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BACKGROUND: Health status outcomes, including symptoms, function, and quality of life, are worse for Black compared with White patients with heart failure. Sodium–glucose cotransporter 2 inhibitors (SGLT2is) reduce cardiovascular mortality and improve health status in patients with heart failure, but whether the health status benefit of SGLT2is is similar across races is not established. The objective of this study was to compare the treatment effect of SGLT2is (versus placebo) on health status for Black compared with White patients with heart failure. METHODS: We combined patient-level data from 3 randomized clinical trials of SGLT2is: DEFINE-HF (Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure; n=263), PRESERVED-HF (Dapagliflozin in Preserved Ejection Fraction Heart Failure; n=324), and CHIEF-HF (A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure; n=448). These 3 United States–based trials enrolled a substantial proportion of Black patients, and each used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure health status at baseline and after 12 weeks of treatment. Among 1035 total participants, selecting self-identified Black and White patients with complete information yielded a final analytic cohort of 935 patients. The primary endpoint was KCCQ Clinical Summary score. Twelve-week change in KCCQ with SGLT2is versus placebo was compared between Black and White patients by testing the interaction between race and treatment using multivariable linear regression models adjusted for trial, baseline KCCQ (as a restricted cubic spline), race, and treatment. The data that support the findings of this study are available from the corresponding author upon reasonable request. RESULTS: Among 935 participants, 236 (25%) self-identified as Black, and 469 (50.2%) were treated with an SGLT2i. Treatment with an SGLT2i, compared with placebo, resulted in KCCQ Clinical Summary score improvements at 12 weeks of +4.0 points (95% CI, 1.7–6.3; P =0.0007) in White patients and +4.7 points (95% CI, 0.7–8.7; P =0.02) in Black patients, with no significant interaction by race and treatment (P =0.76). Other KCCQ scales showed similar results. CONCLUSIONS: Treatment with an SGLT2i resulted in consistent and significant improvements in health status for both Black and White patients with heart failure. [ABSTRACT FROM AUTHOR]

Whether initial invasive management in older vs younger adults with chronic coronary disease and moderate or severe ischemia improves health status or clinical outcomes is unknown. The goal of this study was to examine the impact of age on health status and clinical outcomes with invasive vs conservative management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial. One-year angina-specific health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ) (score range 0-100; higher scores indicate better health status). Cox proportional hazards models estimated the treatment effect of invasive vs conservative management as a function of age on the composite clinical outcome of cardiovascular death, myocardial infarction, or hospitalization for resuscitated cardiac arrest, unstable angina, or heart failure. Among 4,617 participants, 2,239 (48.5%) were aged <65 years, 1,713 (37.1%) were aged 65 to 74 years, and 665 (14.4%) were aged ≥75 years. Baseline SAQ summary scores were lower in participants aged <65 years. Fully adjusted differences in 1-year SAQ summary scores (invasive minus conservative) were 4.90 (95% CI: 3.56-6.24) at age 55 years, 3.48 (95% CI: 2.40-4.57) at age 65 years, and 2.13 (95% CI: 0.75-3.51) at age 75 years (P interaction = 0.008). Improvement in SAQ Angina Frequency was less dependent on age (P interaction = 0.08). There were no age differences between invasive vs conservative management on the composite clinical outcome (P interaction = 0.29). Older patients with chronic coronary disease and moderate or severe ischemia had consistent improvement in angina frequency but less improvement in angina-related health status with invasive management compared with younger patients. Invasive management was not associated with improved clinical outcomes in older or younger patients. (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches [ISCHEMIA]; NCT01471522) [Display omitted] [ABSTRACT FROM AUTHOR]

Objective: To examine whether TTM treatment was aligned with predicted mortality risk in patients with resuscitated OHCA during a period when it was a class I guideline-recommended therapy.Methods: Within the Cardiac Arrest Registry to Enhance Survival for OHCA, we identified adult patients with OHCA who survived to hospital admission and were presumed eligible for TTM. Multivariable models were constructed using pre-hospital variables to predict in-hospital death in patients with shockable and non-shockable rhythms. Within each rhythm category, we divided patients into deciles of predicted mortality risk and examined TTM treatment rates across deciles.Results: From 2013-2019, there were 25,882 successfully resuscitated patients with shockable rhythms and 43,414 patients with non-shockable rhythms presumed eligible for TTM. Of patients with shockable rhythms, predicted in-hospital mortality ranged from 16%-78% in deciles 1-10. TTM treatment increased from 44% in decile 1 to 59% in decile 10 (P for trend < 0.001), but over a third of patients in deciles 4-9 were not treated with TTM. Of patients with non-shockable rhythms, predicted mortality ranged from 48%-95% in deciles 1-10. Although TTM treatment rates increased from 36% in decile 1 to 43% in decile 10 (P for trend 0.003), TTM treatment rates were agnostic to mortality risk (44% to 47%) from decile 2-9.Conclusion: TTM treatment patterns were not well-aligned with patients' mortality risk during a period when it was a guideline-recommended treatment for OHCA. Identifying strategies to better align guideline-recommended treatments with patients' mortality risk is critical for efforts to improve OHCA survival. [ABSTRACT FROM AUTHOR]

The article focuses on questioning the interpretation of the primary results of a restrictive transfusion strategy in acute myocardial infarction patients by Carson et al., emphasizing the potential harms overlooked by null-hypothesis testing. Bayesian analyses, incorporating prior probabilities, indicate a high probability of harm from a restrictive transfusion strategy, ranging from 90.8 percent to 99.8 percent, challenging the notion that the trial's results are negative.

Background: The ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial randomized participants with chronic coronary disease (CCD) to guideline-directed medical therapy with or without angiography and revascularization. The study examined the association of nonadherence with health status outcomes.Objectives: The study sought to compare 12-month health status outcomes of adherent and nonadherent participants with CCD with an a priori hypothesis that nonadherent patients would have better health status if randomized to invasive management.Methods: Self-reported medication-taking behavior was assessed at randomization with a modified 4-item Morisky-Green-Levine Adherence Scale, and participants were classified as adherent or nonadherent. Twelve-month health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ-7) summary score (SS), which ranges from 0 to 100 (higher score = better). The association of adherence with outcomes was evaluated using Bayesian proportional odds models, including an interaction by study arm (conservative vs invasive).Results: Among 4,480 randomized participants, 1,245 (27.8%) were nonadherent at baseline. Nonadherent participants had worse baseline SAQ-7 SS in both conservative (72.9 ± 19.3 vs 75.6 ± 18.4) and invasive (71.0 ± 19.8 vs 74.2 ± 18.7) arms. In adjusted analyses, adherence was associated with higher 12-month SAQ-7 SS in both treatment groups (mean difference in SAQ-7 SS with conservative treatment = 1.6 [95% credible interval: 0.3-2.9] vs with invasive management = 1.9 [95% credible interval: 0.8-3.1]), with no interaction by treatment.Conclusions: More than 1 in 4 participants reported medication nonadherence, which was associated with worse health status in both conservative and invasive treatment strategies at baseline and 12 months. Strategies to improve medication adherence are needed to improve health status outcomes in CCD, regardless of treatment strategy. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522). [ABSTRACT FROM AUTHOR]

