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Objectives: The objectives of this study were to compare risk-standardized hospital visit ratios of the predicted to expected number of unplanned hospital visits within 7 days of same-day surgeries performed at US hospital outpatient departments (HOPDs) and to describe the causes of hospital visits. Summary of Background Data: More than half of procedures in the US are performed in outpatient settings, yet little is known about facility-level variation in short-term safety outcomes. Methods: The study cohort included 1,135,441 outpatient surgeries performed at 4058 hospitals between October 1, 2015 and September 30, 2016 among Medicare Fee-for-Service beneficiaries aged ≥65 years. Hospital-level, risk-standardized measure scores of unplanned hospital visits (emergency department visits, observation stays, and unplanned inpatient admissions) within 7 days of hospital outpatient surgery were calculated using hierarchical logistic regression modeling that adjusted for age, clinical comorbidities, and surgical procedural complexity. Results: Overall, 7.8% of hospital outpatient surgeries were followed by an unplanned hospital visit within 7 days. Many of the leading reasons for unplanned visits were for potentially preventable conditions, such as urinary retention, infection, and pain. We found considerable variation in the risk-standardized ratio score across hospitals. The 203 best-performing HOPDs, at or below the 5th percentile, had at least 22% fewer unplanned hospital visits than expected, whereas the 202 worst-performing HOPDs, at or above the 95th percentile, had at least 29% more post-surgical visits than expected, given their case and surgical procedure mix. Conclusions: Many patients experience an unplanned hospital visit within 7 days of hospital outpatient surgery, often for potentially preventable reasons. The observed variation in performance across hospitals suggests opportunities for quality improvement. [ABSTRACT FROM AUTHOR]

This study exploited both the magic of randomization and generalizability of real-world data by linking the patient-level data from the DAPT trial with real-world registry data. However, in subgroup analyses in reweighted data from patients with DAPT score >=2, the significant reduction in stent thrombosis in the group receiving prolonged DAPT was retained without significant impact on bleeding. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation). [Extracted from the article]

Poor hypertension awareness and underuse of guideline-recommended medications are critical factors contributing to poor hypertension control. Using data from 8095 hypertensive people aged ≥18 years from the National Health and Nutrition Examination Survey (2011-2018), we examined recent trends in racial and ethnic differences in awareness and antihypertensive medication use, and their association with racial and ethnic differences in hypertension control. Between 2011 and 2018, age-adjusted hypertension awareness declined for Black, Hispanic, and White individuals, but the 3 outcomes increased or did not change for Asian individuals. Compared with White individuals, Black individuals had a similar awareness (odds ratio, 1.20 [0.96-1.45]) and overall treatment rates (1.04 [0.84-1.25]), and received more intensive antihypertensive medication if treated (1.41 [1.27-1.56]), but had a lower control rate (0.72 [0.61-0.83]). Asian and Hispanic individuals had significantly lower awareness rates (0.69 [0.52-0.85] and 0.74 [0.59-0.89]), overall treatment rates (0.72 [0.57-0.88] and 0.69 [0.55-0.82]), received less intensive medication if treated (0.60 [0.50-0.72] and 0.86 [0.75-0.96]), and had lower control rates (0.66 [0.54-0.79] and 0.69 [0.57-0.81]). The racial and ethnic differences in awareness, treatment, and control persisted over the study period and were consistent across age, sex, and income strata. Lower awareness and treatment were significantly associated with lower control in Asian and Hispanic individuals (P<0.01 for all) but not in Black individuals. These findings highlight the need for interventions to improve awareness and treatment among Asian and Hispanic individuals, and more investigation into the downstream factors that may contribute to the poor hypertension control among Black individuals. [ABSTRACT FROM AUTHOR]

Background: New methods such as machine learning techniques have been increasingly used to enhance the performance of risk predictions for clinical decision-making. However, commonly reported performance metrics may not be sufficient to capture the advantages of these newly proposed models for their adoption by health care professionals to improve care. Machine learning models often improve risk estimation for certain subpopulations that may be missed by these metrics.Methods and Results: This article addresses the limitations of commonly reported metrics for performance comparison and proposes additional metrics. Our discussions cover metrics related to overall performance, discrimination, calibration, resolution, reclassification, and model implementation. Models for predicting acute kidney injury after percutaneous coronary intervention are used to illustrate the use of these metrics.Conclusions: We demonstrate that commonly reported metrics may not have sufficient sensitivity to identify improvement of machine learning models and propose the use of a comprehensive list of performance metrics for reporting and comparing clinical risk prediction models. [ABSTRACT FROM AUTHOR]

Background: Slow uptake of sacubitril/valsartan in patients with heart failure with reduced ejection fraction has been reported, which may negatively impact clinical outcomes. We characterized prior authorization (PA) burden, prescription copayment, and utilization of sacubitril/valsartan by insurance plan type to identify potential barriers to its use.Methods: We conducted a national population-level, cross-sectional study using PA data from an insurance coverage website accessed in March 2019 and IQVIA National Prescription Audit data from August 2018 to July 2019. Primary outcomes were proportion of plans requiring PA, frequency of specific PA criteria, number of sacubitril/valsartan prescriptions, and copayments per insurance plan type.Results: Overall, 48.1% (1394/2896) of insurance plans required PA for sacubitril/valsartan. Fewer Medicare (27.7%) than commercial (57.2%) plans required PA (P<0.001). For both plan types, the most frequently required PA criteria were ejection fraction (71.6%, 90.9%) and New York Heart Association class (60.4%, 90.8%) for Medicare and commercial plans, respectively. Copayment amounts varied by plan type, with more sacubitril/valsartan prescriptions for commercial plans not requiring a patient copayment (32.4%) compared with Medicare plans (19.3%; P<0.001). There were 814 437 sacubitril/valsartan prescriptions for Medicare and 822 292 for commercial plans dispensed from August 2018 to July 2019. Based on estimated heart failure with reduced ejection fraction populations for each plan type, 4-fold more sacubitril/valsartan prescriptions were dispensed in commercial than in Medicare plans (820 versus 215 prescriptions/1000 individuals in the heart failure with reduced ejection fraction population). The estimated proportion of heart failure with reduced ejection fraction patients prescribed sacubitril/valsartan was 3.6% (1.5%-6.8%) for Medicare and 13.7% (4.9%-31.8%) for commercial plan populations.Conclusions: Despite commercial plans having greater PA requirements than Medicare, population-adjusted use of sacubitril/valsartan was higher in commercial plans. Given that commercial plans had more prescriptions with low copayments than Medicare, copayment policies may be more influential on sacubitril/valsartan use than its PA policies. Low sacubitril/valsartan use in both plan types highlights the multifactorial nature of medication underutilization that includes factors beyond the drug policies that we evaluated. [ABSTRACT FROM AUTHOR]

