scholarly journals Bleeding management in computed tomography-guided liver biopsies by biopsy tract plugging with gelatin sponge slurry

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Nikolaus A. Handke ◽  
Dennis C. Koch ◽  
Eugen Muschler ◽  
Daniel Thomas ◽  
Julian A. Luetkens ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Liver Biopsy ◽  
Adverse Events ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Gelatin Sponge ◽  
Minor Bleeding ◽  
Safe Procedure ◽  
Bleeding Events ◽  
Major Bleeding Events

AbstractTo evaluate the safety and impact of biopsy tract plugging with gelatin sponge slurry in percutaneous liver biopsy. 300 consecutive patients (158 females, 142 males; median age, 63 years) who underwent computed tomography-guided core biopsy of the liver in coaxial technique (16/18 Gauge) with and without biopsy tract plugging were retrospectively reviewed (January 2013 to May 2018). Complications were rated according to the common criteria for adverse events (NCI-CTCAE). The study cohort was dichotomized into a plugged (71%; n = 214) and an unplugged (29%; n = 86) biopsy tract group. Biopsy tract plugging with gelatin sponge slurry was technically successful in all cases. Major bleeding events were only observed in the unplugged group (0.7%; n = 2), whereas minor bleedings (4.3%) were observed in both groups (plugged, 3.6%, n = 11; unplugged, 0.7%, n = 2). Analysis of biopsies and adverse events showed a significant association between number of needle-passes and overall (P = 0.038; odds ratio: 1.395) as well as minor bleeding events (P = 0.020; odds ratio: 1.501). No complications associated with gelatin sponge slurry were observed. Biopsy tract plugging with gelatin sponge slurry is a technically easy and safe procedure that can prevent major bleeding events following liver biopsy.

Calculation of HAS-BLED Score Is Useful for Early Identification of Venous Thromboembolism Patients at High Risk for Major Bleeding Events: A Prospective Outpatients Cohort Study

2017 ◽  
Vol 44 (04) ◽  
pp. 348-352 ◽  
Author(s):  
Reinhard Raggam ◽  
Franz Hafner ◽  
Alexander Avian ◽  
Gerald Hackl ◽  
Gerhard Cvirn ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Bleeding Complications ◽  
Minor Bleeding ◽  
Prospective Evaluation ◽  
Bleeding Events ◽  
Increased Risk ◽  
Major Bleeding Events

AbstractThe aim of this study was prospective evaluation of the performance of the HAS-BLED score in predicting major bleeding complications in a real-world outpatient cohort, during long-term anticoagulation for venous thromboembolism (VTE), treated with a broad spectrum of anticoagulants. We analyzed 111 outpatients objectively diagnosed with VTE and treated long-term with various anticoagulants. Patients were grouped in three cohorts based on the anticoagulant regimen. Calculation of the HAS-BLED score and documentation of bleeding events were performed every 6 months for 1 year. Patients with a HAS-BLED score ≥ 3 had an increased risk for major bleeding events (odds ratio [OR]: 13.05, 95% confidence interval [CI]: 0.96–692.58, p = 0.028) and a trend to higher risk for minor bleeding events as well (OR: 2.25, 95% CI: 0.87–5.85, p = 0.091) when compared with patients with a HAS-BLED score < 3.This indicates that a HAS-BLED score ≥ 3 allows for identification of patients with VTE on long-term anticoagulation at an increased risk for major bleeding events, irrespective of the anticoagulant agent used.

Clinical impact of chemotherapy-induced thrombocytopenia in patients with gynecologic cancer.

1994 ◽  
Vol 12 (11) ◽  
pp. 2317-2320 ◽  
Author(s):  
G L Goldberg ◽  
D G Gibbon ◽  
H O Smith ◽  
C DeVictoria ◽  
C D Runowicz ◽  
...  
Keyword(s):  
Platelet Count ◽  
Major Bleeding ◽  
Gynecologic Cancer ◽  
Minor Bleeding ◽  
Clinical Effects ◽  
Bleeding Events ◽  
Transfusion Therapy ◽  
Platelet Counts ◽  
Major Bleeding Events ◽  
Platelet Transfusions

