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Background: The American College of Cardiology Reduce the Risk: PCI Bleed Campaign was a hospital-based quality improvement campaign designed to reduce post-percutaneous coronary intervention (PCI) bleeding events. The aim of the campaign was to provide actionable evidence-based tools for participants to review, adapt, and adopt, depending upon hospital resources and engagement., Methods: We used data from 8 757 737 procedures in the National Cardiovascular Data Registry between 2015 and 2021 to compare patient and hospital characteristics and bleeding outcomes among campaign participants (n=195 hospitals) and noncampaign participants (n=1384). Post-PCI bleeding risk was compared before and after campaign participation. Multivariable hierarchical logistic regression was used to determine the adjusted association between campaign participation and post-PCI bleeding events. Prespecified subgroups were examined., Results: Campaign hospitals were more often higher volume teaching facilities located in urban or suburban locations. After adjustment, campaign participation was associated with a significant reduction in the rate of bleeding (bleeding: adjusted odds ratio, 0.61 [95% CI, 0.53-0.71]). Campaign hospitals had a greater decrease in bleeding events than noncampaign hospitals. In a subgroup analysis, the reduction in bleeding was noted in non-ST-segment-elevation acute coronary syndrome and ST-segment-elevation myocardial infarction patients, but no significant reduction was seen in patients without acute coronary syndrome., Conclusions: Participation in the American College of Cardiology Reduce the Risk: PCI Bleed Campaign was associated with a significant reduction in post-PCI bleeding. Our results underscore that national quality improvement efforts can be associated with a significant impact on PCI outcomes., Competing Interests: Dr Amin has institutional grant support (modest) from GE Healthcare and Chiesi. Dr Abbott has the following relationships with industry: research: Boston Scientific and Microport; consulting: Abbott, Medtronic, Penumbra, Shockwave, and Philips. Dr Masoudi had a contract with the American College of Cardiology for his role as the Chief Scientific Advisor, National Cardiovascular Data Registry. The other authors report no conflicts.

Importance: Limited data exist regarding the characteristics of hospitals that do and do not participate in voluntary public reporting programs., Objective: To describe hospital characteristics and trends associated with early participation in the American College of Cardiology (ACC) voluntary reporting program for cardiac catheterization-percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries., Design, Setting, and Participants: This cross-sectional study analyzed enrollment trends and characteristics of hospitals that did and did not participate in the ACC voluntary public reporting program. All hospitals reporting procedure data to the National Cardiovascular Data Registry (NCDR) CathPCI or ICD registries that were eligible for the public reporting program from July 2014 (ie, program launch date) to May 2017 were included. Stepwise logistic regression was used to identify hospital characteristics associated with voluntary participation. Enrollment trends were evaluated considering the date US News & World Report (USNWR) announced that it would credit participating hospitals. Data analysis was performed from March 2017 to January 2018., Main Outcomes and Measures: Hospital characteristics and participation in the public reporting program., Results: By May 2017, 561 of 1747 eligible hospitals (32.1%) had opted to participate in the program. Enrollment increased from 240 to 376 hospitals (56.7%) 1 month after the USNWR announcement that program participation would be considered as a component of national hospital rankings. Compared with hospitals that did not enroll, program participants had increased median (IQR) procedural volumes for PCI (481 [280-764] procedures vs 332 [186-569] procedures; P < .001) and ICD (114 [56-220] procedures vs 62 [25-124] procedures; P < .001). Compared with nonparticipating hospitals, an increased mean (SD) proportion of participating hospitals adhered to composite discharge medications after PCI (0.96 [0.03] vs 0.92 [0.07]; P < .001) and ICD (0.88 [0.10] vs 0.81 [0.12]; P < .001). Hospital factors associated with enrollment included participation in 5 or more NCDR registries (odds ratio [OR],1.98; 95% CI, 1.24-3.19; P = .005), membership in a larger hospital system (ie, 3-20 hospitals vs ≤2 hospitals in the system: OR, 2.29; 95% CI, 1.65-3.17; P = .001), participation in an NCDR pilot public reporting program of PCI 30-day readmissions (OR, 2.93; 95% CI, 2.19-3.91; P < .001), university affiliation (vs government affiliation: OR, 3.85, 95% CI, 1.03-14.29; P = .045; vs private affiliation: OR, 2.22; 95% CI, 1.35-3.57; P < .001), Midwest location (vs South: OR, 1.47; 95% CI, 1.06-2.08; P = .02), and increased comprehensive quality ranking (4 vs 1-2 performance stars in CathPCI: OR, 8.08; 95% CI, 5.07-12.87; P < .001; 4 vs 1 performance star in ICD: OR, 2.26; 95% CI, 1.48-3.44; P < .001) (C statistic = 0.829)., Conclusions and Relevance: This study found that one-third of eligible hospitals participated in the ACC voluntary public reporting program and that enrollment increased after the announcement that program participation would be considered by USNWR for hospital rankings. Several hospital characteristics, experience with public reporting, and quality of care were associated with increased odds of participation.

