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Background: Measurement of hospital quality has traditionally focused on processes of care and postprocedure outcomes. Appropriateness measures for percutaneous coronary intervention (PCI) assess quality as it relates to patient selection and the decision to perform PCI. The association between patient selection for PCI and processes of care and postprocedural outcomes is unknown.Methods and Results: We included 203 531 patients undergoing nonacute (elective) PCI from 779 hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry between July 2009 and April 2011. We examined the association between a hospital's proportion of nonacute PCIs categorized as inappropriate by the 2009 Appropriate Use Criteria (AUC) for Coronary Revascularization and in-hospital mortality, bleeding complications, and use of optimal guideline-directed medical therapy at discharge (ie, aspirin, thienopyridines, and statins). When categorized as hospital tertiles, the range of inappropriate PCI was 0.0% to 8.1% in the lowest tertile, 8.1% to 15.2% in the middle tertile, and 15.2% to 58.6% in the highest tertile. Compared with lowest-tertile hospitals, mortality was not significantly different at middle-tertile (adjusted odds ratio [OR], 0.93; 95% confidence interval [CI], 0.73-1.19) or highest-tertile hospitals (OR, 1.12; 95% CI, 0.88-1.43; P=0.35 for differences between tertiles). Similarly, risk-adjusted bleeding did not vary significantly (middle-tertile OR, 1.13; 95% CI, 1.02-1.16; highest-tertile OR, 1.02; 95% CI, 0.91-1.16; P=0.07 for differences between tertiles) nor did use of optimal medical therapy at discharge (85.3% versus 85.7% versus 85.2%; P=0.58).Conclusions: In a national cohort of nonacute PCIs, a hospital's proportion of inappropriate PCIs was not associated with in-hospital mortality, bleeding, or medical therapy at discharge. This suggests PCI appropriateness measures aspects of hospital PCI quality that are independent of how well the procedure is performed. Therefore, PCI appropriateness and postprocedural outcomes are both important metrics to inform PCI quality. [ABSTRACT FROM AUTHOR]

Background: Bystander cardiopulmonary resuscitation (CPR) is associated with higher survival for out-of-hospital cardiac arrest, but whether its association with survival differs by patients' sex and race and ethnicity is less clear., Methods: Within a large US registry, we identified 623 342 nontraumatic out-of-hospital cardiac arrests during 2013 to 2022 for this observational cohort study. Using hierarchical logistic regression, we examined whether there was a differential association between bystander CPR and survival outcomes by patients' sex and race and ethnicity, overall and by neighborhood strata., Results: Mean age was 62.1±17.1 years, and 35.9% were women. Nearly half of patients (49.8%) were non-Hispanic White; 20.6% were non-Hispanic Black; 7.3% were Hispanic; 2.9% were Asian; and 0.4% were Native American. Overall, 58 098 (9.3%) survived to hospital discharge. Although bystander CPR was associated with higher survival in each race and ethnicity group, the association of bystander CPR compared with patients without bystander CPR in each racial and ethnic group was highest in individuals who were White (adjusted odds ratio [OR], 1.33 [95% CI, 1.30-1.37]) and Native American (adjusted OR, 1.40 [95% CI, 1.02-1.90]) and lowest in individuals who were Black (adjusted OR, 1.09 [95% CI, 1.04-1.14]; P interaction <0.001). The adjusted OR for bystander CPR compared with those without bystander CPR for Hispanic patients was 1.29 (95% CI, 1.20-1.139), for Asian patients, it was 1.27 (95% CI, 1.12-1.42), and for those of unknown race, it was 1.31 (95% CI, 1.25-1.36). Similarly, bystander CPR was associated with higher survival in both sexes, but its association with survival was higher in men (adjusted OR, 1.35 [95% CI, 1.31-1.38]) than women (adjusted OR, 1.15 [95% CI, 1.12-1.19]; P interaction <0.001). The weaker association of bystander CPR in Black individuals and women was consistent across neighborhood race and ethnicity and income strata. Similar results were observed for the outcome of survival without severe neurological deficits., Conclusions: Although bystander CPR was associated with higher survival in all patients, its association with survival was weakest for Black individuals and women with out-of-hospital cardiac arrest., Competing Interests: None.

Background: Prompt initiation of bystander cardiopulmonary resuscitation (CPR) is critical to survival for out-of-hospital cardiac arrest (OHCA). However, the association between delays in bystander CPR and OHCA survival is poorly understood., Methods: In this observational study using a nationally representative US registry, we identified patients who received bystander CPR from a layperson for a witnessed OHCA from 2013 to 2021. Hierarchical logistic regression was used to estimate the association between time to CPR (<1 minute versus 2-3, 4-5, 6-7, 8-9, and ≥10-minute intervals) and survival to hospital discharge and favorable neurological survival (survival to discharge with cerebral performance category of 1 or 2 [ie, without severe neurological disability])., Results: Of 78 048 patients with a witnessed OHCA treated with bystander CPR, the mean age was 63.5±15.7 years and 25, 197 (32.3%) were women. The median time to bystander CPR was 2 (1-5) minutes, with 10% of patients having a≥10-minute delay before initiation of CPR. Overall, 15 000 (19.2%) patients survived to hospital discharge and 13 159 (16.9%) had favorable neurological survival. There was a graded inverse relationship between time to bystander CPR and survival to hospital discharge ( P for trend <0.001). Compared with patients who received CPR within 1 minute, those with a time to CPR of 2 to 3 minutes were 9% less likely to survive to discharge (adjusted odds ratio, 0.91 [95% CI, 0.87-0.95]) and those with a time to CPR 4 to 5 minutes were 27% less likely to survive (adjusted odds ratio, 0.73 [95% CI, 0.68-0.77]). A similar graded inverse relationship was found between time to bystander CPR and favorable neurological survival ( P for trend <0.001)., Conclusions: Among patients with witnessed OHCA, there was a dose-response relationship between delays in bystander initiation of CPR and lower survival rates., Competing Interests: Disclosures Dr Chan receives funding from the American Heart Association and is a consultant for Optum Rx. Dr McNally is the Executive Director of the CARES, which receives funding from the American Heart Association and American Red Cross. Dr Spertus reports providing consultative services on patient-reported outcomes and evidence valuation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare. He holds research grants from Bristol Meyers Squibb, Abbott Vascular and Janssen. He owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. The other authors report no conflicts.