[Figure: see text]. [ABSTRACT FROM AUTHOR]

Background: Intraoperative data may improve models predicting postoperative events. We evaluated the effect of incorporating intraoperative variables to the existing preoperative model on the predictive performance of the model for coronary artery bypass graft.Methods: We analyzed 378 572 isolated coronary artery bypass graft cases performed across 1083 centers, using the national Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2014 and 2016. Outcomes were operative mortality, 5 postoperative complications, and composite representation of all events. We fitted models by logistic regression or extreme gradient boosting (XGBoost). For each modeling approach, we used preoperative only, intraoperative only, or pre+intraoperative variables. We developed 84 models with unique combinations of the 3 variable sets, 2 variable selection methods, 2 modeling approaches, and 7 outcomes. Each model was tested in 20 iterations of 70:30 stratified random splitting into development/testing samples. Model performances were evaluated on the testing dataset using the C statistic, area under the precision-recall curve, and calibration metrics, including the Brier score.Results: The mean patient age was 65.3 years, and 24.7% were women. Operative mortality, excluding intraoperative death, occurred in 1.9%. In all outcomes, models that considered pre+intraoperative variables demonstrated significantly improved Brier score and area under the precision-recall curve compared with models considering pre or intraoperative variables alone. XGBoost without external variable selection had the best C statistics, Brier score, and area under the precision-recall curve values in 4 of the 7 outcomes (mortality, renal failure, prolonged ventilation, and composite) compared with logistic regression models with or without variable selection. Based on the calibration plots, risk restratification for mortality showed that the logistic regression model underestimated the risk in 11 114 patients (9.8%) and overestimated in 12 005 patients (10.6%). In contrast, the XGBoost model underestimated the risk in 7218 patients (6.4%) and overestimated in 0 patients (0%).Conclusions: In isolated coronary artery bypass graft, adding intraoperative variables to preoperative variables resulted in improved predictions of all 7 outcomes. Risk models based on XGBoost may provide a better prediction of adverse events to guide clinical care. [ABSTRACT FROM AUTHOR]

Background: China has seen a burgeoning epidemic of obesity in recent decades, but few studies reported nationally on obesity across socio-demographic subgroups. We sought to assess the prevalence and socio-demographic associations of obesity nationwide.Methods: We assessed the prevalence of overall obesity (body mass index ≥28 kg/m2) and abdominal obesity (waist circumference ≥85/90 cm for women/men) among 2.7 million community-dwelling adults aged 35 to 75 years in the China PEACE Million Persons Project from 2014 to 2018 and quantified the socio-demographic associations of obesity using multivariable mixed models.Results: Age-standardized rates of overall and abdominal obesity were 14.4% (95% CI, 14.3%-14.4%) and 32.7% (32.6%-32.8%) in women and 16.0% (15.9%-16.1%) and 36.6% (36.5%-36.8%) in men. Obesity varied considerably across socio-demographic subgroups. Older women were at higher risk for obesity (eg, adjusted relative risk [95% CI] of women aged 65-75 versus 35-44 years: 1.29 [1.27-1.31] for overall obesity, 1.76 [1.74-1.77] for abdominal obesity) while older men were not. Higher education was associated with lower risk in women (eg, adjusted relative risk [95% CI] of those with college or university education versus below primary school: 0.47 [0.46-0.48] for overall obesity, 0.61 [0.60-0.62] for abdominal obesity) but higher risk in men (1.07 [1.05-1.10], 1.17 [1.16-1.19]).Conclusions: In China, over 1 in 7 individuals meet criteria for overall obesity, and 1 in 3 for abdominal obesity. Wide variation exists across socio-demographic subgroups. The associations of age and education with obesity are significant and differ by sex. Understanding obesity in contemporary China has broad domestic policy implications and provides a valuable international reference. [ABSTRACT FROM AUTHOR]

[Figure: see text]. [ABSTRACT FROM AUTHOR]

BACKGROUND: Quasi-experimental methods (QEMs) are a family of techniques used to estimate causal relationships when randomized controlled trials are unfeasible or unethical. They offer a powerful alternative to observational studies by introducing random assignment of individuals or groups into their design, thereby offering stronger means of establishing causation. The use of QEMs in cardiovascular research has not been systematically examined to determine steps toward improving and expanding their use. METHODS: We identified 4 main techniques using a systematic search strategy from 2016 to 2021: instrumental variable analysis, interrupted time series analysis, difference-in-differences analysis, and regression discontinuity designs. QEMs are examined as alternatives to randomized controlled trials and traditional observational studies; as more observational data becomes available to researchers, there are more opportunities to apply these techniques. Eligible articles were selected based on publication in high-ranked journals. The quality of eligible articles was appraised using the Joanna Briggs Institute checklist for quasi-experimental studies. RESULTS: Data from 380 studies were extracted based on our inclusion criteria. Forty-two of these studies were published in the top 10 medical or top 20 cardiovascular disease journals, and 25 studies were included after quality appraisal. The review identifies the main features and limitations associated with each technique, providing readers with practical guidance on how to apply these to their research. A graphical decision aid was developed to facilitate the routine use of QEMs. CONCLUSIONS: The use of QEMs in cardiovascular research published in contemporary, high-impact articles was examined. Findings are biased toward this segment of literature, which represents the latest developments in this growing area of cardiovascular research. The decision aid is a novel schematic that researchers can adopt into practice. [ABSTRACT FROM AUTHOR]