Introduction: Patients with critical limb ischemia (CLI) can undergo endovascular peripheral vascular intervention (PVI) to restore blood flow and decrease risk of amputation. As a potential indicator of quality for CLI care, we sought to describe 30-day major amputation rates following PVI. We also examined rate variability, and patient-level and sitelevel factors predicting amputations, using a national electronic health record (EHR) database. Methods: Using the Cerner Health Facts de-identified EHR database, patients with CLI diagnosis codes undergoing PVI were identified. The rate of amputation within 30 days of PVI was calculated. Risk ratios predicting amputation were derived using a mixed effects Poisson regression model adjusting for 16 patient and clinical factors. Median risk ratios (MRRs) were calculated to quantify site-level variability in amputations. Results: A total of 20,204 PVI procedures for CLI from 179 healthcare sites were identified. Mean age at procedure was 69.0 ± 12.6 years, 58.0% were male, and 29.6% were persons of color. Amputation within 30 days of PVI occurred after 570 (2.8%) procedures. Malnutrition, previous amputation, diabetes, and being of Black race were predictors of amputation. Amputation rates across sites ranged from 0.0% to 10.0%. The unadjusted MRR was 1.40 (95% CI 1.35-1.46), which was attenuated after adjusting for patient-level factors (MRR 1.30, 95% CI 1.26-1.34) and site characteristics (MRR 1.11, 95% CI 1.09-1.13). Conclusions: Among PVI procedures for CLI treatment, 30-day amputation rates varied across institutions. Although patient-level factors explained some variability, site-level factors explained most variation in the rates of these outcomes. [ABSTRACT FROM AUTHOR]

Aims: Clinically important thresholds in patient‐reported outcomes measures like the Kansas City Cardiomyopathy Questionnaire (KCCQ) have not been defined for patients with heart failure and preserved ejection fraction (HFpEF). The aim of this study was to estimate meaningful thresholds for improvement or worsening in the KCCQ physical limitation score (PLS) in patients with HFpEF. Methods and results: In this pre‐specified analysis from VITALITY‐HFpEF, anchor‐ and distribution‐based approaches were used to estimate thresholds for improvement or worsening in the KCCQ‐PLS using Patient Global Impression of Change (PGIC) as an anchor. The KCCQ‐PLS contains six elements, with each increment in response resulting in a change of 4.17 points when converted to a 0–100 scale. The mean change in KCCQ‐PLS from baseline to week 12 was calculated for each PGIC group to estimate a meaningful within‐patient change. Of 789 patients enrolled, 698 had complete KCCQ‐PLS and PGIC data at week 12. The mean (± standard deviation) changes in KCCQ‐PLS corresponding to PGIC changes of 'a little better', 'better', and 'much better' were 5.7 ± 18.6, 11.6 ± 19.3, and 18.4 ± 25.3 points, respectively. The scores of patients who responded 'a little better' (n = 177) overlapped substantially with those who reported 'no change' (n = 193; mean change 2.8 ± 18.9). The mean change in KCCQ‐PLS for patients responding 'a little worse' (n = 32) was −2.6 ± 18.0 points. The threshold for meaningful within‐patient change in KCCQ‐PLS based on distribution‐based analyses was 12.3 points. Using area under the curve (AUC) analyses of KCCQ‐PLS, the sensitivity and specificity of a 4.17‐point change were 0.61 and 0.57, for an 8.33‐point change they were 0.49 and 0.64, and for a 12.5‐point change they were 0.44 and 0.72 for being at least a little better on the PGIC (AUC = 0.54). Conclusion: In the VITALITY‐HFpEF trial, a change in KCCQ‐PLS of ≥8.33 points (corresponding to an improvement in ≥2 response categories of KCCQ‐PLS) may represent the minimal clinically important difference for improvement and a change of ≤ −4.17 points (corresponding to a worsening in ≥1 response category of KCCQ‐PLS) may suggest deterioration in patients with HFpEF. [ABSTRACT FROM AUTHOR]

Background: ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy.Methods: In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index).Results: Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment.Conclusions: In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT01471522. [ABSTRACT FROM AUTHOR]

Background: Improving symptoms is a primary treatment goal in patients with obstructive hypertrophic cardiomyopathy. Currently available pharmacological options for hypertrophic cardiomyopathy are not disease-specific and are often inadequate or poorly tolerated. We aimed to assess the effect of mavacamten, a first-in-class cardiac myosin inhibitor, on patients' health status-ie, symptoms, physical and social function, and quality of life.Methods: We did a health status analysis of EXPLORER-HCM, a phase 3, double-blind, randomised, placebo-controlled trial. The study took place at 68 clinical cardiovascular centres in 13 countries. Adult patients (≥18 years) with symptomatic obstructive hypertrophic cardiomyopathy (gradient ≥50 mm Hg and New York Heart Association class II-III) were randomly assigned (1:1) to mavacamten or placebo for 30 weeks, followed by an 8-week washout period. Both patients and staff were masked to study treatment. The primary outcome for this secondary analysis was the Kansas City Cardiomyopathy Questionnaire (KCCQ), a well validated disease-specific measure of patients' health status. It was administered at baseline and weeks 6, 12, 18, 30 (end of treatment), and 38 (end of study). Changes from baseline to week 30 in KCCQ overall summary (OS) score and all subscales were analysed using mixed model repeated measures. This study is registered with ClinicalTrials.gov, NCT03470545.Findings: Between May 30, 2018, and July 12, 2019, 429 adults were assessed for eligibility, of whom 251 (59%) were enrolled and randomly assigned. Of 123 patients randomly assigned to mavacamten, 92 (75%) completed the KCCQ at baseline and week 30 and of the 128 patients randomly assigned to placebo 88 (69%) completed the KCCQ at baseline and week 30. At 30 weeks, the change in KCCQ-OS score was greater with mavacamten than placebo (mean score 14·9 [SD 15·8] vs 5·4 [13·7]; difference +9·1 [95% CI 5·5-12·8]; p<0·0001), with similar benefits across all KCCQ subscales. The proportion of patients with a very large change (KCCQ-OS ≥20 points) was 36% (33 of 92) in the mavacamten group versus 15% (13 of 88) in the placebo group, with an estimated absolute difference of 21% (95% CI 8·8-33·4) and number needed to treat of five (95% CI 3-11). These gains returned to baseline after treatment was stopped.Interpretation: Mavacamten markedly improved the health status of patients with symptomatic obstructive hypertrophic cardiomyopathy compared with placebo, with a low number needed to treat for marked improvement. Given that the primary goals of treatment are to improve symptoms, physical and social function, and quality of life, mavacamten represents a new potential strategy for achieving these goals.Funding: MyoKardia, a Bristol Myers Squibb company. [ABSTRACT FROM AUTHOR]

