scholarly journals Major Bleeding in Adults Undergoing Peripheral Extracorporeal Membrane Oxygenation (ECMO): Prognosis and Predictors

2022 ◽  
Vol 2022 ◽  
pp. 1-10
Author(s):  
Tung Phi Nguyen ◽  
Xuan Thi Phan ◽  
Tuan Huu Nguyen ◽  
Dai Quang Huynh ◽  
Linh Thanh Tran ◽  
...  

Background. Major bleeding has been a common and serious complication with poor outcomes in ECMO patients. With a novel, less-invasive cannulation approach and closer coagulation monitoring regime, the incidence of major bleeding is currently not determined yet. Our study aims to examine the incidence of major bleeding, its determinants, and association with mortality in peripheral-ECMO patients. Method. We conducted a single-center retrospective study on adult patients undergoing peripheral-ECMO between January 2019 and January 2020 at a tertiary referral hospital. Determinants of major bleeding were defined by logistic regression analysis. Risk factors of in-hospital mortality were determined by Cox proportional hazard regression analysis. Results. Major bleeding was reported in 33/105 patients (31.4%) and was associated with higher in-hospital mortality [adjusted hazard ratio (aHR) 3.56, 95% confidence interval (CI) 1.63–7.80, p < 0.001 ). There were no significant difference in age, sex, ECMO indications, ECMO modality, pre-ECMO APACHE-II and SOFA scores between two groups with and without major bleeding. Only APTT >72 seconds [adjusted odds ratio (aOR) 7.10, 95% CI 2.60–19.50, p < 0.001 ], fibrinogen <2 g/L [aOR = 7.10, 95% CI 2.60–19.50, p < 0.001 ], and ACT >220 seconds [aOR = 3.9, 95% CI 1.20–11.80, p = 0.017 ] on days with major bleeding were independent predictors. Conclusions. In summary, major bleeding still had a fairly high incidence and poor outcome in peripheral-ECMO patients. APTT > 72 seconds, fibrinogen < 2 g/L were the strongest predicting factors for major bleeding events.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V.L Malavasi ◽  
E Fantecchi ◽  
V Tordoni ◽  
L Melara ◽  
A Barbieri ◽  
...  

Abstract Background Natural history of atrial fibrillation (AF) shows a progression of arrhythmia from non-permanent to permanent AF. Permanent AF was found associated with a worse prognosis than non-permanent one. Aim To assess the factors associated with progression to permanent AF in an unselected population of AF patients with non-permanent AF. Methods In this prospective study we enrolled in- as well as out-patients with non-permanent AF and age ≥18 years, with at least one episode of ECG-documented AF within 1 year. The patients were followed-up at 1 month and every 6 months thereafter. Results Out of 523 patients, 314 (60%) were in non-permanent AF (80 [25.5%] paroxysmal AF, 165 [52.5%] persistent AF, 69 [2%] first diagnosed AF), mostly male (188, 59.9%), median age 71 years (IQ range 62–77), median CHA2DS2VASc 3 (1–4), median HATCH score 1 (1–2). After a median follow-up of 701 (IQ range 437–902) days, 66 patients (21%) showed permanent AF. CHA2DS2VASc and HATCH scores were incrementally associated to progression to permanent AF (CHA2DS2VASc χ2 p=0.001; HATCH χ2 p=0.017; p for trend CHA2DS2VASc &lt;0.001, HATCH p=0.001). At multivariable Cox proportional hazard regression the following variables were significantly associated with AF progression: age (hazard ratio [HR] 1.041; 95% CI: 1.004–1.079; p=0.028), at least moderate left atrial (LA) enlargement (&gt;42 ml/m2) (HR 2.092; 95% CI: 1.132–3.866; p=0.018), antiarrhythmics drugs after the enrollment (HR 0.087; 95% CI: 0.011–0.662; p=0.018), EHRA score &gt;2 (HR 0.351; 95% CI: 0.158–0.779; p=0.010) and Valvular HD (HR 2.161; 95% CI: 1.057–4.420; p=0.035). Adding LA dilation to HATCH score (HATCH-LA) and assigning 2 points based on multivariable Cox regression, HATCH-LA was statistically better in ROC curves in prediction of AF progression vs HATCH score (area under the curve 0.695 vs 0.636; DeLong p=0.0225). Survival-free curves on freedom from permanent AF using as discriminator HATCH-LA score ≤2 vs &gt;2 led to a statistically significant difference (χ2=16.080 p&lt;0.001), but the same was not found for HATCH score (χ2 =3.099; p=0.078). Conclusions In patients without permanent AF, progression of AF was independentely related to age, LA dilation, AF symptoms severity, antiarrhythmic drugs and Valvular HD. HATCH score predicted AF progression and adding to it LA dilation (at least moderate) improved patients stratification for the risk of evolution to permanent AF. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1445.1-1445
Author(s):  
F. Girelli ◽  
A. Ariani ◽  
M. Bruschi ◽  
A. Becciolini ◽  
L. Gardelli ◽  
...  

