Severe Bleeding Complications Research Articles

Comparison of In-hospital Outcomes of Percutaneous Coronary Intervention between Young Male and Female Patients with Acute Coronary Syndrome

Background: Acute coronary syndrome (ACS) among young people is increasingly prevalent. However, there is a scarcity of data on the gender differences of in-hospital adverse outcomes among ACS patients after percutaneous coronary intervention (PCI) among young Bangladeshis. This study was conducted to compare the in-hospital outcomes of PCI between young males and females presenting with ACS.Methods: This prospective observational study was done in the Department of Cardiology, National Institute of Cardiovascular Diseases (NICVD) fromApril 2016 to March 2017. 190 young patients with ACS and undergoing PCI were enrolled. They were equally divided into two groups, group I (young females <55 years) and group II (young males <45 years).Results: The mean age of young females and males was 43.8±6.9 years and 40.1±4.3 years respectively. Young women had significantly higher risk factors of hypertension (62.1% vs 33.7%, p<0.0010) and diabetes (57.9% vs 31.6%, p<0.001) in comparison to young men. Young women had angiographically less severe coronary artery disease (CAD), with significantly higher numbers of ACC/AHA lesion type B2 (40% vs 25.3%, p=0.03) and C (20% vs 9.47%, p=0.03), and greater frequency of multivessel disease. Overall, young women experienced greater incidence of in-hospital adverse events in comparison to young men (13.7% vs. 6.3%, p=0.09) and had significantly higher rates of severe bleeding (6.3% vs 1.1%, p=0.04) and vascular access site complications (8.4% vs 2.1%, p=0.04). Major adverse cardiac events were higher among young females, in comparison to young males (2.1% vs 0%, p=0.47). Young females experienced significantly higher rates of short-term net adverse clinical events (NACE) than young males (10.5% vs 3.2%, p=0.04). Female gender (odds ratio [OR] 11.7), diabetes (OR 2.5), hypertension (OR 1.78), decreased ejection fraction (OR 1.41) and smaller stent diameter (OR 1.15) were identified as independent predictors of adverse in-hospital outcomes among young ACS patients undergoing PCI.Conclusion: Young women with ACS presented with significantly more risk factors and experienced more adverse in-hospital outcomes after PCI, despite angiographically less severe CAD. They had significantly greater NACE, largely driven by increased rates of major bleeding. Female gender was an independent predictor of adverse in-hospital outcomes among young ACS patients undergoing PCI.University Heart Journal Vol. 12, No. 2, July 2016; 61-67

Acute Promyelocytic Leukemia: A Summary

Acute promyelocytic leukemia is a distinct subtype of acute myeloid leukemia. The disease is characterized by a chromosomal abnormality involving translocation between chromosomes 15 and 17. Current therapy has advanced to include agents such as all-trans retinoic acid and arsenic trioxide, which have improved remission and survival rates. Induction, consolidation, and maintenance regimens have now been studied and are outlined. As patients affected can develop severe bleeding complications, rapid diagnosis and initiation of appropriate treatment are vital. During treatment, unique complications such as disseminated intravascular coagulation and differentiation syndrome can occur. Prompt recognition of complications is imperative.

Outcomes following transcatheter transseptal versus transapical mitral valve-in-valve and valve-in-ring procedures.

Introduction: Transcatheter mitral valve-in-valve (ViV) & valve-in-ring (ViR) are relatively novel therapeutic alternatives for patients with degenerated bioprostheses or failed annuloplasty rings whose reoperative risk is too high. The predominant procedural access for both procedures is transapical or transseptal. However, whether there are differences in outcomes of this procedure using transseptal versus transapical access has not yet been defined. Methods: We conducted a systematic review of all published articles from MEDLINE and EMBASE to explore the outcomes of these two procedural approaches. Results:total of 55 studies including 183 patients (154 ViV and 29 ViR) were included. Patients that underwent ViV (101 transapical and 53 transseptal) using the transseptal approach required more iatrogenic atrial septal defect (ASD) closure (19% versus 0.0 %; P < 0.001) and hence had a lower device success rate (68% versus 89%; P = 0.001). However, there was no significant difference between the two groups in procedural success and all-cause mortality at 30 days. Overall severe bleeding complications (major or life threatening) were not different the two groups (3.7% versus 7.9%; P = 0.321). In the ViR group (19 transapical and 10 transseptal), no difference in procedural success, device success or 30-day outcomes were identified between transseptal and transapical groups, although sample size was small. Conclusion: In conclusion, mitral ViV and ViR using the two different procedural approaches appear to confer equal and reasonable 30-day outcomes.

Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial

ObjectivesThis study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management. BackgroundThere are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention. MethodsIn the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding. ResultsAmong 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (pint = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (pint = 0.79), myocardial infarction (pint = 0.25), stroke (pint = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (pint = 0.45). ConclusionsWomen showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.

Analysis of cardiovascular mortality, bleeding, vascular and cerebrovascular events in patients with atrial fibrillation vs. sinus rhythm undergoing transfemoral Transcatheter Aortic Valve Implantation (TAVR)

BackgroundTranscatheter aortic valve replacement (TAVR) has been demonstrated to be an established therapy for high-risk, inoperable patients with severe symptomatic aortic valve stenosis. For patients with moderate surgical risk, TAVR is equivalent to conventional aortic valve surgery. However, atrial fibrillation (AF) is also present in many of these patients, thus requiring post-implantation oral anticoagulation therapy in addition to the inhibition of thrombocyte aggregation, which poses the risk of bleeding complications. The aim of our work was to investigate the influence of AF on mortality and the occurrence of bleeding, vascular and cerebrovascular complications related to TAVR according to the VARC-2 criteria.MethodsTwo hundred eighty-three patients who underwent TAVR between March 2010 and April 2016 were retrospectively examined. In total, 257 patients who underwent transfemoral access were included in this study. The mean patient age was 81 ± 6 years, 54.1% of the patients were women, and 42.4% had pre-interventional AF.ResultsCompared to patients with sinus rhythm (SR, n = 148), patients with AF (n = 109) had an almost three-fold higher incidence of major vascular complications (AF 14.7% vs. SR 5.4%, p = 0.016) and life-threatening bleeding (AF 11.9% vs. SR 4.1%, p = 0.028) during the first 30 post-procedural days. However, the rate of cerebrovascular complications (AF 3.7% vs. SR 2.7%, p = 0.726) did not significantly differ between the two groups. Overall mortality was significantly higher in patients with AF during the first month (AF 8.3% vs. SR 2.0%, p = 0.032) and the first year (AF 28.4% vs. SR 15.3%; p = 0.020) following TAVR.ConclusionPatients with AF had significantly more severe bleeding complications after TAVR, which were significantly related to mortality. Future prospective randomized studies must clarify the optimal anticoagulation therapy for patients with AF after TAVR.Trial registrationDRKS00011798 on DRKS (Date 17.03.2017).

Anticoagulation strategies in patients with atrial fibrillation after PCI or with ACS : The end of triple therapy?

Clinicians struggle daily with the optimal regimen for patients with an indication for antiplatelet therapy after stenting and in patients needing oral anticoagulation treatment for atrial fibrillation (AF). This is not only difficult in patients with acute coronary syndrome (ACS) but also in the large number of patients with AF undergoing elective percutaneous coronary intervention (PCI). The challenge is to strike a balance between the increasing risk of bleeding events and ischemic or thrombotic events. Until recently, guidelines were based on expert consensus and afew small, many of them retrospective, trials. Aso-called triple therapy with avitaminK antagonist (VKA) and dual antiplatelet therapy (DAPT) with aspirin and clopidogrel was recommended for patients with AF undergoing PCI in stable coronary artery disease or for those with ACS. However, severe bleeding complications remain amajor issue during triple therapy, particularly in the growing aging population. In the past year, randomized controlled trials (RCT) with direct-acting oral anticoagulants (DOACs) have modified the standard use of care, now favoring dual therapy with DOACs. This review elucidates the current influential RCTs on the new antiplatelet and anticoagulation strategies for patients with AF undergoing PCI or with ACS, and discusses whether triple therapy is still required.

