Major Thromboembolic Complications Research Articles

Endovascular treatment of wide-neck bifurcation aneurysms using pCONUS2 HPC bridging device with single antiplatelet: A Case Series.

Wide neck bifurcation aneurysms (WNBA) are technically challenging for both surgical and endovascular treatments. Endovascular treatment for WNBA often requires dual antiplatelet therapy (DAPT) post stent insertion. Novel devices such as the pCONUS2 HPC neck bridging device have an HPC coating which reduces the device thrombogenicity. This theoretically allows for use of single antiplatelet therapy (SAPT), which would be advantageous, particularly in treating ruptured aneurysms. This case series aims to evaluate the safety of SAPT regimen only post stent insertion, by presenting our center early clinical experience in using pCONUS2 HPC neck bridging device in patients that are not suitable for DAPT. We report the cases of 3 patients (2 females, 1 male; range: 64-71 years old) who underwent coil embolization for WNBA using the pCONUS2 HPC device (2 unruptured WNBA, and 1 ruptured WNBA). As all 3 patients were allergic to Aspirin, they could only be started on SAPT post endovascular therapy. All 3 patients were diagnosed with WNBA on angiographic studies. Patient 1 had an unruptured left middle cerebral artery aneurysm; Patient 2 had a ruptured basilar tip aneurysm; Patient 3 had an unruptured anterior communicating artery (ACOM) aneurysm. All 3 WNBA were treated with pCONUS2 HPC neck bridging device. There were no immediate complications. The immediate angiographic result of aneurysm treatment in Patient 1 and Patient 2 demonstrated incomplete occlusions, with delayed complete occlusion of aneurysm in Patient 1 and growth of aneurysmal neck in Patient 2 on follow-up angiograms (range: 6-9 months). No major thrombo-embolic or hemorrhagic complications in the first 2 patients. For Patient 3, the immediate angiographic result of the treated aneurysm demonstrated complete occlusion. However, the patient readmitted 11 days post procedure with cerebral infarction, scoring 5 on the modified Rankin scale on discharge. pCONUS2 HPC as a neck bridging device in treating WNBA has yet to be shown superior to traditional techniques and devices. The theoretical advantage of HPC coating reducing its thrombogenicity requiring only SAPT is yet to be proven safe in clinical practice.

Early Termination versus Standard Regimen Duration of Dual Antiplatelet Therapy in Intracranial Aneurysm Patients Treated With Pipeline Embolization Device Flex With Shield Technology: Preliminary Experience of 3 U.S. Centers

Pipeline Flex Embolization Device with Shield Technology (PED-Shield) is a third-generation flow diverter with reduced thromboembolic potential. However, safety profile and dual antiplatelet therapy (DAPT) recommendations with PED-Shield is not well -established. We aim to assess the safety and complication profile with early termination of DAPT with use of PED-Shield. Databases of 3 high-volume cerebrovascular centers were retrospectively reviewed. We identified patients with unruptured and ruptured intracranial aneurysms treated with PED-Shield. Patient demographics, aneurysm characteristics, complications, and angiographic outcomes were extracted. All patients who had early termination of DAPT, defined as <180 days, as well as standard duration were included. A total of 37 patients, totaling 37 aneurysms, had early termination of DAPT and 24 patients with 24 aneurysms received standard duration (>180 days) of DAPT. There was no difference in pre-procedural DAPT regimens between the groups (P= 0.503). Following DAPT termination, o1ne major thromboembolic complication was observed in the early termination group while no major or minor thromboembolic or hemorrhagic complication was noted in the standard duration group. Time of angiographic follow-up was not statistically different (P= 0.063) between the early termination (343 days, interquartile range [IQR] 114-371 days) and the standard duration (175 days, IQR 111-224.5 days) groups. There were no statistically significant differences in complete aneurysm occlusion (P= 0.857), residual neck (P= 0.582), and aneurysm remnant (P= 0.352) rates between the groups on angiography. Early termination of DAPT proves safe after PED-Shield treatment of intracranial aneurysms with comparable complete occlusion rates.

Tranexamic Acid for Intracerebral Hemorrhage in Patients on Non-Vitamin K Antagonist Oral Anticoagulants (TICH-NOAC): A Multicenter, Randomized, Placebo-Controlled, Phase 2 Trial.

