new devices

新设备
  • 文章类型: Journal Article
    经皮腔内血管成形术是狭窄衰竭的动静脉瘘(AVF)的首选治疗方法,但由于肌内膜增生的发展而受到血管再狭窄率增加的阻碍。
    这项对聚合物涂层低剂量紫杉醇洗脱支架(波士顿科学公司的ELUvia支架)在狭窄的AVF接受血液透析(ELUDIA)的多中心观察研究是在希腊和新加坡的三家三级医院联合进行的。根据K-DOQI标准定义AVF失败,并通过减影血管造影确定明显的瘘狭窄(视觉估计>50%DS)。根据球囊血管成形术后的明显弹性回缩,考虑将患者插入ELUVIA支架,以治疗天然AVF内的单血管狭窄。主要结果指标是治疗的病变/瘘回路的持续长期通畅,定义为成功的支架置入,恢复不间断的血液透析,并且在随访期间没有明显的血管再狭窄(50%DS阈值)或其他次要干预。
    约23名患者接受了ELUVIA紫杉醇洗脱支架(8个放射性头颅,12头臂,和三个转位的腕带原生AVF)。失败时的平均AVF年龄为33.9±20.4个月。治疗的病变包括在吻合段的12个狭窄,九个在流出静脉处,和两个头弓病变,平均直径狭窄为86±8%。所用支架直径和长度的中值分别为7毫米和40毫米,分别。经过20个月的中位随访期,23例患者中约18个支架保持通畅(累计率为78.3%),无任何复发性狭窄的临床或影像学证据.通过Kaplan-Meier方法,在2年时,ELUVIA支架的原发通畅率为80.6%,相应的瘘管回路的原发通畅率为65.1%。
    这项观察性研究显示了聚合物涂层紫杉醇洗脱支架治疗失败的动静脉瘘的长期结果。大规模的对照研究是必要的。
    UNASSIGNED: Percutaneous transluminal angioplasty is the preferred treatment of stenosed failing arteriovenous fistulas (AVF) but is hampered by increasing rates of vascular restenosis because of development of myointimal hyperplasia.
    UNASSIGNED: This multicenter observational study of polymer-coated low-dose paclitaxel-eluting stents (ELUvia stents by Boston Scientific) in stenosed AVF undergoing hemoDIAlysis (ELUDIA) was jointly conducted in three tertiary hospitals from Greece and Singapore. Failure of AVF was defined according to K-DOQI criteria and significant fistula stenosis (>50%DS by visual estimate) was determined with subtraction angiography. Patients were considered for ELUVIA stent insertion based on significant elastic recoil following balloon angioplasty for the treatment of a single vascular stenosis within a native AVF. The primary outcome measure was sustained long-term patency of the treated lesion/fistula circuit defined as successful stent placement with resumption of uninterrupted hemodialysis and without significant vascular restenosis (50%DS threshold) or other secondary interventions during follow-up.
    UNASSIGNED: Some 23 patients received the ELUVIA paclitaxel-eluting stent (eight radiocephalic, 12 brachiocephalic, and three transposed brachiobasilic native AVFs). Mean AVF age at the time of failure was 33.9 ± 20.4 months. Treated lesions included 12 stenoses at the juxta-anastomotic segment, nine at the outflow veins, and two cephalic arch lesions with a mean diameter stenosis of 86 ± 8%. Median stent diameter and length used were 7 mm and 40 mm, respectively. After a median follow-up period of 20 months, some 18 stents out of 23 cases remained patent (cumulative rate 78.3%) without any clinical or imaging evidence of recurrent stenosis. Estimated primary patency of the ELUVIA stents was 80.6% and of the corresponding fistula circuit 65.1% at 2 years by Kaplan-Meier methods.
    UNASSIGNED: This observational study has shown promising long-term results of polymer-coated paclitaxel-eluting stents for the treatment of failing arteriovenous fistulas. Large-scale controlled studies are necessary.
