Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis

Objective: A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). Methods: We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. Results: We included nine studies with a total of 2865 patients (plug-based n ¼ 1631, suture-based n ¼ 1234). There was no significant difference in primary outcome of all bleeding when using plugbased as opposed to suture-based VCDs (RR 1.14 [0.62e2.06] I2 ¼ 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38e3.58] I2 ¼ 65%), major vascular complications (RR 0.84 [0.35e2.00] I2 ¼ 55%), minor vascular complications (RR 1.05 [0.56e1.95] I2 ¼ 42%), pseudo aneurysm (RR 1.84 [0.11e29.98] I 2 ¼ 44%), stenosis-dissection (RR 0.98 [0.66e1.47] I2 ¼ 0%), VCD failure (RR 1.71 [0.96e3.04] I2 ¼ 0%), and blood transfusion (RR 1.01 [0.38e2.71], I2 ¼ 61%). Conclusion: Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

Research progress of vascular closure devices / 中国介入影像与治疗学

Vascular closure device is a kind of medical devices for hemostasis at the puncture site after percutaneous arterial puncture, including active vascular closure devices and passive vascular closure devices. The principle, application range, advantages and disadvantages of common products of vascular closure devices were reviewed in this paper.

Clinical application of ExoSealTM vascular closure device in interventional management via retrograde femoral artery access / 介入放射学杂志

Objective To discuss the safety and efficacy of using ExoSealTM vascular closure device to obtain rapid hemostasis of puncture site in interventional procedure via retrograde femoral artery access.Methods The clinical data of 124 patients,who were admitted to authors' hospital during the period from March 2016 to April 2016 to receive interventional procedure via retrograde femoral artery access,were retrospectively analyzed.During the performance of intervention,ExoSealTM vascular closure device (ExoSealTM group,n=52) or manual compression (MC group,n=72) was employed to make femoral artery puncture point hemostasis.The time spent for hemostasis,the manual compression time,the limb immobilization time,the amount of blood loss during compression process,and the procedure-related complications were recorded and the results were compared between the two groups.Results Technical success rate in ExoSealTM group was 98.1％(51/52).In ExoSealTM group and MC group,the time spent for hemostasis was (0.28±0.08) min and (5.83±1.46) min respectively,the manual compression time was (2.65 ±0.57) min and (7.70± 1.88) min respectively,the limb immobilization time was (2.72±0.43) h and (6.15±0.69) h respectively;all the differences between the two groups were statistically significant (P＜0.01).In ExoSealTM group subcutaneous hemotoma occurred in one patient,while in MC group subcutaneous hemotoma occurred in 3 patients and pseudoaneurysm in one patient;the complication rates were 1.92％ (1/52) and 5.56％ (4/72) respectively,but the difference was not statistically significant (P＞0.05).In MC group the amount of blood loss during compression process was (1.11±0.86) ml,which was remarkably less than (7.83±2.08) ml in ExoSealTM group,the difference between the two groups was statistically significant (P＜0.01).Conclusion For hemostasis of puncture site in interventional management via retrograde femoral artery access,the use of ExoSealTM vascular closure device is safe and effective.

Application of ExoSeal vascular closure device in interventional management via antegrade femoral access / 中国介入影像与治疗学

Objective To investigate the safety and clinical value of using ExoSeal vascular closure device (VCD) in interventional management via antegrade femoral access.Methods Clinical and imaging data of 303 patients (316 affected limbs) who were received interventional procedure via antegrade femoral access closure were retrospectively analyzed.ExoSeal VCD (VCD group,n=127) and manual compression (MC group,n =176) were performed to make femoral artery puncture point hemostasis.The time of hemostasis,actual immobilization time,technical success rate and vascular related complications were recorded and compared between the two groups.Results In VCD group and MC group,the time of hemostasis were (3.68 ± 2.40) min and (18.32 ± 4.54) min,the actual immobilization time were (3.45±5.30) h and (10.44±14.68) h,the technical success rates were 98.52％ (133/135) and 93.92％ (170/181),and the complication rates were 2.22％ (3/135) and 8.84％ (16/181),respectively.There were statistically significant differences between two groups (all P＜0.05).In VCD group,there were 2 cases of subcutaneous hematomas,and 1 case of retroperitoneal hematoma.In MC group,there were 15 cases of subcutaneous hematomas and 1 case of acute thrombosis in the puncture side limb.Conclusion Regarding hemostasis of puncture site in interventional management via antegrade femoral access,the use of ExoSeal VCD is safe and effective.

