Incidence Of Bleeding In Patients Research Articles

Clinical and economic benefits of patients undergoing lobectomy with the use of powered vascular staplers—based on China’s real-world data

Background Endoscopic surgery is widely performed with an increasing use of powered vascular staplers (PVS). However, few studies have examined PVS use in China, most of which have focused on clinical effects; fewer studies have examined the economic benefits of PVS. This study evaluated the clinical and economic benefits of the PVS compared to standard-of-care (SOC) staplers in lobectomy using results from a single-arm, multicenter clinical trial conducted in China and actual clinical use in a hospital collected in a real healthcare setting. Methods Patients with lung cancer undergoing thoracoscopic lobectomy were included in the study. The clinical and economic benefits of powered vascular stapler have been evaluated from a hospital’s perspective based on parameters such as bleeding occurrence, hospitalization time, secondary thoracotomy, and hospitalization costs. To compare the bleeding associated with use of PVS and SOC stapler in clinical use, PVS single-arm multi-center clinical trial data is used for the intervention group, and sampling data from hospitals is used for the control group. To ensure the outcome indicators between the two groups are comparable, we set the same inclusion criteria for the two groups of data and then used propensity score matching (PSM) to match two groups of patients according to the baseline characteristics. Results The results show that bleeding incidence in patients with SOC stapler group is 17.33% from hospital sampling data. In contrast, in the PVS group, it is 4.00%, and these rates are statistically different (P = 0.0167). Considering converted to open thoracic surgery, the rate of the SOC stapler group is 5.78% and that of the PVS group is 4.00%. These rates are not statistically different (P = 0.6166). Regarding hospitalization days, the length of the SOC stapler group is 18.97 days, while that in the PVS group is 12.38 days, and these data are statistically different (P = 0.0002). As patients in the PVS group have reduced bleeding, they will require less resource use from blood transfusion, drug services and surgical services. If PVS is used for transection of vessel, it can reduce the bleeding incidence by 13.33% and save 75.47 CNY in blood transfusion costs, 571.36 CNY in drug costs, and 183.38 CNY in surgical service costs per patient. From these three aspects, the hospital saves per patient 830.21 CNY. Conclusions Compared with the SOC stapler group, the PVS group has a lower bleeding incidence and shorter hospital days for lobectomy. In terms of blood transfusion costs, drug costs and surgical service costs, the hospital saves per patient 830.21 CNY.

Evaluation of bleeding events in a cohort of patients with transthyretin cardiac amyloidosis

Abstract Introduction and purpose transthyretin amyloidosis is an infiltrative disease with several comorbidities, including bleeding. The aim of this study was to evaluate the incidence of bleeding in patients with transthyretin amyloidosis and the underlying risk factors that promote bleeding. Methods a retrospective observational study was conducted on a cohort of patients with transthyretin amyloidosis diagnosed between 2016 and 2023 according to the diagnostic criteria of the Working Group on Myocardial and Pericardial Diseases of the European Society of Cardiology. Bleeding risk was calculated according to HAS-BLED score and bleeding events at follow-up were analysed. Results 184 patients were diagnosed with a median age of 84 years [IQR 79-8], 154 (8%) males. 123 patients (67%) were on anticoagulant therapy. 91 patients (50%) had a bleeding event, with a total of 189 events recorded and a median time from transthyretin amyloidosis diagnosis to bleeding of 10 months [IQR 6-14]. The most frequent bleeding sites were gastrointestinal (32%) and cutaneous (22%). 35 patients (39%) had a haemorrhage which fulfilled severe bleeding criteria and 4 patients died of haemorrhagic causes. As a consequence of bleeding, 6 atrial appendage closure were indicated and anticoagulation therapy was modified in 15 individuals. The incidence rate of haemorrhage was 50 bleeds per 100 patient-years and 58 per 100 patient-years in patients on anticoagulant treatment. Anticoagulant therapy resulted in a 3,5-fold raise in bleeding (95% CI 2-7) and a punctuation ≥2 in HAS-BLED score increased haemorrhages 4,6 times (95% CI 2-9), with higher rates of bleeding the higher the score on the scale. Conclusions bleeding is a frequent complication in transthyretin amyloidosis, with a higher risk in those individuals with anticoagulant therapy or with a HAS-BLED score ≥2. Subsequently, it should be considered in the follow-up both haemorrhagic risk and anticoagulant treatment, with the aim of implementing strategies to reduce the bleeding risk.

No contraindication to internal jugular central venous catheter insertion in patients at increased risk of bleeding: Results from a prospective observational study in a internal medicine department.

