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BACKGROUND: Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease. METHODS: We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with International Classification of Diseases, Ninth Revision codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics. RESULTS: At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; P=0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; P<0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively. CONCLUSIONS: Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events. [ABSTRACT FROM AUTHOR]

Background: Among patients with implantable defibrillators (ICD), use of remote patient monitoring (RPM) is associated with lower risk of death and rehospitalization. Standard ICD RPM can be supplemented with weight and blood pressure data. It is not known whether standard RPM plus routine weight and blood pressure transmission (RPM+) is associated with better outcomes.Methods and Results: RPM+ patients (n=4106) were compared with patients who only transmitted standard ICD RPM data (n=14 183). Logistic regression models identified patient, physician, and hospital characteristics associated with RPM+ utilization. Mortality and rehospitalization were examined using landmark analyses at 180 days after ICD implant in Medicare fee-for-service patients. In these analyses, we examined the independent association between RPM+ utilization and times to events up to 3 years after device implantation with Cox regression models. We further examined whether the association between RPM+ and outcomes varied by frequency or type of transmissions. Determinants of RPM+ utilization included impaired ejection fraction, cardiac resynchronization therapy, and institutional practice. The risk of mortality of RPM+ patients was similar to standard ICD RPM patients (hazard ratio, 1.06; 95% confidence interval, 0.94-1.19; P=0.34). RPM+ patients also had similar risks of all-cause hospitalization (subdistribution hazard ratio, 1.03; 95% confidence interval, 0.94-1.14; P=0.52), cardiovascular hospitalization (subdistribution hazard ratio, 0.92; 95% confidence interval, 0.83-1.02; P=0.15), or heart failure hospitalizations (subdistribution hazard ratio, 0.90; 95% confidence interval, 0.78-1.05; P=0.18). RPM+ transmission frequency was not associated with outcomes.Conclusions: In patients using standard ICD RPM, the added transmission of weight and blood pressure data was not associated with improved outcomes. [ABSTRACT FROM AUTHOR]

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States.Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events.Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA2DS2-VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P=0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication.Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events. [ABSTRACT FROM AUTHOR]

Background: Whether increasing use of radial access has improved percutaneous coronary intervention outcomes remains unknown. We sought to determine the relationship between increasing facility-level use of transradial percutaneous coronary intervention (TRI) and periprocedural outcomes.Methods and Results: Within the National Cardiovascular Data Registry CathPCI Registry, we estimated the risk-adjusted association between hospital category of change in TRI use (during the 3-year period from 2009 to 2012) and trends in access site and overall bleeding, fluoroscopy time, and contrast use among 818 facilities with low baseline TRI use. There were 4 categories of hospital change in TRI use: very low (baseline, 0.2% increasing to 1.8% at the end of 3 years), low (0.9% increasing to 8.9%), moderate (1.6% increasing to 27.2%), and high (1.0% increasing to 45.1%). Risk-adjusted access site bleeding decreased over time for all hospital categories; however, the rate of decline varied across hospital categories (P for interaction, <0.001). The decrease in access site bleeding was significantly greater for hospitals with moderate or high increases in TRI use (relative risk, 0.45, 95% confidence interval, 0.36-0.56) when compared with that of very low or low hospitals (relative risk, 0.65; 95% confidence interval, 0.58-0.74; P for comparison, 0.002). Similar findings were observed for overall bleeding. An increase in fluoroscopy time (≈1.3 minutes) was noted at hospitals with moderate and high use of TRI (P=0.01). Trends in contrast use were similar across hospital categories.Conclusions: In a national sample of hospitals performing percutaneous coronary intervention, bleeding rates decreased over time for all hospital categories of change in TRI use. The decline in bleeding outcomes was larger at hospitals with increased adoption of TRI when compared with hospitals with minimal or no change in TRI use. [ABSTRACT FROM AUTHOR]

