Severe Bleeding Complications Research Articles

Bleeding Risk in Women on Anticoagulants While Undergoing Minor Gynecologic Procedures [ID 2683602

INTRODUCTION: The objective of this study was to determine the bleeding risk in women undergoing minor gynecologic procedures while concurrently taking various anticoagulants. METHODS: Patient charts from January 2008 to August 2013 were reviewed to identify patients who underwent minor procedures while taking anticoagulants. Bleeding complications were graded as none, mild, moderate, or severe. No-bleeding diagnoses were defined as a hemostatic biopsy site. Mild bleeding was classified as occasional spotting, requiring pressure for less than 5 minutes. Moderate bleeding required the use of suture for hemostasis. Severe bleeding complications required transfer to a tertiary center or blood transfusion. RESULTS: We reviewed 7,453 medical records yielding 269 minor procedures during which patients were concurrently taking anticoagulants. The mean age was 65 years (range, 30–96 years), with 148 African Americans and 121 Caucasian patients. Bleeding complications occurred in 14 patients: 13 mild and 1 moderate. Bleeding complications were not affected by age (P=.5576) or race (P=.1359) but were related to procedure type (P<.0001). Specifically, the loop electrosurgical excision procedure was the only procedure to result in a statistically significant mild complication rate (P=.0353). There was no association between the type of anticoagulant used (P=.6294) or medical diagnosis for anticoagulation (P=.7589) and bleeding risk. CONCLUSION: Minor gynecologic surgical procedures can safely be undertaken on women who are concurrently taking antiplatelet/anticoagulant medications.

Bleeding complications, coagulation disorders, and their management in acute myocardial infarction-related cardiogenic shock rescued by veno-arterial ECMO: A retrospective cohort study

PurposeManagement of dual antiplatelet therapy (DAPT) in patients on venoarterial-extracorporeal membrane (VA-ECMO) after acute myocardial infarction (AMI) is challenging. Our objective was to describe the frequency, management and outcomes of severe bleeding complications and determine their occurrence risk factors. Material and methodsWe conducted a retrospective observational cohort study including post-AMI cardiogenic shock patients requiring VA-ECMO. Severe bleeding was defined based on the Bleeding Academic Research Consortium classification. We calculated multivariable Fine–Gray models to assess factors associated with risk of severe bleeding. ResultsFrom January 2015 to July 2019, 176 patients received VA-ECMO after AMI and 132 patients were included. Sixty-five (49%) patients died. Severe bleeding occurred in 39% of cases. Severe thrombocytopenia (< 50 G/L) and hypofibrinogenemia (<1,5 g/L) occurred in respectively 31% and 19% of patients. DAPT was stopped in 32% of patients with a 6% rate of stent thrombosis. Anticoagulation was stopped in 39% of patients. Using a multivariate competing risk model, female sex, time on ECMO, troponin at admission and Impella® implantation were independently associated with severe bleeding. ConclusionsBleeding complications and coagulation disorders were frequent and severe in patients on VA-ECMO after AMI, leading of antiplatelet therapy withdrawal in one third of patients.

Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial

Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding.The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100Units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100Units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2-5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation.

A Comprehensive Evaluation of the NAVITOR Transcatheter Aortic Valve Replacement System.

Transcatheter aortic valve replacement (TAVR) has undergone significant advancements in the last two decades, expanding its indications and refining transcatheter heart valve (THV) and delivery system designs to improve procedural success and patient outcomes. This review focuses on the Navitor™ valve, a third-generation intra-annular Portico™ valve (Abbott Structural Heart, St Paul, MN, USA) designed to address TAVR complications, particularly paravalvular leak (PVL). We present an overview of the Navitor™ system, comparing it to the first-generation Portico™ THV in terms of THV design, key iterations and clinical outcomes. The Navitor™ THV introduces two key refinements-a protective outer sealing skirt and a more flexible delivery system. These enhancements have led to a significant reduction in 30 day PVL rates, from 6.3% with the first-generation Portico™ to 0% with the Navitor™ system. Additionally, the Navitor™ system exhibited lower rates of severe bleeding (27.3% versus 13.1%) and major vascular complications (5.8% versus 0.7%) compared with the first-generation Portico™. The Navitor™ valve represents a promising advancement in TAVR technology, with notable reductions in complications such as PVL, severe bleeding, and major vascular issues, compared with its predecessor. While further research is needed to assess long-term durability, these results underscore its potential benefits in enhancing patient outcomes and reducing complications. This review provides insights into the evolving landscape of TAVR technology and its quantifiable impact on patient care.

