Peppelenbosch Noud, Buth Jacob, Harris Peter L, van Marrewijk Corine, Fransen Gerdine
The EUROSTAR Data Registry Center, Catharina Hospital, Eindhoven, The Netherlands.
J Vasc Surg. 2004 Feb;39(2):288-97. doi: 10.1016/j.jvs.2003.09.047.
This study was undertaken to determine the effect of the preoperative diameter of abdominal aortic aneurysms on the midterm outcome after endovascular abdominal aneurysm repair (EVAR).
The data for 4392 patients who had undergone EVAR were analyzed. Patients were enrolled over 6 years to June 2002 in the EUROSTAR database. Outcomes were compared between three groups defined by the preoperative diameter of the aneurysm: group A (n = 1962), 4.0 to 5.4 cm; group B (n = 1528), 5.5 to 6.4 cm; and group C (n = 902), 6.5 cm or larger. Patient characteristics, details of aortoiliac anatomy, operative procedures, old or current device generation, and postoperative complications in the three patient groups were compared. Outcome events included aneurysm-related death, unrelated death, conversion, and post-EVAR rupture of the aneurysm. Life table analysis and log-rank tests were used to compare outcome in the three study groups. Multivariate Cox models were used to determine whether baseline and follow-up variables were independently associated with adverse outcome events.
Patients in group C were significantly older than patients in groups A and B (73 years vs 70 and 72 years, respectively; P =.003 - P <.0001 for different group comparisons), and more frequently were at higher operative risk (American Society of Anesthesiologists classification >or=3; 63% vs 48% and 54%; P =.0002-P <.0001). Device-related (type I) endoleaks were more frequently observed at early postoperative arteriography in group C compared with groups A and B (9.9% vs 3.7% and 6.8%; P =.01-P <.0001). Postoperatively systemic complications were more frequently present in group C (17.4% vs 12.0% in group A and 12.6% in group B; P <.0001 and.001). The first-month mortality was approximately twice as high in group C compared with the other groups combined (4.1% vs 2.1%; P <.0001). Late rupture was most frequent in group C. Follow-up results at midterm were less favorable in groups C and B compared with group A (freedom from rupture, 90%, 98%, and 98% at 4 years in groups C, B, and A, respectively; P <.0001 for group C vs groups A and B). Aneurysm-related death was highest in group C (88% freedom at 4 years, compared with 95% in group B and 97% in A; P =.001 and P <.0001, respectively; group B vs A, P =.004). The annual rate of aneurysm-related death in group C was 1% in the first 3 years, but accelerated to 8.0% in the fourth year. Incidence of unrelated death also was higher in groups C and B than in group A (76% and 82% freedom at 4 years vs 87%; P <.0001 for both comparisons). Ratio of aneurysm-related to unrelated death was 23%, 21%, and 50% in groups A, B, and C, respectively. Cox models demonstrated that the correlation between large aneurysms (group C) and all assessed outcome events was independent and highly significant. Older generation devices had an independent association with aneurysm-related and unrelated deaths (P =.02 and P =.04, respectively). However, this correlation was less strong than large aneurysm diameter (P =.0001 and P =.0009, respectively).
The midterm outcome of large aneurysms after EVAR was associated with increased rates of aneurysm-related death, unrelated death, and rupture. Reports of EVAR should stratify their outcomes according to the diameter of the aneurysm. Large aneurysms need a more rigorous post-EVAR surveillance schedule than do smaller aneurysms. In small aneurysms EVAR was associated with excellent outcome. This finding may justify reappraisal of currently accepted management strategies.
本研究旨在确定腹主动脉瘤术前直径对血管腔内腹主动脉瘤修复术(EVAR)中期疗效的影响。
分析了4392例行EVAR患者的数据。这些患者于6年期间纳入至2002年6月的EUROSTAR数据库。根据动脉瘤术前直径将患者分为三组进行疗效比较:A组(n = 1962),直径4.0至5.4 cm;B组(n = 1528),直径5.5至6.4 cm;C组(n = 902),直径6.5 cm或更大。比较了三组患者的特征、主髂动脉解剖细节、手术操作、新旧器械类型以及术后并发症。观察指标包括动脉瘤相关死亡、非动脉瘤相关死亡、中转开放手术以及EVAR术后动脉瘤破裂。采用寿命表分析和对数秩检验比较三组研究对象的疗效。采用多变量Cox模型确定基线和随访变量是否与不良观察指标独立相关。
C组患者显著比A组和B组患者年龄大(分别为73岁、70岁和72岁;不同组比较,P =.003 - P <.0001),且手术风险更高(美国麻醉医师协会分级≥3级;分别为63%、48%和54%;P =.0002 - P <.0001)。与A组和B组相比,C组术后早期血管造影时更常观察到器械相关(I型)内漏(分别为9.9%、3.7%和6.8%;P =.01 - P <.0001)。C组术后全身并发症更常见(分别为17.4%、A组为12.0%、B组为12.6%;P <.0001和.001)。C组第一个月的死亡率约为其他两组总和的两倍(4.1%对2.1%;P <.0001)。晚期破裂在C组最常见。中期随访结果显示,与A组相比,C组和B组的情况较差(C组、B组和A组4年时动脉瘤未破裂率分别为90%、98%和98%;C组与A组和B组比较,P <.0001)。C组动脉瘤相关死亡最高(4年时存活88%,B组为95%,A组为97%;分别为P =.001和P <.0001;B组与A组比较,P =.004)。C组动脉瘤相关死亡年发生率在最初3年为1%,但在第4年加速至8.0%。C组和B组非动脉瘤相关死亡发生率也高于A组(4年时存活分别为76%和82%对87%;两组比较P均<.0001)。A组、B组和C组动脉瘤相关死亡与非动脉瘤相关死亡的比例分别为23%、21%和50%。Cox模型显示,大动脉瘤(C组)与所有评估的观察指标事件之间的相关性独立且高度显著。旧一代器械与动脉瘤相关死亡和非动脉瘤相关死亡独立相关(分别为P =.02和P =.04)。然而,这种相关性不如大动脉瘤直径强(分别为P =.0001和P =.0009)。
EVAR术后大动脉瘤的中期疗效与动脉瘤相关死亡、非动脉瘤相关死亡和破裂发生率增加有关。EVAR报告应根据动脉瘤直径对疗效进行分层。与小动脉瘤相比,大动脉瘤EVAR术后需要更严格的监测方案。对于小动脉瘤,EVAR疗效良好。这一发现可能为重新评估目前公认的治疗策略提供依据。