BACKGROUND: Biodegradable (BD) stents made from polydioxanone have been used only in human airways. These stents combine the advantages of classical tracheal stents, and fewer side effects are expected due to their biocompatibility and their time-limited presence in airways. However, new clinical consequences have arisen. Here, the authors share their experiences with BD stents for tracheal indications, focusing on their safety and efficacy. METHODS: This was a retrospective review of a collected database of adult patients who underwent implantation of biodegradable tracheal stents between September 2013 and December 2022 at the Department of Respiratory Medicine of the 1st Faculty of Medicine in Prague and Thomayer University Hospital. The indications included functionally significant nonmalignant tracheal stenosis and tracheomalacia. Self-expandable, biodegradable, polydioxanone tracheal stents manufactured by ELLA-CS Ltd. (Hradec Kralove, Czech Republic) were implanted during rigid bronchoscopy under general anaesthesia. All patients were followed up in the department and were provided with the necessary care. The main efficacy and safety parameters and relationships were analysed using descriptive statistics and Fisher´s exact, Wilcoxon and Kruskal‒Wallis tests. RESULTS: A total of 65 stents were implanted in 47 adult patients. During the first two months after implantation, when adequate function was expected, the stent was found to be effective in 26 out of 39 patients who completed this period (66.7%). The clinical effectiveness reached 89.7%, as early restenoses were mostly mild and necessitated treatment in only 4 patients. The frequencies of significant mucostasis, migration and granulation tissue growth were 2.6%, 7.5% and 23.1%, respectively, during this period. Thirty-four participants completed the half-year follow-up period after the first or second stent insertion, and some were followed up beyond this period. Poor control of symptoms, the development of restenosis and the need for interventions were characteristic of this period as the stents degraded. Twenty-two patients who experienced remodelling or stabilization of the tracheal lumen achieved a stent-free state. Seven patients underwent subsequent surgical treatment. CONCLUSIONS: BD stents are safe and provide adequate tracheal support until they begin to degrade. The use of BD stents necessitates close monitoring of patients and accurate treatment of possible restenosis. TRIAL REGISTRATION: Based on project NT14146 - Biodegradable stents in the management of the large airways (2013-2015, MZ0/NT), registered on May 1, 2013, in the Research and Development and Innovation Information System of the Czech Republic and at ClinicalTrials.gov (reg. no. NCT02620319, December 2, 2015).
- Klíčová slova
- Biodegradable, Bronchoscopy, Interventional pneumology, Polydioxanone, Stents, Tracheal stenosis,
- MeSH
- bronchoskopie * MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- polydioxanon MeSH
- protézy - design MeSH
- retrospektivní studie MeSH
- senioři MeSH
- stenóza průdušnice * chirurgie MeSH
- stenty * MeSH
- trachea chirurgie MeSH
- tracheomalacie chirurgie MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
Biodegradable stents are promising treatments for many diseases, e.g., coronary artery disease, urethral diseases, tracheal diseases, and esophageal strictures. The mechanical properties of biodegradable stent materials play a key role in the safety and efficacy of treatment. In particular, insufficient creep resistance of the stent material could result in premature stent collapse or narrowing. Commercially available biodegradable self-expandable SX-ELLA stents made of polydioxanone monofilament were tested. A new, simple, and affordable method to measure the shear modulus of tiny viscoelastic wires is presented. The important mechanical parameters of the polydioxanone filament were obtained: the median Young's modulus was [Formula: see text] = 958 (922, 974) MPa and the shear modulus was [Formula: see text] = 357 (185, 387) MPa, resulting in a Poisson's ratio of ν = 0.34. The SX-ELLA stents exhibited significant force relaxation due to the stress relaxation of the polydioxanone monofilament, approximately 19% and 36% 10 min and 48 h after stent application, respectively. However, these results were expected, and the manufacturer and implanting clinician should be aware of the known behavior of these biodegradable materials. If possible, a biodegradable stent should be designed considering therapeutic force rather than initial force. Additionally, new and more advanced biodegradable shape-memory polymers should be considered for future study and use.
- MeSH
- biokompatibilní materiály chemie MeSH
- lidé MeSH
- mechanické jevy MeSH
- modul pružnosti MeSH
- polydioxanon chemie MeSH
- protézy - design MeSH
- stenty * MeSH
- testování materiálů MeSH
- vstřebatelné implantáty * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- biokompatibilní materiály MeSH
- polydioxanon MeSH
BACKGROUND: Biodegradable stents that disintegrate after a period of time are expected to be well tolerated and have advantages over other stents that are more commonly used in practice today. Polydioxanone is a biodegradable polymer that is widely used during surgery with absorbable sutures. METHODS: We present cases from the first four patients to undergo a tracheal polydioxanone stent insertion. Indications included significant non-malignant tracheal stenosis in cases where primary surgical treatment was not possible. The stents were implanted using rigid bronchoscopy and patients received regular follow-ups as needed. This use of biodegradable stents in adult patients was a novel, previously untested approach. The study was approved by the Institutional Ethics Committee and was based on a project entitled; "Biodegradable stents in the management of stenoses of large airways" (project NT 14146-3/2013). RESULTS: Six biodegradable stents were implanted in four patients with benign stenoses. No technical difficulties occurred and no serious or life-threatening events were recorded. All patients reported some benefit from treatment. CONCLUSION: Polydioxanone tracheal stents can be considered when a need for temporary support is expected, and as an alternative to other stents if the latter could compromise the patient. Owing to limited experience and observed disadvantages, further research is needed to fully assess this treatment. TRIAL REGISTRATION: This work is based on project NT14146 - Biodegradable stents in the management of stenoses of the large airways (2013-2015, MZ0/NT), registered from May 1, 2013 in The Research and Development and Innovation Information System of the Czech Republic and in ClinicalTrials.gov, reg. no. NCT02620319, December 2, 2015.
