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Background: It is unclear how the type of an atherosclerotic cardiovascular disease (ASCVD) event potentially influences patients' likelihood of smoking cessation., Methods: Using 2013 to 2018 data from the US based National Cardiovascular Data Registry Practice Innovation and Clinical Excellence outpatient cardiac registry, we identified patients who were current smokers at a clinic visit and followed them over time for a subsequent ASCVD event. Self-reported smoking status was assessed at each consecutive visit and used to determine smoking cessation after each interim ASCVD event (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, stroke/transient ischemic attack, peripheral artery disease). We constructed separate multivariable Cox models with nonproportional hazards to examine the association of each interim ASCVD event with smoking cessation, compared with not having an interim ASCVD event. We estimated the relative association of ASCVD event type with smoking cessation using contrast tests. Analyses were stratified by presence versus absence of ASCVD at baseline., Results: Across 530 cardiology practices, we identified 1 933 283 current smokers (mean age 62±15, male 54%, ASCVD at baseline 50%). Among the 322 743 patients who had an interim ASCVD event and were still smoking, 41 336 (12.8%) quit smoking by their first subsequent clinic visit, which was higher among those with baseline ASCVD (13.4%) as compared with those without baseline ASCVD (11.5%). Each type of ASCVD event was associated with an increased likelihood of smoking. Patients who had an myocardial infarction, underwent coronary artery bypass graft (hazard ratio, 1.60 [95% CI, 1.55-1.65]), or had a stroke or transient ischemic attack were more likely to quit smoking as compared with those who underwent elective percutaneous coronary intervention or had a new diagnosis of peripheral artery disease (hazard ratio, 1.20 [95% CI, 1.17-1.22])., Conclusions: Only 13% of patients reported smoking cessation after an ASCVD event, with the type of event being associated with the likelihood of smoking cessation, prompting the need for patient-centered interventions., Competing Interests: Disclosures None.

Background: Although rapid response teams have been widely promoted as a strategy to reduce unexpected hospital deaths, most studies of rapid response teams have not adjusted for secular trends in mortality before their implementation. We examined whether implementation of a rapid response team was associated with a reduction in hospital mortality after accounting for preimplementation mortality trends., Methods: Among 56 hospitals in Get With The Guidelines-Resuscitation linked to Medicare, we calculated the annual rates of case mix-adjusted mortality for each hospital during 2000 to 2014. We constructed a hierarchical log-binomial regression model of mortality over time (calendar-year), incorporating terms to capture the effect of rapid response teams, to determine whether implementation of rapid response teams was associated with reduction in hospital mortality that was larger than expected based on preimplementation trends, while adjusting for hospital case mix index., Results: The median annual number of Medicare admissions was 5214 (range, 408-18 398). The median duration of preimplementation and postimplementation period was 7.6 years (≈2.5 million admissions) and 7.2 years (≈2.6 million admissions), respectively. Hospital mortality was decreasing by 2.7% annually during the preimplementation period. Implementation of rapid response teams was not associated with a change in mortality during the initial year (relative risk for model intercept, 0.98 [95% CI, 0.94-1.02]; P =0.30) or in the mortality trend (relative risk for model slope, 1.01 per year [95% CI, 0.99-1.02]; P =0.30). Among individual hospitals, implementation of a rapid response team was associated with a lower-than-expected mortality at only 4 (7.1%) and higher-than-expected mortality at 2 (3.7%) hospitals., Conclusions: Among a large and diverse sample of US hospitals, we did not find implementation of rapid response teams to be associated with reduction in hospital mortality. Studies are needed to understand best practices for rapid response team implementation, to ensure that hospital investment in these teams improves patient outcomes.

Background: Although studies have reported variation in out-of-hospital cardiac arrest (OHCA) survival by geographic location, little is known about variation in OHCA survival at the level of emergency medical service (EMS) agencies-which may have modifiable practices, unlike counties and regions. We quantified the variation in OHCA survival across EMS agencies and explored whether variation in 2 specific EMS resuscitation practices were associated with survival to hospital admission., Methods: Within the Cardiac Arrest Registry to Enhance Survival, a prospective registry representing ≈51% of the US population, we identified 258 342 OHCAs from 764 EMS agencies with > 10 OHCA cases annually during 2015 to 2019. Using hierarchical logistic regression, risk-standardized rates of survival to hospital admission were computed for each EMS agency. We quantified inter-agency variation in survival with median odds ratios and assessed the association of 2 resuscitation practices (EMS response time and the proportion of OHCAs with termination of resuscitation without meeting futility criteria) with EMS agency survival rates to hospital admission., Results: Across 764 EMS agencies comprising 258 342 OHCAs, the median risk-standardized rate of survival to hospital admission was 27.3% (interquartile range, 24.5%-30.1%; range: 16.0%-45.6%). The adjusted median odds ratio was 1.35 (95% CI, 1.32-1.39), denoting that the odds of survival of 2 patients with identical covariates varied by 35% at 2 randomly selected EMS agencies. EMS agencies in the lowest quartile of risk-standardized survival had longer EMS response times when compared with the highest quartile (12.0±3.4 versus 9.0±2.6 minutes; P <0.001), and a higher proportion of OHCAs with termination of resuscitation without meeting futility criteria (27.9±16.1% versus 18.9±11.4%; P <0.001)., Conclusions: Survival after OHCA varies widely across EMS agencies. EMS response times and termination of resuscitation practices were associated with agency-level rates of survival to hospital admission, suggesting potentially modifiable practices which can improve OHCA survival.

