Chronic limb-threatening ischemia (CLTI)

  • 文章类型: Journal Article
    本综述旨在探讨生物可吸收支架在膝下动脉的治疗效果。从可吸收裸金属支架的出现到聚合物和抗增殖药物与涂层生物可吸收血管支架(BVS)混合的最新技术。目前,关于BVSs在膝下动脉介入治疗中的安全性和有效性的数据相互矛盾,特别是与当前一代的药物洗脱支架(DES)相比。这篇综述将涵盖BVS在重建膝下动脉血流方面的现有数据,以及为BVS的未来迭代进行积极的临床试验。在原发通畅率和靶病变血运重建率方面,关于BVSs重建膝下动脉血流的有效性的现有研究表明,BVS在3-12个月内与当前的DESs兼容;长期数据尚未报道。ABSORBBVS是心血管疾病(CAD)中研究最多的BVS。最初,ABSORBBVS显示出有希望的结果。管理外周动脉疾病的复杂区域,如分支或冗长的病变,仍然是一项艰巨的任务。与标准永久性支架手术中看到的动脉深度狭窄相反,生物可吸收支架具有促进后期血液通道扩张和有益合并的潜力。此外,置入支架和重建内皮功能可以降低再狭窄或血栓形成的可能性。然而,生物可吸收支架在多大程度上可以同时保持动脉通畅并保证其结构完整性仍不确定。血液在股浅动脉和pop动脉中施加的强大而复杂的机械应力会对插入血管的任何植入物造成负面影响。不管它的组成,甚至是金属.此外,合并支架有利于治疗持续性闭塞性病变,因为它不会影响后期治疗,包括纠正旁路操作。关于使用生物可吸收支架治疗膝下病变的证据很少。利用生物可吸收支架在轻微的膝下病变可以成功地保持血管腔的通畅,而球囊血管成形术不能提供这种益处。测试这些材料的主要重点是确定生物可吸收支架是否可以在高度钙化的细长病变中提供足够的径向力。的确,使用“-limus”药物洗脱技术与生物可吸收支架结合使用,以前在治疗the动脉方面提供了临床益处,有限的试验证明了这一点。与永久性金属支架相比,用于外周动脉疾病(PAD)的BVS显示出希望,并有可能提供更少炎症和更血管友好的选择。然而,目前的证据尚不允许对其使用提出普遍建议.因此,正在进行,和未来的研究,例如那些研究具有改进的机械性能和吸收概况的新一代生物可吸收支架(BRS)的人,对于定义BRS在管理PAD中的作用至关重要。
    This review aimed to explore the therapeutic effect of bioabsorbable stents in the inferior genicular artery, from the emergence of absorbable bare metal stents to the latest technology in polymer and anti-proliferative eluting drugs mixed with coated bioresorbable vascular stents (BVSs). Currently, there are conflicting data regarding the safety and effectiveness of BVSs in infrapopliteal artery interventions, especially compared to the current generation of drug-eluting stents (DESs). This review will cover the existing data on BVSs in reconstructing the infrapopliteal arterial blood flow and active clinical trials for future iterations of BVSs. In terms of primary patency rate and target lesion revascularization rate, the available research on the effectiveness of BVSs in reconstructing the infrapopliteal arterial blood flow suggests that a BVS is compatible with current DESs within 3-12 months; long-term data have not yet been reported. The ABSORB BVS is the most studied BVS in cardiovascular disease (CAD). Initially, the ABSORB BVS showed promising results. Managing intricate regions in peripheral artery disorders, such as branching or lengthy lesions, continues to be a formidable undertaking. In contrast to the advanced narrowing of arteries seen in standard permanent stent procedures, bioabsorbable stents have the potential to promote the expansion and beneficial merging of blood channels in the latter stages. Furthermore, incorporating stents and re-establishing the endothelial function can diminish the probability of restenosis or thrombosis. Nevertheless, the extent to which bioabsorbable stents may simultaneously preserve arterial patency and guarantee their structural integrity remains uncertain. The powerful and intricate mechanical stresses exerted by the blood in the superficial femoral artery and popliteal artery can cause negative consequences on any implant inserted into the vessel, regardless of its composition, even metal. Furthermore, incorporating stents is advantageous for treating persistent occlusive lesions since it does not impact later treatments, including corrective bypass operations. Evidence is scarce about the use of bioabsorbable stents in treating