EUROSTAR Data Registry Centre, Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.
Eur J Vasc Endovasc Surg. 2011 Sep;42 Suppl 1:S63-71. doi: 10.1016/j.ejvs.2011.06.012.
The outcomes for patients after endovascular treatment of abdominal aortic aneurysm (AAA) are determined primarily by the endpoints of death and endoleaks, the latter representing continued risk of rupture. The data of a multicentre registry were analysed with regard to the early outcome of stent-graft procedures for AAA and the complications associated with this treatment. In addition, the results during follow-up were analysed by determining mortality and endoleak development as separate endpoints and as a combined endpoint defined as endoleak-free survival.
38 European institutions of Vascular Surgery collaborating in a multicentre registry project.
899 patients with AAA underwent between May 1994 and March 1998 elective endovascular repair (818 men and 81 women; mean age 69 years). 80 (8.9%) of the patients had medical conditions that excluded them from open repair. 818 (91%) of patients had a bifurcated device, 63 (7%) had a straight tube graft, and only 18 (2%) had an aorto-uni-iliac device. Clinical examination and contrast-enhanced computed tomography was performed at fixed follow-up intervals to assess increase or decrease of the maximum transverse diameter (MTD). Endoleaks observed at follow-up were discriminated into persistent endoleak and temporary endoleak. The latter is defined as single time observed endoleaks or with two or more negative imaging studies between observed endoleaks. Life-table analyses were used to calculate the rates of freedom-from-endoleak (no endoleak at any time), freedom-from-persistent endoleak (no persistent endoleak), patient survival, and persistent-endoleak-free-survival.
The median follow-up of this patient series was 6.2 months. The ratio between observed and expected follow-up data was 82% for the overall follow-up period. However, at 18 months of follow-up this rate was only 45%. The number of patients followed during this period was sufficient to allow statistically meaningful assessment. The MTD in patients with temporary endoleaks demonstrated a significant decrease at 6 to 12 months compared to preoperative values (mean 57 and 53 respectively, p = 0.004). In patients with persistent endoleaks there was no change between the preoperative and 6-month MTD (mean 57 and 60 mm respectively). At 6 and 18 months freedom-from-endoleak was 83% and 74% and freedom-from-persistent endoleak was 93% and 90%, respectively. The 18-month cumulative patient survival was 88% and the main outcome measure, the persistent endoleak-free-survival was 79%.
The MTD decreases in patients with temporary endoleak, but not in patients with persistent endoleak. Therefore, the use of the rate of freedom-from-persistent endoleak, reflecting absence of persisting endoleaks to estimate the prognosis with regard to the AAA, is justified. Determining persistent endoleak-free survival appears a rational approach to provide a realistic outlook for patients with stent-grafted AAA. The observed 18-month endoleak-free survival reflects a satisfactory mid-term result.
腹主动脉瘤（AAA）血管内治疗的患者结局主要取决于死亡和内漏的终点，后者代表持续破裂的风险。对多中心注册处的数据进行了分析，以了解 AAA 血管内支架植入术的早期结果和与这种治疗相关的并发症。此外，通过将死亡率和内漏发展确定为单独的终点，并将其定义为无内漏生存的组合终点，来分析随访期间的结果。
38 家欧洲血管外科机构参与了一项多中心注册项目。
1994 年 5 月至 1998 年 3 月，899 例 AAA 患者接受了选择性血管内修复（818 名男性和 81 名女性；平均年龄 69 岁）。80 例（8.9%）患者有排除开放修复的医学状况。818 例（91%）患者使用分叉装置，63 例（7%）使用直管移植物，仅 18 例（2%）使用腹主动脉-单-髂装置。固定随访间隔进行临床检查和增强 CT 扫描，以评估最大横径（MTD）的增加或减少。在随访中观察到的内漏分为持续性内漏和暂时性内漏。后者定义为单次观察到的内漏或在观察到的内漏之间有两次或更多次阴性影像学研究。生存表分析用于计算无内漏（任何时候都无内漏）、无持续性内漏（无持续性内漏）、患者生存率和持续性内漏无生存的概率。
该患者系列的中位随访时间为 6.2 个月。整个随访期间，观察到的数据与预期数据的比例为 82%。然而，在 18 个月的随访中，这一比例仅为 45%。在此期间随访的患者数量足以进行有统计学意义的评估。在有暂时性内漏的患者中，MTD 在 6 至 12 个月时与术前值相比显著下降（分别为 57 和 53，p=0.004）。在有持续性内漏的患者中，术前和 6 个月时的 MTD 没有变化（分别为 57 和 60mm）。在 6 个月和 18 个月时，无内漏的概率分别为 83%和 74%，无持续性内漏的概率分别为 93%和 90%。18 个月时累积患者生存率为 88%，主要观察指标为持续性内漏无生存的概率为 79%。
在有暂时性内漏的患者中，MTD 下降，但在有持续性内漏的患者中没有下降。因此，使用无持续性内漏的概率来评估 AAA 的预后是合理的。确定持续性内漏无生存似乎是为接受支架植入 AAA 治疗的患者提供现实前景的合理方法。观察到的 18 个月内漏无生存反映了中期结果令人满意。
