PDF(Pubmed)
Abstract：
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.
BACKGROUND: 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).
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.
BACKGROUND: 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).
摘要：
背景：由聚二恶烷酮制成的可生物降解（BD）支架仅用于人体气道。这些支架结合了经典气管支架的优点，由于它们的生物相容性和在气道中的时间限制，预计副作用较少。然而,出现了新的临床后果。这里,作者分享了他们使用BD支架治疗气管适应症的经验，关注其安全性和有效性。
方法：这是对2013年9月至2022年12月在布拉格第一医学院呼吸内科和Thomayer大学医院接受生物可降解气管支架植入的成年患者数据库的回顾性回顾。适应症包括功能显着的非恶性气管狭窄和气管软化。自膨胀,可生物降解，ELLA-CSLtd.制造的聚二恶烷酮气管支架（HradecKralove，捷克共和国）在全身麻醉下进行刚性支气管镜检查。所有患者均在该部门进行了随访，并获得了必要的护理。使用描述性统计和Fisher精确分析了主要疗效和安全性参数及其关系，威尔科克森和克鲁斯卡尔·瓦利斯测试。
结果：47例成人患者共植入65个支架。在植入后的头两个月，当预期有足够的功能时，在完成这一时期的39例患者中,有26例(66.7%)发现支架有效.临床有效率达89.7%,由于早期再狭窄大多是轻度的，只有4例患者需要治疗。显著粘液停滞的频率，迁移和肉芽组织生长为2.6%，7.5%和23.1%，分别,在此期间。34名参与者在第一次或第二次支架插入后完成了半年的随访期，有些人在这段时间之后得到了跟进。症状控制不佳，再狭窄的发展和需要干预是这一时期的特征,因为支架退化.经历了气管腔重塑或稳定的22例患者达到了无支架状态。7名患者接受了随后的手术治疗。
结论：BD支架是安全的，并在开始降解之前提供足够的气管支持。BD支架的使用需要密切监测患者并对可能的再狭窄进行准确治疗。
背景：基于项目NT14146-大型气道管理中的可生物降解支架（2013-2015，MZ0/NT），于2013年5月1日在捷克共和国的研发与创新信息系统和ClinicalTrials.gov（reg。不。NCT02620319，2015年12月2日）。
方法：这是对2013年9月至2022年12月在布拉格第一医学院呼吸内科和Thomayer大学医院接受生物可降解气管支架植入的成年患者数据库的回顾性回顾。适应症包括功能显着的非恶性气管狭窄和气管软化。自膨胀,可生物降解，ELLA-CSLtd.制造的聚二恶烷酮气管支架（HradecKralove，捷克共和国）在全身麻醉下进行刚性支气管镜检查。所有患者均在该部门进行了随访，并获得了必要的护理。使用描述性统计和Fisher精确分析了主要疗效和安全性参数及其关系，威尔科克森和克鲁斯卡尔·瓦利斯测试。
结果：47例成人患者共植入65个支架。在植入后的头两个月，当预期有足够的功能时，在完成这一时期的39例患者中,有26例(66.7%)发现支架有效.临床有效率达89.7%,由于早期再狭窄大多是轻度的，只有4例患者需要治疗。显著粘液停滞的频率，迁移和肉芽组织生长为2.6%，7.5%和23.1%，分别,在此期间。34名参与者在第一次或第二次支架插入后完成了半年的随访期，有些人在这段时间之后得到了跟进。症状控制不佳，再狭窄的发展和需要干预是这一时期的特征,因为支架退化.经历了气管腔重塑或稳定的22例患者达到了无支架状态。7名患者接受了随后的手术治疗。
结论：BD支架是安全的，并在开始降解之前提供足够的气管支持。BD支架的使用需要密切监测患者并对可能的再狭窄进行准确治疗。
背景：基于项目NT14146-大型气道管理中的可生物降解支架（2013-2015，MZ0/NT），于2013年5月1日在捷克共和国的研发与创新信息系统和ClinicalTrials.gov（reg。不。NCT02620319，2015年12月2日）。