Implantation of centrally inserted central venous catheter (CICC) may be complicated by bleedings particularly in patients with severe coagulopathy or taking antithrombotic drugs. It has been shown that the application of the Italian Group for Venous Access Devices (GAVeCeLT) bundle reduces the incidence of bleeding in patients admitted to intensive care units (ICU), but its effectiveness has never been demonstrated in different contexts. In this study we evaluated the incidence of bleeding after urgent internal jugular CICC (J-CICC) implantation in patients with increased or no risk of bleeding complications when recommended preventive strategies are applied systematically. We included 185 patients admitted to Internal Medicine Units who underwent urgent J-CICC implantation from April 2016 to December 2018. The incidence of major and minor bleeding immediately after the procedure and in the following 30 days was recorded. None of the enrolled patients showed major bleeding. The incidence of minor bleedings was 2.1% (95% IC: 0.03-4.2) with two patients requiring line removal and repositioning (1.1%; 95% IC: -0.45 to 2.6). Bleeds were not correlated with age or sex, although they all occurred in female subjects. The incidence of bleeds was not increased in patients with increased risk of bleeding compared with those without (5.0% vs 1.3%; p = 0.16). The use of anti-thrombotic medications was significantly associated with increased risk of minor bleedings (p = 0.03). In this study we demonstrated that the application of the GAVeCeLT suggested bundle can minimize the number of bleeding complications even in patients hospitalized in Internal Medicine Units. Further data are needed in patients taking antithrombotic drugs who appear to be more prone to minor bleeding, however the benefit of completing the procedure appears to significantly outweigh the risk of mechanical complications.

Abstract 17633: Age and Racial Disparities in Gastrointestinal Bleeding Incidence Among Atrial Fibrillation Patients on Direct Oral Anticoagulants: A Retrospective Cohort Study

Introduction: Atrial fibrillation (Afib), a major cause of morbidity and mortality, particularly affects the elderly. Direct oral anticoagulants (DOACs), despite being the preferred stroke risk reduction treatment in Afib patients, often result in gastrointestinal bleeding. This study aims to examine the incidence of this side effect across age and racial groups. Hypothesis: The risk of gastrointestinal bleeding while on DOACs increases with age. Racial variation in GI bleeding in Afib patients taking DOACs exists due to non-modifiable and modifiable risk factors. Methods: Utilizing the 'All of Us' national database, we conducted a retrospective cohort study of 6,961 Afib patients who started DOACs from 2018 to 2023. EHR data including ICD-9/10 codes and medication history were used to conduct the analysis. Patients who developed gastrointestinal bleeding after the introduction of DOACs within this period were identified. Incidence rates were further analyzed according to age and race. Results: Out of 6,961 Afib patients on DOACs, 791 developed gastrointestinal bleeding (21.9 cases per 1000 person-year). The incidence rate was highest among patients aged under 50 years (36.8 cases per 1000 person-year) and those over 80 years (24.0 cases per 1000 person-year). Patients aged 60-70 years had the lowest incidence rate (19.7 cases per 1000 person-year). Racial analysis revealed African-Americans had the highest incidence rates (29.3 cases per 1000 person-year), followed by Asians (21.9 cases per 1000 person-year), and Whites (19.6 cases per 1000 person-year; p<0.001). Conclusions: Our study revealed a bimodal peak in GI bleeding incidence in patients on DOACs for Afib, with heightened risk in those under 50 years and above 80 years. Racial disparities were also evident, with African-Americans at the highest risk. These findings underscore the need for further research to elucidate risk factors, particularly in younger patients and specific racial groups.

Incidence of venous thromboembolism, recurrence, and bleeding after isolated superficial vein thrombosis: findings from the Venous Thrombosis Registry in Østfold Hospital

BackgroundThere are limited data on the long-term risk of venous thromboembolism (VTE) after high-risk isolated superficial vein thrombosis (iSVT) treated with anticoagulants. ObjectivesTo determine the short- and long-term risk of VTE and iSVT recurrence after cessation of anticoagulant treatment and to calculate 45-day cumulative bleeding incidence in patients with iSVT. MethodsBetween January 2014 and December 2021, 229 patients with high-risk iSVT (ie, thrombus length ≥5cm), without active cancer, with no history of VTE or iSVT, and who had received anticoagulant treatment for the iSVT were identified through the Venous Thrombosis Registry in Østfold Hospital (TROLL registry), Norway. Cumulative incidences of VTE and iSVT recurrence, as well as cumulative incidences of major and clinically relevant nonmajor bleeding events, were assessed. ResultsMedian age was 60 years (IQR, 48-71), and 125 (55%) were women. Most patients were treated with direct oral anticoagulants (74%), and of these, 79% received a dose of rivaroxaban 10 mg daily. Low-molecular-weight heparin was given to 26% of the patients. The 1- and 5-year cumulative incidences of VTE after iSVT were 4.6% (95% CI, 2.5-8.3) and 15.9% (95% CI, 10.8-22.9), respectively. Further, the 1- and 5-year cumulative incidences of iSVT recurrence were 6.5% (95% CI, 3.9-10.7) and 15.9% (95% CI, 10.8-23.1), respectively. The overall 45-day cumulative incidence of major and clinically relevant nonmajor bleeding events was 0.4% (95% CI, 0.06-3.06) and 1.8% (95% CI, 0.7-4.6), respectively. No major bleeding events were observed in patients treated with direct oral anticoagulants. ConclusionDespite anticoagulant treatment, the risk of VTE after high-risk iSVT was substantial, while bleeding complications were low.

