Clinic for vascular and endovascular surgery, Medizinische Fakultät, Universität of Augsburg, Germany.
Clinic for Vascular and Endovascular Surgery, University Clinic, Klinikum rechts der Isar, Munich, Germany.
Vasa. 2024 Nov;53(6):411-419. doi: 10.1024/0301-1526/a001148. Epub 2024 Sep 9.
The objective of the study was to analyze mid-term results of unselected patients treated with the TREO (Terumo Aortic, Florida, USA) device at six German hospital sites. A multicenter, retrospective analysis of patients treated within and outside instructions for use (IFU) from January 2017 to November 2020 was performed. Primary outcomes were technical success, mortality and endograft related complications according to IFU status. Secondary outcomes were aneurysm/procedure related re-interventions. 150 patients (92% male, mean age 73 ±8 years) were treated (within IFU 84% vs. outside IFU 16%) with the TREO device for abdominal aortic aneurysms (n=127 intact, n=17 symptomatic and n=6 ruptured; p=0.30). Technical success was achieved in 147/150 (within IFU 99% vs. outside IFU 92%, p=0.08). 30-day mortality was 2%, one year and overall mortality was 3% and 5%. During a mean follow-up of 28.4 months (range: 1-67.4 months), 35 (25%; within IFU 23% vs. outside IFU 35%, p=0.23) patients suffered from endoleaks. The majority were endoleaks type II (n=33), the remaining type Ia (n=5) and type Ib (n=3). No endoleaks type III-V, migrations or aneurysm ruptures occurred. Overall, 19 patients (13%; within IFU 13% vs. 15% outside IFU, p=0.70) received a secondary intervention: nine endoleak related endovascular procedures, three open conversions, two endograft limb related interventions, four surgical revisions of the femoral access sites and two bowl ischemia related procedures, respectively. This non industry-sponsored, multicenter trial indicates that using the TREO device in a real-world setting (both within and outside IFU) seems feasible in the treatment of patients suffering from AAA. While the rate of complications and secondary interventions is in line with previously published data, the findings highlight the fact that standard EVAR is associated with serious adverse events.
本研究的目的是分析在德国六个医院应用 TREO（Terumo Aortic，佛罗里达州，美国）装置治疗的未经选择的患者的中期结果。对 2017 年 1 月至 2020 年 11 月期间，按照使用说明（IFU）和超出 IFU 范围进行治疗的患者进行了一项多中心回顾性分析。主要结局是根据 IFU 状态评估技术成功率、死亡率和移植物相关并发症。次要结局是与动脉瘤/手术相关的再次干预。共有 150 例患者（92%为男性，平均年龄 73±8 岁）接受了 TREO 装置治疗腹主动脉瘤（127 例完整，17 例症状性，6 例破裂；p=0.30）。150 例患者中有 147 例（IFU 内 99%，IFU 外 92%，p=0.08）达到技术成功。30 天死亡率为 2%，1 年和总死亡率为 3%和 5%。在平均 28.4 个月（范围：1-67.4 个月）的随访期间，35 例（25%；IFU 内 23%，IFU 外 35%，p=0.23）患者发生内漏。大多数为内漏 II 型（n=33），其余为 I 型 a（n=5）和 Ib（n=3）。未发生 III-V 型内漏、移植物迁移或动脉瘤破裂。总的来说，19 例（13%；IFU 内 13%，IFU 外 15%，p=0.70）患者接受了二次干预：9 例与内漏相关的血管内治疗、3 例开放转换、2 例移植物分支相关干预、4 例股动脉入路的外科修正和 2 例碗部缺血相关手术。这项非工业赞助的多中心试验表明，在真实环境中使用 TREO 装置（IFU 内和 IFU 外）治疗 AAA 患者似乎是可行的。虽然并发症和二次干预的发生率与之前发表的数据一致，但这些发现强调了标准 EVAR 与严重不良事件相关的事实。
