Schanzer Andres, Hevelone Nathanael, Owens Christopher D, Belkin Michael, Bandyk Dennis F, Clowes Alexander W, Moneta Gregory L, Conte Michael S
Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA.
J Vasc Surg. 2007 Dec;46(6):1180-90; discussion 1190. doi: 10.1016/j.jvs.2007.08.033.
The influence of operator-dependent variables on the outcomes of lower extremity bypass (LEB) surgery have primarily been reported in single-institution, retrospective studies. We utilized data from a prospective, multicenter trial to identify technical variables that were significantly associated with early and midterm results of autogenous LEB for limb salvage.
The PREVENT III trial database includes 1404 North American patients with critical limb ischemia (CLI) who underwent LEB using excised autogenous vein. The study protocol excluded claudicants and in situ reconstructions. Technical factors analyzed included vein diameter, conduit type, graft length, vein orientation, location of proximal and distal anastomoses, and performance of completion imaging. Univariate analysis was used to determine the effect of these factors on 30 day and 1-year outcomes. Multivariate Cox regression models evaluated the influence of these factors while adjusting for age, sex, race, tobacco, diabetes, dialysis-dependency, previous index limb bypass, and study drug (edifoligide) administration. The primary outcomes were primary patency (PP), primary assisted patency (PAP), and secondary patency (SP) assessed by Kaplan-Meier method.
Univariate analysis revealed that vein diameter <3.5 mm and composite graft type were significantly associated with early (30 day) graft failure. At 1 year, multivariate analysis revealed that patency rates were negatively associated with diameter <3.5 mm (PP, PAP, SP), non-great saphenous vein (GSV) type (PP, SP), and graft lengths >50 cm (PP only). Limb salvage and survival at 1 year were not significantly impacted by technical variables. Employing a prespecified trial definition of high-risk conduits (diameter <3mm or nonsingle segment GSV; 24% of entire cohort) revealed that use of such conduits was associated with a 2.1-fold increased risk of 30 day graft failure (P < .05), as well as reduced PP, PAP, and SP at 1 year. Use of a high-risk conduit was also associated with an increased index length of stay (mean 9.37 vs 8.71 days, P = .03) and a greater number of reinterventions (mean 0.67 vs 0.42, P < .0001) over the ensuing year.
In this large, multicenter cohort of patients undergoing LEB for CLI, vein diameter and conduit type were the dominant technical determinants of early and late graft failure. High-risk conduits and longer grafts may benefit from aggressive postoperative graft surveillance.
手术相关变量对下肢旁路移植（LEB）手术结果的影响主要在单机构回顾性研究中有所报道。我们利用一项前瞻性多中心试验的数据，以确定与自体LEB保肢的早期和中期结果显著相关的技术变量。
PREVENT III试验数据库纳入了1404例北美严重肢体缺血（CLI）患者，这些患者接受了使用切除的自体静脉的LEB手术。研究方案排除了间歇性跛行患者和原位重建患者。分析的技术因素包括静脉直径、导管类型、移植物长度、静脉方向、近端和远端吻合口位置以及完成成像情况。采用单因素分析来确定这些因素对30天和1年结果的影响。多因素Cox回归模型在调整年龄、性别、种族、吸烟、糖尿病、透析依赖、既往指数肢体旁路移植和研究药物（依地福明）给药情况后，评估这些因素的影响。主要结局为通过Kaplan-Meier法评估的原发性通畅率（PP）、原发性辅助通畅率（PAP）和继发性通畅率（SP）。
单因素分析显示，静脉直径<3.5 mm和复合移植物类型与早期（30天）移植物失败显著相关。在1年时，多因素分析显示，通畅率与直径<3.5 mm（PP、PAP、SP）、非大隐静脉（GSV）类型（PP、SP）和移植物长度>50 cm（仅PP）呈负相关。技术变量对1年时的保肢和生存率没有显著影响。采用预先设定的高危导管试验定义（直径<3mm或非单段GSV；占整个队列的24%）显示，使用此类导管与30天移植物失败风险增加2.1倍相关（P <.05），以及1年时PP、PAP和SP降低。使用高危导管还与指数住院时间延长（平均9.37天对8.71天，P =.03）和随后一年中更多的再次干预相关（平均0.67次对0.42次，P <.0001）。
在这个接受LEB治疗CLI的大型多中心队列中，静脉直径和导管类型是早期和晚期移植物失败的主要技术决定因素。高危导管和较长的移植物可能受益于积极的术后移植物监测。