Impact of Endoscopic Band Ligation on Bleeding Incidence in Patients with Chronic Liver Disease and High-Risk Varices

Impact of Endoscopic Band Ligation on Bleeding Incidence in Patients with Chronic Liver Disease and High-Risk Varices

Risk of post-sphincterotomy bleeding in patients with thrombocytopenia.

Reports suggest that the rate of adverse events (AEs) post-endoscopic sphincterotomy (ES) to be as high as 10%, with gastrointestinal bleeding being most common after post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. The aim of this study was to characterize the incidence of bleeding in patients with thrombocytopenia following ES. Retrospective observational cohort study. Patients with thrombocytopenia (defined as <150,000 platelets/μL) who underwent ES between May 2017 and December 2020 were identified at a tertiary care medical center. The incidence of immediate (intraprocedural oozing >5 min or requiring intervention) or delayed (clinical bleeding with associated hemoglobin drop within 14 days) post-ES bleeding was determined via manual chart review. A total of 221 patients with a mean platelet count of 108,000 ± 13,000 platelets/μL underwent ERCP with ES. Immediate bleeding occurred in 11 (5%) patients with no significant drop in hemoglobin or transfusion requirement. Two patients (0.9%), both of whom were noted to have immediate bleeding, also developed delayed bleeding. Presence of malignancy was associated with an increased risk of bleeding (36.4% versus 11.4%, p = 0.037) while platelet count was not. In a cohort of patients with thrombocytopenia, rates of immediate and delayed bleeding are similar to previously reported AE rates of ES in the general patient population. Careful attention should be given to patients with a history of active malignancy as well as those who develop immediate bleeding as they appear to be at increased risk for bleeding complications.

Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project.

Venous thromboembolism (VTE) is a major cause of death in the world. After the acute-phase treatment, the optimal duration of anticoagulation is still debatable. The latest guidelines suggest maintaining long-term anticoagulation in patients with cancer-associated thrombosis (CAT) or with unprovoked VTE and a low bleeding risk. Methods: The MAC Project is an ongoing prospective-cohort, multi-center, observational study in Italy. The project aims to collect real-life clinical information in unselected patients given oral anticoagulants for VTE over a 5-year follow-up period. There were no exclusion criteria, except for life expectancy <6 months and refusal to sign the informed consent form or to attend the planned follow-up visit. All patients were followed-up prospectively with clinical controls scheduled at 3, 6, and 12 months after the index event, and then annually for up to 5 years. The primary efficacy and safety outcomes were symptomatic recurrent VTE and major bleeding. Results: We analyzed 450 consecutive patients treated with rivaroxaban and referred them to the MAC Project database for unprovoked or recurrent VTE. Of these, 267 (55%) were unprovoked VTE, and 377 (87%) were symptomatic. We followed up with the patients for a mean of 22 months (Q1 10.7; Q3 37.4 months). Recurrent VTE occurred in 12 patients on rivaroxaban treatment (IR 1.7 per 100 person-years). Males had more recurrence than women. During the follow-up period, we recorded 13 (2.9%) major bleeding, 12 (2.7%) clinically relevant non-major bleeding, 8 minor bleeding, and no fatal bleeding events. Overall, bleeding events occurred in 33 (7.3%) patients, most occurring within the first 2 years of treatment. In addition, we observed a statistically significant higher incidence of bleeding in patients with a baseline HAS-BLED score of 3 to 4 compared with those with a score of 0 to 2, with most events occurring during the first 3 months of treatment (RR 5.9). Discussion: Rivaroxaban appears to be safe and effective for the long-term treatment of patients with recurrent or unprovoked VTE. Our results match previously published data, and we are confident that the continuation of the follow-up for up to 5 years will confirm these outcomes.

