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The article focuses on cohort analysis performed to understand the association between bleeding and percutaneous coronary intervention (PCI) and subsequent association with increased morbidity and health care costs. Post procedural bleeding is associated with nonfatal myocardial infraction, blood transfusion and stroke. The study was conducted on CathPCI registry performed in the U.S. between 2004 - 2011. The results obtained showed that in-hospitality mortality rate increased with increase in number of post procedural bleeding events in PCI-registered patients.

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 [ABSTRACT FROM AUTHOR]

The article discusses a study to assess variations in drug-eluting stents (DES) use among U.S. physicians participating in the National Cardiovascular Data Registry (NCDR), the association between predicted target vessel revascularization (TVR) risk with bare-metal stents (BMS) with DES use and the estimated clinical and economic consequences of lower DES use in patients with low TVR risk. It concludes that DES use is common even on those predicted to be at the lowest restenosis risk.

The article reports on the link between the National Cardiovascular Data Registry CathPCI Registry and longitudinal claims data from the Centers for Medicare & Medicaid (CMS) in the U.S. The study focused on hospitals and patients that are representative of the elderly population, those age 65 years and above. It concluded that a representative cohort of data was created by using deterministic matching strategies.

Background: Among Medicare value-based payment programs for acute myocardial infarction (AMI), the Hospital Readmissions Reduction Program uses International Classification of Diseases, Tenth Revision (ICD-10) codes to identify the program denominator, while the Bundled Payments for Care Improvement Advanced program uses diagnosis-related groups (DRGs). The extent to which these programs target similar patients, whether they target the intended population (type 1 myocardial infarction), and whether outcomes are comparable between cohorts is not known.Methods: In a retrospective study of 2176 patients hospitalized in an integrated health system, a cohort of patients assigned a principal ICD-10 diagnosis of AMI and a cohort of patients assigned an AMI DRG were compared according to patient-level agreement and outcomes such as mortality and readmission.Results: One thousand nine hundred thirty-five patients were included in the ICD-10 cohort compared with 662 patients in the DRG cohort. Only 421 patients were included in both AMI cohorts (19.3% agreement). DRG cohort patients were older (70 versus 65 years, P<0.001), more often female (48% versus 30%, P<0.001), and had higher rates of heart failure (52% versus 33%, P<0.001) and kidney disease (42% versus 25%, P<0.001). Comparing outcomes, the DRG cohort had significantly higher unadjusted rates of 30-day mortality (6.6% versus 2.5%, P<0.001), 1-year mortality (21% versus 8%, P<0.001), and 90-day readmission (26% versus 19%, P=0.006) than the ICD-10 cohort. Two observations help explain these differences: 61% of ICD-10 cohort patients were assigned procedural DRGs for revascularization instead of an AMI DRG, and type 1 myocardial infarction patients made up a smaller proportion of the DRG cohort (34%) than the ICD-10 cohort (78%).Conclusions: The method used to identify denominators for value-based payment programs has important implications for the patient characteristics and outcomes of the populations. As national and local quality initiatives mature, an emphasis on ICD-10 codes to define AMI cohorts would better represent type 1 myocardial infarction patients. [ABSTRACT FROM AUTHOR]

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

Background: Societal guidelines and payor coverage decisions for transcatheter aortic valve replacement (TAVR) attempt to strike a balance between providing access and maintaining quality. The extent to which dissemination of TAVR has achieved these ideals remains unknown.Objectives: This study sought to define patterns of TAVR dissemination in the United States and their influence on outcomes.Methods: Using data from the TVT (Transcatheter Valvular Therapy) registry, this study identified TAVR sites from 2011 to 2018 and calculated drive-times from existing to new sites. In a contemporary cohort, this study compared site and patient characteristics by annual case volume and density of sites per million Medicare beneficiaries. Using hierarchical regression and Cox methods, this study determined the association between case volumes, site density, and changes in volume and density with patient risk profiles and outcomes.Results: TAVR sites participating in the TVT registry increased from 198 to 556 from 2011 to 2018. Median drive-time from existing to new sites decreased from 403 minutes (interquartile range: 211-587 minutes) to 26 minutes (interquartile range: 17-48 minutes). In a contemporary cohort, higher site density was associated with lower procedural risk as well as with an increased hazard of 30-day risk-adjusted mortality (P = 0.017). Similarly, longitudinal increases in site density over time were associated with a higher hazard of 30-day (P = 0.011) and 1-year (P = 0.013) mortality.Conclusions: TAVR has expanded significantly over time, but with regional clustering of sites. Although procedural risk is lower at higher density sites, these sites demonstrate an increased hazard of mortality. These findings suggest that the expansion of TAVR services in the United States may have had unintended consequences on procedural quality. [ABSTRACT FROM AUTHOR]

Background: Standardization of risk is critical in benchmarking and quality improvement efforts for percutaneous coronary interventions (PCIs). In 2018, the CathPCI Registry was updated to include additional variables to better classify higher-risk patients.Objectives: This study sought to develop a model for predicting in-hospital mortality risk following PCI incorporating these additional variables.Methods: Data from 706,263 PCIs performed between July 2018 and June 2019 at 1,608 sites were used to develop and validate a new full and pre-catheterization model to predict in-hospital mortality, and a simplified bedside risk score. The sample was randomly split into a development cohort (70%, n = 495,005) and a validation cohort (30%, n = 211,258). The authors created 1,000 bootstrapped samples of the development cohort and used stepwise selection logistic regression on each sample. The final model included variables that were selected in at least 70% of the bootstrapped samples and those identified a priori due to clinical relevance.Results: In-hospital mortality following PCI varied based on clinical presentation. Procedural urgency, cardiovascular instability, and level of consciousness after cardiac arrest were most predictive of in-hospital mortality. The full model performed well, with excellent discrimination (C-index: 0.943) in the validation cohort and good calibration across different clinical and procedural risk cohorts. The median hospital risk-standardized mortality rate was 1.9% and ranged from 1.1% to 3.3% (interquartile range: 1.7% to 2.1%).Conclusions: The risk of mortality following PCI can be predicted in contemporary practice by incorporating variables that reflect clinical acuity. This model, which includes data previously not captured, is a valid instrument for risk stratification and for quality improvement efforts. [ABSTRACT FROM AUTHOR]

