Risk Of Bleeding Complications Research Articles

Risk of bleeding complications and atrial fibrillation associated with ibrutinib treatment: A systematic review and meta-analysis.

The use of ibrutinib is hampered by major bleeding events and atrial fibrillation. Speculating whether randomized controlled trials might underestimate the risk of adverse events in clinical practice, we conducted a systematic review and meta-analysis studying patients treated in any setting and indication. We systematically searched the literature using MEDLINE and EMBASE databases for case series, cohort studies, or randomized controlled trials and retrieved all data in parallel. Proportions of patients with adverse events were pooled in relevant subgroups using the binominal distribution and Freeman-Tukey double arcsine transformation. Among 2'537 records screened, 85 were finally included, comprising 7'317 patients. Methodological quality according to the Newcastle-Ottawa Scale was rated as moderate to poor with regard to bleeding events and atrial fibrillation; 106 studies were excluded because of missing data at all. Reported events varied substantially between 0 % and 78 % (any bleedings), 0 % and 25 % (major bleedings), and 0 % and 38 % (new-onset atrial fibrillation). Pooled estimates were 28 % (95 % confidence interval 22 %, 34 %), 3 % (2 %, 4 %), and 8 % respectively (7 %, 10 %). The risk of events was higher in studies with an older population, high ibrutinib dosage, thrombocytopenia, antithrombotic treatment, and retrospective studies. In conclusions, reporting of bleeding events and atrial fibrillation varied substantially among studies. These observations, in combination with the estimates obtained, suggest a relevant risk in clinical practice.

Do women with venous thromboembolism bleed more than men during anticoagulation? Data from the real-life, prospective START-Register.

Background:Venous thromboembolism (VTE) is a frequent and serious disease that requires immediate and long-term anticoagulant treatment, which is inevitably associated with a risk of bleeding complications. Some studies, though not all, reported a higher risk of bleeding in female patients treated with either old anticoagulants [vitamin k antagonists (VKAs)] or recent anticoagulants [direct oral anticoagulants (DOACs)]. Furthermore, analyses of clinical trials reported an abnormal vaginal bleeding in women of reproductive age treated with DOACs. This study aimed at comparing the risk of bleeding in an inception cohort of VTE women and men included in a prospective observational registry.Methods:Baseline characteristics and bleeding events occurring during anticoagulation in patients of both sexes, included in the START-Register after a first VTE, were analyzed.Results:In all, 1298 women were compared with 1290 men. Women were older and more often had renal diseases; their index events were often provoked (often by hormonal contraception and pregnancy), and more frequently presented as isolated pulmonary embolism (PE). The rate of bleeding was similar in women (2.9% patient-years) and men (2.1% patient-years), though it was higher when uterine bleeds were included (3.5% patient-years, p = 0.0141). More bleeds occurred in VKA- than DOAC-treated patients (6.4% versus 2.6%, respectively; p = 0.0013). At multivariate analysis, age ⩾ 75 years was associated with higher prevalence of bleeds.Conclusion:The occurrence of bleeding was not different between women and men during anticoagulation after VTE. Only after inclusion of vaginal/uterine bleeds, the rate of bleeding was higher in women. The incidence of bleeding was higher in women treated with VKAs.Plain Language SummaryThe risk of bleeding in women anticoagulated for deep vein thrombosis or pulmonary embolism is not higher than that in men, except for vaginal bleedingBackground:The occurrence of a venous thromboembolic event (VTE, including deep vein thrombosis and pulmonary embolism) necessarily requires a period of at least 3–6 months of treatment with anticoagulant drugs [either vitamin k antagonists (VKA) or, more recently, direct oral anticoagulants (DOACs)]. Anticoagulation therapy, however, is associated with a risk of bleeding that is influenced by several factors. Sex is one of these factors as some authors have hypothesized that women are at higher risk than men. Furthermore, some studies have recently found more vaginal bleeding in VTE women treated with a DOAC compared with those who received VKAs.Methods:The present study aimed to compare the frequency of bleeds occurring in women and in men who were treated with DOACs or VKAs for a first VTE event and followed in real-life conditions. Since the beginning of their anticoagulant treatment, the patients were included in a prospective, multicenter, observational registry (the START-Register), and bleeding events were recorded.Results:A total of 1298 women were compared with 1290 men. Women were older and more often were affected by renal diseases; their VTE events were often associated with risk factors (especially hormonal contraception and pregnancy) and presented as isolated pulmonary embolism. The rate of all bleeding events (including major, non-major but clinically relevant, and minor bleeds) was higher in women (3.5% patient-years) than in men (2.1% patient-years, p = 0.0141); however, the difference was no longer statistically significant after exclusion of uterine bleeds (2.9% patient years). More bleeding occurred in women receiving VKA as anticoagulant drug compared with those treated with a DOAC (6.4% versus 2.6%, respectively; p = 0.0013). At multivariate analysis, age ⩾ 75 years was associated with higher prevalence of bleeds.Conclusion:In conclusion, we found that in real-life conditions, the rate of bleeding events occurring during anticoagulation after a VTE episode is not higher in women than in men. Only after inclusion of vaginal bleeds, the rate of bleeding was higher in women. More bleeds (including vaginal bleeding) occurred in women treated with VKA than DOACs.

