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Background Left atrial appendage occlusion (LAAO) is increasingly used as an alternative to oral anticoagulation for stroke prevention in select patients with atrial fibrillation. Data on outcomes in racial and ethnic minority individuals are limited. This analysis assessed differences in the use and outcomes of LAAO by race and ethnicity in a large national registry. Methods and Results This analysis acquired data on patients who underwent WATCHMAN FLX implantation from the retrospective NCDR (National Cardiovascular Data Registry) LAAO registry through September 2022. All patients with an attempted WATCHMAN FLX implantation and known race and ethnicity were included. Baseline characteristics and 1‐year event rates were compared. A total of 97 185 patients were analyzed; 87 339 were White individuals (90%), 3750 Black individuals (3.9%), and 2866 Hispanic individuals (Hispanic/Latinx), 2.9%). Black and Hispanic patients were younger, with a higher incidence of prior stroke and significant bleeding compared with White patients. Black and Hispanic patients were treated with LAAO in smaller numbers relative to their proportion of the US population. Rates of procedural success were similar between groups. Though direct oral anticoagulants were prescribed in most patients across the groups, dual and single antiplatelet therapy were prescribed more often in Black patients. Black patients had significantly higher rates of 1‐year death and bleeding compared with White and Hispanic patients. Conclusions Patients from racial and ethnic minority groups comprise a disproportionately small fraction of all patients who undergo LAAO. Black and Hispanic patients were younger but had significantly higher comorbidities compared with White patients. Procedural success was similar among the groups, but Black patients experienced higher rates of death and bleeding at 1 year.

Background Frailty is rarely assessed in clinical trials of patients who receive dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. This study investigated whether frailty defined using claims data is associated with outcomes following percutaneous coronary intervention, and if there is a differential association in patients receiving standard versus extended duration DAPT. Methods and Results Patients ≥65 years of age in the DAPT (Dual Antiplatelet Therapy) Study, a randomized trial comparing 30 versus 12 months of DAPT following percutaneous coronary intervention, had data linked to Medicare claims (n=1326), and a previously validated claims‐based index was used to define frailty. Net adverse clinical events, a composite of all‐cause mortality, myocardial infarction, stroke, and major bleeding, were compared between frail and nonfrail patients. Patients defined as frail using claims data (12.0% of the cohort) had higher incidence of net adverse clinical events (23.1%) compared with nonfrail patients (10.7%; P

Background Mortality prediction in critically ill patients with cardiogenic shock can guide triage and selection of potentially high‐risk treatment options. Methods and Results We developed and externally validated a checklist risk score to predict in‐hospital mortality among adults admitted to the cardiac intensive care unit with Society for Cardiovascular Angiography & Interventions Shock Stage C or greater cardiogenic shock using 2 real‐world data sets and Risk‐Calibrated Super‐sparse Linear Integer Modeling (RiskSLIM). We compared this model to those developed using conventional penalized logistic regression and published cardiogenic shock and intensive care unit mortality prediction models. There were 8815 patients in our training cohort (in‐hospital mortality 13.4%) and 2237 patients in our validation cohort (in‐hospital mortality 22.8%), and there were 39 candidate predictor variables. The final risk score (termed BOS,MA2) included maximum blood urea nitrogen ≥25 mg/dL, minimum oxygen saturation

Background Clinical characteristics and outcomes in people living with HIV (PLWH) undergoing percutaneous coronary intervention (PCI) remain poorly described. We sought to compare real‐world treatment of coronary artery disease, as well as patient and procedural factors and outcomes after PCI between PLWH and uninfected controls. Methods and Results We utilized procedural registry data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program between January 1, 2009 and December 31, 2019 to analyze patients with obstructive coronary artery disease on angiography. In the PCI subgroup, we used inverse probability of treatment weighting and applied Cox proportional hazards to evaluate the association of HIV serostatus with outcomes, including all‐cause mortality at 5 years. Among 184 310 patients with obstructive coronary artery disease, treatment strategy was similar between PLWH and controls—35.7% versus 34.2% PCI, 13.6% versus 15% coronary artery bypass grafting, and 50.7% versus 50.8% medical therapy. The PCI cohort consisted of 546 (0.9%) PLWH and 56 811 (99.1%) controls. PLWH undergoing PCI had well‐controlled HIV disease, and compared with controls, were younger, more likely to be Black, had fewer traditional risk factors, more acute coronary syndrome, less extensive coronary artery disease, and similar types of stents and P2Y12 therapy. However, PLWH experienced worse survival as early as 6 months post‐PCI, which persisted over time and amounted to a 21% increased mortality risk by 5 years (hazard ratio, 1.21 [95% CI, 1.03–1.42; P=0.02]). Conclusions Despite well‐controlled HIV disease, a more favorable overall cardiovascular risk profile, and similar PCI procedural metrics, PLWH still have significantly worse long‐term survival following PCI than controls.