Background: Recognizing the value of outcomes research to understand and bridge translational gaps, to establish evidence in clinical practice and delivery of medicine, and to generate new hypotheses on ongoing questions of treatment and care, the National Heart, Lung, and Blood Institute of the National Institutes of Health established the Centers for Cardiovascular Outcomes Research program in 2010.Methods and Results: The National Heart, Lung, and Blood Institute funded 3 centers and a research coordinating unit. Each center has an independent project focus, including (1) characterizing care transition and predicting clinical events and quality of life for patients discharged after an acute coronary syndrome; (2) identifying center and regional factors associated with better patient outcomes across several cardiovascular conditions and procedures; and (3) examining the impact of healthcare reform in Massachusetts on overall and disparate care and outcomes for several cardiovascular conditions and venous thromboembolism. Cross-program collaborations seek to advance the field methodologically and to develop early-stage investigators committed to careers in outcomes research.Conclusions: The Centers for Cardiovascular Outcomes Research program represents a significant investment in cardiovascular outcomes research by the National Heart, Lung, and Blood Institute. The vision of this program is to leverage scientific rigor and cross-program collaboration to advance the science of healthcare delivery and outcomes beyond what any individual unit could achieve alone. [ABSTRACT FROM AUTHOR]

Background: Variation in outcomes after percutaneous coronary interventions (PCI) may reflect differences in quality of care. To date, however, we lack a methodology to monitor and improve national hospital 30-day mortality rates among patients undergoing PCI.Methods and Results: We developed hierarchical logistic regression models to calculate hospital risk-standardized 30-day all-cause PCI mortality rates. Due to differences in risk, patients were divided into 2 cohorts: those with ST-segment elevation myocardial infarction or cardiogenic shock, and those with no ST-segment elevation myocardial infarction and no cardiogenic shock. The models were derived using 2006 data from the CathPCI Registry linked with administrative claims data, and validated using comparable 2005 data. In the derivation cohort of the ST-segment elevation myocardial infarction or shock model (n=15 123), the unadjusted 30-day mortality rate was 9.2%. The final model included 13 variables with the observed mortality rates ranging from 1.4% to 40.3% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate were 8.5% and 9.7%, with 5th and 95th percentiles of 7.6% and 11.0%. In the derivation cohort of the no ST-segment elevation myocardial infarction and no shock model (n=110 529), the unadjusted 30-day mortality rate was 1.4%. The final model included 16 variables with the observed predicted mortality rates ranging from 0.1% to 7.0% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate across 612 hospitals were 1.3% and 1.6%, with 5th and 95th percentiles of 1.0% and 2.0%.Conclusions: These National Quality Forum endorsed registry-based models produce estimates of hospital risk-standardized mortality rates for patients undergoing PCI. [ABSTRACT FROM AUTHOR]

The article discusses research on the use of intra-aortic balloon pumps (IABP) in hospitals among high risk percutaneous coronary intervention (PCI) patients and its impact on mortality. High risk PCI has many features, including unprotected left main artery as the primary target. Variaion in the use of IABP did not have impact on in-hospital mortality.

The article discusses a study which concluded that advanced age was associated with moderately increased risk of complications or in-house mortality in patients undergoing implantable cardioverter-defibrillators (ICD). It is stated that adverse clinical outcomes are driven mostly by comorbidities that increase and worsen with age. However, a major finding is that cardiac and non-cardiac conditions like renal disease were responsible for perioperative complications more than advanced age.

The article discusses a study that examined the association between elevated B-type natriuretic peptide (BNP) level with increased risk of in-hospital mortality or cardiac arrest in patients undergoing implantable cardioverter-defibrillator (ICD). Findings found an increase in the rate of in-hospital mortality or cardiac arrest with elevated BNP level. It also showed that the association was more significant in men, renal dysfunction patients, and those undergoing biventricular ICD implantation.

The article discusses as study which examined regional variations in the utilization of primary prevention implantable cardioverter-defibrillators (ICD) for the primary prevention of sudden cardiac death in the U.S. Results showed substantial variation across quantiles of rate ratios of ICD implantation, ranging from 0.39 to 1.77. In addition, 13% of patients receiving ICDs did not meet trial criteria. It concluded that marked geographic variation in the use of primary prevention ICDs exists which is not correlated with physician supply.

