The HAS-BLED and ORBIT scores have been proposed to assess bleeding risk in anticoagulated atrial fibrillation patients. We performed a systematic review and meta-analysis to compare the predictive ...ability by using these two scores.
We searched the Cochrane Library, Elsevier and PubMed databases for related studies. Statistical analysis was performed with Revman 5.3 Manager software. We chose the C-statistic to reflect the diagnostic value.
In our seven selected studies, the pooled C- statistic of continuous variables for major bleeding was 0.65 (0.60,0.69) for ORBIT and 0.63 (0.60,0.66) for HAS-BLED. Compared with HAS-BLED, more anticoagulated AF patients (88.45% versus 32.59%) and major bleeding events (75.57% versus 25.57%) were categorized as low risk. The ORBIT score had a 1.21, 1.73 and 1.44-fold elevated risk of major bleeding in the low, intermediate and high risk strata respectively. Calibration analysis demonstrated that the ORBIT score under-predicted major bleeding in the low, intermediate, and high risk stratifications, where a odds ratio of 0.64 (0.37-1.10), 0.63 (0.38-1.05) and 0.64 (0.38-1.06), respectively.
Compared with HAS-BLED , the ORBIT score does not perform better in predicting major bleeding events in anticoagulated atrial fibrillation patients. More anticoagulated AF patients and major bleeding events were categorized as low risk when using ORBIT.
Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, ...efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population.
A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1 ± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n = 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36 ± 23months (range: 1-97 months). No device-related complications were detected throughout the FU period. Long-term imaging work-up (computed tomography) in selected patients ≥5years post-implant (range: 5.1-8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n = 166) revealed a relative risk reduction of 87.5% with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC.
The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00567515.
Risk scores in patients with atrial fibrillation (AF) based on clinical factors alone generally have only modest predictive value for predicting high risk patients that sustain events. Biomarkers ...might be an attractive prognostic tool to improve bleeding risk prediction. The new ABC-Bleeding score performed better than HAS-BLED score in a clinical trial cohort but has not been externally validated. The aim of this study was to analyze the predictive performance of the ABC-Bleeding score compared to HAS-BLED score in an independent "real-world" anticoagulated AF patients with long-term follow-up. We enrolled 1,120 patients stable on vitamin K antagonist treatment. The HAS-BLED and ABC-Bleeding scores were quantified. Predictive values were compared by c-indexes, IDI, NRI, as well as decision curve analysis (DCA). Median HAS-BLED score was 2 (IQR 2-3) and median ABC-Bleeding was 16.5 (IQR 14.3-18.6). After 6.5 years of follow-up, 207 (2.84 %/year) patients had major bleeding events, of which 65 (0.89 %/year) had intracranial haemorrhage (ICH) and 85 (1.17 %/year) had gastrointestinal bleeding events (GIB). The c-index of HAS-BLED was significantly higher than ABC-Bleeding for major bleeding (0.583 vs 0.518; p=0.025), GIB (0.596 vs 0.519; p=0.017) and for the composite of ICH-GIB (0.593 vs 0.527; p=0.030). NRI showed a significant negative reclassification for major bleeding and for the composite of ICH-GIB with the ABC-Bleeding score compared to HAS-BLED. Using DCAs, the use of HAS-BLED score gave an approximate net benefit of 4 % over the ABC-Bleeding score. In conclusion, in the first "real-world" validation of the ABC-Bleeding score, HAS-BLED performed significantly better than the ABC-Bleeding score in predicting major bleeding, GIB and the composite of GIB and ICH.
Background:
Several bleeding risk assessment models have been developed in atrial fibrillation (AF) patients with oral anticoagulants, but the most appropriate tool for predicting bleeding remains ...uncertain. Therefore, we aimed to assess the diagnostic accuracy of the Hypertension, Abnormal liver/renal function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly, Drugs/alcohol concomitantly (HAS-BLED) score compared with other risk scores in anticoagulated patients with AF.
Methods:
We comprehensively searched the PubMed and Embase databases until July 2021 to identify relevant pieces of literature. The predictive abilities of risk scores were fully assessed by the C-statistic, net reclassification improvement (NRI) and integrated discrimination improvement (IDI) values, calibration data, and decision curve analyses.
