Association of periprocedural neurological deficit in carotid stenting with increased anticardiolipin antibodies.

INTRODUCTION: Carotid stenting (CS) has become a therapeutic alternative to endarterectomy in selected patients. Periinterventional plaque thromboembolism leading to neurological ischemic events remain the major risk of the procedure. We prospectively studied the potential role of thrombophilic conditions including anticardiolipin antibodies (ACA, IgG and IgM isotype), lupus anticoagulants, activated protein C resistance, antithrombin, and protein C and S. MATERIAL AND METHODS: The study was approved by the local ethics committee, and written informed consent was obtained from all patients. In total, 236 consecutive patients were included (158 men, 78 woman; median age 73 years). Prothrombotic markers were quantitated on the day of admission. Periprocedural neurological deficits (PND) occurring within 48 hours of the intervention were recorded and classified by an independent neurologist as transient ischemic attack, minor or major stroke. Uni- and multivariable logistic regression analysis were performed to test for the influence of thrombophilic conditions, demographic factors and lesion characteristics on PND. RESULTS: Neurologic complications occurred in 18 interventions (7.6%). In 4 (36.4%; 3 minor, 1major stroke) out of 11 patients with elevated IgG-ACA neurological events were observed as compared to 14 (6.2%; 6 TIA, 5 minor stroke, 3 major stroke) out of 225 patients with normal IgG-ACA levels. In multivariable analysis, two variables were independently associated with PND: elevated IgG-ACA (OR 6.09, 95% CI 1.49-25.88; P=0.012) and lesion length >10 mm (OR 4.36, 95% CI 1.19 to 16.01; P=0.027). CONCLUSIONS: A thrombophilic condition due to elevation of anticardiolipin antibodies increases the risk of periinterventional neurological complications during CS.

Access site management after peripheral percutaneous transluminal procedures: Neptune pad compared with conventional manual compression.

PURPOSE: To investigate the safety and efficacy of the procoagulant wound dressing Neptune Pad (Biotronik, Berlin, Germany) compared with those of conventional manual compression for access site management after peripheral percutaneous interventions. MATERIALS AND METHODS: The study was approved by the institutional ethics committee, and all patients gave written informed consent. Two hundred one consecutive patients were enrolled and were randomly assigned to be treated with the Neptune Pad (n = 100) or conventional manual compression (n = 101). Patients were followed up clinically until hospital discharge and with duplex ultrasonography at 24 hours after the procedure to evaluate occurrence of access site complications. Time to hemostasis and time to ambulation were recorded, and patient and physician discomfort were measured by using a visual analogue scale. RESULTS: The risk for access site complications was not significantly different between the Neptune Pad group and the conventional compression group (adjusted odds ratio, 1.15; 95% confidence interval: 0.47, 2.84; P = .76). Time to hemostasis was marginally reduced in the Neptune Pad group. Patient and physician discomfort were lessened with use of the device. CONCLUSION: The hemostatic device Neptune Pad does not improve the safety of access site management after peripheral percutaneous procedures. Markedly improved comfort was noted among patients in the Neptune Pad group and by the physicians obtaining hemostasis.

Prediction of iatrogenic pseudoaneurysm after percutaneous endovascular procedures.

PURPOSE: To prospectively evaluate the accuracy of using physical examination to identify puncture-related groin pseudoaneurysms, as assessed by using duplex ultrasonography (US), after percutaneous transluminal procedures and to prospectively evaluate the association between preinterventional platelet count, antiplatelet medication, and the occurrence of pseudoaneurysms. MATERIALS AND METHODS: This study was approved by the local ethics committee, and informed consent was obtained from all patients. The study prospectively included 273 consecutive patients (161 men, 112 women; age range, 34-90 years) who were referred for duplex US evaluation of the inguinal arterial puncture site 1 day after endovascular procedures. Prior to duplex US, all patients underwent physical examination of the groin. In addition, clinical characteristics and preinterventional laboratory parameters were assessed. Statistical significance was determined by using chi2 tests, the Fischer exact test, and unpaired t tests. RESULTS: Twenty-three pseudoaneurysms were found in 273 patients by using duplex US. Pulsatile groin masses that were detected at physical examination were used to correctly identify all pseudoaneurysms (positive predictive value, 100%; negative predictive value, 100%). Painful pulse palpation had a slightly lower predictive power (positive predictive value, 92% [95% confidence interval: 81%, 100%]; negative predictive value, 100% [95% confidence interval: 100%, 100%]). Other clinical parameters, such as the presence of superficial hematomas, systolic bruits, or nonpulsatile groin masses, had no adequate predictive properties. Interobserver agreement was excellent between observers (97% agreement [95% confidence interval: 92%, 100%]). All patients with pseudoaneurysms had a preprocedural platelet count of less than 200 x 10(9)/L. No subacute complications were observed at the access site in patients with a platelet count of more than 200 x 10(9)/L. CONCLUSION: Physical examination revealed sufficient predictive capability in facilitating the identification of iatrogenic pseudoaneurysms after percutaneous vascular procedures. A platelet count of less than 200 x 10(9)/L was associated with high predictive capability, thereby warranting further assessment in a larger series of patient.

Atorvastatin reduces thrombin generation after percutaneous coronary intervention independent of soluble tissue factor.