Cone-Beam Computed Tomography-Guided Cryobiopsy Combined with Conventional Biopsy for Ground Glass Opacity-Predominant Pulmonary Nodules

Introduction: Cryobiopsy (CB) using a 1.1-mm cryoprobe under fluoroscopic guidance is feasible and safe for diagnosis of ground glass opacity (GGO) lesions. However, the efficacy of CB combined with cone-beam CT (CBCT) for GGO-predominant pulmonary nodules remains elusive. Methods: We retrospectively studied patients who underwent CB combined with conventional biopsy under CBCT guidance for GGO-predominant pulmonary nodules with a consolidation-to-tumour ratio <50.0%. Results: A total of 32 patients with GGO-predominant pulmonary nodules were enrolled: 17 pure GGOs and 15 mixed GGOs. The mean lesion diameter was 15.81 ± 5.52 mm and the overall diagnostic yield was 71.9%. Seven lesions were diagnosed by CB alone, which increased the diagnostic outcomes by 21.9%. Diagnostic yields for CB, forceps biopsy (FB), brushing, and guide sheath flushing were 65.6%, 46.9%, 15.6%, and 14.3%, respectively. Univariate analysis revealed that positive computed tomography (CT) bronchus sign (p = 0.035), positive CBCT sign (p < 0.01), and CB-first biopsy sequence (p = 0.036) were significant predictive factors for higher diagnostic yield. Specimens obtained by CB had larger mean sample size (p < 0.01), lower blood cell area (p < 0.01), and fewer crush artefacts (p < 0.01) than specimens from FB. No severe bleeding or other complications occurred. Conclusion: CB using a 1.1-mm cryoprobe under CBCT guidance increased diagnostic yield for GGO-predominant pulmonary nodules based on conventional biopsy. Further, it provided larger and nearly intact samples compared with forceps.

Predictors of Diagnostic Delays and Loss to Follow-up in Women with Von Willebrand Disease

Background: Diagnostic and treatment delays in von Willebrand disease (vWD) disproportionately affect women. Such delays may lead to poor health outcomes from preventable bleeding complications related to menstruation, childbirth, and surgeries. They may also result in increased health resource utilization, including increased emergency department (ED) visits, transfusions, and surgical interventions. Patient and disease-related factors associated with diagnostic delays and loss to follow-up have been poorly documented, but are important to examine particularly in relation to gynecological outcomes. Aims: 1) To examine the prevalence and predictors of diagnostic delays and loss to follow-up in women with vWD. 2) To assess the impact of diagnostic delays on rates of ED visits, red cell transfusions, and hysterectomies. Methods: This retrospective cohort study included women ≥18 years with a diagnosis of vWD followed by the Northern Alberta Bleeding Disorders Program. Diagnostic delay was determined from the time of first documented bleeding event to the time of vWD diagnosis, with delayed diagnosis defined as &amp;gt;5 years. All bleeding events on the ISTH-BAT were included in the above definition, except for easy bruising due to its subjectivity and suboptimal documentation. Loss to follow-up was defined as ≥5 years since last hematology visit at the time of data collection. We collected the following patient and disease-related factors: age, rural status, year of diagnosis (pre-2000, 2000-2010, or 2011-2021), vWD type, baseline vWF activity, ISTH-BAT, family history of vWD, abnormal coagulation screen (INR/aPTT) prior to diagnosis, and status-post endometrial ablation or hysterectomy. Logistic regression was used to assess predictors of diagnostic delays and loss to follow-up. Research ethics approval was obtained. Results: We included 173 women: 140 (81%) type 1, 23 (13%) type 2, 5 (3%) type 3, and 5 (3%) platelet-type vWD. The median age of diagnosis was 27 years (IQR 18-38). The median time from first bleeding symptom to vWD diagnosis was 12.1 years (IQR 4.6-24.2), with 66 (38%) women presenting with ≥3 bleeding events prior to diagnosis. Further, 71 (41%) presented with ≥1 severe bleeding event (requiring ED visit, hospitalization, red cell transfusion, or surgical hemostasis) prior to diagnosis. Timing from first bleeding symptom to diagnosis was available in 154 (89%) women, of whom 113 (73%) experienced delayed diagnosis. Compared to women with delayed diagnosis, those diagnosed within 5 years of their first bleeding symptom were more likely to have a known family history of vWD (51% vs 26%, P=0.01) or have been diagnosed between 2000-2010 (56% vs 33%, P=0.002). Urban/rural residence, vWD type, baseline vWF activity, blood type, and abnormal coagulation screen were not significantly associated with diagnostic delays (Table 1). Of the 155 patients with available follow-up data, 44 (28%) were lost to follow-up for ≥5 years. Only rural residence (OR 1.8, 95% CI 0.9-5.3, P=0.07) trended towards higher odds of loss to follow-up. Age, year of diagnosis, vWD type, baseline vWF activity, ISTH-BAT, and prior hysterectomy/ablation status were not associated with loss to follow-up. Women with diagnostic delays had a significantly higher ISTH-BAT (median 7 vs 5, P=0.005). They also had significantly higher rates of hysterectomies for heavy menstrual bleeding (HMB; 20% vs 0%, P=0.0006), as well as a non-significant trend towards higher rates of dilatation and curettage (D&amp;C; 12% vs 2%, P=0.11) and endometrial ablations (12% vs 5%, P=0.36) (Table 2). 17 women underwent surgical procedures for HMB (D&amp;C, endometrial ablation, and/or hysterectomy) prior to their vWD diagnosis. Conclusion: Women with vWD often experience prolonged diagnostic delays. In our study, many women had bleeding symptoms for at least 5 years, and often greater than 10 years, prior to diagnosis. There was also a high rate of loss to follow-up, particularly in rural populations. Delayed diagnosis occurred even in women with a known family history of vWD and in women with severe bleeding events. Alarmingly, the rate of delayed diagnosis increased over time and was associated with higher rates of surgical interventions for HMB. For this reason, a high index of suspicion is paramount to ensure a prompt diagnosis of vWD, as this may prevent severe gynecological bleeding complications and their need for invasive surgical management.

