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The last half century has seen extraordinary advances in the field of cardiology, including innovations in medications, diagnostic modalities, and therapeutics. Even so, cardiovascular disease remains the leading cause of morbidity and mortality globally, with suboptimal quality of care, inconsistent health outcomes, and unsustainable costs. It is clear that cardiovascular medicine must undergo a digital transformation to enhance the delivery of quality care and to improve outcomes. To meet this need, the American College of Cardiology developed an innovation program focused on the digital transformation of cardiovascular care, with the goal of improving heart health for individuals and populations. [ABSTRACT FROM AUTHOR]

The article focuses on the application of wearable digital health technologies in cardiovascular medicine, presenting a clinical vignette illustrating remote monitoring in the care of a patient with cardiovascular disease. Topics include the utilization of a remote patient monitoring program, the role of wearable devices in managing hypertension and atrial fibrillation, and the potential benefits of continuous monitoring for disease progression and treatment adjustments.

The article presents a scientific statement from the American Heart Association (AHA) on the use of mobile devices, social media, and crowdsourcing as digital strategies to enhance emergency cardiovascular care. It says that cardiac arrest, acute myocardial infarction (AMI), and stroke impact millions of people in the U.S. yearly.

The potential for big data analytics to improve cardiovascular quality of care and patient outcomes is tremendous. However, the application of big data in health care is at a nascent stage, and the evidence to date demonstrating that big data analytics will improve care and outcomes is scant. This Review provides an overview of the data sources and methods that comprise big data analytics, and describes eight areas of application of big data analytics to improve cardiovascular care, including predictive modelling for risk and resource use, population management, drug and medical device safety surveillance, disease and treatment heterogeneity, precision medicine and clinical decision support, quality of care and performance measurement, and public health and research applications. We also delineate the important challenges for big data applications in cardiovascular care, including the need for evidence of effectiveness and safety, the methodological issues such as data quality and validation, and the critical importance of clinical integration and proof of clinical utility. If big data analytics are shown to improve quality of care and patient outcomes, and can be successfully implemented in cardiovascular practice, big data will fulfil its potential as an important component of a learning health-care system. [ABSTRACT FROM AUTHOR]

The article reports on the statement of the American Heart Association (AHA) concerning cardiovascular health promotion and disease reduction. It highlights the goal that focuses on outcomes that people notices and cares about such as survival, symptoms, and the health related quality of life. It reinforces the importance of assessing the impact of diseases and the medical treatment among patient's according to function and the quality of life.

The authors reflect on updated heart failure guidelines from the British National Institute for Health and Clinical Excellence (NICE). They state that some of the recommendations, such as the cost effectiveness of serial natriuretic peptide monitoring and the use of implantable cardiovascular defibrillators for primary prevention, may fuel debate. They also mention that the NICE guidelines deserve credit for their focus on patient value, engagement, and implementation.

Background: A lower proportion of patients with chronic heart failure receive palliative care compared to patients with advanced cancer.Objective: We examined the relative need for palliative care in the two conditions by comparing symptom burden, psychological well-being, and spiritual well-being in heart failure and cancer patients.Design: This was a cross-sectional study.Participants: Sixty outpatients with symptomatic heart failure and 30 outpatients with advanced lung or pancreatic cancer.Measurements: Symptom burden (Memorial Symptom Assessment Scale-Short Form), depression symptoms (Geriatric Depression Scale-Short Form), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale).Main Results: Overall, the heart failure patients and the cancer patients had similar numbers of physical symptoms (9.1 vs. 8.6, p = 0.79), depression scores (3.9 vs. 3.2, p = 0.53), and spiritual well-being (35.9 vs. 39.0, p = 0.31) after adjustment for age, gender, marital status, education, and income. Symptom burden, depression symptoms, and spiritual well-being were also similar among heart failure patients with ejection fraction < or =30, ejection fraction >30, and cancer patients. Heart failure patients with worse heart failure-related health status had a greater number of physical symptoms (13.2 vs. 8.6, p = 0.03), higher depression scores (6.7 vs. 3.2, p = 0.001), and lower spiritual well-being (29.0 vs. 38.9, p < 0.01) than patients with advanced cancer.Conclusions: Patients with symptomatic heart failure and advanced cancer have similar needs for palliative care as assessed by symptom burden, depression, and spiritual well-being. This implies that heart failure patients, particularly those with more severe heart failure, need the option of palliative care just as cancer patients do. [ABSTRACT FROM AUTHOR]

The editorialists reply to letters written in response to the article "Effect of PCI on Quality of Life in Patients with Stable Coronary Disease," published in the August 14, 2008 issue, by W.S. Weintraub, J.A. Spertus, P. Kolm, et al.