Results:
A total of 39 studies met the inclusion criteria. The C-statistic of the HAS-BLED score for predicting major bleeding was 0.63 (0.61–0.65) in anticoagulated patients regardless of vitamin k antagonists 0.63 (0.61–0.65) and direct oral anticoagulants 0.63 (0.59–0.67). The HAS-BLED had the similar C-statistic to the Hepatic or renal disease, Ethanol abuse, Malignancy, Older, Reduced platelet count or function, Re-bleeding risk, Hypertension (uncontrolled), Anemia, Genetic factors, Excessive fall risk, Stroke (HEMORR
2
HAGES), the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA), the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT), the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF), or the Age, Biomarkers, Clinical History (ABC) scores, but significantly higher C-statistic than the Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke/transient ischemic attack history (CHADS
2
) or the Congestive heart failure/left ventricular ejection fraction ≤ 40%, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke/transient ischemic attack/thromboembolism history, Vascular disease, Age 65–74 years, Sex (female) (CHA
2
DS
2
-VASc) scores. NRI and IDI values suggested that the HAS-BLED score performed better than the CHADS
2
or the CHA
2
DS
2
-VASc scores and had similar or superior predictive ability compared with the HEMORR
2
HAGES, the ATRIA, the ORBIT, or the GARFIELD-AF scores. Calibration and decision curve analyses of the HAS-BLED score compared with other scores required further assessment due to the limited evidence.
Conclusion:
The HAS-BLED score has moderate predictive abilities for bleeding risks in patients with AF regardless of type of oral anticoagulants. Current evidence support that the HAS-BLED score is at least non-inferior to the HEMORR
2
HAGES, the ATRIA, the ORBIT, the GARFIELD-AF, the CHADS
2
, the CHA
2
DS
2
-VASc, or the ABC scores.
Patients with atrial fibrillation are associated with a 4-5-fold risk of having a stroke. The most effective treatment for atrial fibrillation is to prevent the formation of blood clots by ...administering anticoagulant drugs. Warfarin is an anticoagulant drug that has a narrow therapeutic index with side effects of the risk of bleeding; hence it needs supervision in its use. In this study, the HAS-BLED score was used to measure major bleeding risk and as a value representing each risk factor for bleeding. The bleeding risk can be prevented by maintaining a warfarin response in the therapeutic range with an INR (International Normalized Ratio) measurement 2-3. This study was an observational study conducted with retrospective data collection through medical records of patients with a primary diagnosis of atrial fibrillation who received oral warfarin anticoagulant therapy at Harapan Kita National Heart Center in the period of January-December 2017. Using a sample of 40 patients who met the inclusion criteria. According to the data, found that atrial fibrillation patients who received oral warfarin therapy 55% were male patients, while 45% were female patients. Patients with atrial fibrillation who got the most oral warfarin therapy were patients who were over 40 years old with 90% of the total sample, with the highest group in patients aged 50-54 years with 22.5%. The HAS-BLED values arranged from 0-9, the percentage of patients who had HAS-BLED values of 0, 1, 2 respectively at 7.5%, 42.5%, 30%. The HAS-BLED score ≥ 3 showed patients classified as at high risk of bleeding by 20%. The most risk factors based on HAS-BLED score from all study samples were 18 patients with abnormal kidney or 45%. The average INR score in patients at high risk of bleeding showed that 37.5% had an average INR score in the target ratio score of INR 2-3.
Aim
Evidence on antithrombotic therapy use in centenarians diagnosed with atrial fibrillation (AF) is sparse. Our objective was to investigate a possible underprescribing in centenarians relative to ...younger cohorts of the oldest‐old. We assumed lower AF rates; and, within AF patients, lower use of anticoagulants in those who died as centenarians (aged ≥100 years) than in those who died aged in their 80s (≥80 years) or 90s (≥90 years).
Methods
The present study was a quarterly structured cohort study over the 6 years before death using administrative data from German institutionalized and non‐institutionalized insured patients (whole sample n = 1398 and subsample of AF patients n = 401 subclassified according to age‐of‐death groups ≥80, ≥90, ≥100 years). AF, medication, stroke risk (Congestive heart failure; Hypertension; 2 × Age ≥75 years; Diabetes mellitus; 2 × Stroke; Vascular disease; Age 65–74 years; Sex female (CHA2DS2‐VASc)) and risk of major bleeding (Hypertension; Abnormal renal and liver function; Stroke; Bleeding; Labile International Normalized Ratio omitted in the present analysis; Elderly; Drugs or alcohol (HAS‐BLED)) were calculated. Generalized estimation equations were used to model the trajectories.
