Randomized comparison of effects of suture-based and collagen-based vascular closure devices on post-procedural leg perfusion.
BACKGROUND
Vascular closure devices (VCD) are well established to facilitate hemostasis after cardiac catheterization procedures. However, impairment of flow due to the reduction of femoral artery diameter remains a major concern. The present study aims to evaluate leg perfusion before and after application of collagen- and suture-based vascular closure devices.


METHODS
A total of 366 patients (age: 64.3 years+/-10.7, male: 71.3%) were randomized to receive femoral access site closure with either a collagen-based closure device (group A) (n=214) or a suture-mediated device (group B) (n=152), immediately following coronary catheterization procedures. In all patients, the ankle-brachial-index (ABI) was measured before and the day after closure device application.


RESULTS
In group A, mean ABI at baseline was 1.09+/-0.2, in group B 1.11+/-0.2. In both groups, there was a significant, albeit clinically not relevant, reduction in post-procedural ABI (group A: 1.04+/-0.2, p<0.01 vs baseline, group B: 1.06+/-0.2, p<0.01 vs baseline). DeltaABI was not different between both VCD groups (p=0.55). In patients with peripheral vascular disease (PVD), neither the Angioseal device (mean ABI at baseline 0.76+/-0.1) nor the Perclose-device (mean ABI at baseline 0.79+/-0.1) induced a remarkable impairment of leg perfusion (Angioseal: 0.77+/-0.1, p=0.9 vs baseline, Perclose: 0.78+/-0.1, p=1.0 vs baseline). Clinically, no aggravation of claudication was observed in the PVD patient group.


CONCLUSIONS
Both vascular closure devices are not associated with clinically relevant reduction in ABI. There was no difference between the two groups with respect to the level of flow impairment. Both devices may be safely used in patients with reduced ABI.
Kälsch
H I M
HI
Department of Cardiology, West-German Heart Center, Hufelandstr. 55, 45122, Essen, Germany. Hagen.Kaelsch@uk-essen.de
Eggebrecht
H
H
Mayringer
S
S
Konorza
T
T
Sievers
B
B
Sack
S
S
Erbel
R
R
Kroeger
K
K
D000368:Aged; D001783:Blood Flow Velocity; D006328:Cardiac Catheterization; D003094:Collagen; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D006487:Hemostasis; D006801:Humans; D007383:Intermittent Claudication / Q000601:surgery; D007866:Leg / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000601:surgery; D011183:Postoperative Complications / Q000209:etiology*; D011446:Prospective Studies; D013536:Suture Techniques; D014656:Vascular Surgical Procedures / Q000379:methods*
D003094:Collagen