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

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.

scholarly journals Antegrade common femoral artery access site closure using the MANTA vascular closure device

2020 ◽  
Vol 15 (11) ◽  
pp. 2205-2207
Author(s):  
Wouter Stomp ◽  
Daniël Eefting ◽  
Jan van Schaik ◽  
Davy R. Sudiono ◽  
Rutger W. van der Meer
Keyword(s):  
Femoral Artery ◽  
Common Femoral Artery ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Access Site

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

2019 ◽  
Vol 21 (1) ◽  
pp. 79-85 ◽  
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.

Abstract 275: Angioscore Balloon in the Treatment of Collagen Plug Occlusion and Acute Limb Ischemia: Case Report

2012 ◽  
Vol 32 (suppl_1) ◽  
Author(s):  
Pooja M Swamy ◽  
Abeer Berry ◽  
Mahir D Elder
Keyword(s):  
Case Report ◽  
Lower Extremity ◽  
Femoral Artery ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Common Femoral Artery ◽  
Closure Device ◽  
Acute Limb Ischemia ◽  
Access Site ◽  
Left Lower Extremity

BACKGROUND: Complications of the vascular access-site (VAS) are not uncommon. With the evolution of hemostatic techniques used in the access site closure, in the last two decades, the rate of VAS related complications has significantly reduced from 6% to 2%. However, they still remain to be an important cause of morbidity following catheterization procedures. The most common complications encountered with closure of VAS are hematoma formation, arterio-venous fistula, dissection, pseudo -aneurysm and limb ischemia. According to two meta-analyses, the incidences of these complications were very low. The incidence of collagen plug from an Angioseal(™) device causing acute leg ischemia is low and upon occurrence, the use of an Angioscore(™) balloon in successful revascularization has never been reported. CASE PRESENTATION: A 62-year-old male with known severe peripheral artery disease, diabetes mellitus, hypertension and hypercholesterolemia had a successful angioplasty of a 100% chronically occluded right superficial femoral artery (SFA) via the left common femoral artery. An Angioseal (™) closure device was used to achieve hemostasis. The patient was discharged home after an uneventful post procedural course. Two days later, he presented to the ER with a cold and numb left lower extremity. On exam, the left lower extremity had no palpable pulse from below right femoral artery, confirmed by Doppler. The extremity was cold to touch with decreased sensory perception. Patient was found to have critical left lower extremity ischemia. He was emergently taken for a selective left lower extremity angiogram using the right common femoral artery for access. Fragments of the closure device and a collagen plug causing a total occlusion of the left common femoral artery were found. After a pre-dilatation with a 4.0x 40 balloon under prolonged inflations, a lesion reduction from 100 % to 30% with a TIMI 0 to TIMI 3 flow was achieved using an Angioscore (™) 5.0x 40 balloon inflated at 10 atmospheres. Subsequently, using laser 2.0 atherectomy of the left common femoral artery was performed. Flow in the dorsalis pedis artery was confirmed with Doppler. DISCUSSION: The Angio-Seal(™) device has a polylactide and polyglycolide polymer anchor, a collagen plug and a suture contained within a carrier system. Hemostasis is achieved by compressing the arterial puncture site between the anchor and the collagen plug. With newer studies, it appears that the occurrence of critical limb ischemia from collagen plug is under recognized. We therefore, with this case report urge the physicians to be aware of this serious though rare complication of closure devise and also highlight the successful use of Angioscore (™) balloon in the emergent treatment of non-athermatous vascular occlusion causing critical limb ischemia.

Common Femoral Artery Stenting: Computed Tomography Angiography Based Long-Term Patency

2021 ◽  
pp. 153857442110104
Author(s):  
Rabellino Martin ◽  
Di Caro Vanesa G ◽  
Juan Valle Raleigh ◽  
Chas Jose ◽  
Kotowicz Vadim ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Femoral Artery ◽  
Computed Tomography Angiography ◽  
Stent Placement ◽  
Common Femoral Artery ◽  
Secondary Patency ◽  
Technical Success ◽  
Nitinol Stents

Background: Despite considerable morbid-mortality rates, common femoral endarterectomy is still considered the gold standard for atherosclerotic common femoral artery (CFA) disease. The aim of this study was to demonstrate computed tomography angiography based long-term patency after CFA stent placement and to analyze associated risk factors for restenosis. Methods: A retrospective and observational study was carried out in consecutive patients treated with endovascular stent placement in CFA lesions. A clinical follow-up and imaging study was performed using MD-CTA to assess different degrees of in stent restenosis (ISR) and primary, assisted, and secondary patency rates. Results: In a 5-year period, 35 extremities were treated in 33 patients with self-expandable nitinol stents. The technical success was 100% without complications related to the procedure. The mean follow-up (FU) was 32.2 months, and 8 limbs were lost. The degree of CFA stenosis was reduced from 79.69 ± 26.47% to 11.23 ± 24.53%. ISR < 20%, 20–70%, and ≥ 70% was evident in 15 (55.6%), 9 (33.3%), and 3 (11.1%) limbs, respectively. Estimated primary, assisted, and secondary patency was 79.5, 96.3, and 96.3%, respectively, after 24 months and 79.5, 96.3, and 96.3%, respectively after 60 months, with a freedom of clinical driven target lesion revascularisation rate of 87.8%. Conclusion: Endovascular treatment with self-expandable nitinol stents in CFA lesions had a high technical success rate and was related to few complications. A mild form of intimal hyperplasia was observed in a considerable number of cases. However, long-term patency was high; therefore, CFA stent placement might be a suitable therapeutic alternative in selected patients.

Femoral Vascular Closure Device: The Surgical View

Vascular ◽  
2008 ◽  
Vol 16 (5) ◽  
pp. 295-296
Author(s):  
Alfried Germing ◽  
Michael Lindstaedt ◽  
Delawer Reber
Keyword(s):  
Case Report ◽  
Coronary Angiography ◽  
Vascular Access ◽  
Femoral Artery ◽  
Common Femoral Artery ◽  
Percutaneous Closure ◽  
Closure Device ◽  
Vascular Closure Device ◽  
The Common ◽  
Diagnostic Coronary Angiography

This case report describes the surgical findings of a percutaneous closure device, which was used after diagnostic coronary angiography. The features of the device are described. Surgeons should be familiar with the existence of these devices to avoid complications during vascular access procedures at the level of the common femoral artery.

Closure device use for common femoral artery antegrade access is higher risk than retrograde access

2021 ◽  
Author(s):  
Joel L. Ramirez ◽  
Eric J.T. Smith ◽  
Devin S. Zarkowsky ◽  
Jose Lopez ◽  
Caitlin W. Hicks ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Common Femoral Artery ◽  
Closure Device ◽  
Device Use
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