Background US policymakers are debating whether to expand the Medicare program by lowering the age of eligibility. The goal of this study was to determine the association of Medicare eligibility and enrollment with healthcare access, affordability, and financial strain from medical bills in a contemporary population of low- and higher-income adults in the US. Methods and findings We used cross-sectional data from the National Health Interview Survey (2019) to examine the association of Medicare eligibility and enrollment with outcomes by income status using a local randomization-based regression discontinuity approach. After weighting to account for survey sampling, the low-income group consisted of 1,660,188 adults age 64 years and 1,488,875 adults age 66 years, with similar baseline characteristics, including distribution of sex (59.2% versus 59.7% female) and education (10.8% versus 12.5% with bachelor’s degree or higher). The higher-income group consisted of 2,110,995 adults age 64 years and 2,167,676 adults age 66 years, with similar distribution of baseline characteristics, including sex (40.0% versus 49.4% female) and education (41.0% versus 41.6%). The share of adults age 64 versus 66 years enrolled in Medicare differed within low-income (27.6% versus 87.8%, p < 0.001) and higher-income groups (8.0% versus 85.9%, p < 0.001). Medicare eligibility at 65 years was associated with a decreases in the percentage of low-income adults who delayed (14.7% to 6.2%; −8.5% [95% CI, −14.7%, −2.4%], P = 0.007) or avoided medical care (15.5% to 5.9%; −9.6% [−15.9%, −3.2%], P = 0.003) due to costs, and a larger decrease in the percentage who were worried about (66.5% to 51.1%; −15.4% [−25.4%, −5.4%], P = 0.003) or had problems (33.9% to 20.6%; −13.3% [−23.0%, −3.6%], P = 0.007) paying medical bills. In contrast, there were no significant associations between Medicare eligibility and measures of cost-related barriers to medication use. For higher-income adults, there was a large decrease in worrying about paying medical bills (40.5% to 27.5%; −13.0% [−21.4%, −4.5%], P = 0.003), a more modest decrease in avoiding medical care due to cost (3.5% to 0.6%; −2.9% [−5.3%, −0.5%], P = 0.02), and no significant association between eligibility and other measures of healthcare access and affordability. All estimates were stronger when examining the association of Medicare enrollment with outcomes for low and higher-income adults. Additional analyses that adjusted for clinical comorbidities and employment status were largely consistent with the main findings, as were analyses stratified by levels of educational attainment. Study limitations include the assumption adults age 64 and 66 would have similar outcomes if both groups were eligible for Medicare or if eligibility were withheld from both. Conclusions Medicare eligibility and enrollment at age 65 years were associated with improvements in healthcare access, affordability, and financial strain in low-income adults and, to a lesser extent, in higher-income adults. Our findings provide evidence that lowering the age of eligibility for Medicare may improve health inequities in the US. Rahul Aggarwal and colleagues explore the association of Medicare eligibility and enrollment with health care access, affordability, and financial strain from medical bills in low- and higher-income adults in the US. Author summary Why was this study done? In the United States, low-income adults are more likely to lack health insurance coverage, face barriers accessing healthcare, and disproportionately experience financial strain due to healthcare expenditures compared with higher-income adults. Policymakers are increasingly debating whether to expand the Medicare program by lowering the age of eligibility. We determine if Medicare eligibility and enrollment at age 65 years is associated with changes in healthcare access, affordability, and financial strain for low-income and higher-income adults. What did the researchers do and find? In this cross-sectional study, Medicare eligibility and enrollment were associated with decreases in the percentage of low-income adults who delayed or avoided medical care due to costs, as well as in the percentage whom were worried about or had problems paying medical bills. These findings were more modest and less consistent in higher-income adults. Medicare was not associated with changes in the percentage of low-income or higher-income adults who experienced cost-related barriers to medication use. What do these findings mean? As the debate on lowering the age of Medicare eligibility continues, policymakers should consider the potential implications of doing so on healthcare access and affordability for low-income adults and, more broadly, health equity in the US.

