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Experimental Trial of Balloon-Expandable, Metallic Palmaz Stent in the Trachea FREE

J. Carlos Fraga, MD, PhD; Robert M. Filler, MD; Vito Forte, MD; Andre Bahoric, DVM; Charles Smith, MD
Arch Otolaryngol Head Neck Surg. 1997;123(5):522-528. doi:10.1001/archotol.1997.01900050072010
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Objective:  To determine the effect of the Palmaz stent, which has been successfully used to relieve airway obstruction in a small group of children, on the normal and operated on animal trachea.

Design:  In this experimental trial, stents were placed bronchoscopically in the thoracic tracheae of 4 groups of 50 anesthetized cats. The cats in group 1 (adults, n=10) and group 2 (kittens, n=10) had normal tracheae; the cats in group 3 (adults, n=15) underwent horizontal tracheal incision and closure; and the cats in group 4 (adults, n=15) underwent pericardial patch tracheoplasty. In groups 3 and 4, the stents were inserted in 10 cats and 5 cats served as controls. Stents were inflated to a 15-mm diameter in group 1 and an 8-mm diameter in the other groups. Half of the animals with stents were killed 5 weeks after the procedure, and the others, 10 weeks after the procedure.

Setting:  The Hospital for Sick Children, Toronto, Ontario.

Results:  In group 1, 1 animal died of tracheal perforation. A mild cough was noted in 15 of the 39 cats with stents. In group 4, 3 cats had difficulty eating and lost weight. The results of esophagoscopy excluded esophageal inflammation or obstruction in these 3 animals. The results of bronchoscopy indicated a nonobstructing rim of granulation tissue at the end of the stent in 15 of 20 cats in groups 1 and 2 and 17 of 20 cats in groups 3 and 4 and at the repair site in all animals with stents from groups 3 and 4. The results of autopsy indicated the cross-sectional area at the site of the stent was greater than normal in group 1 (P<.003) and smaller than the normal trachea at the site of the tracheoplasty in group 4 controls without stents (P<.02); however, the cross-sectional area at the tracheoplasty site with the stent was not smaller (P<.13). The results of histologic examination indicated a mild inflammatory reaction, with granulation tissue in all animals with stents, but in group 1, with overexpanded stents, the reaction was more severe, with epithelial ulceration, fibrosis, and sealed-off perforations in most animals. In group 3, the tracheae with stents had significantly more inflammatory reaction, granulation tissue, and epithelial damage than the controls without stents.

Conclusions:  The Palmaz stent provokes an inflammatory reaction in the normal trachea and the trachea recently operated on. With the exception of the group 1 animals with overexpanded stents, this reaction is clinically insignificant. The Palmaz stent is able to maintain a normal lumen size after pericardial tracheoplasty in cats.Arch Otolaryngol Head Neck Surg. 1993;119:522-528

REFERENCES

Filler RM, Forte V, Fraga JC, Matute J.  The use of expandable metallic airways stents for tracheobronchial obstruction in children . J Pediatr Surg . 1995;;30: 1050-1056.
Palmaz JC, Windeler SA, Garcia F, Tio FO, Sibbitt RR, Reuter SR.  Atherosclerotic rabbit aortas: expandable intraluminal grafting . Radiology . 1986;;160:723-726.
Howard A. Calculus with Analytic Geometry: Late Trigonometry Version . 3rd ed. New York, NY: John Wiley & Sons Inc; 1989;:876-877.
Nashef SAM, Dromer C, Velly JF, Labrousse L, Couraud L.  Expanding wire stents in benign tracheobronchial disease: indications and complications . Ann Thorac Surg . 1992;;54:937-940.
Wallace MJ, Charnsangavej C, Ogawa K, et al.  Tracheobronchial tree: expandable metallic stents used in experimental and clinical applications . Radiology . 1986;; 158:309-312.
Tsang V, Goldstraw P.  Self-expanding metal stent for tracheobronchial strictures . Eur J Cardiothorac Surg . 1992;;6:555-560.
Filler RM.  Congenital anomalies . In: Pearson FG, Deslauriers J, Ginsberg RJ, et al, eds. Thoracic Surgery . New York, NY: Churchill Livingstone Inc; 1995;: 235-250.
Zannini P, Mellonni G, Chiesa G, et al.  Self-expanding stents in the treatment of tracheobronchial obstruction . Chest . 1994;;1:86-90.
Varela A, Maynar M, Irving D, et al.  Use of Gianturco self-expandable stents in the tracheobronchial tree . Ann Thorac Surg . 1990;;49:806-809.
Egan AM, Dennis C, Flower DR.  Expandable metal stents for tracheobronchial obstruction . Clin Radiol . 1994;;49:162-165.
Rousseau H, Dahan M, Lauque D, et al.  Self-expandable prostheses in the tracheobronchial tree . Radiology . 1993;;188:199-203.
Mair EA, Parsons DS, Lally KP, Van Dellen AF.  Comparison of expandable endotracheal stents in the treatment of surgically induced piglet tracheomalacia . Laryngoscope . 1991;;101:1002-1008.
Bugmann P, Rouge J-C, Berner M, Friedli B, Le Coultre C.  Use of Gianturco Z stents in the treatment of vascular compression of the tracheobronchial tree in childhood . Chest . 1994;;106:1580-1582.
Spatenka J, Khagani A, Irving JD, Theodoropoulos S, Slavik Z, Yacoub MH.  Gianturco self-expanding metallic stents in treatment of tracheobronchial stenosis after single lung and heart and lung transplantation . Eur J Cardiothorac Surg . 1991;;5:648-652.
George PJM, Irving D, Khaghani A, Dick R.  Role of the Gianturco expandable metal stent in the management of tracheobronchial obstruction . Cardiovasc Intervent Radiol . 1992;;15:375-381.
Nomori H, Kobayashi R, Kodera K, Morinaga S, Ogawa K.  Indications for an expandable metallic stent for tracheobronchial stenosis . Ann Thorac Surg . 1993;; 56:1324-1328.
Vinograd I, Klin B, Brosh T, Weinberg M, Flomenblit Y, Nevo Z.  A new intratracheal stent made from nitinol, an alloy with 'shape memory effect.' J Thorac Cardiovasc Surg . 1994;;107:1255-1261.
Rauber K, Franke C, Rau W.  Self-expanding stainless steel endotracheal stents: an animal study . Cardiovasc Intervent Radiol . 1989;;12:274-276.
Sawada S, Tanabe Y, Fujiwara Y, et al.  Endotracheal expandable metallic stent placement in dogs . Acta Radiol . 1991;;32:79-80.
Sawada S, Tanigawa N, Kobayashi M, Furui S, Ohta Y.  Malignant tracheobronchial obstructive lesions: treatment with Gianturco expandable metallic stents . Radiology . 1993;;188:205-208.

