the Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands; the Division of Vascular Surgery, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
the Division of Vascular Surgery, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
J Vasc Surg. 2020 Mar;71(3):780-789. doi: 10.1016/j.jvs.2019.04.486. Epub 2019 Aug 20.
The purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date.
Patients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak.
Through 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up.
In the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.
本研究旨在报告迄今为止最大的前瞻性真实世界队列中 II 型内漏的发生率、自然史和结局。
从前瞻性 Endurant 支架移植物自然选择全球上市后注册研究（ENGAGE）中提取患者。分析了两组患者：第一组为单纯 II 型内漏患者；第二组为存在 II 型内漏且随后出现 I 型内漏的患者。对早期 II 型内漏患者和无内漏患者的健康状况进行了分析。其次，试图确定随后出现 I 型内漏的 II 型内漏患者的风险因素。
在 5 年的随访期间，共发现 197 例（15.6%）孤立性 II 型内漏患者。大多数在最初的 30 天内（n=73[37.1%]）和第 1 年内（n=73[37.1%]）被发现，其余在随访 1 年后被发现（n=51[25.8%]）。II 型内漏患者的瘤体生长发生率和二次血管内治疗（EVAR）的发生率更高（5 年时分别为 15.4%和 7.5%；P<0.001）。孤立性 II 型内漏组的总生存率高于无内漏组（5 年时分别为 77.2%和 67.0%；P=0.010）。22 例（10%）II 型内漏患者被诊断为迟发性 I 型内漏（IA 型，n=10；IB 型，n=12），5 年内二次干预率为 67.5%。在 1 年随访时，早期 II 型内漏患者和无任何类型内漏患者的健康状况评分无差异。
在 ENGAGE 登记研究中，15.6%的患者在随访期间存在孤立性 II 型内漏。大多数不需要进行二次干预，早期孤立性 II 型内漏在 1 年内对健康状况没有影响。然而，一小部分 II 型内漏患者会出现 I 型内漏，导致二次干预率高，瘤体相关并发症风险大。