Background Patients undergoing implantable cardioverter-defibrillator (ICD) implantations have high rates of long-term device-related complications and reoperations. Whether physician specialty training is associated with differences in long-term outcomes following ICD implantation is unclear. Methods and Results We linked data from the National Cardiovascular Data Registry ICD Registry with Medicare fee-for-service claims to identify physicians who performed ≥10 index ICDs from 2006 to 2009. We used data from the American Board of Medical Specialties to group the specialty of the implanting physician into mutually exclusive categories: electrophysiologists, interventional cardiologists, general cardiologists, thoracic surgeons, and other specialties. Primary outcomes were long-term device-related complications requiring reoperations or hospitalizations and reoperations for reasons other than complications. We compared the cumulative incidence rates and case-mix adjusted rates of long-term outcomes of index ICD implantations across physician specialties. Our analysis had a median follow-up of 47 months and included 107 966 index ICD implantations. Electrophysiologists had the lowest rates of incident long-term device-related complications (14.1%; interventional cardiologists, 15.3%; general cardiologists, 15.4%; thoracic surgeons, 16.4%; other specialists, 15.2%; P<0.001) and reoperations for reasons other than complications (electrophysiologists, 16.7%; interventional cardiologists, 17.0%; general cardiologists, 18.0%; thoracic surgeons, 18.4%; other specialists, 18.0%; P<0.001). Compared with patients whose ICDs were implanted by electrophysiologists, patients with implantations performed by nonelectrophysiologists were at higher risk of having long-term device-related complications (relative risk for interventional cardiologists: 1.16 [95% CI, 1.08-1.25]; general cardiologists: 1.13 [1.08-1.18]; thoracic surgeons: 1.20 [1.06-1.37]; all P<0.001, but not other specialists: 1.08 [0.99-1.17]; P=0.07). Compared to patients with implantations performed by electrophysiologists, patients with implantations performed by general cardiologists and thoracic surgeons were at higher risk of reoperation for noncomplication causes (relative risk for general cardiologists: 1.10 [1.05-1.15]; thoracic surgeons: 1.16 [1.00-1.33]; both P<0.05). Conclusions Patients with ICD implantations performed by electrophysiologists had the lowest risks of having long-term device-related complications and reoperations for noncomplication causes. Consideration of physician specialty before ICD implantation may represent an opportunity to minimize long-term adverse outcomes. [ABSTRACT FROM AUTHOR]

Background Despite improvements on individual process of care measures for acute myocardial infarction (AMI), little is known about performance on a composite measure of AMI care that assesses the delivery of many components of high-quality AMI care. We sought to examine trends in patient- and hospital-level performance on a composite defect-free care measure, identify disparities in the performance across sociodemographic groups, and identify opportunities to further improve quality and outcomes. Methods and Results We calculated the proportion of patients in the National Cardiovascular Data Registry-Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (now known as the Chest Pain - Myocardial Infarction Registry) between January 1, 2010, and December 31, 2017, receiving defect-free AMI care including guideline-recommended pharmacotherapy, timely provision of medical and reperfusion therapy, assessment of ventricular function, referral to cardiac rehabilitation, and smoking cessation counseling for patients with AMI. A total of 522 800 patients at 222 hospitals were included. Overall, the proportion of patients receiving defect-free care significantly increased from 66.0% in 2010 to 77.1% in 2017 ( P<0.001). Improvements in performance were observed across all sociodemographic subgroups, with the greatest absolute improvement observed for black and Hispanic patients ( P<0.001). However, absolute performance was consistently lower among older patients, women, black and Hispanic patients, and those with government insurance in 2017 ( P<0.001 for all). Improvements in care and reduced variation in performance were observed at the hospital level overall (2010, median [IQR] 67.2% [40.7%-76.3%]; 2017, median [IQR] 80.7% [73.1%-88.1%]; P<0.001) as well as across region, safety net status, teaching status, and proportion of patients who are nonwhite and have Medicaid insurance coverage ( P<0.001 for all). Conclusions Despite improvements in the proportion of patients with AMI receiving defect-free care overall and across sociodemographic groups, nearly 1 in 4 patients in 2017 still did not receive optimal care and absolute performance was consistently lower among older patients, women, black, and Hispanic patients. Composite measures of cardiovascular care, which assess the delivery of several evidence-based processes of care, can illuminate opportunities to improve the quality of care beyond that provided by conventional process measures. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]