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髂动脉瘤及不良动脉瘤特征在使用说明中的更高依从性——单机构使用Nellix血管内动脉瘤封堵系统的初步经验

Greater Compliance within Instruction for Use for Concomitant Iliac Aneurysms and Adverse Aneurysm Characteristics-Initial Experience with the Nellix Endovascular Aneurysm Sealing System at a Single Institution.

作者信息

Jeffrey Hing Jun X, Ch'ng Jack K, Tay Kiang H, Chong Tze T

机构信息

Department of General Surgery, Singapore General Hospital, Singapore.

Department of Vascular Surgery, Singapore General Hospital, Singapore.

出版信息

Ann Vasc Surg. 2018 May;49:144-151. doi: 10.1016/j.avsg.2018.01.063. Epub 2018 Feb 9.

DOI:10.1016/j.avsg.2018.01.063
PMID:29428533
Abstract

BACKGROUND

The Nellix was introduced to Asia in 2014. Data in Asians have been sparse. Two balloon-expandable stents, each surrounded by a polymer-filled endobag, are deployed in parallel to obliterate and seal the aneurysm. This paradigm shift to treating abdominal aortic aneurysms confers advantages for certain adverse aneurysm morphology that is outside the instruction-for-use (IFU) for standard endovascular aneurysm repair (EVAR) devices. We examine outcomes of 15 Asian patients with concomitant infrarenal aortic and iliac artery aneurysms treated with the Nellix at our institution.

METHOD

Between July 2014 and August 2016, 15 male patients underwent elective EVAS at a single tertiary center by the same team of vascular surgeons and interventional radiologists. Patient demographics, clinical presentations, aneurysm morphology, perioperative complications, and follow-up imaging according to the standardized protocol were studied. Preoperative CT images were analyzed using validated automatic 3-dimensional sizing software EndoSize.

RESULT

The novel stent-graft deployment proves consistent and achieved a 100% technical success. Eleven patients (70%) complied within specified Nellix IFU, as compared to 20% if standard endovascular aneurysm repair (EVAR) IFU was applied. The difference is due to the presence of concurrent common iliac aneurysms (n = 5), short neck length (n = 3), and angulated necks (n = 3). Adjunct procedures included 3 open access endarterectomy with embolectomy, 1 coil embolization of internal iliac artery, 1 bilateral renal artery chimneys, and 1 proximal stent deployment. There was no conversion to open surgery. Average operative time was 133 min. Median length of stay was 4 days. Thirty-day mortality was 0%. Perioperative morbidity included exacerbation of pre-existing renal impairment (n = 6), peripheral vascular disease (n = 3), and postimplantation syndrome (n = 5). One endoleak (7%) and 2 instances of stent migration (14%) were detected. There was no complication of aneurysm or endobag rupture, limb thromboses, or fracture.

CONCLUSIONS

Early data in our center are encouraging and highlight high procedural success with minimal complications despite challenging patient anatomy.

摘要

背景

Nellix于2014年引入亚洲。亚洲人群的数据较为稀少。该装置由两个可球囊扩张的支架组成,每个支架周围环绕着一个填充聚合物的内袋,两个支架平行展开以闭塞并密封动脉瘤。这种治疗腹主动脉瘤的模式转变为某些不符合标准血管内动脉瘤修复(EVAR)装置使用说明书(IFU)的不良动脉瘤形态带来了优势。我们研究了在我院接受Nellix治疗的15例合并肾下主动脉和髂动脉瘤的亚洲患者的治疗结果。

方法

2014年7月至2016年8月期间,15例男性患者在单一三级中心由同一组血管外科医生和介入放射科医生进行了选择性EVAS。根据标准化方案研究患者的人口统计学资料、临床表现、动脉瘤形态、围手术期并发症及随访影像学检查结果。术前CT图像使用经过验证的自动三维测量软件EndoSize进行分析。

结果

新型支架移植物的植入过程顺利,技术成功率达100%。11例患者(70%)符合Nellix特定的IFU,而若应用标准血管内动脉瘤修复(EVAR)的IFU,符合率仅为20%。差异的原因在于存在同时合并的髂总动脉瘤(n = 5)、短瘤颈(n = 3)和成角瘤颈(n = 3)。辅助手术包括3例开放性入路动脉内膜切除术联合栓子切除术、1例髂内动脉线圈栓塞术、1例双侧肾动脉烟囱技术和1例近端支架植入术。无中转开放手术病例。平均手术时间为133分钟。中位住院时间为4天。30天死亡率为0%。围手术期并发症包括原有肾功能损害加重(n = 6)、外周血管疾病(n = 3)和植入后综合征(n = 5)。检测到1例内漏(7%)和2例支架移位(14%)。未发生动脉瘤或内袋破裂、肢体血栓形成或骨折等并发症。

结论

我们中心的早期数据令人鼓舞,表明尽管患者解剖结构具有挑战性,但该手术成功率高且并发症极少。

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引用本文的文献

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The Nellix endovascular aneurysm sealing system: current perspectives.内利克斯血管内动脉瘤封堵系统:当前观点
Med Devices (Auckl). 2019 Feb 19;12:65-79. doi: 10.2147/MDER.S155300. eCollection 2019.