Background: Although many studies show an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer-term outcomes is unknown.Methods: Using the National Cardiovascular Data Registry CathPCI registry data linked with Medicare claims data, we examined the association between operator PCI volume and long-term outcomes among patients ≥65 years of age. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (<50 PCIs), intermediate- (50-100), and high- (>100) volume operators. One-year unadjusted rates of death and major adverse coronary events (MACEs; defined as death, readmission for myocardial infarction, or unplanned coronary revascularization) were calculated with Kaplan-Meier methods. The proportional hazards assumption was not met, and risk-adjusted associations between operator volume and outcomes were calculated separately from the time of PCI to hospital discharge and from hospital discharge to 1-year follow-up.Results: Between July 1, 2009, and December 31, 2014, 723 644 PCI procedures were performed by 8936 operators: 2553 high-, 2878 intermediate-, and 3505 low-volume operators. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI, and their patients had fewer cardiovascular comorbidities. Over 1-year follow-up, 15.9% of patients treated by low-volume operators had a MACE compared with 16.9% of patients treated by high-volume operators ( P=0.004). After multivariable adjustment, intermediate- and high-volume operators had a significantly lower rate of in-hospital death than low-volume operators (odds ratio, 0.91; 95% CI, 0.86-0.96 for intermediate versus low; odds ratio, 0.79; 95% CI, 0.75-0.83 for high versus low). There were no significant differences in rates of MACEs, death, myocardial infarction, or unplanned revascularization between operator cohorts from hospital discharge to 1-year follow-up (adjusted hazard ratio for MACEs, 0.99; 95% CI, 0.96-1.01 for intermediate versus low; hazard ratio, 1.01; 95% CI, 0.99-1.04 for high versus low).Conclusions: Unadjusted 1-year outcomes after PCI were worse for older adults treated by operators with higher annual volume; however, patients treated by these operators had more cardiovascular comorbidities. After risk adjustment, higher operator volume was associated with lower in-hospital mortality and no difference in postdischarge MACEs. [ABSTRACT FROM AUTHOR]

Background: Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. Operator volume patterns and associated outcomes since this change are unknown.Objectives: The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample.Methods: Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality.Results: The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding.Conclusions: Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses. [ABSTRACT FROM AUTHOR]

Background--Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes. Methods and Results--We used CathPCI Registry data from July 2009 to December 2012 to identify new radial operators, defined by an exclusively femoral percutaneous coronary intervention approach for 6 months after their first percutaneous coronary intervention in the database and 5 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed by using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54561 TRI procedures performed at 704 sites, 942 operators performed 1 to 10 procedures, 942 operators performed 11 to 50 procedures, 375 operators performed 51 to 100 procedures, and 148 operators performed 101 to 200 procedures. As radial caseload increased, more TRIs were performed in women, in patients presenting with ST-segment elevation myocardial infarction, and for emergency indications. Decreased fluoroscopy time and contrast use were nonlinearly associated with greater operator TRI experience, with faster reductions observed for newer (<30-50 cases) compared with more experienced (>30-50 cases) operators. Procedure success was high, whereas mortality, bleeding, and vascular complications remained low across TRI volumes. Conclusions--As operator TRI volume increases, higher-risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30 to 50 cases. [ABSTRACT FROM AUTHOR]

Background-Radial access for percutaneous coronary intervention (r-PCI) is associated with reduced vascular complications; however, previous reports have shown that <2% of percutaneous coronary intervention (PCI) procedures in the United States are performed via the radial approach. Our aims were to evaluate temporal trends in r-PCI and compare procedural outcomes between r-PCI and transfemoral PCI. Methods and Results-We conducted a retrospective cohort study from the CathPCI registry (n=2 820 874 procedures from 1381 sites) between January 2007 and September 2012. Multivariable logistic regression models were used to evaluate the adjusted association between r-PCI and bleeding, vascular complications, and procedural success, using transfemoral PCI as the reference. Outcomes in high-risk subgroups such as age ≥75 years, women, and patients with acute coronary syndrome were also examined. The proportion of r-PCI procedures increased from 1.2% in quarter I 2007 to 16.1% in quarter 3 2012 and accounted for 6.3% of total procedures from 2007 to 2012 (n=178 643). After multivariable adjustment, r-PCI use in the studied cohort of patients was associated with lower risk of bleeding (adjusted odds ratio, 0.51; 95% confidence interval, 0.49-0.54) and lower risk of vascular complications (adjusted odds ratio, 0.39; 95% confidence interval, 0.31-0.50) in comparison with transfemoral PCI. The reduction in bleeding and vascular complications was consistent across important subgroups of age, sex, and clinical presentation. Conclusions-There has been increasing adoption of r-PCI in the United States. Transradial PCI now accounts for 1 of 6 PCIs performed in contemporary clinical practice. In comparison with traditional femoral access, transradial PCI is associated with lower vascular and bleeding complication rates. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to characterize long-term outcomes of percutaneous coronary intervention (PCI) in elderly diabetic patients in routine practice. Background: Although drug-eluting stent (DES) implantation in diabetic patients is common practice, pivotal randomized trials enrolled <2,500 diabetic patients, most of whom were <65 years of age. Methods: Data from 405,679 patients ≥65 years old (33% had diabetes mellitus, of whom 9.8% had insulin-treated diabetes mellitus [ITDM], and 23.3% had noninsulin-treated diabetes mellitus [NITDM]) undergoing PCI from 2004 to 2008 at 946 U.S. hospitals were linked with Medicare inpatient claims data. Results: Over 18.4 months median follow-up (25th to 75th percentile: 8.0 to 30.8 months), ITDM/NITDM were associated with significantly increased adjusted hazards of death (hazard ratio [HR]: 1.91 [95% confidence interval (CI): 1.86 to 1.96], p < 0.001/HR: 1.32 [95% CI: 1.29 to 1.35], p < 0.001) and myocardial infarction (HR: 1.87 [95% CI: 1.79 to 1.95], p < 0.001/HR: 1.29 [95% CI: 1.25 to 1.34], p < 0.001) compared with nondiabetic patients. The adjusted hazard of undergoing additional revascularization procedures (HR: 1.14 [95% CI: 1.10 to 1.18, p < 0.001/HR: 1.08 [95% CI: 1.05 to 1.10], p < 0.001) and subsequent hospitalization for bleeding (HR: 1.40 [95% CI: 1.31 to 1.50], p < 0.001/HR: 1.18 [95% CI: 1.13 to 1.24], p < 0.001) were also significantly increased. Compared with nondiabetic patients, there were similar excess risks associated with ITDM/NITDM in patients selected for DES and BMS use; selection for use of DES was associated with reductions in death in ITDM/NITDM and myocardial infarction in ITDM, but not NITDM. There were no significant interactions between diabetes status and stent type for revascularization or bleeding. Conclusions: One-third of older patients undergoing PCI have diabetes. After adjustment for other comorbidities, diabetes, particularly ITDM, remains independently and strongly associated with increased long-term adverse events after both DES and BMS implantation. [Copyright &y& Elsevier]

