High Risk Of Bleeding Complications Research Articles

Rationale supporting an “opt-out” policy for pharmacological venous thromboembolism prophylaxis in hospitalized medical patients

Pulmonary embolism is the number one cause of preventable death among hospitalized patients. Prescription of either low dose low molecular weight heparin, such as enoxaparin or dalteparin, or prescription of low dose fondaparinux can halve the rate of deep vein thrombosis or pulmonary embolism, without increasing major bleeding complications. Nevertheless, there has been a "failure-to-prophylax" syndrome, especially among hospitalized medical patients at risk. One approach is to mandate venous thromboembolism prophylaxis for these patients without exception or flexibility. The alternative approach is to institute or maintain an "opt-out" policy so that the responsible clinician can make the final decision as to whether the benefits of prophylaxis outweigh the risks. This paper, makes the case for an "opt-out" policy, so that we can personalize, individualize, and humanize our medical care. Such an approach permits flexibility, encourages collaborative "buy-in" to the concept of prophylaxis, and allows the clinician to withhold anticoagulation in special situations that do not fit prespecified protocols. Ultimately, such an "opt-out" policy might make VTE prophylaxis more effective by avoiding anticoagulation of low thrombosis risk patients who are at high risk of bleeding complications.

Clinical review: bleeding - a notable complication of treatment in patients with acute coronary syndromes: incidence, predictors, classification, impact on prognosis, and management.

This article focuses on the incidence, predictors, classification, impact on prognosis, and management of bleeding associated with the treatment of acute coronary syndrome. The issue of bleeding complications is related to the continual improvement of ischemic heart disease treatment, which involves mainly (a) the widespread use of coronary angiography, (b) developments in percutaneous coronary interventions, and (c) the introduction of new antithrombotics. Bleeding has become an important health and economic problem and has an incidence of 2.0% to 17%. Bleeding significantly influences both the short- and long-term prognoses. If a group of patients at higher risk of bleeding complications can be identified according to known risk factors and a risk scoring system can be developed, we may focus more on preventive measures that should help us to reduce the incidence of bleeding.

Primär- und Sekundärprävention des Schlaganfalls

Despite considerable advances in acute stroke therapy, stroke prevention remains the most promising approach for reducing the burden of stroke. A healthy lifestyle and the treatment of cardiometabolic risk factors are the cornerstones of both primary and secondary stroke prevention. Due to a proportionately higher risk of bleeding complications, platelet inhibitors are not recommended for primary stroke prevention. Platelet inhibitors are effective in the secondary prevention of stroke with acetyl salicylic acid (ASS) and clopidogrel showing the most consistent data. New oral anticoagulants are slightly more effective than coumarin and significantly reduce the risk of intracranial hemorrhage. They offer the opportunity to bring more patients with atrial fibrillation at risk for stroke into anticoagulation particularly those on ASS therapy. Surgery for patients with asymptomatic carotid artery stenosis should be viewed critically with respect to an only marginal benefit and improvement in medical therapies. Carotid endarterectomy remains the gold standard for patients with symptomatic carotid stenosis because of an increased procedural stroke risk with carotid stenting. Patients with symptomatic intracranial stenosis or cryptogenic stroke and a patent foramen ovale should receive only medical treatment.

The application of 120-W high-performance system GreenLight laser vaporization of the prostate in high-risk patients

The purpose of this study is to evaluate the safety and efficacy of 120-W potassium titanyl phosphate (KTP) laser vaporization in patients with benign prostatic hyperplasia (BPH) who also had cardiopulmonary diseases who were taking long-term anticoagulants and were at high risk of bleeding complications. The prospective study included 188 patients with severe lower urinary tract symptoms who underwent 120-W KTP laser vaporization of the prostate. All patients were at high cardiopulmonary risk, having presented with an American Society of Anesthesiology score of 3 or greater. Of those, 45 patients were taking oral anticoagulants, and 1 had a severe bleeding disorder. BPH was successfully treated with 120-W KTP laser vaporization in all patients. Mean preoperative prostate volume ± SD was 66 ± 23.1ml, and mean operative time was 50.8 ± 15.5min. There were no major complications intraoperatively or postoperatively, and no blood transfusions were required. Postoperatively, only 14 patients (7.4%) required bladder irrigation. Average catheterization time was 1.9 ± 1.5days (range, 1-5days). Three patients required reoperation due to enlarged prostates from residual adenoma. At 3-, 6,- 12-, and 24-month follow-ups, mean urinary peak flow increased from 8.0 ± 3.6ml/s to 19.1 ± 5.6, 19.2 ± 4.7, 19.1 ± 4.65, and 19.2 ± 4.34ml/s, respectively. Mean International Prostate Symptom Scores decreased over time, from 25.6 ± 5.1 (3months) to 9.4 ± 2.8, 7.05 ± 1.46, 6.24 ± 1.36, and 6.20 ± 1.32 (24months), respectively. 120-W HPS KTP laser vaporization is a safe and effective treatment option in BPH patients at high risk and those on anticoagulation therapy who have severe LUTS secondary to BPH.

