vascular grafting

血管移植
  • 文章类型: Journal Article
    研究揭示了起源的变化,number,和旋股外侧动脉(LCFA)的分支模式。本研究旨在记录这些变化及其潜在的临床适用性。解剖了16具经过防腐处理的成年人尸体的32个股骨三角形,以研究起源的变化,number,和LCFA的分枝模式。独立跟踪LCFA的主要分支,以了解分支模式的数值变化。在每种情况下还测量了LCFA的起点与腹股沟中点(MIP)之间的距离。LCFA最常见于股骨深部(PF),其次是股动脉(FA)和股动脉共同干(CFA)。在15(46.87%)肢体中观察到复制LCFA,在5例(31.25%)中,重复仅在右侧,在4例(25%)中,重复仅在左侧,在3例(18.75%)中,重复是双边的。LCFA重复的案件,显示出数值变化,下降模式是最常见的。LCFA1和LCFA2距腹股沟中点的平均距离分别为5.77±1.35cm和6.14±2.05cm。关于重复发生的详细信息对于外科医生来说非常重要,介入放射科医生,和其他医疗专业人员在股骨区域执行手术。了解LCFA分支模式的变化至关重要,因为外科医生在旁路移植术和血管重建手术中使用LCFA的下降分支。
    Studies reveal variations in the in the origin, number, and branching patterns of the lateral circumflex femoral artery (LCFA). The present study aimed to document such variations and their potential clinical applicability. Thirty-two femoral triangles of 16 embalmed adult human cadavers were dissected to investigate the variation in the origin, number, and branching patterns of LCFA. The main branches of the LCFA were tracked independently for numerical variations in branching pattern. The distance between the origin of LCFA and mid inguinal point (MIP) was also measured in each case. LCFA was most commonly arising from profunda femoris (PF), followed by femoral artery (FA) and common trunk of the femoral artery (CFA). Duplication LCFA was observed in 15 (46.87%) limbs, in 5 (31.25%) cases duplication was only on right side, in 4 (25%) cases duplication was only on left side and in 3 (18.75%), duplication was bilateral. Cases with duplication of LCFA, showed numerical variations with descending pattern being the most common. The average distance of LCFA1 and LCFA2 from mid-inguinal point was 5.77±1.35 cm and 6.14±2.05 cm respectively. Detailed information regarding the occurrence of duplication will be great importance for surgeons, interventional radiologists, and other medical professionals performing procedures in the femoral region. Knowledge of variation of branching pattern of LCFA is utmost important as surgeons use the descending branch of the LCFA in bypass grafting and vascular reconstruction surgeries.
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  • 文章类型: Journal Article
    目的:血运重建治疗慢性威胁肢体缺血(CLTI)后的心血管并发症是指导治疗的主要关注点。我们的目标是在CLTI患者的最佳血管内治疗与最佳外科治疗(BEST-CLI)试验中评估围手术期心脏和血管严重不良事件(SAE)。
    方法:BEST-CLI是一项前瞻性随机试验,比较了CLTI患者的手术(OPEN)和血管内(ENDO)血运重建。30天SAE,分类为心脏或血管,进行了分析。不良事件在试验中影响安全性时被定义为严重事件,需要长期住院,导致严重的残疾或失能,危及生命,或导致死亡。以每个方案的方式分析干预。
    结果:在BEST-CLI试验中,评估了850个OPEN和896个ENDO干预措施。40例(4.7%)和34例(3.8%)患者在OPEN和ENDO干预后至少经历了一次心脏SAE,分别(P=.35)。总体而言,OPEN后有53例心脏SAE(每位患者.06例),ENDO干预后有40例(每位患者.045例)。OPEN组的心脏SAE被分类为与缺血相关(50.9%),心律失常(17%),心力衰竭(15.1%),逮捕(13.2%),和心脏传导阻滞(3.8%);在ENDO组中,它们被分类为缺血(47.5%),心力衰竭(17.5%),心律失常(15%),逮捕(15%)和心脏传导阻滞(5%)。大约一半的SAE被归类为严重的OPEN和ENDO。SAE肯定或可能与OPEN和ENDO臂中的30.2%和25%的手术有关,分别为(P=2)。OPEN和ENDO血运重建后58例(6.8%)和86例(9.6%)患者发生血管SAE,分别(P=.19)。总的来说,OPEN和ENDO手术后有59例(每位患者.07例)和87例(每位患者.097例)血管SAE.OPEN组的血管SAE分为远端缺血/感染(44.1%),出血(16.9%),闭塞(15.3%),血栓栓塞(15.3%),脑血管(5.1%),和其他(3.4%);在ENDO臂中,他们是远端缺血/感染(40.2%),闭塞(31%),出血(12.6%),血栓栓塞(8%),脑血管(1.1%),和其他(4.6%)。SAE被分类为严重的OPEN占45.8%,ENDO占46%。SAE肯定或可能与OPEN和ENDO臂中的23.7%和35.6%的手术相关(P=.35),分别。
    结论:接受OPEN和ENDO血运重建的患者经历了相似程度的心脏和血管SAE。大多数与指数干预无关,但大约一半是严重的。
    OBJECTIVE: Cardiovascular complications after revascularization to treat chronic limb-threatening ischemia (CLTI) are a major concern that guides treatment. Our goal was to assess periprocedural cardiac and vascular serious adverse events (SAEs) in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.
