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Background: New methods such as machine learning techniques have been increasingly used to enhance the performance of risk predictions for clinical decision-making. However, commonly reported performance metrics may not be sufficient to capture the advantages of these newly proposed models for their adoption by health care professionals to improve care. Machine learning models often improve risk estimation for certain subpopulations that may be missed by these metrics., Methods and Results: This article addresses the limitations of commonly reported metrics for performance comparison and proposes additional metrics. Our discussions cover metrics related to overall performance, discrimination, calibration, resolution, reclassification, and model implementation. Models for predicting acute kidney injury after percutaneous coronary intervention are used to illustrate the use of these metrics., Conclusions: We demonstrate that commonly reported metrics may not have sufficient sensitivity to identify improvement of machine learning models and propose the use of a comprehensive list of performance metrics for reporting and comparing clinical risk prediction models.

Background: Bleeding avoidance strategies (BASs) are increasingly adopted for patients undergoing percutaneous coronary intervention (PCI) due to bleeding complications. However, their association with bleeding events outside of Western countries remains unclear. In collaboration with the National Cardiovascular Data Registry (NCDR) CathPCI registry, we aimed to assess the time trend and impact of BAS utilization among Japanese patients., Methods: Our study included 19,656 consecutive PCI patients registered over 10 years. These patients were divided into 4-time frame groups (T1: 2008-2011, T2: 2012-2013, T3: 2014-2015, and T4: 2016-2018). BAS was defined as the use of transradial approach or vascular closure device (VCD) use after transfemoral approach (TFA). Model performance of the NCDR CathPCI bleeding model was evaluated. The degree of bleeding reduction associated with BAS adoption was estimated via multilevel mixed-effects multivariable logistic regression analysis., Results: The NCDR CathPCI bleeding risk score demonstrated good discrimination in the Japanese population (C-statistics 0.79-0.81). The BAS adoption rate increased from 43% (T1) to 91% (T4), whereas the crude CathPCI-defined bleeding rate decreased from 10% (T1) to 7% (T4). Adjusted odds ratios for bleeding events were 0.25 (95% confidence interval, 0.14-0.45, P< .001) for those undergoing TFA with VCD in T4 and 0.26 (95% confidence interval 0.20-0.35, P< .001) for transradial approach in T4 compared to patients that received TFA without VCD in T1., Conclusions: BAS use over the studied time frames was associated with lower risk of bleeding complications among Japanese. Nonetheless, observed bleeding rates remained higher compared to the US population., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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.)

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 US population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on (a) varied clinical presentations; (b) appropriate personal protection equipment (PPE) for health care workers; (c) the roles of the emergency department, emergency medical system, and the cardiac catheterization laboratory (CCL); and (4) regional STEMI systems of care. During the COVID-19 pandemic, primary percutaneous coronary intervention (PCI) remains the standard of care for STEMI patients at PCI-capable hospitals when it can be provided in a timely manner, 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., (© 2020 Wiley Periodicals, Inc.)

Importance: Determining the association of contrast volume during percutaneous coronary intervention (PCI) with the risk of acute kidney injury (AKI) is important for optimizing PCI safety., Objective: To quantify how the risk of AKI is associated with contrast volume, accounting for the possibility of nonlinearity and heterogeneity among different baseline risks., Design, Setting, and Participants: This prognostic study used data from the American College of Cardiology National Cardiovascular Data Registry CathPCI Registry for 1694 US hospitals. Derivation analysis included 2 076 694 individuals who underwent PCI from July 1, 2011, to June 30, 2015. Validation analysis included 961 863 individuals who underwent PCI from July 1, 2015, to March 31, 2017. Data analysis took place from July 2018 to May 2019., Exposure: Contrast volume during PCI., Main Outcomes and Measures: Acute kidney injury was defined using 3 thresholds for preprocedure to postprocedure creatinine level increase (ie, ≥0.3 mg/dL, ≥0.5 mg/dL, and ≥1.0 mg/dL). A model quantifying the association of contrast volume with AKI was developed, and the existence of nonlinearity and heterogeneity were examined by likelihood ratio tests. The model was derived in the training set (a random 50% of the derivation cohort), and performance was evaluated in the test set (the remaining 50% of the derivation cohort) and an independent validation set by area under the receiver operating characteristic curve (AUC) and calibration slope of observed vs predicted risks., Results: The 2 076 694 patients in the derivation set had a mean (SD) age of 65.1 (12.1) years, and 662 525 (31.9%) were women; 133 306 (6.4%) had creatinine level increases of at least 0.3 mg/dL, 66 626 (3.2%) had creatinine level increases of at least 0.5 mg/dL, and 28 378 (1.4%) had creatinine level increases of at least 1.0 mg/dL. In the validation set of 961 843 patients (mean [SD] age, 65.7 [12.1] years; 305 577 [31.8%] women), these rates were 62 913 (6.5%), 34 229 (3.6%), and 15 555 (1.6%), respectively. The association of contrast volume and AKI risk was nonlinear (χ226 = 1436.2; P < .001) and varied by preprocedural risk (χ220 = 105.6; P < .001). In the test set, the model yielded an AUC of 0.777 (95% CI, 0.775-0.779) for predicting risk of a creatinine level increase of at least 0.3 mg/dL, 0.839 (95% CI, 0.837-0.841) for predicting risk of a creatinine level increase of at least 0.5 mg/dL, and 0.870 (95% CI, 0.867-0.873) for predicting risk of a creatinine level increase of at least 1.0 mg/dL; it achieved a calibration slope of 0.998 (95% CI, 0.989-1.007), 0.999 (95% CI, 0.989-1.008), and 0.986 (95% CI, 0.973-0.998), respectively, for the AKI severity levels. The model had similar performance in the validation set (creatinine level increase of ≥0.3 mg/dL: AUC, 0.794; 95% CI, 0.792-0.795; calibration slope, 1.039; 95% CI, 1.030-1.047; creatinine level increase of ≥0.5 mg/dL: AUC, 0.845; 95% CI, 0.843-0.848; calibration slope, 1.063; 95% CI, 1.054-1.074; creatinine level increase of ≥1.0 mg/dL: AUC, 0.872; 95% CI, 0.869-0.875; calibration slope, 1.103; 95% CI, 1.089-1.117)., Conclusions and Relevance: The association of contrast volume with AKI risk is complex, varies by baseline risk, and can be predicted by a model. Future research to evaluate the effect of the model on AKI is needed.