Objectives: This study sought to assess percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) stenosis in routine U.S. clinical practice. Background: Percutaneous coronary intervention for ULMCA stenosis is controversial; however, current use and outcomes of ULMCA PCI in routine U.S. clinical practice have not been described. Methods: We evaluated 5,627 patients undergoing ULMCA PCI at 693 centers within the National Cardiovascular Data Registry Catheterization Percutaneous Coronary Intervention Registry for temporal trends in PCI use (2004 to 2008), patient characteristics, and in-hospital mortality. Thirty-month mortality and composite major adverse events (death, myocardial infarction, and revascularization) with drug-eluting versus bare-metal stents were compared using inverse probability weighted (IPW) hazard ratios (HRs) in a nonrandomized Medicare-linked (age ≥65 years) patient cohort (n = 2,765). Results: ULMCA PCI was performed in 4.3% of patients with ULMCA stenosis. Unadjusted in-hospital mortality rates ranged from 2.9% for elective cases to 45.1% for emergent/salvage cases. By 30 months, 57.9% of the elderly ULMCA PCI population experienced death, myocardial infarction, or revascularization, and 42.7% died. Patients receiving drug-eluting stents (versus bare-metal stents) had a lower 30-month mortality (IPW HR: 0.84, 95% confidence interval [CI]: 0.73 to 0.96), but the composite of major adverse events were similar (IPW HR: 0.95, 95% CI: 0.84 to 1.06). Conclusions: In the United States, ULMCA PCI is performed in <5% of patients with ULMCA disease and is generally reserved for those at high procedural risk. Adverse events are common in elderly patients and are related to patient and procedural characteristics, including stent type. [ABSTRACT FROM AUTHOR]

Background: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear., Methods: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis., Results: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke ( P interaction <0.05 for both instrumental variable and propensity-weighted analyses)., Conclusions: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR., Competing Interests: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs, the US Government, or the National Institutes of Health. Dr Butala is supported by grants from the Boettcher Foundation and the American Heart Association and reports consulting fees from Shockwave Medical and Boston Scientific and consulting fees and ownership interest in HiLabs and Catch Bio, outside the current work. Dr Yeh is a Special Government Employee of the US Food and Drug Administration. He has institutional research grants with the US FDA, Boston Scientific, Abbott Vascular and Medtronic. He is a consultant for Abbott Vascular, Boston Scientific, Elixir Medical, InfraRedx, Medtronic, Shockwave Medical, and Zoll. Dr Messenger reports institutional grant support from Philips Medical Systems and Medtronic. Dr Cohen reports institutional research grants from Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, Zoll, IRhythm, Corvia, Philips, CathWorks, and Ancora. He is a consultant to Abbott, Boston Scientific, Edwards Lifesciences, and Heartbeam. Dr Vemulapalli reports grants/contracts from: American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and UG3), Cytokinetics, Abbott Vascular, Boston Scientific. Consulting/Advisory Board: Astra Zeneca, Medtronic, Boehringer Ingelheim, Veralox Therapeutics, Icon, HeartFlow, TotalCME.

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.

The role of continuous hemodynamic assessment with pulmonary artery (PA) catheter placement in cardiogenic shock (CS) remains debated. We aimed to assess the association between PA catheter placement and clinical outcomes in patients with CS secondary to ST-elevation myocardial infarction (STEMI) treated with an intravascular microaxial flow pump. We identified patients hospitalized with STEMI complicated by CS on mechanical circulatory support with an intravascular microaxial flow pump (Impella, Abiomed, Danvers, Massachusetts) using the National Inpatient Sample database and compared the outcomes in those treated with and without PA catheters. The primary outcome was in-hospital mortality. The secondary outcomes included in-hospital complications, hospital length of stay, inpatient costs, and temporal trends. The total cohort included 14,635 hospitalizations for STEMI complicated by CS treated with Impella between 2016 and 2020, of whom 5,505 (37.6%) received PA catheters. Over the study period, the use of PA catheters increased significantly from 25.9% to 41.8% (p trend <0.01). Similarly, the use of Impella increased from 9.9% to 18.9% (p trend <0.01). After adjustment for baseline characteristics using a multivariate logistic regression analysis, PA catheter use was associated with lower in-hospital mortality (adjusted odds ratio 0.80, 95% confidence interval 0.67 to 0.96, p = 0.01) and similar cardiovascular, neurologic, renal, and hematologic complications; length of stay; and inpatient costs compared with no PA catheter use. In conclusion, PA catheter use in patients with STEMI complicated by CS treated with Impella is associated with reduced in-hospital mortality and similar complication rates. Given the mortality benefit, further research is necessary to optimize PA catheter use in patients with STEMI with CS., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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.

