embolotherapy

Embolotherapy
  • 文章类型: Journal Article
    膝骨关节炎(OA)影响全球数百万人,导致疼痛和生活质量下降。常规治疗往往不能提供足够的救济,需要新的治疗方法。这项研究评估了使用永久性微球治疗轻中度膝关节OA患者的膝动脉栓塞(GAE)的有效性和安全性。在这个前景中,单中心研究,17名参与者接受了GAE。KOOS(膝关节损伤和骨关节炎结果评分),WOMAC(西安大略省和麦克马斯特大学关节炎指数),和IPAQ(国际身体活动问卷)得分,连同物理性能测试,药物使用,和双能X射线吸收法(DEXA)扫描,在基线和6个月的多个随访点进行评估。主端点,六个月的VAS,显着改善(中位数从66毫米减少到40毫米,p=0.0004)。所有疼痛和功能评分,以及物理性能测试,明显改善。六个月后未观察到药物使用或DEXA参数的临床相关变化。只有未成年人,发生了自我限制的不良事件。这项研究表明,GAE是一种有前途的微创治疗膝关节OA,提供显著的疼痛缓解和功能改善。然而,进一步长期,需要随机试验来证实这些发现,并建立最佳的患者选择标准.
    Knee osteoarthritis (OA) affects millions worldwide, leading to pain and reduced quality of life. Conventional treatments often fail to provide adequate relief, necessitating new therapeutic approaches. This study evaluated the efficacy and safety of genicular artery embolization (GAE) using permanent microspheres in patients with mild-to-moderate knee OA. In this prospective, single-center study, 17 participants underwent GAE. KOOS (Knee injury and Osteoarthritis Outcome Score), WOMAC (The Western Ontario and McMaster Universities Arthritis Index), and IPAQ (International Physical Activity Questionnaire) scores, along with physical performance tests, medication use, and dual-energy X-ray absorptiometry (DEXA) scans, were assessed at baseline and at multiple follow-up points over six months. The primary endpoint, VAS at six months, showed significant improvement (median reduction from 66 mm to 40 mm, p = 0.0004). All pain and function scores, as well as physical performance tests, improved significantly. No clinically relevant changes in medication use or DEXA parameters were observed after six months. Only minor, self-limiting adverse events occurred. This study indicates that GAE is a promising minimally invasive treatment for knee OA, providing significant pain relief and functional improvement. However, further long-term, randomized trials are needed to confirm these findings and establish optimal patient selection criteria.
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  • 文章类型: Case Reports
    风湿性心脏病(RHD)和肺动静脉畸形(PAVM)并存是一种罕见的临床情况,对诊断和治疗提出了挑战。本病例报告探讨了临床表现,诊断旅程,以及对同时患有这两种疾病的患者进行多学科管理。
    一名47岁女性,有RHD病史,表现为劳累时呼吸困难和发紫的症状,提示心脏受累和肺部受累。随后涉及成像的调查,超声心动图,有创肺动脉造影显示患者左肺下叶RHD和多发性PAVM共存。患者接受了量身定制的治疗计划,最初涉及RHD的经皮二尖瓣球囊瓣膜成形术,1个月后,采用Amplatzer™血管栓塞II进行经导管PAVM封堵术。干预后她的饱和度恢复正常。病人的进展受到密切监测,根据不断发展的临床情况对治疗计划进行调整。患者在短期随访中仍然良好。
    此案例突出了管理RHD和PAVM并存的两种不同疾病的患者的复杂性,从而强调多学科方法的重要性。心脏和肺部病理的独特交集需要仔细考虑诊断细微差别和量身定制的治疗策略。从这个案例中吸取的经验教训为遇到类似情况的临床医生提供了宝贵的见解,并强调了个性化的重要性,以患者为中心的护理可优化双重病理患者的预后。
    UNASSIGNED: The coexistence of rheumatic heart disease (RHD) and pulmonary arteriovenous malformation (PAVM) is a rare clinical scenario that poses diagnostic and therapeutic challenges. This case report explores the clinical presentation, diagnostic journey, and multidisciplinary management of a patient presenting with both conditions.
