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Int J Angiol 2015; 24(02): 133-136
DOI: 10.1055/s-0035-1547449
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Comparison of Angioseal and Manual Compression in Patients Undergoing Transfemoral Coronary and Peripheral Vascular Interventional Procedures

Abdullah M. Alshehri
1   Division of Cardiology, Department of Internal Medicine, University of Dammam, Saudi Arabia
,
Mohamed Elsharawy
2   Division of Vascular Surgery, Department of General Surgery, University of Dammam, Saudi Arabia
› Author Affiliations
Further Information

Publication History

Publication Date:
23 March 2015 (online)

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Abstract

Vascular closure devices (VCDs) were introduced in the early 1990s with the goal of limiting the time, labor, bed rest, and patient discomfort associated with manual compression (MC) for hemostasis after cardiovascular interventions. However, its advantage over MC has not been extensively studied after interventional procedures. The aim of this study was to do prospective, randomized study comparing the safety and efficacy of the Angio-Seal (AS) to that of MC in patients undergoing transfemoral coronary and peripheral vascular interventional procedure.

A prospective, randomized trial was undertaken on consecutive series of patients admitted to King Fahd Hospital of the University for transfemoral coronary and peripheral vascular interventional procedures over 1 year. The study was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving AS with those undergoing MC. All patients were on antiplatelets and received heparin during the procedure.

During the study period, 160 patients were included, 80 in each group. There was a significant difference in mean time to hemostasis in minutes (15.83 ± 1.63 minutes for MC and 0.42 ± 0.04 minutes for the AS; p < 0.001), time to ambulation in minutes (280 ± 15 for MC and 120 for AS; p = 0.04) and in minor complications (33.8% in MC vs. AS 5%; p < 0.001). However, the major complication rate did not significantly differ between the two groups (0% in AS vs. 2.5% in MC; p = 0.15).

AS was found to achieve rapid closure of the femoral access site safely in patients undergoing coronary and peripheral vascular interventional procedures under antiplatelets and systemic heparinization.

Keywords

coronary artery disease - peripheral artery disease - vascular closure devices

Note

This article was presented at the 6th Annual joint Meeting of ISES & MEET, June 2013, Rome, Italy.


 

