van Dijk L C, van Urk H, du Bois N A, Yo T I, Koning J, Jansen W B, Wittens C H
Department of Vascular Surgery, University Hospital Rotterdam Dijkzigt, The Netherlands.
Eur J Vasc Endovasc Surg. 1995 Aug;10(2):162-7. doi: 10.1016/s1078-5884(05)80107-8.
This prospective randomised multicentre trial was conducted to test whether a new "closed" technique for in situ vein bypass would result in a lower frequency of wound complications, without negative effects on patency rates and without an intolerable increase in residual arteriovenous fistulae compared to the conventional "open" technique.
We have developed a new "closed" technique using a co-axial catheter embolisation system for intra-operative coil embolisation of side branches, in order to avoid long incisions.
In four centres and 95 patients, 97 in situ bypasses were performed: 47 "closed" and 50 "open". Randomisation was stratified for below knee femoropopliteal bypasses (60) and femorocrural bypasses (37). Indications were disabling intermittent claudication (29), restpain (26) or ulcers and/or necrosis (42).
Postoperative mortality was 2% (one in the "closed", one in the "open" group). A total number of 16 (34%) wound complications (grade 1, 2 and 3) occurred in the closed group compared to 36 (72%) in the open group (p < 0.05). Deep wound complications (grade 2) occurred in six patients (13%) of the "closed" group, compared to 15 (30%) in the "open" group. In both groups, three patients (6%) developed deep wound complications including the bypass area (grade 3). In the "closed" group, 20 patients needed additional treatment for arteriovenous fistulae, compared to four in the "open" group. One-year patency rates did not show a statistically significant difference: primary patency rates were 65% and 61% and secondary patency rates were 86% and 76% respectively for the "closed" and "open" group.
These results indicate that a "closed" technique reduces wound complication rate, without negative effects on the short term patency rates. The "closed" technique results in an increased number of postoperative treatments for residual arteriovenous fistulae.
开展这项前瞻性随机多中心试验,以检验与传统“开放”技术相比,一种用于原位静脉搭桥的新“闭合”技术是否会降低伤口并发症的发生率,且对通畅率无负面影响,以及不会导致残余动静脉瘘不可耐受地增加。
我们研发了一种新的“闭合”技术,使用同轴导管栓塞系统在术中对侧支进行线圈栓塞,以避免长切口。
在四个中心的95例患者中,共进行了97次原位搭桥手术:47例采用“闭合”技术,50例采用“开放”技术。随机分组根据膝下股腘动脉搭桥(60例)和股小腿动脉搭桥(37例)进行分层。适应症包括致残性间歇性跛行(29例)、静息痛(26例)或溃疡和/或坏死(42例)。
术后死亡率为2%(“闭合”组1例,“开放”组1例)。“闭合”组共发生16例(34%)伤口并发症(1级、2级和3级),而“开放”组为36例(72%)(p<0.05)。“闭合”组6例患者(13%)发生深部伤口并发症(2级),“开放”组为15例(30%)。两组中均有3例患者(6%)发生包括搭桥区域的深部伤口并发症(3级)。“闭合”组有20例患者需要对动静脉瘘进行额外治疗,“开放”组为4例。一年通畅率未显示出统计学上的显著差异:“闭合”组和“开放”组的一期通畅率分别为65%和61%,二期通畅率分别为86%和76%。
这些结果表明,“闭合”技术可降低伤口并发症发生率,且对短期通畅率无负面影响。“闭合”技术导致术后对残余动静脉瘘的治疗次数增加。