Analysis of hemorrhage upon ultrasound-guided percutaneous renal biopsy in China: a retrospective study

PurposeUltrasound-guided percutaneous renal biopsy (PRB) has been considered as a golden standard for CKD diagnosis and is employed to identify potential therapeutic targets since 1950s. Post-biopsy hemorrhage is the most common complication, while severe bleeding complication might cause nephrectomy or death. Therefore, how to reduce the occurrence of complications while ensuring the success of PRB is always a clinical research topic.MethodsThis study retrospectively collected and established a renal biopsy database of each patient who underwent ultrasound-guided PRB at a tertiary teaching hospital from September 2017 to December 2020 through the Health Information System. All the data were statistically processed by SPSS software.ResultsA total of 1146 patients underwent PRB for various reasons. The overall rate of post-biopsy hemorrhage was 37.70% (432/1146). Of those bleedings, minor bleeding after PRB was found in 337 (29.41%), middle bleeding 84 (7.33%), major bleeding 11 (0.96%). Besides that, there were 96 patients (8.38%) reported their discomfort symptoms. There was no death. Females were at significantly increased risk of hemorrhagic complication than males (OR = 2.017, CI = 1.531–2.658). While the risk for hemorrhagic complication significantly decreased as BMI and platelet before renal biopsy increased (OR = 0.956, CI = 0.924–0.989; OR = 0.998, CI = 0.996–1.000). As the APTT time prolonged, the risk for hemorrhagic complication significantly increased (OR = 1.072, CI = 1.023–1.123). Those patients whose albumin were higher, also had higher risk for hemorrhagic complication than other patients (OR = 1.020, CI = 1.000–1.041). Specifically, postoperative urination within 4 h increased the risk for hemorrhagic complication (OR = 1.741, CI = 1.176–2.576).ConclusionOur analysis finds that the incidence of post-biopsy bleeding complication is 37.70%, and its risk is associated with female, lower BMI, lower platelet before renal biopsy, prolonged APTT, higher albumin, and postoperative urination within 4 h. The findings highlighted the importance of perioperative management for renal biopsy, including adequate risk assessment, tailored careful observation after PRB. And medical staff should pay more attention to fluid management after ultrasound-guided PRB.

Abstract 13838: Hemostatic Disorder During Left Ventricular Assist Device Implantation in Swine

Introduction: Implantation of left ventricular assist devices (LVAD) conventionally requires the use of cardiopulmonary bypass (CPB). Among others, mechanical circulatory support devices favor intraoperative hemostatic disorder. Hypothesis: Despite the high risk of severe bleeding and thromboembolic complications, little is known about the intraoperative extent of hemostatic disorder during LVAD implantation.This study aimed to determine the extent of hemostatic disorder during LVAD implantation in a porcine model under CPB and LVAD support, separately. Methods: We performed LVAD implantation in 10 female German Landrace pigs (body weight 104 ± 13 kg). Blood samples were collected three times: at (1) Baseline, (2) after CPB and (3) after LVAD. For CPB, cannulation of the left jugular vein and right femoral artery was performed. After sternotomy and pericardiotomy, apical coring was performed under CPB. A continuous-flow LVAD with transventricular outflow graft was implanted. For CPB and LVAD, a flow rate of 3-7 L/min and a rotational speed of 4000 to 7200 rpm were aimed, respectively. Hemostatic laboratory markers from all times were compared by Wilcoxon signed rank test. Results: Compared to Baseline, CPB led to a significant decrease of fibrinogen and antithrombin as well as an increase of von Willebrand factor (vWF) ratio and D dimer (DD). Compared to after CPB, there was a continued decrease of antithrombin and an increase of DD, as well as a significant increase of vWF and vWF activity under LVAD support. Conclusion: Among others, CPB and LVAD separately contribute to hemostatic disorder during LVAD implantation. Human laboratory markers allowed early detection of intraoperative hemostatic changes in pigs. Further studies are needed to investigate whether off-pump LVAD implantation reduces perioperative hemostatic disorder.

