Bleeding Rates Research Articles

Comparing the real-world and clinical trial bleeding rates associated with oral anticoagulation treatment for atrial fibrillation

Abstract Background The prevention of stroke in patients with atrial fibrillation (AF) involves the use of oral anticoagulation, commonly in the form of direct oral anticoagulants (DOAC). However, it comes with an increased risk of bleeding and therefore, counselling patients on their individual risk is important. Although majority of patients initiated on DOAC have been represented within the clinical trials, there are some cohorts which are under-represented in whom clinicians are unable to practice evidence-based medicine. Methods Utilising the pooled clinical trial (CT) data sourced from Medidata Enterprise Data Store, 5 recent open-label industry sponsored AF trials were compared with Real-World data (RWD) was sourced from the HealthVerity Marketplace with the occurrence of bleeding events as the primary outcome of interest. Results A total of 64,421 patients were included in the analysis, with 3207 patients from the clinical DOAC trials and 61,214 patients from the RWD cohort. Overall, the patients from RWD cohort had more co-morbidities, were older (72.2 ± 11.9 vs 65.3 ±10.7 years old, p<0.001), had higher mean CHA2DS2VASc (3.98 ± 1.9 vs 2.87 ± 1.73, p<0.001) and HAD-BLED scores (2.13 ± 1.02 vs 1/04 ± 0.93, p<0.001) when compared to the trial data. When comparing the incidence of first major bleed at 12 months post treatment initiation, rates in the RWD cohort was significantly higher (10.69 vs 18.97 per 100 person-years). The impact of comorbidities such as age, CHA2DS2VASc and HAD-BLED scores were similar in both cohorts, however, there was an under-representation of older, females and more co-morbid patients within the clinical trial cohort. Conclusion DOAC treated patients have higher bleeding incidence rate in the RWD cohort as compared to clinical trials. This can be explained by the older patient age group with more complex medical histories and higher HAS-BLED scores. The under-representation of higher risk patients and lower proportion of females within clinical trials should be addressed to better translate clinical trial data into real world clinical practice.

Oral anticoagulants or antiplatelets for cryptogenic stroke: a systematic review and meta-analysis

Abstract Background Cryptogenic strokes comprise 20 to 30% of ischemic strokes and include a substantial proportion classified as embolic stroke of undetermined source (ESUS). However, the optimal antithrombotic strategy for cryptogenic stroke remains contentious. Purpose We conducted a systematic review and meta-analysis to compare the efficacy and safety of oral anticoagulants (OAC) versus antiplatelets in patients with cryptogenic stroke. Methods Six electronic databases of PubMed, Embase, Web of Science, the Cochrane Library, Google Scholar and ClinicalTrials.gov were searched from inception to Feb 15, 2024 to identify relevant randomized controlled trials (RCTs) comparing stroke recurrence and major bleeding rates between OAC and antiplatelets in cryptogenic stroke patients. We included trials adhering to a stringent diagnostic work-up for cryptogenic stroke, defined as cerebral infarction not attributed to definite sources of cardioembolism, large artery atherosclerosis, or small artery disease despite undergoing comprehensive investigations. The primary outcome was recurrent ischemic stroke, and the secondary outcome was major bleeding based on International Society of Thrombosis and Hemostasis criteria. Subgroup analysis was conducted for ESUS patients with an increased risk of cardiac emboli, such as patent foramen ovale (PFO) and atrial cardiopathy, defined as lead V1 terminal P-wave > 5000 μV × ms in electrocardiogram, serum N-terminal pro-B-type natriuretic peptide level > 250 pg/mL, and left atrial diameter (LAE) > 4 cm, or LAE index ≥ 3 cm/m2 on echocardiogram. Hazard ratio (HR) with 95% confidence (CI) was used as a measure of the effect estimates for aforementioned outcomes. Random-effects meta-analysis was performed using a restricted maximum likelihood model given between-study variance is inevitable. Results Our meta-analysis included 9 RCTs with a total of 15,139 patients (OAC = 7,343; antiplatelets = 7,796). ARCADIA, RE-SPECT ESUS, and NAVIGATE ESUS Trial investigated apixaban, dabigatran, and rivaroxaban, respectively, while warfarin was primarily used as OAC in the remaining six trials. Aspirin was predominantly utilized for antiplatelet therapy. There was no significant difference in recurrent ischemic stroke between OAC and antiplatelets (HR, 0.90; 95% CI, 0.78 to 1.04; I2 = 0%). However, OAC use was associated with a significantly higher risk of major bleeding (HR, 1.66; 95% CI, 1.07 to 2.56; I2 = 36%). Subgroup analysis in ESUS patients revealed comparable rates of recurrent ischemic stroke in those with atrial cardiopathy (HR, 0.91; 95% CI, 0.65 to 1.29; I2 = 0%) and PFO (HR, 0.72; 95% CI, 0.49 to 1.07; I2 = 0%). Conclusions Our meta-analysis suggests that OAC use does not decrease the risk of recurrent ischemic stroke compared with antiplatelet use but is associated with a significantly higher risk of major bleeding in patients with cryptogenic stroke.Primary (A) and secondary (B) outcomesSubgroup analysis for recurrent stroke