    UNASSIGNED: A 47-year-old female with a history of RHD presented with symptoms of dyspnoea on exertion and cyanosis, suggestive of both cardiac involvement and pulmonary involvement. Subsequent investigations involving imaging, echocardiography, and invasive pulmonary angiography revealed the coexistence of RHD and multiple PAVM in the patient\'s left lower lobe of the lung. The patient underwent a tailored treatment plan, initially involving percutaneous mitral balloon valvuloplasty for RHD, followed by a staged procedure of transcatheter PAVM closure with Amplatzer™ Vascular Plug II performed 1 month later. Her saturation normalized following the intervention. The patient\'s progress was monitored closely, with adjustments made to the treatment plan based on evolving clinical scenarios. The patient remained well in short-term follow-up.
    UNASSIGNED: This case highlights the complexity of managing patients having two diverse conditions RHD and PAVM coexisting together, thus emphasizing the importance of a multidisciplinary approach. The unique intersection of cardiac and pulmonary pathologies necessitates careful consideration of diagnostic nuances and tailored treatment strategies. Lessons learned from this case offer valuable insights for clinicians encountering similar scenarios and underscore the significance of individualized, patient-centred care in optimizing outcomes for those with dual pathologies.
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  • 文章类型: Journal Article
    这项回顾性研究的目的是评估支气管动脉栓塞术前计算机断层扫描血管造影(CTA)对咯血患者的附加值。
    在这项回顾性研究中,我们评估了2010年至2021年因咯血入院并接受导管引导栓塞治疗的患者.建立术前计算机断层扫描(CT)的质量标准后,患者根据术前成像评估分为两组:优质CT血管造影(QCTA组)和次优术前成像(次优CTA,未增强或无CT评估;对照组)。根据放射学上的成功进行了比较,手术相关并发症,和临床成功,包括停止咯血,复发率,和总死亡率。
    我们纳入了QCTA组的31名患者,对照组为35。QCTA组的临床成功率为n=24/31(77.4%),对照组为n=27/35(77.1%)(p=0.979)。QCTA组的技术成功率为n=37/42(88.1%),对照组为n=39/42(92.86%)(p=0.820)。总复发率为10.6%。轻微并发症发生率为27.3%,报告了一个主要并发症。QCTA组受影响的出血肺与血管造影过程中病理动脉的识别之间的一致性更好(p=0.045)。罪犯动脉的平均数量(支气管,QCTA组的非支气管系统动脉[NBSA]或肺)未明显高于对照组。
    与直接血管造影相比,术前QCTA能更好地识别受影响的肺部出血和出血血管。临床成功没有区别,并发症,复发率,或观察到死亡率。
    UNASSIGNED: The aim of this retrospective study was to evaluate the added value of pre-procedural computed tomography angiography (CTA) prior to bronchial artery embolization for patients presenting with hemoptysis.
    UNASSIGNED: In this retrospective study, we evaluated patients admitted for hemoptysis from 2010 to 2021 and treated by catheter-directed embolization. After establishing quality criteria for pre-procedural computed tomography (CT), patients were divided into two groups depending on their pre-procedural imaging assessment: Quality CT-angiography (QCTA group) and suboptimal pre-procedural imaging (suboptimal CTA, unenhanced or no CT evaluation; control group). Groups were compared based on radiological success, procedure-related complications, and clinical success, including cessation of hemoptysis, recurrence rates, and overall mortality.
