Bleeding and vascular complications at the femoral access site following percutaneous coronary intervention (PCI): An evaluation of hemostasis strategies

Journal of Invasive Cardiology

Volumn 24, Issue 7, 2012, Pages 328-334

  Tavris, Dale R ^a   Wang, Yongfei ^b   Jacobs, Samantha ^a   Gallauresi, Beverly ^a   Curtis, Jeptha ^b   Messenger, John ^c   Resnic, Frederic S ^d   Fitzgerald, Susan ^e  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^b YALE UNIVERSITY   (United States)

^c UNIVERSITY OF COLORADO   (United States)

^d BRIGHAM AND WOMEN S HOSPITAL   (United States)

^e AMERICAN COLLEGE OF CARDIOLOGY   (United States)

Author keywords

hemostasis patch; mechanical compression; vascular closure device

Indexed keywords

ARTERIOVENOUS FISTULA; ARTERY DISSECTION; ARTERY OCCLUSION; ARTICLE; ARTIFICIAL EMBOLISM; BLEEDING; CARDIOVASCULAR DISEASE; CONTROLLED STUDY; DISEASE REGISTRY; FALSE ANEURYSM; FEMALE; FEMORAL ARTERY; HEMOSTASIS; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE; PERCUTANEOUS CORONARY INTERVENTION; VASCULAR CLOSURE DEVICE;

ANEURYSM, FALSE; EMBOLISM; FEMALE; FEMORAL ARTERY; HEMORRHAGE; HEMOSTATIC TECHNIQUES; HUMANS; INCIDENCE; LOGISTIC MODELS; MALE; MULTIVARIATE ANALYSIS; PERCUTANEOUS CORONARY INTERVENTION; PRESSURE; REGISTRIES; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOUND CLOSURE TECHNIQUES;

EID: 84864336518     PISSN: 10423931     EISSN: 15572501     Source Type: Journal    
DOI: None     Document Type: Article

References (27)

1. Marso SP, Amin AP, House JA, et al; on behalf of the National Cardiovascular Data Registry. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA. 2010;303(21):2156-2164.
2. Heart Disease and Stroke Statistics - 2011 Update. American Heart Association, 2011.
3. Tavris DR, Gallauresi BA, Dey S, Brindis R, Mitchel K. Risk of local adverse events by gender following cardiac catheterization. Pharmacoepidemiol Drug Saf. 2007;16(2):125-131. (Pubitemid 46291165)
4. United States Food and Drug Administration (US FDA). Manufacturer and user facility device experience; MAUDE Database, 2001: Accessed at www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfmaude/TextResults.cfm
5. Tavris DR, Dey S, Gallauresi B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II. J Invasive Cardiol. 2005;17(12):644-650.
6. An initiative of the American College of Cardiology Foundation, the NCDR, National Cardiovascular Data Registry, is a comprehensive, outcomes-based suite of registries focused on quality improvement. www.ncdr.com.
7. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Propensity score analysis of vas cular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998-2003. Catheter Cardiovasc Interv. 2006;67(4):556-562.
8. Applegate RJ, Sacrinty M, Kutcher MA, et al. Vascular complications with newer generations of Angio-Seal vascular closure devices. J Interv Cardiol. 2006;19(1):67-74.
9. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Propensity score analysis of vascu lar complications after diagnostic cardiac catheterization and percutaneous coro nary intervention using thrombin hemostatic patch-facilitated manual compres sion. J Invasive Cardiol. 2007;19(4):164-170. (Pubitemid 46558002)
10. Sulzbach-Hoke LM, Ratcliffe SJ, Kimmel SE, et al. Predictors of complications following sheath removal with percutaneous coronary intervention. J Cardiovasc Nurs. 2010;25(3):E1-E8.
11. Legrand V, Doneux P, Martinez C, et al. Femoral access management: Comparison between two different vascular closure devices after percutaneous coronary inter vention. Acta Cardiol. 2005;60(5):482-488. (Pubitemid 41433653)
12. Hermiller JB, Simonton C, Hinohara T, et al. The StarClose Vascular Closure System: Interventional results from the CLIP study. Catheter Cardiovasc Interv. 2006;68(5):677-683. (Pubitemid 44721086)
13. Martin JL, Pratsos A, Magargee E, et al. A randomized trial comparing com pression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: The CAP trial. Catheter Cardiovasc Interv. 2008;71(1):1-5. (Pubitemid 351158339)
14. Deuling JH, Vermeulen RP, Anthonio RA, et al. Closure of the femoral artery after cardiac catheterization: A comparison of Angio-Seal, StarClose, and manual compression. Catheter Cardiovasc Interv. 2008;71(4):518-523. (Pubitemid 351498096)
15. Wong SC, Bachinsky W, Cambier P, et al; ECLIPSE Trial Investigators. A ran domized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: The ECLIPSE (Ensure s Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009;2(8):785-793.
16. Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J. 2007;153(4):606-611. (Pubitemid 46440677)
17. Castillo-Sang M, Tsang AW, Almaroof B, et al. Femoral artery complications after cardiac catheterization: A study of patient profile. Ann Vasc Surg. 2010;24(3):328-335.
18. Sanborn TA, Ebrahimi R, Manoukian SV, et al. Impact of femoral vascular clo sure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circ Cardiovasc Interv. 2010;3(1):57-62.
19. Iqtidar AF, Li D, Mather J, McKay RG. Propensity matched analysis of bleeding and vascular complications associated with vascular closure devices vs standard manual compression following percutaneous coronary intervention. Conn Med. 2011;75(1):5-10.
20. Marso SP, Amin AP, House JA, et al; National Cardiovascular Data Registry. As sociation between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA. 2010;303(21):2156-2164.
21. Ahmed B, Piper WD, Malenka D, et al. Significantly improved vascular compli cations among women undergoing percutaneous coronary intervention: A report from the Northern New England Percutaneous Coronary Intervention Registry. Circ Cardiovasc Interv. 2009;2(5):423-429.
22. Trimarchi S, Smith DE, Share D, et al; BMC2 Registry. Retroperitoneal hema toma after percutaneous coronary intervention: prevalence, risk factors, manage ment, outcomes, and predictors of mortality: A report from the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry. JACC Car diovasc Interv. 2010;3(8):845-850.
23. Vaitkus PT. A meta-analysis of percutaneous vascular closure devices after diag nostic catheterization and percutaneous coronary intervention. J Invasive Cardiol. 2004;16(5):243-246. (Pubitemid 38637895)
24. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization - sys tematic review and meta-analysis. JAMA. 2004;291(3):350-357. (Pubitemid 38101608)
25. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary proce dures: A meta-analysis. J Am Coll Cardiol. 2004;44(6):1200-1209. (Pubitemid 39208874)
26. Biancari F, D Andrea V, Di Marco C, et al. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angio plasty. Am Heart J. 2010;159(4):518-531.
27. Tavris DR, Dey S, Gallauresi B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II. J Invasive Cardiol. 2005;17(12): 644-650.