In-hospital Bleeding Research Articles

Left appendage closure after intracranial hemorrhage: safety, efficacy and timing

Abstract Background Oral anticoagulation (OAC) use increases the risk of intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF). Left atrial appendage occlusion (LAAO) is an alternative to OAC, however data about its use in patients with prior ICH is scare and the timing of its performance is controversial. Furthermore, the long-term outcomes in this group of patients have not been described. Objective To evaluate the safety and efficacy of LAAO in patients with non-valvular AF and prior ICH (CHA2SVASc >2) and to determine adequate timing of its performance. Methods The sample was obtained from a cohort of 397 patients with AF in which LAAO was performed between 2009 and 2020. In 115 of these patients, the indication for this procedure was ICH (29.8 %). Patients were divided into two groups: early occlusion (n=68; 59%), in which the procedure was performed before 90 days had elapsed after the bleeding, and late occlusion (n=47; 41%), after 90 days. Results Procedure success was 97% globally. Annual incidence of ischemic events was of 0,6%, with an absolute risk reduction of 5,9% and relative risk reduction of 90,3% compared to the predicted risk by CHA2DS2-VASC score. Regarding major hemorrhagic events, annual incidence was of 4%, with an absolute risk reduction of 3,4% and relative risk reduction of 45% compared to the predicted risk by HASBLED score. There were no significant differences between the procedures performed in patients with history of intracranial bleeding and other indications for the procedure. Early closure (first 90 days after the intracranial hemorrhage) was as safe as late closure, without an increase in in-hospital bleedings or complications. Furthermore, long-term follow-up demonstrated a significant reduction in all-cause mortality (11.76% versus 46.8%; HR 0.2, IC95% 0.07-0.55; p<0.001). compared with late occlusion. Conclusions Left atrial appendage occlusion is an effective and safe treatment option to reduce the risk of ischemic stroke in selected patients with AF patients and history of ICH over mean follow-up of 3 years. Early occlusion seems to be at least as safe and effective as late occlusion and therefore could potentially reduce the rate of complications after ICH in selected patients.Survival and closure timingIschemic and bleeding risk reduction

Pretreatment with parenteral anticoagulation in patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis

Abstract Background and Aim According to ESC guidelines, parenteral anticoagulation is recommended for all patients presenting with ST-segment elevation myocardial infarction (STEMI) during primary percutaneous coronary intervention (PPCI). However, no specific recommendations are made regarding the timing of administration. In fact, whether upstream anticoagulation improves clinical outcomes in STEMI patients is not well established. We conducted a systematic review and meta-analysis of current evidence on parenteral anticoagulation timing for patients presenting with STEMI. Methods We performed a systematic search of electronic databases (PubMed, CENTRAL and Scopus) until December 2022. Studies were considered eligible if they a) compared upstream anticoagulation with administration at the catheterization lab; and b) enrolled patients with STEMI undergoing PPCI. Studies comparing different anticoagulants were excluded from the analysis. Random-effects meta-analyses were performed. Efficacy outcomes included TIMI flow-grade pre- and post-PPCI, in-hospital cardiogenic shock (CS) and 30-day all-cause mortality. Safety outcome was defined as major in-hospital bleeding events. Results Overall, 9 studies were included (all non-randomized), with a total of 69,571 patients (30,693 in the pretreatment arm). In all but one, anticoagulation strategy was exclusively based on unfractionated heparin. Pretreatment was associated with a significant reduction in the incidence of 30-day all-cause mortality (OR 0.61; 95% CI 0.47-0.80; p<0.001) and in-hospital CS (OR 0.69; 95% CI 0.59-0.81; p<0.001). Upstream anticoagulation was also associated with a significant increase of spontaneous reperfusion of the culprit artery before PPCI (pre-PPCI TIMI > 0: OR 1.47; 95% CI 1.35-1.60; p<0.001) and TIMI flow ≥ 2 after coronary intervention (OR 1.28; 95% CI 1.05-1.56; p=0.016). Regarding safety outcomes, pretreatment was not associated with an increase of in-hospital major bleeding (OR 1.01; 95% CI 0.70-1.44; p=0.970). Multiple sensitivity analyses, including propensity-matched populations, showed consistent results. Conclusions Upstream anticoagulation was associated with a significant lower risk of 30-day all-cause mortality, incidence of in-hospital cardiogenic shock and improved reperfusion of culprit artery. These benefits were not accompanied by an increased risk of major bleeding, suggesting an overall clinical benefit of early anticoagulation in patients presenting with STEMI. These results require confirmation in a randomized clinical trial.

