Surgical complications from hemostatic puncture closure devices

BACKGROUND: For securing immediate hemostasis following percutaneous arteri al catheterization, the Food and Drug Administration has approved three hem ostatic 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 catheteriz ation. RESULTS: An immediate mechanical failure of the device was experienced in 3 4 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patient s following Angio-Seal versus 0.3% (5 of 1662) following routine manual com pression (P = 0.004). In 5 patients, the device caused either complete occl usion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery. CONCLUSION: During the first year of utilization of a percutaneous hemostat ic closure device following cardiac catheterization, we observed a marked i ncrease in arterial occlusive complications requiring surgical repair. Surg eons must be familiar with the design of these devices to achieve precise r epair of surgical complications. Am J Surg. 1999;178:511-516. (C) 1999 by E xcerpta Medica, Inc.