Background: Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates., Methods: We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients' predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding., Results: Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 - a period more reflective of the contemporary practice., Conclusions: Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding., (Copyright © 2021. Published by Elsevier Inc.)

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.

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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.)

Background Quality of care incentives and reimbursements for cardiovascular testing differ between insurance providers. We hypothesized that there are differences in the use of guideline-concordant testing between Medicaid versus commercial insurance patients <65 years, and between Medicare Advantage versus Medicare fee-for-service patients ≥65 years. Methods and Results Using data from the Colorado All-Payer Claims Database from 2015 to 2018, we identified patients eligible to receive a high-value test recommended by guidelines: assessment of left ventricular function among patients hospitalized with acute myocardial infarction or incident heart failure, or a low-value test that provides minimal patient benefit: stress testing prior to low-risk surgery or routine stress testing within 2 years of percutaneous coronary intervention or coronary artery bypass graft surgery. Among 145 616 eligible patients, 37% had fee-for-service Medicare, 18% Medicare Advantage, 22% Medicaid, and 23% commercial insurance. Using multilevel logistic regression models adjusted for patient characteristics, Medicaid patients were less likely to receive high-value testing for acute myocardial infarction (odds ratio [OR], 0.84 [0.73-0.98]; P =0.03) and heart failure (OR, 0.59 [0.51-0.70]; P <0.01) compared with commercially insured patients. Medicare Advantage patients were more likely to receive high-value testing for acute myocardial infarction (OR, 1.35 [1.15-1.59]; P <0.01) and less likely to receive low-value testing after percutaneous coronary intervention/ coronary artery bypass graft (OR, 0.63 [0.55-0.72]; P <0.01) compared with Medicare fee-for-service patients. Conclusions Guideline-concordant testing was less likely to occur among patients with Medicaid compared with commercial insurance, and more likely to occur among patients with Medicare Advantage compared with fee-for-service Medicare. Insurance plan features may provide valuable targets to improve guideline-concordant testing.

Importance: Mechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit., Objective: To examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use., Design, Setting, and Participants: This cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020., Exposures: Therapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only., Main Outcomes and Measures: Use of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use., Results: Among the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only., Conclusions and Relevance: This study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.

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

Background Sex differences in health status outcomes after percutaneous coronary intervention among patients without acute myocardial infarction are not well described. Methods and Results A total of 2237 patients (33.4% women) without acute myocardial infarction undergoing percutaneous coronary intervention were enrolled from 39 Chinese tertiary hospitals in the PEACE (China Patient-centered Evaluative Assessment of Cardiac Events) prospective percutaneous coronary intervention study. Data were collected immediately before and 1 year following percutaneous coronary intervention. Health status was measured using the disease-specific Seattle Angina Questionnaire (SAQ) Angina Frequency and Quality of Life domains, as well as the SAQ Summary Score. Among the study population, women were older, more often single, had lower levels of education, and had a higher prevalence of cardiac risk factors such as hypertension and diabetes mellitus. Women had lower mean 1-year SAQ Angina Frequency scores (mean±SD, 91.0±17.3 versus 93.9±13.3; P <0.01), SAQ Quality of Life scores (mean±SD, 67.3±23.0 versus 70.6±21.6; P <0.01), and SAQ Summary Scores (mean±SD, 81.6±13.8 versus 84.8±11.9; P <0.01), a difference of marginal clinical significance that persisted after multivariable adjustment. A slightly larger improvement in the SAQ Summary Score was observed in women as compared with men (20.9±22.6 versus 18.5±21.3; P =0.007) in unadjusted analysis. However, women were less likely to achieve clinically significant improvement in SAQ Angina Frequency (adjusted odds ratio, 0.67; 95% CI, 0.45-1.00) and SAQ Quality of Life (adjusted odds ratio, 0.73; 95% CI, 0.56-0.96) after adjustment. Conclusions There were no clinically significant differences in 1-year health status outcomes and improvement in health status by sex among patients without acute myocardial infarction following percutaneous coronary intervention. However, female sex was associated with poorer 1-year health status and a lower likelihood of experiencing clinically improvement in health status. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01624922.

Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real-world surveillance system exists to monitor their long-term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee-for-service claims for patients aged ≥65 years who underwent PCI with drug-eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES: 7652 for in-stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow-up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI. Conclusions Most repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real-world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in-depth examination to accurately assess stent safety.

