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The worldwide pandemic caused by the novel acute respiratory syndrome coronavirus 2 has resulted in a new and lethal disease termed coronavirus disease-2019 (COVID-19). Although there is an association between cardiovascular disease and COVID-19, the majority of patients who need cardiovascular care for the management of ischemic heart disease may not be infected with this novel coronavirus. The objective of this document is to provide recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic. There is a recognition of two major challenges in providing recommendations for AMI care in the COVID-19 era. Cardiovascular manifestations of COVID-19 are complex with patients presenting with AMI, myocarditis simulating an ST-elevation myocardial infarction (STEMI) presentation, stress cardiomyopathy, non-ischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury, and the prevalence of COVID-19 disease in the U.S. population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on 1) the varied clinical presentations; 2) appropriate personal protection equipment (PPE) for health care workers; 3) role of the Emergency Department, Emergency Medical System and the Cardiac Catheterization Laboratory; and 4) Regional STEMI systems of care. During the COVID-19 pandemic, primary PCI remains the standard of care for STEMI patients at PCI capable hospitals when it can be provided in a timely fashion, with an expert team outfitted with PPE in a dedicated CCL room. A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option., (Copyright © 2020 American College of Cardiology Foundation and Wiley Periodicals, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in PCI practice patterns., Objectives: Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan., Methods: The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017., Results: PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001)., Conclusions: Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In patients with end-stage renal disease (ESRD), surgical aortic valve replacement is associated with higher early and late mortality, and adverse outcomes compared with patients without renal disease. Transcatheter aortic valve replacement (TAVR) offers another alternative, but there are limited reported outcomes., Objectives: The purpose of this study was to determine the outcomes of TAVR in patients with ESRD., Methods: Among the first 72,631 patients with severe aortic stenosis (AS) treated with TAVR enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT (Transcatheter Valve Therapies) registry, 3,053 (4.2%) patients had ESRD and were compared with patients who were not on dialysis for demographics, risk factors, and outcomes., Results: Compared with the nondialysis patients, ESRD patients were younger (76 years vs. 83 years; p < 0.01) and had higher rates of comorbidities leading to a higher STS predicted risk of mortality (median 13.5% vs. 6.2%; p < 0.01). ESRD patients had a higher in-hospital mortality (5.1% vs. 3.4%; p < 0.01), although the observed to expected ratio was lower (0.32 vs. 0.44; p < 0.01). ESRD patients also had a similar rate of major vascular complications (4.5% vs. 4.6%; p = 0.86), but a higher rate of major bleeding (1.4% vs. 1.0%; p = 0.03). The 1-year mortality was significantly higher in dialysis patients (36.8% vs. 18.7%; p < 0.01)., Conclusions: Patients undergoing TAVR with ESRD are at higher risk and had higher in-hospital mortality and bleeding, but similar vascular complications, when compared with those who are not dialysis dependent. The 1-year survival raises concerns regarding diminished benefit in this population. TAVR should be used judiciously after full discussion of the risk-benefit ratio in patients on dialysis., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

As we enter the information age of health care, digital health technologies offer significant opportunities to optimize both clinical care delivery and clinical research. Despite their potential, the use of such information technologies in clinical care and research faces major data quality, privacy, and regulatory concerns. In hopes of addressing both the promise and challenges facing digital health technologies in the transformation of health care, we convened a think tank meeting with academic, industry, and regulatory representatives in December 2016 in Washington, DC. In this paper, we summarize the proceedings of the think tank meeting and aim to delineate a framework for appropriately using digital health technologies in healthcare delivery and research., (Copyright © 2018 American College of Cardiology Foundation. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve., Objectives: The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes., Methods: The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events., Results: Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003), and bleeding (p < 0.001) but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57% to 2.15%), bleeding (9.56% to 5.08%), vascular complications (6.11% to 4.20%), and stroke (2.03% to 1.66%). Vascular and bleeding volume-outcome associations were nonlinear with a higher risk of adverse outcomes in the first 100 cases. An association of procedure volume with risk-adjusted outcomes was also seen in the subgroup having transfemoral access., Conclusions: The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume-outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Stratifying patient risk for acute kidney injury (AKI) prior to percutaneous coronary intervention (PCI) can enable clinicians to tailor their approach to minimize AKI. The National Cardiovascular Data Registry (NCDR) CathPCI Registry recently developed 2 prediction models: for AKI and AKI requiring dialysis (AKI-D)., Objectives: This study sought to externally validate the NCDR AKI and AKI-D models in a Japanese population. Determining the generalizability of the U.S. model could support quality improvement efforts in Japan., Methods: The NCDR prediction models were applied to 11,041 consecutive patients in the Japanese multicenter PCI registry. AKI was defined as an absolute increase ≥ 0.3 mg/dl or a relative increase of 50% in serum creatinine, in accordance with the definition of AKI Network criteria; AKI-D was defined as initiation of dialysis after PCI. Discrimination and calibration of the NCDR models were tested in the Japanese cohort. If the model was perfectly calibrated, the slope and intercept would equal 1.0 and 0.0, respectively., Results: In the Japanese PCI cohort, AKI and AKI-D occurred in 10.5% and 1.5% of patients, respectively. The NCDR AKI prediction model showed good discrimination (c-statistic = 0.76) and calibration (slope = 0.93 and intercept = -0.10) in both acute and nonacute PCI. The AKI-D prediction model had good discrimination (c-statistic = 0.92), but while the calibration slope was good (1.04), the intercept was significantly underestimated (0.96). However, this was corrected with recalibration (slope = 1.04 and intercept = -0.087)., Conclusions: In a Japanese population, the NCDR AKI models validly predict post-procedural AKI and, with recalibration, AKI-D. Prospective use of these models to inform clinical decision making should be tested as a means of reducing AKI after PCI in Japan. (Japan Cardiovascular Database, Percutaneous Coronary Intervention Registry; UMIN R000004736)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: 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., Objectives: The purpose of this study was to compare the outcomes of nonagenarians to younger patients undergoing TAVR in current practice., Methods: 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 versus <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire., Results: 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%; p < 0.001; 1 year: 24.8% vs. 22.0%; p < 0.001, 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%; p < 0.001) 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., Conclusions: 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., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Public reporting of health care data continues to proliferate as consumers and other stakeholders seek information on the quality and outcomes of care. Medicare's Hospital Compare website, the U.S. News & World Report hospital rankings, and several state-level programs are well known. Many rely heavily on administrative data as a surrogate to reflect clinical reality. Clinical data are traditionally more difficult and costly to collect, but more accurately reflect patients' clinical status, thus enhancing the validity of quality metrics. We describe the public reporting effort being launched by the American College of Cardiology and partnering professional organizations using clinical data from the National Cardiovascular Data Registry (NCDR) programs. This hospital-level voluntary effort will initially report process of care measures from the percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries of the NCDR. Over time, additional process, outcomes, and composite performance metrics will be reported., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: 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., Objectives: 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., Methods: The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared., Results: 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%., Conclusions: 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., (Copyright © 2015 American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Rates of referral to cardiac rehabilitation after percutaneous coronary intervention (PCI) have been historically low despite the evidence that rehabilitation is associated with lower mortality in PCI patients., Objectives: This study sought to determine the prevalence of and factors associated with referral to cardiac rehabilitation in a national PCI cohort, and to assess the association between insurance status and referral patterns., Methods: Consecutive patients who underwent PCI and survived to hospital discharge in the National Cardiovascular Data Registry between July 1, 2009 and March 31, 2012 were analyzed. Cardiac rehabilitation referral rates, and patient and institutional factors associated with referral were evaluated for the total study population and for a subset of Medicare patients presenting with acute myocardial infarction., Results: Patients who underwent PCI (n = 