Ischemic and bleeding risk after ST-segment elevated myocardial infarction in patients with active cancer

Abstract Background Treatment of patients with cancer presenting with ST-elevation myocardial infarction (STEMI) is complex given the increased risk of both thrombotic and major bleeding complications. We evaluated the risk of major bleeding and re-infarction in patients with or without cancer following admission with STEMI Methods A nationally-linked cohort of STEMI patients between January 2005 and March 2019 were obtained from the UK Myocardial Infarction National Audit Project (MINAP) registry and the UK national Hospital Episode Statistics Admitted Patient Care (HES APC) registry. Cox proportional hazard models were used, and Kaplan-Meier survival and cumulative survival curves were constructed. Results A total of 322,776 STEMI indexed admissions were identified between Jan 2005 and March 2019. Of those, 7050 (2.2%) patients were diagnosed with active cancer. Cancer patients were older with more cardiovascular comorbidities. Cancer patients received invasive coronary angiography (62.2% vs 72.7%, p<0.001) and PCI (58.4% vs 69.5%) less often compared to patients without cancer and were less likely to be prescribed DAPT (85% vs 95.4%). Major bleeding rate at one year was higher in cancer patients (6.5% vs 3.5%) while re-infarction rates were similar (cancer 5.7%, no cancer 5.1%). Adjustment for differences in baseline covariates, a similar risk of re-infarction (SHR 1.10, 95% CI 0.94-1.27) and a 50% increased risk of major bleeding (SHR 1.49, 95% CI 1.30-1.71) was observed in cancer patients. Conclusion Compared to non-cancer patients, cancer patients have a higher risk of major bleeding but not of re-infarction. Mitigating bleeding risk in STEMI patients with cancer is of paramount importance to improve outcomes.bleeding risk at 1 yearRe-infarction risk at 1 year

Bleeding and Thrombotic Events in Hemodialysis Patients with Atrial Fibrillation on Anticoagulation and Antiplatelet Therapy: A 24-Month Cohort Study

Background and Objectives: Patients undergoing chronic hemodialysis (HD) are predisposed to both thrombotic and bleeding complications due to the complex interplay of end-stage renal disease (ESRD), cardiovascular comorbidities, and the routine use of anticoagulant and antiplatelet therapies. This study aimed to investigate the incidence of bleeding and thrombotic events in chronic HD patients receiving anticoagulant and antiplatelet therapy, with a specific focus on those with atrial fibrillation (AF). Materials and Methods: A total of 224 patients, with 43 (19%) of them diagnosed with AF, were included in this single-center, observational cohort study conducted over 24 months. The cohort was divided into three groups: patients without anticoagulation, those on warfarin monotherapy, and those on combined warfarin and aspirin therapy. Bleeding events were classified as major, clinically relevant non-major bleeding (CRNMB), or minor bleeding, while thrombotic events included ischemic stroke, myocardial infarction, pulmonary embolism, and arteriovenous fistula thrombosis. Results: Overall, 35.7% of patients experienced a bleeding event, with major bleeding occurring in 9.4%. Patients with AF had significantly higher rates of major bleeding (18.6%) compared to those without AF (7.18%; p = 0.043), especially in the combined therapy group. Mortality due to bleeding was also higher in AF patients (14%). In contrast, thrombotic events occurred in 26.8% of patients, with AF patients experiencing significantly more events (48.8%) compared to non-AF patients (21.5%; p = 0.0006). The hazard ratio (HR) for major bleeding in patients on combined warfarin and aspirin therapy was 2.56 (p = 0.016), while the HR for thrombotic events was 2.34 (p = 0.0202). Conclusions: These findings highlight the increased risks of both bleeding and thrombosis in chronic HD patients with AF, particularly those on combined anticoagulation and antiplatelet therapy.

Intracapsular versus extracapsular tonsil surgery: Comparison of postoperative haemorrhage outcomes in the Australasian setting

ObjectiveTo investigate the incidence and timing of postoperative haemorrhage between intracapsular (ICT) and extracapsular tonsillectomy (ECT) techniques and evaluate factors influencing haemorrhage risk and severity. MethodsA retrospective review of patients undergoing tonsillectomy over 5 years across otolaryngology services in Australia and New Zealand. Primary outcomes were rate and timing of post-tonsillectomy haemorrhage. ResultsA total of 12,275 patients were included in this study. The overall post-tonsillectomy bleed rate was 3.3 %, with 0.65 % requiring return to theatre. ICT had a significantly lower bleed rate of 1.7 % compared to 4.1 % for ECT (p < 0.001). The rate of return to theatre was markedly lower for ICT (0.08 %) compared to ECT (0.93 %, p < 0.001). Median day of bleeding was not different between the techniques. Patients undergoing surgery for recurrent tonsillitis had the highest rate of postoperative haemorrhage (15 %), while those with sleep-disordered breathing alone had the lowest (3 %, p < 0.001). ConclusionICT results in significantly lower rates of postoperative haemorrhage and need for surgical intervention compared to ECT. This was most pronounced in paediatric patients with sleep-disordered breathing. ICT may be considered a preferable option for certain patient groups, especially younger children with sleep-disordered breathing, though more evidence is needed to confirm its efficacy and safety in patients with recurrent tonsillitis.