Safety and Feasibility of Percutaneous Gastrostomy Placement in Patients on Antiplatelet Therapy.

Background: Guidelines recommend the discontinuation of clopidogrel prior to gastrostomy tube placement. The aim of this study was to examine the safety and feasibility of performing radiologically inserted gastrostomy (RIG) tube placement in patients taking clopidogrel and/or aspirin.Methods: We performed an institutional review board–approved retrospective analysis of the medical records for 237 consecutive patients following RIG tube placement secondary to dysphagia from August 2017 to January 2019. Antiplatelet medications and RIG type placement techniques (push vs pull) were compared with bleeding complications. Complications were categorized based on the Society of Interventional Radiology clinical practice guidelines. Of the 237 patients with RIG tubes placed, 77 patients were on antiplatelet therapy: 55 on single antiplatelet therapy and 22 on dual antiplatelet therapy. Of the 55 patients on single antiplatelet therapy, 26 were taking clopidogrel and 29 were taking aspirin.Results: A total of 9 bleeding complications were observed. The most common complication was minimal bleeding or hematoma around the incision site (n=7). No statistically significant increase was seen in bleeding rates when comparing patients on any antiplatelet therapy regimen vs none (P=0.15), single antiplatelet therapy vs none (P=0.13), clopidogrel vs none (P=0.71), or dual antiplatelet therapy vs none (P=0.61). No significant increase in the bleeding complication rate was noted when comparing the aspirin-only regimen vs clopidogrel alone (P=0.34).Conclusion: These findings suggest that the risk of bleeding complications is not increased in patients taking clopidogrel and/or aspirin prior to RIG tube placement.

Abstract 13529: Percutaneous Coronary Intervention in Ambulatory Surgery Centers: Is It Safe?

Introduction: In January 2020, Medicare began reimbursing for percutaneous coronary intervention (PCI) performed in ambulatory surgery centers (ASCs), but little is known about characteristics and outcomes of patients who have undergone ASC PCI previously. Methods: Using commercial insurance claims from the MarketScan® Databases, we characterized patients 18 years or older who underwent hospital outpatient department (HOPD) or ASC PCI for stable ischemic heart disease between April 1, 2007, and December 1, 2016. We used propensity score matching of HOPD and ASC PCI cohorts to measure the association between treatment setting and 30-day outcomes (myocardial infarction, bleeding complications, and all-cause admission). Results: The unmatched sample consisted of 95,492 HOPD and 849 ASC PCI patients. Patients were more likely to undergo ASC PCI if they were younger than 65 (OR 1.72, 95% CI 1.43-2.06), lived in the southern U.S., or were covered by managed (OR 2.31, 95% CI 1.73-3.08) or consumer-driven (OR 2.57, 95% CI 1.73-3.82) compared to comprehensive health plans. ASC PCI was less likely in patients with a history of stroke (OR 0.45, 95% CI 0.28-0.72). Intravascular imaging and physiology testing were more frequently performed in HOPD than in ASC PCI (18.3% vs. 12.5%, respectively; p < 0.001). After propensity-score matching, ASC PCI was associated with increased odds of bleeding complications (OR 2.43, 95% CI 1.22-4.84, p = 0.011). Differences in other outcomes were not statistically significant. Conclusions: Patients undergoing outpatient elective PCI in ASCs were younger and more likely to live in the southern U.S or have managed or consumer-driven health insurance plans. Intravascular imaging and physiology testing were performed more frequently in HOPD than in ASC PCI. PCI in the ASC setting was also associated with an increased risk of bleeding complications. Further study of this population is warranted as ASC PCI volume increases under Medicare.

