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An American College of Cardiology (ACC)/American Heart Association (AHA) task force on practice guidelines in 2001 published evidence-based recommendations for performing percutaneous coronary interventions (PCIs). These guidelines grouped the indications for PCI into 4 classes (I, IIa, IIb, and III) based on analyses of risks and benefits. In a previous study, we found that clinical success and in-hospital adverse events varied by indications class. However, no adjustment for risk was used in those comparisons. The ACC/National Cardiovascular Data Registry (ACC-NCDR) previously developed a risk-adjustment model for the adverse event of in-hospital PCI mortality. We investigated how the 14 individual risk factors in the ACC-NCDR PCI mortality model might differ across the 4 indications classes and whether estimated mortality for each class approximated the observed mortality for that class. We analyzed the ACC-NCDR PCI database for January 1, 2001 to December 31, 2004. We excluded procedures performed for treatment of acute ST-segment elevation myocardial infarction; all others were included, yielding 559,273 procedures for analysis. An algorithm derived from the 2001 guidelines was used to assign procedures to an indications class. Increasing frequencies of risk components were observed across classes I, IIa, IIb, and III. Expected mortalities for each class calculated by the risk-adjustment model were close to observed values (expected 0.52%, 0.59%, 1.72%, and 1.96%, respectively; observed 0.49%, 0.63%, 1.88%, and 1.60%, respectively). In conclusion, the ACC-NCDR risk-adjusted mortality model can be linked to the ACC/AHA PCI guidelines, and together these produce mortality risk estimates by indications classes that are close to actual observed values. With further refinement, these methods should be able to be used as powerful analytic tools for quality assurance and appropriateness purposes.

Data demonstrating the outcome of transcatheter aortic valve replacement (TAVR) in the very elderly patients are limited, as they often represent only a small proportion of the trial populations.The purpose of this study was to compare the outcomes of nonagenarians to younger patients undergoing TAVR in current practice.We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. Outcomes at 30 days and 1 year were compared between patients ≥90 years versus90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire.Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90 years. The 30-day and 1-year mortality rates were significantly higher among nonagenarians (age ≥90 years vs.90 years: 30-day: 8.8% vs. 5.9%; p0.001; 1 year: 24.8% vs. 22.0%; p0.001, absolute risk: 2.8%, relative risk: 12.7%). However, nonagenarians had a higher mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score (10.9% vs. 8.1%; p0.001) and, therefore, had similar ratios of observed to expected rates of 30-day death (age ≥90 years vs.90 years: 0.81, 95% confidence interval: 0.70 to 0.92 vs. 0.72, 95% confidence interval: 0.67 to 0.78). There were no differences in the rates of stroke, aortic valve reintervention, or myocardial infarction at 30 days or 1 year. Nonagenarians had lower (worse) median Kansas City Cardiomyopathy Questionnaire scores at 30 days; however, there was no significant difference at 1 year.In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality rates were statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in nonagenarians as in younger patients. These data support safety and efficacy of TAVR in select very elderly patients.

Background— Surgical risk scores do not include frailty assessments (eg, gait speed), which are of particular importance for patients with severe aortic stenosis considering transcatheter aortic valve replacement. Methods and Results— We assessed the association of 5-m gait speed with outcomes in a cohort of 8039 patients who underwent transcatheter aortic valve replacement (November 2011–June 2014) and were included in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. We evaluated the association between continuous and categorical gait speed and 30-day all-cause mortality before and after adjustment for Society of Thoracic Surgeons–predicted risk of mortality score and key variables. Secondary outcomes included in-hospital mortality, bleeding, acute kidney injury, and stroke. The overall median gait speed was 0.63 m/s (25th–75th percentile, 0.47–0.79 m/s), with the slowest walkers (0.83 m/s) constituting 24% of the population. Thirty-day all-cause mortality rates were 8.4%, 6.6%, and 5.4% for the slowest, slow, and normal walkers, respectively ( P Conclusions— Gait speed is independently associated with 30-day mortality after transcatheter aortic valve replacement. Identification of frail patients with the slowest gait speeds facilitates preprocedural evaluation and anticipation of a higher level of postprocedural care. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01737528.

The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease.This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers.The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared.Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%.The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.

Background Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient‐centered outcomes and longitudinal outcomes are under‐represented in current assessments. Methods and Results The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working Group to define a consensus standard set of outcome measures and risk factors for tracking, comparing, and improving the outcomes of CAD care. Members were drawn from 4 continents and 6 countries. Using a modified Delphi method, the ICHOM Working Group defined who should be tracked, what should be measured, and when such measurements should be performed. The ICHOM CAD consensus measures were designed to be relevant for all patients diagnosed with CAD, including those with acute myocardial infarction, angina, and asymptomatic CAD. Thirteen specific outcomes were chosen, including acute complications occurring within 30 days of acute myocardial infarction, coronary artery bypass grafting surgery, or percutaneous coronary intervention; and longitudinal outcomes for up to 5 years for patient‐reported health status (Seattle Angina Questionnaire [SAQ‐7], elements of Rose Dyspnea Score, and Patient Health Questionnaire [PHQ‐2]), cardiovascular hospital admissions, cardiovascular procedures, renal failure, and mortality. Baseline demographic, cardiovascular disease, and comorbidity information is included to improve the interpretability of comparisons. Conclusions ICHOM recommends that this set of outcomes and other patient information be measured for all patients with CAD.

Purpose In the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), simvastatin/ezetimibe combination was associated with a 6% relative risk reduction in the combined cardiovascular outcome compared with simvastatin alone in patients with acute coronary syndrome. Given strict inclusion criteria (low-density lipoprotein cholesterol 50-125 mg/dL and no use of statins more potent than simvastatin 40 mg), the implications of this important trial in routine acute coronary syndrome care are unknown. Methods We identified patients with acute coronary syndrome from the Veterans Affairs health care system over a 5-year period and determined what proportion would be candidates for ezetimibe on the basis of IMPROVE-IT criteria. We then evaluated what proportion could potentially see an increase in ezetimibe use if IMPROVE-IT criteria are not strictly followed. Results Of 219,625 patients with acute coronary syndrome, 69,508 (31.6%) would qualify for ezetimibe on the basis of strict criteria. Among those who did not meet IMPROVE-IT criteria (n = 150,117), ezetimibe could potentially be prescribed by clinicians in a further 28% of patients (n = 61,635) using statins more potent than simvastatin 40 mg, 7.1% of patients (15,527) with a documented statin intolerance, and 10.4% of patients (22,758) with low-density lipoprotein cholesterol >125 mg/dL. Conclusions Our results provide a first look at the implications of this trial in a large health care system. Although 31.6% of patients would qualify for ezetimibe, there is a large potential for an increase in ezetimibe use in acute coronary syndrome outside of the strict trial inclusions. These findings call for a discussion on ezetimibe's role in patients with acute coronary syndrome already taking high-intensity statins or those with statin intolerance.