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  • 文章类型: Journal Article
    Epicutaneo-Caval导管(ECCs)对于良好的新生儿护理至关重要。以前没有研究评估哪种插入方法提供最高的成功可能性。
    本研究旨在比较改良的Seldinger技术(MST)和分裂针技术(SNT)的成功率和成本。MST被介绍给圣迈克尔的新生儿病房,SNT已经在使用。从临床记录中回顾性收集有关ECC插入的常规记录数据。从业者能够使用他们首选的插入方法。对35周GA出生的患者的成功率进行了亚组分析。
    首次通过(53%vs26%;p=0.014)和总体(72%vs40%;p=0.0046)成功的ECC插入率明显较高,每次成功的ECC使用MST(2.5vs6.5;p=0.002)。Logrank测试表明,对于所有GA患者(p=0.003)和35周出生的新生儿(p=0.015),MST的ECC插入成功率明显更高。成功的MSTECC成本为156.41英镑,而SNT为152.51英镑。
    在这项不受控制的回顾性研究中,使用MST成功插入ECC的可能性更高,每个成功的ECC减少了穿孔的数量和类似的成本。在随机研究中需要进一步的工作来验证这一发现,并且应该关注其他临床结果。包括中线相关血流感染率。
    UNASSIGNED: Epicutaneo-Caval Catheters (ECCs) are critical for good neonatal care. No previous studies have evaluated which insertion method provides the highest likelihood of success.
    UNASSIGNED: This study aimed to compare the success rates and cost of modified Seldinger technique (MST) and split needle technique (SNT). MST was introduced to St Michael\'s Neonatal Unit, SNT was already in use. Routinely documented data on ECC insertion was retrospectively collected from the clinical notes. Practitioners were able to use their preferred insertion method. A sub-group analysis of success rates in patients born at ⩾35-weeks GA was performed.
    UNASSIGNED: There was a significantly higher first pass (53% vs 26%; p = 0.014) and overall (72% vs 40%; p = 0.0046) successful ECC insertion rate with fewer venipunctures per successful ECC with MST (2.5 vs 6.5; p = 0.002). Logrank test demonstrated a significantly higher successful ECC insertion with MST for patients of all GA (p = 0.003) and for neonates born at ⩾35 weeks (p = 0.015). The cost per successful MST ECC was £156.41 versus £152.51 for SNT.
    UNASSIGNED: In this uncontrolled retrospective study, there was a higher chance of successful ECC insertion with MST, with a reduced number of venipunctures and similar costs per successful ECC. Further work in randomised studies is needed to verify this finding and should focus on other clinical outcomes, including rates in central line associated blood stream infections.
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  • 文章类型: Journal Article
    BACKGROUND: Vascular access for central venous catheter placement is technically challenging in children. Ultrasound guidance is recommended for pediatric central venous catheter placement, yet many practitioners rely on imprecise anatomic landmark techniques risking procedure failure due to difficulty mastering ultrasound guidance. A novel navigation system provides a visual overlay on real-time ultrasound images to depict needle trajectory and tip location during cannulation. We report the first pediatric study assessing feasibility and preliminary safety of using a computer-assisted needle navigation system to aid in central venous access.
    METHODS: A prospective, institutional review board-approved feasibility study was performed. All participants provided written informed consent. Ten patients (mean age: 11.4 years, five males) underwent central venous catheter placement with ultrasound and navigation system guidance. All procedures were performed by interventional radiologists expert in vascular access. Feasibility was measured through binary (yes/no) responses from participating users assessing device usability and feasibility. The number of needle passes and procedure time measures were also recorded.
    RESULTS: Internal jugular veins (seven right sided, three left sided) were cannulated in all patients with no complications. Users confirmed navigation system feasibility in all 10 participants. Mean vein diameter and depth was 13.3 × 9.8 ± 3.4 × 2.1 and 7.0 ± 1.7 mm, respectively. Successful cannulation occurred in all patients and required only a single needle pass in 9 of 10 patients. Mean device set-up and vascular access times were 5:31 ± 2:28 and 1:48 ± 2:35 min, respectively.
    CONCLUSIONS: This pilot study suggests that it is feasible to use a novel computer-assisted needle navigation system to safely obtain central venous access under ultrasound guidance in pediatric patients.
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  • 文章类型: Clinical Trial
    评估Wattson临时起搏导丝的安全性和有效性。
    经导管主动脉瓣置换术(TAVR)需要用于装置输送的引导线,通常需要用于突发和备用起搏的临时起搏线。Wattson导线提供伴随支持和双极起搏,而无需放置临时静脉起搏器(TVP)。
    这是一项单中心非随机前瞻性临床试验,纳入20名患者。主要终点定义为成功的快速起搏和经导管心脏瓣膜(THV)输送,无夺获损失。安全,还分析了定性和定量次要结局.