Endovascular Repair Using Suture-Mediated Closure Devices and Balloon Tamponade following Inadvertent Subclavian Artery Catheterization with Large-Caliber Hemodialysis Catheter

Accidental subclavian artery cannulation is an uncommon but potentially serious complication of central venous catheterization. Removal of a catheter inadvertently placed in the subclavian artery can lead to substantial bleeding, as achieving hemostasis in this area through manual compression presents considerable difficulty. Additionally, surgical treatment might be unsuitable for high-risk patients due to comorbidities. Here, we report a case of an inadvertently-inserted 11.5-French hemodialysis catheter in the subclavian artery during internal jugular venous catheterization. We performed percutaneous closure of the subclavian artery using three 6-French Perclose Proglide® devices with a balloon tamponade in the proximal part of the subclavian artery. Closure was completed without embolic neurological complications.

Fatores de risco para complicações relacionadas ao acesso vascular em pacientes submetidos à estratégia invasiva precoce / Risk factors for vascular access-related complications in patients undergoing early invasive strategy

Introdução: O conhecimento dos fatores de risco relacionados às complicações do acesso vascular em pacientes submetidos à estratégia invasiva precoce permite adotar estratégias capazes de minimizá-las. Métodos: Realizamos subanálise do estudo ARISE, com o objetivo de identificar preditores de complicações vasculares em pacientes randomizados para as técnicas radial ou femoral com emprego de dispositivo de oclusão vascular (DOV). Resultados: Foram incluídos 240 pacientes, com média de idade de 63,0 ± 10,7 anos, sendo 30,8% diabéticos e, exceto pela maior prevalência de mulheres no grupo radial, não foram observadas diferenças clínicas entre os grupos. Intervenção coronária percutânea foi realizada em 86,7% dos casos. A taxa de complicações vasculares aos 30 dias foi de 13,3% no grupo radial, à custa de hematomas > 5 cm (6,7%) e oclusão arterial assintomática (5,8%), e de 12,5% no grupo femoral, à custa de hematomas > 5 cm, sem diferença significativa. Foram identificados como fatores de risco para complicações do acesso vascular o índice de massa corporal (IMC), o acidente vascular encefálico prévio, a maior duração do procedimento e o insucesso do DOV. Pela análise estratificada, o sexo feminino e o escore CRUSADE de alto ou muito alto risco foram variáveis preditoras de complicações apenas para o grupo femoral. No modelo multivariado, os fatores que permaneceram significantes foram o IMC e o insucesso do DOV. Conclusões: As técnicas radial e femoral, com o emprego de DOV, compartilharam variáveis preditoras de complicações. Fatores de risco, como sexo feminino e escore CRUSADE de alto risco, foram atenuados pela utilização da técnica radial

Background: The knowledge of risk factors related to vascular access complications in patients undergoing early invasive strategy allows the adoption of methods to minimize them. Methods: We performed a subanalysis of the ARISE study, aiming to identify predictors of vascular complications in patients randomized to the radial or femoral techniques with the use of vascular closure device (VCD). Results: A total of 240 patients with a mean age of 63.0 ± 10.7 years were included, with 30.8% of diabetics. Except for a higher prevalence of women in the radial group, there were no clinical differences between the groups. Percutaneous coronary intervention was performed in 86.7% of the cases. The rate of vascular complications after 30 days was 13.3% in the radial group, due to hematoma > 5 cm (6.7%) and asymptomatic artery occlusion (5.8%), and 12.5% in femoral group, due to hematoma > 5 cm, without significant difference. The following were identified as risk factors for vascular access complications: body mass index (BMI), previous stroke, longer duration of the procedure, and VCD failure. At the stratified analysis, female gender and high or very high-risk CRUSADE score were predictors of complications only for the femoral group. In the multivariate model, the factors that remained significant were BMI and VCD failure. Conclusions: The radial and femoral techniques, with the use of VCD, shared variables that were predictors of complications. Risk factors, such as female gender and high-risk CRUSADE score, were attenuated by the use of the radial technique