Objectives: To determine whether multisite versus single-site dual-lumen (SSDL) cannulation is associated with outcomes for COVID-19 patients requiring venovenous extracorporeal membrane oxygenation (VV-ECMO)., Design: Retrospective analysis of the Extracorporeal Life Support Organization Registry. Propensity score matching (2:1 multisite vs SSDL) was used to control for confounders., Patients: The matched cohort included 2,628 patients (1,752 multisite, 876 SSDL) from 170 centers. The mean ( sd ) age in the entire cohort was 48 (11) years, and 3,909 (71%) were male. Patients were supported with mechanical ventilation for a median (interquartile range) of 79 (113) hours before VV-ECMO support., Interventions: None., Measurements: The primary outcome was 90-day survival. Secondary outcomes included survival to hospital discharge, duration of ECMO support, days free of ECMO support at 90 days, and complication rates., Main Results: There was no difference in 90-day survival (49.4 vs 48.9%, p = 0.66), survival to hospital discharge (49.8 vs 48.2%, p = 0.44), duration of ECMO support (17.9 vs 17.1 d, p = 0.82), or hospital length of stay after cannulation (28 vs 27.4 d, p = 0.37) between multisite and SSDL groups. More SSDL patients were extubated within 24 hours (4% vs 1.9%, p = 0.001). Multisite patients had higher ECMO flows at 24 hours (4.5 vs 4.1 L/min, p < 0.001) and more ECMO-free days at 90 days (3.1 vs 2.0 d, p = 0.02). SSDL patients had higher rates of pneumothorax (13.9% vs 11%, p = 0.03). Cannula site bleeding (6.4% vs 4.7%, p = 0.03), oxygenator failure (16.7 vs 13.4%, p = 0.03), and circuit clots (5.5% vs 3.4%, p = 0.02) were more frequent in multisite patients., Conclusions: In this retrospective study of COVID-19 patients requiring VV-ECMO, 90-day survival did not differ between patients treated with a multisite versus SSDL cannulation strategy and there were only modest differences in major complication rates. These findings do not support the superiority of either cannulation strategy in this setting., Competing Interests: Dr. O’Gara received funding from Sedana Medical. Dr. Shaefi’s institution received funding from the National Institutes for Health (NIH); they received support for article research from the NIH. Dr. Seethala received funding from BD consulting, LivaNova, and Fresenius Medical Care; he disclosed that he is Chair of the Executive Committee for ECMONet and President-elect from Extracorporeal Life Support Organization. Dr. Faugno received funding from Moderna. Drs. Brodie and Garan received funding from Abiomed. Dr. Brodie received funding from Xenios, Medtronic, Cellenkos, Inspira, and LivaNova. Dr. Garan received funding from NuPulseCV; his institution received funding from Verantos; he received support for article research from Abbott. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Background: Covered stent (CS) use for the transcatheter treatment of coarctation of the aorta (COA) was first described over 20 years ago. The covered Cheatham-platinum stent received Food and Drug Administration approval for COA treatment in 2016. Data collected as part of the National Cardiovascular Data Registry IMPACT registry were evaluated for contemporary usage patterns of CS for the treatment of COA from 2016 to 2021., Methods: Version 2 of the IMPACT registry was queried for all patients who underwent stent placement for treatment of COA from 2016 to 2021. Trends in CS use were evaluated by year and age of patient at the time of implant. Analysis was limited to clinical factors collected as part of the registry and was performed to identify factors associated with CS use., Results: Data were available for 1989 case entries. Most patients (92%) received a single stent. The overall percentage of CS use in the cohort was 23% and remained consistent throughout the study period. The probability of CS use was significantly associated with increasing patient age at implant. Additional factors associated with CS use included smaller initial COA diameter, native COA, and the presence of a pseudoaneurysm. Procedural adverse event rates were low., Conclusions: CS use to treat COA was more common in adult patients and remained stable over the study period. Factors associated with CS use, including smaller COA diameter and aortic pseudoaneurysm, demonstrate the perceived value of CS as a tool to reduce the risk of aortic wall injury during treatment of COA., Competing Interests: Disclosures None.

Objective: With antiretroviral therapy, people with HIV (PWH) are developing age-related diseases, including peripheral arterial disease (PAD). This study examined frequency and outcomes of peripheral vascular intervention (PVI) and primary amputation in PWH., Design: We used the National Inpatient Sample (NIS) database to examine demographics, comorbidities, and temporal trends among PVI and primary amputation admissions by HIV status from 2012 to 2018., Methods: Inverse probability of treatment weighting was used to calculate adjusted odds of in-hospital death and amputation. Cost of hospitalization and length of stay were compared by HIV status and revascularization approach., Results: Of the 347 824 hospitalizations for PVI/amputation, 0.6% were PWH, which was stable over time. PWH had more renal and hepatic disease, whereas uninfected individuals had more traditional PAD risk factors. 55.2% of HIV+ admissions were endovascular compared with 49.3% in HIV- admissions, and 28.9% of the HIV+ admissions were elective compared with 42.1% among HIV-. HIV status did not impact amputation following PVI. In-hospital death was similar between groups following PVI or primary amputation. PWH had lower costs of hospitalization and a trend towards shorter hospital stays., Conclusion: Although PWH are developing more age-related chronic illnesses, the number of PAD-associated procedures has remained flat. Despite being younger with fewer traditional PAD risk factors, PWH had higher rates of unplanned PVI admissions and endovascular revascularization but similar in-hospital outcomes. These findings suggest PWH have different risk factors for PAD and are likely underdiagnosed and undertreated, whereas those who are treated have similar outcomes to the general population., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Coronary artery calcium score (CACS) is an anatomic measure of calcified atherosclerosis. Myocardial perfusion defects and reduced myocardial blood flow reserve (MBFR) are physiological measures of ischemia and coronary circulatory health. We aimed to assess the relative prognostic importance of MBFR, perfusion defects, and CACS in patients with suspected coronary artery disease., Methods: A total of 5983 consecutive patients without known history of coronary artery disease or cardiomyopathy, who underwent a CACS and 82 Rb positron emission tomography myocardial perfusion imaging between 2010 and 2016, were followed for all-cause death (n=785) over median of 3 years. Prognostic value was assessed using multivariable Cox regression models, and incremental risk discrimination for imaging variables was evaluated by comparing model c-indices after adjusting for clinical risk factors (RF)., Results: Mean age was 67.1 years, 60% were female, and 83% were symptomatic. CACS was 0 in 22%, abnormal perfusion in 19%, and MBFR <2 in 53.3%. When added to RF, the model with MBFR had the best fit (c=0.78, P <0.0001). Addition of CACS to model with RF and perfusion (c=0.77) offered modest improvement in discrimination over the model with RF and perfusion (c=0.76, P =0.02). Adding CACS to a model with RF, perfusion, and MBFR did not provide incremental prognostic value (c=0.785 for both, P =0.16). CACS and MBFR both had independent prognostic value in patients with normal and abnormal myocardial perfusion imaging. Even among patients with CACS of 0, MBFR <2 was present in 37.8%, being associated with higher risk of death (hazard ratio per 0.1↓, 1.10 [1.04-1.15]; P <0.001), but perfusion defects were not., Conclusions: Use of anatomic testing such as CACS of 0 to avoid myocardial perfusion imaging in symptomatic patients could lead to missing microvascular dysfunction in 4 out of 10 patients, a finding associated with a high mortality risk. Higher CACS was independently associated with the risk of death but did not provide incremental prognostic value over positron emission tomography with MBFR.

Background: Myocardial perfusion imaging (MPI) identifies abnormalities that occur early in the ischemic cascade leading to angina. Our aim was to study the association between ischemic measures on positron emission tomography MPI and patients' health status; their symptoms, function, and quality of life., Methods: Health status was collected using the Seattle Angina Questionnaire (SAQ-7, 0-100, higher=better) and Rose Dyspnea Score (RDS) on 1515 outpatients with known or suspected coronary artery disease presenting for clinically indicated pharmacological 82 Rb positron emission tomography MPI from July 2018 to July 2019. Adjusted multivariable ordinal regression models were used to assess the association between MPI findings of ischemia and the SAQ physical limitation, angina frequency, quality of life, summary score, and the RDS., Results: The mean SAQ and RDS scores of the cohort (mean age 71.7 years, 55% male, 37.6% prior myocardial infarction or revascularization) were 73.8±28.6 (physical limitation), 87.4±21.7 (angina frequency), 79.0±26.1 (quality of life), 81.3±19.0 (summary score), and 2±2 (RDS). No perfusion, flow or function abnormalities were significantly associated with SAQ angina frequency scores. Low left ventricular ejection fraction reserve (≤0%), low global and regional myocardial blood flow reserve (<2) were independently associated with worse SAQ Physical Limitation score, SAQ summary score, and RDS (30% to 57% greater odds; all P ≤0.01), but reversible perfusion defects were not., Conclusions: Impaired augmentation of left ventricular ejection fraction and myocardial blood flow with stress is associated with significant angina-associated functional limitation, health status, and dyspnea in patients who underwent positron emission tomography MPI, but not the frequency of their angina. Future studies should evaluate whether therapies that improve stress-induced abnormalities in systolic function and myocardial flow may improve patients' health status.