Clinical outcomes after reversal of dabigatran in daily practice: real-world use of idarucizumab 2015–2019

Abstract Background Idarucizumab was introduced in Europe in December 2015 as an antidote to dabigatran. Whether reversing the anticoagulant effect of dabigatran actually reduces the risk of bleeding complications and mortality remains sparsely described. No randomized placebo-controlled trial evaluating the efficacy of idarucizumab has been conducted. Therefore, evaluation of real-world data is of major importance to further investigate the use of idarucizumab in daily clinical practice. Purpose We aimed to investigate the real-world use of idarucizumab and associated clinical outcomes. Methods The study was conducted as an observational case series. Using our regional electronic patient record, all patients treated with idarucizumab from market introduction to end of 2019 were identified. We had complete coverage of the use of idarucizumab at a large University Hospital in Denmark. During Spring 2020, we will also include patients from regional hospitals. Results A total of 39 patients were treated with idarucizumab. All patients but one received dabigatran due to atrial fibrillation. Indications for idarucizumab use were “need for acute surgery” in 21 (54%), “bleeding” in 14 (36%), “prior to thrombolysis” in two (5%), and “dabigatran intoxication” due to renal failure in two (5%, one presenting with bleeding and one patient without). No patients were treated with activated carbon or dialysis. A total of five patients (13%) experienced bleeding within 30 days after infusion and none had thromboembolic complications. After 30 days follow-up, 32 (82%) patients were alive and 29 restarted anticoagulant treatment (19 lowmolecular-weight heparin, 11 dabigatran, one rivaroxaban, and one apixaban). Conclusion Among patients treated with idarucizumab, few experienced adverse outcomes and the 30-day survival rate was high. In line with observations from the REVERSE-AD trial, our data supports that idarucizumab is safe in patients experiencing life-threatening bleeding or needing acute surgery. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Unrestricted research grant from Boehringer Ingelheim

Lumbar puncture in patients on anticoagulants

Lumbar puncture is an important invasive procedure often used in the diagnosis of neurological disorders. Generally, lumbar puncture is a safe procedure, with a very low incidence of serious complications, the risk of which, however, may increase in the group of patients on anticoagulant therapy (anticoagulants and platelet anti-aggregation agents). This applies to both the risk of haemorrhagic complications and the risk of thrombotic events during temporary discontinuation of anticoagulants. This paper presents the current knowledge on the management in patients receiving anticoagulants (vitamin K antagonists, new anticoagulants, heparins, fondaparinux) and platelet anti-aggregation agents (P2Y12 platelet receptor antagonists, glycoprotein IIb/IIIa inhibitors, acetylsalicylic acid) who require lumbar puncture. Furthermore, we present the issue of bridging therapy in patients at a high risk of thrombotic complications. In the case of neurological indications for a lumbar puncture in a patient on anticoagulants or anti-aggregation therapy, the urgency of the procedure and the risk of adverse effects should be assessed and other diagnostic methods should be considered in the first place. If there is a need for an urgent lumbar puncture, treatment modification or the use of drugs to reverse the anticoagulant or anti-aggregation effect may be necessary. Each case must be treated individually, considering medical and family history, comorbidities and other medications taken by the patient. Most of the available recommendations related to the presented problem have been developed by anaesthetic associations. There is a need to popularise the principles of management in patients on anticoagulants who require lumbar puncture due to neurological disorders.

Bleeding and thromboembolism risk of standard antithrombotic prophylaxis after hip or knee replacement within an enhanced recovery program

IntroductionPrevention of venous thromboembolism (VTE) generally consists of low molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs) after total hip arthroplasty (THA) or total knee arthroplasty (TKA). Enhanced recovery after surgery (ERAS) protocols may reduce the VTE risk after these procedures. The aim of this study was to compare the risk of VTE and the risk of bleeding complications in a non-selected population of primary THA and TKA cases done within an ERAS protocol. HypothesisThe risk of postoperative VTE after primary THA and TKA is lower than the risk of bleeding complications within an ERAS protocol. MethodsThis was a prospective observational study conducted on a national scale in France. All patients who underwent primary unilateral THA or TKA at one of 11 participating hospitals between October 2016 and October 2017 were enrolled and followed for 3 months. The occurrence of a VTE or major bleeding event was recorded. No patients were lost to follow-up at 3 months. ResultsOf the 1110 THA cases, there were 5 VTE (0.4%) and 19 bleeding events (1.7%). Of the 893 TKA cases, there were 9 VTE (1.0%) and 14 bleeding events (1.7%). There was no significant difference in the VTE incidence and bleeding event incidence after THA and TKA. The overall incidence of bleeding complications (1.7%) was significantly greater than the overall incidence of VTE complications (0.7%) (p=0.005). This was the case after THA (p=0.004) but not after TKA. DiscussionThe primary finding of this study is that bleeding complications are significantly more common than VTE complications after THA or TKA within an ERAS protocol. Based on these findings, the cost-benefit ratio of antithrombotic prophylaxis by LMWH or DOACs in this context should be reassessed.Level of evidence: IV; Prospective cohort study without control group.

