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Bleeding Complications (bleeding + complications)
Kinds of Bleeding Complications Selected AbstractsRole of Manual Compression Time and Bed Rest Duration on the Occurrence of Femoral Bleeding Complications After Sheath Retrieval Following 4Fr Left-Sided Cardiac CatheterizationJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2001VÉRONIQUE THORÉ R.N. To shorten hospital stay or to allow ambulatory procedures, 4Fr catheters for left-sided cardiac catheterization can be used. These latter parameters may also be influenced by compression time and bed rest duration. The role of these parameters was assessed by prospectively including 130 consecutive patients who underwent 4Fr femoral diagnostic procedures. The patients were randomized into two groups: group 1 consisted of 70 patients undergoing 5-minute compression and group 2 consisted of 60 patients with 15-minute compression. In each group, a second randomization was applied to determine the bed rest duration (2,4 hours). More group 1 patients experienced immediate bleeding following manual compression than group 2 patients (12 [17%] vs 3 [5%], P < 0.03, respectively). Compared to group 2, a slight but nonsignificant increase in the total number of hematomas was observed in group 1 (31 vs 22%, NS). No difference existed in terms of local large hematomas at 24 hours (7% in each group) or in terms of benign 10 cm diffuse subcutaneous ecchymosis at 7-day follow-up (13 [19%] group 1 patients vs 8 [13%] group 2 patients, NS). However, persistence of diffuse subcutaneous ecchymosis at 7-day follow-up appeared to be related to the history of immediate bleeding following manual compression in both groups (group 1: 5/13 vs 7/57 patients [P < 0.04] and group 2: 3/8 vs 0/52 patients [P < 0.002]). In conclusion, 4Fr femoral left-sided cardiac catheterization is safe and could be performed as an ambulatory procedure. However, it requires 15-minute duration of manual compression associated with 2-hour bed rest to decrease local bleeding complications. (J Interven Cardiol 2001;14:7,10) [source] Bleeding Complications in Acute Coronary Syndromes and Percutaneous Coronary Intervention: Predictors, Prognostic Significance, and Paradigms for Reducing RiskCLINICAL CARDIOLOGY, Issue S2 2007Steven V. Manoukian M.D. Abstract In clinical trials up to 30% of patients with acute coronary syndromes (ACS) or undergoing percutaneous coronary intervention (PCI) experience bleeding complications, and even higher rates have been reported in contemporary practice. A growing body of data suggests a strong correlation between bleeding and both short- and long-term adverse outcomes, including mortality, which is independent of baseline characteristics and remains evident in most trials, despite variations in the definition of major bleeding. Although the value of antithrombin and antiplatelet therapy in reducing the risk of ischemic events is well established, the mechanisms of action that confer the benefits of these therapies have an inherent tendency to increase the risk of bleeding complications. As a result, characterization of baseline hemorrhagic risk is critical and must be accomplished before selecting an antithrombotic therapy. Risk factors for bleeding may be divided into two categories: nonmodifiable (including age, gender, race, weight, renal insufficiency, anemia, and acuity of presentation) and modifiable (including choice of antithrombotic therapy and PCI procedural characteristics). Of these predictive factors, the choice, dosage, and duration of the antithrombin and/or antiplatelet regimen are perhaps the most readily modifiable, especially in patients with an increased risk of bleeding. This review explores the nature of the association between bleeding and adverse outcomes, including mortality; evaluates risk factors for bleeding; and examines mechanisms for reducing bleeding complications through the selection of appropriate antithrombotic therapy. Copyright © 2007 Wiley Periodicals, Inc. [source] Current concepts for the prevention of venous thromboembolismEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 2005P. Bramlage Abstract Venous thromboembolism (VTE) is a major cause of morbidity and mortality worldwide and the annual incidence of VTE is 1 per 1000. The individual risk for venous thromboembolism may be substantially higher and is determined by expositional and dispositional factors. Unfractionated heparin and warfarin have been the mainstays for the prevention of VTE until the early 1980s. Bleeding complications and side effects limited the use of these agents and subsequently low molecular weight heparins (LMWH) were introduced into clinical practice. These are most commonly used for the prophylaxis and treatment of VTE today. In the last decade, the pace of development of further anticoagulants has accelerated with the introduction of new treatment regimens and new substances. In this context, novel drugs directed against clotting factor Xa (such as fondaparinux) and direct thrombin inhibitors (such as melagatran/ximelagatran) have been developed. Fondaparinux shows a favourable efficacy/safety profile and has been documented to be cost-effective compared to enoxaparin in the US and the UK. [source] Bleeding complications: therapeutic strategies in haemostasisISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue n1 2010M. Spannagl Several haemostyptic agents as well as cellular and plasmatic blood products are available for treatment of bleeding complications. Selective application of these compounds according to the patient's haemostatic disturbances is superior to standard application of cellular concentrates and fresh frozen plasma. Near-patient testing of whole blood coagulation and fibrinolysis has been suggested for goal directed therapy. Recent data show reduction of consumption of blood products using algorithms and tailored therapy. [source] Bleeding complications from hepatic mucoidal aneurysmata: Value of color duplex sonography after liver transplantationLIVER TRANSPLANTATION, Issue 7 