Vascular Patency

血管通畅
  • 文章类型: Journal Article
    目的:充分的血液透析需要功能性和持久的血管通路。动静脉瘘优于人工移植物或中心静脉导管。但它与原发性失败和成熟失败的高比率有关。术前用彩色多普勒超声(CDU)绘制手臂血管有助于实现更好的短期和长期结果。不幸的是,比体格检查更耗时,并且需要经验丰富的检查者和特殊设备;一些作者认为CDU不应该成为常规术前评估的一部分。我们报告了我们使用彩色多普勒超声进行术前血管标测的经验,目的是为手术团队提供血管通路,血管通路的监测,和主要结果的评估(主要失败,成熟失败,和通畅性)。
    方法:这是一项单中心回顾性研究,包括在2019年1月至2021年12月期间参加特定预约血管通路计划咨询的患者。肾脏科医生进行了体格检查和血管标测,并向血管外科医生团队提出了血管通路的特定类型和位置。通过功能性血管通路对患者进行随访,直到第一次血液透析后一个月。
    结果:在这项研究中,评估了167例患者(114例事件患者-慢性肾脏病4或5期-和53例流行患者-通过中心静脉导管进行血液透析)。肾脏科医师建议的血管通路为70例(41.9%)的radial头动静脉瘘,50例患者(29.9%)的头臂动静脉瘘,34例(20.4%)患者的臂-贵重动静脉瘘,动静脉移植8例(4.8%),中心静脉导管2例(1.2%)。141例患者建立了血管通路:57例患者(40.4%)远端动静脉瘘,54例(38.3%)的肱-头动静脉瘘,27例患者(19.1%),动静脉移植3例(2.1%)。创建的访问对应于129名患者(91.5%)的建议访问。记录了22个(15.6%)主要故障。远端动静脉瘘和糖尿病与原发性衰竭的高风险相关(OR=3.929(1.485-10.392),p=0.004;OR=3.867(1.235-12.113),分别为p=0.014)。8周时成熟失败的发生率为4.8%。在6、12和24个月的主要通畅率为76.3%,70.4%和49.2%。初级辅助通畅率在6个月和12个月为84.8%,在24个月为81.3%。
    结论:这项研究表明,用彩色多普勒超声对整个血管区域进行研究,在一个由肾病学家和血管外科医生组成的多学科团队中,与高的自体进入率和极低的原发性失败和成熟失败率相关(在文献中几乎是前所未有的)。
    OBJECTIVE: Functional and durable vascular access is needed for adequate hemodialysis. Arteriovenous fistula is preferred over prosthetic grafts or central venous catheters, but it is associated with high rates of primary failure and maturation failure. Preoperative mapping of arm vessels with color Doppler ultrasound (CDU) has been shown to be helpful in achieving better short and long-term outcomes. Unfortunately, is more time-consuming than a physical examination and requires an experienced examiner and special equipment; some authors defend that CDU should not be part of the routine preoperative assessment. We reported our experience in preoperative vessel mapping using color Doppler ultrasound to purpose a vascular access to the surgical team, surveillance of vascular access, and evaluation of main outcomes (primary failure, maturation failure, and patency).
    METHODS: This is a single-center retrospective study that includes patients who attended a specific appointment for vascular access planning consultation between January 2019 and December 2021. A nephrologist performed the physical exam and vascular mapping and proposed to the vascular surgeon team a specific type and location of vascular access. Patients were followed until one month after the first hemodialysis through functioning vascular access.