Objectives: The aims of this study were to examine rates of radial artery access in post-coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach., Background: There are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI., Methods: Using the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access., Results: The rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG., Conclusions: The rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG., Competing Interests: Funding Support and Author Disclosures The American College of Cardiology National Cardiovascular Data Registry is an initiative of the American College of Cardiology Foundation. This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry. Dr. Rymer has received research grants from Boston Scientific and Abbott Pharmaceuticals. Dr. Swaminathan receives research support from ACIST Medical; and provides consulting services for Medtronic. Dr. Abbott has received grant support with no personal compensation from Sinomed, CSL Behring, AstraZeneca, Bristol Myers Squibb, and Abbott Vascular; and provides consulting services for Recor and Philips. Dr. Gilchrist provides consulting services for Cardinal Health and Terumo Medical Corporation. Dr. Panetta is the co-owner of the medical device company LP Medical. Dr. Brilakis provides consulting services for Abbott Vascular, the American Heart Association (associate editor, Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; receives research support from Regeneron and Siemens; and is a shareholder in MHI Ventures. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Among Medicare value-based payment programs for acute myocardial infarction (AMI), the Hospital Readmissions Reduction Program uses International Classification of Diseases, Tenth Revision ( ICD-10 ) codes to identify the program denominator, while the Bundled Payments for Care Improvement Advanced program uses diagnosis-related groups (DRGs). The extent to which these programs target similar patients, whether they target the intended population (type 1 myocardial infarction), and whether outcomes are comparable between cohorts is not known., Methods: In a retrospective study of 2176 patients hospitalized in an integrated health system, a cohort of patients assigned a principal ICD-10 diagnosis of AMI and a cohort of patients assigned an AMI DRG were compared according to patient-level agreement and outcomes such as mortality and readmission., Results: One thousand nine hundred thirty-five patients were included in the ICD-10 cohort compared with 662 patients in the DRG cohort. Only 421 patients were included in both AMI cohorts (19.3% agreement). DRG cohort patients were older (70 versus 65 years, P <0.001), more often female (48% versus 30%, P <0.001), and had higher rates of heart failure (52% versus 33%, P <0.001) and kidney disease (42% versus 25%, P <0.001). Comparing outcomes, the DRG cohort had significantly higher unadjusted rates of 30-day mortality (6.6% versus 2.5%, P <0.001), 1-year mortality (21% versus 8%, P <0.001), and 90-day readmission (26% versus 19%, P =0.006) than the ICD-10 cohort. Two observations help explain these differences: 61% of ICD-10 cohort patients were assigned procedural DRGs for revascularization instead of an AMI DRG, and type 1 myocardial infarction patients made up a smaller proportion of the DRG cohort (34%) than the ICD-10 cohort (78%)., Conclusions: The method used to identify denominators for value-based payment programs has important implications for the patient characteristics and outcomes of the populations. As national and local quality initiatives mature, an emphasis on ICD-10 codes to define AMI cohorts would better represent type 1 myocardial infarction patients.

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

The worldwide pandemic caused by the novel acute respiratory syndrome coronavirus 2 has resulted in a new and lethal disease termed coronavirus disease 2019 (COVID-19). Although there is an association between cardiovascular disease and COVID-19, the majority of patients who need cardiovascular care for the management of ischemic heart disease may not be infected with this novel coronavirus. The objective of this document is to provide recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic. There is a recognition of two major challenges in providing recommendations for AMI care in the COVID-19 era. Cardiovascular manifestations of COVID-19 are complex with patients presenting with AMI, myocarditis simulating an ST-elevation myocardial infarction (STEMI) presentation, stress cardiomyopathy, non-ischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury, and the prevalence of COVID-19 disease in the US population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on (a) varied clinical presentations; (b) appropriate personal protection equipment (PPE) for health care workers; (c) the roles of the emergency department, emergency medical system, and the cardiac catheterization laboratory (CCL); and (4) regional STEMI systems of care. During the COVID-19 pandemic, primary percutaneous coronary intervention (PCI) remains the standard of care for STEMI patients at PCI-capable hospitals when it can be provided in a timely manner, with an expert team outfitted with PPE in a dedicated CCL room. A fibrinolysis-based strategy may be entertained at non-PCI-capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option., (© 2020 Wiley Periodicals, Inc.)

Background: Procedural anticoagulation with bivalirudin (BIV), trans-radial intervention (TRI), and use of a vascular closure device (VCD) are thought to mitigate percutaneous coronary intervention (PCI)-related bleeding. We compared the impact of these bleeding avoidance strategies (BAS) for PCIs stratified by bleeding risk., Methods: We performed a retrospective cohort analysis of PCIs from 18 facilities within one health care system from 2009Q3 to 2017Q4. Bleeding risk was assessed per the National Cardiovascular Data Registry CathPCI bleeding model, with procedures stratified into 6 categories (first, second, third quartiles, 75th-90th, 90th-97.5th, and top 2.5th percentiles). Regression models were used to assess the impact of BAS on bleeding outcome., Results: Of 74 953 PCIs, 9.4% used no BAS, 12.0% used BIV alone, 20.8% used TRI alone, 26.8% used VCD alone, 5.4% used TRI+BIV, and 25.6% used VCD+BIV. The crude bleeding rate was 4.4% overall. Only 2 comparisons showed significant trends across all risk strata: VCD+BIV versus no BAS, odds ratio (95% CI) range: first quartile, 0.36 (0.18-0.72) to top 2.5th percentile, 0.50 (0.32-0.78); TRI versus no BAS, odds ratio (95% CI) range: first quartile, 0.15 (0.06-0.38) to top 2.5th percentile, 0.49 (0.28-0.86). TRI had lower odds of bleeding compared with BIV for all risk strata except the top 2.5th percentile. Addition of BIV to TRI did not change the odds of bleeding for any risk strata. Factors potentially limiting use of TRI (renal failure, shock, cardiac arrest, and mechanical circulatory support) were present in ≤10% of procedures below the 90th percentile., Conclusions: Among individual BAS, only TRI had consistently lower odds of bleeding across all risk strata. Factors potentially limiting TRI were found infrequently in procedures below the 90th percentile of bleeding risk. For transfemoral PCI, VCD+BIV had lower odds of bleeding compared with no BAS across all risk strata.