Impact of extended lymphadenectomy on morbidity and regional recurrence-free survival in melanoma patients

Introdurction: Current guidelines for malignant melanoma do not set a concrete cutoff limit for the number of lymph nodes to be resected during regional lymph node dissection (LND). Here, we investigate if extended LND (ext-LND) has an impact on surgical morbidity and oncological outcome in melanoma patients.Material and methods: A total of 245 melanoma patients receiving axillary or inguinal LND in curative intention were investigated retrospectively. Ext-LND was defined as axillary LND with 20 or more and inguinal LND with 10 or more resected lymph nodes. Surgical morbidity and regional recurrence-free survival were investigated.Results: Ext-LND did not lead to increased surgical morbidity in the overall study collective. After ext-LND, 55.4% of the patients experienced one of the investigated complications compared to 46.2% in the limited LND group (p = .2113). There was no difference in the occurrence of lymphatic fistula, wound infection, severe bleeding or neurological complications. In addition, patients with positive lymph node status showed improved regional recurrence-free survival following ext-LND (p = .0425).Conclusion: Ext-LND can be considered a quality marker of LND in melanoma patients.

Fetal exposure to maternal human platelet antigen-1a does not induce tolerance. An analytical observational study.

Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a disease that may cause severe bleeding complications with risk of perinatal death or lifelong disability. The main cause of FNAIT is maternal antibodies against human platelet antigen (HPA)-1a. Both fetomaternal bleeding and transplacental trafficking of fetal cells during pregnancy could be the cause of alloimmunization. Persistence of fetal cells in the mother (fetal microchimerism) and maternal cells in the child (maternal microchimerism) are well-recognized phenomena. Thus, it could be envisaged that fetal exposure to the HPA-1a antigen could tolerize an HPA-1a negative female fetus and prevent production of anti-HPA-1a antibodies later in life if she becomes pregnant with an HPA-1a positive fetus. The objective of the current study was to assess if the risk of producing anti-HPA-1a antibodies and the severity of neonatal thrombocytopenia in HPA-1a negative women with HPA-1a positive mothers (i.e. the mother is HPA-1a/b), was lower than in HPA-1a negative women with HPA-1a negative mothers. HPA-1a negative women with HPA-1a antibodies, identified from a Norwegian screening study (1996–2004), where HPA-1 genotype of their mothers was available, were included in the study. The frequency of HPA-1a positive mothers to HPA-1a immunized daughters were compared to the calculated frequency in the general population. We did not find any difference in the frequency of HPA-1ab among mothers to daughters with HPA-1a antibodies as compared with the general population. Furthermore, acknowledging sample-size limitations, we neither found an association between the mothers’ HPA type and their daughters’ anti-HPA-1a antibody levels or any difference between the two groups of mothers (HPA-1ab vs HPA-1bb), with respect to frequency of thrombocytopenia in the children of their daughters with HPA-1a antibodies. Hence, there was no indication of tolerance against fetal HPA-1a antigen in HPA-1bb women who had been exposed to HPA-1a antigen during fetal development.

Respiratory extracorporeal membrane oxygenation for severe sepsis and septic shock in adults: a propensity score analysis in a multicenter retrospective observational study.

AimThis multicenter retrospective observational study aimed to evaluate the efficacy of extracorporeal membrane oxygenation (ECMO) support for septic patients with severe respiratory failure using propensity score analyses.MethodsThe data of severe sepsis patients from 42 intensive care units between January 2011 and December 2013 were retrospectively collected. Propensity score matching analyses were undertaken for severe respiratory failure patients with/without veno‐venous ECMO support. The main outcome was in‐hospital all‐cause mortality.ResultsOf 3195 patients with severe sepsis, 570 had severe respiratory failure. Forty patients in the ECMO group were matched with 150 patients in the control group. A survival time analysis revealed no difference in the in‐hospital survival (hazard ratio, 0.854; 95% confidence interval, 0.531–1.373; P = 0.515). Two‐hundred and eighty‐five patients had severe respiratory failure induced by lung infection. Twenty‐five ECMO group patients were matched with 89 patients in the control group. In the ECMO group, the survival time was longer than in the control group (hazard ratio, 0.498; 95% confidence interval, 0.279–0.889; P = 0.018). The number of renal replacement therapy‐ and vasopressor‐free days improved. The ECMO group received more red blood cells transfused than the control group, but there was no significant difference in the rate of severe bleeding complications between the groups.ConclusionsThere was no difference in the in‐hospital survival between the ECMO group and control group among overall septic patients with severe respiratory failure. However, in sepsis patients with severe respiratory failure induced by lung infection, ECMO support may improve their survival time.

