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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse irregularity or variability from these data has the potential to identify atrial fibrillation or atrial flutter (AF, collectively). The rapidly expanding consumer base of these devices allows for detection of undiagnosed AF at scale.Methods: The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants (NCT03335800). The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc, Cupertino, CA) with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1) characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2) estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants.Conclusions: The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The Apple Heart Study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening. [ABSTRACT FROM AUTHOR]

Background: Dual antiplatelet therapy (DAPT) is recommended following transcatheter aortic valve replacement (TAVR); however, the optimal antiplatelet strategy is undefined, and little is known about practice patterns. We aimed to describe contemporary practice patterns of antiplatelet therapy and their relationship to outcomes post-TAVR.Methods: The population was derived from the National Cardiovascular Data Registry, Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry with Center for Medical Services linkage for 1-year outcomes from October 1, 2011 to June 30,2016. The primary outcome measured was DAPT use in patients without anticoagulation. Secondary outcomes included death, major bleeding, myocardial infarction (MI), and stroke at 1 year.Results: Overall, 16,694 patients underwent transfemoral TAVR at 444 hospitals and were discharged without anticoagulation. Among these, 13,546 (81.1%) patients were discharged on DAPT, whereas 3,148 patients (18.9%) were discharged on monotherapy. Patients discharged on DAPT versus monotherapy were similar in age, sex, and most comorbid illnesses but had higher rates of coronary artery disease (64.6% vs 52.3%; P < .01) and peripheral artery disease (25.2% vs 22.3%; P < .01). Hospital prescribing patterns varied significantly (median frequency of DAPT 85.7%, interquartile range 94.1%-74.2%). DAPT (vs monotherapy) patients had a similar mortality risk at 1 year (adjusted hazard ratio 0.92, 95% CI 0.81-1.05), significantly higher risk for major bleeding (1.48, 1.10-1.99), and similar hazard for stroke (1.04, 0.83-1.31) and MI (1.00, 0.72-1.39).Conclusions: In the United States, most patients were discharged on DAPT following TAVR. Practice patterns varied significantly among hospitals. Patients discharged with DAPT had a similar adjusted risk of mortality, stroke, and MI compared to antiplatelet monotherapy, although risk for bleeding was significantly higher. Future investigation is needed to define the optimal antiplatelet therapy for patients undergoing TAVR. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Many patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis also have significant mitral regurgitation (MR). We sought to understand the association of concomitant MR with TAVR clinical outcomes, as well changes in MR after TAVR. Methods Patients who underwent TAVR in the US Transcatheter Valve Therapy Registry from January 3, 2012, to December 31, 2013, were studied, with longer-term clinical outcomes from Center for Medicare Services data. Results Of 11,104 patients, 3,481 (31.3%) had moderate MR, and 605 (5.5%) had severe MR. At 1 year, mortality was 21.0%, 21.5%, 26.3%, and 28.0% ( p < 0.0001) and heart failure (HF) rehospitalization was 13.9%, 15.8%, 20.3%, and 23.4% ( p < 0.0001) in the no, mild, moderate, and severe MR patients, respectively. After adjustment for baseline differences, significant MR was associated with increased risk of 1-year mortality or HF rehospitalization, with a HR of 1.16 (95% CI, 0.99 to 1.35) for moderate MR and 1.21 (95% CI, 0.97 to 1.50) for severe MR, compared with no MR. MR improved early after TAVR grade ≥ 1 in 79% of the severe MR patients and 66% of the moderate MR patients. Patients whose baseline moderate or severe MR improved had lower mortality ( p = 0.022) and HF rehospitalization ( p < 0.001) compared with patients whose MR did not improve. Conclusions Moderate or severe MR accompanying severe AS treated with TAVR is associated with increased mortality or HF rehospitalization. This increased risk may be attributable to the minority of patients whose MR does not improve, suggesting a potential role for surveillance and targeted intervention for those patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The use of transcatheter aortic valve replacement (TAVR) to treat aortic stenosis in the United States is growing, yet little is known about the variation in procedural outcomes in community practice. We developed a TAVR in-hospital mortality risk model and used it to quantify variation in mortality