    METHODS: BEST-CLI was a prospective randomized trial comparing surgical (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAEs, classified as cardiac or vascular, were analyzed. Adverse events are defined as serious when they affect safety in the trial, require prolonged hospitalization, result in significant disability or incapacitation, are life-threatening, or result in death. Interventions were analyzed in a per protocol fashion.
    RESULTS: In the BEST-CLI trial, 850 OPEN and 896 ENDO interventions were evaluated. Forty (4.7%) and 34 (3.8%) patients experienced at least one cardiac SAE after OPEN and ENDO intervention, respectively (P = .35). Overall, there were 53 cardiac SAEs (0.06 per patient) after OPEN and 40 (0.045 per patient) after ENDO interventions. Cardiac SAEs in the OPEN arm were classified as related to ischemia (50.9%), arrhythmias (17%), heart failure (15.1%), arrest (13.2%), and heart block (3.8%); in the ENDO arm, they were classified as ischemia (47.5%), heart failure (17.5%), arrhythmias (15%), arrest (15%), and heart block (5%). Approximately half of SAEs were classified as severe for both OPEN and ENDO. SAEs were definitely or probably related to the procedure in 30.2% and 25% in the OPEN and ENDO arms, respectively (P = .2). Vascular SAEs occurred in 58 (6.8%) and 86 (9.6%) of patients after OPEN and ENDO revascularization, respectively (P = .19). In total, there were 59 (0.07 per patient) and 87 (0.097 per patient) vascular SAEs after OPEN and ENDO procedures. Vascular SAEs in the OPEN arm were classified as distal ischemia/infection (44.1%), bleeding (16.9%), occlusive (15.3%), thromboembolic (15.3%), cerebrovascular (5.1%), and other (3.4%); in the ENDO arm, they were distal ischemia/infection (40.2%), occlusive (31%), bleeding (12.6%), thromboembolic (8%), cerebrovascular (1.1%), and other (4.6%). SAEs were classified as severe for OPEN in 45.8% and ENDO in 46%. SAEs were definitely or probably related to the procedure in 23.7% and 35.6% in the OPEN and ENDO arms (P = .35), respectively.
    CONCLUSIONS: Patients undergoing OPEN and ENDO revascularization experienced similar degrees of cardiac and vascular SAEs. The majority were not related to the index intervention, but approximately half were severe.
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  • 文章类型: Journal Article
    慢性威胁肢体缺血患者的最佳血管内治疗与最佳手术治疗试验是一项具有里程碑意义的试验,为慢性威胁肢体缺血的治疗决策提供了高质量的数据。总的来说,该试验表明,在有足够大隐静脉导管的患者中,考虑到优越的结局,旁路手术应作为一线治疗.在这篇文章中,我们概述了对审判的常见批评,随后是回答,以更深入地了解这项重要试验的优势和局限性.
