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Background: Intracerebral hemorrhage (ICH) is the deadliest form of stroke. In observational studies, lower serum magnesium has been linked to more hematoma expansion (HE) and intracranial hemorrhage, implying that supplemental magnesium sulfate is a potential acute treatment for patients with ICH and could reduce HE. FAST-MAG (Field Administration of Stroke Therapy - Magnesium) was a clinical trial of magnesium sulfate started prehospital in patients with acute stroke within 2 hours of last known well enrolled. CT was not required prior to enrollment, and several hundred patients with acute ICH were enrolled. In this ancillary analysis, we assessed the effect of magnesium sulfate treatment upon HE in patients with acute ICH. Methods: We retrospectively analyzed data that were prospectively collected in the FAST-MAG study. Patients received intravenous magnesium sulfate or matched placebo within 2 hours of onset. We compared HE among patients allocated to intravenous magnesium sulfate or placebo with a Mann-Whitney U . We used the same method to compare neurological deficit severity (National Institutes of Health Stroke Scale) and global disability (modified Rankin Scale) at 3 months. Results: Among 268 patients with ICH meeting study entry criteria, mean 65.4±13/4 years, 33% were female, and 211 (79%) had a history of hypertension. Initial deficit severities were median (interquartile range) of 4 (3–5) on the Los Angeles Motor Scale in the field and National Institutes of Health Stroke Scale score of 16 (9.5–25.5) early after hospital arrival. Follow-up brain imaging was performed a median of 17.1 (11.3–22.7) hours after first scan. The magnesium and placebo groups did not statistically differ in hematoma volume on arrival, 10.1 (5.6–28.7) versus 12.4 (5.6–28.7) mL ( P =0.6), or HE, 2.0 (0.1–7.4) versus 1.5 (−0.2 to 8) mL ( P =0.5). There was no difference in functional outcomes (modified Rankin Scale score of 3–6), 59% versus 50% ( P =0.5). Conclusions: Magnesium sulfate did not reduce HE or improve functional outcomes at 90 days. A benefit for patients with initial hypomagnesemia was not addressed. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00059332.

Introduction: Application of machine learning (ML) algorithms has shown promising results in estimating ischemic core volumes using routine non-contrast CT (NCCT). We aimed to assess the performance of the e-Stroke Suite software (Brainomix, Oxford, United Kingdom) in assessing ischemic core volumes on NCCT compared to CTP in patients with acute ischemic stroke. Methods: In this retrospective study, consecutive patients with anterior circulation large vessel occlusions who underwent pretreatment NCCT and CTP and posttreatment MRI were included. Ischemic core volumes were automatically calculated on NCCTs using e-Stroke Suite (Brainomix) which uses a combination of traditional 3D graphics and ML classification techniques to identify ischemic core voxels. Estimated ischemic core volumes were also automatically calculated from CTP using Olea Sphere (Olea Medical SAS, SP23) using a combination of rCBF5 sec. Estimated core volumes were compared against the final infarct volume on posttreatment MRI in patients who achieved successful reperfusion (mTICI ≥2b). Results: 83 patients [52 female; age (mean ± SD): 73.1 ±15.3] were included. The estimated ischemic core volumes (mean ± SD) were 18.9 ± 13.5 mL on NCCT and 17.5 ± 16.5 mL on CTP, not significantly different (p=0.54) and demonstrated significant correlation (r=0.51, pFigure 1 ). Among patients with successful recanalization (n=49), there was no significant difference in estimated ischemic core volume between NCCT vs. CTP (p=0.80) and NCCT vs. MRI (p=0.38). There was significant correlation between estimated ischemic core volume on NCCT vs. CTP (r=0.75, p Conclusions: Results show estimated ischemic core volumes obtained automatically by ML-based approach (Brainomix) on NCCT correlates well with ischemic core volumes on acute CTP and with post-treatment MR infarct volume.

Background Although image‐derived predictors of intracranial aneurysm (IA) rupture have been well explored, current understanding of IA growth is limited. Pulsatility index (PI) and wall shear stress PI (WSSPI) are important metrics measuring temporal hemodynamic instability. However, they have not been investigated in IA growth research. The present study seeks to verify reliable predictors of IA growth with comparative analyses of several important morphological and hemodynamic metrics between stable and growing cases among a group of unruptured IAs. Methods Using 3‐dimensional images, vascular models of 16 stable and 20 growing cases were constructed and verified using geodesic techniques. With an overall mean follow‐up period of 25 months, cases exhibiting a ≥10% increase in diameter were considered growing. Patient‐specific, pulsatile simulations were performed, and hemodynamic calculations were computed at 5 important regions of each aneurysm (inflow artery, aneurysm neck, body, dome, and outflow artery). Index values were compared between growing and stable IAs using ANCOVA controlling for aneurysm diameter. Stepwise multiple logistic regression and receiver operation characteristic analyses were conducted to investigate predictive models of IA growth. Results Compared with stable IAs, growing IAs exhibited significantly higher intrasaccular PI, intrasaccular WSSPI, intrasaccular spatial flow rate deviation, and intrasaccular spatial wall shear stress deviation. Stepwise logistic regression analysis revealed a significant predictive model involving PI at aneurysm body, WSSPI at inflow artery, and WSSPI at aneurysm body. Conclusions Our results showed that high degrees of hemodynamic variation within IAs are linked to growth, even after controlling for morphological parameters. Furthermore, evaluation of PI in conjunction with WSSPI yielded a highly accurate predictive model of IA growth. On validation in future cohorts, these metrics may aid in early identification of IA growth and understanding of IA remodeling mechanisms.

