Adverse Events and Modes of Failure Related to VASCADE Vascular Closure Device System: The Utility of the MAUDE Database

Purpose: Percutaneous mechanical circulatory support (pMCS) with the Impella® device is routinely used in cardiogenic shock and high risk percutaneous coronary interventions (PCI). However, safety and feasibility to close the large bore access (LBA) post-hoc remain a challenge. Materials and Methods: In patients with planned termination of Impella therapy, corresponding LBA closure was attempted using an undersized AngioSeal® device, which was deployed after insertion of a 0.035 in J-wire through the guidewire access port. Cross-over angiographic visualization before and after deployment as well as in-hospital follow up were performed to assess closure success and screening for short-term adverse events. Results: We evaluated 17 patients (68 year old, IQR 58–76, 71% male) in whom 14 F LBA closure after pMCS using the Impella CP® was achieved with an undersized AngioSeal® device. Clinical indication for pMCS was cardiogenic shock in 94% and protected PCI in 6%. Impella CP® devices were withdrawn after a median of 4 days (IQR 3–6 days). Primary hemostasis was achieved in the majority of patients (14/17; 82%) while single cross-over balloon inflation led to hemostasis in the remaining patients. One patient suffered acute ischemia later in the course of the disease, but this was not directly related to the closure device. In this study, no major bleeding or other device-related adverse events were observed. Conclusion: The 8 F AngioSeal® vascular closure device has been safely used for removal of the Impella CP® microaxial pump in most cases of predominantly normal weight patients. This technique may be considered feasible for post-hoc LBA closure in the context of pMCS, especially when preclosure options are not suitable or unavailable.

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Symptomatic vascular complications after vascular closure device use following diagnostic and interventional catheterisation

VASA ◽

10.1024/0301-1526.33.2.78 ◽

2004 ◽

Vol 33 (2) ◽

pp. 78-81 ◽

Cited By ~ 21

Author(s):

Thalhammer ◽

Aschwanden ◽

Jeanneret ◽

Labs ◽

Jäger

Keyword(s):

Current Literature ◽

Vascular Complications ◽

University Hospital ◽

Closure Device ◽

Ultrasound Guided ◽

Vascular Closure Device ◽

Device Use ◽

Arterial Stenoses ◽

The University ◽

Stenotic Lesions

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.

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Endovascular treatment of acute limb ischemia caused by an intravascularly deployed bioabsorbable plug of a vascular closure device

VASA ◽

10.1024/0301-1526/a000260 ◽

2013 ◽

Vol 42 (2) ◽

pp. 144-148 ◽

Cited By ~ 3

Author(s):

Daniel Maxien ◽

Barbara Behrends ◽

Karla M. Eberhardt ◽

Tobias Saam ◽

Sven F. Thieme ◽

...

Keyword(s):

Endovascular Treatment ◽

Limb Ischemia ◽

Closure Device ◽

Acute Limb Ischemia ◽

Vascular Closure Device

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First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery

10.1055/s-0040-1705487 ◽

2020 ◽

Author(s):

A. El-Sayed Ahmad ◽

S. Salamate ◽

M. Amer ◽

S. Sirat ◽

Ö. Akhavuz ◽

...

Keyword(s):

Minimally Invasive ◽

Valve Surgery ◽

Closure Device ◽

Vascular Closure Device ◽

Minimally Invasive Valve Surgery

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Influence of Use of a Vascular Closure Device on Incidence and Surgical Management of Access Site Complications after Percutaneous Interventions

Journal of Vascular Surgery ◽

10.1016/j.jvs.2011.06.012 ◽

2011 ◽

Vol 54 (2) ◽

pp. 584

Author(s):

J. Klocker ◽

A. Gratl ◽

A. Chemelli ◽

N. Moes ◽

G. Goebel ◽

...

Keyword(s):

Surgical Management ◽

Closure Device ◽

Vascular Closure Device ◽

Access Site ◽

Percutaneous Interventions

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Limitations of closing percutaneous transthoracic ventricular access ports using a commercial collagen vascular closure device

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.22941 ◽

2011 ◽

Vol 77 (7) ◽

pp. 1079-1085 ◽

Cited By ~ 8

Author(s):

Israel M. Barbash ◽

Christina E. Saikus ◽

Kanishka Ratnayaka ◽

Anthony Z. Faranesh ◽

Ozgur Kocaturk ◽

...

Keyword(s):

Closure Device ◽

Vascular Closure Device

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

Journal of Endovascular Therapy ◽

10.1177/152660289500200309 ◽

1995 ◽

Vol 2 (3) ◽

pp. 289-296 ◽

Cited By ~ 4

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.

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