Objective--In myocardial infarction (MI), we studied whether documentation of ischemic symptoms is associated with quality of care and outcomes, and compared patient reports of ischaemic symptoms during interviews with chart documentation Design--Observational acute myocardial infarction study from 2003-2004 (Prospective Registry Evaluating Myocardial Infarction: Event and Recovery) Setting--19 diverse US hospitals Patients--2,094 consecutive MI patients (10,911 patients screened; 3,953 patients were eligible and enrolled) with both positive cardiac enzymes and other evidence of infarction (e.g., symptoms, electrocardiographic changes). Transferred patients and those with confounding noncardiac comorbidity were not included (n=1859). Main outcome measures--Quality of care indicators and adjusted in-hospital survival Results--The records of 10% of all MI patients (217/2094) contained no documented ischaemic symptoms at presentation. Patients without documented symptoms were less likely (p<0.05) to: receive aspirin (89% vs. 96%) or beta-blockers (77% vs. 90%) within 24hr, reperfusion therapy for STEMI (7% vs. 58%) or to survive their hospitalization (adjusted OR=3.2, 95% CI 1.8–5.8). Survivors without documented symptoms were also less likely (p<0.05) to be discharged with aspirin (87% vs. 93%), beta-blockers (81% vs. 91%), ACE/ARB (67% vs. 80%), or smoking cessation counseling (46% vs. 66%). In the subset of 1,356 (65%) interviewed patients, most of those without documented ischaemic symptoms (75%) reported presenting symptoms consistent with ischaemia. Conclusions--Failure to document patients’ presenting MI symptoms is associated with poorer quality of care from admission to discharge, and higher in-hospital mortality. Symptom recognition may represent an important opportunity to improve the quality of MI care. [ABSTRACT FROM AUTHOR]

The article presents a study which evaluates the relationship between clinical outcomes and nonadherence to medications in large community cohort of subjects with diabetes. The researchers have evaluated the association between medication nonadherence and adverse outcomes among subject with diabetes. The results showed that among the cohort of subjects with diabetes, 13.0% required both insulin and oral hypoglycemic agents, 57.9% required hypoglycemic agents only, and 97% required insulin only.

The article cites a study that evaluates the prognostic importance of transient, new or persistent depression on outcomes at 6 months after myocardial infarction (MI). The study found that the depressive symptoms following MI are closely associated with poor prognosis. The findings suggest that the depressive symptoms after MI are associated with the outcome of re-hospitalization or mortality and patient health status, which suggests that early screening of depressive symptoms is important.

The article evaluates the association between medication nonadherence and clinical outcomes with diabetes mellitus. Medication noncompliance is prevalent among patients with diabetes mellitus and is linked with negative outcomes. Interventions are required to increase medication adherence so that patients can realize the full benefit of prescribed therapies.

Abstract: Purpose: An analysis of reginal variation across the United States in the treatment and outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) has not been previously performed. Subjects and Methods: We assessed contemporary practice and outcomes in 56,466 high-risk patients with NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes) admitted to 310 hospitals across four defined regions in the United States from January 1, 2001, to September 30, 2003. Patient clinical characteristics, acute (<24 hours) and discharge medications, in-hospital procedures, and in-hospital case-fatality rates were evaluated. Results: Statistically significant but clinically small differences in baseline characteristics including age, gender, rates of diabetes, hypertension, and smoking, as well as medical treatment, including a greater than 5% variation in acute use of beta-blockers, clopidogrel, and statins use, were noted across regions. Adjusted rates of revascularization were similar across regions. Overall in-hospital case-fatality rate was 4.1%, with the highest rates in the Midwest (4.6%) and the lowest in the Northeast (3.5%). Adjusted odds ratios (OR) (95% confidence interval [CI] for death were significantly higher in the Midwest (OR 1.42, CI 1.19-1.70), West (OR 1.40 CI 1.05-1.87), and South (OR 1.33, CI 1.08-1.62), compared with the Northeast. Conclusions: Management of high-risk patients with NSTE ACS is relatively uniform across the United States. However, in-hospital case-fatality rates vary significantly by region, and the differences are not explained by adjustment for standard clinical variables. [Copyright &y& Elsevier]