Acquired Isolated Factor VII Deficiency in Plasma Cell Dyscrasias: A Brief Presentation of Two Plasma-Cell-Leukemia-Related Cases and Review of Literature.

Acquired isolated factor VII (FVII) deficiency is a rare but important discovery in patients with plasma cell disorders with significant therapeutic and prognostic implications. The present analysis and review of cases reported in the literature is intended to highlight disease-related characteristics associated with this rare clotting defect, clinical manifestations and outcome, and potential underlying mechanisms, and to provide guidance on how to manage these patients in terms of prophylactic and therapeutic measures. The discovery of acquired FVII deficiency in a patient with multiple myeloma (MM) or monoclonal gammopathy of uncertain significance (MGUS) should prompt an evaluation for AL amyloidosis, particularly for amyloid hepatosplenic involvement, whenever not previously documented. Acquired FVII deficiency in patients with MM and AL amyloidosis is frequently associated with severe bleeding diathesis, also related to a number of concomitant predisposing factors, adversely affecting the outcome. The prompt institution of a rapidly acting therapy is crucial to prevent severe bleeding complications and positively impact outcome. Recombinant activated factor VII (rVIIa) may represent a useful supportive care measure, both in treating active bleeding and in the peri-procedural setting. However, further clinical experience is needed to optimize the therapeutic management of this rare disorder.

Severe Spontaneous Hematomas in Patients Hospitalized with COVID-19.

To describe the epidemiological, clinical, laboratory, and radiological characteristics, medical treatment, and outcomes of a case series of severe spontaneous hematoma in COVID-19. Material and Methods. This retrospective study included patients hospitalized for COVID-19 who were diagnosed with severe spontaneous bleeding complications by following a standardized treatment protocol that included computed tomography angiography (CTA) from 1 March 2020 to 28 February 2022. The main outcomes were embolization and all-cause mortality. Baseline variables were analyzed for their association with mortality using bivariable logistic regression, and results were expressed as odds ratios (OR) and 95% confidence intervals (CI). In total, 2450 adults were hospitalized for COVID-19 in our center during the study period. 20 patients presented severe and spontaneous intramuscular bleeding (8.1 per 1000 COVID-19 admission vs. 0.47 per 1000 non-COVID-19 admissions, p < 0.001); their median age was 68.5 years (interquartile range (IQR) 63, 80), they had high comorbidity (median Charlson comorbidity index 4.5), and 95% were receiving high doses of heparin. The median interval from COVID-19 symptoms to bleeding was 17 days (IQR 13, 24), and 70% reported cough as a previous symptom. Hypovolemic shock, hypotension, and abdominal pain were the most frequent symptoms of the hematoma. All presented decreased hemoglobin, and 95% required transfusion. Intramuscular hematoma occurred most frequently in the rectus sheath, iliopsoas compartment, and femoral-iliac compartment. All patients underwent embolization; mortality was 45%. We did not identify risk factors associated with an increased risk of death. Although severe bleeding is an uncommon complication of COVID-19, its prevalence is higher than in inpatients without COVID-19, it usually needs embolization, and it is associated with high mortality.

Dual Versus Mono Antiplatelet Therapy in Patients with Acute Mild-to-Moderate Stroke: A Multicentre Perspective Cohort Study.

The purpose of this study was to evaluate the association between different antiplatelet therapy regimens and the functional outcomes and bleeding complications among mild-to-moderate ischaemic stroke patients based on real-world data. We used data from the SEACOAST trial (Safety and efficacy of aspirin-clopidogrel in acute noncardiogenic minor ischaemic stroke) to analyse the data of patients with mild-to-moderate stroke within 72 h after onset who were treated with aspirin or clopidogrel alone or a combination of clopidogrel and aspirin from September 2019 to November 2021. Propensity score matching (PSM) was used to balance the differences between groups. We performed an analysis to evaluate the association of different antiplatelet regimens and 90-day disability, which was defined as a modified Rankin Scale score ≥2, as well as disability ascribed to index or recurrent stroke by the local investigator. In terms of safety, we then compared the bleeding events between the two groups. A total of 2822 mild-to-moderate ischaemic stroke patients were treated with either clopidogrel plus aspirin (n = 1726, 61.2%) or aspirin/clopidogrel (n = 1096, 38.8%). Of 1726 patients in the dual antiplatelet group, 1350 (78.5%) received less than or equal to 30 days of combined therapy. At 90 days, 433 (15.3%) patients were disabled. Patients who received combined therapy had a lower overall disability rate (13.7% versus 17.9%; OR 0.78 (0.6-1.01); P = 0.064). However, investigators found that index stroke was the reason for significantly fewer patients in the dual antiplatelet group having disability (8.4% versus 12%; OR, 0.72 (0.52-0.98); P = 0.038). There was no statistically significant difference in the incidence of moderate to severe bleeding complications between the dual and mono antiplatelet drug regimens (0.4% versus 0.2%; HR 1.5 (0.25, 8.98); P = 0.657). Aspirin plus clopidogrel was associated with a reduction in the incidence of disability attributed to index stroke. There was no statistically significant difference in the incidence of moderate to severe bleeding complications between the two antiplatelet drug regimens. ChiCTR1900025214.