- MeSH
- biokompatibilní materiály chemie MeSH
- bronchoskopie MeSH
- lidé středního věku MeSH
- lidé MeSH
- polydioxanon chemie MeSH
- senioři MeSH
- stenóza průdušnice chirurgie MeSH
- stenty klasifikace MeSH
- trachea chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinická studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
- Názvy látek
- biokompatibilní materiály MeSH
- polydioxanon MeSH
OBJECTIVE: This study was undertaken to evaluate safety and biocompatibility of a novel biodegradable polydioxanone stent in a rabbit tracheal model. Metallic and silicone stents represent standard therapeutic approaches for hollow organ stenosis, although complications have been reported repeatedly. Biodegradable stents could reduce the risks associated with this procedure while still achieving the purpose of maintaining lumen patency. METHODS: A commercially available polydioxanone suture strand with a long safety record was used to manufacture the self-expanding stents. The polydioxanone stents were then implanted bronchoscopically and under fluoroscopic guidance into the tracheas of white rabbits (N = 25). Periodic clinical examination was performed. Histopathologic examination concluded the study for the 5 experimental groups at 3, 4, 5, 10, and 15 weeks after implantation. RESULTS: There were no unexpected deaths and no stent displacements during the study. The animals remained in good condition, without stent debris expectoration. Macroscopic examination revealed that the tracheal lumen stayed open. Histologic examination showed that tracheal damage score was highest 5 weeks after stenting, including in-stent necrosis of the epithelium. Stent degradation was complete with no remnants after 10 weeks, leaving the trachea completely healed at 15 weeks after implantation. CONCLUSIONS: This animal airway model has demonstrated acceptable safety and biocompatibility of this novel biodegradable polydioxanone stent. We suggest that polydioxanone stenting be used for further clinical studies for cases in which complete stent degradation after temporary airway treatment is desirable.
- MeSH
- bronchoskopie škodlivé účinky přístrojové vybavení MeSH
- časové faktory MeSH
- fluoroskopie MeSH
- intervenční radiografie metody MeSH
- králíci MeSH
- modely u zvířat MeSH
- polydioxanon * MeSH
- protézy - design MeSH
- stenty * MeSH
- testování materiálů MeSH
- trachea diagnostické zobrazování patologie chirurgie MeSH
- vstřebatelné implantáty * MeSH
- zvířata MeSH
- Check Tag
- králíci MeSH
- ženské pohlaví MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- hodnotící studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- polydioxanon * MeSH
OBJECTIVES: To assess the outcome of self-expandable, biodegradable stent insertion for anastomotic strictures following treatment for rectosigmoid carcinoma. METHODS: Three male patients (median age 66) developed benign strictures after radiotherapy and resection of a recto-sigmoid carcinoma. These were resistant to balloon dilatation and prevented stoma reversal. Biodegradable stent insertion was performed as an experimental treatment on a named-patient basis with approval of the institutional review board. Patients had monthly follow-up with endoscopy and contrast medium enemas to monitor performance and degradation of the stents. RESULTS: All stents were placed successfully without complications after pre-dilatation to 20 mm under fluoroscopic guidance. Stent degradation occurred in all patients 4-5 months following implantation, and long-term anastomotic patency was demonstrated in all. This allowed reversal of the colostomy and physiological defecation in two patients. Reversal was not undertaken in one due to subsequent development of liver metastases. No stent migration or occlusion occurred. CONCLUSIONS: Biodegradable stents can maintain an adequate lumen across anastomotic strictures resistant to balloon dilatation. They seem to allow stricture re-modelling resulting in maintained dilatation after degradation. This potentially allows reversal of a colostomy, which might otherwise be prevented by stricture recurrence.
