van Marrewijk C J, Fransen G, Laheij R J F, Harris P L, Buth J
Catharina Hospital, P.O.Box 1350, 6502 ZA Eindhoven, The Netherlands.
Eur J Vasc Endovasc Surg. 2004 Feb;27(2):128-37. doi: 10.1016/j.ejvs.2003.10.016.
There is still debate whether type II endoleaks represent a risk for the patient after EVAR. Treatment policies vary from fairly conservative to active intervention. In this analysis risk factors for type II endoleak and adverse events during follow-up were assessed. In addition, risk factors and causes for conversion to open repair and for rupture post-EVAR were studied.
The data of 3595 patients, who underwent operation between 1996 and 2002 in 114 European institutions that collaborated in the EUROSTAR Registry, were assessed. To accurately assess the influence of type II endoleaks patients with type I, III and combined endoleaks were excluded from the present study cohort.
A combined adverse outcome event consisting of aneurysmal growth, transfemoral reintervention, and transabdominal secondary procedures (including laparoscopic branch vessel clipping) occurred in 55% in patients with type II endoleak at 3 years, compared to 15% in patients without any endoleak (p<0.0001). Conversion to open repair or post-EVAR rupture was not significantly associated with type II endoleaks. An independent association of device migration and expansion of the aneurysm with late conversion was observed. The cumulative incidence of aneurysm rupture at 3 years of follow-up was 1.2% for an annual rate of 0.4%. Variables that significantly and independently correlated with rupture were size of the aneurysm at preoperative measurement and device migration during follow-up.
Endoleak type II may not be harmless as it was more frequently associated with enlargement of the aneurysm and reinterventions. Large aneurysms and migration of the device were the main risk factors for rupture. The clinical implications of these findings may involve more frequent surveillance visits for patients with type II endoleak. Aneurysm expansion is a clear indication for reintervention. Patients with large aneurysms, 65 mm or larger, may also benefit from a more comprehensive surveillance schedule.
关于Ⅱ型内漏对腔内修复术后患者是否构成风险仍存在争议。治疗策略从相当保守到积极干预各不相同。在本分析中,评估了Ⅱ型内漏的风险因素以及随访期间的不良事件。此外,还研究了转为开放修复以及腔内修复术后破裂的风险因素和原因。
评估了1996年至2002年期间在欧洲114个机构参与EUROSTAR注册研究的3595例接受手术患者的数据。为准确评估Ⅱ型内漏的影响,本研究队列排除了Ⅰ型、Ⅲ型及合并内漏的患者。
3年时,Ⅱ型内漏患者中由动脉瘤生长、经股动脉再次干预及经腹二次手术(包括腹腔镜分支血管夹闭)组成的联合不良结局事件发生率为55%,而无任何内漏的患者为15%(p<0.0001)。转为开放修复或腔内修复术后破裂与Ⅱ型内漏无显著相关性。观察到器械移位和动脉瘤扩张与晚期转为开放修复独立相关。随访3年时动脉瘤破裂的累积发生率为1.2%,年发生率为0.4%。与破裂显著且独立相关的变量为术前测量的动脉瘤大小及随访期间的器械移位。
Ⅱ型内漏可能并非无害,因为它更常与动脉瘤增大和再次干预相关。大动脉瘤和器械移位是破裂的主要风险因素。这些发现的临床意义可能包括对Ⅱ型内漏患者进行更频繁的随访。动脉瘤扩张是再次干预的明确指征。直径65mm或更大的大动脉瘤患者也可能从更全面的随访计划中获益。