Acute coronary syndrome (ACS) admissions are common and costly. The association between comprehensive ACS care pathways, outcomes, and costs are lacking. From 434,172 low-risk, uncomplicated ACS patients eligible for early discharge (STEMI 35%, UA/NSTEMI 65%) from the Premier database, we identified ACS care pathways, by stratifying low-risk, uncomplicated STEMI and UA/NSTEMI patients by access site for PCI (trans-radial intervention [TRI] vs transfemoral intervention [TFI]) and by length of stay (LOS). Associations with costs and outcomes (death, bleeding, acute kidney injury, and myocardial infarction at 1-year) were tested using hierarchical, mixed-effects regression, and projections of cost savings with change in care pathways were obtained using modeling. In low-risk uncomplicated STEMI patients, compared with TFI and LOS ≥3 days, a strategy of TRI with LOS <3 days and TFI with LOS <3 days were associated with cost savings of $6,206 and $4,802, respectively. Corresponding cost savings for UA/NSTEMI patients were $7,475 and $6,169, respectively. These care-pathways did not show an excess risk of adverse outcomes. We estimated that >$300 million could be saved if prevalence of the TRI with LOS <3 days and TFI with LOS <3 days strategies are modestly increased to 20% and 70%, respectively. In conclusion, we demonstrate the potential opportunity of cost savings by repositioning ACS care pathways in low-risk and uncomplicated ACS patients, toward transradial access and a shorter LOS without an increased risk of adverse outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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

Contrast-induced acute kidney injury (AKI) is a common and severe complication of percutaneous coronary intervention (PCI). Despite its substantial burden, contemporary data on the incremental costs of AKI are lacking. We designed this large, nationally representative study to examine: (1) the independent, incremental costs associated with AKI after PCI and (2) to identify the departmental components of cost contributing to the incremental costs associated with AKI. In this observational cross-sectional study from the Premier database, we analyzed 1,443,297 PCI patients at 518 US hospitals from 1/2006 to 12/2015. Incremental cost of AKI from a hospital perspective obtained by a microcosting approach, was estimated using mixed-effects, multivariable linear regression with hospitals as random effects. Costs were inflation-corrected to 2016 US$. AKI occurred in 82,683 (5.73%) of the PCI patients. Those with AKI had higher hospitalization cost than those without ($38,869, SD 42,583 vs $17,167 SD 13,994, p <0.001). After adjustment, the incremental cost associated with an AKI was $9,448 (95% confidence interval $9,338 to $9,558, p <0.001). AKI was also independently associated with an incremental length of stay of 3.6 days (p <0.001). Room and board costs were the largest driver of AKI costs ($4,841). Extrapolated to the United States, our findings imply an annual AKI cost burden of 411.3 million US$. In conclusion, in this national study of PCI patients, AKI was common and independently associated with ∼$10,000 incremental costs, implying a substantial burden of AKI costs in US hospitals. Successful efforts to prevent AKI in patients who underwent PCI could result in meaningful cost savings., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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.

Importance: Better prediction of major bleeding after percutaneous coronary intervention (PCI) may improve clinical decisions aimed to reduce bleeding risk. Machine learning techniques, bolstered by better selection of variables, hold promise for enhancing prediction., Objective: To determine whether machine learning techniques better predict post-PCI major bleeding compared with the existing National Cardiovascular Data Registry (NCDR) models., Design, Setting, and Participants: This comparative effectiveness study used the NCDR CathPCI Registry data version 4.4 (July 1, 2009, to April 1, 2015), machine learning techniques were used (logistic regression with lasso regularization and gradient descent boosting [XGBoost, version 0.71.2]), and output was then compared with the existing simplified risk score and full NCDR models. The existing models were recreated, and then performance was evaluated through additional techniques and variables in a 5-fold cross-validation in analysis conducted from October 1, 2015, to October 27, 2017. The setting was retrospective modeling of a nationwide clinical registry of PCI. Participants were all patients undergoing PCI. Percutaneous coronary intervention procedures were excluded if they were not the index PCI of admission, if the hospital site had missing outcomes measures, or if the patient underwent subsequent coronary artery bypass grafting., Exposures: Clinical variables available at admission and diagnostic coronary angiography data were used to determine the severity and complexity of presentation., Main Outcomes and Measures: The main outcome was in-hospital major bleeding within 72 hours after PCI. Results were evaluated by comparing C statistics, calibration, and decision threshold-based metrics, including the F score (harmonic mean of positive predictive value and sensitivity) and the false discovery rate., Results: The post-PCI major bleeding rate among 3 316 465 procedures (patients' median age, 65 years; interquartile range, 56-73 years; 68.1% male) was 4.5%. The existing full model achieved a mean C statistic of 0.78 (95% CI, 0.78-0.78). The use of XGBoost and full range of selected variables achieved a C statistic of 0.82 (95% CI, 0.82-0.82), with an F score of 0.31 (95% CI, 0.30-0.31). XGBoost correctly identified an additional 3.7% of cases identified as high risk who experienced a bleeding event and an overall improvement of 1.0% of cases identified as low risk who did not experience a bleeding event. The data-driven decision threshold helped improve the false discovery rate of the existing techniques. The existing simplified risk score model improved the false discovery rate from more than 90% to 78.7%. Modifying the model and the data decision threshold improved this rate from 78.7% to 73.4%., Conclusions and Relevance: Machine learning techniques improved the prediction of major bleeding after PCI. These techniques may help to better identify patients who would benefit most from strategies to reduce bleeding risk.

