Incidence of delayed angiographic femoral artery complications using the EXOSEAL vascular closure device

Background and purpose Femoral artery injuries are known complications of percutaneous vascular closure devices (VCDs). We studied the incidence of delayed femoral artery angiographic irregularities after neurointerventional procedures in which the EXOSEAL extravascular closure device was used for femoral arterial puncture closure. Methods Adult patients who underwent femoral arterial puncture closures with an EXOSEAL VCD and had a follow-up femoral artery angiogram from June 2012 through August 2013 were reviewed. A blinded radiologist compared pre-deployment and follow-up femoral arteriograms for the presence of femoral artery stenosis, dissection, pseudoaneurysm, or development of an arteriovenous fistula. Hospital records were reviewed for major or minor complications of the groin site or femoral artery. Results The EXOSEAL VCD achieved hemostasis, without evidence of a groin hematoma or requiring subsequent prolonged manual compression, in 400 of 441 closures following transfemoral arterial access, representing a device success rate of 90.7%. A total of 98 patients underwent 102 repeat angiograms following closure with the EXOSEAL VCD. The average time to the repeat angiogram was 73.5 days (range 0–488, median 28). Follow-up femoral arteriography demonstrated an irregularity in seven cases, all of which were vessel stenoses of <50%. There were no dissections, pseudoaneurysms, infections, or ischemic events in the study population. Conclusions Angiographic irregularities were seen in 6.86% of cases after closure with the EXOSEAL VCD. There were no clinically significant vascular complications. Thus, femoral artery closure with EXOSEAL carries a low risk of clinically significant delayed angiographic findings.

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Femoral artery occlusion with a percutaneous arterial closure device after a routine coronary angiogram: a case report and literature review

Annals of The Royal College of Surgeons of England ◽

10.1308/147870811x591143 ◽

2011 ◽

Vol 93 (6) ◽

pp. e102-e104 ◽

Cited By ~ 6

Author(s):

T Hussain ◽

S Al-Hamali

Keyword(s):

Femoral Artery ◽

Common Femoral Artery ◽

Arterial Disease ◽

Vessel Diameter ◽

Artery Occlusion ◽

Arterial Puncture ◽

Closure Device ◽

Coronary Angiogram ◽

Puncture Site ◽

Vascular Closure Devices

Groin vessels are most commonly used to obtain vascular access for angiography because of their size and accessibility. Haemostasis at the puncture site can be achieved with manual compression alone or by using a vascular closure device. We highlight the case of a 68-year-old woman who developed acute claudication in the right leg after a routine diagnostic coronary angiogram when an Angio-Seal™ device had been employed to close a relatively low arterial puncture. On exploring the common femoral artery, fragments of the device were found occluding the bifurcation. A patch angioplasty was carried out and the patient’s claudicant symptoms improved. The Angio-Seal™ device has a polylactide and polyglycolide polymer anchor, a collagen plug and a suture contained within a carrier system. Haemostasis is achieved by compressing the arterial puncture site between the anchor and the collagen plug. The manufacturer’s recommended criterion for using the device safely permits its use only for common femoral artery punctures with an internal vessel diameter of 4mm. Anatomical confirmation of the puncture site and evidence of any arterial disease or stenosis in the artery is detected on fluoroscopy during the procedure. Recent meta-analyses have cast doubt on the assumption that vascular closure devices are superior to mechanical compression alone and serious complications do occur occasionally but are under-reported. Clinicians should be aware of the potentially serious problems that may occur when deciding to employ vascular closure devices, especially with an anatomically low puncture site.

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

VASA ◽

10.1024/0301-1526/a000677 ◽

2018 ◽

Vol 47 (2) ◽

pp. 119-124 ◽

Cited By ~ 2

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

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Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry

Journal of the American Heart Association ◽

10.1161/jaha.120.018042 ◽

2020 ◽

Vol 9 (21) ◽

Author(s):

Sergio Berti ◽

Francesco Bedogni ◽

Arturo Giordano ◽

Anna S. Petronio ◽

Alessandro Iadanza ◽

...

Keyword(s):

Propensity Score ◽

Propensity Score Analysis ◽

Vascular Complications ◽

Bleeding Complications ◽

Efficacy And Safety ◽

End Point ◽

Transcatheter Aortic Valve ◽

Vascular Closure Devices ◽

Score Analysis

Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clinicaltrials.gov ; Unique identifier: NCT02713932.

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

European Heart Journal ◽

10.1093/ehjci/ehaa946.2588 ◽

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<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

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Inadvertent Subclavian Artery Cannulation: Endovascular Repair Using a Collagen Closure Device—Report of Two Cases and Review of the Literature

Case Reports in Vascular Medicine ◽

10.1155/2012/150343 ◽

2012 ◽

Vol 2012 ◽

pp. 1-4 ◽

Cited By ~ 1

Author(s):

Ganapathy Ananthakrishnan ◽

Richard D. White ◽

Rajesh Bhat ◽

Sam Chakraverty

Keyword(s):

Subclavian Artery ◽

Closure Device ◽

Endovascular Management ◽

Review Of The Literature ◽

Artery Cannulation ◽

Computed Tomographic ◽

Line Insertion ◽

Vascular Closure Devices ◽

Angiographic Findings ◽

Uncommon Complication

Inadvertent line insertion into the subclavian artery is an uncommon complication of subclavian venous catheterisation, and its timely recognition is vital to minimise risk of harm to the patient. We describe the radiographic, computed tomographic (CT), and angiographic findings in two patients and illustrate the subsequent endovascular management using collagen vascular closure devices.

