Division of Vascular and Endovascular Surgery, Department of Surgery, University of California San Diego, La Jolla, Calif.
Division of Vascular Surgery, Department of Surgery, University of South Florida, Tampa, Fla.
J Vasc Surg. 2021 Aug;74(2):489-498.e1. doi: 10.1016/j.jvs.2020.12.088. Epub 2021 Feb 4.
Despite prior literature recommending against limb salvage in patients with poor functional status such as nonambulatory patients with chronic limb-threatening ischemia (CLTI), peripheral endovascular interventions continue to be carried out in this group of patients. Clinical outcomes following these interventions are, however, not well-characterized.
A retrospective review was conducted on all patients treated for CLTI in the Vascular Quality Initiative from September 2016 to December 2019. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression analyses were used as appropriate to study outcomes. The primary outcomes were 30-day mortality and 1-year amputation-free survival. The secondary outcomes were in-hospital death, postoperative complications, 1-year freedom from major amputation, and 2-year survival.
Of the 49,807 patients studied, 28,469 (57.2%) were ambulatory, 15,148 (31.0%) were ambulatory with assistance, 5395 (10.8%) were wheelchair bound, and 525 (1.1%) were bedridden. There was a 2-fold increase in the odds of 30-day death in patients who were ambulatory with assistance (odds ratio [OR], 2.03; 95% confidence interval [CI], 1.77-2.34; P < .001) and wheelchair-bound patients (OR, 2.09; 95% CI, 1.74-2.51; P < .001), and a more than 6-fold increase in bedridden patients (OR, 6.28; 95% CI, 4.55-8.65; P < .001) compared with ambulatory patients. There was a significantly higher odds of postoperative complications in patients who were ambulatory with assistance or bedridden, but no difference with wheelchair-bound patients. Among ambulatory patients, the risks of major amputation and death within 1 year were only 10% and 12%, respectively, whereas that of bedridden patients were as high as 30% and 38%, respectively. A stepwise decrease in amputation-free survival from 81% with full ambulatory capacity to less than 50% (47.7%) in bedridden patients was observed. The risk of major amputation or death within 1 year was 35% higher for ambulatory with assistance (hazard ratio [HR], 1.35; 95% CI, 1.26-1.44; P < .001), 65% higher for wheelchair-bound (HR, 1.65; 95% CI, 1.51-1.79; P < .001) and 2.6-fold higher for bedridden (HR, 2.64; 95% CI, 2.17-3.21; P < .001) compared with ambulatory. A similar association was seen for 1-year freedom from major amputation and 2-year survival.
Ambulatory impairment in patients with CLTI is associated with a significant increase in 30-day mortality and significant decrease in amputation-free survival after peripheral endovascular intervention. Bedridden patients had a 6-fold increase in the 30-day death rate, whereas their amputation-free survival dropped to less than 50% at 1 year. These risks should be considered during shared decision-making regarding management options for nonambulatory patients with CLTI.
尽管先前的文献建议避免对功能状态不佳的患者进行保肢治疗,如患有慢性肢体威胁性缺血(CLTI)的非卧床患者,但外周血管腔内介入治疗仍在这组患者中进行。然而,这些介入治疗后的临床结果尚未得到很好的描述。
对 2016 年 9 月至 2019 年 12 月期间血管质量倡议中所有接受 CLTI 治疗的患者进行回顾性分析。使用逻辑回归、Kaplan-Meier 生存估计、对数秩检验和 Cox 回归分析等方法研究结局。主要结局是 30 天死亡率和 1 年无截肢生存率。次要结局是院内死亡、术后并发症、1 年免于主要截肢和 2 年生存率。
在研究的 49807 名患者中,28469 名(57.2%)为活动能力正常,15148 名(31.0%)为活动能力正常但需辅助,5395 名(10.8%)为轮椅依赖,525 名(1.1%)为卧床不起。与活动能力正常的患者相比,辅助活动能力的患者(优势比 [OR],2.03;95%置信区间 [CI],1.77-2.34;P<0.001)和轮椅依赖的患者(OR,2.09;95%CI,1.74-2.51;P<0.001)30 天死亡的可能性增加了两倍,而卧床不起的患者增加了六倍以上(OR,6.28;95%CI,4.55-8.65;P<0.001)。与活动能力正常的患者相比,辅助活动能力或卧床不起的患者术后并发症的可能性显著增加,但与轮椅依赖的患者没有差异。在活动能力正常的患者中,1 年内主要截肢和死亡的风险分别仅为 10%和 12%,而卧床不起的患者则分别高达 30%和 38%。观察到从完全活动能力的 81%到卧床不起患者的不到 50%(47.7%)的截肢无生存率逐步下降。辅助活动能力的患者(危险比 [HR],1.35;95%CI,1.26-1.44;P<0.001)、轮椅依赖的患者(HR,1.65;95%CI,1.51-1.79;P<0.001)和卧床不起的患者(HR,2.64;95%CI,2.17-3.21;P<0.001)的 1 年内主要截肢或死亡风险分别增加了 35%、65%和 2.6 倍。对于 1 年免于主要截肢和 2 年生存率,也存在类似的关联。
CLTI 患者的活动能力受损与外周血管腔内介入治疗后 30 天死亡率显著增加和无截肢生存率显著降低相关。卧床不起的患者 30 天死亡率增加了 6 倍,而他们的无截肢生存率在 1 年内下降到不足 50%。在为非卧床 CLTI 患者制定管理方案的共同决策过程中,应考虑这些风险。