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一项评估 Bonastent 在中央气道阻塞中的安全性、可行性和并发症的多中心观察性研究。

A multicenter observational study assessing the safety, feasibility, and complications of Bonastent in central airway obstruction.

机构信息

Department of Medicine, Pulmonary & Critical Care Medicine, Albany Medical Center, 16 New Scotland Avenue, Albany, NY 12208, USA.

Department of Medicine, Pulmonary & Critical Care Medicine, Albany Medical Center, Albany, NY, USA.

出版信息

Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241260235. doi: 10.1177/17534666241260235.

DOI:10.1177/17534666241260235
PMID:39301895
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11437588/
Abstract

BACKGROUND

Self-expandable metallic stents (SEMS) are increasingly used in the management of both malignant and nonmalignant airway stenosis. There are multiple stents available in the market; however, the current literature on the efficacy and safety of newly available 3rd generation SEMS (Bonastent) is extremely limited and only has data from single center studies.

OBJECTIVES

To report the efficacy and early (<7 days) and late (⩾7 days) complications in patients with central airway obstruction (CAO) treated with Bonastent placement at two institutions.

DESIGN

We performed a retrospective analysis of data of consecutive patients who underwent therapeutic bronchoscopy and Bonastent placement at two tertiary care university hospitals between January 2019 and November 2023.

METHODS

Bonastent deployment was performed in the operating room. Stents were deployed using rigid or flexible bronchoscopy under direct visualization with a flexible bronchoscope and in conjunction with fluoroscopic guidance. We then analyzed the effectiveness, short-term, and long-term complications of Bonastent placement.

RESULTS

A total of 107 Bonastents® were placed in 96 patients. The most common etiology of CAO was malignancy, 92.7% ( = 89), followed by excessive dynamic airway collapse (EDAC) and post-intubation tracheal stenosis. Seventy-three patients (76%) had improvement in symptoms or imaging within 7 days of stent placement, including successful liberation from mechanical ventilation in a patient with CAO. Early complications occurred in seven patients (two-airway bleeding, two-mucus plugging that improved with airway clearance, two-stent migrations, and one-cough).Late complications occurred in 23 patients (1-stent migration requiring revision bronchoscopy and replacement of airway stent, 11-mucus plugging, 6-granulation tissue, 2-pneumonia, 1-cough, 1-tumor ingrowth/stent fracture, 1-airway emergency due to excessive granulation tissue obstructing the distal end of the stent and had a failed cricothyroidotomy leading to death). Overall, the early complication rate was 7.3% (7/96) and late complication rate was 23.9% (23/96).

CONCLUSION

Our study is the first multicenter study that found a good safety profile with a low complication rate after tracheobronchial Bonastent placement with improvement in symptoms soon after stent placement.

摘要

背景

自膨式金属支架(SEMS)越来越多地用于恶性和非恶性气道狭窄的治疗。市场上有多种支架可供选择;然而,关于新的第三代 SEMS(Bonastent)的疗效和安全性的当前文献非常有限,仅来自单中心研究的数据。

目的

报告在两家机构接受 Bonastent 置入治疗的中心气道阻塞(CAO)患者的疗效以及早期(<7 天)和晚期(⩾7 天)并发症。

设计

我们对 2019 年 1 月至 2023 年 11 月在两家三级护理大学医院接受治疗性支气管镜检查和 Bonastent 置入的连续患者的数据进行了回顾性分析。

方法

在手术室中进行 Bonastent 放置。在柔性支气管镜直视下,结合透视引导,使用刚性或柔性支气管镜放置支架。然后,我们分析了 Bonastent 放置的有效性、短期和长期并发症。

结果

总共在 96 名患者中放置了 107 个 Bonastent®。CAO 的最常见病因是恶性肿瘤,占 92.7%(=89),其次是过度动态气道塌陷(EDAC)和插管后气管狭窄。73 名患者(76%)在支架放置后 7 天内症状或影像学改善,包括一名 CAO 患者成功从机械通气中解放出来。7 名患者发生早期并发症(2 例气道出血,2 例黏液栓经气道清除后改善,2 例支架移位,1 例咳嗽)。23 名患者发生晚期并发症(1 例支架移位需要修订支气管镜检查和更换气道支架,11 例黏液栓,6 例肉芽组织,2 例肺炎,1 例咳嗽,1 例肿瘤生长/支架骨折,1 例由于支架远端过多的肉芽组织阻塞导致气道紧急情况和环甲切开术失败导致死亡)。总体而言,早期并发症发生率为 7.3%(7/96),晚期并发症发生率为 23.9%(23/96)。

结论

我们的研究是第一项多中心研究,发现经气管支气管 Bonastent 放置后安全性良好,并发症发生率低,支架放置后不久症状即改善。

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本文引用的文献

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Safety of hybrid bronchial stents in transplant airway complications: a single center experience.混合支气管支架在移植气道并发症中的安全性:单中心经验
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Safety and Efficacy of the Tracheobronchial Bonastent: A Single-Center Case Series.气管支气管 Bonastent 的安全性和疗效:单中心病例系列。
Respiration. 2020;99(4):353-359. doi: 10.1159/000506815. Epub 2020 Apr 7.
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A Single Center Experience of Feasibility of a Novel Self-Expanding Metallic Airway Stent (Bonastent): A Case Series.
新型自膨式金属气道支架(博纳支架)可行性的单中心经验:病例系列
J Bronchology Interv Pulmonol. 2019 Oct;26(4):254-259. doi: 10.1097/LBR.0000000000000603.
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A Single-Center Case Series Describing Tracheobronchial Bonastent Implantation.一项描述气管支气管Bonastent植入术的单中心病例系列研究。
J Bronchology Interv Pulmonol. 2019 Oct;26(4):265-272. doi: 10.1097/LBR.0000000000000567.
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