Safety and efficacy of staple-mediated femoral arteriotomy closure: Results from a randomized multicenter study

Catheterization and Cardiovascular Interventions

Volumn 67, Issue 4, 2006, Pages 546-553

  Ansel, Gary ^a,i   Yakubov, Stephen ^a   Neilsen, Christopher ^b   Allie, David ^c   Stoler, Robert ^d   Hall, Patrick ^e   Fail, Peter ^f   Sanborn, Timothy ^g   Caputo, Ronald P ^h  

^a Division of Cardiology   (United States)

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c Southwest Medical Center   (United States)

^d Baylor Hospital   (United States)

^e South Carolina Heart Center   (United States)

^f Terrebonne General Medical Center   (United States)

^g Division of Cardiology   (United States)

^h St Joseph's Hospital   (United States)

ⁱ NONE   (United States)

Author keywords

Closure device; Femoral artery

Indexed keywords

ANTICOAGULANT AGENT; FIBRINOGEN RECEPTOR ANTAGONIST;

ADULT; AGED; ARTERIOTOMY; ARTICLE; BLEEDING; CLINICAL TRIAL; COMPRESSION THERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEVICE; FALSE ANEURYSM; FEMALE; FEMORAL ANGIOGRAPHY; FEMORAL ARTERY; FOLLOW UP; HEMATOMA; HEMOSTASIS; HUMAN; INFECTION; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; LEG ISCHEMIA; MAJOR CLINICAL STUDY; MALE; MOBILIZATION; MULTICENTER STUDY; PERIPHERAL VASCULAR DISEASE; RANDOMIZED CONTROLLED TRIAL; RETROPERITONEAL HEMORRHAGE; SAFETY; STAPLER; WOUND DEHISCENCE;

AGED; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CATHETERIZATION, PERIPHERAL; EQUIPMENT DESIGN; FEMALE; FEMORAL ARTERY; FOLLOW-UP STUDIES; HEMOSTASIS, SURGICAL; HUMANS; MALE; MIDDLE AGED; SURGICAL STAPLERS; SURGICAL STAPLING; TREATMENT OUTCOME;

EID: 33646030622     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.20628     Document Type: Article

References (48)