2002Barbara Braden MD [source] Development of an inhibitory antibody fragment to human tissue factor using phage display technologyDRUG DEVELOPMENT RESEARCH, Issue 3 2009S.M. Meiring Abstract Tissue factor is involved in the etiology of thrombotic diseases initiating the thrombosis associated with the inflammation that occurs during infection. The prevention of blood coagulation and inflammation is of primary importance in a number of pathological situations. A single-chain variable antibody fragment of molecular weight of 26,kD that inhibits the action of human tissue factor was selected by phage display technology, purified and tested for its tissue factor inhibitory effect, purified on a protein A column, and its purity evaluated on SDS-PAGE. The effects of the antibody fragment on prothrombin times, Factor Xa production, and thrombin generation were assessed with increasing fragment concentrations, using chromogenic and fluorometric substrates. The antibody fragment dose-dependently prolonged the prothrombin time (IC50=0.5,,M) and delayed the lag phase before the thrombin generation burst and the peak thrombin concentration in the thrombin generation assay. The effect on thrombin generation was more pronounced in thrombophilic plasma than in normal plasma. Antibody-based tissue factor inhibitors therefore may provide an effective treatment for thrombotic disease without serious bleeding complications. Drug Dev Res 2009. © 2009 Wiley-Liss, Inc. [source] Complications of hysterectomy in women with von Willebrand diseaseHAEMOPHILIA, Issue 4 2009A. H. JAMES Summary., Case reports and small case series suggest that women with von Willebrand disease (VWD) are at a very high risk of bleeding complications with hysterectomy. As the procedure may be beneficial to women who suffer from heavy menstrual bleeding and have completed childbearing, an understanding of the true risks involved is essential for appropriate decision making. To estimate the incidence of bleeding and other complications in women with VWD who undergo hysterectomy. The United States Nationwide Inpatient Sample (NIS) from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality for the years 1988,2004 was queried for all hysterectomies for non-malignant conditions. Data were analysed based on the NIS sampling design. Bivariate analyses were used to examine the differences between women with and without VWD. Multivariate analysis was used to adjust for potential confounders among women who underwent hysterectomy for heavy menstrual bleeding. 545 of the 1 358 133 hysterectomies were to women with VWD. Women with VWD were significantly more likely to experience intraoperative and postoperative bleeding (2.75% vs. 0.89%, P < 0.001) and require transfusion (7.34% vs. 2.13%, P < 0.001) than women without VWD. One woman with VWD died. While the risk of bleeding complications from hysterectomy in women with VWD is smaller than previously reported, women with VWD did experience significantly more bleeding complications than women without VWD. Nonetheless, for women who have completed childbearing, the risks of hysterectomy may be acceptable. [source] Recombinant activated factor VII for haemophilia patients with inhibitors undergoing orthopaedic surgery: a review of the literatureHAEMOPHILIA, Issue 2 2008A. OBERGFELL Summary., Arthropathy is prevalent in patients with haemophilia and inhibitors and is a major source of pain and disability, significantly reducing quality of life. Recombinant activated factor VII (rFVIIa; NovoSeven®) is one of the treatments available for acute life-threatening bleeding episodes in haemophilia patients with inhibitors. It has also been used successfully in a range of orthopaedic surgical procedures in these patients. This is a review of published data on elective orthopaedic procedures in haemophilia patients with inhibitors under cover of rFVIIa from January 2002 to November 2006. Articles were retrieved from MEDLINE using specified search parameters. Twelve articles covering a total of 80 orthopaedic procedures were identified. In the vast majority of cases, rFVIIa provided safe and effective haemostatic cover during orthopaedic surgery with no bleeding complications. There was variation in the administered dose, although the majority of patients were treated with 90 ,g kg,1 bolus followed by either continuous infusion or bolus infusion. Of those cases reporting bleeding complications, most were considered to be related to an inadequate amount of rFVIIa. The cumulative experience presented here suggests that rFVIIa is safe and effective for providing adequate haemostatic cover for haemophilia patients with inhibitors undergoing orthopaedic surgery. The optimal dosing regimen and mode of administration has yet to be identified. Further controlled trials are needed to confirm these experiences. [source] Dental procedures in adult patients with hereditary bleeding disorders: 10 years experience in three Italian Hemophilia CentersHAEMOPHILIA, Issue 5 2005M. Franchini Summary., Excessive bleeding after dental procedures are one of the most frequent complications occurring in patients with hereditary bleeding disorders. In this retrospective study we collected data from 10 years of experience in the oral care of patients with congenital haemorrhagic disorders in three Italian Hemophilia Centers. Between 1993 and 2003, 247 patients with inherited bleeding disorders underwent 534 dental procedures including 133 periodontal treatments, 41 conservative dentistry procedures, 72 endodontic treatments and 288 oral surgery procedures. We recorded 10 bleeding complications (1.9%), most of which occurred in patients with severe/moderate haemophilia A undergoing multiple dental extractions. Thus, our protocol of management of patients with hereditary bleeding tendency undergoing oral treatment or surgery has been shown to be effective in preventing haemorrhagic complications. [source] Prophylactic recombinant factor VIIa in haemophilia patients with inhibitorsHAEMOPHILIA, Issue 3 2005G. Young Summary., Prevention of bleeding, especially