Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass 01655, USA.
J Vasc Surg. 2010 Jun;51(6):1419-24. doi: 10.1016/j.jvs.2010.01.083. Epub 2010 Apr 24.
Studies of infrainguinal lower extremity bypass for critical limb ischemia (CLI) have traditionally emphasized outcomes of patency, limb salvage, and death. Because functional outcomes are equally important, our objectives were to describe the proportion of CLI patients who did not achieve symptomatic improvement 1 year after bypass, despite having patent grafts, and identify preoperative factors associated with this outcome.
The prospectively collected Vascular Study Group of Northern New England database was used to identify all patients with elective infrainguinal lower extremity bypass for CLI (2003 to 2007) for whom long-term follow-up data were available. The primary composite study end point was clinical failure at 1 year after bypass, defined as amputation or persistent or worsened ischemic symptoms (rest pain or tissue loss), despite a patent graft. Variables identified on univariate screening (inclusion threshold, P < .20) were included in a multivariable logistic regression model to identify independent predictors.
Long-term follow-up data were available for 1012 patients who underwent infrainguinal bypasses for CLI, of which 788 (78%) remained patent at 1 year. Of these, 79 (10%) met criteria for the composite end point of clinical failure: 21 (2.7%) for major amputations and 58 (7.4%) for persistent rest pain or tissue loss. In multivariable analysis, significant predictors of clinical failure included dialysis dependence (odds ratio [OR], 3.74; 95% confidence interval [CI], 1.84-7.62; P < .001) and preoperative inability to ambulate independently (OR, 2.17; 95% CI, 1.26-3.73; P = .005). A history of coronary artery bypass graft or percutaneous coronary intervention was protective (OR, 0.52; 95% CI, 0.29-0.93; P = .03).
After infrainguinal lower extremity bypass for CLI, 10% of patients with a patent graft did not achieve clinical improvement at 1 year. Preoperative identification of this specific patient subgroup remains challenging. To improve surgical decision making and the overall care of CLI patients, further emphasis needs to be placed on functional outcomes in addition to traditional surgical end points.
研究用于治疗严重肢体缺血（CLI）的下肢动静脉旁路术，传统上强调通畅率、肢体挽救率和死亡率等结果。由于功能结果同样重要，我们的目标是描述在旁路手术后 1 年，尽管移植物通畅，但仍有症状未改善的 CLI 患者的比例，并确定与该结果相关的术前因素。
使用前瞻性收集的新英格兰北部血管研究小组数据库，确定所有因 CLI 接受择期下肢动静脉旁路术的患者（2003 年至 2007 年），这些患者有长期随访数据。主要的复合研究终点是旁路手术后 1 年时的临床失败，定义为尽管移植物通畅，但仍截肢或持续或加重的缺血症状（静息痛或组织损失）。在单变量筛选中确定的变量（纳入阈值，P<.20）被纳入多变量逻辑回归模型，以确定独立预测因素。
1012 例 CLI 患者接受下肢动静脉旁路术，其中 788 例（78%）在 1 年内移植物保持通畅。其中，79 例（10%）符合临床失败的复合终点标准：21 例（2.7%）为主要截肢，58 例（7.4%）为持续静息痛或组织损失。在多变量分析中，临床失败的显著预测因素包括透析依赖（比值比 [OR]，3.74；95%置信区间 [CI]，1.84-7.62；P<.001）和术前不能独立行走（OR，2.17；95%CI，1.26-3.73；P=0.005）。冠状动脉旁路移植术或经皮冠状动脉介入治疗史有保护作用（OR，0.52；95%CI，0.29-0.93；P=0.03）。
在 CLI 下肢动静脉旁路术后，10%的移植物通畅的患者在 1 年内未获得临床改善。术前识别这一特定的患者亚组仍然具有挑战性。为了改善 CLI 患者的手术决策和整体护理，除了传统的手术终点外，还需要更加重视功能结果。
