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PubMed1992

Postoperative venous thromboembolism and brain tumors: Part II. Hemostatic profile.

Preoperative hemostatic data were obtained on 42 brain tumor patients and correlated with the subsequent occurrence of venous thrombosis detected with 125I-labeled fibrinogen leg scans. The occurrence of thrombosis correlated significantly with an increased prothrombin time, plasminogen, and total fibrinolytic activity and a decreased fibrinogen level. This overall trend in the group of patients with postoperative thrombosis indicates that the hemostatic disorder noted in brain tumor patients is most closely related to a subclinical form of chronic disseminated intravascular coagulation syndrome. Differences in hemostatic parameters seen with the various types of brain tumors suggest that biological factors specific to each tumor are likely responsible for the described hemostatic disorder and support the need for further research directed at the tumor tissue level.

Blood Coagulation Tests↗
PubMedDate not supplied

Predictive value of factors of the hemostatic system in screening procedures for coronary artery disease.

Thromboembolic events play a major pathogenetic role in the final occlusion of atherosclerotic vessels. May such a catastrophic event be predicted or an increased risk be indicated by analyzing the hemostatic system in plasma? A hugh literature exists about disturbances of the platelet, coagulation and fibrinolytic systems after atherosclerotic events such as myocardial infarction or stroke. This data, however, has no predictive significance. In contrast, the epidemiological studies in healthy persons have shown fibrinogen to be a potent risk predictor which is independent from other risk factors such as age, cholesterol or cigarette smoking. Results on factor VII:C are still controversial. Ongoing studies have included further factors of the hemostatic system. A second approach to elaborate the predictive power of hemostatic factors is to follow up patients with overt atherosclerotic disease and to correlate baseline hemostatic tests with event recurrences. The ECAT Angina Pectoris Study performed in 19 European clinical centers will present its prospective results by 1990. Some correlations of risk factors at baseline point to the many interrelationships among each other and to the need of careful statistical management of such data. It is reasonable to include fibrinogen in the recently developed coronary risk scores. So far, thrombin clotting time procedures, such as the Clauss method, appear to be appropriate for the purposes of risk prediction.

Blood Coagulation Factors↗
PubMed2006

Cellular, hemostatic, and inflammatory parameters of the surgical stress response in pigs undergoing partial pericardectomy via open thoracotomy or thoracoscopy.

BACKGROUND: Thoracoscopy has been shown to reduce the inflammatory and immunologic response to surgical stress, as compared with corresponding open procedures in humans. The influence on the hemostatic system, however, has not been thoroughly evaluated. The current study aimed to compare the perioperative and immediate postoperative changes in cellular, hemostatic, and inflammatory parameters after a partial pericardectomy performed by either thoracoscopy or thoracotomy. METHODS: For this study, 16 pigs were randomly assigned to have a partial pericardectomy performed thoracoscopically or by thoracotomy. Blood was collected intraoperatively, then 10 min, 3 h, and 6 h after surgery. Whole ethylenediaminetetraacetic acid (EDTA)-stabilized blood and plasma were examined for cellular, hemostatic, and inflammatory parameters, respectively, and thromboelastography (TEG) was performed on citrated whole blood. RESULTS: No significant difference in any of the parameters measured was found between the two groups except for the TEG parameter R-time, which was significantly shorter in the thoracoscopic group 3 h postoperatively. In both groups, a significant postoperative state of hypercoagulability and increase in inflammatory parameters was found. Additionally, pig blood showed a high degree of hypercoagulability in preoperative measurements, as compared with other species. CONCLUSIONS: Partial pericardectomy performed by thoracotomy or thoracoscopy in pigs produces a surgical stress response of equal magnitude, as measured by cellular, hemostatic, and inflammatory changes.

Animals↗
PubMed2003

Prevention and treatment of bleeding by pro-hemostatic treatment strategies.

