Vascular Closure Devices

血管闭合装置
  • 文章类型: Journal Article
    血管通路是最初的,非常重要,血管内手术的步骤。各种进入部位包括股总动脉,肱动脉,桡动脉,pop动脉,和胫骨远端血管(足动脉)。成功的动脉通路需要先进的解剖学知识,以及适当的培训和经验。今天,应使用实时获得血管通路,超声引导以减少访问时间,患者不适,和穿刺相关的并发症,包括夹层,动静脉通讯,和出血。然而,在外周手术中支持这一建议的高水平证据有限,A级数据主要来自仅研究桡动脉和股骨入路的随机心脏试验.用于股骨通路的血管闭合装置(VCD)可大致归类为主动闭合装置。压缩辅助装置,和外部/局部止血装置。有高水平的证据表明,它们的使用与更少的步行时间和增加的患者满意度有关。然而,现有数据未能清楚地证明在外周血管内动脉手术中与标准手动压迫相比在并发症方面的益处,VCD使用后报告的血栓性和感染性并发症仍然是一个问题。文献中提到的异质性,由各种各样的设备引起的,访问站点,护套尺寸,临床情景,和程序,给数据分析和未来研究设计带来了困难。因此,目前建议对≥5Fr股动脉通路进行个性化的VCD使用,这不仅是为了缩短止血和下床活动的时间,也是为了提高患者的舒适度,但也减少出血并发症的情况下,股骨入路出血风险增加,紊乱的凝血,和大口径通道,尽管支持这一后来建议的大量证据是有限的.关键点:美国的指导是强烈建议股骨入路,是强制性的,以获得更具挑战性的访问。使用VCD进行股骨止血通常是安全的,有效,目前有一级证据支持。正确的培训和正确的VCD选择,根据患者的个体特征,必须优化结果。
    Vascular access is the initial, very important, step of endovascular procedures. Various access sites include the common femoral artery, brachial artery, radial artery, popliteal artery, and distal tibial vessels (pedal arteries). Successful arterial access requires advanced knowledge of anatomy, as well as proper training and experience. Today, vascular access should be obtained using real-time, ultrasound guidance to reduce access time, patient discomfort, and puncture-related complications including dissection, arteriovenous communication, and bleeding. Nevertheless, high-level evidence to support this recommendation in peripheral procedures is limited and level A data are mainly derived from randomized cardiac trials investigating only radial and femoral access. Vascular closure devices (VCDs) for femoral access can be broadly categorized as active closure devices, compression assist devices, and external/topical hemostasis devices. There is high-level evidence demonstrating that their use is related to less time for ambulation and increased patient satisfaction. However, available data failed to clearly demonstrate a benefit in complications compared to standard manual compression in peripheral endovascular arterial procedures, and thrombotic and infectious complications reported following VCD use remain an issue. Heterogeneity noted in the literature, caused by the vast variety of devices, access sites, sheath sizes, clinical scenarios, and procedures, poses difficulties in data analysis and future study design. As a result, an individualized VCD use is currently suggested for ≥ 5 Fr femoral artery access not only to reduce time to hemostasis and ambulation and to improve patient comfort, but also to reduce bleeding complications in cases of femoral access with increased bleeding risk, deranged coagulation, and large-bore access, though a high level of evidence to support this later recommendation is limited. KEY POINTS: US guidance is strongly recommended for femoral access and is mandatory to obtain more challenging access. The use of VCDs for femoral hemostasis is generally safe, effective, and currently supported by level I evidence. Proper training and correct VCD choice, based on the patient\'s individual characteristics, are imperative to optimize outcomes.
