CardioVascular and Interventional Radiology

, Volume 30, Issue 2, pp 182–188 | Cite as

Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures

  • Lakshmi A. Ratnam
  • Jowad Raja
  • Graham J. Munneke
  • Robert A. Morgan
  • Anna-Maria BelliEmail author


We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis (p < 0.0001). A significant number of very thin patients failed to achieve hemostasis (p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males (p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease.


Angio-Seal Starclose Manual compression Arterial closure device Complications 


  1. 1.
    Muller DW, Shamir KJ, Ellis SG, et al. (1992) Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol 69:63–68PubMedCrossRefGoogle Scholar
  2. 2.
    Fram DB, Giri S, Jamil G, et al. (2001) Suture closure of the femoral arteriotomy following invasive cardiac procedures: A detailed analysis of efficacy, complications, and the impact of early ambulation in 1,200 consecutive, unselected cases. Cathet Cardiovasc Diagn 53:163–173Google Scholar
  3. 3.
    Baim DS, Knopf WD, Hinohara T, et al. (2000) Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate and discharge (STAND I and STAND II) trials. Am J Cardiol 85:864–869PubMedCrossRefGoogle Scholar
  4. 4.
    Rinder MR, Tamirisa PK, Taniuchi M, et al. (2001) Safety and efficacy of suture mediated closure after percutaneous coronary interventions. Cathet Cardiovasc Intervent 54: 146–151CrossRefGoogle Scholar
  5. 5.
    D?Souza S (2004) Closure devices: indications and results. In: Wyatt MG, Watkinson AF (eds) Endovascular Intervention: Current Controversies. TFM Publishing. Shrewsbury, pp 205–216Google Scholar
  6. 6.
    Kussmaul WG, Buchbinder M, Whitlow PL, et al. (1995) Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: Results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol 25:1685–1692PubMedCrossRefGoogle Scholar
  7. 7.
    Applegate RJ, Grabarczyk MA, Little WC, et al. (2002) Vascular closure devices in patient treated with anticoagulation and IIb/IIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 40:78–83PubMedCrossRefGoogle Scholar
  8. 8.
    Duffin DC, Muhlestein JB, Allisson SB, et al. (2001) Femoral arterial puncture management after percutaneous coronary procedures: A comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol 13:354–362PubMedGoogle Scholar
  9. 9.
    Hermiller J, Simonton C, Hinohara T (2005) Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization. J Invasive Cardiol 17:504–551PubMedGoogle Scholar
  10. 10.
    Ruygrok PN, Ormiston JA, Stewart JT, et al. (2005) Initial experience with a new femoral artery closure device following percutaneous coronary intervention with glycoprotein IIb/IIa inhibition. Cathet Cardiovasc Interv 66:185–191CrossRefGoogle Scholar
  11. 11.
    Sacks D, Marinelli DL, Martin LG, et al. (1997) Reporting standard for clinical evaluation of new peripheral arterial revascularization devices. J Vasc Intervent Radiol 8:137–149CrossRefGoogle Scholar
  12. 12.
    Leoni CJ, Potter JE, Rosen MP, et al. (2001) Classifying complications of interventional procedures: A survey of practicing radiologists. J Vasc Intervent Radiol 12:55–59Google Scholar
  13. 13.
    Semler HJ. (1985) Transfemoral catheterization: mechanical versus manual control of bleeding. Radiology 154:235Google Scholar
  14. 14.
    Macdonald S, Thomas SM, Cleveland TJ, et al (2002) Outpatient vascular intervention: A two-year experience. Cardiovasc Intervent Radiol 25:403–412PubMedCrossRefGoogle Scholar
  15. 15.
    Popma JJ, Satler LF, Pichard AD, et al. (1993) Vascular complications after balloon and new device angioplasty. Circulation 88:1569–1578PubMedGoogle Scholar
  16. 16.
    Nasser TK, Mohler ER, Wilensky RL, et al. (1995) Peripheral vascular complications following coronary interventional procedures. Clin Cardiol 18: 609–614PubMedCrossRefGoogle Scholar
