Cao Piergiorgio, De Rango Paola, Parlani Gianbattista, Verzini Fabio
Unit of Vascular and Endovascular Surgery, University of Perugia, Italy.
J Vasc Surg. 2009 Apr;49(4):859-65. doi: 10.1016/j.jvs.2008.11.044.
BACKGROUND/OBJECTIVE: Durability is the main concern of aortic endografting, but it is not clear to what extent trial results are applicable to "real world" patients. The purpose of this study was to assess the durability of a single model of aortic endograft in an unselected population with core lab analysis of morphological changes.
Computed tomography (CT) images of patients treated with Talent Unidoc (Medtronic, Santa Rosa, Calif) endografts from 2002 to 2006 in nine European centers with more than 1 year follow-up were centrally reviewed using a dedicated software with multiplanar and volume reconstructions. Images were checked for aneurysm growth >/=5 mm, neck enlargement >3 mm, graft migration >/=10 mm, endoleak, structural integrity. Morphological changes were defined clinically relevant when associated with reintervention or aneurysm-related death.
A total of 349 patients (mean age 73.8 years, 90% males) were available for analysis; 1187 CT examinations were reviewed. Median abdominal aortic aneurysm (AAA) diameter was 56 mm (interquartile range [IQR] 49-62), neck length 20 mm (IQR 16-30), and neck diameter 25 mm (IQR 23-26). Mean follow-up was 25 months (range 12-60 months). During the study period, 10 late deaths (1 aneurysm-related, 0.3%) with a survival rate of 89.2% at 48 months and 33 reinterventions including 8 conversions (2.2%), 2 AAA ruptures (0.6%) and 1 (0.3%) loss of graft integrity were recorded. Cumulative reintervention rate was 6%, 8%, 13%, and 16% at 1, 2, 3, and 4 years, respectively. According to core lab analysis, 22 AAA grew, 169 were unchanged, and 158 shrunk, with a growing AAA rate of 3.1% patients/year. Five growths required reintervention, one for rupture. Forty-seven (6.5% patients/year) neck enlargements, three clinically relevant, 17 migrations (2.4% patients/year), five clinically relevant, and 70 endoleaks (9.7 % patients/year), 11 clinically relevant, were detected.
Data from this real world experience monitored with a centralized imaging review show that endovascular repair of abdominal aortic aneurysm with the latest generation of a single model of endograft is associated with low graft thrombosis and graft fatigue, and low late aneurysm rupture and related death risks. Neck enlargement although common after EVAR, is almost always without clinical consequences but a longer follow-up and prospective clinical studies are advisable to confirm the present results.
背景/目的：耐久性是主动脉腔内修复术的主要关注点，但试验结果在多大程度上适用于“现实世界”的患者尚不清楚。本研究的目的是通过对形态学变化进行核心实验室分析，评估单一型号主动脉腔内移植物在未选择人群中的耐久性。
对2002年至2006年在9个欧洲中心接受Talent Unidoc（美敦力公司，加利福尼亚州圣罗莎）腔内移植物治疗且随访超过1年的患者的计算机断层扫描（CT）图像，使用具有多平面和容积重建功能的专用软件进行集中回顾。检查图像有无动脉瘤增大≥5mm、颈部增粗>3mm、移植物移位≥10mm、内漏及结构完整性。当形态学变化与再次干预或动脉瘤相关死亡相关时，定义为具有临床相关性。
共有349例患者（平均年龄73.8岁，90%为男性）可供分析；共回顾了1187次CT检查。腹主动脉瘤（AAA）中位直径为56mm（四分位间距[IQR]49 - 62），颈部长度20mm（IQR 16 - 30），颈部直径25mm（IQR 23 - 26）。平均随访25个月（范围12 - 60个月）。在研究期间，记录到10例晚期死亡（1例与动脉瘤相关；0.3%），48个月生存率为89.2%，33次再次干预，包括8次转为开放手术（2.2%），2例AAA破裂（占0.6%），1例（占0.3%）移植物完整性丧失。1、2、3和4年时的累计再次干预率分别为6%、8%、13%和16%。根据核心实验室分析，22例AAA增大，169例无变化，158例缩小，AAA年增大率为3.1%患者。5例增大需要再次干预，1例因破裂。检测到47例（6.5%患者/年）颈部增粗，3例具有临床相关性，17例移位（2.4%患者/年），5例具有临床相关性，70例内漏（9.7%患者/年），11例具有临床相关性。
通过集中影像回顾监测的这一现实世界经验数据表明，使用最新一代单一型号腔内移植物进行腹主动脉瘤腔内修复与低移植物血栓形成和移植物疲劳相关，且晚期动脉瘤破裂及相关死亡风险较低。尽管EVAR术后颈部增粗常见，但几乎总是无临床后果，不过建议进行更长时间的随访和前瞻性临床研究以证实目前的结果。