Pro-hemostatic therapy may achieve an improvement of hemostasis, by amelioration of primary hemostasis, stimulation of fibrin formation or inhibition of fibrinolysis. Pro-hemostatic interventions appear to be effective in reducing peri-operative blood loss and reducing transfusion requirements in specific situations and may be helpful adjuncts in the management of severe spontaneous and post-operative bleeding. The risk of a higher incidence of thrombotic complications associated with the use of pro-hemostatic therapy is unknown but seems not to be very high in clinical practice. There is a need for more systematic and adequately controlled clinical observations to better establish the efficacy and safety of pro-hemostatic interventions.

Antifibrinolytic Agents↗
PubMed2005

Overview of hemostatic factors involved in atherosclerotic cardiovascular disease.

Hemostatic factors associated with the development of cardiovascular disease (CVD) include fibrinogen, von Willebrand factor, tissue plasminogen activator (tPA) antigen, plasminogen activator inhibitor-1 (PAI-1), and factor VII. Each SD increment of these increases the association by 24-30%. Most hemostatic factors are intercorrelated with inflammatory markers [e.g., C-reactive protein (CRP)] and LDL cholesterol. Fibrinogen seems the most fundamental hemostatic risk factor for CVD. The Framingham Study reaffirms the significant linear risk factor trends across fibrinogen tertiles (P< 0.001) for age, body mass index, smoking, diabetes mellitus, total cholesterol, HDL cholesterol, and TG in both sexes. Fibrinogen may also directly increase CVD risk because of its role in platelet aggregation, plasma viscosity, and fibrin formation. Fibrinogen is also an acute-phase reactant that is elevated in inflammatory states. Fibrinogen mediates the thrombogenic effect of other risk factors. Fibrinogen levels increase with the number of cigarettes smoked and quickly fall after smoking cessation. This rapid fibrinogen decline may be a mechanism for CVD risk reduction after smoking cessation. Weight loss is accompanied by reduced fibrinogen. The correlation between fibrinogen and LDL cholesterol suggests that lipid-imposed CVD risk is mediated partly through fibrinogen. Hyperreactive platelets of diabetics may result in part from their increased fibrinogen. Elevated fibrinogen and CRP of unstable angina suggest an acute-phase reaction. Prevalence, case-control, angiographic, and echocardiogram investigations incriminate hemostatic and inflammatory markers as strong independent risk factors for initial and recurrent CVD. Framingham Study data indicate that each SD increase in fibrinogen imposes a 20% independent increment in risk. It may be concluded that fibrinogen and CRP determination may be useful screening tools to identify individuals at added risk for thrombotic complications of CVD.

Atherosclerosis↗
PubMed1990

Disorders of the hemostatic system and the risk of the development of thrombotic and cardiovascular diseases: limitations of laboratory diagnosis.

The relationship between hemostatic abnormalities and thrombotic and cardiovascular diseases is summarized. All known congenital and acquired abnormalities in the biochemistry of hemostasis are related to thrombotic and cardiovascular diseases in the way that would be expected on the basis of theories about the role of balances between coagulation and fibrinolysis and between activating and inhibiting factors. Notwithstanding the consistency between theory and observed abnormalities, a causal relationship between biochemical abnormality and clinical symptoms has been proved only in a limited number of situations, and it is possible that certain abnormalities only (or also) mark pathologic events. The limitations of laboratory diagnosis of hemostatic disorders in relation to hemostasis as a local process are discussed. It is proposed that more attention be paid to methods of evaluating the local aspects, for example, methods that assess reaction products in the circulation and that can provide an averaged message of the local phenomena. In addition, such methods can provide information about the dynamic balances in the hemostatic system, whereas historically more attention has been paid to the static balances in the potential of hemostatic processes.

Blood Coagulation↗
PubMed1996

Regulation of interleukin-1-beta-stimulated inducible nitric oxide synthase expression in cultured vascular smooth muscle cells by hemostatic proteins.

