Marone Enrico Maria, Marazzi Giulia, Brioschi Chiara, Rinaldi Luigi Federico
Vascular Surgery, Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
Department of Vascular Surgery, Policlinico di Monza, Monza, Italy.
J Endovasc Ther. 2025 Feb;32(1):208-213. doi: 10.1177/15266028231170161. Epub 2023 Apr 28.
Newer generation abdominal endografts, including Treo (Terumo Aortic, Sunrise, Florida), have shown optimal safety and effectiveness in treating abdominal aortic aneurysms (AAAs), even with hostile anatomy over the short- and mid-term. The durability of such results, however, is still a controversial issue, due to the paucity of long-term data. Our aim is to show the long-term outcomes of endovascular aortic repair of both standard and hostile AAAs with the Treo endograft on a cohort of patients treated between 2016 and 2017.
We analyzed the postoperative follow-up of 37 consecutive patients who have undergone endovascular aortic repair (EVAR) with the Treo Endograft between 2016 and 2017, whose baseline clinical conditions, operative data, and short-term outcomes had been published in 2018. All patients were followed up by computed tomography angiography (CTA) at 6 and 12 months and 5 years postoperatively. Primary endpoints were aortic-related mortality, type I-III endoleak (EL), and reintervention rate. Secondary endpoints were the rates of type II ELs and aneurysm sac regression.
Of 37 patients, 27 had at least one criterion of anatomic hostility and 11 were performed outside the device-specific instructions for use (IFU). In the perioperative period, we observed 100% technical success, with no perioperative mortality. Over a mean follow-up of 5.5 years (66 months), 3 patients (8.1%) were lost to follow-up and 3 (8.1%) died of non-aortic causes (overall survival: 91.9%). One type IA EL of an AAA with a hostile neck (but within the IFU) and a type III EL of an AAA with standard anatomy were observed and treated by endovascular relining (overall reintervention rate: 5.5%). Four type II ELs were associated with aneurysm sac stability over time and are still under surveillance. Mean aneurysm shrinkage was 11.25±8.30 mm.
The optimal results of the Treo Endograft in terms of complication and reintervention rates reported over the mid-term by the current literature (ITA-ENDOBOOT registry) are maintained on the long term, both in case of hostile and friendly aortic anatomy, with a satisfactory shrinkage rate of the aneurysm sac.
The innovative characteristics of Treo and its short-term results are well-known and reported. The present case series contributes to the scientific validation of a new-generation abdominal aortic endograft over the long-term, focusing especially on its performance in treating AAAs with hostile anatomy. Its 5-years outcomes confirm the optimal results already reported over the short- and mid-term.
新一代腹主动脉内移植物，包括Treo（泰尔茂主动脉公司，佛罗里达州日出市），在治疗腹主动脉瘤（AAA）方面已显示出最佳的安全性和有效性，即使是在解剖结构复杂的情况下，短期和中期效果也较好。然而，由于长期数据匮乏，这些结果的耐久性仍是一个有争议的问题。我们的目的是展示2016年至2017年间接受Treo内移植物治疗的标准型和复杂型AAA患者进行血管内主动脉修复的长期结果。
我们分析了2016年至2017年间连续37例接受Treo内移植物血管内主动脉修复（EVAR）患者的术后随访情况，其基线临床状况、手术数据和短期结果已于2018年发表。所有患者在术后6个月、12个月和5年时接受计算机断层扫描血管造影（CTA）随访。主要终点是主动脉相关死亡率、I - III型内漏（EL）和再次干预率。次要终点是II型EL的发生率和动脉瘤囊缩小率。
37例患者中，27例至少有一项解剖结构复杂的标准，11例手术操作超出了设备特定的使用说明（IFU）。围手术期，我们观察到技术成功率为100%，无围手术期死亡。平均随访5.5年（66个月），3例患者（8.1%）失访，3例（8.1%）死于非主动脉相关原因（总生存率：91.9%）。观察到1例复杂颈部AAA的IA型EL（但在IFU范围内）和1例标准解剖结构AAA的III型EL，并通过血管腔内衬里治疗（总再次干预率：5.5%）。4例II型EL与动脉瘤囊随时间稳定相关，仍在监测中。动脉瘤平均缩小11.25±8.30 mm。
目前文献（ITA - ENDOBOOT注册研究）中期报道的Treo内移植物在并发症和再次干预率方面的最佳结果在长期得以维持，无论是复杂型还是标准型主动脉解剖结构，动脉瘤囊缩小率均令人满意。
Treo的创新特性及其短期结果已广为人知并被报道。本病例系列有助于对新一代腹主动脉内移植物进行长期的科学验证，尤其关注其在治疗复杂解剖结构AAA方面的性能。其5年结果证实了短期和中期已报道的最佳结果。