Evidence-based hemostatic treatment for intracerebral hemorrhage (ICH) associated with non-vitamin K antagonist oral anticoagulants (NOACs) is lacking. Tranexamic acid (TXA) is an antifibrinolytic drug potentially limiting hematoma expansion. We aimed to assess the efficacy and safety of TXA in NOAC-ICH. We performed a double-blind, randomized, placebo-controlled trial at 6 Swiss stroke centers. Patients with NOAC-ICH within 12 hours of symptom onset and 48 hours of last NOAC intake were randomized (1:1) to receive either intravenous TXA (1 g over 10 minutes followed by 1 g over 8 hours) or matching placebo in addition to standard medical care via a centralized Web-based procedure with minimization on key prognostic factors. All participants and investigators were masked to treatment allocation. Primary outcome was hematoma expansion, defined as ≥33% relative or ≥6 mL absolute volume increase at 24 hours and analyzed using logistic regression adjusted for baseline hematoma volume on an intention-to-treat basis. Between December 12, 2016, and September 30, 2021, we randomized 63 patients (median age, 82 years [interquartile range, 76-86]; 40% women; median hematoma volume, 11.5 [4.8-27.4] mL) of the 109 intended sample size before premature trial discontinuation due to exhausted funding. The primary outcome did not differ between TXA (n=32) and placebo (n=31) arms (12 [38%] versus 14 [45%]; adjusted odds ratio, 0.63 [95% CI, 0.22-1.82]; P=0.40). There was a signal for interaction with onset-to-treatment time (Pinteraction=0.024), favoring TXA when administered within 6 hours of symptom onset. Between the TXA and placebo arms, the proportion of participants who died (15 [47%] versus 13 [42%]; adjusted odds ratio, 1.07 [0.37-3.04]; P=0.91) or had major thromboembolic complications within 90 days (4 [13%] versus 2 [6%]; odds ratio, 1.86 [0.37-9.50]; P=0.45) did not differ. All thromboembolic events occurred at least 2 weeks after study treatment, exclusively in participants not restarted on oral anticoagulation. In a smaller-than-intended NOAC-ICH patient sample, we found no evidence that TXA prevents hematoma expansion, but there were no major safety concerns. Larger trials on hemostatic treatments targeting an early treatment window are needed for NOAC-ICH. URL: https://clinicaltrials.gov; Unique identifier: NCT02866838.

JAK inhibition in the treatment of inflammatory rheumatic diseases.

The most common immune-mediated inflammatory rheumatic diseases, rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis and have reached significant advances in recent years with the introduction of biological therapies against cytokines and immune cells, but also against intracellular enzymes, specifically Janus kinases (JAKs). Intracellular JAK signalling is activated by binding of various cytokines or growth factors to the respective cellular receptors, allowing the activation of STAT (Signal Transducers and Activators of Transcription) transcription factors and ultimately the transcription of genes with important roles during the innate and adaptive immune response. Four Janus kinases have been described: JAK1, JAK2, JAK3 and tyrosine kinase-2 (TYK2). Four JAK inhibitors (tofacitinib, baricitinib, upadacitinib and filgotinib) are currently approved for the treatment of rheumatoid arthritis, and some for the treatment of psoriatic arthritis and axial spondyloarthritis. JAK inhibitors have varying selectivity against individual kinases. Some JAK inhibitors are being tested in other rarer systemic connective tissue diseases. The general advantages of JAK inhibitors are oral administration, rapid onset of action, and efficacy in monotherapy. The safety profile of JAK inhibitors compared with biologic therapy appears to be comparable, with a higher incidence of herpes zoster, and an increased incidence of major cardiovascular disease, thromboembolic complications, and cancer in at-risk patients is discussed. The aim of this paper will be to summarize the latest findings on JAK inhibitors in approved indications for the most common rheumatic diseases.

Tissue Factor and Vascular Endothelial Growth Factor in Detecting Thromboembolic Complications in Diabetic Atherosclerotic Patients.

