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

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.

2020 ◽  
Author(s):  
Armando Del Prete ◽  
Domenico Giovanni Della Rocca ◽  
Simone Calcagno ◽  
Riccardo Di Pietro ◽  
Giuseppe Del Prete ◽  
...  

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.


VASA ◽  
2004 ◽  
Vol 33 (2) ◽  
pp. 78-81 ◽  
Author(s):  
Thalhammer ◽  
Aschwanden ◽  
Jeanneret ◽  
Labs ◽  
Jäger

Background: Haemostatic puncture closure devices for rapid and effective hemostasis after arterial catheterisation are a comfortable alternative to manual compression. Implanting a collagen plug against the vessel wall may become responsible for other kind of vascular injuries i.e. thrombotic or stenotic lesions and peripheral embolisation. The aim of this paper is to report our clinically relevant vascular complications after Angio-Seal® and to discuss the results in the light of the current literature. Patients and methods: We report the symptomatic vascular complications in 17 of 7376 patients undergoing diagnostic or therapeutic catheterisation between May 2000 and March 2003 at the University Hospital Basel. Results: Most patients presented with ischaemic symptoms, arterial stenoses or occlusions and thrombotic lesions (n = 14), whereas pseudoaneurysms were extremely rare (n = 3). Most patients with ischaemic lesions underwent vascular surgery and all patients with a pseudoaneurysm were successfully treated by ultrasound-guided compression. Conclusions: Severe vascular complications after Angio-Seal® are rare, consistent with the current literature. There may be a shift from pseudoaneurysms to ischaemic lesions.


VASA ◽  
2018 ◽  
Vol 47 (2) ◽  
pp. 119-124 ◽  
Author(s):  
Artur I. Milnerowicz ◽  
Aleksandra A. Milnerowicz ◽  
Marcin Protasiewicz ◽  
Wiktor Kuliczkowski

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


Author(s):  
Chetan Pasrija ◽  
Daniel A. Bernstein ◽  
Maryjoe Rice ◽  
Douglas Tran ◽  
David Morales ◽  
...  

Objective Percutaneous femoral cannulation for venoarterial extracorporeal membrane oxygenation (ECMO) is commonly performed but percutaneous removal of arterial cannulas has not been broadly accepted. We hypothesized that a system that allows endovascular access to ECMO circuits along with the MANTA® large-bore vascular closure device could be used to successfully close arterial ECMO cannulation sites in a large animal model. Methods Yorkshire swine (40 to 60 kg, n = 2) were used for this study. In the first swine, the infrarenal abdominal aorta was exposed. The aorta was cannulated once using a 15 Fr cannula and twice with a 19 Fr arterial cannula. A novel adaptor system that facilitates endovascular access to ECMO circuits was connected, and a 0.035″ Benston wire was placed through the adaptor and guided into the aorta. The cannula was removed over the wire and manual pressure was applied. The MANTA® sheath was inserted over the wire followed by the closure unit and was deployed. The process was repeated at 2 separate sites. A similar experiment was performed in a second swine, but through a median sternotomy to cannulate the ascending aorta. Results Good hemostasis was achieved at all cannulation sites. Angiography demonstrated unobstructed flow across all closure sites with no evidence of extravasation. Conclusions The data presented here support the use of the MANTA® vascular closure device for the closure of arterial cannulation sites following ECMO decannulation and demonstrates utility of a novel adaptor system for establishing endovascular access in this context.


2011 ◽  
Vol 57 (14) ◽  
pp. E1673
Author(s):  
Venkatesan D. Vidi ◽  
Sripal Bangalore ◽  
Michael E. Matheny ◽  
Sharon-Lise T. Normand ◽  
Frederic S. Resnic

2022 ◽  
Author(s):  
Florim Cuculi ◽  
Philipp Burkart ◽  
Giacomo Cioffi ◽  
Federico Moccetti ◽  
Mehdi Madanchi ◽  
...  

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.


2020 ◽  
Vol 15 (11) ◽  
pp. 2205-2207
Author(s):  
Wouter Stomp ◽  
Daniël Eefting ◽  
Jan van Schaik ◽  
Davy R. Sudiono ◽  
Rutger W. van der Meer

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