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Outcomes of Orbital Atherectomy in Patients with Critical Limb Threatening Ischemia and Diabetes. 眶动脉粥样硬化切除术治疗严重肢体缺血和糖尿病患者的疗效。
Pub Date : 2022-06-01
Momodou L Jammeh, Julia Suggs, George L Adams, Ehrin J Armstrong, Jihad Mustapha, Mohamed A Zayed

Purpose: Patients with diabetes and critical limb threatening ischemia (CLTI) are at significantly higher risk of limb loss and death. Here we evaluate the outcomes of orbital atherectomy (OA) for treatment of CLTI in patients with and without diabetes.

Methods: Retrospective analysis of the LIBERTY 360 study was performed to evaluate baseline demographics, and peri-procedural outcomes between patients with CLTI, and with and without diabetes. Hazard ratios (HRs) were determined with Cox regression to examine the impact of OA in patients with diabetes and CLTI over a 3-year follow-up.

Results: A total of 289 patients (201 with diabetes, 88 without diabetes) with Rutherford classification 4-6 were included. Patients with diabetes had higher proportion of renal disease (48.3% vs 28.4%, p=0.002), prior minor/major limb amputation (26% vs 8%, p<0.005), and presence of wounds (63.2% vs 48.9%, p=0.027). Operative times, radiation dosage, and contrast volume were similar between groups. The rate of distal embolization was higher in patients with diabetes (7.8% vs 1.9%, p=0.01; OR 4.33 [0.99, 18.88], p=0.05). However, at 3-years post-procedure, patients with diabetes had no differences in freedom from target vessel/lesion revascularization (HR 1.09, p=0.73), major adverse events (MAE; HR 1.25, p=0.36), major target limb amputation (HR 1.74, p=0.39), and death (HR 1.11, p=0.72).

Conclusion: The LIBERTY 360 observed high limb preservation and low MAEs in patients with diabetes and CLTI. Higher distal embolization was observed with OA in patients with diabetes, but OR did not indicate a significant difference in risk between groups.

目的:糖尿病合并严重肢体威胁缺血(CLTI)患者肢体丧失和死亡的风险显著增高。在这里,我们评估了眼眶动脉粥样硬化切除术(OA)治疗伴有和不伴有糖尿病的CLTI患者的结果。方法:对LIBERTY 360研究进行回顾性分析,以评估CLTI患者、合并和不合并糖尿病患者之间的基线人口统计学和围手术期结局。在3年的随访中,采用Cox回归法确定OA对糖尿病和CLTI患者的影响。结果:共纳入Rutherford分类4-6的289例患者(糖尿病201例,非糖尿病88例)。糖尿病患者有较高比例的肾脏疾病(48.3% vs 28.4%, p=0.002),既往的小/大截肢(26% vs 8%)。结论:LIBERTY 360观察到糖尿病和CLTI患者的肢体保留率高,MAEs低。糖尿病OA患者远端栓塞率较高,但OR未显示组间风险有显著差异。
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引用次数: 0
Single-Center Experience With Optical Coherence Tomography-Guided Directional Atherectomy System for Below-the-Knee Critical Limb Ischemia 单中心经验光学相干断层扫描引导定向动脉粥样硬化系统在膝以下严重肢体缺血
Pub Date : 2021-03-15 DOI: 10.25270/jcli/oem21-00002
Sehrish Memon
BACKGROUND. Below-the-knee (BTK) peripheral arterial disease (PAD) more often presents as critical limb ischemia. Endovascular revascularization strategies continue to evolve to achieve long-term limb-salvage outcomes. A single-center experience with optical coherence tomography (OCT)-guided atherectomy using Pantheris SV (Avinger) is reported. METHODS. All patients with PAD in femoropopliteal or infrapopliteal vessels (n = 27) who underwent plaque debulking by Pantheris SV were analyzed retrospectively. Baseline comorbidities, Rutherford classification, lesion length and characteristics, adjunctive treatment strategy, device-related failures/complications, and major adverse events were analyzed. Additionally, 6-month target-lesion revascularization (TLR) rate was available for 21 of 27 patients. RESULTS. Mean patient age was 70.5 years, 16 patients (59%) were women, and 19 patients (70%) had Rutherford class 5 to 6 symptoms. A total of 58 vessels were treated, including 32 iliofemoropopliteal and 26 infrapopliteal vessels. Chronic occlusions were present in 19% of iliofemoropopliteal lesions and 17.2% of infrapopliteal lesions. The most commonly treated BTK lesion (12 of 26) was the anterior tibial artery (ATA). Following atherectomy, 21 were treated with angioplasty, 4 with angioplasty followed by coronary drug-eluting stent (DES), and 1 with cutting balloon and laser atherectomy. Four failures/complications occurred; 3 of these were device related (failure to pass through lesion due to proximal ATA angulation, coronary DES dislodgment while treating BTK in-stent restenosis, and 1 requiring laser atherectomy for no-flow post atherectomy and angioplasty). At 6 months, 2 of 21 patients (9.5%) required revascularization interventions. CONCLUSION. Treatment of BTK-PAD with imaging guided Pantheris SV atherectomy device appears to be safe, with low rate of TLR at 6 months. Future multicenter randomized trials are needed to confirm these findings.