Atherosclerosis, which is one of the leading causes of death all over the world, can create major or minor thromboembolic complications with the exponentially increasing diabetic status. Despite all the studies, the mechanism by which endothelial damage in atherosclerosis is triggered in diabetic setting is still not fully understood. In this study, tissue factor (TF), which is thought to act together in the formation of vasular endothelial growth factor (VEGF-A) and coagulopathy in diabetic atherosclerotic patients, may be an important indicator in this regard, a total of 100 cases who were undergone off-pump coronary artery bypass (OPCAB) which were at same risk group examined by dividing into diabetic status. Early postoperative process and biochemical parameters analyzed in terms of TF and VEGF-A levels measured before and after the operation. TF and VEGF-A expression of the T1DM group were statistically high compared to non-diabetics. Significantly longer hospital stays with changes in TF and VEGF-A were found in patients in the diabetic group compared to pre- and postoperatively, respectively; TF (95% CI: 0.879-0.992; p = 0.025), VEGF-A (95% CI: 0.964-0.991; p = 0.001) and hospital stay (95% CI: 1.96-7.49; p = 0.0001). Preoperatively measured carotid intima-media thickness (CT) was higher in diabetics and was significantly associated with atrial fibrillation (AF), (r = 0.873). Surgical team and protocols were same and OPCAB procedures were routinely applied to all patients in our clinic. No minor or major events were observed in any of the cases. TF and VEGF-A values in patients with diabetic atherosclerosis may be important in the early detection of thromboembolic complications.

Clinical effects of restarting antiplatelet therapy in patients with intracerebral hemorrhage

ObjectiveAntiplatelet (APT) medications have been used to treat ischemic stroke and cardiovascular diseases. However, they involve a risk of re-bleeding, especially in patients with intracerebral hemorrhage (ICH), which limits their clinical application. This study aimed to compare the incidence of recurrent ICH and ischemic events in ICH survivors on APT, as well as to assess the clinical effect and safety of APT resumption. MethodsWe retrospectively reviewed the medical records of patients with spontaneous ICH at two tertiary medical centers between January 2011 and December 2020. We included adult patients with ICH who regularly took APT medications for various medical conditions. The patients were divided into two groups based on their APT resumption. Subsequently, we performed between-group comparisons of clinical or radiological characteristics; moreover, analyzed the incidence of re-bleeding and ischemic events, as well as the various risk factors for each event. ResultsWe included 202 patients; among them, 118 patients restarted APT after initial ICH (APT resumption group) while 84 patients did not (no-APT resumption group). Compared with patients in the no-APT resumption group, those in the APT resumption group were more likely to have hyperlipidemia (p < 0.001) and a previous ischemic stroke event (p = 0.026). Recurrent ICH and ischemic vascular events occurred in 14 and 15 patients, respectively. Univariate analysis demonstrated that the risk factors for recurrent ICH were older age, renal dysfunction, and no APT resumption; however, only renal dysfunction significantly increased the risk of re-bleeding in multivariate analysis (HR, 4.631; 95 % CI 1.432–14.977; p = 0.010). Moreover, previous cerebral ischemia and atrial fibrillation were positively associated with ischemic events in univariate analysis; however, only atrial fibrillation demonstrated a significant correlation in multivariate analysis (HR, 4.309; 95 % CI 1.383–13.426; p = 0.012). APT resumption had a significant prevention effect on recurrent ICH (HR, 0.180; 95 % CI 0.055–0.586; p = 0.004) and ischemic vascular events (HR, 0.240; 95 % CI 0.077–0.750; p = 0.014). ConclusionsOur findings indicated that restarting APT in patients with ICH was not associated with an increased risk of recurrent ICH. APT can be safely restarted to prevent major thromboembolic complications in patients on previous antithrombotic treatment.

The Safety and Efficacy of Low-Molecular-Weight Heparin in Pregnant Women With Rheumatic Heart Disease and Valves Replacement.