Trente ans d’immunologie plaquettaire dans la prise en charge des thrombopénies fœtales et néonatales allo-immunes, état des lieux

Fetal and neonatal allo-immune thrombocytopenia (FNAIT) is considered as a rare disease due to the incidence (1/1000–1/2000 births). The major complication of severe thrombocytopenia is bleeding and particularly intra-cranial hemorrhage and neurologic sequelae following. Serology and molecular biology developments have reconfigured the platelet immunology diagnosis. Anti-HPA-1a allo-immunisation is responsible for more than 80% FNAIT cases with a high recurrence rate of severe bleeding complications. Therapeutic management has changed over the coming years from an invasive concept associating fetal blood sampling and in utero platelet transfusion to a non invasive treatment by intravenous immunoglobulins injection (IVIg). The purpose of this article is to provide an update on FNAIT management in the light of current developments over the past 30years.

Mortality caused by intracranial bleeding in non‐severe hemophilia A patients

Background Non-severe hemophilia (factor VIII concentration [FVIII:C] of 2-40 IU dL-1 ) is characterized by a milder bleeding phenotype than severe hemophilia A. However, some patients with non-severe hemophilia A suffer from severe bleeding complications that may result in death. Data on bleeding-related causes of death, such as fatal intracranial bleeding, in non-severe patients are scarce. Such data may provide new insights into areas of care that can be improved. Aims To describe mortality rates, risk factors and comorbidities associated with fatal intracranial bleeding in non-severe hemophilia A patients. Methods We analyzed data from the INSIGHT study, an international cohort study of all non-severe hemophilia A patients treated with FVIII concentrates during the observation period between 1980 and 2010 in 34 participating centers across Europe and Australia. Clinical data and vital status were collected from 2709 patients. We report the standardized mortality rate for patients who suffered from fatal intracranial bleeding, using a general European male population as a control population. Results Twelve per cent of the 148 deceased patients in our cohort of 2709 patients died from intracranial bleeding. The mortality rate between 1996 and 2010 for all ages was 3.5-fold higher than that in the general population (95% confidence interval [CI] 2.0-5.8). Patients who died from intracranial bleeding mostly presented with mild hemophilia without clear comorbidities. Conclusion Non-severe hemophilia A patients have an increased risk of dying from intracranial bleeding in comparison with the general population. This demonstrates the need for specialized care for non-severe hemophilia A patients.

Anticoagulation-direct oral anticoagulants

Since direct oral anticoagulants (DOAC) have become available, use of anticoagulant treatment has become easier and safer-for patients suffering from thromboembolic diseases as well as for patients with atrial fibrillation: Because of constant bioavailability, fixed dose regimen treatment is possible, monitoring not necessary and severe bleeding complications-particularly intracranial hemorrhages-rare in comparison to vitaminK anticoagulants. To gain all these advantages, it is essential to give DOAC in the correct dosage. Dose reduction of single DOAC has to be considered depending on underlying disease, body weight and renal function. DOAC are not allowed in patients with artificial heart valves, in pregnancy and in children. In case of severe bleeding complications under DOAC treatment, prothrombin complex concentrates is one treatment option. For dabigatran an antidote is available.

Intravenous Thrombolysis in Acute Ischemic Stroke Patients Pretreated With Non-Vitamin K Antagonist Oral Anticoagulants: An Editorial Review.