Subcutaneous versus transvenous ICDs: a population-level comparison of incidence, patient characteristics, and complications of S-ICDs, ICDs, and CRT-Ds in a nationwide Dutch cohort (2018-2020)

Abstract Background Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have emerged as a safe and effective alternative to ICDs for the prevention of sudden cardiac death. Compared to ICDs, S-ICDs aim to reduce morbidities associated with the transvenous lead including lead dislocation and infection. Limited evidence exists for the utilization, patient selection, and complications of S-ICDs in current real-world clinical practice. Purpose Our aim was to compare the implantation rate, patient characteristics, and complications of patients who underwent S-ICD, ICD, and CRT-D implants and replacements in the Netherlands from 2018 to 2020. Methods The Netherlands Heart Registration includes all adult patients who underwent an ICD implant or replacement at 28 hospitals in the Netherlands (2018-2020). Annual crude, age-, and sex-standardized incidence rates were assessed with Poisson regression models with robust variances. Patient characteristics and complications were compared between ICD types with ANOVA tests. Determinants of complications were identified with multivariable logistic regression models. Results Of 17,080 patients who had a de novo ICD implant (n=10,317) or replacement (n=6,763) in the Netherlands (2018-2020), 1408 (8.2%) patients had an S-ICD, 9441 (55.3%) patients received an ICD only, and 6231 (36.5%) patients received a CRT-D. The incidence of de novo S-ICDs were stable over time, however the incidence of de novo ICD only and CRT-D implants decreased by 5% and 11%, respectively (p<0.05 for both; Figure 1). Patients who received S-ICDs were younger (53 years, IQR 41-62) than ICD (66 years, IQR 57-73) and CRT-D (70 years, IQR 62-75) patients (p<0.05). A greater proportion women had S-ICDs (25.0%) and CRT-Ds (26.7%) implanted compared to ICDs (19.9%) (p<0.05). Further, less atrial fibrillation patients had S-ICDs (21.6% vs ICD 30.9%, and CRT-D 32.4%). ICDs for primary prevention were implanted in 56.4%, 48.4%, and 81.2% of S-ICD, ICD, and CRT-D patients, respectively (p<0.05). The incidence of lead dislocations was less among S-ICD patients compared to ICD and CRT-D patients (p<0.001; Figure 2). There was no difference detected for other complications or long-term mortality (p>0.05 for all; Figure 2). Infections in S-ICD patients [aOR 0.2 (95% CI 0.1-0.9)] and in-hospital bleeding for CRT-D patients [aOR 0.4 (95% CI 0.2-0.9)] decreased among patients who underwent an ICD implant in recent years. In addition, advancing age was identified as a risk factor for in hospital bleeding in S-ICD patients [aOR 1.1 (95% CI 1.0-1.2)] and for pneumothorax in CRT-D patients [aOR 3.6 (95% CI 2.0-6.8)]. Conclusion In real-world practice, S-ICDs were implanted in younger patients with fewer comorbidities and portended a lower risk of lead dislodgement than ICDs and CRT-Ds; however, the population-level implantation rate of S-ICDs did not vary between 2018 to 2020 in the Netherlands.

Systemic Coagulation Inflammation Index Associated With Bleeding in Acute Coronary Syndrome.

Assessment of the inflammatory component of acute coronary syndrome (ACS) and the degree of activation of the coagulation cascade may provide prognostic information. The systemic coagulation-inflammation index (SCI) assesses both inflammation and the coagulation system, and it has also been found to be associated with clinical outcomes. We investigated the relationship between SCI and in-hospital clinical events (acute kidney injury, cardiogenic shock, life-threatening arrhythmia, bleeding) and mortality. The study included 396 patients aged ≥18 yrs who were hospitalized with a diagnosis of ACS. The SCI was calculated using the formula: platelet count (103 / µl) X fibrinogen (g / l) / white blood cell (WBC) count (103 / µl). Patients were divided into two groups according to whether their SCI score was >100 or <100, and the relationship between clinical and laboratory characteristics was analyzed accordingly. The mean age of the patients was 61.4±12.2 years and 78.3 % (n=310) were male. The type of ACS was NSTEMI in 56.1 % (n=222). The responsible vessel was the left anterior descending artery (LAD) in 42.4 % of the patients (n=168). The mean SCI score was 97.5±47.1. WBC, neutrophil, and lymphocyte counts were higher in the SCI <100 group, whereas fibrinogen, C-reactive protein, and platelet count were higher in the SCI >100 group. Bleeding from any cause as an in-hospital complication was significantly higher in patients with SCI >100 (p<0.05). Other in-hospital events were not significantly associated with SCI (p>0.05). Bleeding in ACS patients was significantly more common in the group with SCI >100. Thus, SCI may be a useful parameter for predicting in-hospital bleeding complications in ACS. On the other hand, SCI was not associated with mortality and other in-hospital clinical events.