Background: In patients with rheumatic heart disease (RHD) and prosthetic valve replacement, the risk of thromboembolic complications is the highest during and immediately after pregnancy. Therapeutic anticoagulation during this period is crucial to minimize the risk of thromboembolic complications. The use of low-molecular-weight heparin (LMWH) remains an off-label indication. The type of anticoagulants used, dosing regimens, target anti-Xa levels, and frequency of anti-Xa monitoring are highly variable in the pregnant population and have been derived from pilots, observational studies, and empirical evidence. Herein, in a real-world setting, we sought to examine the efficacy and safety of variable anticoagulation options with a focus on LMWH in the management of RHD-related valvular disease in pregnant women.Methods: This study is a retrospective study conducted at a large university-affiliated tertiary care center (King Saud University Medical City) between January 2011 and February 2020. All pregnant women with RHD who had heart valve replacements were reviewed. Patient data were extracted for demographic information, baseline characteristics, anticoagulation type, and primary outcomes. Primary endpoints were thromboembolic events, hemorrhagic complications, and fetal outcomes.Results: A total of 744 pregnancies in 149 women were identified. The mean age ± SD of the women was 43.8 ± 12 years. A total of 86 women (58%) were on the LMWH regimen, 35 women (23%) were on LMWH and warfarin regimen, and 28 women (19%) were on unfractionated heparin (UFH) and warfarin regimen. Overall, thromboembolic events developed in five (0.7%) pregnancies. Of those, two were in the LMWH group, two were in the LMWH and warfarin group, and one was in the UFH and warfarin group. In addition, significant hemorrhagic complications occurred in five pregnancies. Of these, two occurred in the LMWH group, two in the LMWH and warfarin group, and one in the UFH and warfarin group. No adverse maternal and fetal outcomes were noted.Conclusion: This study presents the largest retrospective study of variable anticoagulation options in pregnant women with RHD and prosthetic valve replacement. LMWH is both safe and effective in preventing major thromboembolic complications compared to other forms of anticoagulation used during pregnancy.

Prothrombotic Milieu, Thrombotic Events and Prophylactic Anticoagulation in Hospitalized COVID-19 Positive Patients: A Review

The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in significant morbidity and mortality worldwide. Although initial reports concentrated on severe respiratory illness, emerging literature has indicated a substantially elevated risk of thromboembolic events in patients with COVID-19 disease. Pro-inflammatory cytokine release has been linked to endothelial dysfunction and activation of coagulation pathways, as evident by elevated D-dimer levels and deranged coagulation parameters. Both macrovascular and microvascular thromboses have been described in observational cohort and post-mortem studies. Concurrently, preliminary data have suggested the role of therapeutic anticoagulation in preventing major thromboembolic complications in moderately but not critically ill patients. However, pending results from randomized controlled trials, clear guidance is lacking regarding the intensity and duration of anticoagulation in such patients. Herein, we review the existing evidence on incidence and pathophysiology of COVID-19 related thromboembolic complications and guide anticoagulation therapy based on current literature and societal consensus statements.

Tranexamic Acid for Adult Patients with Spontaneous Intracerebral Hemorrhage: A Systematic Review with Meta-analysis.

The effects of tranexamic acid on spontaneous intracerebral hemorrhage in reducing hematoma expansion and mortality as well as its role in thromboembolic complications and in the improvement of functional outcomes remain substantially uncertain. The objective of this systematic review was to evaluate the efficacy and safety of tranexamic acid in patients with spontaneous intracerebral hemorrhage. Several databases were searched from inception up to 20 June, 2021. We included randomized controlled trials that compared tranexamic acid with placebo or no treatment for the management of intracerebral hemorrhage. The primary outcomes were hematoma expansion and 90-day mortality. The secondary outcomes were hemorrhagic volume change, thromboembolic complications, and functional outcomes. Overall, six trials with 2800 patients were included in this meta-analysis. Tranexamic acid was associated with a reduced risk of hematoma expansion (relative risk 0.87, 95% confidence interval [CI] 0.77-0.99, p=0.03, I2=0%, six trials with 2800 participants) and a lessening of hematoma volume change (mean difference -1.28, 95% CI -2.44 to -0.12; p=0.03; I2=0%, four trials with 2626 participants), without a corresponding higher rate of major thromboembolic complications (relative risk 1.20, 95% CI 0.85-1.69; p=0.80; I2=0%, five trials with 2759 participants). The present analysis also demonstrated that tranexamic acid had no effect on reducing 90-day mortality (relative risk 1.02, 95% CI 0.88-1.19; p=0.80; I2=0%, five trials with 2770 participants). In adults with spontaneous intracerebral hemorrhage, tranexamic acid reduced the risk of intracerebral hemorrhage growth compared with the control. The effects on 90-day mortality remained inconclusive. Further studies should report death within 24h and death due to bleeding whenever possible.