Importance: Recent data support percutaneous revascularization as an alternative to coronary artery bypass grafting in unprotected left main (ULM) coronary lesions. However, the relevance of these trials to current practice is unclear, as patterns and outcomes of ULM percutaneous coronary intervention (PCI) in contemporary US clinical practice are not well studied., Objective: To define the current practice of ULM PCI and its outcomes and compare these with findings reported in clinical trials., Design, Setting, and Participants: This cross-sectional multicenter analysis included data collected from 1662 institutions participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry between April 2009 and July 2016. Data were collected from 33 128 patients undergoing ULM PCI and 3 309 034 patients undergoing all other PCI. Data were analyzed from June 2017 to May 2018., Main Outcomes and Measures: Patient and procedural characteristics and their temporal trends were compared between ULM PCI and all other PCI. In-hospital major adverse clinical events (ie, death, myocardial infarction, stroke, and emergent coronary artery bypass grafting) were compared using hierarchical logistic regression. Characteristics and outcomes were also compared against clinical trial cohorts., Results: Of the 3 342 162 included patients, 2 223 570 (66.5%) were male, and the mean (SD) age was 64.2 (12.1) years. Unprotected left main PCI represented 1.0% (33 128 of 3 342 162) of all procedures, modestly increasing from 0.7% to 1.3% over time. The mean (SD) annualized ULM PCI volume was 0.5 (1.5) procedures for operators and 3.2 (6.1) procedures for facilities, with only 1808 of 10 971 operators (16.5%) and 892 of 1662 facilities (53.7%) performing an average of 1 or more ULM PCI annually. After adjustment, major adverse clinical events occurred more frequently with ULM PCI compared with all other PCI (odds ratio, 1.46; 95% CI, 1.39-1.53). Compared with clinical trial populations, patients in the CathPCI Registry were older with more comorbid conditions, and adverse events were more frequent., Conclusions and Relevance: Use of ULM PCI has increased over time, but overall use remains low. These findings suggest that ULM PCI occurs infrequently in the United States and in an older and more comorbid population than that seen in clinical trials.

Importance: Despite a rapid increase in percutaneous coronary intervention (PCI) procedures in China, little is known about patient-reported health status before and after PCI in patients without acute myocardial infarction (AMI)., Objective: To describe self-perceived angina-specific health status prior to PCI and 1 year after the procedure in patients without AMI in China., Design, Setting, and Participants: The China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI was a population-based, multicenter cohort study of a consecutive sample of 1611 patients without AMI undergoing elective PCI. Participants were enrolled from 40 hospitals in 18 provinces in China from December 2012 to August 2014. Participants were eligible if they underwent PCI for stable and unstable angina and did not have AMI. Participants were excluded if they died in hospital, withdrew from follow-up, or had missing data on self-reported health status at baseline or at 1 year after PCI. The date of the analysis was September 15, 2018., Exposures: Percutaneous coronary intervention for ischemic heart disease., Main Outcomes and Measures: Angina frequency and angina-related quality of life were assessed with the Seattle Angina Questionnaire (SAQ) immediately prior to PCI and 1 year after the procedure. Either (1) an increase in the SAQ Angina Frequency score of 10 or more points or (2) an increase in the SAQ Quality-of-Life score of 10 or more points was considered to represent clinically significant improvement., Results: Of 1611 patients, 520 (32.3%) were women; mean (SD) age was 61.3 (9.8) years. Among these patients, 443 (27.5%) had stable coronary artery disease and 1168 (72.5%) had unstable angina. One hundred fourteen of 443 patients undergoing PCI for stable coronary artery disease (25.7%) and 175 of 1168 undergoing PCI for unstable angina (15.0%) had no reported angina symptoms at the time of the procedure (SAQ Angina Frequency score = 100). Moreover, 18% of all patients (290) had minimal angina symptoms (SAQ Angina Frequency score >90) and, thus, no potential for substantial clinical improvement. Patients with smaller clinical improvements in angina symptom burden at 1 year following PCI had significantly higher baseline SAQ scores for all scales than patients with greater clinical improvement, but generally similar sociodemographic and procedural characteristics., Conclusions and Relevance: In this study, 25.7% of patients undergoing PCI for stable coronary artery disease had no reported angina symptoms at the time of the procedure. Patients with smaller clinical improvements in angina symptom burden had higher baseline SAQ scores, which highlights the importance of ascertaining impairment from angina among patients without AMI prior to performing PCI.