PURPOSE AND METHODS This retrospective analysis of 501 patients with gynecologic cancer treated with chemotherapy evaluates the relationship between platelet count and clinical bleeding, as well as the clinical effects of platelet transfusion therapy. Thrombocytopenic patients were divided into six groups according to platelet counts, and major or minor bleeding manifestations were documented. Thrombocytopenia was defined as a platelet count less than 100,000/microL. RESULTS Thrombocytopenia occurred in 182 (36.3%) patients over 808 of 1,546 chemotherapy cycles (52%). No intracranial or life-threatening bleeding occurred in any patient. The majority of patients (139 [76.4%]) had no clinical bleeding. Minor bleeding, such as purpura, occurred in 34 patients (18.7%) and 44 cycles (5.4%). Major bleeding occurred in nine patients (4.9%) and 10 cycles (1.3%). Five major bleeding events occurred in 49 patients with platelet counts between 0 and 10,000/microL. Forty-three of these patients received platelet transfusions. Thirty-eight of 43 transfused patients (88.3%) had no bleeding. Of the remaining five patients, two were transfused prophylactically with no effect. Three major bleeding events occurred in patients with platelet counts that ranged from 11,000 to 20,000/microL, but these were due to chronic instrumentation or trauma. In patients with platelet counts more than 20,000/microL, major bleeding occurred only from necrotic metastatic lesions. Random-donor platelet transfusions provided inconsistent increments in platelet counts. Overall, 27.5% of patients achieved the expected increase in platelet number based on units of platelet concentrate transfused. The use of single-donor or human leukocyte antigen (HLA)-matched platelets did not provide greater increments in those patients who were refractory to random-donor platelets. CONCLUSION Platelet counts > or = 10,000/microL are not associated with spontaneous major bleeding. Prophylactic platelet transfusions in patients with gynecologic malignancies and chemotherapy-induced thrombocytopenia should be limited to those with platelet counts < or = 10,000/microL, provided they are not bleeding and have no major anatomic or pathophysiologic precursors of bleeding.

Major Bleeding with Ibrutinib: More Than Expected

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3229-3229 ◽  
Author(s):  
Paul R Kunk ◽  
Joesph Mock ◽  
Michael E. Devitt ◽  
Surabhi Palkimas ◽  
Jeremy Sen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Event ◽  
Lymphocytic Leukemia ◽  
Significant Activity ◽  
University Of Virginia ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Introduction: Ibrutinib is a Bruton's tyrosine kinase inhibitor that has significant activity in treating lymphoma. While approved for patients with Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL), its activity in other lymphomas and solid tumors is under investigation and its use is increasing dramatically. Overall it is well tolerated compared to chemotherapy, but bleeding has emerged as a common adverse event with rates as high as 50% and major bleeding around 3% (Jones, abstract #1990, 2014 ASH Annual Meeting). As the use of ibrutinib increases outside of a clinical trial setting, the rate of major bleeding is likely to rise. Methods: To better understand the risk of bleeding in ibrutinib treated patients, we reviewed all patients at the University of Virginia and satellite clinics who were treated with ibrutinib between January 2012 and May 2016. Patients were required to be treated for at least 1 month with documented follow up for assessment of adverse events. Medical charts were reviewed for age, gender, ibrutinib indication and dose, length of treatment, concurrent medications, blood tests and bleeding events. All forms of anti-platelets and anticoagulants drugs, as well as medications interacting with cytochrome P450 3A4 (3A4), which metabolizes ibrutinib, were recorded. All bleeding events were recorded and graded according the Common Toxicity Criteria for Adverse Events, v4.0. Major bleeding events were reviewed by all investigators. Results: Eighty-nine patients were identified. Eighteen patients were excluded for insufficient follow up leaving 71 patients for analysis. Median age was 73 years old (44-92) with 74% male. The most common indications for treatment were CLL (65%) and MCL (27%). Most patients were treated with either 420mg (64%) or 560mg (21%). Median length of time on ibrutinib was 412 days, most with ongoing use at time of data collection. Seventy percent of patients were also treated with an anti-platelet medication, mostly aspirin for CAD with several patients on multiple anti-platelet medications. Seventeen percent were treated with an anti-coagulant, mostly apixaban for atrial fibrillation. Thirteen percent of patients (9/71) were treated with combined anti-platelet and anti-coagulant medications. Ten percent of patients were treated with a medication that has a moderate or strong interaction with 3A4. Bleeding of any grade occurred in 56% of patients, mostly bruising and epistaxis. Major bleeding, defined as grade 3 or higher, occurred in 18% of patients. Three patients developed major bleeding after an invasive procedure without ibrutinib being held. One patient died as a result of peri-procedural bleeding. Of the 9 patients treated with combined anti-platelet and anti-coagulant therapy, 78% suffered a major bleeding event. Of the ten patients on ibrutinib alone, without concurrent use of an anti-platelet, anti-coagulant or 3A4 drug interaction, no major bleeding events occurred. Conclusion: In this study examining real world use of ibrutinib, the rates of major bleeding are higher than previously reported. Most patients who suffered major bleeding were also treated with an anti-coagulant and/or anti-platelet medication. As the use of ibrutinib increases outside of clinical trials, a careful review of medications should be performed in addition to adherence to perioperative drug withholding guidelines. Patients requiring anti-coagulant and/or anti-platelet medications while on ibrutinib need careful consideration of the risks and benefits given the higher incidence of bleeding in this population. Table 1 Table 1. Disclosures Portell: AbbVie: Research Funding; Roche/Genentech: Research Funding; Infinity: Research Funding; Acerta: Research Funding. Williams:Janssen and Pharmacyclics: Research Funding; University of Virginia: Employment.