Novel and Emerging Therapies: Thrombus-Targeted Fibrinolysis

Thrombolytic therapy by infusion of analogs of tissue plasminogen activator (tPA), other recombinant-based plasminogen activators (e.g., alteplase, reteplase, and tenecteplase), streptokinase, and urokinase (uPA) aims to clear blood clots and restore blood flow in occluded blood vessels. Thrombolytic therapy is thereby frequently used in patients with myocardial infarction, stroke, peripheral arterial disease, and massive pulmonary embolism. The leading drawbacks of thrombolysis and associated therapy are represented by a significant burden of inefficacy combined with a high risk of bleeding complications. Recent advances in understanding the complex pathophysiology of vascular occlusions, combined with important technological innovations, are notably improving the therapeutic armamentarium against thrombotic and occlusive disorders. Most of the past and ongoing research in this area have entailed thrombus-targeted fibrinolytic therapy with either tissue- and fibrin-specific immunoconjugates, fibrinolytic-bearing erythrocytes, or fibrinolytic-bearing nanoparticles. The greatest advantages of thrombus-targeted fibrinolysis, especially with biocompatible nanoparticles, are represented by their preferential localization within developing clots, effectual thrombolysis and enhanced safety due to substantial reduction of the dosage of fibrinolytic agents, and reduced onstream adverse effects. These positive biological features, coupled with minimal extravasation and favorable clearance from the circulation, appear advantageous for obtaining more efficacious and durable thrombolytic effects while concomitantly lowering or even eliminating the risk of systemic bleeding complications that typically accompany the injection of free or soluble plasminogen activators. Although an ideal technique has not been definitely established so far, tPA-bearing nanoparticles exhibiting affinity for clot-specific cells and biomolecules coupled with low-frequency ultrasound seem to bear the greatest advantages for prevention and therapy of acute thrombosis, with the possibility to specifically guide and concentrate the thrombolytic agent at the site of pathologic thrombi and clear preexisting clots by a series of mechanisms combining mechanical stress and increased penetration and effectiveness of the drugs employed.

Current Oral Antiplatelets: Focus Update on Prasugrel

Platelet activation and aggregation plays an integral role in the pathogenesis of acute coronary syndrome (ACS). The mainstay of ACS treatment revolves around platelet inhibition. It is known that greater platelet inhibition results in better ischemic outcomes; hence, focus in drug development has been to create more potent inhibitors of platelet aggregation. Prasugrel, a potent, third-generation thienopyridine, was approved by the US Food and Drug Administration in July 2009 for its use in ACS and percutaneous coronary intervention. The addition of prasugrel to aspirin for dual antiplatelet therapy has been shown to reduce the ischemic outcomes compared with clopidogrel and aspirin in combination. However, being a more potent antiplatelet agent, prasugrel increases the risk of bleeding, especially in those patients who are at a higher risk of bleeding complications. Elderly patients ≥75 years, patients who weigh ≥60 kg, and patients with a history of stroke or transient ischemic attack are at a higher risk of bleeding complications when prasugrel is used in combination with aspirin. Newer antiplatelets currently are being clinically evaluated to assess their efficacy in reducing ischemic events without increasing the bleeding risk.

How to manage invasive procedures in children with haemophilia

Invasive procedures can be performed safely in children with haemophilia due to the availability of factor VIII/IX for patients without inhibitors. Most guidelines are based on the experiences in adults, but still there is no established consensus on the optimal factor levels or duration of replacement therapy for adults undergoing surgery. Few publications have focused on surgery in children with haemophilia. Children who have developed inhibitors to factor VIII/IX have to be treated with bypassing agents and constitute a group at higher risk for bleeding complications during surgery. The aim of this review is to summarize the experiences and opinions in the literature on replacement treatment of children with haemophilia, with and without inhibitors, during and after surgery, with a focus on the most prevalent clinical situations.