Background: Health status outcomes are increasingly being promoted as measures of health care quality, given their importance to patients. In heart failure (HF), an American College of Cardiology/American Heart Association Task Force proposed using the proportion of patients with preserved health status as a quality measure but not as a performance measure because risk adjustment methods were not available., Methods: We built risk adjustment models for alive with preserved health status and for preserved health status alone in a prospective registry of outpatients with HF with reduced ejection fraction across 146 US centers between December 2015 and October 2017. Preserved health status was defined as not having a ≥5-point decrease in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 1 year. Using only patient-level characteristics, hierarchical multivariable logistic regression models were developed for 1-year outcomes and validated using data from 1 to 2 years. We examined model calibration, discrimination, and variability in sites' unadjusted and adjusted rates., Results: Among 3932 participants (median age [interquartile range] 68 years [59-75], 29.7% female, 75.4% White), 2703 (68.7%) were alive with preserved health status, 902 (22.9%) were alive without preserved health status, and 327 (8.3%) had died by 1 year. The final risk adjustment model for alive with preserved health status included baseline Kansas City Cardiomyopathy Questionnaire Overall Summary, age, race, employment status, annual income, body mass index, depression, atrial fibrillation, renal function, number of hospitalizations in the past 1 year, and duration of HF (optimism-corrected C statistic=0.62 with excellent calibration). Similar results were observed when deaths were ignored. The risk standardized proportion of patients alive with preserved health status across the 146 sites ranged from 62% at the 10th percentile to 75% at the 90th percentile. Variability across sites was modest and changed minimally with risk adjustment., Conclusions: Through leveraging data from a large, outpatient, observational registry, we identified key factors to risk adjust sites' proportions of patients with preserved health status. These data lay the foundation for building quality measures that quantify treatment outcomes from patients' perspectives.

Background: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown., Methods: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients' baseline health status accounted for variability in outcomes, the proportion of variability ( R 2 ) explained by sequentially adding these variables to the model was quantified., Results: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients' baseline KCCQ-OS score ( R 2 =25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume., Conclusions: There is moderate variation across sites in their patients' achievement of health status benefits from TMVr, with patient's baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr.

Background: Many clinical investigations depend on participant self-report as a principal method of identifying health care events. If self-report is used as the trigger to collect and adjudicate medical records, any event that is not reported by the patient will be missed by the investigators, reducing the power of the study and misrepresenting the risk of its participants. We sought to determine the rates and predictors of underreporting hospitalization events during the follow-up period of a prospective study of patients hospitalized with an acute myocardial infarction., Methods and Results: The TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status) registry, a longitudinal multicenter cohort study of people with acute myocardial infarction in the United States, queried patients for hospitalization events during interviews at 1, 6, and 12 months. To validate these self-reports, medical records for all events at every hospital where the patient reported receiving care were acquired for adjudication, not just those for the reported events. Of the 4340 participants in TRIUMPH, 1209 (28%) reported at least one hospitalization. After medical records abstraction and adjudication, we identified 1086 hospitalizations from 639 participants (60.2±12 years of age, 38.2% women). Of these hospitalizations, 346 (31.9%) were underreported by the participants. Rates of underreporting ranged from 22.5% to 55.6% based on different patient characteristics. The odds of underreporting were highest for those not currently working (adjusted odds ratio, 1.66 [95% CI, 1.04-2.63]), lowest for those married (adjusted odds ratio, 0.50 [95% CI, 0.33-0.76]), and increased the longer the elapsed time between the admission and the patient's follow-up interview (adjusted odds ratio per month, 1.16 [95% CI, 1.08-1.24]). There was a substantial within-individual variation on the accuracy of reporting., Conclusions: Hospitalizations after acute myocardial infarction are commonly underreported in interviews and should not be used alone to determine event rates in clinical studies.

Background Survival and health status (eg, symptoms and quality of life) are key outcomes in clinical trials of heart failure treatment. However, health status can only be recorded on survivors, potentially biasing treatment effect estimates when there is differential survival across treatment groups. Joint modeling of survival and health status can address this bias. Methods and Results We analyzed patient-level data from the PARTNER 1B trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement versus standard care. Health status was quantified with the Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization, 1, 6, and 12 months. We compared hazard ratios for survival and mean differences in KCCQ scores at 12 months using several models: the original growth curve model for KCCQ scores (ignoring death), separate Bayesian models for survival and KCCQ scores, and a Bayesian joint longitudinal-survival model fit to either 12 or 30 months of survival follow-up. The benefit of transcatheter aortic valve replacement on 12-month KCCQ scores was greatest in the joint-model fit to all survival data (mean difference, 33.7 points; 95% credible intervals [CrI], 24.2-42.4), followed by the joint-model fit to 12 months of survival follow-up (32.3 points; 95% CrI, 22.5-41.5), a Bayesian model without integrating death (30.4 points; 95% CrI, 21.4-39.3), and the original growth curve model (26.0 points; 95% CI, 18.7-33.3). At 12 months, the survival benefit of transcatheter aortic valve replacement was also greater in the joint model (hazard ratio, 0.50; 95% CrI, 0.32-0.73) than in the nonjoint Bayesian model (0.54; 95% CrI, 0.37-0.75) or the original Kaplan-Meier estimate (0.55; 95% CI, 0.40-0.74). Conclusions In patients with severe symptomatic aortic stenosis and prohibitive surgical risk, the estimated benefits of transcatheter aortic valve replacement on survival and health status compared with standard care were greater in joint Bayesian models than other approaches.