Background Mechanical circulatory support devices, such as the intra‐aortic balloon pump (IABP) and Impella, are often used in patients on veno‐arterial extracorporeal life support (VA‐ECLS) with cardiogenic shock despite limited supporting clinical trial data. Methods and Results Hospitalizations for cardiogenic shock from 2016 to 2018 were identified from the National Inpatient Sample. Trends in the use of VA‐ECLS with and without an IABP or Impella were assessed semiannually. Multivariable logistic regression and general linear regression evaluated the association of Impella and IABP use with in‐hospital outcomes. Overall, 12 035 hospitalizations with cardiogenic shock and VA‐ECLS were identified, of which 3115 (26%) also received an IABP and 1880 (16%) an Impella. Use of an Impella with VA‐ECLS substantially increased from 10% to 18% over this period ( P P P Conclusions From 2016 to 2018 in the United States, use of an Impella and IABP with VA‐ECLS significantly increased. More than half of Impellas and IABPs were placed on the same day as VA‐ECLS, and the use of a second mechanical circulatory support device did not impact in‐hospital mortality. Further studies are needed to decipher the optimal timing and patient selection for this growing practice.

INTRODUCTION Intravascular imaging-guided percutaneous coronary intervention (PCI) has shown to improve outcomes in randomized controlled trials. However, there are little real-world data about intravascular imaging utilization during PCI and its outcomes in the United States. METHODS We conducted an observational analysis on the use of intravascular imaging (Intravascular Ultrasound or Optical Coherence Tomography)-guided PCI in 2,425,036 patients undergoing PCI between January 2010 and December 2014 from the Nationwide Inpatient Sample database. Utilizing propensity score matching, 83,988 matched pairs were identified. The primary outcome was in-hospital mortality. The secondary outcomes included cardiogenic shock and acute kidney injury. RESULTS Among the 2,425,036 patients, 161,808 (6.7%) underwent imaging-guided PCI. Use of imaging-guidance increased from 6% in 2010 to 6.6% in 2014 (Ptrend < 0.001). The in-hospital mortality was significantly different between imaging-guided PCI and angiography-guided PCI [1.0% vs. 1.5%; adjusted OR: 0.67; 95% confidence interval (CI): 0.54-0.83, P < 0.001]. The rates of cardiogenic shock (2.5% vs. 3.1%; adjusted OR: 0.78; 95% CI: 0.66-0.93; P = 0.005) were significantly lower in imaging-guided PCI group and acute kidney injury rates (7.0% vs. 7.1%; adjusted OR: 0.99; 95% CI: 0.89-1.12; P = 0.919) were not significantly different. CONCLUSIONS Imaging-guided PCI is associated with lower in-hospital mortality. Yet, a small proportion of patients undergoing PCI have imaging-guidance.

The number of patients with left ventricular assist devices (LVAD) has increased over the years and it is important to identify the etiologies for hospital admission, as well as the costs, length of stay and in-hospital complications in this patient group. Using the National Readmission Database from 2010 to 2015, we identified patients with a history of LVAD placement using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code V43.21. We aimed to identify the etiologies for hospital admission, patient characteristics, and in-hospital outcomes. We identified a total of 15,996 patients with an LVAD, the mean age was 58 years and 76% were males. The most common cause of hospital readmission after LVAD was heart failure (HF, 13%), followed by gastrointestinal (GI) bleed (11.8%), device complication (11.5%), and ventricular tachycardia/fibrillation (4.2%). The median length of stay was 6 days (3-11 days) and the median hospital costs was $12,723 USD. The in-hospital mortality was 3.9%, blood transfusion was required in 26.8% of patients, 20.5% had acute kidney injury, 2.8% required hemodialysis, and 6.2% of patients underwent heart transplantation. Interestingly, the most common cause of readmission was the same as the diagnosis for the preceding admission. One in every four LVAD patients experiences a readmission within 30 days of a prior admission, most commonly due to HF and GI bleeding. Interventions to reduce HF readmissions, such as speed optimization, may be one means of improving LVAD outcomes and resource utilization.

Background The mechanisms linking menopausal age and heart failure (HF) incidence are controversial. We investigated for heterogeneity by obesity on the relationship between menopausal age and HF incidence. Methods and Results Using postmenopausal women who attended the Atherosclerosis Risk in Communities Study Visit 4, we estimated hazard ratios of incident HF associated with menopausal age using Cox proportional hazards models, testing for effect modification by obesity and adjusting for HF risk factors. Women were categorized by menopausal age: P interaction 0.02 and 0.001, respectively. The hazard ratios of incident HF for a SD increase in body mass index was elevated in women with menopausal age Conclusions As obesity worsened, the risk of developing HF became significantly greater when compared with women with lower body mass index and waist circumference, particularly among those who had experienced menopause at age ≥55 years.