Postoperative Bleeding Risk in Thyroid Surgery: Differences between Conventional and Endoscopic Video-Assisted Neck Surgery Methods.

Postoperative bleeding is a potentially life-threatening complication following thyroidectomy, but the risk factors and timing remain insufficiently understood. The bleeding rate for endoscopic surgery, specifically video-assisted neck surgery (VANS), also remains unclear in Japan. We conducted a retrospective case-control study of postoperative bleeding requiring readmission to the operating room. The overall postoperative bleeding rate was 1.85%. Multivariate analysis revealed that postoperative bleeding was independently associated with antithrombotic therapy (odds ratio 2.95; 95% confidence interval 1.15-7.59) and dialysis (odds ratio 6.53; 95% confidence interval 1.75-24.2). Among patients with postoperative bleeding, the complication developed within 6 h in 56.1% and within 24 h in 93.0%. The postoperative bleeding rate in endoscopic surgery was 1.6%. The most common site of bleeding was around the thyroid in conventional surgery and around the flap in endoscopic surgery. Post-thyroidectomy bleeding is associated with antithrombotic therapy or dialysis. While the bleeding rate in endoscopic surgery is similar to that in conventional surgery, the bleeding site differs.

Study on Engineering Properties and Mechanism of Loess Muck Grouting Materials

Shield tunneling generates a massive amount of muck, and achieving the on-site reuse of muck is an urgent need in the field of shield tunneling. This study, based on a section of the Xianyang diversion tunnel in a loess stratum, aims to optimize the mix ratios of loess muck grouting materials to meet specific performance requirements. Laboratory tests were conducted to analyze the effects of the bentonite content and water–solid ratio on the properties of grout. The engineering properties, cost, and environmental impact of the optimized loess muck grouting materials were compared with those of traditional grouting materials. Additionally, XRD, SEM, and CT were employed to investigate the solidification mechanism of loess muck grouting materials. The results show that the bleeding rate, setting time, fluidity, and consistency of loess muck grouting materials decreased with increasing bentonite content, while these properties increased as the water–solid ratio rose. The compressive strength reached 0.26 MPa and 1.05 MPa at 3 d and 28 d, respectively. Compared to traditional grouting materials, the economic cost and carbon emissions of loess muck grouting materials were reduced by 49.46% and 37.17%, respectively. As the curing time increased, gel filling and particle agglomeration reduced the number of pores. The dense microstructure is the primary factor for the improvement of strength.

Comparison of diagnostic yields, operative times, and post-operative hemorrhage between twist drill versus burr hole craniotomy approaches for stereotactic needle brain biopsy.

Stereotactic frameless needle brain biopsy is a common neurosurgical procedure performed via twist drill or open burr hole approaches. We aim to compare diagnostic yields and surgical outcomes to delineate the safety and efficacy of both approaches. A retrospective database of all stereotactic needle biopsy procedures performed at a single institution over 30 months was conglomerated. Demographics, medical comorbidities, operative details/complications, immediate post-operative imaging, and pathology were abstracted. Two hundred and twenty-five needle biopsies were identified, of which 165 (73.3%) were open, and 60 (26.7%) were twist drill. Diagnostic pathology yield rates between open (84.8%) and twist drill (93.3%) approaches were similar (p = 0.15), with a median of 4 cores taken in each (p = 0.30). Diagnostic tissue yields with an intra-operative pause for pathology confirmation was 90.4% compared to 79.1% without pause (p = 0.036, OR 2.49). Median operative times for open versus twist drill procedures were 68.0min (IQR 49-83) versus 35.5min (IQR 26-54), respectively (Wilcoxon p < 0.001), which remained significant after controlling for awaiting intraoperative pathology using bivariable linear modeling (p < 0.001). Intraoperative bleeding through the needle cannula was noted in 22 patients (9.8%), including eight twist drill (13.3%) and 14 open needles (8.5%). Of 197 cases (87.6%) with post-operative cranial imaging (CT/MRI), 90 (45.7%) demonstrated some degree of post-operative hemorrhage characterized as superficial (n = 10, 11.1%), deep/intralesional (n = 64, 71.1%) bleeding, or both (n = 16, 17.9%). Bleeding rates between open (46.7%) and twist drill (43.3%) approaches were similar (p = 0.78). Post-operative clinical decline or neurological change was noted in 9 patients (4.0%), including one twist drill (1.7%) and eight open needles (4.8%), among which 7 (78%) had deep blood products identified on post-operative imaging. Stereotactic needle biopsy via twist drill approach has similar diagnostic yield rates, asymptomatic bleeding rates, and post-operative complications with significantly shorter operative time and smaller incision size than conventional open burr hole needle biopsy. Using intra-operative frozen histopathology for presumed sufficient diagnostic tissue may improve final pathologic diagnostic rates regardless of approach technique.