Results
Half a year before death (T1), AF rates were higher in patients aged ≥80 years (31.8%) and ≥90 years (30.6%) compared with patients aged ≥100 years (22.4%), whereas there were no significant differences between age groups 6 years before death (T0). Of all AF patients with AF at T1, 26.7% received anticoagulants; 11.2% vitamin K antagonists; 15.7% non‐vitamin K antagonist oral anticoagulants; and 17.5% platelet inhibitors; yet 58.1% received none of these drugs. Centenarians received significantly fewer anticoagulants compared with the other age groups. Prescriptions of anticoagulants were not associated with CHA2DS2‐VASc with and without adjustment for HAS‐BLED.
Conclusions
The present findings highlight the need for more appropriate use of anticoagulation therapy in older patients, as well as for new treatment guidelines taking the heterogeneity of very old patients into account. Geriatr Gerontol Int 2018; 18: 1634–1640.
Assessment of bleeding risk in patients with pulmonary embolism (PE) is challenging. Recently, the VTE-BLEED score was shown to predict major bleeding. Therefore, we aimed to investigate the ...VTE-BLEED score and assess the prognostic impact of major bleeding in a real-world cohort of PE patients.
Consecutive PE patients included in a prospective single-center cohort study between 09/2008 and 11/2016 were eligible for analysis; patients treated with thrombolysis were excluded. The VTE-BLEED was calculated post-hoc; in-hospital major bleeding was defined using the ISTH definition.
Overall, 522 patients (median age 69, IQR 56–78 years; 53% female) were included in the present analysis; major bleeding occurred in 18 (3.5%) patients. A VTE-BLEED score ≥2 points identified patients at high-risk for major bleeding (OR 3.7, 95% CI 1.1–13.0, sensitivity 83%, specificity 42%). Additionally, a GFR <30 ml/min/1.73 m2 (OR 6.0, 95% CI 1.8–19.8) and previous surgery (OR 3.6, 95% CI 1.4–9.3) were associated with major bleeding. A less frequent use of unfractionated heparin as initial treatment was associated with a decrease of major bleeding over time. Major bleeding was identified as strong predictor of in-hospital (OR 7.7, 95% CI 2.3–25.8) and 1-year mortality (HR 3.6, 95% CI 2.0–6.6), especially in normotensive patients (OR 12.1, 95% CI 3.5–43.0 and HR 6.0, 95% CI 2.9–12.6, respectively).
In a real-world cohort, the VTE-BLEED score identified PE patients at risk for in-hospital major bleeding. However, for assessment of bleeding risk, renal function and previous surgery should be considered. Major bleeding emerged as strong predictor of in-hospital and 1-year mortality.
•The VTE-BLEED score identified patients at risk for in-hospital major bleeding.•However, renal function and previous surgery might deserve more attention.•In-hospital major bleeding was a predictor of in-hospital and 1-year mortality.