Anticoagulation has revolutionized stroke prevention in patients with atrial fibrillation either with vitamin K antagonists (VKA) or non-VKA oral anticoagulants (NOACs). However, a substantial number of patients may experience acute ischemic stroke (AIS) because of inadequate anticoagulation, noncardioembolic stroke pathogenesis, or true treatment failure and can present to the emergency room within the time window for intravenous thrombolysis (IVT).1 In a series of AIS patients potentially eligible for IVT, 8.7% were pretreated with oral anticoagulants.2 Because of the increased bleeding risk in patients pretreated with VKA, IVT is formally contraindicated if international normalized ratio on hospital admission is >1.7 in patients presenting within 3 hours from symptom onset and in all AIS patients regardless of international normalized ratio during the time window of 3 to 4.5 hours,3 whereas IVT is contraindicated if a patient takes oral anticoagulants regardless of international normalized ratio according to the European license of intravenous (IV) tissue-type plasminogen activator (tPA).4 The use of point-of-care international normalized ratio devices has simplified the management of IVT in AIS patients pretreated with VKAs. On the contrary, because NOAC-specific coagulation assays are more complex with limited availability, this specific subgroup of patients is often excluded from IVT. These treatment recommendations regarding the use of IV-tPA in AIS patients pretreated with NOACs aim to prevent severe bleeding complications, in particular, symptomatic intracranial hemorrhage (sICH). However, because they are based on expert opinion, they could result in withholding IVT in otherwise eligible patients who may eventually benefit from timely tPA administration. Because NOAC use increases exponentially in clinical practice worldwide, there are a growing number of reports of patients on NOACs who receive IVT for …

The impact of prophylactic external carotid artery ligation on postoperative bleeding after transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma

BackgroundTransoral robotic-assisted surgery (TORS) is increasingly utilized in the treatment of oropharyngeal squamous cell carcinoma (OPSCC). Postoperative bleeding is a significant and potentially fatal complication of TORS. Prophylactic ligation of ipsilateral external carotid artery (ECA) branches is a recognized strategy to reduce postoperative bleeding risk. We examined the incidence and sequelae of postoperative oropharyngeal bleeding with and without routine ECA ligation. MethodsOPSCC patients treated with TORS between 2010 and 2015 with minimum 30days follow up were included. Clinicopathological data, operative details, and postoperative course were abstracted for analysis. Cases of postoperative bleeding were classified as Minor, Intermediate, Major, and Severe. The incidence and severity of bleeding was compared between patients treated with and without prophylactic ECA ligation. ResultsBleeding after TORS was documented in 13/201 (6.5%) patients. The majority of bleeding episodes were observed among anticoagulated or previously radiated patients. By surgeon preference, 52 patients had prophylactic ECA ligation during neck dissection while the remaining 149 patients did not. There was no significant difference in overall incidence of postoperative bleeding between patients with prophylactic ECA ligation (3/52, 5.8%) and patients without (10/149, 6.7%) [p=0.53]. However, severe bleeding complications (4, 2.0%) were only observed in patients without prophylactic ligation. ConclusionA small but meaningful risk of bleeding after TORS for OPSCC exists, particularly among anticoagulated or previously radiated patients. Prophylactic ECA ligation did not significantly impact the overall incidence of postoperative bleeding but may reduce the risk of severe (life-threatening) bleeding.

Depression and post-traumatic stress disorder in individuals with hereditary hemorrhagic telangiectasia: A cross-sectional survey

IntroductionHereditary hemorrhagic telangiectasia (HHT) is characterized by frequent severe bleeding, particularly epistaxis, and life-threatening complications including stroke, brain abscess and heart failure. The psychological impact of HHT is not known. We conducted this cross sectional study to determine the prevalence of depression and post-traumatic stress disorder (PTSD) related to HHT. MethodsA survey tool comprising demographic and clinical information and two validated self-administered questionnaires, the PTSD checklist for DSM-5 (PCL-5) and Beck Depression Inventory-II (BDI-II), was distributed to individuals with HHT. Associations with clinical and demographic variables with depression and PTSD were evaluated in a logistic regression model. ResultsA total of 222 individuals responded to the survey. Of these, 185 completed either the BDI II or PCL-5 and were included in the analysis. Median age was 54years and 142 (76.8%) were female. An existing diagnosis of depression, anxiety disorder and PTSD was present in 81 (43.8%), 59 (31.9%) and 16(8.6%) respondents, respectively. BDI-II scores>13 indicating at least mild depressive symptoms were present in 142 (88.7%) patients and 52 (28.1%) patients had a positive screen for PTSD (PCL-5 score≥38). On multivariable analysis, depression [OR 2.17 (95% CI 1.045–4.489), p=0.038], anxiety disorder [OR 2.232 (95% CI 1.066–4.676), p=0.033], and being unemployed [OR 2.234 (95% CI 1.46–4.714), p=0.019) were associated with PTSD. ConclusionWe report a high prevalence of depressive and PTSD symptoms in individuals with HHT. While selection bias may lead to overestimation of prevalence in this study, our results are concerning and clinicians should remain vigilant for signs of psychological distress and consider screening for these disorders.