Analysis of perinatal outcomes in pregnant women with the resolution of placenta previa in the second trimester

Objective: To investigate perinatal outcomes of pregnant women with the resolution of placenta previa in the second trimester. Methods: This study was a retrospective cohort study, which included singleton pregnant women who received prenatal care and delivered at Peking University Third Hospital from January 1st 2019 to December 31st 2020. A total of 403 pregnant women diagnosed with placenta previa by ultrasound at 20-24 weeks of gestation and the placental position returned to normal before delivery were included in the study group, and 403 pregnant women with normal placental position matched 1∶1 were the control group. The primary outcome was postpartum hemorrhage rate, and secondary outcomes included postpartum bleeding volume, severe hemorrhage complications, blood transfusion, drug application, the application of instrument or surgical hemostasis measures, gestational week of delivery, and neonatal outcomes. The perinatal outcomes were analyzed by univariate and multivariate logistic regression methods. Results: (1) Compared with the control group, the incidence of postpartum hemorrhage [10.4% (42/403) vs 17.6% (71/403)], postpartum hemorrhage volume (median: 375 vs 400 ml), the proportion of postpartum hemorrhage≥500 ml [18.6% (75/403) vs 30.5% (123/403)], and the proportion of application of instrument or surgical hemostasis measures [1.7% (7/403) vs 4.5% (18/403)] in the study group were increased, and the differences were statistically significant (all P<0.05). Neonatal outcomes, including birth weight, small for gestational age, hospitalization in neonatal intensive care unit and incidence of neonatal asphyxia, were compared between the two groups, and there were no statistically significant differences (all P>0.05). (2) In pregnant women with vaginal delivery, the postpartum hemorrhage rate [31.7% (66/208) vs 17.5% (39/223)], postpartum hemorrhage volume (median: 390 vs 380 ml), the proportion of instrument or surgical hemostasis measures [3.8% (8/208) vs 0.4% (1/223)] of the study group were higher than those of the control group, and the differences were statistically significant (all P<0.05). There was no significant difference in the rate of postpartum hemorrhage between the study group and the control group who gave birth by cesarean setion (P=0.545), but the proportion of postpartum hemorrhage≥500 ml in the study group and the control group were 29.2% (57/195) and 20.0% (36/180), and the difference was statistically significant (P=0.039). (3) The results of multivariate analysis showed that compared with the control group, the risk of postpartum hemorrhage (aOR=2.042, 95%CI: 1.313-3.175), the application of drugs (aOR=1.684, 95%CI: 1.142-2.484) and the application of instruments or surgical hemostasis measures (aOR=2.696, 95%CI: 1.089-6.675) were significantly increased in the study group (all P<0.05). Among women who delivered vaginally, the risk of postpartum hemorrhage in the study group was 2.021 times greater than that in the control group (95%CI: 1.269-3.220; P=0.003). Conclusion: In women with placental previa in the second trimester of pregnancy, even if the placental position returns to normal before delivery, it is still a high risk factor for postpartum hemorrhage, especially in vaginal delivery.

Diagnostic value of prenatal ultrasound screening and analysis of pregnancy outcomes in velamentous umbilical cord insertion

Objective: To explore diagnostic value of prenatal ultrasound screening in velamentous umbilical cord insertion (VCI) and its influence on perinatal outcomes, and to provide theoretical basis for clinical practice. Methods: Fifty-eight pregnant women diagnosed with VCI before or after delivery admitted to the First Affiliated Hospital of Xi'an Jiaotong University were selected from January 2012 to December 2022. The clinical features and perinatal outcomes of 45 women finally with VCI after delivery (VCI group) were retrospectively analyzed, and 225 women with normal umbilical cord attachment were selected as the control group during the same period. Results: (1) Among 58 women, 54 (93.1%, 54/58) were diagnosed with VCI by prenatal ultrasound screening, 4 patients (6.9%, 4/58) were missed; and 13 (22.4%, 13/58) were misdiagnosed. Finally, a total of 45 women were confirmed by postpartum placental examination, and 11 (24.4%,11/45) were combined with vasa previa. (2) There were no differences in age, number of pregnancies, and number of induced abortions between the two groups (all P>0.05). Compared with the control group, the rate of assisted reproductive technology [13.3% (6/45) vs 0.4% (1/225); P<0.01], and twin pregnancy rate [8.9% (4/45) vs 0.4% (1/225); P<0.01] in the VCI group were significant higher. (3) Compared with the control group, the rate of placenta previa, succenturiate placenta, vasa previa, postpartum hemorrhage, prenatal hemorrhage and postpartum intrauterine remainder in the VCI group were significant higher (all P<0.05); there was no significant difference in the incidence of placental abruption, premature rupture of membranes, fetal distress and single umbilical artery between the two groups (all P>0.05). The incidence of fetal structural abnormalities in the VCI group (4.4%, 2/45) was higher than that in the control group (1.3%, 3/225), but there was no significant difference between the two groups (P=0.195). (4) The cesarean section rate [75.0% (33/44) vs 45.1% (101/224); P<0.01], preterm birth rate [29.5% (13/44) vs 5.4% (12/224); P<0.01], rate of small for gestational age [20.5% (9/44) vs 5.4% (12/224); P<0.01] in the VCI group were significant higher. However, neonatal birth weight [(2 928±552) vs (3 353±498) g; P<0.01], and 1-minute Apgar score (median: 10 vs 10; P<0.01) in the VCI group were lower than those in the control group. Conclusions: Prenatal ultrasound screening is an important method to diagnose VCI. VCI is more prone to adverse pregnancy outcomes, such as postpartum hemorrhage, premature delivery, small for gestational age, et al. Its risk factors include twin pregnancy, assisted reproductive technology, placenta previa, and para-placenta.