Background: Coronary artery bypass graft (CABG) surgery is a focus of bundled and alternate payment models that capture outcomes up to 90 days postsurgery. While clinical registry risk models perform well, measures encompassing mortality beyond 30 days do not currently exist. We aimed to develop a risk-adjusted hospital-level 90-day all-cause mortality measure intended for assessing hospital performance in payment models of CABG surgery using administrative data.Methods: Building upon Centers for Medicare and Medicaid Services hospital-level 30-day all-cause CABG mortality measure specifications, we extended the mortality timeframe to 90 days after surgery and developed a new hierarchical logistic regression model to calculate hospital risk-standardized 90-day all-cause mortality rates for patients hospitalized for isolated CABG. The model was derived from Medicare claims data for a 3-year cohort between July 2014 to June 2017. The data set was randomly split into 50:50 development and validation samples. The model performance was evaluated with C statistics, overfitting indices, and calibration plot. The empirical validity of the measure result at the hospital level was evaluated against the Society of Thoracic Surgeons composite star rating.Results: Among 137 819 CABG procedures performed in 1183 hospitals, the unadjusted mortality rate within 30 and 90 days were 3.1% and 4.7%, respectively. The final model included 27 variables. Hospital-level 90-day risk-standardized mortality rates ranged between 2.04% and 11.26%, with a median of 4.67%. C statistics in the development and validation samples were 0.766 and 0.772, respectively. We identified a strong positive correlation between 30- and 90-day risk-standardized mortality rates, with a regression slope of 1.09. Risk-standardized mortality rates also showed a stepwise trend of lower 90-day mortality with higher Society of Thoracic Surgeons composite star ratings.Conclusions: We present a measure of hospital-level 90-day risk-standardized mortality rates following isolated CABG. This measure complements Centers for Medicare and Medicaid Services' existing 30-day CABG mortality measure by providing greater insight into the postacute recovery period. It offers a balancing measure to ensure efforts to reduce costs associated with CABG recovery and rehabilitation do not result in unintended consequences. [ABSTRACT FROM AUTHOR]

BACKGROUND: Hospitals with high mortality and readmission rates for patients with heart failure (HF) might also perform poorly in other quality concepts. We sought to evaluate the association between hospital performance on mortality and readmission with hospital performance rates of safety adverse events. METHODS: This cross-sectional study linked the 2009 to 2019 patient-level adverse events data from the Medicare Patient Safety Monitoring System, a randomly selected medical records-abstracted patient safety database, to the 2005 to 2016 hospital-level HF-specific 30-day all-cause mortality and readmissions data from the United States Centers for Medicare & Medicaid Services. Hospitals were classified to one of 3 performance categories based on their risk-standardized 30-day all-cause mortality and readmission rates: better (both in <25th percentile), worse (both >75th percentile), and average (otherwise). Our main outcome was the occurrence (yes/no) of one or more adverse events during hospitalization. A mixed-effect model was fit to assess the relationship between a patient's risk of having adverse events and hospital performance categories, adjusted for patient and hospital characteristics. RESULTS: The study included 39 597 patients with HF from 3108 hospitals, of which 252 hospitals (8.1%) and 215 (6.9%) were in the better and worse categories, respectively. The rate of patients with one or more adverse events during a hospitalization was 12.5% (95% CI, 12.1–12.8). Compared with patients admitted to better hospitals, patients admitted to worse hospitals had a higher risk of one or more hospital-acquired adverse events (adjusted risk ratio, 1.24 [95% CI, 1.06–1.44]). CONCLUSIONS: Patients admitted with HF to hospitals with high 30-day all-cause mortality and readmission rates had a higher risk of in-hospital adverse events. There may be common quality issues among these 3 measure concepts in these hospitals that produce poor performance for patients with HF. [ABSTRACT FROM AUTHOR]

Keywords: angiotensin receptor antagonists; drug recalls; drug utilization; health services research; hypertension EN angiotensin receptor antagonists drug recalls drug utilization health services research hypertension 411 413 3 04/20/20 20200204 NES 200204 On July 9, 2018, Health Canada announced a voluntary recall of 6 generic valsartan products because a known carcinogen N-nitrosodimethylamine was detected.[1] In total, more than 22 countries, including the United States, initiated recalls. Before the recall, 0.11% of the cohort had ED visits for hypertension per month, with no monthly change in the rate of ED visits for hypertension before the recall ( I P i =0.68). Angiotensin receptor antagonists, drug recalls, drug utilization, health services research, hypertension. [Extracted from the article]

Background: Amid national efforts to improve the quality of care for people with cardiovascular disease in China, the use of traditional Chinese medicine (TCM) is increasing, yet little is known about its use in the early management of acute myocardial infarction (AMI).Methods and Results: We aimed to examine intravenous use of TCM within the first 24 hours of hospitalization (early IV TCM) for AMI. Data come from the China Patient-centered Evaluative Assessment of Cardiac Events Retrospective Study of Acute Myocardial Infarction, restricted to a large, representative sample of Western medicine hospitals throughout China (n=162). We conducted a chart review of randomly sampled patients with AMI in 2001, 2006, and 2011, comparing early intravenous TCM use across years, predictors of any early intravenous TCM use, and association with in-hospital bleeding and mortality. From 2001 to 2011, early intravenous TCM use increased (2001: 38.2% versus 2006: 49.1% versus 2011: 56.1%; P<0.01). Nearly all (99%) hospitals used early intravenous TCM. Salvia miltiorrhiza was most commonly prescribed, used in one third (35.5%) of all patients admitted with AMI. Patients receiving any early intravenous TCM, compared with those who did not, were similar in age and sex and had fewer cardiovascular risk factors. In multivariable hierarchical models, admission to a secondary (versus tertiary) hospital was most strongly associated with early intravenous TCM use (odds ratio: 2.85; 95% confidence interval: 1.98-4.11). Hospital-level factors accounted for 55% of the variance (adjusted median odds ratio: 2.84). In exploratory analyses, there were no significant associations between early intravenous TCM and in-hospital bleeding or mortality.Conclusions: Early intravenous TCM use for AMI in China is increasing despite the lack of evidence of their benefit or harm. There is an urgent need to define the effects of these medications because they have become a staple of treatment in the world's most populous country.Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01624883. [ABSTRACT FROM AUTHOR]