Background: Recent European guidelines recommended the CHA2DS2-VASc score for thromboembolic and the HAS-BLED score for bleeding risk stratifications. We validated these scores in 7,384 Japanese ...patients with nonvalvular atrial fibrillation (NVAF) enrolled in the J-RHYTHM Registry. Methods and Results: Of the study cohort, 6,387 patients taking warfarin and the other 997 not taking warfarin were prospectively examined for 2 years. Thromboembolic and major bleeding risks were stratified by modified CHA2DS2-VASc (mCHA2DS2-VASc) and HAS-BLED (mHAS-BLED) scores, respectively. Of the patients with mCHA2DS2-VASc score 0, 1, and ≥2, thromboembolism occurred in 2/141 (0.7%/year), 4/233 (0.9%/year), and 24/623 (1.9%/year), respectively, in the non-warfarin group, and in 1/346 (0.1%/year, P=0.19 vs. non-warfarin), 4/912 (0.2%/year, P=0.05), and 92/5,129 (0.9%/year, P=0.0005), respectively, in the warfarin group. When female sex was excluded from the score, thromboembolism occurred in 2/180 patients (0.6%/year), 5/245 (1.0%/year), and 23/572 (1.6%/year), respectively, in the non-warfarin group, and in 1/422 (0.1%/year, P=0.20 vs. non-warfarin), 5/1,096 (0.2%/year, P=0.02), and 91/4,869 (0.9%/year, P=0.0005), respectively, in the warfarin group. Patients with mHAS-BLED scores ≥3 were at high risk for major bleeding irrespective of warfarin treatment (1.3 and 2.6%/year in the non-warfarin and warfarin groups, respectively). Conclusions: In Japanese NVAF patients, the mCHA2DS2-VASc score is useful for identifying patients at truly low risk of thromboembolism. Female sex may be excluded as a risk from the score. mHAS-BLED score ≥3 is useful for identifying patients at high risk of major bleeding. (Circ J 2014; 78: 1593–1599)
Nonvalvular atrial fibrillation (NVAF) affects almost 6 million Americans and is a major contributor to stroke but is significantly undiagnosed and undertreated despite explicit guidelines for oral ...anticoagulation.
The aim of this study is to investigate whether the use of semisupervised natural language processing (NLP) of electronic health record's (EHR) free-text information combined with structured EHR data improves NVAF discovery and treatment and perhaps offers a method to prevent thousands of deaths and save billions of dollars.
We abstracted 96,681 participants from the University of Buffalo faculty practice's EHR. NLP was used to index the notes and compare the ability to identify NVAF, congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category (CHA
DS
-VASc), and Hypertension, Abnormal liver/renal function, Stroke history, Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage (HAS-BLED) scores using unstructured data (International Classification of Diseases codes) versus structured and unstructured data from clinical notes. In addition, we analyzed data from 63,296,120 participants in the Optum and Truven databases to determine the NVAF frequency, rates of CHA
DS
‑VASc ≥2, and no contraindications to oral anticoagulants, rates of stroke and death in the untreated population, and first year's costs after stroke.
The structured-plus-unstructured method would have identified 3,976,056 additional true NVAF cases (P<.001) and improved sensitivity for CHA
DS
-VASc and HAS-BLED scores compared with the structured data alone (P=.002 and P<.001, respectively), causing a 32.1% improvement. For the United States, this method would prevent an estimated 176,537 strokes, save 10,575 lives, and save >US $13.5 billion.
Artificial intelligence-informed bio-surveillance combining NLP of free-text information with structured EHR data improves data completeness, prevents thousands of strokes, and saves lives and funds. This method is applicable to many disorders with profound public health consequences.
Background
Videocapsule endoscopy (VCE) is considered the gold standard for overt and obscure gastrointestinal bleeding (OGIB), after negative upper and lower endoscopy. Nonetheless, VCE’s diagnostic ...yield is suboptimal, and it represents a costly, time-consuming, and often not easily available technique. In order to evaluate bleeding risk in patients with atrial fibrillation, several scoring systems have been proposed, but their utilization outside the original clinical setting has rarely been explored. The aim of the study is to evaluate potential role of bleeding risk scoring systems in predicting the occurrence of positive findings at VCE examination, and therefore in increasing VCE diagnostic yield.
Methods
Data from consecutive patients undergoing VCE between April 2015 and June 2020 were retrospectively retrieved, and clinical and demographic characteristics were collected. HAS-BLED, ATRIA, and ORBIT scores were calculated, and patients were considered at low or high risk of bleeding accordingly. Discriminative ability of the scores for positive VCE findings has been evaluated by area under receiver operator characteristic curve (AUC) calculation. Diagnostic yield of scores in high- and low-risk patients was calculated.
Results
A total of 413 patients underwent VCE examination, among which 368 (89%) for OGIB. Positive findings were observed in 246 patients (67%), with angiodysplasias being the most frequent lesion (92%). The three scores displayed similar consistent discriminative ability for positive VCE findings (mean AUC = 0.69), and identified high-risk group of patients in which VCE has a higher diagnostic yield.
Conclusions
In the present retrospective study, bleeding scores accurately discriminated patients with higher probability of positive findings at VCE examination. Bleeding scores utilization may help in the management of patients with OGIB, with a potential consistent resource optimization and cost-saving.
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