Background: Long-term exposure to particulate matter <2.5 µm in diameter (PM 2.5 ) and ozone has been associated with the development and progression of cardiovascular disease and, in the case of PM 2.5 , higher cardiovascular mortality. Whether exposure to PM 2.5 and ozone is associated with patients' health status and quality of life is unknown. We used data from 2 prospective myocardial infarction (MI) registries to assess the relationship between long-term PM 2.5 and ozone exposure with health status outcomes 1 year after an MI., Methods and Results: TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction) and PREMIER (Prospective Registry Evaluating Myocardial Infarction: Events and Recovery) enrolled patients presenting with MI at 31 US hospitals between 2003 and 2008. One year later, patients were assessed with the disease-specific Seattle Angina Questionnaire, and 5-year mortality was assessed with the Centers for Disease Control's National Death Index. Individual patients' exposures to PM 2.5 and ozone over the year after their MI were estimated from the Environment Protection Agency's Fused Air Quality Surface Using Downscaling tool that integrates monitoring station data and atmospheric models to predict daily air pollution exposure at the census tract level. We assessed the association of exposure to ozone and PM 2.5 with 1-year health status and mortality over 5 years using regression models adjusting for age, sex, race, socioeconomic status, date of enrollment, and comorbidities. In completely adjusted models, higher PM 2.5 and ozone exposure were independently associated with poorer Seattle Angina Questionnaire summary scores at 1-year (β estimate per +1 SD increase =-0.8 [95% CI, -1.4 to -0.3; P=0.002] for PM 2.5 and -0.9 [95% CI, -1.3 to -0.4; P<0.001] for ozone). Moreover, higher PM 2.5 exposure, but not ozone, was independently associated with greater mortality risk (hazard ratio =1.13 per +1 SD [95% CI, 1.07-1.20; P<0.001])., Conclusions: In our study, greater exposure to PM 2.5 and ozone was associated with poorer 1-year health status following an MI, and PM 2.5 was associated with increased risk of 5-year death.

Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Methods and Results Among 13 351 patients who underwent TAVR at 252 US sites between November 9, 2011 and June 30, 2015, the rate of poor outcome at 1 year after TAVR was 38.9%, which was because of death in 20.7% and poor quality of life or quality of life decline in 18.2%. The rate of poor outcome has decreased slightly over time, from 42.0% in 2012 to 37.8% in 2015 ( P for trend=0.076). The original TAVR poor outcome risk model did not calibrate well on this population. We then reestimated the intercept and coefficients in the model and retested model performance, after which it performed well (both overall and in subgroups), with a C index 0.65 and excellent calibration. Conclusions In a large cohort of unselected patients in the United States, we found that while a substantial minority of patients continue to have a poor outcome after TAVR, outcomes have slowly improved over time. After recalibration, the TAVR poor outcome risk model performed well. This model could potentially be used before TAVR to help patients have appropriate expectations of recovery.

Background: Missing health-related quality of life (HRQOL) data in longitudinal studies can reduce precision and power and bias results. Using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), we sought to identify factors associated with missing HRQOL data, examine the impact of these factors on estimated HRQOL assuming missing at random missingness, and perform sensitivity analyses to examine missing not at random (MNAR) missingness because of illness severity., Methods and Results: INTERMACS patients (n=3248) with a preimplantation profile of 1 (critical cardiogenic shock) or 2 (progressive decline) were assessed with the EQ-5D-3L visual analog scale and Kansas City Cardiomyopathy Questionnaire-12 summary scores pre-implantation and 3 months postoperatively. Mean and median observed and missing at random-imputed HRQOL scores were calculated, followed by sensitivity analyses. Independent factors associated with HRQOL scores and missing HRQOL assessments were determined using multivariable regression. Independent factors associated with preimplantation and 3-month HRQOL scores, and with the likelihood of missing HRQOL assessments, revealed few correlates of HRQOL and missing assessments ( R 2 range, 4.7%-11.9%). For patients with INTERMACS profiles 1 and 2 and INTERMACS profile 1 alone, missing at random-imputed mean and median HRQOL scores were similar to observed scores, before and 3 months after implantation, whereas MNAR-imputed mean scores were lower (≥5 points) at baseline but not at 3 months., Conclusions: We recommend use of sensitivity analyses using an MNAR imputation strategy for longitudinal studies when missingness is attributable to illness severity. Conduct of MNAR sensitivity analyses may be less critical after mechanical circulatory support implant, when there are likely fewer MNAR data., (© 2017 American Heart Association, Inc.)