  17. 17.
    The Royal College of Radiology. Standards in vascular radiology. BFCR 99:9–40Google Scholar
  18. 18.
    Hoffer EK, Bloch RD (2003) Percutaneous closure devices. J Vasc Intervent Radiol 14:865–886Google Scholar
  19. 19.
    Mandak JS, Blankenship JC, Gardner LH (1998) Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibatide. J Am Coll Cardiol 31:1518–1524PubMedCrossRefGoogle Scholar
  20. 20.
    Piper WD, Malenka DJ, Ryan TJ (2003) Predicting vascular complications in percutaneous coronary interventions. Am Heart J 145:1022–1029PubMedCrossRefGoogle Scholar
  21. 21.
    Aggarwal K, Murtaza M (2004) Vascular closure device complications: The case is not closed yet. J Invasive Cardiol 16(5):251PubMedGoogle Scholar
  22. 22.
    Castriota F, Tarantino F, Troiani E, et al. (1998) Femoral arterial hemostasis using the Angio-Seal system after coronary and vascular percutaneous angioplasty and stenting. J Invasive Cardiol 10:464–469PubMedGoogle Scholar
  23. 23.
    O?Sullivan GJ, Buckenham TM, Belli AM (1999) The use of the Angio-seal haemostatic puncture device in high-risk patients. Clin Radiol 54:51–55PubMedCrossRefGoogle Scholar
  24. 24.
    Abando A, Hood D, Weaver F (2004) The use of the Angioseal device for femoral artery closure. J Vasc Surg 40:287–290PubMedCrossRefGoogle Scholar
  25. 25.
    Carey D, Martin JR, Moore CA, et al. (2001) Complications of femoral artery closure devices. Cathet Cardiol Intervent 52:3–7CrossRefGoogle Scholar
  26. 26.
    Henry M, Amor M, Allaoui M, et al. (1995) A new access site management tool: The Angio-Seal hemostatic puncture closure device. J Endovasc Surg 2:289–296PubMedCrossRefGoogle Scholar
  27. 27.
    Shaw JA, Gravereaux EC, Winters GL, et al. (2003) An unusual cause of claudication. Cathet Cardiol Intervent 60:562–565CrossRefGoogle Scholar
  28. 28.
    Caputo RP, Ebner A, Grant W, et al. (2002) Percutaneous femoral arteriotomy repair: Initial experience with a novel staple closure device. J Invasive Cardiol 14:652–656PubMedGoogle Scholar
  29. 29.
    Park Y, Roh HG, Choo SW, et al. (2005) Prospective comparison of collagen plug (Angio-Seal) and suture-mediated (the Closer S) closure devices at femoral access sites. Korean J Radiol 6:248–255PubMedCrossRefGoogle Scholar
  30. 30.
    Eidt JF, Habibipour S, Saucedo JF, et al. (1999) Surgical complications from hemostatic puncture closure devices. Am J Surg 178:511–516PubMedCrossRefGoogle Scholar
  31. 31.
    Aksoy M, Becquemin JP, Desgranges P, et al. (2006) The safety and efficacy of Angioseal in therapeutic endovascular interventions. Eur J Vasc Endovasc Surg 32(1):90–93PubMedCrossRefGoogle Scholar
  32. 32.
    Shammas NW, Rajendran VR, Alldredge SG, et al. (2002) Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty. Cathet Cardiovasc Intervent 55:421–425CrossRefGoogle Scholar
  33. 33.
    Bown MJ, Blanshard KS, Cutress ML, et al. (2002) Off-license use of Angio-Seal arterial puncture closure device. Eur J Vasc Endovasc 24:372–373CrossRefGoogle Scholar
  34. 34.
    Shrake KL (2000) Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 85:1024–1025PubMedCrossRefGoogle Scholar
  35. 35.
    Eggebrecht H, von Birgelen C, Naber C, et al. (2004) Impact of gender on femoral access complications secondary to application of a collagen-based vascular closure device. J Invasc Cardiol 16:247–250Google Scholar

Copyright information

© Springer Science+Business Media, Inc. 2007

Authors and Affiliations

  • Lakshmi A. Ratnam
    • 1
  • Jowad Raja
    • 1
  • Graham J. Munneke
    • 1
  • Robert A. Morgan
    • 1
  • Anna-Maria Belli
    • 1
    Email author
  1. 1.Department of RadiologySt. George’s HospitalLondonUK

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