    RESULTS: In this study, 167 patients were evaluated (114 incident patients - chronic kidney disease stage 4 or 5 - and 53 prevalent patients - under hemodialysis through central venous catheter). The vascular accesses proposed by nephrologist were radial-cephalic arteriovenous fistula in 70 patients (41.9%), brachio-cephalic arteriovenous fistula in 50 patients (29.9%), brachio-basilic arteriovenous fistula in 34 patients (20.4%), arteriovenous graft in 8 patients (4.8%) and central venous catheter in 2 patients (1.2%). Vascular access was constructed in 141 patients: distal arteriovenous fistula in 57 patients (40.4%), brachio-cephalic arteriovenous fistula in 54 patients (38.3%), brachio-basilic AVF in 27 patients (19.1%), and arteriovenous graft in 3 patients (2.1%). The created access corresponds to the proposed access in 129 patients (91.5%). Twenty-two (15.6%) primary failures were registered. Distal arteriovenous fistulas and diabetes mellitus were associated with a higher risk of primary failure (OR=3.929 (1.485-10.392), p=0.004; OR=3.867 (1.235-12.113), p=0.014, respectively). The incidence of maturation failure at eight weeks was 4.8%. The primary patency at 6, 12 and 24 months was 76.3%, 70.4% and 49.2%. Primary assisted patency was 84.8% at 6 and 12 months and 81.3% at 24 months.
    CONCLUSIONS: This study demonstrates that the study of the entire vascular territory performed with color Doppler ultrasound, within a multidisciplinary team of nephrologists and vascular surgeons, is associated with high rates of autologous access and very low rates of primary failure and maturation failure (almost unprecedented in the literature).
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  • 文章类型: Journal Article
    目的:本系统综述和荟萃分析旨在评估近期证据,评估上腔静脉患者在不同时间点的通畅性结局,锁骨下,和接受过支架置入术的头臂静脉狭窄。
    方法:PubMed,Scopus,和Cochrane图书馆数据库进行了搜索,以进行截至2022年12月的研究。
    方法:测量结果包括技术成功率,小学,初级辅助,和二次通畅在不同的时间点。还进行了亚组分析,以比较恶性和良性梗阻。等级用于评估证据的确定性。
    结果:meta分析中纳入了报告1539例患者结局的39项研究。术后1年的原发性通畅率为81.5%(95%CI74.5-86.9%)。1年后,主要通畅率在12-24个月时下降至63.2%(95%CI51.9-73.1%)。≥24个月的一级辅助通畅率和二级通畅率分别为72.7%(95%CI49.1-88.0%)和76.6%(95%CI51.1-91.1%)。在亚组分析中,1-3个月和12-24个月时,恶性狭窄患者的原发通畅率明显高于良性狭窄。比较恶性和良性亚组时,合并的次级通畅率没有显着差异。等级分析确定所有结果的证据的确定性非常低。
    结论:支架置入术是上腔静脉良恶性狭窄的有效干预措施,锁骨下,和头臂静脉.手术后1年主要通畅率良好,81.5%的支架在6-12个月时保持通畅。一年后通畅率下降,在12-24个月时,原发性通畅率为63.2%,继发性通畅率为89.3%,显示再干预后结果改善。缺乏高质量的证据。需要更多的研究来调查通畅性结果以及对监测或再干预计划的需求。
    OBJECTIVE: This systematic review and meta-analysis aimed to appraise recent evidence assessing patency outcomes at various time points in patients with superior vena cava, subclavian, and brachiocephalic vein stenosis who had undergone stenting.
    METHODS: PubMed, Scopus, and Cochrane Library databases were searched for studies up to December 2022.
    METHODS: Measured outcomes included technical success rate, primary, primary assisted, and secondary patency at various time points. A subgroup analysis was also conducted to compare malignant and benign obstruction. GRADE was used to assess the certainty of evidence.
    RESULTS: Thirty nine studies reporting outcomes in 1539 patients were included in the meta-analysis. Primary patency up to 1 year after the procedure was 81.5% (95% CI 74.5 - 86.9%). Primary patency declined after 1 year to 63.2% (95% CI 51.9 - 73.1%) at 12 - 24 months. Primary assisted patency and secondary patency at ≥ 24 months were 72.7% (95% CI 49.1 - 88.0%) and 76.6% (95% CI 51.1 - 91.1%). In the subgroup analysis, primary patency was significantly higher in patients with a malignant stenosis compared with a benign stenosis at 1 - 3 and 12 - 24 months. No significant difference was seen for pooled secondary patency rates when comparing the malignant and benign subgroups. GRADE analysis determined the certainty of evidence for all outcomes to be very low.