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.)

Importance: Physicians have been criticized for having an overly enthusiastic response to new device approvals, especially for novel technologies. However, to our knowledge, the rates of new product adoption and patterns of new device usage in clinical practice have not been well described., Objective: To characterize the patterns of uptake of bioresorbable vascular scaffolds (BVS) within the United States following device approval and to describe changes in response to subsequent releases of data and US Food and Drug Administration (FDA) warnings., Design, Setting, and Participants: This analysis of the uptake of BVS between January 2016 and June 2017 used CathPCI Registry data; all percutaneous coronary intervention (PCI) procedures with an implant of either a BVS or conventional stent were included. Data analysis was performed in October 2017., Exposures: Implant of BVS., Main Outcomes and Measures: The primary outcome was monthly use of BVS in the United States. In addition, the characteristics of patients who received BVS and of hospitals that used BVS were assessed and comparisons of patient characteristics between BVS recipients and patients who were treated contemporaneously with metallic stents were made., Results: Of 682 951 procedures, 471 064 (69.0%) were done in men, 587 301 (86.0%) were among white people, and the mean (SD) age of those undergoing procedures with BVS vs conventional stents was 62.6 (11.4) years vs 65.7 (11.9) years. Of these, 4265 procedures (0.6%) used BVS overall (after FDA approval of BVS). Procedures with implants of BVS occurred among patients with fewer comorbidities and lower-acuity presentations compared with procedures with implants of conventional stents. The patient characteristics for BVS use were not dissimilar to the inclusion criteria of the ABSORB III FDA approval trial, with notable differences based on trial eligibility (eg, excluding patients with myocardial infarctions). The maximum monthly use of BVS was 1.25% of all PCI procedures that occurred 90 days after FDA approval, but with site-to-site variability. Declines in use were observed coincident with the scientific presentation of adverse event data as well as FDA warnings., Conclusions and Relevance: Most US physicians and hospitals were selective in their use of BVS, primarily using them in patients similar to those in the device's FDA approval trial. In addition, declines in use were evident in the subsequent month following the release of data that reported negative outcomes. These results illustrate an example of an appropriate physician response to adverse data updates and FDA warnings.

Background Although recommended in the guidelines, the safety of chronic P2Y 12 inhibitor therapy in patients with chronic kidney disease ( CKD ) after an acute myocardial infarction ( MI ) is not well studied. Methods and Results The TRANSLATE -ACS (Treatment with ADP Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study included 11 108 MI patients treated with percutaneous coronary intervention and discharged alive on a P2Y 12 inhibitor from 233 US hospitals. We compared rates of GUSTO (Global Use of Strategies to Open Occluded Arteries) severe/moderate bleeding and premature discontinuation of P2Y 12 inhibitor by 1 year after MI among patients with varying CKD severity. The majority of MI patients treated with percutaneous coronary intervention had CKD : 42% had stage 2 (mild), 27% had stage 3 (moderate), and 4% had stage ≥4 (severe/end stage). Higher potency P2Y 12 inhibitors (prasugrel or ticagrelor) were prescribed at discharge in 39%, 35%, 23%, and 15% ( P<0.01) of patients with stages 1, 2, 3, and ≥4, respectively. One-year GUSTO severe/moderate bleeding rates were higher with each stage of CKD : 1% in patients with CKD stage 1 or no CKD , 2% with an adjusted hazard ratio of 1.61 (95% CI, 1.05-2.35) for CKD stage 2, 4% with an adjusted hazard ratio of 1.92 (95% CI, 1.21-3.02) for CKD stage 3, and 10% with an adjusted hazard ratio of 2.44 (95% CI, 1.40-4.23) for patients with CKD stage ≥4. By 1 year after MI , 16% of patients overall had prematurely discontinued P2Y 12 inhibitor therapy; however, this rate was not largely affected by CKD stage. Premature P2Y 12 inhibitor-discontinuation rates were higher for patients discharged on higher potency P2Y 12 inhibitors in patients with CKD stage ≥2 ( P<0.01). Conclusions CKD severity was associated with a higher bleeding risk among those with acute MI treated with a P2Y 12 inhibitor. Patients with more advanced CKD were not significantly more likely than those with less advance CKD to prematurely discontinue P2Y 12 inhibitor therapy.

Background: SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminated early for lower than expected event rates. Whether this was because of patient selection or better access site practice among trial patients is unknown., Methods and Results: SAFE-PCI was conducted within the National Cardiovascular Data Registry CathPCI registry. Using the National Cardiovascular Research Infrastructure Identification, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible female CathPCI registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment. Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups. Enrolled SAFE-PCI patients and registry patients from the 3 time periods were linked to Centers for Medicare and Medicaid Services data to compare 30-day death and unplanned revascularization rates. At 54 SAFE-PCI sites, there were 496 SAFE-PCI trial patients with a PCI visit within the CathPCI registry. There were 24 958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15 904 trial-eligible registry patients during trial enrollment. Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients. Among 12 212 Centers for Medicare and Medicaid Services-linked patients, there were no significant differences in 30-day death and unplanned revascularization among the 4 groups., Conclusions: Lower predicted risk of bleeding and mortality among SAFE-PCI trial patients compared with registry patients suggests that lower-risk patients were selectively enrolled for the trial. These data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01406236.

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.