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Background: Contemporary, nationally representative 30-day readmissions data after carotid artery stenting (CAS) and carotid endarterectomy (CEA) are lacking., Methods: Patients undergoing CAS or CEA were identified from the 2013 to 2014 Nationwide Readmissions Databases. Propensity matching was used to balance baseline clinical characteristics. Thirty-day nonelective readmission rates, length of stay, and causes of readmission were compared., Results: Overall, 85 337 (national estimate of 194 332) patients were identified before propensity score matching, 11 490 (13.4%) of whom underwent CAS and 73 847 (86.6%) of whom underwent CEA. Crude 30-day readmission rates were higher for patients treated with CAS than CEA (8.3% versus 6.8%; P <0.001), but these differences were negated in the propensity-matched cohort (n=22 214; 8.4% versus 7.9%, P =0.20), and readmission length of stay was longer for CEA than CAS (2 versus 1 day, respectively; P =0.002). The most common reasons for readmission were neurological and cardiac events; readmission reasons varied by revascularization modality. Readmission due to a stroke or transient ischemic attack was more common among patients treated with CAS than CEA (1.2% versus 0.9%; P =0.042), while readmission for procedural or medical complications occurred more often following CEA than CAS (1.1% versus 0.5%; P <0.001); readmission rates for cardiac causes were similar between groups., Conclusions: Less than 8% of patients are readmitted within 30 days of a carotid revascularization procedure. After adjusting for baseline differences, readmission rates are similar for CAS and CEA although readmission length of stay is longer after the latter. Readmission for neurological causes was more common following CAS while readmission for procedural or medical complications occurred more often following CEA. Higher annual institutional CEA volumes were associated with lower risk for 30-day readmission; in contrast, institutional CAS volumes were not related to readmission risk. These data provide important insights into the short-term, outcomes of patients following carotid artery revascularization.

Background Ticagrelor and prasugrel are potent P2Y12 inhibitors with superior efficacy compared with clopidogrel among patients with ST-segment-elevation myocardial infarction (STEMI), though use in recent practice is not well described. In this retrospective study, we assessed trends, predictors, and variation in use of P2Y12 inhibitors in patients with STEMI in the United States. Methods and Results We identified 169 505 STEMI patients in the Chest Pain-Myocardial Infarction Registry from October 2013 through March 2017. We determined national utilization rates of P2Y12 inhibitors at discharge, patient predictors for each medication, and variation in use between hospitals. In a subset of 9655 Medicare patients ≥65 years old, we compared 1-year adjusted risks of death, myocardial infarction, stroke, and bleeding based on hospital quartile of potent P2Y12 inhibitor use. Rates of ticagrelor use increased from 18.0% to 44.0%, while rates of prasugrel and clopidogrel use decreased from 24.6% to 13.5% and 57.4% to 42.6%, respectively. Prior percutaneous coronary intervention was the strongest clinical predictor for use of ticagrelor (adjusted odds ratio, 1.13 [95% CI, 1.09-1.18]) and prasugrel (adjusted odds ratio, 1.27 [95% CI, 1.21-1.34]) compared with clopidogrel. Predictors of clopidogrel use included no insurance, insurance with Medicare or Medicaid, and features associated with higher bleeding risk. The median hospital usage rate for newer P2Y12 inhibitors was 51.3% (interquartile range, 35.0%-65.9%), with substantial variation between hospitals (adjusted median odds ratio, 2.92 [95% CI, 2.77-3.10]). Among patients ≥65 years old, there were no differences in adjusted 1-year risks of adverse outcomes across hospital quartiles of potent P2Y12 inhibitor use. Conclusions Almost one-half of STEMI patients by 2017 were discharged on ticagrelor while far fewer received prasugrel. Patient characteristics are associated with P2Y12 inhibitor selection, though substantial hospital variation exists. Identifying barriers to use of more potent P2Y12 inhibitors may improve patient-centered decision-making for STEMI patients.

Background: The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking., Methods: We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs., Results: Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; P =0.002), myocardial infarction (1.9% versus 2.7%; P =0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; P <0.001), acute kidney injury (10.5% versus 11.9%; P =0.043), fasciotomy (1.9% versus 8.9%; P <0.001), major bleeding (16.7% versus 21.0%; P <0.001), and transfusion (10.3% versus 18.5%; P <0.001), but higher vascular complications (1.4% versus 0.7%; P =0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; P =0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization., Conclusions: In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.

Background: The objective of this study was to evaluate the evidence-base supporting the American Heart Association and American College of Cardiology guidelines on peripheral vascular interventions., Methods and Results: American Heart Association/American College of Cardiology guideline documents available as of May 2018 were abstracted for both endovascular and surgical peripheral vascular intervention. The number of recommendations, class of recommendations (I, II, and III) and the distribution of their respective level of evidence (LOE; A, B, and C) were determined for each procedure. Guidelines were also evaluated for changes in recommendations over time. Of 5 current guidelines reporting 134 recommendations, only 13% were supported by LOE A and 39% were supported by LOE C. Overall, most recommendations were class II (54%), while 35% were class I. Lower LOEs were observed for interventions for pulmonary embolism/deep vein thrombosis (A 0%, B 24%, C 76%), inferior vena cava filter (A 0%, B 31%, C 69%), and renal artery stenosis (A 0%, B 67%, C 33%). Comparatively higher LOE A was observed for endovascular stroke therapy (24%). Compared with previous versions, total number of recommendations for lower extremity peripheral artery disease in the current guideline, decreased from 49 to 26, without an improvement in high-quality evidence., Conclusions: There is significant variation in the LOE supporting various peripheral vascular intervention in the current American Heart Association/American College of Cardiology guidelines. Overall, the availability of high-quality evidence remains low and the LOE appears insufficient to support many guideline recommendations for peripheral vascular intervention. These findings highlight the need for more objective and comparative evidence to support the use of endovascular and surgical therapy and in some areas, for updated guidelines.

Background: Readmissions within 30 days after acute myocardial infarction have been used as a performance metric for hospitals. However, evolving concepts of value-based reimbursement have shifted the focus to 90 days after hospital discharge. Tools are needed to determine risk for 90-day readmission to identify patients who might benefit from enhanced transitional healthcare resources., Methods and Results: In this cohort study, we identified all Medicare beneficiaries with a primary diagnosis of acute myocardial infarction who were discharged from hospitals participating in National Cardiovascular Data Registry ACTION registry between 2008 and 2014. Among a random 70% sample (derivation cohort), we performed hierarchical proportional hazards regression, accounting for death as a competing risk, to assess predictors of all-cause readmission within 90 days. Models were validated in the remaining 30%. Among 86 849 unique patients, 23 912 (27.5%) were readmitted within 90 days. Of the readmissions, 55% occurred within 30 days and 81% occurred within 60 days. Predictors of readmission included older age and a history of diabetes mellitus or heart failure. Coronary revascularization was associated with a lower risk of readmission. A simple risk score incorporating patient demographic and clinical characteristics known before discharge identified groups of patients with readmission risks ranging from 13.1% to 42.9%. Model discrimination was moderate (C statistic=0.662), and calibration was excellent (slope=0.97, intercept=-0.04)., Conclusions: Readmission within 90 days of hospitalization for acute myocardial infarction can be predicted by variables known before discharge and offers the potential to prospectively design transitional care to the risks of individual patients.

Background To improve value in the care of patients with acute myocardial infarction (MI), payment models increasingly hold providers accountable for costs. As such, providers need tools to predict length of stay (LOS) during hospitalization and the likelihood of needing postacute care facilities after discharge for acute MI patients. We developed models to estimate risk for prolonged LOS and postacute care for acute MI patients at time of hospital admission to facilitate coordinated care planning. Methods and Results We identified patients in the National Cardiovascular Data Registry ACTION registry (Acute Coronary Treatment and Intervention Outcomes Network) who were discharged alive after hospitalization for acute MI between July 1, 2008 and March 31, 2017. Within a 70% random sample (Training cohort) we developed hierarchical, proportional odds models to predict LOS and hierarchical logistic regression models to predict discharge to postacute care. Models were validated in the remaining 30%. Of 633 737 patients in the Training cohort, 16.8% had a prolonged LOS (≥7 days) and 7.8% were discharged to a postacute facility (extended care, a transitional care unit, or rehabilitation). Model discrimination was moderate in the validation dataset for predicting LOS (C statistic=0.640) and strong for predicting discharge to postacute care (C statistic=0.827). For both models, discrimination was similar in ST-segment-elevation MI and non-ST-segment-elevation MI subgroups and calibration was excellent. Conclusions These models developed in a national registry can be used at the time of initial hospitalization to predict LOS and discharge to postacute facilities. Prospective testing of these models is needed to establish how they can improve care coordination and lower costs.

