Success and reliability of extrafemoral Exoseal vascular closure device: “Off-label” usage

Aim The aim of this study is to present the reliability and efficacy of Exoseal vascular closure device (EVCD) for closure of extrafemoral punctures. Materials and methods All patients who were treated with EVCD following arterial endovascular treatment involving an extrafemoral puncture between April 2013 and January 2014 were examined retrospectively. This study included 11 patients (4 women and 7 men between the ages of 48 and 87 years; average age = 65 years). A total of 13 procedures were performed in 11 patients involving the following access routes: brachial artery (n = 5), popliteal artery (n = 4), and polytetrafluoroethylene graft (n = 4). Results Twelve out of 13 EVCD procedures achieved technical success and procedural success. One minor and one major complications occurred. Both complications were revealed to be pseudoaneurysms, both in the brachial artery. Pseudoaneurysm of the minor complication was treated by Fibrin Sealant (Tisseel) injection guided by ultrasonography and the other pseudoaneurysm was treated by covered stent placement. Conclusions The femoral artery is an essential access route of arterial endovascular procedures; however, in some cases, the extrafemoral arterial route is necessary. In this study, EVCD was found to be useful for closing extrafemoral arterial routes. This study had a limited number of cases and more large-scale studies are needed.

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Off-label Use of Angio-Seal™ Vascular Closure Device for Brachial Artery Puncture Closure—Deployment Modification and Initial Results After Transbrachial PTA

European Journal of Vascular and Endovascular Surgery ◽

10.1016/j.ejvs.2005.05.030 ◽

2006 ◽

Vol 31 (4) ◽

pp. 431-433 ◽

Cited By ~ 11

Author(s):

D. Bilecen ◽

G. Bongartz ◽

W. Ostheim-Dzerowycz

Keyword(s):

Brachial Artery ◽

Closure Device ◽

Off Label Use ◽

Vascular Closure Device ◽

Off Label ◽

Initial Results ◽

Label Use

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Safety and efficacy of Mynx vascular closure device for the closure of common femoral artery access after ipsilateral stent placement

The Journal of Vascular Access ◽

10.1177/1129729820966946 ◽

2020 ◽

pp. 112972982096694

Author(s):

Jin Ho Hwang ◽

Sang Woo Park ◽

Woo Young Yang ◽

Yong Wonn Kwon ◽

Jeeyoung Min ◽

...

Keyword(s):

Femoral Artery ◽

Stent Placement ◽

Common Femoral Artery ◽

Bleeding Complications ◽

Closure Device ◽

Technical Failure ◽

Technical Success ◽

Vascular Closure Device ◽

Access Site ◽

Low Bmi

Introduction: To evaluate the feasibility and safety of the Mynx vascular closure device (VCD) for arteriotomy closure after stent placement near the common femoral artery (CFA) access site. Methods: A total of 88 patients (73 men; mean age, 72 ± 9.2 years; 136 procedures) who underwent closure of CFA arteriotomy using the Mynx VCD after stent placement in proximal superficial femoral artery (SFA) with antegrade approach, or in common or external iliac artery with retrograde approach were retrospectively studied. Technical success and access site complication were evaluated. Body mass index (BMI), platelet count, international normalized ratio, prior history of ipsilateral CFA access, access direction, degree of CFA calcification, stent location and diameter, total procedure time, and sheath size were analyzed to evaluate their relationship with technical failure and development of bleeding complications. Results: Technical success was achieved in 94.9% (129/136) patients. The mean time to hemostasis was 0.7 ± 1.8 min. Technical failure was significantly associated with low BMI ( p = 0.001). Other variables presented no significant relationship with technical failure and development of complications. Ultrasonography on the day after the procedure revealed that 8 (5.9%) patients had hematoma. Conclusions: Mynx VCD for arteriotomy closure is feasible and provides hemostatic safety after stent placement near antegrade or retrograde CFA access. However, Mynx VCD may have a poor technical success rate among patients with low BMI.

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Obturator foramen bypass for infective groin caused by closure device

Asian Cardiovascular and Thoracic Annals ◽

10.1177/0218492316648584 ◽

2016 ◽

Vol 25 (2) ◽

pp. 131-133

Author(s):

Yoshihito Irie ◽

Shunichi Kondo ◽

Kyu Rokkaku ◽

Eitoshi Tsuboi ◽

Hiroshi Takano ◽

...

Keyword(s):

Femoral Artery ◽

Closure Device ◽

Vascular Closure Device ◽

Wound Irrigation ◽

Obturator Foramen ◽

Artery Pseudoaneurysm ◽

The Right ◽

And Control ◽

Patch Plasty ◽

Leg Ischemia

A 69-year-old man underwent carotid artery stenting through the right femoral artery with a percutaneous vascular closure device for hemostasis. Eleven days later, an infective femoral artery pseudoaneurysm was diagnosed by computed tomography. At surgery, a defect in the femoral artery was observed, corresponding to the remnants of the closure device. Removal of the foreign material, debridement, wound irrigation, and arterial patch plasty were performed, but the infection and leg ischemia did not improve. After several failed attempts to revascularize and control the infection, obturator foramen bypass was performed. The postoperative course was uneventful, indicating the usefulness of this procedure.