Background: Clopidogrel is one of the most commonly prescribed medications because of its ability to improve clinical outcomes for a broad range of cardiovascular conditions. After patent protection expired for Plavix in 2012, many healthcare systems adopted generic clopidogrel as a strategy to reduce healthcare costs.Methods and Results: We conducted a population-based observational study to determine whether generic clopidogrel was noninferior to Plavix. Patients who were hospitalized with an acute coronary syndrome (ACS) from 2009 to 2014 in Ontario, Canada, >65 years, survived ≥7 days after discharge, were eligible for inclusion. The primary outcome was a composite of death and recurrent ACS at 1 year. The noninferiority margin was prespecified at a relative hazard difference of 10%. Inverse propensity of treatment weighting of the propensity score was used to account for differences in baseline characteristics between the treatment groups. The effect of clopidogrel on the hazard of clinical outcomes was estimated using a Cox proportional hazards model within the propensity-weighted cohort using Plavix as a reference. Our study included 24 530 patients with ACS, 12 643 were prescribed Plavix and 11  887 were prescribed generic clopidogrel at hospital discharge. The mean age was 77 years, 57% were men, and 21% had an ST-segment-elevation myocardial infarction. At 1 year, 17.6% of patients prescribed Plavix and 17.9% of patients prescribed clopidogrel experienced the primary outcome (hazard ratio, 1.02; 95% confidence interval, 0.96-1.08; P=0.005 for noninferiority). No significant differences between rates of death, all-cause readmission, ACS, stroke or transient ischemic attack, or bleeding were observed.Conclusions: Generic clopidogrel was noninferior to Plavix with respect to the composite end point of death and recurrent hospitalization for ACS at 1 year among adults >65 years after an ACS hospitalization. Our findings support generic clopidogrel in ACS, which could lead to substantial healthcare cost savings. [ABSTRACT FROM AUTHOR]

Background: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure.Methods and Results: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03).Conclusions: Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies.Clinical Trial Registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212. [ABSTRACT FROM AUTHOR]

Background: In response to urban-rural disparities in healthcare resources, China recently launched a healthcare reform with a focus on improving rural care during the past decade. However, nationally representative studies comparing medical care and patient outcomes between urban and rural areas in China during this period are not available.Methods and Results: We created a nationally representative sample of patients in China admitted for ST-segment-elevation myocardial infarction in 2001, 2006, and 2011, using a 2-stage random sampling design in 2 urban and 3 rural strata. In China, evidence-based treatments were provided less often in 2001 in rural hospitals, which had lower volume and less availability of advanced cardiac facilities. However, these differences diminished by 2011 for reperfusion therapy (54% in urban versus 57% in rural; P=0.1) and reversed for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (66% versus 68%; P=0.04) and early β-blockers (56% versus 60%; P=0.01). The risk-adjusted rate of in-hospital death or withdrawal from treatment was not significantly different between urban and rural hospitals in any study year, with an adjusted odds ratio of 1.13 (0.77-1.65) in 2001, 0.99 (0.77-1.27) in 2006, and 0.94 (0.74-1.19) in 2011.Conclusions: Although urban-rural disparities in evidence-based treatment for myocardial infarction in China have largely been eliminated, substantial gaps in quality of care persist in both settings. In addition, urban hospitals providing more resource-intensive care did not achieve better outcomes.Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01624883. [ABSTRACT FROM AUTHOR]

Background: Following treatment for acute decompensated heart failure, in-hospital observation on oral diuretics (OOD) is recommended, assuming it provides actionable information on discharge diuretic dosing and thus reduces readmissions. Methods: In the Mechanisms of Diuretic Resistance (MDR) cohort, we analyzed in-hospital measures of diuretic response, provider's decisions, and diuretic response ≈30 days postdischarge. In a Yale multicenter cohort, we assessed if in-hospital OOD was associated with 30-day readmission risk. The main objective of this study was to evaluate the utility of in-hospital OOD. Results: Of the 468 patients in the MDR cohort, 57% (N=265) underwent in-hospital OOD. During the OOD, weight change and net fluid balance correlated poorly with each other (r =0.36). Discharge diuretic dosing was similar between patients who had increased, stable, or decreased weight (decreased discharge dose from OOD dose in 77% versus 72% versus 70%, respectively), net fluid status (decreased discharge dose from OOD dose in 100% versus 69% versus 74%, respectively), and urine output (decreased discharge dose from OOD dose in 69% versus 79% versus 72%, respectively) during the 24-hour OOD period (P >0.27 for all). In participants returning at 30 days for formal quantification of outpatient diuretic response (n=98), outpatient and inpatient OOD natriuresis was poorly correlated (r =0.26). In the Yale multicenter cohort (n=18 454 hospitalizations), OOD occurred in 55% and was not associated with 30-day hospital readmission (hazard ratio, 0.98 [95% CI, 0.93–1.05]; P =0.51). Conclusions: In-hospital OOD did not provide actionable information on diuretic response, was not associated with outpatient dose selection, did not predict subsequent outpatient diuretic response, and was not associated with lower readmission rate. Additional research is needed to replicate these findings and understand if these resources could be better allocated elsewhere. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02546583. [ABSTRACT FROM AUTHOR]