Experiments were performed to examine the mechanism by which specific hemostatic proteins regulate the release of nitric oxide (NO) from interleukin-1 beta (IL-1beta) stimulated cultured rate aortic smooth muscle cells. Treatment of smooth muscle cells with IL-Beta stimulated inducible nitric oxide synthase (iNOS) mRNA expression, which preceded the release of NO (as measured by the accumulation of nitrite in the culture media). The cytokine-stimulated production of nitrite was blocked by the protein synthesis inhibitor cycloheximide, the transcriptional inhibitor actinomycin D, and the competitive inhibitor of NOS nitro-L-arginine. However, only actinomycin D inhibited IL-1beta-stimulated iNOS mRNA expression, Treatment of smooth muscle cells with IL-1beta in the presence of platelet derived growth factor or thrombin resulted in the inhibition of cytokine-stimulated expression of iNOS mRNA and NO release. The inhibitory effect of thrombin was reversed by hirudin and was mimicked by a 14 amino acid thrombin receptor activating peptide. In contract, the concomitant exposure of smooth muscle cells to IL-1beta-and plasmin resulted resulted in the potentiation of both IL-1beta-stimulated iNOS expression and NO generation. Finally, treatment of smooth muscle cells with IL-1beta in the presence of the hemostatic proteins did not affect the half-life of iNOS mRNA. These results demonstrate that specific protein components of the hemostatic system regulate IL- 1beta-stimulated iNOS mRNA expression in vascular smooth muscle cells. The capacity of hemostatic proteins to modulate the induction of vascular iNOS activity may play an important role in governing the release of NO and regulating thrombogenesis in vivo.

Amino Acid Sequence↗
PubMed1993

The effects of saturated fat and n-6 polyunsaturated fat on postprandial lipemia and hemostatic activity.

The effect of different fat loads on postprandial lipemia and hemostatic activity was examined in 10 middle-aged men using 3 different meals. One meal was rich in saturated fatty acids (cream), the other rich in n-6 polyunsaturated fatty acids (sunflower oil) and the third was fat-free containing only carbohydrates. Lipoprotein lipids and hemostatic parameters were measured during fasting and 2, 4, 6 and 8 h after the test meal. In fasting samples, several hemostatic parameters were significantly associated with lipoprotein lipids. Most notable were the strong associations of fibrinolysis parameters tissue plasminogen activator antigen and plasminogen activator inhibitor activity (PAI-1) with total and very low density lipoprotein (VLDL) triglycerides. During lipemia, the associations were approximately similar or slightly weaker than in the fasting state. Both fat loads resulted in similar postprandial lipid responses: VLDL and high density lipoprotein (HDL) triglycerides reached maximum at 4 h after the meal. VLDL cholesterol also increased 4 and 6 h after the fat loads. HDL3 cholesterol declined after the fatty meals but no change was observed in the HDL2 fraction. The fat-free meal gave no significant lipid changes during the time course studied. Factor VII activity (F VII:C) increased 6 and 8 h after the fatty meals, whereas a decrease was observed after the fat-free meal. The changes (+/- S.D.) at 8 h after cream, sunflower oil and fat-free meal were 5.2 +/- 3.3, 3.3 +/- 4.2 and -5.8 +/- 7.9 percentage points, respectively, and the effect of the meal on the changes was statistically significant (F (8,99) = 2.99, P = 0.0048). F VII antigen (F VII:Ag) tended to decline during the day but there was no difference between the meals. Factor VIII activity (F VIII:C) was highest after the polyunsaturated fat meal and lowest after the fat-free meal. PAI-1 declined during the day and the decline tended to be steepest after the fat-free morning meal. The effect of the meal on the changes in lipoprotein lipids and hemostatic factors varied significantly between individuals. In conclusion, postprandial lipemia after a single fatty meal was associated with procoagulatory change in F VII:C but there was no difference between saturated fat and n-6 polyunsaturated fat.

