Use of vascular closure devices for endovascular interventions requiring a direct puncture of PETE grafts

VASA ◽  
2018 ◽  
Vol 47 (2) ◽  
pp. 119-124 ◽  
Author(s):  
Artur I. Milnerowicz ◽  
Aleksandra A. Milnerowicz ◽  
Marcin Protasiewicz ◽  
Wiktor Kuliczkowski
Keyword(s):  
Statistical Significance ◽  
Vascular Complications ◽  
Vascular Complication ◽  
Inguinal Region ◽  
Closure Device ◽  
Manual Compression ◽  
Direct Puncture ◽  
Endovascular Interventions ◽  
Vascular Closure Devices ◽  
Closure Group

Abstract. Background: Effectiveness of vascular closure devices during endovascular procedures requiring a direct puncture of a vascular prosthesis placed in the inguinal region is unknown. Patients and methods: The retrospective analysis included 134 patients with a history of polyethylene terephthalate (PETE) graft implantation in the inguinal region. In 20 (15 %) patients, haemostasis was achieved with manual compression, in 21 (16 %) with the StarClose™, and in 93 (69 %) with the AngioSeal™ device. Results: The incidence of vascular complications in the manual compression group was higher (at a threshold of statistical significance) than in the device closure group (45.0 vs. 24.5 %, p = 0.059). The difference was considered statistically significant when manual compression was compared with the AngioSeal™ closure group (45.0 vs. 13.9 %, p < 0.01). The vascular complication rate in the StarClose™ group was significantly higher than in the AngioSeal™ group (71.4 vs. 13.9 %, p < 0.000001). While haematomas were the only vascular complications observed after application of AngioSeal™, both haematomas and pseudoaneurysms were found in the StarClose™ group. Conclusions: The AngioSeal™ vascular closure device provides better local haemostasis than the StarClose™ device or manual compression during endovascular interventions requiring a direct puncture of PETE grafts

Perclose Proglide™ for vascular closure

2020 ◽  
Author(s):  
Armando Del Prete ◽  
Domenico Giovanni Della Rocca ◽  
Simone Calcagno ◽  
Riccardo Di Pietro ◽  
Giuseppe Del Prete ◽  
...  
Keyword(s):  
Vascular Complications ◽  
Effective Alternative ◽  
Closure Device ◽  
Manual Compression ◽  
Vascular Closure Device ◽  
Patient Discomfort ◽  
The Past ◽  
Vascular Closure Devices

In the past 20 years, numerous percutaneous vascular closure devices have been tested and compared with manual compression and to surgical cut-down. The suture-mediated closure device Perclose ProGlide™ system (Abbott Vascular, CA, USA) emerged as a safe and effective alternative for many procedures requiring either small or large bore vascular accesses. In this review, we will discuss the characteristics of this vascular closure device and the main studies that proved its potential to reduce vascular complications, time to deambulation, time to discharge and patient discomfort.

A New Access Site Management Tool: The Angio-Seal™ Hemostatic Puncture Closure Device

1995 ◽  
Vol 2 (3) ◽  
pp. 289-296 ◽  
Author(s):  
Michel Henry ◽  
Max Amor ◽  
Mohamed Allaoui ◽  
Olivier Tricoche
Keyword(s):  
Arterial Wall ◽  
Bypass Graft ◽  
Vascular Complications ◽  
Common Femoral Artery ◽  
Management Tool ◽  
Closure Device ◽  
Manual Compression ◽  
Vascular Closure Device ◽  
Arterial Lumen ◽  
Manual Pressure

Purpose: Given the increasing number of percutaneously applied endovascular therapies, the incidence of access-related vascular complications can be expected to rise, particularly in association with those techniques requiring large sheaths or anticoagulation. The need exists for a safe, easy to use, and effective hemostatic technique to replace the labor-intensive method of manual compression. Methods: A bioabsorbable, sheath-delivered vascular closure device (Angio-Seal™) has been developed that deposits a small collagen plug within the arterial wall to mechanically seal the puncture defect. An anchor connected by suture to the plug is first deployed in the arterial lumen and pulled flush against the interior arterial wall to guard against intraluminal deposition of the collagen. Results: The Angio-Seal device was deployed successfully in 80 (96%) of 83 attempts involving common femoral arteries accessed for peripheral angioplasty (n = 30), coronary angiography (n = 30), and coronary angioplasty (n = 16). Three popliteal artery access sites and one femoropopliteal bypass graft were also treated. Hemostasis was immediate in 78 cases (98%); 2 sites required a 5-minute manual compression to effect a secure seal. Three devices failed to deploy, and manual pressure was used to close the puncture. Nondeployment did not cause any sequelae, and no complications were encountered with the technique. Conclusions: This novel vascular closure device is quick (< 1 minute application time) and simple to use, providing a positive seal of common femoral artery puncture sites for both peripheral and coronary interventions. It appears to be a reliable alternative to standard manual hemostasis.