into joints, with prophylactic factor infusions is the most effective treatment for severe haemophilia patients. Approximately 15,30% of patients with factor VIII deficiency and 3,5% of patients with factor IX deficiency develop neutralizing antibodies (inhibitors) to factor precluding their use. Such patients often have significant bleeding complications including life- and limb-threatening bleeds and severe joint disease. Prophylaxis for such patients is not generally considered because of the fact that the standard (bypassing) agents for such patients are not as effective as natural factor replacement, because of concerns for thrombotic complications and also because of the very high cost of bypassing agents. We treated two patients with high titre inhibitors with prophylactic recombinant factor VIIa (rFVIIa). The first patient was treated as a result of development of a target joint and to reduce the use of agents that can lead to anamnesis of his inhibitor. The second patient had multiple severe bleeds and was hospitalized 20% of the time over a 2-year period. He had a very poor quality of life. Both patients had shown good responses previously to rFVIIa for treatment of bleeds. Both patients had an outstanding response to prophylaxis albeit at a very high cost. Prophylaxis with rFVIIa can be an effective approach in select inhibitor patients with severe complications related to bleeding. [source] Haemophilia 2002: emerging risks of treatmentHAEMOPHILIA, Issue 3 2002B. L. EVATT Haemophilia care and treatment products have greatly improved over the past 2 decades. Transitions in treatment produced by these changes were accompanied by the emergence of unexpected risks and new complications. In order to provide the best comprehensive care to patients with haemophilia, healthcare providers periodically need to re-evaluate and adjust their management and therapeutic products to prevent or minimize the effects produced by the emerging issues. For example, reducing the effects of infectious agents remains the highest priority for the haemophilia community because of the high level of morbidity and mortality that has resulted from earlier therapeutic agents. In many countries, the goal has been to achieve absolute zero risk for infectious agents. In some instances, the screening procedures to achieve these goals reduced the availability of plasma needed for manufactured derivatives and produced another emerging risk, shortages of clotting factor preparations. Similarly, better diagnostic methods identified other potential agents that were not inactivated by current technology. Likewise, immune tolerance regimens and the prophylactic management of haemophilia introduced different therapeutic delivery systems with their own risks. The drugs used to manage diseases such as human immunodeficiency virus (HIV), which were transmitted by products manufactured before mid-1980, create their own set of risks for this community. Topical emerging risks of treatment, including variant Creutzfeldt,Jakob disease, an assessment of its risks and impact, the complications of using indwelling catheters, and the role of protease inhibitors used to treat HIV may have on bleeding complications of haemophilia are discussed. [source] Efficacy of desmopressin as surgical prophylaxis in patients with acquired von Willebrand disease undergoing thyroid surgeryHAEMOPHILIA, Issue 2 2002M. FRANCHINI Coagulation abnormalities may occur in patients with thyroid diseases. We report on 14 patients undergoing thyroid surgery for a thyroid disease with an alteration of coagulation parameters resembling von Willebrand disease. Subcutaneous desmopressin was first tested and then used successfully in these patients as surgical prophylaxis, with no side-effects or bleeding complications during or after surgery. This study highlights the need for coagulation studies in patients with thyroid diseases undergoing thyroid surgery. Subcutaneous desmopressin may be used in these patients in order to prevent a surgically related bleeding risk. [source] Proposal of a standard approach to dental extraction in haemophilia patients.HAEMOPHILIA, Issue 5 2000A case-control study with good results We found no case,control studies on dental extraction in haemophilia patients in the literature even though the use of antifibrinolytic agents following a single infusion of factor VIII or IX has been accompanied by a lower number of bleeding complications in dental extractions. In this study we verified the incidence of bleeding complications after dental extraction in a group of 77 haemophilia patients. One hundred and eighty-four male patients requiring dental extraction represented the control group. All haemophilia patients received 20 mg kg,1 of tranexamic acid and a single infusion of factor VIII or IX to achieve a peak level about 30% of factor VIII or IX in vivo prior to dental extraction. Forty-five of 98 (45.9%) dental extractions in haemophilia patients and 110 of 239 (46%) dental extractions in the control group were surgical ones. We registered two bleeding complications in the group of haemophilia patients (one late bleeding and one haematoma in the site of the anaesthetic injection) and one (a late bleeding) in the control group. The difference of bleeding complications in the two groups of patients were not statistically significant (P=0.2; OR 0.2; CI 0.01,2.22). The protocol proposed in this study, characterized by the feasibility and the number of haemorrhagic complications not different from normal population, make dental extractions in haemophilia patients possible on an out-patient basis with a cost reduction for the community and minor discomfort for the patients. [source] Low-molecular-weight heparin as bridging therapy during interruption of oral anticoagulation in patients undergoing colonoscopy or gastroscopyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2 2007M. Constans Summary Nowadays, most patients under oral anticoagulant therapy (OAT) require invasive procedures such as colonoscopy (CC) or gastroscopy (GC). The goals of the management