Sansosti Alexandra A, O'Donnell Thomas F X, Skripochnik Edvard, Bajakian Danielle R, Morrissey Nicholas J, Miller Lydia, Takayama Hiroo, Patel Virendra I
Division of Cardiac, Thoracic, and Vascular Surgery, New York-Presbyterian, Columbia University Irving Medical Center, Columbia University Vagelos College of Physicians and Surgeons, New York, NY.
Division of Cardiac, Thoracic, and Vascular Surgery, New York-Presbyterian, Columbia University Irving Medical Center, Columbia University Vagelos College of Physicians and Surgeons, New York, NY; New York Presbyterian Westchester, Bronxville, NY.
J Vasc Surg. 2025 Aug 6. doi: 10.1016/j.jvs.2025.07.052.
Aneurysm sac behavior has been associated with long-term survival and reinterventions, spurring an interest in more active management of the aneurysm sac during endovascular aortic repair (EVAR). We therefore investigated the utility of sac embolization with shape memory polymer (SMP) plugs (Shape Memory Medical), a novel, biodegradable, nonartifact-producing implant inserted into the aneurysm sac between the graft and vessel wall to promote sac thrombosis and regression.
We retrospectively studied all patients undergoing EVAR of infrarenal aneurysms at two centers from February 2022, to January 2024, where SMP plugs were used. Safety outcomes included inadvertent embolization and sac perforation during manipulation. Efficacy outcomes were volume and diameter changes, as well as endoleaks, and reinterventions using TeraRecon radiologic software.
There were 29 patients who underwent EVAR with SMP plugs during the study period who had 1-year imaging data available for review. The mean age was 77 years (standard deviation, 8.8 years), and 72% were men. Preoperative median total aneurysm volume was 98 mL (interquartile range [IQR], 80-157 mL), and median preoperative blood lumen volume was 70 mL (IQR, 58-96.7 mL), with 62% patent inferior mesenteric arteries and one accessory renal artery. The median number of plugs used per patient was 90 (IQR, 51-130). The most frequently used grafts were the Gore Excluder (n = 23) and Cook Zenith (n = 6), with four iliac branch devices, five hypogastric coil covers, and Aptus Endoanchors in one patient. At 1 year, there were no patients with evidence of endoleak, no reinterventions, no adverse safety events during the procedure, and no perioperative deaths. The median percentage change in aneurysm volume at 1 year was 17% regression (IQR, 7%-33%), and the median change in aneurysm diameter was 6 mm regression (IQR, -10 mm to -1 mm). By diameter at 1 year postoperatively, 55% of patients (n = 16) demonstrated regression, 45% of patients (n = 13) demonstrated stability, and there were no patients with expansion. In volume analysis, 67% of those patients who regressed showed >10% regression in aneurysm volume.
Preemptive aneurysm sac embolization at the time of EVAR is a safe and effective method of inducing sac thrombosis. At 1-year follow-up, patients have demonstrated high rates of sac regression, no endoleaks, and no need for reintervention. The SMP plugs hold promise over other coil or liquid embolic methods as they are biodegradable, and do not produce significant artifact on computed tomography scan. Longer-term data are needed to confirm these outcomes; however, 1-year postoperative outcomes continue to demonstrate promise.
动脉瘤囊的行为与长期生存及再次干预相关，这激发了人们对在血管腔内主动脉修复术（EVAR）期间更积极地处理动脉瘤囊的兴趣。因此，我们研究了使用形状记忆聚合物（SMP）栓塞栓（Shape Memory Medical）栓塞瘤囊的效用，这是一种新型的、可生物降解的、不产生伪影的植入物，可插入移植血管与血管壁之间的动脉瘤囊中，以促进瘤囊血栓形成和缩小。
我们回顾性研究了2022年2月至2024年1月在两个中心接受肾下腹主动脉瘤EVAR且使用SMP栓塞栓的所有患者。安全性结果包括操作过程中的意外栓塞和瘤囊穿孔。疗效结果包括体积和直径变化、内漏情况，以及使用TeraRecon放射学软件进行的再次干预情况。
在研究期间，有29例接受SMP栓塞栓EVAR的患者有可供复查的1年影像学数据。平均年龄为77岁（标准差8.8岁），72%为男性。术前动脉瘤总体积中位数为98 mL（四分位间距[IQR]，80 - 157 mL），术前血腔体积中位数为70 mL（IQR，58 - 96.7 mL），62%的患者肠系膜下动脉通畅，1例有副肾动脉。每位患者使用栓塞栓的中位数为90个（IQR，51 - 130）。最常用的移植物是戈尔Excluder（n = 23）和库克Zenith（n = 6），4例使用髂支装置，5例使用髂内动脉线圈覆盖物，1例患者使用Aptus Endoanchors。1年时，没有患者出现内漏迹象，没有再次干预，手术过程中没有不良安全事件，也没有围手术期死亡。1年时动脉瘤体积的中位数变化为缩小17%（IQR，7% - 33%），动脉瘤直径的中位数变化为缩小6 mm（IQR，-10 mm至-1 mm）。术后1年按直径计算，55%的患者（n = 16）瘤体缩小，45%的患者（n = 13）瘤体稳定，没有患者瘤体增大。在体积分析中，瘤体缩小的患者中有67%的动脉瘤体积缩小超过10%。
EVAR时预防性栓塞动脉瘤囊是诱导瘤囊血栓形成的一种安全有效的方法。在1年的随访中，患者显示出瘤囊高度缩小率、无内漏且无需再次干预。与其他线圈或液体栓塞方法相比，SMP栓塞栓具有优势，因为它们是可生物降解的，并且在计算机断层扫描上不会产生明显伪影。需要更长时间的数据来证实这些结果；然而，术后1年的结果仍显示出前景。