The hazards of interrupting anticoagulation therapy in atrial fibrillation

This editorial refers to ‘Increased short-term risk of thrombo-embolism or death after interruption of warfarin treatment in patients with atrial fibrillation’, by J. Raunso et al. , doi:10.1093/eurheartj/ehr454 Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia and is associated with a substantial burden of morbidity (mainly thrombo-embolism) and mortality. Vitamin K antagonists such as warfarin are highly effective for the prevention of stroke and systemic embolism in patients with AF,1 but their use is hampered by multiple food and drug interactions, the need for routine coagulation monitoring, and a high risk of bleeding complications.2 Hence warfarin not only is underutilized, but among those who are prescribed warfarin the treatment is frequently interrupted or permanently discontinued.3,4 No large studies have explored the possible impact of stopping warfarin on the short-term risk of subsequent major adverse cardiovascular outcomes, such as stroke and death, in patients with AF. Raunso and co-workers have now reported the results of a Danish nationwide retrospective cohort study in which they explored outcomes after warfarin interruption in patients with AF.5 Patients with a first hospitalization for AF in the period 1 January 1997 to 31 December 2008 were identified using the Danish National Patient Registry, and warfarin interruption was determined by cross-linkage with prescription claims from the Danish Registry of Medicinal Product Statistics. The primary outcome of the study was hospitalization for thrombo-embolism (ischaemic stroke, transient ischaemic attack, or unspecified stroke), pulmonary …

Percutaneous Mechanical Thrombectomy for Extensive Acute Lower-Extremity Deep Venous Thrombosis in a Patient After Double-Lung Transplantation

Venous thromboembolism, which includes deep venous thrombosis (DVT) and pulmonary embolism (PE), has been estimated to affect 25% of patients after major surgery; however, the literature on venous thromboembolism after thoracic transplantation and optimal approach remains limited. We report the status of a 67-year-old female who developed massive right lower-extremity DVT after double-lung transplantation. Because her surgery had taken place a week before this event, it was decided that pharmaco-thrombolysis was contraindicated due to the high risk of bleeding complications in a fresh double-lung transplant recipient. The patient was taken emergently to the operating room for percutaneous mechanical thrombectomy, which provided grade III (complete lysis) and restored venous patency in the affected extremity. This report highlights the successful use of purely percutaneous mechanical thrombectomy for acute DVT in a double-lung recipient, and also advocates inferior vena cava filter placement to prevent embolic events during the mechanical thrombectomy.

Cardiovascular disease in women: Implications for improving health outcomes

To collate data on women and cardiovascular disease in Australia and globally to inform public health campaigns and health care interventions. Literature review. Women with acute coronary syndromes show consistently poorer outcomes than men, independent of comorbidity and management, despite less anatomical obstruction of coronary arteries and relatively preserved left ventricular function. Higher mortality and complication rates are best documented amongst younger women and those with ST-segment-elevation myocardial infarction. Sex differences in atherogenesis and cardiovascular adaptation have been hypothesised, but not proven. Atrial fibrillation carries a relatively greater risk of stroke in women than in men, and anticoagulation therapy is associated with higher risk of bleeding complications. The degree of risk conferred by single cardiovascular risk factors and combinations of risk factors may differ between the sexes, and marked postmenopausal changes are seen in some risk factors. Sociocultural factors, delays in seeking care and differences in self-management behaviours may contribute to poorer outcomes in women. Differences in clinical management for women, including higher rates of misdiagnosis and less aggressive treatment, have been reported, but there is a lack of evidence to determine their effects on outcomes, especially in angina. Although enrolment of women in randomised clinical trials has increased since the 1970s, women remain underrepresented in cardiovascular clinical trials. Improvement in the prevention and management of CVD in women will require a deeper understanding of women's needs by the community, health care professionals, researchers and government.