背景。膝以下(BTK)外周动脉疾病(PAD)多表现为严重肢体缺血。血管内血运重建策略继续发展,以实现长期的肢体挽救结果。本文报道了使用Pantheris SV (Avinger)进行光学相干断层扫描(OCT)引导的动脉粥样硬化切除术的单中心经验。方法。回顾性分析所有经Pantheris SV减容的股腘血管或股腘血管下PAD患者(n = 27)。分析基线合并症、卢瑟福分类、病变长度和特征、辅助治疗策略、器械相关失败/并发症和主要不良事件。此外,27例患者中有21例6个月靶区血管重建率(TLR)。结果。患者平均年龄70.5岁,16例(59%)为女性,19例(70%)有Rutherford 5 ~ 6级症状。总共治疗了58条血管,包括32条髂股腘血管和26条股腘下血管。慢性闭塞存在于19%的髂股腘窝病变和17.2%的股腘窝下病变。最常治疗的BTK病变(26例中的12例)是胫骨前动脉(ATA)。动脉粥样硬化切除术后,21例行血管成形术,4例行血管成形术+冠状动脉药物洗脱支架(DES), 1例行球囊切割+激光动脉粥样硬化切除术。失败/并发症4例;其中3例与装置相关(由于近端ATA成角导致病变不能通过,治疗BTK支架内再狭窄时冠状动脉DES脱位,1例在动脉粥样硬化切除术和血管成形术后无血流需要激光动脉粥样硬化切除术)。6个月时,21例患者中有2例(9.5%)需要血运重建干预。结论。成像引导Pantheris SV动脉粥样硬化切除术治疗BTK-PAD似乎是安全的,6个月时TLR率低。需要未来的多中心随机试验来证实这些发现。
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引用次数: 0
Acute Occlusion of 14 Fr Femoral Access Site After Suture/Collagen Device Failure and Successful Transradial Recanalization 缝线/胶原蛋白装置失败后股骨通道急性闭塞及经桡骨再通成功
Pub Date : 2021-03-15 DOI: 10.25270/jcli/clig21-00008
G. Latsios, A. Karanasos, A. Synetos, C. Tsioufis, K. Toutouzas
This case demonstrates the need for caution when using a collagen-based closure device as bailout for failure of suture-based devices in large-diameter arterial access, as acute vessel closure is possible. Standard interventional cardiology techniques aided the rapid resolution of this complication, while radial artery as secondary access did not hamper our efforts.