Introduction: Although image-derived parameters such as wall shear stress (WSS), flow rate (FR), aspect ratio (AR), size ratio (SR), and non-sphericity index (NSI) were previously linked to risks of intracranial aneurysm (IA) growth, findings across studies have been inconsistent. Here, we revisit existing hemodynamic and morphological metrics and compare them between stable and growing IAs. We hypothesize that some may differentiate growing and stable trajectories of IAs. Methods: Unruptured IA cases between 2018-2020 were identified from UCLA Medical Center electronic medical records, with follow-up data used to determine growth status. From CTA/MRA images, models of 16 stable and 20 growing unruptured IA cases were reconstructed. Aneurysm diameter, height, neck width, surface area, volume, parent artery diameter, AR, SR, NSI, volume ratio, and surface area ratio were calculated. With data from hemodynamic simulations, we also measured FR and WSS. To capture spatial variations in hemodynamics, we calculated location-dependent mean deviation of WSS and FR at 3 locations within an aneurysm: neck, body, and dome. Pearson chi-square tests were used to compare background variables between groups. MANOVA was employed to compare the index values between stable and growing IAs. Results: Variables including location, diameter, race, history of smoking, and SAH were not significantly different between groups (p>>.05). Gender (p=0.06) and multiplicity (p=0.06) approached significance. Among the size-related and morphological parameters described above, only IA height (3.07±1.94mm vs. 5.49±3.61mm, p=0.03), neck width (4.93±1.42mm vs. 7.14±3.78mm, p=0.04), and size ratio (1.40±0.62 vs. 2.27±1.27, p =0.02) were significantly different (stable vs. growing, respectively). Growing IA had significantly higher FR spatial variation (0.43±0.35 vs. 0.75±0.44; p=0.03) and WSS spatial variations (0.24±0.20 vs. 0.49±0.28; p=0.008). Conclusions: Our findings support that location-dependent hemodynamic variations and SR may be potential risk factors of IA growth. Upon validation in larger studies, these parameters may aid in early identification of incidentally found IAs’ trajectories.

Introduction: Oscillations in blood flow over the cardiac cycle are relevant to endothelial function and vascular health. But, as yet the relationship between pulsatile flow characteristics and intracranial aneurysm (IA) growth is unclear. We analyzed time-based hemodynamic indices within unruptured IAs with known growth or stable trajectories. We hypothesize that combining pulsatile parameters can yield a predictive model for IA growth. Methods: Unruptured IA cases with at least 3 imaging studies were identified from UCLA Medical Center electronic medical records. Cases with an increase in diameter of at least 10% were assigned to the growing group and all other cases were assigned to the stable group. 16 stable and 20 growing cases from 2018-2020 qualified for the study. For each IA image study, computational fluid dynamic (CFD) flow simulation was performed and pulsatility index (PI) and wall shear stress PI (WSSPI) were recorded at 5 locations: inflow artery, IA neck, body, dome, and outflow artery. Values were compared with MANOVA. A stepwise logistic regression with growth as the outcome variable and WSSPI and PI at all locations as covariates was then performed. Results: PI was significantly higher in growing IA at the body (0.81±0.44 vs. 1.76±1.18, p=0.006) and dome (1.22±0.76 vs. 1.91±1.20 p=0.04). WSSPI was significantly higher in growing IA at the inflow artery (0.68±0.05 vs. 0.87±0.36, p=0.049), body (1.07±0.22 vs. 1.55±0.73, p=0.02), and dome (1.15±0.30 vs. 1.64±0.70, p=0.01). Logistic regression yielded a predictive model with 88.2% accuracy and AUC of 0.944: logit(growth) = 2.035 х PI_ body + 14.004 х WSSPI_ inflow + 4.263 х WSSPI_ body -17.342. Conclusions: Based on a finding of elevated pulsatility in growing IA, we propose a model to predict subsequent IA growth. This should be further tested in larger CFD studies. Upon confirmation, the model may be helpful in guiding clinical decisions.

Introduction: The US Centers for Medicare and Medicaid Services (CMS) currently publicly reports hospital-quality, risk-adjusted mortality measure for ischemic stroke but not intracerebral hemorrhage (ICH). The NIHSS, which is captured in CMS administrative claims data, is a candidate metric for use in ICH risk adjustment and has been shown to predict clinical outcome with accuracy similar to the ICH Score. Correlation between early NIHSS and initial ICH volume would further support use of the NIHSS for ICH risk adjustment. Methods: Among consecutive ICH patients enrolled in a large multicenter trial (FAST-MAG), the relation between early NIHSS and early ICH volume was assessed with correlation and linear trend analysis, in all patients and separately in; left vs right; IVH-positive vs IVH-negative, hyperacute (≤60min) vs acute (61-120min) imaging; men vs women; and younger ( Results: Among 372 patients with ICH, age was 65y (SD 13), 67% were men, early NIHSS was 16 (IQR 9-25) and initial ICH volume was 14.9 cc (IQR 6.1-36.4). Overall, there was substantial correlation between NIHSS and ICH volume, r=0.77 (p Conclusion: Early NIHSS deficit severity values correlate strongly with initial ICH hematoma volume. As with ischemic stroke, lesion volume increases produce greater NIHSS changes in the left than right hemisphere, reflecting greater NIHSS sensitivity to left hemisphere function. These findings provide further support for the use of the NIHSS in risk-adjusted mortality measures for intracerebral hemorrhage.