infrapopliteal lesions. Utilizing bioabsorbable stents in minor infrapopliteal lesions can successfully maintain the patency of the blood vessel lumen, whereas balloon angioplasty cannot offer this benefit. The primary focus of testing these materials is determining whether bioabsorbable scaffolds can provide adequate radial force in highly calcified elongated lesions. Indeed, using \"-limus\" medication elution technology in conjunction with bioabsorbable stents has previously offered clinical benefits in treating the popliteal artery, as evidenced by limited trials.BVSs for peripheral arterial disease (PAD) show promise and have the potential to offer a less inflammatory and more vessel-friendly option compared to permanent metallic stents. However, current evidence does not yet allow for a universal recommendation for their use. Thus, ongoing, and future studies, such as those examining the newer generation of bioresorbable scaffolds (BRSs) with improved mechanical properties and resorption profiles, will be crucial in defining the role of BRSs in managing PAD.
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  • 文章类型: Journal Article
    背景:慢性威胁肢体缺血(CLTI)与长期心血管死亡率高相关。在这部分患者中,由于无法进行运动测试,检测阻塞性冠状动脉疾病(CAD)的运动压力测试可能很困难。存在平衡的缺血和严重的冠状动脉钙化(CAC)。
    目的:验证在CLTI患者中应用regadenoson应力动态灌注CT(DPCT)的可行性。
    方法:在2018年至2023年之间,冠状动脉计算机断层扫描血管造影(CTA)和,在钙评分高于400的情况下,DPCT,在25例有血管内血运重建史的CLTI患者中进行。
    结果:在25名患者中,19具有高于400的钙评分,需要DPCT图像采集。25例患者中有10例可以排除阻塞性CAD。15例CTA/DPCT+患者中,13进行冠状动脉造影(CAG)。所有13例患者都需要进行血运重建。在这13名患者中,冠状动脉CTA/DPCT的血管敏感性和特异性与侵入性评估相比为75%,分别。在随访(27±21个月)时,CTA/DPCT阳性和阴性患者的全因死亡率无统计学差异(p=0.065)。
    结论:尽管严重CAC的患病率很高,DPCT补充冠状动脉CTA可能是检测CLTI患者阻塞性和功能显著CAD的可行方法.
    BACKGROUND: Chronic limb-threatening ischemia (CLTI) is associated with high rates of long-term cardiovascular mortality. Exercise stress testing to detect obstructive coronary artery disease (CAD) can be difficult in this subset of patients due to inability to undergo exercise testing, presence of balanced ischemia and severe coronary artery calcification (CAC).
    OBJECTIVE: To test the feasibility of regadenoson stress dynamic perfusion computed tomography (DPCT) in CLTI patients.
    METHODS: Between 2018 and 2023, coronary computed tomography angiography (CTA) and, in the case of a calcium score higher than 400, DPCT, were performed in 25 CLTI patients with a history of endovascular revascularization.
    RESULTS: Of the 25 patients, 19 had a calcium score higher than 400, requiring DPCT image acquisition. Obstructive CAD could be ruled out in 10 of the 25 patients. Of the 15 CTA/DPCT+ patients, 13 proceeded to coronary angiography (CAG). Revascularization was necessary in all 13 patients. In these 13 patients, vessel-based sensitivity and specificity of coronary CTA/DPCT as compared to invasive evaluation was 75%, respectively. At follow-up (27 ± 21 months) there was no statistically significant difference in all-cause mortality between CTA/DPCT- positive and -negative patients (p = 0.065).
    CONCLUSIONS: Despite a high prevalence of severe CAC, coronary CTA complemented by DPCT may be a feasible method to detect obstructive and functionally significant CAD in CLTI patients.