Background: Previous studies suggest that among patients with stable coronary artery disease, patients with diabetes mellitus (DM) have less angina and more silent ischemia when compared with those without DM. However, the burden of angina in diabetic versus nondiabetic patients after elective percutaneous coronary intervention (PCI) has not been recently examined., Methods and Results: In a 10-site US PCI registry, we assessed angina before and at 1, 6, and 12 months after elective PCI with the Seattle Angina Questionnaire angina frequency score (range, 0-100, higher=better). We also examined the rates of antianginal medication prescriptions at discharge. A multivariable, repeated-measures Poisson model was used to examine the independent association of DM with angina over the year after treatment. Among 1080 elective PCI patients (mean age, 65 years; 74.7% men), 34.0% had DM. At baseline and at each follow-up, patients with DM had similar angina prevalence and severity as those without DM. Patients with DM were more commonly prescribed calcium channel blockers and long-acting nitrates at discharge (DM versus not: 27.9% versus 20.9% [ P =0.01] and 32.8% versus 25.5% [ P =0.01], respectively), whereas β-blockers and ranolazine were prescribed at similar rates. In the multivariable, repeated-measures model, the risk of angina was similar over the year after PCI in patients with versus without DM (relative risk, 1.04; range, 0.80-1.36)., Conclusions: Patients with stable coronary artery disease and DM exhibit a burden of angina that is at least as high as those without DM despite more antianginal prescriptions at discharge. These findings contradict the conventional teachings that patients with DM experience less angina because of silent ischemia., (© 2017 American Heart Association, Inc.)

Background: In SPRINT (Systolic Blood Pressure Intervention Trial), patients with hypertension and high cardiovascular risk treated with intensive blood pressure (BP) control (<120 mm Hg) had fewer major adverse cardiovascular events (MACE) and deaths but higher rates of treatment-related serious adverse events (SAE) than patients randomized to standard BP control (<140 mm Hg). However, the degree of benefit or harm for an individual patient could vary because of heterogeneity in treatment effect., Methods and Results: Using patient-level data from 9361 randomized patients in SPRINT, we developed models to predict risk for MACE or death and treatment-related SAE to allow for individualized BP treatment goals based on each patient's projected risk and benefit of intensive versus standard BP control. Models were internally validated using bootstrap resampling and externally validated on 4741 patients from the ACCORD-BP (The Action to Control Cardiovascular Risk in Diabetes blood pressure) trial. Among 9361 SPRINT patients, 755 patients (8.1%) had a MACE or death event and 338 patients (3.6%) had a treatment-related SAE during a median follow-up of 3.3 years. The MACE/death and the SAE model had C statistics of 0.72 and 0.70, respectively, in the derivation cohort and 0.69 and 0.65 in ACCORD. The MACE/death model had 10 variables including treatment interactions with age, baseline systolic BP, and diastolic BP, and the SAE model had 8 variables including treatment interaction with number of BP medications. Intensive BP treatment was associated with a mean 2.2±2.6% lower risk of MACE/death compared with standard treatment (range, 20.7% lower risk to 19.6% greater risk among individual patients) and a mean 2.2±1.2% higher risk for SAEs (range, 0.5%-15.8% more harm in individual patients)., Conclusions: To translate the findings from SPRINT to clinical practice, we developed prediction models to tailor the intensity of BP control based on the projected risk and benefit for each unique patient. This approach should be prospectively tested to better engage patients in shared medical decision making and to improve outcomes., Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT01206062., (© 2017 American Heart Association, Inc.)

Background: Rehospitalizations after acute myocardial infarction for unplanned coronary revascularization and unstable angina (UA) are common. However, despite the inclusion of these events in composite end points of many clinical trials, their association with health status has not been studied., Methods and Results: We included 3283 patients with acute myocardial infarction enrolled in a prospective, 24-center US study who had rehospitalizations independently classified by experienced cardiologists. Health status was assessed using Seattle Angina Questionnaire and EuroQol-5D Visual Analog Scale. In the propensity-matched cohorts, 1-year health status was compared between those who did and did not experience rehospitalization for UA or revascularization using a hierarchical linear model. Overall, mean age was 59 years, 33% were women, and 70% were white. Rehospitalization rates for UA and unplanned revascularization at 1 year were 4.3% and 4.7%. One-year Seattle Angina Questionnaire summary scores were worse in patients with rehospitalizations for UA (mean difference, -10.1; 95% confidence interval, -12.4 to -7.9) and unplanned revascularization (mean difference, -5.7; 95% confidence interval, -8.8 to -2.5) when compared with patients without such rehospitalizations. Similarly, EuroQol-5D Visual Analog Scale scores were worse among patients with such readmissions. Individual Seattle Angina Questionnaire domains indicated worse 1-year angina and quality of life outcomes among patients rehospitalized for UA or unplanned revascularization., Conclusions: Within the first year after acute myocardial infarction, rehospitalizations for UA and unplanned revascularization are associated with worse health status. These findings highlight the impact of such events from a patient's perspective, beyond their economic impact and support the use of UA and unplanned revascularization as elements of composite end points., (© 2016 American Heart Association, Inc.)

