White G H, May J, McGahan T, Yu W, Waugh R C, Stephen M S, Harris J P
Department of Vascular Surgery, Royal Prince Alfred Hospital, University of Sydney, Australia.
J Vasc Surg. 1996 Feb;23(2):201-11; discussion 211-2. doi: 10.1016/s0741-5214(96)70264-1.
Currently no randomized studies show the relative morbidity and mortality of the open and endoluminal methods of abdominal aortic aneurysm (AAA) repair. The aim of this study was to analyze the outcome of two matched groups of patients with AAA, one undergoing open repair and the other undergoing endoluminal repair.
Two groups of patients who had undergone repair of AAA by open technique (group 1) or by endoluminal methods (group 2) were compared. A historic control cohort of 27 patients was selected from 56 consecutive patients who underwent open repair of AAA between January 1991 and February 1992. Patients considered unsuitable for the endoluminal method on the basis of computed tomography and aortography were excluded (n=29). Between May 1992 and November 1994 prospective data were recorded for 62 consecutive patients who underwent endoluminal repair by tube or bifurcated endografts. Twenty-eight patients who had been specifically referred for endoluminal AAA repairs because of preexisting severe medical comorbidities were excluded. Six of the endoluminal cases had failure, requiring conversion to open operation, and were excluded for separate analysis, leaving 28 patients in group 2. Patients in both groups were thus fit and suitable for either open or endoluminal repair and were comparable in relation to age, sex, risk factors, dimensions, and form of AAA.
The mean values for operation time, blood loss, intensive care stay, and hospital stay for group 1 and group 2 were 2.6 versus 3.1 hours, 1422 versus 873 ml,* 1.8 versus 0.7 days,* and 12.4 versus 11.1 days, respectively (*p<0.05). Local/vascular complications occurred in 15% of patients in group 1 compared with 25% in group 2 (p=0.55), whereas remote/systemic complications occurred in 37% and 29%, respectively (p=0.3). Five of 28 patients in the endoluminal group had complications requiring early operative repair (n=3) or late revision (n=2). When comparison was made on an intention-to-treat basis (with failed procedures included), the incidence of local/vascular complications was significantly greater for endoluminal repair (p=0.047).
The incidence of systemic/remote complications was similar for the two groups in spite of significantly less blood loss and shorter intensive care unit stay with endoluminal repair. The incidence of local/vascular complications had a tendency to be higher for endoluminal compared with standard open method (and was significantly greater if failed procedures were included). In this early experience with prototype devices, patients who were medically suitable for open surgical procedures did not derive benefit from the less invasive endoluminal technique with respect to duration of operation, length of hospital stay, or perioperative morbidity and mortality. On the other hand, because they also did not have worse outcome, a randomized study is now justified in this group.
目前尚无随机研究表明腹主动脉瘤（AAA）开放修复术和腔内修复术的相对发病率和死亡率。本研究的目的是分析两组匹配的AAA患者的治疗结果，一组接受开放修复，另一组接受腔内修复。
比较两组采用开放技术（第1组）或腔内方法（第2组）修复AAA的患者。从1991年1月至1992年2月连续接受AAA开放修复的56例患者中选择27例作为历史对照队列。根据计算机断层扫描和主动脉造影被认为不适合腔内方法的患者被排除（n = 29）。1992年5月至1994年11月，对连续62例接受管状或分叉型腔内移植物腔内修复的患者记录前瞻性数据。28例因存在严重内科合并症而被专门转诊接受腔内AAA修复的患者被排除。腔内修复组中有6例失败，需要转为开放手术，并被排除进行单独分析，第2组剩下28例患者。两组患者均适合开放或腔内修复，在年龄、性别、危险因素、AAA大小和形态方面具有可比性。
第1组和第2组的手术时间、失血量、重症监护病房停留时间和住院时间的平均值分别为2.6小时对3.1小时、1422毫升对873毫升*、1.8天对0.7天*、12.4天对11.1天（p<0.05）。第1组15%的患者发生局部/血管并发症，第2组为25%（p = 0.55），而远处/全身并发症分别发生在37%和29%的患者中（p = 0.3）。腔内修复组28例患者中有5例出现需要早期手术修复（n = 3）或后期翻修（n = 2）的并发症。在意向性治疗基础上进行比较（包括失败的手术）时，腔内修复的局部/血管并发症发生率显著更高（p = 0.047）。
尽管腔内修复的失血量明显减少且重症监护病房停留时间更短，但两组的全身/远处并发症发生率相似。与标准开放方法相比，腔内修复的局部/血管并发症发生率有升高趋势（如果包括失败的手术则显著更高）。在使用原型装置的这一早期经验中，在手术持续时间、住院时间或围手术期发病率和死亡率方面，医学上适合开放手术的患者并未从侵入性较小的腔内技术中获益。另一方面，由于他们的结果也没有更差，现在对这组患者进行随机研究是合理的。