Background: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. Methods: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. Results: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted ( P Conclusions: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

INTRODUCTION Transapical transcatheter aortic valve replacement (TAVR) is associated with increased morbidity compared with endovascular TAVR. We sought to compare the differences in clinical outcomes between endovascular and transapical TAVR approaches utilizing a propensity score model. METHODS Patients undergoing TAVR (International Classification of Diseases, Ninth Revision, Clinical Modification codes 35.05 and 35.06) between January 2011 and November 2014 were identified in the Nationwide Readmissions Database, and a propensity score-matched analysis was performed comparing transapical versus endovascular approach. The primary outcome of interest was in-hospital mortality and 30-day all-cause readmission. We also evaluated trends in use of TAVR over the years. RESULTS We identified 28,302 endovascular TAVR and 7967 transapical TAVR performed during the study period. The propensity score-matching algorithm yielded 7879 well-matched patients in each group. The in-hospital mortality rates were significantly lower in endovascular TAVR compared with transapical TAVR (1.7% vs 6.7%; OR, 0.24; 95% CI, 0.17- 0.35; P < 0.001). The 30-day readmission rate was lower in endovascular TAVR (14.4% vs 16.8%; OR, 0.83; 95% CI, 0.70-0.98; P = 0.036). Use of TAVR increased from 585 (74% endovascular TAVR) in 2011 to 16,801 in 2014 (82.8% endovascular TAVR). CONCLUSIONS Endovascular TAVR is associated with significantly lower in-patient mortality and lower readmission rate when compared with transapical TAVR. Heart failure remains the most common cause for readmission after TAVR regardless of approach.

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn disease (CD), has emerged as a global disease with an increasing incidence in developing and newly industrialized regions such as South America. This global rise offers the opportunity to explore the differences and similarities in disease presentation and outcomes across different genetic backgrounds and geographic locations. Our study includes 265 IBD patients. We performed an exploratory analysis of the databases of Chilean and North American IBD patients to compare the clinical phenotypes between the cohorts. We employed an unsupervised machine-learning approach using principal component analysis, uniform manifold approximation, and projection, among others, for each disease. Finally, we predicted the cohort (North American vs Chilean) using a random forest. Several unsupervised machine learning methods have separated the 2 main groups, supporting the differences between North American and Chilean patients with each disease. The variables that explained the loadings of the clinical metadata on the principal components were related to the therapies and disease extension/location at diagnosis. Our random forest models were trained for cohort classification based on clinical characteristics, obtaining high accuracy (0.86 = UC; 0.79 = CD). Similarly, variables related to therapy and disease extension/location had a high Gini index. Similarly, univariate analysis showed a later CD age at diagnosis in Chilean IBD patients (37 vs 24; P = .005). Our study suggests a clinical difference between North American and Chilean IBD patients: later CD age at diagnosis with a predominantly less aggressive phenotype (39% vs 54% B1) and more limited disease, despite fewer biological therapies being used in Chile for both diseases.

Background: Circadian variations in stroke onset provide critical information for allocation of prehospital and hospital resources in clinical care and clinical trials. Studies of stroke circadian timing have had conflicting findings, and understanding would benefit from analysis confined to patients with defined onset in waking and clearly distinguished ischemic and hemorrhagic stroke subtypes. Methods: We analyzed all patients enrolled in the NIH FAST-MAG phase 3 trial of field-initiated neuroprotective agent in patients with hyperacute stroke within 2h of onset (last known well). Onset times were analyzed in 1h time blocks throughout the 24h day-night cycle. Patient demographic and clinical features, medical history, imaging characteristics, and stroke deficit severity were evaluated for association with onset times. Results: Among 1632 patients, final diagnoses were acute cerebral ischemia in 76.2% and intracranial hemorrhage in 23.7%. Hourly circadian variation in onset is shown in the Figure. Acute cerebral ischemia (ACI) had a unimodal distribution with peak onset at midday (12:00-12:59); intracerebral hemorrhage (ICH) a bimodal distribution with peaks at mid-morning (08:00-08:59) and early evening (18:00-18:59). Events were markedly reduced in early morning, with only 3.4% starting in the 25% of the day between 00:00-05:59. The proportion of events that were hemorrhagic was higher in the first 8h of the day (00:00-07:59) than the remaining 16h, 33.3% vs 22.5%, p=0.006. Both among ACI and ICH patients, vascular risk factors, presenting deficit severity, and initial brain imaging findings were fairly homogenous throughout all day-night time periods. Conclusion: There is marked, more than 10-fold, circadian variation in onset of acute cerebrovascular disease, and circadian variation in the ratio of ischemic to hemorrhagic neurovascular events. These findings can inform resource planning for regional systems of acute stroke care.