    CONCLUSIONS: Stenting is an effective intervention for benign and malignant stenosis of the superior vena cava, subclavian, and brachiocephalic veins. Primary patency rates were good up to 1 year after the procedure, with 81.5% of stents retaining patency at 6 - 12 months. Patency rates declined after 1 year, to 63.2% primary and 89.3% secondary patency at 12 - 24 months, showing improved outcomes following re-intervention. High quality evidence is lacking. More research is needed to investigate patency outcomes and the need for surveillance or re-intervention programme.
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  • 文章类型: Journal Article
    目的:比较药物涂层球囊(DCB)与普通球囊血管成形术(PTA)后透析动静脉瘘(AVF)的主要通畅率和再狭窄率。
    方法:这项回顾性研究纳入了157例患者,这些患者在2012年1月至2022年期间接受了AVF血管成形术以治疗固有AVF狭窄。瘘管是头臂(75%),Brachobasillic(17%),和头颅(8%)。指标干预是DCB或经皮腔内血管成形术(PTA),随后进行随访。中心静脉狭窄患者,血栓性瘘,瘘管支架,排除索引程序后的AV移植物或手术干预。
    结果:28例患者使用DCB和129例患者使用PTA进行了动静脉瘘血管成形术。共有108例患者出现单一狭窄,42有2个狭窄,和7个有3个狭窄。这些狭窄的位置在静脉流出道(57%),吻合段(31%),和头弓(12%)。PTA再干预的中位时间为216天,而DCB为304天(p=0.079)。在6个月时,PTA和DCB分别为60.4%和75%(p=0.141)结论:尽管与PTA相比,DCB血管成形术治疗初治功能失调的AVF倾向于改善干预时间和6个月的原发性通畅。这一差异没有达到统计学意义.
    OBJECTIVE: To compare the primary patency and restenosis rates in treatment naieve dialysis arteriovenous fistulas (AVFs) after drug-coated balloons (DCB) versus plain balloon angioplasty (PTA).
    METHODS: This retrospective study included 157 patients who underwent AVF angioplasty for treatment-native AVF stenosis between January 2012 to 2022. The fistulas were Brachiocephalic (75%), Brachiobasilic (17%), and radiocephalic (8%). The index intervention was with either DCB or percutaneous transluminal angioplasty (PTA) with subsequent follow up. Patients with central venous stenosis, thrombosed fistula, fistula stents, AV graft or surgical intervention after the index procedure were excluded.
    RESULTS: Arteriovenous fistula angioplasty was done in 28 patients using DCB and in 129 patients using PTA. A total of 108 patients presented with a single stenosis, 42 with 2 stenoses, and 7 with 3 stenoses. The location of these stenoses was in the venous outflow (57%), the juxta anastomotic segment (31%), and cephalic arch (12%). The median time to re-intervention for the PTA was 216 days compared to 304 days for the DCB (p=0.079). Primary patency at 6 months was 60.4% for PTA and 75% for DCB (p=0.141) CONCLUSION: Although DCB angioplasty of treatmentnaïve dysfunctional AVF tends to improve the time to intervention and 6-month primary patency compared to PTA, this difference did not reach statistical significance.
