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.
JiangJZouJMaH, et al.Network Meta-analysis of Randomized Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis. Scientific Rep2015; 5(1): 13761. 10.1038/srep13761
2.
HeldeSGewaltSIbrahimT, et al.Gender specific analysis of the randomized ISAR-CLOSURE trial: the comparison of vascular closure devices versus manual compression after femoral artery puncture. J Am Coll Cardiol2014; 6411(B): B245. 10.1161/CIRCINTERVENTIONS.117.006074
3.
BarbettaIvan den BergJ. Access and Hemostasis: Femoral and Popliteal Approaches and Closure Devices-Why, What, When, and How?Semin Interv Radiol2014; 31(04): 353–360. 10.1055/s-0034-1393972
4.
PruskiMJBlachutAMKonkolewskaM, et al.MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge. Vasc Endovascular Surg2017; 51(2): 67–71. 10.1177/1538574416689424
5.
KrishnasamyVPHagarMJScherDJ, et al.Vascular Closure Devices: Technical Tips, Complications, and Management. Tech Vasc Interv Radiol2015; 18(2): 100–112. 10.1053/j.tvir.2015.04.008
6.
ChaudhuriAYorkADeyR. Percutaneous vascular closure using an anchored collagen plug provides effective haemostasis following both antegrade and retrograde femoral arterial punctures. Eur J Vasc Endovascular Surg2014; 48(2): 220–225. 10.1016/j.ejvs.2014.04.017
7.
ChiuAHYColesSRTibballsJ, et al.The StarClose Vascular Closure Device in Antegrade and Retrograde Punctures: A Single-Center Experience. J Endovascular Ther2010; 17(1): 46–50. 10.1583/09-2873.1
8.
SekharASuttonBSRahejaP, et al.Femoral arterial closure using ProGlide is more efficacious and cost-effective when ambulating early following cardiac catheterization. IJC Heart & Vasculature2016; 13: 6–13. 10.1016/j.ijcha.2016.09.002
9.
MirandaJPallisterZHansrajN, et al.2021. Duplex-Ultrasound Assisted Mynx Closure of Superficial Femoral Artery Antegrade Access Following Lower-Extremity Endovascular Intervention. Journal of Critical Limb ischemia, 1(2).
10.
FilippiadisDKBinkertCPellerinO, et al.Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. CardioVascular Interv Radiol2017; 40(8): 1141–1146. 10.1007/s00270-017-1703-4
11.
ShethRAWalkerTGSaadWE, et al.Quality Improvement Guidelines for Vascular Access and Closure Device Use. J Vasc Interv Radiol2014; 25(1): 73–84. 10.1016/j.jvir.2013.08.011
12.
ModiSGadviRBabuS. Initial experience with Angioseal™: Safety and efficacy of the endovascular closure device. Indian Journal Radiology Imaging2013; 23(2): 134, 8. 10.4103/0971-3026.116566
13.
BakerNCEscarcegaROLipinskiMJ, et al.Active Versus Passive Anchoring Vascular Closure Devices Following Percutaneous Coronary Intervention: A Safety and Efficacy Comparative Analysis. J Interv Cardiol2016; 29(1): 108–112. 10.1111/joic.12264
14.
VeaseyRALargeJKSilberbauerJ, et al.A randomised controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital - the SCOAST study. Int J Clin Pract2008; 62(6): 912–918. 10.1111/j.1742-1241.2008.01761.x
15.
LucatelliPFanelliFCannavaleA, et al.Angioseal VIP® vs. StarClose SE® closure devices: a comparative analysis in non-cardiological procedures. J Cardiovascular Surgery2017; 58: 80–86. 10.23736/S0021-9509.16.07654-0
16.
SpiliopoulosSKatsanosKKarnabatidisD, et al.Safety and Efficacy of the StarClose Vascular Closure Device in More Than 1000 Consecutive Peripheral Angioplasty Procedures. J Endovascular Ther2011; 18(3): 435–443. 10.1583/10-3277.1.
17.
Klein-WieleOBaliotaMKaraK, et al.Safety and efficacy of clip-based vs. suture mediated vascular closure for femoral access hemostasis: A prospective randomized single center study comparing the StarClose and the ProGlide device. Catheterization Cardiovasc Interventions2017; 91(3): 402–407. 10.1002/ccd.27116
18.
BiancariFRomppanenHSavontausM, et al.MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation. Int J Cardiol2018; 263: 29–31. 10.1016/j.ijcard.2018.04.065.
19.
BertiSBedogniFGiordanoA, et al.Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry. J Am Heart Assoc2020; 9(21); e018042. 10.1161/JAHA.120.018042
FieldsJDLiuKCLeeDS, et al.Femoral artery complications associated with the Mynx closure device. Am J Neuroradiology2010; 31(9): 1737–1740. 10.3174/ajnr.A2153
22.
SaadNEASaadWEADaviesMG, et al.Pseudoaneurysms and the Role of Minimally Invasive Techniques in Their Management. RadioGraphics2005; 25(suppl_1): S173–S189. 10.1148/rg.25si055503
23.
HacklGGaryTBelajK, et al.Exoseal for puncture site closure after antegrade procedures in peripheral arterial disease patients. Diagn Interv Radiol2014; 20(5): 426–431. 10.5152/dir.2014.14002
24.
GutzeitAvan SchieBSchochE, et al.Feasibility and Safety of Vascular Closure Devices in an Antegrade Approach to Either the Common Femoral Artery or the Superficial Femoral Artery. CardioVascular Interv Radiol2012; 35(5): 1036–1040. 10.1007/s00270-012-0454-5
25.
RatnamLARajaJMunnekeGJ, et al.Prospective nonrandomized trial of manual compression and Angio-seal and StarClose arterial closure devices in common femoral punctures. CardioVascular Interv Radiol2007; 30(2): 182–188. 10.1007/s00270-006-0226-1
26.
LupattelliTTannouriFGaraciFG, et al.Efficacy and Safety of Antegrade Common Femoral Artery Access Closure Using the Angio-Seal Device: Experience With 1889 Interventions for Critical Limb Ischemia in Diabetic Patients. J Endovascular Ther2010; 17(3): 366–375. 10.1583/09-2960.1
27.
ThurleyPDO’NeillRHabibS, et al.Re: Looby et al.: “Efficacy and Safety of the Angioseal Vascular Closure Device Post Antegrade Puncture”. CardioVascular Interv Radiol2008; 31(6): 1255–1256. 10.1007/s00270-008-9411-8
28.
HwangJHParkSWYangWY, et al.Safety and efficacy of Mynx vascular closure device for the closure of common femoral artery access after ipsilateral stent placement. The J Vasc Access2020: 112972982096694. 10.1177/1129729820966946