INTRODUCTION: Statins were previously shown to suppress cellular tissue factor (TF) in vitro. Here, we investigated the effect of atorvastatin on the TF-pathway and thrombin generation after coronary angioplasty and stenting in vivo. MATERIALS AND METHODS: A cohort of 30 patients with coronary artery disease (CAD) was randomised to treatment with either none (n=10), 10 mg (n=10) or 80 mg (n=10) atorvastatin per day for the postinterventional period of 6 months starting the day before percutaneous coronary intervention (PCI). Fasting blood samples were collected on admission and after 6 weeks and 6 months of statin therapy to determine sTF, free tissue factor pathway inhibitor (TFPI) and prothrombin fragment F1.2 by immunoassay. RESULTS: Soluble TF (sTF) significantly correlated with thrombin generation as measured by prothrombin fragment F1.2 at baseline. This correlation was lost 6 weeks and 6 months after initiation of statin therapy. In vivo, F1.2 was significantly lowered after 6 months of statin therapy by both, low dose (0 vs. 10 mg: 1.3+/-0.3 vs. 0.7+/-0.2 ng/ml; P<0.05) and high dose (0 vs. 80 mg: 1.2+/-0.3 vs. 0.6+/-0.2 ng/ml; P=0.01) atorvastatin compared to control. However, sTF and free TFPI did not change significantly with atorvastatin therapy when compared to baseline or control. CONCLUSIONS: Our results demonstrate reduced in vivo generation of thrombin six months after percutaneous coronary intervention and statin therapy independent of sTF and free TFPI.

Abciximab reduces monocyte tissue factor in carotid angioplasty and stenting.

BACKGROUND AND PURPOSE: Abciximab, a nonselective glycoprotein IIb/IIIa inhibitor, was shown to reduce peri-interventional stroke rate in carotid stenting. We evaluated the effect of adjunct abciximab therapy on monocyte-platelet cross talk and neurological deficit in unprotected carotid stenting and compared its efficacy with distal filter protection. METHODS: Fifty patients were randomized to either standard antithrombotic therapy (n=30) consisting of aspirin, clopidogrel, and heparin or adjunct bolus (0.25 mg/kg) and 12-hour infusion (0.125 microg x kg(-1) x min(-1)) of abciximab (n=20). A third cohort of patients was stented with filter protection (n=30). Monocyte-platelet aggregate formation and monocyte tissue factor expression were determined by whole blood flow cytometry, and F1.2 generation and soluble CD40 ligand (sCD40L) were determined by immunoassay. RESULTS: The incidence of peri-interventional ischemic episodes (23% versus 10%; P=0.2) and the number of de novo ischemic lesions detected by diffusion-weighted MRI (47% versus 30%; P=0.17) were not significantly different between standard antithrombotic therapy and adjunct abciximab but were reduced with filter protection (P=0.023). However, the number of transient ischemic attacks was lower (P=0.05) and the National Institutes of Health Stroke Score rapidly decreased in patients with adjunct abciximab. This clinical improvement was paralleled by a reduction in the postinterventional percentage of activated monocyte-platelet aggregates (CD62P+/CD14+; P=0.018) and the number of tissue factor-positive monocytes (TF+/CD14+; P=0.005). Both abciximab and filter protection suppressed F1.2 generation and significantly reduced sCD40L. CONCLUSIONS: Abciximab limits thrombus propagation and thrombus stabilization after carotid stenting by reducing monocyte-platelet cross talk and sCD40L. Although abciximab seems inferior to filter devices in peri-interventional cerebral protection, it may be considered in patients who do not allow placement of protection devices.

Weight loss reduces tissue factor in morbidly obese patients.

OBJECTIVE: To investigate the tissue factor (TF) pathway in clinical obesity and associated metabolic syndrome. RESEARCH METHODS AND PROCEDURES: Thirty-seven morbidly obese patients (4 men; BMI, 48 +/- 7 kg/m(2); range, 42 to 53 kg/m(2)), undergoing elective gastroplasty for the induction of weight loss, were examined for hemostatic, metabolic, and inflammatory parameters at baseline and 14 +/- 5 months postoperatively. RESULTS: Weight loss significantly reduced circulating plasma TF (314 +/- 181 vs. 235 +/- 113 pg/mL, p = 0.04), coagulation factor VII (130 +/- 22% vs. 113 +/- 19%, p = 0.023), and prothrombin fragment F1.2 (2.4 +/- 3.4 vs. 1.14 +/- 1.1 nM, p = 0.04) and normalized glucose metabolism in 50% of obese patients preoperatively classified as diabetic or of impaired glucose tolerance. The postoperative decrease in plasma TF correlated with the decrease of F1.2 (r = 0.56; p = 0.005), a marker of in vivo thrombin formation. In subgroup analysis stratified by preoperative glucose tolerance, baseline circulating TF (402.6 +/- 141.6 vs. 176.2 +/- 58.2, p < 0.001) and TF decrease after gastroplasty (DeltaTF: 164.7 +/- 51.4 vs. -81 +/- 31 pg/mL, p = 0.02) were significantly higher in obese patients with impaired glucose tolerance than in patients with normal glucose tolerance. DISCUSSION: Procoagulant TF is significantly reduced with weight loss and may contribute to a reduction in cardiovascular risk associated with obesity.