On the prevention of gastrointestinal bleeding in burned patients treated with omeprazole

Background: The incidence of gastrointestinal bleeding in patients with severe burns can reach up to 10%.Objective: Evaluation of the risk factors for gastrointestinal bleeding and of the effectiveness of stress ulcer prophylaxis in patients with severe burns receiving proton pump inhibitors.Material and methods: The study included the results of treatment of 270 patients with burns more than 10% of total body surface area (TBSA), in whom 13 potential risk factors for gastrointestinal bleeding were studied. All patients received omeprazole therapy with 40 mg № 1 intravenous or 20 mg № 2 orally. The data obtained were processed in Microsoft Office Excel 2007 and IBM SPSS 20.0.Results: Significant risk factors for gastrointestinal bleeding were hypotension requiring treatment with vasopressors (dopamine ≥ 10 μg/kg/min or norepinephrine ≥ 0.5 μg/kg/min) for 2 or more days (χ2 = 5.126; p = 0.024) and full thickness burns with more than 50% of total body surface area (χ2 = 7.031; p = 0.008). The incidence of gastrointestinal bleeding was 4%. These bleedings were hemodynamically insignificant; in all cases, acute ulcers were the cause for them. There were no recurrences of bleeding and no repeated endoscopy or surgical treatment was required. The developed bleeding did not have a significant effect on mortality.Conclusion: Using proton pump inhibitors minimizes the frequency and intensity of gastrointestinal bleeding and also prevents lifethreatening complications during their development. More complex prevention of stress ulceration is necessary for patients with full thickness burns more than 50% of TBSA which develop hypotension requiring long‑term vasopressor therapy.

Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo-controlled, randomized clinical trial

AbstractEvidence of the effectiveness of prophylactic use of tranexamic acid (TXA) in thrombocytopenia is lacking. To determine whether TXA safely reduces bleeding incidence in patients undergoing treatment for hematologic malignancies, a randomized, double-blind clinical trial was conducted from June 2016 through June 2020. Of 3120 screened adults, 356 patients were eligible and enrolled, and 337 patients (mean age, 53.9; 141 [41.8%] women), randomized to 1300 mg TXA orally or 1000 mg TXA through IV (n = 168) vs placebo (n = 169) thrice daily for maximum 30 days. Three hundred thirty patients were activated when their platelet counts fell below 30 000 per µL; 279 (83%) had complete outcome ascertainment. World Health Organization (WHO) grade ≥2 bleeding was observed in the 30 days following activation in 50.3% (73/145) and 54.2% (78/144) of patients in the TXA and placebo groups, with an adjusted odds ratio of 0.83 (95% confidence interval [CI], 0.50-1.34; P = .44). There was no statistically significant difference in the mean number of platelet transfusions (mean difference, 0.1; 95% CI, −1.9 to 2.0), mean days alive without grade ≥2 bleeding (mean difference, 0.8; 95% CI, −0.4 to 2.0), thrombotic events (6/163 [3.7%] TXA, 9/163 [5.5%] placebo), or deaths due to serious bleeding. Most common adverse events were: diarrhea (116/164 [70.7%] TXA and 114/163 [69.9%] placebo); febrile neutropenia (111/164 [67.7%] TXA, 105/163 [64.4%] placebo); fatigue (106/164 [64.6%] TXA, 109/163 [66.9%] placebo); and nausea (104/164 [63.4%] TXA, 97/163 [59.5%] placebo). Among patients with hematologic malignancy undergoing chemotherapy or hematopoietic stem cell transplantation, prophylactic treatment with TXA compared with placebo did not significantly reduce the risk of WHO grade ≥2 bleeding.

Effectiveness and Safety of Direct Oral Anticoagulants vs. Warfarin and Recurrence After Discontinuation in Patients With Acute Venous Thromboembolism in the Real World.

The efficacy of direct oral anticoagulants (DOACs) compared with warfarin for the treatment of venous thromboembolism (VTE), and the recurrence of VTE after discontinuation of anticoagulation therapy in research are limited. This retrospective study enrolled 893 patients with acute VTE between 2011 and 2019. The cohort was divided into the transient risk, unprovoked, continued cancer treatment, and cancer remission groups. The following were compared between DOACs and warfarin: composite outcome of all-cause death, VTE recurrence, bleeding and composite outcome of VTE-related death, recurrence and bleeding. In the continued cancer treatment group, more bleeding was seen in warfarin-treated patients than in patients treated with DOACs (53.2% vs. 31.2%, [P=0.048]). In addition, composite outcome of VTE-related death and recurrence after discontinuation of anticoagulation therapy (n=369) was evaluated. The continued cancer treatment group (multivariate analysis: HR: 3.62, 95% CI: 1.84-7.12, P<0.005) and bleeding-related discontinuation of therapy (HR: 2.60, 95% CI: 1.32-5.13, P=0.006) were independent predictors of the event after discontinuation of anticoagulation therapy. VTE recurrence after discontinuation of anticoagulation therapy in the cancer remission group was 1.6% and a statistically similar occurrence was found in the transient risk group (12.4%) (P=0.754). DOACs may decrease bleeding incidence in patients continuing to receive cancer treatment. In patients with bleeding-related discontinuation of anticoagulation therapy, VTE recurrence may increase. Discontinuation of anticoagulant therapy might be a treatment option in patients who have completed their cancer treatment.