Background The AHA Registry (American Heart Association COVID‐19 Cardiovascular Disease Registry) captures detailed information on hospitalized patients with COVID‐19. The registry, however, does not capture information on social determinants of health or long‐term outcomes. Here we describe the linkage of the AHA Registry with external data sources, including fee‐for‐service (FFS) Medicare claims, to fill these gaps and assess the representativeness of linked registry patients to the broader Medicare FFS population hospitalized with COVID‐19. Methods and Results We linked AHA Registry records of adults ≥65 years from March 2020 to September 2021 with Medicare FFS claims using a deterministic linkage algorithm and with the American Hospital Association Annual Survey, Rural Urban Commuting Area codes, and the Social Vulnerability Index using hospital and geographic identifiers. We compared linked individuals with unlinked FFS beneficiaries hospitalized with COVID‐19 to assess the representativeness of the AHA Registry. A total of 10 010 (47.0%) records in the AHA Registry were successfully linked to FFS Medicare claims. Linked and unlinked FFS beneficiaries were similar with respect to mean age (78.1 versus 77.9, absolute standardized difference [ASD] 0.03); female sex (48.3% versus 50.2%, ASD 0.04); Black race (15.1% versus 12.0%, ASD 0.09); dual‐eligibility status (26.1% versus 23.2%, ASD 0.07); and comorbidity burden. Linked patients were more likely to live in the northeastern United States (35.7% versus 18.2%, ASD 0.40) and urban/metropolitan areas (83.9% versus 76.8%, ASD 0.18). There were also differences in hospital‐level characteristics between cohorts. However, in‐hospital outcomes were similar (mortality, 23.3% versus 20.1%, ASD 0.08; home discharge, 45.5% versus 50.7%, ASD 0.10; skilled nursing facility discharge, 24.4% versus 22.2%, ASD 0.05). Conclusions Linkage of the AHA Registry with external data sources such as Medicare FFS claims creates a unique and generalizable resource to evaluate long‐term health outcomes after COVID‐19 hospitalization.

Background Given that percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) is indicated primarily for symptom relief, identifying patients most likely to benefit is critically important for patient selection and shared decision‐making. Therefore, we identified factors associated with residual angina frequency after CTO PCI and developed a model to predict postprocedure anginal burden. Methods and Results Among patients in the OPEN‐CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated the association between patient characteristics and residual angina frequency at 6 months, as assessed by the Seattle Angina Questionnaire Angina Frequency Scale. We then constructed a prediction model for angina status after CTO PCI using ordinal regression. Among 901 patients undergoing CTO PCI, 28% had no angina, 31% had monthly angina, 30% had weekly angina, and 12% had daily angina at baseline. Six months later, 53% of patients had a ≥20‐point increase in Seattle Angina Questionnaire Angina Frequency Scale score. The final model to predict residual angina after CTO PCI included baseline angina frequency, baseline nitroglycerin use frequency, dyspnea symptoms, depressive symptoms, number of antianginal medications, PCI indication, and presence of multiple CTO lesions and had a C index of 0.78. Baseline angina frequency and nitroglycerin use frequency explained 71% of the predictive power of the model, and the relationship between model components and angina improvement at 6 months varied by baseline angina status. Conclusions A 7‐component OPEN‐AP (OPEN‐CTO Angina Prediction) score can predict angina improvement and residual angina after CTO PCI using variables commonly available before intervention. These findings have implications for appropriate patient selection and counseling for CTO PCI.

Abstract Background Catheter ablation (CA) has emerged as an effective treatment for symptomatic atrial fibrillation (AF). However practice patterns and patient factors associated with referral for CA within the first 12 months after diagnosis are poorly characterized. This study examined overall procedural trends and factors predictive of catheter ablation for newly-diagnosed atrial fibrillation in a young, commercially-insured population. Methods A large nationally-representative sample of patients age 20 to 64 from years 2010 to 2016 was studied using the IBM MarketScan® Commercial Database. Patients were included with a new diagnosis of AF in the inpatient or outpatient setting with continuous enrollment for at least 1 year pre and post index visit. Patients were excluded if they had prior history of AF or had filled an anti-arrhythmic drug (AAD) in the pre-index period. Results Early CA increased from 5.0% in 2010 to 10.5% in 2016. Patients were less likely to undergo CA if they were located in the Northeast (OR: 0.80, CI: 0.73–0.88) or North Central (OR: 0.91, CI: 0.83–0.99) regions (compared with the West), had higher CHA2DS2-VASc scores, or had Charlson Comorbidity Index (CCI) score of 3 or greater (OR: 0.61; CI: 0.51–0.72). Conclusions CA within 12 months for new-diagnosed AF increased significantly from 2010 to 2016, with most patients still trialed on an AAD prior to CA. Patients are less likely to be referred for early CA if they are located in the Northeast and North Central regions, have more comorbidities, or higher CHA2DS2-VASc scores.