Peripheral artery disease (PAD) is a progressive atherosclerotic disease associated with high rates of morbidity and mortality. Symptomatic PAD typically presents with claudication, and symptom severity strongly associates with reduced health-related quality of life (HRQoL). Existing treatment strategies for PAD are aimed at reducing symptom severity and improving functional outcomes. However, there is a need to incorporate patient-reported outcome measures (PROMs) into PAD treatment and research in order to provide more patient-centered care. This review will discuss the impact of PAD on HRQoL, existing PROMs available to assess PAD-related HRQoL, utilization of PROMs in research studies and registries, and challenges and solutions related to the integration of PROMs into research and clinical settings. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs) are elicited directly from patients so they can describe their overall health status, including their symptoms, function, and quality of life. While commonly used as end points in clinical trials, PROs can play an important role in routine clinical care, population health management, and as a means for quantifying the quality of patient care. In this review, we propose that PROs be used to improve patient-centered care in the treatment of cardiovascular diseases given their importance to patients and society and their ability to improve doctorprovider communication. Furthermore, given the current variability in patients' health status across different clinics and the fact that PROs can be improved by titrating therapy, we contend that PROs have a key opportunity to serve as measures of healthcare quality. [ABSTRACT FROM AUTHOR]

To improve the patient-centeredness of care, patient-reported outcomes have been increasingly used to quantify patients' symptoms, function, and quality of life. In heart failure, the Kansas City Cardiomyopathy Questionnaire (KCCQ) has been qualified by the U.S. Food and Drug Administration as a Clinical Outcome Assessment and recommended as a performance measure for quantifying the quality of care. By systematically asking the same questions reproducibly over time, the KCCQ can validly and sensitively capture the impact of heart failure on patients' lives and is strongly associated with clinical events over time. This review describes how to interpret the KCCQ, how it should be analyzed in clinical trials to maximize the interpretability of results, and how it can be used in clinical practice and population health. By providing a deeper understanding of the KCCQ, it is hoped that its use can further improve the patient-centeredness of heart failure care. [ABSTRACT FROM AUTHOR]

Background: In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status.Methods: We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy.Results: Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4).Conclusions: Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.). [ABSTRACT FROM AUTHOR]

Background: In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.Methods: We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.Results: At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).Conclusions: In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.). [ABSTRACT FROM AUTHOR]

Background: Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).Methods: From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levels: time period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).Results: Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008-2016) versus the pre-Impella era (years 2004-2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with death: odds ratio, 1.24 (95% CI, 1.13-1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00-1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18-1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds ratio, 1.08 (95% CI, 1.00-1.17).Conclusions: Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI. [ABSTRACT FROM AUTHOR]

Background: Prior studies with single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) have shown a survival benefit with early revascularization in patients with >10% to 12.5% ischemic myocardium. The relationship among positron emission tomography (PET)-derived extent of ischemia, early revascularization, and survival is unknown.Objectives: The purpose of this study was to evaluate the association among percent ischemia on PET MPI, revascularization, and survival.Methods: A total of 16,029 unique consecutive patients who were undergoing Rubidium-82 rest-stress PET MPI from 2010 to 2016 were included. Patients with known cardiomyopathy and nondiagnostic perfusion results were excluded. Percent ischemic myocardium was estimated from a 17-segment model. Propensity scoring was used to account for nonrandomized referral to early revascularization (90 days of PET). A Cox model was developed, adjusting for propensity scores for early revascularization and percent ischemia, and an interaction between ischemia and early revascularization was tested.Results: Median follow-up was 3.7 years. Overall, 1,277 (8%) patients underwent early revascularization and 2,493 (15.6%) died (738 cardiac). Nearly 37% of patients (n = 5,902) had ischemia, with 13.5% (n = 2,160) having ≥10%. In propensity-adjusted analyses, there was a significant interaction between ischemia and early revascularization (p < 0.001 for all-cause and cardiac death), such that patients with greater ischemia had improved survival with early revascularization, with a potential ischemia threshold at 5% (upper limit 95% confidence interval at 10%). There was no differential association between ischemia and early revascularization on death based on history of known coronary artery disease (interaction p = 0.72).Conclusions: In a contemporary cohort of patients undergoing PET MPI, patients with greater ischemia had a survival benefit from early revascularization. On exploratory analyses, this threshold was lower than that previously reported for SPECT. These findings require future validation in prospective cohorts or trials. [ABSTRACT FROM AUTHOR]

Background: Prior studies have reported higher in-hospital survival with prompt defibrillation and epinephrine treatment in patients with in-hospital cardiac arrest (IHCA). Whether this survival benefit persists after discharge is unknown.Methods: We linked data from a national IHCA registry with Medicare files and identified 36 961 patients ≥65 years of age with an IHCA at 517 hospitals between 2000 and 2011. Patients with IHCA caused by pulseless ventricular tachycardia or ventricular fibrillation were stratified by prompt (≤2 minutes) versus delayed (>2 minutes) defibrillation, whereas patients with IHCA caused by asystole or pulseless electric activity were stratified by prompt (≤5 minutes) versus delayed (>5 minutes) epinephrine treatment. The association between prompt treatment and long-term survival for each rhythm type was assessed with multivariable hierarchical modified Poisson regression models.Results: Of 8119 patients with an IHCA caused by ventricular tachycardia or ventricular fibrillation, the rate of 1-year survival was higher in those treated with prompt defibrillation than with delayed defibrillation (25.7% [1466 of 5714] versus 15.5% [373 of 2405]; adjusted relative risk [RR], 1.49; 95% confidence interval [CI] 1.32-1.69; P<0.0001). This survival advantage persisted at 3 years (19.1% versus 11.0%; adjusted RR, 1.45; 95% CI, 1.23-1.69; P<0.0001) and at 5 years (14.7% versus 7.9%; adjusted RR, 1.50; 95% CI, 1.22-1.83; P<0.0001). Of 28 842 patients with an IHCA caused by asystole/pulseless electric activity, the rate of 1-year survival with prompt epinephrine treatment was higher than with delayed treatment (5.4% [1341 of 24 885] versus 4.3% [168 of 3957]; adjusted RR, 1.20; 95% CI, 1.02-1.41; P=0.02), but this survival benefit was no longer present at 3 years (3.5% versus 2.9%; adjusted RR, 1.17; 95% CI, 0.95-1.45; P=0.15) and at 5 years (2.3% versus 1.9%; adjusted RR, 1.18; 95% CI, 0.88-1.58; P=0.27).Conclusions: Prompt defibrillation for IHCA caused by ventricular tachycardia or ventricular fibrillation was associated with higher rates of long-term survival throughout 5 years of follow-up, whereas prompt epinephrine treatment for asystole/pulseless electric activity was associated with greater survival at 1 year but not at 3 or 5 years. By quantifying the greater survival associated with timely defibrillation and epinephrine administration, these findings provide important insights into the durability of survival benefits for 2 process-of-care measures in current resuscitation guidelines. [ABSTRACT FROM AUTHOR]