Objective: Imaging technology for unruptured intracranial aneurysms (UIA) has improved detection of such aneurysms. However, there is limited information on UIA change over time, and how to predict the rate of enlargement. The objective of this study was to quantify the accuracy of the Predicted Aneurysm Trajectory (PAT) model recently developed by Chien et al. (J Neurosurgery. 2019; Mar 1:1-11). Methods: Patients diagnosed with UIA were prospectively enrolled at the UCLA Medical Center, and followed through serial imaging. 16 UIA cases exhibiting growth across multiple follow-ups were included in this study. Prior images and medical records were collected. Characteristics relevant to the PAT model (mean ± stdev), including initial UIA size (7.26 ± 6.38), patient age (67.4 ± 9.48 yrs.), sex (4 male), history of smoking (n=5), hypothyroidism (n=4), and follow-up duration (36.5 ± 50.0 mos.) were used to predict UIA size at each follow-up. Predicted and actual UIA sizes at follow-up were compared using symmetric mean absolute percentage error (SMAPE) with percentage error ranging from 0-100%. Results: The 16 UIA cases were split by initial UIA size. For UIA smaller than 7 mm (10 cases, 23 follow-up), SMAPE = 11.13%. For UIA greater than 7 mm (6 cases, 15 follow-up), SMAPE = 8.07%. For all UIA cases (16 cases, 38 follow-up), SMAPE = 9.92%. Conclusions: The PAT model predicts the rate of enlargement for UIA, as opposed to whether or not UIA will grow. With this new sample of data, we found the predicted UIA size at follow-up to be quite accurate, deviating in the range of 10% from the actual, measured size. Patient characteristics such as the demographics and behavior included in the model influence the growth of UIA, which allows prediction of growth to optimize treatment and management in future cases.

Background: As hemorrhagic and ischemic strokes progress, acute stroke therapy is time dependent. To emphasize treatment speed for time-sensitive conditions, emergency medicine has developed not only the concept of the “golden hour,” but also the “platinum thirty”. Acute stroke patients treated within the first half-hour of onset have not been previously characterized. Methods: We analyzed all patients with acute stroke symptoms enrolled in the multicenter NIH-funded FAST-MAG trial, testing paramedic prehospital start of neuroprotective agent within 2h of onset. The frequency, demographic, clinical, and outcome features of patients with treatment start within the platinum 30m were compared with later treated patients. Results: Among the 1700 enrolled patients, 180 (10.6%) received study agent within 30 minutes of last known well (LKW). In these platinum-30 patients, final diagnoses were: acute cerebral ischemia in 70.0% (ischemic stroke 59.4%, TIA 10.6%); intracranial hemorrhage in 26.7%; and mimic in 2.8%, similar to the overall study population. Mean age was 68.3 (±13.2) years, 46.1% were women, initial deficit in the field on the Los Angeles Motor Scale was mean 4.1 (±1.2) and early-post-arrival NIHSS deficit was 11.3 (±10.5). Time from LKW to 911 call was median 4m (IQR 2-6); from LKW to paramedic evaluation 10m (IQR 7-12); from LKW to study drug start 27m (IQR 25-29); and from LKW to ED arrival 36m (IQR 31-41). Outcomes at 3 months included freedom from disability (mRS 0-1) in 35.0%, functional independence (mRS 0-2) in 53.3%, and mortality in 17.2%. Demographic, medical history, presenting deficit severity, and 3m outcomes among the platinum-30 patients were largely similar to the 1415 patients treated between 31-120m after onset. Conclusions: Paramedic prehospital initiation of neuroprotection study agent permits treatment start within the platinum first 30 minutes in a substantial proportion of acute ischemic and hemorrhagic stroke patients, accounting for more than 1 in 10 patients enrolled in a multicenter trial. Hyperacute

Objective We carried out a meta-analysis summarizing the efficacy and safety of direct factor Xa inhibitor (DXI) in patients receiving guideline-based antiplatelet therapy (GBAT) after an acute coronary syndrome. Background Randomized-controlled trials have shown that the addition of a DXI to GBAT after acute coronary syndrome can reduce ischemic events, the trade-off being an increase in major bleeding complications. Methods PubMed, Central, Embase, The Cochrane Register, Google Scholar databases, and the scientific session abstracts were searched for eligible randomized trials from 1 January 1990 through 31 December 2016. Results Nine randomized-controlled trials were included in this meta-analysis enrolling a total of 45651 patients. There was a significant reduction in major adverse cardiovascular events with DXIs/GBAT compared with GBAT alone [odds ratio (OR): 0.88; 95% confidence interval (CI): 0.82-0.94, number needed to treat=52]. There were also significant reductions in two individual components of major adverse cardiovascular events: myocardial infarction (OR: 0.89; 95% CI: 0.81-0.98) and stent thrombosis (OR: 0.73; 95% CI: 0.59-0.90), favoring the DXI/GBAT group. There was an increased risk of major bleeding (OR: 2.51; 95% CI: 1.82-3.46) and intracranial hemorrhage (OR: 3.47; 95% CI: 1.76-6.86) compared with GBAT. Conclusion In acute coronary syndromes, the addition of a DXI to GBAT results in a significant reduction of major adverse cardiovascular events, myocardial infarction, and stent thrombosis, offset by an increased risk of bleeding.