Abstract 12836: Safety and Efficacy of Left Atrial Appendage Occlusion in Patients With Chronic Kidney Disease: A Meta-Analysis

Introduction: Left atrial appendage occlusion (LAAO) has been recognized as an alternative to preventing thromboembolic stroke in selected patients with non-valvular atrial fibrillation (AF). However, limited evidence exists regarding the safety of LAAO in patients with chronic kidney disease (CKD). This meta-analysis aims to evaluate the safety and efficacy of LAAO in CKD patients. Methods: We conducted a comprehensive search across various electronic databases, including PubMed, Embase, and the Cochrane Library, to identify relevant studies comparing the outcomes of CKD and non-CKD patients undergoing LAAO. The outcomes of interest included procedural success, in-hospital mortality, major bleeding, stroke, transient ischemic attack (TIA), and pericardial effusion/tamponade. The outcomes were pooled using the Hartung-Knapp-Sidik-Jonkman random-effects model, and the results were expressed as odds ratios (OR) with their corresponding 95% confidence intervals (CI). Results: Seven studies involving 38,184 patients (5,742 CKD, 32,442 non-CKD) were included in the final analysis. The rate of procedural success (98.4% vs. 97.2%, OR 1.64, 95% CI: 0.78-3.45, p=0.19) was similar between both groups. Regarding procedural complications, there were no significant differences in terms of the risk of in-hospital mortality (OR 1.87, 95% CI: 0.60-5.82, p=0.28), stroke (OR 2.19, 95% CI: 0.76-6.29, p=0.15), TIA (OR 1.64, 95% CI: 0.78-3.45, p=0.19), major bleeding (OR 1.85, 95% CI: 0.78-4.42, p=0.16), or pericardial effusion/tamponade (OR 1.23, 95% CI: 0.76-2.00, p=0.39) between the two patient groups. Conclusions: Our study demonstrates comparable safety and efficacy of LAAO in patients with CKD compared to those without CKD. Further large prospective studies are warranted to confirm these findings.

Abstract 18054: Contemporary In-Hospital Outcomes of Congestive Heart Failure With Multiple Myeloma; a Regression Matched Analysis

Introduction: Multiple myeloma (MM) is a disease commonly found in elderly individuals and is associated with a high burden of cardiovascular comorbidity. Various disease manifestations in MM, including amyloidosis, anemia, hyperviscosity, hypercalcemia, intramedullary arteriovenous fistula formations, and chemotherapy-related complications, contribute to an increased risk of congestive heart failure (CHF). The objective of this study was to examine the clinical outcomes of MM patients admitted with CHF. Methods: The National Inpatient Sample database from 2016-2020 was queried to identify patients with a primary diagnosis of CHF and stratified based on the presence of MM. The primary outcome measured was in- hospital mortality. The adjusted odds ratio (aOR) of in-hospital outcomes were calculated using software STAT v.17. Results: Of the 536,700 primary hospitalizations with CHF, 1,965 (0.36%) had MM. On adjusted analysis, the CHF-MM cohort had a higher odds of cardiac arrest (aOR 2.5, 95% CI 1.2-5.5), need for new hemodialysis (aOR 2.4, 95% CI 1.6-3.6) and GI bleeding (aOR 2.1, 95% CI 1.1-3.8) However, there was no statistically significant difference in the odds of in-hospital mortality, stroke, AMI or major bleeding. Furthermore, the presence of MM in CHF related hospitalizations was not associated with higher length of stay and adjusted total cost. Conclusion: Our study reveals that MM patients admitted with CHF have an increased risk of cardiac arrest, new hemodialysis, and GI bleeding. To optimize cardiovascular outcomes in this high-risk patient population, a multidisciplinary approach involving hemato-oncologists and cardiologists is necessary.

Abstract 12054: Activated Clotting Time and Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the PROGRESS-CTO Registry

Introduction: The optimal range of activated clotting time (ACT) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. Methods: We examined the association between ACT and in-hospital ischemic and bleeding outcomes in patients who underwent CTO PCI in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). Results: ACT values were available for 4,377 patients who underwent CTO PCI between 2012 and 2023 at 29 centers. Mean ACT distribution was: <250 seconds (19%), 250-349 seconds (50%), and ≥350 seconds (31%). The incidence of ischemic events was 0.8%, bleeding events 3.0%, and net adverse cardiovascular events (NACE, composite of in-hospital all-cause mortality, myocardial infarction, stroke, urgent repeat revascularization, pericardiocentesis, and bleeding) 3.8%. In multiple logistic regression analysis, increasing nadir ACT was associated with decreasing ischemic events: adjusted odds ratio (aOR) per 50-second increments: 0.69 (95% confidence interval [CI] 0.50-0.94, p=0.017); and increasing peak ACT was associated with increasing bleeding events: aOR per 50-second increments 1.17 (95% CI 1.01-1.36, p=0.032). A U-shaped association was seen between mean ACT and NACE, where restricted cubic spline analysis demonstrated that patients with low (<200 seconds) or high (>400 seconds) ACT had increasing NACE risk, compared with ACT 200-400 seconds (aOR 2.06, 95% CI 1.18-3.62, p=0.012) (Figure). Conclusions: Among patients who underwent CTO PCI, mean ACT had a U-shaped relationship with NACE, where patients with low (<200 seconds) ACT (driven by ischemic events) or high (>400 seconds) ACT (driven by bleeding) had higher NACE compared with ACT of 200-400 seconds.