Background: Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment).Methods: Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%.Results: The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95).Conclusions: The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement. [ABSTRACT FROM AUTHOR]

Background Quantifying quality of life (QoL) after left ventricular assist device (LVAD) remains challenging. Heart failure (HF)-specific health status measures are ideal for assessing symptoms of HF; however, if patients’ QoL is limited by other factors, they may experience improved HF-specific QoL but no concurrent improvement in generic QoL. We sought to examine and predict discrepancies between disease-specific and generic QoL measures after LVAD. Methods We examined HF-specific and generic QoL with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQol-5D Visual Analog Scale (VAS), respectively, among 1,888 patients with advanced heart failure who underwent LVAD implantation from 2012 to 2014 as part of the INTERMACS registry. Results Both measures showed substantial improvement, on average, at 6 months after LVAD, with mean changes of 32.7 ± 25.0 and 27.6 ± 27.4, respectively. Among the 1,539 patients (81.5%) with moderate/large improvement in KCCQ, 334 (21.7%) had discordant changes in generic QoL (i.e., VAS did not substantially increase despite improvement in KCCQ). In a multivariable logistic regression model, baseline VAS score was the strongest predictor of KCCQ-VAS discordance, whereas post-LVAD complications were not significant predictors of discordance. Conclusions Most patients have major improvements in both HF-specific and generic QoL after LVAD implantation, and discordance in these measures after LVAD is uncommon. When it did occur, discordance was primarily observed in patients who reported good generic QoL on the VAS before LVAD (despite substantial impairment due to congestive HF). These results support the continued use of HF-specific health status measures to monitor QoL before and after LVAD implantation. [ABSTRACT FROM AUTHOR]

Background: Up to 65% of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (MVCAD). Long-term health status of STEMI patients after multivessel revascularization is unknown.Objectives: This study investigated the relationship between multivessel revascularization and health status outcomes (symptoms and quality of life [QoL]) in STEMI patients with MVCAD.Methods: Using a U.S. myocardial infarction registry and the Seattle Angina Questionnaire (SAQ), we determined the health status of patients with STEMI and MVCAD at the time of STEMI and 1 year later. We assessed the association of multivessel revascularization during index hospitalization with 1-year health status using multivariable linear regression analysis, and also examined demographic, clinical, and angiographic factors associated with multivessel revascularization.Results: Among 664 STEMI patients with MVCAD, 251 (38%) underwent multivessel revascularization. Most revascularizations were staged during the index hospitalization (64.1%), and 8.0% were staged after discharge, with 27.9% performed during primary percutaneous coronary intervention. Multivessel revascularization was associated with age and more diseased vessels. At 1 year, multivessel revascularization was independently associated with improved symptoms (4.5 points higher SAQ angina frequency score; 95% confidence interval [CI]: 1.0 to 7.9) and QoL (6.6 points higher SAQ QoL score; 95% CI: 2.7 to 10.6). One-year mortality was not different between those who did and did not undergo multivessel revascularization (3.6% vs. 3.4%; log-rank test p = 0.88).Conclusions: Multivessel revascularization improved angina and QoL in STEMI patients with MVCAD. Patient-centered outcomes should be considered in future trials of multivessel revascularization. [ABSTRACT FROM AUTHOR]

Importance: After patients survive an in-hospital cardiac arrest, discussions should occur about prognosis and preferences for future resuscitative efforts.Objective: To assess whether patients' decisions for do-not-resuscitate (DNR) orders after a successful resuscitation from in-hospital cardiac arrest are aligned with their expected prognosis.Design, Setting, and Participants: Within Get With The Guidelines-Resuscitation, we identified 26,327 patients with return of spontaneous circulation (ROSC) after in-hospital cardiac arrest between April 2006 and September 2012 at 406 US hospitals. Using a previously validated prognostic tool, each patient's likelihood of favorable neurological survival (ie, without severe neurological disability) was calculated. The proportion of patients with DNR orders within each prognosis score decile and the association between DNR status and actual favorable neurological survival were examined.Exposures: Do-not-resuscitate orders within 12 hours of ROSC.Main Outcomes and Measures: Likelihood of favorable neurological survival.Results: Overall, 5944 (22.6% [95% CI, 22.1%-23.1%]) patients had DNR orders within 12 hours of ROSC. This group was older and had higher rates of comorbidities (all P < .05) than patients without DNR orders. Among patients with the best prognosis (decile 1), 7.1% (95% CI, 6.1%-8.1%) had DNR orders even though their predicted rate of favorable neurological survival was 64.7% (95% CI, 62.8%-66.6%). Among patients with the worst expected prognosis (decile 10), 36.0% (95% CI, 34.2%-37.8%) had DNR orders even though their predicted rate for favorable neurological survival was 4.0% (95% CI, 3.3%-4.7%) (P for both trends <.001). This pattern was similar when DNR orders were redefined as within 24 hours, 72 hours, and 5 days of ROSC. The actual rate of favorable neurological survival was higher for patients without DNR orders (30.5% [95% CI, 29.9%-31.1%]) than it was for those with DNR orders (1.8% [95% CI, 1.6%-2.0%]). This pattern of lower survival among patients with DNR orders was seen in every decile of expected prognosis.Conclusions and Relevance: Although DNR orders after in-hospital cardiac arrest were generally aligned with patients' likelihood of favorable neurological survival, only one-third of patients with the worst prognosis had DNR orders. Patients with DNR orders had lower survival than those without DNR orders, including those with the best prognosis. [ABSTRACT FROM AUTHOR]

