In-hospital Bleeding Events Research Articles

Impact of bleeding complications after transcatheter mitral valve repair.

Bleeding in the context of cardiac catheterization is frequent and negatively impacts on short- and long-term patient outcome. We evaluated the clinical impact of in-hospital bleeding events after transcatheter mitral valve repair (TMVr) in the long-term follow- up. 586 consecutive patients treated with first-time TMVr were enrolled in this registry. In-hospital MVARC (Mitral Valve Academic Research Council) bleedings were assessed and patients were grouped according to the incidence of a bleeding event. Multivariate logistic regression was used to identify significant independent predictors of MVARC bleeding. This study received approval by local ethics committee. 78 patients (13.3%) suffered from an MVARC bleeding event (Access site-related bleedings: 46.2%; GI tract bleeding: 35.9%; Other bleedings: 17.9%). Among these bleeding subgroups, neither relevant differences in baseline characteristics nor in severity of bleeding events were observed. Despite not being an independent predictor for overall death in the multivariate Cox regression analysis, MVARC bleeding was associated with prolonged hospital stay. The ORBIT bleeding score was the best match to predictors of any MVARC bleeding found in our cohort (c-score overall cohort: 0.68; c-score GI bleeding cohort: 0.72). MVARC bleedings after TMVr are frequent findings but were only in half of the cases related to the access site. The ORBIT score could be useful for identification of patients at high risk for non-access site bleeding and especially GI bleeding.

Association of In-Hospital Surgical Bleeding Events with Prolonged Hospital Length of Stay, Days Spent in Critical Care, Complications, and Mortality: A Retrospective Cohort Study Among Patients Undergoing Neoplasm-Directed Surgeries in English Hospitals.

PurposeTo evaluate the association of in-hospital surgical bleeding events with the outcomes of hospital length of stay (LOS), days spent in critical care, complications, and mortality among patients undergoing neoplasm-directed surgeries in English hospitals.Patients and MethodsThis is a retrospective cohort study using English hospital discharge data (Hospital Episode Statistics [HES]) linked to electronic health records (Clinical Practice Research Datalink [CPRD]). HES includes information on patient demographics, admission and discharge dates, diagnoses and procedures, days spent in critical care, and discharge status. CPRD includes information on patient demographics, diagnoses and symptoms, drug exposures, vaccination history, and laboratory tests. Patients aged ≥18 years who underwent selected neoplasm-directed surgeries between 1-Jan-2010 and 29-February-2016: hysterectomy, low anterior resection (LAR), lung resection, mastectomy, and prostate surgery were included. The primary independent variable was in-hospital surgical bleeding events identified by diagnosis of haemorrhage and haematoma complicating a procedure or reopening/re-exploration and surgical arrest of postoperative bleeding. Outcomes included LOS, days spent in critical care, in-hospital complications (diagnoses of infections, acute renal failure, vascular events), and in-hospital mortality, identified during surgery through discharge. Multivariable regression was used to examine the adjusted association of bleeding events with outcomes.ResultsThe study included 26,437 neoplasm-directed surgeries (hysterectomy=6092; LAR=2957; lung=1538; mastectomy=12,806; prostate=3044). Incidence proportions of bleeding events were: hysterectomy=1.9% (95% confidence interval=1.1–2.5%); LAR=3.0% (CI=2.3–3.6%); lung=1.8% (CI=1.1–2.5%); mastectomy=1.6% (CI=1.3–1.8%); prostate=1.0% (CI=0.6–1.3%). In adjusted analyses, bleeding events were associated with: prolonged LOS: 3.1 (CI=1.1–6.3) mastectomy to 5.7 (CI=3.6–8.2) LAR days longer; more days spent in critical care: 0.4 (CI=0.03–0.27) mastectomy to 6.5 (CI=2.5–13.6) hysterectomy days more; and higher incidence proportions of all examined complications; all P<0.05.ConclusionThis study quantifies a substantial clinical and healthcare resource utilization burden associated with surgical bleeding among patients undergoing neoplasm-directed surgery in England hospitals.