26. Does anticoagulant thromboprophylaxis increase bleeding complications in spinal surgery and spinal cord injury? A systematic review and meta-analysis

BACKGROUND CONTEXT The routine use of anticoagulants for the prevention of venothromboembolism in spinal patients is controversial and the risk benefit analysis is poorly described. PURPOSE The objective of this systematic review and meta-analysis is to collate the current evidence and quantify the risk of bleeding associated with anticoagulant thromboprophylaxis in the spinal patient, both in the elective and trauma settings. STUDY DESIGN/SETTING Spinal surgery and trauma inpatients. PATIENT SAMPLE A total of 92,406 patients. OUTCOME MEASURES Outcomes of interest were the number of patients with spinal epidural hematoma or wound hemorrhagic complications that were associated with neurological symptoms or required treatment, including either operative or nonoperative intervention. METHODS MEDLINE, EMBASE, Cochrane Trial Register databases and the grey literature were searched. Data were pooled via a meta-analysis from randomized trials and cohort studies comparing the rates of spinal epidural hematoma and wound hemorrhagic complications in spinal surgery patients receiving low molecular weight and low dose unfractionated heparin (LMWH/UFH) thromboprophylaxis and those not anticoagulated. The risk of bias within individual studies and across all the studies was assessed using the Cochrane risk of bias tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool, respectively. RESULTS The meta-analysis included 11 studies of 92,406 patients with 1,007 relevant bleeding complications. A significant increase in the risk of extra-spinal wound hemorrhage was found in patients receiving perioperative LMWH/UFH thromboprophylaxis compared to controls (OR 1.56, 95% CI 1.18 - 2.06, p=0.002, I2=8%). The same comparison revealed no significant increase in the risk of spinal epidural hemorrhage (OR 1.20, 95% CI 0.65 - 2.22, p=0.56, I2=0%). The quality of evidence for both outcomes was low. There was insufficient data to conclude about the risk of hemorrhagic complications in spinal trauma and in patients receiving nonheparin thromboprophylaxis agents. CONCLUSIONS Our results raise concern about a possible increased risk of extraspinal wound hemorrhage associated with LMWH/LDUFH thromboprophylaxis in spinal surgery. FDA DEVICE/DRUG STATUS low molecular weight heparin (Approved for this indication), low dose unfractionated heparin (Approved for this indication)

Thrombopoietin Receptor Agonists in Patients with Chronic Liver Disease.

Thrombocytopenia is one of the most common hematologic complications in cirrhosis. Despite limited data linking platelet count and bleeding risk in patients with cirrhosis, the use of platelets transfusions for invasive procedures has been a common practice. Recently, thrombopoietin (TPO) receptor agonists have been approved for use in patients with chronic liver disease (CLD) undergoing invasive procedures. The aim of this study was to review current literature on bleeding risk in patients with cirrhosis and the use of platelet transfusions and TPO receptor agonists in the context of invasive procedures. PubMed search was conducted to find articles relating to cirrhosis, thrombocytopenia, and new novel treatments for this condition. Search terms included CLD, cirrhosis, thrombocytopenia, bleeding, thrombosis, coagulopathy, hemostasis, and TPO receptor agonists. Romiplostim, eltrombopag, avatrombopag, and lusutrombopag are approved TPO receptor agonists, with avatrombopag and lusutrombopag specifically approved for use in patients with CLD undergoing invasive procedures. In patients with platelet counts < 50,000/mm3, avatrombopag and lusutrombopag increased the platelet counts above this threshold in the majority of treated patients and reduced the frequency of platelet transfusions. At the approved doses, incidence of thrombosis was not increased and therapies were well tolerated. Studies were not powered to assess whether risk of bleeding complications was reduced and the fundamental question of whether correction of thrombocytopenia is warranted in patients undergoing invasive procedures remains unanswered. The use of TPO receptor agonists has resulted in less requirement for platelet transfusions. In patients with cirrhosis undergoing invasive procedures for whom platelet transfusion is planned, TPO receptor agonists are an alternative and avoid the risks associated with transfusions. However, there is need for a thoughtful approach to manage bleeding risk in patients with cirrhosis undergoing procedures, with the consideration of a comprehensive hemostatic profile, the severity of portal hypertension, and the complexity of the invasive procedure to guide decisions regarding transfusions or use of TPO receptor agonists.