Objective To recommend methods for assessing quality of care via patient-reported outcome-based performance measures (PRO-PMs) of symptoms, functional status, and quality of life. Methods A Technical Expert Panel was assembled by the American Medical Association–convened Physician Consortium for Performance Improvement. An environmental scan and structured literature review were conducted to identify quality programs that integrate PRO-PMs. Key methodological considerations in the design, implementation, and analysis of these PRO-PM data were systematically identified. Recommended methods for addressing each identified consideration were developed on the basis of published patient-reported outcome (PRO) standards and refined through public comment. Literature review focused on programs using PROs to assess performance and on PRO guidance documents. Results Thirteen PRO programs and 10 guidance documents were identified. Nine best practices were developed, including the following: provide a rationale for measuring the outcome and for using a PRO-PM; describe the context of use; select a measure that is meaningful to patients with adequate psychometric properties; provide evidence of the measure’s sensitivity to differences in care; address missing data and risk adjustment; and provide a framework for implementation, interpretation, dissemination, and continuous refinement. Conclusion Methods for integrating PROs into performance measurement are available. [ABSTRACT FROM AUTHOR]

Background--Many clinical trials use composite end points to reduce sample size, but the relative importance of each individual end point within the composite may differ between patients and researchers. Methods and Results--We asked 785 cardiovascular patients and 164 clinical trial authors to assign 25 "spending weights" across 5 common adverse events comprising composite end points in cardiovascular trials: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. We then calculated end point ratios for each participant's ratings of each nonfatal end point relative to death. Whereas patients assigned an average weight of 5 to death, equal or greater weight was assigned to myocardial infarction (mean ratio, 1.12) and stroke (ratio, 1.08). In contrast, clinical trialists were much more concerned about death (average weight, 8) than myocardial infarction (ratio, 0.63) or stroke (ratio, 0.53). Both patients and trialists considered revascularization (ratio, 0.48 and 0.20, respectively) and hospitalization (ratio, 0.28 and 0.13, respectively) as substantially less severe than death. Differences between patient and trialist end point weights persisted after adjustment for demographic and clinical characteristics OP<0.001 for all comparisons). Conclusions--Patients and clinical trialists did not weigh individual components of a composite end point equally. Whereas trialists are most concerned about avoiding death, patients place equal or greater importance on reducing myocardial infarction or stroke. Both groups considered revascularization and hospitalization as substantially less severe. These findings suggest that equal weights in a composite clinical end point do not accurately reflect the preferences of either patients or trialists. [ABSTRACT FROM AUTHOR]

Background: Many clinical trials use composite end points to reduce sample size, but the relative importance of each individual end point within the composite may differ between patients and researchers.Methods and Results: We asked 785 cardiovascular patients and 164 clinical trial authors to assign 25 "spending weights" across 5 common adverse events comprising composite end points in cardiovascular trials: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. We then calculated end point ratios for each participant's ratings of each nonfatal end point relative to death. Whereas patients assigned an average weight of 5 to death, equal or greater weight was assigned to myocardial infarction (mean ratio, 1.12) and stroke (ratio, 1.08). In contrast, clinical trialists were much more concerned about death (average weight, 8) than myocardial infarction (ratio, 0.63) or stroke (ratio, 0.53). Both patients and trialists considered revascularization (ratio, 0.48 and 0.20, respectively) and hospitalization (ratio, 0.28 and 0.13, respectively) as substantially less severe than death. Differences between patient and trialist end point weights persisted after adjustment for demographic and clinical characteristics (P<0.001 for all comparisons).Conclusions: Patients and clinical trialists did not weigh individual components of a composite end point equally. Whereas trialists are most concerned about avoiding death, patients place equal or greater importance on reducing myocardial infarction or stroke. Both groups considered revascularization and hospitalization as substantially less severe. These findings suggest that equal weights in a composite clinical end point do not accurately reflect the preferences of either patients or trialists. [ABSTRACT FROM AUTHOR]

The extent to which angina pectoris (AP) predicts secondary cardiovascular events beyond independent of measures of disease severity is unknown. We evaluated the association between AP frequency and secondary events in patients with stable coronary heart disease (CHD). We administered the Seattle Angina Questionnaire to 1,023 participants with stable CHD enrolled from September 2000 to December 2002 and followed for a median of 8.9 years. We used Cox proportional hazards to evaluate the association of AP frequency with death and subsequent hospitalization for AP, revascularization, myocardial infarction (MI), or heart failure. At enrollment, 633 (62%) participants reported no AP, 279 (27%) reported monthly AP, and 111 (11%) reported daily or weekly AP. During follow-up, 396 participants died, 204 were hospitalized for AP, 194 for revascularization, 140 for MI, and 188 for heart failure. Compared with participants without AP, participants with daily or weekly AP were more likely to be hospitalized for AP (hazard ratio [HR] 3.3; 95% confidence interval [CI] 2.3 to 4.7; p <0.001), revascularization (HR 2.0; 95% CI 1.3 to 2.9; p = 0.001), or heart failure (HR 1.6; 95% CI 1.0 to 2.5; p = 0.03) and more likely to die (HR 1.5; 95% CI 1.1 to 2.0; p = 0.01). AP was not independently associated with MI (HR 1.3; 95% CI 0.8 to 2.3; p = 0.29). After adjusting for demographics, co-morbidities, treadmill exercise capacity, ejection fraction, and inducible ischemia, frequency of AP remained independently associated with hospitalization for AP (HR 2.4; 95% CI 1.6 to 3.6; p <0.001), revascularization (HR 1.7; 95% CI 1.1 to 2.7; p = 0.02), and death (HR 1.4; 95% CI 1.0 to 2.0; p = 0.045). In conclusion, in outpatients with stable CHD, AP frequency predicts higher rates of secondary cardiovascular events and death, independent of objective measures of disease severity. [ABSTRACT FROM AUTHOR]