Background: Patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL are at high risk of atherosclerotic cardiovascular disease events. Treatment guidelines recommend intensive treatment in these patients. Variation in the use of lipid-lowering therapies (LLTs) in these patients in a national sample of cardiology practices is not known., Methods and Results: Using data from the American College of Cardiology National Cardiovascular Data Registry-Practice Innovation and Clinical Excellence registry, we assessed the proportion of patients with LDL-C ≥190 mg/dL (n=49 447) receiving statin, high-intensity statin, LLT associated with ≥50% LDL-C lowering, ezetimibe, or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor between January 2013 and December 2016. We assessed practice-level rates and variation in LLT use using median rate ratio (MRR) adjusted for patient and practice characteristics. MRRs represent the likelihood that 2 random practices would differ in treatment of identical patients with LDL-C ≥190 mg/dL. The proportion of patients receiving a statin, high-intensity statin, LLT associated with ≥50% LDL-C reduction, ezetimibe, or PCSK9 inhibitor were 58.5%, 31.9%, 34.6%, 8.5%, and 1.5%, respectively. Median practice-level rates and adjusted MRR for statin (56% [interquartile range, 47.3%-64.8%]; MRR, 1.20 [95% confidence interval [CI], 1.17-1.23]), high-intensity statin (30.2% [interquartile range, 12.1%-41.1%]; MRR, 2.31 [95% CI, 2.12-2.51]), LLT with ≥50% LDL-C lowering (31.8% [interquartile range, 15.3%-45.5%]; MRR, 2.12 [95% CI, 1.95-2.28]), ezetimibe (5.8% [interquartile range, 2.8%-9.8%]; MRR, 2.42 [95% CI, 2.21-2.63]), and PCSK9 inhibitors (0.16% [interquartile range, 0%-1.9%]; MRR, 2.38 [95% CI, 2.04-2.72]) indicated significant gaps and >200% variation in receipt of several of these medications for patients across practices. Among those without concomitant atherosclerotic cardiovascular disease, even larger treatment gaps were noted (proportion of patients on a statin, high-intensity statin, LLT with ≥50% LDL-C reduction, ezetimibe, or PCSK9 inhibitor were 50.8%, 25.25%, 26.8%, 4.9%, and 0.74%, respectively)., Conclusions: Evidence-based LLT use remains low among patients with elevated LDL-C with significant variation in care. System-level interventions are needed to address these gaps and reduce variation in care of these high-risk patients., (© 2018 American Heart Association, Inc.)

Background: Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment)., Methods: Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%., Results: The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95)., Conclusions: The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement., (© 2017 American Heart Association, Inc.)

Background: Thirty-day readmission rates have gained increasing importance as a key quality metric. A significant number of patients are hospitalized for the management of critical limb ischemia (CLI), but limited data are available on the incidence, predictors, and causes of 30-day readmission after hospitalization for CLI., Methods: Hospitalizations for a primary diagnosis of CLI during which patients underwent endovascular or surgical therapy (revascularization and/or amputation) and were discharged alive were identified in the 2013 to 2014 Nationwide Readmissions Databases. Incidence, reasons, and costs of 30-day unplanned readmissions were determined. Hierarchical logistic regression models were used to identify independent predictors of 30-day readmissions., Results: We included 60 998 (national estimate, 135 110) index CLI hospitalizations (mean age, 68.9±11.9 years; 40.8% women; 24.6% for rest pain, 37.2% for ulcer, and 38.2% for gangrene). The 30-day readmission rate was 20.4%. Presentation with ulcer or gangrene, age ≥65 years, female sex, large hospital size, teaching hospital status, known coronary artery disease, heart failure, diabetes mellitus, chronic kidney disease, anemia, coagulopathy, obesity, major bleeding, acute myocardial infarction, vascular complications, and sepsis were identified as independent predictors of 30-day readmission. Mode of revascularization was not independently associated with readmissions. Infections (23.5%), persistent or recurrent manifestations of peripheral artery disease (22.2%), cardiac conditions (11.4%), procedural complications (11.0%), and endocrine issues (5.7%) were the most common reasons for readmission. The inflation-adjusted aggregate costs of 30-day readmissions for CLI during the study period were $624 million., Conclusions: Approximately 1 in 5 patients hospitalized for CLI and undergoing revascularization is readmitted within 30 days. Risk of readmission is influenced by CLI presentation, patient demographics, comorbidities, and in-hospital complications, but not by the mode of revascularization., (© 2017 American Heart Association, Inc.)

Background: Public reporting of percutaneous coronary intervention (PCI) outcomes may create disincentives for physicians to provide care for critically ill patients, particularly at institutions with worse clinical outcomes. We thus sought to evaluate the procedural management and in-hospital outcomes of patients treated for acute myocardial infarction before and after a hospital had been publicly identified as a negative outlier., Methods: Using state reports, we identified hospitals that were recognized as negative PCI outliers in 2 states (Massachusetts and New York) from 2002 to 2012. State hospitalization files were used to identify all patients with an acute myocardial infarction within these states. Procedural management and in-hospital outcomes were compared among patients treated at outlier hospitals before and after public report of outlier status. Patients at nonoutlier institutions were used to control for temporal trends., Results: Among 86 hospitals, 31 were reported as outliers for excess mortality. Outlier facilities were larger, treating more patients with acute myocardial infarction and performing more PCIs than nonoutlier hospitals ( P <0.05 for each). Among 507 672 patients with acute myocardial infarction hospitalized at these institutions, 108 428 (21%) were treated at an outlier hospital after public report. The likelihood of PCI at outlier (relative risk [RR], 1.13; 95% confidence interval [CI], 1.12-1.15) and nonoutlier institutions (RR, 1.13; 95% CI, 1.11-1.14) increased in a similar fashion (interaction P =0.50) after public report of outlier status. The likelihood of in-hospital mortality decreased at outlier institutions (RR, 0.83; 95% CI, 0.81-0.85) after public report, and to a lesser degree at nonoutlier institutions (RR, 0.90; 95% CI, 0.87-0.92; interaction P <0.001). Among patients that underwent PCI, in-hospital mortality decreased at outlier institutions after public recognition of outlier status in comparison with prior (RR, 0.72; 9% CI, 0.66-0.79), a decline that exceeded the reduction at nonoutlier institutions (RR, 0.87; 95% CI, 0.80-0.96; interaction P <0.001)., Conclusions: Large hospitals with higher clinical volume are more likely to be designated as negative outliers. The rates of percutaneous revascularization increased similarly at outlier and nonoutlier institutions after report of outlier status. After outlier designation, in-hospital mortality declined at outlier institutions to a greater extent than was observed at nonoutlier facilities., (© 2017 American Heart Association, Inc.)