Background Troponin release in ST-segment-elevation myocardial infarction (STEMI) has predictable kinetics with early levels reflective of ischemia duration. Little research has examined the value of admission troponin levels in STEMI patients undergoing primary percutaneous coronary intervention. We investigated the relationship between troponin on presentation and mortality in a large, real-world cohort of STEMI patients undergoing primary percutaneous coronary intervention. Methods and Results We used multivariable adaptive regression modeling to examine the association between admission troponin levels and in-hospital mortality for patients who underwent primary percutaneous coronary intervention for STEMI. We adjusted for known clinical risk factors using a validated mortality risk model derived from the NCDR (National Cardiovascular Data Registry) CathPCI database, and this same model was used to calculate patients' predicted mortality based on clinical and demographic factors. Patients were then stratified by troponin groups to compare predicted versus observed mortality. Of the 14 061 patients included in the cohort, 47.2% had initial troponin levels that were undetectable or within the reference range. Admission troponin was an independent predictor of in-hospital mortality, and any value above the reference range was associated with increased mortality (1.8% versus 5.1%, [standardized difference, 18.2%]). Patients with the highest predicted risk for mortality (13% predicted) in the highest admission troponin grouping experienced an observed mortality of 19.5%. Patients in low troponin groupings consistently demonstrated lower than predicted mortality based on their clinical and demographic risk profile. Conclusions Nearly half of patients undergoing primary percutaneous coronary intervention had normal troponin on presentation and had a relatively good outcome. Mortality increases with elevated admission troponin levels, regardless of baseline clinical risk. The substantial number of patients who present with markedly elevated troponin and their relatively worse outcomes highlights the need for continued improvement in prehospital STEMI detection and care.

Background: The current acute kidney injury (AKI) risk prediction model for patients undergoing percutaneous coronary intervention (PCI) from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) employed regression techniques. This study aimed to evaluate whether models using machine learning techniques could significantly improve AKI risk prediction after PCI., Methods and Findings: We used the same cohort and candidate variables used to develop the current NCDR CathPCI Registry AKI model, including 947,091 patients who underwent PCI procedures between June 1, 2009, and June 30, 2011. The mean age of these patients was 64.8 years, and 32.8% were women, with a total of 69,826 (7.4%) AKI events. We replicated the current AKI model as the baseline model and compared it with a series of new models. Temporal validation was performed using data from 970,869 patients undergoing PCIs between July 1, 2016, and March 31, 2017, with a mean age of 65.7 years; 31.9% were women, and 72,954 (7.5%) had AKI events. Each model was derived by implementing one of two strategies for preprocessing candidate variables (preselecting and transforming candidate variables or using all candidate variables in their original forms), one of three variable-selection methods (stepwise backward selection, lasso regularization, or permutation-based selection), and one of two methods to model the relationship between variables and outcome (logistic regression or gradient descent boosting). The cohort was divided into different training (70%) and test (30%) sets using 100 different random splits, and the performance of the models was evaluated internally in the test sets. The best model, according to the internal evaluation, was derived by using all available candidate variables in their original form, permutation-based variable selection, and gradient descent boosting. Compared with the baseline model that uses 11 variables, the best model used 13 variables and achieved a significantly better area under the receiver operating characteristic curve (AUC) of 0.752 (95% confidence interval [CI] 0.749-0.754) versus 0.711 (95% CI 0.708-0.714), a significantly better Brier score of 0.0617 (95% CI 0.0615-0.0618) versus 0.0636 (95% CI 0.0634-0.0638), and a better calibration slope of observed versus predicted rate of 1.008 (95% CI 0.988-1.028) versus 1.036 (95% CI 1.015-1.056). The best model also had a significantly wider predictive range (25.3% versus 21.6%, p < 0.001) and was more accurate in stratifying AKI risk for patients. Evaluated on a more contemporary CathPCI cohort (July 1, 2015-March 31, 2017), the best model consistently achieved significantly better performance than the baseline model in AUC (0.785 versus 0.753), Brier score (0.0610 versus 0.0627), calibration slope (1.003 versus 1.062), and predictive range (29.4% versus 26.2%). The current study does not address implementation for risk calculation at the point of care, and potential challenges include the availability and accessibility of the predictors., Conclusions: Machine learning techniques and data-driven approaches resulted in improved prediction of AKI risk after PCI. The results support the potential of these techniques for improving risk prediction models and identification of patients who may benefit from risk-mitigation strategies., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: SSD is supported by the Department of Veterans Affairs. WLS is a consultant for Hugo, a personal health information platform. CIM is a consultant for Cook, Bard, Medtronic, Abbott and Cardinal Health. FPW is supported by the National Science Foundation grant R01DK113191. JSR is the Chief Innovation Officer for the American College of Cardiology. HMK is a recipient of research agreements from Medtronic and from Johnson & Johnson (Janssen), through Yale University, to develop methods of clinical trial data sharing; was the recipient of a grant from the Food and Drug Administration and Medtronic to develop methods for postmarket surveillance of medical devices; works under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures; chairs a cardiac scientific advisory board for UnitedHealth; is a member of the Advisory Board for Element Science and the Physician Advisory Board for Aetna; is a participant/participant representative of the IBM Watson Health Life Sciences Board; and is the founder of Hugo, a personal health information platform. JAS is supported by grants from Gilead, Genentech, Lilly, Amorcyte, and EvaHeart and has a patent for the Seattle Angina Questionnaire with royalties paid. He also owns the copyright to the Seattle Angina Questionnaire. He is the PI of an Analytic Center for the American College of Cardiology Foundation and has an equity interest in Health Outcomes Sciences. FAM has a contract (through his primary institution) for his role as Chief Science Officer of the NCDR. BJM is an associate editor for PLOS ONE, which is involved in this special issue. He has a relationship with the American College of Cardiology in selecting and pursuing innovative research based upon their registry data (unrelated to this paper). He has a pending patent application for an EHR-based prediction tool in Yale New Haven Health, as well as two funded studies, one by the DoD-Advanced Research Projects Agency and one with the NSF to support student travel to conferences in the body sensor networks field. American College of Cardiology may incorporate this work, or future iterations, into its registry. No other organisation named above has a competing interest in relation to this work. The other authors report no potential competing interests.