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Filler RM, Forte V, Fraga JC, Matute J.  The use of expandable metallic airways stents for tracheobronchial obstruction in children . J Pediatr Surg . 1995;;30: 1050-1056.
Palmaz JC, Windeler SA, Garcia F, Tio FO, Sibbitt RR, Reuter SR.  Atherosclerotic rabbit aortas: expandable intraluminal grafting . Radiology . 1986;;160:723-726.
Howard A. Calculus with Analytic Geometry: Late Trigonometry Version . 3rd ed. New York, NY: John Wiley & Sons Inc; 1989;:876-877.
Nashef SAM, Dromer C, Velly JF, Labrousse L, Couraud L.  Expanding wire stents in benign tracheobronchial disease: indications and complications . Ann Thorac Surg . 1992;;54:937-940.
Wallace MJ, Charnsangavej C, Ogawa K, et al.  Tracheobronchial tree: expandable metallic stents used in experimental and clinical applications . Radiology . 1986;; 158:309-312.
Tsang V, Goldstraw P.  Self-expanding metal stent for tracheobronchial strictures . Eur J Cardiothorac Surg . 1992;;6:555-560.
Filler RM.  Congenital anomalies . In: Pearson FG, Deslauriers J, Ginsberg RJ, et al, eds. Thoracic Surgery . New York, NY: Churchill Livingstone Inc; 1995;: 235-250.
Zannini P, Mellonni G, Chiesa G, et al.  Self-expanding stents in the treatment of tracheobronchial obstruction . Chest . 1994;;1:86-90.
Varela A, Maynar M, Irving D, et al.  Use of Gianturco self-expandable stents in the tracheobronchial tree . Ann Thorac Surg . 1990;;49:806-809.
Egan AM, Dennis C, Flower DR.  Expandable metal stents for tracheobronchial obstruction . Clin Radiol . 1994;;49:162-165.
Rousseau H, Dahan M, Lauque D, et al.  Self-expandable prostheses in the tracheobronchial tree . Radiology . 1993;;188:199-203.
Mair EA, Parsons DS, Lally KP, Van Dellen AF.  Comparison of expandable endotracheal stents in the treatment of surgically induced piglet tracheomalacia . Laryngoscope . 1991;;101:1002-1008.
Bugmann P, Rouge J-C, Berner M, Friedli B, Le Coultre C.  Use of Gianturco Z stents in the treatment of vascular compression of the tracheobronchial tree in childhood . Chest . 1994;;106:1580-1582.
Spatenka J, Khagani A, Irving JD, Theodoropoulos S, Slavik Z, Yacoub MH.  Gianturco self-expanding metallic stents in treatment of tracheobronchial stenosis after single lung and heart and lung transplantation . Eur J Cardiothorac Surg . 1991;;5:648-652.
George PJM, Irving D, Khaghani A, Dick R.  Role of the Gianturco expandable metal stent in the management of tracheobronchial obstruction . Cardiovasc Intervent Radiol . 1992;;15:375-381.
Nomori H, Kobayashi R, Kodera K, Morinaga S, Ogawa K.  Indications for an expandable metallic stent for tracheobronchial stenosis . Ann Thorac Surg . 1993;; 56:1324-1328.
Vinograd I, Klin B, Brosh T, Weinberg M, Flomenblit Y, Nevo Z.  A new intratracheal stent made from nitinol, an alloy with 'shape memory effect.' J Thorac Cardiovasc Surg . 1994;;107:1255-1261.
Rauber K, Franke C, Rau W.  Self-expanding stainless steel endotracheal stents: an animal study . Cardiovasc Intervent Radiol . 1989;;12:274-276.
Sawada S, Tanabe Y, Fujiwara Y, et al.  Endotracheal expandable metallic stent placement in dogs . Acta Radiol . 1991;;32:79-80.
Sawada S, Tanigawa N, Kobayashi M, Furui S, Ohta Y.  Malignant tracheobronchial obstructive lesions: treatment with Gianturco expandable metallic stents . Radiology . 1993;;188:205-208.

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