A double‐blind, randomized, placebo‐controlled trial of melatonin as an adjuvant agent for induction of labor: The MILO trial

AbstractIntroductionMelatonin has been suggested to have a biological role in the onset and progress of labor. We tested the hypothesis that the addition of melatonin during an induction of labor will reduce the need for a cesarean birth.Material and MethodsThis trial underwent protocol amendments that are detailed in the main text of the article. This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12616000311459). At a multi‐center health service including secondary and tertiary obstetric hospitals, we performed a randomized, double‐blind, placebo‐controlled trial in women with a singleton cephalic pregnancy, free of significant maternal or perinatal complications who were undergoing induction of labor (with or without cervical ripening). Women were randomized to 10 mg melatonin vs placebo, with cervical ripening as required, and then 6‐h during their induction of labor to a maximum of four doses or until birth. The primary outcome was cesarean birth. Secondary outcomes included labor, maternal, and neonatal outcomes. Data were analyzed using intention to treat. Sub‐group analyses based on mode of ripening and parity were also performed.ResultsBetween 2019 and 2021 we randomized 189 women (103 to melatonin and 86 to placebo). The study was prematurely terminated due to logistical complications resulting from the COVID‐19 pandemic. Cesarean rates were 28/103 (27.2%) in the melatonin group versus 20/84 (23.3%) in the placebo group (RR 1.17 95% CI 0.71–1.92). There were no significant differences in rate of cesarean birth between the melatonin and placebo groups for failure to progress (13.4% and 9.3%, respectively, RR 1.46; 95% CI 0.64–3.32) or suspected fetal distress (10.7% and 10.5%, respectively, RR 1.02; 95% CI 0.44–2.34). The melatonin group had significantly lower rates of spontaneous vaginal birth within 24 h (35.0% vs. 50.0%; RR 0.70 95% CI 0.50–0.98). The rates of secondary outcomes such as total length of labor, rate of postpartum hemorrhage, and instrumental birth were comparable. Babies born in the melatonin group were more likely to need admission to the special care nursery, namely for hypoglycemic monitoring (18.5% vs. 8.1% RR 2.26; 95% CI 1.00–5.10).ConclusionsIn women undergoing induction of labor, melatonin does not reduce the cesarean section rate. Melatonin use intrapartum may also be associated with neonatal hypoglycemia.

Radiosurgery versus observation for brainstem cavernous malformations: a 5-year multicentre cohort study.

The role of radiosurgery in preventing haemorrhage in brainstem cavernous malformations remains a subject of debate. This study aims to evaluate whether radiosurgery provides a protective benefit against haemorrhage in these patients. This multicentre, prospective observational study was conducted in 17 centres and enrolled eligible patients with brainstem cavernous malformations consecutively. Data collected included clinical baseline information, radiosurgery planning details, periodic follow-up evaluations, and any adverse radiation effects. The primary outcome of the study was the incidence of first prospective haemorrhage, while the secondary outcome was the development of new or worsening neurological dysfunctions. The impact of radiosurgery was assessed using multivariate Cox regression analysis. From March 2016 to August 2018, the study enrolled 377 patients: 280 in the observation group receiving standard care alone and 97 in the radiosurgery group receiving both radiosurgery and standard care. The overall cohort consisted of 173 females (45.9%) with a mean age of 40.5 years (range, 18-68 years), and there were no significant differences in baseline characteristics between the two groups. After a median follow-up period of 70 months, haemorrhage occurred in 25.0% (n = 70) of patients in the observation group and 10.3% (n = 10) of patients in the radiosurgery group. Multivariate Cox regression analysis identified radiosurgery as an independent protective factor against haemorrhage (hazard ratio 0.379, 95% confidence interval 0.195-0.738, P = 0.004). Following 1:2 propensity score matching, the incidence of prospective haemorrhage were 24.9% (45/181) in the observation group compared to 10.3% (10/97) in the radiosurgery group (hazard ratio 0.379, 95% confidence interval 0.190-0.755, P = 0.006). Adverse radiation effects were observed in 12 patients (12.4%), with none were permanent. Additionally, new or worsening neurological dysfunctions were significantly more common in the observation group (28.9%) compared to the radiosurgery group (16.5%) (P = 0.016). These results suggest that radiosurgery is associated with a low rate of haemorrhage in patients with brainstem cavernous malformations and could provide a benefit in selected patients. However, further research is required to confirm these findings.