Background: There is great promise in ‘big data’ analytics that leverage multiple data sources including clinical registries and claims data, creating large, broadly distributed, and clinically detailed analytical platforms to study a range of cardiovascular topics, including practice patterns associated with optimal clinical outcomes. Objective: Describe a newly created integrated analytical platform utilizing U.S. cardiovascular registry records and healthcare claims data from real-world clinical practices. Methods: The analytical platform includes records from five American College of Cardiology (ACC) National Cardiovascular Data Registry programs and pharmacy, private practitioner and hospital claims data from Symphony Health Solutions (SHS). The NCDR registries include ≈ 650,000 patients in ACTION Registry-GWTG (acute coronary syndrome), 6.7m in CathPCI (diagnostic cardiac catheterizations and PCI), 660,000 in ICD (implantable cardioverter defibrillators), 33,000 in IMPACT (pediatric and adult congenital treatment) and 3.4m in PINNACLE (ambulatory CAD, HTN, HF and AFib). With history as early as 2003, SHS currently receives one or more pharmacy, practitioner or hospital claims annually for ≈274m patients in the U.S. All payer types are represented, including self-pay pharmacy patients. Patient inclusion criteria: 1) Data within 2006 [[Unable to Display Character: –]] 2014, 2) one or more records in ≥ 1 of 5 NCDR registries, 3) one or more claims observed in ≥ 1 of 3 SHS datasets: pharmacy, private practitioner or hospital claims, 4) populated data fields enabling generation of a unique, patient-level, synthetic identifier (ID) for matching and longitudinal linkage across the registry(s) and the dataset(s). The analytical platform has been developed using a HIPAA and HITECH compliant, certified approach. Results: Over 8.7 million patients have been successfully linked between the NCDR registries and the SHS claims data. On average, 95% of patients in the registry(s) sample was also observed and matched in the SHS datasets. Conclusion: High match rates were observed between the ACC and SHS data, identifying large populations of patients with cardiovascular disease. Clinical registry data combined with longitudinal claims data will generate a ‘broad’ and ‘deep’ data platform for analytics of quality of care and outcomes.

Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials.To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States.Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for MedicareMedicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014.Transcatheter aortic valve replacement.One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling.The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs75 years, 1.61 [95% CI, 1.24-2.09]; HR for 85-94 years vs75 years, 1.35 [95% CI, 1.18-1.55]; and HR for 75-84 years vs75 years, 1.23 [95% CI, 1.08-1.41]), male sex (HR, 1.21; 95% CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% CI, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% CI, 1.15-1.71).Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.

Background— Guidelines for heart failure (HF) recommend prescription of guideline-directed medical therapy before hospital discharge; some of these therapies are included in publicly reported performance measures. The burden of new medications for individual patients has not been described. Methods and Results— We used Get With The Guidelines–HF registry data from 2008 to 2013 to characterize prescribing, indications, and contraindications for angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, aldosterone antagonists, hydralazine/isosorbide dinitrate, and anticoagulants. The difference between a patient’s medication regimen at hospital admission and that recommended by HF quality measures at discharge was calculated. Among 158 922 patients from 271 hospitals with a primary discharge diagnosis of HF, initiation of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was indicated in 18.1% of all patients (55.5% of those eligible at discharge were not receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers at admission), β-blockers in 20.3% (50.5% of eligible), aldosterone antagonists in 24.1% (87.4% of eligible), hydralazine/isosorbide dinitrate in 8.6% (93.1% of eligible), and anticoagulants in 18.0% (58.0% of eligible). Cumulatively, 0.4% of patients were eligible for 5 new medication groups, 4.1% for 4 new medication groups, 9.4% for 3 new medication groups, 10.1% for 2 new medication groups, and 22.7% for 1 new medication group; 15.0% were not eligible for new medications because of adequate prescribing at admission; and 38.4% were not eligible for any medications recommended by HF quality measures. Compared with newly indicated medications (mean, 1.45±1.23), actual new prescriptions were lower (mean, 1.16±1.00). Conclusions— A quarter of patients hospitalized with HF need to start >1 medication to meet HF quality measures. Systems for addressing medication initiation and managing polypharmacy are central to HF transitional care.

When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States.Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored.Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable (p = 0.012).Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR.

OBJECTIVE: To describe the epidemiology, impact, pathogenesis, patient presentation, and treatment of stable angina, including the use of vasculoprotective and antianginal drug therapies and coronary revascularization procedures. SUMMARY: Stable angina is an age-related condition that typically affects men at an earlier age than women, adversely affects quality of life, and increases mortality. Stable angina is the result of an increase in myocardial oxygen demand in the setting of coronary arteries chronically narrowed by large, stable atherosclerotic plaques and a diminished myocardial oxygen supply. The characteristics of the chest pain or discomfort contribute to the clinical presentation. Treatment guidelines call for efforts to modify CHD risk, antianginal drug therapy, and patient education. Angiotensinconverting enzyme inhibitors and low-dose aspirin or clopidogrel may be used to reduce the risk of myocardial infarction and death. A beta-blocker or a nondihydropyridine calcium channel blocker may be used as initial antianginal drug therapy, and a long-acting nitrate or dihydropyridine calcium channel blocker may be added. The choice among antianginal drug therapies often hinges on patient characteristics, contraindications, and adverse effects. Revascularization with percutaneous coronary intervention or coronary artery bypass graft surgery is an option for ischemia refractory to maximum tolerated dosages of antianginal therapy. CONCLUSION: Various drug therapies may be used to manage stable angina, with coronary revascularization as an option in patients who are refractory to drug therapy. However, antianginal drug therapies may prove inadequate for managing anginal episodes for a variety of reasons, and revascularization is not always effective.

Background— Although drug-eluting stents (DES) significantly reduce restenosis, they require 3 to 6 months of thienopyridine therapy to prevent stent thrombosis. The rate and consequences of prematurely discontinuing thienopyridine therapy after DES placement for acute myocardial infarction (MI) are unknown. Methods and Results— We used prospectively collected data from a 19-center study of MI patients to examine the prevalence and predictors of thienopyridine discontinuation 30 days after DES treatment. We then compared the mortality and cardiac hospitalization rates for the next 11 months between those who stopped and those who continued thienopyridine therapy. Among 500 DES-treated MI patients who were discharged on thienopyridine therapy, 68 (13.6%) stopped therapy within 30 days. Those who stopped were older, less likely to have completed high school or be married, more likely to avoid health care because of cost, and more likely to have had preexisting cardiovascular disease or anemia at presentation. They were also less likely to have received discharge instructions about their medications or a cardiac rehabilitation referral. Patients who stopped thienopyridine therapy by 30 days were more likely to die during the next 11 months (7.5% versus 0.7%, P P =0.08; adjusted hazard ratio=1.5; 95% confidence interval=0.78 to 3.0). Conclusions— Almost 1 in 7 MI patients who received a DES were no longer taking thienopyridines by 30 days. Prematurely stopping thienopyridine therapy was strongly associated with subsequent mortality. Strategies to improve the use of thienopyridines are needed to optimize the outcomes of MI patients treated with DES.