Factor XIa Inhibitors as a Novel Anticoagulation Target: Recent Clinical Research Advances.

While current clinically administered anticoagulant medications have demonstrated effectiveness, they have also precipitated significant risks: severe bleeding complications including, but not limited to, gastrointestinal hemorrhaging and intracranial and other life-threatening major bleedings. An ongoing effort is being made to identify the best targets for anticoagulant-targeted drugs. Coagulation factor XIa (FXIa) is emerging as an important target of current anticoagulant treatment. This review will summarize the development of anticoagulants and recent advances in clinical trials of experimental factor XI inhibitors from a clinical application perspective. As of 1 January 2023, our search screening included 33 clinical trials. We summarized the research progress of FXIa inhibitors from seven clinical trials that evaluated their efficacy and safety. The results showed no statistically meaningful distinction in the primary efficacy between patients receiving FXIa inhibitors compared to controls (RR = 0.796; 95% CI: 0.606-1.046; I2 = 68%). The outcomes did not indicate a statistical difference in the occurrence of any bleeding between patients receiving FXIa inhibitors compared to controls (RR = 0.717; 95% CI: 0.502-1.023; I2 = 60%). A subgroup analysis found significant differences in severe bleeding and clinically relevant hemorrhaging in subjects receiving FXIa inhibitors compared to Enoxaparin (RR = 0.457; 95% CI: 0.256-0.816; I2 = 0%). Clinical trials to date have indicated that factor XIa is a potential anticoagulation target, and factor XIa inhibitors may play an important role in the development of anticoagulants.

Ultrasound-guidance for femoral venipuncture reduces access site complications after ablation of atrial fibrillation and other left atrial tachycardias: a retrospective single- center analysis

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Access site complications are significant adverse events related to ablation therapy. Periprocedural continuation of anticoagulation is common practice and leads to a reduction of cerebrovascular ischemic events but may increase the likelihood of access site complications. Methods 619 consecutive patients who underwent left-atrial ablation for AF were assessed for venipuncture associated complications after either landmark or ultrasound-guided venipuncture using data on hospital readmissions, outpatient visits or a structured telephone interview. AV-fistula, pseudoaneurysm and need of either interventional or surgical treatment of a vascular complication as well as blood transfusion were considered as access site complications. Continuous data are given as mean ± standard error of the mean, categorical data are expressed as number and percentages. Differences between groups were determined by Student’s t-test, chisquare-test, and Fisher’s exact test using SPSS software. A p-value of &amp;lt;0.05 was deemed significant. Results The patients' mean age was 69.1 ± 10.8 years and 51.5% were female. Mean BMI was 28.4 ± 5.5 kg/m2. Procedural safety was preserved with low observed rates of serious adverse events. The rate of postprocedural stroke (0.2% vs. 0%), pericardial effusion (0.8% vs. 0.6%) and in-hospital mortality (0% vs. 0%) did not differ between the groups. After conventional landmark-guided venipuncture the vascular complication rate was 4.8% (12/248). The rate of access site complications was significantly reduced to 0.8% (3/371) (p&amp;lt;0.01, OR 0.194, 95%-CI: 0.0529-0.712) when real time ultrasound-imaging was used for femoral venous cannulation. Severe bleeding complications related to the access site that required surgical or interventional treatment did not occur in the ultrasound group, compared to 2.0% (5/248) in the landmark-guided group (p = 0.010). The absolute risk reduction for access site complications using ultrasound-guidance was 3.2%, resulting in a number needed to treat (NNT) of 32 and a NNT of 50 for severe access site complications. Discussion Ultrasound-imaging while performing venipuncture identifies complex or uncommon anatomical conditions and facilitates safe cannulation of the common femoral vein. The use of ultrasound visual guidance for femoral sheath introduction had a remarkable beneficial effect on the occurrence of vascular access site complications in this retrospective single-center analysis. Outstandingly, the total rate of vascular access site complications had been significantly reduced resulting in a reduction of interventional or surgical treatment down to 0,0% in the us-guidance group, this may lead to fewer interruptions of OAC ant therefore lower risk of peri-interventional cerebrovascular events.