Essential thrombocythemia complicated by multivessel intracranial dolichoectasia with subarachnoid hemorrhage and recurrent cerebral infarction

BackgroundPatients with essential thrombocythemia (ET) can develop systemic thrombotic and hemorrhagic vascular complications due to increased and dysfunctional platelets.Case presentationWe encountered a 49-year-old Japanese woman with a history of essential ET, cerebral infarction, hypertension, and hyperlipidemia. She had been taking anagrelide (2.5 mg/day) and aspirin (100 mg/day) and had vomited at home. At the time of admission to our hospital, she was in a deep stupor. We thought these symptoms were caused by intracranial hypertension. Head computed tomography showed severe subarachnoid hemorrhage (SAH) at the interhemispheric fissure, hematoma at the corpus callosum, and intraventricular hemorrhages. Digital subtraction angiography demonstrated multiple dilated, stenotic, tortuous intracranial arteries, and a dissecting aneurysm at the right anterior cerebral artery (ACA). The dissecting aneurysm measured 7.7 × 15.5 mm, and a bleb was observed. Our diagnosis was ruptured ACA dissecting aneurysm and diffuse intracranial arterial dolichoectasia (DIADE). We performed stent-assisted coil embolization of the aneurysm. She remained apathetic and manifested unilateral apraxia and alien limb syndrome due to a partial callosal disconnection. Two months thereafter her symptoms gradually improved, her consciousness level and limb function improved, and her modified Rankin scale (mRS) score was 2. However, when we tapered her antiplatelet therapy, she again developed an acute cerebral infarct.ConclusionsThis is the first presentation of a patient with ET complicated by DIADE, both of which can result in ischemic and hemorrhagic vascular complications including SAH. As antithrombotic therapy in patients with DIADE and ET may be associated with higher hemorrhage rates, its effects must be monitored carefully.

A Rare Case of a Child with Bended Scarf-Pin in Left Bronchus: Case Report with Systematic Review And Meta-Analysis.

In this report, we present the case of a 19-month-old female diagnosed with hijab pin aspiration after a week of persistent coughing, along with a meta analysis and systematic review of the relevant literature. A comprehensive search was conducted across multiple databases, including Ovid Medline, Cochrane, PubMed, Web of Science, and SCOPUS, yielding 182 records until August 2024. A total of 7 published study and our case included to final analysis. The complication, morbidity, and mortality analysis has been performed using Jamovi software v2.4 MAJOR proportion analysis section. A 19-month-old female was admitted to another hospital with a persistent cough complaint. In X-ray left hijab pin has been detected. The patient underwent a succesfull removal with rigid broncoscopy (RB). A total of 71 patients included this meta analysis. The thoracotomy rate was 8%. The bleeding rate was reported as 1.4%. The reoperation rate was reported as 9.8%. The postoperative intubation rate was reported as 1.4%. The calculated complication rate was found to be 5.6% based on the existing literature. The postoperative hemoptysis incidence was calculated as 0%. Mortality was not reported across any included studies. However, the mortality incidence was calculated as 0% based on included studies. Effective and timely intervention is crucial for managing pediatric hijab pin aspiration. Multidisciplinary approaches ensure successful outcomes and prevent serious complications.

Superior Prophylactic Effectiveness of a Recombinant FVIIIFc Over Standard Half-Life FVIII in Hemophilia A: A-SURE Study.

The 24-month, prospective, non-interventional, European multicenter A-SURE study evaluated the real-world effectiveness of prophylaxis using an extended half-life recombinant factor VIII (FVIII) Fc fusion protein, efmoroctocog alfa (hereinafter rFVIIIFc), compared with prophylaxis using standard half-life (SHL) FVIII products in patients with hemophilia A. Primary endpoints were annualized bleeding rate (ABR), annualized injection frequency, and annualized factor consumption. A comparative study design unique for an observational hemophilia study was implemented to reduce potential confounding in effectiveness estimates, wherein each patient prescribed rFVIIIFc was matched with one receiving SHL FVIII. Propensity scores were used for adjustment in statistical analyses. Outcomes for all primary endpoints were significantly better in the rFVIIIFc group (n = 184) compared with the SHL FVIII group (n = 170): mean ABR 1.5 versus 2.3 (difference of -0.8; p = 0.0147); mean annualized injection frequency 114.4 versus 169.2 (difference of -54.8; p < 0.0001); and mean annualized factor consumption 243 024.2 versus 288 718.6 International Units (difference of 45 694.5; p = 0.0003). rFVIIIFc was well tolerated, with no inhibitor development. rFVIIIFc has superior prophylactic effectiveness versus SHL FVIII, providing higher bleed protection with fewer injections and lower factor consumption.