Background There is a substantial literature on short-term mortality risk factors for coronary artery bypass graft (CABG) surgery. However, very few studies have examined risk factors for long-term mortality. Methods We analyzed 56,543 veterans who underwent CABG surgery at one of 43 VA cardiac surgery centers between October 1, 1991, and March 30, 2001. Each patient was followed for a minimum of 3.5 months and a maximum of 9.5 years for mortality assessment. The time-varying effects of 22 mortality preoperative risk factors were evaluated using both standard Cox regression models and Cox B-spline regression models. Results Six variables showed significant varying effects over time on mortality after surgery. The effects of previous heart surgery or preoperative intra-aortic balloon pump carried about 5 times and 3 times the risk, respectively, of dying on the first day after surgery, but were not significant during long-term follow-up. Conversely, diabetes had little additional risk immediately after surgery, but the risk increased steadily and doubled at 9.5 years after surgery. Three other risk variables—age, chronic obstructive pulmonary disease, and urgent or emergent status—also had risk changing by 50% to 60% over the next decade. Most of the other 16 risk variables were significantly associated with mortality, but the risk did not vary substantially over time. Conclusions Risk associated with some preoperative variables can change significantly during the decade after surgery, and risk assessments that assume constant risk during the postoperative period may substantially overestimate or underestimate risk at some times. These findings may help clinicians identify appropriate management strategies for patients during the years after CABG surgery, and support an emphasis on noncardiac comorbidities during later postoperative periods.

Background More information on the longitudinal care and outcomes of patients after myocardial infarction (MI) is needed to further improve the quality of MI care. The PREMIER study was designed to meet this need. Methods Patients with MI were prospectively screened and enrolled from 19 US centers between January 1, 2003, and June 28, 2004. Consenting patients had detailed chart abstractions of their medical history and processes of inpatient care, supplemented with a detailed, patient-centered interview. Centralized follow-up at 1, 6, and 12 months is being conducted to quantify patients' postdischarge care and outcomes, with a focus on their health status (symptoms, function, and quality of life). In 2003, detailed chart abstractions, devoid of all personal health information, were collected for patients eligible but not enrolled in PREMIER. Results Of 10 911 patients screened, 3953 were eligible and 2498 enrolled into PREMIER. Few clinically significant differences between the total MI population and those enrolled into PREMIER were observed. Adherence to accepted processes of quality care, such as aspirin and β-blockers on admission (96% and 91%) or discharge (96% and 93%), was high. One-month follow-up rates were high, with only 9% of patients being lost to follow-up. Conclusion PREMIER is a novel registry with detailed insights into patients' sociodemographic, clinical, and health status characteristics, as well as detailed monitoring of their inpatient and outpatient processes of care. Ultimately, PREMIER will describe patients' health status outcomes and identify determinants of these outcomes as an important step toward improving MI care.

Little is known about medication nonadherence in heart failure populations. We evaluated the association between 1 aspect of medication nonadherence, patient-reported difficulty taking medications as directed, and health status among heart failure outpatients, and then examined whether this association was explained by depression.A total of 522 outpatients with left ventricular ejection fraction0.40 completed clinical evaluation, Kansas City Cardiomyopathy Questionnaire (KCCQ), Medical Outcomes Study-Depression questionnaire, and categorized their difficulty taking medications (5-level Likert-scale question). Multivariable regression was used to evaluate the cross-sectional association between difficulty taking medications and health status, with incremental adjustment for medical history and depressive symptoms. Patients with difficulty taking medications (n = 64; 12.2%) had worse health status (8.2 +/- 2.7 point lower mean KCCQ summary scores; P = .008) and more depressive symptoms (43.8% versus 27.1%; P = .006). Adjusting for demographic and clinical factors had little effect on the association between difficulty taking medications and health status (8.0 +/- 3.2 point lower KCCQ scores; P = .01); however, the relationship was attenuated with adjustment for depressive symptoms (4.7 +/- 2.9 point lower KCCQ scores; P = .11).Among heart failure outpatients, difficulty taking medications is associated with worse health status. This association appears to be explained, in part, by coexistent depression. Future studies should evaluate interventions such as depression treatment to improve medication adherence and health status.

ObjectivesWe tested the hypothesis that one health status measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), provides prognostic information independent of other clinical data in outpatients with heart failure (HF).BackgroundHealth status measures are used to describe a patient’s clinical condition and have been shown to predict mortality in some populations. Their prognostic value may be particularly useful among patients with HF for identifying candidates for disease management in whom increased care may reduce hospitalizations and prevent death.MethodsWe evaluated 505 HF patients from 13 outpatient clinics who had an ejection fraction

Preamble......237 Medicine is experiencing an unprecedented focus on quantifying and improving health care quality. The American College of Cardiology (ACC) and the American Heart Association (AHA) have developed a multi-faceted strategy to facilitate the process of improving clinical care. The

Background We developed risk models for predicting acute kidney injury ( AKI ) and AKI requiring dialysis ( AKI ‐D) after percutaneous coronary intervention ( PCI ) to support quality assessment and the use of preventative strategies. Methods and Results AKI was defined as an absolute increase of ≥0.3 mg/ dL or a relative increase of 50% in serum creatinine ( AKIN Stage 1 or greater) and AKI ‐D was a new requirement for dialysis following PCI . Data from 947 012 consecutive PCI patients and 1253 sites participating in the NCDR Cath/ PCI registry between 6/09 and 7/11 were used to develop the model, with 70% randomly assigned to a derivation cohort and 30% for validation. AKI occurred in 7.33% of the derivation and validation cohorts. Eleven variables were associated with AKI : older age, baseline renal impairment (categorized as mild, moderate, and severe), prior cerebrovascular disease, prior heart failure, prior PCI , presentation (non‐ ACS versus NSTEMI versus STEMI ), diabetes, chronic lung disease, hypertension, cardiac arrest, anemia, heart failure on presentation, balloon pump use, and cardiogenic shock. STEMI presentation, cardiogenic shock, and severe baseline CKD were the strongest predictors for AKI . The full model showed good discrimination in the derivation and validation cohorts (c‐statistic of 0.72 and 0.71, respectively) and identical calibration (slope of calibration line=1.01). The AKI ‐D model had even better discrimination (c‐statistic=0.89) and good calibration (slope of calibration line=0.99). Conclusion The NCDR AKI prediction models can successfully risk‐stratify patients undergoing PCI . The potential for this tool to aid clinicians in counseling patients regarding the risk of PCI , identify patients for preventative strategies, and support local quality improvement efforts should be prospectively tested.