Australian and New Zealand consensus guideline for paediatric newly diagnosed immune thrombocytopaenia endorsed by Australian New Zealand Children's Haematology and Oncology Group.

In children, the majority of cases are self-limiting and thus many paediatric patients can be managed conservatively with minimal complications. This varies considerably compared to adult newly diagnosed immune thrombocytopaenia (NDITP) where, in most cases, thrombocytopaenia persists with higher risk of moderate to severe bleeding complications. In the past decade, local and international guidelines have emerged to support approaches to the investigation and management of NDITP, with a focus primarily on adult immune thrombocytopaenia (ITP). International consensus guidelines on paediatric NDITP have been developed, however gaps remain, and approaches vary between North American, Asia, Europe and the UK. There are no current Australian or New Zealand paediatric ITP guidelines readily available, rather differing guidelines for each state, territory or island. These inconsistencies cause uncertainty for patients, families and physicians managing cases. Subsequently, physicians, including paediatric haematologists and general paediatricians, have come together to provide a consensus approach guideline specific to paediatric NDITP for Australian or New Zealand. Persistent or chronic paediatric ITP remains a complex and separate entity and are not discussed here.

Final results of a phase 1b/2 study of tivozanib in combination with durvalumab in patients with advanced hepatocellular carcinoma in both previously untreated patients and patients progressing on atezolizumab and bevacizumab.

585 Background: The approval of atezolizumab + bevacizumab for untreated advanced HCC was a significant benefit for patients, but with an increased risk of potentially severe bleeding complications. Tivozanib (a selective VEGFR 1, 2, &amp; 3 tyrosine kinase inhibitor [TKI]) has been combined with durvalumab in the DEDUCTIVE study; preliminary results presented in January 2022 showed that this combination was well tolerated with comparable efficacy to other immune checkpoint and VEGF containing regimens in patients with previously untreated HCC ( J Clin Oncol 40, no. 4 suppl 462-462). We now report the final results of this cohort (cohort A) of patients as well as those with previously treated HCC, including safety results for all the patients. Methods: Major eligibility criteria included age &gt;18 yrs with documented advanced HCC, Child-Pugh Class A, ECOG 0 or 1, and creatinine clearance &gt;40 ml/min. Major exclusion criteria included co-infection with HBV and HCV and significant organ dysfunction. Patients were treated with 0.89 mg tivozanib p.o., 21 days on followed by 7 days off and 1500 mg durvalumab i.v. every 28 days. The primary objective was to determine the safety and tolerability of this combination in patients with advanced HCC; secondary objectives included assessing objective response rate (ORR), progression free survival, and overall survival (OS). The study was amended in 2021 to include a cohort of patients previously treated with atezolizumab and bevacizumab (cohort B). Results: 21 patients were enrolled in cohort A and 6 in cohort B; the median age was 67, 88% of patients were male, and 24% were Asian. The median follow-up time was 13.2 mos and 3.4 mos for cohorts A and B, respectively. Data were available for 25 of the 27 patients enrolled. For cohort A, the ORR was 25% (5/20) and 1-year OS was 76%. For safety analysis, 24 (96%) patients had at least 1 treatment-emergent adverse event (TEAE); 92% were attributed possibly to either tivozanib or durvalumab; 32% were serious TEAEs and there was 1 TEAE leading to death (unrelated). Of the 8 (32%) serious TEAE, 2 were coronavirus infection. 2 patients had serious (grade 3) treatment-related AEs: 1 pneumonitis and 1 with gastrointestinal hemorrhage and anemia. There were no grade 4 or 5 treatment-related AEs. Conclusions: Treatment with the combination of tivozanib and durvalumab in patients with either untreated advanced HCC or those previously treated with atezolizumab and bevacizumab was well tolerated; no severe bleeding events occurred in this study. Efficacy outcomes were comparable to other IO-TKI combinations in HCC. Data for PDL1 status, HBV/HCV status was collected and will be presented along with final safety and efficacy results for both cohorts. Clinical trial information: NCT03970616 .