Many patients undergo elective coronary angiography without preprocedural stress testing that may be suitable if performed in patients with more angina pectoris or more frequently identified obstructive coronary artery disease (CAD). Patients in the National Cardiovascular Data Registry CathPCI Registry undergoing elective coronary angiography from July 2009 to April 2013 were assessed for differences in angina (Canadian Cardiovascular Society [CCS] class) and severity of obstructive CAD in those with and without preprocedural stress testing, stratified by CAD history. Given the large sample size, differences were considered clinically meaningful if the standardized difference (SD) was >10%. Of 790,601 patients without CAD history, 36.9% did not undergo preprocedural stress testing. Compared with patients with preprocedural stress testing, patients without preprocedural stress testing were more frequently angina free (CCS class 0; 28.2% with stress test vs 38.5% without, SD = 14.8%) and had similar rates of obstructive CAD (40.1% with stress test vs 35.7% without, SD = 9.0). Of 449,579 patients with CAD history, 44.2% did not undergo preprocedural stress testing. Patients without preprocedural stress testing reported more angina (CCS class III/IV angina: 17.8% vs 13.4%; SD = 11.3%) but were not more likely to have obstructive CAD (78.7% vs 81.1%; SD = 5.8%) than patients with preprocedural stress testing. In conclusion, approximately 40% of patients undergoing elective coronary angiography did not have preprocedural risk stratification with stress testing. For these patients, the clinical decision to proceed directly to invasive evaluation was not driven primarily by severe angina and did not result in higher detection rates for obstructive CAD. [ABSTRACT FROM AUTHOR]

The article discusses the depression treatment and health status outcomes in young patients with acute myocardial infarction (AMI) and presents study on same. Topics include continued antidepressant medications and depression counseling received by patients; measuring treatment effects with random effects for marital status, diabetes mellitus, and heart failure; and higher depression rates in women among AMI survivors.

Aims Risk stratification in patients admitted with worsening heart failure (HF) is essential for tailoring therapy and counselling. Risk models are available but rarely used, in part because many require laboratory and imaging results that are not routinely available. Body temperature is associated with prognosis in other illnesses, and we hypothesized that low body temperature would be associated with worse outcomes in patients admitted with worsening HF. Methods and results The Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial was an event-driven, randomized, double-blind, placebo-controlled study of tolvaptan in 4133 patients hospitalized for worsening HF with an EF <40%. Co-primary endpoints were all-cause mortality and cardiovascular (CV) death or HF rehospitalization. Body temperature was measured orally at randomization and entered in analyses both as a continuous variable and categorized into three groups (<36°C, 36–36.5°C, and >36.5°C) using Cox regression models. The composite of CV death or HF rehospitalization occurred in 1544 patients within 1 year. For every 1°C decrease in body temperature, the risk of adverse outcomes increased by 16% [hazard raio (HR) 1.16, 95% confidence interval (CI) 1.04–1.28], after adjustment for age, gender, race, systolic blood pressure, EF, blood urea nitrogen, and serum sodium. In fully adjusted analysis, the risk of adverse outcomes in the lowest body temperature group (<36°C) was 51% higher than that of the index group (>36.5°C) (HR 1.35, 95% CI 1.15–1.58). Conclusions Low body temperature is an independent marker of poor cardiovascular outcomes in patients admitted with worsening HF and reduced EF. [ABSTRACT FROM PUBLISHER]

Objectives: The aim of this study was to examine the prescribing patterns of medications quantified by the performance measures for acute myocardial infarction (AMI). Background: Current performance measures for AMI are designed to improve quality by quantifying the use of evidence-based treatments. However, these measures only assess medication prescription. Whether patients receive optimal dosing of secondary prevention medications at the time of and after discharge after AMI is unknown. Methods: We assessed treatment doses of beta-blockers, statins, and angiotensin-converting enzyme inhibitors (ACEI)/angiotensin II receptor blockers (ARBs) at discharge and 12 months after AMI among 6,748 patients from 31 hospitals enrolled in 2 U.S. registries (2003 to 2008). Prescribed doses were categorized as none, low (<50% target [defined from seminal clinical trials]), moderate (50% to 74% target), or goal (≥75% target). Patients with contraindications were excluded from analyses for that medication. Results: Most eligible patients (>87%) were prescribed some dose of each medication at discharge, although only 1 in 3 patients were prescribed these medications at goal doses. Of patients not discharged on goal doses, up-titration during follow-up occurred infrequently (approximately 25% of patients for each medication). At 12 months, goal doses of beta-blockers, statins, and ACEI/ARBs were achieved in only 12%, 26%, and 32% of eligible patients, respectively. After multivariable adjustment, prescription of goal dose at discharge was strongly associated with being at goal dose at follow-up: beta-blockers, adjusted odds ratio (OR): 6.08 (95% confidence interval [CI]: 3.70 to 10.01); statins, adjusted OR: 8.22 (95% CI: 6.20 to 10.90); ACEI/ARBs, adjusted OR: 5.80 (95% CI: 2.56 to 13.16); p < 0.001 for each. Conclusions: Although nearly all patients after an AMI are discharged on appropriate secondary prevention medications, dose increases occur infrequently, and most patients are prescribed doses below those with proven efficacy in clinical trials. Integration of dose intensity into performance measures might help improve the use of optimal medical therapy after AMI. [Copyright &y& Elsevier]

The article examines the evidence-based treatment for patients with ST-segment elevation myocardial infarction (STEMI) disorder. The refers to guidelines specified by National Institute for Health and Care Excellence (NICE ) which calls for monitoring of adjunctive therapies for primary percutaneous coronary intervention (PCI). It also states that clinical trials conducted for STEMI care do not correspond to measures of patients' symptoms and quality of life.

Background: Modification of traditional cardiac risk factors is an important goal for patients after an acute myocardial infarction (AMI). Risk factor prevalence and secondary prevention efforts at discharge are well characterized among older patients; however, research is limited for younger and minority AMI populations, particularly among women. Methods: Among 2369 AMI patients enrolled in a 19-center prospective study, we compared the prevalence and cumulative number of five cardiac risk factors (hypertension, hypercholesterolemia, current smoking, diabetes, obesity) by age, sex, and race. We also compared secondary prevention strategies at discharge for these risk factors, including prescription of antihypertensive or lipid-lowering medications and counseling on preventive behaviors (smoking cessation, diabetes management, diet/weight management). Results: Approximately 93% of patients had ≥1 risk factor, 72% had ≥2 factors, and 40% had ≥3 factors. The prevalence of multiple risk factors was markedly higher for blacks than for whites within each age-sex group; black women had the greatest risk factor burden of any subgroup (60% of older black women and 54% of younger black women had ≥3 risk factors). Secondary prevention efforts for smoking cessation were less common for black compared with white patients, and younger black patients were less often prescribed antihypertensive and lipid-lowering medications compared with younger white patients. Conclusions: Multiple cardiac risk factors are highly prevalent in AMI patients, particularly among black women. Secondary prevention efforts, however, are less common for blacks compared to whites, especially among younger patients. Our findings highlight the need for improved risk factor modification efforts in these high-risk subgroups. [ABSTRACT FROM AUTHOR]