Abstract 15975: Cardiogenic Shock Teams Are Associated With Lower Mortality, Bleeding and Vascular Complications: A Systematic Review and Meta-Analysis

Introduction: Short-term mortality and morbidity associated with cardiogenic shock (CS) remains high. However, observational studies suggest that CS teams improve outcomes. Our aim is to systematically evaluate the outcomes associated with CS team use by performing a meta-analysis of the published literature. Methods: A comprehensive literature search of the PubMed/EMBASE, Cochrane databases and published abstracts was performed from inception to 06/01/2023 including studies comparing CS outcomes before and after the implementation of CS teams (excluding case reports and pediatric studies). Outcomes included in-hospital mortality, bleeding, vascular complications, use of temporary mechanical circulatory support (tMCS), and renal replacement therapy (RRT). Odds ratios (OR) with 95% confidence intervals (CI) were calculated using DerSimonian-Laird method. The Eggers test was used to assess publication bias; significant heterogeneity was considered if I 2 > 75%. Results: Of 524 studies screened, 5 met inclusion criteria. This included 2,331 subjects (1091 managed with a CS team and 1270 without, mean age 62.5 years, 72.1% male, 41% non-white). The implementation of CS teams was associated with lower risk of in-hospital mortality ([OR] = 0.63 [95% CI 0.49 - 0.81]; I 2 =19%; p < 0.001) (Fig), major bleeding (OR = 0.69 [95% CI 0.48 - 0.99]; I 2 =0%; p = 0.042), and vascular complications (OR = 0.61 [95% CI 0.40 - 0.93]; I 2 =0%; p = 0.021) compared to management without CS teams. There were no differences in tMCS (OR = 0.81 [95% CI 0.56 - 1.17]; I 2 =52%; p = 0.26) or RRT use (OR = 0.74 [95% CI 0.44 - 1.25]; I 2 =78%; p = 0.26). There was no evidence of publication bias (p > 0.05). Conclusions: In this meta-analysis, CS team implementation was associated with lower in-hospital mortality, major bleeding, and vascular complications, but no difference in the use of tMCS or RRT. These findings support further prospective studies to assess the impact of CS teams in improving outcomes.

Abstract 16830: Feasibility and Safety of Intracardiac Echocardiography Guidance in Mitral Transcatheter Edge-to-Edge Repair: Analysis of the National Inpatient Sample Data From 2015 to 2020

Introduction: Data on use of ICE guidance in TEER procedure is limited to case reports and small case series. Our study aims to assess the feasibility, safety, utilization patterns and clinical outcomes of mitral TEER procedure with ICE guidance using a nationally representative real-world cohort of patients.Hypothesis: There is no difference between ICE-guided TEER and TEE-guided TEER in the clinical outcomes and complications. Methods: This study used the National Inpatient Sample database from quarter 4 of 2015 to 2020. We used a propensity-matched analysis and adjusted odds ratios for in-hospital outcomes/complications. A P value of <0.05 was considered significant. Results: A total of 38,770 weighted cases of mitral TEER were identified. Of the included patients 665 patients underwent ICE-guided TEER while 38,105 had TEE-guided TEER. There were no differences in the in-hospital mortality between both groups (2.5% vs. 3.0%, p=0.58). Adjusted odds of in-hospital mortality (aOR 0.83, 95%CI [0.42-1.64]) were not significantly different. There were no differences in periprocedural complications including cardiac (aOR 0.85, 95%CI [0.54-1.35]), bleeding (aOR 1.45, 95%CI [0.93-2.33]), respiratory (aOR 0.88, 95%CI [0.61-1.25]), and renal (aOR 0.89, 95%CI [0.66-1.20]) complications between patients undergoing ICE-guided versus TEE-guided TEER. There was no difference in GI complications between both groups (aOR 1.11, 95%CI [0.46-2.70]). The adjusted length of stay was less among ICE-guided TEER (median: 1 vs. 2, p<0.01) with no differences in costs of hospitalization ($137,312 vs. $153,773, p=0.06), Conclusions: In conclusion, ICE-guided mitral TEER is safe when compared with TEE guided TEER with no significant differences in in-hospital mortality, cardiac, bleeding, respiratory, and renal complications. The length of stay in ICE group is shorter as compared with the TEE group.

Abstract 15445: Extracorporeal Membrane Oxygenation and Reperfusion Strategies in High-Risk Pulmonary Embolism Hospitalizations