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.

Importance: Same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is associated with lower costs and preferred by patients. However, to our knowledge, contemporary patterns of SDD after elective PCI with respect to the incidence, hospital variation, trends, costs, and safety outcomes in the United States are unknown., Objective: To examine (1) the incidence and trends in SDD; (2) hospital variation in SDD; (3) the association between SDD and readmissions for bleeding, acute kidney injury (AKI), acute myocardial infarction (AMI), or mortality at 30, 90, and 365 days after PCI; and (4) hospital costs of SDD and its drivers., Design, Setting, and Participants: This observational cross-sectional cohort study included 672 470 patients enrolled in the nationally representative Premier Healthcare Database who underwent elective PCI from 493 hospitals between January 2006 and December 2015 with 1-year follow-up., Exposures: Same-day discharge, defined by identical dates of admission, PCI procedure, and discharge., Main Outcomes and Measures: Death, bleeding requiring a blood transfusion, AKI and AMI at 30, 90, or 365 days after PCI, and costs from hospitals' perspective, inflated to 2016., Results: Among 672 470 elective PCIs, 221 997 patients (33.0%) were women, 30 711 (4.6%) were Hispanic, 51 961 (7.7%) were African American, and 491 823 (73.1%) were white. The adjusted rate of SDD was 3.5% (95% CI, 3.0%-4.0%), which increased from 0.4% in 2006 to 6.3% in 2015. We observed substantial hospital variation for SDD from 0% to 83% (median incidence rate ratio, 3.82; 95% CI, 3.48-4.23), implying an average (median) 382% likelihood of SDD at one vs another hospital. Among SDD (vs non-SDD) patients, there was no higher risk of death, bleeding, AKI, or AMI at 30, 90, or 365 days. Same-day discharge was associated with a large cost savings of $5128 per procedure (95% CI, $5006-$5248), driven by reduced supply and room and boarding costs. A shift from existing SDD practices to match top-decile SDD hospitals could annually save $129 million in this sample and $577 million if adopted throughout the United States. However, residual confounding may be present, limiting the precision of the cost estimates., Conclusions and Relevance: Over 2006 to 2015, SDD after elective PCI was infrequent, with substantial hospital variation. Given the safety and large savings of more than $5000 per PCI associated with SDD, greater and more consistent use of SDD could markedly increase the overall value of PCI care.

Background: The Physician Consortium for Performance Improvement recently proposed percutaneous coronary intervention (PCI)-specific process measures. However, information about hospital performance on these measures and the association of PCI process and outcomes measures are not available., Methods and Results: We linked the National Cardiovascular Data Registry (NCDR) CathPCI Registry with Medicare claims data to assess hospital performance on established PCI process measures (aspirin, thienopyridines, and statins on discharge; door-to-balloon time; and referral to cardiac rehabilitation), newly proposed PCI process measures (documentation of contrast dose, glomerular filtration rate, and PCI indication; appropriate indication for elective PCI; and use of embolic protection device), and a composite of all process measures. We calculated weighted pair-wise correlations between each set of process metrics and performed weighted correlation analyses to assess the association between composite measure performance with corresponding 30-day risk-standardized mortality and readmission rates. We reported the variance in risk-standardized 30-day outcome rates explained by process measures. We analyzed 1 268 860 PCIs from 1331 hospitals. For many process measures, median hospital performance exceeded 90%. We found strong correlations between medication-specific process measures ( P <0.01) and weak correlations between hospital performance on the newly proposed and established process measures. The composite process measure explained only 1.3% and 2.0% of the observed variation in mortality and readmission rates, respectively., Conclusions: Hospital performance on many PCI-specific process measures demonstrated little opportunity for improvement and explained only a small percentage of hospital variation in 30-day outcomes. Efforts to measure and improve hospital quality for PCI patients should focus on both process and outcome measures., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: Fibrinolytic therapy is the primary reperfusion strategy for ST-segment elevation myocardial infarction in China, and yet little is known about the quality of care regarding its use and whether it has changed over time. This issue is particularly important in hospitals without the capacity for cardiovascular intervention., Methods: Using a sequential cross-sectional study with two-stage random sampling in 2001, 2006, and 2011, we characterised the use, timing, type and dose of fibrinolytic therapy in a nationally representative sample of patients with ST-segment elevation myocardial infarction admitted to hospitals without the ability to perform percutaneous coronary intervention., Results: We identified 5306 patients; 2812 (53.0%) were admitted within 12 hours of symptom onset, of whom 2463 (87.6%) were ideal candidates for fibrinolytic therapy. The weighted proportion of ideal candidates receiving fibrinolytic therapy was 45.8% in 2001, 50.0% in 2006, and 53.0% in 2011 ( P trend =0.0042). There were no regional differences in fibrinolytic therapy use. Almost all ideal patients (95.1%) were treated after admission to the hospital rather than in the emergency department. Median admission to needle time was 35 minutes (interquartile range 10-82) in 2011, which did not improve from 2006. Underdosing was common. Urokinase, with little evidence of efficacy, was used in 90.2% of patients., Conclusions: Over the past decade in China, the potential benefits of fibrinolytic therapy were compromised by underuse, patient and hospital delays, underdosing and the predominant use of urokinase, an agent for which there is little clinical evidence. There are ample opportunities for improvement.

