Use of Angio-Seal closure device when the arteriotomy is above or below the common femoral artery.

Background: The majority of vascular complications during diagnostic coronary angiography occur while accessing the femoral artery. Angio-Seal vascular closure devices are indicated for closure of arteriotomies of the femoral artery, but not when the puncture site is above or below the femoral artery.

Hypothesis: Under certain circumstances, use of the Angio-Seal closure device above or below the common femoral artery may be safe and effective.

Methods: Consecutive patients at a single high-volume medical center having documented high or low arteriotomies were closed using an Angio-Seal closure device. Patients were chosen when they received a single arterial puncture, the arteriotomy was away from branch vessels, and the diameter of the artery at the site of sheath entry was of large enough caliber to suggest placement would be successful. Patients were then followed longitudinally for complications.

Results: Sixty-two patients had non-femoral artery sheath placement. Twenty-two patients had "high" puncture sites, and 40 patients had "low" puncture sites. All were successfully closed using the Angio-Seal vascular closure device and had no complications.

Conclusions: Although not approved for placement in areas above or below the femoral artery, off-label use of the Angio-Seal arteriotomy closure may be safely performed when patient characteristics are favorable.