    UNASSIGNED: We included 31 patients in the QCTA group, and 35 in the control group. Clinical success was n = 24/31 (77.4%) in the QCTA group and n = 27/35 (77.1%) in the control group (p = 0.979). Technical success was n = 37/42 (88.1%) in the QCTA group and n = 39/42 (92.86%) in the control group (p = 0.820). Overall recurrence was 10.6%. Minor complications occurred in 27.3%, and one major complication was reported.The concordance between the affected bleeding lung and the identification of pathological arteries during angiography was better in the QCTA group (p = 0.045).The average number of culprit arteries (bronchial, non-bronchial systemic arteries [NBSA] or pulmonary) in the QCTA group was not significantly higher than that in the control group.
    UNASSIGNED: Preprocedural QCTA better identifies the affected bleeding lung and bleeding vessels compared to direct angiography. No difference in clinical success, complications, recurrence rates, or mortality was observed.
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  • 文章类型: Journal Article
    背景:经导管动脉栓塞(TAE)是控制成人急性腹部和盆腔创伤出血的既定方法。然而,其在小儿创伤中的应用还没有得到很好的证实。这项研究旨在评估TAE在钝性创伤儿科患者中的安全性和有效性。
    方法:这项回顾性研究是在2014年2月至2022年7月期间因钝性创伤而接受TAE的儿科患者(<18岁)中进行的。根据年龄和体重将患者分为亚组。患者人口统计学,损伤严重程度,输血要求,并对临床结局进行分析。
    结果:正好73例患者接受了TAE。所有患者均取得技术成功(100%),临床成功率为83.6%。死亡率和并发症发生率分别为4.1%和1.4%,分别。平均住院时间为19.3天。亚组分析显示,年龄,体重,性别对临床成功率无显著影响.损伤严重程度评分和输血需求是临床成功的预测因素,较低的值与更好的结果相关。
    结论:TAE对于处理较年轻和较轻的儿童钝性创伤是有效和安全的。损伤严重程度和输血需求是临床成功的预测因素。
    BACKGROUND: Transcatheter arterial embolization (TAE) is an established approach for controlling hemorrhage in adults with acute abdominal and pelvic trauma. However, its application in pediatric trauma is not well established. This study aimed to evaluate the safety and effectiveness of TAE in a population of pediatric patients with blunt trauma.
    METHODS: This retrospective study was conducted in pediatric patients (<18 years) who underwent TAE for blunt trauma between February 2014 and July 2022. The patients were categorized into subgroups based on age and body weight. Patient demographics, injury severity, transfusion requirements, and clinical outcomes were analyzed.
    RESULTS: Exactly 73 patients underwent TAE. Technical success was achieved in all patients (100%), and clinical success was achieved in 83.6%. The mortality and complication rates were 4.1% and 1.4%, respectively. The mean duration of hospitalization was 19.3 days. Subgroup analysis showed that age, body weight, and sex did not significantly affect clinical success. The injury severity score and transfusion requirement were predictors of clinical success, with lower values associated with better outcomes.
    CONCLUSIONS: TAE is effective and safe for managing blunt pediatric trauma in younger and lighter patients. Injury severity and transfusion requirement are predictors of clinical success.
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  • 文章类型: Case Reports
    背景:动静脉畸形(AVM)导致动脉和静脉网络之间的直接连接,其中不涉及毛细血管分支。盆腔AVM是一种良性和罕见的疾病,会引起严重的疼痛,血尿,直肠或阴道出血.
    方法:一名36岁女性,有5个月的血尿史。她的病史并不引人注目,实验室检查结果均在正常范围内.腹骨盆计算机断层扫描(CT)扫描显示左外侧骨盆有一个血管肿块,延伸到膀胱颈,并提示AVM。患者接受了剖腹手术切除AVM。第一次血管造影显示左髂内动脉有AVM。患者接受了线圈和凝胶泡沫栓塞。第二次血管造影显示由于右髂内动脉(RIIA)的多个线圈和AVM导致左髂内动脉完全阻塞,用胶水和碘油栓塞。一周后,静脉造影显示另一左髂静脉畸形经泡沫硬化治疗栓塞。四十天后,第三次血管造影显示右髂动脉有另一个AVM,用三瓶聚乙烯醇(PVA)栓塞。经过两个月的随访,症状没有恢复。
    结论:本研究报告了一例罕见的复发性盆腔AVM,导致女性患者无痛性血尿。对病变进行了几次血管栓塞治疗。
    结论:血管栓塞是AVM的主要治疗选择之一。应根据AVM的位置准确选择合适的材料进行AVM栓塞,尺寸,和条件。
    BACKGROUND: Arteriovenous malformation (AVM) leads to a direct connection between arterial and venous networks, in which capillary branches are not involved. Pelvic AVM is a benign and rare condition causing severe pain, hematuria, and rectal or vaginal bleeding.
    METHODS: A 36-year-old woman presented with five months history of hematuria. Her medical history was unremarkable, and laboratory findings were all within normal ranges. Abdominopelvic computed tomography (CT) scan revealed a vascular mass in the left lateral pelvis that extended to the bladder neck and was suggestive of an AVM. The patient underwent a laparotomy for the resection of AVM. The first angiography revealed an AVM in the left internal iliac artery. The patient underwent embolization with coil and gel foam. The second angiography revealed complete obstruction of the left internal iliac artery due to multiple coils and AVM of the right internal iliac artery (RIIA), embolized with glue and lipiodol. A week later, venography revealed another left iliac vein malformation embolized with foam sclerotherapy. Forty days later, the third angiography revealed another AVM in the right iliac artery, embolized with three vials of polyvinyl alcohol (PVA). Following two months of follow-up, the symptoms did not return.
    CONCLUSIONS: The present study reported a rare case of recurrent pelvic AVM causing painless hematuria in a female patient. The lesion was treated with several angioembolization sessions.
    CONCLUSIONS: Angioembolization is one of the main therapeutic options for AVM. Appropriate material should be precisely chosen for AVM embolization regarding the AVM\'s location, size, and condition.
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  • 文章类型: Case Reports
    该研究描述了使用混合手术成功治疗鞋底罕见类型的动静脉畸形(AVM),包括开放性切除和栓塞。此外,提出了除血管造影外,在检查期间利用超声诊断鞋底AVM的可能性。
    The study describes the successful treatment of a rare type of arteriovenous malformation (AVM) in the sole using hybrid surgery, which consists of open resection and embolization. Moreover, the possibility of utilizing ultrasound during examination in addition to angiography for the diagnosing of AVM of the sole is proposed.
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  • 文章类型: Journal Article
    经颈静脉肝内门体分流术(TIPS)预防胃食管静脉曲张再出血的作用仍存在争议。因此,我们进行了一项荟萃分析,以比较静脉曲张再出血的发生率,分流功能障碍,脑病,仅接受TIPS治疗的患者与接受TIPS联合VE治疗的患者之间的死亡。
    我们使用PubMed进行了文献检索,EMBASE,Scopus,和Cochrane数据库,用于比较单独TIPS和有VE的TIPS的并发症发生率的所有研究。主要结果是静脉曲张再出血。次要结果包括分流功能障碍,脑病,和死亡。根据支架类型进行亚组分析(覆盖与裸金属)。随机效应模型用于计算相对风险(RR)和相应的95%置信区间(CI)。P值<0.05被认为是统计学上显著的。
    纳入了11项研究,共1,075例患者(597:单独TIPS和478:TIPS加VE)。与单独的TIPS相比,有VE的TIPS患者静脉曲张再出血的发生率显著降低(RR:0.59,95%CI:0.43~0.81,P=0.001).亚组分析显示,覆膜支架的结果相似(RR:0.56,95%CI:0.36-0.86,P=0.008),但两组在裸支架和联合支架的亚组分析中没有显着差异。脑病风险差异无统计学意义(RR:0.84,95%CI:0.66-1.06,P=0.13),分流功能障碍(RR:0.88,95%CI:0.64-1.19,P=0.40),和死亡(RR:0.87,95%CI:0.65-1.17,P=0.34)。当根据支架类型进行分层时,组间的这些次要结果也没有类似差异。
    在TIPS中添加VE可降低肝硬化患者静脉曲张再出血的发生率。然而,仅在有覆盖支架的情况下观察到获益.需要进一步的大规模随机对照试验来验证我们的发现。
    UNASSIGNED: The role of variceal embolization (VE) during transjugular intrahepatic portosystemic shunt (TIPS) creation for preventing gastroesophageal variceal rebleeding remains controversial. Therefore, we performed a meta-analysis to compare the incidence of variceal rebleeding, shunt dysfunction, encephalopathy, and death between patients treated with TIPS alone and those treated with TIPS in combination with VE.