Background:The available biosimilars of etanercept are as effective and well tolerated as their bio originator molecule in the naive treatment of chronic autoimmune arthritis. More data about the switching from the bio originator are needed.Objectives:To compare the clinical outcomes of the treatment with etanercept biosimilars (SB4 and GP2015) naïve and after the switch from their corresponding originator in patients affected by autoimmune arthritis in a real life settingMethods:We retrospectively analyzed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of etanercept (originator or biosimilar) in our Rheumatology Units from January 2000 to January 2020. We stratified the study population according to biosimilar use. Descriptive data are presented by medians (interquartile range [IQR]) for continuous data or as numbers (percentages) for categorical data. Drug survival distribution curves were computed by the Kaplan-Meier method and compared by a stratified log-rank test. A Cox proportional hazards regression analysis stratified by indication, drug, age, disease duration, sex, treatment line, biosimilar use and prescription year was performed. P values≤0.05 were considered statistically significant.Results:477 patients (65% female, median age 56 [46-75] years, median disease duration 97 [40.25-178.75] months) treated with etanercept were included in the analysis. 257 (53.9%) were affect by rheumatoid arthritis, 139 (29.1%) by psoriatic arthritis, and 81 (17%) by axial spondylarthritis. 298 (62.5%) were treated with etanercept originator, 97 (20.3%) with SB4, and 82 (17.2%) with GP2015. Among the biosimilars 90/179 (50.3%) patients were naïve to etanercept treatment. Among the 89 switchers we observed 8 treatment discontinuations: one due to surgical infection complication, three due to disease flare, two due to subjective worsening and one due to remission. The overall 6- and 12-month retentions rate were 92.8% and 80.2%. The 6- and 12-month retention rate for etanercept, SB4 and GP2015 were 92.7%, 93.4% and 90.2%, and 82%, 74.5% and 88.1% respectively, without significant differences among the three groups (p=0.374). Patients switching from originator to biosimilars showed and overall higher treatment survival when compared to naive (12-month retention rate 81.2% vs 70.8%, p=0.036). The Cox proportional hazard regression analysis highlighted that the only predictor significantly associated with an overall higher risk of treatment discontinuation was the year of prescription (HR 1.08, 95% CI 1.04 to 1.13; p<0.0001).Conclusion:In our retrospective study etanercept originator and its biosimilars (SB4 and GP2015) showed the same effectiveness. Patients switching from originator to biosimilar showed an significant higher retention rate when compared to naive. The only predictor of treatment discontinuation highlighted by the Cox proportional hazard regression analysis was the year of treatment prescription.Disclosure of Interests:Francesco Girelli: None declared, Alarico Ariani: None declared, Marco Bruschi: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, Lucia Gardelli: None declared, Maurizio Nizzoli: None declared


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Sirui Zhang ◽  
Yupei Li ◽  
Guina Liu ◽  
Baihai Su