Simple Risk-Score Model for In-Hospital Major Bleeding Based on Multiple Blood Variables in Patients with Acute Myocardial Infarction

Background: In-hospital bleeding is associated with poor prognosis in patients with acute myocardial infarction (AMI). We sought to investigate whether a combination of pre-procedural blood tests could predict the incidence of in-hospital major bleeding in patients with AMI. Methods and Results: A total of 1684 consecutive AMI patients who underwent primary percutaneous coronary intervention (PCI) were recruited and randomly divided into derivation (n=1010) and validation (n=674) cohorts. A risk-score model was created based on a combination of parameters assessed on routine blood tests on admission. In the derivation cohort, multivariate analysis revealed that the following 5 variables were significantly associated with in-hospital major bleeding: hemoglobin level 10000/μL (OR, 2.58), platelet count < 150000/μL (OR, 2.51), albumin level < 3.8 mg/dL (OR, 2.51), and estimated glomerular filtration rate < 60 mL/min/1.73 m 2 (OR, 2.31). Zero to five points were given according to the number of these factors each patient had. Incremental risk scores were significantly associated with a higher incidence of in-hospital major bleeding in both cohorts ( P < 0.001). Receiver operating characteristic curve analysis of risk models showed adequate discrimination between patients with and without in-hospital major bleeding (derivation cohort: area under the curve [AUC], 0.807; 95% confidence interval [CI], 0.759 – 0.848; validation cohort: AUC, 0.793; 95% CI, 0.725 – 0.847). Conclusions: Our novel laboratory-based bleeding risk model could be useful for simple and objective prediction of in-hospital major bleeding events in patients with AMI

Accuracy of available scoring systems for prediction of in-hospital major bleeding in acute pulmonary embolism patients

Bleeding prediction scores may help guide acute management of patients with pulmonary embolism (PE). However existing scoring systems have not been validated for in-hospital assessment. We compared 6 available bleeding scores for the prediction of major bleeding in the in-hospital phase in a real-life cohort. We recorded in-hospital characteristics of 2754 PE patients included in a prospective observational multicenter cohort study contributing 18,028 person-days of follow-up. The VTE-BLEED, RIETE, ORBIT, HEMORR 2 HAGES, ATRIA, and HAS-BLED scores were assessed at baseline. ISTH-defined bleeding events were independently adjudicated. The accuracy of the overall, original 3-level and newly defined optimal 2-level outcome of the scores were evaluated and compared. We observed 82 first in-hospital major bleeding events [3.0% (95% CI, 2.4–3.7)]. Overall, the predictive power of bleeding scores was poor, with a Harrel's C index ranging from 0.57 to 0.69. The Riete score had the numerically highest model fit and discrimination capacity but without reaching statistical significance versus the ORBIT, HEMORR 2 HAGES, and ATRIA scores. The VTE-BLEED and HAS-BLED scores had significantly lower C indices, integrated discrimination improvement, and net reclassification improvement compared to the others. The rate of observed in-hospital major bleeding in score-defined low-risk patients was high, at between 15% to 34%. Current available scoring systems are not sufficiently accurate for the prediction of in-hospital major bleeding in patients with acute PE. There is a need to develop risk scores specific to acute PE to optimally target bleeding-prevention strategies.

Combination of fondaparinux with radial access is associated with low rates of in-hospital MACE and major bleeding events in patients with acute coronary syndrome

Abstract Background Fondaparinux and radial access use were associated with lower rates of cardiovascular events in patients with acute coronary syndrome (ACS). The benefits of combining these two treatment strategies are not well described. Methods In 1167 consecutive patients admitted for ACS who underwent an invasive treatment strategy, data on the primary combined endpoint – major bleeding (OASIS-5 criteria) and major adverse cardiovascular events (MACE) – were prospectively collected for the hospitalization period and compared according to anticoagulation regimen (Fondaparinux or Enoxaparin) and arterial access site (femoral vs radial). Results Overall, mean age was 65±12 years, 57% were male, 32% had diabetes and 17% presented with ST segment elevation myocardial infarction (STEMI). Fondaparinux and radial access were used in 756 (65%) and 554 (48%) patients, respectively. An endpoint occurred in 112 patients (9.6%) – MACE in 79 (6.8%) and major bleeding in 42 (3.6%). Endpoint was 3.4% in Fondaparinux plus radial access, 9.9% for Fondaparinux plus femoral access, 8% Enoxaparin plus radial access and 19.9% in enoxaparin plus femoral access (p&amp;lt;0.001). Fondaparinux use was associated with a significant reduction in the rate of the primary endpoint in both radial (RR 0.42 CI 95% 0.19–0.90; p&amp;lt;0.05) and femoral (RR 0.5 CI 95% 0.33–0.79; p&amp;lt;0.001) access patients. The primary endpoint was also reduced in the radial access patients regardless if Fondaparinux (RR 0.33 CI 95% 0.18–0.62; p&amp;lt;0.001) or Enoxaparin (RR 0.40 CI 95% 0.21–0.74; p&amp;lt;0.01) was used. In multivariable analysis (adjusted for age, sex, diabetes, heart failure, previous CABG, creatinine, ejection fraction, haemoglobin, STEMI, and hospital length of stay) Fondaparinux (OR 0.50 CI 95% 0.31–0.79; p&amp;lt;0.01) and radial access (OR 0.39 CI 95% 0.23–0.66; p&amp;lt;0.001) where both independently associated with lower rates of primary endpoint. There was no interaction between both variables (p=0.83). Conclusion The use of fondaparinux plus radial access was associated with the lowest rates of MACE and major bleeding when compared with either strategy alone and therefore, is a very attractive approach to be used routinely in patients with ACS. Funding Acknowledgement Type of funding source: None

