Division of Vascular and Endovascular Surgery, Carolinas Medical Center, Charlotte, NC.
Division of Vascular and Endovascular Surgery, University of Alabama at Birmingham, Birmingham, AL.
J Vasc Surg. 2023 Dec;78(6):1418-1425.e1. doi: 10.1016/j.jvs.2023.07.058. Epub 2023 Aug 7.
Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year. This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory cohort.
The 70 patients from the ANCHOR Registry were cohort submitted to regulators for approval of the Endurant short neck indication. Patients had an infrarenal neck length of ≥ 4 mm and <10 mm. At 5 years, this short neck cohort had clinical and imaging follow-up compliance rates of 85% (28/33) and 70% (23/33), respectively.
The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. Kaplan Meier freedom from all-cause mortality was 68.5 ± 6.2%, freedom from aneurysm-related mortality was 90.1 ± 4.5%, freedom from any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and freedom from rupture was 95.6 ± 3.2%. Eight patients had a total of nine type IA endoleaks detected through 5 years, of which three resolved spontaneously by the next follow-up visit. There were two patients with renal complications who did not undergo reintervention and there were no device migrations reported through 5 years. After 5 years, 68.2% of patients (15/22) had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared with their 1-month measurements.
After ESAR treatment using Heli-FX EndoAnchors with Endurant, the 5-year outcomes of the short neck cohort from the ANCHOR registry had encouraging results with regards to proximal neck-related complications, secondary procedures, and sac regression. This review of ESAR in patients with short proximal necks showed positive outcomes through 5 years although follow-up of a larger cohort is necessary.
众所周知，近端短颈等敌对的主动脉颈解剖结构会使患者发生 IA 型内漏、移位和需要再次干预的风险增加。Heli-FX 血管内锚定系统旨在改善主动脉支架移植物的密封效果。使用 EndoAnchors 进行血管内缝合动脉瘤修复（ESAR）结合 Endurant 支架移植物治疗短颈患者在一年的时间内被证明是安全有效的。本研究报告了使用 Heli-FX 血管内锚定系统全球注册（ANCHOR）短颈监管队列进行的动脉瘤治疗的 5 年患者结果。
来自 ANCHOR 注册的 70 名患者被提交给监管机构，以批准 Endurant 短颈适应症。患者的肾下颈部长度≥4mm且<10mm。5 年后，该短颈队列的临床和影像学随访依从率分别为 85%（28/33）和 70%（23/33）。
短颈队列的平均年龄为 71.3±8.1 岁，其中 27.1%（19/70）为女性。全因死亡率的 Kaplan-Meier 无事件生存率为 68.5±6.2%，动脉瘤相关死亡率的无事件生存率为 90.1±4.5%，任何血管内或外科二次手术的无事件生存率为 76.9±7.2%，破裂的无事件生存率为 95.6±3.2%。8 名患者共有 9 例 IA 型内漏，其中 3 例在下次随访时自发消退。有 2 例出现肾并发症且未行再次干预，5 年内未发生器械移位。5 年后，68.2%（15/22）的患者有瘤腔缩小，13.6%（3/22）的患者瘤腔稳定，18.2%（4/22）的患者瘤腔直径与 1 个月时相比增加。
使用 Heli-FX 血管内锚定系统和 Endurant 进行 ESAR 治疗后，ANCHOR 注册的短颈队列的 5 年结果在近端颈部相关并发症、二次手术和瘤腔缩小方面有令人鼓舞的结果。虽然需要对更大的队列进行随访，但对近端短颈患者进行 ESAR 的回顾性研究显示 5 年内有积极的结果。