Background: Guidelines recommend that Percutaneous coronary intervention (PCI) should be performed in hospitals with onsite cardiac surgery (CS). However, emerging data suggest that there is no significant difference in clinical outcomes following primary, or elective PCI between the two groups. We performed a meta-analysis and meta-regression to assess the safety and efficacy of performing PCI in centers with, and without on-site CS. Methods: We conducted electronic database searches in PubMed, CENTRAL, EMBASE. The Cochrane Register, Google Scholar databases, and the scientific session abstracts were searched for eligible studies. Risk ratios and 95% confidence intervals were computed with the Mantel-Haenszel method. Fixed-effect models were used; if heterogeneity (I 2 )>25 was identified, effects were obtained with random models. Meta-regression analyses were performed to determine whether the effects of PCI without on-site CS were modulated by pre-specified study-level factors Results: Twenty-seven studies were included with total n=8,558,618 patients. No significant difference was observed for all-cause mortality (RR 1.02, 95% CI 0.86-1.21, p=0.82, I 2 =97.2%), cardiovascular mortality rates (RR 1.18, 95% CI 0.93-1.50, p=0.17, I 2 2.98%), myocardial infarction rates (RR 0.89, 95% CI 0.62-1.29, p=0.55, I2= 88.5%), repeat revascularization (RR 0.87, 95% CI 0.43-1.76, p=0.69, I 2 =98.8%), stroke (RR 1.28, 95% CI 0.56-2.91, p=0.55, I 2 98.8%), shock (RR 0.76, 95% CI 0.43-1.35, p=0.35, I 2 = 93.7%), mechanical circulatory support (RR 0.83, 95% CI 0.46-1.50, p=0.53, I 2 99.8%), bleeding (RR 0.88, 95% CI 0.43-1.81, p=0.73, I 2 =99.6%), and emergency CABG (RR 0.97, 95% CI 0.64-146, p= 0.87, I 2 =84.1%). In a meta-regression analysis, the effect of PCI without on-site CS, baseline clinical features did not affect the long-term all-cause mortality outcome. Conclusion: There was no significant difference in complications rates, and clinical outcomes for PCI performed at centers without on-site CS compared to centers with on-site CS.

Background: Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain. Methods and Results: Patients (n=5213) who underwent a MitraClip procedure in the National Cardiovascular Data Registry Transcatheter Valve Therapy registry were evaluated for the primary composite outcome of all-cause mortality, stroke, and new requirement for dialysis by creatinine clearance (CrCl). Centers for Medicare and Medicaid Services–linked data were available in 63% of patients (n=3300). CrCl was 60 mL/min, 1.4%; 30–P 60 mL/min. Rates of 1-year mortality were higher with lower CrCl (>60 mL/min, 13.2%; 30–P 60 mL/min. Conclusions: The majority of patients who undergo MitraClip have renal disease. Preprocedural renal disease is associated with poor outcomes, particularly in stage 4 or 5 renal disease where 1-year mortality is observed in nearly one-third. Studies to determine how to further optimize outcomes in this population are warranted.

Introduction: Expansion of intracerebral hemorrhage (ICH) is associated with increased disability and mortality. The trajectory and rate of hematoma expansion (HE) have not been well described. We evaluated ultra-early baseline and follow up CT and MRI scans to describe the direction and rate of expansion. Methods: We analyzed consecutive ICH patients enrolled in the multicenter, NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) clinical trial with baseline and follow up imaging between 6 to 48 hours. HE was defined as growth more than 33% or more than 6mL. Topographic locations were determined using x-, y-, and z- coordinates on OsiriX software. Direction of HE was described by a change in coordinates and correlated with anatomic location. Hematoma growth (HG) rate was described as hematoma volume divided by symptoms onset to scan time in hours. HE rate was described as change in hematoma volume between initial and follow up imaging divided by the time lapse in hours. Results: There were 387 patients with intracerebral hemorrhage enrolled in the FAST-MAG clinical trial. 260 patients had initial and follow up imaging without undergoing hematoma evacuation. The median age was 64, 176 (66.7%) were male. 97 patients were on antiplatelets and 25 were on anticoagulation. Median SBP on admission was 178 and median DBP was 95. 80 (30.7%) patients demonstrated hematoma expansion. The most common location observed was the basal ganglia (69.6%). These hemorrhages tend to expand in all x-, y- and z- coordinates with the greatest change in z- expanding cortically through the corona radiata. There is a high rate of intraventricular hemorrhage (51.5%). Average HG rate was 18.09mL/hr (17.9) and the average HE rate was 1.37mL/hr (1.86). Interestingly, basal ganglia and thalamic hemorrhages had higher rates of expansion. Both HG rate and HE rate were influenced by changes in blood pressure and use of antiplatelets or anticoagulantion. Conclusion: Hematoma expansion location can be predicted based on the location of the initial hemorrhage location. Hematoma trajectory and HE rate can help predict poor outcomes in ICH.

