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Introduction The objective of this study was to evaluate tracheal reactivity induced by a biodegradable polydioxanone tracheal stent. Materials and methods Twenty-two rabbits were divided into 3 groups assigned to different survival times (30, 60 and 90 days post-implantation). A biodegradable stent was implanted in each animal, except for 1 from each group (negative control). Implantation was performed through a small tracheotomy under fluoroscopic control. CT and histopathological studies were scheduled at the end of survival times. Results No animal died during the procedure or follow-up. The stent had disappeared in 100% of the cases at 90 days, in 50% at 60 days, and in none at 30 days. CT studies revealed a greater tracheal wall thickness at 30 days than at 60 and 90 days (1.60 ± 0.41 mm in the central part of the stent versus 1.11 ± 0.18 and 0.94 ± 0.11; P = .007, respectively). No granulomas were observed on histopathology. Some degree of histological changes were noted at 30 days, which had reduced at 60 and 90 days. Differences were also found in both CT and histology between animals in which the stent was present and animals in which it had degraded. Conclusions Polydioxanone stents produce a mild reaction that reverts with tracheal degradation. The use of these biodegradable stents in benign tracheal disease is promising.

Resumen Introduccion El objetivo de este estudio es evaluar la reactividad traqueal inducida por un stent traqueal biodegradable de polidioxanona. Material y metodos Veintidos conejos se dividieron en 3 grupos con diferentes tiempos de supervivencia (30, 60 y 90 dias postimplantacion). Se implanto un stent biodegradable en cada animal, excepto en uno de cada grupo (control negativo). La implantacion se realizo a traves de una pequena traqueotomia y bajo control fluoroscopico. Al finalizar los tiempos de supervivencia programados se realizaron estudios de TC y anatomopatologicos. Resultados Ningun animal murio durante el procedimiento ni en el seguimiento. El stent habia desaparecido en el 100% de los casos a los 90 dias, en el 50% a los 60 dias y en ninguno a los 30 dias. En los estudios de TC se observo un grosor de la pared traqueal mayor a los 30 que a los 60 y 90 dias (1,60 ± 0,41 mm en la parte central del stent frente a 1,11 ± 0,18 y 0,94 ± 0,11; p = 0,007). En el estudio anatomopatologico no se encontraron granulomas. A los 30 dias se observaba cierto grado de alteracion histologica, la cual se reduce a los 60 y 90 dias. Tambien se encuentran las diferencias, tanto en las TC como en la histologia, entre animales con el stent presente y animales con el stent degradado. Conclusiones Los stents de polidioxanona producen una leve reaccion traqueal que revierte con la degradacion. El uso de estos stents biodegradables en la patologia traqueal benigna es prometedor.

Benign strictures of the bile duct may be difficult to treat endoscopically due to altered bowel anatomy. Furthermore, recurrence of stenosis and symptoms remains high. The aim of the Spanish Prospective Registry BiELLA study was to investigate the safety and efficacy of absorbable stents in the treatment of benign biliary strictures and their outcomes on the medium and long-term follow-up. A prospective, multicenter, observational, non-randomized study (the BiELLA study) was conducted from January 2014 to September 2018. One hundred fifty-nine patients with benign biliary strictures, mostly postsurgical, were enrolled for implantation of absorbable biliary stents in the 11 participating Spanish tertiary hospitals. The average patient follow-up was 45.4 ± 15.9 months (range, 12–60 months). The follow-up data included symptoms, biochemical parameters, and ultrasound images at 1, 6, and 12 months and then yearly for up to 60 months. The immediate technical and clinical success rates were 100%. In all patients, stent placement resulted in improvement of clinical symptoms and biochemical parameters. The primary mean patency for stent was 86.7, 79.6, and 78.9% at 12, 36, and 60 months, respectively (95% CI). Biliary restenosis and occlusion occurred in 40 (26.6%) patients. Of the 40 patients, 18 (12%) patients were treated with a second stent and 22 (14.6%) patients had operative repair of the recurrent strictures. There were no major complications associated with stent implantation. Implantation of an absorbable polydioxanone biliary stent is safe and effective for treatment of benign biliary strictures refractory to balloon dilatation or other biliary intervention. • Percutaneous implantation of biodegradable prostheses for the treatment of benign postsurgical biliary strictures is a safe and effective procedure. • More than 75% of the patients presented patency of the stented biliary tree at 5 years follow-up. • Absorbable stents improved clinical symptoms and signs (jaundice, itching, fever), and laboratory parameters in a few days after stent placement.