    平均年龄为77.4±9.0岁。胸外科学会(STS)平均评分为3.0±1.5%。所有患者均通过经股动脉入路接受球囊扩张瓣膜。所有患者均符合主要终点。1例(5%)有球囊扩张,6例(30%)有球囊扩张,所有使用电线。平均起搏阈值为2.2±1.2mA,在导线上放置绝缘导管之前进行评估。一名患者需要放置TVP并随后植入永久性起搏器,原因是THV部署后心脏完全阻滞。没有发生心脏穿孔或填塞。一名患者需要瓣膜再介入,这与设备无关。
    Wattson导丝提供可预测的导丝支持,同时在低阈值下进行可靠的双极起搏,以便在该患者队列中安全输送THV。它有可能使TAVR成为更安全,更有效的程序。
    To assess the safety and efficacy of the Wattson temporary pacing guidewire.
    Transcatheter aortic valve replacement (TAVR) requires a guidewire for device delivery and generally requires temporary pacing wire for burst and back-up pacing. The Wattson wire provides concomitant support and bipolar pacing without the need to place a temporary venous pacemaker (TVP).
    This was a single-center nonrandomized prospective clinical trial enrolling 20 patients. The primary endpoint was defined as successful rapid pacing and transcatheter heart valve (THV) delivery with no loss of capture. Safety, qualitative and quantitative secondary outcomes were also analyzed.
    Mean age was 77.4 ± 9.0 years. Mean Society of Thoracic Surgery (STS) score was 3.0 ± 1.5%. All patients received a balloon-expandable valve via a transfemoral approach. All patients met the primary end-point. One patient (5%) had balloon predilatation and six patients (30%) had postdilatation, all using the wire. Mean pacing threshold was 2.2 ± 1.2 mA that was evaluated prior to placing an insulating catheter over the wire. One patient required TVP placement and subsequent permanent pacemaker implantation due to complete heart block post THV deployment. There were no incidences of cardiac perforation or tamponade. One patient required valve reintervention, which was not related to the device.
    The Wattson wire offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe THV delivery in this patient cohort. It has the potential to make TAVR a safer and more efficient procedure.
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  • 文章类型: Journal Article
    经导管主动脉瓣植入术(TAVI)是针对无法手术或心脏直视手术风险高的患者的既定疗法。逆行经股动脉入路应用最广泛,是TAVI的首选。然而,周围血管疾病或髂股动脉小的存在往往限制了经股动脉的应用。经静脉顺行经中隔TAVI是一个有吸引力的选择,但由于其技术复杂性已经被放弃。
    我们之前已经描述了一种简化顺行经中隔球囊主动脉瓣成形术的新技术,它利用定制的Inoue球囊导管与两个探针。该技术被称为环状井上气球技术,在动物模型和临床病例中证明了其可行性和有效性。我们将此技术应用于TAVI。本研究旨在评估环状井上球囊技术在两只健康猪中用于TAVI的可行性。两头猪的瓣膜植入都成功了,虽然猪在植入后不久(2小时和24小时)死亡。死亡原因是介入部位出血(病例1)和人工瓣膜移位(病例2)。
    虽然还需要一些改进和进一步的研究,研究结果表明,使用环状井上气球技术顺行TAVI是可行的。
    Transcatheter aortic valve implantation (TAVI) is an established therapy for patients who are inoperable or at high risk for open heart surgery. The retrograde transfemoral approach is the most widely used and is the first choice in TAVI. However, existence of peripheral vascular disease or a small iliofemoral artery often limits the application of the transfemoral approach. Transvenous antegrade transseptal TAVI is an attractive option, but has already been abandoned due to its technical complexities.
    We have previously described a novel technique to simplify antegrade transseptal balloon aortic valvuloplasty, which utilizes a custom-made Inoue balloon catheter with two stylets. The technique is named as the looped Inoue balloon technique, and its feasibility and efficacy were proven in an animal model and a clinical case. We applied this technique to TAVI. The present study aimed to assess the feasibility of the looped Inoue balloon technique for TAVI in two healthy pigs. The valve implantation was successful in both pigs, although the pigs died soon after the implantation (2 and 24h). The causes of death were access site bleeding (Case 1) and migration of the prosthetic valve (Case 2).
    Although several improvements and further studies are required, the study results indicate that antegrade TAVI using the looped Inoue balloon technique is feasible.
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