Brief introduction of vascular closure device / 介入放射学杂志

A vascular closure device (VCD) is a medical apparatus which is used for stopping bleeding at the puncture point after percutaneous vascular puncturing management. According to its principles , these devices can be categorized into active closure device, compression-assisted device and local hemostatic plaster. The use of these devices can shorten the time of hemostasis, the time of limb immobilization, and the time of hospitalization; it can also reduce the damage to the patient, improve patient’s comfort, and reduce the work load of the medical staff as well. But each VCD has its own applicable scope and learning curve , thus it might cause serious complications when it is improperly used. Therefore , in using VCD the interventional physicians should be familiar with the characteristics of each special VCD and have enough knowledge concerning the treatment of the common complications. This paper aims to make a comprehensive review of the closure device manufacturer data and the relevant literatures recently published so as to make a brief introduction of the principle, characteristics, scope of application and practical tips of several common vascular closure devices.

Meta-analysis of per close vascular closure device hemostasis by femoral artery intervention application / 中国实用护理杂志

Objective To evaluate the effect of Angio-Seal vascular closure device by the femoral artery hemostasis.Methods Relative literature was searched by computer,according to the inclusion and the exclusion criteria,which were analyzed by RevMan5.2 software.Results A total of four studies of randomized controlled trial were brought into this research,the total sample size was involved in 3 191 cases,the sample size of the intervention group and the control group respectively was 1 583 and 1 608.The analysis results showed,Angio-seal vascular closure device can significantly shorten the time of hemostasis after femoral artery interventional therapy in patients and the limb braking time.The sensitive analysis results showed that the results stability were high and the conclusions were reliable.Conclusions Application of Angio-seal vascular closure device can significantly shorten the interventional therapy in patients with bleeding time and braking time.

Coronary Artery Fistula Draining into Lung Parenchyma Causing Localized Pulmonary Edema: Transcatheter Closure with an Amplatzer Vascular Plug 4

Coronary artery fistula draining into lung parenchymal vasculature has not been reported. Herein, we describe a case of an 81-year-old woman who presented with a localized pulmonary edema on right upper lobe associated with coronary fistula emptied into vasculature in right upper lobe. She underwent transcatheter closure of the fistula with an Amplatzer Vascular Plug 4, which resulted in complete occlusion and improved localized pulmonary edema.

Per-left auricle suture of mitral valve using modified vascular closure device: An in vitro experiment / 第二军医大学学报

Objective To investigate the feasibility of per-left auricle suture of mitral valve using modified vascular closure device via in vitro experiment, so as to search for new technique for treatment of mitral regurgitation. Methods The market vascular closure devicewas modified by cutting the tip of extension tube, while reserving the marking hole for passing the puncture wire and broadening the needle pitch. Twenty goat hearts were obtained and the pericardium was opened to expose the left auricle. After puncture of the left auricle with the Cordis needle, a "J" type guide wire was inserted through the needle sheath. It was confirmed that the "J" type guide wire must be in the left ventricle through cutting the left ventricle along the interventricular groove. Then the modified vascular closure device was introduced into the left ventricle along the "J" wire. The anterior leaflet and posterior leaflet of mitral valve were sutured together by the vascular closure device in ventricular side of the mitral valve. Results Ourmodified vascular closure device could successfully suture the anterior leaflet and posterior leaflet of mitral valve, without damaging the valve structure. Conclusion The modified vascular closure device is well designed and can be used for suturing anterior leaflet and posterior leaflet of mitral valve.

