Top

Clinical Research in Cardiology

Published in:

01-09-2011 | Original Paper

The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization

Authors: Emilia Stegemann, Rainer Hoffmann, Steven Marso, Berthold Stegemann, Nikolaus Marx, Thomas Lauer

Published in: Clinical Research in Cardiology | Issue 9/2011

Abstract

Objective

This study aimed at exploring access site-related vascular complication rates associated with the use of the vascular closure device (VCD) Angio-Seal™ in an unselected patient population undergoing elective as well as emergency coronary angiography or intervention.

Background

The VCD Angio-Seal™ is widely used to achieve hemostasis after diagnostic and interventional cardiac procedures. There are only little data on the frequency of vascular complications after the use of the VCD Angio-Seal™ in patients in non-elective settings.

Method

In-hospital vascular complications were prospectively assessed in 4,653 consecutive cardiac catheterization procedures, which included 2,772 elective diagnostic and 960 elective percutaneous coronary interventions (PCI), and 921 emergency cardiac catheterizations in patients with NSTEMI/STEMI. In 2,077 procedures manual compression (MC) and in 2,576 procedures VCD was applied. Complication rates for manual compression and VCD use were studied and multivariate analyses performed to disclose predictors for access site-related vascular complications.

Results

Vascular complication rates in patients receiving MC to achieve hemostasis were similar to those receiving a VCD (MC 3.4% vs. VCD 3.2%, p = n.s.). Separate analysis of vascular complication rates for subgroups revealed a significant reduction in vascular complications for the PCI group using a VCD (MC 7.7% vs. VCD 3.2%, p = 0.003). In emergencies VCD use lead to a rise in vascular complications (MC 0.9% vs. VCD 6.3%, p < 0.001).

Conclusions

In contrast to elective settings, the risk of access site-related vascular complications is significantly increased after application of the VCD Angio-Seal™ in patients undergoing emergency catheterizations for NSTEMI/STEMI compared with manual compression.

Kussmaul WG III, Buchbinder M, Whitlow PL, Aker UT, Heuser RR, King SB, Kent KM, Leon MB, Kolansky DM, Sandza JG Jr (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(7):1685–1692. pii:(0735-1097(95)00101-9)PubMedCrossRef

Ward SR, Casale P, Raymond R, Kussmaul WG III, Simpfendorfer C (1998) Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Angio-Seal investigators. Am J Cardiol 81(5):569–572. pii:(S0002914997009703)PubMedCrossRef

Dangas G, Mehran R, Kokolis S, Feldman D, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB (2001) Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 38(3):638–641. pii:(S0735-1097(01)01449-8)PubMedCrossRef

Resnic FS, Blake GJ, Ohno-Machado L, Selwyn AP, Popma JJ, Rogers C (2001) Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol 88(5):493–496. pii:(S0002-9149(01)01725-8)PubMedCrossRef

Applegate RJ, Grabarczyk MA, Little WC, Craven T, Walkup M, Kahl FR, Braden GA, Rankin KM, Kutcher MA (2002) Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 40(1):78–83. pii:(S0735109702019241)PubMedCrossRef

Juergens CP, Leung DY, Crozier JA, Wong AM, Robinson JT, Lo S, Kachwalla H, Hopkins AP (2004) Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention. Catheter Cardiovasc Interv 63(2):166–170. doi:10.1002/ccd.20161 PubMedCrossRef

Chevalier B, Lancelin B, Koning R, Henry M, Gommeaux A, Pilliere R, Elbaz M, Lefevre T, Boughalem K, Marco J, Dupouy P (2003) Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial. Catheter Cardiovasc Interv 58(3):285–291. doi:10.1002/ccd.10431 PubMedCrossRef

Kalsch HI, Eggebrecht H, Mayringer S, Konorza T, Sievers B, Sack S, Erbel R, Kroeger K (2008) Randomized comparison of effects of suture-based and collagen-based vascular closure devices on post-procedural leg perfusion. Clin Res Cardiol 97(1):43–48. doi:10.1007/s00392-007-0575-z PubMedCrossRef

Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M (2004) Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA 291(3):350–357. doi:10.1001/jama.291.3.350 PubMedCrossRef

10.

Vaitkus PT (2004) A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. J Invasive Cardiol 16(5):243–246PubMed

11.

Nikolsky E, Mehran R, Halkin A, Aymong ED, Mintz GS, Lasic Z, Negoita M, Fahy M, Krieger S, Moussa I, Moses JW, Stone GW, Leon MB, Pocock SJ, Dangas G (2004) Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol 44(6):1200–1209. doi:10.1016/j.jacc.2004.06.048 PubMed

12.