rates across United States (US) TAVR centers.Methods and Results: We analyzed data from 22 248 TAVR procedures performed at 318 sites participating in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 to October 2014). A Bayesian hierarchical model was developed to estimate hospital-specific risk-adjusted mortality rates adjusting for 40 patient baseline factors. A total of 1130 in-hospital deaths (5.1%) were observed. Reliability-adjusted risk-adjusted mortality rate estimates ranged from 3.4% to 7.7% with an interquartile range of 4.8% to 5.4%. A patient's predicted odds of dying was 80% higher if treated by a hospital 1 standard deviation above the mean compared with a hospital 1 standard deviation below the mean (odds ratio =1.8; 95% credible interval, 1.4%-2.2%).Conclusions: Risk modeling of TAVR in-hospital mortality revealed variation in risk-adjusted mortality rates during the US early commercial experience. Transcatheter Valve Therapy Registry analyses using this model will support research, feedback reporting, and the identification of factors associated with quality. [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]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background--Although transcatheter aortic valve replacement (TAVR) is an effective treatment for aortic stenosis, long-term mortality after TAVR remains high and challenging to predict. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a health status measure, assessed directly from patients, that integrates 2 clinically relevant factors (symptoms and functional status) that may predict TAVR outcomes. Methods and Results--Among 7769 patients from 286 sites in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we examined the association between preprocedure (baseline) patient health status, as assessed by the KCCQ, and 1-year mortality after TAVR. The KCCQ Overall Summary Score was categorized as very poor: <25, poor: 25 to 49, fair: 50 to 74, or good: ≥75. Before TAVR, health status was rated as very poor in 28%, poor in 38%, fair in 24%, and good in 10%. Patients with worse health status were more likely to be women and had more comorbidities and higher STS mortality risk scores. Compared with those with good health status before TAVR and after adjusting for a broad range of baseline covariates, patients with very poor health status had a 2-fold increased hazard of death over the first year after TAVR (adjusted hazard ratio, 2.00; 95% confidence interval, 1.58-2.54), whereas those with poor and fair health status had intermediate outcomes (adjusted hazard ratio, 1.54; 95% confidence interval, 1.22-1.95 and adjusted hazard ratio, 1.20; 95% confidence interval, 0.94-1.55, respectively). Conclusions--In a national, contemporary practice cohort, worse preprocedure patient health status, as assessed by the KCCQ, was associated with greater long-term mortality after TAVR. These results support the measurement and integration of the KCCQ into mortality risk assessments for patients considering TAVR. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years by improving cardiovascular prevention. An important tool in the success of programs like Million Hearts is public ranking on the quality of practices, yet different measures may provide different rankings, so the true quality of practices is difficult to discern. We evaluated the quality of ambulatory cardiology care using performance measure metrics. Methods We compared rankings of practices participating in the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence Registry using measures from (1) the physician quality reporting system and (2) the American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement. We compared achievement rates for measures between the 2 frameworks and determined correlations in rankings using Spearman correlation coefficients. Results From January 1, 2008 to December 31, 2012, there were 1,711,326 patients enrolled from 111 US practices. Among eligible patients, the physician quality reporting system and American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement measures were achieved in 76.1% versus 77.4% for antiplatelet prescription ( P < .001), 68.3% versus 90.8% for blood pressure control ( P < .001), 26.9% versus 43.4% for cholesterol control ( P < .001), and 37.4% versus 40.6% for smoking cessation ( P = .383). Practice rankings were strongly correlated for antiplatelet prescription (correlation coefficient 0.98) and cholesterol control (0.92) but poorly correlated for blood pressure control (0.39) and smoking cessation (0.22). Conclusions Evaluation of preventive care and individual practice rankings vary significantly depending on how measures are defined. Publicly reported measures need to be validly associated with outcomes to avoid incorrectly evaluating practice performance and failing to achieve public health goals. [ABSTRACT FROM AUTHOR]