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  • 文章类型: Randomized Controlled Trial
    对于慢性威胁肢体缺血(CLTI)患者而言,有效和持久的选择有限。
    Saval试验是一项前瞻性试验,多中心,CLTI和膝下动脉病变患者的随机试验,总病变长度为140mm,狭窄70%,卢瑟福第4-5类按2:1分为SAVAL自膨式紫杉醇药物洗脱支架(DES)或无涂层球囊经皮腔内血管成形术(PTA)。主要有效性终点是主要血管通畅(即,在没有临床驱动的靶病变血运重建或靶病变手术旁路的情况下,12个月时,核心实验室裁定的基于双工超声的血流)。主要安全终点为12个月无主要不良事件(MAE)率;MAE定义为踝关节以上指数截肢的复合,重大再干预,30天死亡率在2.5%的单方面显著性水平下预先指定了终点的优越性(有效性)和非劣效性(安全性)。
    共纳入201例患者,并随机分配接受治疗(N=130DES,N=71PTA)。DES组为68.1±35.2mm,PTA组为68.7±49.2mm,和31.0%和27.6%的患者,分别,有闭塞。DES组的12个月主要通畅率为68.0%,PTA组为76.0%(P差=0.8552)。MAE游离率分别为91.6%和95.3%,分别为(次优=0.0433)。
    Saval试验未显示与PTA相比,镍钛诺DES在长度达140mm的膝下动脉病变中的有效性和安全性相关的益处。需要持续创新,为CLTI提供最佳治疗方法。(ClinicalTrials.gov标识符:NCT03551496)。
    Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited.
    The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%.
    A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433).
    The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).
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  • 文章类型: Journal Article
    UNASSIGNED:提出了全球肢体解剖分期系统(GLASS)来评估手术复杂性和技术故障率,并对慢性威胁肢体缺血(CLTI)的解剖模式进行分层。然而,需要更多的证据来验证GLASS在接受药物涂层球囊(DCBs)的CLTI患者血管内治疗后的分期结局.这项研究旨在评估GLASS在预测DCB治疗的CLTI患者预后中的作用。
    未经评估:此多中心,回顾性队列研究纳入2016年7月至2019年6月接受DCBs治疗的CLTI患者.为每个肢体分配GLASS阶段。基于肢体的通畅率(LBP),临床驱动靶病变血运重建(CD-TLR)率,临床改善,在12个月的随访中,对GLASS各阶段的安全性终点进行了分析和比较.使用Cox回归分析确定LBP丢失的危险因素。
    未经评估:共纳入90条肢体,其中55例(61.1%)有孤立的股pop病变,35例(38.9%)有股pop和股下病变。四肢,17(18.9%),12(13.3%),61人(67.8%)被分配到GLASS第一阶段,II,III,分别。Kaplan-Meier对12个月LBP的估计为65.4%,在不同阶段之间没有发现差异(I阶段81.1%;II阶段85.2%;III阶段54.4%;P=0.080)。III期LBP低于I和II期(I和II期83.5%;III期54.4%;P=0.027)。对于不同阶段中的CD-TLR的自由率,发现了类似的结果。随访时踝肱指数值从0.42±0.29提高到0.78±0.35(P<0.001)。死亡率,任何截肢,两组之间的主要截肢手术相似。GLASSIII期和冠心病被确定为12个月时LBP丧失的独立危险因素。
    UNASSIGNED:GLASSIII期的1年LBP和无CD-TLR率低于I期和II期。GLASS分类可以预测DCB治疗股pop病变的CLTI患者的预后。
    UNASSIGNED: The Global Limb Anatomic Staging System (GLASS) was proposed to assess the procedural complexity and technical failure rate and stratify the anatomic pattern of chronic limb-threatening ischemia (CLTI). However, more evidence is needed to validate the GLASS in staging outcomes after endovascular therapy in patients with CLTI treated with drug-coated balloons (DCBs). This study aims to evaluate the role of the GLASS in predicting outcomes of CLTI patients treated with DCBs.