Background: Visit-to-visit variability (VVV) in blood pressure values has been reported in clinical studies. However, little is known about VVV in clinical practice and whether it is associated with patient characteristics in real-world setting. Methods: We conducted a retrospective cohort study to quantify VVV in systolic blood pressure (SBP) values in a real-world setting. We included adults (age ≥18 years) with at least 2 outpatient visits between January 1, 2014 and October 31, 2018 from Yale New Haven Health System. Patient-level measures of VVV included SD and coefficient of variation of a given patient's SBP across visits. We calculated patient-level VVV overall and by patient subgroups. We further developed a multilevel regression model to assess the extent to which VVV in SBP was explained by patient characteristics. Results: The study population included 537 218 adults, with a total of 7 721 864 SBP measurements. The mean age was 53.4 (SD 19.0) years, 60.4% were women, 69.4% were non-Hispanic White, and 18.1% were on antihypertensive medications. Patients had a mean body mass index of 28.4 (5.9) kg/m2 and 22.6%, 8.0%, 9.7%, and 5.6% had a history of hypertension, diabetes, hyperlipidemia, and coronary artery disease, respectively. The mean number of visits per patient was 13.3, over an average period of 2.4 years. The mean (SD) intraindividual SD and coefficient of variation of SBP across visits were 10.6 (5.1) mm Hg and 0.08 (0.04). These measures of blood pressure variation were consistent across patient subgroups defined by demographic characteristics and medical history. In the multivariable linear regression model, only 4% of the variance in absolute standardized difference was attributable to patient characteristics. Conclusions: The VVV in real-world practice poses challenges for management of patients with hypertension based on blood pressure readings in outpatient settings and suggest the need to go beyond episodic clinic evaluation. [ABSTRACT FROM AUTHOR]

The Centers for Cardiovascular Outcomes Research (CCORs) held a meeting to review how cardiovascular outcomes research had evolved in the decade since the National Heart, Lung, and Blood Institute 2004 working group report and to consider future directions. The conference involved representatives from governmental agencies, outcomes research thought leaders, and public and private healthcare partners. The main purposes of this meeting were to (1) advance collaborative high-yield, high-impact outcomes research; (2) identify priorities and barriers to important cardiovascular outcomes research; and (3) define future needs for the field. This report highlights the key topics covered during the meeting, including an examination of the recent history of outcomes research, an evaluation of the current academic climate, and a vision for the future of cardiovascular outcomes research. [ABSTRACT FROM AUTHOR]

Randomized trials of hypertension have seldom examined heterogeneity in response to treatments over time and the implications for cardiovascular outcomes. Understanding this heterogeneity, however, is a necessary step toward personalizing antihypertensive therapy. We applied trajectory-based modeling to data on 39 763 study participants of the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) to identify distinct patterns of systolic blood pressure (SBP) response to randomized medications during the first 6 months of the trial. Two trajectory patterns were identified: immediate responders (85.5%), on average, had a decreasing SBP, whereas nonimmediate responders (14.5%), on average, had an initially increasing SBP followed by a decrease. Compared with those randomized to chlorthalidone, participants randomized to amlodipine (odds ratio, 1.20; 95% confidence interval [CI], 1.10-1.31), lisinopril (odds ratio, 1.88; 95% CI, 1.73-2.03), and doxazosin (odds ratio, 1.65; 95% CI, 1.52-1.78) had higher adjusted odds ratios associated with being a nonimmediate responder (versus immediate responder). After multivariable adjustment, nonimmediate responders had a higher hazard ratio of stroke (hazard ratio, 1.49; 95% CI, 1.21-1.84), combined cardiovascular disease (hazard ratio, 1.21; 95% CI, 1.11-1.31), and heart failure (hazard ratio, 1.48; 95% CI, 1.24-1.78) during follow-up between 6 months and 2 years. The SBP response trajectories provided superior discrimination for predicting downstream adverse cardiovascular events than classification based on difference in SBP between the first 2 measurements, SBP at 6 months, and average SBP during the first 6 months. Our findings demonstrate heterogeneity in response to antihypertensive therapies and show that chlorthalidone is associated with more favorable initial response than the other medications. [ABSTRACT FROM AUTHOR]

Background: Coronary artery disease is prevalent in China, with concomitant increases in the volume of coronary artery bypass grafting (CABG). The present study aims to compare CABG-related outcomes between China and the United States among large teaching and urban hospitals.Methods and Results: Observational analysis of patients aged ≥18 years, discharged from acute-care, large teaching and urban hospitals in China and the United States after hospitalization for an isolated CABG surgery. Data were obtained from the Chinese Cardiac Surgery Registry in China and the National Inpatient Sample in the United States. Analysis was stratified by 2 periods: 2007, 2008, and 2010; and 2011 to 2013 periods. The primary outcome was in-hospital mortality, and the secondary outcome was length of stay. The sample included 51 408 patients: 32 040 from 77 hospitals in the China-CABG group and 19 368 from 303 hospitals in the US-CABG group. In the 2007 to 2008, 2010 period and for all-age and aged ≥65 years, the China-CABG group had higher mortality than the US-CABG group (1.91% versus 1.58%, P=0.059; and 3.12% versus 2.20%, P=0.004) and significantly higher age-, sex-, and comorbidity-adjusted odds of death (odds ratio, 1.58; 95% confidential interval, 1.22-2.04; and odds ratio, 1.73; 95% confidential interval, 1.24-2.40). There were no significant mortality differences in the 2011 to 2013 period. For preoperative, postoperative, and total hospital stay, respectively, the median (interquartile range) length of stay across the entire study period between China-CABG and US-CABG groups were 9 (8) versus 1 (3), 9 (6) versus 6 (3), and 20 (12) versus 7 (5) days (all P<0.001). This difference did not change significantly over time.Conclusions: In 2011 to 2013, there was no significant difference in in-hospital mortality among patients who underwent an isolated CABG surgery in large teaching and urban hospitals in China and the United States. The longer length of stay in China may represent an opportunity for improvement. [ABSTRACT FROM AUTHOR]

