Paclitaxel coated balloon versus conventional balloon angioplasty in dysfunctional dialysis arteriovenous fistula: a systematic review and meta-analysis of randomized controlled trials

PurposeTo compare the efficacy and safety between paclitaxel coated balloon (PCB) angioplasty and conventional balloon (CB) angioplasty in the treatment of dysfunctional arteriovenous fistula (AVF).MethodsWe searched four major electronic databases (PubMed, EMBASE, Web of Science and the Cochrane Library) for randomized controlled trials (RCTs) published from inception through November 28, 2021. Outcomes of interest included target lesion primary patency (TLPP), technical success and all-cause mortality. The STATA package version 15.1 was utilized to undertake meta-analyses.ResultsFourteen RCTs totaling 1535 patients were analyzed. The available data showed that there were no significant differences of TLPP rates at 3, 6, 9 and 12 months between the PCB group and the CB group (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93–1.07, p = 1.000, I² = 33.5%, Cochrane Q test p = 0.185, fixed-effect model; RR 1.17, 95% CI 0.99–1.39, p = 0.065, I² = 75.4%, Cochrane Q test p = 0.000, random-effect model; RR 0.81, 95% CI 0.35–1.89, p = 0.625, I² = 62.8%, Cochrane Q test p = 0.045, random-effect model; RR 1.19, 95% CI 0.97–1.47, p = 0.096, I² = 40.5%, Cochrane Q test p = 0.071, random-effect model). In addition, two groups had similar technical success rates (RR 1.00, 95% CI 0.97–1.03, p = 1.000, I² = 0.0%, Cochrane Q test p = 0.596, fixed-effect model) and all-cause mortality rates (RR 1.00, 95% CI 0.54–1.84, p = 1.000, I² = 0.0%, Cochrane Q test p = 0.599, fixed-effect model).ConclusionsPCB angioplasty did not appear to convey any obvious advantage over CB angioplasty in the treatment of dysfunctional AVF. However, further multi-center, large-scale and well-designed RCTs are needed to prove outcomes.     

A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts

ObjectivePaclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts.MethodsIn this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year.ResultsAt 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted.ConclusionsAngioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.     

超声引导下腔内血管成形术治疗动静脉内瘘狭窄早期疗效评估

目的探讨超声引导下腔内血管成形术在治疗血液透析动静脉内瘘(AVF)狭窄的早期疗效。方法回顾性分析接受超声引导下经皮腔内血管成形术(PTA)治疗的24例前臂AVF狭窄的透析患者的临床资料,比较术前及术后即刻狭窄处内径,对通畅率采用Kaplan-Meier生存分析。结果 24例患者均获得技术成功,成功率为100%(24/24)。无穿刺部位假性动脉瘤及皮下血肿等并发症发生,除1例术后AVF血栓形成,围术期无患者死亡。术后随访3、6、9、12个月的初级通畅率分别为87.50%(21/24)、83.33%(20/24)、79.17%(19/24)、58.33%(14/24)。结论超声引导下PTA治疗AVF狭窄性病变微创、安全,是AVF狭窄性病变的合理治疗方法,近期效果明显。     

Spinal dural arteriovenous fistulas: a plea for neurosurgical treatment

Summary Spinal dural arteriovenous fistulas are the most common type of arteriovenous malformation involving the spinal cord, especially in middle-aged men. We report 21 patients with this malformation who had signs and symptoms of myelopathy. The diagnosis was established by selective spinal angiography in patients whose neurological deficits, myelograms or magnetic resonance tomographies suggested the presence of a spinal arteriovenous fistula. They were treated by microsurgical coagulation of the fistula nidus located in the dura and intradural division of the draining vein. Twenty patients improved neurologically following surgery, one remained unchanged. Complete obliteration of all lesions was verified by intra-operative microvascular Doppler sonography and in 3 cases by postoperative angiography. There were only a few minor and transient complications after surgery: one neurological deterioration where venous thrombosis was suspected, one cerebrospinal fluid accumulation and, in one case a transient wound healing impairment. Two patients had to be operated on again. In one case with difficult localization of a fistula at the L5/S1 level, the fistula was still visible in the postoperative angiogram. In another patient, a spinal epidural haematoma occurred a few hours after surgery. We conclude that microsurgical treatment of spinal dural arteriovenous fistulas is a safe, fast, simple and effective method of treating these lesions. However, recovery after surgical management was often incomplete because the diagnosis was established too late and the patient already presented with severe and long-lasting deficit. Thus, the main problem remains a diagnostic and not a surgical one. This paper is dedicated to Professor Fritz Loew, Chief-editor emeritus of Acta Neurochirurgica     