Adult↗
PubMed1996

Prospective evaluation of hemostatic predictors of subacute stent thrombosis after coronary Palmaz-Schatz stenting.

OBJECTIVES: This study sought to investigate hemostatic predictors of subacute occlusive coronary stent thrombosis. BACKGROUND: Better hemostatic monitoring may improve antithrombotic therapy after stenting. METHODS: In 140 consecutive patients undergoing Palmaz-Schatz stent implantation for suboptimal angioplasty results, we obtained serial blood samples immediately before and daily for 12 days after stenting. We prospectively tested the hypothesis that subacute stent thrombosis was more frequent if the surface expression of the inducible fibrinogen receptor on platelets (flow cytometry) or the concentration of plasma fibrinogen or that of the prothrombin fragments F1 + 2 before stent implantation exceeded the 75th percentile of the entire study cohort. RESULTS: All five stent occlusions encountered during the study occurred in patients with platelet fibrinogen receptor expression above the 75th percentile. Thus, the rate of stent occlusion differed significantly between the groups defined by platelet fibrinogen receptor expression (14.3% vs. 0%, p = 0.0008). In both the group with fibrinogen concentration and that with F1 + 2 concentration above the 75th percentile, three stent occlusions occurred. Between the groups defined by these variables, the rate of stent occlusion did not differ significantly (8.6% vs. 1.9%, p = 0.10). Logistic regression analysis, including angiographic and hemostatic variables, confirmed platelet fibrinogen receptor expression as an independent predictor of stent occlusion (p = 0.020). Stent occlusion could not be predicted by the time course of any of the hemostatic variables. CONCLUSIONS: Platelet fibrinogen receptor expression is an independent predictor of subacute stent occlusion. However, fibrinogen and F1 + 2 concentrations do not show a strong relation to the risk of stent occlusion.

Adult↗
PubMed2005

Hemodynamic, hemostatic, and endothelial reactions to psychological and physical stress in coronary artery disease patients.

Episodes of psychological and physical stress may elicit thrombotic cardiac events, such as myocardial infarction. These events are triggered when there are concurrent hemodynamic, hemostatic, and endothelial abnormalities. Hemodynamic, hemostatic, and endothelial reactions of 72 (15 women, 57 men) coronary artery disease patients to psychological and physical stress were examined. Blood pressure, electrocardiography, and impedance cardiography were recorded during rest, mental arithmetic, and exercise. Blood was collected, via catheter, at rest and after each task. Mental arithmetic elicited increases in blood pressure, heart rate, cardiac output, and cardiac contractility, but no consistent changes in hemostatic and endothelial markers. In contrast, exercise, in addition to increasing blood pressure, heart rate, cardiac output, cardiac contractility, and lowering peripheral resistance, elicited increases in plasma viscosity, hematocrit, platelets, and tissue plasminogen activator together with a decrease in plasminogen activator inhibitor. This pattern of hemodynamic, hemostatic, and endothelial reactions suggests that acute psychological and physical stress influence the thrombotic system differently in these high risk patients. Future research is needed to investigate how these stress responses are prospectively related to acute cardiac events.

Acute Disease↗
PubMed2005

Strategies to reduce hemostatic activation during cardiopulmonary bypass.