本病例表明,在大直径动脉通道中使用基于胶原蛋白的闭合装置作为基于缝合线的装置失败的救助时,需要谨慎,因为急性血管闭合是可能的。标准的介入心脏病学技术有助于快速解决这一并发症,而桡动脉作为次要通路并没有阻碍我们的努力。
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引用次数: 0
CLI is a Major Public Health Concern With Prognosis Worse Than Many Types of Cancer CLI是一个主要的公共卫生问题,其预后比许多类型的癌症都差
Pub Date : 2021-03-15 DOI: 10.25270/jcli/oem21-00001
J. Mustapha
Despite advancing technologies available to treat CLI, we clearly have a long journey ahead of us on behalf of our patients. With the Journal of Critical Limb Ischemia, we are pleased to be able to provide a forum for original CLI work that will be reviewed by multidisciplinary, international CLI experts who understand the complex nature of CLI. The Editorial Board of Journal of Critical Limb Ischemia comprises physicians from across the globe who understand the difficulty and complexity of gathering CLI data. They are vascular surgeons, interventional cardiologists and radiologists, podiatrists, angiologists, and wound care experts. These experts are well aware of the reality of the advanced and complex nature of CLI disease with high 5-year mortality. Because of this, we believe that CLI trials should be modeled after diseases that have a high mortality rate over a short period of time. We must be able to capture the true nature of the disease and its impact on patients affected by it. If we continue to model CLI studies under the conventional nature of vascular disease in general we will never be able to achieve meaningful and convincing data to change the course of therapy. We desperately need new technologies to treat CLI to reduce the incidence of unnecessary amputations occurring in the United States and throughout the world. We clearly can, and must, do better. Our patients are demanding progress.
尽管有先进的技术可以用于治疗CLI,但很明显,代表我们的病人,我们还有很长的路要走。通过《危急肢体缺血杂志》,我们很高兴能够为原始的CLI工作提供一个论坛,这些工作将由了解CLI复杂性的多学科国际CLI专家进行审查。《重症肢体缺血杂志》的编辑委员会由来自世界各地的医生组成,他们了解收集CLI数据的难度和复杂性。他们是血管外科医生、介入心脏病专家和放射科医生、足病医生、血管专家和伤口护理专家。这些专家都清楚地认识到CLI疾病具有高5年死亡率的先进性和复杂性。正因为如此,我们认为CLI试验应该以在短时间内死亡率高的疾病为模型。我们必须能够捕捉到这种疾病的真实性质及其对受其影响的患者的影响。如果我们继续在一般血管疾病的传统性质下对CLI研究进行建模,我们将永远无法获得有意义和令人信服的数据来改变治疗过程。我们迫切需要新技术来治疗CLI,以减少在美国和全世界发生的不必要截肢的发生率。我们显然能够而且必须做得更好。我们的病人要求取得进展。
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引用次数: 0
Optimizing Laser Atherectomy for Different Lesion Morphologies 不同病变形态的激光动脉粥样硬化切除术优化
Pub Date : 2021-03-15 DOI: 10.25270/jcli/clig21-00007
George L. Adams, V. Subramanian
Objective. To understand the impact of fluence and repetition rate on outcomes of superficial femoral artery (SFA) and popliteal artery laser atherectomy based on lesion type (calcific, homogenous, heterogeneous, and restenosis). Methods. Patients with de novo or restenotic (≥50%) SFA and popliteal artery atherosclerotic disease were enrolled. All lesions were sequentially treated with Turbo-Power laser atherectomy (Spectranetics) at 3 predetermined intensity settings: low (fluency, 40 mJ/mm2; repetition rate, 60 Hz); medium (fluency, 60 mJ/mm2; repetition rate, 40 Hz); and high (fluency, 60 mJ/mm2; repetition rate, 60 Hz). Angiography and intravascular ultrasound (IVUS) were performed to characterize plaque morphology and evaluate residual stenosis. Follow-up was 30 days and medical records were reviewed through 12 months for adverse events. Results. Forty-five patients with 57 lesions (12 homogenous, 15 heterogeneous, 15 calcific, and 15 restenotic) were enrolled. Rutherford classification ranged from 2-5, average lesion length was 98.2 ± 91.2 mm, and average diameter stenosis was 82.5 ± 17.9%. Compared with baseline, all lesion types had significant improvement in final postprocedure (atherectomy + any adjunctive therapies) diameter stenosis. Prior to adjunctive therapy, the heterogeneous and restenosis groups saw improvement in minimum lumen area following each stage of the laser treatment. However, the calcific and homogenous groups saw little change in minimum lumen area between the medium- and high-intensity laser treatments. Within 6 months, a total of 6 patients had target-lesion revascularizations. No major amputations or deaths occurred through follow-up. Conclusion. Laser intensity settings during atherectomy should be selected based on lesion morphology. IVUS was essential in defining plaque morphology.