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  • 文章类型: Journal Article
    目的:关于鞘管大小≥6Fr的经腋窝和经肱入路之间的入路部位并发症发生率的知识有限。我们回顾性地回顾了我们机构使用6Fr至10Fr鞘管尺寸的经皮腋窝和经肱动脉介入治疗的介入部位并发症的经验。
    方法:我们检查了18个月内进行的67项血管内介入治疗,限于6Fr到10Fr的护套尺寸。包括在超声引导下使用经肱(41例)和经腋窝(26例)入路的程序。排除涉及血液透析的病例和需要手术切除的病例。主要结局指标是30天内发生主要通路部位并发症(SIRII级/III级),收集止血方法的数据,护套尺寸,和并发症。统计分析涉及ANCOVA和Fisher精确检验,显著性设置为p<.05。
    结果:在所有情况下,采用两种方法(经腋窝或经肱动脉)均可成功进入经皮动脉。所有腋窝穿刺和71%的肱穿刺均采用闭合装置。经肱组41例中有7例(17%)发生主要通路部位并发症,经腋组26例中有4例(15%)发生。然而,两组并发症发生率无统计学差异,无论接入部位或鞘管大小。
    结论:经腋窝入路作为一种安全有效的上肢入路方法,与经肱入路相比,经皮血管内手术需要7Fr或更大的鞘管。
    OBJECTIVE: Limited knowledge exists regarding access site complication rates between trans-axillary and trans-brachial approaches with sheath sizes ≥6Fr. We retrospectively reviewed our institution experience with access site complications for percutaneous trans-axillary and trans-brachial arterial interventions using sheath sizes ranging from 6Fr to 10Fr.
    METHODS: We examined 67 endovascular interventions performed over 18 months, restricted to sheath sizes of 6Fr to 10Fr. Procedures utilizing trans-brachial (41 cases) and trans-axillary (26 cases) approaches under sonographic guidance were included. Cases involving hemodialysis accesses and those requiring surgical cut-down were excluded. The primary outcome measure was the occurrence of major access site complications (SIR grade-II/III) within 30 days, with data collected on hemostasis method, sheath size, and complications. Statistical analysis involved ANCOVA and Fisher\'s exact tests, with significance set at p < .05.
    RESULTS: Successful percutaneous arterial access was achieved in all cases using either approach (trans-axillary or trans-brachial). Closure devices were employed in all axillary punctures and in 71% of brachial punctures. Major access site complications occurred in 7 out of 41 cases (17%) in the trans-brachial group and in 4 out of 26 cases (15%) in the trans-axillary group. However, there was no statistically significant difference in complication rates between the two groups, regardless of access site or sheath size.
    CONCLUSIONS: Trans-axillary access serves as a safe and effective upper limb access method for percutaneous endovascular procedures requiring sheath size of 7Fr or larger when compared to trans-brachial approach.
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  • 文章类型: Letter
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  • 文章类型: Journal Article
    背景:经导管主动脉瓣植入术(TAVI)的患者中常见双股动脉通路,具有初级治疗通道(TAVI通道)和次级非TAVI通道。假性动脉瘤(PSA)是股动脉穿刺的重要并发症。TAVI后的主要血管并发症有很好的描述,但对PSA知之甚少。患者和方法:2014年1月至2020年1月,共有2063例患者接受了经股动脉TAVI。在TAVI前后评估股总动脉的血管超声。我们比较了患者特征,围手术期风险评分,程序特征,和根据瓣膜学术研究联盟3(VARC-3)标准的进入部位出血事件,停留时间(LOS)有(46)和没有(2017)PSA的患者之间的一年全因死亡率。结果:TAVI术后PSA发生率为2.2%(46/2063)。所有PSA均成功采用超声引导手动压迫(UGMC)或凝血酶注射(UGTI)治疗,无并发症。PSA患者的血小板计数较低(210×1000/μl与234×1000/μl;p<0.05),入院时出现更多心力衰竭症状(91%vs.25%;p<0.05),更常使用(N)OAC治疗心房颤动(AF;54%vs.38%;p<0.05),并且很少使用阿司匹林治疗(35%vs.51%;p<0.03)。多变量分析确定次要进入部位(比值比[OR]8.11;p<0.001)和(N)OAC治疗(OR1.31;p=0.037)为PSA发展的危险因素。PSA与VARC-3型1-3进入部位出血和较长的LOS相关(15.2±11.3dvs.11.6±8.9d;p<0.01),但这并不影响一年死亡率(17%vs.14%;p=0.53)。结论:假性动脉瘤是TAVI术后的重要并发症,与介入部位出血和住院时间延长有关。(N)OAC治疗和二次接入是重要的危险因素。假性动脉瘤可以通过注射凝血酶安全有效地治疗,并且不会影响一年的死亡率。
    Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/μl vs. 234×1000/μl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.
