Review of Vascular Closure Devices

599 - 607

Bryan G. Schwartz, MDa, Steven Burstein, MDb, Christina Economides, MDb, Robert A. Kloner, MD, PhDa,c, David M. Shavelle, MDc, Guy S. Mayeda, MDb


1. Waksman R, King SB III, Douglas JS, et al. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol 1995;75:886–889. 2. Omoigui NA, Califf RM, Pieper K, et al. Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I). J Am Coll Cardiol 1995;26:922–930. 3. Piper WD, Malenka DJ, Ryan TJ Jr, et al. Predicting vascular complications in percutaneous coronary interventions. Am Heart J 2003;145:1022–1029. 4. Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: The second decade. J Am Coll Cardiol 2007;50:1617–1626. 5. Tavris DR, Gallauresi BA, Lin B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 2004;16:459–464. 6. Marso SP, Amin AP, House JA, et al. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA 2010;303:2156–2164. 7. Derham C, Davies JF, Shahbazi R, Homer-Vanniasinkam S. Iatrogenic limb ischemia caused by angiography closure devices. Vasc Endovascular Surg 2007;40:492–494. 8. Carey D, Martin JR, Moore CA, et al. Complications of femoral artery closure devices. Catheter Cardiovasc Interv 2001;52:3–7. 9. Mlekusch W, Minar E, Dick P, et al. Access site management after peripheral percutaneous transluminal procedures: Neptune pad compared with conventional manual compression. Radiology 2008;249:1058–1063. 10. Nguyen N, Hasan S, Caufield L, et al. Randomized controlled trial of topical hemostasis pad use for achieving vascular hemostasis following percutaneous coronary intervention. Catheter Cardiovasc Interv 2007;69:801–807. 11. Mlekusch W, Dick P, Haumer M, et al. Arterial puncture site management after percutaneous transluminal procedures using a hemostatic wound dressing (Clo-Sur P.A.D.) versus conventional manual compression: A randomized controlled trial. J Endovasc Ther 2006;13:23–31. 12. Balzer JO, Schwarz W, Thalhammer A, et al. Postinterventional percutaneous closure of femoral artery access sites using the Clo-Sur PAD device: Initial findings. Eur Radiol 2007;17:693–700. 13. Rastan A, Sixt S, Schwarzwalder U, et al. VIPER-2: A prospective, randomized single-center comparison of 2 different closure devices with a hemostatic wound dressing for closure of femoral artery access sites. J Endovasc Ther 2008;15:83–90. 14. Nader RG, Garcia JC, Drushal K, Pesek T. Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures. J Invasive Cardiol 2002;14:305–307. 15. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention using thrombin hemostatic patch-facilitated manual compression. J Invasive Cardiol 2007;19:164–170. 16. Kunert M, Gremmler B, Schleiting H, Ulbricht LJ. Use of FemoStop system for arterial puncture site closure after coronary angioplasty. J Invasive Cardiol 2004;16:240–242. 17. 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;81:970–976. 18. Chamberlin JR, Lardi AB, McKeever LS, et al. Use of vascular sealing devices (VasoSeal and Perclose) versus assisted manual compression (Femostop) in transcatheter coronary interventions requiring abciximab (ReoPro). Catheter Cardiovasc Interv 1999;47:143–147. 19. 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;76:235–240. 20. Juergens CP, Leung DY, Crozier JA, et al. Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention. Catheter Cardiovasc Interv 2004;63:166–170. 21. Gall S, Tarique A, Natarajan A, Zaman A. Rapid ambulation after coronary angiography via femoral artery access: A prospective study of 1,000 patients. J Invasive Cardiol 2006;18:106–108. 22. Doyle BJ, Godfrey MJ, Lennon RJ, et al. Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization. Catheter Cardiovasc Interv 2007;69:203–208. 23. Seltzer S, Alejos JC, Levi DS. Experience with the Cardiva Boomerang Catalyst system in pediatric cardiac catheterization. Catheter Cardiovasc Interv 2009;74:476–481. 24. Kussmaul WG III, 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;25:1685–1692. 25. Bui QT, Kolansky DM, Bannan A, Herrmann HC. “Double wire” Angio-Seal closure technique after balloon aortic valvuloplasty. Catheter Cardiovasc Interv 2010;75:488–492. 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;40:78–83. 27. Martin JL, Pratsos A, Magargee E, et al. A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: The CAP trial. Catheter Cardiovasc Interv 2008;71:1–5. 28. 