Background: In 2010, New York State began excluding selected patients with cardiac arrest and coma from publicly reported mortality statistics after percutaneous coronary intervention. We evaluated the effects of this exclusion on rates of coronary angiography, revascularization, and mortality among patients with acute myocardial infarction and cardiac arrest., Methods and Results: Using statewide hospitalization files, we identified discharges for acute myocardial infarction and cardiac arrest January 2003 to December 2013 in New York and several comparator states. A difference-in-differences approach was used to evaluate the likelihood of coronary angiography, revascularization, and in-hospital mortality before and after 2010. A total of 26 379 patients with acute myocardial infarction and cardiac arrest (5619 in New York) were included. Of these, 17 141 (65%) underwent coronary angiography, 12 183 (46.2%) underwent percutaneous coronary intervention, and 2832 (10.7%) underwent coronary artery bypass grafting. Before 2010, patients with cardiac arrest in New York were less likely to undergo percutaneous coronary intervention compared with referent states (adjusted relative risk, 0.79; 95% confidence interval, 0.73-0.85; P <0.001). This relationship was unchanged after the policy change (adjusted relative risk, 0.82; 95% confidence interval, 0.76-0.89; interaction P =0.359). Adjusted risks of in-hospital mortality between New York and comparator states after 2010 were also similar (adjusted relative risk, 0.94; 95% confidence interval, 0.87-1.02; P =0.152 for post- versus pre-2010 in New York; adjusted relative risk, 0.88; 95% confidence interval, 0.84-0.92; P <0.001 for comparator states; interaction P =0.103)., Conclusions: Exclusion of selected cardiac arrest cases from public reporting was not associated with changes in rates of percutaneous coronary intervention or in-hospital mortality in New York. Rates of revascularization in New York for cardiac arrest patients were lower throughout., (© 2017 American Heart Association, Inc.)

Background: Compared with men, women are at higher risk of rehospitalization in the first month after discharge for acute myocardial infarction (AMI). However, it is unknown whether this risk extends to the full year and varies by age. Explanatory factors potentially mediating the relationship between sex and rehospitalization remain unexplored and are needed to reduce readmissions. The aim of this study was to assess sex differences and factors associated with 1-year rehospitalization rates after AMI., Methods: We recruited 3536 patients (33% women) ≥18 years of age hospitalized with AMI from 24 US centers into the TRIUMPH study (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status). Data were obtained by medical record abstraction and patient interviews, and a physician panel adjudicated hospitalizations within the first year after AMI. We compared sex differences in rehospitalization using a Cox proportional hazards model, following sequential adjustment for covariates and testing for an age-sex interaction., Results: One-year crude all-cause rehospitalization rates for women were significantly higher than men after AMI (hazard ratio, 1.29 for women; 95% confidence interval, 1.12-1.48). After adjustment for demographics and clinical factors, women had a persistent 26% higher risk of rehospitalization (hazard ratio, 1.26; 95% confidence interval, 1.08-1.47). However, after adjustment for health status and psychosocial factors (hazard ratio, 1.14; 95% confidence interval, 0.96-1.35), the association was attenuated. No significant age-sex interaction was found for 1-year rehospitalization, suggesting that the increased risk applied to both older and younger women., Conclusions: Regardless of age, women have a higher risk of rehospitalization compared with men over the first year after AMI. Although the increased risk persisted after adjustment for clinical factors, the poorer health and psychosocial state of women attenuated the difference., (© 2017 American Heart Association, Inc.)

Background: Rehospitalizations after acute myocardial infarction for unplanned coronary revascularization and unstable angina (UA) are common. However, despite the inclusion of these events in composite end points of many clinical trials, their association with health status has not been studied., Methods and Results: We included 3283 patients with acute myocardial infarction enrolled in a prospective, 24-center US study who had rehospitalizations independently classified by experienced cardiologists. Health status was assessed using Seattle Angina Questionnaire and EuroQol-5D Visual Analog Scale. In the propensity-matched cohorts, 1-year health status was compared between those who did and did not experience rehospitalization for UA or revascularization using a hierarchical linear model. Overall, mean age was 59 years, 33% were women, and 70% were white. Rehospitalization rates for UA and unplanned revascularization at 1 year were 4.3% and 4.7%. One-year Seattle Angina Questionnaire summary scores were worse in patients with rehospitalizations for UA (mean difference, -10.1; 95% confidence interval, -12.4 to -7.9) and unplanned revascularization (mean difference, -5.7; 95% confidence interval, -8.8 to -2.5) when compared with patients without such rehospitalizations. Similarly, EuroQol-5D Visual Analog Scale scores were worse among patients with such readmissions. Individual Seattle Angina Questionnaire domains indicated worse 1-year angina and quality of life outcomes among patients rehospitalized for UA or unplanned revascularization., Conclusions: Within the first year after acute myocardial infarction, rehospitalizations for UA and unplanned revascularization are associated with worse health status. These findings highlight the impact of such events from a patient's perspective, beyond their economic impact and support the use of UA and unplanned revascularization as elements of composite end points., (© 2016 American Heart Association, Inc.)

Background and Purpose: Carotid artery revascularization was previously found to incrementally reduce stroke risk among patients with carotid stenosis treated with medical therapy. However, the frequency with which optimal medical therapies are used at discharge after carotid endarterectomy (CEA) and carotid artery stenting (CAS) is not known, and the influence of patient, operator, and hospital characteristics on the likelihood of prescription is poorly understood., Methods: In a retrospective cohort study of 23 112 patients undergoing CAS or CEA between January 2007 and June 2012 at US hospitals participating in the CARE registry (Carotid Artery Revascularization and Endarterectomy), we examined antiplatelet therapy and statin utilization at discharge. Hierarchical multivariable logistic regression was used in adjusted analyses., Results: Antiplatelet agents and statins were prescribed at discharge in 99% and 78%, respectively, after CAS and 93% and 75%, respectively, after CEA. After adjustment, antiplatelet therapy was more often prescribed after CAS than CEA (odds ratio 2.4 [95% confidence interval 1.68-3.45]), but statin prescription was equally likely (odds ratio 1.11 [95% confidence interval 0.84-1.49]). Operator specialty (medical>radiology/surgery) and hospital community setting (suburban>urban>rural) independently predicted antiplatelet and statin agent use at discharge, whereas hospital geographic location (Northeast>Midwest/South>West) predicted use of statins but not antiplatelet therapy at discharge., Conclusions: US antiplatelet agent and statin discharge prescription rates were suboptimal after both CAS and CEA and varied by revascularization modality, operating physician specialty, and hospital characteristics. Improved and more uniform utilization after these procedures will be critical to the success of comprehensive stroke risk reduction efforts., (© 2016 American Heart Association, Inc.)

Objectives: Complete coronary revascularization has been associated with improved mortality among patients undergoing surgical bypass grafting. A similar evaluation among patients undergoing percutaneous coronary intervention (PCI) for multivessel disease has produced largely concordant results, although complete percutaneous revascularization is often not achieved in this population. The present study sought to evaluate the clinical and anatomic limitations to complete revascularization among contemporary patients undergoing percutaneous revascularization for multivessel coronary artery disease., Methods: All patients undergoing nonemergent PCI for unprotected left main or multivessel coronary artery disease were identified at two academic medical centers from 2009 to 2012. Complete revascularization was determined through a review of the electronic medical records and corresponding coronary angiograms. The underlying reasons that precluded complete revascularization were then derived from a review of the clinical and angiographic findings., Results: Among 978 patients with multivessel coronary artery disease, 267 (27%) underwent complete percutaneous coronary revascularization. Factors that prevented complete revascularization included chronic total occlusions (54%), treatment limited to the culprit lesion (24%), or persistent disease in small nondominant vessels (24%). After multivariable adjustment, the presence of a chronic total occlusion was associated with significantly reduced odds of receiving complete revascularization (adjusted odds ratio: 0.18, 95% confidence interval: 0.12-0.27)., Conclusion: Complete percutaneous revascularization is uncommon and is hindered by the presence of chronic total occlusions or isolated treatment of an angiographic culprit lesion. Evolving interventional techniques enabling treatment of chronic total occlusions may increase the prevalence of complete percutaneous revascularization in the future.