Objectives: This study sought to compare the appropriate use and outcomes of percutaneous coronary intervention (PCI) between top-ranked and nonranked hospitals., Background: The U.S. News & World Report "Best Hospitals" rankings are an influential consumer-directed publication of hospital quality, and are commonly used in promotional campaigns by hospital systems., Methods: Hospitals in the National Cardiovascular Data Registry CathPCI registry between July 1, 2014, and June 30, 2015, were classified as top-ranked if they were included in the 2015 U.S. News & World Report 50 best "Cardiology and Heart Surgery" hospitals. The remaining were classified as nonranked. We compared in-hospital mortality, post-procedural bleeding, post-procedural acute kidney injury, and the proportion of appropriate PCI procedures between top-ranked and nonranked hospitals., Results: A total of 509,153 PCIs at 654 hospitals were included, of which 55,550 (10.9%) were performed at 44 top-ranked hospitals. After adjusting for patient case mix, PCIs performed at top-ranked hospitals had similar odds of in-hospital mortality (adjusted odds ratio [aOR]: 0.96; 95% confidence interval [CI]: 0.83 to 1.12; p = 0.64), acute kidney injury (aOR: 1.10; 95% CI: 0.98 to 1.22; p = 0.099), and bleeding (aOR: 1.15; 95% CI: 0.99 to 1.31; p = 0.052). Top-ranked hospitals had a slightly lower proportion of appropriate PCI compared with nonranked hospitals (89.2% vs. 92.8%; OR: 0.56; 95% CI: 0.45 to 0.69; p < 0.001)., Conclusions: PCI performed at top-ranked hospitals was not associated with superior outcomes compared with PCI at nonranked hospitals. The inclusion of metrics based on clinical data may be important for hospital quality rankings., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to describe the contemporary incidence of chronic total occlusions (CTOs) and the success rates of CTO percutaneous coronary intervention (PCI), as well as the complications and long-term outcomes of these patients., Background: The contemporary prevalence and management of coronary CTOs is understudied., Methods: Consecutive veterans undergoing coronary angiography at 79 Veterans Affairs sites between 2007 and 2013 were examined. Detailed baseline clinical, angiographic, and follow-up outcomes were evaluated using national data from the Veterans Affairs Clinical Assessment Reporting and Tracking program., Results: Among 111,273 patients with obstructive coronary artery disease, 29,399 (26.4%) had ≥1 CTO, most commonly in the right coronary artery distribution (n = 18,986 [64.6%]). Elective CTO PCI was attempted in 2,394 patients (8.1%), with a procedural success rate of 79.7%. The odds of CTO PCI success increased over the years of the study (odds ratio: 1.08; 95% confidence interval [CI]: 1.01 to 1.16; p = 0.03). Compared with failed CTO PCI, successful CTO PCI was associated with a decreased adjusted risk for mortality (hazard ratio: 0.67; 95% CI: 0.47 to 0.95; p = 0.02) and coronary artery bypass graft surgery (hazard ratio: 0.14; 95% CI: 0.08 to 0.24; p < 0.01) at 2 years but no significant change in the risk for hospitalization for myocardial infarction (hazard ratio: 0.89; 95% CI: 0.58 to 1.36; p = 0.58)., Conclusions: Approximately 1 in 4 patients with obstructive coronary artery disease on coronary angiography had CTOs. Among patients who went on to elective CTO PCI, the success rate was 79.7%. Compared with failed CTO PCI, successful CTO PCI was associated with a decreased risk for mortality as well as a decreased need for subsequent coronary artery bypass graft surgery., (Published by Elsevier Inc.)

Objectives: This study sought to determine variability and stability in risk-standardized mortality rates (RSMR) of percutaneous coronary intervention (PCI) operators meeting minimum case volume standards and identify differences in case mix and practice patterns that may account for RSMR variability., Background: RSMR has been suggested as a metric to evaluate the performance of PCI operators; however, variability of operator-level RSMR and the stability of this metric over time among the same operator are unknown., Methods: The authors calculated mean RSMRs for PCI operators with average annual volume of ≥50 cases in the National Cardiovascular Data Registry CathPCI Registry. Funnel plots were used to account for operator case volume. Demographic, clinical, and treatment variables of patients treated by operators with outlying high or low RSMRs (identified by RMSR greater than or less than 2 σ above or below the mean [analogous to 2 SD], respectively) were compared with nonoutlier operators. RMSR stability was assessed by calculating average annual operator RMSR during the study period and by determining if operators were consistently classified into RMSR categories in each year., Results: Between October 1, 2009, and September 30, 2014, a total of 2,352,174 PCIs were performed at 1,373 hospitals by 3,760 operators. Of these, 242 operators (6.5%) had RSMR >2 σ above the mean and 156 operators (4.1%) had RSMR >2 σ below the mean. Both high and low RSMR outlier operators treated patients with lower expected mortality risk, compared with nonoutlier operators. There was significant instability in annual operator RMSR during the study period., Conclusions: There is significant variability in risk-standardized PCI mortality among U.S. operators meeting minimum volume standards that is not explained by case mix or procedure characteristics. Operator RMSR was unstable from year to year, thus limiting its utility as a sole performance measure for PCI quality., (Published by Elsevier Inc.)

Background: Acute kidney injury (AKI) remains a common complication after percutaneous coronary intervention (PCI) and is associated with adverse in-hospital patient outcomes. The incidence of adverse events after hospital discharge in patients having post-PCI AKI is poorly defined, and the relationship between AKI and outcomes after hospital discharge remains understudied., Methods and Results: Using the National Cardiovascular Data Registry CathPCI registry, we assessed the incidence of AKI among Medicare beneficiaries after PCI from 2004 to 2009 and subsequent post-discharge adverse events at 1 year. AKI was defined using Acute Kidney Injury Network (AKIN) criteria. Adverse events included death, myocardial infarction, bleeding, and recurrent kidney injury. Using Cox methods, we determined the relationship between in-hospital AKI and risk of post-discharge adverse events by AKIN stage. In a cohort of 453 475 elderly patients undergoing PCI, 39 850 developed AKI (8.8% overall; AKIN stage 1, 85.8%; AKIN 2/3, 14.2%). Compared with no AKI, in-hospital AKI was associated with higher post-discharge hazard of death, myocardial infarction, or bleeding (AKIN 1: hazard ratio [HR], 1.53; confidence interval [CI], 1.49-1.56 and AKIN 2/3: HR, 2.13; CI, 2.01-2.26), recurrent AKI (AKIN 1: HR, 1.70; CI, 1.64-1.76; AKIN 2/3: HR, 2.22; CI, 2.04-2.41), and AKI requiring dialysis (AKIN 1: HR, 2.59; CI, 2.29-2.92; AKIN 2/3: HR, 4.73; CI, 3.73-5.99). For each outcome, the highest incidence was within 30 days., Conclusions: Post-PCI AKI is associated with increased risk of death, myocardial infarction, bleeding, and recurrent renal injury after discharge. Post-PCI AKI should be recognized as a significant risk factor not only for in-hospital adverse events but also after hospital discharge., (© 2017 American Heart Association, Inc.)