Introduction: Extracorporeal membrane oxygenation (ECMO) offers potentially life-saving circulatory support in patients with high-risk pulmonary embolism (PE) and refractory hemodynamic instability. Optimal reperfusion strategies in combination are unclear. Hypothesis: To investigate the contemporary use of ECMO in conjunction with reperfusion strategies in high-risk PE. Methods: We identified high-risk PE hospitalizations in the Nationwide Inpatient Sample (years 2016-2020) and investigated the use of ECMO in conjunction with thrombolysis-based (systemic thrombolysis or catheter-directed thrombolysis) and mechanical (surgical embolectomy or catheter-based thrombectomy) reperfusion strategies with regards to in-hospital mortality and major bleeding. Results: Among 122,735 hospitalizations for high-risk PE ECMO was used in 2,805 (2.3%); stand-alone in 1.4%, with thrombolysis-based reperfusion in 0.4%, and with mechanical reperfusion in 0.5%. Compared to neither reperfusion nor ECMO, ECMO plus thrombolysis-based reperfusion was associated with reduced in-hospital mortality (adjusted OR, 0.60; 95% CI, 0.38-0.97), whereas no difference was found with ECMO plus mechanical reperfusion (1.02; 0.66-1.59), and ECMO stand-alone was associated with increased in-hospital mortality (1.59; 1.21-2.09). In the cardiac arrest subgroup, ECMO was associated with reduced in-hospital mortality (0.71; 0.53-0.93). Among all patients on ECMO, thrombolysis-based reperfusion was significantly associated (0.54; 0.32-0.90), and mechanical reperfusion showed a trend (0.74; 0.47-1.18) towards reduced in-hospital mortality compared to no reperfusion, without increases in major bleeding. Conclusions: In patients with high-risk PE and refractory hemodynamic instability, ECMO may be a valuable supportive treatment in conjunction with reperfusion treatment but not as stand-alone treatment especially for patients suffering from cardiac arrest.

Abstract 15587: Iimpact of Body Mass Index on Bleeding Events Patients Undergoing Percutaneous Coronary Intervention With or Without High Bleeding Risk

Introduction: High body mass index (BMI) values are associated with a lower risk of ischemic complications after percutaneous coronary intervention (PCI). Hypothesis : Higher BMI values may correlate with fewer bleeding after PCI in patients meeting or not the High Bleeding Risk (HBR) criteria of the Academic Research Consortium (ARC). Methods: All patients undergoing PCI between 2012 and 2019 at the Mount Sinai Hospital were included and stratified in 5 BMI categories according to World Health Organization definition. Patients where considered at HBR if they fulfilled ≥1 major or ≥2 minor ARC-HBR criteria. The primary outcome was major bleeding, the secondary outcome was post-discharge major bleeding at 1 year after PCI. Risks for these outcomes were obtained using a multivariable Cox regression model adjusted for the ARC-HBR criteria. Results: Among 16,229 patients, 20.2% had a BMI ≥18.5-25 (normal), 40.7% had a BMI ≥25-30, 24.4% had a BMI ≥30-35, 9.2% had a BMI ≥35-40, and 4.8% had a BMI ≥40 kg/m 2 . The proportion of patients meeting the ARC-HBR criteria progressively decreased from 48% in the normal BMI group to 41% in the highest BMI group. As compared to the normal BMI group (6.0%), the 1-year risk of major bleeding was significantly lower (p<0.05) in the groups with BMI ≥25-30 (4.1%, adj. HR 0.73, 95% CI 0.60-0.88), with BMI ≥30-35 (3.5%, Adj. HR 0.62, 95% CI 0.49-0.77), with BMI ≥35-40 (4.2%; Adj. HR 0.72, 95% CI 0.54-0.9), while it was similar in the group of BMI ≥40 (4.9%, Adj. HR 0.83, 95% CI 0.58-1.18) ( A ). These differences were driven by lower rates of in-hospital bleeding in patients with BMI ≥25-40 kg/m 2 . Among HBR patients, 1-year rates of major bleeding were consistently above 4% in each BMI category, but relatively lower for BMI ≥25-40 kg/m 2 ( B ). Conclusions: BMI values between 25 and 40 kg/m 2 were associated with an attenuated risk of major bleeding at 1-year in patients undergoing PCI and this association was consistent among HBR individuals.

Transplacental Transfer of Emicizumab: Experience with Emicizumab in a Pregnant Female with Severe Hemophilia Α and an Inhibitor

Introduction: Severe hemophilia A (HA) in females is incredibly rare particularly if complicated by a high-titer factor VIII (FVIII) inhibitor. We report, to the best of our knowledge, the first-of-its-kind use of emicizumab (emi) ante/post-partum, its effect on the newborn, and its excretion in breast milk. Baseline details: 29-year-old-female was diagnosed with severe HA at age 1 following prolonged bleeding from a venipuncture site. She had no family history of HA. One stage FVIII activity (OSA) was less than 1%. She was compound heterozygous for F8 type 1 and type 2 intron 22 inversions. At 21 months of age, she developed a high-titer inhibitor (peak: 35 Bethesda unit[BU]). She was not treated with immune tolerance induction and had remained on factor eight inhibitor bypassing activity (FEIBA) as prophylaxis until transferring to our center. She was transitioned to monthly emi prophylaxis and recombinant FVIIa (rFVIIa, NovoSeven) for breakthrough bleeding at age 26. She was medically advised against pregnancy due to unclear safety profile of emi in pregnancy and theoretical concerns for an increased risk of bleeding and thrombotic complications associated with the use of bypassing agents in the peripartum setting. Nevertheless, she desired pregnancy and continued on emi prophylaxis every 4 weeks during her pregnancy. Clinical course in pregnancy: She had an uncomplicated antepartum course and did not require rFVIIa for breakthrough bleeds. Blood emi levels and FVIII inhibitor levels were measured in each trimester of pregnancy (Table 1). Her labor was induced with oxytocin while on rFVIIa and tranexamic acid (TXA) support. She had a spontaneous, unassisted vaginal delivery immediately complicated by post-partum hemorrhage resulting in estimated blood loss of 1100cc. She did not require blood transfusion. She continued on 90 mcg/kg rFVIIa support every 2 hours, gradually prolonging the dosing interval by 2 hours every 24 hours (q2, q4, q6, etc.), and experienced no further in-hospital bleeding. She delivered a healthy female newborn. The infant developed cephalhematoma but transcranial ultrasound was negative for intracranial bleeding. Cord blood was collected at the time of delivery and sent for emi level, FVIII activity and FVIII inhibitor titer (Table 2). FVIII inhibitor assay with bovine reagent (CBU) was performed using chromogenic substrate assay (CSA) after pre-analytical heat-inactivation of patient plasma. The infant's CSA FVIII level was measured using a bovine chromogenic FVIII assay, and FVIII was also assayed using a one-stage APTT-based assay. Mother opted to breast-feed the infant. Emi level was measured in breast milk (Table 1). Conclusion: In this highly unusual case, we demonstrate that emi crossed the placenta and is excreted in breast milk. We also demonstrate that the maternal FVIII inhibitor did not cross the placenta into the newborn. Drawing conclusions on the safety of emi despite placental and breast milk transmission and transmissibility of inhibitor based on a single case would be premature. The conglomeration of several rarities in a single case renders our report unique and insightful and provides a baseline experience for future cases.

