Axley John C, McFarland Graeme E, Novak Zdenek, Scali Salvatore T, Patterson Mark A, Pearce Benjamin J, Spangler Emily L, Passman Marc A, Beck Adam W
Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, AL.
Division of Vascular Surgery & Endovascular Therapy, University of Florida, Gainesville, FL.
Ann Vasc Surg. 2020 Jan;62:133-141. doi: 10.1016/j.avsg.2019.08.073. Epub 2019 Sep 5.
The natural history of intermittent claudication (IC) is that only 25% of patients will experience worsening of their claudication symptoms, and only approximately 1-3% will progress to major amputation. The impact of increasing use of endovascular therapies on the natural history of IC has not been well established. The purpose of this study is to evaluate the incidence and identify predictors of major and minor amputations after peripheral vascular intervention (PVI) for IC.
A retrospective cohort of patients treated for IC was derived from the national PVI Vascular Quality Initiative database evaluating both preoperative and intraoperative variables from 2003 to 2017. We examined rates of major or minor amputations after ipsilateral PVI for IC. Multivariable logistic regression models were created to identify predictors of amputation along with Kaplan-Meier (KM) plots to estimate amputation-free survival.
We identified 11,887 PVI procedures for patients undergoing elective treatment for IC without a previous history of lower extremity PVI or bypass. Major and minor amputations occurred at a combined rate of 1.08% (n = 128). Minor amputations occurred in 0.56% (n = 67) of patients at 1 year, whereas major amputations were reported in 0.51% (n = 61) of cases. KM plots of amputation-free survival revealed that patients with preoperative ankle brachial indexes (ABIs) <0.2 or noncompressible ABIs (>1.3) had significantly higher rates of any amputation compared with subjects with ABIs between 0.20-0.49, 0.50-0.89, and 0.90-1.30 (log rank, <0.001). Multivariate analysis showed that patients with preoperative symptomatic congestive heart failure (CHF) (odds ratio [OR], 6.48; 95% confidence interval [95% CI], 2.43-17.20; P < 0.001), American Society of Anesthesiologists (ASA) class IV (OR, 9.34; 95% CI, 1.94-44.89; P = 0.005), and nonwhite race (OR, 3.32; 95% CI, 1.50-7.36; P = 0.003) had significant increase in risk of major amputation after PVI. Odds of major or minor amputation were increased when patients underwent only a tibial-level intervention (major: OR, 6.26; 95% CI, 1.50-26.10; P = 0.012 and minor: OR, 7.04; 95% CI, 1.02-8.51; P = 0.001).
With relation to amputation, the natural history of IC does not appear to be impacted by PVI sicker patients with higher ASA or symptomatic CHF, and those with isolated tibial interventions are at higher risk for amputation, and we cannot determine if this is due to patient substrate, presentation, or the intervention itself. Importantly, there are key prognostic preoperative and intraoperative indicators that can assist the clinician with predicting patients who are at a higher risk of amputation.
间歇性跛行(IC)的自然病程是,只有25%的患者会出现跛行症状加重,只有约1%-3%的患者会进展至大截肢。血管内治疗使用增加对IC自然病程的影响尚未明确。本研究的目的是评估外周血管介入治疗(PVI)治疗IC后大截肢和小截肢的发生率,并确定相关预测因素。
从国家PVI血管质量改进数据库中选取接受IC治疗的患者回顾性队列,评估2003年至2017年的术前和术中变量。我们检查了同侧PVI治疗IC后大截肢或小截肢的发生率。建立多变量逻辑回归模型以确定截肢的预测因素,并绘制Kaplan-Meier(KM)曲线以估计无截肢生存率。
我们确定了11887例接受择期IC治疗且既往无下肢PVI或旁路手术史的患者的PVI手术。大截肢和小截肢的总发生率为1.08%(n = 128)。1年时,0.56%(n = 67)的患者发生小截肢,而0.51%(n = 61)的病例发生大截肢。无截肢生存率的KM曲线显示,术前踝肱指数(ABI)<0.2或不可压缩ABI(>1.3)的患者与ABI在0.20 - 0.49、0.50 - 0.89和0.90 - 1.30之间的患者相比,任何截肢的发生率显著更高(对数秩检验,<0.001)。多变量分析显示,术前有症状性充血性心力衰竭(CHF)的患者(比值比[OR],6.48;95%置信区间[95%CI],2.43 - 17.20;P < 0.001)、美国麻醉医师协会(ASA)IV级(OR,9.34;95%CI,1.94 - 44.89;P = 0.005)以及非白人种族(OR,3.32;95%CI,1.50 - 7.36;P = 0.003)在PVI后发生大截肢的风险显著增加。当患者仅接受胫部水平介入治疗时,大截肢或小截肢的几率增加(大截肢:OR,6.26;95%CI,1.50 - 26.10;P = 0.012;小截肢:OR,7.04;95%CI,1.02 - 8.51;P = 0.001)。
关于截肢,IC的自然病程似乎未受PVI影响。ASA分级较高或有症状性CHF的病情较重患者,以及仅接受胫部介入治疗的患者截肢风险较高,我们无法确定这是由于患者基础情况、临床表现还是介入治疗本身所致。重要的是,有一些关键的术前和术中预后指标可帮助临床医生预测截肢风险较高的患者。