Inactivated whole-virion SARS-CoV-2 vaccines and long-term clinical outcomes in patients with coronary atherosclerosis disease in China: a prospective cohort study.

AIMS: Publicized adverse events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) raised concern among patients with coronary atherosclerosis disease (CAD). We sought to study the association between SARS-CoV-2 vaccines and long-term clinical outcomes including ischaemic and bleeding events among patients with CAD. METHODS AND RESULTS: Inpatients diagnosed with CAD by coronary angiography, without a history of SARS-CoV-2 infection and vaccination, were included between 1 January and 30 April 2021, and underwent follow-up until 31 January 2022. Two doses of inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, BBIBPCorV, or WIBP-CorV) were available after discharge, and the group was stratified by vaccination. The primary composite outcomes were cardiovascular death, non-fatal myocardial infarction, stent thrombosis, unplanned revascularization, ischaemic stroke, venous thrombo-embolism, or peripheral arterial thrombosis. The bleeding outcomes were Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. Cox regression models with vaccination status as a time-dependent covariate were used to calculate the hazard ratio (HR) for the outcomes. A propensity score matching method was used to reduce confounding biases. This prospective cohort study included 2078 individuals with CAD, 1021 (49.1%) were vaccinated. During a median follow-up of 9.1 months, 45 (4.3%) primary composite outcomes occurred in the unvaccinated group, and 33 (3.2%) in the vaccinated group. In Cox regression, the adjusted HR was 1.13 [95% confidence interval (CI) 0.65-1.93]. The adjusted HR for the bleeding outcomes associated with vaccination was 0.81 [95% CI 0.35-1.19]. After matching, the adjusted HR for the primary composite outcomes associated with vaccination was 1.06 [95% CI 0.57-1.99] and for the bleeding outcomes was 0.91 [95% CI 0.35-2.38]. Similar results were found in the seven prespecified subgroups. No grade 3 adverse reactions after vaccination were recorded. CONCLUSION: Our results indicated no evidence of an increased ischaemic or bleeding risk after vaccination with inactivated SARS-CoV-2 vaccine among Chinese patients with CAD, with limited statistical power.

Thromboprophylaxis in gynaecology: a review of current evidence

Key content: Thromboembolism is a major cause of preventable morbidity and mortality. Hospital acquired thrombosis (HAT) accounts for 50-60% of all thromboembolic events. As well as effects on patient safety, there are considerable cost implications to both prophylaxis and treatment. While guidance exists on thromboprophylaxis for patients in obstetrics and those undergoing general surgery, there is a paucity of guidance relating to gynaecological practice. Increasing prevalence of risk factors and multimorbidity is paralleled by higher risk of thromboembolic events. Gynaecological surgery presents some unique risk factors for thrombosis. Learning objectives: To understand the basic pathophysiology of thrombosis in relation to risk factors particularly relevant to gynaecology and pelvic surgery. To know the current evidence in key areas relevant to gynaecological practice: early pregnancy;day case surgery;minimally invasive gynaecological surgery;open and complex benign gynaecology and gynaecological oncology. To be aware of proposed guidance on risk assessment and prophylaxis in thrombosis as relevant to the gynaecologist based on current evidence. Ethical issues: Problems with thromboprophylaxis in high-risk patients include noncompliance and refusing animal products/injections. Clinicians may be reluctant to institute thromboprophylaxis, most times because of the possible risks of bleeding. Copyright © 2022 Royal College of Obstetricians and Gynaecologists.

Outcomes of COVID-19 in Adult Males With Hemophilia A: A Propensity Score-Matched Analysis.