of OAT are to minimise the risk of thromboembolism and bleeding. We have performed the first prospective, observational study to evaluate these parameters using fixed-dose high-risk thromboprophylactic therapy with sodic bemiparin (Hibor®) as bridging therapy. From January 2004 to January 2005, patients under OAT were included. Periprocedure prophylaxis consisted of: Acenocumarol patients: Day ,3: withdrawal acenocumarol. Days ,2,,1,0: Hibor ®3500 UI/d sc and days +1,+2,+3: Hibor® 3500 U/I + acenocumarol. And day +5: acenocumarol only. Warfarin patients: Days ,5,,4: withdrawal warfarin, ,3,,2,,1, 0; Hibor® 3500 UI/day sc, days +1,+2,+3,+4: Hibor® 3500 UI/day sc and warfarin and day +5; warfarin only. Thromboembolic complications and bleeding were recorded in a 3 month follow-up. We included 100 consecutive patients in the intention-to-treat group. The remaining 98 patients were 50 women and 48 men. Mean age of women was 71.1 (range: 46,87) years and 70.7 (range: 39,86) years in men. Eighty-three took acenocumarol, and 15 warfarin. Thirty-two gastroscopies and 61 colonoscopies were performed and in five patients both were performed. No thromboembolic and bleeding complications related to bemiparin were observed in the 103 endoscopies. Two patients developed pruritus at the punction site. Fixed-dose high-risk thromboprophilactic therapy with bemiparin (Hibor®) is safe and effective as a bridging therapy in patients under OAT who require GC or CC. [source] Antiplatelet Therapy: Anti-Ischemic Benefits versus Bleeding RiskJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2008C. MICHAEL GIBSON M.D., F.A.C.C. Balance between efficacy and safety is a major concern in therapeutic interventions of patients with acute coronary syndromes. Identifying and managing the risks that may negatively affect this balance can potentially minimize the incidence of morbidity and/or mortality among patients with acute coronary syndromes. Unstable angina and non-ST-elevation myocardial infarction are potentially life-threatening disorders and a major cause of hospitalization and emergency medical care. At the time of presentation, the use of algorithms that provide reasonable assessment of a patient's risk of cardiovascular events, such as the Thrombolysis in Myocardial Infarction risk score, can help clinicians identify which patients will most likely benefit from a specific strategy. The ultimate goal of treatment for non-ST-elevation myocardial infarction is to reduce short- and long-term morbidity and mortality, as well as salvage myocardial cells and cardiac function. Pharmacologic intervention with antiplatelet and/or antithrombotic agents has proven to be effective in achieving this goal in numerous outcome studies. However, clinicians must balance anti-ischemic efficacy with the need to minimize the risk of serious bleeding complications (e.g., hemorrhage). Issues related to safety include timing of the dose, duration of infusion, drug compatibility, errors in estimating a patient's weight and/or age, failure to adjust the dosage based upon renal function, and errors in drug preparation. [source] Transcatheter Closure of Patent Foramen Ovale in Patients with Paradoxical Embolism.JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2008Follow-up Results after Implantation of the Starflex® Occluder Device with Conjunctive Intensified Anticoagulation Regimen, Procedural Background:Prevalence of patent foramen ovale (PFO) is higher in patients with paradoxical embolism and associated with increased risk for recurrent thromboembolic events. By percutaneous closure of PFO, surgical closure or permanent oral anticoagulation can be avoided. So far, published series included different occluder systems and various indications and regimens of postprocedural anticoagulation. The aim of the present study was to evaluate the short- and long-term results after implantation of the Starflex® occluder in patients with PFO using an intensified anticoagulation regimen. Methods and Results:154 patients with PFO (94 men; age: 44 ± 13 years) and >1 thromboembolic event were included. Other causes for embolism were excluded. PFO closure was successful in 147 patients (95.5%). All patients were treated with phenprocoumon (INR 2.5) and aspirin (100 mg/die) for 6 months. Transesophageal echocardiography (TEE) was repeated at 6 months. Mean clinical follow-up period was 26 ± 18 months. After 6 months, five patients had a significant residual shunt, and five patients had suspected thrombus formation on the occluder. In three of these five patients, the occluder was surgically removed and foreign body reaction was noted. During follow-up, nine patients suffered from neurological events (two strokes, seven transient ischemic attacks [TIA]), though complete closure of the PFO was documented by TEE. Two patients died during follow-up; three patients had bleeding complications. Conclusion:Percutaneous closure of PFO in symptomatic patients by Starflex® occluder represents an effective therapy with a low incidence of periinterventional complications and recurrent thromboembolism. However, thrombus formation at the occluder system may occur in some patients despite an aggressive anticoagulation regimen. [source] Body mass index and mortality in patients with acute venous thromboembolism: findings from the RIETE registryJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 4 2008R. BARBA Summary.,Background:,There is little information on the influence of body mass index (BMI) on mortality in patients with acute venous thromboembolism (VTE). Patients and methods:,RIETE is an ongoing registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. We examined the association between BMI and mortality during the first 3 months of therapy. Results:,Of the 10 114 patients enrolled as of March 2007: 153 (1.5%) were underweight (BMI < 18.5); 2882 (28%) had a normal weight (BMI 18.5,24.9); 4327 (43%) were overweight (BMI 25.0,30); and 2752 (27%) were obese (BMI > 30). The overweight and obese patients were significantly older, and were less likely to have had