Acute Kidney Injury After Percutaneous Edge-to-Edge Mitral Repair

BackgroundIn catheter-based procedures, acute kidney injury (AKI) is a frequent, serious complication ranging from 10% to 30%. In MitraClip (Abbott Vascular, Santa Clara, California), a usually contrast-free procedure, there is scarce data about its real incidence and impact. ObjectivesThis study aimed to evaluate incidence, predictive factors, and midterm outcomes of AKI in patients with significant mitral regurgitation (MR) undergoing transcatheter valve repair with MitraClip. MethodsA total of 721 patients undergoing MitraClip were included. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, or the need for hemodialysis during index hospitalization. ResultsThe mean age of the patients was 72 ± 11 years (28.3% women). Median estimated glomerular filtration rate (eGFR) was 43.7 ml/min/1.73 m2 (interquartile range: 30.9 to 60.1 ml/min/1.73 m2), and was <60 ml/min/1.73 m2 in 74.9% of the patients. AKI after MitraClip occurred in 106 patients (14.7%). Baseline hemoglobin (<11 g/dl) (odds ratio [OR]: 1.97; p = 0.003), urgent procedure (OR: 3.44; p = 0.003), and absence of device success (OR: 3.37; p < 0.001) were independent predictors of AKI. Patients with AKI had worse outcomes compared to those without AKI, including a higher proportion of in-hospital bleeding events (3.8% vs. 0.8%; p = 0.011), 2-year all-cause mortality (40.5% vs. 18.7%; p <0.001), and major adverse cardiac events (63.6% vs. 23.5%; p <0.001). Combination of AKI with significant residual MR after the procedure conferred even worst outcomes (2-year all-cause mortality 50.0% vs. 19.6%; p = 0.001, and major adverse cardiac events 70.0% vs. 18.9%; p < 0.001). ConclusionsDespite being a “zero-contrast” procedure, one-sixth of patients undergoing transcatheter mitral valve repair had AKI, linked to device failure or other severe conditions. The occurrence of AKI was associated with worse outcomes, highlighting the importance to detect and reduce this complication in high-risk population.

Impact of coronary angioplasty in elderly patients with non-ST-segment elevation myocardial infarction.

BackgroundAs treatment of coronary artery disease improved over the last years, management of elder patients remained a matter of debate since this age group has been underrepresented in most trials. The study aimed to evaluate a population of patients with ≥ 85 years old with non-ST-segment elevation myocardial infarction (NSTEMI) and compare the prognosis according to coronary revascularization execution.MethodsWe retrospectively studied 324 patients included in a national multicenter registry between October 2010 and October 2018, who underwent coronary angiography and had at least one stenosis ≥ 50%.ResultsIn this population, 73.1% of the patients underwent percutaneous coronary intervention (PCI) and 26.9% of the patients underwent optimized medical treatment (OMT). The OMT group had more past history of diabetes, stroke and dementia. On coronary angiography, the PCI group used more often the femoral artery access and single-vessel lesions were also more common. Three-vessel disease was more common in the OMT group. During hospitalization, there were more major bleeding events and death in the PCI group. During the one-year follow-up, there were no significant differences in all-cause mortality rate.ConclusionsVery old patients with NSTEMI submitted to OMT had more comorbidities and more three-vessel disease, factors that could have influenced the therapeutic decision. Patients undergoing PCI had more in-hospital major bleeding events and mortality, with no significant differences after one year.

Development and Implementation of an In-Hospital Bleeding Risk Model for Percutaneous Coronary Intervention