- MeSH
- anastomóza chirurgická škodlivé účinky metody MeSH
- hodnocení rizik MeSH
- katetrizace škodlivé účinky metody MeSH
- kolektomie škodlivé účinky metody MeSH
- kolostomie škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory rekta patologie chirurgie MeSH
- následné studie MeSH
- opakovaná terapie MeSH
- polydioxanon * MeSH
- senioři MeSH
- staging nádorů MeSH
- stenóza etiologie terapie MeSH
- stenty * MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- vzorkové studie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- polydioxanon * MeSH
OBJECTIVE: To evaluate the safety and effectiveness of novel biodegradable (BD) stents to treat bronchial anastomotic stenosis in patients after lung transplantation. METHODS: Twenty BD stents were implanted endoscopically in six patients (median age 41.5 years (range 35-57 years)) with post-transplant bronchial anastomotic stenoses, between 2006 and 2010. All stents were custom-made from bio-absorbable polydioxanone (PDS). The median stent diameter was 12 mm (8-17 mm) and median length was 20mm (12-30 mm). All patients were evaluated clinically, by bronchoscopy and high-definition computed tomography (CT). RESULTS: The stenosis was initially relieved in all cases. There was no bleeding, perforation or displacement after BD stent implantation. Four patients needed multiple stenting for anastomotic re-stenosis. Median time to any re-stenting was 5 months (2-15 months). There was one sudden death, 1 year after the last BD stent implantation, from a pulmonary embolus. All five survivors are in good clinical condition up to 4 years' follow-up (median 40 months, range 7-48 months) since first stenting and intervention-free up to 44 months (median 24 months, range 7-44 months). CONCLUSIONS: This small pilot study shows that BD stents are a safe, effective and reliable alternative to classical metallic stents in patients with anastomotic stenosis after lung transplantation, and may avoid the need for permanent stenting.
- MeSH
- anastomóza chirurgická škodlivé účinky MeSH
- bronchiální nemoci etiologie chirurgie MeSH
- bronchoskopie MeSH
- dospělí MeSH
- epidemiologické metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- obstrukce dýchacích cest etiologie chirurgie MeSH
- polydioxanon MeSH
- protézy - design MeSH
- stenóza etiologie chirurgie MeSH
- stenty * MeSH
- transplantace plic škodlivé účinky MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- hodnotící studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- polydioxanon MeSH
- MeSH
- katetrizace MeSH
- lidé MeSH
- litotripse MeSH
- nemoci žlučových cest terapie MeSH
- polydioxanon MeSH
- protézy - design MeSH
- senioři MeSH
- stenóza terapie MeSH
- stenty * MeSH
- vstřebatelné implantáty MeSH
- žlučové cesty intrahepatální * MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
- práce podpořená grantem MeSH
- Názvy látek
- polydioxanon MeSH
UNLABELLED: Uncomplicated healing of surgical wounds is one of the most important factors which contribute to the success of operations. In particular dehiscence of laparotomy is an important complication associated with considerable morbidity and lethality. A number of factors which contribute to the healing of the surgical wound at the time of operation cannot be influenced, it is however possible to influence the technique of wound closure and the material used. The authors compare in their study early postoperative and long-term results of closure of laparotomy in three groups of patients where for closure of laparatomy PDSII loop suture was used, continuous suture with Vicryl and classical suture by individual silone stitches. The investigation revealed a significantly lower incidence of early postoperative complications in patients where modern absorbable materials were used, in particular early infections. The incidence of dehiscence of laparotomy or hernia in the scar did not differ significantly although in the group with absorbable materials, contrary to the group with silone, there was no dehiscence of laparotomy without an infectious complication of wound healing. CONCLUSION: Empirical experience and the conclusions of some major investigations indicate that the best method of closure of laparotomy is continuous suture using absorbable material.
- MeSH
- absorpce MeSH
- dehiscence operační rány MeSH
- infekce chirurgické rány MeSH
- laparotomie škodlivé účinky metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- nylony MeSH
- polydioxanon MeSH
- polyglactin 910 MeSH
- prospektivní studie MeSH
- šicí techniky * MeSH
- silikony MeSH
- sutura * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- anglický abstrakt MeSH
- časopisecké články MeSH
- klinické zkoušky kontrolované MeSH
- klinické zkoušky MeSH
- Názvy látek
- nylony MeSH
- polydioxanon MeSH
- polyglactin 910 MeSH
- siliconized nylon MeSH Prohlížeč
- silikony MeSH
The author describes his experience with suture of the Achilles tendon by absorbable material of Ethicon Co. from a small medial incision by minimal traumatization of soft tissues and a somewhat modified postoperative fixation.
- MeSH
- absorpce MeSH
- Achillova šlacha zranění chirurgie MeSH
- dospělí MeSH
- lidé MeSH
- polydioxanon * MeSH
- ruptura MeSH
- šicí techniky MeSH
- sutura * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- anglický abstrakt MeSH
- časopisecké články MeSH
- Názvy látek
- polydioxanon * MeSH
The demand of biological treatment of acromioclavicular luxations is met by the use of Polydioxanon strips (PDS). Artificial damage of the joint does not occur and the bond is elastic. Thus removal of metal which ensures rigid fixation of the joint is eliminated. This makes it possible to achieve within a short period a normal range of movements.
- MeSH
- absorpce MeSH
- akromioklavikulární kloub zranění chirurgie MeSH
- dislokace kloubu chirurgie MeSH
- lidé MeSH
- polydioxanon MeSH
- protézy a implantáty * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- polydioxanon MeSH