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Treatment of Refractory Iatrogenic Femoral Artery Pseudoaneurysm with a Vascular Closure Device

Journal of Vascular and Interventional Radiology ◽

10.1016/j.jvir.2009.08.023 ◽

2009 ◽

Vol 20 (12) ◽

pp. 1639-1640 ◽

Cited By ~ 7

Author(s):

Ding-Cheng Xiang ◽

William B. Hillegass ◽

Guo-xin Luo ◽

Jian-xin He

Keyword(s):

Femoral Artery ◽

Closure Device ◽

Vascular Closure Device ◽

Artery Pseudoaneurysm

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FemoSeal® vascular closure device for antegrade common femoral artery access: Safety and technical notes

The Journal of Vascular Access ◽

10.1177/1129729819854593 ◽

2019 ◽

Vol 21 (1) ◽

pp. 79-85 ◽

Cited By ~ 1

Author(s):

Francesco Bruno Tagliaferro ◽

Gianluigi Orgera ◽

Luca Mascagni ◽

Florindo Laurino ◽

Marcello Andrea Tipaldi ◽

...

Keyword(s):

Body Mass Index ◽

Platelet Count ◽

Femoral Artery ◽

Partial Thromboplastin Time ◽

Common Femoral Artery ◽

International Normalized Ratio ◽

Closure Device ◽

Technical Success ◽

Vascular Closure Device ◽

Puncture Site

Purpose: To retrospectively assess the efficacy and safety of FemoSeal® vascular closure device to achieve hemostasis following antegrade common femoral artery puncture after lower limb revascularization using vascular sheaths from 5 to 8 Fr. Methods: We reviewed the hemostatic outcome achieved with FemoSeal in 103 consecutive patients (mean age: 69 ± 8 years, 71 males) that undergone to 111 antegrade common femoral artery accesses for percutaneous lower limbs revascularization using 5- to 8-Fr vascular sheaths. We used FemoSeal in an unselected population, without exclusion criteria. The primary outcome was the technical success, meant as achieving complete hemostasis without immediate complications. Results: Hemostasis was achieved in all 111 puncture sites (100% technical success). We observed eight (7%) puncture site minor complications (hematomas), none of which affecting the patients’ outcome or requiring further therapies or increasing the hospital stay. There were no statistically significant differences between the variables potentially related to the occurrence of complications (age, international normalized ratio, platelet count, partial thromboplastin time ratio, body mass index, and common femoral arteries calcification grade) in patients with and without complications. Complications group mean body mass index was 26.4 ± 2.8 kg/m2 versus non-complications group 26.6 ± 4.4 kg/m2, p = 0.92. Mean international normalized ratio and partial thromboplastin time ratio were 1.05 ± 0.01 and 1.05 ± 0.14 versus 1.13 ± 0.2 (p = 0.39) and 1.12 ± 0.23 (p = 0.53), respectively. Common femoral arteries calcification grade was the same (mean: 1, p = 1). Platelet count was 202 × 103/mL ± 66.7 versus 226 × 103/mL ± 91.2, p = 0.55. Mean age was 72.3 ± 10 years versus 72.8 ± 8 years, p = 0.86. Conclusion: The low rate (7%) and grading of the adverse events, combined with the high technical success rate (100%), in an unselected group of patients treated in daily routine, suggest high safety and efficacy of FemoSeal vascular closure device in antegrade common femoral artery puncture site hemostasis when using vascular sheaths ranging from 5 to 8 Fr. Therefore, FemoSeal could be considered as a first-line hemostasis strategy in such cases.

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A novel double clip-based vascular closure device in antegrade and retrograde femoral punctures: A single-center experience in peripheral non-cardiac procedures

The Journal of Vascular Access ◽

10.1177/11297298211012829 ◽

2021 ◽

pp. 112972982110128

Author(s):

Annette Thurner ◽

Anjana Heuer ◽

Anne Marie Augustin ◽

Carsten Gietzen ◽

Thorsten A Bley ◽

...

