Single-centre real world experience of the Mynx Femoral closure device in patients undergoing percutaneous coronary intervention
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Abstract
Background: Vascular closure devices are routinely used following femoral artery access to perform percutaneous coronary interventions (PCI). A number of devices are available on the market. We have reported previously on our experience of the Mynx device following diagnostic coronary angiography.
Aims: To assess the success and complication rates of the Mynx device used in all-comers in the context of PCI within a single cardiac centre.
Methods: Retrospective analysis of data available for patients who underwent PCI via the femoral route and received a Mynx device at a single tertiary centre.
Results: The device was used to achieve haemostasis in 113 patients following PCI. In all cases weight-adjusted Heparin as well as dual antiplatelet therapy (Aspirin and Clopidogrel/ Ticagrelor) was administered as per PCI protocol. The device was successfully deployed in 111 cases (98.2%). The were 2 cases of device failure, one due to operator error and the other due to Mynx grip balloon bursting during device deployment. In 15 cases (13.2%; 9 male and 6 female) there were reports of small haematomas (<2cm) or oozing resulting in application of manual pressure or Femstop (St. Jude). A further patient required ultrasound-guided compression of the artery due to a large retroperitoneal bleed resulting from access complications. A larger proportion of the cases with complications were done as PPCI (44% vs 33%). The group with complications had higher systolic BP (140mmHg vs 128mmHg; P<0.05) and MABP (97mmHg vs 75mmHg; P<0.05) as compared with the group without any complications.
Conclusion: The Mynx closure device is safe and easy to use in the context of PCI, in both the elective and emergency (PPCI) settings. Complication rates, predominately minor, can be minimised in experienced hands.
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Copyright (c) 2019 Thirunavukarasu S, et al.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, et al. Registry-Based Prospective, Active Surveillance of Medical-Device Safety. N Engl J Med. 2017; 376: 526-535. Ref.: https://bit.ly/2Kp4Eqi
Grandhi R, Kanaan H, Shah A, Harrison G, Bonfield C, et al. Safety and efficacy of percutaneous femoral artery access followed by Mynx closure in cerebral neurovascular procedures: a single center analysis. J Neurointerv Surg. 2014; 6: 445-450. Ref.: https://bit.ly/2WBabAz
Taha A, Walsh EK, Wright KA, Ahmed I, Supakul N, et al. Safety and feasibility of a novel vascular closure device in neurointerventional procedures. Interv Neuroradiol. 2013; 19: 353-358. Ref.: https://bit.ly/2wyaX2v
Baker NC, Escarcega RO, Lipinski MJ, Magalhaes MA, Koifman E, et al. Active Versus Passive Anchoring Vascular Closure Devices Following Percutaneous Coronary Intervention: A Safety and Efficacy Comparative Analysis. J Interv Cardiol. 2016; 29: 108-112. Ref.: https://bit.ly/2WlFXlK
Azmoon S, Pucillo AL, Aronow WS, Ebrahimi R, Vozzolo J, et al. Vascular complications after percutaneous coronary intervention following hemostasis with the Mynx vascular closure device versus the AngioSeal vascular closure device. J Invasive Cardiol. 2010; 22: 175-178. Ref.: https://bit.ly/2wFhOXP
Hutchings D, Hayat A, Karunakaran A, Malik N. Success, Safety, and Efficacy of the Mynx Femoral Closure Device in a Real-World Cohort: Single-Center Experience. J Invasive Cardiol. 2016; 28: 104-108. Ref.: https://bit.ly/2HQYyNv
Islam MA, George AK, Norris M. Popliteal artery embolization with the Mynx closure device. Catheter Cardiovasc Interv. 2010; 75: 35-37. Ref.: https://bit.ly/2HRVReG
Fargen KM, Hoh BL, Mocco J. A prospective randomized single-blind trial of patient comfort following vessel closure: extravascular synthetic sealant closure provides less pain than a self-tightening suture vascular compression device. J Neurointerv Surg. 2011; 3: 219-223. Ref.: https://bit.ly/2QHJ7Ki
Scheinert D, Sievert H, Turco MA, Schmidt A, Hauptmann KE, Mueller R, et al. The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx. Catheter Cardiovasc Interv. 2007; 70: 627-633. Ref.: https://bit.ly/2wBotlT
Fields JD, Liu KC, Lee DS, Gonda SJ, Dogan A, et al. Femoral artery complications associated with the Mynx closure device. AJNR Am J Neuroradiol. 2010; 31: 1737-1740. Ref.: https://bit.ly/311JYue
Resnic FS, Wang TY, Arora N, Vidi V, Dai D, et al. Quantifying the learning curve in the use of a novel vascular closure device: an analysis of the NCDR (National Cardiovascular Data Registry) CathPCI registry. JACC Cardiovasc Interv. 2012; 5: 82-89. Ref.: https://bit.ly/2wybLo3
Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol. 2007; 49: 1362-1368. Ref.: https://bit.ly/2ESgQMG
Sulzbach-Hoke LM, Ratcliffe SJ, Kimmel SE, Kolansky DM, Polomano R. Predictors of complications following sheath removal with percutaneous coronary intervention. J Cardiovasc Nurs. 2010; 25: E1-8. Ref.: https://bit.ly/2HSKa7x
Noor S, Meyers S, Curl R. Successful reduction of surgeries secondary to arterial access site complications: a retrospective review at a single center with an extravascular closure device. Vasc Endovascular Surg. 2010; 44: 345-349. Ref.: https://bit.ly/2XmocPx