Abstract Background Anticoagulation in hospitalized COVID-19 patients has been associated with survival benefit; however, the optimal anticoagulant strategy has not yet been defined. The objective of this meta-analysis was to investigate the effect of intermediate-to-therapeutic versus prophylactic anticoagulation for thromboprophylaxis on the primary outcome of in-hospital mortality and other patient-centered secondary outcomes in COVID-19 patients. Methods MEDLINE, EMBASE, and Cochrane databases were searched from inception to August 10th 2021. Cohort studies and randomized clinical trials that assessed the efficacy and safety of intermediate-to-therapeutic versus prophylactic anticoagulation in hospitalized COVID-19 patients were included. Baseline characteristics and relevant data of each study were extracted in a pre-designed standardized data-collection form. The primary outcome was all-cause in-hospital mortality and the secondary outcomes were incidence of thrombotic events and incidence of any bleeding and major bleeding. Pooled analysis with random effects models yielded relative risk with 95 % CIs. Results This meta-analysis included 42 studies with 28,055 in-hospital COVID-19 patients totally. Our pooled analysis demonstrated that intermediate-to-therapeutic anticoagulation was not associated with lower in-hospital mortality (RR=1.12, 95 %CI 0.99-1.25, p=0.06, I2=77 %) and lower incidence of thrombotic events (RR=1.30, 95 %CI 0.79-2.15, p=0.30, I2=88 %), but increased the risk of any bleeding events (RR=2.16, 95 %CI 1.79-2.60, p<0.01, I2=31 %) and major bleeding events significantly (RR=2.10, 95 %CI 1.77-2.51, p<0.01, I2=11 %) versus prophylactic anticoagulation. Moreover, intermediate-to-therapeutic anticoagulation decreased the incidence of thrombotic events (RR=0.71, 95 %CI 0.56-0.89, p=0.003, I2=0 %) among critically ill COVID-19 patients admitted to intensive care units (ICU), with increased bleeding risk (RR=1.66, 95 %CI 1.37-2.00, p<0.01, I2=0 %) and unchanged in-hospital mortality (RR=0.94, 95 %CI 0.79-1.10, p=0.42, I2=30 %) in such patients. The Grading of Recommendation, Assessment, Development, and Evaluation certainty of evidence ranged from very low to moderate. Conclusions We recommend the use of prophylactic anticoagulation against intermediate-to-therapeutic anticoagulation among unselected hospitalized COVID-19 patients considering insignificant survival benefits but higher risk of bleeding in the escalated thromboprophylaxis strategy. For critically ill COVID-19 patients, the benefits of intermediate-to-therapeutic anticoagulation in reducing thrombotic events should be weighed cautiously because of its association with higher risk of bleeding. Trial registration The protocol was registered at PROSPERO on August 17th 2021 (CRD42021273780). Graphical abstract


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19501-e19501 ◽  
Author(s):  
Amar Harry Kelkar ◽  
Asha R. Dhanarajan ◽  
Mona Arti Kelkar ◽  
John R. Wingard

e19501 Background: Management of acute leukemia is often complicated by acute venous thromboembolism (VTE) and bleeding. However, it is unknown which risk factors contribute to these VTE and bleeding events, how they impact survival, or whether they warrant VTE prophylaxis. Methods: A retrospective study was conducted at the University of Florida Health Shands Hospital System. The study included patients aged 18 or older with acute leukemia who received induction chemotherapy between January 2000 and December 2011. Bleeding was defined as clinically significant non-major bleeding and major bleeding per the International Society on Thrombosis and Haemostasis guidelines. VTE was defined as pulmonary embolism, deep vein thrombosis of the upper or lower extremities, or visceral vein thrombosis. Results: Of the 250 patients with acute leukemia, 65 had VTE, 60 had bleeding, and 152 had no significant VTE or bleeding. There were 27 patients with both VTE and bleeding. There were no significant differences in demographics or disease types between these three groups. There was a total of 77 VTE events and 72 bleeding events. We performed a logistic regression analysis in a mixed model to identify risk factors for VTE and bleeding, considering leukemia type, presence of infection, chemotherapy, number of comorbidities, VTE prophylaxis, and transplant as covariates. Presence of infection and number of comorbidities were significantly associated with VTE (p = 0.0094 and 0.0009, respectively). We did not find any significant risk factor associated with bleeding. Kaplan-Meier survival analysis showed a non-significant difference in survival between the non-VTE, non-bleed group and the VTE group (Logrank test, p = 0.52). In contrast, survival in the non-VTE, non-bleed group was significantly higher than the bleed group (Logrank test, p = 0.0006). The table demonstrates higher two-year survival in the non-VTE, non-bleed group (68.7%) compared to the VTE and bleed groups (54.4% and 30.3%, respectively). Conclusions: Acute leukemia patients without VTE or bleeding had significantly higher duration of survival than patients with bleeding. Patients with acute leukemia and presence of infection or multiple comorbidities may warrant greater consideration of VTE prophylaxis. [Table: see text]