1,432,399) at 1,310 participating hospitals were assessed. Cardiac rehabilitation referral rates were 59.2% and 66.0% for the overall population and the AMI/Medicare subgroup, respectively. In multivariable analyses, presentation with ST-segment elevation myocardial infarction (odds ratio 2.99; 95% confidence interval: 2.92 to 3.06) and non-ST-segment elevation myocardial infarction (odds ratio: 1.99; 95% confidence interval: 1.94 to 2.03) were associated with increased odds of referral to cardiac rehabilitation. Models adjusted for insurance status showed significant site-specific variability in referral rates, with more than one-quarter of all hospitals referring <20% of patients., Conclusions: Approximately 60% of patients undergoing PCI in the United States are referred for cardiac rehabilitation. Site-specific variation in referral rates is significant and is unexplained by insurance coverage. These findings highlight the potential need for hospital-level interventions to improve cardiac rehabilitation referral rates after PCI., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is significant interest in measuring health care value, but this concept has not been operationalized in specific patient cohorts. The longitudinal outcomes and costs for patients after percutaneous coronary intervention (PCI) provide an opportunity to measure an aspect of health care value., Objectives: This study evaluated variations in 1-year outcomes (risk-adjusted mortality) and risk-standardized costs of care for all patients undergoing PCI in the Veterans Affairs (VA) system from 2007 to 2010., Methods: This retrospective cohort study evaluated all veterans undergoing PCI at any of 60 hospitals in the VA health care system, using data from the national VA Clinical Assessment, Reporting, and Tracking (CART) program. Primary outcomes were 1-year mortality and costs following PCI. Risk-standardized mortality and cost ratios were calculated, adjusting for cardiac and noncardiac comorbidities., Results: A median of 261 PCIs were performed in the 60 hospitals during the study period. Median 1-year unadjusted hospital mortality rate was 6.13%. Four hospitals were significantly above the 1-year risk-standardized median mortality rate, with median mortality ratios ranging from 1.23 to 1.28. No hospitals were significantly below median mortality. Median 1-year total unadjusted hospital costs were $46,302 per patient. There were 16 hospitals above and 19 hospitals below the risk-standardized median cost, with risk-standardized ratios ranging from 0.45 to 2.09, reflecting a much larger magnitude of variability in costs than in mortality., Conclusions: There is much smaller variation in 1-year risk adjusted mortality than in risk-standardized costs after PCI in the VA. These findings suggest that there are opportunities to improve PCI value by reducing costs without compromising outcomes. This approach to evaluating outcomes and costs together may be a model for other health systems and accountable care organizations interested in operationalizing value measurement., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In a significant update, the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines recommend fixed-dose statin therapy for those at risk and do not recommend nonstatin therapies or treatment to target low-density lipoprotein cholesterol (LDL-C) levels, limiting the need for repeated LDL-C testing., Objectives: The goal of this study was to examine the impact of the 2013 ACC/AHA cholesterol guidelines on current U.S. cardiovascular practice., Methods: Using the NCDR PINNACLE (National Cardiovascular Data Registry Practice Innovation and Clinical Excellence) registry data from 2008 to 2012, we assessed current practice patterns as a function of the 2013 cholesterol guidelines. Lipid-lowering therapies and LDL-C testing patterns by patient risk group (atherosclerotic cardiovascular disease [ASCVD], diabetes, LDL-C ≥190 mg/dl, or an estimated 10-year ASCVD risk ≥7.5%) were described., Results: Among a cohort of 1,174,545 patients, 1,129,205 (96.1%) were statin-eligible (91.2% ASCVD, 6.6% diabetes, 0.3% off-treatment LDL-C ≥190 mg/dl, 1.9% estimated 10-year ASCVD risk ≥7.5%). There were 377,311 patients (32.4%) not receiving statin therapy and 259,143 (22.6%) receiving nonstatin therapies. During the study period, 20.8% of patients had 2 or more LDL-C assessments, and 7.0% had more than 4., Conclusions: In U.S. cardiovascular practices, 32.4% of statin-eligible patients, as defined by the 2013 ACC/AHA cholesterol guidelines, were not currently receiving statins. In addition, 22.6% were receiving nonstatin lipid-lowering therapies and 20.8% had repeated LDL-C testing. Achieving concordance with the new cholesterol guidelines in patients treated in U.S. cardiovascular practices would result in significant increases in statin use, as well as significant reductions in nonstatin therapies and laboratory testing., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Since 2003, the Seventh Report of the Joint National Committee (JNC-7) has been the predominant guideline for blood pressure management. A 2014 expert panel recommended increasing the blood pressure targets for patients age 60 years and older, as well as those with