Background: As US health care increasingly focuses on outcomes as a means for quantifying quality, there is a growing demand for risk models that can account for the variability of patients treated at different hospitals so that equitable comparisons between institutions can be made. We sought to apply aspects of prior risk-standardization methodology to begin development of a risk-standardization tool for the National Cardiovascular Data Registry (NCDR) IMPACT (Improving Pediatric and Adult Congenital Treatment) Registry., Methods and Results: Using IMPACT, we identified all patients undergoing diagnostic or interventional cardiac catheterization between January 2011 and March 2013. Multivariable hierarchical logistic regression was used to identify patient and procedural characteristics predictive of experiencing a major adverse event after cardiac catheterization. A total of 19,608 cardiac catheterizations were performed between January 2011 and March 2013. Among all cases, a major adverse event occurred in 378 of all cases (1.9%). After multivariable adjustment, 8 variables were identified as critical for risk standardization: patient age, renal insufficiency, single-ventricle physiology, procedure-type risk group, low systemic saturation, low mixed venous saturation, elevated systemic ventricular end-diastolic pressure, and elevated main pulmonary artery pressures. The model had good discrimination (C statistic, 0.70), confirmed by bootstrap validation (validation C statistic, 0.69)., Conclusions: Using prior risk-standardization efforts as a foundation, we developed and internally validated a model to predict the occurrence of a major adverse event after cardiac catheterization for congenital heart disease. Future efforts should be directed toward further refinement of the model variables within this large, multicenter data set., (© 2015 American Heart Association, Inc.)

Background: Early readmission after percutaneous coronary intervention is an important quality metric, but prediction models from registry data have only moderate discrimination. We aimed to improve ability to predict 30-day readmission after percutaneous coronary intervention from a previously validated registry-based model., Methods and Results: We matched readmitted to non-readmitted patients in a 1:2 ratio by risk of readmission, and extracted unstructured and unconventional structured data from the electronic medical record, including need for medical interpretation, albumin level, medical nonadherence, previous number of emergency department visits, atrial fibrillation/flutter, syncope/presyncope, end-stage liver disease, malignancy, and anxiety. We assessed differences in rates of these conditions between cases/controls, and estimated their independent association with 30-day readmission using logistic regression conditional on matched groups. Among 9288 percutaneous coronary interventions, we matched 888 readmitted with 1776 non-readmitted patients. In univariate analysis, cases and controls were significantly different with respect to interpreter (7.9% for cases and 5.3% for controls; P=0.009), emergency department visits (1.12 for cases and 0.77 for controls; P<0.001), homelessness (3.2% for cases and 1.6% for controls; P=0.007), anticoagulation (33.9% for cases and 22.1% for controls; P<0.001), atrial fibrillation/flutter (32.7% for cases and 28.9% for controls; P=0.045), presyncope/syncope (27.8% for cases and 21.3% for controls; P<0.001), and anxiety (69.4% for cases and 62.4% for controls; P<0.001). Anticoagulation, emergency department visits, and anxiety were independently associated with readmission., Conclusions: Patient characteristics derived from review of the electronic health record can be used to refine risk prediction for hospital readmission after percutaneous coronary intervention., (© 2015 American Heart Association, Inc.)

Background and Purpose: It is not known whether racial or ethnic disparities observed with other revascularization procedures are also seen with carotid artery stenting (CAS) and endarterectomy (CEA)., Methods: We compared the utilization and outcomes of CAS and CEA across racial/ethnic groups within the CARE Registry between May 2007 and December 2012., Results: Between 2007 and 2012, of the 13 129 patients who underwent CAS, majority were non-Hispanic whites (89.3%), followed by blacks (4.4%), Hispanics (4.3%), and other groups (2.0%). A similar distribution was observed among the 10 953 patients undergoing CEA (non-Hispanic whites, 92.6%; blacks, 3.5%; Hispanics, 2.8%; and other groups, 1.1%). During this time period, a trend toward proportionate increase in CAS utilization was observed in non-Hispanic whites and other groups, whereas the opposite was observed among Hispanics and blacks. This trend persisted even when hospitals performing both CAS and CEA were exclusively analyzed. Adherence to antiplatelet and statin therapy was significantly lower among blacks post CEA. In-hospital major adverse cardiac and cerebrovascular events remained comparable across groups post CAS and CEA. At 30 days, the incidence of stroke (7.2%) and major adverse cardiac and cerebrovascular events (8.8%) was higher among blacks post CEA (P<0.05), after risk adjustment., Conclusion: During the study period, utilization of CAS and CEA was highest among non-Hispanic whites. There was a trend toward increased CAS utilization over time among non-Hispanic whites and other groups, and a trend toward increased CEA utilization among Hispanics and blacks. In-hospital major adverse cardiac and cerebrovascular events remained comparable between groups, whereas 30-day major adverse cardiac and cerebrovascular events were significantly higher in blacks., (© 2015 American Heart Association, Inc.)

Background: Decisions to proceed with surgical versus percutaneous revascularization for multivessel coronary artery disease are often based on subtle clinical information that may not be captured in contemporary registries. The present study sought to evaluate the association between surgical ineligibility documented in the medical record and long-term mortality among patients with unprotected left main or multivessel coronary artery disease undergoing percutaneous coronary intervention., Methods and Results: All subjects undergoing nonemergent percutaneous coronary intervention for unprotected left main or multivessel coronary artery disease were identified at 2 academic medical centers from 2009 to 2012. Documentation of surgical ineligibility was assessed through review of electronic medical records. Cox proportional hazard models adjusted for known mortality risk factors were created to assess long-term mortality in patients with and without documentation of surgical ineligibility. Among 1013 subjects with multivessel coronary artery disease, 218 (22%) were deemed ineligible for coronary artery bypass graft surgery. The most common explicitly cited reasons for surgical ineligibility in the medical record were poor surgical targets (24%), advanced age (16%), and renal insufficiency (16%). After adjustment for known risk factors, documentation of surgical ineligibility remained independently associated with an increased risk of in-hospital (odds ratio, 6.26; 95% confidence interval, 2.16-18.15; P<0.001) and long-term mortality (hazard ratio, 2.98; 95% confidence interval, 1.88-4.72, P<0.001) after percutaneous coronary intervention., Conclusions: Documented surgical ineligibility is common and associated with significantly increased long-term mortality among patients undergoing percutaneous coronary intervention with unprotected left main or multivessel coronary disease, even after adjustment for known risk factors for adverse events during percutaneous revascularization., (© 2014 American Heart Association, Inc.)

Background: Rehospitalization within 30 days after an admission for percutaneous coronary intervention (PCI) is common, costly, and a future target for Medicare penalties. Causes of readmission after PCI are largely unknown., Methods and Results: To illuminate the causes of PCI readmissions, patients with PCI readmitted within 30 days of discharge between 2007 and 2011 at 2 hospitals were identified, and their medical records were reviewed. Of 9288 PCIs, 9081 (97.8%) were alive at the end of the index hospitalization. Of these, 893 patients (9.8%) were readmitted within 30 days of discharge and included in the analysis. Among readmitted patients, 341 patients (38.1%) were readmitted for evaluation of recurrent chest pain or other symptoms concerning for angina, whereas 59 patients (6.6%) were readmitted for staged PCI without new symptoms. Complications of PCI accounted for 60 readmissions (6.7%). For cases in which chest pain or other symptoms concerning for angina prompted the readmission, 21 patients (6.2%) met criteria for myocardial infarction, and repeat PCI was performed in 54 patients (15.8%). The majority of chest pain patients (288; 84.4%) underwent ≥1 diagnostic imaging test, most commonly coronary angiography, and only 9 (2.6%) underwent target lesion revascularization., Conclusions: After PCI, readmissions within 30 days were seldom related to PCI complications but often for recurrent chest pain. Readmissions with recurrent chest pain infrequently met criteria for myocardial infarction but were associated with high rates of diagnostic testing.