    UNASSIGNED: This multicenter, retrospective cohort study enrolled patients with CLTI treated with DCBs from July 2016 to June 2019. GLASS stages were assigned for every limb. The limb-based patency (LBP) rate, clinically driven target lesion revascularization (CD-TLR) rate, clinical improvement, and safety endpoints were analyzed and compared across the GLASS stages over 12 months of follow-up. Risk factors for the loss of LBP were identified using Cox regression analysis.
    UNASSIGNED: A total of 90 limbs were enrolled, with 55 (61.1%) having isolated femoropopliteal lesions and 35 (38.9%) having femoropopliteal and infrapopliteal lesions. Of the limbs, 17 (18.9%), 12 (13.3%), and 61 (67.8%) were assigned to GLASS stages I, II, and III, respectively. The Kaplan-Meier estimate of the 12-month LBP was 65.4%, and no difference was found among the different stages (stage I 81.1%; stage II 85.2%; stage III 54.4%; P=0.080). The LBP was lower in stage III than in stages I and II combined (stage I and II 83.5%; stage III 54.4%; P=0.027). Similar results were found for the freedom from CD-TLR rates among the different stages. The ankle-brachial index values improved from 0.42±0.29 to 0.78±0.35 at follow-up (P<0.001). The rates of mortality, any amputation, and major amputation were similar among the groups. GLASS stage III and coronary heart disease were identified as independent risk factors for the loss of LBP at 12 months.
    UNASSIGNED: The 1-year LBP and freedom from CD-TLR rates were lower in GLASS stage III than in stages I and II. The GLASS classification could predict the outcomes of CLTI patients with femoropopliteal lesions treated with DCB.
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  • 文章类型: Journal Article
    未经证实:慢性威胁肢体缺血(CLTI)对晚期心脏病的影响,这需要手术治疗,很少有报道。这项研究的目的是回顾CLTI患者心脏手术的结果,并确定危险因素。特别关注CLTI的严重性。
    UNASSIGNED:回顾性分析33例接受CLTI治疗并接受心脏手术的患者的基线特征和结局。根据伤口评估CLTI的状态,缺血,和足部感染(WIfI)分类系统,33例患者分为低WIfI组(1-2期,n=13)和高WIfI组(3-4期,n=20)。
    UNASSIGNED:低WIfI组住院死亡率为0%,高WIfI组住院死亡率为35%(p=0.027)。术后并发症,特别是严重的感染,高WIfI组的发生率高于低WIfI组(70.0%vs.23.1%,p<0.01)。多变量分析确定足部感染等级为WIfI分类因素,较低的白蛋白水平为与术后并发症显着相关的因素。低WIfI组的1年和2年生存率分别为84.6%和67.7%,高WIfI组的1年和2年生存率分别为45%和28.1%。分别(p=0.011)。
    UNASSIGNED:对于高WIfI阶段的患者,心脏手术是一种极其高风险的手术。在这样的病人中,可以考虑在心脏手术前通过下肢血运重建和/或病变部位清创术来降低WIfI分期.
    UNASSIGNED: The effect of chronic limb threatening ischemia (CLTI) on advanced cardiac disease, which requires surgical treatment, has rarely been reported. The purpose of this study was to review the outcomes of cardiac surgery in patients with CLTI and determine the risk factors, with a particular focus on the severity of CLTI.
    UNASSIGNED: The baseline characteristics and outcomes of 33 patients who were treated for CLTI and underwent cardiac surgery were retrospectively analyzed. The states of CLTI were evaluated based on the Wound, Ischemia, and foot Infection (WIfI) classification system, and 33 patients were divided into the low-WIfI group (stages 1-2, n = 13) and high-WIfI group (stages 3-4, n = 20).