Background: Under-recognition of angina by physicians may result in undertreatment with revascularization or medications that could improve patients' quality of life. We sought to describe characteristics associated with under-recognition of patients' angina., Methods and Results: Patients with coronary disease from 25 US cardiology outpatient practices completed the Seattle Angina Questionnaire before their clinic visit, quantifying their frequency of angina during the previous month. Immediately after the clinic visit, physicians independently quantified their patients' angina. Angina frequency was categorized as none, monthly, and daily/weekly. Among 1257 patients, 411 reported angina in the previous month, of whom 173 (42%) were under-recognized by their physician, defined as the physician reporting a lower frequency category of angina than the patient. In a hierarchical logistic model, heart failure (odds ratio, 3.06, 95% confidence interval, 1.89-4.95) and less-frequent angina (odds ratio for monthly angina [versus daily/weekly], 1.69; 95% confidence interval, 1.12-2.56) were associated with greater odds of under-recognition. No other patient or physician factors were associated with under-recognition. Significant variability across physicians (median odds ratio, 2.06) was observed., Conclusions: Under-recognition of angina is common in routine clinical practice. Although patients with less-frequent angina and those with heart failure more often had their angina under-recognized, most variation was unrelated to patient and physician characteristics. The large variation across physicians suggests that some physicians are more accurate in assessing angina frequency than others. Standardized prospective use of a validated clinical tool, such as the Seattle Angina Questionnaire, should be tested as a means to improve recognition of angina and, potentially, improve appropriate treatment of angina., (© 2016 American Heart Association, Inc.)

Background: Although patients with diabetes mellitus experience high rates of adverse events after acute myocardial infarction (AMI), including death and recurrent ischemia, some diabetic patients are likely at low risk, whereas others are at high risk. We sought to develop prediction models to stratify risk after AMI in patients with diabetes mellitus., Methods and Results: We developed prediction models for long-term mortality and angina among 1613 patients with diabetes mellitus discharged alive after AMI from 24 US hospitals and then validated the models in a separate, multicenter registry of 786 patients with diabetes mellitus. Event rates in the derivation cohort were 27% for 5-year mortality and 27% for 1-year angina. Parsimonious prediction models demonstrated good discrimination (c-indices=0.78 and 0.69, respectively) and excellent calibration. Within the context of the predictors we estimated, the strongest predictors for mortality were higher creatinine, not working at the time of the AMI, older age, lower hemoglobin, left ventricular dysfunction, and chronic heart failure. The strongest predictors for angina were angina burden in the 4 weeks before the AMI, younger age, history of prior coronary bypass graft surgery, and non-white race. The lowest and highest deciles of predicted risk ranged from 4% to 80% for mortality and 12% to 59% for angina. The models also performed well in external validation (c-indices=0.78 and 0.73, respectively)., Conclusions: We found a wide range of risk for adverse outcomes after AMI in diabetic patients. Predictive models can identify patients with diabetes mellitus for whom closer follow-up and aggressive secondary prevention strategies should be considered., (© 2016 American Heart Association, Inc.)

Background: There is a growing demand to collect patients' experiences of their health status (their symptoms, function, and quality of life) in clinical trials, quality assessment initiatives, and in routine clinical care. In heart failure, the 23-item, disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) has been shown to be valid, reliable, sensitive to clinical change, and prognostic of both clinical events and costs. However, its use has been limited, in part, by its length. We sought to develop a shortened version of the instrument that maintains the psychometric properties of the full KCCQ., Methods and Results: Using data from 3 clinical studies incorporating 4168 patients, we derived and validated a 12-item KCCQ, the KCCQ-12, to capture symptom frequency, physical and social limitations, and quality of life impairment as a result of heart failure, as well as an overall summary score. The KCCQ-12 scores had high correlations with the original scales (>0.93 for all scales in all clinical settings), high test–retest reliability (>0.76 for all domains), high responsiveness (16–31 point improvements after discharge from hospitalization; standardized response mean =0.61–1.12), and comparable prognostic significance and interpretation of clinically important differences as compared with the full KCCQ., Conclusions: The KCCQ-12 is a shorter version of the original 23-item instrument that should be more feasible to implement while preserving the psychometric properties of the full instrument.

Background: Smoking cessation after acute myocardial infarction (AMI) decreases the risk of recurrent AMI and mortality by 30% to 50%, but many patients continue to smoke. The association of smoking with angina and health-related quality of life (HRQOL) after AMI is unclear., Methods and Results: Patients in 2 US multicenter AMI registries (n=4003) were assessed for smoking and HRQOL at admission and 1, 6, and 12 months after AMI. Angina and HRQOL were measured with the Seattle Angina Questionnaire and Short Form-12 Physical and Mental Component Scales. At admission, 29% never had smoked, 34% were former smokers (quit before AMI), and 37% were active smokers, of whom 46% quit by 1 year (recent quitters). In hierarchical, multivariable, regression models that adjusted for sociodemographic, clinical and treatment factors, never and former smokers had similar and the best HRQOL in all domains. Recent quitters had intermediate HRQOL levels, with angina and Short Form-12 Mental Component Scale scores similar to never smokers. Persistent smokers had worse HRQOL in all domains compared with never smokers and worse Short Form-12 Mental Component Scale scores than recent quitters., Conclusions: Smoking after AMI is associated with more angina and worse HRQOL in all domains, whereas smokers who quit after AMI have similar angina levels and mental health as never smokers. These observations may help encourage patients to stop smoking after AMI.