Gender Specified In-Hospital Outcome after Left Atrial Appendage Closure with a Dual Occlusive Mechanism Device

Background: Recent studies have suggested an increased rate of adverse events in women following left atrial appendage occlusion (LAAO), particularly with dual occlusive mechanism devices. Objectives: This study aimed to investigate gender disparities in in-hospital adverse events and short-term device-related outcomes in an experienced center using dual occlusive mechanism devices exclusively. Methods: In a single-center retrospective study, patients who received dual occlusive mechanism devices (Amplatzer cardiac plug and Amulet) were analyzed. We assessed gender differences in patient characteristics, LAAO indications, procedural data, in-hospital complications, and short-term device-related outcomes in the form of one-month follow-up transesophageal echocardiography. Results: Among 474 patients, 211 (45%) were women. At device implantation, women were significantly older (77.45±6.98 years vs. 75.89±7.26; p = 0.01), with higher CHA2DS2Vasc scores (5.03±1.46 vs. 4.28±1.51; p < 0.01) and lower HASBLED scores (3.78±1.06 vs. 4.03±1.12; p = 0.01) compared to men. Men had a higher prevalence of coronary artery disease (52% vs. 32%; p < 0.01). LAAO indications did not significantly differ. Device success was 99% in men and 98% in women (p = 0.75). In-hospital complications, including deaths, major bleedings, and pericardial effusion, did not significantly vary by gender. Rates of device-related thrombus and device closure with a residual jet ≤ 5 mm were similar. Conclusions: In a large cohort of consecutive LAAO patients at an experienced center, gender was not linked to higher in-hospital complications.

Efficacy and safety of patients with chronic kidney disease undergoing left atrial appendage closure for atrial fibrillation.

The relative safety and efficacy of left atrial appendage closure (LAAC) for atrial fibrillation (AF) in patients with chronic kidney disease (CKD) have not been well defined. To evaluate the results in this cohort, we conducted a systematic review and meta-analysis of observational studies. We searched the PubMed, EMBASE, Web of Science, and Cochrane Library databases from inception to January 2023 for all relevant studies. Our inclusion criteria were met by twelve observational studies that included 61324 patients altogether. Compared with no CKD group, in-hospital mortality (OR: 2.84, 95% CI: 2.12-3.81, p<0.01, I2 = 0%), acute kidney injury (AKI) (OR: 4.39,95% CI:4.00-4.83, P<0.01, I2 = 3%), major bleeding events (OR: 1.44, 95% CI: 1.29-1.60, p<0.01 I2 = 0%), and pericardial effusion/tamponade (OR 1.30; 95% CI 1.13-1.51, p < 0.01; I2 = 0%) were more common in the CKD group, especially in patients with end-stage renal disease (ESRD). No significant difference was observed in the occurrence of stroke (OR: 1.24, 95% CI: 0.86-1.78, P = 0.25, I2 = 0%), LAAC success rates (OR: 1.02, 95% CI: 0.33-3.16, p = 0.97, I2 = 58%) and vascular access complications (OR: 1.13, 95% CI: 0.91-1.39, p = 0.28, I2 = 0%) between the two groups. During the follow-up, there was no difference in the risk of stroke between the two groups. CKD patients who receive LAAC have a greater risk of in-hospital mortality, AKI, pericardial effusion/tamponade, and major bleeding events than those without CKD, especially in patients with ESRD. No significant difference in the risk of stroke was found in the long-term follow-up after LAAC between the two groups, demonstrating a similar efficacy of LAAC to prevent stroke in CKD patients.

Takotsubo syndrome before and during the COVID-19 pandemic in Austria: a retrospective cohort study (TOSCA-19).