Comparison of post-operative bleeding incidence in laser hemorrhoidoplasty with and without hemorrhoidal artery ligation: a double-blinded randomized controlled trial

IntroductionThe effectiveness of hemorrhoidal artery ligation supplementation in reducing the incidence of post laser hemorrhoidoplasty bleeding has not been investigated.MethodsThis was a double-blind, randomized controlled trial comparing post-operative bleeding incidence in patients undergoing laser hemorrhoidoplasty (LHP) only versus LHP with hemorrhoidal artery ligation (HAL). Outcome measures included post-operative bleeding and its severity (i.e. verbal rating scale and Clavien-Dindo classification), presence of perianal swelling and pain score (visual analog score) at 1-day, 1-week and 6-weeks post-operatively. Statistical tests were performed and a value of P < 0.05 was considered significant.ResultsSeventy-six patients were randomized. There was no difference in median operating time. The bleeding incidence was highest at 1-week post-operatively (17.1%), and decreased to 1.3% at 6-weeks. There was no significant difference in bleeding incidence between both groups at any of the measured timepoints (P > 0.05). Severity of bleeding and incidence of post-operative perianal swelling were similar in both groups (P > 0.05). There was no difference in median pain scores.ConclusionSupplementation of HAL to LHP does not reduce the post-operative bleeding incidence. LHP is sufficient as a stand-alone procedure for treating haemorrhoids.Trial registration: National Registration Number is NMRR-15-1112-24065 (IIR). The trial start date was 1st January 2015 with the ClinicalTrials.gov identifier and registration number as NCT04667169.

Incidence of gastrointestinal bleeding after transoesophageal echocardiography in patients with gastro-oesophageal varices: a systematic review and meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transoesophageal echocardiography (TEE) is useful for cardiac assessment and intraoperative monitoring. However, the safety of TEE in cirrhotic patients with gastro-oesophageal varices has remained uncertain. Purpose This meta-analysis aims to determine the incidence of gastrointestinal bleeding after TEE in patients with varices. The secondary objectives are to compare the bleeding risks between patients with and without varices; and to determine the incidences of TEE-related oesophageal perforation and mortality. Methods Systematic literature search was conducted on MEDLINE, EMBASE and Cochrane Database using the terms "Transoesophageal echocardiography", "Varices", "Bleeding", and related terms. Articles describing the incidence of post-TEE bleeding in patients with varices were included. Non-English articles were excluded. Risk of bias was assessed through a validated scale for bias assessment in prevalence studies. The level of evidence was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation approach. Pooled weighted incidence of gastrointestinal bleeding and risk difference in bleeding were calculated with a random effects model. Results 569 articles were identified initially, and 10 articles (comprising of 908 patients) were included. The incidence of post-TEE bleeding in patients with varices was 0.84% (95% CI 0.34%-1.56%). When stratified by TEE indication, the pooled incidence of bleeding was 0.68% (95% CI 0.11%-1.63%) in intraoperative TEE; and 1.03% (95% CI 0.23%-2.29%) in diagnostic TEE. No cases of oesophageal perforation or mortality were reported. 6 studies included a comparator group of patients without varices, and the bleeding risk was comparable between patients with and without varices (risk difference 0.26%; 95% CI -0.80%-1.32%; I2 = 0%, p = 0.88). Eight studies had moderate or high risk of bias, and overall level of evidence was low. Conclusion TEE appears to be associated with low gastrointestinal bleeding incidence in patients with gastro-oesophageal varices. Nonetheless, results should be treated with caution due to bias and low level of evidence. Large-scale high-quality studies will be required to confirm the safety of TEE in patients with gastro-oesophageal varices. Abstract Figure. Study selection process Abstract Figure. Forest plot of pooled bleeding incidence

Incidence and Predictors of Bleeding in Patients With Cancer and Atrial Fibrillation