Background: For patients who undergo primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction, the door-to-balloon time is an important performance measure reported to the Centers for Medicare & Medicaid Services (CMS) and tied to hospital quality assessment and reimbursement. We sought to assess the use and impact of exclusion criteria associated with the CMS measure of door-to-balloon time in primary PCI., Methods and Results: All primary PCI-eligible patients at 3 Massachusetts hospitals (Brigham and Women's, Massachusetts General, and North Shore Medical Center) were evaluated for CMS reporting status. Rates of CMS reporting exclusion were the primary end points of interest. Key secondary end points were between-group differences in patient characteristics, door-to-balloon times, and 1-year mortality rates. From 2005 to 2011, 26% (408) of the 1548 primary PCI cases were excluded from CMS reporting. This percentage increased over the study period from 13.9% in 2005 to 36.7% in the first 3 quarters of 2011 (P<0.001). The most frequent cause of exclusion was for a diagnostic dilemma such as a nondiagnostic initial ECG, accounting for 31.2% of excluded patients. Although 95% of CMS-reported cases met door-to-balloon time goals in 2011, this was true of only 61% of CMS-excluded cases and consequently 82.6% of all primary PCI cases performed that year. The 1-year mortality for CMS-excluded patients was double that of CMS-included patients (13.5% versus 6.6%; P<0.001)., Conclusions: More than a quarter of patients who underwent primary PCI were excluded from hospital quality reports collected by CMS, and this percentage has grown substantially over time. These findings may have significant implications for our understanding of process improvement in primary PCI and mechanisms for reimbursement through Medicare.

Background: Little is known about the clinical features, procedural risks, or survival of patients receiving replacement versus new implantable cardioverter-defibrillators (ICDs)., Methods and Results: Entries in the National Cardiovascular Data Registry (NCDR) ICD Registry from 2005 through 2010 were eligible for inclusion (n=463,978). Baseline demographic data, clinical information, and procedural variables were compared between patients receiving new (n=359,993; 77.6%) and replacement (n=103,985; 22.4%) ICDs and entered into a propensity match model to determine adjusted survival rates. Patients receiving replacement ICDs were older (70.7 versus 67.5 years of age) and more likely to have atrial fibrillation (41.8% versus 31.4%; P<0.001) and ventricular tachycardia (60.5% versus 33.9%; P<0.001) compared with patients receiving new ICDs. Median battery life was only 4.6 years (25%-75% interquartile range, 3.7-5.8) for all replaced devices, 5.8 (25%-75% interquartile range, 4.2-7.5) for single-chamber, 5.1 (25%-75% interquartile range, 4.1-6.1) for dual-chamber, and 3.9 (25%-75% interquartile range, 3.2-4.6) years for biventricular devices. Patients receiving replacement ICDs had lower rates of index admission complications (0.9% versus 3.2%; P<0.001) but greater risk for death compared receiving patients receiving new ICDs in unadjusted analysis (hazard ratio, 1.18; 95% confidence interval, 1.16-1.20; P<0.0001) and after propensity-score matching (hazard ratio, 1.28; 95% confidence interval, 1.25-1.30; P<0.0001)., Conclusions: Patients receiving replacement ICDs are older and at greater risk for death compared with those receiving initial ICD implants. The battery life of initial ICDs is shorter than previously reported.

Background: The direct thrombin inhibitor, bivalirudin, is associated with similar efficacy and superior safety in patients undergoing percutaneous coronary intervention. However, the role of direct thrombin inhibitors in carotid artery stenting is not well defined. The objective of this study was to compare the safety and effectiveness of bivalirudin and unfractionated heparin (UFH) for carotid artery stenting. We hypothesized that bivalirudin would be associated with less in-hospital postprocedure bleeding than UFH but similar rates of in-hospital and 30-day ischemic outcomes., Methods and Results: We compared the incidence of in-hospital hemorrhagic and in-hospital/30-day ischemic outcomes among patients in the CARE Registry who underwent carotid artery stenting between May 2005 and March 2012 using bivalirudin or UFH. Propensity score matching was used to obtain a balanced cohort of 3555 patients in each treatment group. Patients treated with bivalirudin had a significantly lower incidence of bleeding or hematoma requiring red blood cell transfusions (0.9% versus 1.5%; odds ratio, 0.57 [0.36-0.89]; P=0.01) when compared with UFH-treated patients. The incidence of in-hospital and 30-day ischemic outcomes, including death, myocardial infarction, stroke, transient ischemic attack, and the composite outcome, death/myocardial infarction/stroke, did not differ significantly between groups., Conclusions: Bivalirudin was associated with lower rates of hemorrhagic outcomes compared with UFH during the index hospitalization for carotid artery stenting. In-hospital and 30-day ischemic events were similar between the 2 groups. Randomized comparisons of these agents are needed to confirm these findings.

Background and Purpose: Benchmark trials of carotid endarterectomy often did not include elderly patients, and the results may not be easily extrapolated to the general population. Using the Carotid Artery Revascularization and Endarterectomy registry, we sought to determine real-world outcomes of carotid endarterectomy in the elderly., Methods: This was a retrospective cohort study of patients aged >70 years. We compared outcomes stratified by age among symptomatic and asymptomatic patients., Results: There were 4149 patients who underwent carotid endarterectomy; 1376 (33.1%) were symptomatic. Overall mortality rate was 0.5%. The primary outcome of in-hospital death, stroke, and myocardial infarction showed a significant trend and was highest in the age >85 years group (5.6%). Among symptomatic patients, mortality and the primary outcome were not statistically different between those aged >75 years and those aged 70 to 74 years. Among asymptomatic elderly patients, mortality rate was significantly higher in age group >75 years compared with <75 years (0.7% vs 0.0%); however, the combined outcome of stroke, death, and myocardial infarction was not statistically different., Conclusions: Elderly patients >85 years of age were at increased risk for death or perioperative complications of stroke, death, and myocardial infarction compared with those who were relatively younger. More elderly patients underwent carotid endarterectomy for asymptomatic carotid stenosis and had higher mortality than the younger counterparts, underlining need for caution in subjecting them to the procedure.

Background: Although drug-eluting stents and intensive secondary prevention have contributed to improved outcomes after percutaneous coronary intervention (PCI), repeat revascularization remains relatively common in contemporary practice. We used data from the multicenter Evaluation of Drug-Eluting Stents and Ischemic Events registry to evaluate the relative frequency and timing of staged revascularization, target lesion revascularization (TLR), and other nontarget revascularization during the first year after contemporary PCI., Methods and Results: Patients with staged revascularization, TLR, and other unplanned procedures (elsewhere in the target vessel or in other coronary arteries) were evaluated in time-dependent models using Kaplan-Meier life-table estimation. Predictors of TLR and unplanned revascularization at nontarget sites were identified using logistic regression. Between July 2004 to June 2007, 10 144 patients undergoing PCI were enrolled at 55 US hospitals, of whom 86% were treated with at least 1 drug-eluting stent. Twelve percent required repeat revascularization within the first year (3% staged; 9% unplanned). More than 75% of staged revascularizations were performed <30 days after index PCI, although there was significant variation in this practice across hospitals (range, 0%-54%). TLR occurred in 4.5% of patients, with higher hazard rates between 2 to 9 months after PCI, whereas the risk of unplanned non-TLR (4.4% cumulative incidence) was constant over time., Conclusions: Among unselected patients undergoing PCI in the drug-eluting stent era, the incidence of repeat revascularization at 1 year is ≈12%. Among unplanned procedures, only half are performed for TLR. To achieve further improvements in PCI outcomes, future efforts should concentrate as much on identifying ischemia-producing lesions and intensifying secondary prevention therapies as on the prevention of restenosis.