Thrombolytic Therapy for Acute Ischemic Stroke after Recent Transient Ischemic Attack

Safety and efficacy of intravenous thrombolysis in stroke patients with recent transient ischemic attack are hotly debated. Patients suffering transient ischemic attack may present with diffusion-weighted imaging lesions, and although normal computed tomography would not preclude thrombolysis, the concern is that they may be at higher risk for hemorrhage post-thrombolysis treatment. Prior ipsilateral transient ischemic attack might provide protection due to ischemic preconditioning. We assessed post-thrombolysis outcomes in stroke patients who had prior transient ischemic attack. Multicentered prospective study of consecutive acute stroke patients treated with intravenous tissue plasminogen activator (tPA). Ipsilateral transient ischemic attack, baseline characteristics, risk factors, etiology, and time-lapse to treatment were recorded. National Institutes of Health Stroke Scale at seven-days and modified Rankin Scale at three-months, symptomatic intracranial hemorrhage, and mortality were compared in patients with and without transient ischemic attack. There were 877 patients included, 60 (6·84%) had previous ipsilateral transient ischemic attack within one-month prior to the current stroke (65% in the previous 24 h). Transient ischemic attack patients were more frequently men (70% vs. 53%; P = 0·011), younger (63 vs. 71 years of age; P = 0·011), smokers (37% vs. 25%; P = 0·043), and with large vessel disease (40% vs. 25%; P = 0·011). Severity of stroke at onset was similar to those with and without prior transient ischemic attack (median National Institutes of Health Stroke Scale score 12 vs. 14 P = 0·134). Those with previous transient ischemic attack were treated earlier (117 ± 52 vs. 144 ± 38 mins; P < 0·005). After adjustment for confounding variables, regression analysis showed that previous transient ischemic attack was not associated with differences in stroke outcome such as independence (modified Rankin Scale 0-2) (odds ratios: 1·035 (0·57-1·93) P = 0·91), mortality (odds ratios: 0·99 (0·37-2·67) P = 0·99), or symptomatic intracranial hemorrhage (odds ratios: 2·04 (0·45-9·32) P = 0·36). Transient ischemic attack preceding ischemic stroke does not appear to have a major influence on outcomes following thrombolysis. Patients with prior ipsilateral transient ischemic attack appear not to be at higher risk of bleeding complications.

Glycoprotein IIb‐IIIa Inhibitors

Platelets play a pivotal role in the pathogenesis of coronary artery disease and myocardial infarction. Therefore, great interests have been focused in the last decades on improvement in antiplatelet therapies, that currently are regarded as main pillars in the prevention and treatment of coronary artery disease, with special attention to glycoprotein IIb-IIIa (GP IIb-IIIa) receptors, that mediates the final stage of platelet activation. GP IIb-IIIa inhibitors, especially abciximab, have been shown to improve clinical outcome in patients undergoing primary angioplasty for STEMI. Upstream administration cannot routinely recommended, but may potentially be considered among high-risk patients within the first 4 h from symptoms onset. In case of periprocedural administration of antithrombotic therapy, Bivalirudin should be considered, especially in patients at high risk for bleeding complications. Among high-risk patients with acute coronary syndromes, an early invasive strategy with selective downstream administration of GP IIb-IIIa inhibitors is the strategy of choice, whereas bivalirudin should be considered in patients at high risk for bleeding complications. Among patients with unstable angina GP IIb-IIIa inhibitors should be considered only in case of evidence of intracoronary thrombus or in case of thrombotic complications (as provisional use). Further, randomized trials are certainly needed in the era of new oral antiplatelet therapies, and with strategies to prevent bleeding complications such as larger use of radial approach, mechanical closure devices, bivalirudin, or postprocedural protamine administration to promote early sheat removal.

Rationale and design of STOP DVT study: Rosuvastatin for the prevention of deep vein thrombosis in patients undergoing total knee replacement arthroplasty — A prospective randomized open-label controlled trial

Background Deep vein thrombosis (DVT) frequently occurs in high-risk cardiovascular patients receiving orthopedic surgery, despite prophylactic measures for its prevention. Statins, a class of drugs used to lower cholesterol levels, have been reported to help prevent the development of DVT. Methods We will conduct a prospective randomized clinical trial to compare the effects of high-dose rosuvastatin plus a low-molecular-weight heparin (LMWH), enoxaparin, with conventional LMWH therapy in the prevention of DVT. Patients will be naive to both statins and anti-coagulants and then underwent total knee replacement arthroplasty (TKRA). In total, 180 patients will be randomized into two groups of 90, consisting of a LMWH group (40 mg enoxaparin subcutaneously beginning at 12 h prior to surgery and continuing for 7 days every 24 h after surgery) and a statin plus LMWH group (20 mg rosuvastatin orally for 14 days, 7 days before and after surgery in combination with LMWH). All patients will undergo computed tomography angiography of both extremities 7 days after index surgery to assess the development of DVT. Discussion DVT remains prevalent despite the use of conventional prophylactic measures, in part because certain patients (particularly the elderly) are unable to receive preventive treatment because of a high risk of bleeding complications and co-morbidity. Statins have been shown to have beneficial effects in arterial atherothrombosis and are frequently administered to elderly patients to treat coronary artery. We hypothesize that peri-operative statin treatment may be beneficial in those patients restricted from the conventional prophylaxis for DVT.