Spotlight on romiplostim in the treatment of children with chronic immune thrombocytopenia: design, development, and potential place in therapy.

Primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by isolated thrombocytopenia. In approximately one-third of cases, the duration of thrombocytopenia will extend beyond 12 months consistent with a diagnosis of chronic ITP. Minor bleeding manifestations are common in chronic ITP while severe or life-threatening bleeding complications are uncommon. Moreover, spontaneous resolution occurs in the majority of children with chronic ITP necessitating treatment in only those children with ongoing bleeding manifestations or impairment in health-related quality of life (HRQOL). The characterization of thrombopoietin (TPO) and remarkable advancements in our understanding of the pathophysiology of ITP has led to the development of a new class of agents, the TPO-receptor agonists that have documented efficacy in the amelioration of thrombocytopenia and bleeding manifestations in chronic ITP. Romiplostim is a second-generation TPO-receptor agonist that has undergone limited evaluation in the treatment of chronic ITP in children. Evolving data suggest that romiplostim may be a safe and effective agent in the treatment of chronic ITP in children. Additional data are needed to confirm its ability to increase platelet counts, decrease bleeding manifestation, and improve the HRQOL of children and caregivers impacted by chronic ITP.

Ebola virus disease in the light of epidemiological triad

Ebola virus disease (EVD) is one of the most virulent pathogens among viral hemorrhagic fevers affecting economically deprived countries of the world with reported case fatality rates of up to 90% due to multiorgan failure and severe bleeding complications. The most recent outbreak of 2014 has set the alarm bell ringing across the globe for increased focus, funding, research, and development toward the control and management of this emerging viral communicable disease that has a potential pandemic threat. This manuscript review and update current knowledge with regard to epidemiology of EVD problem statement, historical perspective, agent, host, environment, reservoir of infection, routes of transmission, pathogenesis, clinical features, laboratory diagnosis, management, and control. The review was undertaken using the key words epidemiology, public health, outbreak control of Ebola virus, EVD, emerging disease, and/or pandemic disease through medical search engines and abstracting databases such as Pubmed, Google Scholar, and websites of international health agencies such as the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC).

Risk Factors for Severe Bleeding Complications in Percutaneous Renal Biopsy

BackgroundPercutaneous renal biopsy is essential for diagnosis of many renal diseases. Previous studies have revealed a variety of factors associated with bleeding complications of renal biopsy; however, data are not sufficient in the Chinese population. We aimed to investigate the risk factors for severe post-biopsy bleeding events in a large cohort of Chinese patients. Materials and MethodsThe data of patients who underwent percutaneous renal biopsy from January 2008 to December 2012 were collected. Severe bleeding complication was defined as requiring intervention, including blood transfusion or an invasive procedure (radiological or surgical) due to bleeding. Logistic regression analysis was used to assess risk factors. ResultsOver the 5-year period, 3,577 native kidney biopsies were performed. Severe bleeding complication occurred in 14 biopsies (0.39%). The patients with complications were older, had higher blood pressure, lower hemoglobin, lower platelet count and worse renal function. Multivariable logistic regression demonstrated that platelet level and the estimated glomerular filtration rate were independently associated with the risk of complications. Each 10 × 109/L increase of platelet count was associated with an 11% decrease of severe bleeding risk (odds ratio = 0.89; 95% CI: 0.80-0.98; P = 0.02). Each 1mL/minute/1.73m2 increase of the estimated glomerular filtration rate was associated with a 4% decrease of severe bleeding risk (odds ratio = 0.96; 95% CI: 0.94-0.99; P = 0.004). ConclusionsPatients with worse renal function and lower platelet counts had a higher risk of developing severe bleeding events after renal biopsy.

Antithrombin Supplementation and Mortality in Sepsis-Induced Disseminated Intravascular Coagulation: A Multicenter Retrospective Observational Study.

