracheal stenosis. The mean duration of stenting was 14 months for benign tracheal disease (longest, 6.2 years) and 4 months for malignancy (longest, 4.7 years). Complications were uncommon, usually easily managed, and rarely life threatening. The main complications were migration (9.5%), obstruction by secretions (3.6%), and granulation (7.9%). Rare complications included airway ulceration, infection, septic shock, and aphonia. Secondary obstruction due to extrinsic compression of the prosthesis was never observed. Routine yearly evaluations are recommended, with other evaluations based on clinical indications. Based on our 7-year experience, we conclude that the Dumon stent represents an effective way to reestablish a viable airway in patients with benign and malignant tracheobronchial disease.

linked to a silicone prosthesis as a tracheal ..

When we replaced a tracheal segment, we used silicone tubes (stents) for the endoluminal calibration of the porous titanium prostheses. Their hardness was 50 Shore A; they were 80 mm long with an internal diameter of 19 mm. They protruded from each end of the prosthesis by 25 mm, thus protecting the tracheo-prosthetic anastomoses. The prosthetics and silicone tubes were sterilized by autoclaving before implantation.

October 1991 · AORN journal

We performed five different implantation methods: Implantation method 1 (IM1) ( = 5) involved direct implantation of the porous titanium prosthesis with an endoprosthetic silicone tube in place of a tracheal segment. With the animal in the supine position after a vertical midline cervicotomy, the infrahyoid muscles were separated from the tracheal axis. After dissecting to the level of the thyroid, we resected a tracheal segment of six to seven rings (50 mm). Each tracheal extremity was then inserted into the prosthesis, which replaced the defect. A silicone tube was placed in the titanium prosthesis and sutured to the prosthesis with one proximal and one distal stitch (vicryl 2.0). For animal 1, the stent-prosthesis suture was not performed. The porous titanium prosthesis and the tracheal extremities were joined by eight proximal and distal sutures (prolene 2.0). Before closing the skin and the subcutaneous layers without drainage, we performed a myoplasty to cover the prosthesis and limit possible peritracheal leakage.

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