Background Hypercoagulability is a major pathologic event in COVID-19. Factor VIII plays an important role in hemostasis, and high levels of factor VIII have been shown to be associated with an increased risk of thrombosis and severe disease. Little is known about the impact of COVID-19 on clinical outcomes in patients with hemophilia A. Methodology Retrospective data of adult male patients with COVID-19 with and without hemophilia A were retrieved from the TriNetX database (Cambridge, USA). The 1:1 propensity score-matching was performed to balance baseline characteristics. Patients were matched for age, race, body mass index, and medical comorbidities. Thirty-day outcomes were assessed. Results We identified 1,758 patients with pre-existing hemophilia A diagnosis prior to COVID-19 diagnosis and 5,191,908 comparators. After 1:1 propensity score matching, groups were balanced on demographics and comorbidities. All-cause mortality rates were similar between the two groups (HR 0.805; 95% CI 0.467-1.389). The frequency of severe infection, ICU admission, and composite thrombotic events did not differ between the groups. Patients with hemophilia A were hospitalized more frequently than those without a history of hemophilia A (19.2% vs. 14.4%; p<0.05). Additionally, gastrointestinal (GI) bleeding and composite bleeding events occurred more frequently in patients with hemophilia A (3.2% vs. 2.2%; p<0.05 and 4.0% vs. 2.8%; p<0.05, respectively). Conclusions The mortality of individuals with hemophilia A due to COVID-19 is comparable to the general population but with higher risks of hospitalization and bleeding.

Young mother with lupus and life-altering cardiocerebrovascular nightmare: a case report.

Background: Systemic lupus erythematosus (SLE) predominantly affects women and increases their cardiovascular disease risk up to three-fold. Young women with SLE face various challenges and gender-specific issues, especially concerning pregnancy. Case summary: A female patient, 37 years old, married with two children, hospitalized for SLE, consulted for chest pain, shortness of breath, and dry cough. She quit her medication in the past 7 years prior to her admission in the hope of conceiving. Physical examinations showed signs of heart failure. Electrocardiogram revealed recent myocardial infarction. She had increased hs-Troponin T 180.3 pg/mL and NTproBNP 13 419 ng/L. An echocardiogram demonstrated a low ejection fraction at 30.4%, left ventricle thrombus, and wall motion abnormalities. The angiogram showed severe coronary artery disease. Her condition was then complicated by embolic stroke and recurrent bleeding from anticoagulant subcutaneous punctured sites. Discussion: Patients with SLE are prone to hypercoagulability and accelerated atherosclerosis, which may lead to pre-mature mortality. In this case, balancing risk for bleeding vs. ischaemia is a see-saw decision. The current risk scores do not cater specifically to this population, but the existing ones suggest this patient will have an equally undesired outcome. Hence, a multi-disciplinary team discussion was needed. Considering the immense risk of any intervention at the time, the decision was to administer a conservative treatment. Conclusion: Recognizing and anticipating gender-specific issues in managing patients with SLE are keys to preventing catastrophic complications. Multi-disciplinary team involvement is critical in dealing with complex cases.

Severe Thrombocytopenic Purpura Associated with COVID-19 in a Pediatric Patient.

Purpose: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is known to cause a diverse spectrum of clinical manifestations ranging from mild, flu-like symptoms to severe progressive pneumonia, acute respiratory distress syndrome with or without other extrapulmonary impairment. Hematological changes such as lymphopenia, neutrophilia, and anemia as the disease progresses, are frequently found in COVID-19. Thrombocytopenia may be drug-induced or can occur secondary to sepsis, disseminated intravascular coagulation or bone marrow suppression. Immune thrombocytopenic purpura (ITP) is frequently observed in children aged 2-5 years and in 60% of cases may proceed an upper respiratory tract infection. The present paper aimed to raise awareness of ITP as a possible pediatric presentation of coronavirus disease. Patients and Methods: We present the case of previously healthy, eight-year-old female patient, who developed an immune thrombocytopenia flare, also known as immune thrombocytopenic purpura (ITP), in the context of COVID-19, with diffuse petechiae and ecchymosis on her body, face and oral mucosa, and a nadir platelet count of 0×103/µL. Results: Platelet count recovery was observed after seven days of combined treatment with intravenous immunoglobulin (IVIG) and corticosteroids. Conclusion: The growing body of literature regarding the clinical and laboratory manifestations of COVID-19 infection in children, has reported thrombocytopenia in relation to unfavorable disease progression or multisystem inflammatory syndrome (MIS-C). Clinicians must be aware that ITP may appear both in mild and severe COVID-19, at any time during its course, and can be associated with a higher bleeding risk, thus its diagnostic may be critical.

