Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty.
AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.
Shammas
Nicolas W
NW
Genesis Heart Institute and Cardiovascular Medicine, P.C., Davenport, Iowa 52803, USA. shammas@home.com
Rajendran
Vijay R
VR
Alldredge
Stephen G
SG
Witcik
William J
WJ
Robken
Jon A
JA
Lewis
J Randolph
JR
McKinney
Dawn
D
Hansen
Christena A
CA
Kabel
M Elizabeth
ME
Harris
Melodee
M
Jerin
Michael J
MJ
Bontu
Prakash R
PR
Dippel
Eric J
EJ
Labroo
Ajay
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D003094:Collagen / Q000009:adverse effects* / Q000627:therapeutic use*; D017023:Coronary Angiography / Q000009:adverse effects*; D003327:Coronary Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D004434:Early Ambulation; D004868:Equipment Failure; D005260:Female; D006488:Hemostasis, Surgical / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013537:Sutures / Q000009:adverse effects*; D013997:Time Factors
D003094:Collagen