INTRODUCTION: We evaluated whether a modified protocol for cardiopulmonary bypass (CPB) could reduced the systemic hemostatic activation associated with this procedure. MATERIALS AND METHODS: The in vivo rates of thrombin, fibrin, plasmin and D-dimer generation were determined in each subject during CPB using measured levels of hemostatic factors combined with a computer model of the cardiovascular and hemostatic systems. A standard CPB group using uncoated circuits, standard heparin levels and direct shed blood reinfusion (n=9) was compared to a modified CPB group using heparin-coated circuits, shed blood collection, washing and reinfusion post-operatively, lower heparin levels and epsilon-amino-caproic acid (n=10). RESULTS AND CONCLUSIONS: Standard CPB increased average thrombin generation 9-fold, decreased fibrin generation 2-fold, increased plasmin generation 11-fold and increased fibrin degradation and D-dimer generation 19-fold. During CPB in the modified group thrombin generation was not increased beyond surgical levels, lower heparin concentrations allowed each thrombin to make more fibrin prior to inhibition, while fibrin degradation was suppressed by epsilon-amino-caproic acid. At baseline for every 100 fibrins formed only 1-2 were degraded to D-dimer. During standard CPB for every 100 fibrins generated on average 34 fibrins were degraded with some subjects showing a net fibrin loss. In contrast, in the modified CPB group for every 100 fibrins formed only 4 fibrins were degraded (p<0.0001 vs. standard group). Kinetic modeling of hemostasis in individual patients showed that a modified CPB protocol could reduce excessive thrombin generation during CPB and suppress fibrin degradation moving hemostatic regulation back towards normal.

Aged↗
PubMed2001

Hemostatic state and atrial fibrillation (the Framingham Offspring Study).

Atrial fibrillation (AF) is strongly associated with thromboembolic complications, although the mechanism for the increased risk has not been fully explained. To determine whether AF might be associated with a hypercoagulable state, we studied hemostatic factors in subjects with or without AF in the Framingham Heart Study. In 3,577 subjects, we measured fibrinogen, von Willebrand factor antigen, tissue plasminogen activator (tPA) antigen, and plasminogen activator inhibitor-1 antigen. Forty-seven subjects had AF at the index clinic examination and 15 had AF on a prior examination, but not on the current examination. Before matching, the 47 subjects with prevalent AF had higher levels of fibrinogen, von Willebrand factor, and tPA antigen than those without AF, all p < or =0.03. Compared with 167 referent subjects matched for age, sex, and other risk factors, those with AF had higher tPA antigen levels than those without AF, 1 1.8 +/- 4.0 ng/ml versus 10.5 +/- 3.9 ng/ml (p = 0.04). However, when further stratified according to their cardiovascular disease status, the differences in hemostatic factors were no longer significant. We conclude that the prothrombotic profile associated with AF was explained by the risk factors of the subjects and the presence of cardiovascular disease. Nonetheless, the hemostatic changes may contribute toward the propensity for thromboembolic complications in AF. Further prospective studies are needed to evaluate whether measurement of these and other hemostatic factors will identify patients with AF who are at increased risk for thromboembolic complications, and who may therefore benefit from more intensive therapy.

Aged↗
PubMed2000

Effect of atorvastatin on hemorheologic-hemostatic parameters and serum fibrinogen levels in hyperlipidemic patients.

Plasma fibrinogen and hemorheologic-hemostatic factors contribute to dyslipidemia-induced morbidity. Some of these parameters can be favorably affected when abnormal serum lipoprotein levels are corrected. Thus, we investigated whether treatment with atorvastatin would result in changes in plasma viscosity and other hemorheologic and hemostatic parameters. Twenty-two hyperlipidemic men at a university lipid clinic were treated single-blinded with atorvastatin 80 mg/day for 12 weeks to determine hemostatic-hemorheologic parameters including blood viscosity, fibrinogen levels, whole blood platelet aggregation, tissue plasminogen activator antigen, hematocrit, plasminogen activator inhibitor activity, factor VII activity, red blood cell (RBC) deformity and lipid ratio, sedimentation rate, and fasting serum lipoprotein levels. Atorvastatin treatment provided significant lowering of serum lipoprotein levels: low-density lipoprotein -53% (p = 0.0001), very low density lipoprotein -43% (p = 0.0001), and triglycerides -35% (p < 0.0001). These effects were accompanied by changes in plasma viscosity -10% (p = 0.0007), arachidonic acid-induced whole blood platelet aggregation -11% (p = 0.006), factor VII -8% (p = 0.001), RBC lipid composition +5% (p = 0.0003), and RBC sedimentation -33% (p = 0.0002). Plasma fibrinogen levels were not affected. Thus, atorvastatin 80 mg/day produced marked reductions in serum low-density lipoprotein cholesterol (-53%), very low density lipoprotein cholesterol (-43%), and triglycerides levels (-35%), and significant changes in plasma viscosity as well as other hemorheologic-hemostatic parameters, but no changes in plasma fibrinogen levels.