Background: Studies of kidney disease associated with cardiac catheterization typically rely on billing records rather than laboratory data. We examined the associations between percutaneous coronary interventions, acute kidney injury, and chronic kidney disease progression using comprehensive Veterans Affairs clinical and laboratory databases., Methods and Results: Patients undergoing percutaneous coronary interventions between 2005 and 2010 (N=24 405) were identified in the Veterans Affairs Clinical Assessment, Reporting, and Tracking registry and examined for associated acute kidney injury and chronic kidney disease development or progression relative to 24 405 matched population controls. Secondary outcomes analyzed included dialysis, acute myocardial infarction, and mortality. The incidence of chronic kidney disease progression following percutaneous coronary interventions complicated by acute kidney injury, following uncomplicated coronary interventions, and in matched controls were 28.66, 11.15, and 6.81 per 100 person-years, respectively. Percutaneous coronary intervention also increased the likelihood of chronic kidney disease progression in both the presence and absence of acute injury relative to controls in adjusted analyses (hazard ratio [HR], 5.02 [95% CI, 4.68-5.39]; and HR, 1.76 [95% CI, 1.70-1.86]). Among patients with estimated glomerular filtration rate <60 mL/min per 1.73 m 2 , acute kidney injury increased the likelihood of disease progression by 8-fold. Similar results were observed for all secondary outcomes., Conclusions: Acute kidney injury following percutaneous coronary intervention was associated with increased chronic kidney disease development and progression and mortality., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: Prasugrel is more effective than clopidogrel in preventing thrombotic complications after percutaneous coronary intervention (PCI) among patients with acute coronary syndromes (ACS), but it increases the risk of bleeding in subgroups of patients. There is limited data on whether prasugrel use in routine practice is targeted to clinical settings with greatest anticipated patient benefit., Methods: In a national cohort of 11 617 veterans who underwent PCI between 2010 and 2013 at Veterans Administration hospitals nationwide, we assessed overall trends in the use of prasugrel and the frequency of prasugrel use in patients with contraindications (prior transient ischemic attack or cerebrovascular accident), higher bleeding risk (age ≥75 or weight <60 kg), and nonindicated settings (non-acute coronary syndrome [non-ACS]). We then evaluated the association between prasugrel use and 1-year risk-adjusted mortality, myocardial infarction, and major bleeding rates., Results: Overall, 1040 (9.0%) patients who received prasugrel after PCI were included. Prasugrel was infrequently used in contraindicated (2.4%) or higher-bleeding-risk (1.8%) settings. Additionally, 35.8% of patients received prasugrel in settings that lack evidence of clinical benefit (ie, non-ACS). Compared with clopidogrel, there were no significant differences in risk-adjusted mortality, myocardial infarction, or major bleeding outcomes with prasugrel therapy at 1-year follow-up., Conclusions: Prasugrel use after PCI in the Veterans Administration is low and prasugrel was rarely used in contraindicated or high-bleeding-risk settings. However, a third of patients received prasugrel for off-label non-ACS indications that lack efficacy data., (© 2016 Wiley Periodicals, Inc.)

Background: Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (ACTION Registry-GWTG) was designed to measure and improve the treatment and outcomes of patients with acute myocardial infarction (AMI), yet it is unknown whether performance of Medicare Hospital Compare metrics and outcomes differ between hospitals participating versus those not participating in the registry., Methods: Using 2007 to 2010 Hospital Compare data, we matched participating to nonparticipating hospitals based on teaching status, size, percutaneous coronary intervention capability, and baseline (2007) Hospital Compare AMI process measure performance. We used linear mixed modeling to compare 2010 Hospital Compare process measure adherence, 30-day risk-adjusted mortality, and readmission rates. We repeated these analyses after stratification according to baseline performance level., Results: Compared with nonparticipating hospitals, those participating were larger (median 288 vs 139 beds, P < .0001), more often teaching hospitals (18.8% vs 6.3%, P < .0001), and more likely had interventional catheterization lab capabilities (85.7% vs 34.0%, P < .0001). Among 502 matched pairs of participating and nonparticipating hospitals, we found high levels of process measure adherence in both 2007 and 2010, with minimal differences between them. Rates of 30-day mortality and readmission in 2010 were also similar between both groups. Results were consistent across strata of baseline performance level., Conclusions: In this observational analysis, there were no significant differences in the performance of Hospital Compare process measures or outcomes between hospitals in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines and other hospitals not in the registry. However, baseline performance on the Hospital Compare process measures was very high in both groups, suggesting the need for new quality improvement foci to further improve patient outcomes., (Copyright © 2016 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.)

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: 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., Methods: 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., Results: 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., Conclusions: 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., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Stress testing after percutaneous coronary intervention (PCI) in fee-for-service settings is common and rates vary by hospital. Rates of stress testing after PCI within integrated healthcare systems, such as the Veterans Affairs (VA) are unknown., Methods and Results: We evaluated all VA patients who underwent PCI from October 2007 through June 2010. To avoid the influence of Medicare eligibility on rates of stress testing use in the VA, we excluded Medicare eligible patients during the follow-up period. Hospital-level variation in risk-standardized rates of stress testing and the association with 1-year mortality and myocardial infarction was determined from Markov chain Monte Carlo methods. Among 10 293 patients undergoing PCI at 55 VA hospitals, 2239 (21.8%) had a stress test performed within 1 year of PCI and 3902 (37.9%) within 2 years. Most stress tests after PCI were performed with nuclear imaging (79.8%). The hospital-level risk-standardized rate of stress testing differed significantly from the average at 14 hospitals, with 8 (14.5%) hospitals significantly below and 6 (10.9%) hospitals significantly above the average stress testing rate. Hospital-level risk-standardized stress testing rates were not significantly correlated with risk-standardized mortality (Spearman ρ=-0.24; P=0.08) or myocardial infarction rates (Spearman ρ=0.20; P=0.14)., Conclusions: In the VA, nearly 40% of patients underwent stress testing in the 2 years after PCI, which is a third less than published studies from other healthcare systems. However, stress testing rates varied across VA hospitals, suggesting opportunities to optimize the use of stress testing are still present in integrated healthcare systems., (© 2015 American Heart Association, Inc.)