Background: After left ventricular assist device (LVAD) placement for advanced heart failure, increased cerebral perfusion should result in improved cognitive function. However, stroke (a well-known LVAD complication) and subclinical cerebral ischemia may result in transient or permanent cognitive decline. We sought to describe the incidence and predictors of cognitive decline after LVAD using a valid, sensitive assessment tool., Methods and Results: Among 4419 patients in the Interagency Registry for Mechanically Assisted Circulatory Support who underwent LVAD implantation between May 2012 and December 2013, cognitive function was assessed in 1173 patients with the Trail Making B Test before LVAD and at 3, 6, and 12 months. The test detects several forms of cognitive impairment, including subclinical stroke. Cognitive decline was defined as a clinically important increase during follow-up using a moderate Cohen d effect size of 0.5×baseline SD (32 s). The cumulative incidence of cognitive decline in the year after LVAD implantation, treating death and transplantation as competing risks, was 29.2%. In adjusted analysis, older age (≥70 versus <50 years; hazard ratio, 2.24; 95% confidence interval 1.46-3.44; P(trend)<0.001) and destination therapy (hazard ratio, 1.42; 95% confidence interval, 1.05-1.92) were significantly associated with greater risk of cognitive decline., Conclusions: Cognitive decline occurs commonly in patients in the year after LVAD and is associated with older age and destination therapy. These results could have important implications for patient selection and improved communication of risks before LVAD implantation. Additional studies are needed to explore the association between cognitive decline and subsequent stroke, health status, and mortality in patients after LVAD., (© 2015 American Heart Association, Inc.)

Background: Diabetes mellitus (DM) is common in patients hospitalized with an acute myocardial infarction (AMI), representing in some cases the first opportunity to recognize and treat DM. We report the incidence of new DM and its recognition among patients with AMI., Methods and Results: Patients in a 24-site US AMI registry (2005-08) had glycosylated hemoglobin assessed at a core laboratory, with results blinded to clinicians and local clinical measurements left to the discretion of the treating providers. Among 2854 AMI patients without known DM on admission, 287 patients (10%) met criteria for previously unknown DM, defined by a core laboratory glycosylated hemoglobin of ≥6.5%. Among these, 186 (65%) were unrecognized by treating clinicians, receiving neither DM education, glucose-lowering medications at discharge, nor documentation of DM in the chart (median glycosylated hemoglobin of unrecognized patients, 6.7%; range, 6.5-12.3%). Six months after discharge, only 5% of those not recognized as having DM during hospitalization had been initiated on glucose-lowering medications versus 66% of those recognized (P<0.001)., Conclusions: Underlying DM that has not been previously diagnosed is common among AMI patients, affecting 1 in 10 patients, yet is recognized by the care team only one third of the time. Given its frequency and therapeutic implications, including but extending beyond the initiation of glucose-lowering treatment, consideration should be given to screening all AMI patients for DM during hospitalization. Inexpensive, ubiquitous, and endorsed as an acceptable screen for DM, glycosylated hemoglobin testing should be considered for this purpose., (© 2015 American Heart Association, Inc.)

Background: As new techniques emerge to quantify patients' health status, new opportunities are created to validate patient-reported outcome questionnaires. The Seattle Angina Questionnaire (SAQ), a widely used coronary artery disease-specific health status tool, has not been validated against daily records of angina frequency and sublingual nitroglycerin (SL NTG) use. Additional evidence supporting the validity of the SAQ could justify its broader use as an outcome for clinical studies designed to evaluate treatments that may improve patients' symptoms, function, and quality of life., Methods and Results: We used data from 917 patients with type 2 diabetes mellitus, coronary artery disease, and stable angina from the multinational Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina (TERISA) trial. The number of angina episodes and SL NTG used were recorded and transmitted daily using an electronic diary. In cross-sectional analyses, there was a strong relationship between the 2 SAQ angina frequency questions (ie, frequency of angina and SL NTG use) and the corresponding diary responses, with correlation coefficients of -0.64 for angina frequency (95% confidence interval,-0.68 to -0.60) and -0.69 for SL NTG use (95% confidence interval, -0.73 to -0.66). Longitudinally, changes in SAQ angina frequency scores from day 1 to week 8 also correlated with changes in angina frequency (-0.42; 95% confidence interval, -0.48 to -0.30) and SL NTG use by diary (-0.38; 95% confidence interval, -0.43 to -0.32) over the corresponding time period. Correlations were similar when stratified by age, sex, or geography., Conclusions: In a multinational cohort of patients with stable angina, the SAQ angina frequency domain was significantly correlated, both cross sectionally and longitudinally, with daily diary entries of angina frequency and SL NTG use. These data further support the validity of the SAQ angina frequency domain across a broad spectrum of patients with stable angina., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT01425359., (© 2014 American Heart Association, Inc.)