Major arterial and venous thromboembolic complications in patients with COVID-19

Abstract Background Cardiovascular complications; myocardial infarction (MI), ischemic stroke, and pulmonary embolism (PE), represent an important source of adverse outcomes in COVID-19 disease. Objectives To evaluate the incidence of thromboembolic events, specifically PE, MI and stroke; risk factors, management patterns and outcomes in patients who tested positive for COVID-19 through RT-PCR in a regional hospital. Methods We included 1125 adults patients admitted for COVID-19 infection between April 1 and October 30, 2020. The total cohort was analyzed by site of care: Intensive care (n=124) and nonintensive care (n=1001). Results Cardiovascular risk factors prevalence in patients with COVID-19 were: hypertension (25.5%), hyperlipidemia (23.2%) and diabetes (12%). Prophylactic anticoagulation and therapeutic anticoagulation was prescribed in intensive care group (91.1% and 33.1%, respectively) versus (84.8% and 12.5%, respectively) in nonintensive care setting. Frequencies of major arterial or venous thromboembolism, pulmonary embolism and myocardial infarction were highest in the intensive care group (29%, 20% and 8%, respectively) than nonintensive care cohort (1.4%, 0.7% and 0,5%, respectively). Hospital mortality was 29% in intensive care group and 1.3% in nonintensive care group. Conclusions Patients admitted for COVID-19 had a high risk of major arterial or venous thromboembolism events, especially in the intensive care setting, despite the use of thromboprophylaxis with heparin. Funding Acknowledgement Type of funding sources: None.

Bowel Obstruction Revealing a Mesenteric Infarct in a SARS COV 2 Infection Area: A Case Report

SARS COV 2 is an RNA virus with pulmonary tropism responsible not only for severe pneumopathy but which can cause major thromboembolic and cardiovascular complications with life-threatening consequences and are more serious with the presence of cardiovascular risk factors, cases of massive pulmonary embolism has been described in several articles as well as occlusion of the superior mesenteric artery.

Major Thromboembolic Complications in Liver Transplantation: The Role of Rotational Thromboelastometry and Cryoprecipitate Transfusion.

Although hemorrhage is a major concern during liver transplantation (LT), the risk for thromboembolism is well recognized. Implementation of rotational thromboelastometry (ROTEM) has been associated with the increased use of cryoprecipitate; however, the role of ROTEM-guided transfusion strategy and cryoprecipitate administration in the development of major thromboembolic complications (MTCs) has never been documented. We conducted a study on patients undergoing LT before and after the implementation of ROTEM. We defined MTC as intracardiac thrombus, pulmonary embolism, hepatic artery thrombosis, and ischemic stroke in 30 d after LT. We used a propensity score to match patients during the 2 study periods. Among 2330 patients, 119 (4.9%) developed MTC. The implementation of ROTEM was significantly associated with an increase in cryoprecipitate use (1.1 ± 1.1 versus 2.9 ± 2.3 units, P < 0.001) and MTC (4.2% versus 9.5%, P < 0.001). Further analysis demonstrated that the use of cryoprecipitate was an independent risk factor for MTC (odds ratio 1.1, 95% confidence interval 1.04-1.24, P = 0.003). Patients with MTC had significantly lower 1-y survival. Our study suggests that the implementation of ROTEM and the use of cryoprecipitate play significant roles in the development of MTC in LT. The benefits and risks of cryoprecipitate transfusion should be carefully evaluated before administration.

Major Thromboembolic Complications in Liver Transplantation: The Role of Rotational Thrombelastometry and Cryoprecipitate Transfusion.

Major Thromboembolic Complications in Liver Transplantation: The Role of Rotational Thrombelastometry and Cryoprecipitate Transfusion.

Low-ProfileVisualized IntraluminalSupport Jr Braided Stent Versus Atlas Self-Expandable Stent for Treatment of Intracranial Aneurysms: A Single Center Experience.