cancer, recent immobility or renal insufficiency. After 3 months of therapy their death rates were 28%, 12%, 6.2% and 4.2%, respectively. In multivariate analysis, the relative risks for death after adjusting for confounding variables including age, cancer, renal insufficiency or idiopathic VTE were: 2.1 (95% CI, 1.5,2.7); 1.0 (reference); 0.6 (95% CI, 0.5,0.7); and 0.5 (95% CI, 0.4,0.6), respectively. The rates of fatal pulmonary embolism (2.0%, 2.1%, 1.2% and 0.8%, respectively) also decreased with BMI. There were no differences in the rate of fatal bleeding, but patients who were underweight had an increased incidence of major bleeding complications (7.2% vs. 2.7%; odds ratio, 2.7; 95% CI, 1.4,5.1). Conclusions:,Obese patients with acute VTE have less than half the mortality rate when compared with normal BMI patients. This reduction in mortality rates was consistent among all subgroups and persisted after multivariate adjustment. [source] The influence of extreme body weight on clinical outcome of patients with venous thromboembolism: findings from a prospective registry (RIETE)JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 5 2005R. BARBA Summary.,Background:,Data evaluating the safety of using weight-based dosing of low-molecular-weight heparin (LMWH) in either underweight or obese patients with venous thromboembolism (VTE) are limited. Thus, recommendations based on evidence from clinical trials might not be suitable for patients with extreme body weight. Patients and Methods:,Patients with objectively confirmed, symptomatic acute VTE are consecutively enrolled into the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry. For this analysis, data from patients in the following ranges of body weight were examined: <50, 50,100, and >100 kg. Patient characteristics, underlying conditions, treatment schedules and clinical outcomes during the first 15 days of treatment were compared. Results:,As of August 2004, 8845 patients with acute VTE were enrolled from 94 participating centers. Of these, 169 (1.9%) weighed <50 kg, 8382 (95%) weighed 50,100 kg and 294 (3.3%) weighed >100 kg. Patients weighing <50 kg were more commonly females, were taking non-steriodal antiinflammatory drugs (NSAIDs), and had severe underlying diseases more often than patients weighing 50,100 kg. Their incidence of overall bleeding complications was significantly higher than in patients weighing 50,100 kg (odds ratio 2.2; 95% CI: 1.2,4.0). Patients weighing >100 kg were younger, most commonly males, and had cancer less often than those weighing 50,100 kg. Incidences of recurrent VTE, fatal pulmonary embolism or major bleeding complications were similar in both groups. Conclusions:,Patients with VTE weighing <50 kg have a significantly higher rate of bleeding complications. The clinical outcome of patients weighing over 100 kg was not significantly different from that in patients weighing 50,100 kg. [source] Non-fatal major bleeding during treatment with vitamin K antagonists: influence of soluble thrombomodulin and mutations in the propeptide of coagulation factor IXJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 7 2004J. F. Van Der Heijden Summary., Background and objectives : The key complication of treatment with vitamin K antagonists (VKAs) is bleeding. The major determinant of VKA-induced bleeding is the intensity of anticoagulation. Individual patient characteristics may also influence bleeding risk. In addition, soluble thrombomodulin (s-TM) levels and mutations in the propeptide of factor (F)IX are important candidate risk factors in this respect. Patients and methods : A matched case,control study was designed to search for risk factors that predict bleeding during VKA treatment. We selected cases that had experienced major bleeding during treatment with VKA and matched controls without bleeding complications from the databases of two Thrombosis Services. The controls were matched for indication of treatment, age, gender, type of anticoagulant used and whether or not treatment with VKA was stopped. DNA and plasma were stored of all cases and controls. Results and conclusions : In total 110 patients and 220 controls consented to participate. The results indicate that s-TM levels, measured by ELISA, may be a risk indicator for bleeding [crude odds ratio 3.25 for the highest quartile vs. the lowest quartile (95% confidence interval 1.40, 7.51)]. Three novel mutations, determined by direct sequencing, in the gene portion encoding the propeptide of FIX were identified that do not seem to play an important role in bleeding risk during treatment with VKAs. [source] Neonates with severe infantile hepatic hemangioendothelioma: Limitations of liver transplantationPEDIATRIC TRANSPLANTATION, Issue 5 2009Enke Grabhorn Abstract:, IHHE as the most common vascular tumor of the liver in infancy can present with acute postnatal liver and congestive heart failure. LTx may be a lifesaving option, but can be complicated by extrahepatic involvement and bleeding complications, especially in neonates. Here we discuss the benefit of LTx in cases of acute postnatal deterioration and massive extent of the hepatic tumor. Three infants with IHHE were transplanted at our institution between 2005 and 2007. Two were neonates with acute postnatal decompensation and progressive liver and heart failure within days. Treatment with steroids and chemotherapy was ineffective; resection surgery and interventional treatment were not considered appropriate. LTx was performed at the age of 7 and 24 days, respectively. An additional infant with a bilobar tumor that evolved more slowly was transplanted on day-of-life 56. Patients 1 and 2 had to be resuscitated during the LTx procedure because of massive bleeding and both died during the procedure. Patient 3 had a complicated post-operative course but is doing well one-yr post-LTx. Neonates with extended hepatic and extrahepatic involvement of IHHE should be evaluated carefully prior to LTx. Whenever possible, alternative interventional treatment options should be considered. [source] Sustained delivery of