scholarly journals Efficacy and Safety of Direct Oral Anticoagulants in Obese Patients with Venous Thromboembolism

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3675-3675
Author(s):  
Renata Almeida Sa ◽  
Fatimah Al-Ani ◽  
Alejandro Lazo-Langner ◽  
Martha L Louzada
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Minor Bleeding ◽  
Obese Patients ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Major Bleeding Events

Background: Obesity is a well-known risk factor for venous thromboembolism (VTE), however, obese patients are under-represented in clinical trials (1;2). Four direct oral anticoagulants (DOACs) have been approved for the treatment of acute VTE (3-6), including the direct Factor Xa inhibitors rivaroxaban, apixaban and edoxaban and the direct thrombin inhibitor, dabigatran. Given the lack of data in this population, it is unclear if DOACs can be used safely. Objectives: To evaluate the efficacy and safety of DOACs for the treatment of VTE in obese patients. Methods: We conducted a retrospective, single-centre cohort study in London (Canada) to compare the efficacy and safety of DOACs for the treatment of acute VTE in obese patients. We screened electronic and hard copy charts of adult patients referred to our thrombosis clinic for treatment of an objectively confirmed acute VTE between January 2012 and December 2017. Patients treated with DOACs or Warfarin were selected and followed from diagnosis of the index event until cessation of anticoagulation or up to 1 year. Our study population was analyzed by BMI (BMI ≥ 30 kg/m2versus &lt; 30 kg/m2) and body weight (≥120 kg vs. &lt;120 kg). Patients were excluded if they were on anticoagulation therapy for conditions other than VTE (e.g; atrial fibrillation), cancer-associated thrombosis, or missing data. The primary outcome measure was VTE recurrence during the anticoagulation treatment period and was defined according to the ISTH criteria (7). Our secondary outcome was the occurrence of bleeding events A bleeding event is defined as: a) Major Bleeding: bleed resulting in a hemoglobin drop of &gt; 20 g/L, clinically overt and requiring more than 2 units of packed red blood cells, a hemorrhage requiring permanent cessation of anticoagulation and any retroperitoneal or intracranial hemorrhage; b) Minor Bleeding: bleed with no or little clinical significance, associated with no cost and does not require medical evaluation; and c) clinically significant non-major bleeding: does not fulfill criteria for major or minor bleeding but requires patients to be seek medical attention and/or minor procedures (8). Groups were compared using Chi-square or Fisher's exact test for categorical variables, as appropriate. The significance level was set at 0.05. Risk ratios (RR) and 95% confidence intervals (95% CI) for VTE recurrence and bleeding among DOAC groups and patients treated with Warfarin were analyzed by logistic regression. All statistical analyses were conducted using IBM SPSS Statistics version 25 (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Results: Of 1143 potentially eligible patients, 777 fulfilled our inclusion criteria: 278 (35.8%) obese patients treated with DOACs, 266 (34.2%) non-obese patients on DOACS and 233 (30%) obese patients on Warfarin. Of the patients on DOACs, 80% (n= 436) were on rivaroxaban, while the remaining 20% were either on apixaban or edoxaban (n= 108). Among patients on DOACs VTE recurrence was observed in 2.1% (N=6) of patients with BMI ≥ 30 kg/m2 and 2.8% (N=2) of patients with 120 kg or more, with no differences in the risk of VTE recurrence (Table 1). The proportion of major bleeding events for patients on DOACs was 1.1% (N=3) for patients with BMI ≥ 30 kg/m2 and 1.4% (N=1) for patients with 120kg or more. There were no significant differences with respect to major and total bleeding risk (Table1). When comparing obese patients on DOACs vs Warfarin we did not find differences in the risk of VTE recurrence among patients with a BMI ≥ 30 kg/m2 [RR 2.59 95% IC (0.51-12.96), p= 0. 247] or body weight ≥120 kg [RR 4.33 95% IC (0.21-89.43), p= 0. 337] (Table 2). Among obese patients those treated with DOACs had a similar proportion and risk of total bleeding and major bleeding events compared to those on warfarin (Table 2). Conclusions: Our retrospective study suggests that DOACs at standard doses appear to have similar efficacy and safety in obese patients as defined herein. However, since most of our patients were treated with rivaroxaban, information on other agents is inconclusive. Information on patients with extreme body weight was limited. Disclosures Louzada: Bayer: Honoraria; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria.

