Helsingborg Regional Hospital, Helsingborg, Sweden; Vascular Centre, Skåne University Hospital, Malmö, Sweden.
Vascular Centre, Skåne University Hospital, Malmö, Sweden.
Eur J Vasc Endovasc Surg. 2021 Apr;61(4):550-558. doi: 10.1016/j.ejvs.2020.12.012. Epub 2021 Jan 15.
Fenestrated endovascular aneurysm repair (FEVAR) is a well established treatment for complex abdominal aortic aneurysms (AAAs). FEVAR with custom made devices (CMDs) has limitations in both the emergency and elective settings due to time consuming manufacture. "Off the shelf" (OTS) fenestrated stent grafts are a potential solution. The primary goal was to evaluate the five year outcome of the COOK Zenith p-Branch OTS device at a single centre.
Patients with juxtarenal AAA meeting the inclusion criteria for the COOK Zenith p-Branch device were enrolled in a prospective, non-randomised, non-comparative trial from July 2012 to September 2015. Demographic, anatomical, procedure related, and five year follow up data were collected, analysed, and adjudicated by a core laboratory. The primary aims were to assess intervention free survival and overall survival at five years.
Twenty-three patients were treated and 21 completed follow up. Mean time to p-Branch implantation after patient presentation was 28 hours (range 0-122 hours) in emergency cases and 67 days (range 20-112 days) in elective cases. Median procedure time was 283 minutes (range 161-475 minutes) and technical success was 91%. Mean follow up was 45 months (standard deviation ± 24.4 months). The most common adverse events were renal injuries. Primary target vessel patency was 96.4% and 94.0% after one and five years respectively. Mean time to first re-intervention was 469 days (range 0-1 567 days). Survival during the follow up period was 76%, with no aneurysm related deaths.
FEVAR with the COOK Zenith p-Branch device is safe and effective for juxtarenal AAA in a selected patient population, in both elective and emergency settings. Long term outcomes are acceptable although inferior to CMDs. Mid and long term outcomes emphasise the p-Branch as a possible endovascular treatment for juxtarenal aortic pathology where CMD is not an option. Further innovation to address target vessel complications is needed, as these seem more prevalent than after repair with CMDs.
腔内血管修复术（FEVAR）是治疗复杂腹主动脉瘤（AAA）的一种成熟治疗方法。由于制造时间长，定制设备（CMDs）的 FEVAR 在急诊和择期情况下都有局限性。“现货供应”（OTS）的开窗支架移植物是一种潜在的解决方案。主要目标是评估单个中心的库克 Zenith p-Branch OTS 装置的五年结果。
符合库克 Zenith p-Branch 装置纳入标准的肾周 AAA 患者于 2012 年 7 月至 2015 年 9 月期间参加了一项前瞻性、非随机、非对照的试验。收集了人口统计学、解剖学、手术相关和五年随访数据，并由核心实验室进行分析和裁定。主要目标是评估五年时的无干预生存率和总生存率。
23 名患者接受了治疗，21 名患者完成了随访。在急诊情况下，从患者就诊到植入 p-Branch 的平均时间为 28 小时（范围 0-122 小时），在择期情况下为 67 天（范围 20-112 天）。中位手术时间为 283 分钟（范围 161-475 分钟），技术成功率为 91%。平均随访时间为 45 个月（标准差±24.4 个月）。最常见的不良事件是肾损伤。一级靶血管通畅率分别为术后 1 年和 5 年时的 96.4%和 94.0%。首次再次介入治疗的平均时间为 469 天（范围 0-1567 天）。随访期间的生存率为 76%，无动脉瘤相关死亡。
对于选定的患者人群，库克 Zenith p-Branch 装置的 FEVAR 治疗肾周 AAA 既安全又有效，适用于急诊和择期情况。长期结果是可以接受的，尽管不如 CMDs。中期和长期结果强调了 p-Branch 作为 CMD 不是选择的情况下治疗肾周主动脉病变的一种可能的血管内治疗方法。需要进一步创新来解决靶血管并发症，因为这些并发症似乎比用 CMD 修复后更为普遍。