therapeutic concentrations of human clotting factor IX , a comparison of adenoviral and AAV vectors administered in uteroTHE JOURNAL OF GENE MEDICINE, Issue 1 2002Holm Schneider Abstract Background Prenatal somatic gene therapy has been considered for genetic disorders presenting with morbidity at birth. Haemophilia is associated with an increased risk of catastrophic perinatal bleeding complications such as intracranial haemorrhage, which could be prevented by gene transfer in utero. Prenatal gene therapy may be more promising than postnatal treatment, as the fetus may be more amenable to uptake and integration of therapeutic DNA and the immaturity of its immune system may permit life-long immune tolerance of the transgenic protein, thus avoiding the dominant problem in haemophilia treatment, the formation of inhibitory antibodies. Methods Adenovirus serotype 5-derived or AAV serotype 2-derived vectors carrying human clotting factor IX (hfIX) cDNA or a reporter gene were administered intramuscularly, intraperitoneally or intravascularly to late-gestation mouse fetuses. Both vector types were evaluated with respect to the kinetics of hfIX delivery to the systemic circulation and possible immune responses against the vector or the transgene product. Results Mice treated in utero by intramuscular injection of an adenoviral vector carrying hfIX cDNA exhibited high-level gene expression at birth and therapeutic , albeit continuously decreasing , plasma concentrations of hfIX over the entire 6 months of the study. Adenoviral vector spread to multiple organs was detected by polymerase chain reaction (PCR). Intramuscular, intraperitoneal or intravascular application of AAV vectors carrying hfIX cDNA led to much lower plasma concentrations of hfIX shortly after birth, which appeared to decline during the first month of life but stabilized in some of the mice at detectable levels. No signs of immune responses were found, either against the different viral vectors or against hfIX. Conclusion This study demonstrates for the first time that sustained systemic delivery of a therapeutic protein can be achieved by prenatal gene transfer. It thus shows the feasibility of gene therapy in utero and provides a basis for considering this concept as a preventive therapeutic strategy for haemophilia and perhaps also for other plasma protein deficiencies. Copyright © 2002 John Wiley & Sons, Ltd. [source] Peri-operative management of an adult patient with type 2N von Willebrand's disease scheduled for coronary artery bypass graftANAESTHESIA, Issue 4 2007V. Gerling Summary We describe a patient with type 2N von Willebrand's disease scheduled for elective coronary artery bypass graft for severe three-vessel coronary artery disease with involvement of the left main stem. He was given a pre-operative bolus of 3000 IU factor VIII/Willebrand factor concentrate (, 40 IU.kg,1), followed by a continuous infusion of 3 IU.h,1 (228 IU.h,1) before undergoing coronary surgery with full heparinisation and cardiopulmonary bypass. There were no intra-operative bleeding complications and only one unit of packed red blood cells was required postoperatively. Thromboprophylaxis with low-molecular weight heparin and aspirin was given and the infusion of factor VIII/von Willebrand factor concentrate continued for 2 days. As a result of haematological monitoring, heparin therapy was changed from prophylactic to therapeutic on day 5,6 and stopped on day 7. [source] Efficacy and Safety of Anticoagulation With Heparin Versus Heparin Plus Epoprostenol in Patients Undergoing Extracorporeal Liver Support With PrometheusARTIFICIAL ORGANS, Issue 1 2010Peter Krisper Abstract Anticoagulation for extracorporeal liver support is delicate due to underlying coagulation disorders in patients with liver failure and to the associated elevated bleeding risk. To date, there has been no detailed report on anticoagulation issues in patients treated with Prometheus, a device based on the principle of fractionated plasma separation and adsorption. We studied 17 patients from two centers treated with Prometheus, comparing standard anticoagulation with heparin (15 treatments) and a combination of heparin and the synthetic prostacyclin epoprostenol (22 treatments). Standard coagulation tests, proteins C and S, and thrombin,antithrombin (TAT) complex were determined, and adverse events were recorded. All but two treatments could be completed as scheduled, although filter exchange due to filter clotting was required in 24% of the treatments. Three out of 17 patients developed severe bleeding complications within 24 h of treatment. There were no overt thrombotic events. Addition of epoprostenol neither reduced coagulation-related adverse events nor improved standard coagulation parameters. Protein C, but not protein S, showed a significant reduction (23 ± 18%) after Prometheus treatments, but levels rebounded to baseline within 18 h. TAT levels,a measure for activation of coagulation,were only altered by Prometheus in patients where TAT was already elevated before treatment. In conclusion, anticoagulation of Prometheus with heparin is feasible but still associated with a relatively high frequency of filter clotting and a considerable risk of severe bleeding in this high-risk patient population. As addition of epoprostenol did not prove beneficial, other strategies, such as regional anticoagulation with citrate, should be further evaluated. [source] Thrombocytopenia in hydropic fetuses with parvovirus B19 infection: incidence, treatment and correlation with fetal B19 viral loadBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 1 2008TR De Haan Objective, To examine (1) the incidence of fetal thrombocytopenia in hydropic fetuses with congenital B19 virus infection, (2) the effect of intrauterine platelet transfusions and (3) the correlation between fetal B19 viral load and severity of thrombocytopenia. Design, Retrospective analysis of data from prospectively collected fetal blood samples. Setting, Leiden University Medical Centre, the national centre for management of intrauterine