BackgroundBleeding is a common complication of percutaneous coronary intervention (PCI) that is associated with worse clinical outcomes and increased costs. Improved pre-procedural bleeding risk prediction could promote strategies that have been shown to reduce post-PCI bleeding, including increased adoption of radial access. MethodsWe studied patients in the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA CART) program receiving PCI in VA hospitals. Logistic regression was performed to develop a model for major in-hospital bleeding using demographic, clinical, and procedural variables. The discriminatory ability of the model was compared to the existing National Cardiovascular Data Registry (NCDR) CathPCI bleeding risk model. ResultsAmong 107,451 patients treated from 2008 to 2019, 5218 (4.86%) experienced an in-hospital bleeding event. Twelve variables were associated with bleeding risk. Predictors of bleeding included emergency or salvage status, cardiogenic shock, NSTEMI, Atrial fibrillation, elevated INR, and peripheral vascular disease, while radial access, greater body surface area, and stable or unstable angina were associated with lower risk of bleeding. The developed model had superior discrimination compared with the NCDR CathPCI model (c-index 0.756, 95% CI 0.749–0.764 vs. 0.707, 95% CI 0.700–0.714, p < 0.001), especially among the highest risk patients. A web-based tool has been created to facilitate calculation of bleeding risk using this model at the point of care. ConclusionThe VA CART bleeding risk model uses baseline clinical and procedural variables to predict post-PCI in-hospital bleeding events and has improved discrimination compared to other available models in this patient population. Implementation of this model can facilitate risk stratification at the point of care and permit improved risk-adjustment for quality assessment.

Sex differences in platelet reactivity in patients with myocardial infarction treated with triple antiplatelet therapy - results from assessing platelet activity in coronary heart disease (APACHE)

)Several earlier studies have reported increased risk of bleeding in women with myocardial infarction, (MI) compared to men. The reasons for the observed difference are incompletely understood, but one suggested explanation has been excess dosing of antithrombotic drugs in women. The aim of this prospective observational study was to assess sex differences in platelet activity in patients treated with three different platelet inhibitors. We recruited 125 patients (37 women and 88 men) with MI, scheduled for coronary angiography. All patients received clopidogrel and aspirin. A subgroup of patients received glycoprotein (GP) IIb/IIIa-inhibitor. Platelet aggregation in whole blood was assessed at several time points, using impedance aggregometry. Soluble P-selectin was measured 3 days after admission. There were no significant differences between women and men in baseline features or comorbidities except higher frequency of diabetes, lower hemoglobin value, and lower estimated glomerular filtration rate, in women on admission. We observed significantly more in-hospital bleeding events in women compared to men (18.9% vs. 6.8%, p = .04). There were no differences in platelet aggregation using three different agonists, reflecting treatment effect of GPIIb/IIIa-inhibitors, clopidogrel, and aspirin, 6–8 hours, 3 days, 7–9 days, or 6 months after loading dose. Moreover, there was no significant difference in soluble P-selectin. The main finding of this study was a consistent lack of difference between the sexes in platelet aggregation, using three different agonists at several time-points. Our results do not support excess dosing of anti-platelet drugs as a major explanation for increased bleeding risk in women.

Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

Vascular and bleeding complications were commonly reported in transcatheter aortic valve replacement clinical trials. Little is known about complication rates in contemporary US clinical practice or clinical outcomes associated with these complications. In the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we evaluated patients undergoing transcatheter aortic valve replacement from November 1, 2011 to June 30, 2016. The primary outcomes were in-hospital vascular complications and bleeding events. Secondary outcomes included all-cause mortality, stroke, and rehospitalization at 1 year. P values for trends were calculated for rates over time, and multivariable logistic regression was used to determine the association between vascular/bleeding complications and in-hospital clinical outcomes. Overall, 34 893 patients undergoing transcatheter aortic valve replacement at 445 hospitals were analyzed. Of these, 9.3% (n=3257) experienced a vascular complication while 7.6% (n=2651) had an in-hospital bleeding event. Rates of both vascular complications and bleeding events decreased over time (P value for trend test <0.0001); however, there was significant variation in rates across hospital sites (adjusted median rate, 11.4%; IQR, 8.9-14.5). Vascular complications were independently associated with 30-day death (adjusted HR, 2.23 [95% CI, 1.80-2.77]) and death (adjusted HR, 1.17 [95% CI, 1.05-1.30]) and rehospitalization (adjusted HR, 1.14 [95% CI, 1.07-1.22]) at 1 year. Bleeding events were also associated with 30-day death (adjusted HR, 3.71 [95% CI, 2.94-4.69]), and with death (adjusted HR, 1.39 [95% CI, 1.23-1.56]) and hospital readmission (adjusted HR, 1.19 [95% CI, 1.11-1.27]) at 1 year. In patients undergoing transcatheter aortic valve replacement in the US, vascular complications and in-hospital bleeding events were common, but rates have declined over time with significant variation in complication rates across hospital sites. Vascular and bleeding complications are both associated with worse short- and long-term clinical outcomes including all-cause mortality. Further innovation to reduce sheath sizes and optimize antithrombotic therapy is necessary to reduce the incidence of these detrimental complications.