To examine the association between depressive symptoms and exercise capacity, we performed a cross-sectional study of 944 outpatients with stable coronary artery disease and found that the presence of depressive symptoms was independently associated with poor exercise capacity (<5 MET tasks achieved; adjusted odds ratio 1.8, 95% confidence interval 1.1 to 2.7, p = 0.01). Depressive symptoms should be considered in the differential diagnosis of poor exercise capacity. [Copyright &y& Elsevier]

: ObjectivesThe purpose of this study was to assess whether depressive symptoms are independently associated with changes in heart failure (HF)-specific health status.: BackgroundDepression is common in patients with HF, but the impact of depressive symptoms on the health status of these patients over time is unknown.: MethodsWe conducted a multicenter prospective cohort study of outpatients with HF. Data from 460 patients who completed a baseline Medical Outcomes Study-Depression Questionnaire and both a baseline and follow-up (6 ± 2 weeks) Kansas City Cardiomyopathy Questionnaire (KCCQ) were analyzed. The KCCQ measures HF-specific health status, including symptoms, physical and social function, and quality of life. Multivariable regression was used to evaluate depressive symptoms as a predictor of change in KCCQ scores, adjusting for baseline KCCQ scores and other patient variables. The primary outcome was change in KCCQ summary scores (range 0 to 100; higher scores indicate better health status; 5 points is a clinically meaningful change).: ResultsApproximately 30% (139/460) of the patients had significant depressive symptoms at baseline. Depressed patients had markedly lower baseline KCCQ summary scores (β = −19.6; p < 0.001). After adjustment for potential confounders, depressed patients were at risk for significant worsening of their HF symptoms, physical and social function, and quality of life (average change in KCCQ summary score = −7.1 points; p < 0.001). Depressive symptoms were the strongest predictor of decline in health status in the multivariable models.: ConclusionsDepressive symptoms are a strong predictor of short-term worsening of HF-specific health status. The recognition and treatment of depression may be an important component of HF care. [Copyright &y& Elsevier]

: ObjectivesWe compared six-month health-related quality of life (HRQL) for high-risk patients with medically refractory ischemia randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery.: BackgroundMortality rates after PCI and CABG surgery are similar. Therefore, differences in HRQL outcomes may help in the selection of a revascularization procedure.: MethodsPatients were enrolled in a Veterans Affairs multicenter randomized trial comparing PCI versus CABG for patients with medically refractory ischemia and one or more risk factors for adverse outcome; 389 of 423 patients (92%) alive six months after randomization completed an Short Form-36 (SF-36) health status survey. Primary outcomes were the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36. Multivariable analyses were used to evaluate whether PCI or CABG surgery was associated with better PCS or MCS scores after adjusting for over 20 baseline variables.: ResultsThere were no significant differences in either PCS scores (38.7 vs. 37.3 for PCI and CABG, respectively; p = 0.23) or MCS scores (45.5 vs. 46.1, p = 0.58) between the treatment arms. In multivariable models, there remained no difference in HRQL for post-PCI versus post-CABG patients (for PCS, absolute difference = 0.56 ± standard error of 1.14, p = 0.63; for MCS, absolute difference = −1.23 ± 1.12, p = 0.27). We had 97% power to detect a four-point difference in scores, where four to seven points is a clinically important difference.: ConclusionsHigh-risk patients with medically refractory ischemia randomized to PCI versus CABG surgery have equivalent six-month HRQL. Therefore, HRQL concerns should not drive decision-making regarding selection of a revascularization procedure for these patients. [Copyright &y& Elsevier]