Background: Policies to reduce unnecessary hospitalizations after percutaneous coronary intervention (PCI) are intended to improve healthcare value by reducing costs while maintaining patient outcomes. Whether facility-level hospitalization rates after PCI are associated with cost of care is unknown., Methods and Results: We studied 32,080 patients who received PCI at any 1 of 62 Veterans Affairs hospitals from 2008 to 2011. We identified facility outliers for 30-day risk-standardized hospitalization, mortality, and cost. Compared with the risk-standardized average, 2 hospitals (3.2%) had a lower-than-expected hospitalization rate, and 2 hospitals (3.2%) had a higher-than-expected hospitalization rate. We observed no statistically significant variation in facility-level risk-standardized mortality. The facility-level unadjusted median per patient 30-day total cost was $23,820 (interquartile range, $19,604-$29,958). Compared with the risk-standardized average, 17 hospitals (27.4%) had lower-than-expected costs, and 14 hospitals (22.6%) had higher-than-expected costs. At the facility level, the index PCI accounted for 83.1% of the total cost (range, 60.3%-92.2%), whereas hospitalization after PCI accounted for only 5.8% (range, 2.0%-12.7%) of the 30-day total cost. Facilities with higher hospitalization rates were not more expensive (Spearman ρ=0.16; 95% confidence interval, -0.09 to 0.39; P=0.21)., Conclusions: In this national study, hospitalizations in the 30 day after PCI accounted for only 5.8% of 30-day cost, and facility-level cost was not correlated with hospitalization rates. This challenges the focus on reducing hospitalizations after PCI as an effective means of improving healthcare value. Opportunities remain to improve PCI value by reducing the variation in total cost of PCI without compromising patient outcomes., (© 2015 American Heart Association, Inc.)

Public reporting has been proposed as a strategy to improve health care quality. Percutaneous coronary interventions (PCIs) performed in the United States from July 1, 2009, to June 30, 2011, included in the CathPCI Registry were identified (n = 1,340,213). Patient characteristics and predicted and observed in-hospital mortality were compared between patients treated with PCI in states with mandated public reporting (Massachusetts, New York, Pennsylvania) and states without mandated public reporting. Most PCIs occurred in states without mandatory public reporting (88%, n = 1,184,544). Relative to patients treated in nonpublic reporting states, those who underwent PCI in public reporting states had similar predicted in-hospital mortality (1.39% vs 1.37%, p = 0.17) but lower observed in-hospital mortality (1.19% vs 1.41%, adjusted odds ratio [ORadj] 0.80; 95% confidence interval [CI] 0.74, 0.88; p <0.001). In patients for whom outcomes were available at 180 days, the differences in mortality persisted (4.6% vs 5.4%, ORadj 0.85, 95% CI 0.79 to 0.92, p <0.001), whereas there was no difference in myocardial infarction (ORadj 0.97, 95% CI 0.89 to 1.07) or revascularization (ORadj 1.05, 95% CI 0.92 to 1.20). Hospital readmissions were increased at 180 days in patients who underwent PCI in public reporting states (ORadj 1.08, 95% CI 1.03 to 1.12, p = 0.001). In conclusion, patients who underwent PCI in states with mandated public reporting of outcomes had similar predicted risks but significantly lower observed risks of death during hospitalization and in the 6 months after PCI. These findings support considering public reporting as a potential strategy for improving outcomes of patients who underwent PCI although further studies are warranted to delineate the reasons for these differences., (Copyright © 2015 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: The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents. Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed., Methods and Results: Within the National Cardiovascular Data Registry CathPCI Registry, we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study. We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry. Standardized differences between groups were estimated. Between September 2009 and July 2011, 1.1 million PCIs were performed among 1276 hospitals, of which 309 (24.2%) participated in the Dual Antiplatelet Therapy Study. Participating hospitals were larger (468 versus 311 beds), more frequently located in urban settings (61.2% versus 42.6%), and had higher annual PCI volumes (858 versus 378) compared with nonparticipating hospitals, although hospital case mix and procedural outcomes were similar. Compared with CathPCI patients, trial patients undergoing PCI with drug-eluting stents were similar with respect to race, sex, and rates of diabetes mellitus, hypertension, and smoking, although they had lower rates of prior cardiovascular disease., Conclusions: Within the Dual Antiplatelet Therapy Study, clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites. Although trial participants were representative of PCI patients with respect to race, sex and most comorbidities, they had a lower prevalence of chronic cardiovascular disease compared with registry patients. Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients, differences between eligible patients and those actually enrolled remained., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT00977938., (© 2014 American Heart Association, Inc.)

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.

A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system., (Published by Elsevier Inc.)

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.)

Background: The safety of percutaneous coronary intervention (PCI) at medical facilities without on-site cardiothoracic (CT) surgery has been established in clinical trials. However, the comparative effectiveness of this strategy in real-world practice, including impact on patient access and outcomes, is uncertain. The Veterans Affairs (VA) health care system has used this strategy, with strict quality oversight, since 2005, and can provide insight into this question., Methods and Results: Among 24,387 patients receiving PCI at VA facilities between October 2007 and September 2010, 6616 (27.1%) patients underwent PCI at facilities (n=18) without on-site CT surgery. Patient drive time (as a proxy for access), procedural complications, 1-year mortality, myocardial infarction, and rates of subsequent revascularization procedures were compared by facility. Results were stratified by procedural indication (ST-segment-elevation myocardial infarction versus non-ST-segment-elevation myocardial infarction/unstable angina versus elective) and PCI volume. With the inclusion of PCI facilities without on-site CT surgery, median drive time for patients treated at those facilities decreased by 90.8 minutes (P<0.001). Procedural need for emergent coronary artery bypass graft and mortality rates were low and similar between facilities. Adjusted 1-year mortality and myocardial infarction rates were similar between facilities (hazard ratio in PCI facilities without relative to those with on-site CT surgery, 1.02; 95% confidence interval, 0.87-1.2), and not modified by either PCI indication or PCI volume. Subsequent revascularization rates were higher at sites without on-site CT surgery facilities (hazard ratio, 1.21; 95% confidence interval, 1.03-1.42)., Conclusions: This study suggests that providing PCI facilities without on-site CT surgery in an integrated health care system with quality oversight improves patient access without compromising procedural or 1-year outcomes., (© 2014 American Heart Association, Inc.)