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;44:1200–1209. 29. Vaitkus PT. A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. J Invasive Cardiol 2004;16:243–246. 30. Scheinert D, Sievert H, Turco MA, et al. The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: Initial clinical results for Mynx. Catheter Cardiovasc Interv 2007;70:627–633. 31. Azmoon S, Pucillo AL, Aronow WS, et al. Vascular complications after percutaneous coronary intervention following hemostasis with the Mynx vascular closure device versus the Angio-Seal vascular closure device. J Invasive Cardiol 2010;22:175–178. 32. Wong SC, Bachinsky W, Cambier P, et al. A randomized 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;2:785–793. 33. Bavry AA, Raymond RE, Bhatt DL et al. Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: The multicenter randomized clinical trial of the FISH device. J Invasive Cardiol 2008;20:152–156. 34. Hermiller JB, Simonton C, Hinohara T, et al. The StarClose Vascular Closure System: Interventional results from the CLIP study. Catheter Cardiovasc Interv 2006;68:677–683. 35. 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;71:518–523. 36. Chiu AH, Coles SR, Tibballs J, Nadkarni S. The StarClose vascular closure device in antegrade and retrograde punctures: A single-center experience. J Endovasc Ther 2010;17:46–50. 37. Williams RE, Angel CY, Bourkaib R, et al. Multicenter safety and efficacy analysis of assisted closure after antegrade arterial punctures using the StarClose device. J Endovasc Ther 2007;14:498–505. 38. Gray BH, Miller R, Langan EM III, et al. The utility of the StarClose arterial closure device in patients with peripheral arterial disease. Ann Vasc Surg 2009;23:341–344. 39. Branzan D, Sixt S, Rastan A, et al. Safety and efficacy of the StarClose vascular closure system using 7-F and 8-F sheath sizes: A consecutive single-center analysis. J Endovasc Ther 2009;16:475–482. 40. Gonsalves M, Walkden M, Belli AM. Laceration of the common femoral artery following deployment of the StarClose vascular closure system. Cardiovasc Intervent Radiol 2008;31:817–820. 41. Stone PA, Campbell JE, Andrews KH, Bates MC. Posterior wall capture and resultant common femoral occlusion complicating StarClose access closure. J Vasc Surg 2008;48:469–471. 42. Bent CL, Kyriakides C, Matson M. Femoral artery stenosis following percutaneous closure using a StarClose closure device. Cardiovasc Intervent Radiol 2008;31:814–816. 43. Bhatt DL, Raymond RE, Feldman T, et al. Successful “pre-closure” of 7Fr and 8Fr femoral arteriotomies with a 6Fr suture-based device (the Multicenter Interventional Closer Registry). Am J Cardiol 2002;89:777–779. 44. Lee WA, Brown MP, Nelson PR, et al. Midterm outcomes of femoral arteries after percutaneous endovascular aortic repair using the Preclose technique. J Vasc Surg 2008;47:919–923. 45. Gerckens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: Evaluating a suture-mediated closure device. Am J Cardiol 1999;83:1658–1663. 46. 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;85:864–869. 47. 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;57:297–302. 48. Chou TM. Vascular complications and arteriotomy closure devices during percutaneous coronary procedures. J Am Coll Cardiol 2005;45:2095–2096. 49. 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;291:350–357. 50. Biancari F, D’Andrea V, Di MC, et al. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J 2010;159:518–531. 51. 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;22:1273–1279. 52. 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;34:210–214. 53. Michalis LK, Rees MR, Patsouras D, et al. A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett). Cardiovasc Intervent Radiol 2002;25:423–429. 54. The 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;143:612–619. 55. Katsouras CS, Michalis LK, Leontaridis I, et al. Treatment of acute lower limb ischemia following the use of the Duett sealing device: Report of three cases and review of the literature. Cardiovasc Intervent Radiol 2004;27:268–270. 56. Boston US, Panneton JM, Hofer JM, et al. Infectious and ischemic complications from percutaneous closure devices used after vascular access. Ann Vasc Surg 2003;17:66–71. 57. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:638–641. 58. Chambers CE, Eisenhauer MD, McNicol LB, et al.

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