Background— A significant proportion of patients requiring aortic valve replacement (AVR) have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Data on relative utilization and comparative outcomes of transcatheter (TAVR) versus surgical AVR (SAVR) in patients with prior CABG are limited. Methods and Results— We queried the 2012 to 2014 National Inpatient Sample databases to identify isolated AVR hospitalizations in adults with prior CABG. In-hospital outcomes of TAVR versus SAVR were compared using propensity-matched analysis. Of 147 395 AVRs, 15 055 (10.2%) were in patients with prior CABG. The number of TAVRs in patients with prior CABG increased from 1615 in 2012 to 4400 in 2014, whereas the number of SAVRs decreased from 2285 to 1895 ( P trend P =0.71) but lower incidence of myocardial infarction (1.5% versus 3.4%; P P P P Conclusions— TAVR is being increasingly used as the preferred modality of AVR in patients with prior CABG. Compared with SAVR, TAVR is associated with similar in-hospital mortality but lower rates of in-hospital complications in this important subset of patients.

Background— Nonvalvular atrial fibrillation is the most common arrhythmia. Patients with nonvalvular atrial fibrillation are at increased risk of stroke; therefore, we evaluated the efficacy and safety of different approaches to prevent this major complication. Methods and Results— We conducted electronic database searches of phase III randomized controlled trials. The groups were novel oral anticoagulants, Watchman left atrial appendage occlusion device (DEVICE), and warfarin. Efficacy outcomes were stroke or systemic embolism, and all-cause mortality. Safety outcome was major bleeding and procedure-related complications. A subgroup analysis of the elderly population was done. We used random-effects model to compare pooled outcomes and tested for heterogeneity. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed for each outcome. Seven randomized controlled trials (n=73 978) were included. There was a significant difference favoring novel oral anticoagulants for systemic embolism (OR, 0.84; 95% CI, 0.72–0.97; P =0.01), all-cause mortality (OR, 0.89; 95% CI, 0.84–0.94; P P =0.026) compared with warfarin. No difference was seen between DEVICE and warfarin for efficacy end points; however, DEVICE had more complications (OR, 1.85; 95% CI, 1.14–3.01; P =0.012). In the elderly (6 randomized controlled trials, n=30 699), systemic embolism was favored with novel oral anticoagulants over warfarin (OR, 0.77; 95% CI, 0.68–0.87; P ≤0.001). No evidence of significant publication bias was found. Conclusions— Novel oral anticoagulants is superior to warfarin for stroke prevention in nonvalvular atrial fibrillation. This benefit was also observed in the elderly population. DEVICE is a reasonable noninferior alternative to warfarin for stroke prevention, but cautious use is essential given safety concerns.

Background: As clinical and research interventions for intracerebral hemorrhage (ICH) migrate to the prehospital setting, patients are being treated earlier than ever before. The frequency, determinants, and outcomes of hematoma expansion among hyperacute, EMS-transported patients have not been previously characterized. Methods: We analyzed all ICH patients enrolled in the NIH Phase 3 Field Administration of Stroke Therapy - Magnesium (FAST-MAG) prehospital trial who had both ED-arrival and 6 to 48-hour follow-up brain CT or GRE-MRI. Hematoma expansion (HE) was defined as hematoma volume growth by ≥ 6 ml. Results: Among 262 ICH patients meeting entry criteria, age was 64.8±12.9, 32.4% were female, and last known well to ED arrival was 52 mins (IQR 44-70). Hematoma expansion occurred in 80 (30.5%). Clinical predictors of HE included: anticoagulant use at onset, 11.3% vs 3.8%, p=0.03; lower level of consciousness at ED arrival, median GCS 14 vs 15, p Conclusions: Hematoma expansion is frequent among hyperacute, EMS-transported ICH patients, occurring in more than 3 in 10 patients. Anticoagulant use, reduced level of consciousness, and greater neurologic deficit are independent determinants of HE, and collectively predict HE moderately well. Hematoma expansion is clinically consequential, associated with a 5-fold increase in odds of early neurology deterioration and 8-fold increase in odds of death by 90 days.

Background: Several noncontrast CT findings may increase risk of intracerebral hemorrhage (ICH) expansion, including ICH volume, location, margin irregularity, heterogeneity, the blend sign, and leukoaraioisis. Hyperacute EMS-transported patients have more frequent hematoma progression and may have distinctive predisposing imaging features. Methods: We analyzed consecutive patients enrolled in the NIH Phase 3 Field Administration of Stroke Therapy - Magnesium (FAST-MAG) prehospital trial and who had both ED-arrival and 6 to 48h follow-up brain CT or GRE-MRI. Hematoma expansion (HE) was defined as hematoma volume growth by ≥ 6ml. Results: Among 262 ICH patients meeting entry criteria, age was 64.8 (±12.9), 32.4% were female, arrival GCS was median 15 (IQR 11-15), and arrival NIHSS median 15 (IQR 9-24). Initial imaging was with CT in 95.8% and GRE-MRI in 4.2%. Median time from last known well to first imaging was 80 min (IQR 66-98) and from first to follow-up imaging 16.7 hr (IQR 11.3-22.3). Overall, 30.5% of patients experienced hematoma expansion. Univariate imaging predictors of HE were: hematoma volume, 25.1 vs 18.6 ml, p Conclusions: Among hyperacute, EMS-transported intracerebral hemorrhage patients, several conventional and novel imaging findings on noncontrast CT are associated with hematoma expansion. Key independent predictors of hematoma growth are early evidence of moderate-severe midline shift and hematoma density heterogeneity.

Introduction: Numerous previous studies have discussed the correlation between patient age and aneurysm rupture. However, the existing base of knowledge regarding the relationship between patient age and aneurysm growth, specifically growth rate, is significantly smaller. The objective of this study is to examine the correlation between patient age and aneurysm growth in order to help devise better clinical management strategies. Hypothesis: Growing aneurysms in older patients will exhibit a higher mean growth rate relative to those in younger patients. Methods: In this study, the records of 361 patients between the age of 40 and 97 at the time of initial diagnosis with unruptured intracranial aneurysms in the UCLA Medical Center between January 2005 and December 2015 were reviewed. These patients were continuously followed using CTA neurovascular imaging, ending when the patient either received surgical or endovascular treatment or discontinued follow-up visits. Results: A total of 496 UIA in the 361 patients were classified into four groups by patient age (40-49, n=56; 50-59, n=120; 60-69, n=145; 70+, n=175). Incidence of growth was 14.29%, 11.67%, 8.28%, and 12.57% for the 40-49, 50-59, 60-69, and 70+ groups, respectively. Growth rates were 0.30±0.12, 0.58±0.42, 0.90±0.72, and 0.78±0.75 mm/yr for the 40-49, 50-59, 60-69, and 70+ groups, respectively. Differences in growth rates were not significant between the four groups (ANOVA, p=0.15). However, when patients were divided by age 50 years, growth rates were significantly higher in the 50+ group (p Conclusion: Although there was a high level of variation in growth rate between individual cases, this study found that patients with growing aneurysms over the age of 50 are at a higher risk for rapid aneurysm growth compared to younger patients, a finding that may prove helpful in developing clinical management protocols.

Background— Prior studies have reported higher inhospital mortality in women versus men with non–ST-segment–elevation myocardial infarction. Whether this is because of worse baseline risk profile compared with men or sex-based disparities in treatment is not completely understood. Methods and Results— We queried the 2003 to 2014 National Inpatient Sample databases to identify all hospitalizations in patients aged ≥18 years with the principal diagnosis of non–ST-segment–elevation myocardial infarction. Complex samples multivariable logistic regression models were used to examine sex differences in use of an early invasive strategy and inhospital mortality. Of 4 765 739 patients with non–ST-segment–elevation myocardial infarction, 2 026 285 (42.5%) were women. Women were on average 6 years older than men and had a higher comorbidity burden. Women were less likely to be treated with an early invasive strategy (29.4% versus 39.2%; adjusted odds ratio, 0.92; 95% confidence interval, 0.91–0.94). Women had higher crude inhospital mortality than men (4.7% versus 3.9%; unadjusted odds ratio, 1.22; 95% confidence interval, 1.20–1.25). After adjustment for age (adjusted odds ratio, 0.96; 95% confidence interval, 0.94–0.98) and additionally for comorbidities, other demographics, and hospital characteristics, women had 10% lower odds of inhospital mortality (adjusted odds ratio, 0.90; 95% confidence interval, 0.89–0.92). Further adjustment for differences in the use of an early invasive strategy did not change the association between female sex and lower risk-adjusted inhospital mortality. Conclusions— Although women were less likely to be treated with an early invasive strategy compared with men, the lower use of an early invasive strategy was not responsible for the higher crude inhospital mortality in women, which could be entirely explained by older age and higher comorbidity burden.

Introduction: Intracranial aneurysms, especially small and asymptomatic ones, are often monitored with imaging studies. However, the prognosis of aneurysms varies according to many factors, which is reflected in variation in growth. Hypothesis: A time course analysis with a long follow up period can reveal characteristics of aneurysm growth and factors related to growth. Methods: All patients who underwent two CTA, including one in 2015, were reviewed. Intracranial saccular aneurysms were selected and fusiform, dissecting and mycotic aneurysms were excluded. Aneurysm characteristics, patient information, and medical history were recorded. Growth was defined as more than a 0.5 mm size increase compared with the first study. Log-rank and Cox regression tests were applied to identify factors related growth. Results: This study included 119 aneurysms of 91 patients that underwent a total of 474 CTA, with initial size 0.0-17.0 mm and follow-up duration of 42.9 ± 44.8 months. Eighteen aneurysms increased in size. Follow-up period to growth was 25.4 ± 20.8 months. Growth rate was highly variable (0.74 ± 3.23 mm/year). On univariate log-rank or Cox regression test, only history of transient ischemic attack (TIA) (P = 0.016) showed significance for aneurysm growth. On multivariate Cox regression test, history of TIA (P = 0.010, hazard ratio = 7.939), the maximum diameter at the first CTA (P = 0.026, hazard ratio = 1.216) and history of cancer (P = 0.028, hazard ratio = 4.499). Cancers existed in breast, thyroid, and lung. Conclusions: Aneurysm growth rate can vary even in the same patient. Aneurysm growth frequency varied according to size and risk factors. History of cancer has not previously been associated with aneurysm growth and may benefit from further study.