    UNASSIGNED: The in-hospital mortality rate was 0% in low-WIfI group and 35% in high-WIfI group (p = 0.027). Postoperative complications, particularly severe infections, occurred more frequently among high-WIfI group than low-WIfI group (70.0% vs. 23.1%, p < 0.01). Multivariable analysis identified foot infection grade as a WIfI classification factor and lower albumin levels as factors significantly associated with postoperative complications. The 1-year and 2-year survival rates were 84.6% and 67.7% in low-WIfI group and 45% and 28.1% in high-WIfI group, respectively (p = 0.011).
    UNASSIGNED: Cardiac surgery in patients with high WIfI stage was an extremely high-risk procedure. In such patients, lowering the WIfI stage by lower extremity revascularization and/or debridement of diseased parts prior to cardiac surgery can be considered.
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  • 文章类型: Journal Article
    在糖尿病(DM)患者中,对慢性威胁肢体缺血(CLTI)进行紧急计划的血管内治疗后,大截肢的风险更高。这项全国性队列研究的目的是比较2010年至2014年CLTI紧急计划开放血运重建后有和无DM患者的结局。在瑞典血管登记处登记的1537人中,569人在国家糖尿病登记册中注册。进行了倾向评分调整的Cox回归分析,以比较有和没有DM的组之间的结果。有和没有DM的患者的中位随访时间为4.3年和4.5年。分别。DM患者更常出现足部溃疡(p=0.034),并且在基线时经历过更多的截肢手术(p=0.001)。死亡率没有差异,心血管死亡,主要不良心血管事件(MACE),或大截肢观察组之间。与无糖尿病患者相比,糖尿病患者的卒中发生率高70%(95%CI:1.11-2.59;p=0.0137),急性心肌梗死(AMI)的发生率高39%(95%CI:1.00-1.92;p=0.0472)。开放血管手术仍然是大量CLTI患者的一线选择,特别是对于DM患者的肢体抢救。在开放血管手术治疗腹股沟下CLTI后,DM患者中风和AMI的发生率较高,需要术前特别考虑,以优化药物治疗以改善术后心血管预后。
    The risk of major amputation is higher after urgently planned endovascular therapy for chronic limb-threatening ischemia (CLTI) in patients with diabetes mellitus (DM). The aim of this nationwide cohort study was to compare outcomes between patients with and without DM following urgently planned open revascularization for CLTI from 2010 to 2014. Out of 1537 individuals registered in the Swedish Vascular Registry, 569 were registered in the National Diabetes Register. A propensity score adjusted Cox regression analysis was conducted to compare outcome between the groups with and without DM. Median follow-up was 4.3 years and 4.5 years for patients with and without DM, respectively. Patients with DM more often had foot ulcers (p = 0.034) and had undergone more previous amputations (p = 0.001) at baseline. No differences in mortality, cardiovascular death, major adverse cardiovascular events (MACE), or major amputation were observed between groups. The incidence rate of stroke was 70% higher (95% CI: 1.11-2.59; p = 0.0137) and the incidence rate of acute myocardial infarction (AMI) 39% higher (95% CI: 1.00-1.92; p = 0.0472) among patients with DM in comparison to those without. Open vascular surgery remains a first-line option for a substantial number of patients with CLTI, especially for limb salvage in patients with DM. The higher incidence rates of stroke and AMI among patients with DM following open vascular surgery for infrainguinal CLTI require specific consideration preoperatively with the aim of optimizing medical treatment to improve cardiovascular outcome postoperatively.