The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Whether the introduction of transcatheter aortic valve replacement (TAVR) has affected hospitals’ surgical aortic valve replacement (SAVR) and overall aortic valve replacement (AVR) case volumes and outcomes in the United States is unknown. Methods We utilized data from The Society of Thoracic Surgeons (STS) adult cardiac surgery database and the STS/American College of Cardiology (ACC) transcatheter valve therapies registry to examine SAVR and TAVR procedures. Temporal trends in total case volume (SAVR plus TAVR), and observed and risk-adjusted in-hospital mortality rates were assessed among low-risk cases (STS predicted risk of operative mortality < 4%), intermediate-risk cases (4% to 8%), and high-risk cases (> 8%). A contemporary control was provided by non-TAVR centers. Results From 2008 to 2013, the total annual volume of AVR among 246 TAVR-performing hospitals increased from 19,578 to 33,004, with a 22% growth in SAVR volumes; non-TAVR hospital (n = 555) increases were more modest (16,563 to 19,134; 16% growth). Expanded volumes at TAVR hospitals included increased SAVR use in low- and intermediate-risk cases, and TAVR use in high-risk cases. In parallel, in-hospital mortality for all AVR procedures at TAVR sites declined from 3.4% to 2.9% (observed to expected [O:E] ratio 0.75 to 0.58, p < 0.001); the greatest declines were among intermediate- and high-risk SAVR patients. Owing to reduced SAVR mortality, TAVR centers experienced a significantly greater decline in O:E ratio for high-risk patient in-hospital mortality than non-TAVR centers (TAVR center O:E ratio, 0.81 to 0.61; non-TAVR center O:E ratio, 0.85 to 0.76; p < 0.001). After approval of TAVR for clinical use, a trend toward higher in-hospital mortality rates and O:E ratios for TAVR procedures was observed at new (but not at established) TAVR centers (O:E ratio, 0.41 to 0.67; p = 0.08). Conclusions Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve. [ABSTRACT FROM AUTHOR]

Background Delays in filling clopidogrel prescriptions after percutaneous coronary intervention (PCI) have been demonstrated previously and associated with adverse outcomes. Methods This was a retrospective cohort study of 11,418 patients undergoing PCI with stent placement in Veterans Affairs (VA) hospitals between January 1, 2005, and September 30, 2010. Data were obtained from the national VA Clinical Assessment, Reporting, and Tracking Program, including post-PCI clopidogrel prescription fill date and outcomes of myocardial infarction and death within 90 days of discharge. Patients who did not fill a clopidogrel prescription on the day of discharge were considered to have a delay. Multivariable models assessed the association between clopidogrel delay and myocardial infarction/death using clopidogrel delay as a time-varying covariate. Results Of the patients, 7.2% had a delay in filling their clopidogrel prescription. Delay in filling clopidogrel was associated with increased risk of major adverse events (hazard ratio 2.34, 95% CI 1.66-3.29, P < .001). The percentage of patients who delayed filling varied by hospital, ranging from 0 to 43.5% with a median of 6.2% ( P < .001, χ 2 for difference across hospitals) and a median odds ratio of 2.13 (95% CI 1.85-2.68) suggesting large site variation in clopidogrel delay across hospitals. Conclusions In a health care system with integrated inpatient and outpatient pharmacy services, 1 in 14 patients delays filling a clopidogrel prescription. The large site variation suggests a need to identify best practices that allow hospitals to optimize prescription filling at discharge to potentially improve patient outcomes. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Dabigatran is a novel oral anti-coagulant (NOAC) that reduces risk of stroke in patients with non-valvular atrial fibrillation (NVAF). It does not require routine monitoring with laboratory testing which may have an adverse impact on adherence. We aimed to describe adherence to dabigatran in the first year after initiation and assess the association between non-adherence to dabigatran and clinical outcomes in a large integrated healthcare system. Methods: We studied a national cohort of 5,376 patients with NVAF, initiated on dabigatran between October-2010 and September-2012 at all Veterans Affairs hospitals. Adherence to dabigatran was calculated as proportion of days covered (PDC) and association between PDC and outcomes was assessed using standard regression techniques. Results: Mean age of the study cohort was 71.3 ± 9.7 years; 98.3% were men and mean CHADS2 score was 2.4 ± 1.2 (mean CHA2DS2VASc score 3.2 ± 1.4). Median PDC was 94% (IQR 76%-100%; mean PDC 84% ± 22%) over a median follow-up of 244 days (IQR 140-351). A total of 1,494 (27.8%) patients had a PDC <80% and were classified as non-adherent. After multivariable adjustment, lower adherence was associated with increased risk for combined all-cause mortality and stroke (HR 1.13, 95% CI 1.07–1.19 per 10% decrease in PDC). Adherence to dabigatran was not associated with non-fatal bleeding or myocardial infarction. Conclusions: In the year after initiation, adherence to dabigatran for a majority of patients is very good. However, 28% of patients in our cohort had poor adherence. Furthermore, lower adherence to dabigatran was associated with increased adverse outcomes. Concerted efforts are needed to optimize adherence to NOACs. [Copyright &y& Elsevier]