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  • 文章类型: Journal Article
    背景:心房颤动(AF)导管消融术后,通路部位并发症仍然很常见。与手动压缩相比,股血管闭合装置(VCD)可缩短止血时间,尽管缺乏比较两种方法临床结局的大规模数据.
    方法:使用全球联合研究网络(TriNetX)从36个医疗机构中确定了两组接受房颤消融术的患者:那些接受VCD股动脉止血的患者,和那些没有收到VCD的人。使用基于基线特征的1:1倾向评分匹配(PSM)模型来创建两个可比较的群组。主要结果是全因死亡率的复合结果,血管并发症,出血事件,需要输血.在早期(消融后7天内)和延长随访(消融后8-30天内)评估结果。
    结果:PSM后,包括28872例患者(每组14436例)。早期VCD队列中主要复合结局发生率较低(1.97%vs.2.60%,优势比(OR)0.76,95%置信区间(CI)0.65-0.88;p<.001)和延长随访(1.15%与1.43%,OR0.80,95%CI0.65-0.98;p=0.032)。这是由于VCD队列早期随访期间血管并发症发生率较低(0.83%vs.1.26%,OR0.66,95%CI0.52-0.83;p<.001),早期出血事件较少(0.90%vs.1.23%,OR0.73,95%CI0.58-0.92;p=.007)和延长随访(0.36%与0.59%,OR0.61,95%CI0.43-0.86;p=.005)。
    结论:房颤消融术后,与无VCD的股静脉止血相比,采用VCD的股静脉止血可减少并发症.
    BACKGROUND: Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking.
    METHODS: Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation).
    RESULTS: After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005).
    CONCLUSIONS: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.
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  • 文章类型: Journal Article
    这项回顾性研究旨在评估安全性,实用性,当双侧股总动脉入路不可用时,独立逆行入路再通股浅动脉(SFA)闭塞的疗效,如血管内动脉瘤修复术或髂总动脉支架置入术后。
    对侧髂动脉闭塞的患者考虑进行这种治疗,严重的髂弯曲,或先前接受过血管内动脉瘤修复术或髂总支架置入术的患者。排除SFA病变延伸到pp动脉的P1-P2段或P3段钙化的患者。通过the动脉入路进行血管成形术和支架置入术,在穿刺部位使用外seal血管闭合装置实现止血。在3、6和12个月时对患者进行常规随访,此后每年。
    本研究纳入了48例连续的SFA闭塞患者,这些患者通过逆行pop动脉入路接受了血管内治疗。在所有情况下,逆行穿刺the动脉均成功。所有程序均使用六法国鞘。48例均成功应用了EXOSEAL血管闭合装置。没有假性动脉瘤,动静脉瘘,大出血,或观察到栓塞并发症。SFA再通的技术成功率为100%。所有患者均经历了临床改善。踝臂指数从入院时的初始0.33±0.11显著升高至出院时的0.81±0.19(P<0.001)。平均随访时间为25.1±11.7个月。Kaplan-Meier分析显示,12个月时的原发性通畅率为82.5%,24个月时为71.8%。随访期间无患者需要大截肢。
    通过独立逆行入路血管内治疗SFA闭塞是一种可行的替代方法,显示穿刺相关并发症的发生率低,再通成功率高。
    UNASSIGNED: This retrospective study aims to evaluate the safety, practicality, and efficacy of the independent retrograde popliteal approach for recanalization superficial femoral artery (SFA) occlusions when the bilateral common femoral artery approach is unavailable, such as after endovascular aneurysm repair or common iliac artery stenting.