Evaluation of a Clinical Decision Support System for the most evidence-based approach to managing perioperative anticoagulation.

STUDY OBJECTIVE: We explored the feasibility of a Clinical Decision Support System (CDSS) to guide evidence-based perioperative anticoagulation. DESIGN: Prospective randomised clinical management simulation multicentre study. SETTING: Five University and 11 general hospitals in Germany. PARTICIPANTS: We enrolled physicians (anaesthesiologist (n = 73), trauma surgeons (n = 2), unknown (n = 1)) with different professional experience. INTERVENTIONS: A CDSS based on a multiple-choice test was developed and validated at the University Hospital of Frankfurt (phase-I). The CDSS comprised European guidelines for the management of anticoagulation in cardiology, cardio-thoracic, non-cardio-thoracic surgery and anaesthesiology. Phase-II compared the efficiency of physicians in identifying evidence-based approach of managing perioperative anticoagulation. In total 168 physicians were randomised to CDSS (PERI-KOAG) or CONTROL. MEASUREMENTS: Overall mean score and association of processing time and professional experience were analysed. The multiple-choice test consists of 11 cases and two correct answers per question were required to gain 100% success rate (=22 points). MAIN RESULTS: In total 76 physicians completed the questionnaire (n = 42 PERI-KOAG; n = 34 CONTROL; attrition rate 54%). Overall mean score (max. 100% = 22 points) was significantly higher in PERI-KOAG compared to CONTROL (82 ± 15% vs. 70 ± 10%; 18 ± 3 vs. 15 ± 2 points; P = 0.0003). A longer processing time is associated with significantly increased overall mean scores in PERI-KOAG (≥33 min. 89 ± 10% (20 ± 2 points) vs. <33 min. 73 ± 15% (16 ± 3 points), P = 0.0005) but not in CONTROL (≥33 min. 74 ± 13% (16 ± 3 points) vs. <33 min. 69 ± 9% (15 ± 2 points), P = 0.11). Within PERI-KOAG, there is a tendency towards higher results within the more experienced group (>5 years), but no significant difference to less (≤5 years) experienced colleagues (87 ± 10% (19 ± 2 points) vs. 78 ± 17% (17 ± 4 points), P = 0.08). However, an association between professional experience and success rate in CONTROL has not been shown (71 ± 8% vs. 70 ± 13%, 16 ± 2 vs. 15 ± 3 points; P = 0.66). CONCLUSIONS: CDSS significantly improved the identification of evidence-based treatment approaches. A precise usage of CDSS is mandatory to maximise efficiency.

Retroperitoneal hematoma in COVID-19 patients - case series.

COVID-19 patients, particularly those with severe pulmonary involvement, are at an increased thromboembolic risk related, among various causes, to the cytokine storm and excessive activation of the coagulation cascade and platelets. Different intensity of anticoagulation for them is proposed, mainly with low molecular weight heparins (LMWHs); in a confirmed pulmonary embolism (PE) the therapeutic dose of LMWH is routinely used. Some authors suggest that hemorrhagic complications in COVID-19 patients are rare. At the same time, one can find reports on internal bleeding, including retroperitoneal hematoma (RPH) and other abdominal hematomas. CASE REPORTS: The authors describe 5 cases (3 of those aged more than 80 years) with giant RPHs and with moderate/severe COVID-19 pneumonia, treated before RPH diagnosis with different enoxaparin doses. The therapeutic dose was given to the male with verified PE limited to the segmental/subsegmental pulmonary arteries and initially to the female in whom echocardiography was strongly suggestive of PE, yet this diagnosis was excluded on CT angiography. In one patient, the enoxaparin dose was escalated from 40 mg bd to 60 mg bd after the D-dimer increase. Two patients had bleeding complications despite the enoxaparin dose restricted to 40 mg/daily or bd. Two males had a coexistent psoas hematoma while in only one female there was a coexistent femoral hematoma. RPHs occurred between day 4 and 14 of hospitalization and all were treated conservatively. Three patients who died were particularly charged, so their deaths were not merely directly associated with RPH, which was closely analyzed in one autopsy performed. The authors underline that the choice of anticoagulation intensity in patients with COVID-19 pneumonia without venous thromboembolism seems sometimes difficult but recent publications indicate the low prophylactic enoxaparin dose as an optimal option. Anticoagulation dose escalation based only on the D-dimer level may not be appropriate for certain patients; moreover, the D-dimer increase is commonly observed during internal bleeding.