Cardiovascular disease is a leading cause of death and disability in the United States. National programs, such as the National Cardiovascular Data Registry, facilitate assessments of the quality of care and outcomes for broad populations of patients with cardiovascular disease. This report provides data for 2014 from 4 National Cardiovascular Data Registry hospital quality programs: 1) CathPCI (Diagnostic Catheterization and Percutaneous Coronary Intervention) for coronary angiography and percutaneous coronary intervention (667,424 procedures performed in 1,612 hospitals); 2) ICD Registry for implantable cardioverter-defibrillators (158,649 procedures performed in 1,715 hospitals); 3) ACTION-GWTG (Acute Coronary Treatment and Intervention Outcomes Network-Get With The Guidelines) for acute coronary syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT (Improving Pediatric and Adult Congenital Treatment) for cardiac catheterization and intervention for pediatric and adult congenital heart disease (20,169 procedures in 76 hospitals). The report provides perspectives on the demographic and clinical characteristics of enrolled patients, characteristics of participating centers, and selected measures of processes and outcomes of care in these programs., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The number of percutaneous coronary interventions (PCI) in China has increased more than 20-fold over the last decade. Consequently, there is a need for national-level information to characterize PCI indications and long-term patient outcomes, including health status, to understand and improve evolving practice patterns., Objectives: This nationwide prospective study of patients receiving PCI is to: (1) measure long-term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient-reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient- and hospital-level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures., Methods: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012-2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in-hospital outcomes from medical charts, and conducted baseline, 1-, 6-, and 12-month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12-month follow-up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys., Conclusion: China PEACE Prospective Study of PCI will be the first study to generate novel, high-quality, comprehensive national data on patients' socio-demographic, clinical, treatment, and metabolic/genetic factors, and importantly, their long-term outcomes following PCI, including health status. This will build the foundation for PCI performance improvement efforts in China. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc., (© 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc.)

Importance: The use of coronary catheterization and percutaneous coronary intervention (PCI) is increasing in China, but, to date, there are no nationally representative assessments of the quality of care and outcomes in patients undergoing these procedures., Objective: To assess the quality of care and outcomes of patients undergoing coronary catheterization and PCI in China., Design, Setting, and Participants: In a clinical observational study (China PEACE [Patient-Centered Evaluative Assessment of Cardiac Events]-Retrospective CathPCI Study), we used a 2-stage, random sampling strategy to create a nationally representative sample of 11 241 patients undergoing coronary catheterization and PCI at 55 urban Chinese hospitals in calendar years 2001, 2006, and 2011. Data analysis was performed from July 11, 2014, to November 20, 2015., Main Outcomes and Measures: Patient characteristics, treatment patterns, quality of care, and outcomes associated with these procedures and changes over time., Results: Of the 11 241 patients included in the study, the samples included, for 2001, 285 women (weighted percentage, 28.6%); for 2006, 826 women (weighted percentage, 32.2%), and for 2011, 2588 women (weighted percentage, 35.7%). Mean (SD) ages were 58 (8), 60 (11), and 61 (11) years, respectively. Between 2001 and 2011, estimated national rates of hospitalizations for coronary catheterization increased from 26 570 to 452 784 and for PCI, from 9678 to 208 954 (17-fold and 21-fold), respectively. More than half of stable patients undergoing coronary catheterization had nonobstructive coronary artery disease; this amount did not change significantly over time (2001: 60.3% [95% CI, 56.1%-64.5%]; 2011: 57.5% [95% CI, 55.8%-59.3%], P = .05 for trend). The proportion of PCI procedures performed via radial approach increased from 3.5% (95% CI, 1.7%-5.3%) in 2001 to 79.0% (95% CI, 77.7%-80.3%) in 2011 (P < . 001 for trend). The use of drug-eluting stents (DESs) increased from 18.0% (95% CI, 14.2%-21.7%) in 2001 to 97.3% (95% CI, 96.9%-97.7%) in 2011 (P < .001 for trend) largely owing to increased use of domestic DESs. The median length of stay decreased from 14 days (interquartile range [IQR], 9-20) in 2001 to 10 days (IQR, 7-14) in 2011 (P < .001 for trend). In-hospital mortality did not change significantly, but both adjusted risk of any bleeding (odds ratio [OR], 0.53 [95% CI, 0.36-0.79], P < .001 for trend) and access bleeding (OR, 0.23 [95% CI, 0.12-0.43], P < .001) were decreased between 2001 and 2011. The medical records lacked documentation needed to calculate commonly used process metrics including door to balloon times for primary PCI and the prescription of evidence-based medications at discharge., Conclusions and Relevance: Although the use of catheterization and PCI in China has increased dramatically, we identified critical quality and documentation gaps that represent opportunities to improve care. Our findings can serve as a foundation to guide future quality improvement initiatives in China.