Background: Despite calls to expand measurement of acute myocardial infarction (AMI) outcomes to include symptom burden, little has been done to describe hospital-level variation in this patient-centered outcome, or its association with mortality. Understanding the relationship between symptoms and longer-term mortality could inform the importance of these outcomes for monitoring quality of care., Methods and Results: Among 4316 patients with AMI treated at 24 hospitals participating in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) study, we assessed risk-standardized 1-year symptom burden as measured by the Seattle Angina Questionnaire Angina Frequency Score and mortality attributed to the hospital that provided AMI care. Median odds ratios were used to assess outcome variation and reflect the relative odds of an outcome for 2 patients with identical covariates at different, randomly selected, hospitals. We then evaluated the correlation between hospital-level mortality and angina. Finally, we determined the extent to which variation in mortality and angina was explained by achievement of AMI performance measures. We observed hospital variation in risk-adjusted 1-year mortality (range, 4.9%-8.6%; median odds ratio, 1.30; P=0.01) and angina (range, 17.7%-29.4%; median odds ratio, 1.34; P<0.001). At the hospital level, mortality and angina at 1 year were weakly correlated (r=0.40; 95% confidence interval, 0.00-0.68; P=0.05). Accounting for the quality of AMI care did not attenuate variation in risk-adjusted 1-year mortality or angina., Conclusions: Symptom burden and mortality vary at the hospital level after AMI and are only weakly correlated. These findings suggest that symptom burden should be considered a separate quality domain that is not well captured by current quality metrics., (© 2014 American Heart Association, Inc.)

Background: Clinical trials and national performance measures increasingly mandate reporting patients' perspectives of their health status: their symptoms, function, and quality of life. Although the Seattle Angina Questionnaire (SAQ) is a validated disease-specific health status instrument for coronary artery disease (CAD) with high test-retest reliability, predictive power, and responsiveness, its use in routine clinical practice has been limited, in part, by its length (19 items)., Methods and Results: Using data from 10 408 patients with CAD from 5 multicenter registries, we derived and validated a shortened version of the SAQ (SAQ-7) among patients presenting with stable CAD, undergoing percutaneous coronary intervention, and after acute myocardial infarction. We examined the psychometric properties of the SAQ-7 as compared with the full SAQ. Seven items from the Physical Limitation, Angina Frequency, and Quality of Life domains were identified for the SAQ-7, with high levels of concordance (0.88-1.00) with each original SAQ domain. The SAQ-7 demonstrated good construct validity (compared with Canadian Cardiovascular Society class for angina), with a correlation of 0.62 and 0.38 for patients with stable CAD and undergoing percutaneous coronary intervention, respectively. It was highly reproducible in patients with stable CAD (intraclass correlation, ≥0.78) and exhibited excellent responsiveness in patients after percutaneous coronary intervention (≥18 points in each SAQ domain). Finally, the SAQ-7 was predictive of 1-year mortality and readmission., Conclusions: To increase the feasibility of measuring patient-reported outcomes in patients with CAD, we developed and validated a shortened 7-item SAQ instrument for use in clinical trials and routine care., (© 2014 American Heart Association, Inc.)

Background: On average, acute coronary syndrome patients treated with prasugrel experience fewer ischemic complications, but more bleeding, than those receiving clopidogrel. However, heterogeneity in treatment effects can alter the likelihood of benefits and risks of an individual patient. We developed predictive models of the benefits (reduced ischemic events) and risks (increased bleeding) to support targeting prasugrel to those who benefit most from treatment., Methods and Results: Using 12 579 patients from Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38 (TRITON-TIMI 38), we fit risk models for ischemic events (cardiovascular death, spontaneous myocardial infarction, stroke) and bleeding (TIMI major/minor) over a 14.8-month follow-up and then calculated each patient's predicted risk for major ischemia and bleeding with both prasugrel and clopidogrel. We found substantial heterogeneity of the treatment effect of prasugrel (mean absolute reduction in the ischemia risk with prasugrel=1.5±3.0%, ranging from an 8.4% increased risk to a 31.2% reduction in risk for ischemia compared with clopidogrel). The mean absolute increase in the bleeding risk with prasugrel versus clopidogrel was 1.3±1.4% and ranged from a 7.9% lower risk to an 11.2% higher risk with prasugrel. The ratio of the difference in predicted ischemia risk/difference in predicted bleeding risk between prasugrel and clopidogrel was calculated for each patient to identify the proportion likely to benefit from prasugrel. Considering both ischemia and bleeding risk, a large proportion of TRITON participants (42%) were predicted to experience net benefit with prasugrel, a rate that increased if patients more strongly preferred avoiding ischemic events than bleeding., Conclusions: The expected benefits and risks of prasugrel versus clopidogrel depend highly on patient characteristics. The use of risk models could support individualized thienopyridine selection to maximize the benefits and safety of these drugs.

Background: Mean blood glucose (BG) during acute myocardial infarction (AMI) is an important predictor of inpatient mortality but does not capture glucose variability (GV), which has been shown to be independently associated with mortality in critically ill patients. Whether GV is associated with in-hospital mortality during AMI, after accounting for mean BG, is unknown., Methods and Results: We analyzed 18 563 consecutive patients with AMI with ≥3 BGs in the first 48 hours admitted to 61 US hospitals from 2000 to 2008. Five different GV metrics were compared for their ability to predict in-hospital mortality (range, standard deviation, mean amplitude of glycemic excursions, mean absolute glucose change, and average daily risk range) using hierarchical logistic regression models that sequentially adjusted for mean BG, hypoglycemia (<70 mg/dL), and multiple patient characteristics. In unadjusted analyses, range and average daily risk range had the highest C-indices (0.620 for range, 0.635 for average daily risk range; both P<0.0001). Greater GV was associated with higher mortality for all metrics (eg, mortality was 3.8%, 5.5%, 7.1%, and 11.3% for increasing quartiles of range, P<0.0001); however, the association between GV and mortality for each metric was no longer significant after multivariable adjustment. In contrast, mean BG remained an important predictor of survival (P<0.001, all models)., Conclusions: Although greater GV is associated with increased risk of in-hospital mortality in patients with AMI in unadjusted analyses, GV is no longer independently predictive after controlling for multiple patient factors, including mean BG. These findings suggest that GV does not provide additional prognostic value above and beyond already recognized risk factors for mortality during AMI.