Forty-five-months follow-up of a minimally invasive, interdisciplinary treated hemangioma of the mandible with a high risk of severe bleeding – a case report

BackgroundHemangiomas are benign tumours, mostly seen in the soft tissues. The intraosseous appearance is rare, in particular in the jaws they represent a very seldom malformation.AimTo present a combined endodontic and surgical management report of a clinical case with a rare intraosseous hemangioma diagnosis in the mandible.Case presentationThis well-documented case report describes the interdisciplinary treatment approach of an intraosseous hemangioma in the left mandible of a 70-year-old male patient. This incidental finding was detected through a routine dental examination. The panoramic radiograph revealed an asymptomatic, apical translucency approximately 15 mm diameter with contact to the mesial root of the tooth 36. The clinical examinations showed no abnormalities. The multifaceted specialized treatments started with the endodontic treatment of the tooth prior to the surgical removal of the lesion and were followed by the histological assessment. As derived from the histologically verified diagnosis, this rare case included the risk of severe bleeding complications during therapy.

Older Adults and Immune Thrombocytopenia: Considerations for the Clinician

Many epidemiological studies have shown that the incidence of immune thrombocytopenia (ITP) increases after age 60 years and peaks in patients over age 80 years. Therefore, ITP is a concern for physicians taking care of older patients, especially regarding its diagnosis and management. The diagnostic work-up should exclude other causes of thrombocytopenia and secondary ITP, including myelodysplastic syndrome and drug-induced ITP. The treatment decision is influenced by an increased risk of bleeding, infectious diseases and thrombosis in this population and should take into account comorbidities and concomitant medications such as anticoagulant drugs. First-line treatment is based on short corticosteroids courses and intravenous immunoglobulin, which should be reserved for patients with more severe bleeding complications, with their higher risk of toxic effects as compared with younger patients. Second-line treatment should be tailored to the patient's history, comorbidities and preferences. Preferred second-line treatments are thrombopoietin receptor agonists for most groups and guidelines given their good efficacy/tolerance ratio, but the thrombotic risk is increased in older people. Other second-line options that can be good alternatives depending on the clinical context include rituximab, dapsone, fostamatinib or immunosuppressive drugs. Splenectomy is less often performed but remains an option for fit patients with chronic refractory disease. Emerging treatments such as Syk or Bruton tyrosine kinase inhibitors and FcRn antagonists are becoming available for ITP and may modify the treatment algorithm in the near future. The aim of this review is to describe the particularities of the diagnosis and treatment of ITP in older people, including the response and tolerance to the currently available drugs. We also discuss some situations related to co-morbidities that can frequently lead to adapt the management strategy in older patients.

Female Genital Cutting or Circumcision

Woman genital slicing additionally referred to as woman genital mutilation or circumcision, is a deeply rooted cultural exercise that entails the partial or overall elimination of outside lady genitalia for non-scientific reasons. Despite being extensively criticized for its bodily and psychological fitness dangers, as well as its violation of human rights, the practice persists in various parts of the sector, specifically in Africa, the Middle East, and Asia. Female genital reduction is regularly justified inside communities as a ceremony of passage, a method of maintaining purity, or a way to control ladies’ sexuality. However, its effects are long-lasting and negative. The system can result in severe pain, bleeding, infections, and long-term period complications, which include urinary issues, headaches throughout childbirth, and mental trauma. The ethical issues surrounding this practice are obtrusive, as it infringes upon physical autonomy, sexual well-being, and gender equality. Efforts to eliminate female genital slicing span scientific, legal, and social dimensions. Several worldwide groups and governments have denounced the practice and enacted legal guidelines against it, specializing in cognizance campaigns, education, and community engagement. Grassroots projects inside affected groups have proven effective in transferring perceptions and hardening the deeply ingrained beliefs that perpetuate the exercise. To put off lady genital slicing, a holistic method is vital-one that includes not only the best criminal measures but also complete sex schooling, female empowerment, and collaboration with cultural and religious leaders. By addressing the underlying social norms and offering alternative cultural practices, societies can safeguard the rights and fitness of girls and women, letting them lead lives free from the bodily and emotional burdens of female genital reduction.

Bleeding complications in patients undergoing percutaneous coronary intervention in coronary artery bypass grafts: the impact of clinical presentation, access site and selection bias