Long-term safety of drug-eluting stents in patients on warfarin treatment

Background. The safety of drug-eluting stents (DES) in patients on long-term warfarin treatment has been questioned due to high risk of bleeding complications during prolonged triple (aspirin, clopidogrel, and warfarin) antithrombotic therapy. Methods. We analysed the long-term outcome of 415 consecutive warfarin-treated patients who underwent DES (n = 191) or bare-metal (n = 224) stenting in six hospitals. Results. The mean duration of triple therapy was longer (4.2 ± 3.1 versus 2.1 ± 1.8 months; P < 0.001) in the DES group. The incidence of major adverse cardiovascular and cerebrovascular events was comparable in the DES and bare-metal groups (39.8% versus 42.4%; P = 0.59) during a median follow-up of 3.5 years. Similarly, major bleeding events occurred equally often in both study groups (14.7% versus 12.9%). Six patients in the DES group and seven patients in the bare-metal group suffered stent thrombosis (3.1% versus 3.1%). In the propensity score analyses of 101 matched pairs, the outcome was similar in the two groups. Conclusion. Selective use of DES with a short triple therapy seems to be safe in patients with warfarin therapy. The prognosis of this fragile patient population is quite poor, and major bleeding events are common irrespective of stent type.

Effect of Hydroxyethyl Starch 130/0.4 on Blood Loss and Coagulation in Patients With Recent Exposure to Dual Antiplatelet Therapy Undergoing Off-Pump Coronary Artery Bypass Graft Surgery

Hydroxyethyl starch (HES) solutions are often used for maintaining intravascular volume and improving microperfusion, while a large amount of HES can cause adverse effects on coagulation. As the indications for clopidogrel expand, an increasing number of patients undergoing off-pump coronary artery bypass surgery (OPCAB) are also undergoing dual antiplatelet therapy (DAPT), with its higher risk of bleeding complications. The aim of the present study was to determine whether a moderate dose of 6% HES 130/0.4 significantly increases perioperative blood loss in patients with continued DAPT within 5 days of OPCAB. Patients who received clopidogrel and aspirin within 5 days of OPCAB were randomly allocated to receive HES 130/0.4 (≤ 30 ml/kg) followed by crystalloid infusion (HES group, n=53), or crystalloid only (crystalloid group, n=53) perioperatively. The amount of perioperative blood loss (sum of bleeding during the intraoperative and postoperative 24-h period), transfusion requirements, modified thromboelastography and coagulation variables, hemodynamic parameters, and fluid balance were recorded. Perioperative blood loss and coagulation profiles were similar between the groups, but the postoperative hemoglobin level was higher in the crystalloid group. Up to 30 ml·kg⁻¹·day⁻¹ of 6% HES 130/0.4 did not increase the perioperative blood loss compared to crystalloid in patients with recent exposure to DAPT undergoing OPCAB. HES 130/0.4 caused a similar degree and duration of coagulation impairment as observed when only crystalloid was given.

003 Radial approach and bleeding risk in acute coronary syndromes without ST elevation-comparison study between fondaparinus vs. enoxaparin