药物涂层球囊治疗股腘动脉长段病变的中远期结果及其预后因素

目的探讨药物涂层球囊(DCB)治疗股腘动脉长段病变的中远期结果及其预后因素。方法回顾性分析2016年6月至2021年5月于清华大学附属北京清华长庚医院血管外科接受DCB治疗的114例股腘动脉长段病变(卢瑟福分级2～6级)患者的临床资料。男性75例, 女性39例, 年龄(71.9±8.4)岁(范围:49～89岁)。114例患者共有138处股腘动脉长段病变, 其中初次病变111处(80.4%, 111/138), 闭塞病变116处(84.1%, 116/138), 病变长度(280.9±78.7)mm(范围:150～520 mm);联合减容治疗59处(42.8%, 59/138), 植入补救支架27处(19.6%, 27/138)。通过Kaplan-Meier生存曲线分别计算患者的累积初始通畅率、免于临床驱动的靶病变再次干预率、累积总体生存率。通过Cox比例风险模型进行单因素及多因素分析, 筛选影响股腘动脉长段病变通畅率的相关因素。结果 114例患者均完成DCB治疗, 技术成功率为98.2%(112/114)。术后平均随访18个月(范围:3～54个月)。术后12、24和36个月累积初始通畅...     

Development of drug-coated balloon for the treatment of multiple peripheral artery segments

ObjectivePeripheral artery disease is the second most common cardiovascular disease. It can often occur in complex form when there is a presence of long, diffuse, and multiple lesions. Current treatments use either single long drug-coated balloons (DCBs) or multiple DCBs; however, treatment success is limited. The purpose of this study was to investigate the preclinical feasibility of our multiple-release Tailored Medical Devices DCB (MR-TMD-DCB) to treat multiple arterial segments using a single DCB.MethodsThe MR-TMD-DCBs were developed using a two-layer coating approach. The DCBs were developed in a certified Current Good Manufacturing Practices facility using presterilized materials and reagent and then characterized for coating morphology, thermal and chemical changes, and in vitro particulate shedding. The drug loss, tissue uptake, and undelivered drug amounts were analyzed using an in vitro peripheral artery flow model and explanted pig arteries. Then, an in vivo survival study was performed using a healthy porcine model to measure the short-term drug uptake (seven swine; 14 treatments at day 1) and retention (seven swine; 14 treatments at day 7) in two different arterial segments after treatment with a single MR-TMD-DCB.ResultsThe coating on the MR-TMD-DCB was smooth and homogeneous with paclitaxel molecularly dispersed in its amorphous state. A negligible number of particulates were shed from the MR-TMD-DCB coating. A similar amount of drug was accurately delivered into two separate explanted arteries using a single MR-TMD-DCB during the in vitro flow model testing (707 ± 109 ng/mg in the first explanted artery and 783 ± 306 ng/mg in the second explanted artery). The MR-TMD-DCB treatment resulted in equivalent drug amounts in the two arterial segments at day 1 (63 ± 19 ng/mg in the first treatment site and 59 ±19 ng/mg in the second treatment site) and at day 7 (9 ± 6 ng/mg in the first treatment site and 10 ± 6 ng/mg in the second treatment site). In addition, the drug levels at each time point were in the clinically relevant range to prevent neointimal hyperplasia.ConclusionsThe MR-TMD-DCBs provided equivalent and clinically relevant drug retention levels into two different arterial segments. Thus, MR-TMD-DCBs can be used to accurately deliver drug into multiple arterial segments with the use of a single DCB. The clinical outcomes of these findings need further investigation. Future long-term pharmacokinetics and safety studies will be performed to evaluate the safety and efficacy of the MR-TMD-DCB.     

药物涂层球囊在股腘动脉硬化性病变中的应用进展

经皮腔内血管成形术是治疗股腘动脉硬化性病变的首选方法,术后较高的再狭窄率是临床亟待解决的问题。药物涂层球囊(DCB)作为一种新兴治疗手段,可抑制血管内膜增生及炎症反应,在股腘动脉硬化性病变的初次治疗及支架内再狭窄的治疗方面可明显降低晚期管腔丢失及靶病变血运重建率。此外,DCB联合斑块切除术、DCB联合金属支架植入术可改善股腘动脉重度狭窄的临床疗效。本文对近年来DCB在股腘动脉硬化性病变中的应用进展进行综述。     