1. Simonsen M. Expanding use of interventional treatment drives cardiology sector. Am Health Consult BBI Newsletter 2000;5: 1-6.
2. Strategic growth opportunities in cardiovascular interventional product markets, 2000-2001. Meditech Insight 2000;12:1-45.
3. Slaughter PM, Chetty R, Flintoft VF. 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;34:8-13.
4. Copelen K. Improving productivity with the Angio-Seal device. Cathet Lab Digest 2000;(Suppl):4-7.
5. Rogers EW, Doty WD, Stewart J. Significant improvements in patient care and cost savings resulting form percutaneous vascular surgery (PVS). J Cardiovasc Manage 1999;10:13-17.
6. Spector KS, Lawson WE. Optimizing safe femoral access during cardiac catheterization. Catheter Cardiovasc Interv 2001;53:209-212.
7. Duffin DC, Muhlestein JB, Allison SB, Home BD, Fowles RE, Sorensen SG, Revenaugh JR, Bair TL, Lappe DL. 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 Invas Cardiol 2001;13:354-362.
8. Popma JJ, Satler LF, Pichard AD, Kent KM, Campbell A, Chuang YC, Clark C, Merritt AJ, Bucher TA, Leon MB. Vascular complications after balloon and new device angioplasty. Circulation 1993;88(Pt 1):1569-1578.
9. Muller DWM, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications aftger conventional and complex percutaneous coronary interventional procedures. Am J Cardiol 1992;69:63-68.
10. Dangas G, Mehran R, Kokolis S, Feldman D, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:638-644.
11. Camenzind E, Grossholz M, Urban P, Dorsaz PA, Didier D, Meier B. Collagen application versus manual compression: a prospective randomized trial for arterial puncture site closure after coronary angioplasty. J Am Coll Cardiol 1994;24:655-662.
12. Sanborn TA, Gibbs JJ, 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 1999;22:1273-1279.
13. Pracyk JB, Wall TC, Longabough TC, et al. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol 1998;81:970-976.
14. Kapadia SR, Raymond R, Knopf W, Jenkins S, Chapekis A, Ansel G, Rothbaum D, Kussmaul W, Teirstein P, Reisman M, Casale P, Oster L, Simpfendorfer C. The 6FR Angio-Seal arterial closure device: results from a multimember prospective registry. Am J Cardiol 2001;87:789-791.
15. Effebrecht H, Haude M, Birgelen C, Woerten U, Schmermund A, Baumgart D, Kaiser C, Naber C, Kroeger K, Erbel R. Early clinical experience with the 6 French Angio-Seal device: immediate closure of femoral puncture sites after diagnostic and interventional coronary procedures. Catheter Cardiovasc Interv 2001; 53:437-442.
16. Heyer G, Atzenhofer K, Meixl H, Lampersberger C, Gershony G. Arterial access site closure with a novel sealing device: Duett. Vasc Surg 2001;35:199-201.
17. Fram DB, Giri S, Jamil G, Mitchel JF, Boden WE, Din S, Kiernan FJ. 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;53:163-173.
18. Baim DS, Knopf WD, Hinohara T, Schwarten DE, Schatz RA Pinkerton CA, Cutlip DE, Fitzpatrick M, Ho KKL, Kuntz RE. Suture-mediated closure of the femoral access site after cardiac catheterizations: results of the Suture to Ambulate and Discharge (STAND I and STAND II) trials. Am J Cardiol 2000;85:864-869.
19. Morice MC, Dumas P, Lefevre T, Loubeyre C, Louvard Y, Piechaud JF. Systematic use of transradial approach or suture of the femoral artery after angioplasty: attempt at achieving zero access site complications. Catheter Cardiovasc Interv 2000;51:417-421.
20. Balzer JO, Scheinen D, Diebold T, Haufe M, Vogl TJ, Biamino G. Postinterventional transcutaneous suture of femoral artery access sites in patients with peripheral arterial occlusive disease: a study of 930 patients. Catheter Cardiovasc Interv 2001;53:174-181.
21. Michaels AD, Ports TA. Use of a percutaneous arterial suture device (Perclose) in patients undergoing percutaneous balloon aortic valvuloplasty. Catheter Cardiovasc Interv 2001;53:445-447.
22. Carey D, Martin JR, Moore CAQ, Valentine MC,Niggards Nygaard TW. Complications of femoral artery closure devices. Catheter Cardiovasc Interv 2001;52:3-7.
23. Shrake KL. Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 2000;85: 1024-1025.
24. Cura FA, Kapadia SR, L'Allier PL, Schneider JP, Kreindel MS, Silver MJ, Yadav JS, Simpfendorfer CC, Raymoind RR, Tuzcu EM, Franco I, Whitlow PL, Topol EJ, Ellis SG. Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol 2000;86:780-782.
25. Nehler MR, Lawrence A, Whitehill TA, Charette SD, Jones DN, Krupske WC. Iatrogenic vascular injuries from percutaneous vascular suturing devices. J Vasc Surg 2001;33:943-947.
26. Sprouse LR, Botta DM, Hamilton IN. The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices. J Vasc Surg 2001;33:688-693.
27. Cleveland K, Gelfand MS. Invasive staphylococcal infections complicating percutaneous transluminal coronary angioplasty: three cases and review. Clin Infect Dis 1995;21:93-96.
28. Mondy JS, Brophy C, Nesbit R, Pipkin W. Early experience with infectious complications of percutaneous femoral artery closure devices. J Vasc Surg 2000;32:205-208.
29. Angio-Seal Vascular Closure Device. Daig/St. Jude Medical Co., Minnetonka, MN. Instructions for use.
30. Techstar Vascular Closure Device. Abbott Vascular Devices, Redwood City, CA. Instructions for use.
31. Vaso-Seal Vascular Closure Device. Datascope Corporation, Montvale, NJ. Instructions for use.
32. Duett Vascular Closure Device. Vascular Solutions, Minneapolis MN. Instructions for use.
33. Schnyder G, Sawhney N, Whisenant B, Tsimikas S, Turi ZG. Common femoral artery anatomy is influenced by demographics and comorbidity: implications for cardiac and peripheral invasive studies. Catheter Cardiovasc Interv 2001;53:289-295.
34. Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg 2001;33:812-819.
35. Deb S, Martin B, Sun LK, Burris D, Wherry D, Pikoulis E, Rhee P. Comparison of titanium vascular closure staples with suture repair of the thoracic aorta in swine. Chest 2000;118:1762-1767.
36. Zeebregts C, Zengerink H, Buikema H, Verhoeven E, van den Dungen J. Improved preservation of endothelial integrity after vascular anastomoses using nonpenetrating staples. Eur Surg Res 2000;32(Suppl):112.
37. Kirsch WM, Zhu YH, Hardesty RA, Chapolini R. A new method for microvascular anastamosis: report of experimental and clinical research. Am Surg 1992;58;722-727.
38. Robicsek F. The birth of the surgical stapler. Surg Gynecol Obstet 1980;150;579-583.
39. Gerbault O, Arrouvel C, Servant JM, Revol M, Banzet P. VCS microclip anastomosis on blood vessels of less than 2 millimeters in diameter: preliminary experimental study in the rat. Ann Chir Plast Esther 1998;43:27-29.
40. Lambert F, Coulturaud B, Cruel T, Lecoin G, Cariou JL. Vascular microanastomosis by eversion and stapling using VCS forceps: presentations of the technique and experimental evaluation of its reliability. Ann Chir Plast Esther 1998;43:14-26.
41. Eggebrecht H, Haude M, Woertegen U, Schmermund A, von Birgelen C, Naber C, Baumgart d, Kaiser C, Oldesburg O, Bartel T, Kroeger K, Erbel R. Systematic use of collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients. Catheter Cardiovasc Interv 2002;57:486-495.
42. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol 2003;14:865-885.
43. Ernst SM, Jhonjaegin RM, Schrader R, Kaltenbach M, Sigwart U, Sanborn TA, Plokker HW. Immediate sealing of arterial puncture sites after cardiac catheterization and coronary angioplasty using a biodegradable plug: results of an international registry. J Am Coll Cardiol 1993;21:851-855.
44. Hollis HW, Rehring T. Femoral endarteritis associated with percutaneous suture closure: new technology, challenging complications. J Vasc Surg 2003;38:83-87.
45. Yamamoto N, Koyano K, Azuma M, Ochiai H, Kashiawabara T. Groin infection caused by a percutaneous femoral artery closure device: report of a case. Surg Today 2003;33:801-804.
46. Gemmete JJ, Dasika N, Forauer AR, Cho K, Williams DM. Successful angioplasty of a superficial femoral artery stenosis caused by a suture-mediated closure device. Cardiovass Interv Radiol 2003;28:410-412.
47. Tiesenhauusen K, Tomka M, Baumann M, Hessinger H, Portugaller H, Mahler E. Femoral artery infection associated with a percutaneous arterial suture device. VASA 2004;33:83-85.
48. Wagner SC, Gansalves CF, Eschelman DJ, Sullivan KL, Bonn J. Complications of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure: a case-controlled study. J Vasc Interv Radiol 2003;14:735-741.