Magnesium and Risk of Bleeding Complications From Ventriculostomy Insertion.

Hemorrhages are a serious complication of brain surgery, and magnesium has shown hemostatic properties in hemorrhagic stroke and non-neurological surgeries. External ventricular drain (EVD) insertion is an advantageous model of emergency neurosurgical hemorrhage risk because it is common, standardized, and the operator is blinded to the outcome during the procedure. We tested the hypothesis that low magnesium is associated with risk of hemorrhagic complications from EVD insertion. Patients with spontaneous intracerebral hemorrhage and aneurysmal subarachnoid hemorrhage were enrolled in a prospective, observational study. Demographic and clinical variables were prospectively recorded, including serum magnesium measurements. Catheter tract hemorrhage (CTH) was measured on postoperative head computed tomography within 48 hours of EVD insertion. We observed 50 CTH among 327 EVD procedures (15.3%) distributed similarly among intracerebral hemorrhage (21/116 [18.1%]) and subarachnoid hemorrhage (29/211 [13.7%]). Magnesium was lower in patients with CTH compared with those without (median 1.8 versus 2.0 mg/dL, P<0.0001). Higher magnesium was associated with lower odds of CTH (odds ratio 0.67 per 0.1 mg/dL magnesium [95% CI, 0.56-0.78], P<0.0001) after adjustment for other risk factors, with similar effect in the intracerebral hemorrhage and subarachnoid hemorrhage subgroups. Preprocedural increase in magnesium (odds ratio 0.68 [0.52-0.85]) and dose of preprocedural magnesium sulfate (odds ratio 0.67 [0.40-0.97]) were associated with reduced CTH risk after adjustment for initial magnesium and other risk factors. Lower magnesium at the time of EVD insertion was an independent predictor of hemorrhagic complications. Baseline risk was attenuated by preprocedural increases in magnesium, suggesting a therapeutic opportunity.

Problem of prescribing anticoagulant therapy in patients with atrial fibrillation on the regional level

Introduction. Cardiovascular diseases are the leading cause of morbidity and mortality worldwide, with heart rhythm disorders accounting for a significant proportion of them. Atrial fibrillation (AF) is an arrhythmia that poses a risk of thromboembolic complications and is difficult to treat with ongoing preventive anticoagulant therapy. Aim of the study. To analyze the prescription of anticoagulant therapy to patients with AF on the regional level. Methods and results. The study included 72 patients with the nonvalvular form of AF (from 41 to 82 years old) of the Department of Rhythm and Conductivity Abnormalities of the State Budgetary Institution of the Republic of Mordovia RCH № 4 for 2019. Three groups were singled out depending on the AF form: the first one – patients with the constant form (n = 22), the second one (n = 24) – with the persistent form, the third one (n = 24) – with the paroxysmal form. The risk of thromboembolic complications was assessed using the CHA2DS2-VASc scale and hemorrhagic complications using the HAS-BLED scale. All patients had a high risk of thromboembolism (index above 2 points), which reflects multiple risk factors and indicates the need for oral anticoagulants (OAC). According to HAS-BLED scale calculations, the risk of haemorrhagic complications was low in most patients (2 or less points) – there was no significant increase in the risk of bleeding, but careful monitoring is required. Analysis of the results revealed that only 54% of patients took OAC, despite the fact that all patients were shown anticoagulant therapy. When analyzing the cases of patients who did not take anticoagulants, it was found that 23% of patients, despite the doctor’s recommendations, refused to take the drugs, 47% of patients justified the inability to control IHR and 30% were unable to purchase expensive new OAC. Conclusion. Despite the recommendations for the management of patients with atrial fibrillation, only 54% were prescribed oral anticoagulants.