Comparative outcomes of microdebrider adenoidectomy, curettage adenoidectomy through oral cavity under 70 endoscope, and endoscopic transoral low-temperature ablation for adenoid hypertrophy

AimWe aimed to compare the effects of microdebrider adenoidectomy, curettage adenoidectomy through oral cavity under 70°endoscope, and endoscopic transoral low-temperature ablation on adenoid hypertrophy. MethodsA total of 180 children suffering from adenoid hypertrophy hospitalized during November 2019 and November 2023 were allocated to group A (microdebrider adenoidectomy, n = 65), group B (curettage adenoidectomy through oral cavity under 70° nasal endoscope, n = 54), and group C (nasal endoscopic transoral low-temperature adenoid ablation, n = 61). The operation data (operation time and bleeding amount), pain score, postoperative recovery, and complications were compared. ResultsThe operation time of group A was significantly shorter than those of other two groups, while group C had a significantly smaller bleeding amount than those of other two groups (P < 0.05). An incidence rate of secondary bleeding at 6.15 % was detected in group A, without other complications. Group B had an adenoid residual rate of 35.19 % and a recurrence rate of 14.81 %, significantly exceeding those of other two groups (P < 0.05). The soft palate injury rate was 24.59 % in group C, which was raised significantly compared with those of other two groups (P < 0.05). In comparison to other two groups, significant increases in postoperative pain score and pain duration were detected in Group C (P < 0.05). ConclusionThere is no significant difference in the effective rate among the three methods. Nasal endoscopic transoral low-temperature adenoid ablation is recommended as the first choice because of small bleeding amount, few postoperative residuals, and low recurrence rate, but it poses high requirements on the operation of doctors.

IVUS-Guided vs Angiography-Guided PCIin Patients With Diabetes With AcuteCoronary Syndromes: The IVUS-ACS Trial.

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) reduces the risk for clinical events in patients with acute coronary syndromes (ACS), compared with angiographic guidance. However, the benefits of IVUS guidance in high-risk patients with diabetes with ACS is uncertain. The aim of this prespecified stratified subgroup analysis from the IVUS-ACS randomized trial was to determine the effectiveness of IVUS-guided PCI vs angiography-guided PCI in patients with diabetes with ACS. From August 20, 2019, to October 27, 2022, 1,105 patients with diabetes with ACS were randomized, including 554 patients in the IVUS-guided group and 551 in the angiography-guided group. The primary endpoint was the rate of target vessel failure (TVF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization. At 1-year follow-up, TVF occurred in 20 patients in the IVUS guidance group and in 46 patients in the angiographic guidance group (Kaplan-Meier rates 3.6% vs 8.3%; HR: 0.46; 95%CI: 0.27-0.81; P=0.007), driven by a reduction in clinically driven target vessel revascularization (0.9% vs 3.8%; P=0.003). IVUS-guided PCI also reduced the risk for TVF without procedural myocardial infarction (2.0% vs 6.7%; HR: 0.29; 95%CI: 0.15-0.57; P< 0.001) and all-cause mortality (HR: 0.30; 95%CI: 0.10-0.93; P=0.037). There were no significant differences in the rates of stent thrombosis or major bleeding between the groups. In the large-scale IVUS-ACS trial, IVUS-guided PCI improved 1-year clinical outcomes in high-risk patients with diabetes with ACS. (1-Month vs 12-Month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials; NCT03971500).

Identify of Preoperative and Postoperative Complication of Planned Management and Emergency Management of Patients with PAS Disorder

Background: Placenta accreta spectrum (PAS) often results in significant blood loss and peripartum hysterectomy; the mother may not survive. In many cases, timely prenatal diagnosis allows for careful birth planning in a specialized facility with a highly qualified multidisciplinary team. This has been shown to reduce maternal morbidity. Scheduled deliveries are associated with lower rates of bleeding and emergency procedures when compared to emergency deliveries. Objective: The aim of this study is to identify the preoperative and postoperative complication of planned management and emergency management of patients with PAS disorder. Methods: The cross-sectional comparative study was conducted in the Department of Obstetrics &amp; Gynaecology, Dhaka Medical College Hospital, Dhaka from 18th January 2020 to 17th July 2020. A total of 84 patients diagnosed as a case of PAS disorder (antenatally and peroperative diagnosed) and scheduled for planned management or emergency management of PAS were included according to inclusion and exclusion criteria. 42 planned management of PAS disorder patients as Group A and 42 emergency management of PAS disorder patients as Group B. The questionnaire was pretested, corrected and finalized. Data were collected by face-to-face interview and analyzed by appropriate computer based programmed software Statistical Package for the Social Sciences (SPSS), version 24. Results: In this study, mean ± SD of age was calculated 26.3 ± 4.3 years for Group – A and 28.1 ± 3.2 years for Group – B. Urban population were predominant in group-A. About 30 (70.0%)) patients in group-A and 10 (23.8%) patients in group-B came from urban. Large number of respondents 22 (52.4%) and 10 (50.0%) were housewife in both groups. Among the patients, the lower class 18 (42.9%) and 23 (54.8%) comprised the major percentage of the patients in both groups. More participants in Group-A 29 (69.00%) received ANC regularly than Group B 10 (23.80%), the difference was statistically significant (p&lt;0.05). In group-A maximum patients presented with only USG findings of PAS disorders and with APH or without APH 26 (61.8%). In group-B, PPH and internal haemorrhage 10 (23.8) was noted predominantly. The mild anemia was more in 23 (54.8%) patients in group A and 16 (38.1%) patients in group B which was statistically significant (p &lt; 0.001). More participants in Group-B 26 (61.9%) required early termination, whereas majority of group A 35 (83.3%) was terminated at 35-36 weeks. There was a statistically significant difference between groups. Maximum patients were managed by peripartum hysterectomy 35 (82.0%) and 31 (73.8%) in group A &amp; B respectively. Presence of multidisciplinary team was arranged in 38 (90.4%) in group A and 18 (42.9%) in group B. General anesthesia and CV line was given in 36 (85.7%) patients in group-A and 27 (64.3%) patients in group-B. Massive blood transfusion was needed in 23 (54.8%) patients in Group B &amp; only 3 (7.1%) patients in Group A. Placenta acreta was present 11 (26.2%) patients in group A and 7 (16.7%) patients in group B. Placenta percreta with bladder invasion and peroperative bladder injury was higher in group-B patients. More than 3 L blood was transfused 3 (7.1%) patients in group A and 23 (54.8%) patients in group B. PPH, Sepsis, Re-exploration, DIC and ICU admission were the significant complication in Group-B patients, reported 41 (95.0), 4 (9.5%), 8 (19.0%), 9 (21.4%) and 21 (50.0%) of women and in less complication in Group A 13 (31.0), 0%, 0%, 1 (2.3) and 4 (9.5). In this study mortality rate was 2 (4.8%) in group-B (due to irreversible shock &amp;DIC). Poor outcomes were significantly higher in group-B. NICU admission for prematurity was required in 9 (21.4%) of the babies in group-A and 23 (54.8%) babies of group-B. Birth asphyxia was observed in 4 (9.5%) of the babies in group-A and 13 (31.0%) in Group-B. Conclusion: Prenatal diagnosis and placenta preservation may be linked to lower rates of morbidity in mothers. For morbidly adherent placenta linked with placenta previa, we advise hysterectomy as the preferred course of therapy following extremely thorough prenatal counseling. Maternal problems and fetal outcomes may be improved by early risk factor identification and proactive management.