Background: Women have an increased risk of rehospitalization in the immediate postdischarge period; however, few studies have determined how readmission risk dynamically changes on a day-to-day basis over the full year after hospitalization by sex and how these differences compare with the risk for mortality.Methods and Results: We identified >3 000 000 hospitalizations of patients with a principal discharge diagnosis of heart failure, acute myocardial infarction, or pneumonia and estimated sex differences in the daily risk of rehospitalization/death 1 year after discharge from a population of Medicare fee-for-service beneficiaries aged 65 years and older. We calculated the (1) time required for adjusted rehospitalization/mortality risks to decline 50% from maximum values after discharge, (2) time required for the adjusted readmission risk to approach plateau periods of minimal day-to-day change, and (3) extent to which adjusted risks are greater among recently hospitalized patients versus Medicare patients. We identified 1 392 289, 530 771, and 1 125 231 hospitalizations for heart failure, acute myocardial infarction, and pneumonia, respectively. The adjusted daily risk of rehospitalization varied by admitting condition (hazard rate ratio for women versus men, 1.10 for acute myocardial infarction; hazard rate ratio, 1.04 for heart failure; and hazard rate ratio, 0.98 for pneumonia). However, for all conditions, the adjusted daily risk of death was higher among men versus women (hazard rate ratio women versus with men, <1). For both sexes, there was a similar timing of peak daily risk, half daily risk, and reaching plateau.Conclusions: Although the association of sex with daily risk of rehospitalization varies across conditions, women are at highest risk after discharge for acute myocardial infarction. Future studies should focus on understanding the determinants of sex differences in rehospitalization risk among conditions. [ABSTRACT FROM AUTHOR]

Background: Consumer-reported patient-provider communication (PPC) assessed by Consumer Assessment of Health Plans Survey in ambulatory settings is incorporated as a complementary value metric for patient-centered care of chronic conditions in pay-for-performance programs. In this study, we examine the relationship of PPC with select indicators of patient-centered care in a nationally representative US adult population with established atherosclerotic cardiovascular disease.Methods and Results: The study population consisted of a nationally representative sample of 6810 individuals (aged ≥18 years), representing 18.3 million adults with established atherosclerotic cardiovascular disease (self-reported or International Classification of Diseases, Ninth Edition diagnosis) reporting a usual source of care in the 2010 to 2013 pooled Medical Expenditure Panel Survey cohort. Participants responded to questions from Consumer Assessment of Health Plans Survey that assessed PPC, and we developed a weighted PPC composite score using their responses, categorized as 1 (poor), 2 (average), and 3 (optimal). Outcomes of interest were (1) patient-reported outcomes: 12-item Short Form physical/mental health status, (2) quality of care measures: statin and ASA use, (3) healthcare resource utilization: emergency room visits and hospital stays, and (4) total annual and out-of-pocket healthcare expenditures. Atherosclerotic cardiovascular disease patients reporting poor versus optimal were over 2-fold more likely to report poor outcomes; 52% and 26% more likely to report that they are not on statin and aspirin, respectively, had a significantly greater utilization of health resources (odds ratio≥2 emergency room visit, 1.41 [95% confidence interval, 1.09-1.81]; odds ratio≥2 hospitalization, 1.36 [95% confidence interval, 1.04-1.79]), as well as an estimated $1243 ($127-$2359) higher annual healthcare expenditure.Conclusions: This study reveals a strong relationship between PPC and patient-reported outcomes, utilization of evidence-based therapies, healthcare resource utilization, and expenditures among those with established atherosclerotic cardiovascular disease. [ABSTRACT FROM AUTHOR]

In recent years, there has been growing public awareness and increasing attention to young women with acute myocardial infarction (AMI), who represent an extreme phenotype. Young women presenting with AMI may develop coronary disease by different mechanisms and often have worse recoveries, with higher risk for morbidity and mortality compared with similarly aged men. The purpose of this cardiovascular perspective piece is to review recent studies of AMI in young women. More specifically, we emphasize differences in the epidemiology, diagnosis, and management of AMI in young women (when compared with men) across the continuum of care, including their pre-AMI, in-hospital, and post-AMI periods, and highlight gaps in knowledge and outcomes that can inform the next generation of research. [ABSTRACT FROM AUTHOR]

Background: Young women (≤55 years of age) with acute myocardial infarction (AMI) have higher mortality risk than similarly aged men. Elevated inflammatory markers are associated with an increased risk of cardiovascular outcomes after AMI, but little is known about whether young women have higher inflammatory levels after AMI compared with young men.Methods and Results: We assessed sex differences in post-AMI inflammatory markers and whether such differences account for sex differences in 12-month health status, using data from 2219 adults with AMI, 18 to 55 years of age, in the United States. Inflammatory markers including high-sensitivity C-reactive protein (hsCRP) and lipoprotein-associated phospholipase A2 were measured 1 month after AMI. Overall, women had higher levels of hsCRP and lipoprotein-associated phospholipase A2 after AMI compared with men, and this remained statistically significant after multivariable adjustment. Regression analyses showed that elevated 1-month hsCRP was associated with poor health status (symptom, function, and quality of life) at 12 months. However, the association between hsCRP and health status became nonsignificant after adjustment for sociodemographics, comorbidities, and treatment factors. Half of these patients had residual inflammatory risk (hsCRP >3 mg/L) compared with a third who had residual cholesterol risk (Low-density lipoprotein cholesterol >100 mg/dL).Conclusions: Young women with AMI had higher inflammatory levels compared with young men. Elevated 1-month hsCRP was associated with poor health status at 12 months after AMI, but this was attenuated after adjustment for patient characteristics. Targeted anti-inflammatory treatments are worthy of consideration for secondary prevention in these patients if ongoing trials of anti-inflammatory therapy prove effective. [ABSTRACT FROM AUTHOR]