Background Depression is associated with mortality in several cardiovascular populations, but has not been evaluated in patients undergoing cardiac valve surgery. Because identifying nonsurgical mediators of survival is important for accurate risk adjustment and the development of interventions to improve outcomes of care, we evaluated the hypothesis that depression predicts mortality following cardiac valve surgery. Methods This prospective cohort study enrolled 648 patients undergoing valve surgery at 14 Veteran Administration hospitals. A preoperative mental health inventory (MHI) depression screen was performed in all patients and patients were classified as depressed or not depressed using the standard MHI cutoff score of less than or equal to 52. Multivariable logistic regression was used to evaluate the association between depression and 6-month all-cause mortality, adjusting for other clinical risk variables. Results Overall, 29.2% (189/648) of the patients were depressed at baseline. Depressed patients were younger, more frequently had New York Heart Association class III/IV symptoms, and more likely required emergent surgery, preoperative intravenous nitroglycerin, or intraaortic balloon pump. Unadjusted 6-month mortality was 13.2% for depressed patients compared with 7.6% for nondepressed patients ( p = 0.03). In multivariable analyses, depression remained significantly associated with mortality (odds ratio 1.90; 95% confidence interval 1.07 to 3.40, p = 0.03). These findings were consistent across subgroups of patients undergoing aortic valve replacement, mitral valve replacement and valve replacement without coronary artery bypass graft. Conclusions Preoperative depression is an independent risk factor for mortality following cardiac valve surgery. Depression screening should be incorporated into preoperative risk stratification, and future studies are warranted to determine if preoperative or postoperative interventions to treat depression can improve outcomes.

For every affection of the mind that is attended with either pain or pleasure, hope or fear, is the cause of an agitation whose influence extends to the heart. — William Harvey In 1628, William Harvey defined the circulatory system as we know it and proposed a link between the mind and the heart. This potential association received little attention for >300 years, until Frasure-Smith and colleagues1 published a study demonstrating that patients who are depressed at the time of an acute myocardial infarction (MI) have markedly elevated mortality as compared with patients who are not depressed. Since then, >100 studies have investigated this relationship, providing evidence that depression is prevalent (≈20% to 35%) in populations with cardiovascular disease, is predictive of developing cardiovascular disease, and is predictive of adverse outcomes among patients with existing cardiac disease.2,3 Depression, however, remains largely off the radar screen of cardiac care, in large part because of confusion about the nature of the association between depression and cardiovascular disease and the role of cardiovascular clinicians with regard to depressed patients. See p 271 In this issue of Circulation , Mallik et al4 add to our understanding of the relationship between depression and outcome in cardiac patients. Prospectively evaluating 963 coronary artery bypass graft (CABG) surgery patients, they found that 25% had substantial perioperative depressive symptoms. A graded, inverse relationship was noted between the severity of perioperative depressive symptoms and improvement in physical functional status 1 year after surgery. Patients with moderate to severe depressive symptoms were one third less likely to experience improvement in physical function after the operation, even after adjustment for >20 clinical variables. In other words, perioperative depressive symptoms appear to diminish the functional benefits of CABG surgery. The study by Mallik et al is an important contribution …

ObjectivesThe objective of this study was to identify the factors associated with the development of depressive symptoms in outpatients with heart failure (HF).BackgroundDepression is common in patients with HF and has been linked to adverse outcomes.MethodsThis was a multicenter prospective cohort study of outpatients with HF and ejection fraction

To examine the association between depressive symptoms and exercise capacity, we performed a cross-sectional study of 944 outpatients with stable coronary artery disease and found that the presence of depressive symptoms was independently associated with poor exercise capacity (

Study objective The objective of this study is to evaluate health-related quality of life as a risk factor for subsequent emergency department (ED) utilization in a cohort of patients with asthma. Methods We conducted a 1-year prospective cohort study of 1,406 adult asthma patients. Baseline physical and mental health status were measured using the Physical Component Summary and Mental Component Summary scores from the Short Form-12 health status survey. Asthma-specific health-related quality of life was measured with the mini–Asthma Quality of Life Questionnaire. Multivariable regression was used to assess the independent association between baseline Physical Component Summary, Mental Component Summary, and Asthma Quality of Life Questionnaire scores and asthma-related ED visits during the subsequent year. Results During the 1-year follow-up period, 116 patients made at least 1 asthma-related ED visit. After adjustment for multiple sociodemographic and clinical factors, both the Physical Component Summary score (odds ratio [OR] 1.72; 95% confidence interval [CI] 1.46 to 2.02) and the Asthma Quality of Life Questionnaire score (OR 1.34; 95% CI 1.18 to 1.52) were associated with subsequent asthma-related ED utilization. In contrast, overall mental health status was not associated with subsequent asthma-related ED utilization (OR 1.17; 95% CI 0.96 to 1.44). Conclusion Overall physical health status and asthma-specific quality of life predict subsequent ED utilization. Health-related quality of life may be useful in identifying patients at increased risk for asthma exacerbation requiring emergency care.

Background Although there is accumulating evidence that renal insufficiency is an independent risk factor for mortality after acute myocardial infarction (AMI), it is not known whether renal dysfunction is associated with an increased mortality rate after a broad range of acute coronary syndromes, including unstable angina. Methods We examined consecutive patients from 24 Veterans Affairs hospitals with confirmed AMI or unstable angina between March 1998 and February 1999, who were categorized into groups according to estimated glomerular filtration rate (GFR). Multivariable regression was used to assess the independent association between GFR and the 7-month mortality rate, adjusting for differences in patient characteristics and treatment. Results Of the 2706 patients, 436 (16%) had normal renal function (GFR >90 mL/min/1.73 m 2 ), 1169 (43%) had mild renal insufficiency (GFR 60–89 mL/min/1.73 m 2 ), 864 (32%) had moderate renal insufficiency (GFR 30–59 mL/min/1.73 m 2 ), and 237 (9%) had severe renal insufficiency (GFR 2 ). Patients with renal insufficiency were less likely to undergo coronary angiography or to receive aspirin or β-blockers at discharge. In multivariable models, renal insufficiency was associated with a higher odds of death (mild renal insufficiency: odds ratio [OR] = 1.76; 95% CI, 0.93–3.33; moderate renal insufficiency: OR=2.72; 95% CI, 1.43–5.15; and severe renal insufficiency: OR=6.18; 95% CI, 3.09–12.36; all compared with normal renal function). The associations between renal insufficiency and mortality rate were similar in both the AMI and unstable angina subgroups ( P value for interaction=.45). Conclusions Renal insufficiency is common and is associated with higher risks for death in patients with a broad range of ACS at presentation. Future efforts should be dedicated to determining whether more aggressive treatment will optimize outcomes in this patient population.