scholarly journals Efficacy and Safety of Bivalirudin Versus Heparin Anticoagulation Therapy for Extracorporeal Membrane Oxygenation: Meta-Analysis

2021 ◽  
Author(s):  
Jie Gu ◽  
Hongjie Yu ◽  
Dang Lin
Keyword(s):  
Extracorporeal Membrane Oxygenation ◽  
Hospital Mortality ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Minor Bleeding ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Heparin Induced Thrombocytopenia ◽  
Membrane Oxygenation ◽  
Major Bleeding Events

Abstract Background We aimed to compare the efficacy and safety of bivalirudin versus heparin as the anticoagulant in patients undergoing Extracorporeal Membrane Oxygenation (ECMO). Methods We conducted a search in PubMed, Embase and the Cochrane Library for all the studies in which bivalirudin was compared to heparin as the anticoagulant for ECMO. Efficacy outcomes were defined as the time to reach therapeutic levels, time within therapeutic range (TTR), thrombotic events, circuit thrombosis, circuit exchanges. Safety outcomes were reported as Heparin-Induced Thrombocytopenia (HIT), major bleeding events, minor bleeding events. Other outcomes included hospital length of stay (LOS), ICU LOS, mortality, 30-day mortality and in-hospital mortality. Results Ten studies were included, involving 1091 patients (Bivalirudin was administered in 405 patients while 686 patients were treated with heparin). A significant reduction in thrombotic events [OR 0.51, 95%CI 0.36,0.73, p=0.0002, I2=0%], major bleeding events [OR 0.31, 95%CI 0.10,0.92, p=0.04, I2=75%] and in-hospital mortality [OR 0.63, 95%CI 0.44,0.89, p=0.009, I2=0%] treated with bivalirudin were found compared with heparin. There were no significant differences between groups regarding the time to reach therapeutic levels[MD 3.53, 95%CI -4.02,11.09, p=0.36, I2=49%], TTR[MD 8.64, 95%CI -1.72,18.65, p=0.10, I2=77%], circuit exchanges[OR 0.92, 95%CI 0.27,3.12, p=0.90, I2=38%], Heparin-Induced Thrombocytopenia (HIT)[OR 0.25, 95%CI 0.02,2.52, p=0.24, I2=0%], minor bleeding events[OR 0.93, 95%CI 0.38,2.29, p=0.87, I2=0%], hospital LOS[MD -2.93, 95%CI -9.01,3.15, p=0.34, I2=45%], ICU LOS[MD -4.22, 95%CI -10.07,1.62, p=0.16, I2=0%], mortality[OR 1.84, 95%CI 0.58,5.85, p=0.30, I2=60%] and 30-day mortality[OR 0.75, 95%CI 0.38,1.48, p=0.41, I2=0%]. The benefit of bivalirudin over heparin was not significant for patients undergoing ECMO for major bleeding events while ruling out the Rivosecchi’s study (OR 0.44, 95%CI 0.71-1.14). Subgroup analysis by patient’s type revealed that studies in children generated lower rate of thrombotic events and major bleeding events compared with adults. Conclusion Our meta-analysis suggests that bivalirudin use as the anticoagulant for ECMO are associated with lower thrombotic events, major bleeding events and in-hospital mortality. Meanwhile, the differences are more pronounced in children than adults. However, the results should be interpreted with caution and further larger, randomized trials are needed to confirm the results.