P4619Comparison of the CRUSADE, ACUITY-HORIZONS, and ACTION bleeding risk scores for predicting in-hospital bleeding in acute myocardial infarction patients undergoing primary PCI

Abstract Background Considering clinical importance of bleeding complications in patients with acute myocardial infarction (AMI), bleeding risk stratification is a key part of the management of these patients. CRUSADE, ACTION and ACUITY-HORIZONS bleeding risk scores are available for predicting in-hospital major bleeding events in patients with acute myocardial infarction. Purpose We aimed to evaluate performance of the three above mentioned risk scores for predicting in-hospital bleeding events defined according to The Bleeding Academic Research Consortium (BARC) criteria. Methods From a prospective electronic registry of a high-volume catheterization laboratory in a period from January 2009 to December 2017, a total of 6505 consecutive patients with acute myocardial infarction who underwent pPCI were included in analysis. Calibration and discrimination of the three risk models were evaluated by the Hosmer-Lemeshow (H-L) goodness-of-fit test and C-statistic, respectively. Results Overall there were 372 (5.7%) bleeding events out of which 117 (1.8%) fulfilled stage BARC 3 or higher bleeding criteria. All three scores showed good model calibration as assessed by the H-Ls test and very good discriminative power for BARC 3 of higher bleeding events detection as assessed by C-statistics (Table 1 &amp; Figure 1): Bleeding events stage BARC 3 or higher were statistically highly related with higher in-hospital mortality (13.7% vs. 3.5%; p&lt;0.000). Table 1 Risk score H-L H-L p AUC 95% CI p CRUSADE 11.46 0.177 0.761 0.750–0.771 vs. ACUITY = ns vs. ACTION &lt;0.000 ACUITY-HORIZONS 10.47 0.236 0735 0.724–0.745 vs. ACTION = ns ACTION 5.74 0.677 0.701 0.698–0.712 Figure 1 Conclusions All three evaluated scores showed very good discriminative capacity for predicting BARC 3 or higher bleeding events in patients undergoing pPCI for AMI.

D-dimer levels enhance the discriminatory capacity of bleeding risk scores for predicting in-hospital bleeding events in acute pulmonary embolism

IntroductionBleeding is a major complication of anticoagulation in acute pulmonary embolism (APE) while estimating individual bleeding risk remains challenging. Elevated D-dimer levels (DD) have been shown to predict bleeding events. Objectives(1) direct comparison of the capacity of bleeding risk prediction scores (VTE-BLEED, RIETE, HAS-BLED, HEMORR2HAGES) to prognosticate in-hospital bleeding events in the acute phase of APE in a real-life population of APE patients;(2) augmentation of the discriminative capacity of fore mentioned scores with DD. MaterialsPost-hoc analysis of a prospective observational study. DD levels were measured using the VIDAS D-dimer Exclusion test. Receiver operating characteristic curves, areas under the curve (AUC) for bleeding prediction were calculated for scores and DD. Bleeding scores+DD were compared using an established index quantifying the reclassification of patients (net reclassification index, NRI). Results310 APE patients were included. 35(11.3%) bleeding events occurred (hematomas, GI, urinary tract, retroperitoneal, uterine, CNS, respiratory tract): 17 major (MB) and 18 clinically-relevant non-major bleedings (CRNMB), none were fatal. All scores had satisfactory AUCs (0.754–0.767), except HAS-BLED (AUC = 0.512; 0.455–0.569). DD were higher in patients with bleeding events (29,911 ng/ml vs. 4805 ng/ml, p = .031), AUC 0.621(0.520–0.721), p = .02. DD = 5750 ng/ml was characterized by OR = 2.3(95%CI 1.05–5.0) for all bleeding events. Adding DD improved the discriminatory capacity of tested scores in the non-high risk of bleeding category, NRI 0.07–03. ConclusionsOf the tested scores RIETE, HEMORR2HAGES, VTE-BLEED performed best at identifying APE patients at risk of in-hospital bleeding complications. DD levels may predict in-hospital bleeding events and may improve identifying patients classified as non-high risk who experience bleeding complications.

PCN160 IN-HOSPITAL BLEEDING EVENTS IN CANCER-DIRECTED SURGERIES IN ENGLISH INPATIENT HOSPITALS: INCIDENCE AND IMPACT ON LENGTH OF STAY AND CRITICAL CARE UTILIZATION