EkoSonic™ Endovascular System-Directed Thrombolysis in a Patient With COVID-19 Infection Presenting With Bilateral Large Pulmonary Embolism Causing Right Ventricular Strain: A Case Report.

We discuss a case of a 31-year-old male patient who presented to the accident and emergency department with shortness of breath and chest pain since the morning of the day of presentation. His polymerase chain reaction (PCR) test had returned positive for severe acute respiratory syndrome coronavirus 2 (SARS­CoV­2), which causes coronavirus disease 2019 (COVID-19), two weeks ago and his main symptoms had been shortness of breath, dry cough, generalized body pain, and fever. He was not vaccinated against the COVID-19 virus. He had not required hospitalization for COVID-19 and his symptoms had improved on day 10 from the date of diagnosis; however, he developed pleuritic chest pain with shortness of breath on the day of presentation. He was found to have tachypnoea, hypoxia, and tachycardia on assessment. His electrocardiogram showed a right bundle branch block with sinus tachycardia. He underwent a CT pulmonary angiography (CTPA) that showed bilateral large pulmonary emboli extending from the main pulmonary arteries bilaterally extending to the sub-segmental level. There was evidence of right heart strain on the scan. He also had a bedside echocardiogram performed after the CT scan, which showed an enlarged right ventricle but no left ventricular thrombus. His blood results showed D-dimer levels of 14,000 ng/mL and troponin T of 255 ng/L. He received treatment with low molecular weight heparin (LMWH) and underwent emergency EkoSonic™ Endovascular System (EKOS) thrombolysis (Boston Scientific, Marlborough, MA). He remained on ultrasound-accelerated thrombolysis (USAT) for the next 12 hours and showed significant improvement and was taken off oxygen post-EKOS thrombolysis. He was discharged home on oral rivaroxaban after 48 hours of hospital stay; follow-up after two months showed normal-sized right ventricle with no evidence of pulmonary hypertension.

Validation of a Prognostic Score to Identify Hospitalized Patients with COVID-19 at Increased Risk for Bleeding.

INTRODUCTION: Hospitalized patients with COVID-19 are at increased risk for venous thromboembolism (VTE), but also for bleeding. We previously derived a prognostic score including four variables (elevated D-dimer, elevated ferritin, critical illness, and therapeutic-dose anticoagulation) that identified those at increased risk for major bleeding. METHODS: We aimed to validate the score in a subsequent cohort of hospitalized patients with COVID-19 receiving standard-, intermediate- or therapeutic doses of VTE prophylaxis. We evaluated its capacity to predict major bleeding, non-major bleeding, and bleeding-related death. RESULTS: The cohort included 972 patients from 29 hospitals, of whom 280 (29%) received standard-; 412 (42%) intermediate-, 157 (16%) therapeutic doses of VTE prophylaxis and 123 (13%) other drugs. Median duration of prophylaxis was 14.7 ± 10.3 days. Major bleeding occurred in 65 patients (6.7%) and non-major bleeding in 67 (6.9%). Thirty patients with major bleeding (46%) died within the first 30 days after bleeding. The prognostic score identified 203 patients (21%) at very low risk, 285 (29%) at low risk, 263 (27%) intermediate-risk and 221 (23%) at high risk for bleeding. Major bleeding occurred in 1.0%, 2.1%, 8.7% and 15.4% of the patients, respectively. Non-major bleeding occurred in 0.5%, 3.5%, 9.5% and 14.2%, respectively. The c-statistics was: 0.74 (95% confidence intervals [CI]: 0.68-0.79) for major bleeding, 0.73 (95% CI: 0.67-0.78) for non-major bleeding and 0.82 (95% CI: 0.76-0.87) for bleeding-related death. CONCLUSIONS: In hospitalized patients with COVID-19, we validated that a prognostic score including 4 easily available items may identify those at increased risk for bleeding.