The Neuroform Atlas Stent and Low-profileVisualized IntraluminalSupport (LVIS) and LVIS Jr stents are used to treat intracranial aneurysms (IAs), but their safety, performance, and outcomes have not been directly compared. To compare the technical performance and outcomes of Atlas and LVIS Jr stents for treatment of IAs. IAs treated by stent-assisted coiling using an Atlas (Stryker, Kalamazoo, Michigan) or LVIS Jr (MicroVention, Aliso Viejo, California) device between January 2014 to November 2019 were retrospectively evaluated. Patient demographics, aneurysm size and location, technical difficulties, and clinical and angiographic follow-up were analyzed. A total of 116 patients, (mean age 64.2± 11.8 yr, 72.7% female) with 121 aneurysms underwent stent-assisted coiling with deployment of Atlas (n=64) or LVIS Jr (n=57) stents. Mean aneurysm size was 6.2± 2.7mm. Immediate rates of Raymond-Roy (RR) 1/2 were 89.0% (57/64) and 80.7% (46/57) for the Atlas and LVIS Jr groups, respectively. Neither group had major postoperative thromboembolic complications; however, 15.8% (9/57) of the LVIS Jr procedures had technical issues. Additionally, 88.5% (46/52) and 91.2% (33/36) of patients in the Atlas and LVIS Jr groups had RR 1/2 at a mean follow-up of 13.6 and 18.7 mo, respectively. Treatment of IAs with Atlas and LVIS Jr stents results in favorable clinical outcomes and angiographic results at follow-up, with low rates of recurrence and retreatment, suggesting both devices are safe and effective. Notably, LVIS Jr had more technical problems than Atlas.

Incidence and risk factors for thromboembolism and major bleeding in patients with mechanical heart valves: a tertiary hospital-based study in Botswana.

Mechanical heart valve (MHV) prostheses increase the risk of thromboembolic complications. While warfarin anticoagulation reduces this risk, its use increases the risk of bleeding. We sought to estimate the rate of thromboembolic and bleeding complications among patients with MHVs at a tertiary hospital in Botswana. Factors associated with bleeding and thromboembolic complications are also described. This retrospective cohort study involved a cohort of patients with MHV at Princess Marina Hospital who were operated on before September 2017. The study documented bleeding and thromboembolic events since the valve replacement, patients' demographic information, co-existing medical conditions, drug history and details of valve replacement. Using the recent international normalised ratio (INR) results, each patient's time in therapeutic range (TTR) was calculated to assess the level of anticoagulation control. The study enrolled 142 patients with a mean (SD) age of 42 (12) years and a median (IQR) duration since valve replacement of four years (1.8-10.0). The median (IQR) TTR was 29.8% (14.1-51.0) and only 14.8% of the patients had an optimal anticoagulation control. The rates of major bleeding and thromboembolic complications were 1.5 per 100 person-years and 2.80 per 100 person-years, respectively. A longer duration of warfarin use was associated with an increased risk of both bleeding (p = 0.008) and thromboembolic complications (p = 0.01). Bleeding and thromboembolic complications were common in MHV prosthesis patients in this study. Long duration of anticoagulation, albeit sub-optimal control, was a risk factor for bleeding and thromboembolic complications in these patients. Therefore, long-term efforts are necessary to address these complications and possibly improve the quality of life of these patients.

Coagulopathy of Coronavirus Disease 2019.

Objectives:Recent studies have reported a high prevalence of thrombotic events in coronavirus disease 2019. However, the significance of thromboembolic complications has not been widely appreciated. The purpose of this review is to provide current knowledge of this serious problem.Design:Narrative review.Data Sources:Online search of published medical literature through PubMed using the term “COVID-19,” “SARS,” “acute respiratory distress syndrome,” “coronavirus,” “coagulopathy,” “thrombus,” and “anticoagulants.”Study Selection and Data Extraction:Articles were chosen for inclusion based on their relevance to coagulopathy and thrombosis in coronavirus disease 2019, and anticoagulant therapy. Reference lists were reviewed to identify additional relevant articles.Data Synthesis:Coronavirus disease 2019 is associated with a strikingly high prevalence of coagulopathy and venous thromboembolism that may contribute to respiratory deterioration. Monitoring coagulation variables is important, as abnormal coagulation tests are related to adverse outcomes and may necessitate adjuvant antithrombotic interventions. In the initial phase of the infection, d-dimer and fibrinogen levels are increased, while activated partial prothrombin time, prothrombin time, and platelet counts are often relatively normal. Increased d-dimer levels three times the upper limit of normal may trigger screening for venous thromboembolism. In all hospitalized patients, thromboprophylaxis using low-molecular-weight heparin is currently recommended. The etiology of the procoagulant responses is complex and thought to be a result of specific interactions between host defense mechanisms and the coagulation system. Although the coagulopathy is reminiscent of disseminated intravascular coagulation and thrombotic microangiopathy, it has features that are markedly distinct from these entities.Conclusions:Severe acute respiratory syndrome coronavirus 2/coronavirus disease 2019 frequently induces hypercoagulability with both microangiopathy and local thrombus formation, and a systemic coagulation defect that leads to large vessel thrombosis and major thromboembolic complications, including pulmonary embolism in critically ill hospitalized patients. d-dimers and fibrinogen levels should be monitored, and all hospitalized patients should undergo thromboembolism prophylaxis with an increase in therapeutic anticoagulation in certain clinical situations.