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 &y& Elsevier]

Mineralocorticoid receptor antagonists (MRA) reduce morbidity and mortality in heart failure with reduced ejection fraction but can cause hyperkalemia and acute kidney injury. Guidelines recommend measurement of serum potassium (K) and creatinine (Cr) before and serially after MRA initiation, but the extent to which this occurs is unknown.Using electronic data from 3 health systems 2005 to 2008, we performed a retrospective review of laboratory monitoring among 490 patients hospitalized for heart failure with reduced ejection fraction who were subsequently initiated on MRA therapy. Median age at time of MRA initiation was 73 years, and 37.1% were women. Spironolactone accounted for 99.4% of MRA use. Initial ambulatory MRA dispensing occurred at hospital discharge in 70.0% of cases. In the 30 days before MRA initiation, 94.3% of patients had a K or Cr measurement. Preinitiation K was >5.0 mmol/L in 1.4% and Cr >2.5 mg/dL in 1.7%. In the 7 days after MRA initiation among patients who remained alive and out of the hospital, 46.5% had no evidence of K measurement; by 30 days, 13.6% remained untested. Patient factors explained a small portion of postinitiation K testing (c-statistic, 0.67).Although laboratory monitoring before MRA initiation for heart failure with reduced ejection fraction is common, laboratory monitoring after MRA initiation frequently does not meet guideline recommendations, even in patients at higher risk for complications. Quality improvement efforts that encourage the use of MRA should also include mechanisms to address recommended monitoring. [ABSTRACT FROM AUTHOR]

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 &y& Elsevier]

Background: Contrast left ventriculography is a method of measuring left ventricular function usually performed at the discretion of the invasive cardiologist during cardiac catheterization. We sought to determine variation in the use of left ventriculography in the Veterans Affairs (VA) Health Care System. Methods and Results: We identified adult patients who underwent cardiac catheterization including coronary angiography between 2000 and 2009 in the VA Health Care System. We determined patient and hospital predictors of the use of left ventriculography as well as the variation in use across VA facilities. Results were validated using data from the VA's Clinical Assessment, Reporting, and Tracking (CART) program. Of 457 170 cardiac catheterization procedures among 336 853 patients, left ventriculography was performed on 263 695 (58%) patients. Use of left ventriculography decreased over time (64% in 2000 to 50% in 2009) and varied markedly across facilities (<1->95% of cardiac catheterizations). Patient factors explained little of the large variation in use between facilities. When the cohort was restricted to those with an echocardiogram in the prior 30 days and no intervening event, left ventriculography was still performed in 50% of cases. Conclusions: There is large variation in the use of left ventriculography across VA facilities that is not explained by patient characteristics. [ABSTRACT FROM AUTHOR]