目标。了解影响和重复率对基于病变类型(钙化、均匀、非均匀和再狭窄)的股浅动脉(SFA)和腘动脉激光动脉粥样硬化切除术结果的影响。方法。纳入了新发或再狭窄(≥50%)SFA和腘动脉粥样硬化性疾病的患者。所有病变依次接受涡轮功率激光动脉粥样硬化切除术(光谱)在3个预定的强度设置:低(流畅,40 mJ/mm2;重复频率,60 Hz);中等(流畅度,60 mJ/mm2;重复频率,40 Hz);高流畅度,60 mJ/mm2;重复频率,60赫兹)。血管造影和血管内超声(IVUS)表征斑块形态和评估残余狭窄。随访30天,回顾12个月的不良事件医疗记录。结果。45例患者共57个病变(12例均质性,15例异质性,15例钙化,15例再狭窄)。Rutherford分型范围为2-5,平均病变长度为98.2±91.2 mm,平均狭窄直径为82.5±17.9%。与基线相比,所有病变类型的最终术后(动脉粥样硬化切除术+任何辅助治疗)内径狭窄均有显著改善。在辅助治疗之前,异质性和再狭窄组在激光治疗的每个阶段后最小管腔面积都有所改善。然而,钙化组和同质组在中强度和高强度激光治疗之间的最小管腔面积几乎没有变化。6个月内,共有6例患者发生了靶病变血运重建术。随访期间未发生重大截肢或死亡。结论。在动脉粥样硬化切除术中激光强度的设置应根据病变形态来选择。IVUS对确定斑块形态至关重要。
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引用次数: 0
Use of the Ranger Paclitaxel-Coated Balloon in Patients With Chronic Limb-Threatening Ischemia: Short-Term Safety and Efficacy Results From Singapore 使用Ranger紫杉醇包被球囊治疗慢性肢体缺血患者:来自新加坡的短期安全性和有效性结果
Pub Date : 2021-03-15 DOI: 10.25270/jcli/clig20-00002
Mervin Lim, T. Chong, S. L. Chan, S. Yap, Ankur Patel, K. H. Tay, T. Tang
Chronic limb-threatening ischemia, also known as critical limb ischemia (CLI), is the most advanced stage of peripheral arterial disease (PAD), and patients have high risk of major lower-limb amputation and mortality. An endovascular-first approach has become the preferred revascularization strategy for these patients. The aim of the study was to evaluate the safety and short-term efficacy of the Ranger paclitaxel-coated balloon (PCB; Boston Scientific) in the setting of CLI. Methods. This was a single-center, single-arm, multi-investigator, prospective study of CLI patients who underwent endovascular revascularization using the Ranger PCB from July 2019 to November 2019 at Singapore General Hospital in Singapore. Data were retrieved from the Vascular Quality Initiative database recently set up at this institution. Primary lesion patency, amputation-free survival (AFS), freedom from target-lesion revascularization (TLR), and complete wound healing were the efficacy endpoints of interest at 6 months post intervention. Results. A total of 84 patients (87 limbs; 229 lesions) were enrolled. Fifty-one of the 84 patients (60.7%) were men. Baseline characteristics included diabetes mellitus in 76/84 patients (90.5%), chronic renal impairment in 25/84 patients (29.8%), and Rutherford category 6 foot wounds in 22/87 limbs (24.7%). TASC D lesions were present in 63/229 lesions (27.9%) and moderate/severe vessel wall calcification was present in 167/229 lesions (72.9%). Immediate technical success was achieved in 218/229 lesions (95.2%) with no device-related mortality at 30 days. Primary patency rates at 3 months and 6 months were 76/82 (92.7%) and 69/81 (85.2%), respectively. Six-month primary patency rates of below-the-knee (BTK) lesions treated with and without Ranger balloons were 89/94 (94.7%) and 34/41 (82.9%), respectively (P=.03). Six-month AFS occurred in 68/78 (87.2%) and freedom from TLR occurred in 73/81 (90.1%). Six-month complete wound healing rate was respectable, at 28/50 (56.0%). Conclusion. Use of the Ranger PCB showed favorable outcomes and short-term patency rates, especially in the BTK region, in what is an otherwise challenging patient cohort. Extended follow-up is awaited to evaluate the long-term safety and efficacy of the balloon.
