FEMORAL ARTERIAL HEMOSTASIS USING THE ANGIO-SEAL(TM) SYSTEM AFTER CORONARY AND VASCULAR PERCUTANEOUS ANGIOPLASTY AND STENTING

The procedures of left cardiac catheterization and revascularization b y angioplasty: are associated with a substantial risk of hemorrhagic c omplications. This risk increases clearly in patients with an intravas cular stent who require early high doses of anticoagulant therapy. The first purpose of our study was to evaluate the effectiveness of a mec hanical system of femoral hemostasis (Angio-Seal(TM), Sherwood Davis & Geck, St. Louis, Missouri) deployed in a group of 411 consecutive pat ients (302 males, 109 females, mean age 59 +/- 15) who successfully un derwent percutaneous angioplasty (PA) and application of an intravascu lar stent (378 coronary, 33 vascular). The arterial closure system con sists of a small absorbable anchor and a collagen pad connected to a s uture thread which, at the end of the procedure, is positioned by perc utaneous introduction at the site of the femoral puncture. All the pat ients studied received long-term platelet anti-aggregant therapy (ticl opidine 500 mg/day and ASA 150 mg/day) for 3-4 days before and for one month after the procedure, and an anticoagulant regimen of heparin so dium administered via intravenous bolus (10,000 IU) during the procedu re, followed by subcutaneous heparin calcium (12,500 IU/day) for 21 da ys. Thirteen patients were treated intravenously with 10 mg abciximab and seven received pre-procedure coumadin. The ACT when the hemostasis system was positioned was 355 +/- 43 seconds. Successful hemostasis w as reached in more than 95% of the patients (394/411 pts., 95.86%). In 17 (4.14%) of the 411 patients studied, the system failed; nine (2.19 %) of these were attributed by the operator to a failure of the positi oning device procedure, and the remaining 8 (1.95%) were attributed to a malfunction of the system. Overall complications were observed in 2 3/411 (5.6%) of the patients (pts) studied; eighteen were minor non-su rgical hemorrhagic complications (bleeding and/or hematoma) which occu rred primarily in the first 4 hours. In 4 cases (1%) vascular surgery was necessary for femoral pseudoaneurysm repair (2 pts) and femoral he matoma (2 pts). One patient (0.24%) complained of severe claudication related to a severe stenosis in the femoral artery caused by a malposi tioning of the anchor. This patient was successfully treated,vith ball oon angioplasty and stenting of the femoral artery. The average time t o early mobilization was 9 hours, and all the patients without complic ations were completely mobile within 12 hours after the procedure; 380 /411 (92.46%) of the patients were discharged 18-24 hours after percut aneous angioplasty. The second purpose of our study was to compare dat a from 411 consecutive patients treated with the Angio-Seal(TM) device after coronary and vascular angioplasty and stenting (Angio-Seal grou p), to a group of 387 consecutive patients where the femoral arterial hemostasis was obtained using manual compression after coronary angiop lasty and stenting (manual compression group). We found significant di fferences (p < 0.01) in the most important elements concerning general patient management after the interventional procedure, with excellent improvements using the Angio-Seal device, including: successful hemos tasis (95.86% vs. 88.37%); reduction of non-surgical hematomas (1.22% vs. 4.65%); reduction of surgical hematomas (0.49% vs. 2.84%); mobiliz ation time (9 +/- 3 hours vs. 19 +/- 8 hours); and discharge within 18 -24 hours (92.46% vs. 0.00%).