Background: Black patients with myocardial infarction (MI) have worse outcomes than white patients, including higher mortality rates, more angina, and worse quality of life. The Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) study was designed to examine whether racial differences in socioeconomic, clinical, genetic, metabolic, biomarker, or treatment characteristics mediate observed disparities in outcomes., Methods and Results: Between April 11, 2005, and December 31, 2008, 31 567 patients with MI were prospectively screened; 6152 had an eligible MI, and 4340 (71%) were enrolled from 24 US centers. Consenting patients had detailed chart abstractions of their medical history and processes of inpatient care, supplemented with a detailed baseline interview. Detailed genetic and metabolic data were obtained at hospital discharge in 2979 (69%) and 3013 patients (69%), respectively. In a subset of patients, blood and urine samples were obtained at 1 month (obtained in 27% of survivors) and blood samples at 6 months (obtained in 19% of survivors). Centralized follow-up interviews sought to quantify patients' postdischarge care and outcomes, with a focus on their health status (symptoms, function, and quality of life). At 1, 6, and 12 months, 23%, 27%, and 24%, respectively, were lost to follow-up. Vital status was available for 99% of patients at 12 months., Conclusions: TRIUMPH is a novel MI registry with detailed information on patients' sociodemographic, clinical, treatment, health status, metabolic, and genetic characteristics. The wealth of patient data collected in TRIUMPH will provide unique opportunities to examine factors that may mediate racial differences in mortality and health status after MI and the complex interactions between genetic and environmental determinants of post-MI outcomes.

Background: Data on the health status benefits of percutaneous coronary intervention for coronary chronic total occlusions (CTOs), a principal indication for the procedure, are lacking., Methods and Results: In the FlowCardia Approach to CTO Recanalization (FACTOR) trial, patients (n=125) completed the Seattle Angina Questionnaire (SAQ) at baseline and 1 month after percutaneous coronary intervenion. One-month health status outcomes were compared by multivariable analysis, adjusting for group differences between those whose CTO was successfully and unsuccessfully recanalized. These changes were also analyzed according to baseline symptoms. Procedural success was 55% (n=64) and independently associated with angina relief (difference between those with successful and unsuccessful percutaneous coronary intervention [Delta] in SAQ angina frequency=9.5 points; 95% confidence interval, 1.6 to 17.5; P=0.019), improved physical function (Delta in SAQ physical limitation=13.1 points; 95% confidence interval, 5.1 to 21.1; P=0.001), and enhanced quality of life (Delta in SAQ quality of life [QoL]=20.3 points; 95% confidence interval, 11.9 to 28.6; P<0.001). The benefit of successful percutaneous coronary intervention was greatest in symptomatic patients as compared with asymptomatic patients although statistically significantly so only for QoL (DeltaSAQ angina frequency domain=10.3 versus 4.3 points, P=0.51, Deltaphysical limitation =15.9 versus 6.3 points, P=0.25; DeltaQoL=27.3 versus 8.5 points, P=0.047)., Conclusions: Successful CTO recanalization is associated with significant early improvements in patient symptoms, function, and QoL but only among symptomatic patients. Percutaneous treatment of a CTO offers the potential to provide significant health status benefits in symptomatic patients.

Background: Prior studies have associated low social support (SS) with increased rehospitalization and mortality after acute myocardial infarction. However, relatively little is known about whether similar patterns exist for other outcomes, such as health status and depressive symptoms, and whether these patterns vary by sex., Methods and Results: Using data from 2411 English- or Spanish-speaking patients with acute myocardial infarction enrolled in a 19-center prospective study, we examined the association of SS (low, moderate, high) with health status (angina, disease-specific quality of life, general physical and mental functioning) and depressive symptoms over the first year of recovery. Overall and sex-stratified associations were evaluated using mixed-effects Poisson and linear regression, adjusting for site, baseline health status, baseline depressive symptoms, and demographic and clinical factors. Patients with the lowest SS (relative to those with the highest) had increased risk of angina (relative risk, 1.27; 95% confidence interval [CI], 1.10, 1.48); lower disease-specific quality of life (mean difference [beta]=-3.33; 95% CI, -5.25, -1.41), lower mental functioning (beta=-1.72; 95% CI, -2.65, -0.79), and more depressive symptoms (beta=0.94; 95% CI, 0.51, 1.38). A nonsignificant trend toward lower physical functioning (beta=-0.87; 95% CI, -1.95, 0.20) was observed. In sex-stratified analyses, the relationship between SS and outcomes was stronger for women than for men, with a significant SS-by-sex interaction for disease-specific quality of life, physical functioning, and depressive symptoms (all P<0.02)., Conclusions: Lower SS is associated with worse health status and more depressive symptoms over the first year of acute myocardial infarction recovery, particularly for women.