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  • 文章类型: Journal Article
    目的:通过系统的动脉期CT评估方法描述减肥手术后胃的残余动脉供应,该方法可以帮助诊断和治疗术后并发症,并有助于规划未来的手术。
    方法:回顾性分析了在3个学术机构接受Roux-en-Y胃旁路术(RYGB)或袖状胃切除术(SG)的46例患者的动脉期CT,以评估左胃动脉(LGA)的通畅性。右胃动脉(RGA),胃表皮动脉(GEA),和左膈下动脉(LIPA)和胃穿孔的存在。
    结果:在25例RYGB和21例SG患者中,平均直径为LGA2.2±0.4毫米,RGA1.6±0.5mm,和GEA1.7±0.4mm。在RYGB扫描中,所有LGA,RGA,并确定了24/25(96%)的GEA。在20/25(80%)的LGA中发现了良好的通畅性,21/25(84%)RGA,和23/24(96%)GEAs。在SG扫描中,所有LGA,18/21(86%)的RGA,和20/21(95%)GEA被确定。在17/21(81%)的LGA中观察到良好的通畅性,15/18(83%)RGA,和20/20(100%)GEAs。就胃穿孔器而言,在RYGB的23/25(92%)和SG扫描的17/17(100%)上观察到LGA供应。在13/21(62%)RYGB和9/18(50%)SG扫描上看到RGA供应。在19/23(83%)RYGB扫描中发现了GEA供应。SG扫描中未发现通过GEA进行的胃供应。
    结论:在这项研究中,在所有RYGB和SG病例中,通过LGA向胃的动脉供应得到一致确认,表明在保留LGA方面手术方法简单。建议使用专用的CT血管造影协议或导管导向血管造影,以准确和全面地评估胃血液供应,特别是在手术再干预之前。
    OBJECTIVE: To describe residual arterial supply to the stomach after bariatric surgery via a systematic arterial-phase CT assessment approach that can aid in diagnosis and treatment of postoperative complications and facilitate planning for future procedures.
    METHODS: Arterial-phase CT of 46 patients who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at 3 academic institutions were retrospectively reviewed to assess patency of left gastric artery (LGA), right gastric artery (RGA), gastroepiploic artery (GEA), and left inferior phrenic artery (LIPA) and presence of gastric perforators.
    RESULTS: In 25 RYGB and 21 SG patients, mean diameters were LGA 2.2 ± 0.4 mm, RGA 1.6 ± 0.5 mm, and GEA 1.7 ± 0.4 mm. On RYGB scans, all LGAs, RGAs, and 24/25 (96%) of GEAs were identified. Excellent to good patency was seen in 20/25 (80%) LGAs, 21/25 (84%) RGAs, and 23/24 (96%) GEAs. On SG scans, all LGAs, 18/21 (86%) of RGAs, and 20/21 (95%) GEAs were identified. Excellent to good patency was seen in 17/21 (81%) LGAs, 15/18 (83%) RGAs, and 20/20 (100%) GEAs. In terms of gastric perforators, LGA supply was seen on 23/25 (92%) of RYGB and 17/17 (100%) of SG scans. RGA supply was seen on 13/21 (62%) RYGB and 9/18 (50%) SG scans. GEA supply was seen on 19/23 (83%) RYGB scans. No gastric supply via GEA was seen on SG scans.
    CONCLUSIONS: In this study, arterial supply to the stomach through the LGA was consistently identified in all RYGB and SG cases, indicating an uncomplicated surgical approach with regard to preserving the LGA. Dedicated CT angiography protocol or catheter-directed angiography is recommended for accurate and comprehensive assessment of the gastric blood supply, particularly before surgical re-intervention.