: ObjectivesWe evaluated the effect of African American (AA) and Hispanic American (HA) ethnicity on mortality and complications following coronary artery bypass graft (CABG) surgery in the Veterans Health Administration (VHA).: BackgroundFew studies have examined the impact of ethnicity on outcomes following cardiovascular procedures.: MethodsThis study included all 29,333 Caucasian, 2,570 AA, and 1,525 HA patients who underwent CABG surgery at any one of the 43 VHA cardiac surgery centers from January 1995 through March 2001. We evaluated the relationship between ethnicity (AA vs. Caucasian and HA vs. Caucasian) and 30-day mortality, 6-month mortality, and 30-day complications, adjusting for a wide array of demographic, cardiac, and noncardiac variables.: ResultsAfter adjustment for baseline characteristics, AA and Caucasian patients had similar 30-day (AA/Caucasian odds ratio [OR] 1.07; 95% confidence interval [CI] 0.84 to 1.35; p = 0.59) and 6-month mortality risk (AA/Caucasian OR 1.10; 95% CI 0.91 to 1.34; p = 0.31). However, among patients with low surgical risk, AA ethnicity was associated with higher mortality (OR 1.52, CI 1.10 to 2.11, p = 0.01), and AA patients were more likely to experience complications following surgery (OR 1.28; 95% CI 1.14 to 1.45; p < 0.01). In contrast, HA patients had lower 30-day (HA/Caucasian OR 0.70; 95% CI 0.49 to 0.98; p = 0.04) and 6-month mortality risk (HA/Caucasian OR 0.66; 95% CI 0.50 to 0.88; p < 0.01) than Caucasian patients.: ConclusionsEthnicity does not appear to be a strong risk factor for adverse outcomes following CABG surgery in the VHA. Future studies are needed to determine why AA patients have more complications, but ethnicity should not affect the decision to offer the operation. [Copyright &y& Elsevier]

Discusses the predictors of the quality of life in patients who suffered from acute coronary syndromes in the past. Key issues of interest; Analysis of pertinent topics and relevant issues; Implications on cardiology.

Considers how health-related quality of life has not been evaluated as a predictor of mortality following coronary artery bypass graft (CABG) surgery. Study to determine if the Physical and Mental Component Summary scores from the preoperative Short-Form 36 health status survey predict mortality following CABG surgery after adjustment for known clinical risk variables; Design; Setting; Patients; Main outcome measures; Results; Conclusions.

In this Viewpoint, Harlan Krumholz and colleagues discuss the promise that social media data hold for helping researchers better understand social determinants of health, and the challenges that must be overcome to reliably link social network data to clinical and health outcomes. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses questions that should be addressed to successfully integrate artificial intelligence into clinical care. [ABSTRACT FROM AUTHOR]

The authors reflect on the use of medical therapy in the treatment of angina. They suggest that in the past, patients received antianginal medications for stable angina and that percutaneous coronary intervention was only an option, but that in 2008 intervention is routinely performed. They argue that despite research which has indicated that percutaneous coronary intervention is effective, the question of whether it should always be the first course of treatment remains to be answered.

The article discusses cardiac risk management in conjunction with severe mental illness. The authors note that patients with serious mental illness have a rate of mortality 1.5 times greater than the general population. The article contends that the higher death rates are related to coronary heart disease. Drugs that patients with severe mental illnesses, (such as schizophrenia), take can affect cardiac health. For example, many antipsychotic drugs affect weight and insulin levels. Also, it is possible that schizophrenics are more prone to becoming addicted to nicotine than non schizophrenics. Beyond the risk factors that smoking and diabetes represent for heart disease, it is thought that as many as half of the mentally ill do not follow doctors' instructions at some time during their treatment.

Hypertension is a major contributor to worldwide cardiovascular mortality, however, only one-third of patients with hypertension have their blood pressure treated to guideline recommended levels. To improve hypertension control, there may need to be a fundamental shift in care delivery, one that is population-based and simultaneously addresses patient, provider and system barriers. One potential approach is home-based disease management, based on the triad of home monitoring, team care, and patient self-care. Although there may be challenges to achieving the vision of home-based disease management, there are tremendous potential benefits of such an approach for reducing the global burden of cardiovascular disease. [ABSTRACT FROM AUTHOR]

To determine whether self-reported angina pectoris is associated with objective evidence of myocardial ischemia, we assessed angina symptoms, using the Seattle Angina Questionnaire, and measured ischemia using stress echocardiography in 933 patients with known coronary artery disease. We observed no association between self-reported angina pectoris and objective evidence of inducible ischemia. [Copyright &y& Elsevier]

The article discusses the importance of monitoring personal health outcomes to improve quality of healthcare in the U.S. with focus on the Veterans Affairs (VA) Patient Reported Health Status Assessment (PROST) system model. Topics discussed include the guidelines by the National Quality Forum on the measurement of outcomes, the thrust from volume-based to quality-based health care results and the VA clinical assessment reporting and tracking (CART) program.