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Radial Access for Neurointervention

10.1093/med/9780197524176.001.0001 ◽

2021 ◽

Keyword(s):

Femoral Artery ◽

Lower Risk ◽

Vascular Complications ◽

Artery Occlusion ◽

Arterial Access ◽

Transradial Access ◽

Pseudo Aneurysm ◽

Neurointerventional Procedures ◽

Device Technology

Although femoral artery catheterization has been the mainstay of arterial access for cerebral angiography, there has been a recent increase in the use of transradial access among neurointerventionalists. Despite its widespread use among interventional cardiologists, there is a paucity of evidence for its use in the neurosurgical literature. With the constant evolution of device technology and the need of multimodal treatments for complex neurovascular pathologies, most neurointerventionalists resort to femoral artery access because of the vessel’s larger diameter and having been trained with that approach. However, transradial access confers a number of benefits, most notably lower risk of vascular complications, shorter recovery, and increased patient satisfaction and cost reduction. Femoral artery catheterization requires patients to tolerate a painful and uncomfortable procedure, with associated potential complications such as pseudo-aneurysm formation, retroperitoneal hematoma, and artery occlusion. Compared with groin access, radial artery catheterization has been shown to confer a lower risk of local neurovascular complications and improved quality-of-life metrics. This book is the first of its kind, detailing step by step all the technical nuances of the transradial approach in the neurointerventional world, from diagnostic cerebral angiograms to neurointerventional procedures. This is the perfect book for physicians who decided to make the transition of their practice to transradial.

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Stenosis Caused by Suture-Mediated Vascular Closure Device in an Angiographic Normal Common Femoral Artery: Its Mechanism and Management

Vascular and Endovascular Surgery ◽

10.1177/1538574418791883 ◽

2018 ◽

Vol 53 (1) ◽

pp. 58-61

Author(s):

Young Jin Youn ◽

Salman Khalid ◽

Michael Azrin ◽

Juyong Lee

Keyword(s):

Femoral Artery ◽

Vascular Complications ◽

Bed Rest ◽

Common Femoral Artery ◽

Artery Stenosis ◽

Closure Device ◽

Standard Management ◽

Percutaneous Coronary ◽

Coronary Procedure ◽

Femoral Puncture

Vascular closing devices (VCDs) are widely used to replace manual compression at the femoral puncture site and to reduce the discomfort of patients undergoing percutaneous coronary procedure by shortening bed rest. Among the vascular complications related to these devices, the femoral artery stenosis or occlusion is rarely reported, and its standard management is not well established. We report a case of symptomatic femoral artery stenosis caused by suture-mediated VCD and managed using rotational atherectomy device and balloon angioplasty. In addition, we propose the possible mechanisms for this complication.

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Initial experience with the AXERA 2 Femoral Access System in neurovascular procedures

Interventional Neuroradiology ◽

10.1177/1591019915582163 ◽

2015 ◽

Vol 21 (3) ◽

pp. 412-417 ◽

Cited By ~ 1

Author(s):

Ramesh Grandhi ◽

Nathan T Zwagerman ◽

Xiaoran Zhang ◽

Stephanie H Chen ◽

Ashutosh P Jadhav ◽

...

Keyword(s):

Femoral Artery ◽

Common Femoral Artery ◽

Manual Compression ◽

Femoral Access ◽

Device Failure ◽

Arterial Access ◽

Access System ◽

Small Series ◽

Vascular Closure Devices ◽

Groin Hematoma

Introduction Conventional cerebral angiography is a commonly performed procedure in medicine. Vascular closure devices have been developed as alternatives to manual compression at the arteriotomy site and prolonged bed rest. The risks of using these devices include arterial dissection, groin hematoma, and device failure. Herein, we describe our experience with the use of a novel device used for arterial access and closure, the AXERA 2 Access System. Methods A total of 13 patients underwent vascular access and closure with the AXERA 2 Access System. Results Arterial access using the AXERA 2 Access System was achieved in 11 of 13 patients. Amongst the patients with successful access, one patient experienced a groin hematoma requiring manual compression and two patients suffered occlusions of the common femoral artery due to dissections, with both patients requiring femoral artery thromboendarterectomies. Conclusions This small series highlights a heretofore underreported serious complication rate of the AXERA 2 Access System. Additional studies are warranted to provide further insight into risk factors for device failure and complication development.

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Management of Haemostasis with Combined Use of Vascular Closure Devices and Bivalirudin – A Review

Interventional Cardiology Review ◽

10.15420/icr.2011.6.2.177 ◽

2011 ◽

Vol 6 (2) ◽

pp. 177

Author(s):

Emanuela de Cillis ◽

Giuseppe Massimo Sangiorgi ◽

Alessandro Santo Bortone ◽

◽

...

Keyword(s):

High Risk ◽

Vascular Complications ◽

Coronary Intervention ◽

Closure Device ◽

Vascular Closure Device ◽

High Risk Patients ◽

Vascular Closure Devices ◽

Combined Use ◽

Percutaneous Coronary ◽

Risk Patients

Bleeding and vascular complications related to invasive cardiovascular procedures are associated with significant morbidity and mortality. The aim of this article is to evaluate the literature to determine haemostasis strategies in percutaneous coronary intervention when using bivalirudin with or without a vascular closure device. The literature data seem to underline that the combination of vascular closure devices and bivalirudin was associated with significantly lower bleeding rates. However, these strategies were less often used among high-risk patients. We recommend that prospective clinical studies are undertaken to determine the potential disadvantages of using vascular closure devices and bivalirudin in combination in high-risk patients.

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Perclose Proglide™ for vascular closure

Future Cardiology ◽

10.2217/fca-2020-0065 ◽

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.

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