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股下静脉旁路移植血管的外科手术和血管腔内修复:PREVENT III试验的中期结果分析

Surgical and endovascular revision of infrainguinal vein bypass grafts: analysis of midterm outcomes from the PREVENT III trial.

作者信息

Berceli Scott A, Hevelone Nathanael D, Lipsitz Stuart R, Bandyk Dennis F, Clowes Alexander W, Moneta Gregory L, Conte Michael S

机构信息

University of Florida and the Malcom Randall VAMC, Gainesville, FL, USA.

出版信息

J Vasc Surg. 2007 Dec;46(6):1173-1179. doi: 10.1016/j.jvs.2007.07.049. Epub 2007 Oct 22.

Abstract

OBJECTIVE

Data supporting the utility of percutaneous treatment to maintain vein graft patency have been limited to a collection of single-institution, retrospective analyses. Using the prospective, multi-institutional PREVENT III database, we sought to define the outcomes for endovascular vs surgical vein bypass graft revision and to define predictors for the success or failure of these interventions.

METHODS

A nested cohort study of 1404 patients in the PREVENT III trial who underwent infrainguinal vein bypass grafting for critical limb ischemia was performed to identify those patients who underwent either open surgical or endovascular graft revision. All patients in PREVENT III were followed up for 1 year from the initial bypass operation. The following were modeled as end points from the time of the initial open surgical or endovascular revision: freedom from graft reintervention, occlusion, amputation, and death.

RESULTS

A total of 156 open surgical and 134 endovascular reinterventions were performed, with a mean follow-up after revision of 193 and 151 days, respectively. Although the demographics for each group were similar, the choice of repair was influenced by the interval between the index graft placement and the initial revision, with a high percentage of the early graft revisions treated with an open surgical procedure (0-1 months: 84% open surgical vs 16% endovascular; P < .001). The primary end point (ie, failure resulting in repeat graft revision, graft occlusion, or major amputation) was reached in 30.2% of the endovascular and 26.2% of the open surgical individuals, with significant improvements in the durability of graft revisions noted in the open surgical group (12-month amputation-/revision-free survival of 75% for the open surgical and 56% for the endovascular group; hazard ratio, 2.2; 95% confidence interval, 0.92-5.26; P = .043). Furthermore, subgroup analysis revealed this benefit to be most profound within the subset of thrombosed grafts undergoing salvage (P = .006). For revisions performed to treat graft stenosis, early outcomes were similar, with a trend favoring the open surgical group developing beyond 6 months. Although 80% of open surgical and 64% of endovascular-revised grafts required no further intervention, endovascular revisions necessitated significantly more reinterventions to maintain patency. The mean hospital lengths of stay (open surgical, 2.1 days; endovascular, 1.7 days) and quality of life at completion of the study (VascuQoL: open surgical, 4.72; endovascular, 4.76) were similar between the groups.

CONCLUSIONS

Open surgical revision of infrainguinal vein grafts provides an increased freedom from further reinterventions or major amputation, but early success rates for endovascular procedures were similar, particularly for nonoccluded grafts. With time, endovascular revisions necessitate an increasing number of reinterventions and manifest higher rates of failure.

摘要

目的

支持经皮治疗以维持静脉移植物通畅性的效用的数据仅限于单机构回顾性分析。利用前瞻性、多机构的PREVENT III数据库,我们试图确定血管内与外科静脉旁路移植修复的结果,并确定这些干预措施成功或失败的预测因素。

方法

对PREVENT III试验中1404例因严重肢体缺血接受股下静脉旁路移植术的患者进行巢式队列研究,以确定那些接受开放手术或血管内移植修复的患者。PREVENT III的所有患者从初次旁路手术开始随访1年。以下指标作为初次开放手术或血管内修复后的终点指标:无需再次移植干预、无移植闭塞、无截肢和无死亡。

结果

共进行了156例开放手术和134例血管内再次干预,修复后的平均随访时间分别为193天和151天。尽管每组的人口统计学特征相似,但修复方式的选择受首次移植放置与初次修复之间间隔的影响,早期移植修复采用开放手术的比例很高(0 - 1个月:84%为开放手术,16%为血管内修复;P < 0.001)。30.2%的血管内修复患者和26.2%的开放手术患者达到了主要终点(即导致再次移植修复、移植闭塞或大截肢的失败),开放手术组的移植修复耐久性有显著改善(开放手术组12个月无截肢/无修复生存率为75%,血管内修复组为56%;风险比为2.2;95%置信区间为0.92 - 5.26;P = 0.043)。此外,亚组分析显示,这种益处在接受挽救的血栓形成移植物亚组中最为显著(P = 0.006)。对于为治疗移植狭窄而进行的修复,早期结果相似,6个月后有倾向于开放手术组的趋势。尽管80%的开放手术修复移植物和64%的血管内修复移植物无需进一步干预,但血管内修复需要更多的再次干预以维持通畅。两组的平均住院天数(开放手术组为2.1天,血管内修复组为1.7天)和研究结束时的生活质量(血管生活质量评分:开放手术组为4.72,血管内修复组为4.76)相似。

结论

股下静脉移植物的开放手术修复可减少进一步的再次干预或大截肢,但血管内手术的早期成功率相似,尤其是对于未闭塞的移植物。随着时间的推移,血管内修复需要越来越多的再次干预,且失败率更高。

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