Abstract Background Percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass graft (CABG) surgery is commonly done via the femoral approach. Relatively few cases are done via the radial approach. Purpose To assess bleeding complications in patients with either radial/brachial or femoral access when undergoing graft PCI, saphenous vein graft or internal mammary artery (IMA) graft. Method Data was collected for quality control on all patients that underwent PCI between 2010 and 2018 at 6 tertiary care hospitals in our system. Outcomes were classified and reported in accordance with the Bleeding Academic Research Consortium (BARC) criteria. BARC Type 4 (CABG-related) and BARC Type 5 (fatal) bleeds were excluded. Major bleeding was defined as BARC Type ≥3. Major adverse cardiac and cerebrovascular events (MACCE) was the combined endpoint of hospital death; post procedural myocardial infarction; cerebrovascular events (ischemic and hemorrhagic) and major bleeding complications. Due to the high intraclass correlation of procedures within patients, only the first procedure within the study period was selected from each patient for analysis. The two-sample t-test, Wilcoxon rank sum test, chi-square or Fisher's exact test were used as appropriate. Results A total of 1153 of 1196 patients who underwent graft intervention had BARC outcome data. Of these only 81 (7%) was via radial/brachial access. Baseline clinical characteristics are shown in the Table. A higher percentage of BARC ≥3 patients presented with NSTEMI/STEMI or had IMA graft intervention. Access site was not associated with bleeding complications. However, MACCE, post procedural heart failure (HF) and post procedural myocardial infarction (MI) rates were higher in patients who had femoral access (Figure). Conclusions In a large contemporary dataset of post CABG patients undergoing graft interventions: 1) the majority of patients (93%) underwent graft PCI via femoral access; 2) clinical presentation and acuity was associated with more severe bleeding complications; 3) access site did not seem to be associated with bleeding complications (possible selection bias); and 4) there was a trend towards higher MACCE rates in patients who had a femoral access. Additional analysis will be done to further investigate our findings. Funding Acknowledgement Type of funding sources: None.

S698 Bleeding Complications From Fecal Management Systems in the COVID Era: A Single Center Experience

Introduction: Fecal Management Systems (FMS) have become common practice in hospitalized patients with severe diarrhea, or pressure wounds. These devices allow diversion of stool away from the body in an enclosed system. Contraindications to FMS placement include hemorrhoids, anal strictures, rectal mucosal impairment and device use for greater than 29 days. Although FMS are generally safe and effective, severe rectal bleeding has been reported in a small number of studies and case reports though characteristics not well-defined. The goal of this study was to investigate patient characteristics with FMS use and subsequent development of severe bleeding complications. Methods: We reviewed endoscopy reports for rectal ulcerations and identified 16 patients who developed severe rectal bleeding from FMS at a large medical center from August 1, 2019 to August 1, 2021. Severe rectal bleeding was defined as requirement of blood transfusion, endoscopy or embolization. Demographics, medications, and hospitalization characteristics were extracted from the medical record. Mean, standard deviation, and percentages were calculated for variables of interest. Results: Patients who bled with FMS had prolonged hospitalizations (mean 67.4 days), and 50% (8/16) died during hospitalization (Table). 43.8% (7/16) had COVID-19 infection, and 75% (12/16) were cared for in intensive care units. 18.8% (3/16) were on antiplatelets, and 50% were on anticoagulation. 93.8% (15/16) of patients who bled with FMS required blood transfusion, receiving 6.1±6.3 units of blood during their hospital admission. 81.3% (13/16) required endoscopy, 12.5% (2/16) required second endoscopy for hemostasis, and 6.3% (1/16) required embolization by Interventional Radiology. Of note, 18.8% (3/16) patients had hemorrhoids, 18.8% (3/16) had FMS for longer than 29 days, and only 37.5% (6/16) had an order for a rectal tube placed. No severe bleeding complications occurred in the 10 months prior to COVID-19 pandemic. (Figure) Conclusion: FMS has clinical utility but carries risks of severe bleeding complications. It remains unclear how COVID-19 impacted rates of these complications as baseline utilization could not be assessed in our center. Careful attention to hemorrhoids, FMS placement > 29 days, and other relative contraindications like coagulopathy is important to improve patient safety. Interventions should be developed to ensure safe, appropriate FMS placement and timely removal of FMS to avoid adverse events.Figure 1.: Total number of fecal management system (FMS) severe bleeding complications from August 1, 2019-August 1, 2021. Table 1. - Characteristics of patients undergoing sigmoidoscopy or colonoscopy for bleeding from rectal tubes (n =16) Variable N (%) or mean (SD) Length of hospitalization (days) 67.4 (30.6) Death during hospitalization 8 (50.0) Hospitalization in intensive care unit (ICU) 13 (81.3) Age (years) 63.4 (14.9) Male sex 13 (81.3) RaceWhite or CaucasianBlack or African-AmericanAsian 8 (50.0)6 (37.5)2 (12.5) Body mass index 26.9 (6.7) History of hemorrhoids 3 (18.8) Immobility 12 (75.0) Mechanical ventilation 11 (68.8) Aspirin use 10 (62.5) Antiplatelet use 3 (18.8) Anticoagulant use 8 (50.0) NSAID use 2 (12.5) Bowel regimen use 12 (75.0) Vasopressor use 9 (56.3) COVID-19 diagnosis 7 (43.8) Rectal tube order placement 6 (37.5) Duration of rectal tube use (days) 18.5 (14.5) Rectal tube placement >29 days 3 (18.8) Receipt of blood transfusion 15 (93.8) Number of blood transfusions 6.1 (6.3)