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

Background: We explored the risks/benefits of revascularization versus medical management in syncope patients with obstructive coronary artery disease (CAD)., Methods: We retrospectively examined Medicare patients ≥65 years undergoing percutaneous coronary intervention (PCI) for syncope at 539 CathPCI Registry hospitals with ≥70% stenosis in at least 1 coronary artery, excluding those with ST-segment elevation myocardial infarction (MI), cardiogenic shock, left main disease, and coronary artery bypass grafting. In a propensity-matched population, we compared short-term (90-day) all-cause readmission risk and long-term (3-year) risks of readmission for syncope and MI, as well as mortality in those receiving PCI versus medical management., Results: Among 14,674 syncope patients, 9,549 (65%) had at least 1-vessel obstructive CAD. After exclusions, 3,196 of 7,338 patients (44%) underwent PCI. In the propensity-matched cohort, there was no significant difference in 90-day all-cause readmission risk (28.2% vs 30.3%, adjusted hazard ratio [HR] 0.92, 95% CI 0.83-1.02) or long-term risks of readmission for syncope (7.0% vs 6.1%, adjusted HR 1.06, 95% CI 0.83-1.35). PCI-treated patients had significantly higher risk of readmission for MI (5.6% vs 4.0%, adjusted HR 1.56, 95% CI 1.18-2.06) but lower risk of long-term mortality (27.0% vs 30.3%, adjusted HR 0.86, 95% CI 0.77-0.97) than medically managed patients., Conclusions: In patients presenting with syncope and obstructive CAD, PCI was not associated with significant improvements in the risk of readmission but was associated with lower long-term mortality compared with medical therapy, suggesting the need to more definitively assess the benefit of PCI among elderly syncope patients., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to explore whether the use of bleeding avoidance strategies (BAS) explains variability in hospital-level bleeding following percutaneous coronary intervention., Background: Prior studies have reported that bleeding rates following percutaneous coronary intervention vary markedly among hospitals, but the extent to which use of BAS explains this variation is unknown., Methods: Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, estimated hospital-level bleeding rates from 2,459,686 procedures at 1,358 sites were determined. A series of models were fit to estimate random-effect variance, adjusting for patient risk (using the validated CathPCI bleeding risk model, C statistic = 0.77) and various combinations of BAS (transradial access, bivalirudin, vascular closure device use). The rate of any BAS use was also estimated for each hospital, and the association between percentage BAS use and predicted bleeding rates was determined., Results: In total, 125,361 bleeding events (5.1%) were observed; patients experiencing bleeding events had lower rates of radial access (5.0% vs. 11.2%; p < 0.001), bivalirudin therapy (43.8% vs. 59.4%), and vascular closure device use (32.9% vs. 42.4%, p < 0.001) than those without bleeding. There was significant variation in bleeding rates across hospitals (median 5.0%; interquartile range [IQR]: 2.7% to 6.6%), which persisted after incorporating patient-level risk (median 5.1%; IQR: 4.0% to 4.4%). Patient factors accounted for 20% of the overall hospital-level variation, and radial access plus bivalirudin use accounted for an additional 7.8% of the overall hospital-level variation. The median hospital rate of any BAS use was 86.6% (IQR: 72.5% to 94.1%). A significant decrease in observed hospital-level bleeding was seen in hospitals above the median in BAS use (adjusted odds ratio: 0.90; 95% confidence interval: 0.88 to 0.93)., Conclusions: A modest proportion of the variation in hospitals' rates of bleeding following percutaneous coronary intervention is attributable to differential use of BAS. Further analyses are required to determine the remaining approximately 70% causes of variation in percutaneous coronary intervention bleeding seen among hospitals., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated., Methods and Results: Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, we assessed temporal trends in risk profiles and rates of hospital admission among 999 279 patients undergoing PCI qualifying for outpatient reimbursement. We estimated mortality and bleeding risk using validated models from the registry. From 2009 to 2014, the proportion of outpatients not admitted to a hospital after PCI increased from 32.8% to 66.3% (P<0.001). Patients who were admitted after PCI were older, had greater comorbidities, and experienced more post-PCI complications (all P<0.001). Among those not admitted, the proportion of patients at high risk for predicted mortality increased significantly from 17.0% to 19.8% during the study period (P<0.001). In contrast, 16.7% of patients admitted after PCI were at low risk for mortality., Conclusions: Among patients undergoing PCI procedures that qualify for outpatient reimbursement, there has been a temporal decrease in postprocedure hospital admission. Concomitantly, the proportion of these outpatients at high risk for mortality has significantly increased over time. These data suggest that current reimbursement classification could be improved by incorporating patient risk to appropriately match the necessary resources to the needed level of care., (© 2016 American Heart Association, Inc.)