Surgical Treatment of Acute Arterial Occlusion after Applying the Vascular Closure Device for Hemostasis of Femoral Arteriotomy in Vascular Intervention

Vascular intervention via the femoral artery can cause vascular access complications and complications from closure of the arteriotomic incision site such as bleeding, thrombotic complications and vascular trauma. These types of complications occur in about 2% to 10% of the cases. After removal of the catheter, hemostasis is traditionally achieved by manual compression as a standard method. Many vascular closure devices have been developed in an attempt to improve the patient's comfort and to decrease the time to ambulation. Yet the safety and effectiveness of these vascular closure devices as compared to that of manual compression remains unclear. Herein we report on a case of femoral arterial occlusion due to vascular closure devices and the operative management.

Efficacy of Femoral Vascular Closure Devices in Patients Treated with Anticoagulant, Abciximab or Thrombolytics during Percutaneous Endovascular Procedures

OBJECTIVE: This study assessed the outcomes of using vascular closure devices following percutaneous transfemoral endovascular procedures in the patients who were treated with heparin, abciximab or thrombolytics (urokinase or t-PA) during the procedures. MATERIALS AND METHODS: From March 28, 2003 to August 31, 2004, we conducted a prospective and randomized study in which 1,676 cases of 1,180 patients were treated with one of the two different closure devices (the collagen plug device was Angio-SealTM; the suture-mediated closure device was The Closer STM) at the femoral access site after instituting percutaneous endovascular procedures. Among the 1,676 cases, 108 cases (the drug group) were treated with heparin only (n = 94), thrombolytics only (n = 10), heparin and thrombolytics (n = 3), or abciximab and thrombolytics (n = 1) during the procedures; 1,568 cases (the no-drug group) were treated without any medication. We compared the efficacy and complications between the two groups. Of the drug group, 42 cases underwent arterial closures with the collagen plug devices and 66 cases underwent arterial closures with the suture-mediated closure devices. We also compared the efficacy and complications between these two groups. RESULTS: The immediate hemostasis rates were 92.9% (1,456/1,568) in the no-drug group and 91.7% (99/108) in the drug group. Early complications occurred in four cases of the drug group. These included two episodes of rebleeding with using the Closer S, which required manual compression for at least 10 minutes, and two episodes of minor oozing with using one Angio-Seal and one Closer S, which required two hours of additional bed rest. There was no late complication. So, the total success rates were 90.8% (1,423/1,568) in the no-drug group and 88.0% (95/108) in the drug group. These results were not significantly different between the two groups (p = 0.34). In the drug group, the difference of the successful hemostasis rate between the collagen plug devices and the suture-mediated devices was also not statistically significant (92.9% vs. 84.8%, respectively; p = 0.21). CONCLUSION: Arterial closure of the femoral access site with using vascular closure devices is both safe and effective, even in the patients who received heparin, abciximab or thrombolytics.

The closure device for the puncture point of femoral artery:an experiment in vitro / 介入放射学杂志

Objective To assess the blocking effects of a new-type closure device for the puncture point of femoral artery in vitro.Methods An embolic colloidal substance with stable swelling value was embedded in an extracorporeal model which was used as an imitator of femoral artery blood flow velocity.Results The embolization colloid was not displaced by the imitated blood flow lash,the embolic colloid was firmly attached to the puncture point and no fluid extravasation occurred.Conclusion This new-type closure device for the puncture point of femoral artery is simple in structure and easy to manipulate with satisfactory blocking results.

Application of vascular closure device with the new Angio-Seal STS to cardiac catheterization / 中国实用内科杂志

Objective To evaluate the value of Vascular Closure Device(VCD)with the new Angio-Seal STS(Self-Tightening Suture)in femoral artery closure after coronary angiography(CAG)or percutaneous coronary intervention(PCI).Methods Totally 298 patients were divided into Angio-Seal STS group(group A,n=120)and manual compression group(group B,n=178).The success rate of hemostasis,the time of hemostasis,the time of bedrest and the complication rate were observed.Results Compared with group B,the time of hemostasis,the time of bedrest and the rate of distress on the waist were markedly decreased in group A(P0.05).Conclusion Angio-Seal STS vascular closure derice provided a safe and effective means of obtainig rapid arterial hemostasis after cardiac catheterization.It reduces the bedrest time and discomfort without increasing complications.Angio-seal STS device has the feature of self tightening suture,and doesn't need the post-placement tension spring.