scholarly journals Assessment of Predicted Rate and Associated Factors of Dabigatran-induced Bleeding Events in Malaysian Patients with Non-Valvular Atrial Fibrillation

2017 ◽  
Vol 20 (1) ◽  
pp. 365 ◽  
Author(s):  
Semira Abdi Beshir ◽  
Lok Bin Yap ◽  
Szyuin Sim ◽  
Kok Han Chee ◽  
Yoke Lin Lo
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Congestive Heart Failure ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Laboratory Test Results ◽  
Major Bleeding Events

Purpose: To assess the predicted rate and the factors associated with bleeding events among patients with non-valvular atrial fibrillation (NVAF) receiving dabigatran therapy. Methods: This retrospective cohort study includes adult patients of two tertiary hospitals in Malaysia. Potential study subjects were identified using pharmacy supply database or novel oral anticoagulant (NOAC) registry. Demographics, clinical data and laboratory test results were extracted from the medical records of the patients or electronic databases. The main outcome measure is the occurrence of a bleeding event. Bleeding events were classified into major bleeding, clinically relevant non-major bleeding, or minor bleeding, according to the International Society on Thrombosis and Haemostasis criteria. We consider clinically relevant non-major bleeding events or major bleeding events as clinically relevant bleeding events. An occurrence of any bleeding event was recorded from the initiation of NOAC therapy until the death of a patient, or the date of permanent discontinuation of NOAC use, or the last day of data collection. The predicted rate of dabigatran-induced bleeding events per 100 patient-years was estimated. Results: During a median follow-up period of 18 months, 73 patients experienced 90 bleeding events. Among these patients, 25 including 4 fatal cases, experienced major bleeding events. The predicted rate per 100 patient-years of follow-up of any bleeding events was 9.0 [95% CI 6.9 to 11.1]; clinically relevant bleeding events 6.0 [95% CI 4.8 to 8.3], and major bleeding events 3.0 [95% CI 1.9 to 4.2]. The independent risk factor for clinically relevant bleeding events is prior bleeding. While prior bleeding or congestive heart failure is linked with major bleeding events. Conclusions: The predicted rate for dabigatran-induced major bleeding episodes is low but these adverse events carry a high fatality risk. Preventive measures should target older patients who have prior bleeding or congestive heart failure. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Effectiveness of the Alfalfa App in Warfarin Therapy Management for Patients Undergoing Venous Thrombosis Prevention and Treatment: A Cohort Study (Preprint)

2020 ◽  
Author(s):  
Hua Cao ◽  
Shaojun Jiang ◽  
Meina Lv ◽  
Tingting Wu ◽  
Wenjun Chen ◽  
...  
Keyword(s):  
Emergency Department ◽  
Cohort Study ◽  
Major Bleeding ◽  
Hospital Admissions ◽  
Point Of Care ◽  
Emergency Department Visits ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Anticoagulation Management ◽  
Major Bleeding Events