diabetes or chronic kidney disease., Objectives: The purpose of this study was to examine the effect of the 2014 expert panel blood pressure management recommendations on patients managed in U.S. ambulatory cardiovascular practices., Methods: Using the National Cardiovascular Data Registry PINNACLE Registry, we assessed the proportion of patients who met the 2003 and 2014 panel recommendations, highlighting the populations of patients for whom the blood pressure goals changed., Results: Of 1,185,253 patients in the study cohort, 706,859 (59.6%) achieved the 2003 JNC-7 goals. Using the 2014 recommendations, 880,378 (74.3%) patients were at goal. Among the 173,519 (14.6%) for whom goal achievement changed, 40,323 (23.2%) had a prior stroke or transient ischemic attack, and 112,174 (64.6%) had coronary artery disease. In addition, the average Framingham risk score in this group was 8.5 ± 3.2%, and the 10-year ASCVD risk score was 28.0 ± 19.5%., Conclusions: Among U.S. ambulatory cardiology patients with hypertension, nearly 1 in 7 who did not meet JNC-7 recommendations would now meet the 2014 treatment goals. If the new recommendations are implemented in clinical practice, blood pressure target achievement and cardiovascular events will need careful monitoring, because many patients for whom the target blood pressure is now more permissive are at high cardiovascular risk., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Stenosis of saphenous vein grafts (SVGs) after coronary artery bypass grafting (CABG) is common and often requires percutaneous coronary interventions (PCI) for treatment. However, data for the effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS) in SVG-PCI are unclear., Objectives: This study sought to examine the association between DES versus BMS used during SVG PCI and clinical outcomes in the national Veterans Affairs integrated healthcare system., Methods: We studied a national cohort of 2,471 post-CABG veterans undergoing SVG-PCI between 2008 and 2011 at all Veterans Affairs hospitals and compared clinical outcomes of between those receiving DES and BMS. Clinical outcomes included procedural complications, myocardial infarction (MI), and all-cause mortality. Comparisons were made in a propensity-matched cohort using Cox proportional hazards regression models., Results: DES were used in 1,549 SVG-PCI patients (63%) and the use of DES increased progressively with each calendar year (50% in 2008 to 69% in 2011). Incidence of procedural complications was low and comparable in both groups (2.8% among BMS vs. 2.3% among DES patients; p = 0.54). During long-term (>2 years) follow-up, use of DES was associated with lower mortality than BMS (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.57 to 0.89) and similar rates of MI (HR: 0.94; 95% CI: 0.71 to 1.24) in the propensity-matched cohort., Conclusions: In a national cohort of veterans, we observed widespread and increasing use of DES during SVG-PCI. In long-term follow-up, compared with BMS, DES use was safe and effective in SVG-PCI patients., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Public reporting of hospital and individual provider quality of care measures is not a new concept. In the United States, the first national public reports of hospital mortality data occurred in 1986, and detailed physician-level data for cardiac surgery are now reported in 4 states. The development of the "Hospital Compare," and more recently, the "Physician Compare" websites has further expanded public reporting for hospitals and providers. Several professional organizations, including the American Medical Association, Society of Thoracic Surgeons, and the American College of Cardiology, have published policy statements articulating key principles to guide the public reporting process. Despite the rapid proliferation of public reporting efforts, more research is needed to better define meaningful measures to report and fully understand the impact of public reporting on healthcare delivery., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine if an integrated healthcare system is selective and consistent in the use of angiography, as reflected by normal coronary rates., Background: Rates of normal coronary arteries with elective coronary angiography vary considerably among U.S. community hospitals. This variation may in part reflect incentives in fee-for-service care., Methods: Using national data from the Veterans Affairs (VA) Clinical Assessment Reporting and Tracking (CART) program representing all 76 VA cardiac catheterization laboratories, we evaluated all patients who underwent elective coronary angiography from October 2007 to September 2010. Normal coronary angiography was defined as <20% stenosis in all vessels. To assess hospital-level variation in normal coronary rates, we categorized hospitals by quartiles as defined by their proportion of normal coronaries., Results: Overall, 4,829 of 22,538 patients (21.4%) had normal coronary angiography. Hospital proportions of normal coronaries varied markedly (median hospital proportion 20.5%; interquartile range: 15.1% to 25.3%; range: 5.5% to 48.5%). Categorized as hospital quartiles, the median proportion of normal coronaries in the lowest quartile was 10.8%, as compared with a median