Adult↗
PubMed1989

Simultaneous use of microfibrillar collagen hemostat and blood saving devices in a canine kidney perfusion model.

Intraoperative autotransfusion and topical microfibrillar collagen hemostats have been increasingly used, often simultaneously, in various surgical procedures to minimize intraoperative blood loss and thus reduce the inherent risks of homologous blood transfusion. As moderate amounts of small particles have been shown to pass through filtering devices during intraoperative autotransfusion, concern has been raised over the amount of heterologous collagen fibrils transfused and their effect on the host. We found that 2% of microfibrillar collagen hemostat particles pass through the 20-microns millipore filter contained in the tested autotransfusion device (William Harvey H-4700 cardiotomy reservoir). Using a canine kidney perfusion model, we found multifocal perivascular inflammatory reactions within the renal parenchyma five days after transfusion of filtered autologous blood containing minute amounts of microfibrillar collagen hemostat. The findings demonstrate a strong inflammatory foreign body response to heterologous collagen particles trapped in the microcirculation of the perfused kidneys. It is concluded that despite using filters with a pore size of 20 microns, using intraoperative autotransfusion and microfibrillar collagen hemostats simultaneously creates a potential risk because adverse reactions can be elicited especially within the microvasculature of tissues containing end-arterial circulation.

Animals↗
PubMed2004

Endoscopic hemostatic treatment under irrigation for upper-GI hemorrhage: a comparison of one third and total circumference transparent end hoods.

BACKGROUND: Endoscopic hemostasis for upper-GI hemorrhage often is difficult to achieve if the view of the bleeding lesion is poor because of the presence of mucus, blood, and clots. An end hood that facilitates endoscopic hemostatic procedures while simultaneously allowing irrigation of the bleeding site was designed by us. Based on this design, a one-third partial irrigating end hood was developed, and its usefulness for treatment of non-variceal hemorrhage was evaluated. METHODS: The end hood was fabricated by drilling a side hole in the cap portion of a transparent end hood. An irrigation tube was glued to the exterior surface over the hole. A "total" (type 1) and a "one-third partial" (type 2) transparent end hood were fabricated. These differ with respect to the proportion of the endoscope circumference that is hooded by the device. The fabricated transparent end hood was placed on the tip of a standard endoscope. With the end hood in place, endoscopic hemostatic treatment under irrigation was performed in 35 patients (type 1 end hood, 18; type 2, 17) with non-variceal upper-GI hemorrhage. OBSERVATIONS: Hemostatic treatment was enhanced by simultaneous irrigation beneath the end hood, and hemostasis was successfully achieved in 34 of 35 cases. The time required to achieve hemostasis was significantly shorter in the type 2 group than the type 1 group (median 11.8 vs. 16.9 minutes; p < 0.05). CONCLUSIONS: The end hood was extremely useful for endoscopic hemostatic treatment under irrigation. The "one-third partial" end hood is superior to the total end hood in terms of duration of time required to achieve hemostasis.

Aged↗
PubMed1986

Hemostatic effect of endoscopic local injection with hypertonic saline-epinephrine solution and pure ethanol for digestive tract bleeding.