Purpose Although of great importance to clinicians, hospitals, and health care systems, little is known about factors that influence treatment satisfaction after acute coronary syndromes (ACS). The objective of this study was to identify potentially modifiable factors associated with treatment satisfaction 7 months after ACS. Methods The study population included 1957 patients with ACS who were enrolled in the multicenter, prospective Veterans' Health Administration Access to Cardiology Study. The primary outcome was treatment satisfaction 7 months after ACS as measured by the Seattle Angina Questionnaire. Multivariable regression models were developed to determine the association between treatment satisfaction and patient characteristics, physician-patient communication, and current angina frequency. Results Patient characteristics associated with reduced treatment satisfaction included a history of depression, atrial fibrillation, prior heart surgery, arthritis, hypertension, younger age, and a discharge diagnosis of unstable angina (as opposed to myocardial infarction). After adjusting for patient characteristics, patient-reported inability to reach one or more of their physicians (OR, 2.40; 95% CI, 1.47 to 3.91), being given confusing information (OR, 3.48; 95% CI, 2.08 to 5.83), and poor overall communication with one or more of their physicians (OR, 4.94; 95% CI, 2.93 to 8.34) were all associated with reduced satisfaction. Finally, after adjustment for both patient characteristics and physician communication, weekly (OR, 3.52; 95% CI, 2.28 to 5.45) and daily angina (OR, 3.88; 95% CI, 2.23 to 6.75) were associated with worse treatment satisfaction. Conclusions Current angina symptoms and aspects of physician communication are independently associated with treatment satisfaction after ACS. These results suggest that treatment satisfaction may be improved through better communication and better control of angina symptoms.

Several recent clinical trials in heart failure have failed to demonstrate improvements in survival, suggesting that new approaches must be adopted if there are to be further improvements in heart failure treatment. We propose a broader paradigm for heart failure care based on a chronic rather than an acute illness model. This approach recognizes a broader range of outcomes including patient-perceived health status, expanded populations of interest that more closely reflect the changing epidemiology of heart failure, and a wider scope of interventions that address co-morbidity and health behavior. This approach will require a rationally designed health care delivery system that applies the best available evidence to the care of individual patients with heart failure.

A systematic approach to develop a research agenda for improving the quality of emergency care is presented. This approach is based on the six domains of quality outlined by the Institute of Medicine (effective, timely, efficient, safe, patient-centered, and equitable care) and a sequence of four research steps (evidence, synthesis, assessment, and intervention). Examples related to the care of patients with acute myocardial infarction are used to illustrate the proposed approach. Examples of other emergency medicine research topics relevant to the Institute of Medicine quality domains are also presented. Research to improve the quality of emergency care can benefit from a more systematic consideration of the domains of quality and the research steps necessary to generate evidence and inform quality improvement efforts in practice.

Study objective: Previous studies have shown that Medicare patients without supplemental insurance are less likely to receive preventive services, such as mammography. The effect of supplemental insurance on the appropriate use of emergency services is unknown. We sought to determine whether the absence of supplemental Medicare coverage is associated with increased delay in seeking care for acute myocardial infarction. Methods: In this retrospective cohort study, we compared the time from symptom onset to hospital arrival (the time-delay interval) in Medicare patients with and without supplemental insurance coverage who presented with an acute myocardial infarction to 1 of 19 hospitals in King County, WA, from 1989 to 1993. There were 1,373 patients with Medicare-only coverage and 2,050 patients with Medicare plus supplemental insurance coverage. Results: The age-, sex-, and race-adjusted median time delay was 135 minutes for the Medicare-only group and 130 minutes for the Medicare plus supplemental insurance group ( P =.34; 95% confidence interval for median time-delay difference in minutes −5 to 10). There was no significant association between the presence of Medicare supplemental insurance coverage and time delay in Cox regression models, which also adjusted for event year, income, education, past cardiac history, and clinical symptoms. Conclusion: For this cohort of Medicare patients, the absence of supplemental insurance coverage did not lead to significantly increased delays in seeking care for myocardial infarction. Lack of supplemental insurance for Medicare patients might not have as great an effect on the use of emergency services as it has on other health care services. [ Ann Emerg Med. 2002;40:381-387.]

Importance Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for severe aortic stenosis in patients who cannot undergo surgery and for patients at high operative risk. Use of TAVR for off-label indications has not been previously reported. Objective To evaluate patterns and adverse outcomes of off-label use of TAVR in US clinical practice. Design, Setting and Participants Patients receiving commercially funded TAVR in the United States are included in the Transcatheter Valve Therapy Registry. A total of 23 847 patients from 328 sites performing TAVR between November 9, 2011, and September 30, 2014, were assessed for this study. Off-label TAVR was defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis. Data were linked with the Centers for Medicare & Medicaid Services for 15 397 patients to evaluate 30-day and 1-year outcomes. Exposure Off-label use of TAVR. Main Outcomes and Measures Frequency of off-label TAVR use and the association with in-hospital, 30-day, and 1-year adverse outcomes. Results Among the 23 847 patients in the study (11 876 women and 11 971 men; median age, 84 years [interquartile range, 78-88 years]), off-label TAVR was used in 2272 patients (9.5%). In-hospital mortality was higher among patients receiving off-label TAVR than those receiving on-label TAVR (6.3% vs 4.7%; P P P = .001). Adjusted 30-day mortality was higher in the off-label group (hazard ratio, 1.27; 95% CI, 1.04-1.55; P = .02), while adjusted 1-year mortality was similar in the 2 groups (hazard ratio, 1.11; 95% CI, 0.98-1.25; P = .11). The median rate of off-label TAVR use per hospital was 6.8% (range, 0%-34.7%; interquartile range, 3.4%-12.1%), with hospitals in the highest tertile of off-label use associated with increased 30-day adverse cardiovascular events compared with the lowest tertile. However, this difference was not observed in adjusted 30-day or 1-year outcomes. Conclusions and Relevance Approximately 1 in 10 patients in the United States have received TAVR for an off-label indication. After adjustment, 1-year mortality was similar in these patients to that in patients who received TAVR for an on-label indication. These results reinforce the need for additional research on the efficacy of off-label TAVR use.