proportion of 19.1% in the second lowest quartile, 23.1% in the second highest quartile, and 30.3% in the highest quartile. Hospitals with lower rates of normal coronaries had higher rates of obstructive coronary disease (59.2% vs. 51.3% vs. 52.6% vs. 44.3%; p < 0.001) and subsequent revascularization (38.1% vs. 33.9% vs. 31.5% vs. 29.3%; p < 0.001)., Conclusions: Approximately 1 in 5 patients undergoing elective coronary angiography in the VA had normal coronaries. This rate is lower than prior published studies in other systems. However, the observed hospital-level variation in normal coronary rates suggests opportunities to improve patient selection for diagnostic coronary angiography., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to examine whether rates of inappropriate percutaneous coronary intervention (PCI) differ by demographic characteristics and insurance status., Background: Prior studies have found that blacks, women, and those who have public or no health insurance are less likely to undergo PCI. Whether this reflects potential overuse in whites, men, and privately insured patients, in addition to underuse in disadvantaged populations, is unknown., Methods: Within the National Cardiovascular Data Registry CathPCI Registry, we identified 221,254 nonacute PCIs performed between July 2009 and March 2011. The appropriateness of PCI was determined using the Appropriate Use Criteria for coronary revascularization. Multivariable hierarchical regression was used to evaluate the association between patient demographics and insurance status and inappropriate PCI, as defined by the Appropriate Use Criteria., Results: Of 211,254 nonacute PCIs, 25,749 (12.2%) were classified as inappropriate. After multivariable adjustment, men (adjusted odd ratio [OR]: 1.08 [95% CI: 1.05 to 1.11]; p < 0.001) and whites (adjusted OR: 1.09 [95% CI: 1.05 to 1.14]; p < 0.001) were more likely to undergo an inappropriate PCI in comparison with women and nonwhites. Compared with privately insured patients, those who had Medicare (adjusted OR: 0.85 [95% CI: 0.83 to 0.88]), other public insurance (adjusted OR: 0.78 [95% CI: 0.73 to 0.83]), and no insurance (adjusted OR: 0.56 [95% CI: 0.50 to 0.61]) were less likely to undergo an inappropriate PCI (p < 0.001). In addition, compared with urban hospitals, those admitted at rural hospitals were less likely to undergo inappropriate PCI, whereas those at suburban hospitals were more likely., Conclusions: For nonacute indications, PCIs categorized as inappropriate were more commonly performed in men, whites, and those who had private insurance. Higher rates of PCI in these patient populations may, in part, be due to procedural overuse., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this report was to characterize the patients, participating centers, and measures of quality of care and outcomes for 5 NCDR (National Cardiovascular Data Registry) programs: 1) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-GWTG (Get With The Guidelines) for acute coronary syndromes; 2) CathPCI Registry for coronary angiography and percutaneous coronary intervention; 3) CARE (Carotid Artery Revascularization and Endarterectomy) Registry for carotid revascularization; 4) ICD Registry for implantable cardioverter defibrillators; and the 5) PINNACLE (Practice INNovation And CLinical Excellence) Registry for outpatients with cardiovascular disease (CVD)., Background: CVD is a leading cause of death and disability in the United States. The quality of care for patients with CVD is suboptimal. National registry programs, such as NCDR, permit assessments of the quality of care and outcomes for broad populations of patients with CVD., Methods: For the year 2011, we assessed for each of the 5 NCDR programs: 1) demographic and clinical characteristics of enrolled patients; 2) key characteristics of participating centers; 3) measures of processes of care; and 4) patient outcomes. For selected variables, we assessed trends over time., Results: In 2011 ACTION Registry-GWTG enrolled 119,967 patients in 567 hospitals; CathPCI enrolled 632,557 patients in 1,337 hospitals; CARE enrolled 4,934 patients in 130 hospitals; ICD enrolled 139,991 patients in 1,435 hospitals; and PINNACLE enrolled 249,198 patients (1,436,328 individual encounters) in 74 practices (1,222 individual providers). Data on performance metrics and outcomes, in some cases risk-adjusted with validated NCDR models, are presented., Conclusions: The NCDR provides a unique opportunity to understand the characteristics of large populations of patients with CVD, the centers that provide their care, quality of care provided, and important patient outcomes., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) transcatheter valve therapy (TVT) registry is a novel, national registry for all new TVT devices created through a partnership of the STS and the ACC in close collaboration with the Food and Drug Administration, the Center for Medicare and Medicaid Services, and the Duke Clinical Research Institute. The registry will serve as an objective, comprehensive, and scientifically based resource to improve the quality of patient care, to monitor the safety and effectiveness of TVT devices, to serve as an analytic resource for TVT research, and to enhance