Background: Serum high-density lipoprotein cholesterol (HDL-C) levels are inversely associated with cardiovascular disease events. Yet, emerging evidence suggests that it is the functional properties of HDL, in particular, reverse cholesterol transport, which is a key protective mechanism mediating cholesterol removal from macrophage cells and reducing plaque lipid content. Cholesterol efflux capacity (CEC) measures the capacity of HDL to perform this function. A systematic review and meta-analysis were conducted to explore the association of CEC and adverse cardiovascular events.Methods: A comprehensive literature review of Embase, PubMed, and Web of Science Core Collection from inception to September 2019 was performed for all studies that examined the association between CEC and cardiovascular outcomes. The primary outcome was adverse cardiovascular events, which were inclusive of atherosclerotic cardiovascular disease (ASCVD) or mortality.Results: A total of 20 trials were included. Compared with low CEC levels, high CEC levels were associated with a 37% lower risk of adverse cardiovascular events (crude RR = 0.63; 95% CI, 0.52–0.76; P < 0.00001). Every SD increase of CEC was associated with a 20% lower risk of adverse cardiovascular events (HR = 0.80; 95% CI, 0.66–0.97; P = 0.02). The association remained significant after adjusting for cardiovascular risk factors, medications, and HDL-C levels (HR = 0.76; 95% CI, 0.63–0.91; P = 0.004). A significant CEC-endpoint relationship was observed (P = 0.024) such that for every 0.1 unit increase in CEC, there was a 5% reduced risk for adverse cardiovascular events (RR = 0.95; 95% CI, 0.91–0.99).Conclusions: Higher CEC is associated with lower adverse cardiovascular outcomes. These findings warrant further research on whether CEC is merely a biomarker or a mechanism that could be targeted as a pharmacologic intervention for improving clinical outcomes.PROSPERO Registration Number: CRD42020146681; https://www.crd.york.ac.uk/prospero/.

Background The optimal treatment strategy for patients with chronic limb‐threatening ischemia (CLTI) is often unclear. Frailty has emerged as an important factor that can identify patients at greater risk of poor outcomes and guide treatment selection, but few studies have explored its utility among the CLTI population. We examine the association of a health record‐based frailty measure with treatment choice and long‐term outcomes among patients hospitalized with CLTI. Methods and Results We included patients aged >65 years hospitalized with CLTI in the Medicare Provider Analysis and Review data set between October 1, 2009 and September 30, 2015. The primary exposure was frailty, defined by the Claims‐based Frailty Indicator. Baseline frailty status and revascularization choice were examined using logistic regression. Cox proportional hazards regression was used to determine the association between frailty and death or amputation, stratifying by treatment strategy. Of 85 060 patients, 35 484 (42%) were classified as frail. Frail patients had lower likelihood of revascularization (adjusted odds ratio [OR], 0.78; 95% CI, 0.75‒0.82). Among those revascularized, frailty was associated with lower likelihood of surgical versus endovascular treatment (adjusted OR, 0.76; CI, 0.72‒0.81). Frail patients experienced increased risk of amputation or death, regardless of revascularization status (revascularized: adjusted hazard ratio [HR], 1.34; CI, 1.30‒1.38; non‐revascularized: adjusted HR, 1.22; CI, 1.17‒1.27). Among those revascularized, frailty was independently associated with amputation or death irrespective of revascularization strategy (surgical: adjusted HR, 1.36; CI, 1.31‒1.42; endovascular: aHR, 1.29; CI, 1.243‒1.35). Conclusions Among patients hospitalized with CLTI, frailty is an important independent predictor of revascularization strategy and longitudinal adverse outcomes.