Importance In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, evaluation of the health status outcomes among unselected patients treated with TAVR is of critical importance. Objective To examine the short- and long-term health status outcomes of surviving patients after TAVR in the context of an unselected population. Design, setting, and participants This observational cohort study included patients with severe aortic stenosis who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry from November 1, 2011, to March 31, 2016, at more than 450 clinical sites. Main outcomes and measures Disease-specific health status was assessed at baseline and at 30 days and 1 year after TAVR using the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score (range, 0-100 points; higher scores indicate less symptom burden and better quality of life). Factors associated with health status at 1 year after TAVR were examined using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites. Results The 30-day analytic sample included 31 636 patients, and the 1-year cohort included 7014 surviving patients (3454 women [49.2%] and 3560 men [50.8%]; median [interquartile range] age, 84 [78-88] years). The mean (SD) baseline KCCQ-OS score was 42.3 (23.7), indicating substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year, with a mean improvement in the KCCQ-OS score of 27.6 (95% CI, 27.3-27.9) points at 30 days and 31.9 (95% CI, 31.3-32.6) points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen use, lower mean aortic valve gradients, prior stroke, diabetes, pacemaker use, atrial fibrillation, slow gait speed, and nonfemoral access were significantly associated with worse health status at 1 year. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life [KCCQ-OS score, ≥60] and no significant decline [≥10 points] from baseline), with the lowest rates seen among patients with severe lung disease (51.4%), those undergoing dialysis (47.7%), or those with very poor baseline health status (49.2%). Conclusions and relevance In a national, contemporary clinical practice cohort of unselected patients, improvement in health status after TAVR was similar to that seen in the pivotal clinical trials. Although the health status results were favorable for most patients, approximately 1 in 3 still had a poor outcome 1 year after TAVR. Continued efforts are needed to improve patient selection and procedural/postprocedural care to maximize health status outcomes of this evolving therapy.

Details on Japanese patients undergoing percutaneous coronary intervention (PCI) and how they compare to US patients remain unclear. Furthermore, the application of US risk models has not been evaluated internationally.The JCD-KiCS, a multicenter registry of consecutive PCI patients, was launched in 2008, with variables defined in accordance with the US NCDR. Patient and procedural characteristics from patients enrolled from 2008 to 2010 in the JCD-KiCS database (n = 9,941) and those in the NCDR (n = 732,345) were compared. The primary outcomes of this analysis were the hospital-level all-cause mortality and bleeding complications. The NCDR risk models for these 2 outcomes were evaluated in the Japanese data set; from the expected mortality and bleeding rates, the observed/expected ratios were calculated.The Japanese patients were older, with a higher proportion of men, diabetes, and smoking than the US patients. The Japanese patients also had a higher rate of complex lesions (26.1 vs 12.7% for bifurcation and 6.2% vs 3.2% for chronic total occlusions, all P.001), longer procedure time (29.7 ± 21.5 vs 14.4 ± 11.5 minutes, P.001), and higher mortality (1.6% vs 0.9%, P.001) and bleeding rates (2.9% vs 1.8%, P.001) compared with US patients. The observed/expected ratios for mortality and bleeding were 0.921 and 0.467, respectively, in Japanese patients, and 1.002 and 0.981, respectively, for US patients.The characteristics of patients undergoing PCI in clinical practice in Japan and the US differ substantially. The NCDR risk models applied well in Japanese patients for prediction of mortality, but not for bleeding, which tended to underestimate the risk.

Organization scholars and astute leaders have known for half a century that involving people in decision-making increases their motivation to implement decisions1 and that integrating research and practice in an organization is associated with higher organizational performance.2 Yet this knowledge has not been used very effectively in implementing research evidence into practice, and the pipeline metaphor of translating research into practice inherently ignores these organizational facts. The pipeline portrays the development of knowledge as the domain of researchers, to be translated into usable form for practitioners and organizations. It also portrays a sequential process that leaves the potential users of research out of its development, contrary to what is needed to motivate the use of research findings. Conducting partnered research and evaluation through bidirectional communication and engagement of key stakeholders holds significant promise for improving the impact of research through the design and implementation of evidence-based practice and policy.

Whether the introduction of transcatheter aortic valve replacement (TAVR) has affected hospitals' surgical aortic valve replacement (SAVR) and overall aortic valve replacement (AVR) case volumes and outcomes in the United States is unknown.We utilized data from The Society of Thoracic Surgeons (STS) adult cardiac surgery database and the STS/American College of Cardiology (ACC) transcatheter valve therapies registry to examine SAVR and TAVR procedures. Temporal trends in total case volume (SAVR plus TAVR), and observed and risk-adjusted in-hospital mortality rates were assessed among low-risk cases (STS predicted risk of operative mortality4%), intermediate-risk cases (4% to 8%), and high-risk cases (8%). A contemporary control was provided by non-TAVR centers.From 2008 to 2013, the total annual volume of AVR among 246 TAVR-performing hospitals increased from 19,578 to 33,004, with a 22% growth in SAVR volumes; non-TAVR hospital (n = 555) increases were more modest (16,563 to 19,134; 16% growth). Expanded volumes at TAVR hospitals included increased SAVR use in low- and intermediate-risk cases, and TAVR use in high-risk cases. In parallel, in-hospital mortality for all AVR procedures at TAVR sites declined from 3.4% to 2.9% (observed to expected [O:E] ratio 0.75 to 0.58, p0.001); the greatest declines were among intermediate- and high-risk SAVR patients. Owing to reduced SAVR mortality, TAVR centers experienced a significantly greater decline in O:E ratio for high-risk patient in-hospital mortality than non-TAVR centers (TAVR center O:E ratio, 0.81 to 0.61; non-TAVR center O:E ratio, 0.85 to 0.76; p0.001). After approval of TAVR for clinical use, a trend toward higher in-hospital mortality rates and O:E ratios for TAVR procedures was observed at new (but not at established) TAVR centers (O:E ratio, 0.41 to 0.67; p = 0.08).Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve.