communication among key stakeholders., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program., Background: Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research., Methods: Before inclusion in the registry, data are filtered through the registry-specific algorithms that require predetermined levels of completeness and consistency for submitted data fields as part of the data quality report. Internal quality assurance protocols enforce data standards before reporting. Within each registry, 300 to 625 records are audited annually in 25 randomly identified sites (i.e., 12 to 25 records per audited site)., Results: In the 2010 audits, the participant average raw accuracy of data abstraction for the CathPCI Registry, ICD Registry, and ACTION Registry-GWTG were, respectively, 93.1% (range, 89.4% minimum, 97.4% maximum), 91.2% (range, 83.7% minimum, 95.7% maximum), and 89.7.% (range, 85% minimum, 95% maximum)., Conclusions: The 2010 audits provided evidence that many fields in the NCDR accurately represent the data from the medical charts. The American College of Cardiology Foundation is undertaking a series of initiatives aimed at creating a quality assurance rapid learning system, which, when complete, will monitor, evaluate, and improve data quality., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study assessed the comparative effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS) among patients ≥85 years of age., Background: Despite an aging population, little is known about the comparative effectiveness of DES versus BMS among patients age ≥85 years undergoing percutaneous coronary intervention (PCI)., Methods: We examined 471,006 PCI patients age ≥65 years at 947 hospitals in the National Cardiovascular Data Registry between 2004 and 2008 and linked to Medicare claims data. Long-term outcomes (median follow-up 640.8 ± 423.5 days) were compared between users of DES and BMS., Results: Patients age ≥85 years comprise an increasing proportion of PCIs performed among elderly subjects, yet rates of DES use declined the most in this age group. Compared with BMS, use of DES was associated with lower mortality: age ≥85 years, 29% versus 38% (adjusted hazard ratio [HR]: 0.80 [95% confidence interval (CI): 0.77 to 0.83]); age 75 to 84 years, 17% versus 25% (HR: 0.77 [95% CI: 0.75 to 0.79]); and age 65 to 74 years, 10% versus 16% (HR: 0.73 [95% CI: 0.71 to 0.75]). However, the adjusted mortality difference narrowed with increasing age (p(interaction) <0.001). In contrast, the adjusted HR for myocardial infarction rehospitalization associated with DES use was significantly lower with increasing age: age ≥85 years, 9% versus 12% (HR: 0.77 [95% CI: 0.71 to 0.83]); age 75 to 84 years, 7% versus 9% (HR: 0.81 [95% CI: 0.77 to 0.84]); and age 65 to 74 years, 7% versus 8% (HR: 0.84 [95% CI: 0.80 to 0.88]) (p(interaction) <0.001)., Conclusions: In this national study of older patients undergoing PCI, declines in DES use were most pronounced among those aged ≥85 years, yet lower adverse-event rates associated with DES versus BMS use were observed., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We examined compliance with performance measures for 14,464 patients enrolled from July 2008 through June 2009 into the American College of Cardiology's PINNACLE (Practice Innovation And Clinical Excellence) program to provide initial insights into the quality of outpatient cardiac care., Background: Little is known about the quality of care of outpatients with coronary artery disease (CAD), heart failure, and atrial fibrillation, and whether sex and racial disparities exist in the treatment of outpatients., Methods: The PINNACLE program is the first, national, prospective office-based quality improvement program of cardiac patients designed, in part, to capture, report, and improve outpatient performance measure compliance. We examined the proportion of patients whose care was compliant with established American College of Cardiology, American Heart Association, and American Medical Association-Physician Consortium for Performance Improvement (ACC/AHA/PCPI) performance measures for CAD, heart failure, and atrial fibrillation., Results: There were 14,464 unique patients enrolled from 27 U.S. practices, accounting for 18,021 clinical visits. Of these, 8,132 (56.4%) had CAD, 5,012 (34.7%) had heart failure, and 2,786 (19.3%) had nonvalvular atrial fibrillation. Data from the PINNACLE program were feasibly collected for 24 of 25 ACC/AHA/PCPI performance measures. Compliance with performance measures ranged from being very low (e.g., 13.3% of CAD patients screened for diabetes mellitus) to very high (e.g., 96.7% of heart failure patients with blood pressure assessments), with moderate (70% to 90%) compliance observed for most performance measures. For 3 performance measures, there were small differences in compliance rates by race or sex., Conclusions: For more than 14,000 patients enrolled from 27 practices in the outpatient PINNACLE program, we found that compliance with performance measures was variable, even after accounting for exclusion criteria, suggesting an important opportunity to improve the quality of outpatient care., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to create contemporary models for