Background: Older adults presenting with acute myocardial infarction (MI) often have multivessel coronary artery disease amenable to percutaneous coronary intervention (PCI), yet the risks of multivessel intervention may outweigh potential benefits in these patients. We sought to determine if nonculprit intervention during the index PCI is associated with better outcomes among older patients with acute MI and multivessel disease., Methods: We examined 19,271 ST-segment elevation MI (STEMI) and 31,361 non-STEMI (NSTEMI) patients 65years or older with multivessel disease in a linked CathPCI Registry-Medicare database, excluding patients with prior coronary artery bypass grafting, left main disease, or cardiogenic shock. Using inverse probability-weighted propensity adjustment, we compared mortality between patients receiving culprit-only vs multivessel intervention during the index PCI procedure., Results: Most older MI patients (91% STEMI and 74% NSTEMI) received culprit-only intervention during the index PCI. Among STEMI patients, multivessel intervention during the index PCI was associated with higher 30-day mortality (8.3% vs 6.3%, adjusted hazard ratio [HR] 1.36, 95% CI 1.14-1.62) than culprit-only intervention, and this trend persisted at 1year (13.8% vs 12.2%, adjusted HR 1.14, 95% CI 0.99-1.31). No significant mortality differences were observed among NSTEMI patients at 30days (3.4% vs 4.1%, adjusted HR 1.01, 95% CI 0.88-1.15) or at 1year (10.1% vs 10.8%, adjusted HR 0.99, 95% CI 0.91-1.08)., Conclusions: Nonculprit intervention during the index PCI was associated with worse outcomes among STEMI patients, but not NSTEMI patients., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Cardiac allograft vasculopathy is a major cause of morbidity and mortality following heart transplantation. Large multicenter studies evaluating the clinical characteristics and inhospital outcomes of heart transplant recipients undergoing percutaneous coronary intervention (PCI) are lacking., Objective: To evaluate the clinical characteristics, treatment patterns and inhospital outcomes of heart transplant recipients undergoing PCI compared to general population., Methods: We analyzed 1,897,328 patients from the National Cardiovascular Data Registry CathPCI registry who underwent PCI of at least 1 native vessel between July 2009 and December 2013 from 1,477 centers, of which 542 patients (0.03%) were heart transplant recipients. Clinical characteristics were evaluated and, after 1:4 propensity matching, inhospital outcomes were compared between 538 heart transplant patients and 2,128 non-transplant patients., Results: Transplant recipients undergoing PCI had a higher prevalence of diabetes, dyslipidemia and peripheral vascular disease; lower prevalence of angina, acute coronary syndrome, abnormal noninvasive functional study, and type C coronary lesions compared to the non-transplant PCI population. After propensity matching, all-cause inhospital mortality was similar between transplant and non-transplant groups (1.3% vs 1.0%; OR, 1.21; 95% CI, 0.54-2.67)., Conclusion: This is the largest series to date outlining the characteristics of heart transplant recipients undergoing PCI. Similar inhospital outcomes were noted in heart transplant recipients compared to the general population. Further studies evaluating long-term outcomes are warranted., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Although platelet function and pharmacogenomic testing have been studied in clinical trials, their adoption into contemporary practice is unknown., Methods: We studied patterns of platelet function and pharmacogenomic testing among 10,048 patients with acute myocardial infarction treated with percutaneous coronary intervention at 226 US hospitals in the TRANSLATE-ACS observational study between April 2010 and October 2012, excluding those receiving research protocol-mandated testing. Inverse probability-weighted propensity adjustment was used to compare 1-year bleeding and major adverse cardiac event risks between patients with and without testing., Results: Overall, 337 (3.4%) patients underwent predischarge platelet function testing, whereas 85 (0.9%) underwent pharmacogenomic testing; 82% and 93% of hospitals never performed any platelet function or pharmacogenomic testing, respectively. Patients undergoing testing were more likely to be on an adenosine diphosphate receptor inhibitor preadmission or to have percutaneous coronary intervention of a previously treated lesion. Tested patients were more likely than nontested patients to be switched from clopidogrel to prasugrel/ticagrelor (25.7% vs 9.7%, P < .001) and were more likely to be on prasugrel/ticagrelor 6 months postdischarge (33.8% vs 25.1%, P < .001). No significant differences in 1-year bleeding and major adverse cardiac event risks were observed between tested and nontested patients (adjusted hazard ratios 1.06 [95% CI 0.68-1.65] and 1.21 [95% CI 0.94-1.54], respectively)., Conclusions: Platelet function and pharmacogenomic testing are rarely performed in contemporary myocardial infarction patients in the United States. When tested, patients were more likely to be treated with higher-potency adenosine diphosphate receptor inhibitors, yet no significant differences in longitudinal outcomes were observed., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Recent reductions in average door-to-balloon (D2B) times have not been associated with decreases in mortality at the population level. We investigated this seemingly paradoxical finding by assessing components of this association at the individual and population levels simultaneously. We postulated that the changing population of patients undergoing primary percutaneous coronary intervention (pPCI) contributed to secular trends toward an increasing mortality risk, despite consistently decreased mortality in individual patients with shorter D2B times., Methods: This was a retrospective study of ST-elevation myocardial infarction (STEMI) patients who underwent pPCI between Jan 1, 2005, and Dec 31, 2011, in the National Cardiovascular Data Registry (NCDR) CathPCI Registry. We looked for catheterisation laboratory visits associated with STEMI. We excluded patients not undergoing pPCI, transfer patients for pPCI, patients with D2B times less than 15 min or more than 3 h, and patients at hospitals that did not consistently report data across the study period. We assessed in-hospital mortality in the entire cohort and 6-month mortality in elderly patients aged 65 years or older matched to data from the Centers for Medicare and Medicaid Services. We built multilevel models to assess the relation between D2B time and in-hospital and 6-month mortality, including both individual and population-level components of this association after adjusting for patient and procedural factors., Findings: 423 hospitals reported data on 150,116 procedures with a 55% increase in the number of patients undergoing pPCI at these facilities over time, as well as many changes in patient and procedural factors. Annual D2B times decreased significantly from a median of 86 min (IQR 65-109) in 2005 to 63 min (IQR 47-80) in 2011 (p<0·0001) with a concurrent rise in risk-adjusted in-hospital mortality (from 4·7% to 5·3%; p=0·06) and risk-adjusted 6-month mortality (from 12·9% to 14·4%; p=0·001). In multilevel models, shorter patient-specific D2B times were consistently associated at the individual level with lower in-hospital mortality (adjusted OR for each 10 min decrease 0·92; 95% CI 0·91-0·93; p<0·0001) and 6-month mortality (adjusted OR for each 10 min decrease, 0·94; 95% CI 0·93-0·95; p<0·0001). By contrast, risk-adjusted in-hospital and 6-month mortality at the population level, independent of patient-specific D2B times, rose in the growing and changing population of patients undergoing pPCI during the study period., Interpretation: Shorter patient-specific D2B times were consistently associated with lower mortality over time, whereas secular trends suggest increased mortality risk in the growing and changing pPCI population. The absence of association of annual D2B time and changes in mortality at the population level should not be interpreted as an indication of its individual-level relation in patients with STEMI undergoing primary PCI., Funding: National Heart, Lung, and Blood Institute., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Information is limited on contemporary use and outcomes of embolic protection devices (EPDs) in saphenous vein graft interventions., Methods and Results: We formed a longitudinal cohort (2005-2009; n=49 325) by linking National Cardiovascular Data Registry CathPCI Registry to Medicare claims to examine the association between EPD use and both procedural and long-term outcomes among seniors (65+ years), adjusting for clinical factors using propensity and instrumental variable methodologies. Prespecified high-risk subgroups included acute coronary syndrome and de novo or graft body lesions. EPDs were used in 21.2% of saphenous vein grafts (median age, 75; 23% women) and were more common in acute coronary syndrome (versus non-acute coronary syndrome; 22% versus 19%), de novo (versus restenotic; 22% versus 14%), and graft body lesions (versus aortic and distal anastomosis; 24% versus 20% versus 8%, respectively). EPDs were associated with a slightly higher incidence of procedural complications, including no reflow (3.9% versus 2.8%; P<0.001), vessel dissection (1.3% versus 1.1%; P=0.05), perforation (0.7% versus 0.4%; P=0.001), and periprocedural myocardial infarction (2.8% versus 1.8%; P<0.001). By 3 years, death, myocardial infarction, and repeat revascularization occurred in 25%, 15%, and 30% of cases, respectively. EPD use was associated with a similar adjusted risk of death (propensity score-matched hazard ratio, 0.96; 95% confidence interval, 0.91-1.02), myocardial infarction (propensity score-matched hazard ratio, 1.00; 95% confidence interval, 0.93-1.09), and repeat revascularization (propensity score-matched hazard ratio, 1.02; 95% confidence interval, 0.96-1.08) in the overall cohort and high-risk subgroups., Conclusions: In this contemporary cohort, EPDs were used more commonly among patients with high-risk clinical indications, yet there was no evidence of improved acute- or long-term outcomes. Further prospective studies are needed to support routine EPD use., (© 2015 American Heart Association, Inc.)