Background: Studies conducted decades ago described substantial disagreement and errors in physicians' angiographic interpretation of coronary stenosis severity. Despite the potential implications of such findings, no large-scale efforts to measure or improve clinical interpretation were subsequently undertaken.Methods and Results: We compared clinical interpretation of stenosis severity in coronary lesions with an independent assessment using quantitative coronary angiography (QCA) in 175 randomly selected patients undergoing elective percutaneous coronary intervention at 7 US hospitals in 2011. To assess agreement, we calculated mean difference in percent diameter stenosis between clinical interpretation and QCA and a Cohen weighted κ statistic. Of 216 treated lesions, median percent diameter stenosis was 80.0% (quartiles 1 and 3, 80.0% and 90.0%), with 213 (98.6%) assessed as ≥70%. Mean difference in percent diameter stenosis between clinical interpretation and QCA was 8.2±8.4%, reflecting an average higher percent diameter stenosis by clinical interpretation (P<0.001). A weighted κ of 0.27 (95% confidence interval, 0.18-0.36) was found between the 2 measurements. Of 213 lesions considered ≥70% by clinical interpretation, 56 (26.3%) were <70% by QCA, although none were <50%. Differences between the 2 measurements were largest for intermediate lesions by QCA (50% to <70%), with variation existing across sites.Conclusions: Physicians tended to assess coronary lesions treated with percutaneous coronary intervention as more severe than measurements by QCA. Almost all treated lesions were ≥70% by clinical interpretation, whereas approximately one quarter were <70% by QCA. These findings suggest opportunities to improve clinical interpretation of coronary angiography. [ABSTRACT FROM AUTHOR]

Background-Studies conducted decades ago described substantial disagreement and errors in physicians' angiographic interpretation of coronary stenosis severity. Despite the potential implications of such findings, no large-scale efforts to measure or improve clinical interpretation were subsequently undertaken. Methods and Results-We compared clinical interpretation of stenosis severity in coronary lesions with an independent assessment usmg quantitative coronary angiography (QCA) in 175 randomly selected patients undergoing elective percutaneous coronary intervention at 7 US hospitals in 2011. To assess agreement, we calculated mean difference in percent diameter stenosis between clinical interpretation and QCA and a Cohen weighted ic statistic. Of 216 treated lesions, median percent diameter stenosis was 80.0% (quartiles 1 and 3, 80.0% and 90.0%), with 213 (98.6%) assessed as ≥70%. Mean difference in percent diameter stenosis between clinical interpretation and QCA was 8.2±8.4%, reflecting an average higher percent diameter stenosis by clinical interpretation (P<0.001). A weighted κ of 0.27 (95% confidence interval, 0.18-0.36) was found between the 2 measurements. Of 213 lesions considered ≥70% by clinical interpretation, 56(26.3%) were <70% by QCA, although none were <50%. Differences between the 2 measurements were largest for intermediate lesions by QCA (50% to <70%), with variation existing across sites. Conclusions-Physicians tended to assess coronary lesions treated with percutaneous coronary intervention as more severe than measurements by QCA. Almost all treated lesions were ≥70% by clinical interpretation, whereas approximately one quarter were <70% by QCA. These findings suggest opportunities to improve clinical interpretation of coronary angiography. [ABSTRACT FROM AUTHOR]

Objectives: This study examined the association between insurance status and physicians' adherence with providing evidence-based treatments for coronary artery disease (CAD).Methods: Within the PINNACLE (Practice Innovation and Clinical Excellence) registry of the NCDR (National Cardiovascular Data Registry), the authors identified 60,814 outpatients with CAD from 30 U.S. practices. Hierarchical modified Poisson regression models with practice site as a random effect were used to study the association between health insurance (no insurance, public, or private health insurance) and 5 CAD quality measures.Results: Of 60,814 patients, 5716 patients (9.4%) were uninsured and 11,962 patients (19.7%) had public insurance, whereas 43,136 (70.9%) were privately insured. After accounting for exclusions, uninsured patients with CAD were 9%, 12%, and 6% less likely to receive treatment with a beta-blocker, an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACE-I/ARB), and lipid-lowering therapy, respectively, than privately insured patients, and patients with public insurance were 9% less likely to be prescribed ACE-I/ARB therapy. Most differences by insurance status were attenuated after adjusting for the site providing care. For example, whereas uninsured patients with left ventricular dysfunction and CAD were less likely to receive ACE-I/ARB therapy (unadjusted RR: 0.88; 95% CI: 0.84 to 0.93), this difference was eliminated after adjustment for site (adjusted RR: 0.95; 95% CI: 0.88 to 1.03; p = 0.18).Conclusions: Within this national outpatient cardiac registry, uninsured patients were less likely to receive evidence-based medications for CAD. These disparities were explained by the site providing care. Efforts to reduce treatment differences by insurance status among cardiac outpatients may additionally need to focus on improving the rates of evidence-based treatment at sites with high proportions of uninsured patients. [ABSTRACT FROM AUTHOR]

Objectives: This study examined the association between insurance status and physicians'' adherence with providing evidence-based treatments for coronary artery disease (CAD). Methods: Within the PINNACLE (Practice Innovation and Clinical Excellence) registry of the NCDR (National Cardiovascular Data Registry), the authors identified 60,814 outpatients with CAD from 30 U.S. practices. Hierarchical modified Poisson regression models with practice site as a random effect were used to study the association between health insurance (no insurance, public, or private health insurance) and 5 CAD quality measures. Results: Of 60,814 patients, 5716 patients (9.4%) were uninsured and 11,962 patients (19.7%) had public insurance, whereas 43,136 (70.9%) were privately insured. After accounting for exclusions, uninsured patients with CAD were 9%, 12%, and 6% less likely to receive treatment with a beta-blocker, an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACE-I/ARB), and lipid-lowering therapy, respectively, than privately insured patients, and patients with public insurance were 9% less likely to be prescribed ACE-I/ARB therapy. Most differences by insurance status were attenuated after adjusting for the site providing care. For example, whereas uninsured patients with left ventricular dysfunction and CAD were less likely to receive ACE-I/ARB therapy (unadjusted RR: 0.88; 95% CI: 0.84 to 0.93), this difference was eliminated after adjustment for site (adjusted RR: 0.95; 95% CI: 0.88 to 1.03; p = 0.18). Conclusions: Within this national outpatient cardiac registry, uninsured patients were less likely to receive evidence-based medications for CAD. These disparities were explained by the site providing care. Efforts to reduce treatment differences by insurance status among cardiac outpatients may additionally need to focus on improving the rates of evidence-based treatment at sites with high proportions of uninsured patients. [Copyright &y& Elsevier]