This study aims to investigate the prevalence of Takotsubo syndrome (TTS) as a percentage of the total number of acute coronary syndrome (ACS), including non-STE-elevation myocardial infarction and ST-elevation myocardial infarction, as well as the short-term outcome of TTS patients before and during the COVID-19 pandemic. We compared patients from two different periods: (i) Period 1 (before the COVID-19 pandemic): 1 March to 30 December 2019, and (ii) Period 2 (during the COVID-19 pandemic): 1 March to 30 December 2020. The retrospective database was created from the archives of the participating hospitals or electronic hospital systems by trained medical personnel. The subjects' medical history, cardiovascular risk factors, laboratory values, echocardiography findings, and an in-hospital outcome were variables of interest. Furthermore, propensity score matching analysis was performed to evaluate the short-term prognosis in TTS and ACS patients. Altogether six Austrian centres-(i) 3rd Medical Department of Cardiology and Intensive Care Medicine, Clinic Ottakring, Vienna, Austria; (ii) 5th Medical Department of Cardiology, Clinic Favoriten, Vienna, Austria; (iii) 2nd Medical Department, Hanusch Hospital, Vienna, Austria; (iv) University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Austria; (v) Department of Cardiology, University Hospital Graz, Graz, Austria; (vi) Department of Cardiology and Intensive Medicine, Kepler University Clinic, Linz, Austria-participated in the study. During period 1, 87 (3.5%) patients out of 2482 ACS patients had TTS in all participating centres. During period 2, 71 (2.7%) patients out of 2572 ACS patients had TTS in all participating centres. Accordingly, the prevalence of TTS remained stable irrespective of potential psychologic stress during the COVID pandemic. Furthermore, the baseline characteristics of TTS patients did not change during the COVID-19 pandemic. The prevalence of in-hospital complications [cardiogenic shock (4.6% vs. 4.3%, P=0.925), ventricle thrombus (1.1% vs. 1.4%, P=0.885) and in-hospital bleeding (3.4% vs. 1.4%, P=0.417)] remained stable. The all-cause in-hospital mortality of TTS patients did not change during the COVID-19 pandemic [χ2 (2)=0.058, P=0.810]. Moreover, a propensity score matching analysis of all-cause in-hospital mortality between matched TTS and ACS patients showed higher in-hospital mortality in ACS patients during COVID-19 pandemic (P=0.043). Despite the well-known increased psychologic stress during the COVID-19 pandemic, the prevalence of TTS during the COVID-19 pandemic and the short-term clinical outcome in Austria remained unimpacted.

Ethnic Disparities in Major Adverse Cardiac and Cerebrovascular Events (MACCEs) and Postoperative Outcomes Following Coronary Artery Bypass in Northeastern Iran (2007-2016).

Turkmens are an ethnic group mainly living in northeastern Iran. Despite previous studies on coronary artery bypass surgery (CABG) outcomes among different ethnicities, the effect of Turkmen ethnicity on outcomes of CABG surgery is still unknown. We aimed to assess the association between Turkmen ethnicity and postoperative outcomes following CABG. We used the CABG data from two heart centers in northeastern Iran between 2007 and 2016. We included adult patients undergoing CABG surgery. The study outcomes were in-hospital major adverse cardiac and cerebrovascular events (MACCEs), consisting of myocardial infarction (MI), stroke, and cardiovascular death, and postoperative outcomes, including postoperative arrhythmia, acute atrial fibrillation (AF), major bleeding, and acute renal failure (ARF). Over the course of one decade, 3632 patients, with an average age (standard deviation) of 59.0 (9.8) years, were studied. Of these, 3,331 patients were of non-Turkmen ethnicity, and 301 patients were Turkmens. According to adjusted analysis, ethnicity was not associated with MACCEs (OR: 1.15, 95 % CI: 0.61, 2.16; P=0.663), postoperative arrhythmia (OR: 1.10, 95% CI: 0.78, 1.54; P=0.588), acute AF (OR: 1.17, 95 % CI: 0.83, 1.66; P=0.359), major bleeding (OR: 1.21, 95 % CI: 0.55, 2.67; P=0.636), or ARF (OR: 2.60, 95 % CI: 0.60, 11.75, P=0.224). This study found that despite ethnic disparity and preoperative differences, Turkmen ethnicity was not associated with in-hospital MACCEs, AF, major bleeding, or ARF after coronary artery bypass.

Temporal trends and outcomes of patients with chronic limb-threatening ischemia with and without history of coronary artery disease: insights from the us national inpatient sample database.