Importance: Diagnostic coronary angiography in asymptomatic patients may lead to inappropriate percutaneous coronary intervention (PCI) due to a diagnostic-therapeutic cascade. Understanding the association between patient selection for coronary angiography and PCI appropriateness may inform strategies to minimize inappropriate procedures., Objective: To determine if hospitals that frequently perform coronary angiography in asymptomatic patients, a clinical scenario in which the benefit of angiography is less clear, are more likely to perform inappropriate PCI., Design, Setting, and Participants: Multicenter observational study of 544 hospitals participating in the CathPCI Registry between July 1, 2009, and September 30, 2013., Main Outcomes and Measures: Hospital proportion of asymptomatic patients at diagnostic coronary angiography and hospital rate of inappropriate PCI as defined by 2012 appropriate use criteria for coronary revascularization., Results: Of 1 225 562 patients who underwent elective coronary angiography, 308 083 (25.1%) were asymptomatic. The hospital proportion of angiography among asymptomatic patients ranged from 1.0% to 73.6% (median, 24.7%; interquartile range, 15.9%-35.9%). By hospital quartile of asymptomatic patients at angiography, hospitals with higher rates of asymptomatic patients at angiography had higher median rates of inappropriate PCI (14.8% vs 20.2% vs 24.0 vs 29.4% from lowest to highest quartile, P < .001 for trend). This outcome was attributable to more frequent use of inappropriate PCI in asymptomatic patients at hospitals with higher rates of angiography in asymptomatic patients (5.4% vs 9.9% vs 14.7% vs 21.6% from lowest to highest quartile, P < .001 for trend). Hospitals with higher rates of asymptomatic patients at angiography also had lower rates of appropriate PCI (38.7% vs 33.0% vs 32.3% vs 32.9% from lowest to highest quartile, P < .001 for trend)., Conclusions and Relevance: In a national sample of hospitals, performance of coronary angiography in asymptomatic patients was associated with higher rates of inappropriate PCI and lower rates of appropriate PCI. Improving preprocedural risk stratification and thresholds for coronary angiography may be one strategy to improve the appropriateness of PCI.

Background: Whether increasing use of radial access has improved percutaneous coronary intervention outcomes remains unknown. We sought to determine the relationship between increasing facility-level use of transradial percutaneous coronary intervention (TRI) and periprocedural outcomes., Methods and Results: Within the National Cardiovascular Data Registry CathPCI Registry, we estimated the risk-adjusted association between hospital category of change in TRI use (during the 3-year period from 2009 to 2012) and trends in access site and overall bleeding, fluoroscopy time, and contrast use among 818 facilities with low baseline TRI use. There were 4 categories of hospital change in TRI use: very low (baseline, 0.2% increasing to 1.8% at the end of 3 years), low (0.9% increasing to 8.9%), moderate (1.6% increasing to 27.2%), and high (1.0% increasing to 45.1%). Risk-adjusted access site bleeding decreased over time for all hospital categories; however, the rate of decline varied across hospital categories (P for interaction, <0.001). The decrease in access site bleeding was significantly greater for hospitals with moderate or high increases in TRI use (relative risk, 0.45, 95% confidence interval, 0.36-0.56) when compared with that of very low or low hospitals (relative risk, 0.65; 95% confidence interval, 0.58-0.74; P for comparison, 0.002). Similar findings were observed for overall bleeding. An increase in fluoroscopy time (≈1.3 minutes) was noted at hospitals with moderate and high use of TRI (P=0.01). Trends in contrast use were similar across hospital categories., Conclusions: In a national sample of hospitals performing percutaneous coronary intervention, bleeding rates decreased over time for all hospital categories of change in TRI use. The decline in bleeding outcomes was larger at hospitals with increased adoption of TRI when compared with hospitals with minimal or no change in TRI use., Competing Interests: Dr Rao has received consulting fees from Terumo Medical and Medtronic. Dr Curtis receives salary support under contract with the National Cardiovascular Data Registry (NCDR) to provide analytic services and with the Centers for Medicare and Medicaid Services to support development of quality measures in addition to equity interest in Medtronic. The other authors report no conflicts., (© 2014 American Heart Association, Inc.)

Background: Older women experience higher complication rates and mortality after percutaneous coronary intervention (PCI) than men, but there is limited evidence about sex-based differences in outcomes among younger patients. We compared rates of complications and inhospital mortality by sex for younger and older PCI patients., Methods: A total of 1,079,751 hospital admissions for PCI were identified in the CathPCI Registry(®) from 2005 to 2008. Complication rates (general, bleeding, bleeding with transfusion, and vascular) and inhospital mortality after PCI were compared by sex and age (<55 and ≥55 years). Analyses were adjusted for demographic and clinical factors and stratified by PCI type (elective, urgent, or emergency)., Results: Overall, 6% of patients experienced complications, and 1% died inhospital. Unadjusted complication rates were higher for women compared with men in both age groups. In risk-adjusted analyses, younger women (odds ratio 1.24, 95% CI 1.16-1.33) and older women (1.27, 1.09-1.47) were more likely to experience any complication than similarly aged men. The increased risk persisted across complication categories and PCI type. Within age groups, risk-adjusted mortality was marginally higher for young women (1.19, 1.00-1.41), but not for older women (1.03, 0.97-1.10). In analyses stratified by PCI type, young women had twice the mortality risk after an elective procedure as young men (2.04, 1.15-3.61)., Conclusions: Women, regardless of age, experience more complications after PCI than men; young women are at increased mortality risk after an elective PCI. Identifying strategies to reduce adverse outcomes, particularly for women younger than 55 years, is important., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Objectives: This study sought to examine the contemporary incidence, predictors and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions., Background: Acute kidney injury (AKI) is a serious and potentially preventable complication of percutaneous coronary interventions (PCIs) that is associated with adverse outcomes. The contemporary incidence, predictors, and outcomes of AKI are not well defined, and clarifying these can help identify high-risk patients for proactive prevention., Methods: A total of 985,737 consecutive patients underwent PCIs at 1,253 sites participating in the National Cardiovascular Data Registry Cath-PCI registry from June 2009 through June 2011. AKI was defined on the basis of changes in serum creatinine level in the hospital according to the Acute Kidney Injury Network (AKIN) criteria. Using multivariable regression analyses with generalized estimating equations, we identified patient characteristics associated with AKI., Results: Overall, 69,658 (7.1%) patients experienced AKI, with 3,005 (0.3%) requiring new dialysis. On multivariable analyses, the factors most strongly associated with development of AKI included ST-segment elevation myocardial infarction (STEMI) presentation (odds ratio [OR]: 2.60; 95% confidence interval [CI]: 2.53 to 2.67), severe chronic kidney disease (OR: 3.59; 95% CI: 3.47 to 3.71), and cardiogenic shock (OR: 2.92; 95% CI: 2.80 to 3.04). The in-hospital mortality rate was 9.7% for patients with AKI and 34% for those requiring dialysis compared with 0.5% for patients without AKI (p < 0.001). After multivariable adjustment, AKI (OR: 7.8; 95% CI: 7.4 to 8.1, p < 0.001) and dialysis (OR: 21.7; 95% CI: 19.6 to 24.1; p < 0.001) remained independent predictors of in-hospital mortality., Conclusions: Approximately 7% of patients undergoing a PCI experience AKI, which is strongly associated with in-hospital mortality. Defining strategies to minimize the risk of AKI in patients undergoing PCI are needed to improve the safety and outcomes of the procedure., (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.)