Vascular closure devices in TAVI: MANTA versus ProGlide in a propensity-matched population

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G Sa Mendes ◽  
A Oliveira ◽  
R Campante Teles ◽  
P Araujo Goncalves ◽  
J Brito ◽  
...  
Keyword(s):  
Propensity Score ◽  
Learning Curve ◽  
Primary Endpoint ◽  
Femoral Artery ◽  
Statistical Significance ◽  
Vascular Complications ◽  
Artery Stenosis ◽  
Closure Device ◽  
Efficacy And Safety ◽  
Life Threatening

Abstract Background Vascular complications increase morbidity and mortality in transcatheter aortic valve implantation (TAVI). A collagen plug-based closure device - MANTA® was recently introduced as an alternative to the suture-mediated ProGlide® vascular closure device (VCD). Data regarding the efficacy and safety comparing both VCD is scarce. The present study sought to compare the effectiveness of both devices. Methods Single center retrospective analysis on prospectively collected data of 300 consecutive patients who underwent TAVI using MANTA® or ProGlide® since 2018. A 1:1 propensity-score matched population derived by a multivariate logistic regression model based on age, sex, body mass index, pre-procedural haemoglobin, EuroSCORE II, main access calcification and the sheath-to-artery ratio. The primary endpoint was the composite of major or life-threatening bleeding (VARC-2 definition), femoral artery stenosis/dissection, pseudoaneurysm and need for endovascular/surgical bailout intervention. Results The propensity score matching resulted in 129 matched pairs. The median age was 84 years old [IQR 80–87], 42% males with a median EuroSCOREII of 4.29% [IQR 3.05–6.24]. There were no differences in the primary endpoint between MANTA ® and ProGlide® cohorts (3.9% vs 7.8%, p=0.287, respectively). The rates of the primary endpoint with the MANTA® device decreased with center experience, with relatively steep learning curve effect concerning device success. Major or life-threatening bleeding (3.1% vs 5.4%, p=0.540) and pseudoaneurysm (0.8% vs 2.3%, p=0.622) occurred less frequently in MANTA® cohort, but the differences did not reach statistical significance. Endovascular (stent or balloon) or surgical rescue intervention (9.3% vs 5.4%, p=0.341) and femoral artery stenosis/dissection (6.2% vs 3.1%, p=0.376), were also similar rates. In ProGlide® cohort, to achieve VCD success (without primary endpoint events), 15.5% needed more than 2 devices, significantly different from MANTA ® (p&lt;0,001). Conclusions In patients undergoing transfemoral TAVI, the MANTA® VCD showed a similar efficacy and safety compared to the ProGlide® device and it reduced significantly the need of additional VCDs for completion of hemostasis. These results were obtained despite a clear learning curve associated with MANTA. Funding Acknowledgement Type of funding source: None

scholarly journals A Stopped Pilot Study of the ProGlide Closure Device After Transbrachial Endovascular Interventions

2019 ◽  
Vol 26 (5) ◽  
pp. 727-731 ◽  
Author(s):  
Max M. Meertens ◽  
Michiel W. de Haan ◽  
Geert W. H. Schurink ◽  
Barend M. E. Mees
Keyword(s):  
Pilot Study ◽  
Brachial Artery ◽  
Secondary Outcome ◽  
Control Group ◽  
Closure Device ◽  
Manual Compression ◽  
Access Site ◽  
Historical Cohort ◽  
Endovascular Interventions ◽  
High Incidence

Purpose: To evaluate the feasibility and safety of the suture-mediated ProGlide device in closure of the brachial artery after endovascular interventions. Materials and Methods: From 2016 to 2017, a pilot study was performed using the ProGlide to achieve hemostasis after percutaneous access of distal brachial arteries >4 mm in diameter. In an interim analysis, the results were compared to a matched control group taken from a 60-patient historical cohort who underwent brachial artery access and manual compression to achieve hemostasis between 2014 and 2017. The primary outcome was access-related reintervention and the secondary outcome was the incidence of access-site complications. Results: Seven patients (mean age 67.9 years; 6 men) were enrolled in the study before it was stopped in 2017. Four patients experienced 6 access-site complications (neuropathy, hematoma, occlusion, and pseudoaneurysm). These resulted in 3 access-related reinterventions: surgical evacuation of a hematoma, thrombectomy of the occluded brachial artery, and surgical repair of the pseudoaneurysm. In the interim comparison to the 19 matched patients (mean age 61.9 years; 6 men), the ProGlide group had proportionally more patients experiencing access-related complications (57% vs 16% for manual compression, p=0.035) and resultant reinterventions (43% vs 11%, p=0.064). Based on this data the trial was stopped. Conclusion: Considering this experience, it is not advisable to use the ProGlide in transbrachial endovascular interventions due to the high incidence of complications and access-related reinterventions.