BACKGROUND In the past years, the internet has enabled considerable progress in the management of chronic diseases, especially hypertension and diabetes. And it also provides novel opportunities in online anticoagulation management. Nevertheless, there is insufficient evidence regarding the effectiveness of online anticoagulation management. OBJECTIVE This study explored the effectiveness and safety of warfarin management via the Alfalfa app, so as to provide evidence in support of anticoagulant management through online services. METHODS In this retrospective, observational cohort study, 824 patients were included. In the offline group, patients went to the hospital clinic for warfarin management. In the Alfalfa app group, patients reported the dose of warfarin, current INR value and other related information through the Alfalfa app. Physicians or pharmacists used the app to adjust the dose of warfarin and determined the time for the next blood INR testing. Patients completed INR testing by point-of-care at home or hospital. The primary outcome of the study was the percentage of time in therapeutic range (TTR). Secondary outcomes included minor and major bleeding events, thrombotic events, warfarin-related emergency department visits, hospital admissions, and high INR values. RESULTS TTR and percentage of INR values in the range were significantly higher in the Alfalfa app than in the offline (79.35% vs. 52.38%, P < .001; 77.39% vs. 47.72%, P < .001, respectively). Patients managed via the Alfalfa app had lower rate of subtherapeutic (4.02% vs. 9.23%, P < .001), supratherapeutic (11.37% vs. 20.99%, P < .001), and extreme subtherapeutic INR values (6.77% vs. 21.66%, P < .001). Additionally, the Alfalfa app had lower incidences of major bleeding (0.47% vs. 3.01%, P = .005), warfarin-related emergency department visits (3.06% vs. 9.07%, P < .001), and hospital admissions (0.24% vs. 3.01%, P = .001) compared with the offline. However, the Alfalfa app had higher incidences of minor bleeding than the offline (10.59% vs. 5.01%, P = .003). There were similar incidences in extreme supratherapeutic INR values (0.44 %vs. 0.40%, P = .782) and thromboembolic events (0.24% vs. 0.25%, P = .964) between the two groups. CONCLUSIONS Warfarin management is superior via Alfalfa app than via offline services in terms of major bleeding events, warfarin-related emergency department visits, and hospital admissions. CLINICALTRIAL

scholarly journals 478 Clinical outcomes of patients at very high stroke risk undergoing watchman implantation

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Michele Magnocavallo ◽  
Domenico Giovanni Della Rocca ◽  
Carlo Lavalle ◽  
Gianni Carola ◽  
Sa Mohanty ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Stroke Risk ◽  
Bleeding Event ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Related Complication ◽  
Watchman Device ◽  
Major Bleeding Events ◽  
Very High

Abstract Aims Left atrial appendage occlusion (LAAO) with the Watchman device is an effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation at high thromboembolic risk. We sought to evaluate the safety and effectiveness of LAAO for stroke and bleeding prevention in patients at very high stroke risk. Methods and results Data were extracted from a prospective database of 488 AF patients who underwent LAA closure with a Watchman device. Periprocedural complications, thromboembolic (TE), and bleeding event rates among patients with a CHA2DS2-VASc ≥ 5 were reported. Predicted annual rates of TE or major bleeding events were compared to the annualized observed risk of the population. Overall, 209 patients with a CHA2DS2-VASc ≥5 (CHA2DS2-VASc: 6.0 ± 1.0; HAS-BLED: 3.7 ± 1.1) were included in the study. The mean age was 78 ± 6 years and 52.2% (n = 109) were males. Watchman implantation was successful in all patients. Overall procedure-related complication rate was 3.3% (n = 7). Two major complications were observed (1.0%): one pericardial tamponade requiring surgery and one major bleeding event at 3 days post-procedure. The incidence of minor complications was 2.3% (n = 5). Specifically, two patients experienced a pericardial effusion that required drainage and three had a groin hematoma. During a mean follow-up duration of 12 ± 5 months (193 pt/years), six TE events (2.9%/annualized rate: 3.1%) were documented after a median of 6.3 months (IQR: 2.2–9.6). Based on the estimated annual TE risk according to the CHA2DS2-VASc score (8.5%), the % risk reduction after LAAO was 63.5%. Four major bleeding events [1.9% (median time to event: 2.1 months; IQR: 1.0–3.4)] and five minor bleeding events occurred (2.5%) during follow-up. Compared to the expected rate of bleeding events as assessed by the HAS-BLED of the population (8.03%), LAAO led to a 42% reduction of bleeding risk. Conclusions In a population at very high TE risk, LAAO with the Watchman device was a safe and effective approach, and led to a 63.5% of stroke risk.

scholarly journals 473 Propensity-matched comparison of left atrial appendage occlusion and direct oral anticoagulation for thromboembolic prevention in octogenarians

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Michele Magnocavallo ◽  
Domenico Giovanni Della Rocca ◽  
Carlo Lavalle ◽  
Cristina Chimenti ◽  
Gianni Carola ◽  
...  
Keyword(s):  
Risk Reduction ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Treatment Strategies ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Left Atrial Appendage Occlusion ◽  
Watchman Device ◽  
Major Bleeding Events