fetal disease in the Netherlands. Population, Thirty hydropic fetuses treated with intrauterine red blood cell and platelet transfusions for human B19 virus-induced severe fetal anaemia and thrombocytopenia over a 10-year period. Methods, Fetal blood samples (n= 30) taken before and after intrauterine transfusion were investigated. No cases were excluded, and there was no loss to follow up. Main outcome measures, Parameters recorded were gestational age, experienced fetal movements, gravidity and parity, severity of fetal hydrops, severity of fetal anaemia and thrombocytopenia and megakaryocyte and reticulocyte counts. Survival and procedure-associated complications were documented. Quantitative B19 viral load measurements were performed on all fetal samples. Results, Forty-six percent of all hydropic fetuses showed severe thrombocytopenia. No antenatal intracerebral haemorrhage or procedure-associated bleeding occurred. Overall, survival was 77%. Platelet counts increased following platelet transfusion and decreased significantly following red blood cell transfusion alone. No correlation was found between fetal viral loads and platelet counts. Conclusion, Thrombocytopenia was frequently encountered in fetal B19V infection, but fetal bleeding complications were not noted. Absence of a direct relationship between fetal B19 viral load and platelet counts suggests a temporal dissociation between these findings. Dilutional thrombocytopenia is frequently seen in the fetus following red blood cell transfusion alone. The clinical significance of this phenomenon is unclear. The risk of fluid overload by fetal platelet transfusion in a severely hydropic fetus should be weighed against the low incidence of fetal bleeding complications. [source] Low molecular weight heparin (dalteparin) for the treatment of venous thromboembolism in pregnancyBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 2 2003Anne Flem Jacobsen Objective To evaluate the effect and dose of dalteparin given to pregnant women with acute venous thromboembolism. Design An observational study of pregnant women in Norway. Setting Delivery and haematological departments in Norway. Population Twenty women, aged 22,41 years, with acute venous thromboembolism verified by objective means. Methods Patients were treated with dalteparin from diagnosis until delivery. Treatment was monitored with anti-activated factor Xa (anti-Xa) activity, and the dose was adjusted to achieve target 0.5,1.0 U/mL 2,3 hours post-injection. Main outcome measure Anti-Xa activity and side effects. Result None of the patients suffered recurrent venous thromboembolism or major bleeding complications. In 9 of 13 women starting with conventional dose of dalteparin (100 iu/kg bd), dose escalation was necessary to reach target anti-Xa activity. None of the six women who started with 105,118 iu/kg bd required dose escalation. One woman who started with 133 iu/kg bd required dose reduction. Bioaccumulation of dalteparin was not observed. Conclusion Our study suggests that dalteparin may be used for the treatment of acute venous thromboembolism in pregnancy. Approximately 10,20% higher doses of dalteparin may be needed as compared with non-pregnant individuals. [source] Donor-site morbidity in buccal mucosa urethroplasty: lower lip or inner cheek?BJU INTERNATIONAL, Issue 4 2005Stefan Kamp Authors from Germany debate the issue as to whether the donor site for oral mucosa used in urethroplasty should be taken from the inner cheek or the lower lip, using morbidity as a deciding factor. As a result of their study they have changed their technique, now using the inner cheek as the donor site whenever possible. OBJECTIVE To evaluate donor-site complications of buccal mucosa urethroplasty and whether there is a difference in morbidity between harvesting the mucosa graft from the inner cheek or the lower lip. PATIENTS AND METHODS Twenty-four consecutive patients with recurrent urethral strictures were treated with buccal mucosa urethroplasty in our department between September 2002 and April 2004. In 12 patients the graft was harvested from the lower lip or cheek and lower lip (group 1), and in 12 patients from the cheek (group 2). The mean (range) age of patients was 51 (26,66) years in group 1 and 53 (32,75) years in group 2. The mean (range) graft length was 6.2 (2,16) cm in group 1 and 5.7 (2,13) cm in group 2. All patients were followed up using a mailed questionnaire that asked about pain, numbness, difficulties in mouth opening or ingestion, and satisfaction, monthly for the first 3 months and then every 6 months. The mean (range) follow-up was 12.5 (6,23) months. RESULTS There were no bleeding complications or disturbances in wound healing. All of the patients reported numbness in the area of the mental and buccal nerves, and graft-site tenderness after surgery. In group 1, the pain lasted for a mean (range) of 5.9 (0.5,22) months, compared to 1 (0.1,7) months in group 2 (P = 0.022). Perioral numbness lasted for a mean (range) of 10.3 (0.5,23) months in group 1 and 0.85 (0.1,3) months (P = 0.0027) in group 2. There were no statistically significant differences in problems with mouth opening or food intake between the two groups, but the patients in group 1 seemed to be less satisfied (6/12 patients satisfied) than those in group 2 (11/12 patients satisfied). CONCLUSIONS Buccal mucosa graft harvesting from the lower lip and the inner cheek are both feasible, but harvesting from the lower lip resulted in a significantly greater long-term morbidity, which resulted in a lower proportion of satisfied patients. This seems to be due to a long-lasting neuropathy of the mental nerve. We therefore have changed our technique entirely from lower lip to inner cheek graft harvesting, whenever possible. [source] Lupus anticoagulant associated with transient severe factor X deficiency: a report of two patients presenting with major bleeding complicationsBRITISH JOURNAL OF HAEMATOLOGY, Issue 4 2003Aneel A. Ashrani Summary. Acquired factor X (FX) deficiency is rare, but has been reported in diverse disease