Background--Cardiac rehabilitation (CR) after acute myocardial infarction (AMI) is a Class I recommendation. Although referral to CR after an AMI has recently become a performance measure, many patients may not participate. To illuminate potential barriers to participation, we examined the prevalence of, and patient-related factors associated with, CR participation within 1 and 6 months after an AMI. Methods and Results--We studied 2096 AMI patients enrolled from 19 US sites in the Prospective Registry Evaluating outcomes after Myocardial Infarction: Events and Recovery (PREMIER) registry. Analyses were limited to those patients referred for CR at the time of AMI hospitalization. A multivariable, conditional logistic regression model, stratified by hospital, was used to identify sociodemographic, comorbidity, and clinical factors independently associated with CR participation within 1 and 6 months of AMI hospital discharge. Only 29% (419/1450) and 48.25% (650/1347) of AMI patients who received referral for CR participated within 1 and 6 months after discharge, respectively. Women (odds ratio [OR], 0.61; 95% confidence interval [CI], 0.44-0.86), uninsured (OR, 0.39; 95% CI, 0.21-0.71), and patients with hypertension (OR, 0.58; 95% CI, 0.43-0.78) and peripheral arterial disease (OR, 0.43; 95% CI, 0.22-0.85) were less likely to participate at 1 month. At 6 months after AMI, older patients (OR, 0.85 for each 10-year increment; 95% CI, 0.74-0.97), smokers (OR, 0.59; 95% CI, 0.44-0.80), and patients with economic burden (OR, 0.56; 95% CI, 0.38-0.81) were less likely to participate. Caucasians (OR, 1.73; 95% CI, 1.16-2.58) and educated patients (OR, 1.81; 95% CI, 1.42-2.30) were more likely to participate at 6 months. Patients with previous percutaneous interventions were less likely to participate at both 1 and 6 months post-AMI. Conclusions--Among patients referred for CR post-AMI, participation remains low both at 1 and 6 months after AMI. Because CR is associated with beneficial changes in cardiovascular risk factors and better outcomes after AMI, more aggressive efforts are needed to increase CR participation after referral. [ABSTRACT FROM AUTHOR]

The article discusses a study to assess variations in drug-eluting stents (DES) use among U.S. physicians participating in the National Cardiovascular Data Registry (NCDR), the association between predicted target vessel revascularization (TVR) risk with bare-metal stents (BMS) with DES use and the estimated clinical and economic consequences of lower DES use in patients with low TVR risk. It concludes that DES use is common even on those predicted to be at the lowest restenosis risk.

The article discusses a study that developed a simple, bedside prediction tool that provides accurate estimation of favorable neurological survival after in-hospital cardiac arrest. Findings show that the rates of favorable neurological survival were similar in the derivation cohort and validation cohort patients. Evidence suggests that the tool provides accurate prognostication after cardiac arrest for physicians, patients and families.

The article discusses a study on the relationship between levels of serum potassium and in-hospital mortality in patients with acute myocardial infarction (AMI) in the era of widespread use of β-blocker and reperfusion therapy. The study used information on 38,689 patients with AMI included in the Health Facts database of Cerner Corp. in the U.S. The occurrence of ventricular fibrillation, ventricular flutter or cardiac arrest in 1707 patients during hospitalization is discussed. AMI patients with postadmission serum potassium levels between 3.5 and less than 4.5 milliequivalents per liter (mEq/L) were found to have the lowest mortality.

Background: Somatic depressive symptoms and certain biomarkers are each associated with worse acute myocardial infarction (AMI) prognosis, but the relationship between depressive symptom domains and inflammatory, neurohormonal, and coagulation markers is unknown. Methods: We examined the relationship between depressive symptoms and 1-month biomarker levels (high-sensitivity C-reactive protein [hs-CRP], N-terminal pro-brain natriuretic peptide [NT-proBNP], white blood cell [WBC], platelet counts) in 1265 AMI patients. Depressive symptoms (9-item Patient Health Questionnaire) were assessed during index hospitalization and categorized as somatic or cognitive. Using median regression models, the upper quartile of somatic and cognitive depression scores and each biomarker were compared with the lower three quartiles, adjusting for site, demographics, and clinical characteristics. Results: Although hs-CRP values were higher in patients with somatic symptoms, this association was attenuated after adjustment (Bper SD increase = .02, 95% confidence interval: .00; .05, p = .07). WBC count was independently associated with somatic depressive symptoms (Bper SD increase = .28, 95% confidence interval: .12; .44, p < .001). Cognitive depressive symptoms were not associated with hs-CRP or WBC count. Neither dimension was associated with NT-proBNP or platelet levels. For each biomarker, the depression dimensions explained <1% of their variation. Conclusions: Neither somatic nor cognitive depressive symptoms were meaningfully associated with hs-CRP, NT-proBNP, WBC, or platelet counts 1 month after AMI, suggesting that the association between depression and long-term outcomes may be unrelated to these biomarkers. Future research should explore other biomarkers to better illuminate pathways by which depression adversely impacts AMI prognosis. [Copyright &y& Elsevier]

Background--Clinical trials have shown that statin therapy reduces cardiovascular morbidity and mortality in patients with coronary artery disease (CAD), even among patients with low-density lipoprotein cholesterol levels <100 mg/dL. We sought to determine the extent to which patients with obstructive CAD in routine outpatient care are treated with statins, nonstatins, or no lipid-lowering therapy. Methods and Results--Within the American College of Cardiology's Practice Innovation and Clinical Excellence (PINNACLE) outpatient registry, we examined rates of treatment with statin and nonstatin medications in 38 775 outpatients with obstructive CAD (history of myocardial infarction or coronary revascularization) and without documented contraindications to statin therapy. Among these patients, 30 160 (77.8%) were prescribed statins, 2042 (5.3%) were treated only with nonstatin lipid-lowering medications, and 6573 (17.0%) were untreated. Lack of medical insurance was associated with no statin treatment, and male sex, coexisting hypertension, and a recent coronary revascularization were associated with statin treatment. Among those not on any lipid-lowering therapy, low-density lipoprotein cholesterol levels were available for 51.2% (3365/6573). Among these untreated patients, low-density lipoprotein cholesterol levels were < 100 mg/dL in 1794 patients (53.3%) and ≥100 mg/dL in 1571 patients (46.7%). Conclusions--Despite robust clinical trial evidence, a substantial number of patients with obstructive CAD remain untreated with statins. A small proportion were treated with nonstatin therapy, and 1 in 6 patients was simply untreated; half of the untreated patients had low-density lipoprotein cholesterol values <100 mg/dL. These findings illustrate important opportunities to improve lipid management in outpatients with obstructive CAD. [ABSTRACT FROM AUTHOR]