Biancari F, D’ Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A (2010) Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J 159(4):518–531. doi:10.1016/j.ahj.2009.12.027 PubMedCrossRef

13.

Arora N, Matheny ME, Sepke C, Resnic FS (2007) A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J 153(4):606–611. doi:10.1016/j.ahj.2006.12.014 PubMedCrossRef

14.

Applegate RJ, Sacrinty MT, Kutcher MA, Kahl FR, Gandhi SK, Santos RM, Little WC (2008) Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. JACC Cardiovasc Interv 1(3):317–326. doi:10.1016/j.jcin.2008.03.013 PubMedCrossRef

15.

Schafer J (1996) Analysis of incomplete multivariate data. In: Analysis of incomplete multivariate data

16.

R-Development-Core-Team (2009) R: A Language and Environment for Statistical Computing. Vienna, Austria

17.

Chandrasekar B, Doucet S, Bilodeau L, Crepeau J, de Guise P, Gregoire J, Gallo R, Cote G, Bonan R, Joyal M, Gosselin G, Tanguay JF, Dyrda I, Bois M, Pasternac A (2001) Complications of cardiac catheterization in the current era: a single-center experience. Catheter Cardiovasc Interv 52(3):289–295. doi:10.1002/ccd.1067 PubMedCrossRef

18.

Ramana RK, Singh A, Dieter RS, Moran JF, Steen L, Lewis BE, Leya F (2008) Femoral angiogram prior to arteriotomy closure device does not reduce vascular complications in patients undergoing cardiac catheterization. J Interv Cardiol 21(2):204–208. doi:10.1111/j.1540-8183.2007.00342.x PubMedCrossRef

19.

Sherev DA, Shaw RE, Brent BN (2005) Angiographic predictors of femoral access site complications: implication for planned percutaneous coronary intervention. Catheter Cardiovasc Interv 65(2):196–202. doi:10.1002/ccd.20354 PubMedCrossRef

20.

Farouque HM, Tremmel JA, Raissi Shabari F, Aggarwal M, Fearon WF, Ng MK, Rezaee M, Yeung AC, Lee DP (2005) Risk factors for the development of retroperitoneal hematoma after percutaneous coronary intervention in the era of glycoprotein IIb/IIIa inhibitors and vascular closure devices. J Am Coll Cardiol 45(3):363–368. doi:10.1016/j.jacc.2004.10.042 PubMedCrossRef

21.

Applegate RJ, Sacrinty M, Kutcher MA, Gandhi SK, Baki TT, Santos RM, Little WC (2006) Vascular complications with newer generations of angioseal vascular closure devices. J Interv Cardiol 19(1):67–74. doi:10.1111/j.1540-8183.2006.00107.x PubMedCrossRef

22.

Saw J, Bhatt DL, Moliterno DJ, Brener SJ, Steinhubl SR, Lincoff AM, Tcheng JE, Harrington RA, Simoons M, Hu T, Sheikh MA, Kereiakes DJ, Topol EJ (2006) The influence of peripheral arterial disease on outcomes: a pooled analysis of mortality in eight large randomized percutaneous coronary intervention trials. J Am Coll Cardiol 48(8):1567–1572. doi:10.1016/j.jacc.2006.03.067 PubMedCrossRef

23.

Germing A, Grewe P, Mugge A, Lindstaedt M (2006) Large femoral aneurysm as a late complication after vessel closure device application. Clin Res Cardiol 95(6):334–337. doi:10.1007/s00392-006-0381-z PubMedCrossRef

24.

Kalsch H, Konorza T, Erbel R (2006) Occlusion of the femoral artery after using the percutaneous suture-mediated closure system perclose. Clin Res Cardiol 95(11):617–619. doi:10.1007/s00392-006-0435-2 PubMedCrossRef

25.

Cura FA, Kapadia SR, L’ Allier PL, Schneider JP, Kreindel MS, Silver MJ, Yadav JS, Simpfendorfer CC, Raymond RR, Tuzcu EM, Franco I, Whitlow PL, Topol EJ, Ellis SG (2000) Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol 86(7):780–782 A789PubMedCrossRef

26.

Gutierrez MJ, Aggarwal A, Gilbert K, Sobel BE, Dauerman HL (2004) Bleeding complications after contemporary pharmacoinvasive therapy for ST elevation myocardial infarction. J Thromb Thrombolysis 18(3):187–192. doi:10.1007/s11239-005-0344-7 PubMedCrossRef

27.