    UNASSIGNED: We performed a literature search using PubMed, EMBASE, Scopus, and Cochrane databases for all studies comparing the incidence of complications between TIPS alone and TIPS with VE. The primary outcome was variceal rebleeding. Secondary outcomes include shunt dysfunction, encephalopathy, and death. Subgroup analysis was performed based on the type of stent (covered vs. bare metal). The random-effects model was used to calculate the relative risk (RR) with the corresponding 95% confidence intervals (CIs) of outcome. A P value < 0.05 was considered statistically significant.
    UNASSIGNED: Eleven studies with a total of 1,075 patients were included (597: TIPS alone and 478: TIPS plus VE). Compared to the TIPS alone, the TIPS with VE had a significantly lower incidence of variceal rebleeding (RR: 0.59, 95% CI: 0.43 - 0.81, P = 0.001). Subgroup analysis revealed similar results in covered stents (RR: 0.56, 95% CI: 0.36 - 0.86, P = 0.008) but there was no significant difference between the two groups in the subgroup analysis of bare stents and combined stents. There was no significant difference in the risk of encephalopathy (RR: 0.84, 95% CI: 0.66 - 1.06, P = 0.13), shunt dysfunction (RR: 0.88, 95% CI: 0.64 - 1.19, P = 0.40), and death (RR: 0.87, 95% CI: 0.65 - 1.17, P = 0.34). There were similarly no differences in these secondary outcomes between groups when stratified according to type of stent.
    UNASSIGNED: Adding VE to TIPS reduced the incidence of variceal rebleeding in patients with cirrhosis. However, the benefit was observed with covered stents only. Further large-scale randomized controlled trials are warranted to validate our findings.
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  • 文章类型: Journal Article
    盆腔静脉淤血综合征(PVCS)是一种常见的,但诊断不足,女性慢性盆腔疼痛(CPP)的原因。PVCS通常发生,但不限于此,在多胎妇女中。其特征是慢性盆腔疼痛持续时间超过六个月,没有炎症性疾病的证据。全科医生面前的病人,妇科医生,血管专家,疼痛专家,胃肠病学家和精神病医生。不同强度的疼痛发生在任何时间,但在月经前期更为严重,走路会加剧这种情况,站立,和疲劳。性交后疼痛,痛经,性交困难,膀胱易怒和直肠不适也很常见。这种情况的诊断可能导致焦虑和抑郁。在这些妇女的调查和管理中采用多学科方法至关重要。非侵入性成像(美国,CT,MRI)对于诊断和排除引起CPP的其他疾病以及明确诊断PVCS至关重要。经导管静脉造影仍然是明确诊断的金标准方式,并且是卵巢静脉栓塞(OVE)的直接前体。保守,据报道,医疗和外科管理策略已被OVE取代,据报道,技术成功率为96-100%,在70-90%的病例中,低并发症发生率和长期症状缓解。条件,本文描述为PVCS,在文献中被各种各样的其他术语引用,混乱的原因。有大量文献描述了OVE后的综合征和良好的结果,但是缺乏前瞻性,用于PVCS的调查和管理的多中心随机对照试验是完全接受两者存在的重要障碍,状况的调查和管理。
    Pelvic venous congestion syndrome (PVCS) is a common, but underdiagnosed, cause of chronic pelvic pain (CPP) in women.PVCS occurs usually, but not exclusively, in multiparous women. It is characterized by chronic pelvic pain of more than six months duration with no evidence of inflammatory disease.The patients present to general practitioners, gynaecologists, vascular specialists, pain specialists, gastroenterologists and psychiatrists. Pain of variable intensity occurs at any time but is worse in the pre-menstrual period, and is exacerbated by walking, standing, and fatigue. Post coital ache, dysmenorrhea, dyspareunia, bladder irritability and rectal discomfort are also common. Under-diagnosis of this condition can lead to anxiety and depression.A