Perioperative Antithrombotic Therapy Management and Venous Thromboembolism Prophylaxis

The management of perioperative anticoagulation, antiplatelet therapy, and perioperative venous thromboembolism (VTE) prophylaxis is essentially a balancing act between patient risk factors for thrombosis and surgical risk factors for bleeding. The purpose of this review is to assist surgeons with the identification of patients at increased risk for thromboembolism when antithrombotic therapy is interrupted, patients for whom bridging anticoagulation should be considered, patients who require perioperative VTE prophylaxis, and patients at increased risk for bleeding complications and to briefly review the literature and major guidelines regarding perioperative antithrombotic therapy management and perioperative VTE prophylaxis. Figures show approaches to the management of perioperative anticoagulation, antiplatelet therapy, and VTE prophylaxis. This review contains 2 figures, 7 tables, and 61 references. Keywords: Venous thromboembolism, pulmonary embolism, anticoagulation, surgery, perioperative period, prophylaxis

Perioperative Antithrombotic Therapy Management and Venous Thromboembolism Prophylaxis

The management of perioperative anticoagulation, antiplatelet therapy, and perioperative venous thromboembolism (VTE) prophylaxis is essentially a balancing act between patient risk factors for thrombosis and surgical risk factors for bleeding. The purpose of this review is to assist surgeons with the identification of patients at increased risk for thromboembolism when antithrombotic therapy is interrupted, patients for whom bridging anticoagulation should be considered, patients who require perioperative VTE prophylaxis, and patients at increased risk for bleeding complications and to briefly review the literature and major guidelines regarding perioperative antithrombotic therapy management and perioperative VTE prophylaxis. Figures show approaches to the management of perioperative anticoagulation, antiplatelet therapy, and VTE prophylaxis. This review contains 2 figures, 7 tables, and 61 references. Keywords: Venous thromboembolism, pulmonary embolism, anticoagulation, surgery, perioperative period, prophylaxis

Perioperative Antithrombotic Therapy Management and Venous Thromboembolism Prophylaxis

The management of perioperative anticoagulation, antiplatelet therapy, and perioperative venous thromboembolism (VTE) prophylaxis is essentially a balancing act between patient risk factors for thrombosis and surgical risk factors for bleeding. The purpose of this review is to assist surgeons with the identification of patients at increased risk for thromboembolism when antithrombotic therapy is interrupted, patients for whom bridging anticoagulation should be considered, patients who require perioperative VTE prophylaxis, and patients at increased risk for bleeding complications and to briefly review the literature and major guidelines regarding perioperative antithrombotic therapy management and perioperative VTE prophylaxis. Figures show approaches to the management of perioperative anticoagulation, antiplatelet therapy, and VTE prophylaxis. This review contains 2 figures, 7 tables, and 61 references. Keywords: Venous thromboembolism, pulmonary embolism, anticoagulation, surgery, perioperative period, prophylaxis

Aortic valve-sparing procedure\u2014a durable choice in liver transplantation recipient

A 44-year old man with aortic regurgitation and aneurysm of the ascending aorta underwent an aortic valve-sparing procedure as a durable treatment before liver transplantation. Since patients with chronic liver failure are at high risk of hemorrhagic complications at time of major surgery, while management of warfarin administration may still represent a concern, the choice of a cardiac procedure which avoids any anticoagulant treatment appeared justified.

The Clinical Conundrum of Managing Ischemic Stroke in Patients with Immune Thrombocytopenia.

Guidelines are lacking for management of acute ischemic stroke and stroke prevention in patients with immune thrombocytopenia (ITP). Our aim is to highlight the dilemma inherent in managing patients with both significant bleeding and thrombotic risk factors. In this review, we present two patients with history of ITP who presented with acute ischemic stroke and received tissue plasminogen activator (tPA) and endovascular thrombectomy (EVT), a rare management strategy in this patient population. In addition, we identified 27 case reports of ischemic stroke in patients with ITP; none of them received tPA or EVT. Furthermore, there are 92 patients with significant thrombocytopenia with no available data regarding the cause of thrombocytopenia, who were acutely treated with tPA or EVT. Conclusive evidence cannot be determined based on these limited number of cases. Future multicenter prospective cohort studies in patients with ITP are needed to provide better evidence-based treatment plans. At present, treatment of acute ischemic stroke in patients with ITP requires close collaboration between hematology and vascular neurology experts to find a balance between the benefit and risk of hemorrhagic complications.