Background In aortic valve disease, the relationship between claims‐based frailty indices (CFIs) and validated measures of frailty constructed from in‐person assessments is unclear but may be relevant for retrospective ascertainment of frailty status when otherwise unmeasured. Methods and Results We linked adults aged ≥65 years in the US CoreValve Studies (linkage rate, 67%; mean age, 82.7±6.2 years, 43.1% women), to Medicare inpatient claims, 2011 to 2015. The Johns Hopkins CFI, validated on the basis of the Fried index, was generated for each study participant, and the association between CFI tertile and trial outcomes was evaluated as part of the EXTEND‐FRAILTY substudy. Among 2357 participants (64.9% frail), higher CFI tertile was associated with greater impairments in nutrition, disability, cognition, and self‐rated health. The primary outcome of all‐cause mortality at 1 year occurred in 19.3%, 23.1%, and 31.3% of those in tertiles 1 to 3, respectively (tertile 2 versus 1: hazard ratio, 1.22; 95% CI, 0.98–1.51; P=0.07; tertile 3 versus 1: hazard ratio, 1.73; 95% CI, 1.41–2.12; P

BACKGROUND In January 2011, Centers for Medicare and Medicaid Services expanded the number of inpatient diagnosis codes from 9 to 25, which may influence comorbidity counts and risk‐adjusted outcome rates for studies spanning January 2011. This study examines the association between (1) limiting versus not limiting diagnosis codes after 2011, (2) using inpatient‐only versus inpatient and outpatient data, and (3) using logistic regression versus the Centers for Medicare and Medicaid Services risk‐standardized methodology and changes in risk‐adjusted outcomes. METHODS AND RESULTS Using 100% Medicare inpatient and outpatient files between January 2009 and December 2013, we created 2 cohorts of fee‐for‐service beneficiaries aged ≥65 years. The acute myocardial infarction cohort and the heart failure cohort had 578 728 and 1 595 069 hospitalizations, respectively. We calculate comorbidities using (1) inpatient‐only limited diagnoses, (2) inpatient‐only unlimited diagnoses, (3) inpatient and outpatient limited diagnoses, and (4) inpatient and outpatient unlimited diagnoses. Across both cohorts, International Classification of Diseases, Ninth Revision (ICD‐9) diagnoses and hierarchical condition categories increased after 2011. When outpatient data were included, there were no significant differences in risk‐adjusted readmission rates using logistic regression or the Centers for Medicare and Medicaid Services risk standardization. A difference‐in‐differences analysis of risk‐adjusted readmission trends before versus after 2011 found that no significant differences between limited and unlimited models for either cohort. CONCLUSIONS For studies that span 2011, researchers should consider limiting the number of inpatient diagnosis codes to 9 and/or including outpatient data to minimize the impact of the code expansion on comorbidity counts. However, the 2011 code expansion does not appear to significantly affect risk‐adjusted readmission rate estimates using either logistic or risk‐standardization models or when using or excluding outpatient data.

Background In the United States, hospitalizations for pulmonary embolism (PE) are increasing among older adults insured by Medicare. Although efforts to reduce health disparities have intensified, it remains unclear whether clinical outcomes differ between socioeconomically disadvantaged and nondisadvantaged Medicare beneficiaries hospitalized with PE. Methods and Results In this study, there were 53 386 Medicare fee‐for‐service beneficiaries age ≥65 years hospitalized for PE between October 2015 and January 2017. Of these, 5494 (10.3%) were socioeconomically disadvantaged and 47 892 (89.7%) were nondisadvantaged. Socioeconomically disadvantaged adults were of similar age as nondisadvantaged adults (77.1 versus 77.0), more likely to be female (68.5% versus 54.2%), and less likely to receive advanced therapies (11.0% versus 12.1%). After adjustment for demographics, 90‐day all‐cause mortality rates were similar between disadvantaged and nondisadvantaged adults. In contrast, 1‐year mortality rates were higher among socioeconomically disadvantaged adults (hazard ratio [HR], 1.16; 95% CI, 1.10–1.22), although these differences were partially attenuated after additional adjustments for comorbidities and PE severity (HR, 1.09; 95% CI, 1.02–1.16). Risk‐adjusted 30‐day and 90‐day all‐cause readmission rates were substantially higher among socioeconomically disadvantaged patients (30‐day HR, 1.14 [95% CI, 1.06–1.22]; 90‐day HR, 1.18 [95% CI, 1.12–1.25]). In addition, 90‐day readmissions attributed to PE, deep vein thrombosis, and/or bleeding were higher among socioeconomically disadvantaged patients (HR, 1.16; 95% CI, 1.02–1.32). Conclusions Socioeconomically disadvantaged older adults hospitalized with PE have higher 1‐year mortality rates compared with their nondisadvantaged counterparts. Nearly 1 in 3 socioeconomically disadvantaged older adults was readmitted within 90 days of a hospitalization for PE. Targeted strategies are needed to improve transitional and ambulatory care for this vulnerable population.