The authors discuss a study which investigated the prediction of the outcome of transcatheter aortic valve replacement (TAVR), by Arnold and colleagues, published within the issue. They offer clinical information on TAVR, as well as the possible outcomes of TAVR, the risk factors that can lead to poor TAVR outcome, and the clinical significance of the study findings.

The results of MASS COMM support the safety of performing percutaneous coronary intervention at centres without on-site cardiothoracic surgery services. To translate these findings into clinical practice, robust quality oversight programmes, with direct measurement of procedural outcomes and complications, are needed. The VA CART programme provides a model for such a strategy. [ABSTRACT FROM AUTHOR]

The authors discuss a study which monitored multiple cardiovascular devices and their comparative outcomes, by F. S. Resnic and colleagues, published within the issue. They commend Resnic and colleagues for showing the feasibility of automated monitoring of device safety signals. They add that the study improves the level of proactive device surveillance in the U.S. The authors also provide examples of national systems for device safety surveillance.

A response is presented by P. Michael Ho and John S. Rumsfeld to a letter to the editor about their article about the adverse events associated with stopping the drug clopidogrel after acute coronary syndrome in a previous issue.

This article presents the authors' views on the obesity therapy drug rimonabant and the Strategy to Reduce Atherosclerosis Development Involving Administration of Rimonabant:The Intravascular Ultrasound Study (STRADIVARIUS) trial. The authors reflect on STRADIVARIUS and note that the study shows that rimonabant is effective in aiding weight loss, but not for halting the progression of heart disease. Other trials that examine rimonabant therapy are also discussed.

A response by P. Michael Ho and John S. Rumsfeld to a letter to the editor about their article "Risk of Adverse Outcomes Associated With Concomitant Use of Clopidogrel and Proton Pump Inhibitors Following Acute Coronary Syndrome" in the 2009 issue is presented.

The article comments on the study which evaluates the effectiveness of citalopram or interpersonal psychotherapy and placebo or clinical management in managing major depression in patients with coronary artery disease. The author states that the data from the clinical trials are limited and does not reveal good evidences that suggest the best treatment strategies in treating depression in these patients. The author also encourages clinicians to find ways to treat depression in cardiac patients.

An app‐based clinical trial enrolment process can contribute to duplicated records, carrying data management implications. Our objective was to identify duplicated records in real time in the Apple Heart Study (AHS). We leveraged personal identifiable information (PII) to develop a dissimilarity score (DS) using the Damerau–Levenshtein distance. For computational efficiency, we focused on four types of records at the highest risk of duplication. We used the receiver operating curve (ROC) and resampling methods to derive and validate a decision rule to classify duplicated records. We identified 16,398 (4%) duplicated participants, resulting in 419,297 unique participants out of a total of 438,435 possible. Our decision rule yielded a high positive predictive value (96%) with negligible impact on the trial's original findings. Our findings provide principled solutions for future digital trials. When establishing deduplication procedures for digital trials, we recommend collecting device identifiers in addition to participant identifiers; collecting and ensuring secure access to PII; conducting a pilot study to identify reasons for duplicated records; establishing an initial deduplication algorithm that can be refined; creating a data quality plan that informs refinement; and embedding the initial deduplication algorithm in the enrolment platform to ensure unique enrolment and linkage to previous records. [ABSTRACT FROM AUTHOR]