P1187Pocket-Hematoma after cardiac implantable electronic devices surgery: a single centre study

Abstract Intro Pocket hematoma is a common complication after pacemaker (PMK) or implantable cardioverter defibrillator (ICD) surgery. In this clinical setting anticoagulant and antiplatelet therapy are associated with an increased risk of hemorrhagic complications, but data are sparse. Purpose We examined the impact of antiplatelet therapy and anticoagulation with vitamin K antagonists (VKA) or heparin on the risk of pocket hematoma. Materials and method: between august 2017 and june 2019, a total of 639 devices were implanted or replaced at our centre. Predictors of hematoma occurrence were determined by multivariate regression analysis. We used a specific definition of pocket hematoma: a) any palpable swelling in the pocket area requiring an unscheduled visit or prolonged hospitalization &amp;gt; 24 h or re-hospitalization for hematoma, b) interruption of antithrombotics, c) reoperation, d) hemoglobin drop &amp;gt; 2 g/dl or blood transfusion. The above criteria were assessed during hospitalization and up to 10 days after discharge. Results: the incidence of pocket hematoma was 7.5%. Among 639 patients (pts) including in the study 33.5% (214 pts) didn’ t take any antithrombotic therapy, 40.2 % (257 pts) were on single antiplatelet therapy (SAPT), 8.8 % (56 pts) were on dual antiplatelet therapy, 11.1 % (71 pts) were on uninterrupted VKA (mean INR 2). Heparin bridging was administered in 6.4% (41 pts). Ejection fraction (43 ±13 %) and hemoglobin value before implantation (12.3 ±2.6 g/dL) in patients who developed hematoma were significantly lower compared with whose without hematoma. Patients with hematoma had a higher prevalence of congestive heart failure, ischemic cardiomyopathy and intake antithrombotic therapy. After adjusting for confounding factors with multivariate logistic regression only the use of dual antiplatelet therapy (OR 5.9 95% CI 1.5-21 p = 0.008) and the bridging with enoxaparin (OR 5.6 95% CI 1.4-22 p = 0.013) increased the risk of pocket hematoma. Single antiplatelet therapy (OR 2.6 95% CI 0.8-8.4 p = ns) and uninterrupted VKA (OR 0.9 95% CI 0.7-11 p = ns) did not increased the risk of pocket hematoma compared to no antithrombotic therapy. Pulse generator change and new device implant/upgrading (OR 1.8 95% CI 0.6-5.2 p = ns) carried the same haemorrhagic risk. Conclusion the use of DAPT or bridging with enoxaparin are highly predictive for the occurrence of perioperative pocket hematoma in patients scheduled for pmk/icd surgery. In contrast, single antiplatelet therapy and uninterrupted VKA did not increase the risk of hematoma.

P471Experience with the use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation and a high risk of hemorrhagic complications

Abstract Background. The use of NOACs in patients with chronic lymphocytic leukemia (CLL) is a difficult task due to the tendency to hemorrhage in these patients associated with CLL. The use of targeted ibrutinib (Ib) therapy in the treatment of CLL patients increases the risk of bleeding due to thrombocytopathy. A feature of targeted Ib therapy is the need for daily and lifelong use. One of the cardiotoxic effects of Ib is the development of atrial fibrillation (AF). Some patients receiving Ib have a history of AF. Warfarin is contraindicated in patients taking Ib, so all patients received NOACs. Purpose. To evaluate the possibility of using NOACs in CLL patients receiving Ib, taking into account the frequency and severity of hemorrhagic manifestations, the need to cancel, reduce the dose and replace with another NOACs. Methods. We examined and observed the dynamics of 224 patients with CLL receiving Ib from 5 to 56 months at a dose of 420 mg per day as 1, 2, 3, and 4 lines of CLL therapy. Patients with CLL aged 32 to 91 years (66.0 (59.0-72.0) years) were Included, of whom 82 are women aged 39 to 83 years (64.0 (54.0-71.0 ) years) and 142 men aged 32 to 91 years (66.0 (60.0-72.0) years). All hemorrhagic manifestations in patients receiving Ib and NOACs were evaluated, taking into account the glomerular filtration rate and platelet count. Results. AF were revealed in 51 patients with CLL receiving Ib. AF was registered in 32 patients during the treatment with Ib, in 19 patients AF was before prescribing of Ib. The need for NOACs because of AF arose in 38 patients with CLL who were prescribed rivaroxaban (n = 11), dabigatran (n = 6), apixaban (n = 21). Hemorrhages were observed in 88.2% of patients receiving NOACs and Ib, represented by hematomas (n = 32), petechiae (n = 4), nosebleeds (n = 6), gingival bleeding (n = 7), hemorrhage in the anterior chamber of the eye (n = 1), hemorrhage in the sclera of the eye (n = 3) and macrohematuria (n = 4). A combination of several hemorrhagic manifestations (combined hemorrhages) was observed in 40.7% of CLL patients receiving NOACs. 10 patients were transferred to the minimum dose of apixaban 2.5 mg twice a day due to the development of recurring nosebleeds (n = 5), macrohematuria (n = 3), large, recurring hematomas with localization on the neck and face (n = 1 ), hemorrhages in the anterior chamber of the eye (n = 1). Cancellation of NOACs in 1 patient was associated with recurrent macrohematuria. Rivaroxaban 20 mg per day was canceled in 6 patients due to the development of persistent thrombocytopenia of less than 50 × 109/L. Conclusions. There were no life-threatening hemorrhages. The main reason for the withdrawal of NOACs was persistent thrombocytopenia. Due to hemorrhagic complication, NOACs was canceled only in 1 patient, 10 patients (26.3%) required a transfer to the minimum dose of apixaban. The arising hemorrhages did not require hospitalization of patients.