Background It is unknown whether clinical events identified with administrative claims have similar prognosis compared with trial‐adjudicated events in cardiovascular clinical trials. We compared the prognostic significance of claims‐based end points in context of trial‐adjudicated end points in the DAPT (Dual Antiplatelet Therapy) study. Methods and Results We matched 1336 patients aged ≥65 years who received percutaneous coronary intervention in the DAPT study with the CathPCI registry linked to Medicare claims. We compared death at 21 months post‐randomization using Cox proportional hazards models among patients with ischemic events (myocardial infarction or stroke) and bleeding events identified by: (1) both trial adjudication and claims; (2) trial adjudication only; and (3) claims only. A total of 47 patients (3.5%) had ischemic events identified by both trial adjudication and claims, 24 (1.8%) in trial adjudication only, 15 (1.1%) in claims only, and 1250 (93.6%) had no ischemic events, with annualized unadjusted mortality rates of 12.8, 5.5, 14.9, and 1.26 per 100 person‐years, respectively. A total of 44 patients (3.3%) had bleeding events identified with both trial adjudication and claims, 13 (1.0%) in trial adjudication only, 65 (4.9%) in claims only, and 1214 (90.9%) had no bleeding events, with annualized unadjusted mortality rates of 11.0, 16.8, 10.7, and 0.95 per 100 person‐years, respectively. Among patients with no trial‐adjudicated events, patients with events in claims only had a high subsequent adjusted mortality risk (hazard ratio (HR) ischemic events: 31.5; 95% CI, 8.9‒111.9; HR bleeding events 23.9; 95% CI, 10.7‒53.2). Conclusions In addition to trial‐adjudicated events, claims identified additional clinically meaningful ischemic and bleeding events that were prognostically significant for death.

Background We systematically reviewed trials comparing different reperfusion strategies for ST‐segment–elevation myocardial infarction and used multivariate network meta‐analysis to compare outcomes across these strategies. Methods and Results We identified 31 contemporary trials in which patients with ST‐segment–elevation myocardial infarction were randomized to ≥2 of the following strategies: fibrinolytic therapy (n=4212), primary percutaneous coronary intervention (PCI) (n=6139), or fibrinolysis followed by routine early PCI (n=5006). We categorized the last approach as “facilitated PCI” when the median time interval between fibrinolysis to PCI was

Background There is an open Centers for Medicare and Medicaid Services National Coverage Decision for Transcatheter Mitral Valve Repair (TMVr) and a recent multisociety consensus document suggesting that TMVr centers should achieve prespecified mitral valve replacement or repair (MVRr). Yet, little is known about the MVRr volume–TMVr outcome relationship. Methods and Results Using Centers for Medicare and Medicaid Services administrative claims from January 1, 2016 to December 31, 2018, we computed the Pearson correlation coefficient and performed multivariable hierarchical modeling to estimate the MVRr volume to TMVr outcome relationship for mortality and heart failure hospitalization. Additionally, we assessed the impact of the consensus recommendations on geographic access to care by hospital referral region. Total annualized MVRr volume was

