ABSTRACT
Post-cardiac catheterization femoral artery hemostasis can be accomplished with several mechanisms, including the FemoSeal® hemostasis device which has been designed and approved for closure of 6 French (F) arterial puncture sites. The aim of this study was to investigate whether the FemoSeal® vascular closure device can effectively and safely seal 7F arterial puncture sites after diagnostic and interventional cardiac catheterizations. Femoral artery puncture sites of 50 consecutive patients undergoing cardiac catheterization were closed with the FemoSeal® vascular closure device, according to the manufacturer's instructions. Efficacy endpoints were time to hemostasis and successful ambulation. Safety endpoints included bleeding complications, vessel occlusion and pseudoaneurysms. Mean time to hemostasis was 57.8±26.3 seconds (0-125 seconds). Hemostasis was achieved in 100 percent of the 50 patients. One patient suffered minor bleeding the next day, i.e. local hematoma. This clinical study demonstrates that the FemoSeal® vascular closure device, initially approved for closure of 6F arterial puncture sites, shows promising efficacy and safety to seal a larger (7F) femoral arterial puncture sites after diagnostic and interventional cardiac catheterizations.
Subject(s)
Cardiac Catheterization/instrumentation , Cardiac Catheterization/methods , Coronary Angiography/instrumentation , Coronary Angiography/methods , Femoral Artery , Hemostasis , Adult , Aged , Aged, 80 and over , Female , Hemorrhage/therapy , Humans , Male , Middle AgedABSTRACT
BACKGROUND: Although high-density lipoprotein cholesterol (HDL-C) and C-reactive protein (CRP) are well-established predictors for future cardiovascular events, little information is available regarding their correlation with the prevalence and severity of angiographically evaluated coronary artery disease (CAD). MATERIAL AND METHODS: Five thousand six hundred forty-one consecutive patients undergoing coronary angiography for the evaluation of CAD were analysed. Cardiovascular risk factors were assessed by routine blood chemistry and questionnaire. CAD severity was graded by visual estimation of lumen diameter stenosis with significant stenoses defined as lumen diameter reduction of >or= 70%. Coronary angiograms were graded as one-, two- or three-vessel disease, as nonsignificant CAD (lumen irregularities < 70%) or non-CAD. RESULTS: HDL-C (60.3 +/- 18.5 vs. 51.9 +/- 15.3 mg dL(-1); P < 0.001) was higher and CRP was lower (0.65 +/- 1.68 vs. 1.02 +/- 2.38 mg dL(-1); P < 0.001) in non-CAD (n = 1517) compared to overall CAD patients (n = 4124). CAD patients were older (65.2 +/- 10.5 years vs. 59.9 +/- 11.4 years), more often diabetics (19.2% vs. 10.6%) and hypertensives (79.2% vs. 66.0%) and included more smokers (18.8% vs. 16.5%) (all P < 0.005). Low-density lipoprotein cholesterol (124.5 +/- 38.3 vs. 126.0 +/- 36.3 mg dL(-1); P = NS) was similar in overall CAD and non-CAD patients with more statin users (43.4% vs. 27.9%; P < 0.001) among CAD patients. Comparing non-CAD with different CAD severities using analysis of variance, results did not change substantially. In a multivariate analysis, HDL-C and CRP remained independently associated with the prevalence of CAD. In addition, HDL-C is also a potent predictor for the severity of CAD. CONCLUSIONS: In this large consecutive patient cohort, HDL-C and CRP are independently associated with the prevalence of CAD. In this analysis, HDL-C is an even stronger predictor for CAD than some other major classical risk factors.