Minimization of the complications associated with bar removal after the Nuss procedure in adults

BackgroundPectus bar removal after Nuss repair is associated with the risk of major complications that are underreported. Of these, surgical bleeding is the main concern. Old age and placement of more than one bar are reported risk factors for pectus bar removal. In this study, we presented our experience regarding the modified skills required to minimize complications during bar removal, especially in adult patients.MethodsConsecutive patients who underwent pectus bar removal as the final stage of Nuss repair between August 2014 and December 2018 were included. The patients were positioned in the supine position. The bar(s) was (were) removed from the left side via the bilateral approach using the previous surgical scars after full dissection of the ends of the bar lateral to the hinge point and after straightening the right end of the bar. Bleeding was carefully checked after removal. An elastic bandage was wrapped around the chest after wound closure to prevent wound hematoma/seroma formation.ResultsA total of 283 patients (260 male and 23 female), with a mean age of 22.8 ± 6.6 years at the time of the Nuss repair were included. The mean duration of pectus bar maintenance interval was 4.3 years (range: 1.9 to 9.8 years). A total of 200 patients (71%) had two bars. The mean estimated blood loss was 11.7 mL (range: 10 mL to 100 mL). Nine patients (3.1%) experienced complications, six had pneumothorax and three had wound hematoma. No major bleeding occurred. Adults and the use of more than one bar were not associated with a significantly higher rate of complications (P = 0.400 and P = 0.260, respectively).ConclusionsAdult patients and removal of multiple bars were not risk factors for complications in our cohort. Skill in preventing intraoperative mediastinal traction, carefully controlling bleeding, and reducing the effect of dead space around the wounds could minimize the risk of bleeding complications. A multicentric study or case accumulation is needed to further evaluate the risk factors of removal pectus bar(s).

INDICATIONS TO SURGICAL TREATMENT OF ATHEROSCLEROTIC IMPACT OF THE CAROTID ARTERIES

Summary. Goal. To analyze the indications for surgical treatment of symptomatic and asymptomatic stenosis of the internal carotid artery.&#x0D; Materials and methods. The well-known tactics of performing carotid endarterectomy in symptomatic and asymptomatic patients still need to be divided into groups with symptomatic and asymptomatic ICA stenosis, depending on the clinical course of the disease and the risk of developing stroke. Of the 140 patients enrolled in the study, 60 patients formed patients with symptomatic ICA lesions, namely: a) 50 patients with symptomatic ICA stenosis; b) 10 patients with visual impairment and ICA stenosis. Of 80 asymptomatic patients with verified atherosclerotic lesions of the carotid arteries without manifestations of acute ischemic cerebral circulation during the last 6 months, of which.&#x0D; Discussion and results. Patients with symptomatic ICA lesions are the most at-risk group for the development of recurrent stroke, they require comprehensive treatment depending on the size of the lesion and the risk of hemorrhagic complication.&#x0D; Conclusions. Patients with multifocal atherosclerosis should be screened for carotid artery screening to reduce the risk of ischemic stroke in the postoperative period. Patients with ischemic stroke should perform an MRI to confirm the focus of the first stage, followed by ultrasound examination of the carotid arteries. In the case of carotid lesions, patients undergo carotid CT scans to establish indications for surgical treatment.