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  • 文章类型: Journal Article
    与股pop闭塞性疾病相比,孤立的pop动脉闭塞很少见。尽管血管内手术在治疗中已经变得重要,传统手术仍然是黄金标准。在这项研究中,我们回顾了使用后入路的pop动脉内膜切除术和补片成形术。回顾性检查了14例因孤立性the动脉闭塞而接受手术的患者。根据年龄对患者进行评估,性别,和风险因素,如伴随疾病和吸烟,手术方法和麻醉,切口类型,术前、术后脉搏检查,踝臂指数,通畅,伤口感染,术后并发症,和应用的治疗。12例(85.7%)患者为男性,2名(14.3%)为女性。11例(78.5%)患者肢体缺血严重(ABI<0.7)。术后平均住院时间为8±3.7天,平均随访时间17±3.4个月。术后早期没有发生需要二次干预的血栓和并发症。虽然随访的前6个月的通畅率为100%,第一年为92.8%,第二年为85.7%。在孤立的pop动脉病变中,后路手术治疗是血管外科医生首选的优先治疗方法。具有足够的再通率和低的围手术期发病率和死亡率。此外,它是有希望的,因为它不能防止膝下股动脉旁路,这是治疗的后续阶段。此外,大隐静脉受到保护,可接受的早期和中期结果令人鼓舞。
    Isolated popliteal artery occlusions are rare compared with femoropopliteal occlusive diseases. Although endovascular procedures have gained importance in treatment, conventional surgery remains the gold standard. In this study, we reviewed popliteal endarterectomy and patch plasty using a posterior approach. Fourteen patients who underwent surgery for isolated popliteal artery occlusions were retrospectively examined. Patients were assessed in terms of age, sex, and risk factors, such as accompanying diseases and smoking, surgical method and anesthesia, incision type, preoperative and postoperative pulse examination, ankle-brachial indices, patency, wound infection, postoperative complications, and the treatment applied. Twelve (85.7%) patients were male, and 2 (14.3%) were female. Limb ischemia was critical (ABI < 0.7) in 11 (78.5%) patients. The average duration of postoperative hospitalization was 8 ± 3.7 days on average, and the average length of follow-up was 17 ± 3.4 months. Thrombosis and complications requiring secondary intervention did not develop during the early postoperative period. While the patency rate in the first 6 months of follow-up was 100%, it was 92.8% in the 1st year and 85.7% in the 2nd year. Surgical treatment with the posterior approach in isolated popliteal artery lesions is preferred by vascular surgeons as a prioritized treatment method, with a sufficient recanalization rate and low perioperative morbidity and mortality rates. Furthermore, it is promising because it does not prevent below-knee femoropopliteal bypass, which is the subsequent stage of treatment. Moreover, the great saphenous vein was protected, and the acceptable early- and mid-term results were encouraging.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    目的:动静脉内瘘(AVF)结构是用于血液透析的重要结构。糖尿病(DM)是影响血管系统的危重疾病。甘油三酯葡萄糖(TyG)指数已被证明与2型DM患者的主要不良心血管事件有关。在这项研究中,我们旨在探讨TyG指数对糖尿病患者原发性AVF通畅性的影响.
    方法:在2018年3月至2023年3月之间,回顾性研究了因终末期肾脏疾病在我们诊所接受AVF手术的DM患者。可以接受血液透析的患者被确定为第1组,不能接受血液透析的患者被确定为第2组。
    结果:共189名患者纳入研究。未发生AVF原发性衰竭的患者被纳入第1组[n=138,中位年龄=59(22-77)岁],和那些包括在第2组[n=51,中位年龄=63(20-81)岁].在多变量分析中,年龄>70岁(OR:0.871,95%CI:0.594-0.983,p=0.039),PAD的存在(OR:0.582,95%CI:0.0.458-0.896,p=0.046),和TyG指数(OR:0.879,95%CI:0.591-0.916,p<0.001)被确定为原发性AVF失败的独立预测因子。
    结论:这项研究表明,TyG指数值,根据糖尿病(DM)血液透析患者入院时采集的血液样本计算,是AVF手术后原发性AVF失败的独立预测因子。
    OBJECTIVE: Arteriovenous fistula (AVF) structures are vital formations used for hemodialysis. Diabetes mellitus (DM) is a critical disease affecting the vascular system. The triglyceride glucose (TyG) index has been shown to be associated with major adverse cardiovascular events in patients with Type 2 DM. In this study, we aimed to investigate the effect of the TyG index on the primary AVF patency of diabetic patients.