Despite patients with cancer having a higher incidence of atrial fibrillation (AF), little is known about the predictors of outcomes in this population. This study aimed to assess the incidence and predictors of bleeding in patients with AF and cancer. The study population comprised 16,056 patients from a Spanish health area diagnosed with AF between 2014 and 2018 (1,137 with cancer). Competing risk analysis were used to evaluate the association of cancer and bleeding. Discrimination and calibration of bleeding risk scores were assessed by the concordance statistic and the Brier score, respectively. During a median follow-up of 4.9 years, the incidence of bleeding in patients with cancer was 13.2 per 100 patients/year. After multivariate adjustment, a significant association between cancer and bleeding was detected (subdistribution hazard ratio [sHR] 1.18, 95% CI 1.07 to 1.30, p=0.001), specifically in patients with active cancer or previous radiotherapy. Early age, male gender, diabetes, and anticoagulation were independent predictors of bleeding. However, only anticoagulation with vitamin K antagonist (sHR 1.36, 95% CI 1.03 to 1.78, p=0.026), not with direct oral anticoagulants (sHR 1.25, 95% CI 0.84 to 1.85, p=0.270), was associated with bleeding. Discrimination and calibration of Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, and Drugs/alcohol concomitantly (HAS-BLED), AnTicoagulation and Risk factors In Atrial fibrillation (ATRIA), and Hepatic or renal disease, Ethanol abuse, Malignancy, Older (age ≥75 years), Reduced platelet count or function, Rebleeding risk, Hypertension, Anaemia, Genetic factors, Excessive fall risk and Stroke (HEMORR2HAGES) scores were poor in patients with cancer (concordance statistic <0.6 and Brier score >0.1). In summary, cancer was associated with an increased risk of bleeding in patients with AF. The predictive ability of bleeding risk scores was poor in this population. Anticoagulation with vitamin K antagonist but not with direct oral anticoagulants, was an independent predictor of bleeding in patients with cancer.

Incidence of Gastrointestinal Bleeding after Transesophageal Echocardiography in Patients with Gastroesophageal Varices: A Systematic Review and Meta-Analysis

Transesophageal echocardiography (TEE) is useful for cardiac assessment and intraoperative monitoring. However, the safety of TEE in patients with cirrhosis and gastroesophageal varices has remained uncertain. The aim of this meta-analysis was to determine the incidence of gastrointestinal bleeding after TEE in patients with varices. The secondary objectives were to compare bleeding risks between patients with and without varices and to determine the incidence of TEE-related esophageal perforation and mortality. A systematic literature search was conducted on MEDLINE, Embase, and the Cochrane Library using the terms "transesophageal echocardiography," "varices," "bleeding," and related terms. Articles describing the incidence of post-TEE bleeding in patients with varices were included. Non-English-language articles were excluded. Risk of bias and level of evidence were assessed using validated scales. The pooled weighted incidence of gastrointestinal bleeding and the risk difference in bleeding were calculated using a random-effects model. Five hundred and sixty-nine articles were identified initially, and 10 articles (comprising of 908 patients) were included. The incidence of post-TEE bleeding in patients with varices was 0.84% (95% CI, 0.34% to 1.56%). When stratified by indication for TEE, the pooled incidence of bleeding was 0.68% (95% CI, 0.11% to 1.63%) for intraoperative TEE and 1.03% (95% CI, 0.23% to 2.29%) for diagnostic TEE. No cases of esophageal perforation or mortality were reported. Six studies included comparator groups of patients without varices, and the bleeding risk was comparable between patients with and those without varices (risk difference, 0.26%; 95% CI, -0.80% to 1.32%; I2=0%; P=.88). Eight studies had moderate or high risk for bias, and the overall level of evidence was low. TEE appears to be associated with low gastrointestinal bleeding incidence in patients with gastroesophageal varices. Nonetheless, results should be treated with caution because of bias and low level of evidence. Large-scale high-quality studies will be required to confirm the safety of TEE in patients with gastroesophageal varices.

Influence of renal dysfunction on clinical outcomes in elderly patients with atrial fibrillation: a subanalysis of the phase 3, randomized, placebo-controlled ELDERCARE-AF trial

