Vascular complications with newer generations of angioseal vascular closure devices.
OBJECTIVE
To evaluate the safety and efficacy of newer generations of a single vascular closure device (VCD), Angioseal, compared to contemporaneous manual compression.


BACKGROUND
Previous assessment of VCD safety and efficacy has been based primarily on outcomes associated with the original VCD. Few data exist comparing safety and efficacy of modifications of the original VCDs.


METHODS
We evaluated in-hospital outcomes of patients undergoing diagnostic cath and percutaneous coronary intervention at a single center: 3,898 with manual compression and 3,898 with the Angioseal VCD. Three generations of the Angioseal device were studied: Generation 1, 7/97-4/00; Generation 2, 5/00-6/02; and Generation 3, 7/02-12/03. Propensity analysis was used to match patients within each generation for clinical and procedural covariates.


RESULTS
Closure success was 98.5% for Generation 1, 98.6% for Generation 2, and 98.1% for Generation 3, P = NS. The odds ratio for any vascular complication comparing Angioseal to manual compression was 0.92 (0.42-2.01) for Generation 1; 0.83 (0.49-1.41) for Generation 2; and 0.75 (0.32-1.77) for Generation 3. Multivariate logistic regression identified closure success and Angioseal device Generation 3 versus Generation 1 as predictive of reduced vascular complications during the entire study period.


CONCLUSIONS
These data indicate that the newest generation of the Angioseal VCD is at least as effective as the original device. Moreover, use of the Angioseal VCD was associated with vascular complications similar to or lower than vascular complications following manual compression for each generation of Angioseal device analyzed.
Section of Cardiology, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1045, USA. bapplega@wfubmc.edu
Robert J
RJ
Applegate
Matthew
M
Sacrinty
Michael A
MA
Kutcher
Sanjay K
SK
Gandhi
Talal T
TT
Baki
Renato M
RM
Santos
William C
WC
Little
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D003324:Coronary Artery Disease / Q000628:therapy*; D004869:Equipment Safety; D005260:Female; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D012189:Retrospective Studies; D016896:Treatment Outcome