To evaluate the incidence of in-hospital bleeding events, and their impact on length of stay (LOS) and critical care utilization, among patients undergoing cancer-directed surgeries in English inpatient hospitals. We conducted a retrospective, observational cohort study using hospital discharge data from English hospitals (Hospital Episode Statistics [HES] database) linked to electronic health records (Clinical Practice Research Datalink [CPRD]). We selected patients aged ≥18 years who underwent one of the following cancer-directed surgeries with a primary diagnosis of cancer between January 2010 and February 2016: hysterectomy, low anterior resection (LAR, rectal), lung (transplant & resection), mastectomy, and prostate (prostatectomy & resection). The primary independent variable was occurrence of in-hospital bleeding events. The primary outcomes were post-procedure LOS and critical care utilization (both in days). We carried out multivariable regression models to compare the study outcomes between patients with vs. without bleeding events, adjusting for patient’s baseline demographic and clinical characteristics measured from the CPRD for the year prior to hospital admission. The study included 26,438 cancer-directed surgeries (hysterectomy: 6,092; LAR: 2,957; lung: 1,539; mastectomy: 12,806; prostate: 3,044). Incidence proportions of in-hospital bleeding events varied by surgical site (hysterectomy: 1.9%; LAR: 2.9%; lung: 1.8%; mastectomy: 1.5%; prostate: 1.0%). In the multivariable analyses, patients with bleeding events had longer post-procedure LOS (hysterectomy: 8.0d vs. 4.7d, p<0.0001; LAR: 17.8d vs. 12.1d, p<0.0001; lung: 12.0d vs. 8.6d, p=0.002; mastectomy: 5.3d vs. 2.2d, p<0.0001; prostate: 8.7d vs. 3.6d, p<0.0001) and spent more days in critical care (hysterectomy: 6.9d vs. 0.4d; p<0.0001; LAR: 4.1d vs. 1.5d; p<0.0001; lung: 5.2d vs. 2.0d; p=0.001; mastectomy: 0.5d vs. 0.1d; p=0.02; prostate: 1.5d vs. 0.1d; p=0.03) as compared with patients without bleeding events. Among patients undergoing cancer-directed surgeries in English inpatient hospitals, in-hospital bleeding events were associated with a large inpatient healthcare utilization burden.

Utility of the HAS-BLED score for risk stratification of patients with acute coronary syndrome.

HAS-BLED score was developed for bleeding prediction in patients with atrial fibrillation (AF). Recently, it was also used in patients undergoing percutaneous coronary interventions (PCI). This study analyzes the HAS-BLED predictivity for bleedings and mortality in patients with acute coronary syndromes (ACS) without AF, and evaluates the utilization of alternative criteria for renal dysfunction. The study population was composed of 704 patients with ACS. Six-hundred and eleven patients completed the follow-up. The HAS-BLED score was calculated both using the original definition of renal dysfunction, both using three alternative eGFR thresholds (< 30, < 60 and ≤ 90ml/min/1.73 mq). In-hospital and post-discharge bleedings and mortality were recorded, and calibration and discrimination of the various risk models were evaluated using the Hosmer-Lemeshow test and the C-statistic. In-hospital bleedings were 4.7% and mortality was 2.7%. Post-discharge bleedings were 3.1% and mortality was 4.4%. Regarding bleeding events and in-hospital mortality, the HAS-BLED original risk model demonstrated a moderate-to-good discriminative performance (C-statistics from 0.65 to 0.76). No significant differences were found in predictive accuracy when applying alternative definitions of renal dysfunction based on eGFR, with the exception of post-discharge mortality, for which HAS-BLED model assuming an eGFR value < 60ml/min/1.73 mq showed a discriminative performance significantly higher in comparison to the other risk models (C-statistic 0.71 versus 0.64-0.66). In conclusion, in our ACS population, the HAS-BLED risk score showed a fairly good predictive accuracy regarding in-hospital and follow-up bleeding events and in-hospital mortality. The use of renal dysfunction alternative criteria based on eGFR values resulted in out-of hospital mortality predictive accuracy enhancement.

Left ventricular thrombosis in acute anterior myocardial infarction: Evaluation of hospital mortality, thromboembolism, and bleeding.

Left ventricular thrombosis (LVT) is a well-known complication of acute myocardial infarction, most commonly seen in anterior wall ST-segment elevation myocardial infarction (STEMI). It is associated with systemic thromboembolism. Our aim was to evaluate the impact of LVT on in-hospital mortality, thromboembolism, and bleeding in patients with anterior STEMI. Data was collected from the Nationwide Inpatient Sample where patients with a primary diagnosis of "Anterior STEMI" [ICD9-CM code 410.1] were included. Comparisons were made between patients with LVT [ICD9-CM code 429.79] vs those without using propensity score matching (PSM). From 2002 to 2014, there were 157 891 cases of anterior STEMI. Among these, 649 (0.4%) had LVT. Post-PSM, there was no difference in in-hospital mortality between the groups with LVT and without (7.3% vs 8.6%). Thromboembolic event rate was higher with LVT compared to those without LVT (7.3% vs 2.1%). There was no difference in bleeding events between patients with LVT and those without (2.9% vs 3.2%). The baseline average length of stay in the group with LVT was longer than the group without LVT (7.9 ± 6.7 days vs 5.1 ± 6.0 days). The average hospitalization-related costs were also significantly higher among patients with LVT compared to those without (95 598 USD vs 66 641 USD per stay) at baseline. Among patients hospitalized with anterior STEMI, presence of LVT is associated with increased thromboembolic events, average length of hospital stay and average cost of hospitalization. However, it is not associated with increased in-hospital mortality or bleeding events.