multidisciplinary approach in the investigation and management of these women is vital.Non-invasive imaging (US, CT, MRI) are essential in the diagnosis and exclusion of other conditions that cause CPP as well in the definitive diagnosis of PVCS. Trans-catheter venography remains the gold standard modality for the definitive diagnosis and is undertaken as an immediate precursor to ovarian vein embolization (OVE). Conservative, medical and surgical management strategies have been reported but have been superseded by OVE, which has a reported technical success rates of 96-100%, low complication rates and long-term symptomatic relief in between 70-90% of cases.The condition, described in this paper as PVCS, is referred to by a wide variety of other terms in the literature, a cause of confusion.There is a significant body of literature describing the syndrome and the excellent outcomes following OVE however the lack of prospective, multicentre randomized controlled trials for both investigation and management of PVCS is a significant barrier to the complete acceptance of both the existence, investigation and management of the condition.
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  • 文章类型: Case Reports
    动静脉畸形(AVM)是发育性血管畸形,由中央眼窝周围的异常动静脉分流组成。这些病变相对不常见,仅占所有良性软组织肿块的7%。大多数AVM发生在大脑中,脖子,骨盆,和下肢,很少出现在脚上。当它们在脚上形成时,非特异性疼痛和缺乏临床特征导致初次就诊时误诊率高。尽管手术切除联合栓塞治疗已成为大型AVM的首选治疗方法,关于足部小病变的最佳治疗方法存在争议。
    一名36岁的非洲裔加勒比男子被转诊到诊所,有2年的前脚疼痛加剧,影响他舒适站立或行走的能力。没有外伤史,尽管换了鞋,患者继续有明显的疼痛。临床检查不明显,除了前脚背部有轻度压痛,X光片正常.磁共振扫描报告了meta骨间血管肿块,但不能排除恶性肿瘤。手术探查和整体切除证实肿块为AVM。手术后一年,患者保持无痛状态,无复发迹象.
    AVM在脚下的稀有性,结合正常的X线片和非特异性临床体征,导致这些病变的诊断和治疗延误。在诊断不确定的情况下,外科医生获得磁共振成像的阈值应该很低。整块手术切除是治疗足部小的适当位置病变的一种选择。
    UNASSIGNED: Arteriovenous malformations (AVM) are developmental vascular malformations consisting of abnormal arteriovenous shunts surrounding a central nidus. These lesions are relatively uncommon, comprising just 7% of all benign soft-tissue masses. Most AVMs occur in the brain, neck, pelvis, and lower extremity and rarely manifest in the foot. When they do form in the foot, non-specific pain and the absence of clinical features contribute to the high rate of misdiagnosis on initial presentation. Although surgical excision combined with embolotherapy has emerged as the preferred treatment for large AVM, controversy exists over the best treatment for small lesions in the foot.
    UNASSIGNED: A 36-year-old Afro-Caribbean man was referred to the clinic with a 2-year history of increasing pain in his forefoot, affecting his ability to stand or walk comfortably. There was no history of trauma, and despite changing his footwear, the patient continued to have significant pain. Clinical examination was unremarkable except for mild tenderness over the dorsum of his forefoot, and radiographs were normal. A magnetic resonance scan reported an intermetatarsal vascular mass but could not exclude malignancy. Surgical exploration and en bloc excision confirmed the mass to be an AVM. One year post-surgery, the patient remains pain-free with no evidence of recurrence.