Benign strictures of the bile duct may be difficult to treat endoscopically due to altered bowel anatomy. Furthermore, recurrence of stenosis and symptoms remains high. The aim of the Spanish Prospective Registry BiELLA study was to investigate the safety and efficacy of absorbable stents in the treatment of benign biliary strictures and their outcomes on the medium and long-term follow-up.A prospective, multicenter, observational, non-randomized study (the BiELLA study) was conducted from January 2014 to September 2018. One hundred fifty-nine patients with benign biliary strictures, mostly postsurgical, were enrolled for implantation of absorbable biliary stents in the 11 participating Spanish tertiary hospitals. The average patient follow-up was 45.4 ± 15.9 months (range, 12-60 months). The follow-up data included symptoms, biochemical parameters, and ultrasound images at 1, 6, and 12 months and then yearly for up to 60 months.The immediate technical and clinical success rates were 100%. In all patients, stent placement resulted in improvement of clinical symptoms and biochemical parameters. The primary mean patency for stent was 86.7, 79.6, and 78.9% at 12, 36, and 60 months, respectively (95% CI). Biliary restenosis and occlusion occurred in 40 (26.6%) patients. Of the 40 patients, 18 (12%) patients were treated with a second stent and 22 (14.6%) patients had operative repair of the recurrent strictures. There were no major complications associated with stent implantation.Implantation of an absorbable polydioxanone biliary stent is safe and effective for treatment of benign biliary strictures refractory to balloon dilatation or other biliary intervention.• Percutaneous implantation of biodegradable prostheses for the treatment of benign postsurgical biliary strictures is a safe and effective procedure. • More than 75% of the patients presented patency of the stented biliary tree at 5 years follow-up. • Absorbable stents improved clinical symptoms and signs (jaundice, itching, fever), and laboratory parameters in a few days after stent placement.

Objective Surgical management of tracheomalacia is a challenge, with current treatments still presenting numerous complications. In the field of veterinary medicine, this same pathology is present in a significant number of dogs. For this reason, we present an experimental clinical trial performed on canines with tracheobronchomalacia, using a new atraumatic removable tracheal spiral stent (SS). Both implantation procedure and clinical improvement have been analyzed in this study. Methods In this study, four small dogs, a mean weight of 4.89 kg and body condition scores IV-V, were included. SS was implanted by two different surgical approaches. Image and clinical follow-up have been performed during 90 days. Symptoms were evaluated from 1 to 10 every week. Results This study achieved 100% technical and clinical success. Median tracheal diameters were as follows: cervical 10.85 (3.3), inlet 7.75 (2.1), and carina 7.75 (1.9) mm, and length was 77.5 (26) mm. A 12 × 10 × 100-mm SS was implanted in all cases. Goose honk cough punctuation improved from 8 to 1; also, there were important changes in exercise intolerance, a mean weight loss of 8.76%. The values of modified Karnofsky scale varied from 50 (20) before surgery to 90 (10) after 30 days of surgery. Neither granuloma tissue nor fractures of the prosthesis was observed. Conclusion The results in dogs are promising, and a new therapeutic alternative seems to be available for veterinarian field. The similarity of this disease between dogs and newborns suggests that this SS design can also be useful for human trials.

Background Canine tracheal collapse is a complex airway pathology without promising treatment results. Currently nitinol stents are the best surgical option; however, some professionals are doubting if stent placement is the best option due to the associated complications. Objective Determine the technical feasibility, safety, and long-term follow-up after the implantation of a new tracheal stent designed for canine tracheal collapse. Methods Thirteen healthy, adult female New Zealander rabbits were involved in this pilot study.A new intra-tracheal device (Reference number 902711 patent registered as CasMin-Twine) was implanted in ten animals. Deployment was performed under general anesthesia, making a puncture incision via a 21 Gauge needle in the intra-tracheal space where the stent was introduced with a screwing process. The device was fixed to the tracheal wall with a non-absorbable suture. Computerized Tomography (CT) and an endoscopy to study structural abnormalities were performed after 30, 90 and 365 days after stent placement. Results Technical and clinical success was 100%. There was no significant change in behavior or respiratory disorders. CT studies showed no significant alterations. After the 30 days, 60% of the animals showed partial endothelization in the endoscopy study, and only one animal still presented partial endothelization after 12 months. Mucus accumulation was only present in 40% of cases and classified as low, without respiratory consequences. Only one animal presented a single granuloma at caudal stent tip. Conclusions This new tracheal stent (CasMin-Twine) is an effective and safe procedure with promising results, and also shows the possibility of removing the device after endothelization has been produced. New studies should be carried out to evaluate the effectiveness in patients with tracheomalacia. Clinical Significance/Impact This new product can give veterinarians a new option of treatment for this complicated pathology. Minimizing specific equipment for its deployment, CasMin-Twine will be more accessible for all professionals.