The burden and prognostic significance of coronary artery disease (CAD) in adults with peripheral artery disease and chronic limb-threatening ischemia (CLTI) is unknown. Temporal trends in prevalence of significant CAD (history of myocardial infarction or coronary revascularizations) in hospitalizations for CLTI were determined using the 2000 to 2018 National Inpatient Sample (NIS) database. A multivariable regression analysis of outcomes was performed based on presence or absence of CAD. Among 13 575 099 hospitalizations for CLTI (41% female, 69% white, mean age 69 years), 23% had concomitant CAD, of which 11% underwent lower extremity arterial revascularization (43.6% endovascular and 56.4% surgical). The prevalence of concomitant CAD with CLTI increased from 15.3% in 2000 to 23.1% in 2018. Furthermore, the frequency of endovascular revascularization in adults with CAD and CLTI increased from 15.1% to 48.3%, while there was a decreasing trend of surgical revascularization, from 84.9% to 51.7%. After multivariate adjustments, CLTI with CAD was associated with increased risk of in-hospital mortality (OR, 1.40; 95% CI, 1.32-1.47; P less than .0001) and bleeding requiring transfusion (OR, 1.10; 95% CI, 1.06-1.12; P less than .0001) compared with patients with CLTI without CAD. As compared with surgical revascularization, endovascular revascularization was associated with lower risk of in-hospital mortality in both patients with CLTI with CAD (OR, 0.69; 95% CI, 0.63-0.76; P less than .001) and CLTI without CAD (OR, 0.71; 95% CI, 0.67-0.76; P less than .001). Prevalence of CAD has increased in adults presenting with CLTI and is associated with poor outcomes, warranting the need for effective interventions and secondary prevention in this high-risk population.

Coronary Artery Bypass Graft Surgery After Primary Percutaneous Coronary Intervention in Patients With ST-Elevation Myocardial Infarction.

To determine whether primary percutaneous coronary intervention (PPCI) is associated with adverse outcomes following coronary artery bypass graft (CABG) among patients with ST-elevation myocardial infarction (STEMI). Patients presenting with acute STEMI who underwent CABG between September 2015 and November 2020 were included. Among 354 patients, 222 (62.7%) underwent PPCI prior to CABG (PPCI+CABG group) and were compared with the rest of the patients (CABG only group). The effects of PPCI on primary endpoints---including in-hospital mortality, length of stay (LOS), and bleeding events---were investigated using the stabilised inverse probability weighting method (S-IPW). Further, in-hospital mortality in various PPCI subgroups was analysed using univariable regression. Patients with and without PPCI were comparable regarding their baseline and surgical characteristics, except that those without PPCI were more likely to have left-main disease (29.5% vs 16.2%, p-value=0.003). Among the PPCI+CABG group, 3.6% mortality and 55.9% bleeding events occurred, and the LOS was 7 [5-10] days. The respective figures for the CABG only group were 4.5%, 50.8%, and 7 [6-10.5] days. Primary percutaneous coronary intervention, as a whole, was not significantly associated with either morality (S-IPW odds ratio (S-IPW OR) 0.61; p=0.393), LOS logarithm (S-IPW β -0.050; p=0.403), or bleeding events (S-IPW OR 1.06; p=0.821). Nevertheless, the unadjusted mortality risk was significantly higher in complicated PPCIs compared with the CABG only group (OR 7.50, 95% CI 2.03-27.77); it was also higher among some other PPCI subgroups, albeit non-significantly. This study found that PPCI did not confer additional risk regarding in-hospital mortality, LOS, or bleeding among patients with acute STEMI who underwent CABG. However, some PPCI subgroups, especially those with complicated PPCI, were at increased risk.

Volume-outcome relationship in balloon aortic valvuloplasty: results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD)

ObjectiveTranscatheter balloon aortic valvuloplasty (BAV) remains an important alternative treatment for severe, symptomatic aortic stenosis. With increasing numbers of BAVs being performed, the need for large-scale volume-outcome relationship assessments has...

Direct Oral Anticoagulant Use Early After Cardiac Surgery: A Retrospective Cohort Study

BackgroundThere is limited literature guiding the prescribing of direct oral anticoagulants (DOACs) early after cardiac surgery as this population has been excluded from landmark randomized controlled trials. This study aims to determine the rate of in-hospital DOAC use compared with warfarin early after cardiac surgery, evaluate factors associated with DOAC use, determine difference in postoperative length of stay, and characterize bleeding events. MethodsA retrospective cohort study was conducted in adult patients with indications for anticoagulation and receiving either a DOAC or warfarin after cardiac surgery during their index hospitalization. Patients were excluded if they had any contraindications to DOAC use. The primary outcome was the proportion of patients discharged on a DOAC compared with warfarin. ResultsOf included 210 patients, 30% received DOACs and 70% received warfarin on discharge. The most common DOAC used was apixaban (74.6%), and median postoperative day of initiation was 5 days. Patients receiving DOACs were older (70.8 vs 68.0 years), had less valvular heart disease (38.1% vs 63.9%), were more likely to be on DOACs preoperatively (50.8% vs 31.3%), and were more likely to have undergone coronary artery bypass graft alone (54.0% vs 24.5%) compared with those on warfarin. Postoperative length of stay (7 vs 9 days; P = 0.59) and in-hospital bleeding (1.6% vs 2.0%; P = 1.00) did not differ between DOAC and warfarin groups. ConclusionsAt a quaternary referral centre for cardiac surgery, DOACs were used in approximately one-third of patients with an indication for anticoagulation early after cardiac surgery.