MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge

Pruski, Maciej; Błachut, Aleksandra; Konkolewska, Magda; Janas, Adam; Hrycek, Eugeniusz; Buszman, Piotr P.; Kiesz, R. Stefan

doi:10.1177/1538574416689424

Cited by 10 publications

(7 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The first prospective study on Mynx for closure of antegrade access reported a low device failure rate (5.9%) and a high procedure success rate (95%). 11 The present study achieved 93.9% technical success considering antegrade access, which is comparable to the result of a previous study. In the previous study, compression was routinely applied for 10 min following device removal as their standard institutional protocol; however, in the present study, successful hemostasis was achieved in 87.9% cases (antegrade access) with compression applied only for 1 min following device removal.…”

Section: Discussionsupporting

confidence: 89%

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

et al. 2020

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 89%

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

et al. 2020

View full text Add to dashboard Cite

show abstract

“…It has a high technical success rate and low rate of vascular complications. [21][22][23] Exoseal (Cordis Corporation, Milpitas, Calif; Fig 6) is a passive approximator that deploys a synthetic, bioabsorbable polyglycolic acid plug to the extravascular space just adjacent to the arteriotomy site. The plug is deployed by retracting the delivery shaft.…”

mentioning

confidence: 99%

A systematic review of vascular closure devices for femoral artery puncture sites

Noori

Eldrup-Jørgensen

2018

Journal of Vascular Surgery

155

114

View full text Add to dashboard Cite

VCDs have shown marked improvement in patients' comfort and satisfaction as well as in time to hemostasis and ambulation after percutaneous vascular procedures. According to multiple small randomized controlled trials, meta-analyses, and a Cochrane review, complication rates, safety and efficacy, and outcomes remain comparable between VCDs and MC (12% for VCDs vs 13% for MC). VCDs have a low incidence of major complications and high success rates, which provides convenience for the practitioner and facilitates turnover of patients. VCDs have a risk of infectious (0.6% with VCDs vs 0.2% with MC) and thrombotic complications (0.3% with VCDs vs none with MC) that is small but may be increased compared with MC. It is important to balance the goals of comfort of the patient, resources of the staff, and early ambulation against periprocedural and anatomic risk factors (ie, individualize use of VCDs to specific clinical scenarios). Users must be familiar with a device and its limitations to safely and effectively achieve hemostasis after femoral artery puncture.

show abstract

“…In 2374 diabetic patients with critical limb ischemia, the use of the Angio-Seal CD for femoral AA was associated with the lowest rate of major access-site complications (20/1889 [1.1%]) compared with RA Angio-Seal use (5/278 [1.8%]) and manual compression (4/205 [2.0%]). 24 Pruski et al 25 reported a 95% (63/66) procedure success rate and no major access site complications after using the Mynx CD for femoral AA for PVI. However, it is important to note that the Angio-Seal device is the only CD that includes use for AA in the IFU.…”

Section: Discussionmentioning

confidence: 99%

Antegrade common femoral artery closure device use is associated with decreased complications

Ramirez

Zarkowsky²,

Sorrentino

et al. 2020

Journal of Vascular Surgery

View full text Add to dashboard Cite

Antegrade common femoral artery closure device use is associated with decreased complications.ABSTRACT Objective: Antegrade femoral artery access is often used for ipsilateral infrainguinal peripheral vascular intervention. However, the use of closure devices (CD) for antegrade access (AA) is still considered outside the instructions for use for most devices. We hypothesized that CD use for antegrade femoral access would not be associated with an increased odds of access site complications.Methods: The Vascular Quality Initiative was queried from 2010 to 2019 for infrainguinal peripheral vascular interventions performed via femoral AA. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether a CD was used or not. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications. A sensitivity analysis using coarsened exact matching was performed using factors different between treatment groups to reduce imbalance between the groups.Results: Overall, 11,562 cases were identified and 5693 (49.2%) used a CD. Patients treated with a CD were less likely to be white (74.1% vs 75.2%), have coronary artery disease (29.7% vs 33.4%), use aspirin (68.7% vs 72.4%), and have heparin reversal with protamine (15.5% vs 25.6%; all P < .05). CD patients were more likely to be obese (31.6% vs 27.0%), have an elective operation (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and a larger access sheath (6.0 6 1.0 F vs 5.5 6 1.0 F; P < .05 for all). CD cases were less likely to develop any access site hematoma (2.55% vs 3.53%; P < .01) or a hematoma requiring reintervention (0.63% vs 1.26%; P < .01) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P ¼ .47) compared with no CD. On multivariable analysis, CD cases had significantly decreased odds of developing any access site hematoma (odds ratio, 0.75; 95% confidence interval, 0.59-0.95) and a hematoma requiring intervention (odds ratio, 0.56; 95% confidence interval, 0.38-0.81). A sensitivity analysis after coarsened exact matching confirmed these findings. Conclusions:In this nationally representative sample, CD use for AA was associated with a lower odds of hematoma in selected patients. Extending the instructions for use indications for CDs to include femoral AA may decrease the incidence of access site complications, patient exposure to reintervention, and costs to the health care system. (J Vasc Surg 2020;-:1-8.)

show abstract

MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge

Abstract: The MynxGrip was safe and effective in sealing access sites after antegrade femoral artery puncture with same-day discharge.

Cited by 10 publications

References 22 publications

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

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

A systematic review of vascular closure devices for femoral artery puncture sites

Antegrade common femoral artery closure device use is associated with decreased complications

Contact Info

Product

Resources

About