Abbruzzese Thomas A, Kwolek Christopher J, Brewster David C, Chung Thomas K, Kang Jeanwan, Conrad Mark F, LaMuraglia Glenn M, Cambria Richard P
Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
J Vasc Surg. 2008 Jul;48(1):19-28. doi: 10.1016/j.jvs.2008.02.003. Epub 2008 Apr 28.
We performed a device-specific comparison of long-term outcomes following endovascular abdominal aortic aneurysm repair (EVAR) to determine the effect(s) of device type on early and late clinical outcomes. In addition, the impact of performing EVAR both within and outside of specific instructions for use (IFU) for each device was examined.
Between January 8, 1999 and December 31, 2005, 565 patients underwent EVAR utilizing one of three commercially available stent graft devices. Study outcomes included perioperative (< or =30 days) mortality, intraoperative technical complications and need for adjunctive procedures, aneurysm rupture, aneurysm-related mortality, conversion to open repair, reintervention, development and/or resolution of endoleak, device related adverse events (migration, thrombosis, or kinking), and a combined endpoint of any graft-related adverse event (GRAE). Study outcomes were correlated by aneurysm morphology that was within or outside of the recommended device IFU. chi2 and Kaplan Meier methods were used for analysis.
Grafts implanted included 177 Cook Zenith (CZ, 31%), 111 Gore Excluder (GE, 20%), and 277 Medtronic AneuRx (MA, 49%); 39.3% of grafts were placed outside of at least one IFU parameter. Mean follow-up was 30 +/- 21 months and was shorter for CZ (20 months CZ vs 35 and 31 months for GE and MA, respectively; P < .001). Overall actuarial 5-year freedom from aneurysm-related death, reintervention, and GRAE was similar among devices. CZ had a lower number of graft migration events (0 CZ vs 1 GE and 9 MA); however, there was no difference between devices on actuarial analysis. Combined GRAE was lowest for CZ (29% CZ, 35% GE, and 43% MA; P = .01). Graft placement outside of IFU was associated with similar 5-year freedom from aneurysm-related death, migration, and reintervention (P > .05), but a lower freedom from GRAE (74% outside IFU vs 86% within IFU; P = .021), likely related to a higher incidence of graft thrombosis (2.3% outside IFU vs 0.3% within IFU; P = .026). The differences in outcome for grafts placed within vs outside IFU were not device-specific.
EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.
我们对血管内腹主动脉瘤修复术（EVAR）后的长期结果进行了特定器械比较，以确定器械类型对早期和晚期临床结果的影响。此外，还研究了在每种器械的特定使用说明（IFU）范围内和范围外进行EVAR的影响。
1999年1月8日至2005年12月31日期间，565例患者接受了使用三种市售支架移植物器械之一的EVAR。研究结果包括围手术期（≤30天）死亡率、术中技术并发症及辅助手术需求、动脉瘤破裂、动脉瘤相关死亡率、转为开放修复、再次干预、内漏的发生和/或消失、器械相关不良事件（移位、血栓形成或扭结），以及任何移植物相关不良事件（GRAE）的综合终点。研究结果与推荐器械IFU范围内或范围外的动脉瘤形态相关。采用卡方检验和Kaplan Meier方法进行分析。
植入的移植物包括177个库克天顶（CZ，31%）、111个戈尔覆膜支架（GE，20%）和277个美敦力AneuRx（MA，49%）；39.3%的移植物放置在至少一个IFU参数范围外。平均随访时间为30±21个月，CZ组较短（CZ为20个月，而GE和MA分别为35个月和31个月；P<.001）。总体而言，5年时三种器械在动脉瘤相关死亡、再次干预和GRAE方面的精算无事件生存率相似。CZ组的移植物移位事件较少（CZ为0例，GE为1例，MA为9例）；然而，精算分析显示器械之间无差异。联合GRAE在CZ组最低（CZ为29%，GE为35%，MA为43%；P=.01）。在IFU范围外放置移植物与5年时动脉瘤相关死亡、移位和再次干预的无事件生存率相似（P>.05），但GRAE的无事件生存率较低（IFU范围外为74%，IFU范围内为86%；P=.021），这可能与移植物血栓形成的发生率较高有关（IFU范围外为2.3%，IFU范围内为0.3%；P=.026）。在IFU范围内和范围外放置移植物的结果差异并非特定于器械。
使用三种市售器械进行的EVAR在5年时提供了相似的临床相关结果，尽管一种肾上固定器械未发生移植物移位。正如预期的那样，在解剖学特定IFU变量范围外应用对晚期结果有渐进性负面影响，这表明遵守此类IFU指南是适当的临床实践。