    The Best Endovascular Versus Best Surgical Therapy in Patients With Chronic Limb-Threatening Ischemia trial was a landmark trial which provides high-quality data for the decision-making regarding the treatment of chronic-limb threatening ischemia. Overall, the trial suggests that in patients with adequate greater saphenous vein conduit, bypass surgery should be offered as a first line treatment given superior outcomes. In this article, we outline the common critiques of the trial, followed by responses to provide a deeper understanding of the strengths and limitations of this important trial.
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  • 文章类型: Journal Article
    研究目的是回顾手术方法,并评估头颈部恶性肿瘤伴颈内动脉侵犯的结果。原发性肿瘤的解剖部位各不相同,包括右扁桃体隐匿性口内癌的固定大量转移性颈部疾病,喉切除术后复发的转移性颈部肿瘤,声门原发癌和原发不明的转移性恶性黑色素瘤。在所有情况下,颈动脉均受到侵犯,因此被切除。在颈总动脉(CCA)和颈内动脉(ICA)之间进行扩展的Javid分流,然后进行CCA移植和插入的隐静脉移植。在一种情况下,迷走神经也被插入腓肠移植物移植。患者总数为3人。通过临床检查,后续和双面扫描,颈动脉移植物的通畅,血管和非血管并发症,分析了疾病复发和生存率。此外,复发有双重异时重建,给研究移植物的采用和对疾病的反应的机会。颈内动脉侵犯预示预后不良。结果表明,颈动脉切除后再进行适当的重建可为治愈或提供合理的缓解。
    The study purpose is to review the surgical approach and evaluate the results in cases of head and neck malignancies with internal carotid artery invasion. The anatomical site of the primary tumor varied including a fixed massive metastatic neck disease of an occult intraoral carcinoma of the right tonsil, a recurrent metastatic neck tumor after laryngectomy for glottic primary carcinoma and a metastatic malignant melanoma of an unknown primary origin. In all cases carotid artery was invaded and therefore resected. An extended Javid shunt was performed between common carotid artery (CCA) and internal carotid artery (ICA) followed by CCA grafting with an interposition saphenous vein graft. In one case the vagus nerve was also grafted with an interposition sural graft. The total patient number was three. By clinical examination, follow-up and duplex scanning, the patency of the carotid grafts, vascular and non-vascular complications, disease recurrence and survival were analysed. Additionally, there was a double metachronous reconstruction for recurrence, giving the opportunity to study the graft adoption and response to disease. Internal carotid artery invasion portends a poor prognosis. The results show that carotid artery resection followed by the appropriate reconstruction yields a chance for cure or can provide reasonable palliation.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    生物管是通过体内组织结构在患者体内形成的自体管状组织,它们显示出早期临床应用作为血管置换的巨大潜力。在这项试点研究中,我们使用大型动物进行植入实验,为Biotube的临床前测试做准备。组织学评估Biotube植入后的生物学反应。设计的生物管(长度:50厘米,内径:4毫米,和壁厚:0.85mm)是通过将模具嵌入六只山羊的背部并持续预定时间(1-5个月)而获得的。相同的山羊使用Biotube(平均长度:12厘米)在颈动脉上进行了旁路手术。植入后,超声心动图用于定期监测通畅性和血流速度。最长观察期为6个月,并在去除移植物后进行组织分析,包括吻合.所有霉菌产生的生物管超过正常山羊颈动脉的拉伸强度,并植入了8个随机选择的生物管。如果抗凝治疗不足,术后立即发生血栓闭塞(1管),还有两根管子,Biotube强度不足(<5N),一周内就破裂了.5根管维持通畅>2个月,未形成动脉瘤。当Biotubes具有较宽的强度分布时,远离吻合口的斑点在3个月内变得狭窄(3管),但其余两个管的形状保持不变6个月。旁路区域的整个长度都被αSMA阳性细胞层围住,2个月时,内皮细胞层覆盖了大部分管腔。植入后3个月获得腔表面的完整内皮铺设,形成了类似于天然血管的血管壁结构,即使在6个月时也保持不变。狭窄是由管腔表面的纤维蛋白粘附引起的,修复巨噬细胞的迁移,和由于αSMA阳性成纤维细胞的过度增殖而形成的肉芽。我们揭示了同质生物管的重要性,证明抗拉强度>5N,并在适当的抗血栓条件下植入,以实现Biotube的长期开放。Further,我们阐明了Biotube的再生过程和狭窄的机制。最后,我们获得了短期内计划的验证性植入研究的必要条件.