Fondaparinux compared to enoxaparin has been showed to reduce the bleeding risk in acute coronary syndromes (ACS). However the bleeding risk has never been compared when radial approach is used for percutaneous coronary interventional (PCI). We investigated 371 consecutive patients (67 ± 13 years, 74% male) admitted for ACS without ST elevation. All patients received a loading dose of clopidogrel (600 mg) and aspirin (250 mg to 500 mg). PCI was performed through radial artery approach with IV heparin (3000UI) delivered directly in radial artery. The choice between low molecular heparin (fondaparinux or enoxaparin) was let free to physician appreciation. Bleeding complication was defined by the need of red cell transfusion of 2 units and in hospital major cardiac events (MACE) by death, stroke and recurrent myocardial infarction. On the whole, 120 (32%) patients were treated by enoxaparin and 251 (68%) by fondaparinux. Patients treated by enoxaparin were older (71 ± 13 years vs. 66 ± 13 years, p = 0.02) and at higher risk of bleeding complications with greater plasmatic creatinin (114 ± 77 vs. 94 ± 57, p = 0.005) and haemoglobin level (12 ± 2g/dL vs. 13 ± 2g/dL, p < 0.0001). However, bleeding complications occurring in only 6 (1.7%) patients did not differ between patients treated by enoxaparin vs. fondaparinux (1.6% vs. 1.6%, p = 0.9). Similarly, in hospital MACE (3%, n = 11) was similar in the two groups (3.3% vs. 2.8%, p = 0.8). Radial approach in ACS is associated with a low rate of bleeding risk and is not affected by the choice of low molecular heparin. These results demonstrate that both enoxaparin and fondaparinus may be used safely when radial approach is performed in ACS.

The Risk Factor Assessment Score and Incidence of Venous Thromboembolism In 629 Patients Undergoing Hematopoietic Stem Cell Transplantation Implications for VTE Prophylaxis

AbstractAbstract 4215 Background:Individuals with hematologic malignancies, are at high risk for Venous thromboembolism (VTE). In patients undergoing hematopoietic stem cell transplantation (HSCT) the incidence and risk of VTE is unclear. Based on this it is difficult to consider prophylaxis in patients who are at potentially high risk for bleeding complications (Gerber, Blood 2008). It is increasingly becoming important to measure the risks of VTE, as the incidence has continued to rise. Different scoring systems have been proposed to assess the risks of VTE in hospitalized patients. In patients who develop VTE during hospitalization their risk of morbidity and mortality is increased. We examined 286 patients who received autologous HSCT transplantation, and 343 patients who underwent allogenic HSCT transplantation at the University of Michigan. We then compared their scores based on the risk assessment score developed by Caprini et al (Ann. Of Surg. 2010). The scoring system was initially validated for patients undergoing surgical procedures, and is currently in use at the University of Michigan to asses risk in bone marrow transplant patients. Risks for the development of VTE range from 10–20% (for moderate risk), 20–40% (higher risk), and 40–80% (highest risk). Objectives: To evaluate the efficacy of Caprinis' risk factor assessment scoring system in patients undergoing autologous and allogenic HSCT and determining the incidence of VTE in the patient cohort. Methods:The medical records of 629 patients between 2005–2008 who received high dose chemotherapy followed by autologous (287) and allogenic (343) stem cell transplants were reviewed. The autologous patient cohort had a mean age of 48.9, and an average BMI of 29.01. The allogenic patient cohort had a mean age of 42.5, with an average BMI of 27.53. HSCT was performed for all of the following conditions: Non-Hodgkin's lymphoma, Neuroblastoma, Multiple myeloma, Leukemia, Myelodysplastic Syndrome, and Hodgkin's lymphoma. The scores were compiled on the day of admission or at the closest date to the actual stem-cell transplant. Based on scoring, the actual incidence of non catheter related VTE in the HSCT patient population was observed. Allogenic patients were observed for VTE incidence from admission to day 30, day 30–100, and 100 days and on. Autologous patients were observed from admission to day 30. Results: 1) Of the 286 patients receiving autologous transplantation the average Caprini risk assessment score was 6.4. The 343 patients receiving allogenic transplantation had an average score of 5.95. Twenty-seven autologous, and fifty-three allogenic patients were at higher risk (3-4 point range) with a 20–40% chance of developing a VTE. 259 autologous patients, and 287 allogenic patients were at the highest risk (5+ point range) with a 40–80% chance of developing a VTE. 2) In both patient cohorts, based on the Caprini risk assessment score HSCT patients were placed in the highest risk category with a 40–80% chance of developing a VTE. 3) Only two patients (0.69%) developed an actual VTE during hospitalization for autologous HSCT. These patients both had a score of 10. Two patients (0.58%) receiving allogenic HSCT developed a VTE from the time of admission to 30 days. These patients had an average score of 7.5. From 30–100 days 5 patients deve loped a VTE, of these patients 1 developed CGVHD, The patients had an average score of 7.6. Twenty patients developed a VTE greater then 100 days, of these patients, 4 of which developed CGVHD. The patients had an average score of 6.55. Conclusion: The Caprini Venous Thromboembolism risk factor a ssessment score is not valid in patients undergoing high dose chemotherapy followed by an autologous or allogenic transplant. HSCT patients are at high risk for bleeding complications and the risk of VTE is relatively low (<1%). Only 2/286 (autologous transplant 0.69%) patients developed a VTE, and 2/343 (allogenic transplant) patients (0.58%) went on to develop a VTE. While VTE prophylaxis may be warranted in surgical and hospitalized patients, this study suggests it may not be necessary in patients undergoing HSCT who are at high risk of bleeding complication. Disclosures:No relevant conflicts of interest to declare.