慢性肢体威胁缺血,又称临界肢体缺血(CLI),是外周动脉疾病(PAD)的最晚期,患者下肢主要截肢和死亡的风险较高。血管内优先入路已成为这些患者首选的血运重建策略。该研究的目的是评估Ranger紫杉醇包被球囊(PCB;波士顿科学公司)在CLI的设置。方法。这是一项单中心、单臂、多研究者的前瞻性研究,研究对象是2019年7月至2019年11月在新加坡新加坡总医院使用Ranger PCB进行血管内血运重建术的CLI患者。数据从该机构最近建立的血管质量倡议数据库中检索。原发病变通畅、无截肢生存(AFS)、无靶病变血运重建术(TLR)和伤口完全愈合是干预后6个月的疗效终点。结果。共84例患者(87肢;229个病变)被纳入。84例患者中男性51例(60.7%)。基线特征包括糖尿病76/84例(90.5%),慢性肾功能损害25/84例(29.8%),卢瑟福6类足创伤22/87例(24.7%)。63/229例病变中存在TASC D病变(27.9%),167/229例病变中存在中重度血管壁钙化(72.9%)。218/229个病变(95.2%)立即获得技术成功,30天无器械相关死亡率。3个月和6个月的原发性通畅率分别为76/82(92.7%)和69/81(85.2%)。使用Ranger气囊治疗和不使用Ranger气囊治疗的6个月膝下(BTK)病变的原发性通畅率分别为89/94(94.7%)和34/41 (82.9%)(P= 0.03)。6个月AFS发生率为68/78 (87.2%),TLR解除率为73/81(90.1%)。6个月伤口完全愈合率为28/50(56.0%)。结论。使用Ranger PCB显示出良好的结果和短期通畅率,特别是在BTK地区,这是一个具有挑战性的患者队列。等待延长随访以评估气囊的长期安全性和有效性。
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引用次数: 1
Antegrade and Retrograde Crossing of Chronic Total Occlusions Using the Outback Re-entry Device 使用内陆再入装置顺、逆行穿越慢性全闭塞
Pub Date : 2021-03-15 DOI: 10.25270/jcli/clig21-00010
T. Clark, A. Vance, M. Mantell, S. Reddy, C. Shackles
Purpose. The Outback device (Cordis) enables true lumen re-entry during subintimal recanalization of chronic total occlusions (CTOs). This study compared outcomes of patients who underwent subintimal recanalization of lower-extremity arterial CTOs utilizing the Outback device via antegrade and retrograde approaches. Methods. A retrospective analysis identified 39 patients with Rutherford 3 (n = 13), 4 (n = 13), and 5 disease (n = 13) where the Outback device was utilized (19 antegrade crossing femoropopliteal CTOs, 20 retrograde [17/20 transpedal access crossing femoropopliteal/tibioperoneal CTOs, 3/20 femoral access crossing iliac CTOs]) after conventional techniques failed. Mean age was 70.5 years and 67% were men. Most patients had multifocal and/or long-segment occlusions, with 41% having combined above- and below-knee disease. Results. Overall technical success was 90% (95% antegrade and 85% retrograde cohort; P=.15). There were no major complications and 4 minor complications (prolonged bleeding, femoral pseudoaneurysm requiring thrombin injection, and 2 small access-site hematomas). Fifteen percent of the retrograde cohort subsequently underwent distal bypass, compared with 0% in the antegrade cohort (P=.23). A single amputation occurred, in the antegrade group. Twelve-month target-vessel unassisted primary patency was higher with antegrade use (76% in the antegrade group vs 48% in the retrograde group; P=.03), but 12-month assisted primary patency was similar (85% in the antegrade group vs 79% in the retrograde group; P=.85). Conclusion. The Outback can be used safely and effectively from both antegrade and retrograde approaches during recanalization of CTOs. Lower target-vessel unassisted primary patency using the retrograde transpedal approach indicates the need for closer surveillance to achieve high rates of limb salvage.
