1 Department of Vascular Surgery, Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia.
2 Department of Vascular and Endovascular Surgery, Pontificia Universidad Catolica de Chile, Santiago, Chile.
J Endovasc Ther. 2018 Jun;25(3):379-386. doi: 10.1177/1526602818771973. Epub 2018 Apr 20.
To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double "D-shaped" stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal.
From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, and blood loss ≥1000 mL), and clinical success (freedom from procedure-related death, type I/III endoleak, migration, thrombosis, and reintervention).
Endografts were successfully implanted in 89 (99%) patients; the single failure was due to delivery system malfunction before insertion in the early-generation device. One (1%) patient died and 4 patients underwent reinterventions (1 type I endoleak, 2 iliac limb stenoses, and 1 endograft occlusion) within the first 30 days. During a median follow-up of 12.5 months (range 11.5-50.9), there were no aneurysm ruptures, surgical conversions, or AAA-related deaths. The cumulative MAE rates were 3% (3/89) at 6 months and 7% (6/89) at 1 year. Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively. Clinical success was 94% (84/89) at 30 days, 98% (85/87) at 6 months, and 99% (82/83) at 1 year.
Early results suggest that properly selected AAA patients can be safely treated using the Altura Endograft System with favorable midterm outcome. Thus, further clinical investigation is warranted to evaluate the role of this device in the treatment of AAA.
报告使用低轮廓（14-F）Altra 血管内动脉瘤修复（EVAR）的初始临床结果，该装置具有双重“D 形”支架设计，具有肾上固定和从远端到近端展开的模块化髂组件。
在 2011 年至 2015 年期间，在 10 个临床地点的 2 项前瞻性对照临床试验中，使用 Altra 移植物治疗了 90 例（平均年龄 72.8±8.3 岁；79 名男性）腹主动脉瘤（AAA；平均直径 53.8±5.7mm）患者。评估的结果包括死亡率、主要不良事件（MAE：所有原因死亡、中风、截瘫、心肌梗死、呼吸衰竭、肠缺血和失血≥1000mL）和临床成功（免于与手术相关的死亡、I/III 型内漏、迁移、血栓形成和再次干预）。
89 例（99%）患者成功植入移植物；单一失败是由于早期装置中插入前输送系统故障。1 例（1%）患者死亡，4 例（1 例 I 型内漏、2 例髂支狭窄和 1 例移植物闭塞）在 30 天内进行了再次干预。在中位随访 12.5 个月（范围 11.5-50.9）期间，无动脉瘤破裂、手术转换或与 AAA 相关的死亡。累积 MAE 率在 6 个月时为 3%（3/89），在 1 年时为 7%（6/89）。2 例患者分别在 6.5 个月和 2.2 年接受了 II 型内漏的线圈栓塞。30 天时临床成功率为 94%（84/89），6 个月时为 98%（85/87），1 年时为 99%（82/83）。
早期结果表明，选择合适的 AAA 患者可以使用 Altra 血管内动脉瘤修复系统安全治疗，中期结果良好。因此，需要进一步的临床研究来评估该装置在 AAA 治疗中的作用。