Supplemental doses of antithrombin (AT) are widely used to treat sepsis-induced disseminated intravascular coagulation (DIC) in Japan. However, evidence on the benefits of AT supplementation for DIC is insufficient. This multicenter retrospective observational study aimed to clarify the effect of AT supplementation on sepsis-induced DIC using propensity score analyses. Data from 3,195 consecutive adult patients admitted to 42 intensive care units for severe sepsis treatment were retrospectively analyzed; 1,784 patients were diagnosed with DIC (n = 715, AT group; n = 1,069, control group). Inverse probability of treatment-weighted propensity score analysis indicated a statistically significant association between AT supplementation and lower in-hospital all-cause mortality (n = 1,784, odds ratio [95% confidence intervals]: 0.748 [0.572-0.978], P = 0.034). However, quintile-stratified propensity score analysis (n = 1,784, odds ratio: 0.823 [0.646-1.050], P = 0.117) and propensity score matching analysis (461 matching pairs, odds ratio: 0.855 [0.649-1.125], P = 0.263) did not show this association. In the early days after intensive care unit admission, the survival rate was statistically higher in the propensity score-matched AT group than in the propensity score-matched control group (P = 0.007). In DIC patients without concomitant heparin administration, similar results were observed. In conclusion, AT supplementation may be associated with reduced in-hospital all-cause mortality in patients with sepsis-induced DIC. However, the statistical robustness of this connection was not strong. In addition, although the number of transfusions needed in patients with AT supplementation increased, severe bleeding complications did not.

Management and outcomes of vaginal bleeding and heavy menstrual bleeding in women of reproductive age on direct oral anti-factor Xa inhibitor therapy: a case series

Observational data and results from post-hoc analyses in clinical trials suggest that direct oral factor Xa inhibitors might increase menstrual bleeding intensity in women of reproductive age, but the extent of this effect is unknown. We aimed to investigate the management and outcomes of vaginal bleeding complications during therapy with direct oral factor Xa inhibitors in a case series of women of reproductive age. To identify individuals for inclusion in this case series, we searched two sources of prospectively collected data from women of reproductive age treated with direct oral factor Xa inhibitors: the non-interventional Dresden NOAC Registry (NCT01588119), which is based in the administrative district of Dresden (Saxony, Germany), and all locally archived data from phase 3 trials of direct oral factor Xa inhibitors done at University Hospital Carl Gustav Carus Dresden. Vaginal bleeding events were defined as any vaginal bleeding complications as reported by the patient. We collected data on type and dosage of anticoagulation; suspected or confirmed bleeding events, hospital admissions, and mortality; and pattern and management of vaginal bleeding events. For all cases of bleeding identified, we reviewed all available source data to identify examination results suggesting potential underlying anatomical causes of bleeding. We identified 178 women of reproductive age who received direct oral factor Xa inhibitor therapy, of whom 57 had vaginal bleeding events, including 50 who received rivaroxaban, six who received apixaban, and one who received edoxaban. These 57 women had 72 vaginal bleeding events, including 59 cases of heavy menstrual bleeding and 13 bleeding events unrelated to the menstrual cycle. 51 (86%) of these heavy menstrual bleeding events (two major bleeding events, 17 clinically relevant non-major bleeding events, 32 minor bleeding events) were treated conservatively (eg, change of oral hormone therapy or reduction, temporary interruption, or discontinuation of direct oral factor Xa inhibitor) and the remaining eight (14%) events (three major bleeding events and five clinically relevant non-major bleeding events) required elective surgical or interventional treatment (hysterectomy, curettage, ovary excision, or excision of ovarian cysts). Of the 57 women, 13 (23%) had a second bleeding event and two (4%) had a third event. Nine patients had underlying anatomical abnormalities; compared with patients without abnormalities, these patients had more intense bleeding, more had recurrent bleeding (five [56%] of nine patients with abnormalities vs eight [17%] of 48 patients without abnormalities), and more needed surgical treatment for bleeding (eight [89%] of nine vs zero of 48). Vaginal bleeding, particularly heavy menstrual bleeding, is a common complication in women of reproductive age on direct oral factor Xa inhibitor therapy. Most cases can be treated conservatively, but patients with severe or recurrent vaginal bleeding complications should be assessed for underlying anatomical abnormalities, which might require surgical or interventional treatment. Further data are needed to provide guidance on prevention and treatment of vaginal bleeding complications in this patient population. None.