    UNASSIGNED: This treatment was considered for patients with contralateral iliac artery occlusion, severe iliac tortuosity, or those who had previously undergone endovascular aneurysm repair or common iliac stenting. Patients with SFA lesions extending into the P1-P2 segment of the popliteal artery or with calcification in the P3 segment were excluded. Angioplasty and stenting were conducted via the popliteal artery approach, with hemostasis at the puncture site achieved using an EXOSEAL vascular closure device. Patients were routinely followed up at 3, 6, and 12 months, and annually thereafter.
    UNASSIGNED: Forty-eight consecutive patients with SFA occlusion who underwent endovascular treatment via the retrograde popliteal artery approach were included in this study. Retrograde puncture of the popliteal artery was successful in all cases. Six-French sheaths were utilized in all procedures. The EXOSEAL vascular closure device was successfully applied in all 48 cases. No instances of pseudoaneurysms, arteriovenous fistulas, major bleeding, or embolic complications were observed. The technical success rate for SFA recanalization was 100 %. All patients experienced clinical improvement. The ankle-brachial index significantly increased from an initial 0.33 ± 0.11 at admission to 0.81 ± 0.19 at discharge (P < 0.001). The mean follow-up period was 25.1 ± 11.7 months. Kaplan-Meier analysis revealed primary patency rates of 82.5 % at 12 months and 71.8 % at 24 months. No patients required major amputation during the follow-up period.
    UNASSIGNED: The endovascular treatment of SFA occlusions via the independent retrograde popliteal approach is a viable alternative, demonstrating a low incidence of puncture-related complications and a high success rate of recanalization.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    目的:介入放射学的穿刺部位并发症有时会导致严重的疾病。血管闭合装置在预防穿刺部位并发症中起重要作用。血管闭合装置分为两种类型,直接缝合或夹持类型(主动逼近器)和粘附密封剂类型(被动逼近器)。然而,尚不清楚哪种类型的血管闭合装置最安全,最有效地实现止血。我们分析了每种类型的血管闭合装置的疗效以及穿刺部位并发症的危险因素。
    方法:本研究调查了在2年研究期间使用经股动脉手术的327例神经血管内手术的连续病例。上半部分主要使用被动逼近器(Angioseal和Exoseal),第二部分主要使用主动逼近器(Perclose)。我们比较了穿刺点并发症的分组和估计的危险因素。
    结果:所有手术均成功。比较有无穿刺点并发症的组,在无显著并发症的组中,被动逼近剂和≥3种抗血栓药物的使用频率趋于更高,皮肤至股动脉的距离和体重指数趋于更低.根据接收器操作特征曲线计算的股动脉深度的截止值为16.43mm。多因素分析显示,在股动脉深度<16.43mm(p<0.001,OR17.08,95CI2.95-57.80)的患者中,≥3种抗血栓药物(p=0.002,OR15.29,95CI2.76-85.76)和被动逼近器的使用在穿刺部位并发症组中明显更高。
    结论:股浅动脉深度患者使用被动逼近器会增加神经血管内治疗的穿刺点并发症。
    OBJECTIVE: Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications.
    METHODS: This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications.
    RESULTS: All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P = 0.002, OR 15.29, 95% CI 2.76-85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95-57.80) were significantly higher in the group with puncture-site complications.
    CONCLUSIONS: Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment.
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  • 文章类型: Journal Article
    背景:对于股静脉入路的闭合前和闭合后缝线介导的血管闭合系统之间的疗效和安全性差异尚未得到充分研究。
    目的:本研究旨在评估这两种缝合技术在股静脉入路中的有效性和安全性。
    方法:使用8-至13-F内径的鞘通过股静脉进行选择性导管消融的患者(n=282)被随机分为使用ProGlide/ProStyle(雅培血管)进行单缝合技术的前或后组。手术后第1天和第90天进行双重超声检查以评估血管并发症。主要疗效终点是需要再压缩的再出血,主要安全终点是90天内发生的任何主要并发症.次要疗效终点包括止血时间和下床活动时间,次要安全终点为90天内发生的任何轻微并发症.