Background: The digital transformation of medical data presents opportunities for novel approaches to manage patients with persistent hypertension. We sought to develop an actionable taxonomy of patients with persistent hypertension (defined as 5 or more consecutive measurements of blood pressure ≥160/100 mmHg over time) based on data from the electronic health records. Methods: This qualitative study was a content analysis of clinician notes in the electronic health records of patients in the Yale New Haven Health System. Eligible patients were 18 to 85 years and had blood pressure ≥160/100 mmHg at 5 or more consecutive outpatient visits between January 1, 2013 and October 31, 2018. A total of 1664 patients met criteria, of which 200 records were randomly selected for chart review. Through a systematic, inductive approach, we developed a rubric to abstract data from the electronic health records and then analyzed the abstracted data qualitatively using conventional content analysis until saturation was reached. Results: We reached saturation with 115 patients, who had a mean age of 66.0 (SD, 11.6) years; 54.8% were female; 52.2%, 30.4%, and 13.9% were White, Black, and Hispanic patients. We identified 3 content domains related to persistence of hypertension: (1) non-intensification of pharmacological treatment, defined as absence of antihypertensive treatment intensification in response to persistent severely elevated blood pressure; (2) non-implementation of prescribed treatment, defined as a documentation of provider recommending a specified treatment plan to address hypertension but treatment plan not being implemented; and (3) non-response to prescribed treatment, defined as clinician-acknowledged persistent hypertension despite documented effort to escalate existing pharmacologic agents and addition of additional pharmacologic agents with presumption of adherence. Conclusions: This study presents a novel actionable taxonomy for classifying patients with persistent hypertension by their contributing causes based on electronic health record data. These categories can be automated and linked to specific types of actions to address them. [ABSTRACT FROM AUTHOR]

Background: The current ability to predict readmissions in patients with heart failure is modest at best. It is unclear whether machine learning techniques that address higher dimensional, nonlinear relationships among variables would enhance prediction. We sought to compare the effectiveness of several machine learning algorithms for predicting readmissions.Methods and Results: Using data from the Telemonitoring to Improve Heart Failure Outcomes trial, we compared the effectiveness of random forests, boosting, random forests combined hierarchically with support vector machines or logistic regression (LR), and Poisson regression against traditional LR to predict 30- and 180-day all-cause readmissions and readmissions because of heart failure. We randomly selected 50% of patients for a derivation set, and a validation set comprised the remaining patients, validated using 100 bootstrapped iterations. We compared C statistics for discrimination and distributions of observed outcomes in risk deciles for predictive range. In 30-day all-cause readmission prediction, the best performing machine learning model, random forests, provided a 17.8% improvement over LR (mean C statistics, 0.628 and 0.533, respectively). For readmissions because of heart failure, boosting improved the C statistic by 24.9% over LR (mean C statistic 0.678 and 0.543, respectively). For 30-day all-cause readmission, the observed readmission rates in the lowest and highest deciles of predicted risk with random forests (7.8% and 26.2%, respectively) showed a much wider separation than LR (14.2% and 16.4%, respectively).Conclusions: Machine learning methods improved the prediction of readmission after hospitalization for heart failure compared with LR and provided the greatest predictive range in observed readmission rates. [ABSTRACT FROM AUTHOR]

Background: Evidence from large randomized clinical trials supports the benefit of SGLT2i (sodium-glucose cotransporter-2 inhibitors) to improve cardiovascular and kidney outcomes in patients with type 2 diabetes with or at high risk for atherosclerotic cardiovascular disease or chronic kidney disease. Considering this evidence, which has been expanding since the product label indication for empagliflozin to reduce risk of cardiovascular death in 2016, clinician-level variation in the prescription of SGLT2i among US Medicare beneficiaries was evaluated.Methods: Antihyperglycemic medication prescribers were identified as those physicians and advanced practice providers prescribing metformin in Medicare part D prescriber data. In this cross-sectional study, the proportion prescribing SGLT2i was assessed overall and across specialties in 2018, with changes assessed from 2014 to 2018. SGLT2i use was compared with other second-line antihyperglycemic medication classes, sulfonylureas and DPP4is (dipeptidyl peptidase-4 inhibitors).Results: Among 232 523 unique clinicians who prescribed metformin for Medicare beneficiaries in 2018 (diabetes-treating clinicians), 45 255 (19.5%) prescribed SGLT2i. There was substantial variation across specialties-from 72% of endocrinologists to 14% of cardiologists who prescribed metformin also prescribed SGLT2i. Between 2014 and 2018, the number prescribing SGLT2i increased 5-fold from 9048 in 2014 to 45 255 in 2018. Among clinicians who prescribed both sulfonylureas and SGLT2i in 2018, SGLT2i was prescribed to a median 33 beneficiaries for every 100 prescribed sulfonylureas (interquartile range, 18-67). SGLT2i use relative to sulfonylureas increased from 19 (interquartile range, 11-34) per 100 in 2014 to 33 (interquartile range, 18-67) per 100 in 2018 (Ptrend<0.001).Conclusions: Eighty percent of clinicians prescribing metformin to Medicare beneficiaries did not prescribe SGLT2i in 2018. Moreover, sulfonylureas prescriptions were 3 times more frequent than those of SGLT2is, although a pattern of increasing uptake may portend future trends. These findings highlight a baseline opportunity to improve care and outcomes for patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background--Return to work after acute myocardial infarction (AMI) is an important outcome and is particularly relevant to young patients. Women may be at a greater risk for not returning to work given evidence of their worse recovery after AMI than similarly aged men. However, sex differences in return to work after AMI has not been studied extensively in a young population (≤55 years). Methods and Results--We analyzed data from 1680 patients with AMI aged 18 to 55 years (57% women) participating in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study who were working full time (≥35 hours) before the event. Data were obtained by medical record abstraction and patient interviews. We conducted multivariable regression analyses to examine sex differences in return to work at 12 months after AMI, and the association of patient characteristics with return to work. When compared with young men, young women were less likely to return to work (89% versus 85%; 85% versus 89%, P=0.02); however, this sex difference was not significant after adjusting for patient sociodemographic characteristics, psychosocial factors, and health measures. Being married, engaging in a professional or clerical type of work, having more favorable physical health, and having no previous coronary disease or hypertension were significantly associated with a higher likelihood of return to work at 12 months. Conclusions--Among a young population, women are less likely to return to work after AMI than men. This disadvantage is explained by differences in demographic, occupational, and health characteristics. [ABSTRACT FROM AUTHOR]

