Vascular closure devices: A review of their use after invasive procedures

American Journal of Cardiovascular Drugs

Volumn 5, Issue 3, 2005, Pages 185-200

  Lasic, Zoran ^a   Nikolsky, Eugenia ^a   Kesanakurthy, Srinivas ^a   Dangas, George ^a  

^a CARDIOVASCULAR RESEARCH FOUNDATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULATION; COMPRESSION; COST EFFECTIVENESS ANALYSIS; DEVICE; HEMOSTASIS; HUMAN; PATIENT MOBILITY; PATIENT SATISFACTION; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; REVIEW; SAFETY; STAPLER; SUTURE; VASCULAR ACCESS; VASCULAR CLOSURE DEVICE;

CASE-CONTROL STUDIES; CATHETERIZATION, PERIPHERAL; FEMORAL ARTERY; HEMOSTASIS, SURGICAL; HUMANS; PUNCTURES; RANDOMIZED CONTROLLED TRIALS;

EID: 22344439271     PISSN: 11753277     EISSN: None     Source Type: Journal    
DOI: 10.2165/00129784-200505030-00005     Document Type: Review

References (73)

1. Sanborn TA, Gibbs HH, Brinker JA, et al. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993 Nov 1; 22 (5): 1273-9
2. Brachmann J, Ansah M, Kosinski E, et al. Improved clinical effectiveness with a collagen vascular hemostasis device for shortened immobilization time following diagnostic angiography and percutaneous transluminal coronary angioplasty. Am J Cardiol 1998; 81: 1502-5
3. Aker UT, Kensey KR, Heuser RR, et al. Immediate arterial hemostatsis after cardiac catheterization: initial experience with a new puncture closure device. Cathet Cardiovasc Diagn 1994; 31: 228-32
4. Sesana M, Vaghetti M, Albiero R, et al. Effectiveness and complications of vascular access closure devices after interventional procedures. J Invasive Cardiol 2000; 12: 395-9
5. Baim DS, Knopf WD, Hinohara T, et al. 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 2000; 85: 864-9
6. Pracyk JB, Wall TC, Longabaugh JP, et al. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol 1998; 81: 970-6
7. Kussmaul WG, Buchbinder M, Whitlow PL, et al. 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 1995 Jun; 25 (7): 1685-92
8. Warren BS, Warren SG, Miller SD. Predictors of complications and learning curve using the AngioSeal closure device following interventional and diagnostic catheterization. Cathet Cardiovasc Interv 1999; 48: 162-6
9. Turi Z. It's time to seal every artery but... comparing apples and oranges in the vascular sealing literature. Catheter Cardiovasc Interv 2001; 53: 443-4
10. Muller DW, Shamir KJ, Ellis SG, et al. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol 1992; 69: 63-8
11. Sreeram S, Lumsden AB, Miller JS, et al. Retroperitoneal hematoma following femoral arterial catheterization: a serious and often fatal complication. Am Surg 1993; 59: 94-8
12. Ricci MA, Trevisani GT, Pilcher DB. Vascular complications of cardiac catheterization. Am J Surg 1994; 167: 375-8
13. Johnson LW, Esente P, Giambartolomei A, et al. Peripheral vascular complications of coronary angioplasty by the femoral and brachial techniques. Cathet Cardiovasc Diagn 1994; 31: 165-72
14. Franco CD, Goldsmith J, Veith FJ, et al. Management of arterial injuries produced by percutaneous femoral procedures. Surgery 1993; 113: 419-25
15. Abbott WM, Austen WG. The effectiveness and mechanism of collagen induced topical hemostasis. Surgery 1975; 78: 723-9
16. Silverstein ME, Chvapil M. Experimental and clinical experiences with collagen fleece as a hemostatic agent. J Trauma 1981; 21: 388-93
17. Chvapil M, Holubec H. Effect of hemostatic fleece on 14C-Serotonin release by human platelets. Jpn Pharmacol Ther 1990; 18: 57 (2913)-62 (2918)
18. Nash JE, Evans DG. The AngioSeal hemostatic puncture closure device: concept and experimental results. Herz 1999 Dec; 24 (8): 597-606
19. Kapadia SR, Raymond R, Knopf W, et al. The 6Fr AngioSeal arterial closure device: results from a multimember prospective registry. Am J Cardiol 2001 Mar 15; 87 (6): 789-91
20. Cremonesi A, Castriota F, Tarantino F, et al. Femoral arterial hemostasis using the angioseal feminine system after coronary and vascular percutaneous angioplasty and stenting. J Invasive Cardiol 1998 Oct; 10 (8): 464-9
21. Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture manage-ment after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol 2001 May; 13 (5): 354-62
22. Ward SR, Casale P, Raymond R, et al. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol 1998; 81: 569-72
23. Chevalier B, Lancelin B, Koning R, et al. Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial. Catheter Cardiovasc Interv 2003 Mar; 58 (3): 285-91
24. Cura FA, Kapadia SR, L'Allier PL, et al. Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol 2000 Oct 1; 86 (7): 780-2, A9
25. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression vs arteriotomy closure devices. J Am Coll Cardiol 2001 Sep; 38 (3): 638-41
26. Applegate RJ, Grabarczyk MA, Little WC, et al. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 2002 Jul 3; 40 (1): 78-83
27. Assali AR, Sdringola S, Moustapha A, et al. Outcome of access site in patients treated with platelet glycoprotein IIb/IIIa inhibitors in the era of closure devices. Catheter Cardiovasc Interv 2003 Jan; 58 (1): 1-5
28. Eggebrecht H, Haude M, Woertgen U, et al. Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients. Catheter Cardiovasc Interv 2002 Dec; 57 (4): 486-95
29. Kirchhof C, Schickel S, Schmidt-Lucke C, et al. Local vascular complications after use of the hemostatic puncture closure device Angio-Seal. Vasa 2002 May; 31 (2): 101-6
30. Amin FR, Yousufuddin M, Stables R, et al. Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the angio-seal device vs the femostop device. Int J Cardiol 2000 Nov-Dec; 76 (2-3): 235-40
31. Lasic Z, Mehran R, Dangas G, et al. Comparison of safety and efficacy between first and second generation of angioseal closure device in interventional patients. J Invasive Cardiol 2004 Jul; 16 (7): 356-8
32. Schrader R, Steinbacher S, Burger W, et al. Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial. Cathet Cardiovasc Diagn 1992 Dec; 27 (4): 298-302
33. Chamberlin JR, Lardi AB, McKeever LS, et al. Use of vascular sealing devices (VasoSeal and Perclose) vs. assisted manual compression (Femostop) in trans-catheter coronary interventions requiring abciximab (ReoPro). Catheter Cardi-ovasc Interv 1999; 47: 143-7
34. Camenzind E, Grossholz M, Urban P, et al. Collagen application versus manual compression: a prospective randomized trial for arterial puncture site closure after coronary angioplasty. J Am Coll Cardiol 1994 Sep; 24 (3): 655-62
35. Gwechenberger M, Katzenschlager R, Heinz G, et al. Use of a collagen plug vs manual compression for sealing arterial puncture site after cardiac catheterization. Angiology 1997 Feb; 48 (2): 121-6
36. Silber S, Bjorvik A, Muhling H, et al. Usefulness of collagen plugging with VasoSeal after PTCA as compared to manual compression with identical sheath dwell times. Cathet Cardiovasc Diagn 1998 Apr; 43 (4): 421-7
37. von Hoch F, Neumann FJ, Theiss W, et al. Efficacy and safety of collagen implants for haemostasis of the vascular access site after coronary balloon angioplasty and coronary stent implantation: a randomized study. Eur Heart J 1995 May; 16 (5): 640-6
38. Slaughter PM, Chetty R, Flintoft VF, et al. A single center randomized trial assessing use of a vascular hemostasis device vs. conventional manual compression following PTCA: what are the potential resource savings? Cathet Cardiovasc Diagn 1995 Mar; 34 (3): 210-4
39. Schickel SI, Adkisson P, Miracle V, et al. Achieving femoral artery hemostasis after cardiac catheterization: a comparison of methods. Am J Crit Care 1999 Nov; 8 (6): 406-9
40. SEAL Trial Study Team. Assessment of the safety and efficacy of the Duett vascular hemostasis device: final results of the Safe and Effective Vascular Hemostasis (SEAL) trial. Am Heart J 2002; 143: 612-9
41. Feldman T, Ellis SG, Mooney MR, et al. Is manual compression really the gold standard for femoral artery closure [abstract]? Am J Cardiol 2000; 86 Suppl. 8A: 54i
42. Zhang Z, Mahoney EM, Gershony G, et al. Impact of the Duett sealing device on quality of life and hospitalization costs for coronary diagnostic and interven-tional procedures: Results from the Study of Economic and Quality of Life substudy of the SEAL trial. Am Heart J 2001 Dec; 142 (6): 982-8
43. Saucedo JF, Feldman T, Puri S, et al. The DUETT arterial closure device in the presence of GP IIb/IIIa inhibitors: overall results from the US clinical trials [abstract]. Am J Cardiol 2000; 86 Suppl. 8A: 56i
44. Saucedo JF, Puri S, Feldman T, et al. Is arterial sheath downsizing necessary if using the DUETT closure device [abstract]? Am J Cardiol 2000; 86 Suppl. 8A: 56i
45. Feldman T, Gershony G, Puri S, et al. Optimizing outcomes with the DUETT arterial closure device: predictors of femoral vascular complications from the US registry and randomized trial [abstract no. 281]. Am J Cardiol 2001, 88 Suppl 5A
46. Yadav JS, Moliterno D, Almany SL, et al. A randomized trial comparing the quickseal femoral arterial closure device with manual control after diagnostic and interventional catheterization procedures [abstract]. Am J Cardiol 2002; 90 Suppl. 6A: 170H
47. Morice MC, Lefevre T. Immediate post PTCA percutaneous suture of femoral arteries with the Perclose device: results of high volume users [abstract]. J Am Coll Cardiol 1998; 31 Suppl. A: 101A