P1521 Prosthetic heart valve-related stroke: a single center experience

Abstract OnBehalf YIG-CVR Introduction Thromboembolic events or bleeding are by far the most frequent complications of prosthetic heart valves. Cerebrovascular stroke is one of the major thromboembolic complications of anticoagulation-related issues of prosthetic heart valves. Aim of the work To determine the pattern and risk factors of acute stroke in patients with prosthetic heart valves. Methods and Patients A retrospective single-center analysis of the database registry of consecutive acute stroke patients with mitral or aortic heart valve prostheses admitted to a tertiary care stroke specialized center from 01/01/2012 to 01/12/2017. All patients were examined by a certified neurologist and underwent a complete work-up evaluation (Computed Tomography or Magnetic Resonance Imaging, Carotid Doppler ultrasound examination, complete blood tests, and electrocardiogram) and a transthoracic echocardiography (TTE) examination as well as transesophageal echocardiography (TOE) if valve dysfunction or thrombosis were suspected. Results 214 patients with mitral or aortic valve prostheses were admitted by acute stroke in the duration from 01/01/2012 to 01/12/2017 with a mean age of 44 ± 15 years, 132 were males (61.7%) and 178 patients had mechanical valves (83.2%). 135 patients had mitral prosthesis (63.1%) and ischemic stroke was encountered in 151 patients (70.6%). Conclusion In a single center experience, mechanical prosthesis at the mitral valve position was associated with higher incidence of ischemic stroke. Proper close follow-up of INR levels as well as the surgical shift to biological instead of mechanical valve should decrease significantly the incidence of prosthetic valve related strokes. Baseline, clinical and other parameters Patients (n = 214) Age (years) 44 ± 15 Mechanical valve 178 (83.2%) Atrial Fibrillation 101 (47.2%) Rheumatic Heart Disease 175 (81.8%) Left ventricular ejection fraction (%) 54 ±13 Mitral Only 135 (63.1%) Aortic Only 51 (23.8%) Double Valve Prosthesis 28 (13.1%) Ischemic stroke 151 (70.6%) Hemorrhagic stroke 47 (22%) Both ischemic and hemorrhagic stroke 16 (7.4%) Data are represented as mean(±SD) or number (Percentage) Abstract P1521 Figure. Valve sites

Dabigatran for the Prevention of Myocardial Injury after Orthopedic Surgery (DMINS-PRE). A Study Protocol For A Randomized, Active-Controlled, Phase II Trial

Background and Aims: Myocardial Injury after Noncardiac Surgery (MINS) is a broader term that includes not only perioperative myocardial infarction but also other prognostically significant myocardial injuries due to ischemia, within 30 days after noncardiac surgery. Annually, around 1 million patients who undergo noncardiac surgery worldwide die during the first 30 days following surgery. The incidence of MINS is around 5-8%, with the majority occurring in the first two days after surgery. A recent study showed a potential positive effect of Dabigatran to prevent major vascular complications among patients with MINS. However, until now there is no evidence related to whether any effective drug may reduce its incidence. Our study aims to assess the efficacy of dabigatran to prevent MINS in a high cardiovascular risk population. Methods: This study will be a multicenter randomized, two-arms (1:1 ratio), active-controlled and double-dummy, phase II trial. We will study 264 adults (45-75 years) with a high cardiovascular risk, assessed by the Framingham Risk Score, who are undergoing elective orthopedic surgery. Patients which troponin measurement keeps negative after surgery will be randomly assigned (1:1) to receive dabigatran 150mg twice daily or enoxaparin daily, 6 hours after surgery for seven days. The primary outcome will be the incidence of MINS as ascertained by the difference in troponin (troponin delta) greater than 14ng/L in the perioperative period, after randomization. Secondary outcomes will be 30-day mortality, major thromboembolic complications, and severe bleeding complications. The potential impact of the study: This clinical trial will be the first to assess the efficacy and the safety of dabigatran to prevent MINS. Given MINS is estimated to affect every year about 8 million patients worldwide and is associated with cardiovascular complications and death after surgery, we believe this trial will provide relevant data to clinical practice and future research directions.