(AVK) Anti Vitamin K Treatment In patients with Fontan Surgery

AbstractAbstract 4397 OBJECTIVESThrombotic events have been reported as a major cause of morbidity after the Fontan procedure. There is no consensus about the type and duration of postoperative anticoagulation prophylaxis, due to the high risk of bleeding complications, the difficulties in monitoring and the questionable therapeutic compliance in children. In spite of the lack of long term prospective studies in this situation, the ACCP has recommended in their guidelines OAT following Fontan or Glenn operation for at least 6 months. This has also been our practice in our institution during the period of study. AIM OF THE STUDYTo analyze the efficacy and complications of OAT in our pediatric patients after undergoing the Fontan operation. METHODSRetrospective chart review of all the children treated with OAT in our institution between 1995 and 2009. All patients were treated initially with acenocumarol 0,2 mg/kg, except the Fontan patients, who received 0,1 mg/kg. Target INR was 2–3 for all patients.The Mann-Whitney test was used to compare the rate of complications, and the percentage of visits out of target INR between the Fontan patients and the rest of the cohort. RESULTSThere were 61 children (26 female/35 males) aged between 1 month and 17 years, who received OAT with a range of follow up between 4 months and 14 years: 27 after Fontan operation (Group A), an 34 for other reasons (Group B: n=13 non prothetic valve cardiopathy, n=21 treatment of thromboembolic disease).The average follow-up was similar in both groups (median of 6.5 months in group A vs.7.5 months in group B). There were few complications: 1 mild epistaxis and 1 thrombotic event in group B, and none in group A. There were no differences in the proportion of controls in normal range between both groups; there was a moderate proportion of controls outside the target range of INR, with higher distribution below the range than above the range. The median dose used to achieve the target INR was 0.3 mg/kg/d in Group A and 0.4 mg/kg/d in Group B. CONCLUSIONSOral Anticoagulant therapy is safe and effective in pediatric patients,with very low rates of thrombotic or hemorragic complications including those undergoing the Fontan surgery. There were not any differences between both groups in any of the analizyed parameters. Disclosures:No relevant conflicts of interest to declare.

Living with the LLSA: Paracentesis and Patientʼs Competence to Consent

Living with the LLSA: Paracentesis and Patientʼs Competence to Consent

Use of Glubran 2 and Glubran tissue skin adhesive in patients with hereditary bleeding disorders undergoing circumcision and dental extraction

Patients with bleeding disorders are at a high risk of bleeding complications during surgical procedures. Cyanoacrylates have been used successfully in many procedures and surgeries. This study was undertaken to evaluate the effectiveness of Glubran 2 and Glubran tissue skin adhesive (Glubran Tiss) in patients with hereditary bleeding disorders who underwent circumcision or dental extraction. Seven patients with congenital bleeding disorders who underwent circumcision or dental extraction were evaluated during 2009. A historical control group was considered for comparison. Glubran 2 acrylic glue was applied in cases of dental extraction and Glubran Tiss in circumcision. The patients were followed up for 6 months to detect complications. Five patients had hemophilia A, one patient had hemophilia B, and one patient had Bernard-Soulier syndrome; six were boys or men and one was a girl. Mean age was 15±8 years (range 5 to 25 years). The results in all patients under circumcision were good with significantly less factor consumption (P=0.043). But in patients who underwent dental extraction, Glubran was effective only in a 5-year-old girl with mandibular premolar tooth extraction, but not successful in a 21-year-old man with extraction of maxillary wisdom tooth. After 6 months of follow-up, no complications were observed in any patients. Our experiences in this small series of patients suggest that adjunct use of Glubran Tiss, in addition to systemic replacement therapy, can be effective in the control of bleeding in patients with hemophilia who undergo circumcision, and helps to lessen factor consumption. But, further studies with larger sample size are needed. However, our experience in using Glubran in dental extraction was not successful.