Comparison of In-Hospital Bleeding and Cardiovascular Events with High-Dose Bolus Tirofiban and Shortened Infusion to Short-Duration Eptifibatide as Adjunctive Therapy for Percutaneous Coronary Intervention

Potent platelet inhibition is one of the most important medical interventions to prevent ischemic complications during and after percutaneous coronary intervention (PCI). Practice has evolved with the introduction of potent oral P2Y12 inhibitors that provide quick, effective platelet inhibition, and the need for routine glycoprotein IIb/IIIa inhibitors (GPIs) has decreased. Additionally, a shorter duration of GPI infusion has been shown to be safe with adequate oral antiplatelet loading, but clinical outcome data are limited to eptifibatide. This single-center, retrospective cohort study analyzed in-hospital outcomes for patients who received adjunctive GPI therapy for PCI before and after an institution-wide switch to high-dose bolus tirofiban with shortened infusion from short-duration eptifibatide. The primary end point was a composite in-hospital outcome of major and minor bleeding and cardiovascular events (death, myocardial infarction, coronary artery bypass grafting, ischemic stroke, and target vessel revascularization). Secondary end points included bleeding and cardiovascular event types. A total of 357 and 446 patients received eptifibatide and tirofiban, respectively, from February 1, 2014 through September 30, 2017. Thirty five eptifibatide and 46 tirofiban patients experienced an in-hospital composite event (9.8% vs 10.3%, p = 0.81). There was no difference found between in-hospital bleeding (6.4% vs 5.4%, p = 0.52) or cardiovascular events (5.6% vs 6.5%, p = 0.60) with the use of eptifibatide or tirofiban, respectively. Multivariable analysis showed that patients with transradial access or an indication of unstable angina were less likely to experience an in-hospital composite event (OR 0.30 and 0.19, respectively, p <0.001 for both). In conclusion, the use of high-dose bolus tirofiban with shortened infusion versus short-duration eptifibatide was not associated with an increase of in-hospital bleeding or cardiovascular events.

A Narrative Review on Thrombolytics in Advanced CKD: Is it an Evidence-Based Therapy?

A timely pharmacoinvasive strategy consisting of thrombolytic therapy (TT) plays a pivotal role in three major scenarios: acute ischemic stroke (AIS), acute myocardial infarction (STEMI), and massive pulmonary embolism (PE). Presence of advanced chronic kidney disease (CKD) (estimated glomerular filtration rate < 30mL/min/1.73m2), known to disturb thrombotic/thrombolytic equilibrium, causes difficulties for clinicians in evaluating risk-benefit balance, as current guidelines do not address the relationship between TT and the advanced CKD. This narrative review aims to evaluate the most important scientific resources regarding the evidences, benefits, and risks of using thrombolytics in advanced CKD. We searched the electronic database of PubMed for studies evaluating the relationship between renal dysfunction and TT in patients with STEMI, AIS, and massive PE. Randomized controlled trials (RCTs), observational studies including prospective or retrospective cohort studies, reviews, meta-analyses, and guidelines were included if referring to TT for one of the three scenarios in advanced CKD. Prothrombotic conditions in CKD, associated with an increased risk of hemorrhages, can affect the safety and efficacy of TT. Concerns regarding in-hospital bleeding events and poor clinical outcomes subsequent to TT in advanced CKD continue to cause underutilization or delaying routine reperfusion therapy. The impact of TT on the outcomes of advanced CKD patients is poorly understood to date, with scarce data available in current guidelines and conflicting results from observational studies. Until evidence-based data from RCTs will be obtained, the clinical challenge of maximizing benefits for this high-risk subgroup lays in the hands of practicing clinicians.