    Biotubes are autologous tubular tissues developed within a patient\'s body through in-body tissue architecture, and they demonstrate high potential for early clinical application as a vascular replacement. In this pilot study, we used large animals to perform implantation experiments in preparation for preclinical testing of Biotube. The biological response after Biotube implantation was histologically evaluated. The designed Biotubes (length: 50 cm, internal diameter: 4 mm, and wall thickness: 0.85 mm) were obtained by embedding molds on the backs of six goats for a predetermined period (1-5 months). The same goats underwent bypass surgery on the carotid arteries using Biotubes (average length: 12 cm). After implantation, echocardiography was used to periodically monitor patency and blood flow velocity. The maximum observation period was 6 months, and tissue analysis was conducted after graft removal, including the anastomosis. All molds generated Biotubes that exceeded the tensile strength of normal goat carotid arteries, and eight randomly selected Biotubes were implanted. Thrombotic occlusion occurred immediately postoperatively (1 tube) if anticoagulation was insufficient, and two tubes, with insufficient Biotube strength (<5 N), were ruptured within a week. Five tubes maintained patency for >2 months without aneurysm formation. The spots far from the anastomosis became stenosed within 3 months (3 tubes) when Biotubes had a wide intensity distribution, but the shape of the remaining two tubes remained unchanged for 6 months. The entire length of the bypass region was walled with an αSMA-positive cell layer, and an endothelial cell layer covered most of the lumen at 2 months. Complete endothelial laying of the luminal surface was obtained at 3 months after implantation, and a vascular wall structure similar to that of native blood vessels was formed, which was maintained even at 6 months. The stenosis was indicated to be caused by fibrin adhesion on the luminal surface, migration of repair macrophages, and granulation formation due to the overproliferation of αSMA-positive fibroblasts. We revealed the importance of Biotubes that are homogeneous, demonstrate a tensile strength > 5 N, and are implanted under appropriate antithrombotic conditions to achieve long-term patency of Biotube. Further, we clarified the Biotube regeneration process and the mechanism of stenosis. Finally, we obtained the necessary conditions for a confirmatory implant study planned shortly.
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  • 文章类型: Journal Article
    目的:当没有足够的大隐静脉时,可以使用替代自体静脉作为导管。我们在实践中采用上肢静脉后,分析了腹股沟下旁路的结果。
    方法:这是一项单中心观察性研究,涉及所有在2019年4月之间使用上肢静脉的患者,2023年2月。
    结果:在研究期间,48例患者进行了49次旁路手术;平均年龄68.1±9.8;男性32(66.7%);体重指数28.0±4.8;手术适应症:慢性威胁肢体缺血41(83.7%);急性肢体缺血3(6.1%);以前的假体3(6.1%)或自体2(4.1%)旁路移植的并发症。静脉剪接用于43(87.8%)旁路,其中3段移植物最常见(26;53.1%)。股骨胫骨24例(49.0%),11(22.4%)股—————————————————————————————————————————————————————————————————————————————————————9(18.4%)股骨踏板,和5(10.2%)扩展跳转旁路程序。18例(36.7%)手术是重新手术。仅使用臂静脉形成21个(42.9%)旁路。中位随访时间为12.9个月(4.5-24.2)。在术后前30天阻塞了两个旁路(2/49;4.1%)。总体30天,1年,2年,原发通畅率为93.7%±3.5%;84.8%±5.9%;80.6%±6.9%,二次通畅率(SP)为95.8%±2.9%;89.2%±5.3%;89.2%±5.3%。1段移植物的通畅性比2-更好,3-,和4段移植物(1年SP100%±0%vs87.6%±6.0%)。2年无截肢生存率为86.8%±6.5%;2年总生存率为88.2%±6.6%。
    结论:臂静脉移植物在腹股沟下旁路手术中的整合可以安全地完成,围手术期移植物失败的发生率低。单段移植物比拼接静脉移植物具有更好的通畅性。获得的早期通畅性和无截肢生存率强烈鼓励其使用。在没有单段大隐静脉的情况下,上肢静脉移植物应该是首选的导管选择。
    BACKGROUND: Alternative autologous veins can be used as a conduit when adequate great saphenous vein is unavailable. We analyzed the results of our infrainguinal bypasses after adopting upper extremity veins in our practice.
