目的:全球血管指南(GVG)建议选择血管内与开放手术方法进行慢性威胁肢体缺血(CLTI)的血运重建,基于全球肢体解剖分期系统(GLASS)和伤口,缺血,和足部感染(WIfI)分类系统。我们评估了GVG推荐的策略在预测临床结果中的实用性。
方法:我们进行了单中心,回顾性回顾2010-2018年在一项全面的肢体保存计划中首次下肢血管重建的研究.通过1)治疗与GVG推荐的策略(一致与非一致组)进行分层,2)玻璃阶段I-III,3)血管内与开放策略。主要结局是5年无重大不良肢体事件(FF-MAE),定义为免于再次干预或严重截肢的自由,次要结局包括5年总生存率,免于严重截肢,免于再干预,在最初的血运重建过程中立即出现技术故障。对主要和次要结局进行Kaplan-Meier(KM)生存分析和Cox比例风险模型的多变量分析。结果:在CLTI的281次首次血运重建中,251例(89.3%)血管内,186例(66.2%)在一致组中,平均临床随访3.02±2.40年。仅在和谐群体中,167例(89.8%)血管内血运重建。一致组慢性肾脏病的发生率较高(60.8%vs45.3%,P=.02),WIfI足部感染等级(0.81±1.1vs0.56±0.80,P=0.03),与不一致组相比,WIfI分期(3.1±0.79vs2.8±1.2,P<0.01)。经过KM和多变量分析,一致组和非一致组的5年FF-MAE生存率和总生存率无显著差异.在KM分析中,非一致组的大截肢自由度更高(83.9%vs74.2%,P=.025),尽管这种差异在多变量分析中没有显著性(HR0.49,95%CI0.21-1.15,P=.10)。与血管内组相比,开放组的男性男性较低(HR0.39,95%CI0.17-0.91,P=.029),这归因于开放组的再干预率较低(HR0.31,95%CI0.11-0.87,P=.026)。GLASS阶段与结果的显着差异无关,但GLASS分期的严重程度与立即的技术故障相关(1期2.1%,2期6.4%,3期11.7%,P=.01).
结论:在这项研究中,根据是否按照GVG推荐的策略接受治疗,CLTI治疗结果没有显着差异。血管内和开放组之间的总生存期没有差异,尽管血管内组的再介入率较高。GVG指南是帮助指导CLTI患者管理的重要资源。然而,在这项研究中,与GVG指南的一致性和GLASS分期在区分主要采用血管内先行方法治疗的复杂CLTI患者的结局方面均不确定.CLTI患者的血运重建方法是一个微妙的决定,必须考虑患者的解剖结构和临床状态。以及医师技能、经验和机构资源。
BACKGROUND: The Global Vascular
Guidelines (GVG) recommend selecting an endovascular versus open-surgical approach to revascularization for chronic limb-threatening ischemia (CLTI), based on the Global Limb Anatomic Staging System (GLASS) and wound, ischemia, and foot infection (WIfI) classification systems. We assessed the utility of GVG-recommended strategies in predicting clinical outcomes.
METHODS: We conducted a single-center, retrospective review of first-time lower-extremity revascularizations within a comprehensive limb-preservation program from 2010 to 2018. Procedures were stratified by (1) treatment concordance with GVG-recommended strategy (concordant versus nonconcordant groups), (2) GLASS stages I-III, and (3) endovascular versus open strategies. The primary outcome was 5-year freedom from major adverse limb events (FF-MALE), defined as freedom from reintervention or major amputation, and secondary outcomes included 5-year overall survival, freedom from major amputation, freedom from reintervention, and immediate technical failure (ITF) during initial revascularization. Kaplan-Meier (KM) survival analysis and multivariate analysis with Cox proportional hazard models were performed on the primary and secondary outcomes.
RESULTS: Of 281 first-time revascularizations for CLTI, 251 (89.3%) were endovascular and 186 (66.2%) were in the concordant group, with a mean clinical follow-up of 3.02 ± 2.40 years. Within the concordant group alone, 167 (89.8%) of revascularizations were endovascular. The concordant group had a higher rate of chronic kidney disease (60.8% vs. 45.3%, P = 0.02), WIfI foot infection grade (0.81 ± 1.1 vs. 0.56 ± 0.80, P = 0.03), and WIfI stage (3.1 ± 0.79 vs. 2.8 ± 1.2, P < 0.01) compared to the non-concordant group. After both KM and multivariate analyses, there were no significant differences in 5-year FF-MALE or overall survival between concordant and non-concordant groups. There was higher freedom from major amputation in the non-concordant group on KM analysis (83.9% vs. 74.2%, P = 0.025), though this difference was non-significant on multivariate analysis (hazard ratio [HR]: 0.49, 95% confidence interval [CI]: 0.21-1.15, P = 0.10). The open group had lower MALE compared to the endovascular group (HR: 0.39, 95% CI: 0.17-0.91, P = 0.029) attributed to a lower reintervention rate in the open group (HR: 0.31, 95% CI: 0.11-0.87, P = 0.026). GLASS stage was not associated with significant differences in outcomes, but the severity of GLASS stage was associated with ITF (2.1% in stage 1, 6.4% in stage 2, and 11.7% in stage 3, P = 0.01).
CONCLUSIONS: In this study, CLTI treatment outcomes did not differ significantly based on whether treatment was received in concordance with GVG-recommended strategy. There was no difference in overall survival between the endovascular and open groups, though there was a higher reintervention rate in the endovascular group. The GVG
guidelines are an important resource to help guide the management of CLTI patients. However, in this study, both concordance with GVG
guidelines and GLASS staging were found to be indeterminate in differentiating outcomes between complex CLTI patients treated primarily with an endovascular-first approach. The revascularization approach for a CLTI patient is a nuanced decision that must take into account patient anatomy and clinical status, as well as physician skill and experience and institutional resources.