Angina and depression are common in ischemic heart disease (IHD), but their association remains understudied. This study was conducted in order to evaluate the association of 1 year change in depression with change in patient-reported outcomes of stable angina. Five hundred sixty-nine stable angina patients completed the Seattle Angina Questionnaire and Patient Health Questionnaire (PHQ) at baseline and 1 year. Participants were divided into four groups: not depressed, new onset of depression at 1 year, remitted at 1 year, and persistently depressed. Associations between depression and angina symptoms were evaluated using regression models. Compared to those not depressed, newly depressed participants reported more angina (β = −11.7, p

Health care has lagged behind other industries in its use of advanced analytics. The Veterans Health Administration (VHA) has three decades of experience collecting data about the veterans it serves nationwide through locally developed information systems that use a common electronic health record. In 2006 the VHA began to build its Corporate Data Warehouse, a repository for patient-level data aggregated from across the VHA's national health system. This article provides a high-level overview of the VHA's evolution toward "big data," defined as the rapid evolution of applying advanced tools and approaches to large, complex, and rapidly changing data sets. It illustrates how advanced analysis is already supporting the VHA's activities, which range from routine clinical care of individual patients--for example, monitoring medication administration and predicting risk of adverse outcomes--to evaluating a systemwide initiative to bring the principles of the patient-centered medical home to all veterans. The article also shares some of the challenges, concerns, insights, and responses that have emerged along the way, such as the need to smoothly integrate new functions into clinical workflow. While the VHA is unique in many ways, its experience may offer important insights for other health care systems nationwide as they venture into the realm of big data.

Introduction: Chronic kidney disease is strongly associated with mortality after acute myocardial infarction (AMI), however, its association with health status outcomes (symptoms, function and quality of life (QoL)) is unknown. Methods: Patients with AMI were enrolled between 2003 and 2008 in the TRIUMPH registry, a national, prospective, multi-center study of health status outcomes after AMI. Detailed interviews with the disease-specific Seattle Angina Questionnaire (SAQ) and generic Short Form-12 (SF-12) were attempted on all survivors at 1, 6 and 12 months following AMI admission. Estimated glomerular filtration rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation and based on the highest calculated eGFR recorded during the AMI hospitalization. Patients with CKD, based on an eGFR < 60 ml/min, were compared to those without CKD. Linear repeated measures models of SAQ angina frequency and QoL and SF-12 PCS and MCS scores were used to control for treatment site, baseline health status and known covariates to assess the independent association between CKD and health status after AMI. Results: Of 3592 3,617 patients, 3,041 (84%) had no CKD and 551 576 (16%) had CKD;, 7980% stage 3 (eGFR 30-59); 1312% stage 4 (eGFR 15-29); and 8% stage 5 (eGFR Conclusion: Among AMI survivorspatients who survived to 1 year, CKD patients have similar quality of life and angina burden compared to those without CKD despite a higher burden of co-morbidities. While CKD patients had lower physical functioning scores, this difference was not clinically significant compared to patients without CKD. These findings suggest that among AMI patients surviving to 1 yearsurvivors, CKD patients can achieve similar health status outcomes compared to non-CKD patients.

Background: 30-day readmission after percutaneous coronary intervention (PCI) is a common, expensive and potentially preventable problem. The relationship between 30-day readmission and long-term patient outcomes has not been studied within integrated care delivery settings. We sought to determine the association between 30-day readmission after PCI and long-term patient outcomes in the VA. Methods: We evaluated all VA patients who underwent PCI from October 2007 through September 2011 using national data from the VA Clinical Assessment Reporting and Tracking (CART) Program. Patient outcomes were followed through September 2012. Our primary outcome was all-cause mortality. Secondary outcomes included myocardial infarction (MI), revascularization, and the composite of all three outcomes. We compared patient demographics, clinical characteristics, and procedural factors by 30-day readmission status. The association between 30-day readmission status and outcomes was assessed using Cox proportional hazards models. Results: Among 32,551 patients undergoing PCI, 4,829 (14.8%) were readmitted within 30 days. Median follow-up after discharge was 30.3 months (IQR: 19.5, 43.6). Over this period of follow-up, a total of 4,548 (14%) died, 2,021 (6.2%) suffered an MI, and 7,040 (21.6%) underwent revascularization. Patients with subsequent readmission were more likely to have chronic kidney disease (26% vs 18%, P Conclusions: In the VA, approximately 15% of patients were readmitted within 30 days of PCI - a rate that is comparable to prior studies from community settings. Patients readmitted within 30-days had significantly higher long-term mortality risks. Future research should aim to understand modifiable causes of readmission and the extent to which 30-day readmission is a quality metric rather than a risk marker.

Background: A prior study demonstrated significant variation between hospitals in the proportion of patients who delay filling a clopidogrel prescription after percutaneous coronary intervention (PCI). We assessed whether this variation changes over time. Methods: Using national data from the VA Clinical Assessment Reporting and Tracking (CART) Program, we determined the hospital proportion of patients with a clopidogrel filling delay at the 62 VA cath labs performing at least 20 PCI annually between October 1, 2009 and September 30, 2012. Delay was defined as filling a clopidogrel prescription any time after the day of PCI hospital discharge. We categorized hospitals into quintiles based on the proportion of patients with delay in 6-month time intervals for each hospital and assessed whether hospitals changed quintiles over time. Results: There were 31,002 PCIs performed from 2009-2012 at 62 PCI sites with an average number of 170.3 (sd. 99.3, median149.5) PCIs performed annually. Patient characteristics included: average age 65.2 ±9.0, 1.7% were women, 48.0% were diabetic, and 33.6% had prior history of MI. 26.7% (n=8,272) of PCIs were performed for acute coronary syndrome (ACS). The mean and median proportion of patients who delayed was 9.2% (7.5%) and by quintiles was: Q5 - 16.6% (15.3%), Q4 - 11.3% (10.2%), Q3 - 8.3% (7.8%), Q2 - 6.4% (6.2%), Q1 - 3.5% (3.6%). Over the 3 years of follow-up, 14 sites remained in the same quintile (9 in the highest, 1 in the third, 1 in the second, and 3 in the lowest quintile) and 48 sites moved between quintiles. In addition, 18 hospitals had increasing proportion of patients with delay, 14 hospitals had decreasing, while the rest of the hospitals (n=30) had fluctuating proportions of patients with delay over time. Conclusion: There is significant temporal variation in clopidogrel delays across PCI hospitals. Future studies should assess what types of processes of care are being implemented at hospitals with low or decreasing rates of clopidogrel delay over time. In addition, these finding highlight an opportunity to implement quality improvement efforts at hospitals with persistently high or increasing rates of clopidogrel delay over time. Figure 1. Hospital Level Proportion of Delay in 14 Sites That Stayed Within Quintile

Background: Patients with chronic kidney disease (CKD) are at increased risk of bleeding and transfusion after cardiac catheterization. Whether rates of these complications or progression to new dialysis are increased in this high-risk population undergoing transradial (TR) access compared to transfemoral (TF) access is unknown. Methods: From the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program between 10/2007-09/2012 we identified 40,160 CKD patients undergoing cardiac catheterization with baseline glomerular filtration rate (GFR) ≤ 60 ml/min. We used multivariable Cox modeling to determine the independent association between TR access and post-procedure transfusion as well as progression to new dialysis using TF as the reference. Results: Overall, 3,828 (9.5%) of CKD patients underwent TR access and tended to be slightly younger but overall had similar rates of CKD severity compared with TF patients (GFR 45-60 ml/min: 77.0% vs. 77.0%; GFR 30-44 ml/min: 19.7% vs. 19.3%; GFR 15-29 ml/min: 3.3% vs. 3.7%, p=0.35). TR patients had longer fluoroscopy times (8.1 vs 6.9 minutes, p= Conclusion: Among CKD patients undergoing cardiac catheterization in the VA health system, TR access is associated with a decreased risk for post-procedure transfusion compared with TF access. There was no significant difference between the two approaches with respect to progression to ESRD. These data suggest that TR is a reasonable option for patients with any level of CKD undergoing cardiac catheterization.