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Alak ◽  
E Ozpelit ◽  
D Cirgamis ◽  
M Abusharekh ◽  
N Baris

Abstract Introduction International guidelines recommend using risk score tools that allow us to assess the risk of bleeding and ischemia when deciding on DAPT. In our research, we aimed to examine the mortality relationship of new risk scores, DAPT and PRECISE-DAPT scores. Method Between 2013–2014, 948 patients admitted to our clinic with ACS were included in our study. We excluded 688 patient (no contact number,CABG, medical treatment, use of oral anticoagulation, active malignant cancer). 260 patients admitted with acute coronary syndrome (58%, 8 STEMI, 35%, 4 non-STEMI, 5%, 4 Unstable angina pectoris) who undergo coronary stent implantation were included in the study. We aimed to focus on the patients who undergo percutaneous coronary intervention and their risk of mortality. The patients' records were retrospectively analyzed through the hospital information system and archive records. Laboratory results, echocardiography and CAG reports of the patients, disease histories were obtained from the information recorded through the system. With these data, PRECISE-DAPT and DAPT scores of patients were calculated. Results The number of patients with a PRECISE-DAPT Score ≥25 was 62 (23.8%). The number of patients with DAPT Score ≥2 was 193 (74.2%). Mortality occurred in 49 (18.8%) patients. Patients with PRECISE-DAPT ≥25 and those with PRECISE-DAPT &lt;25 were compared in terms of mortality and mortality was significantly higher in the high-scoring group [P &lt;0.001 OR 6.94 C (3.53–13.62)]. The patients were divided into 4 groups (PRECISE-DAPT 25 and DAPT ≥2, PRECISE-DAPT ≥25 and DAPT ≥2, PRECISE-DAPT 25 and DAPT 2, PRECISE-DAPT ≥25 and DAPT 2) according to PRECISE-DAPT and DAPT score. Mortality was significantly higher regardless of DAPT score in patients with high PRECISE-DAPT scores (p&lt;0.001). We evaluated the relationship between PRECISE-DAPT score and major bleeding and all bleeding. Compared to the group there was no significant difference in all bleeding events (P=0.56) and major bleeding events (P=0.23). The relationship between bleeding events and mortality was evaluated. There was no significant difference in mortality (p=0.689) with all bleeding events; but mortality was significantly increased in patients with major bleeding [P=0.025 OR 6.16 (1,33–28,49)]. Conclusion In our study, we observed that the patient group with a high PRECISE-DAPT score had a high mortality rate regardless of the DAPT score. The PRECISE-DAPT score is a useful tool in determining the group with high long-term mortality in patients who present with acute coronary syndrome and undergo percutaneous coronary intervention. The clinician should use the PRECISE-DAPT score when deciding on the duration of dual antiplatelet therapy in this patient group and these patients with high scores need to be monitored more closely. The data we have obtained from our study is retrospective and these results need to be supported by prospective and large studies. FUNDunding Acknowledgement Type of funding sources: None.


2021 ◽  
Author(s):  
Yi Bian ◽  
Yue Le ◽  
Ping Zhang ◽  
Zhigang He ◽  
Ye Wang ◽  
...  