外伤性动静脉瘘的诊断与治疗

目的探讨外伤性动静脉瘘的诊断与治疗。方法分析42例动静脉瘘的类型。影像特点，治疗方法。结果随访6个月～20年，除2例采用4头结扎截肢外，其余40例均获治愈。结论动静脉瘘，只要选择正确的治疗方法，均可取得满意疗效。     

Cutting balloon angioplasty in hemodialysis arteriovenous fistula stenosis resistant to conventional balloon angioplasty

Objective To investigate the efficacy and safety of cutting balloon angioplasty for the treatment of hemodialysis arteriovenous fistula stenosis resistant to conventional percutaneous transluminal angioplasty (PTA). Methods The patients with arteriovenous fistula stenosis who had suboptimal results (residual stenosis ＞30%) by conventional PTA from December 2011 to February 2015 were enrolled. All the patients received cutting balloon angioplasty were rechecked every three months. Results A total of 25 patients with age of (60.7±12.9) years had suboptimal PTA results. Eleven patients with native arteriovenous fistula (AVF) and 14 patients with graft fistula (AVG) underwent cutting PTA for 30 times. The technical success rate was 86.7% and clinical success rate was 100%. The diameter stenosis pre-procedural and post-procedural of cutting PTA was (1.7±0.6) mm and (4.5±0.8) mm respectively (P＜0.05). Six patients had multiple lesions and the stenosis consisted of 21 outflow venous, 6 graft-to-vein anastomosis, 6 cephalic arch, 2 artery and 1 puncture hole stenosis. The primary access patency at 3 and 6 months for AVF group were 70.0% and 10.0%, while for AVG group the figures were 64.3% and 7.1% (P＞0.05). The secondary access patency at 3 and 6 months for AVF group were 70.0% and 30.0%, while for AVG group the figures were 85.7% and 64.3% (P＞0.05). The follow-up time was (8.1±7.3) months. The restenosis rate was 64.0%. Cutting PTA failed to achieve technical success for four times, of whom 2 patients required graft stent implantation and 2 patients required ultra-high-pressure balloons angioplasty to finally achieve technical success. The median survival time of fistula was 173 days. Conclusions Cutting balloon angioplasty have well short-term patency and safety in arteriovenous fistula stenosis resistant to conventional PTA, especially for calcified lesion or "balloon waist". Although it could provide a satisfied long patency by recurrent PTA, the use of cutting balloon would be not advocated as the first-line treatment for fistula stenosis. The efficacy superiority of cutting balloon between AVF and AVG, as well as the cost-effect comparison between cutting balloon and high-pressure balloon, remains unclear, the verification of which requires large-sampled, prospective and randomized studies.     

药物涂层球囊与经皮腔内球囊扩张对2型糖尿病膝下动脉病变患者一期通畅率、动脉内氧化应激的影响

目的:探讨药物涂层球囊与经皮腔内球囊扩张对2型糖尿病(T2DM)膝下动脉病变患者一期通畅率、动脉内氧化应激的影响.方法:选取2017年6月至2019年2月在我院诊治的T2DM膝下动脉病变患者134例作为研究对象,以随机数字表法分为对照组与研究组,每组67例.对照组给予经皮腔内球囊扩张治疗,研究组给予药物涂层球囊治疗.比...     

经皮腔内血管成形术在血液透析患者失功或未成熟动静脉内瘘中的应用

<正>自体动静脉内瘘是临床对需长期血液透析的慢性肾衰竭患者建立动静脉通路的常用方式,然而目前动静脉内瘘失功及未成熟的发生率仍较高,其中桡动脉—头静脉内瘘失功及未成熟发生率高达25%~33%~([1])。近年研究~([2-3])强调多数失功或未成熟的动静脉内瘘可通过经皮穿刺技术重塑再通。本研究旨在评估对需长期血液透析的动静脉内瘘患者进行经皮腔内     

Multidisciplinary management of posterior fossa dural arteriovenous fistula: A single-center experience