Real-world experience of emicizumab prophylaxis in Korean children with severe hemophilia A without inhibitors

PurposeHemophilia A is a genetic disorder characterized by a lack of factor VIII (FVIII). Emicizumab, a recombinant humanized bispecific monoclonal antibody, mimics the function of FVIII. In this article, we present data on an initial real-world evaluation of emicizumab use in Korean children with severe hemophilia A without inhibitors.MethodsThis study was conducted from June 2020 to March 2024 at 4 centers in Korea. The participants were pediatric patients with severe hemophilia A without inhibitors who had received emicizumab treatment for over 6 months. The mean and median annualized bleeding rates (ABRs) and mean and median annual joint bleeding rates (AJBRs) were compared.ResultsEach of the 21 patients in the study received an emicizumab loading regimen of 3 mg/kg weekly for 4 weeks, followed by a modified maintenance regimen of which 2 patients (9.5%) received a 1.5 mg/kg weekly dose, 3 patients (14.3%) received a 6 mg/kg dose every 4 weeks, and the remaining 16 patients (76.2%) received a 3 mg/kg dose every 2 weeks. Before emicizumab prophylaxis initiation, the mean and median ABRs for all patients were 7.04 (SD ± 5.83) and 6.52 (range 0–21.74), respectively. After receiving emicizumab treatment, the mean and mediam ABRs decreased to 0.41 and zero, respectively. Additionally, 85.7% of the patients achieved no bleeding events within 6 months of starting the treatment.ConclusionThese first real-world data in Korea indicate that emicizumab is effective and safe for pediatric patients with severe hemophilia A without inhibitors.

Comparison of continuous flow centrifugal left ventricular assist devices as a bridge to transplant strategy in a low organ donation environment: single center experience

ObjectiveIn patients with advanced heart failure, heart transplantation is currently the most effective treatment. However, in a low-organ environment, it is usually necessary to proceed in long-term mechanical circulatory support through left ventricular assist device (LVAD) implantation as bridge-to-transplantation. MethodsThe study included all patients with advanced heart failure who underwent continuous flow LVAD implantation as a bridge to transplant strategy in our center (n = 68). Following LVAD implantation and for the period that patients were on LVAD support, pump thrombosis, strokes, gastrointestinal bleeding, and right heart failure occurrence rates were recorded. Outcomes were compared between patients implanted with HeartMate 3 (HM3) and HeartWare LVADs, as well as between patients who did reach heart transplantation (HTx group) and those who did not (noHTx group). ResultsA total of 35 out of 68 patients underwent heart transplantation at a mean time of 691 ± 457 days; 41 received a HeartWare and 27 a HM3 device. HM3 patients had significantly better survival (p = 0.010) and lower complication rates (p = 0.025). In addition, the noHTx group had significantly higher complication rates compared with the HTx group (p = 0.00041). The 5-year estimated Kaplan–Meier survival rate following heart transplantation was 77%. ConclusionPatients with advanced heart failure gain substantial benefit from LVADs awaiting heart transplantation. In a low organ donation environment, the need for reliable LVADs can further improve the outcomes through the reduction of complications provided by current devices.