Department of Vascular Surgery, University of Patras Medical School, Patras, Greece.
Department of Vascular Surgery, University of Patras Medical School, Patras, Greece.
J Vasc Surg. 2019 Feb;69(2):394-404. doi: 10.1016/j.jvs.2018.05.013. Epub 2018 Aug 11.
To compare two endograft types, the original GORE EXCLUDER AAA endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) with the repositionable GORE EXCLUDER featuring the C3 delivery system, which allows repositioning of the proximal part of the graft to achieve accurate placement in relation to the renal arteries, in unselected patients with aortoiliac aneurysms. In a second nested, substudy we investigated the relative effect of the standard Gore and Gore Dryseal introducer sheaths on intraoperative transfusion needs.
We retrospectively analyzed prospectively collected information. The primary composite outcome measure was the intraoperative misdeployment or migration of the endograft's main body, proximally or distally to the renals (leading to technical failure or requiring either placement of aortic cuff extenders or conversion to open repair). Secondary outcome measures included the composite long-term event of rupture and/or type I/III endoleak.
A total of 313 consecutive patients (303 males; median age, 73 years) had either an original GORE EXCLUDER device (n = 174) or the new device (n = 139) placed between 2004 and 2011 and 2011 and 2017, respectively, to treat an infrarenal aortoiliac aneurysm or an isolated common iliac artery aneurysm. The primary composite outcome measure occurred more often in patients who had the original GORE EXCLUDER device placed (10.9% vs 3.6% for the new device; odds ratio, 0.30; 95% confidence interval, 0.11-0.84; P = .016), confirmed by multivariate logistic regression analysis. This difference between the two groups was exclusively driven by distal misdeployment or migration of the endograft (10.3% vs 2.9% for the new device; P = .01), mostly requiring aortic extender placement. Intraoperative blood transfusion rates were lower in patients who had the GORE Dryseal introducer sheath used (1.1% vs 18.9% for the original GORE introducer sheath; OR, 0.05; 95% confidence interval, 0.006-0.35; P < .001). At a mean follow-up of 1.7 years (maximum, 13 years), 11 patients developed the composite event. On univariate Cox analysis, significant predictors included female gender (P = .003), absence of dyslipidemia (P = .023), the primary outcome measure (P = .006), and failure to cannulate (P = .009), but not device type or other variables. On multivariate Cox regression, female gender (hazard ratio, 37; P < .001), chronic obstructive pulmonary disease (hazard ratio, 3.99; P = .045), the primary outcome measure of the study (hazard ratio, 8.9; P = .002), and failure to cannulate (hazard ratio, 43; P = .003) were all independent predictors.
Our study has demonstrated that the repositionable GORE EXCLUDER has important safety characteristics compared with the original device and equivalent long-term effectiveness. Additional benefit was obtained with the use of the Gore Dryseal introducer sheath.
比较两种血管内移植物类型，即原始戈尔 EXCLUDERAAA 血管内假体（W. L. Gore & Associates，Flagstaff，Ariz）和可重新定位的带有 C3 输送系统的戈尔 EXCLUDER，该系统允许重新定位移植物的近端部分，以实现与肾动脉的准确位置关系，用于未经选择的腹主动脉瘤患者。在第二个嵌套的亚研究中，我们研究了标准戈尔和戈尔 Dryseal 导入鞘对术中输血需求的相对影响。
我们回顾性分析了前瞻性收集的信息。主要复合结局指标是移植物主体的术中不当放置或迁移，近端或远端到肾脏（导致技术失败或需要放置主动脉袖套延长器或转换为开放修复）。次要结局指标包括破裂和/或 I/III 型内漏的复合长期事件。
共有 313 例连续患者（303 例男性；中位年龄 73 岁）分别于 2004 年至 2011 年和 2011 年至 2017 年接受了原始戈尔 EXCLUDER 装置（n=174）或新型装置（n=139）的治疗，以治疗腹主动脉瘤或孤立的髂总动脉瘤。主要复合结局指标在接受原始戈尔 EXCLUDER 装置治疗的患者中更常见（10.9%比新型装置的 3.6%；比值比，0.30；95%置信区间，0.11-0.84；P=0.016），这一差异通过多变量逻辑回归分析得到了证实。两组之间的这种差异完全是由移植物的远端不当放置或迁移引起的（10.3%比新型装置的 2.9%；P=0.01），主要需要放置主动脉延长器。使用戈尔 Dryseal 导入鞘的患者术中输血率较低（1.1%比原始戈尔导入鞘的 18.9%；OR，0.05；95%置信区间，0.006-0.35；P<0.001）。在平均 1.7 年（最长 13 年）的随访中，11 例患者发生了复合事件。在单因素 Cox 分析中，显著预测因素包括女性（P=0.003）、无血脂异常（P=0.023）、主要结局指标（P=0.006）和无法进行套管插入（P=0.009），但不包括设备类型或其他变量。在多因素 Cox 回归中，女性（危险比，37；P<0.001）、慢性阻塞性肺疾病（危险比，3.99；P=0.045）、研究的主要结局指标（危险比，8.9；P=0.002）和无法套管插入（危险比，43；P=0.003）都是独立的预测因素。
我们的研究表明，可重新定位的戈尔 EXCLUDER 与原始设备相比具有重要的安全性特征，并且具有同等的长期效果。使用戈尔 Dryseal 导入鞘还可以获得额外的益处。