PurposeThe management of posterior fossa dural arteriovenous fistulas (pfDAVFs) is challenging. Here, we show how multidisciplinarity leads to their successful management, even in complex cases.MethodsAll pfDAVFs managed from 2010 to 2019 at our center were reviewed. The preoperative clinical and radiological characteristics, their management and the occlusion rate were retrieved. The radiological and functional outcomes were retrieved at discharge and last follow-up (FU).Resultsn = 27 patients were included (6 females, mean age: 61-years-old, mean FU: 22.5 months). n = 8 patients presented with cerebral hemorrhage. Among patients with ruptured pfDAVFs, n = 7 had headache, n = 4 had ataxia, and n = 2 had impaired level of consciousness. In the unruptured group N (n = 19), n = 7 patients had headache, n = 6 patients had focal neurological deficit, n = 4 patients had tinnitus, n = 3 (had ataxia, and one presented with seizure. n = 24 patients were treated by endovascular therapy (EVT), n = 2 patients were treated by microsurgery (MS) and n = 1 patient was managed with a combined approach. Re-treatment was necessary in n = 6 patients. n = 24 patients showed total exclusion at last FU. n = 2 patients died during the first 30 days; n = 1 patient died during FU.ConclusionsWhile EVT should be advocated as the first line therapy whenever possible, MS should not be banned from the treatment armamentarium. Neurosurgeons must be able to achieve direct surgical occlusion when the angioarchitecture speaks against EVT.     

Paclitaxel embolism in a transplant kidney: a rare complication of drug-coated balloon angioplasty

International Urology and Nephrology -     

药物涂层球囊治疗下肢动脉疾病研究进展

下肢动脉疾病(LEAD)是由动脉粥样硬化引起的下肢动脉管腔狭窄、闭塞,导致相应肢体出现缺血症状的一类疾病。腔内介入是治疗LEAD的主要方式,包括经皮腔内血管成型术(PTA)及支架植入术,但术后再狭窄率较高。药物涂层球囊(DCB)可在抑制血管内膜增生及炎症反应的同时避免腔内异物存留,对于原发病变及支架内再狭窄均有较好疗效。本文对DCB作用原理及其治疗LEAD应用现状和研究进展进行综述。     

Primary Arteriovenous Fistulas in the Forearm for Hemodialysis: Effect of Miscellaneous Factors in Fistula Patency

Background. The provision and maintenance of vascular access remains a major cost to end-stage renal failure programs. In addition, vascular access occlusion, results in significant morbidity in hemodialysis patients. Age, gender, diabetes mellitus, malignancy, smoking habits, administration of heparin per hemodialysis session, previous dialysis catheter insertion, number of hemodialysis sessions and location of the fistula may be associated with survival of the primary arteriovenous fistula. We examined the effects of various factors on fistulas in 412 chronic renal insufficiency patients. Methods. From 1995 to 2004, 412 arteriovenous fistulas were created by the Department of Cardiovascular Surgery at the Medical Faculty of Atatürk University for hemodialysis. The mean age of the patients was 45 years (range 6 to 62 years). We evaluated the effects of various factors for patency rates in the patients who had primary arteriovenous fistulas. Primary patency was defined as the duration of fistula patency without revision. Twenty-eight patients (6.7%) with ischemic cardiac disease did not require surgical interference. Analyzed data were age, gender, smoking habits, diabetes mellitus, malignant neoplasm, previous dialysis catheter insertion, number of hemodialysis sessions, and fistula location. Results. In 298 patients, where lower-arm radiocephalic fistulas were created, the fistula patency was 74.1%, 64.2%, 49.8%, 33.7%, and 4.1% after 1, 2, 3, 4, and 5 years, respectively, in the other 114 patients, where upper-arm fistulas were created, these rates were 84.0%, 72.2%, 53.3%, 39.8%, and 12.3%, respectively. There was no significantly difference between the upper-arm fistulas and the lower-arm fistulas statistically (p = 0.069). Factors affecting the primary patency of arteriovenous fistulas were diabetes mellitus (p = 0.0001), hemodialysis counts ≥3 per week (p < 0.0005), presence of malignancy (p < 0.0005), previous catheter insertion (p < 0.0007), and administration of heparin per hemodialysis session (p = 0.0008). Conclusion. While primary arteriovenous fistula patency was shortened in chronic renal insufficiency patients with diabetes mellitus, presence of malignancy, and previous catheter insertion, patency was longer in patients with heparin used for hemodialysis and hemodialysis count per week (≥3).     

药物洗脱支架与药物涂层球囊治疗股腘动脉病变进展

外周动脉疾病(PAD)可累及全身动脉,以下肢动脉较多见。血管内治疗(EVT)是治疗下肢PAD的常用技术之一,主要包括药物洗脱支架(DES)及药物涂层球囊(DCB)。与传统技术相比,DES及DCB治疗PAD后血管通畅率更高、再狭窄率更低,但目前相关研究尚少,且缺乏长期随访结果,二者间如何选择仍需探讨。本文对DES、DCB治疗股腘动脉病变应用进展进行综述。