Background: Although an in-hospital cardiac arrest is common, little is known about readmission patterns and an inpatient resource use among survivors of an in-hospital cardiac arrest.Methods and Results: Within a large national registry, we examined long-term inpatient use among 6972 adults aged ≥65 years who survived an in-hospital cardiac arrest. We examined 30-day and 1-year readmission rates and inpatient costs, overall and by patient demographics, hospital disposition (discharge destination), and neurological status at discharge. The mean age was 75.8±7.0 years, 56% were men, and 12% were black. There were a total of 2005 readmissions during the first 30 days (cumulative incidence rate, 35 readmissions/100 patients; 95% confidence interval, 33-37) and 8751 readmissions at 1 year (cumulative incidence rate, 185 readmissions/100 patients; 95% confidence interval, 177-190). Overall, mean inpatient costs were $7741±$2323 at 30 days and $18 629±$9411 at 1 year. Thirty-day inpatient costs were higher in patients of younger age (≥85 years, $6052 [reference]; 75-84 years, $7444 [adjusted cost ratio, 1.23; 1.06-1.42; 65-74 years, $8291 [adjusted cost ratio, 1.37; 1.19-1.59; both P<0.001) and black race (whites, $7413; blacks, $9044; adjusted cost ratio, 1.22; 1.05-1.42; P<0.001), as well as those discharged with severe neurological disability or to skilled nursing or rehabilitation facilities. These differences in resource use persisted at 1 year and were largely because of higher readmission rates.Conclusions: Survivors of an in-hospital cardiac arrest have frequent readmissions and high follow-up inpatient costs. Readmissions and inpatient costs were higher in certain subgroups, including patients of younger age and black race. [ABSTRACT FROM AUTHOR]

Background: The epidemiology of aortic dissection (AD) has not been well described among older persons in the United States. It is not known whether advancements in AD care over the last decade have been accompanied by changes in outcomes.Methods and Results: The Inpatient Medicare data from 2000 to 2011 were used to determine trends in hospitalization rates for AD. Mortality rates were ascertained through corresponding vital status files. A total of 32 057 initial AD hospitalizations were identified. The overall hospitalization rate for AD remained unchanged at 10 per 100 000 person-years. For 30-day and 1-year mortality associated with AD, the observed rate decreased from 31.8% to 25.4% (difference, 6.4%; 95% confidence interval [CI], 6.2-6.5; adjusted, 6.4%; 95% CI, 5.7-6.9) and from 42.6% to 37.4% (difference, 5.2%; 95% CI, 5.1-5.2; adjusted, 6.2%; 95% CI, 5.3-6.7), respectively. For patients undergoing surgical repair for type A dissections, the observed 30-day mortality decreased from 30.7% to 21.4% (difference, 9.3%; 95% CI, 8.3-10.2; adjusted, 7.3%; 95% CI, 5.8-7.8) and the observed 1-year mortality decreased from 39.9% to 31.6% (difference, 8.3%; 95% CI, 7.5-9.1%; adjusted, 8.2%; 95% CI, 6.7-9.1). The 30-day mortality decreased from 24.9% to 21% (difference, 3.9%; 95% CI, 3.5-4.2; adjusted, 2.9%; 95% CI, 0.7-4.4) and 1-year decreased from 36.4% to 32.5% (difference, 3.9%; 95% CI, 3.3-4.3; adjusted, 3.9%; 95% CI, 2.5-6.3) for surgical repair of type B dissection.Conclusions: Although AD hospitalization rates remained stable, improvement in mortality was noted, particularly in patients undergoing surgical repair. [ABSTRACT FROM AUTHOR]

Background: Sex differences in clinical characteristics and in-hospital outcomes among patients with non-ST-segment-elevation myocardial infarction have been described in Western countries, but whether these differences exist in China is unknown.Methods: We used a 2-stage random sampling design to create a nationally representative sample of patients admitted to 151 Chinese hospitals for non-ST-segment-elevation myocardial infarction in 2006, 2011, and 2015 and examined sex differences in clinical profiles, treatments, and in-hospital outcomes over this time. Multivariable logistic regression models adjusting for age or other potentially confounding clinical covariates were used to estimate these sex-specific differences.Results: Among 4611 patients, the proportion of women (39.8%) was unchanged between 2006 and 2015. Women were older with higher rates of hypertension, diabetes, and dyslipidemia. Among patients without contraindications, women were less likely to receive treatments than men, with significant differences for aspirin in 2015 (90.3% versus 93.9%) and for invasive strategy in 2011 (28.7% versus 45.7%) and 2015 (34.0% versus 48.4%). After adjusting for age, such differences in aspirin and invasive strategy in 2015 were not significant, but the difference in invasive strategy in 2011 persisted. The sex gaps in the use of invasive strategy did not narrow. From 2006 to 2015, a significant decrease in in-hospital mortality was observed in men (from 16.9% to 8.7%), but not in women (from 11.8% to 12.0%), with significant interaction between sex and study year (P=0.023). After adjustment, in-hospital mortality in women was significantly lower than men in 2006, but not in 2011 or 2015.Conclusions: Sex differences in cardiovascular risk factors and invasive strategy after non-ST-segment-elevation myocardial infarction were observed between 2011 and 2015 in China. Although sex gaps in in-hospital mortality were largely explained by age differences, efforts to narrow sex-related disparities in quality of care should remain a focus.Registration: URL: http://www.Clinicaltrials: gov; Unique identifier: NCT01624883. [ABSTRACT FROM AUTHOR]