scholarly journals Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease

2016 ◽  
Vol 64 (1) ◽  
pp. 104-108.e1 ◽  
Author(s):  
Talje M. Fokkema ◽  
Robert C. Minnee ◽  
Gert-Aldert H. Kock ◽  
Joost G.A.M. Blomjous ◽  
Anco C. Vahl ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Closure Device ◽  
Manual Compression ◽  
Peripheral Artery ◽  
Endovascular Interventions ◽  
Artery Disease ◽  
Arterial Closure Device

scholarly journals Manual Compression Versus MANTA Device for Access Management After Impella Removal on the ICU

2022 ◽  
Author(s):  
Florim Cuculi ◽  
Philipp Burkart ◽  
Giacomo Cioffi ◽  
Federico Moccetti ◽  
Mehdi Madanchi ◽  
...  
Keyword(s):  
Vascular Complications ◽  
Left Ventricular ◽  
Ventricular Assist Devices ◽  
Closure Device ◽  
Left Ventricular Assist Devices ◽  
Manual Compression ◽  
Access Management ◽  
Ventricular Assist ◽  
Number Of Patients ◽  
Significant Difference

Abstract Objective: To compare the safety and efficacy of manual compression versus use of the MANTA® closure device for access management after Impella® removal on the intensive care unit (ICU).Background: The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella® and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Methods: Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. Results: We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella® removal on ICU by using either the MANTA® device or manual compression. The cohort´s mean age was 66.1±10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 hours (Interquartile range 24–69 hours). MANTA® was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA® group (6.5% versus 39.3%(odds ratio (OR) 0.10, 95% CI 0.01–0.50; p=0.001), and there was no significant difference in vascular complications between the two groups(p=0.55).Conclusions: Our data suggests that the application of the MANTA® device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.

Femoral Closure – Devices and Strategies in 2010

2010 ◽  
Vol 5 (1) ◽  
pp. 93
Author(s):  
Benjamin H Holland ◽  
Robert J Applegate ◽  
◽  
Keyword(s):  
First Generation ◽  
Vascular Complications ◽  
Patient Comfort ◽  
Manual Compression ◽  
Single Centre ◽  
Access Site ◽  
Vascular Closure Devices ◽  
Improve Patient Comfort ◽  
Post Hoc ◽  
Improve Patient

Vascular closure devices (VCDs) reduce the time to haemostasis and ambulation and improve patient comfort compared with manual compression in patients undergoing vascular procedures from a femoral artery access site. Recent large, single-centre studies andpost hocdata from the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial strongly suggest that newer generations of VCD decrease rates of vascular complications compared with manual compression, in contrast to earlier evaluations of first-generation devices. Unfortunately, utilisation of VCDs remains limited and mitigates the potential benefit that could result from expanded use of these devices. Newer entrants into the VCD market such as Starclose and Mynx are based on extravascular closure methodology. These devices address concerns of intravascular components of a VCD; however, whether these devices reduce vascular complications and bleeding has not been evaluated. In this brief article, we will examine these factors in greater detail and suggest an algorithm for VCD use in clinical practice.

scholarly journals Hemorrhagic complications after endovascular interventions and the effectiveness of vascular closure devices

2021 ◽  
Vol 20 (7) ◽  
pp. 3046
Author(s):  
B. A. Rudenko ◽  
D. A. Feshchenko ◽  
D. K. Vasiliev ◽  
I. G. Sitko ◽  
F. B. Shukurov ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Complication Rate ◽  
Hemorrhagic Complication ◽  
Manual Compression ◽  
Vascular Intervention ◽  
Arterial Access ◽  
Endovascular Interventions ◽  
Vascular Closure Devices ◽  
Hemorrhagic Complications ◽  
Femoral Arterial Access

Aim. To identify the factors associated with hemorrhagic complications after endovascular interventions, as well as to assess the effectiveness of vascular closure devices.Material and methods. The study included 423 patients after endo - vascular intervention with femoral arterial access: 118  — manual compression, 305  — hemostasis using vascular closure devices (VCDs). The development of following complications was recorded: retroperitoneal hematoma, false aneurysm, arteriovenous fistula, bleeding, thigh soft-tissue hematoma. Time to hemostasis, immobilization period, and length of stay were assessed.Results. The complication rate was lower in VCD group compared to manual hemostasis (2,95 vs 11%, p=0,021). In VCD group, hemostasis characteristics significantly differed from the manual compression group: time to hemostasis — 3,1 vs 22,3 min (p=0,001), immobilization duration  — 4,1 vs 20 hours (p=0,001), length of stay  — 4 vs 8 days (p=0,001), respectively. The risk of complications increased with following factors: anticoagulant therapy, female sex, age >65 years, diabetes, body mass index >30 kg/m2 , vascular access calcification, introducer diameter >6 Fr, prior puncture. There were following independent predictors of complications: glycoprotein IIb/IIIa inhibitor therapy, superficial or deep femoral artery puncture.Conclusion. VCDs significantly reduces the hemorrhagic complication rate and improves hemostasis parameters as compared to manual compression.

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