    METHODS: Between March 2018 and March 2023, patients with DM who underwent AVF surgery in our clinic due to end-stage renal disease were retrospectively included in this study. The patients who could receive hemodialysis were determined as Group 1, and those who could not were determined as Group 2.
    RESULTS: A total of 189 patients were included in the study. Those who did not develop AVF primary failure were included in Group 1 [n=138, median age = 59 (22-77) years], and those who did were included in Group 2 [n=51, median age = 63 (20-81) years]. In the multivariate analysis, age >70 years (OR: 0.871, 95% CI: 0.594-0.983, p=0.039), the presence of PAD (OR: 0.582, 95% CI: 0.0.458-0.896, p=0.046), and TyG index (OR: 0.879, 95% CI: 0.591-0.916, p<0.001) were determined as independent predictors for primary AVF failure.
    CONCLUSIONS: This study demonstrated that the TyG index value, calculated from blood samples taken at the time of hospital admission in hemodialysis patients with diabetes mellitus (DM), is an independent predictor of primary AVF failure following AVF surgery.
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  • 文章类型: Clinical Trial Protocol
    背景:血管内治疗已成为大多数动脉区域的一线治疗。然而,开放血管手术(动脉内膜切除术)仍然是股总动脉(CFA)病变的首选治疗方法。这项研究的目的是研究定向斑块切除术加药物涂层球囊(DCB)与动脉内膜切除术治疗新生动脉硬化性CFA病变的急性和中期结果。
    方法:这种前瞻性,随机化,多中心非劣效性研究将纳入306名患有CFA(卢瑟福1-5类)从头狭窄(包括分叉)的参与者。符合两个治疗组条件的患者可以包括在这个1:1随机试验中。主要疗效终点是在12个月时靶病变的通畅性,定义为再狭窄<50%,而不需要临床驱动的靶病变血运重建(cdTLR)。主要安全终点是包括死亡在内的联合终点,心肌梗塞,目标肢体的主要或次要截肢,和围手术期并发症在30天。次要终点包括6个月和24个月时靶病变的原发通畅,二级通畅,cdTLR6、12和24个月,踝臂指数改变,卢瑟福-贝克尔在6、12和24个月上课。肢体抢救,用步行障碍问卷衡量的生活质量变化,以及包括死亡在内的主要不良事件,心肌梗塞,目标肢体的轻微或严重截肢将在6、12、24和36个月时确定。
    结论:CFA病变的血管内治疗仍存在争议。迄今为止,很少有研究将现代血管内治疗方法与所谓的金标准外科动脉内膜切除术进行比较。根据最近的积极结果,本研究旨在确认与外科治疗相比,“不留任何痕迹”的血管内途径联合定向斑块切除术和DCB的非劣效性.
    背景:ClinicalTrials.govNCT02517827。
    BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions.
    METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months.
    CONCLUSIONS: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a \"leaving nothing behind\" endovascular approach combining directional atherectomy and DCB compared to surgical therapy.
    BACKGROUND: ClinicalTrials.gov NCT02517827.
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  • 文章类型: Journal Article
    背景:西罗莫司涂层球囊(SCB)用于治疗股pop(FP)病变尚未得到系统研究,但早期研究的初步结果是有希望的.