states, including systemic amyloidosis and respiratory infections. FX deficiency associated with lupus anticoagulant (LA) and a bleeding diathesis has not been previously reported. We report two patients both of whom presented with a severe bleeding diathesis after a preceding respiratory infection due to isolated FX deficiency associated with a LA. The FX deficiency and LA were transient. We conclude that patients with LA may rarely present with severe acquired FX deficiency. This may be another mechanism whereby patients with antiphospholipid antibodies present with bleeding complications. [source] Use of donor aorta for arterial reconstruction in paediatric liver and multivisceral transplantationBRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 6 2004S. Nishida Background: Arterial reconstruction remains the most important technical issue in paediatric transplantation. The arteries of paediatric donors as well as recipients are small and friable. The aim of this study was to assess the use of the donor aorta as a conduit for arterial reconstruction in paediatric liver and multivisceral transplantation. Methods: Between June 1994 and January 2002, 284 paediatric transplants, including 197 cadaveric liver and multivisceral transplants, were performed in children at this centre. Of these, 41 (20·8 per cent), including nine cadaveric liver transplants and 32 multivisceral transplants, were revascularized by donor aortic reconstruction. Patient demographics, types of donor arterial reconstruction, technical complications and incidence of hepatic artery thrombosis were reviewed. Results: None of the 41 donor aortic reconstructions used in revascularization of paediatric liver and multivisceral transplants thrombosed. There were no bleeding complications and no pseudoaneurysms developed. Conclusion: Arterial reconstruction using donor aorta is a useful option with a low incidence of thrombosis in paediatric transplantation. Copyright © 2004 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Impact of bivalirudin on in-hospital bleeding and six-month outcomes in octogenarians undergoing percutaneous coronary intervention,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2009Gilles Lemesle MD Abstract Objectives: This study aimed to analyze the impact of replacing heparin with bivalirudin in octogenarians undergoing percutaneous coronary intervention (PCI) on postprocedure hemorrhage and 6-month mortality. Background: Randomized trials comparing the antithrombin agent bivalirudin with heparin as the intraprocedural anticoagulant identify a reduction in periprocedural bleeding after PCI. Further, the occurrence of such bleeding seems to predict an increased risk of death or myocardial infarction both in-hospital and at long-term follow-up. Importantly, elderly people who are at the greatest risk of post-PCI bleeding complications are underrepresented in these randomized trials. Methods: From 2000 to 2007, 2,766 consecutive patients from our center who were ,80 years of age underwent PCI with stent implantation and were included in this analysis. Bivalirudin was used in 1,207 (43.6%) patients and heparin in 1,559 (56.4%). We compared the rates of post-PCI bleeding complications and 6-month mortality. Results: The overall in-hospital bleeding and 6-month mortality rates were 4.6% and 11.8%, respectively. By multivariate logistic regression and after adjustment by propensity score analysis, bivalirudin was associated with a significant decrease in in-hospital bleedings (HR = 0.41, 95% CI = 0.23,0.73, P = 0.003). By multivariate Cox analysis, bivalirudin was also associated with a significant decrease (HR = 0.6, 95% CI = 0.4,0.9, P = 0.01) and in-hospital bleedings with a significant increase in the 6-month mortality (HR = 2.5, 95% CI = 1.6,3.9, P < 0.001). Conclusion: This study suggests an important subset for use of bivalirudin in lieu of heparin that will benefit the very elderly. © 2009 Wiley-Liss, Inc. [source] Feasibility and safety of transbrachial approach for patients with severe carotid artery stenosis undergoing stentingCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2006Chiung-Jen Wu MD Abstract Although sporadic successful cases using the transradial approach (TRA) for carotid stenting have been reported, the safety and feasibility of carotid stenting using either TRA or a transbrachial approach (TBA) have not been fully investigated. Recently, we have developed a safe and feasible method of TRA for cerebrovascular angiographic studies. This study investigated whether a TBA approach using a 7-French (F) Kimny guiding catheter for carotid stenting is safe and feasible for patients with severe carotid stenosis. Thirteen patients were enrolled into this study (age range, 63,78 years). Seven of these 13 patients had severe peripheral vascular disease. A retrograde-engagement technique, involving looping 6-F Kimny guiding catheter, was utilized for carotid angiographic study. For carotid stenting, the 6-F Kimny guiding catheter was replaced with a 7-F Kimny guiding catheter, and the procedure was performed as the follows. First, an extra-support wire was inserted into the middle portion of external carotid artery (ECA). Second, a 0.035-inch Teflon wire was advanced into the common carotid artery. Then, the 6-F guiding catheter was exchanged for a 7-F Kimny guiding catheter. Third, if the first and second steps did not provide adequate support for exchanging the guiding catheter, a PercuSurge GuardWireÔ was inserted into the ECA, followed by distal balloon inflation for an anchoring support. FilterWire EXÔ was used in 9 patients and PercuSurge GuardWire in 4 patients to protect from distal embolization during the procedure. The procedure was successful in all patients. No neurological or vascular bleeding complications were observed and all patients were discharged uneventfully. The TBA for carotid stenting was safe and effective, providing a last resort for patients unsuited to femoral arterial access and surgical intervention. © 2006 Wiley-Liss., Inc. [source] | |||||||||||||||||||||||||||||||