Background The Heart Team approach is ascribed a Class I recommendation in contemporary guidelines for revascularization of complex coronary artery disease. However, limited data are available regarding the decision‐making and outcomes of patients based on this strategy. Methods and Results One hundred sixty‐six high‐risk coronary artery disease patients underwent Heart Team evaluation at a single institution between January 2015 and November 2018. We prospectively collected data on demographics, symptoms, Society of Thoracic Surgeons Predicted Risk of Mortality/Synergy Between PCI with Taxus and Cardiac Surgery (STS‐PROM/SYNTAX) scores, mode of revascularization, and outcomes. Mean age was 70.0 years; 122 (73.5%) patients were male. Prevalent comorbidities included diabetes mellitus (51.8%), peripheral artery disease (38.6%), atrial fibrillation (27.1%), end‐stage renal disease on dialysis (13.3%), and chronic obstructive pulmonary disease (21.7%). Eighty‐seven (52.4%) patients had New York Heart Association III‐IV and 112 (67.5%) had Canadian Cardiovascular Society III‐IV symptomatology. Sixty‐seven (40.4%) patients had left main and 118 (71.1%) had 3‐vessel coronary artery disease. The median STS‐PROM was 3.6% (interquartile range 1.9, 8.0) and SYNTAX score was 26 (interquartile range 20, 34). The median number of physicians per Heart Team meeting was 6 (interquartile range 5, 8). Seventy‐nine (47.6%) and 49 (29.5%) patients underwent percutaneous coronary intervention and coronary artery bypass grafting, respectively. With increasing STS‐PROM (low, intermediate, high operative risk), coronary artery bypass graft was performed less often (47.9%, 18.5%, 15.2%) and optimal medical therapy was recommended more often (11.3%, 18.5%, 30.3%). There were no trends in recommendation for coronary artery bypass graft, percutaneous coronary intervention, or optimal medical therapy by SYNTAX score tertiles. In‐hospital and 30‐day mortality was 3.9% and 4.8%, respectively. Conclusions Integrating a multidisciplinary Heart Team into institutional practice is feasible and provides a formalized approach to evaluating complex coronary artery disease patients. The comprehensive assessment of surgical, anatomical, and other risk scores using a decision aid may guide appropriate, evidence‐based management within this team‐based construct.

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

Background Regulators increasingly rely on registries for decision making related to high‐risk medical devices in the United States. However, the limited uniform standards for registries may create substantial variability in registry implementation and utility to regulators. We surveyed the current landscape of US cardiovascular device registries and chart the extent of inconsistency in goals, administration, enrollment procedures, and approach to data access. Methods and Results A systematic review using Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA) guidelines identified studies (1995–2017) referencing cardiovascular device registries with a US‐based institution. Registries were then evaluated by reviewing associated articles and websites. Extracted data included device type, primary scientific aim(s), funding, stewardship (eg, administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. The 138 cardiovascular device registries in the cohort covered devices addressing interventional cardiology (65.9%), arrhythmias (15.2%), heart failure (10.1%), and valvular disease (10.1%). While the majority (55.8%) were industry‐funded, stewardship was predominantly overseen by academic centers (74.0%). Most registry participation was voluntary (77.5%), but a substantial minority (19.7%) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primarily accessible only to stewards (84.1%), with 13.8% providing pathways for external applications. Conclusions The majority of cardiovascular device registries were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries suggests a role for regulators to further strengthen guidelines to improve quality, consistency, and ethical standards.

Background Venous thromboembolism (VTE) is the third leading cause of vascular disease and accounts for $10 billion in annual US healthcare costs. The nationwide burden of 30‐day readmissions after such events has not been comprehensively assessed. Methods and Results We analyzed adults ≥18 years of age with hospitalizations associated with acute VTE between January 1, 2010, and December 31, 2014, in the Nationwide Readmissions Database. International Classification of Disease, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes were used to identify hospitalizations associated with acute pulmonary embolism or deep vein thrombosis. The primary outcome was the rate of unplanned 30‐day readmission. Hierarchical logistic regression was used to calculate hospital‐specific 30‐day risk‐standardized readmission rates, a marker of healthcare quality. Among 1 176 335 hospitalizations with acute VTE, in‐hospital death occurred in 6.2%. VTE was associated with malignancy in 19.7%, recent surgery in 19.3%, recent trauma in 4.6%, hypercoagulability in 3.3%, and pregnancy in 1.0%. Among survivors to discharge, the 30‐day readmission rate was 17.5%, with no significant difference in rates across study years (17.4%–17.7%; P=0.10 for trend). Major predictors of readmission were malignancy (relative risk, 1.49, 95% confidence interval 1.47‐1.50), Medicaid insurance (relative risk, 1.48, 95% confidence interval 1.46‐1.50), and nonelective index admission (relative risk, 1.31, 95% confidence interval 1.29‐1.33). Top causes of readmission included sepsis (9.6%) and procedural complications (8.1%). Median rehospitalization costs were $9781.7 (interquartile range, $5430.7–$18 784.1), and 8.1% died during readmission. The interquartile range in risk‐standardized readmission rates was 16.6% to 18.3%, suggesting modest interhospital heterogeneity in readmission risk. Conclusions Nearly 1 in 5 patients with acute VTE were readmitted within 30 days. Predictors and causes of readmission were primarily related to patient characteristics and complications from comorbid conditions, whereas healthcare quality had a moderate impact on readmission risk.