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 determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial., Background: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear., Methods: Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population., Results: The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access., Conclusions: In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies., Background: Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI)., Methods: We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims., Results: Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS., Conclusions: There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR., (Copyright © 2013 Wiley Periodicals, Inc.)

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.)

Background: Guidelines recommend consideration of cardiac biomarker measurement after elective percutaneous coronary intervention (PCI), especially with complex cases or complicated procedures. However, the long-term prognostic implications of biomarker measurement after elective PCI have not been well characterized in older patients., Methods: We examined 157,825 Medicare patients undergoing elective PCI in the United States from 2004 to 2008 at 711 hospitals in the CathPCI Registry. Clinical characteristics and 1-year mortality risk were studied, stratified by creatine kinase-muscle band measurement., Results: Overall, 26% of patients on elective PCI had postprocedure biomarkers measured. These patients had more complex coronary anatomy and procedures but had similar rates of PCI success and inhospital mortality when compared with patients without biomarker measurement. The treating hospital was a significant factor associated with the likelihood of postprocedure biomarker surveillance. Hospitals that measured creatine kinase-muscle band in ≥ 90% of patients on elective PCI had lower associated 1-year mortality rates (adjusted hazard ratio 0.84, 95% CI 0.75-0.94) compared with hospitals that measured in < 10% of patients., Conclusions: Among older patients undergoing elective PCI, postprocedure cardiac biomarker measurement occurred infrequently and was concentrated at certain hospitals. Hospitals that routinely measured post-PCI biomarkers were associated with lower long-term mortality compared with hospitals without routine measurement., (© 2013.)

Background: Current guidelines for the treatment of ST-segment elevation myocardial infarction recommend a door-to-balloon time of 90 minutes or less for patients undergoing primary percutaneous coronary intervention (PCI). Door-to-balloon time has become a performance measure and is the focus of regional and national quality-improvement initiatives. However, it is not known whether national improvements in door-to-balloon times have been accompanied by a decline in mortality., Methods: We analyzed annual trends in door-to-balloon times and in-hospital mortality using data from 96,738 admissions for patients undergoing primary PCI for ST-segment elevation myocardial infarction from July 2005 through June 2009 at 515 hospitals participating in the CathPCI Registry. In a subgroup analysis using a linked Medicare data set, we assessed 30-day mortality., Results: Median door-to-balloon times declined significantly, from 83 minutes in the 12 months from July 2005 through June 2006 to 67 minutes in the 12 months from July 2008 through June 2009 (P<0.001). Similarly, the percentage of patients for whom the door-to-balloon time was 90 minutes or less increased from 59.7% in the first year to 83.1% in the last year (P<0.001). Despite improvements in door-to-balloon times, there was no significant overall change in unadjusted in-hospital mortality (4.8% in 2005-2006 and 4.7% in 2008-2009, P=0.43 for trend) or in risk-adjusted in-hospital mortality (5.0% in 2005-2006 and 4.7% in 2008-2009, P=0.34), nor was a significant difference observed in unadjusted 30-day mortality (P=0.64)., Conclusions: Although national door-to-balloon times have improved significantly for patients undergoing primary PCI for ST-segment elevation myocardial infarction, in-hospital mortality has remained virtually unchanged. These data suggest that additional strategies are needed to reduce in-hospital mortality in this population. (Funded by the National Cardiovascular Data Registry of the American College of Cardiology Foundation.).

Background: Black, Hispanic, and Asian patients have been underrepresented in percutaneous coronary intervention clinical trials; therefore, there are limited data available on outcomes for these race/ethnicity groups., Methods and Results: We examined outcomes in 423 965 patients in the National Cardiovascular Data Registry CathPCI Registry database linked to Medicare claims for follow-up. Within each race/ethnicity group, we examined trends in drug-eluting stent (DES) use, 30-month outcomes, and relative outcomes of DES versus bare metal stents. Overall, 390 351 white, 20 191 black, 9342 Hispanic, and 4171 Asian patients > 65 years of age underwent stent implantation from 2004 through 2008 at 940 National Cardiovascular Data Registry participating sites. Trends in adoption of DES were similar across all groups. Relative to whites, black and Hispanic patients undergoing percutaneous coronary intervention had higher long-term risks of death and myocardial infarction (blacks: hazard ratio, 1.28; 95% confidence interval, 1.24-1.32; Hispanics: hazard ratio, 1.15; 95% confidence interval, 1.10-1.21). Long-term outcomes were similar in Asians and whites (hazard ratio, 0.99; 95% confidence interval, 0.92-1.08). Use of DES was associated with better 30-month survival and lower myocardial infarction rates compared with the use of bare metal stents among all race/ethnicity groups except Hispanics, who had similar outcomes with DES or bare metal stents., Conclusions: Black and Hispanic patients undergoing percutaneous coronary intervention had worse long-term outcomes relative to white and Asian patients. Compared with bare metal stent use, DES use was generally associated with superior long-term outcomes in all racial and ethnic groups, although these differences were not statistically significant in Hispanic patients.