Western Vascular Institute, Department of Vascular and Endovascular Surgery, University College Hospital Galway, Newcastle Road, Galway, Ireland.
J Endovasc Ther. 2011 Apr;18(2):181-96. doi: 10.1583/10-3072.1.
To gauge the efficacy of applying commercially-available endografts to pararenal endovascular abdominal aortic aneurysm (AAA) repair compared with open surgical repair (OSR).
From 2001 to 2009, 1868 AAA patients were referred to our service for evaluation; of these, 118 patients had pararenal AAAs. Sixty-six patients (51 men; mean age 70.8±7.6 years) had OSR and 52 (44 men; mean age 74.3±7.2 years) underwent pararenal endovascular aneurysm repair (EVAR). The pararenal EVAR patients were older (74.3 versus 70.8 years, p = 0.014), with higher mean comorbidity severity scores (p = 0.0001). Mean aneurysm diameter was larger in the OSR patients (6.6 versus 5.9 cm, p = 0.01). Primary endpoints were aneurysm-related survival and cost per quality-adjusted life years (QALY). Secondary endpoints included 3-year freedom from major adverse clinical events, all-cause mortality, and secondary intervention.
There was no perioperative mortality in the pararenal EVAR group versus 3 (4.5%) deaths among the OSR patients (p = 0.122). The 15% 30-day morbidity with pararenal EVAR was half that of OSR (p = 0.059). Mean follow-up was 28.8 ±21.6 months for pararenal EVAR and 35.7±23.2 months for OSR. There were no aneurysm ruptures in either group and no conversions to open repair in the pararenal EVAR group. Three-year aneurysm-related survival was significantly higher with pararenal EVAR (100%) versus OSR (92.4%, p = 0.045), but the freedom from any-cause death was lower with pararenal EVAR (57.1%) than OSR (84.8%, p = 0.195). Three-year freedom from secondary intervention (pararenal EVAR 83.4% versus OSR 95.5%, p = 0.301) and all-cause survival (pararenal EVAR 57.1% versus OSR 84.8%, p = 0.195) were similar. Over a 3-year period, pararenal EVAR costs (including follow-up and reintervention) averaged €20,375 per patient to give a QALY value of 0.90, while mean costs for OSR were €23,928 per patient (0.86 QALY). The incremental cost-effectiveness ratio for pararenal EVAR was €129,586 saved per QALY gained.
Pararenal EVAR afforded patients longer quality-adjusted time without symptoms or toxicity and superior freedom from major adverse events up to 3 years. Although the relatively low 3-year survival rate reflected the greater comorbidity of the EVAR patients, pararenal EVAR was cost-effective.
评估使用市售内脏支架治疗肾周腹主动脉瘤（AAA）与开放手术修复（OSR）的疗效。
2001 年至 2009 年，1868 例 AAA 患者到我院就诊；其中 118 例为肾周 AAA。66 例患者（51 例男性；平均年龄 70.8±7.6 岁）接受 OSR，52 例（44 例男性；平均年龄 74.3±7.2 岁）接受肾周腔内动脉瘤修复（EVAR）。肾周 EVAR 患者年龄较大（74.3 岁比 70.8 岁，p=0.014），平均合并症严重程度评分较高（p=0.0001）。OSR 患者的平均动脉瘤直径较大（6.6 厘米比 5.9 厘米，p=0.01）。主要终点为动脉瘤相关生存率和每质量调整生命年的成本（QALY）。次要终点包括 3 年无重大不良临床事件、全因死亡率和二次干预的自由。
肾周 EVAR 组无围手术期死亡，而 OSR 组有 3 例（4.5%）死亡（p=0.122）。肾周 EVAR 的 15%的 30 天发病率是 OSR 的一半（p=0.059）。肾周 EVAR 的平均随访时间为 28.8±21.6 个月，OSR 为 35.7±23.2 个月。两组均无动脉瘤破裂，肾周 EVAR 组无中转开放修复。肾周 EVAR 的 3 年动脉瘤相关生存率显著高于 OSR（100%比 92.4%，p=0.045），但肾周 EVAR 的全因死亡率较低（57.1%比 84.8%，p=0.195）。肾周 EVAR 的 3 年无二次干预（83.4%比 OSR 的 95.5%，p=0.301）和全因生存率（57.1%比 OSR 的 84.8%，p=0.195）相似。在 3 年期间，肾周 EVAR 的成本（包括随访和再次介入）平均为每位患者 20375 欧元，获得 0.90 的 QALY 值，而 OSR 的每位患者的平均成本为 23928 欧元（0.86 的 QALY）。肾周 EVAR 的增量成本效益比为每获得一个 QALY 节省 129586 欧元。
肾周 EVAR 为患者提供了更长的无症状或毒性的质量调整时间，并在 3 年内提供了更高的重大不良事件自由。尽管相对较低的 3 年生存率反映了 EVAR 患者的合并症较多，但肾周 EVAR 具有成本效益。