    METHODS: This is a single-center observational study involving all patients whose infrainguinal bypass involved the use of upper extremity veins between April 2019, when we began using arm veins, and February 2023.
    RESULTS: During the study period, 49 bypasses were done in 48 patients; mean age 68.1 ± 9.8; men 32 (66.7%); body mass index 28.0 ± 4.8; indications for surgery: chronic limb threatening ischemia 41 (83.7%); acute limb ischemia 3 (6.1%); complications of previous prosthetic 3 (6.1%), or autologous 2 (4.1%) bypass grafts. Vein splicing was used in 43 (87.8%) bypasses with 3-segment grafts being the most common (26; 53.1%). There were 24 (49.0%) femorotibial, 11 (22.4%) femoropopliteal, 9 (18.4%) femoropedal, and 5 (10.2%) extension jump bypass procedures. Eighteen (36.7%) operations were redo surgeries. Twenty-one (42.9%) bypasses were formed using only arm veins. The median follow-up was 12.9 months (4.5-24.2). Two bypasses occluded during the first 30 postoperative days (2/49; 4.1%). Overall 30-day, 1-year, and 2-year primary patency rates were 93.7% ± 3.5%, 84.8% ± 5.9%, and 80.6% ± 6.9%, and secondary patency (SP) rates were 95.8% ± 2.9%, 89.2% ± 5.3%, and 89.2% ± 5.3%. One-segment grafts had better patencies than 2-, 3-, and 4-segment grafts (1-year SP 100% ± 0% vs 87.6% ± 6.0%). Two-year amputation-free survival was 86.8% ± 6.5%; 2-year overall survival was 88.2% ± 6.6%.
    CONCLUSIONS: Integration of arm vein grafts in infrainguinal bypass practice can be done safely with low incidences of perioperative graft failure. One-segment grafts had better patencies than spliced vein grafts. The achieved early patency and amputation-free survival rates strongly encourage their use. In the absence of a single-segment great saphenous vein, upper extremity vein grafts should be the preferred conduit choice.
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  • 文章类型: Journal Article
    目的:接受CLTI血管重建术的患者经历了目标肢体再干预的高负担。我们分析了BEST-CLI随机试验的数据,比较了初始开放旁路(OPEN)和血管内(ENDO)治疗策略,重点关注与再干预相关的研究终点。
    方法:在计划的二次分析中,我们检查了重大再干预的比率,任何重新干预,以及任何重新干预的综合,在两个试验队列中,通过意向治疗(ITT)分配进行截肢或死亡(RAD)(具有合适的单段大隐静脉[SSGSV]的队列1,N=1434;队列2缺乏合适的SSGSV,N=396)。我们还比较了一段时间内主要和所有指标肢体再干预的累积次数。使用单变量和多变量Cox回归模型对每个队列中的治疗组进行比较。
    结果:在队列1中,分配到OPEN与重大肢体再干预的风险显着降低相关(HR[95%CI]:0.37[0.28,0.49],p<0.001),任何重新干预(HR:0.63[0.53,0.75],p<.001),或RAD(HR:0.68[0.60-0.78],p<.001)。在队列2中,主要再干预的结果相似(HR:0.53[0.33,0.84],p=.007)或任何重新干预(HR:0.71[0.52,0.98],p=.04)。在这两个队列中,与OPEN相比,ENDO组患者的早期(30天)肢体再干预明显较高(14.7%vs4.5%;队列2组16.6%vs5.6%).平均主要事件数(每个受试者的平均事件比率(MR)0.45[95%CI:0.34,0.58],p<0.001)或任何目标肢体再干预(MR0.67[0.57,0.80],p<0.001)每年在队列1的OPEN组中显著较低。在队列1的OPEN组中,每年每个保肢的平均再干预次数较低(MR0.45[0.35,0.57],p<.001和MR0.66[0.55,0.79],主要和所有的p<.001,分别)。大多数指数肢体再干预发生在随机化后的第一年,但事件在试验随访期间持续累积.
