与血管外科学会提出的既定性能标准相比，在慢性肢体威胁性缺血的“所有患者”风险组中进行血管内治疗显示出安全性和有效性。
Endovascular Therapy in an "All-Comers" Risk Group for Chronic Limb-Threatening Ischemia Demonstrates Safety and Efficacy When Compared with the Established Performance Criteria Proposed by the Society for Vascular Surgery.
作者信息
Montero-Baker Miguel, Zulbaran-Rojas Alejandro, Chung Jayer, Barshes Neal R, Elizondo-Adamchik Hector, Shahbazi Mohammad, Ross Jeffrey, Rahemi Hadi, Najafi Bijan, Mills Joseph L
机构信息
Division of Vascular Surgery and Endovascular Therapy, Michael E DeBakey Department of Surgery, Baylor College of Medicine, Houston TX.
Interdisciplinary Consortium on Advanced Motion Performance, Michael E DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX.
出版信息
Ann Vasc Surg. 2020 Aug;67:425-436. doi: 10.1016/j.avsg.2020.03.008. Epub 2020 Mar 21.
BACKGROUND
The aim of this study was to describe the applicability of the Society for Vascular Surgery (SVS) objective performance goals (OPGs) as a tool to evaluate results in the context of endovascular management of noncomplex and complex patients (i.e., end stage renal disease/history of prosthetic conduit) with chronic limb-threatening ischemia (CLTI).
METHODS
Patients diagnosed with CLTI undergoing endovascular procedures from March 2016 to April 2017 were included, and medical records were examined. Patients were categorized as OPG risk (OPGR) and non-OPG risk (nOPGR) groups in accordance with the SVS performance criteria. We compared clinical events between the two groups and then further to the SVS OPGs. Thirty-day outcomes (safety) were major amputation (AMP), major adverse limb events (MALEs), and major adverse cardiovascular events (MACEs), and 1-year outcomes (efficacy) were limb salvage, MALE + 30-day perioperative death (MALE + POD), and survival. Mortality was demonstrated using Kaplan-Meier analysis.
RESULTS
A total of 72 patients were included (OPGR = 58.3% vs. nOPGR = 41.7%). Mean follow-up was 20 months (range, 1-40 months). Retrograde pedal access was used in 65.2% of patients. The overall AMP rate was 2.7% (OPGR = 4.7%, nOPGR = 0%, P = 0.225, vs. SVS OPG<3%), MALE was 4.1% (OPGR = 7.1%, nOPGR = 0%, P = 0.135, vs. SVS OPG<8%), and MACE was 6.9% (OPGR = 2.3%, nOPGR = 13.3%, P = 0.071, vs. SVS OPG<8%). The limb salvage was 90.3% (OPGR = 88%, nOPGR = 93.3%, P = 0.46, vs. SVS OPG>84%), MALE + POD was 76.4% (OPGR = 78.6%, nOPGR = 73.4%, P = 0.606, vs. SVS OPG>71%), and survival was 77.7% (OPGR = 83.3%, nOPGR = 70%, P = 0.18, vs. SVS OPG>80%).
CONCLUSIONS
The SVS OPGs set appropriate safety and efficacy standards as a bar for new technologies. In this series, endovascular therapy in all-comers exceeded the safety and efficacy endpoints proposed by the limited risk OPG panel.
背景
本研究的目的是描述血管外科学会（SVS）客观绩效目标（OPG）作为一种工具在评估非复杂性和复杂性患者（即终末期肾病/人工血管病史）慢性肢体威胁性缺血（CLTI）血管内治疗结果方面的适用性。
方法
纳入2016年3月至2017年4月接受血管内手术的CLTI诊断患者，并检查病历。根据SVS绩效标准，将患者分为OPG风险（OPGR）组和非OPG风险（nOPGR）组。我们比较了两组之间的临床事件，然后进一步与SVS OPG进行比较。30天结局（安全性）为大截肢（AMP）、主要不良肢体事件（MALE）和主要不良心血管事件（MACE），1年结局（有效性）为肢体挽救、MALE + 30天围手术期死亡（MALE + POD）和生存率。使用Kaplan-Meier分析显示死亡率。
结果
共纳入72例患者（OPGR = 58.3% vs. nOPGR = 41.7%）。平均随访20个月（范围1 - 40个月）。65.2%的患者使用了逆行足背入路。总体AMP率为2.7%（OPGR = 4.7%，nOPGR = 0%，P = 0.225，vs. SVS OPG<3%），MALE为4.1%（OPGR = 7.1%，nOPGR = 0%，P = 0.135，vs. SVS OPG<8%），MACE为6.9%（OPGR = 2.3%，nOPGR = 13.3%，P = 0.071，vs. SVS OPG<8%）。肢体挽救率为90.3%（OPGR = 88%，nOPGR = 93.3%，P = 0.46，vs. SVS OPG>84%），MALE + POD为76.4%（OPGR = 78.6%，nOPGR = 73.4%，P = 0.606，vs. SVS OPG>71%），生存率为77.7%（OPGR = 83.3%，nOPGR = 70%，P = 0.18，vs. SVS OPG>80%）。
结论
SVS OPG设定了适当的安全性和有效性标准作为新技术的标杆。在本系列中，所有患者的血管内治疗均超过了有限风险OPG小组提出的安全性和有效性终点。
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