Abstract Aims A significant amount of atrial fibrillation patients does not receive appropriate anticoagulation, owing to contraindications and side effects. Octogenarians have higher competing comorbidities with a remarkable bleeding/thromboembolic (TE) risk. We aimed at analysing the clinical outcomes of LAAO compared with direct oral anticoagulation (DOAC) in octogenarians. Methods and results Data were extracted from two prospective databases including 488 LAAO and 825 DOAC patients. Patients aged 80 years or older accounted for 37.1% (n = 181) and 39.5% (n = 326). In order to attenuate the imbalance in covariates between the groups, a propensity score matching technique was used (covariates: age, sex, CHA2DS2-VASc, and HAS-BLED scores, follow-up duration; tolerance 0.02). This method resulted in matched populations with 108 octogenarian patients per group. The annual stroke/transient ischaemic attack (TIA) risk was estimated based on the CHA2DS2-VASc, and compared to the annualized observed risk, owing to calculate the % risk reduction associated with the two treatment strategies. A total of 216 octogenarians were included in the analysis (84 ± 3 years; CHA2DS2-VASc: 4.9 ± 1.4, HAS-BLED: 3.1 ± 0.9). A Watchman device was successfully deployed in all LAAO ≥ 80 patients; periprocedural adverse events were observed in 2.8% (n = 3) of LAAO patients. During a follow-up of 13 ± 4 months, 3 (2.8%) TE complications (1 stroke, 2 TIA) occurred in LAAO ≥ 80 pts and 4 (3.7%; 1 stroke, 3 TIA) in DOAC ≥ 80 pts (P = 0.99). The annualized risk of stroke/TIA was 2.5% in the first and 3.5% in the second group. Based on the estimated annual TE risk according to the CHA2DS2-VASc score, the % risk reduction after LAAO and DOAC was 54.5% and 36.4%, respectively. Major bleeding events were 3 [1 intracranial, 2 gastrointestinal (GI)] LAAO ≥ 80 pts, and 3 (2 intracranial, 1GI) in DOAC ≥ 80 pts (2.8% in both groups). Minor bleeding events were significantly higher in DOAC ≥ 80 pts [13.0% (n = 14) vs. 2.7% (n = 3); RR: 4.7, 95% CI: 1.4–15.7; P = 0.009]. Conclusions LAAO was safe and similar to DOAC at preventing ischaemic/major bleeding events in a matched population of patients aged ≥80 years. A significantly higher incidence of minor bleeding events was observed in the DOAC group.

Safety Outcomes of Apixaban Compared With Warfarin in Patients With End-Stage Renal Disease

2017 ◽  
Vol 51 (6) ◽  
pp. 445-450 ◽  
Author(s):  
Stefanie C. Sarratt ◽  
Ross Nesbit ◽  
Robert Moye
Keyword(s):  
Renal Disease ◽  
Major Bleeding ◽  
End Stage Renal Disease ◽  
Chronic Hemodialysis ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Warfarin Group ◽  
Major Bleeding Events ◽  
Stage Renal Disease ◽  
End Stage

Background: Current guidelines make no specific recommendations on the selection of direct oral anticoagulants for the prevention and treatment of venous thromboembolism in patients with end-stage renal disease (ESRD) receiving hemodialysis. Based on these guidelines, warfarin remains the anticoagulant of choice in these patients. Objective: To compare bleeding rates in patients receiving apixaban or warfarin with ESRD undergoing chronic hemodialysis. Methods: This was a single-center, retrospective, institutional review board–approved cohort analysis. Patients with ESRD undergoing chronic hemodialysis and receiving anticoagulation therapy with either apixaban or warfarin were included in this study. All data were collected from paper charts and electronic medical records and included documentation of bleeding events and related interventions. The primary outcome of this study was clinically relevant major bleeding events. Secondary outcomes included clinically relevant nonmajor bleeding events and minor bleeding events. Results: A total of 160 patients were included in this study (warfarin group, n = 120; apixaban group, n = 40). There were 7 major bleeding events in the warfarin group compared with zero in the apixaban group ( P = 0.34). There were similar rates of clinically relevant nonmajor bleeding events (12.5% vs 5.8%, P = 0.17) and minor bleeding (2.5% vs 2.5%, P = 0.74) events in patients receiving apixaban and warfarin. Conclusions: There were no observed differences in bleeding rates in patients receiving apixaban compared with those receiving warfarin. Apixaban may be a cautious consideration in hemodialysis patients until there is further insight into the effect of subsequent, multiple doses on drug accumulation and clinical outcomes.

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