  • References

  • 1 Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: the second decade. J Am Coll Cardiol 2007; 50 (17) 1617-1626
    CrossrefPubMedGoogle Scholar
  • 2 Behan MW, Large JK, Patel NR, Lloyd GW, Sulke AN. A randomised controlled trial comparing the routine use of an Angio-Seal STS device strategy with conventional femoral haemostasis methods in a district general hospital. Int J Clin Pract 2007; 61 (3) 367-372
    CrossrefPubMedGoogle Scholar
  • 3 Kolluri R, Fowler B, Nandish S. Vascular access complications: diagnosis and management. Curr Treat Options Cardiovasc Med 2013; 15 (2) 173-187
    CrossrefPubMedGoogle Scholar
  • 4 Boztosun B, Günes Y, Yildiz A , et al. Early ambulation after diagnostic heart catheterization. Angiology 2007; 58 (6) 743-746
    CrossrefPubMedGoogle Scholar
  • 5 Doyle BJ, Konz BA, Lennon RJ, Bresnahan JF, Rihal CS, Ting HH. Ambulation 1 hour after diagnostic cardiac catheterization: a prospective study of 1009 procedures. Mayo Clin Proc 2006; 81 (12) 1537-1540
    CrossrefPubMedGoogle Scholar
  • 6 Hermiller J, Simonton C, Hinohara T , et al. Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization. J Invasive Cardiol 2005; 17 (10) 504-510
    PubMedGoogle Scholar
  • 7 Ratnam LA, Raja J, Munneke GJ, Morgan RA, Belli AM. Prospective nonrandomized trial of manual compression and Angio-Seal and Starclose arterial closure devices in common femoral punctures. Cardiovasc Intervent Radiol 2007; 30 (2) 182-188
    CrossrefPubMedGoogle Scholar
  • 8 Upponi SS, Ganeshan AG, Warakaulle DR, Phillips-Hughes J, Boardman P, Uberoi R. Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures—a randomized controlled trial. Eur J Radiol 2007; 61 (2) 332-334
    CrossrefPubMedGoogle Scholar
  • 9 Veasey RA, Large JK, Silberbauer J , et al. A randomised controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital—the SCOAST study. Int J Clin Pract 2008; 62 (6) 912-918
    CrossrefPubMedGoogle Scholar
  • 10 Macdonald S, Thomas SM, Cleveland TJ, Gaines PA. Outpatient vascular intervention: a two-year experience. Cardiovasc Intervent Radiol 2002; 25 (5) 403-412
    CrossrefPubMedGoogle Scholar
  • 11 Lucatelli P, Fanelli F, Cannavale A , et al. Angioseal VIP® vs. Starclose SE® closure devices: a comparative analysis in non-cardiological procedures. J Cardiovasc Surg (Torino) 2013; (e-pub ahead of print)
    PubMedGoogle Scholar
  • 12 Larsen EN, Hansen CB, Thayssen P, Jensen LO. Immediate mobilization after coronary angiography or percutaneous coronary intervention following hemostasis with the AngioSeal vascular closure device (the MOBS study). Eur J Cardiovasc Nurs 2013; 13 (5) 466-472
    PubMedGoogle Scholar
  • 13 Angio-Seal Vascular Closure Device. Instructions for use. 2010. Available at: www.sjmproffesional.com
    PubMedGoogle Scholar
  • 14 Piper WD, Malenka DJ, Ryan Jr TJ , et al; Northern New England Cardiovascular Disease Study Group. Predicting vascular complications in percutaneous coronary interventions. Am Heart J 2003; 145 (6) 1022-1029
    CrossrefPubMedGoogle Scholar
  • 15 Applegate RJ, Sacrinty M, Kutcher MA , et al. Vascular complications with newer generations of angioseal vascular closure devices. J Interv Cardiol 2006; 19 (1) 67-74
    CrossrefPubMedGoogle Scholar
  • 16 Kara K, Mahabadi AA, Berg MH , et al. Utilization of collagen-based vascular closure devices in patients with severe peripheral artery disease. J Invasive Cardiol 2013; 25 (1) 19-22
    PubMedGoogle Scholar
  • 17 Silber S. Hemostasis success rates and local complications with collagen after femoral access for cardiac catheterization: analysis of 6007 published patients. Am Heart J 1998; 135 (1) 152-156
    CrossrefPubMedGoogle Scholar
  • 18 Gupta A, Sadiq I, Borer S. Distal embolization from Mynx device. Conn Med 2012; 76 (9) 545-548
    PubMedGoogle Scholar
  • 19 Khaldi A, Waldau B, Skowlund C, Velat GJ, Mocco J, Hoh BL. Delayed complication from a percutaneous vascular closure device following a neuro-interventional procedure. Interv Neuroradiol 2011; 17 (4) 495-500
    PubMedGoogle Scholar
  • 20 Durack JC, Thor Johnson D, Fidelman N, Kerlan RK, LaBerge JM. Entrapment of the StarClose Vascular Closure System after attempted common femoral artery deployment. Cardiovasc Intervent Radiol 2012; 35 (4) 942-944
    CrossrefPubMedGoogle Scholar
  • 21 Cianci C, Kowal RC, Feghali G, Hohmann S, Stoler RC, Choi JW. Critical lower limb ischemia from an embolized Angio-Seal closure device. Proc (Bayl Univ Med Cent) 2013; 26 (4) 398-400
    PubMedGoogle Scholar
  • 22 Kara K, Kahlert P, Mahabadi AA , et al. Comparison of collagen-based vascular closure devices in patients with vs. without severe peripheral artery disease. J Endovasc Ther 2014; 21 (1) 79-84
    CrossrefPubMedGoogle Scholar
  • 23 McDonald JS, Kallmes DF, Lanzino G, Cloft HJ. Percutaneous closure devices do not reduce the risk of major access site complications in patients undergoing elective carotid stent placement. J Vasc Interv Radiol 2013; 24 (7) 1057-1062
    CrossrefPubMedGoogle Scholar
  • 24 Gurm HS, Hosman C, Share D, Moscucci M, Hansen BB ; Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Comparative safety of vascular closure devices and manual closure among patients having percutaneous coronary intervention. Ann Intern Med 2013; 159 (10) 660-666
    CrossrefPubMedGoogle Scholar
  • 25 Gregory D, Midodzi W, Pearce N. Complications with Angio-Seal™ vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention. J Interv Cardiol 2013; 26 (6) 630-638
    CrossrefPubMedGoogle Scholar
  • 26 Das R, Ahmed K, Athanasiou T, Morgan RA, Belli AM. Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: a systematic review and meta-analysis. Cardiovasc Intervent Radiol 2011; 34 (4) 723-738
    CrossrefPubMedGoogle Scholar