Boccalandro F, Assali A, Fujise K, Smalling RW, Sdringola S (2004) Vascular access site complications with the use of closure devices in patients treated with platelet glycoprotein IIb/IIIa inhibitors during rescue angioplasty. Catheter Cardiovasc Interv 63(3):284–289. doi:10.1002/ccd.20171 PubMedCrossRef

28.

Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P et al (1987) Thrombolysis in myocardial infarction (TIMI) trial, phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation 76(1):142–154PubMedCrossRef

29.

The GUSTO investigators (1993) An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 329(10):673–682. doi:10.1056/NEJM199309023291001 CrossRef

30.

Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S (2006) Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 114(8):774–782. doi:10.1161/CIRCULATIONAHA.106.612812 PubMedCrossRef

31.

Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, Dangas GD, Lincoff AM, White HD, Moses JW, King SB III, Ohman EM, Stone GW (2007) 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 49(12):1362–1368. doi:10.1016/j.jacc.2007.02.027 PubMedCrossRef

32.

Rao SV, O’Grady K, Pieper KS, Granger CB, Newby LK, Mahaffey KW, Moliterno DJ, Lincoff AM, Armstrong PW, Van de Werf F, Califf RM, Harrington RA (2006) A comparison of the clinical impact of bleeding measured by two different classifications among patients with acute coronary syndromes. J Am Coll Cardiol 47(4):809–816. doi:10.1016/j.jacc.2005.09.060 PubMedCrossRef

33.

Lincoff AM, Bittl JA, Harrington RA, Feit F, Kleiman NS, Jackman JD, Sarembock IJ, Cohen DJ, Spriggs D, Ebrahimi R, Keren G, Carr J, Cohen EA, Betriu A, Desmet W, Kereiakes DJ, Rutsch W, Wilcox RG, de Feyter PJ, Vahanian A, Topol EJ (2003) Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA 289(7):853–863PubMedCrossRef

34.

Moscucci M, Fox KA, Cannon CP, Klein W, Lopez-Sendon J, Montalescot G, White K, Goldberg RJ (2003) Predictors of major bleeding in acute coronary syndromes: the global registry of acute coronary events (GRACE). Eur Heart J 24(20):1815–1823PubMedCrossRef

35.

Rao SV, Eikelboom JA, Granger CB, Harrington RA, Califf RM, Bassand JP (2007) Bleeding and blood transfusion issues in patients with non-ST-segment elevation acute coronary syndromes. Eur Heart J 28(10):1193–1204. doi:10.1093/eurheartj/ehm019 PubMedCrossRef

36.

Metz D, Meyer P, Touati C, Coste P, Petiteau PY, Durand P, Faivre R, Lefevre T, Elaerts J (1997) Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: results of a prospective, multicenter, randomized trial. Am Heart J 134(1):131–137PubMedCrossRef

37.

Nikolsky E, Mehran R, Dangas G, Fahy M, Na Y, Pocock SJ, Lincoff AM, Stone GW (2007) Development and validation of a prognostic risk score for major bleeding in patients undergoing percutaneous coronary intervention via the femoral approach. Eur Heart J 28(16):1936–1945. doi:10.1093/eurheartj/ehm194 PubMedCrossRef

38.

Fitchett D (2007) The impact of bleeding in patients with acute coronary syndromes: how to optimize the benefits of treatment and minimize the risk. Can J Cardiol 23(8):663–671PubMedCrossRef

Title: The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization
Authors: Emilia Stegemann
Rainer Hoffmann
Steven Marso
Berthold Stegemann
Nikolaus Marx
Thomas Lauer
Publication date: 01-09-2011
Publisher: Springer-Verlag
Published in: Clinical Research in Cardiology / Issue 9/2011
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-011-0313-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization

Abstract

Objective

Background

Method

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Background

Method

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 9/2011

Autonomic regulation during mild therapeutic hypothermia in cardiopulmonary resuscitated patients

Vitamin D deficiency is an independent predictor of anemia in end-stage heart failure

Transapical septal occluder for paravalvular leakage of the mitral valve: a novel method for interventional treatment in high-risk patients

43. Jahrestagung der Deutschen Gesellschaft für Pädiatrische Kardiologie, 1. bis 4. Oktober 2011 in Weimar

Age-related differences in antithrombotic therapy, success rate and in-hospital mortality in patients undergoing percutaneous coronary intervention

Clinical experience with a novel subcutaneous implantable defibrillator system in a single center