predicting mortality risk following percutaneous coronary intervention (PCI)., Background: There is a need to identify PCI risk factors and accurately quantify procedural risks to facilitate comparative effectiveness research, provider comparisons, and informed patient decision making., Methods: Data from 181,775 procedures performed from January 2004 to March 2006 were used to develop risk models based on pre-procedural and/or angiographic factors using logistic regression. These models were independently evaluated in 2 validation cohorts: contemporary (n = 121,183, January 2004 to March 2006) and prospective (n = 285,440, March 2006 to March 2007)., Results: Overall, PCI in-hospital mortality was 1.27%, ranging from 0.65% in elective PCI to 4.81% in ST-segment elevation myocardial infarction patients. Multiple pre-procedural clinical factors were significantly associated with in-hospital mortality. Angiographic variables provided only modest incremental information to pre-procedural risk assessments. The overall National Cardiovascular Data Registry (NCDR) model, as well as a simplified NCDR risk score (based on 8 key pre-procedure factors), had excellent discrimination (c-index: 0.93 and 0.91, respectively). Discrimination and calibration of both risk tools were retained among specific patient subgroups, in the validation samples, and when used to estimate 30-day mortality rates among Medicare patients., Conclusions: Risks for early mortality following PCI can be accurately predicted in contemporary practice. Incorporation of such risk tools should facilitate research, clinical decisions, and policy applications., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to report on the all-cause readmission and repeat revascularization rates after percutaneous coronary intervention (PCI)., Background: Although PCIs are frequently performed, 30-day rates of readmission and repeat revascularization after PCI are not known., Methods: Retrospective analysis of a cohort of Medicare fee-for-service admissions associated with a PCI in 2005. Primary outcomes were 30-day all-cause readmission rates and 30-day readmission rates associated with a revascularization procedure., Results: A total of 315,241 PCI procedures performed at 1,108 hospitals were included in the analysis. The all-cause 30-day readmission rate was 14.6%, and the all-cause 30-day mortality rate was 1.0%. All-cause 30-day mortality among readmitted patients was higher than patients who were not readmitted (3.6% vs. 0.6%; p < 0.001). The 30-day readmission rate of acute myocardial infarction (AMI) patients was significantly higher than that of non-AMI patients (AMI 17.5%, non-AMI 13.6%, p < 0.001). Among all patients readmitted within 30 days after the index PCI, 27.5% had an associated revascularization procedure (PCI 25.8%, coronary artery bypass grafting 1.7%). The median readmission rates varied across hospitals, from 8.9% in the lowest decile to 22.0% in the highest decile., Conclusions: A substantial proportion of PCI patients are readmitted within 30 days of discharge, and readmission rates vary widely across hospitals. Readmissions within 30 days of an index PCI procedure were associated with a significantly higher 30-day mortality rate, and more than one-quarter of such readmissions resulted in a repeat revascularization procedure. These findings warrant further attention to determine whether these readmissions are preventable.

Objectives: This study sought to determine the association of pre-hospital electrocardiograms (ECGs) and the timing of reperfusion therapy for patients with ST-segment elevation myocardial infarction (STEMI)., Background: Pre-hospital ECGs have been recommended in the management of patients with chest pain transported by emergency medical services (EMS)., Methods: We evaluated patients with STEMI from the NCDR (National Cardiovascular Data Registry) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) registry who were transported by EMS from January 1, 2007, through December 31, 2007. Patients were stratified by the use of pre-hospital ECGs, and timing of reperfusion therapy was compared between the 2 groups., Results: A total of 7,098 of 12,097 patients (58.7%) utilized EMS, and 1,941 of these 7,098 EMS transport patients (27.4%) received a pre-hospital ECG. Among the EMS transport population, primary percutaneous coronary intervention was performed in 92.1% of patients with a pre-hospital ECG versus 86.3% with an in-hospital ECG, whereas fibrinolytic therapy was used in 4.6% versus 4.2% of patients. Median door-to-needle times for patients receiving fibrinolytic therapy (19 min vs. 29 min, p = 0.003) and median door-to-balloon times for patients undergoing primary percutaneous coronary intervention (61 min vs. 75 min, p < 0.0001) were significantly shorter for patients with a pre-hospital ECG. A suggestive trend for a lower risk of in-hospital mortality was observed with pre-hospital ECG use (adjusted odds ratio: 0.80, 95% confidence interval: 0.63 to 1.01)., Conclusions: Only one-quarter of these patients transported by EMS receive a pre-hospital ECG. The use of a pre-hospital ECG was associated with a greater use of reperfusion therapy, faster reperfusion times, and a suggested trend for a lower risk of mortality.