Keyword(s):

Radiology Department ◽

Closure Device ◽

Limiting Factor ◽

The Novel ◽

Technical Success ◽

Vascular Closure Device ◽

Related Complication ◽

Retroperitoneal Hemorrhage ◽

Technical Success Rate ◽

Antegrade Approach

Background: This retrospective study investigates the efficacy and safety of the novel Celt ACD® vascular closure device (VCD) following antegrade and retrograde common femoral artery (CFA) punctures for the treatment of peripheral artery disease in a challenging patient collective (e.g. calcifications, obesity, and anticoagulation). Methods: A total of 208 VCDs (i.e. 100 antegrade and 108 retrograde) were deployed between October 2019 and December 2020 in a tertiary referral interventional radiology department. Fifty-two devices were undersized in relation to the introducer sheath (up to 2 Fr). Technical success and VCD related complications were evaluated in the immediate post procedure period and the following 24 h clinically. In 68% of cases, additional duplex ultrasound was performed prior to discharge. Results: The overall technical success rate was 97%. Technical failures following antegrade approach were due to a too acute access angle (⩾60°), rendering it impossible to pass the applicator tip through the sheath lumen. A subgroup analysis of technical success pinpoints severe calcification as another key limiting factor in VCD use ( p = 0.004). Comparing equally sized with undersized device selection ( p = 0.196), direction of approach ( p = 0.265), and body mass index ( p = 0.184) proved to be insignificant. Five (2%, 5/208) major complications occurred: Four antegrade (i.e. one false aneurysm, one vessel laceration with retroperitoneal hemorrhage, two device migrations; 4%, 4/100) and one following retrograde access (i.e. >6 cm hematoma, 1%, 1/108)). Complications were successfully managed with manual compression or interventional procedures. Conclusions: The novel clip-based VCD proved to be effective with a low VCD related complication rate.

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Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study

Vascular ◽

10.1177/17085381211062745 ◽

2021 ◽

pp. 170853812110627

Author(s):

Athanasios Diamantopoulos ◽

Romman Nourzaie ◽

Doug Mulholland ◽

Steven G Dolan ◽

Irfan Ahmed ◽

...

Keyword(s):

Prospective Study ◽

Closure Device ◽

Complication Rates ◽

Technical Success ◽

Vascular Closure Device ◽

Safety And Efficacy ◽

Post Procedure ◽

Vascular Sheath ◽

Peripheral Arterial ◽

A Prospective Study

Objectives This article aims to present a prospective study investigating the safety and efficacy of the Mynx Control extravascular closure device (Cordis Corporation, FL, USA), for femoral arterial closure in patients undergoing peripheral arterial procedures. Methods Between January 2020 and February 2021, 100 Mynx Control devices were deployed in 91 consecutive patients (mean age: 67.5 ± 16.9 years) who underwent peripheral arterial procedures. We used ultrasound and/or fluoroscopy during Mynx Control deployment and ultrasound post-procedure to detect complications. Femoral artery punctures included 62 (62%) antegrade and 38 (38%) retrograde punctures. The mean activated clotting time at time of device deployment was 221s. The primary endpoints were technical success, device failure, and complication rates up to 30 days. Results A 5F vascular sheath was used in 43 cases (43%) (36 (36%) 6F and 21 (21%) 7F). The majority of our cases had antegrade access (62%). Overall technical success rate was 97% in both antegrade and retrograde cases. In total, there were 4 minor complications: 3 (3%) cases of pseudoaneurysm and 1 (1%) case of haematoma. No major complications were recorded post-procedure or 30 days post index procedure. Conclusion The Mynx Control vascular closure device is safe and effective in achieving haemostasis in patients undergoing antegrade and retrograde peripheral angioplasty procedures.

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Hemostasis After Brachial Artery Access With the MynxGrip Device: A Case Report

Clinical Medicine Insights Cardiology ◽

10.1177/1179546818759298 ◽

2018 ◽

Vol 12 ◽

pp. 117954681875929 ◽

Cited By ~ 1

Author(s):

Arturo Giordano ◽

Stefano Messina ◽

Gennaro Maresca ◽

Giuseppe Biondi-Zoccai

Keyword(s):

Case Report ◽

Iliac Artery ◽

Brachial Artery ◽

Endovascular Procedures ◽

Standard Of Care ◽

Clinical Vignette ◽

Closure Device ◽

Manual Compression ◽

Alternative Means ◽

Limited Spectrum

Purpose: Brachial access is occasionally used for endovascular procedures when other more established or safer ones (eg, femoral or radial) are contraindicated. Although manual compression is the standard of care after brachial arteriotomy, suboptimal compression may lead to bleeding or thrombosis. Arteriotomy closure devices have thus been proposed as an alternative means to achieve hemostasis after brachial arteriotomy. Yet, there is a paucity of evidence and a limited spectrum of devices suitable for brachial arteriotomy closure. We present the use of the MynxGrip closure device after brachial arteriotomy. Case: A 70-year-old gentleman underwent brachial arteriotomy followed by iliac artery stenting with a 7F compatible device. Hemostasis was then achieved with the MynxGrip device, uneventfully. Conclusions: This clinical vignette highlights the feasibility and safety of brachial use of the MynxGrip device in experienced hands, suggesting that it can represent a useful adjunct to the armamentarium of the endovascular specialist.

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