Background: Prior studies have shown that depression may be associated with longitudinal medication non-adherence for patients with chronic cardiovascular disease. However, little is known about depression and medication adherence following acute coronary syndrome (ACS) hospitalization. Our objective was to assess whether depression was associated with longitudinal medication adherence following ACS among Veterans enrolled in a clinical trial designed to improve medication adherence. Methods: Patients included in the current analysis were enrolled in the MEDICATION study, which tested a multifaceted intervention versus usual care to improve medication adherence in the year following ACS hospitalization at 4 VA Medical Centers. Depression was assessed using the Patient Health Questionnaire (PHQ-9) prior to hospital discharge based on a score of ≥10. Medication adherence was assessed for 4 classes of cardioprotective medications (Statins, ACEI/ARBs, Clopidogrel, and Beta Blockers) in the 12-months following hospital discharge using pharmacy refill data. A proportion of days covered (PDC) was calculated based on the 4 classes of medications, and adherent patients were categorized based on a PDC ≥0.80. Then, we assessed the association between depression and medication adherence in the year after ACS hospitalization. Results: Of the 241 patients, the average age was 63.9 years, mean BMI was 30.9 kg/m 2 , and they had a number of comorbidities: 45.2% had diabetes and 65.6% had a history of coronary artery disease. The mean PHQ-9 score was 8.2 and 35.4% had depression (PHQ≥10) prior to discharge, with no difference in the prevalence of depression between treatment groups. In the year after ACS hospitalization, the mean PDC was 0.90 for all patients and there was no difference between depressed (PDC=0.91) and non-depressed patients (PDC=0.90). Among patients in the usual care group, there was also no difference in adherence between depressed (PDC=0.88) and non-depressed (PDC=0.86) patients. Conclusions: In this cohort of patients enrolled in a clinical trial, depression was present in 1 out of 3 patients during ACS hospitalization but not associated with medication adherence in the year after hospital discharge. A potential explanation for the lack of association between depression and adherence may be related to the overall high adherence rates found in the MEDICATION study. It will be important to assess whether depression is a marker of medication non-adherence in other ACS cohorts.

Introduction: The traditional focus of cardiac care on obstructive (>70% stenosis) CAD potentially distracts from the risks inherent in non-obstructive CAD. However, surprisingly little is known about non-obstructive CAD outcomes. Therefore, we determined the association between non-obstructive CAD and cardiovascular outcomes. Methods: Using the national VA CART program, we studied all veterans undergoing elective coronary angiography for angina between October 2007 and September 2012. Patients were categorized by CAD extent (none (no stenosis >20%), non-obstructive (no stenosis >=70%), obstructive (any stenosis >=70%)) and distribution (1, 2, or 3 vessel), and assessed for major adverse cardiac events (MACE), defined as all-cause mortality and MI. We adjusted for demographic, clinical, and treatment factors using Cox proportional hazards modeling. Secondary analyses sub-divided non-obstructive CAD into mild (20-49% stenosis) and moderate (50-69% stenosis) disease. Results: During the study period, 40,872 veterans underwent catheterization. Of these, 8411 (20.6%) had no CAD, 5219 (17.7%) had 1V non-obstructive CAD, 3034 (10.3%) had 2V non-obstructive CAD, 1388 (4.7%) had 3V non-obstructive CAD, 8588 (29.1%) had 1V obstructive, 5227 (17.7%) had 2V obstructive, and 6017 (20.4%) had 3V/LM obstructive CAD. MACE rates progressively increased with increasing CAD severity (Figure). This association persisted after risk adjustment (HR 1.28 (1.08, 1.51) for 1V non-obstructive, 1.29 (1.08, 1.52) 2V non-obstructive, 1.44 (1.12, 1.86) 3V non-obstructive, 1.93 (1.64, 2.28) 1V obstructive, 2.73 (2.28, 3.27) 2V obstructive, and 2.98 (2.52, 3.53) 3V/LM obstructive CAD)). A trend toward higher MACE in moderate 3V non-obstructive compared to 1V obstructive CAD (HR 1.34 (0.71, 2.52)) was noted. Conclusions: Non-obstructive CAD, relative to no CAD, is associated with 28-44% higher odds of MACE. MACE risk progressively increases by CAD extent, rather than abruptly increasing between non-obstructive and obstructive CAD. The risks of adverse events were similar for 3V non-obstructive CAD and 1V obstructive CAD, highlighting the limitations of a dichotomous characterization of angiographic CAD and a need to recognize the risks inherent in non-obstructive CAD.

Background: Use of stress testing following percutaneous coronary intervention (PCI) is common in community practice with 60% of patients undergoing stress testing within 24 months of PCI. Rates of stress testing following PCI within integrated and salaried healthcare systems like the VA are unknown. Methods: Using national data from the VA Clinical Assessment Reporting and Tracking (CART) Program, we evaluated all VA patients who had PCI from October 2007-September 2011. We assessed the proportion of patients undergoing stress testing, stress test type, and timing of stress testing in the 2 years following PCI. To be consistent with prior studies, we excluded stress tests performed within 60 days of PCI as these may reflect assessment of residual ischemia in anticipation of staged procedures. Timing of follow-up stress testing was determined from 30-day incremental windows of follow-up. Results: Overall, 7,145 of 21,635 patients (33.0%) had a stress test performed within 2 years of PCI. The vast majority of stress tests following PCI were performed with nuclear imaging (80.8%). Treadmill stress ECG without imaging represented 15.2% of stress tests and stress echo 3.9%. Patients undergoing stress testing in follow-up were younger (63.4 vs 65.7 years, P Conclusions: About 1 in 3 patients had a stress test performed in the 2 years following PCI in the VA. This rate is nearly half that reported from prior studies of community practice. Further study is needed to understand if this represents underuse of stress testing in VA or overuse in fee-for-service care.