    UNASSIGNED: The rarity of AVM in the foot, combined with normal radiographs and non-specific clinical signs, contributes to the long delay in diagnosing and treating these lesions. Surgeons should have a low threshold for obtaining magnetic resonance imaging in cases of diagnostic uncertainty. En bloc surgical excision is an option for treating small suitably located lesions in the foot.
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  • 文章类型: Multicenter Study
    目的:评估与使用自膨胀装置进行外周动脉栓塞相关的封堵成功和不良事件。
    方法:这种前瞻性,单臂,使用由相对的镍钛诺纤维和流动阻塞膜组成的Caterpillar™动脉栓塞装置进行了可行性研究。20名患者(24个栓塞部位)在新西兰和澳大利亚的四个研究中心接受治疗,并随访30天。栓塞部位包括肠系膜,副肾,髂动脉和它们的分支.主要结局指标为血管造影术证实的围手术期闭塞和30天无装置相关严重不良事件(SAE)。次要观察包括闭塞时间和不良事件的评估。
    结果:围手术期闭塞100%,在30天时,与设备相关的SAE的自由度为94.7%。一名患者腹部腹胀,需要住院治疗,认为可能与设备或手术有关。24个栓塞部位中有22个被一个装置阻塞(91.7%)。平均手术时间为11.7±8.6min(设备展开时间:1.8±1.0min),平均透视时间为241±290.7s。术中所有栓塞部位均闭塞,62.5%在3分钟内闭塞,91.6%在10分钟内闭塞。无装置迁移或需要重新栓塞。设备和程序相关不良事件的发生率为84.2%。一名患者在随后的辅助腹主动脉血管内手术中死于主动脉破裂,被认为与栓塞装置或手术无关。
    结论:这项关于卡特彼勒栓塞装置的首次人体研究在30天时在所有患者中实现了围手术性闭塞,无94.7%的装置相关SAE。
    方法:2b级-前瞻性,多中心,单臂,首次在人类临床研究。使用描述性统计分析预先指定的终点。
    OBJECTIVE: To assess occlusion success and adverse events associated with the use of a self-expanding device for peripheral artery embolization.
    METHODS: This prospective, single-arm, feasibility study was conducted using the Caterpillar™ Arterial Embolization Device composed of opposing nitinol fibers and a flow-occluding membrane. Twenty patients (24 embolization sites) were treated at four investigational centers in New Zealand and Australia and followed for 30 days. Embolization sites included mesenteric, accessory renal, and iliac arteries and their branches. Primary outcome measures were peri-procedural occlusion confirmed by angiography and freedom from device-related serious adverse events (SAEs) at 30 days. Secondary observations included time to occlusion and assessment of adverse events.
    RESULTS: Peri-procedural occlusion was 100%, and freedom from a device-related SAE was 94.7% at 30 days. One patient had abdominal bloating that required hospitalization deemed possibly related to the device or procedure. Twenty-two of 24 embolization sites were occluded with one device (91.7%). Mean procedure duration was 11.7 ± 8.6 min (device deployment time: 1.8 ± 1.0 min), and mean fluoroscopy time was 241 ± 290.7 s. All embolization sites occluded during the procedure with 62.5% occluded within three minutes and 91.6% occluded within ten minutes. No devices migrated or required re-embolization. Freedom from device- and procedure-related adverse events was 84.2%. One patient died from aortic rupture during a subsequent adjunctive abdominal aortic endovascular procedure deemed unrelated to the embolization device or procedure.
    CONCLUSIONS: This first-in-human study of the Caterpillar embolization device achieved peri-procedural occlusion in all patients with a 94.7% freedom from device-related SAE at 30 days.
    METHODS: Level 2b-prospective, multicenter, single-arm, first-in-human clinical study. Pre-specified endpoints were analyzed using descriptive statistics.
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