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  • 文章类型: Journal Article
    含氟聚合物涂层,紫杉醇洗脱Eluvia支架在跛行患者股pop动脉病变的血管内治疗中显示出令人鼓舞的结果。本研究的目的是评估Eluvia支架治疗亚洲患者股pop长病变的疗效和安全性。这是一个单一的中心,回顾性研究。主要终点是1年的主要通畅。次要结果是30天并发症发生率,技术上的成功,1年无临床驱动的靶病变血运重建(CD-TLR),肢体抢救,生存,无截肢生存率(AFS),伤口愈合,和临床改善。共包括64例患者,其中67例股pop骨病变;78%患有糖尿病,84%患有慢性威胁肢体缺血(CLTI)。在那些有缺血性伤口的人中,79%的人没有脚。平均病变长度为193±128mm,52%严重钙化。在整个队列中,1年的主要通畅率为84%,在使用Eluvia支架的病变完全覆盖患者中为91%。100%的病例获得了技术成功,6例患者发生了30天的并发症。从CD-TLR获得12个月的自由,肢体抢救,生存,AFS为92%,93%,85%,80%,分别。在80%的患者中,我们经历了完全的伤口愈合,84%的患者在1年后有临床改善.Eluvia支架显示有希望的12个月的通畅性和临床结果,用于这种CLTI占主导地位的严重钙化患者人群的股pop治疗,长病变。患者人数是,然而,需要进行小规模的试验来验证这些发现。在某些情况下看到的动脉瘤变化也需要进一步调查。
    The fluoropolymer-coated, paclitaxel-eluting Eluvia stent has shown promising results for the endovascular treatment of femoropopliteal artery lesions in patients with claudication. The aim of the current study was to evaluate efficacy and safety outcomes of the Eluvia stent for the treatment of long femoropopliteal lesions in Asian patients. This is a single-center, retrospective study. The primary endpoint was primary patency at 1 year. Secondary outcomes were 30-days complication rate, technical success, 1-year freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, amputation-free survival (AFS), wound healing, and clinical improvement. A total of 64 patients with 67 femoropopliteal lesions were included; 78% suffered from diabetes and 84% had chronic limb-threatening ischemia (CLTI). Of those with ischemic wounds, 79% did not have run-off to the foot. Mean lesion length was 193 ± 128 mm and 52% were severely calcified. Primary patency at 1 year was 84% in the overall cohort and 91% in patients with complete lesion coverage with the Eluvia stent. Technical success was achieved in 100% of the cases and 30-day complications occurred in six patients. Twelve-month freedom from CD-TLR, limb salvage, survival, and AFS were 92%, 93%, 85%, and 80%, respectively. In 80% of patients, complete wound healing was experienced and 84% had clinical improvement after 1 year. The Eluvia stent showed promising 12-month patency and clinical results for femoropopliteal treatment in this CLTI-dominant patient population with severely calcified, long lesions. Patient numbers were, however, small; larger trials are required to validate these findings. Aneurysmal change seen in some cases also needs further investigation.
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  • 文章类型: Journal Article
    外周动脉疾病(PAD)是动脉粥样硬化的表现,可能会影响下肢动脉.最危险的PAD并发症是慢性威胁肢体缺血(CLTI)。没有血运重建,CLTI经常导致肢体丧失。然而,开放手术血运重建和血管内治疗(EVT)均不能确保长期成功,避免再狭窄和血运重建失败.近年来,EVT在所有血管专科中获得了越来越多的认可,成为CLTI患者血运重建的主要方法。在临床实践中,在接受相同手术(在血运重建技术和疾病定位方面)的相似合并症患者中,EVT后的不同临床结局导致需要解决的未解决的问题.如今,血运重建失败的风险管理是血管领域的主要挑战之一。本文献综述的目的是确定下肢血管内血运重建结果的潜在预测因素和可能的预防策略。
    Peripheral artery disease (PAD) is a manifestation of atherosclerosis, which may affect arteries of the lower extremities. The most dangerous PAD complication is chronic limb-threatening ischemia (CLTI). Without revascularization, CLTI often causes limb loss. However, neither open surgical revascularization nor endovascular treatment (EVT) ensure long-term success and freedom from restenosis and revascularization failure. In recent years, EVT has gained growing acceptance among all vascular specialties, becoming the primary approach of revascularization in patients with CLTI. In clinical practice, different clinical outcomes after EVT in patients with similar comorbidities undergoing the same procedure (in terms of revascularization technique and localization of the disease) cause unsolved issues that need to be addressed. Nowadays, risk management of revascularization failure is one of the major challenges in the vascular field. The aim of this literature review is to identify potential predictors for lower extremity endovascular revascularization outcomes and possible prevention strategies.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.
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