The American College of Cardiology (ACC) and the American Heart Association (AHA) have provided leadership in enhancing the quality of cardiovascular care, including the development of clinical performance measures and clinical registries that permit the evaluation of quality of care and stimulate quality improvement. Compliance with ACC/AHA performance measures and metrics encourages the provision of the strongest evidence-based quality of care, including therapies that are life-extending or life-enhancing. Among quality metrics, only a subset should be considered performance measures-that is, those measures specifically suitable for public reporting, external comparisons, and possibly pay-for-performance programs, in addition to quality improvement. These performance measures have been developed using ACC/AHA methodology, often in collaboration with other organizations, and include the process of public comment and peer review. Quality metrics are those measures that have been developed to support self assessment and quality improvement at the provider, hospital, and/or health care system level. These metrics represent valuable tools to aid clinicians and hospitals in improving quality of care and enhancing patient outcomes, but may not meet all specifications of formal performance measures. These quality metrics may also be considered "candidate" measures that with further research of field testing would meet the criteria for formal performance measures in the future. This measure classification is intended to aid providers, hospitals, health systems, and payers in identifying those measures that the ACC and AHA formally endorse as performance measures, while at the same time promoting the broader range of clinical metrics that are useful for quality improvement efforts.

The assessment of medical practice is evolving rapidly in the United States. An initial focus on structure and process performance measures assessing the quality of medical care is now being supplemented with efficiency measures to quantify the "value" of healthcare delivery. This statement, building on prior work that articulated standards for publicly reported outcomes measures, identifies preferred attributes for measures used to assess efficiency in the allocation of healthcare resources. The attributes identified in this document combined with the previously published standards are intended to serve as criteria for assessing the suitability of efficiency measures for public reporting. This statement identifies the following attributes to be considered for publicly reported efficiency measures: integration of the quality and cost; valid cost measurement and analysis; minimal incentive to provide poor quality care; and proper attribution of the measure. The attributes described in this statement are relevant to a wide range of efforts to profile the efficiency of various healthcare providers, including hospitals, healthcare systems, managed-care organizations, physicians, group practices, and others that deliver coordinated care.

Objectives: The goal of this work was to explore the treatment and outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) age > or =90 years., Background: The elderly are often excluded from clinical trials of NSTE-ACS and are underrepresented in clinical registries., Methods: We used data from the CRUSADE registry to study 5,557 patients with NSTE-ACS age > or =90 years and compared their baseline characteristics, treatment patterns, and in-hospital outcomes with a cohort age 75 to 89 years (n = 46,270)., Results: Although both groups had much in common, compared with the younger elderly, the older elderly were less likely to be diabetic, smokers, or obese. Among patients without contraindications, the older elderly were less likely to receive glycoprotein IIb/IIIa inhibitors and statins during the first 24 h and were less likely to undergo cardiac catheterization within 48 h. The older elderly were more likely to die (12.0% vs. 7.8%) and experienced more frequent adverse events (26.8% vs. 21.3%) during the hospitalization-differences that persisted after adjustment for baseline patient and hospital characteristics. Increasing adherence to guideline-recommended therapies was associated with both increased bleeding and a graded reduction in risk-adjusted in-hospital mortality across both age groups., Conclusions: In this large population of nonagenarians and centenarians with NSTE-ACS, increasing adherence to guideline-recommended therapies was associated with decreased mortality. These findings reinforce the importance of optimizing care patterns for even the oldest patients with NSTE-ACS, while examining novel approaches to reduce the risk of bleeding in this rapidly expanding patient population.

Objectives: We 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)., Background: Health 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., Methods: We evaluated 505 HF patients from 13 outpatient clinics who had an ejection fraction <40% using the KCCQ summary score. Proportional hazards regression was used to evaluate the association between the KCCQ summary score (range, 0 to 100; higher scores indicate better health status) and the primary outcome of death or HF admission, adjusting for baseline patient characteristics, 6-min walk distance, and B-type natriuretic peptide (BNP)., Results: The mean age was 61 years, 76% of patients were male, 51% had an ischemic HF etiology, and 5% were New York Heart Association functional class IV. At 12 months, among the 9% of patients with a KCCQ score <25, 37% had been admitted for HF and 20% had died, compared with 7% (HF admissions) and 5% (death) of those with a KCCQ score > or =75 (33% of patients, p < 0.0001 for both comparisons). In sequential multivariable models adjusting for clinical variables, 6-min walk, and BNP levels, the KCCQ score remained significantly associated with survival free of HF hospitalization., Conclusions: A low KCCQ score is an independent predictor of poor prognosis in outpatients with HF.