Importance: Little contemporary information is available about comparative performance between Veterans Affairs (VA) and non-VA hospitals, particularly related to mortality and readmission rates, 2 important outcomes of care.Objective: To assess and compare mortality and readmission rates among men in VA and non-VA hospitals.Design, Setting, and Participants: Cross-sectional analysis involving male Medicare fee-for-service beneficiaries aged 65 years or older hospitalized between 2010 and 2013 in VA and non-VA acute care hospitals for acute myocardial infarction (AMI), heart failure (HF), or pneumonia using the Medicare Standard Analytic Files and Enrollment Database together with VA administrative claims data. To avoid confounding geographic effects with health care system effects, we studied VA and non-VA hospitals within the same metropolitan statistical area (MSA).Exposures: Hospitalization in a VA or non-VA hospital in MSAs that contained at least 1 VA and non-VA hospital.Main Outcomes and Measures: For each condition, 30-day risk-standardized mortality rates and risk-standardized readmission rates for VA and non-VA hospitals. Mean aggregated within-MSA differences in mortality and readmission rates were also assessed.Results: We studied 104 VA and 1513 non-VA hospitals, with each condition-outcome analysis cohort for VA and non-VA hospitals containing at least 7900 patients (men; ≥65 years), in 92 MSAs. Mortality rates were lower in VA hospitals than non-VA hospitals for AMI (13.5% vs 13.7%, P = .02; -0.2 percentage-point difference) and HF (11.4% vs 11.9%, P = .008; -0.5 percentage-point difference), but higher for pneumonia (12.6% vs 12.2%, P = .045; 0.4 percentage-point difference). In contrast, readmission rates were higher in VA hospitals for all 3 conditions (AMI, 17.8% vs 17.2%, 0.6 percentage-point difference; HF, 24.7% vs 23.5%, 1.2 percentage-point difference; pneumonia, 19.4% vs 18.7%, 0.7 percentage-point difference, all P < .001). In within-MSA comparisons, VA hospitals had lower mortality rates for AMI (percentage-point difference, -0.22; 95% CI, -0.40 to -0.04) and HF (-0.63; 95% CI, -0.95 to -0.31), and mortality rates for pneumonia were not significantly different (-0.03; 95% CI, -0.46 to 0.40); however, VA hospitals had higher readmission rates for AMI (0.62; 95% CI, 0.48 to 0.75), HF (0.97; 95% CI, 0.59 to 1.34), or pneumonia (0.66; 95% CI, 0.41 to 0.91).Conclusions and Relevance: Among older men with AMI, HF, or pneumonia, hospitalization at VA hospitals, compared with hospitalization at non-VA hospitals, was associated with lower 30-day risk-standardized all-cause mortality rates for AMI and HF, and higher 30-day risk-standardized all-cause readmission rates for all 3 conditions, both nationally and within similar geographic areas, although absolute differences between these outcomes at VA and non-VA hospitals were small. [ABSTRACT FROM AUTHOR]

IMPORTANCE. Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials. OBJECTIVE. To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. DESIGN, SETTING, AND PARTICIPANTS Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30,2013, and the end of the follow-up period was June 30,2014. EXPOSURE. Transcatheter aortic valve replacement. MAIN OUTCOMES AND MEASURES. One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. RESULTS. The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% Cl, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% Cl, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% Cl, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for a 95 vs <75 years, 1.61 [95% Cl, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95% Cl, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95% Cl, 1.08-1.41]), male sex (HR, 1.21; 95% Cl, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% Cl, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% Cl, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% Cl, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% Cl, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% Cl, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% Cl, 1.15-1.71). CONCLUSIONS. AND RELEVANCE Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR. [ABSTRACT FROM AUTHOR]

Background--Before outcomes-based measures of quality can be used to compare and improve care, they must be risk-standardized to account for variations in patient characteristics. Despite the importance of health-related quality of life (HRQL) outcomes among patients with acute myocardial infarction (AMI), no risk-standardized models have been developed. Methods and Results--We assessed disease-specific HRQL using the Seattle Angina Questionnaire at baseline and 1 year later in 2693 unselected AMI patients from 24 hospitals enrolled in the Translational Research Investigating Underlying disparities in acute Myocardial infarction Patients' Health status (TRIUMPH) registry. Using 57 candidate sociodemographic, economic, and clinical variables present on admission, we developed a parsimonious, hierarchical linear regression model to predict HRQL. Eleven variables were independently associated with poor HRQL after AMI, including younger age, previous coronary artery bypass graft surgery, depressive symptoms, and financial difficulties (R²=20%). The model demonstrated excellent internal calibration and reasonable calibration in an independent sample of 1890 AMI patients in a separate registry, although the model slightly overpredicted HRQL scores in the higher deciles. Among the 24 TRIUMPH hospitals, 1-year unadjusted HRQL scores ranged from 67-89. After risk-standardization, HRQL score variability narrowed substantially (range=79-83), and the group of hospital performance (bottom 20%/ middle 60%/top 20%) changed in 14 of the 24 hospitals (58% reclassification with risk-standardization). Conclusions--In this predictive model for HRQL after AMI, we identified risk factors, including economic and psychological characteristics, associated with HRQL outcomes. Adjusting for these factors substantially altered the rankings of hospitals as compared with unadjusted comparisons. Using this model to compare risk-standardized HRQL outcomes across hospitals may identify processes of care that maximize this important patient-centered outcome. [ABSTRACT FROM AUTHOR]