BackgroundPrevious research has found that patients with acute cardiovascular conditions treated in teaching hospitals have lower 30‐day mortality during dates of national cardiology meetings. Methods and ResultsWe analyzed 30‐day mortality among Medicare beneficiaries hospitalized with acute myocardial infarction (overall, ST‐segment–elevation myocardial infarction, and non–ST‐segment–elevation myocardial infarction) from January 1, 2007, to November 31, 2012, in major teaching hospitals during dates of a major annual interventional cardiology meeting (Transcatheter Cardiovascular Therapeutics) compared with identical nonmeeting days in the ±5 weeks. Treatment differences were assessed. We used a database of US physicians to compare interventional cardiologists who practiced and did not practice during meeting dates (“stayers” and “attendees,” respectively) in terms of demographic characteristics and clinical and research productivity. Unadjusted and adjusted 30‐day mortality rates were lower among patients admitted during meeting versus nonmeeting dates (unadjusted, 15.3% [482/3153] versus 16.7% [5208/31 556] [P=0.04]; adjusted, 15.4% versus 16.7%; difference −1.3% [95% confidence interval, −2.7% to −0.1%] [P=0.05]). Rates of interventional cardiologist involvement were similar between dates (59.5% versus 59.8% of hospitalizations; P=0.88), as were percutaneous coronary intervention rates (30.2% versus 29.1%; P=0.20). Mortality reductions were largest among patients with non–ST‐segment–elevation myocardial infarction not receiving percutaneous coronary intervention (16.9% versus 19.5% adjusted 30‐day mortality; P=0.008). Compared with stayers, attendees were of similar age and sex, but had greater publications (18.9 versus 6.3; P

BackgroundContemporary rates of oral anticoagulant (OAC) therapy and associated outcomes among patients undergoing percutaneous coronary intervention (PCI) have been poorly described. Methods and ResultsUsing data from an integrated health care system from 2009 to 2014, we identified patients on OACs within 30 days of PCI. Outcomes included in‐hospital bleeding and mortality. Of 9566 PCIs, 837 patients (8.8%) were on OACs, and of these, 7.9% used non–vitamin K antagonist agents. OAC use remained stable during the study (8.1% in 2009, 9.0% in 2014; P=0.11), whereas use of non–vitamin K antagonist agents in those on OACs increased (0% in 2009, 16% in 2014; P

BackgroundHigh success rates are achievable for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the hybrid approach, but periprocedural complications remain of concern. Although scores estimating success and efficiency in CTO PCI have been developed, there is currently no available score for estimation of the risk for periprocedural complications. We sought to develop a scoring tool for prediction of periprocedural complications during CTO PCI. Methods and ResultsWe analyzed data from 1569 CTO PCIs in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) using a derivation and validation sampling ratio of 2:1. Variables independently associated with periprocedural complications in multivariable analysis in the derivation set were assigned points based on their respective odds ratios. Forty‐four (2.8%) patients experienced complications. Three factors were independent predictors of complications and were included in the score: patient age >65 years, +3 points (odds ratio, OR=4.85, CI 1.82‐16.77); lesion length ≥23 mm, +2 points (OR=3.22, CI 1.08‐13.89); and use of the retrograde approach +1 point (OR=2.41, CI 1.04‐6.05). The resulting score showed good calibration and discriminatory capacity in the derivation (Hosmer‐Lemeshow χ2 6.271, P=0.281, receiver‐operating characteristic [ROC] area=0.758) and validation (Hosmer‐Lemeshow χ2 4.551, P=0.473, ROC area=0.793) sets. Score values of 0 to 2, 3 to 4, and ≥5 were defined as low, intermediate, and high risk of complications (derivation cohort 0.4%, 1.8%, 6.5%, P

BackgroundIntravascular imaging can facilitate chronic total occlusion (CTO) percutaneous coronary intervention. Methods and ResultsWe examined the frequency of use and outcomes of intravascular imaging among 619 CTO percutaneous coronary interventions performed between 2012 and 2015 at 7 US centers. Mean age was 65.4±10 years and 85% of the patients were men. Intravascular imaging was used in 38%: intravascular ultrasound in 36%, optical coherence tomography in 3%, and both in 1.45%. Intravascular imaging was used for stent sizing (26.3%), stent optimization (38.0%), and CTO crossing (35.7%, antegrade in 27.9%, and retrograde in 7.8%). Intravascular imaging to facilitate crossing was used more frequently in lesions with proximal cap ambiguity (49% versus 26%, P