Background: Recently, there has been increased interest in leveraging observational studies for comparative effectiveness research. Without robust and valid risk adjustment, however, findings from these nonrandomized studies may remain biased. Previous studies examining long-term mortality with drug-eluting stents (DESs) have demonstrated discordant results between randomized trials and observational studies. To examine the impact of treatment selection bias on these findings, we used data from a prospective percutaneous coronary intervention (PCI) registry (EVENT [Evaluation of Drug Eluting Stents and Ischemic Events]) to compare clinical outcomes between DESs and bare metal stents (BMSs) using conventional (multivariable regression and propensity matching) and novel (instrumental variable analysis) risk-adjustment techniques., Methods and Results: The study population consisted of 9266 patients who underwent nonemergent PCI with stent placement at 55 US centers between 2004 and 2007. All-cause mortality and target lesion revascularization (TLR) were assessed prospectively over 1 year of follow-up. Overall, 8171 patients (88%) received DES, but this proportion substantially differed by treatment year (93% in 2004-2006 and 73% in 2007; P<0.001). One-year rates of death and TLR were significantly lower with DES versus BMS (death, 2.5% versus 5.6%; TLR, 4.2% versus 6.9%; P<0.001 for both), findings that persisted in both multivariable-adjusted and propensity-matched analyses. In contrast, instrumental variable analysis, using enrollment period (2004-2006 versus 2007) as the instrument, demonstrated no significant difference in 1-year mortality (predicted absolute difference, 2.0%; 95% CI, -1.8% to 5.7%; P=0.30) and a strong trend toward reduced TLR with DES use (predicted absolute difference, -4.2%; 95% CI, -8.8% to 0.4%; P=0.07)., Conclusions: Among unselected PCI patients in contemporary practice, DES use tended to be associated with a consistent reduction in TLR regardless of risk-adjustment method but showed discordant effects on mortality with conventional risk adjustment compared with instrumentable variable analysis. These findings underscore the limitations of standard risk-adjustment methods to adequately address treatment selection bias in nonrandomized studies and have important implications for comparative effectiveness research using observational data.

Background: Creatine kinase-MB (CK-MB) elevation after percutaneous coronary intervention (PCI) has been associated with increased risk for mortality. Although most studies have defined periprocedural myocardial infarction (pMI) as an elevation in CK-MB >3× upper limit of normal (ULN), use of different CK-MB assays and variation in site-specific definitions of the ULN may limit the value of such relative thresholds., Methods and Results: We used data from the multicenter Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry to examine the impact of variations in site-specific thresholds for CK-MB elevation on the incidence of pMI as well as the relationship between absolute peak levels of CK-MB after PCI and 1-year mortality. The study cohort consisted of 6347 patients who underwent nonemergent PCI and had normal CK-MB at baseline. Across the 59 study centers, the ULN for CK-MB ranged from 2.6 to 10.4 ng/mL (median, 5.0 ng/mL), and there was an inverse relationship between the site-specific ULN and the incidence of pMI (defined as CK-MB elevation >3× ULN). Although any postprocedure elevation of CK-MB was associated with an adverse prognosis, in categorical analyses, only CK-MB ≥50 ng/mL was independently associated with increased 1-year mortality (hazard ratio, 4.71; 95% confidence interval, 2.42 to 9.13; P<0.001). Spline analysis using peak CK-MB as a continuous variable suggested a graded, nonlinear relationship with 1-year mortality, with an inflection point at ≈30 ng/mL., Conclusions: Among unselected patients undergoing PCI, there is a graded relationship between CK-MB elevation after PCI and 1-year mortality that is particularly strong for large CK-MB elevations (>30 to 50 ng/mL). Future studies that include pMI as a clinical end point should consider using a core laboratory to assess CK-MB (to ensure consistency) and raising the threshold for defining pMI above current levels (to enhance clinical relevance).

Background: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. Although randomized clinical trials are the gold standard for assessing the relative benefits of different treatments, observational research is necessary for determining "real-world" effectiveness. Current recommendations limit the application of CAS to high-risk patients, undermining the ability to "balance" the characteristics of patients treated with either approach. We compared the clinical profiles of patients referred for CAS versus CEA in a large national database., Methods and Results: Clinical characteristics of 12 701 patients referred for CAS or CEA in the National Cardiovascular Data Registry-Carotid Artery Revascularization and Endarterectomy were compared for 44 clinical and demographic variables. To investigate the comparability of CAS and CEA patients, we stratified the cohort into quintiles of the propensity score for referral for CAS. Among 8069 patients referred for CAS and 4632 referred for CEA, the CAS patients had significantly more comorbidities. Whereas the propensity model balanced most covariates, the pooled standardized differences (≥10%) suggested persistent imbalance for ischemic heart disease, recent myocardial infarction, and restenosis of prior CAS/CEA, all of which were more common in the CAS group. After stratification of propensity scores by quintile, CEA patients comprised only 14% of the upper 2 quintiles., Conclusions: Characteristics of patients referred for CAS differ markedly from those referred for CEA. Because of extreme clinical disparities between these patients, generalizable comparative effectiveness analyses of observational data will be difficult.

Background: Prediction of restenosis after percutaneous coronary intervention (PCI) remains challenging, and existing risk assessment algorithms were developed before the widespread adoption of drug-eluting stents (DES)., Methods and Results: We used data from the EVENT registry to develop a risk model for predicting target lesion revascularization (TLR) in 8829 unselected patients undergoing DES implantation between 2004 and 2007. Using a split-sample validation technique, predictors of TLR at 1 year were identified from two thirds of the subjects (derivation cohort) using multiple logistic regression. Integer point values were created for each predictor, and the summed risk score (range, 0 to 10) was applied to the remaining sample (validation cohort). At 1 year, TLR occurred in 4.2% of patients, and after excluding stent thrombosis and early mechanical complications, the incidence of late TLR (more likely representing restenosis-related TLR) was 3.6%. Predictors of TLR were age <60, prior PCI, unprotected left main PCI, saphenous vein graft PCI, minimum stent diameter < or =2.5 mm, and total stent length > or =40 mm. Comparison of observed versus predicted rates of TLR according to risk score demonstrated good model fit in the validation set. There was more than a 3-fold difference in TLR rates between the lowest risk category (score=0; TLR rate, 2.2%) and the highest risk category (score > or =5; TLR rate, 7.5%)., Conclusions: The overall incidence of TLR remains low among unselected patients receiving DES in routine clinical practice. A simple risk model incorporating 6 readily available clinical and angiographic variables helps identify individuals at extremely low (<2%) and modestly increased (>7%) risk of TLR after DES implantation.

Background: Coronary plaque classified as thin-cap fibroatheroma (TCFA) is believed to be associated with plaque rupture and coronary heart disease-related events. Although an association between duration of diabetes and increased coronary heart disease risk has been demonstrated, the relationship between TCFA and diabetes duration is unknown., Methods and Results: Prospective registry of diabetic patients undergoing diagnostic coronary angiography and intravascular ultrasound (IVUS) enrolled in a diabetic gene and biomarker banking registry. Plaque composition in the most diseased 10-mm segment of a single coronary artery was assessed using IVUS virtual histology and was classified by phenotype as IVUS-defined adaptive intimal thickening, pathological intimal thickening, TCFA, fibroatheroma, or fibrocalcific. Patients (n=54) were stratified by duration of diabetes (<10 or > or = 10 years). Patients with diabetes > or = 10 years were older, less likely to have a history of tobacco use, had higher total cholesterol levels, and were more likely to be treated with insulin compared with patients with diabetes <10 years. Longer duration of diabetes was associated with greater plaque burden in the most diseased 10-mm segment (60.4% [53.4% to 66.8%] versus 50.2% [47.7% to 58.4%], P=0.008). The proportion of IVUS-defined TCFA in the > or = 10-year group was greater than the <10-year group (54.4% [11.6% to 77.5%] versus 10.8% [0.0% to 26.1%], P=0.009). This association persisted after adjustment for multiple comparisons, clinical characteristics, and diabetes treatment., Conclusions: In this cohort, longer duration of diabetes was associated with IVUS-defined TCFA, a plaque phenotype associated with risk of rupture and coronary heart disease events., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00428961.