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

Background: Timely identification and reporting of medical device problems is critical to postmarket device surveillance programs to maximize patient safety. Cardiac catheterization laboratories are high-device utilization areas well suited for device surveillance., Objective: To demonstrate the feasibility of the national VA Clinical Assessment, Reporting, and Tracking (CART) system, embedded in the electronic health record of all 76 VA cardiac catheterization laboratories, to document unexpected problems with medical devices at the point of care., Methods: We evaluated 260,258 consecutive cardiac catheterization and/or percutaneous coronary intervention procedures on 175,098 Veterans between August 2006 and February 2012. Unexpected device problems (UDPs) encountered for any equipment used during a procedure were entered by clinicians at the point of care as part of regular care documentation. All UDPs were reviewed in collaboration with the FDA to ascertain the likelihood of a device defect (eg, in manufacture or design) and/or contributing to a procedural complication (level I, unlikely; level II, possibly; level III, likely)., Results: Of the 260,258 procedure reports, 974 (0.37%) UDP's were reported by 71 (92.2%) of the 76 VA hospitals. After triage, 739 (75.9%) were deemed level I, 196 (20.1%) level II, and 39 (4.0%) level III. Of the 39 level III reports, 12 (30.7%) are in the submission phase as a FDA MedWatch report. The number of monthly UDP reports increased significantly from 2006 to 2012 (P<0.001)., Conclusions: Leveraging a clinical application embedded in the electronic health record and in collaboration with FDA, a proactive national cardiac device surveillance program has been successfully implemented in the VA.

Aims: The NCDR CathPCI Registry collects detailed clinical, process-of-care and outcomes data for patients undergoing coronary angiography and percutaneous coronary intervention (PCI) in the USA. The registry contributes to quality of care by providing data feedback on a wide range of performance metrics to participating centres and by facilitating local and national quality improvement efforts., Interventions: No treatments are mandated, participating centres receive routine quality-of-care and outcomes performance feedback reports and access to a quality dashboard for personalized performance reports., Population: Patients undergoing cardiac catheterization and PCI are retrospectively identified. No informed consent is required, as data are anonymised. From inception in 1998, more than 12 million records have been submitted from 1577 participating US centres., Baseline Data: Approximately 250 fields encompassing patient demographics, medical history and risk factors, hospital presentation, initial cardiac status, procedural details, medications, laboratory values, and in-hospital outcomes. Linkages with outside sources of data have permitted longitudinal outcomes assessment in some cases. Centre personnel enter the data into the registry, in some cases facilitated by software vendors. There are non-financial incentives for centre participation. Data completeness is noteworthy with most fields missing at rates less than 5%. A comprehensive data quality program is employed to enhance data validity., Endpoints: Main outcome measures include quality process metrics and in-hospital patient outcomes. Data are available for research by application to: http://www.ncdr.com.

Previous studies describing the no-reflow phenomenon in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) were largely confined to single-center studies or small registries. To better characterize the incidence, predictors, and outcomes of the no-reflow phenomenon in a large contemporary population, we analyzed patients with AMI who were undergoing PCI of native coronary artery stenoses in the CathPCI Registry from January 1, 2004 through September 5, 2008 (n = 291,380). The angiographic no-reflow phenomenon was site reported using a standardized definition. No-reflow developed in 2.3% of the patients with AMI (n = 6,553) during PCI. Older age, ST-segment elevation AMI, prolonged interval from symptom onset to admission, and cardiogenic shock were clinical variables independently associated with the development of no-reflow (p <0.001). The angiographic factors independently associated with no-reflow included longer lesion length, higher risk class C lesions, bifurcation lesions, and impaired preprocedure Thrombolysis In Myocardial Infarction flow (p <0.001). No-reflow was associated with greater in-hospital mortality (12.6% vs 3.8%, adjusted odds ratio 2.20, 95% confidence interval 1.97 to 2.47, p <0.001) and unsuccessful lesion outcome (29.7% vs 6.6%, adjusted odds ratio 4.70, 95% confidence interval 4.28 to 5.17, p <0.001) compared to patients without no-reflow. In conclusion, the development of no-reflow, although relatively uncommon during PCI for AMI, is associated with adverse clinical outcomes. Upfront strategies to reduce the incidence of no-reflow could be considered for high-risk patients to improve outcomes., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Variation in outcomes after percutaneous coronary interventions (PCI) may reflect differences in quality of care. To date, however, we lack a methodology to monitor and improve national hospital 30-day mortality rates among patients undergoing PCI., Methods and Results: We developed hierarchical logistic regression models to calculate hospital risk-standardized 30-day all-cause PCI mortality rates. Due to differences in risk, patients were divided into 2 cohorts: those with ST-segment elevation myocardial infarction or cardiogenic shock, and those with no ST-segment elevation myocardial infarction and no cardiogenic shock. The models were derived using 2006 data from the CathPCI Registry linked with administrative claims data, and validated using comparable 2005 data. In the derivation cohort of the ST-segment elevation myocardial infarction or shock model (n=15 123), the unadjusted 30-day mortality rate was 9.2%. The final model included 13 variables with the observed mortality rates ranging from 1.4% to 40.3% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate were 8.5% and 9.7%, with 5th and 95th percentiles of 7.6% and 11.0%. In the derivation cohort of the no ST-segment elevation myocardial infarction and no shock model (n=110 529), the unadjusted 30-day mortality rate was 1.4%. The final model included 16 variables with the observed predicted mortality rates ranging from 0.1% to 7.0% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate across 612 hospitals were 1.3% and 1.6%, with 5th and 95th percentiles of 1.0% and 2.0%., Conclusions: These National Quality Forum endorsed registry-based models produce estimates of hospital risk-standardized mortality rates for patients undergoing PCI.