Abstract Background: Accumulating evidence has revealed that coagulopathy and widespread thrombosis in the lung are common in patients with Coronavirus Disease 2019 (COVID-19). This raises questions about the efficacy and safety of systemic anticoagulation (AC) in COVID-19 patients. Method: This single-center, retrospective, cohort study unselectively reviewed 2272 patients with COVID-19 admitted to the Tongji Hospital between Jan 25 and Mar 23, 2020. Propensity score-matching between patients adjusted for potential covariates was carried out with the patients divided into two groups depending on whether or not they had received AC treatment (AC group, ³7 days of treatment; non-AC group, no treatment). This yielded 164 patients in each group. Result: In-hospital mortality of the AC group was significantly lower than that of the non-AC group (14.0% vs. 28.7%, P =0.001). Treatment with AC was associated with a significantly lower probability of in-hospital death (adjusted HR=0.273, 95% CI, 0.154 to 0.484, P<0.001). The incidence of major bleeding and thrombocytopenia in the two groups was not significantly different. Subgroup analysis showed the following factors were associated with a significantly lower in-hospital mortality in patients who had received AC treatment; severe cases (13.2% vs. 24.6%, P=0.018), critical cases (20.0% vs 82.4%, P=0.003), patients with a D-dimer level ≥0.5 μg/mL (14.8% vs. 33.8, P<0.001), and moderate (16.7% vs. 60.0%, P=0.003) or severe acute respiratory distress syndrome (ARDS) cases at admission (33.3% vs. 86.7%, P=0.004). During the hospital stay, critical cases (38.3% vs. 76.7%, P<0.001) and severe ARDS cases (36.5% vs. 76.3%, P<0.001) who received AC treatment had significantly lower in-hospital mortality. Conclusions: AC treatment decreases the risk of in-hospital mortality, especially in critically ill patients, with no additional significant, major bleeding events or thrombocytopenia being observed.Trials registration - ChiCTR2000039855


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1238-1238
Author(s):  
Kamolyut Lapumnuaypol ◽  
Thita Chiasakul

Abstract Introduction: The coagulopathy of cirrhosis is characterized by a complex rebalanced hemostasis which increases the risk of bleeding as well as thrombosis. For the treatment and prevention of thromboembolism, low-molecular weight heparin (LMWH) and vitamin K antagonists, such as warfarin, are generally used in cirrhotic patients. Although efficacious, these agents are inconvenient due to the parenteral route of administration, need for monitoring, and interactions with food or drugs. Direct oral anticoagulants (DOACs) may provide safe and effective alternatives for patients with cirrhosis. However, data concerning their safety profile in this population are limited given that patients with advanced liver diseases were excluded from most clinical trials. To address this, we conducted a systematic review and meta-analysis to evaluate the safety of DOACs compared to warfarin or low-molecular weight heparin (LMWH) in patients with cirrhosis. Methods: A systematic literature search was performed using MEDLINE and EMBASE from inception up to June 2018. We included prospective and retrospective studies involving adults ≥18 years with cirrhosis of any stage in whom anticoagulants were indicated for any indications. Included studies are required to report the incidence, odds ratio, or hazard ratio of bleeding events in both patients receiving DOACs and patients receiving warfarin or LMWH (controls). Two authors independently searched the literature, screened for eligibility, and extracted the data. Any discrepancies were resolved by reaching consensus. Primary outcome of interest was all-cause bleeding events. Secondary outcome was major bleeding. Data analysis was performed using Review Manager version 5.3. For all-cause bleeding, pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using Mantel-Haenszel method. For major bleeding, effect estimates and standard errors from individual studies were combined by the generic inverse variance method of DerSimonian and Laird. Random-effects model was used in all analyses. Inter-study heterogeneity was evaluated using Cochran's Q test and I2statistics. Results: A total of 279 articles were identified from MEDLINE and EMBASE, of which 93 were removed because of duplication. After screening by title and abstract, 174 articles were excluded. Full text of 12 articles were reviewed, of which 5 studies (4 observational studies and 1 randomized controlled trial) with a total of 447 patients met eligibility criteria and were included in the final analysis. The indications for anticoagulants included atrial fibrillation, deep venous thrombosis, pulmonary embolism, and portal vein thrombosis. The DOACs used in these studies included dabigatran, rivaroxaban, apixaban, and edoxaban. Heterogeneity among studies was low to moderate. Compared to controls, the use of DOACs in cirrhotic patients did not show any significant difference in all-cause bleeding (RR 0.72; 95% CI, 0.32-1.63; I2=59%, Figure 1). Among 3 studies that reported major bleeding, there was no significant difference in major bleeding between both groups (OR 0.46; 95% CI, 0.10-2.09; I2=42%, Figure 2). Conclusions: Our study demonstrates that, compared to those who were treated with traditional anticoagulants, cirrhotic patients who were treated with DOACs had no significant increase risk of all-cause bleeding and major bleeding. The use of DOACs in patents with cirrhosis appears to be as safe as traditional anticoagulants. Further randomized controlled studies involving larger numbers of patients are required to explore the efficacy as well as potential beneficial effects of DOACs for each indications in cirrhotic patients. Disclosures No relevant conflicts of interest to declare.


