Abstract：
OBJECTIVE: Abdominal aortic aneurysms (AAAs) demonstrating hostile neck anatomy (HNA) are associated with increased perioperative risk and mortality. A number of these patients are not suitable for standard endovascular aneurysm repair (EVAR) and are high risk for open surgery. We present our experience with the first implantations in Scotland of a novel conformable aortic stent-graft designed to overcome some of the challenges of HNAs.
METHODS: From May 2018 to March 2022, 24 consecutive patients with non-ruptured AAAs demonstrating HNAs (neck length < 15 mm, or angulation > 60°) were treated with GORE Excluder Conformable AAA endoprosthesis (CLEVAR) (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) at a Scottish vascular centre. We assessed clinical outcomes and technical success of CLEVAR during deployment, primary admission and the post-operative period at 3- and 12-month clinical follow-up alongside CT angiography.
RESULTS: Twenty-four patients (20 males, mean age 75.6) were included. Primary technical success of proximal seal zones and CLEVAR deployment (no type 1/3 endoleaks, no conversion to open repair, AAA excluded and patient leaving theatre alive) was achieved in 100% of patients. All patients were alive and clinically stable at 3- and 12-month follow-up. There were five patients requiring re-intervention; at the 3-month follow-up, one patient (4.2%) developed a type 1b endoleak requiring graft limb extension, one patient developed a right common femoral artery dissection requiring open repair and one patient required a limb extension of the right iliac limb due to risk of developing a type 1b endoleak. At the 12-month follow-up, two patients required embolization of type 2 endoleaks and no patients demonstrated type 1 or type 3 endoleaks.Conclusions: In-hospital and post-operative 3- and 12-month clinical and angiographic outcomes demonstrate safety and efficacy with CLEVARs in treating unruptured AAAs with HNA. Further research involving larger heterogenous sample sizes is warranted to determine long-term clinical outcomes.
METHODS: From May 2018 to March 2022, 24 consecutive patients with non-ruptured AAAs demonstrating HNAs (neck length < 15 mm, or angulation > 60°) were treated with GORE Excluder Conformable AAA endoprosthesis (CLEVAR) (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) at a Scottish vascular centre. We assessed clinical outcomes and technical success of CLEVAR during deployment, primary admission and the post-operative period at 3- and 12-month clinical follow-up alongside CT angiography.
RESULTS: Twenty-four patients (20 males, mean age 75.6) were included. Primary technical success of proximal seal zones and CLEVAR deployment (no type 1/3 endoleaks, no conversion to open repair, AAA excluded and patient leaving theatre alive) was achieved in 100% of patients. All patients were alive and clinically stable at 3- and 12-month follow-up. There were five patients requiring re-intervention; at the 3-month follow-up, one patient (4.2%) developed a type 1b endoleak requiring graft limb extension, one patient developed a right common femoral artery dissection requiring open repair and one patient required a limb extension of the right iliac limb due to risk of developing a type 1b endoleak. At the 12-month follow-up, two patients required embolization of type 2 endoleaks and no patients demonstrated type 1 or type 3 endoleaks.Conclusions: In-hospital and post-operative 3- and 12-month clinical and angiographic outcomes demonstrate safety and efficacy with CLEVARs in treating unruptured AAAs with HNA. Further research involving larger heterogenous sample sizes is warranted to determine long-term clinical outcomes.
摘要：
目的：表现出不良颈部解剖结构（HNA）的腹主动脉瘤（AAAs）与围手术期风险和死亡率增加相关。这些患者中的许多人不适合进行标准的血管内动脉瘤修复（EVAR），并且是开放手术的高风险。我们介绍了在苏格兰首次植入新型适形主动脉支架的经验，该支架旨在克服HNA的一些挑战。
方法：从2018年5月至2022年3月，连续24例未破裂的AAA表现为HNA（颈部长度<15mm，或角度>60°)用GORE排除器适形AAA内置假体(CLEVAR)(CEXC装置,W.L.GoreandAssociates,弗拉格斯塔夫,AZ,美国）在苏格兰血管中心。我们评估了CLEVAR在部署期间的临床结果和技术成功，主要入院和术后3个月和12个月临床随访以及CT血管造影。
结果：24名患者（20名男性，平均年龄75.6）包括在内。近端密封区和CLEVAR展开的主要技术成功(无1/3型内漏,没有转换为开放式修复，在100％的患者中，AAA被排除在外，并且患者活着离开手术室）。在3个月和12个月的随访中，所有患者均存活且临床稳定。有5名患者需要再次干预；在3个月的随访中，一名患者（4.2%）出现需要移植肢体伸展的1b型内漏，1例患者发生右侧股动脉夹层,需要进行开放性修复,1例患者由于有发生1b型内漏的风险,需要延长右侧髂肢.在12个月的随访中，2例患者需要栓塞2型内漏,无1型或3型内漏.结论：院内和术后3个月和12个月的临床和血管造影结果证明了CLEVAR治疗HNA未破裂的AAA的安全性和有效性。需要进一步研究涉及更大的异质性样本量，以确定长期临床结果。
方法：从2018年5月至2022年3月，连续24例未破裂的AAA表现为HNA（颈部长度<15mm，或角度>60°)用GORE排除器适形AAA内置假体(CLEVAR)(CEXC装置,W.L.GoreandAssociates,弗拉格斯塔夫,AZ,美国）在苏格兰血管中心。我们评估了CLEVAR在部署期间的临床结果和技术成功，主要入院和术后3个月和12个月临床随访以及CT血管造影。
结果：24名患者（20名男性，平均年龄75.6）包括在内。近端密封区和CLEVAR展开的主要技术成功(无1/3型内漏,没有转换为开放式修复，在100％的患者中，AAA被排除在外，并且患者活着离开手术室）。在3个月和12个月的随访中，所有患者均存活且临床稳定。有5名患者需要再次干预；在3个月的随访中，一名患者（4.2%）出现需要移植肢体伸展的1b型内漏，1例患者发生右侧股动脉夹层,需要进行开放性修复,1例患者由于有发生1b型内漏的风险,需要延长右侧髂肢.在12个月的随访中，2例患者需要栓塞2型内漏,无1型或3型内漏.结论：院内和术后3个月和12个月的临床和血管造影结果证明了CLEVAR治疗HNA未破裂的AAA的安全性和有效性。需要进一步研究涉及更大的异质性样本量，以确定长期临床结果。
