University of Massachusetts Medical Center, Worcester, MA.
VA Boston Healthcare, West Roxbury, MA; Boston University School of Medicine, Boston, MA.
J Vasc Surg. 2022 Sep;76(3):680-687. doi: 10.1016/j.jvs.2022.02.020. Epub 2022 Mar 1.
Early generation Endologix AFX endovascular abdominal aortic aneurysm (AAA) stent graft devices are at risk of developing type IIIa (intercomponent/overlap-related) as well as type IIIb (fabric tear) endoleaks over time. Current follow-up studies are limited to short (<24 months) and midterm (24-48 months) reports. The purpose of this study was to identify the incidence of type III endoleaks associated with these endografts over a long-term follow-up (>4 years) period and discuss current management strategies.
A retrospective, single-institution cohort analysis of all Endologix AFX endografts implanted from October 2011 to October 2016 was performed. Patient characteristics, imaging, and follow-up were obtained via chart review. Type III endoleaks were characterized based on computed tomography angiogram/operative findings and confirmed by two surgeons. Statistical analysis was performed with SAS v9.4.
Sixty-three patients underwent AFX stent graft implantation for aneurysmal disease. Forty-seven patients comprised the final cohort for analysis after exclusions were made for primary iliac aneurysms as well as off-label use of the device (eg, hypogastric snorkel) or primary occlusive indications. The average age was 73.3 years, with the longest follow-up being 8.7 years (median, 5.2 years). Most AAAs (89.2%) were fusiform, with initial median diameter 5.5 cm. Initial 30-day mortality was 0%. Of the initial cohort, 10 (21.3%) type III endoleaks were treated, of which six (60%) were type IIIa and four (40%) were type IIIb. By time-to-event analysis at latest follow-up, freedom from type III intervention was 48% at 8 years. The median time to type III endoleak discovery was 4.7 years (range, 1.1-7.2 years), an interval that was similar for type IIIa and type IIIb leak types (P = .73). Patients with type III endoleaks had average sac growth of 1.3 cm over the follow-up interval compared with a net decrease for patients without type III endoleaks (P < .0001). Of the 10 patients treated for type III leaks, seven (70%) underwent complete endovascular re-lining, one (10%) had partial re-lining, and two (20.0%) underwent open endograft explant with aortic graft reconstruction. Reintervention 30-day mortality was 0% for all approaches.
Early generation Endologix AFX stent grafts have a high rate of type III endoleaks, with freedom from type III leak <50% at 8-year follow-up. Most of these are not detected until several years (>4.5 years) after initial implantation, beyond the range of the follow-up interval of most published reports. Long-term imaging surveillance is critical, and a low threshold for complete relining should be considered with any sign of sac enlargement, even if endoleak is not clearly demonstrated in patients with early generation Endologix AFX grafts.
早期的 Endologix AFX 血管内腹主动脉瘤（AAA）支架移植物存在发生 IIIa 型（组件之间/重叠相关）和 IIIb 型（织物撕裂）内漏的风险，随着时间的推移。目前的随访研究仅限于短期（<24 个月）和中期（24-48 个月）报告。本研究的目的是确定这些移植物在长期（>4 年）随访期间与 III 型内漏相关的发生率，并讨论当前的管理策略。
对 2011 年 10 月至 2016 年 10 月期间植入的所有 Endologix AFX 支架移植物进行了回顾性、单中心队列分析。通过病历回顾获取患者特征、影像学和随访资料。根据计算机断层血管造影/手术结果，由两位外科医生对 III 型内漏进行特征描述，并进行确认。采用 SAS v9.4 进行统计分析。
63 例患者因动脉瘤疾病接受了 AFX 支架移植物植入。排除主要的髂动脉瘤以及该装置的非适应证（如，腹主动脉分叉支架的旁路技术）或原发性闭塞适应证后，47 例患者最终被纳入分析队列。平均年龄为 73.3 岁，最长随访时间为 8.7 年（中位数为 5.2 年）。大多数 AAA（89.2%）为梭形，初始直径中位数为 5.5cm。初始 30 天死亡率为 0%。在最初的队列中，有 10 例（21.3%）III 型内漏患者接受了治疗，其中 6 例（60%）为 IIIa 型，4 例（40%）为 IIIb 型。在最新随访时的时间至事件分析中，8 年时 III 型干预的无事件生存率为 48%。III 型内漏发现的中位时间为 4.7 年（范围，1.1-7.2 年），IIIa 型和 IIIb 型漏的间隔时间相似（P=0.73）。与无 III 型内漏的患者相比，有 III 型内漏的患者在随访期间的平均囊腔生长为 1.3cm（P<0.0001）。在接受 III 型漏治疗的 10 例患者中，7 例（70%）患者行完全血管内再衬，1 例（10%）行部分再衬，2 例（20.0%）行开放移植物取出并主动脉移植物重建。所有方法的 30 天再干预死亡率均为 0%。
早期的 Endologix AFX 支架移植物存在较高的 III 型内漏发生率，8 年随访时 III 型漏的无事件生存率<50%。大多数内漏是在初始植入后数年（>4.5 年）才被发现，超出了大多数已发表报告的随访间隔范围。长期影像学监测至关重要，对于早期的 Endologix AFX 移植物患者，即使内漏未明确显示，只要囊腔增大，应考虑行完全再衬，且阈值要低。
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