48. Mehta H, Fleisch M, Chatterjee T, et al. Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures. Invasive Cardiol 2002 Jan; 14 (1): 9-12
49. Sanborn TA, Ogilby JD, Ritter J, et al. Reduced vascular complications after percutaneous coronary interventions with a nonmechanical suture device: re-sults from the Randomized Rapid Ambulation After Closure (RACE) Study [abstract]. Am J Cardiol 2002; 90 Suppl. 6A: 172H
50. Wetter DR, Rickli H, von Smekal A, et al. Early sheath removal after coronary artery interventions with use of a suture-mediated closure device: clinical outcome and results of Doppler US evaluation. J Vasc Interv Radiol 2000 Sep; 11 (8): 1033-7
51. Gerckens U, Cattelaens N, Lampe EG, et al. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol 1999 Jun 5; 83 (12): 1658-63
52. Noguchi T, Miyazaki S, Yasuda S, et al. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg 2000 May; 19 (5): 451-5
53. Rickli H, Unterweger M, Sutsch G, et al. Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions. Catheter Cardiovasc Interv 2002 Nov; 57 (3): 297-302
54. Kahn ZM, Kumar M, Hollander G, et al. Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterizations in a large consecutive population. Catheter Cardiovasc Interv 2002 Jan; 55 (1): 8-13
55. Nasu K, Tsuchikane E, Sumitsuji S. The clinical effectiveness of the Prostar XL suture mediated percutaneous vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial. J Invasive Cardiol 2003 May; 15 (5): 251-6
56. Yamaguchi T, Nakamura M, Muramatsu T, et al. The result of early discharge and economical effectiveness study for new hemostasis device (EDEN) trial. Shinryou Shinyaku 1999; 36: 59-65
57. Fram DB, Giri S, Jamil G, et al. 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. Catheter Cardiovasc Interv 2001 Jun; 53 (2): 163-73
58. Kornowski R, Brandes S, Teplitsky I, et al. Safety and efficacy of a 6 French perclose arterial suturing device following percutaneous coronary interven-tions: a pilot evaluation. J Invasive Cardiol 2002 Dec; 14 (12): 741-5
59. Crocker CH, Cragun KT, Timimi FK, et al. Immediate ambulation following diagnostic coronary angiography procedures utilizing a vascular closure device (The Closer). J Invasive Cardiol 2002 Dec; 14 (12): 728-32
60. Eggebrecht H, Naber C, Woertgen U, et al. Percutaneous suture-mediated closure of femoral access sites deployed through the procedure sheath: initial clinical experience with a novel vascular closure device. Catheter Cardiovasc Interv 2003 Mar; 58 (3): 313-21
61. Caputo RP, Ebner A, Grant W, et al. Percutaneous femoral arteriotomy repair: initial experience with a novel staple closure device. J Invasive Cardiol 2002 Nov; 14 (11): 652-6
62. Anonymous. Therus corporation confirms feasibility of rapid, non-invasive arterial wound closure with theraSeal™. Media release October 2001. Therus Corpora-tion, Seattle. Available from URL: www.therus.com [Accessed 2005 Mar 22]
63. Nader RG, Garcia JC, Drushal K, et al. Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures. J Invasive Cardiol 2002 Jun; 14 (6): 305-7
64. Lunney L, Karim K, Little T. VasoSeal hemostasis following coronary interventions with abciximab. Cathet Cardiovasc Diagn 1998; 44: 405-6
65. Berger HJ, Boekstegers P. Immediate sealing of arterial puncture site after catherization in patients with full coumadin anticoagulation [abstract no. 283]. Am J Cardiol 2001, 88 Suppl 5A
66. 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 Jan; 135 (1): 152-6
67. Webb JG, Carere RA, Dodek AA. Collagen plug hemostatic closure of femoral arterial puncture sites following implantation of intracoronary stents. Cathet Cardiovasc Diagn 1993; 30: 314-6
68. Meyerson SL, Feldman T, Desai TR, et al. Angiographic access site complications in the era of arterial closure devices. Vasc Endovascular Surg 2002 Mar-Apr; 36 (2): 137-44
69. Kim MC, Kini AS, Lee PC, et al. Does the use of vascular closure devices decrease vascular complications in the current era of percutaneous coronary intervention [abstract]? Am J Cardiol 2002; 90 Suppl. 6A: 169H
70. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol 2004 Sep 15; 44 (6): 1200-9
71. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA 2004; 291: 350-7
72. Bos JJ, Hunink MG, Mali WP. Use of a collagen hemostatic closure device to achieve hemostasis after arterial puncture: a cost-effectiveness analysis. J Vasc Interv Radiol 1996 Jul-Aug; 7 (4): 479-86
73. Carere RG, Webb JG, Buller CE, et al. Suture closure of femoral arterial puncture sites after coronary angioplasty followed by same-day discharge. Am Heart J 2000 Jan; 139 (1 Pt 1): 52-8