    结论:在CLTI的血运重建后,再干预是常见的。在被认为适合两种方法的患者中,开放旁路的初始治疗,特别是在有可用SSGSV导管的患者中,与主要和次要目标肢体再干预的数量显着减少相关。
    OBJECTIVE: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints.
    METHODS: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models.
    RESULTS: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial.
    CONCLUSIONS: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    UNASSIGNED:动静脉移植物植入过程中使用的传统缝合静脉吻合术与归因于新内膜增生的随后狭窄的高发生率相关。增生是由多种因素导致的,包括植入过程中的血流动力学异常和血管损伤。设计了一种新颖的吻合连接器装置,以提供一种替代方法。创伤较小,血管内静脉吻合术可以改善与缝合吻合术相关的临床挑战。进行了一项前瞻性单臂多中心研究,以评估使用研究设备进行移植物植入的安全性和有效性。
    UNASSIGNED:在2018年2月至2021年7月之间招募了需要移植且符合研究标准的患者,并观察了6个月。收集的数据包括基线特征,移植物通畅和用于血液透析,移植干预措施,和不良事件。主要研究终点是累积移植物通畅,与预先指定的75%的绩效目标相比。次要终点包括原发性无辅助通畅性和严重不良事件,定义为死亡的发生,移植物感染,紧急手术,大量出血,和假性动脉瘤.
    未经评估:共有来自10个研究中心的158名患者入选,其中144名受试者在6个月时可评估,14名受试者通过部分随访观察被审查.三名患者死亡,移植物在12年被放弃。达到主要终点(p值<0.001)。通过KaplanMeier生存分析,累积通畅率为92.08%,95%置信度较低,为86.98%。原发性无辅助通畅率为60.21%,95%置信度较低,为50.84%。6例患者发生移植物感染,都与研究设备无关。没有紧急手术的报告,大量出血或假性动脉瘤。
    UNASSIGNED:这些结果表明,该研究设备可用于成功进行血液透析的静脉血管内吻合。在6个月时具有可接受的累积通畅性和安全性。
    UNASSIGNED:ClinicalTrials.gov标识符:NCT02532621。
    UNASSIGNED: The traditional sutured venous anastomosis used during arteriovenous graft implantation is associated with a high incidence of subsequent stenosis that is attributed to neointimal hyperplasia. Hyperplasia results from multiple factors, including hemodynamic abnormalities and vessel trauma during implantation. A novel anastomotic connector device was designed to provide an alternative, less traumatic, endovascular venous anastomosis that may ameliorate the clinical challenges associated with a sutured anastomosis. A prospective single-arm multicenter study was performed to evaluate safety and effectiveness of graft implantation using the study device.
    UNASSIGNED: Patients requiring graft creation and who met the study criteria were enrolled between February 2018 and July 2021 and observed for 6 months. Collected data included baseline characteristics, graft patency and use for hemodialysis, graft interventions, and adverse events. The primary study endpoint was cumulative graft patency, compared to a pre-specified Performance Goal of 75%. Secondary endpoints included primary unassisted patency and serious adverse events, defined as the occurrence of death, graft infection, emergent surgery, significant bleeding, and pseudoaneurysm.
    UNASSIGNED: A total of 158 patients were enrolled from 10 study sites, among which 144 subjects were evaluable at 6 months and 14 were censored with partial follow-up observation. Three patients died and the graft was abandoned in 12. The primary endpoint was met (p-value < 0.001). By Kaplan Meier survival analysis, cumulative patency was 92.08% with a lower 95% Confidence Bound of 86.98%. Primary unassisted patency was 60.21% with a lower 95% Confidence Bound of 50.84%. Graft infections occurred in six patients, all unrelated to the study device. There were no reports of emergent surgery, significant bleeding or pseudoaneurysm.
    UNASSIGNED: These results demonstrate that the study device can be used for successful endovascular anastomosis of a vein to a graft for hemodialysis, with acceptable cumulative patency and safety profile at 6 months.
    UNASSIGNED: ClinicalTrials.gov Identifier: NCT02532621.
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