Surgical complications from hemostatic puncture closure devices.
BACKGROUND
For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal).


METHODS
A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization.


RESULTS
An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery.


CONCLUSIONS
During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.
Eidt
J F
JF
Department of Surgery, University of Arkansas for Medical Sciences and John L. McClellan VAMC, Little Rock, USA.
Habibipour
S
S
Saucedo
J F
JF
McKee
J
J
Southern
F
F
Barone
G W
GW
Talley
J D
JD
Moursi
M
M
D001157:Arterial Occlusive Diseases / Q000209:etiology* / Q000601:surgery; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011677:Punctures; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration