Characteristics of High-Performing Hospitals in Cardiogenic Shock Following Acute Myocardial Infarction.

Cardiogenic shock after acute myocardial infarction (AMI-CS) carries significant mortality despite advances in revascularization and mechanical circulatory support. We sought to identify the process-based and structural characteristics of centers with lower mortality in AMI-CS. We analyzed 16,337 AMI-CS cases across 440 centers enrolled in the National Cardiovascular Data Registry's Chest Pain-MI Registry, a retrospective cohort database, between January 1, 2015, and December 31, 2018. Centers were stratified across tertiles of risk-adjusted in-hospital mortality rate (RAMR) for comparison. Risk-adjusted multivariable logistic regression was also performed to identify hospital-level characteristics associated with decreased mortality. The median participant age was 66 (interquartile range 57 to 75) years, and 33.0% (n = 5,390) were women. The median RAMR was 33.4% (interquartile range 26.0% to 40.0%) and ranged from 26.9% to 50.2% across tertiles. Even after risk adjustment, lower-RAMR centers saw patients with fewer co-morbidities. Lower-RAMR centers performed more revascularization (92.8% vs 90.6% vs 85.9%, p <0.001) and demonstrated better adherence to associated process measures. Left ventricular assist device capability (odds ratio [OR] 0.78 [0.67 to 0.92], p = 0.002), more frequent revascularization (OR 0.93 [0.88 to 0.98], p = 0.006), and higher AMI-CS volume (OR 0.95 [0.91 to 0.99], p = 0.009) were associated with lower in-hospital mortality. However, several such characteristics were not more frequently observed at low-RAMR centers, despite potentially reflecting greater institutional experience or resources. This may reflect the heterogeneity of AMI-CS even after risk adjustment. In conclusion, low-RAMR centers do not necessarily exhibit factors associated with decreased mortality in AMI-CS, which may reflect the challenges in performing outcomes research in this complex population.

Defining the Need for Causal Inference to Understand the Impact of Social Determinants of Health: A Primer on Behalf of the Consortium for the Holistic Assessment of Risk in Transplantation (CHART).

Objective: This study aims to introduce key concepts and methods that inform the design of studies that seek to quantify the causal effect of social determinants of health (SDOH) on access to and outcomes following organ transplant. Background: The causal pathways between SDOH and transplant outcomes are poorly understood. This is partially due to the unstandardized and incomplete capture of the complex interactions between patients, their neighborhood environments, the tertiary care system, and structural factors that impact access and outcomes. Designing studies to quantify the causal impact of these factors on transplant access and outcomes requires an understanding of the fundamental concepts of causal inference. Methods: We present an overview of fundamental concepts in causal inference, including the potential outcomes framework and direct acyclic graphs. We discuss how to conceptualize SDOH in a causal framework and provide applied examples to illustrate how bias is introduced. Results: There is a need for direct measures of SDOH, increased measurement of latent and mediating variables, and multi-level frameworks for research that examine health inequities across multiple health systems to generalize results. We illustrate that biases can arise due to socioeconomic status, race/ethnicity, and incongruencies in language between the patient and clinician. Conclusions: Progress towards an equitable transplant system requires establishing causal pathways between psychosocial risk factors, access, and outcomes. This is predicated on accurate and precise quantification of social risk, best facilitated by improved organization of health system data and multicenter efforts to collect and learn from it in ways relevant to specialties and service lines.

Addressing substantial covariate imbalance with propensity score stratification and balancing weights: connections and recommendations.

Objectives: Propensity score (PS) weighting methods are commonly used to adjust for confounding in observational treatment comparisons. However, in the setting of substantial covariate imbalance, PS values may approach 0 and 1, yielding extreme weights and inflated variance of the estimated treatment effect. Adaptations of the standard inverse probability of treatment weights (IPTW) can reduce the influence of extremes, including trimming methods that exclude people with PS values near 0 or 1. Alternatively, overlap weighting (OW) optimizes criteria related to bias and variance, and performs well compared to other PS weighting and matching methods. However, it has not been compared to propensity score stratification (PSS). PSS has some of the same potential advantages; being insensitive extreme values. We sought to compare these methods in the setting of substantial covariate imbalance to generate practical recommendations. Methods: Analytical derivations were used to establish connections between methods, and simulation studies were conducted to assess bias and variance of alternative methods. Results: We find that OW is generally superior, particularly as covariate imbalance increases. In addition, a common method for implementing PSS based on Mantel-Haenszel weights (PSS-MH) is equivalent to a coarsened version of OW and can perform nearly as well. Finally, trimming methods increase bias across methods (IPTW, PSS and PSS-MH) unless the PS model is re-fit to the trimmed sample and weights or strata are re-derived. After trimming with re-fitting, all methods perform similarly to OW. Conclusions: These results may guide the selection, implementation and reporting of PS methods for observational studies with substantial covariate imbalance.

Opportunities and Achievement of Medication Initiation Among Inpatients With Heart Failure With Reduced Ejection Fraction.

BACKGROUND: Initiation of evidence-based medications for patients with heart failure with reduced ejection fraction (HFrEF) during hospitalization in contemporary practice is unknown. OBJECTIVES: This study characterized opportunities for and achievement of heart failure (HF) medication initiation. METHODS: Using the GWTG-HF (Get With The Guidelines-Heart Failure) Registry 2017-2020, which collected data on contraindications and prescribing for 7 evidence-based HF-related medications, we assessed the number of medications for which each patient with HFrEF was eligible, use before admission, and prescribed at discharge. Multivariable logistic regression identified factors associated with medication initiation. RESULTS: Among 50,170 patients from 160 sites, patients were eligible for mean number of 3.9 ± 1.1 evidence-based medications with 2.1 ± 1.3 used before admission and 3.0 ± 1.0 prescribed on discharge. The number of patients receiving all indicated medications increased from admission (14.9%) to discharge (32.8%), a mean net gain of 0.9 ± 1.3 medications over a mean of 5.6 ± 5.3 days. In multivariable analysis, factors associated with lower odds of HF medication initiation included older age, female sex, medical pre-existing conditions (stroke, peripheral arterial disease, pulmonary disease, and renal insufficiency), and rural location. Odds of medication initiation increased during the study period (adjusted OR: 1.08; 95% CI: 1.06-1.10). CONCLUSIONS: Nearly 1 in 6 patients received all indicated HF-related medications on admission, increasing to 1 in 3 on discharge with an average of 1 new medication initiation. Opportunities to initiate evidence-based medications persist, particularly among women, those with comorbidities, and those receiving care at rural hospitals.

Recent Vitamin K Antagonist Use and Intracranial Hemorrhage After Endovascular Thrombectomy for Acute Ischemic Stroke.

Importance: Use of oral vitamin K antagonists (VKAs) may place patients undergoing endovascular thrombectomy (EVT) for acute ischemic stroke caused by large vessel occlusion at increased risk of complications. Objective: To determine the association between recent use of a VKA and outcomes among patients selected to undergo EVT in clinical practice. Design, Setting, and Participants: Retrospective, observational cohort study based on the American Heart Association's Get With the Guidelines-Stroke Program between October 2015 and March 2020. From 594 participating hospitals in the US, 32 715 patients with acute ischemic stroke selected to undergo EVT within 6 hours of time last known to be well were included. Exposure: VKA use within the 7 days prior to hospital arrival. Main Outcome and Measures: The primary end point was symptomatic intracranial hemorrhage (sICH). Secondary end points included life-threatening systemic hemorrhage, another serious complication, any complications of reperfusion therapy, in-hospital mortality, and in-hospital mortality or discharge to hospice. Results: Of 32 715 patients (median age, 72 years; 50.7% female), 3087 (9.4%) had used a VKA (median international normalized ratio [INR], 1.5 [IQR, 1.2-1.9]) and 29 628 had not used a VKA prior to hospital presentation. Overall, prior VKA use was not significantly associated with an increased risk of sICH (211/3087 patients [6.8%] taking a VKA compared with 1904/29 628 patients [6.4%] not taking a VKA; adjusted odds ratio [OR], 1.12 [95% CI, 0.94-1.35]; adjusted risk difference, 0.69% [95% CI, -0.39% to 1.77%]). Among 830 patients taking a VKA with an INR greater than 1.7, sICH risk was significantly higher than in those not taking a VKA (8.3% vs 6.4%; adjusted OR, 1.88 [95% CI, 1.33-2.65]; adjusted risk difference, 4.03% [95% CI, 1.53%-6.53%]), while those with an INR of 1.7 or lower (n = 1585) had no significant difference in the risk of sICH (6.7% vs 6.4%; adjusted OR, 1.24 [95% CI, 0.87-1.76]; adjusted risk difference, 1.13% [95% CI, -0.79% to 3.04%]). Of 5 prespecified secondary end points, none showed a significant difference across VKA-exposed vs VKA-unexposed groups. Conclusions and Relevance: Among patients with acute ischemic stroke selected to receive EVT, VKA use within the preceding 7 days was not associated with a significantly increased risk of sICH overall. However, recent VKA use with a presenting INR greater than 1.7 was associated with a significantly increased risk of sICH compared with no use of anticoagulants.

Variance estimation for the average treatment effects on the treated and on the controls.

Common causal estimands include the average treatment effect, the average treatment effect of the treated, and the average treatment effect on the controls. Using augmented inverse probability weighting methods, parametric models are judiciously leveraged to yield doubly robust estimators, that is, estimators that are consistent when at least one the parametric models is correctly specified. Three sources of uncertainty are associated when we evaluate these estimators and their variances, that is, when we estimate the treatment and outcome regression models as well as the desired treatment effect. In this article, we propose methods to calculate the variance of the normalized, doubly robust average treatment effect of the treated and average treatment effect on the controls estimators and investigate their finite sample properties. We consider both the asymptotic sandwich variance estimation, the standard bootstrap as well as two wild bootstrap methods. For the asymptotic approximations, we incorporate the aforementioned uncertainties via estimating equations. Moreover, unlike the standard bootstrap procedures, the proposed wild bootstrap methods use perturbations of the influence functions of the estimators through independently distributed random variables. We conduct an extensive simulation study where we vary the heterogeneity of the treatment effect as well as the proportion of participants assigned to the active treatment group. We illustrate the methods using an observational study of critical ill patients on the use of right heart catherization.

Neighborhood Socioeconomic Disadvantage and Hospitalized Heart Failure Outcomes in the American Heart Association Get With The Guidelines-Heart Failure Registry.

BACKGROUND: Neighborhood socioeconomic status (SES) is associated with worse health outcomes, yet its relationship with in-hospital heart failure (HF) outcomes and quality metrics are underexplored. We examined the association between socioeconomic neighborhood disadvantage and in-hospital HF outcomes for patients from diverse neighborhoods in the Get With The Guidelines-Heart Failure registry. METHODS: SES-disadvantage scores were derived from geocoded US census data using a validated algorithm, which incorporated household income, home value, rent, education, and employment. We examined the association between SES-disadvantage quintiles with all-cause in-hospital mortality, adjusting for demographics and comorbidities. RESULTS: Of 593 053 patients hospitalized for HF between 2017 and 2020, 321 314 (54%) had residential ZIP Codes recorded. Patients from the most compared with least disadvantaged neighborhoods were younger (mean age 67 versus 76 years), more often Black (42% versus 9%) or Hispanic (14% versus 5%), and had higher comorbidity burden. Demographic-adjusted length of stay increased by ≈1.5 hours with each increment in worsening SES-disadvantage quintiles. Adjusted-mortality odds ratios increased with worsening SES-disadvantage quintiles (Ptrend=0.003), and was 28% higher (adjusted OR=1.28 [1.12-1.48]) for the most compared with least disadvantaged neighborhood groups. CONCLUSIONS: Patients hospitalized for HF from disadvantaged neighborhoods were younger and more often Black or Hispanic. SES disadvantage was independently associated with higher in-hospital mortality. Further research is needed to characterize care delivery patterns in disadvantaged neighborhoods and to address social determinants of health among patients hospitalized for HF. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02693509.

US Surveillance of Acute Ischemic Stroke Patient Characteristics, Care Quality, and Outcomes for 2019.

BACKGROUND: The United States lacks a timely and accurate nationwide surveillance system for acute ischemic stroke (AIS). We use the Get With The Guidelines-Stroke registry to apply poststratification survey weights to generate national assessment of AIS epidemiology, hospital care quality, and in-hospital outcomes. METHODS: Clinical data from the Get With The Guidelines-Stroke registry were weighted using a Bayesian interpolation method anchored to observations from the national inpatient sample. To generate a US stroke forecast for 2019, we linearized time trend estimates from the national inpatient sample to project anticipated AIS hospital volume, distribution, and race/ethnicity characteristics for the year 2019. Primary measures of AIS epidemiology and clinical care included patient and hospital characteristics, stroke severity, vital and laboratory measures, treatment interventions, performance measures, disposition, and clinical outcomes at discharge. RESULTS: We estimate 552 476 patients with AIS were admitted in 2019 to US hospitals. Median age was 71 (interquartile range, 60-81), 48.8% female. Atrial fibrillation was diagnosed in 22.6%, 30.2% had prior stroke/transient ischemic attack, and 36.4% had diabetes. At baseline, 46.4% of patients with AIS were taking antiplatelet agents, 19.2% anticoagulants, and 46.3% cholesterol-reducers. Mortality was 4.4%, and only 52.3% were able to ambulate independently at discharge. Performance nationally on AIS achievement measures were generally higher than 95% for all measures but the use of thrombolytics within 3 hours of early stroke presentations (81.9%). Additional quality measures had lower rates of receipt: dysphagia screening (84.9%), early thrombolytics by 4.5 hours (79.7%), and statin therapy (80.6%). CONCLUSIONS: We provide timely, reliable, and actionable US national AIS surveillance using Bayesian interpolation poststratification weights. These data may facilitate more targeted quality improvement efforts, resource allocation, and national policies to improve AIS care and outcomes.

Trends in Use, Outcomes, and Disparities in Endovascular Thrombectomy in US Patients With Stroke Aged 80 Years and Older Compared With Younger Patients.

Importance: Patients aged 80 years and older were often excluded or underrepresented in pivotal endovascular thrombectomy (EVT) trials. Accordingly, trends in frequency, outcomes, and disparities of EVT use merit close analysis. Objective: To delineate temporal trends in EVT use, outcomes, and disparities among patients with acute ischemic stroke aged 80 years and older vs those younger than 80 years. Design, Setting, and Participants: A US nationwide retrospective cohort study using prospectively collected data was conducted in patients admitted with a primary diagnosis of acute ischemic stroke between April 1, 2012, and June 30, 2019. Data were obtained from hospitals participating in the Get With the Guidelines-Stroke (GWTG-Stroke) program, which is a stroke quality improvement registry, with data collected prospectively, sponsored by the American Heart Association/American Stroke Association. Data analysis was conducted from November 2, 2020, to June 25, 2021. Exposures: Potentially eligible for EVT based on arrival within 6 hours and National Institutes of Health Stroke Scale score greater than or equal to 6. Main Outcomes and Measures: Efficacy outcomes included discharge to home, independent ambulation at discharge, and functional independence (modified Rankin Scale score 0-2) at discharge. Safety outcomes included in-hospital mortality, combined in-hospital mortality or discharge to hospice, and symptomatic intracranial hemorrhage. Results: Among 302 965 patients with ischemic stroke meeting study criteria as potentially eligible for EVT admitted to 614 GWTG-Stroke hospitals, 14.0% (42 422) received EVT (21 634 women [51.0%]), including 10.7% (12 768 of 119 453) of patients aged 80 years and older (median [IQR] age, 85 [82-89] years) and 16.2% (29 654 of 183 512) of patients younger than 80 years (median [IQR] age, 65 [56-73] years). Among patients aged 80 years and older, EVT rates increased substantially during the study period, from 3.3% in early 2012 to 20.8% in early 2019. By study end, the relative rate of EVT among eligible patients aged 80 years and older compared with those younger than 80 years increased from 0.49 (3.3% vs 6.7%) to 0.76 (20.8% vs 27.3%). Older patients had worse outcomes at discharge compared with younger patients, including discharge to home: 12.5% vs 31.1% (adjusted odds ratio [aOR], 0.43; 95% CI, 0.40-0.46), functional independence (modified Rankin Scale score 0-2): 10.9% vs 26.6% (aOR, 0.45; 95% CI, 0.41-0.49), and inpatient death or discharge to hospice, 34.5% vs 16.1% (aOR, 2.22; 95% CI, 2.09-2.36). Symptomatic intracranial hemorrhage rates did not differ significantly (6.9% vs 6.5%; aOR, 1.04; 95% CI, 0.94-1.14). Conclusions and Relevance: In this cohort study, use of EVT among individuals aged 80 years and older increased substantially from 2012 to 2019, although the rate remained lower than in younger patients. Although favorable functional outcomes at discharge were lower and combined mortality or discharge to hospice was higher in the older patients, the risk of symptomatic intracranial hemorrhage was not increased.

Robust statistical inference for matched win statistics.

As alternatives to the time-to-first-event analysis of composite endpoints, the win statistics, that is, the net benefit, the win ratio, and the win odds have been proposed to assess treatment effects, using a hierarchy of prioritized component outcomes based on clinical relevance or severity. Whether we are using paired organs of a human body or pair-matching patients by risk profiles or propensity scores, we can leverage the level of granularity of matched win statistics to assess the treatment effect. However, inference for the matched win statistics (net benefit, win ratio, and win odds)-quantities related to proportions-is either not available or unsatisfactory, especially in samples of small to moderate size or when the proportion of wins (or losses) is near 0 or 1. In this paper, we present methods to address these limitations. First, we introduce a different statistic to test for the null hypothesis of no treatment effect and provided a sample size formula. Then, we use the method of variance estimates recovery to derive reliable, boundary-respecting confidence intervals for the matched net benefit, win ratio, and win odds. Finally, a simulation study demonstrates the performance of the proposed methods. We illustrate the proposed methods with two data examples.

Patterns of care for first-detected atrial fibrillation: Insights from the Get With The Guidelines® - Atrial Fibrillation registry.

BACKGROUND: Despite multiple trials comparing rate with rhythm control, there is no consensus on the optimal management of first-detected atrial fibrillation (AF). OBJECTIVE: We analyzed current patterns of care for first-detected AF in the nationwide Get With The Guidelines® - Atrial Fibrillation registry. METHODS: Patients hospitalized with first-detected AF from 2013 to 2019 were included, and a descriptive analysis was performed comparing planned rate with rhythm control. Multivariable logistic regression analysis was performed to identify predictors for choosing rhythm over rate control. RESULTS: Of the 86,759 patients with AF, 17.8% (15,473) had first-detected AF; 11,685 patients were included from 126 sites. Overall, 51.3% (5999) of patients were treated with rate control and 48.7% (5686) with rhythm control at admission. Patients with planned rhythm control had a shorter length of stay and were more likely to be discharged home than a facility. A higher percentage of patients with planned rhythm control were discharged on anticoagulation than those with planned rate control (75.6% vs 70.9%) despite a higher underlying stroke risk in the rate control group (higher median CHA2DS2-VASc score 4; Q1-Q3 2-5 for rate control vs 3; Q1-Q3 2-4 for rhyhtm control; P < .001). While Hispanic ethnicity, Medicaid insurance, age >70 years, and liver disease decreased the likelihood of rhythm control, factors such as heart failure, stroke, or prior bleeding diathesis had no association with the chosen treatment strategy. CONCLUSION: Less than half of the patients with first-detected AF receive rhythm control at admission. Given recent trial results, further studies should assess the long-term impact of rhythm control on patients' symptoms and quality of life, cardiovascular morbidity, and mortality.

Temporal Trends in Racial and Ethnic Disparities in Endovascular Therapy in Acute Ischemic Stroke.

Introduction Endovascular therapy (EVT) use increased following clinical trials publication in 2015, but limited data suggest there may be persistent race and ethnicity differences. Methods and Results We included all patients with acute ischemic stroke arriving within 6 hours of last known well and with National Institute of Health Stroke Scale (NIHSS) score ≥6 between April 2012 and June 2019 in the Get With The Guidelines-Stroke database and evaluated the association between race and ethnicity and EVT use and outcomes, comparing the era before versus after 2015. Of 302 965 potentially eligible patients; 42 422 (14%) underwent EVT. Although EVT use increased over time in all racial and ethnic groups, Black patients had reduced odds of EVT use compared with non-Hispanic White (NHW) patients (adjusted odds ratio [aOR] before 2015, 0.68 [0.58‒0.78]; aOR after 2015, 0.83 [0.76‒0.90]). In-hospital mortality/discharge to hospice was less frequent in Black, Hispanic, and Asian patients compared with NHW. Conversely discharge home was more frequent in Hispanic (29.7%; aOR, 1.28 [1.16‒1.42]), Asian (28.2%; aOR, 1.23 [1.05‒1.44]), and Black (29.1%; aOR, 1.08 [1.00‒1.18]) patients compared with NHW (24%). However, at 3 months, functional independence (modified Rankin Scale, 0-2) occurred less frequently in Black (37.5%; aOR, 0.84 [0.75‒0.95]) and Asian (33%; aOR, 0.79 [0.65‒0.98]) patients compared with NHW patients (38.1%). Conclusions In a large cohort of patients treated with EVT, Black versus NHW patient disparities in EVT use have narrowed over time but still exist. Discharge related outcomes were slightly more favorable in racial and ethnic underrepresented groups; 3-month functional outcomes were worse but improved across all groups with time.

Seasonal Variation of Atrial Fibrillation Admission and Quality of Care in the United States.

Background Currently, little is known regarding seasonal variation for atrial fibrillation (AF) in the United States and whether quality of care for AF varies between seasons. Methods and Results The GWTG-AFib (Get With The Guidelines-AFib) registry was initiated by the American Heart Association to enhance national guideline adherence for treatment and management of AF. Our analyses included 61 291 patients who were admitted at 141 participating hospitals from 2014 to 2018 across the United States. Outcomes included numbers of AF admissions and quality-of-care measures (defect-free care, defined as a patient's receiving all eligible measures). For quality-of-care measures, generalized estimating equations accounting for within-site correlations were used to estimate odds ratios (ORs) with 95% CIs, adjusting patient and hospital characteristics. The proportion of AF admissions for each season was similar, with the highest percentage of AF admissions being observed in the fall (spring 25%, summer 25%, fall 27%, and winter 24%). Overall, AF admissions across seasons were similar, with no seasonal variation observed. No seasonal variation was observed for incident AF. There were no seasonal differences in care quality (multivariable adjusted ORs and 95% CIs were 0.93 (0.87-1.00) for winter, 1.09 (1.01-1.18) for summer, and 1.08 (0.97-1.20) for fall, compared with spring). Conclusions In a nationwide quality improvement registry, no seasonal variation was observed in hospital admissions for AF or quality of care for AF.

Association of Recent Use of Non-Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Treated With Alteplase.

Importance: Current guidelines recommend against use of intravenous alteplase in patients with acute ischemic stroke who are taking non-vitamin K antagonist oral anticoagulants (NOACs). Objective: To evaluate the safety and functional outcomes of intravenous alteplase among patients who were taking NOACs prior to stroke and compare outcomes with patients who were not taking long-term anticoagulants. Design, Setting, and Participants: A retrospective cohort study of 163 038 patients with acute ischemic stroke either taking NOACs or not taking anticoagulants prior to stroke and treated with intravenous alteplase within 4.5 hours of symptom onset at 1752 US hospitals participating in the Get With The Guidelines-Stroke program between April 2015 and March 2020, with complementary data from the Addressing Real-world Anticoagulant Management Issues in Stroke registry. Exposures: Prestroke treatment with NOACs within 7 days prior to alteplase treatment. Main Outcomes and Measures: The primary outcome was symptomatic intracranial hemorrhage occurring within 36 hours after intravenous alteplase administration. There were 4 secondary safety outcomes, including inpatient mortality, and 7 secondary functional outcomes assessed at hospital discharge, including the proportion of patients discharged home. Results: Of 163 038 patients treated with intravenous alteplase (median age, 70 [IQR, 59 to 81] years; 49.1% women), 2207 (1.4%) were taking NOACs and 160 831 (98.6%) were not taking anticoagulants prior to their stroke. Patients taking NOACs were older (median age, 75 [IQR, 64 to 82] years vs 70 [IQR, 58 to 81] years for those not taking anticoagulants), had a higher prevalence of cardiovascular comorbidities, and experienced more severe strokes (median National Institutes of Health Stroke Scale score, 10 [IQR, 5 to 17] vs 7 [IQR, 4 to 14]) (all standardized differences >10). The unadjusted rate of symptomatic intracranial hemorrhage was 3.7% (95% CI, 2.9% to 4.5%) for patients taking NOACs vs 3.2% (95% CI, 3.1% to 3.3%) for patients not taking anticoagulants. After adjusting for baseline clinical factors, the risk of symptomatic intracranial hemorrhage was not significantly different between groups (adjusted odds ratio [OR], 0.88 [95% CI, 0.70 to 1.10]; adjusted risk difference [RD], -0.51% [95% CI, -1.36% to 0.34%]). There were no significant differences in the secondary safety outcomes, including inpatient mortality (6.3% for patients taking NOACs vs 4.9% for patients not taking anticoagulants; adjusted OR, 0.84 [95% CI, 0.69 to 1.01]; adjusted RD, -1.20% [95% CI, -2.39% to -0%]). Of the secondary functional outcomes, 4 of 7 showed significant differences in favor of the NOAC group after adjustment, including the proportion of patients discharged home (45.9% vs 53.6% for patients not taking anticoagulants; adjusted OR, 1.17 [95% CI, 1.06 to 1.29]; adjusted RD, 3.84% [95% CI, 1.46% to 6.22%]). Conclusions and Relevance: Among patients with acute ischemic stroke treated with intravenous alteplase, use of NOACs within the preceding 7 days, compared with no use of anticoagulants, was not associated with a significantly increased risk of intracranial hemorrhage.

Comfort Measures Only in Myocardial Infarction: Prevalence of This Status, Change Over Time, and Predictors From a Nationwide Study.

BACKGROUND: Patients hospitalized with acute myocardial infarction (AMI) have a high mortality rate. Despite increasing recognition of the role for comfort focused care, little is known about the prevalence of comfort measures only (CMO) care among patients with AMI. The objective of this study was to investigate patient- and hospital-level patterns and predictors of CMO care among patients admitted with AMI. METHODS: This retrospective cohort study used the National Cardiovascular Data Registry Chest Pain-MI Registry, which contains data on patients admitted with AMI. Data were analyzed in 6-month increments from January 2015 to June 2018. RESULTS: Among 483 696 patients with AMI across 827 hospitals, 13 955 (2.9%) had CMO status at discharge (2.6% non-ST-segment-elevation myocardial infarction and 3.4% ST-segment-elevation myocardial infarction). There was a modest decline in CMO rates over time (3.0% to 2.8%). Independent patient characteristics associated with CMO status included male gender, White race, nonprivate insurance, frailty, and higher estimated bleeding and mortality risks. There was substantial variation in CMO rates across hospitals, with the proportion of CMO patients ranging from 0% to 17.1% and a median odds ratio of 1.59 (95% CI, 1.56-1.62). Among the 13 955 patients who were CMO by discharge, 8134 (58.3%) underwent diagnostic catheterization. This is despite significantly elevated risks predicted using precatheterization models, specifically the ACTION Registry GWTG in-hospital major bleeding and mortality risk scores. Patients who were initially managed invasively but later made CMO experienced high rates of procedural complications, including cardiogenic shock (38.3%), dialysis (10.1%), and bleeding (33.3%). CONCLUSIONS: Most patients with AMI who were CMO by discharge had aggressive initial management and became CMO following in-hospital complications of their care. Early identification of high-risk patients and appropriate transition of such patients to CMO, if aligned with their values, remain important areas for future quality programs in AMI.

Association of readmission penalty amount with subsequent 30-day risk standardized readmission and mortality rates among patients hospitalized with heart failure: An analysis of get with the guidelines - heart failure participating centers.

BACKGROUND: The Hospital Readmissions Reduction Program penalizes hospitals with excess 30-day risk-standardized readmission rates (RSRR) for heart failure (HF). The association of financial penalty amount with subsequent short-term clinical outcomes is unknown. METHODS: Patients admitted to American Heart Association Get With The Guidelines-HF registry participating centers from October 1, 2012 through December 1, 2015 who had Medicare-linked data were included. October 2012 hospital-specific penalty amounts were calculated based on diagnosis-related group payments and excess readmission ratios. Adjusted Cox models were created to evaluate the association of penalty amount categories (non-penalized: 0%; low-penalized: >0%-<0.50%; mid-penalized ≥0.50%-<0.99%; high-penalized ≥0.99%) with subsequent 30-day RSRR and risk-standardized mortality rates (RSMR). Trends in post-discharge 30-day RSRR and RSMR from 2012 to 2015 were analyzed across hospitals stratified by penalty amount categories. RESULTS: The present study included 61,329 patients who were admitted across 262 hospitals. Compared with patients admitted to non-penalized hospitals (36.3%), those admitted to increasingly penalized hospitals were more likely to have higher 30-day RSRR (low-penalized [43.9%]: HR, 1.10 [95% CI, 1.04-1.16]; mid-penalized [12.0%]: HR, 1.07 [95% CI, 0.99-1.16]; high-penalized [7.9%]: HR, 1.23 [95% CI, 1.12-1.35]) but not 30-day RSMR. Over time, 30-day RSRR and RSMR did not meaningfully change across penalized versus non-penalized hospitals. CONCLUSIONS: Financial penalties based on 30-day RSRR are not associated with declines in 30-day RSRR or RSMR from 2012 to 2015 among patients hospitalized with HF. Financially penalizing hospitals based on current Hospital Readmissions Reduction Program metrics may not incentivize improvements in short-term clinical outcomes for HF.

Clinical Outcomes With Metformin and Sulfonylurea Therapies Among Patients With Heart Failure and Diabetes.

OBJECTIVES: The authors sought to characterize associations between initiation of metformin and sulfonylurea therapy and clinical outcomes among patients with comorbid heart failure (HF) and diabetes (overall and by ejection fraction [EF] phenotype). BACKGROUND: Metformin and sulfonylureas are frequently prescribed to patients with diabetes for glycemic control. The impact of these therapies on clinical outcomes among patients with comorbid HF and diabetes is unclear. METHODS: The authors evaluated Medicare beneficiaries hospitalized for HF in the Get With The Guidelines-Heart Failure Registry between 2006 and 2014 with diabetes and not prescribed metformin or sulfonylurea before admission. In parallel separate analyses for metformin and sulfonylurea, patients with newly prescribed therapy within 90 days of discharge were compared with patients not prescribed therapy. Multivariable models landmarked at 90 days evaluated associations between prescription of therapy, and mortality and hospitalization for HF (HHF) at 12 months. Negative control (falsification) endpoints included hospitalization for urinary tract infection, hospitalization for gastrointestinal bleed, and influenza vaccination. Prespecified subgroup analyses were stratified by EF ≤40% versus >40%. RESULTS: Of 5,852 patients, 454 (7.8%) were newly prescribed metformin and 504 (8.6%) were newly prescribed sulfonylurea. After adjustment, metformin prescription was independently associated with reduced risk of composite mortality/HHF (HR: 0.81; 95% CI: 0.67-0.98; P = 0.03), but individual components were not statistically significant. Findings among patients with EF >40% accounted for associations with mortality/HHF (HR: 0.68; 95% CI: 0.52-0.90) and HHF (HR: 0.58; 95% CI: 0.40-0.85) endpoints (all P for interaction ≤0.04). After adjustment, sulfonylurea initiation was associated with increased risk of mortality (HR: 1.24; 95% CI: 1.00-1.52; P = 0.045) and HHF (HR: 1.22; 95% CI: 1.00-1.48; P = 0.050) with nominal statistical significance. Associations between sulfonylurea initiation and endpoints were consistent regardless of EF (all P for interaction >0.11). Neither metformin initiation nor sulfonylurea initiation were associated with negative control endpoints. CONCLUSIONS: In this population of older U.S. adults hospitalized for HF with comorbid diabetes, metformin initiation was independently associated with substantial improvements in 12-month clinical outcomes, driven by findings among patients with EF >40%. By contrast, sulfonylurea initiation was associated with excess risk of death and HF hospitalization, regardless of EF.

Achievement and quality measure attainment in patients hospitalized with atrial fibrillation: Results from The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) registry.

BACKGROUND: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry. METHODS: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level. RESULTS: Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHA2DS2-VASc 3.6±1.8) at 132 sites. Site-level defect-free scores ranged from 4.7% to 85.8% (25th, 50th, 75th percentile: 32.7%, 52.1%, 64.4%). Composite opportunity scores ranged from 39.4% to 97.5% (25th, 50th, 75th: 68.1%, 80.3%, 87.1%). Attainment was notably low for the following quality measures: 1) aldosterone antagonist prescription when ejection fraction ≤35% (29% of those eligible); and 2) avoidance of antiplatelet therapy with OAC in patients without coronary/peripheral artery disease (81% of those eligible). CONCLUSIONS: Despite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy.

Is the affordable care act medicaid expansion associated with receipt of heart failure guideline-directed medical therapy by race and ethnicity?

BACKGROUND: Uninsurance is a known contributor to racial/ethnic health inequities. Insurance is often needed for prescriptions and follow-up appointments. Therefore, we determined whether the Affordable Care Act(ACA) Medicaid Expansion was associated with increased receipt of guideline-directed medical treatment(GDMT) at discharge among patients hospitalized with heart failure(HF) by race/ethnicity. METHODS: Using Get With The Guidelines-HF registry, logistic regression was used to assess odds of receiving GDMT(HF medications; education; follow-up appointment) in early vs non-adopter states before(2012 - 2013) and after ACA Medicaid Expansion(2014 - 2019) within each race/ethnicity, accounting for patient-level covariates and within-hospital clustering. We tested for an interaction(p-int) between GDMT and pre/post Medicaid Expansion time periods. RESULTS: Among 271,606 patients(57.5% early adopter, 42.5% non-adopter), 65.5% were White, 22.8% African American, 8.9% Hispanic, and 2.9% Asian race/ethnicity. Independent of ACA timing, Hispanic patients were more likely to receive all GDMT for residing in early adopter states compared to non-adopter states (P <.0001). In fully-adjusted analyses, ACA Medicaid Expansion was associated with higher odds of receipt of ACEI/ARB/ARNI in Hispanic patients [before ACA:OR 0.40(95%CI:0.13,1.23); after ACA:OR 2.46(1.10,5.51); P-int = .0002], but this occurred in the setting of an immediate decline in prescribing patterns, particularly among non-adopter states, followed by an increase that remained lowest in non-adopter states. The ACA was not associated with receipt of GDMT for other racial/ethnic groups. CONCLUSIONS: Among GWTG-HF hospitals, Hispanic patients were more likely to receive all GDMT if they resided in early adopter states rather than non-adopter states, independent of ACA Medicaid Expansion timing. ACA implementation was only associated with higher odds of receipt of ACEI/ARB/ARNI in Hispanic patients. Additional steps are needed for improved GDMT delivery for all.

Sex Differences in Ablation Strategy, Lesion Sets, and Complications of Catheter Ablation for Atrial Fibrillation: An Analysis From the GWTG-AFIB Registry.

BACKGROUND: When presenting for atrial fibrillation (AF) ablation, women, compared with men, tend to have more nonpulmonary vein triggers and advanced atrial disease. Whether this informs differences in AF ablation strategy is not well described. We aimed to characterize ablation strategy and complications by sex, using the Get With The Guidelines-AF registry. METHODS: From the Get With The Guidelines-AF registry ablation feature, we included patients who underwent initial AF ablation procedure between January 7, 2016, and December 27, 2019. Patients were stratified based on AF type (paroxysmal versus nonparoxysmal) and sex. We compared patient demographics, ablation strategy, and complications by sex. RESULTS: Among 5356 patients from 31 sites who underwent AF ablation, 1969 were women (36.8%). Women, compared with men, were older (66.8±9.6 versus 63.4±10.6, P<0.0001) and were more likely to have paroxysmal AF (59.4% versus 49.5%, P<0.0001). In women with nonparoxysmal AF, left atrial linear ablation was more frequent (roof line: 53.9% versus 45.3%, P=0.0002; inferior mitral isthmus line: 10.2% versus 7.0%, P=0.01; floor line: 46.1% versus 40.6%, P=0.02) than in men. In multivariable analysis, the association between patient sex and complications from ablation was not statistically significant. CONCLUSIONS: In this US wide AF ablation quality improvement registry, women with nonparoxysmal AF were more likely to receive adjunctive lesion sets compared with men. These findings suggest that patient sex may inform ablation strategy in ways that may not be strongly supported by evidence and emphasize the need to clarify optimal ablation strategies by sex.