Impact of tranexamic acid use on blood loss and transfusion rates following femoral varus derotational osteotomy in children with cerebral palsy

PurposePrevious studies have established the safety and efficacy of tranexamic acid (TXA) in reducing blood loss after total joint arthroplasty and spinal fusion surgery; however, literature regarding the effectiveness of intraoperative TXA in children with cerebral palsy (CP) is limited. The aim of this study was to investigate the safety and efficacy of intraoperative TXA in reducing blood loss and transfusion requirements for children with CP undergoing a proximal femoral varus derotational osteotomy (VDRO).MethodsThis is a retrospective review of 258 children with CP who underwent VDRO performed at the author’s institution between 2004 and 2017. In all, 36 subjects underwent VDRO surgery with administration of intravenous TXA and 222 subjects underwent VDRO without administration of TXA. Outcome measures including blood loss, transfusion requirements and venous thromboembolic events were compared between groups using t-tests and chi-squared tests.ResultsNo significant differences were seen in the rates of transfusion between groups for the entire hospitalization (TXA group: 11.1% versus No TXA group: 19.8%), intraoperatively (TXA: 2.8% versus No TXA: 9.0%) or postoperatively (TXA: 8.3% versus No TXA: 14.4%). Intraoperative estimated blood loss (TXA: 144.4 mL versus No TXA: 159.0 mL) and percentage blood loss (TXA: 8.9% versus No TXA: 9.2%) were similar between groups. No major thromboembolic complications events occurred in either group.ConclusionThe use of TXA was not associated with thromboembolic complications in this series of children with CP undergoing VDRO surgery. Though there was a trend toward lower rates of intraoperative and postoperative blood transfusion with TXA use in these patients, the differences were not significant, possibly due to low estimated blood loss in both groups and sample size.Level of evidenceIII- retrospective comparative study

ANTICOAGULATION THERAPY DURING RADIOFREQUENCY ABLATION

Purpose. The study assess the effectiveness and safety of pulmonary veins atriums isolation (PVI) and radiofrequency ablation of the cavo - tricuspid isthmus with different modes of anticoagulation in patients with atrial fibrillation (AFb) and atrial flutter (AFl). Materials and methods. The study included 83 patients - 52 with AFb, 18 - with AFl and 13 - with both types of arrhythmia. Of all the included patients 12 used warfarin for antioagulation (15%), 17 - dabigataran (21%), 39 - rivaroxaban (46%) and 15 - apixaban (18%). For patients using warfarin a “bridge therapy” tactic was used. For patients using POAC the drug was cancelled at 2 half - life periods before the procedure. Intraoperational thromboembollic and haemorrhagic complications were calculated, arrhythmia relapses and delayed complications were controlled in 3 and 6 months after the procedure. Results. 18 arrhytmia relapses were reported during the study, among them 79% happened after PVI, 89% - after cavotricuspid isthmus, 62% - after treatment of both types of arrhythmia. 4 major haemorrhagic complications were reported during the study (intraoperational haemopericardium), 3 major thromboembolic complications (a stroke through 6 months after the procedure). The frequency of minor hemorrhagic events amounted to 8 cases. Both modes of anticoagulation are effective and safe for prevention of thromboembolic events in atrial fibrillation and flutter correction surgery, however, a large, although statistically insignificant number of minor haemorrhagic events occurred in the early post - procedure period with dabigataran. The results of the study show the effectiveness of arrhythmia surgery to be 79% in patients with AFb and 89% in patients with AFl.