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.)

Introduction: Public reporting (PR) is a policy mechanism that may improve clinical outcomes for percutaneous coronary intervention (PCI). However, prior studies have shown that PR may have an adverse impact on patient selection. It is unclear whether alternatives to PR, such as collaborative quality improvement (CQI), may drive improvements in quality of care and outcomes for patients receiving PCI without the unintended consequences seen with PR., Methods: Using National Cardiovascular Data Registry CathPCI Registry data from January 2011 through September 2012, we evaluated patients who underwent PCI in New York (NY), a state with PR (N = 51,983), to Michigan, a state with CQI (N = 53,528). We compared patient characteristics, the quality of care delivered, and clinical outcomes., Results: Patients undergoing PCI in NY had a lower-risk profile, with a lower proportion of patients with ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or cardiogenic shock, compared with Michigan. Quality of care was broadly similar in the 2 states; however, outcomes were better in NY. In a propensity-matched analysis, patients in NY were less likely to be referred for emergent, urgent, or salvage coronary artery bypass surgery (odds ratio [OR] 0.67, 95% CI 0.51-0.88, P < .0001) and to receive blood transfusion (OR 0.7, 95% CI 0.61-0.82, P < .0001), and had lower in-hospital mortality (OR 0.72, 95% CI 0.63-0.83, P < .0001)., Conclusions: Public reporting of PCI data is associated with fewer high-risk patients undergoing PCI compared with CQI. However, in comparable samples of patients, PR is also associated with a lower risk of mortality and adverse events. The optimal quality improvement method may involve combining these 2 strategies to protect access to care while still driving improvements in patient outcomes., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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.)

Objectives: The goal of this study was to examine the calibration of a validated risk-adjustment model in very high-risk percutaneous coronary intervention (PCI) cases and assess whether sites' case mix affects their performance ratings., Background: There are concerns that treating PCI patients with particularly high-risk features such as cardiogenic shock or prior cardiac arrest may adversely impact hospital performance ratings. However, there is little investigation on the validity of these concerns., Methods: We examined 624,286 PCI procedures from 1,168 sites that participated in the CathPCI Registry in 2010. Procedural risk was estimated using the recently published Version 4 National Cardiovascular Data Registry (NCDR) PCI risk-adjusted mortality (RAM) model. We calculated observed/expected mortality using several risk classification methods, and simulated hospital performance after combining their highest risk cases over 2 years into a single year., Results: In 2010, crude in-hospital PCI mortality was 1.4%. The NCDR model was generally well calibrated among high risk, however there was slight overprediction of risk in extreme cases. Hospitals treating the highest overall expected risk PCI patients or those treating the top 20% of high-risk cases had lower (better) RAM ratings than centers treating lower-risk cases (1.25% vs. 1.51%). The observed/expected ratio for top-risk quintile versus low-risk quintile was 0.91 (0.87 to 0.96) versus 1.10 (1.03 to 1.17). Combining all the high-risk patients over a 2-year period into a single year also did not negatively impact the site's RAM ratings., Conclusions: Evaluation of a contemporary sample of PCI cases across the United States showed no evidence that treating high-risk PCI cases adversely affects hospital RAM rates., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

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: 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.)

