Hugl Beate, Hakaim Albert G, Biebl Matthias, Oldenburg W Andrew, McKinney J Mark, Nolte Lorraine A, Greenberg Roy K, Chuter Timothy A M
Section of Vascular Surgery, Mayo Clinic Jacksonville, Florida 32224, USA.
J Endovasc Ther. 2007 Apr;14(2):115-21. doi: 10.1177/152660280701400201.
To analyze the 2-year outcomes of female patients after endovascular aortic aneurysm repair (EVAR) with the Zenith AAA Endovascular Graft.
A retrospective analysis was conducted of data from the US Zenith multicenter trial and the Zenith female registry on 40 women (10.9%, study group) and 326 men (89.1%, control group) enrolled. All patients had completed their 2-year follow-up. Primary study endpoints were survival, aneurysm rupture, and conversion rate. Significance was assumed if p<0.05.
Overall rates of mortality (12.5% for women versus 13.2% for men, p = 0.94) and aneurysm rupture (2.5% for women versus 0% for men, p = 0.11) were comparable between groups. Conversion to open repair within 2 years was significantly more frequent in women compared to men (7.5% versus 0.6%, p = 0.01). The incidence of endoleaks of any type was equivalent between groups at 2 years (13.3% for women versus 6.9% for men, p = 0.30). No difference was observed in the need for secondary interventions (15% for women versus 13.5% for men, p = 0.81) or aneurysm dilatation >5 mm (10.5% for women versus 2.3% for men, p = 0.10). None of the patients developed device migration >10 mm or required intervention for migration.
While women underwent conversion to open repair more frequently compared to men at 2 years post EVAR, there was no difference in survival, freedom from aneurysm rupture, or need for secondary interventions between groups. As in men, the Zenith AAA Endovascular Graft provides reliable protection from aneurysm rupture and aneurysm-related death in women in a midterm follow-up.
分析使用Zenith腹主动脉瘤腔内移植物进行腹主动脉瘤腔内修复术(EVAR)后女性患者的2年预后情况。
对美国Zenith多中心试验和Zenith女性注册研究的数据进行回顾性分析,纳入了40名女性(10.9%,研究组)和326名男性(89.1%,对照组)。所有患者均完成了2年的随访。主要研究终点为生存率、动脉瘤破裂率和转化率。若p<0.05,则认为具有统计学意义。
两组之间的总体死亡率(女性为12.5%,男性为13.2%,p = 0.94)和动脉瘤破裂率(女性为2.5%,男性为0%,p = 0.11)相当。女性在2年内转为开放修复的频率显著高于男性(7.5%对0.6%,p = 0.01)。两组在2年时任何类型内漏的发生率相当(女性为13.3%,男性为6.9%,p = 0.30)。在二次干预需求(女性为15%,男性为13.5%,p = 0.81)或动脉瘤扩张>5 mm(女性为10.5%,男性为2.3%,p = 0.10)方面未观察到差异。没有患者发生移植物迁移>10 mm或因迁移需要干预。
虽然与男性相比,女性在EVAR术后2年转为开放修复的频率更高,但两组在生存率、无动脉瘤破裂以及二次干预需求方面没有差异。与男性一样,在中期随访中,Zenith腹主动脉瘤腔内移植物为女性提供了可靠的保护,防止动脉瘤破裂和与动脉瘤相关的死亡。