Posted by: admin on: December 8, 2011
A femoral artery closure device may reduce large hematomas and speed closure compared with manual compression of the catheter access wound, a randomized trial indicated.
Inhospital hematomas larger than 5 cm occurred in 2.2% of patients treated with the FemoSeal device compared with a hematoma rate of 6.7% in patients treated with manual compression alone
Use of the closure device also reduced time to hemostasis by seven minutes compared with manual compression — one minute versus eight
The FemoSeal device “sandwiches” the wound with an anchor inside the artery and cap outside, both made of a fully resorbable polymer without collagen or thrombosing agents
Agostoni pointed out that this mechanism is similar to the Angio-Seal closure device. And Holm noted that the better results with vascular closure devices compared with manual compression appear to be a class effect.
The Closure Devices Used in Everyday Practice (CLOSE-UP) study included 1,001 coronary angiography patients treated using femoral access at a single center without further invasive diagnostics or procedures.
Patients randomized to manual compression got compression until hemostasis, at least five minutes, with a standard of care that discouraged sandbagging and didn’t use a bandage or compression system.
One hour of bed rest after hemostasis was recommended in both groups.
FemoSeal group patients were more likely to be on a statin and to have hypertension and had a higher average body mass index, but use of aspirin, warfarin, and clopidogrel (Plavix) was equivalent between the two groups.
Patient-reported events at the access site 14 days after angiography did not differ by any measure between groups, with no patients needing vascular surgery or having retroperitoneal bleeding and a low rate of major bleeding (0.4% compression versus 0.0% device, P=0.50).
Agostoni called the low infection rates reassuring (0.4% compression and 0.2% device, P=1.00).
Self-assessed large hematomas at 14 days were similar between groups (8.7% versus 6.4%, respectively, P=0.20), as was need for post-discharge medical evaluation (4.2% compression versus 3.8% device, P=0.82) or new inhospital compression (8.8% versus 11.4%, respectively, P=0.18).
The patient-reported outcome reporting can be “tricky,” Agostoni warned in noting the “unusual” endpoints used compared with prior trials.
He also cautioned that these results were in a low-risk population not undergoing percutaneous coronary intervention and reflected the results of expert operators at a single center.
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