Abstract Background Renal dysfunction is common in elderly patients with atrial fibrillation (AF) and is thought to be associated with increased risk of thromboembolic and bleeding events. Once-daily low-dose (15 mg) edoxaban was superior to placebo in preventing stroke or systemic embolic events (S/SEE) without significantly increasing major bleeding events in very elderly (≥80 years) non-valvular AF (NVAF) patients in whom standard oral anticoagulant therapy at approved doses was inappropriate (ELDERCARE-AF trial). Little is known about how renal dysfunction affects the effects of low-dose edoxaban in these patients. Purpose We used prespecified subgroup analysis to investigate the relation between renal function (assessed by creatinine clearance, CrCl) and the efficacy and safety of edoxaban in elderly NVAF patients. Methods ELDERCARE-AF patients were divided into 3 subgroups according to baseline CrCl: normal renal function/mild dysfunction (CrCl &amp;gt;50 mL/min), moderate renal dysfunction (CrCl ≥30 to ≤50 [“30–50”] mL/min) and severe renal dysfunction (CrCl ≥15 to &amp;lt;30 [“15–30”] mL/min). Primary efficacy and safety endpoints were annualized incidence of S/SEE and ISTH-defined major bleeding, respectively. Results Of 984 patients randomized to edoxaban 15 mg or placebo (each group N=492), 681 completed the trial. The 303 discontinuations were due to withdrawal of consent (n=158), death (n=135), or other causes (n=10). Discontinuation rate was the same in the edoxaban and placebo groups. S/SEE incidence in patients with CrCl &amp;gt;50, 30–50 and 15–30 mL/min was 2.0%, 1.3% and 3.5%, respectively, in edoxaban, and 4.4%, 4.6% and 9.7%, respectively, in placebo. In those with CrCl 30–50 and 15–30 mL/min, it was significantly lower in edoxaban than in placebo (adjusted hazard ratio [HR], 0.30 [95% CI, 0.10–0.91], p=0.03; and 0.33 [95% CI, 0.16–0.71], p&amp;lt;0.01, respectively). Incidence of major bleeding in patients with CrCl &amp;gt;50, 30–50 and 15–30 mL/min was 1.0%, 1.8% and 6.2%, respectively, in edoxaban, and 0.9%, 1.5% and 2.4%, respectively, in placebo. Incidence of major bleeding in those with CrCl 15–30 mL/min was higher in edoxaban but not significantly (adjusted HR, 2.53 [95% CI, 0.96–6.72], p=0.062). Incidence of gastrointestinal bleeding in patients with CrCl 15–30 mL/min was 4.3% in edoxaban and 1.6% in placebo (adjusted HR, 2.61 [95% CI, 0.79–8.68], p=0.12). Incidence of all-cause death in patients with CrCl &amp;gt;50, 30–50 and 15–30 mL/min was 5.8%, 6.8% and 15.2%, respectively, in edoxaban, and 7.0%, 6.3% and 15.5%, respectively, in placebo (no significant intergroup differences). Conclusions Incidence of S/SEE, major bleeding and all-cause death increased with declining renal function in elderly NVAF patients. Edoxaban 15 mg remained superior to placebo in preventing S/SEE, even in those with moderate to severe renal dysfunction. Incidence of major bleeding in patients with severe renal dysfunction was higher (non-significantly) with edoxaban than with placebo. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi-Sankyo Co., Ltd.

Incidence of bleeding in patients on different anticoagulants and antiplatelet therapies undergoing thoracentesis

IntroductionThoracentesis is one of the most commonly performed procedures in the inpatient setting. Although coagulation profile is usually evaluated prior to thoracentesis, bleeding is a rare complication, occurring in less...

Incidence of Bleeding Events in Acute Myeloid Leukemia (AML) Patients Receiving Anticoagulation Therapy for Treatment of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) Who Are Also Undergoing Induction or Re-Induction Therapy

Background/Rationale:Venous thromboembolic events (VTE) remain a prevalent complication in cancer patients. Despite this increased risk, the decision on whether or not to treat and/or use prophylactic therapy remains highly debatable among clinicians. Induction and re-induction therapy, in combination with the pathophysiology of the disease can cause profound thrombocytopenia. Additionally, leukemic cells can cause an inappropriate release of procoagulants directly into the bloodstream, initiating the clotting cascade and causing simultaneous clot formation and hemorrhage leading to disseminated intravascular coagulation (DIC). Another major factor to consider in this patient population is central venous access. Although the National Comprehensive Cancer Network (NCCN) guidelines recommend ≥3 months of therapeutic anticoagulation for catheter-associated VTEs, clinicians use anticoagulation cautiously in the AML population due to severe thrombocytopenia and the increased risk of bleeding. Data that can be used to optimize treatment strategies for catheter-associated VTE in patients with acute leukemia are needed as the risk versus benefit for anticoagulation is currently unclear. A recent article by Rajasekhar and colleagues investigated this risk and noted that among patients with severe thrombocytopenia (platelets <50,000/μL) who received therapeutic anticoagulation, 27% experienced a significant bleeding event compared to only 2% of patients who did not receive therapeutic anticoagulation. In order to establish the bleeding complications associated with patients receiving induction or re-induction therapy for AML, we conducted a retrospective chart review evaluating the incidence of bleeding in patients receiving therapeutic anticoagulation for treatment of VTE.Objective:The primary outcome of this study is incidence of bleeding events in AML patients receiving anticoagulation therapy for treatment of DVT or PE who are also undergoing induction or re-induction therapy. Secondary outcomes include incidence of chemical and non-chemical DVT prophylaxis, as well as the difference in incidence of bleeding events among agents.Methods:This is a retrospective chart review evaluating the incidence of bleeding in AML patients receiving anticoagulation for treatment of VTE during induction or re-induction therapy at WFBH from October 2012 to October 2016. AML patients who were >18 years of age who had undergone induction or re-induction chemotherapy and developed a VTE were included in the study. Clinical diagnosis of VTE was confirmed by objective imaging procedures. The following induction or re-induction regimens were excluded: azacitidine or decitabine. Descriptive statistics were used for data analysis.Results: Out of 523 patients screened, 24 met eligibility criteria for a total VTE incidence of 4.6%. The age range for the patients included was 22 to 77, with 14 patients (58.3%) being female and 10 patients (41.7%) being male. Of the patients who developed a VTE, 18 (75%) received non-chemical DVT prophylaxis. Twenty (83.3%) of the 24 VTEs were catheter-associated DVTs. Twenty-two of 24 patients received therapeutic anticoagulation with either heparin (n=21) or enoxaparin (n=1). The 2 patients who did not receive anticoagulation did not have a bleeding event. Patients who developed a bleed were more likely to have supratherapeutic PTTs (defined as PTTs ≥ 90 seconds); however, supratherapeutic levels were isolated and not associated with the time of the bleed. Of the patients who received therapeutic anticoagulation, 8 (36.4%) had a major bleed and 9 (40.9%) had a minor bleed, for an overall bleeding rate of 77.3%. There were no deaths as a result of bleeding events. Of the 20 patients with catheter-associated VTEs, 7 (35%) had a major bleed; 4 of these patients required anticoagulation reversal with protamine.Conclusions:AML patients who received induction or re-induction therapy had a low incidence of VTE overall. However, when patients received anticoagulation for VTE treatment there was a high incidence of bleeding. The results found in this retrospective chart review showed that for patients with catheter-associated VTEs, the risk of bleeding outweighed the risk of VTE. We recommend a risk-adapted strategy where patients do not receive therapeutic anticoagulation until platelet recovery. DisclosuresPowell:Rafael Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees. Ellis:Alexion: Speakers Bureau. Pardee:Rafael Pharmaceuticals: Employment, Research Funding.