2007 ◽  
Vol 64 (10) ◽  
pp. 655-658
Author(s):  
Nebojsa Despotovic ◽  
Goran Loncar ◽  
Maja Nikolic-Despotovic ◽  
Marjan Ilic ◽  
Sinisa Dimkovic

Background/Aim. Enoxaparin (ENOX), the lowmolecular- weight heparin, used in acute myocardial infarction (AMI) could lead to hemorrhage. The aim of this study was to determine whether bleeding was more often in AMI patients older than 65 or 75 years who receive ENOX or unfractionated heparin (UFH). Methods. Among the patients with AMI hospitalized during three successive months receiving ENOX or UFH, three group of parameters were investigated: demographic, ischemic and bleeding TIMI criteria. Results. Among 85 hospitalized patients with signs of AIM, there were 35 (41.2%) old 65 years or less, 32 (38.5) old 66-75 years and 18 (21.2%) older than 75 years. In AMI elderly patients, according to the received ENOX/UFH: ischemic complication (18.2 vs. 21.4%) were insignificantly lower and the number of lethal outcomes (18,2 vs. 17,8%) were insignificantly more often in ENOX group; represented only by one patient (age beyond 75 years), major and non-major bleeding events occurred only in UFH group. Conclusion. The ENOX usage in AMI in patients older than 65 years did not show any significant difference in efficacy and bleeding rate comparing to UFH.


BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Gangqin Xi ◽  
Lida Qiu ◽  
Shuoyu Xu ◽  
Wenhui Guo ◽  
Fangmeng Fu ◽  
...  

Abstract Background Collagen fibers play an important role in tumor initiation, progression, and invasion. Our previous research has already shown that large-scale tumor-associated collagen signatures (TACS) are powerful prognostic biomarkers independent of clinicopathological factors in invasive breast cancer. However, they are observed on a macroscale and are more suitable for identifying high-risk patients. It is necessary to investigate the effect of the corresponding microscopic features of TACS so as to more accurately and comprehensively predict the prognosis of breast cancer patients. Methods In this retrospective and multicenter study, we included 942 invasive breast cancer patients in both a training cohort (n = 355) and an internal validation cohort (n = 334) from one clinical center and in an external validation cohort (n = 253) from a different clinical center. TACS corresponding microscopic features (TCMFs) were firstly extracted from multiphoton images for each patient, and then least absolute shrinkage and selection operator (LASSO) regression was applied to select the most robust features to build a TCMF-score. Finally, the Cox proportional hazard regression analysis was used to evaluate the association of TCMF-score with disease-free survival (DFS). Results TCMF-score is significantly associated with DFS in univariate Cox proportional hazard regression analysis. After adjusting for clinical variables by multivariate Cox regression analysis, the TCMF-score remains an independent prognostic indicator. Remarkably, the TCMF model performs better than the clinical (CLI) model in the three cohorts and is particularly outstanding in the ER-positive and lower-risk subgroups. By contrast, the TACS model is more suitable for the ER-negative and higher-risk subgroups. When the TACS and TCMF are combined, they could complement each other and perform well in all patients. As expected, the full model (CLI+TCMF+TACS) achieves the best performance (AUC 0.905, [0.873–0.938]; 0.896, [0.860–0.931]; 0.882, [0.840–0.925] in the three cohorts). Conclusion These results demonstrate that the TCMF-score is an independent prognostic factor for breast cancer, and the increased prognostic performance (TCMF+TACS-score) may help us develop more appropriate treatment protocols.


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