    目的:作者试图评估SELUTIONSLRSCB的安全性和有效性,由专有的微储层技术结合西罗莫司和生物可降解聚合物组成,当用于治疗日本人群的轻度至中度FP疾病时。
    方法:这个多中心,prospective,单臂研究(SELUTIONSFAJAPAN)纳入134例FP病患者。由成像核心实验室和临床事件委员会独立裁定。主要终点是12个月的主要通畅,通过双工超声定义为收缩期峰值速度比≥2.5,并根据已建立的血管成形术数据与预定的60%的性能目标进行比较。
    结果:平均年龄为73.8±6.9岁,60.3%的患者患有糖尿病。平均病变长度为127.4±59.7mm,17.2%为慢性完全闭塞,47.8%累及the动脉。127例患者(94.8%)获得了12个月再狭窄的数据。12个月的原发性通畅率为87.9%,根据Kaplan-Meier估计,临床驱动的靶病变血运重建(CD-TLR)的发生率为97.0%.主要不良事件发生率为6.7%,由4张CD-TLRs和5人死亡驱动,其中没有一个与设备或程序有关。踝臂指数数据从基线时的0.73±0.16显着改善至术后30天的0.96±0.14,并持续了12个月(0.94±0.13)。
    结论:日本SELUTIONSFA试验表明,新型SELUTIONSCB是有症状的FP疾病患者的安全有效治疗选择。
    BACKGROUND: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising.
    OBJECTIVE: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population.
    METHODS: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data.
    RESULTS: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13).
    CONCLUSIONS: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.
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  • 文章类型: Journal Article
    评估支架移植物(SGs)在血液透析(HD)患者动静脉(AV)介入治疗中心静脉阻塞疾病(CVOD)中的疗效。并确定影响SG治疗结果的预测因素。纳入2018年8月至2022年6月在我们中心接受SGs安置的患有CVOD的HD受试者。使用Kaplan-Meier方法和对数秩检验进行生存曲线分析。采用Cox比例风险回归分析来确定与结果相关的预测因素。总共分析了59例用于CVOD的SG植入手术,其中狭窄30例,闭塞29例。SG放置后6、12和24个月的接入电路主要通畅率(ACPP)为80.9%,53.8%,和31.4%,分别,while,靶病变原发通畅率(TLPP)为91.3%,67.6%,和44.5%,分别。亚组分析显示,狭窄组的TLPP高于闭塞组,虽然差异无统计学意义(P=0.165)。在先前有球囊扩张的患者中,通过SG放置,TLPP显着改善(P<0.001)。Cox比例风险回归将靶病变长度≥30mm和手术缺陷确定为HD患者SG治疗CVOD后TLPP降低的独立预测因子。SG放置证明了在HD患者中管理CVOD的安全性和有效性,改善CVOD血管内治疗(EVT)的TLPP。值得注意的是,长目标病灶(≥30mm)和手术缺陷是影响TLPP的预测因素。
    To assess the efficacy of stent grafts (SGs) in managing central venous obstruction disease (CVOD) in hemodialysis (HD) patients with arteriovenous (AV) access, and to identify predictive factors influencing the SG treatment outcomes. HD subjects with CVOD who underwent SGs placement at our center between August 2018 and June 2022 were enrolled. Survival curve analysis using the Kaplan-Meier method and log-rank test was performed. Cox proportional hazards regression analysis was employed to identify predictive factors associated with outcomes. A total of 59 SG implantation procedures for CVOD were analyzed, comprising 30 cases of stenosis and 29 cases of occlusion. The access circuit primary patency (ACPP) at 6, 12, and 24 months post-SG placement were 80.9%, 53.8%, and 31.4%, respectively, while, the target lesion primary patency (TLPP) were 91.3%, 67.6%, and 44.5%, respectively. Subgroup analysis revealed higher TLPP in the stenosis group compared to the occlusion group, although the difference was not statistically significant (P = 0.165). The TLPP was significantly improved by SG placement in those who had antecedent balloon dilations (P < 0.001). Cox proportional hazards regression identified target lesion length ≥ 30 mm and procedure defects as independent predictors of lower TLPP after SG treatment for CVOD in HD patients. SG placement demonstrates safety and efficacy in managing CVOD among HD patients, leading to improved TLPP of endovascular therapy (EVT) for CVOD. Notably, long target lesions (≥ 30 mm) and procedure defects emerged as predictive factors influencing TLPP.
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