    结果:与关闭后组相比,预关闭组的再出血率显着降低(141中的5[3.5%]比141中的15[10.6%];P=0.03),止血时间更短(254.0±120.4秒vs299.8±208.2秒;P=0.02)。每组5名患者在90天失去随访。两组的主要并发症发生率相似(136人中有1例[0.7%];P=1.00),而在关闭前和关闭后的136例患者中有18例(13.2%)和136例患者中有21例(15.4%)观察到轻微的并发症,分别,无显著性差异(P=0.73)。
    结论:在使用ProGlide/ProStyle的单缝合技术的股静脉入路中,预关闭技术比关闭后技术具有更高的止血率,不影响安全。
    BACKGROUND: Differences in the efficacy and safety between the preclose and postclose suture-mediated vascular closure systems for femoral vein access have not been adequately studied.
    OBJECTIVE: This study aimed to evaluate the efficacy and safety of these 2 suturing techniques in femoral vein access.
    METHODS: Patients subjected to elective catheter ablation via the femoral vein using a sheath of 8- to 13-F inner diameter (n = 282) were randomized to the preclose or postclose groups for the single-suture technique using ProGlide/ProStyle (Abbott Vascular). Duplex ultrasound was performed on days 1 and 90 after the procedure to evaluate vascular complications. The primary efficacy endpoint was rebleeding requiring recompression, and the primary safety endpoint was any major complication occurring within 90 days. The secondary efficacy endpoints included time to hemostasis and time to ambulation, and the secondary safety endpoint was any minor complication occurring within 90 days.
    RESULTS: The preclose group demonstrated a significantly lower rebleeding rate (5 of 141 [3.5%] vs 15 of 141 [10.6%]; P = 0.03) and shorter time to hemostasis (254.0 ± 120.4 seconds vs 299.8 ± 208.2 seconds; P = 0.02) compared with the postclose group. Five patients in each group were lost to follow-up at 90 days. Incidence of major complications were similar in both groups (1 of 136 [0.7%]; P = 1.00), whereas minor complications were observed in 18 of 136 (13.2%) and 21 of 136 (15.4%) patients in the preclose and postclose groups, respectively, without a significant difference (P = 0.73).
    CONCLUSIONS: In femoral vein access using the single-suture technique with ProGlide/ProStyle, the preclose technique presented a higher hemostasis rate than the postclose technique, without compromising safety.
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  • 文章类型: Journal Article
    越来越多的介入手术需要大鞘管技术(>12F),其结果良好,血管内而不是开放的手术通道。然而,血管并发症限制了这些患者的治疗.本试验旨在确定Cross-Seal缝合介导的血管闭合装置在使用8F至18F程序鞘进行介入手术后在目标肢体进入部位止血的有效性和安全性。
    Cross-SealIDE试验(研究设备豁免)是一个前瞻性的,单臂,使用8F至18FID程序鞘进行经皮血管内手术的受试者的多中心研究。主要疗效终点是目标肢体进入部位的止血时间。主要安全终点是术后30天内目标肢体进入部位无主要并发症。
    在2019年8月9日至2020年3月12日期间,共招募了147名受试者。53.7%(79/147)的受试者进行了经导管主动脉瓣置换术,46.3%(68/147)的受试者进行了经皮腹/胸主动脉瘤血管内修复术。平均鞘ID为15.5±1.8mm。止血时间的主要有效性终点为0.4±1.4分钟。9.2%(13/142)的受试者需要辅助干预,其中手术占2.1%(3/142),腔内占5.6%(8/142)。在92.3%(131/142)的受试者中实现了技术成功。目标肢体进入部位的主要并发症发生率为94.3%(83/88)。
    在使用8F至18FID程序鞘进行经皮血管内手术的特定患者中,Cross-Seal缝合介导的血管闭合装置在大口径动脉切开术的闭合中取得了良好的有效性和安全性。
    URL:https://www。clinicaltrials.gov;唯一标识符:NCT03756558。
    UNASSIGNED: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths.
    UNASSIGNED: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure.
    UNASSIGNED: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88).
    UNASSIGNED: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy.
    UNASSIGNED: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.
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