目的。Outback装置(Cordis)能够在慢性全闭塞(CTOs)的内膜下再通期间实现真正的管腔再入。本研究比较了使用Outback装置经顺行和逆行入路行下肢动脉CTOs内膜下再通的患者的结果。方法。回顾性分析发现39例Rutherford 3 (n = 13), 4 (n = 13)和5例(n = 13)患者在常规技术失败后使用了Outback装置(19例顺行穿过股腘动脉cto, 20例逆行[17/20经椎弓根通道穿过股腘/胫腓动脉cto, 3/20股动脉通道穿过髂动脉cto])。平均年龄70.5岁,67%为男性。大多数患者有多灶性和/或长节段闭塞,41%合并膝上下病变。结果。总体技术成功率为90%(95%顺行队列和85%逆行队列;P =酒精含量)。无重大并发症,轻微并发症4例(长时间出血,股假性动脉瘤需要注射凝血酶,2例小切口血肿)。15%的逆行组随后行远端搭桥,而在顺行组中为0% (P= 0.23)。顺行组发生单侧截肢。顺行组12个月无辅助靶血管初级通畅率高于逆行组(76% vs 48%);P=.03),但12个月辅助一期通畅率相似(顺行组85% vs逆行组79%;P = .85)。结论。在cto再通过程中,从顺行和逆行两种途径都可以安全有效地使用内陆。采用逆行椎弓根入路的低靶血管无辅助初级通畅表明需要更密切的监测以获得高的肢体保留率。
{"title":"Antegrade and Retrograde Crossing of Chronic Total Occlusions Using the Outback Re-entry Device","authors":"T. Clark, A. Vance, M. Mantell, S. Reddy, C. Shackles","doi":"10.25270/jcli/clig21-00010","DOIUrl":"https://doi.org/10.25270/jcli/clig21-00010","url":null,"abstract":"Purpose. The Outback device (Cordis) enables true lumen re-entry during subintimal recanalization of chronic total occlusions (CTOs). This study compared outcomes of patients who underwent subintimal recanalization of lower-extremity arterial CTOs utilizing the Outback device via antegrade and retrograde approaches. Methods. A retrospective analysis identified 39 patients with Rutherford 3 (n = 13), 4 (n = 13), and 5 disease (n = 13) where the Outback device was utilized (19 antegrade crossing femoropopliteal CTOs, 20 retrograde [17/20 transpedal access crossing femoropopliteal/tibioperoneal CTOs, 3/20 femoral access crossing iliac CTOs]) after conventional techniques failed. Mean age was 70.5 years and 67% were men. Most patients had multifocal and/or long-segment occlusions, with 41% having combined above- and below-knee disease. Results. Overall technical success was 90% (95% antegrade and 85% retrograde cohort; P=.15). There were no major complications and 4 minor complications (prolonged bleeding, femoral pseudoaneurysm requiring thrombin injection, and 2 small access-site hematomas). Fifteen percent of the retrograde cohort subsequently underwent distal bypass, compared with 0% in the antegrade cohort (P=.23). A single amputation occurred, in the antegrade group. Twelve-month target-vessel unassisted primary patency was higher with antegrade use (76% in the antegrade group vs 48% in the retrograde group; P=.03), but 12-month assisted primary patency was similar (85% in the antegrade group vs 79% in the retrograde group; P=.85). Conclusion. The Outback can be used safely and effectively from both antegrade and retrograde approaches during recanalization of CTOs. Lower target-vessel unassisted primary patency using the retrograde transpedal approach indicates the need for closer surveillance to achieve high rates of limb salvage.","PeriodicalId":73697,"journal":{"name":"Journal of critical limb ischemia","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90830222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Journal of critical limb ischemia
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