Statin but not aspirin treatment is associated with reduced cardiovascular risk in patients with diabetes without obstructive coronary artery disease: a cohort study from the Western Denmark Heart Registry.

Patients with diabetes and no obstructive coronary artery disease (CAD) as assessed by coronary angiography (CAG) are frequently treated with aspirin and statins. We examined the effectiveness of aspirin and statin treatment on cardiovascular and bleeding incidence in patients with diabetes and absent obstructive CAD. The study included patients with diabetes and absent obstructive CAD as assessed by CAG from 2003 to 2016 in Western Denmark. We stratified patients by aspirin and statin treatment within 6 months after CAG in two separate analyses. Outcomes were MACE (major adverse cardiovascular events, a composite of myocardial infarction, ischaemic stroke, and death) and bleeding (aspirin only). To account for confounding, we used propensity score-based weights to estimate the inverse probability of treatment-weighted hazard ratios (HRIPTW). We included 4124 patients with diabetes but without CAD as assessed by CAG, among whom 2474 (60%) received aspirin and 2916 (71%) received statin treatment within 6 months following CAG. Median follow-up was 4.9 years. Aspirin did not reduce 10-year MACE [21.3% vs. 21.8%, HRIPTW 1.01, 95% confidence interval (CI) 0.82-1.25], all-cause death (HRIPTW 0.96, 95% CI 0.74-1.23), or bleeding (HRIPTW 0.95, 95% CI 0.73-1.23), compared to those not receiving aspirin treatment. Statin treatment reduced MACE (25% vs. 37%, HRIPTW 0.58, 95% CI 0.48-0.70) compared to those not receiving statin treatment. Among patients with diabetes and no obstructive CAD, aspirin neither reduced MACE nor increased bleeding. In contrast, statin treatment was associated with a major reduction in risk of MACE.

Prospective observational study on the clinical behaviour of dental implants in patients with haemophilia. Preliminary results

Haemophilia is a recessive congenital hereditary haemorrhagic disorder characterised by the decrease in, or absence of, the functional activity of factor VIII (Haemophilia A) or factor IX (Haemophilia B). The haematological medical treatment for these patients is systemic replacement therapy with factor VIII or factor IX concentrates. Dental implants are considered the gold standard for the replacement of missing teeth. There is no evidence or safe protocol for their use in patients with haemophilia. The objective of this study was to evaluate the clinical osseointegration and the incidence of postoperative bleeding in patients with haemophilia. The patients included in this study were over 18 years old with a diagnosis of haemophilia. A surgical implant protocol was implemented, supported by systemic and local haemostatic measures. Age, type of haemophilia, pre- and post-factor levels, gingival index, surgical duration, oedema, and pain were recorded for each case. In the event of haemorrhage, the bleeding index was determined. At four months, the success of the implant was evaluated using the absence of pain, suppuration, and clinical mobility as parameters. Fifteen surgeries were performed and 21 implants were placed in 10 patients. All the implants were successful in terms of the evaluated parameters. Among the 15 surgeries performed, bleeding was detected in three. The preliminary results found in this study seem to establish that the proposed surgical implant and haemostatic protocol is a predictable treatment for the placement of dental implants in patients with haemophilia.