An uncontrolled study for the assessment of the hemostatic effects of endoscopically injected hypertonic saline-epinephrine (HS-E) solution and pure ethanol (PE) was carried out in 67 patients with nonvariceal gastrointestinal bleeding. The HS-E group included duodenal ulcer (18), gastric ulcer (9), gastric cancer (2), polyp (2), marginal ulcer (1), and esophageal cancer (1). Bleeding was active in 15 (pulsating, 3; oozing, 12). The hemostatic effect was permanent in 29 cases (87.9%) but failed in four cases (12.1%). The PE group consisted of 34 patients with duodenal ulcer (25), gastric ulcer (4), polyp (2), marginal ulcer (2), and gastric cancer (1). There was active bleeding in 14 (pulsating, 3; oozing, 11). The hemostatic effect was permanent in 31 cases (91.2%), temporary in 1 case (2.9%), and failed in 2 cases (5.9%). We conclude that endoscopic local injection with HS-E or PE is a simple maneuver with reasonable cost, high safety, and satisfactory hemostatic efficacy in the treatment of nonvariceal gastrointestinal bleeding.

Adolescent↗
PubMed1999

Comparison of the hemostatic efficacy of the endoscopic hemoclip method with hypertonic saline-epinephrine injection and a combination of the two for the management of bleeding peptic ulcers.

BACKGROUND: The endoscopic hemoclip method is a safe and effective hemostatic method for managing bleeding peptic ulcers. We compared the hemostatic efficacy of the endoscopic hemoclip method with that of hypertonic saline-epinephrine (HSE) injection and a combined method in the management of bleeding peptic ulcers. METHODS: From July 1994 to July 1997, we conducted a randomized clinical trial of endoscopic hemostasis involving 124 patients with actively bleeding or visible vessels at endoscopic inspection. RESULTS: Patients were randomly assigned to hemoclip (41 patients), HSE (41 patients), and combined treatment groups (42 patients). Initial hemostasis was achieved in 97.6%, 95.1%, and 97.6% of cases, respectively. Recurrent bleeding developed in 2.4%, 14.6%, and 9.5% of cases. Emergency operations were performed in 4.9%, 14.6%, and 2.3% of cases. The hemostasis rate was 71.4%, 50%, and 66.7% for spurting hemorrhage in each group. Permanent hemostasis was achieved in 95.1%, 85.4%, and 95.2% of cases. Three patients had complications, all in the HSE group. CONCLUSIONS: The hemoclip method is an effective hemostatic procedure and is safer than HSE injection. The combined method does not provide substantial advantage over use of the hemoclip method alone in the hemostatic management of bleeding peptic ulcers.

Drug Combinations↗
PubMed2001

[Early deambulation following cardiac catheterization by the use of 6 Fr Angio-Seal, a new hemostatic percutaneous puncture closure device].

INTRODUCTION AND OBJECTIVES: Efficacy of the hemostatic puncture closure 8 Fr Angio-Seal device for percutaneous puncture closure after a catheterism has been previously demonstrated, but the experience provided has been obtained with 8 Fr devices. At present the device has been modified and its size reduced to 6 Fr. In this pilot study we evaluate the efficacy of the new hemostatic 6 Fr Angio-Seal device and its safety when early deambulation post-diagnostic and/or therapeutic catheterization is established. PATIENTS AND METHODS: Prospective study of 150 consecutive patients randomized either for application of the 6 Fr Angio-Seal device (group A; n = 75), in which early ambulation was indicated, or manual compression (group B; n = 75), with ambulation 12 h after cardiac catheterization. Basal data, including clinical and angiographic characteristics and previous treatment with heparin and platelet aggregation inhibitors were similar in both groups. RESULTS: The time of hemostasia was significantly shorter in group A than in group B (118 +/- 210 s in A vs 1320 +/- 370 s in B; p (3/4) 0,001), and with early ambulation (3,1 +/- 0,4 h in A vs 12,3 +/- 3,1 h in B; p (3/4) 0,001) no local complications were observed. CONCLUSIONS: The 6 Fr Angio-Seal hemostatic device diminished the hemostasia time and early ambulation could be achieved. In this pilot study no complications due to early movilization were observed, but the safety of the new hemostatic device after diagnostic or therapeutic catheterizations needs to be evaluated in greater series.

Absorbable Implants↗