Impact of Chronic Thrombocytopenia on In-Hospital Outcomes After Percutaneous Coronary Intervention

ObjectivesThis study sought to evaluate the impact of chronic thrombocytopenia (cTCP) on clinical outcomes after percutaneous coronary intervention (PCI). BackgroundThe impact of cTCP on clinical outcomes after PCI is not well described. Results from single-center observational studies and subgroup analysis of randomized trials have been conflicting and these patients are either excluded or under-represented in randomized controlled trials. MethodsUsing the 2012 to 2014 National (Nationwide) Inpatient Sample database, the study identified patients who underwent PCI with or without cTCP as a chronic condition variable indicator. Propensity score matching was performed using logistic regression to control for differences in baseline characteristics. The primary outcome of interest was in-hospital mortality. Secondary outcomes of interest included in-hospital post-PCI bleeding events, post-PCI blood and platelet transfusion, vascular complications, ischemic cerebrovascular accidents (CVAs), hemorrhagic CVAs, and length of stay. ResultsPropensity matching yielded a cohort of 65,130 patients (32,565 with and without cTCP). Compared with those without cTCP, PCI in patients with cTCP was associated with higher risk for bleeding complications (odds ratio [OR]: 2.40; 95% confidence interval [CI]: 2.05 to 2.72; p < 0.0001), requiring blood transfusion (OR: 2.10; 95% CI: 1.80 to 2.24; p < 0.0001), requiring platelet transfusion (OR: 11.70; 95% CI: 6.00 to 22.60; p < 0.0001), higher risk for vascular complications (OR: 1.94; 95% CI: 1.43 to 2.63; p < 0.0001), ischemic CVA (OR: 1.60; 95% CI: 1.20 to 2.10; p = 0.01), and higher in-hospital mortality (OR: 2.30; 95% CI: 1.90 to 2.70; p < 0.0001), but without a significant difference in hemorrhagic CVA (OR: 1.50; 95% CI: 0.70 to 3.10; p = 0.27). ConclusionsIn this large contemporary cohort, patients with cTCP were at higher risk of a multitude of complications, including higher risk of in-hospital mortality.

Association between prothrombin time and bleeding in hospitalized patients receiving rivaroxaban.

Results of an investigation of the pharmacodynamic effect of rivaroxaban anticoagulation, as measured by prothrombin time (PT), on bleeding risk and other outcomes in hospitalized patients are reported. In a single-center retrospective cohort study, adult inpatients who had a PT measured within 24 hours after rivaroxaban administration during a designated 23-month period were identified. Patients who experienced in-hospital bleeding events were compared with those who did not. A multivariable logistic regression model was used to quantify the association between PT and bleeding events while adjusting for albumin levels and use of nonsteroidal antiinflammatory drugs and/or antiplatelet agents. Thromboembolic events were assessed as a secondary outcome. A total of 199 patients met the criteria for inclusion in the analysis; 41 experienced a bleeding event. Among patients with a PT of ≥30 seconds versus a PT of <30 seconds, the overall rate of bleeding events was significantly higher (38.7% versus 17.3%, p = 0.0067). Results of multivariable regression modeling showed that a PT of ≥30 seconds correlated with an approximately 3-fold higher bleeding risk (odds ratio, 3.25; 95% confidence interval, 1.09-9.66). Hypoalbuminemia was also a positive predictor of bleeding risk. There was no significant between-group difference in thromboembolic events. In hospitalized patients receiving rivaroxaban who had coagulation tests performed, a PT of ≥30 seconds was associated with a higher risk of bleeding. Hypoalbuminemia was also associated with bleeding in this population.

Incidence, Predictors, and Prognostic Value of Acute Kidney Injury Among Patients Undergoing Left Atrial Appendage Closure

ObjectivesThe aims of this registry were to determine the incidence, predictors, and prognostic value of periprocedural acute kidney injury (AKI) after left atrial appendage closure (LAAC). BackgroundNo data exist on the occurrence of AKI after LAAC. MethodsA total of 355 patients undergoing LAAC were included in the study. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, after the procedure or the need for hemodialysis during index hospitalization. ResultsThe incidence of AKI was 9%, and patients with worse baseline renal function were at higher risk for developing AKI (odds ratio: 1.32; 95% confidence interval [CI]: 1.09 to 1.61; p = 0.004 for each 10 ml/min decrease in glomerular filtration rate). In-hospital bleeding events occurred more frequently in the AKI group (5.3% vs. 15.6%; p = 0.037). After a median follow-up period of 18 months, patients in the AKI group had higher mortality (hazard ratio [HR]: 2.59; 95% CI: 1.36 to 4.92; p = 0.004), more embolic events (HR: 6.14; 95% CI: 2.23 to 16.92; p = 0.001) and major bleeding events (HR: 2.36; 95% CI: 0.89 to 6.24; p = 0.083). The occurrence of AKI was an independent predictor of midterm mortality (HR: 2.00; 95% CI: 1.02 to 3.91; p = 0.044). ConclusionsThe occurrence of AKI was relatively frequent following LAAC, and patients with lower renal glomerular filtration rates were at high risk for developing this complication. AKI identified a group of patients with worse midterm outcomes, highlighting the importance of further preventive strategies in this population.