Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: Initial U.S. feasibility trial using the Duett vascular closure device

Catheterization and Cardiovascular Interventions

Volumn 50, Issue 1, 2000, Pages 96-102

  Mooney, Michael R ^a   Ellis, Stephen G ^b   Gershony, Gary ^c   Yehyawi, Kais J ^a   Kummer, Barbara ^a   Lowrie, Marsha ^b  

^a Mpls Heart Institute Foundation   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c John Muir Medical Center   (United States)

Author keywords

Angioplasty; Coagulation; Collagen; Thrombin

Indexed keywords

MICROCRYSTALLINE COLLAGEN; PROCOAGULANT; THROMBIN;

ADULT; AGED; ARTICLE; BALLOON CATHETER; CLINICAL ARTICLE; CLINICAL TRIAL; COMPRESSION THERAPY; CROSSOVER PROCEDURE; DEVICE; DOPPLER FLOWMETRY; ENDOVASCULAR SURGERY; FALSE ANEURYSM; FEASIBILITY STUDY; FEMALE; FEMORAL ARTERY; HEART CATHETERIZATION; HEMOSTASIS; HUMAN; MALE; MULTICENTER STUDY; PUNCTURE; ULTRASOUND THERAPY; VASCULAR ACCESS; WOUND CLOSURE;

ADULT; AGED; ANALYSIS OF VARIANCE; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CATHETERS, INDWELLING; EQUIPMENT DESIGN; FEASIBILITY STUDIES; FEMALE; FEMORAL ARTERY; FOLLOW-UP STUDIES; HEART CATHETERIZATION; HEMORRHAGE; HEMOSTATIC TECHNIQUES; HUMANS; MALE; MIDDLE AGED; PROBABILITY; PROSPECTIVE STUDIES; PUNCTURES; SENSITIVITY AND SPECIFICITY; TISSUE ADHESIVES;

EID: 0034016915     PISSN: 15221946     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1522-726X(200005)50:1<96::AID-CCD21>3.0.CO;2-V     Document Type: Article

References (26)

1. Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S. A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994;331:496-501.
2. The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 1994;330:956-961.
3. 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;88:1569-1578.
4. Wyman RM, Safian RD, Portway V, Skillman JJ, McKay RG, Baim DS. Current complications of diagnostic and therapeutic cardiac catheterization. J Am Coll Cardiol 1988;12:1400-1406.
5. Oweida SW, Roubin GS, Smith RB, Salam AA. Post-catheterization vascular complications associated with percutaneous transluminal coronary angioplasty. J Vase Surg 1990;12:310-315.
6. Muller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol 1992;69:63-68.
7. Schatz RA, Baim DS, Leon M, Ellis SG, Goldberg S, Hirshfeld JW, Cleman MW, Cabin HS, Walker C, Stagg J, Buchbinder M, Teirstein PS, Topol EJ, Savage M, Perez JA, Curry RC, Whitworth H, Sousa JE, Tio F, Almagor Y, Ponder R, Penn IM, Leonard B, Levine SL, Fish RD, Palmaz JC. Clinical experience with the Palmaz-Schatz coronary stent: initial results of a multicenter study. Circulation 1991;83:148-161.
8. Dick RJ, Popma JJ, Muller DW, Burek KA, Topol EJ. In-hospital costs associated with new percutaneous coronary devices. Am J Cardiol 1991:68:879-885.
9. Krause PB, Klein LW. Utility of a percutaneous collagen hemostasis device: To plug or not to plug? J Am Coll Cardiol 1993; 22:1280-1282.
10. Kussmaul WG, Buchbinder M, Whitlow PL, Aker UT, Heuser RR, King SB, Kent KM, Leon MB, Kolansky DM, Sandza JG. 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.
11. Silber S. Rapid hemostasis of arterial puncture sites with collagen in patients undergoing diagnostic and interventional cardiac catheterization. Clin Cardiol 1997;20:981-992.
12. Bartorelli AL, Sganzerla P, Fabbiocchi F, Montorsi P, De Cesare N, Child M, Tavasci E, Passaretti B, Loaldi A. Prompt and safe femoral hemostasis with a collagen device after intracoronary implantation of Palmaz Schatz stents. Am Heart J 1995;130:26-32.
13. Schrader R, Steinbacher S, Burger W, Kadel C, Vallbracht C, Kaltenbach M. Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial. Cathet Cardiovasc Diagn 1992;27:298-302.
14. Aker UT, Kensey KR, Heuser RR, Sandza JG, Kussmaul WG. Immediate arterial hemostasis after cardiac catheterization: initial experience with a new puncture closure device. Cathel Cardiovasc Diagn 1994;31:228-232.
15. Kussmaul WG, Buchbinder M, Whitlow PL, Aker UT, Heuser RR, King SB, Kent KM, Leon MB, Kolansky DM, Sandza JG. Femoral artery hemostasis using an implantable device (Angio-Seal) after coronary angioplasty. Cathet Cardiovasc Diagn 1996; 37:362-365.
16. Vainer J, Meier B. Has the time come for the plug? Cathet Cardiovasc Diagn 1996;37:366.
17. Sailer LF, Mintz G. Percutaneous hemostatic closure systems: is the cost worth the price? Cathet Cardiovasc Diagn 1996;37:373-374.
18. Carere RG, Webb JG, Ahmed T, Dodek AA. Initial experience using prostar: a new device for percutaneous suture-mediated closure of arterial puncture sites. Cathet Cardiovasc Diagn 1996; 37:367-372.
19. De Swart H, Dijkman L, Hofstra, Bar F, Van Omen V, Tordoir J, Wellens HJJ. A new hemostatic puncture closure device for the immediate sealing of arterial puncture sites. Am J Cardiol 1993; 72:445-449.
20. Sanborn TA, Gibbs HH, Brinker JA, Knopf WD, Kosinski EJ, Roubin GS. 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.
21. Abbott WM, Austen WG. The effectiveness and mechanism of collagen-induced topical hemostasis. Surgery 1975;78:723-729.
22. Vaughan DE, Schafer AI, Loscalzo J. Normal mechanisms of hemostasis and fibrinolysis. In: Loscalzo J, Creager MA, Dzau VJ, editors. Vascular medicine. Boston: Little Brown; 1992. p 243-244.
23. Gershony G, Brock JM, Powell JS. A novel vascular sealing device for closure of percutaneous vascular access sites. Cathet Cardiovasc Diagn 1998;45:82-88.
24. Silber S, Schoen N, Seidel N, Heis-Bogner J. Inadvertent occlusion of the common femoral artery following Angio-Seal deployment. Z Kardiol 1998;87:51-55.
25. Silber S. Hemostasis success rates and local complications using collagen after femoral access for cardiac catheterization: analysis of 6007 published patients. Am Heart J 1998;135:152-156.
26. Silber S, Gershony G, Spannagl M, Schramm W. Effects of a new vascular sealing device on coagulation parameters and thrombin generation in humans. J Am Coll Cardiol 1998;31:102A.