Background: New methods such as machine learning techniques have been increasingly used to enhance the performance of risk predictions for clinical decision-making. However, commonly reported performance metrics may not be sufficient to capture the advantages of these newly proposed models for their adoption by health care professionals to improve care. Machine learning models often improve risk estimation for certain subpopulations that may be missed by these metrics.Methods and Results: This article addresses the limitations of commonly reported metrics for performance comparison and proposes additional metrics. Our discussions cover metrics related to overall performance, discrimination, calibration, resolution, reclassification, and model implementation. Models for predicting acute kidney injury after percutaneous coronary intervention are used to illustrate the use of these metrics.Conclusions: We demonstrate that commonly reported metrics may not have sufficient sensitivity to identify improvement of machine learning models and propose the use of a comprehensive list of performance metrics for reporting and comparing clinical risk prediction models. [ABSTRACT FROM AUTHOR]

Background: Several antiplatelet medications used during and after percutaneous coronary intervention (PCI) are contraindicated for specific patient groups. A broad assessment of contraindicated medication use and associated clinical outcomes is not well described.Methods and Results: Using national Veterans Affairs Clinical Assessment, Reporting, and Tracking Program data for all PCI between 2007 and 2013, we evaluated patients with contraindications to commonly used antiplatelet medications during and after PCI, defined in accordance with package inserts. Adjusted association between contraindicated medication use and outcomes of periprocedural bleeding and 30-day mortality were assessed using Cox proportional hazards with inverse probability weighting. Among 64 294 patients undergoing PCI, 11 315(17.6%) had a contraindication to a common antiplatelet medication and 737 (6.5%) of these patients received a contraindicated medication. In unadjusted analyses, any contraindicated medication use was associated with both increased bleeding and 30-day mortality. In adjusted models, contraindicated abciximab use in patients with thrombocytopenia (hazard ratio, 2.23; 95% confidence interval, 1.58-3.16) and in patients with a previous stroke (hazard ratio, 1.93; 95% confidence interval, 1.37-2.71) remained significantly associated with increased bleeding. Contraindicated abciximab use was not significantly associated with 30-day mortality in adjusted models. Use of eptifibatide in dialysis patients was not significantly associated with an increased risk of bleeding or mortality.Conclusions: In this national cohort, ≈18% of patients undergoing PCI had contraindications to common antiplatelet medications. Approximately 6% of those patients received a contraindicated medication with attendant bleeding risk, although this did not translate into significantly higher risk of 30-day mortality. Continued efforts to reduce contraindicated medication use may help avoid periprocedural complications. [ABSTRACT FROM AUTHOR]

The article presents a study which identifies whether measures for percutaneous coronary intervention (PCI) are superfluous or complementary to help inform the maximum range of metrics for monitoring quality. Data is analyzed from the National Cardiovascular Data Registry (NCDR) CathPCI Registry to identify the association between a hospital's proportion of inappropriate PCIs and processes of care and post-procedural outcomes.

Objectives: Our purpose was to evaluate percutaneous coronary intervention (PCI) attempt rates in patients with class I indications for coronary artery bypass graft (CABG) surgery after the introduction of drug-eluting stents (DES). Background: In patients with severe, multivessel coronary disease, CABG has historically been recommended over PCI. Practice guidelines for CABG were last updated before the emergence of data on DES efficacy. Methods: We analyzed 265,028 procedures from the NCDR (National Cardiovascular Data Registry) meeting American College of Cardiology/American Heart Association class I indications for surgical revascularization. Temporal trends in PCI attempt rates were analyzed during 3 consecutive time periods: pre-DES (before April 1, 2003), DES diffusion (April 1, 2003 to December 31, 2004), and DES (January 1, 2005 to September 30, 2006). Results: The attempted rate of PCI in patients with class I indications for CABG increased over the 3 time periods (pre-DES: 29.4%, DES diffusion: 33.4%, and DES era: 34.7%, p < 0.001). In a hierarchical multivariable logistic model adjusting for patient and PCI site characteristics, PCI attempts were more likely in the DES compared with pre-DES era (odds ratio: 1.44, 95% confidence interval: 1.40 to 1.48) and the DES diffusion era (odds ratio: 1.20, 95% confidence interval: 1.17 to 1.23). PCI attempt rates increased in all 3 time periods, although the average rate of increase during the DES era was 0.6% per quarter compared with 0.3% per quarter for both the DES diffusion and the pre-DES eras (p = 0.03). Conclusions: DES use in clinical practice was associated with a significant overall increase in PCI to treat patients with class I indications for CABG. Long-term follow-up of this cohort of patients is warranted. [Copyright &y& Elsevier]

Objectives: Our goal was to compare trends in the prevalence and outcomes of the radial and femoral approaches to percutaneous coronary intervention (PCI) in contemporary clinical practice. Background: There are few current data on the use and outcomes of the radial approach to PCI (r-PCI) in clinical practice. Methods: Data from 593,094 procedures in the National Cardiovascular Data Registry (606 sites; 2004 to 2007) were analyzed to evaluate trends in use and outcomes of r-PCI. Logistic regression was used to evaluate the adjusted association between r-PCI and procedural success, bleeding complications, and vascular complications. Outcomes in elderly patients, women, and patients with acute coronary syndrome were specifically examined. Results: Although the proportion of r-PCI procedures has recently increased, it only accounts for 1.32% of total procedures (n = 7,804). Compared with the femoral approach, the use of r-PCI was associated with a similar rate of procedural success (adjusted odds ratio: 1.02 [95% confidence interval: 0.93 to 1.12]) but a significantly lower risk for bleeding complications (odds ratio: 0.42 [95% confidence interval: 0.31 to 0.56]) after multivariable adjustment. The reduction in bleeding complications was more pronounced among patients <75 years old, women, and patients undergoing PCI for acute coronary syndrome. Conclusions: The use of r-PCI is rare in contemporary clinical practice, but it is associated with a rate of procedural success similar to the femoral approach and with lower rates of bleeding and vascular complications, even among high-risk groups. These results suggest that wider adoption of r-PCI in clinical practice may improve the safety of PCI. [Copyright &y& Elsevier]