Objectives: The aim of this study was to determine diagnostic testing patterns after percutaneous coronary intervention (PCI)., Background: Little is known about patterns of diagnostic testing after PCI in the United States or the relationship of these patterns to clinical outcomes., Methods: Centers for Medicare and Medicaid Services inpatient and outpatient claims were linked to National Cardiovascular Data Registry CathPCI Registry data from 2005 to 2007. Hospital quartiles of the cumulative incidence of diagnostic testing use within 12 and 24 months after PCI were compared for patient characteristics, repeat revascularization, acute myocardial infarction, and death., Results: A total of 247,052 patients underwent PCI at 656 institutions. Patient and site characteristics were similar across quartiles of testing use. There was a 9% and 20% higher adjusted risk for repeat revascularization in quartiles 3 and 4 (highest testing rate), respectively, compared with quartile 1 (lowest testing rate) (p = 0.020 and p < 0.0001, respectively). The adjusted risk for death or acute myocardial infarction did not differ among quartiles., Conclusions: Although patient characteristics were largely independent of rates of post-PCI testing, higher testing rates were not associated with lower risk for myocardial infarction or death, but repeat revascularization was significantly higher at these sites. Additional studies should examine whether increased testing is a marker for improved quality of post-PCI care or simply increased health care utilization., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compared the use and effectiveness of bleeding avoidance strategies (BAS) by sex., Background: Women have higher rates of bleeding following percutaneous coronary intervention (PCI)., Methods: Among 570,777 men (67.5%) and women (32.5%) who underwent PCI in the National Cardiovascular Data Registry's CathPCI Registry between July 1, 2009 and March 31, 2011, in-hospital bleeding rates and the use of BAS (vascular closure devices, bivalirudin, radial approach, and their combinations) were assessed. The relative risk of bleeding for each BAS compared with no BAS was determined in women and men using multivariable logistic regressions adjusted for clinical characteristics and the propensity for receiving BAS. Finally, the absolute risk differences in bleeding associated with BAS were compared., Results: Overall, the use of any BAS differed slightly between women and men (75.4% vs. 75.7%, p = 0.01). When BAS was not used, women had significantly higher rates of bleeding than men (12.5% vs. 6.2%, p < 0.01). Both sexes had similar adjusted risk reductions of bleeding when any BAS was used (women, odds ratio: 0.60, 95% confidence interval [CI]: 0.57 to 0.63; men, odds ratio: 0.62, 95% CI: 0.59 to 0.65). Women and men had lower absolute bleeding risks with BAS; however, these absolute risk differences were greater in women (6.3% vs. 3.2%, p < 0.01)., Conclusions: Women continue to have almost twice the rate of bleeding following PCI. The use of any BAS was associated with a similarly lower risk of bleeding for men and women; however, the absolute risk differences were substantially higher in women. These data underscore the importance of applying effective strategies to limit post-PCI bleeding, especially in women., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Objectives: We evaluated temporal trends and geographic variation in choice of stress testing modality after percutaneous coronary intervention (PCI), as well as associations between modality and procedure use after testing., Background: Stress testing is frequently performed post-PCI, but the choices among available modalities (electrocardiography only, nuclear, or echocardiography; pharmacological or exercise stress) and consequences of such choices are not well characterized., Methods: CathPCI Registry(®) data were linked with identifiable Medicare claims to capture stress testing use between 60 and 365 days post-PCI and procedures within 90 days after testing. Testing rates and modality used were modeled on the basis of patient, procedure, and PCI facility factors, calendar quarter, and Census Divisions using Poisson and logistic regression. Post-test procedure use was assessed using Gray's test., Results: Among 284,971 patients, the overall stress testing rate after PCI was 53.1 per 100 person-years. Testing rates declined from 59.3 in quarter 1 (2006) to 47.1 in quarter 4 (2008), but the relative use of modalities changed little. Among exercise testing recipients, adjusted proportions receiving electrocardiography-only testing varied from 6.8% to 22.8% across Census Divisions; and among exercise testing recipients having an imaging test, the proportion receiving echocardiography (versus nuclear) varied from 9.4% to 34.1%. Post-test procedure use varied among modalities; exercise electrocardiography-only testing was associated with more subsequent stress testing (13.7% vs. 2.9%; p < 0.001), but less catheterization (7.4% vs. 14.1%; p < 0.001) than imaging-based tests., Conclusions: Modest reductions in stress testing after PCI occurring between 2006 and 2008 cannot be ascribed to trends in use of any single modality. Additional research should assess whether this trend represents better patient selection for testing or administrative policies (e.g., restricted access for patients with legitimate testing needs). Geographic variation in utilization of stress modalities and differences in downstream procedure use among modalities suggest a need to identify optimal use of the different test modalities in individual patients., (Copyright © 2012 American College of Cardiology Foundation. Published by 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]

The article discusses a study that analyzed patterns of stress testing (ST) and invasive coronary angiography (CA) after percutaneous coronary intervention (PCI) in older patients. It mentions the linking of National Cardiovascular Data Registry CathPCI Registry data with Medicare claims data for patients undergoing PCI from 2005 to 2007. Results show that ST and invasive CA were common in older patients after PCI. The low revascularization field on patients referred for ST after PCI is cited.