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OBJECTIVE: To determine whether burden of multiple chronic conditions (MCCs) influences the risk of receiving inappropriate vs appropriate device therapies. DESIGN: Retrospective cohort study. SETTING: Seven US healthcare delivery systems. PARTICIPANTS: Adults with left ventricular systolic dysfunction receiving an implantable cardioverter‐defibrillator (ICD) for primary prevention. MEASUREMENTS: Data on 24 comorbid conditions were captured from electronic health records and categorized into quartiles of comorbidity burden (0‐3, 4‐5, 6‐7 and 8‐16). Incidence of ICD therapies (shock and antitachycardia pacing [ATP] therapies), including appropriateness, was collected for 3 years after implantation. Outcomes included time to first ICD therapy, total ICD therapy burden, and risk of inappropriate vs appropriate ICD therapy. RESULTS: Among 2235 patients (mean age = 69 ± 11 years, 75% men), the median number of comorbidities was 6 (interquartile range = 4‐8), with 98% having at least two comorbidities. During a mean 2.2 years of follow‐up, 18.3% of patients experienced at least one appropriate therapy and 9.9% experienced at least one inappropriate therapy. Higher comorbidity burden was associated with an increased risk of first inappropriate therapy (adjusted hazard ratio [HR] = 1.94 [95% confidence interval {CI} = 1.14‐3.31] for 4‐5 comorbidities; HR = 2.25 [95% CI = 1.25‐4.05] for 6‐7 comorbidities; and HR = 2.91 [95% CI = 1.54‐5.50] for 8‐16 comorbidities). Participants with 8‐16 comorbidities had a higher total burden of ICD therapy (adjusted relative risk [RR] = 2.12 [95% CI = 1.43‐3.16]), a higher burden of inappropriate therapy (RR = 3.39 [95% CI = 1.67‐6.86]), and a higher risk of receiving inappropriate vs appropriate therapy (RR = 1.74 [95% CI = 1.07‐2.82]). Comorbidity burden was not significantly associated with receipt of appropriate ICD therapies. Patterns were similar when separately examining shock or ATP therapies. CONCLUSIONS: In primary prevention ICD recipients, MCC burden was independently associated with an increased risk of inappropriate but not appropriate device therapies. Comorbidity burden should be considered when engaging patients in shared decision making about ICD implantation. [ABSTRACT FROM AUTHOR]

Importance: The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria.Objective: To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals).Design, Setting, and Participants: Multicenter, longitudinal, serial cross-sectional analysis of 300 151 initial primary prevention ICDs among Medicare beneficiaries from January 1, 2007, through December 31, 2015, at 1809 US hospitals in the National Cardiovascular Data Registry (NCDR) ICD Registry, of which 452 hospitals (with 99 591 primary prevention ICDs) reached settlements with the DOJ.Exposures: The DOJ investigation announcement in 2010.Main Outcomes and Measures: Proportion of initial primary prevention ICDs not meeting NCD criteria.Results: In January 2007, the proportion of initial ICDs not meeting NCD criteria was 25.8% (95% CI, 24.7% to 26.8%) at settlement hospitals and 22.8% (95% CI, 22.1% to 23.5%) at nonsettlement hospitals (P < .001). Over the study period, there was a 62.7% (95% CI, 59.2% to 66.1%) relative decrease and 16.1% (95% CI, 14.8% to 17.5%) absolute decrease in the proportion of ICDs not meeting NCD criteria at settlement hospitals compared with a 53.2% (95% CI, 50.4% to 56.0%) relative decrease and 12.1% (95% CI, 11.2% to 13.0%) absolute decrease in proportion at nonsettlement hospitals (P < .001 for both; P for interaction < .001). Trends significantly differed between hospital groups only in the period following the announcement of the DOJ investigation (January 2010-June 2011) [corrected], with larger and more rapid decreases at settlement hospitals (P for interaction = .01). Over the study period, there was a 32.8% (95% CI, 29.9% to 35.7%) relative decrease and a 1703 ICDs (95% CI, 1520 to 1886) absolute decrease in the volume of primary prevention ICDs implanted at settlement hospitals compared with a 17.4% (95% CI, 14.8% to 20.0%) relative decrease and a 1495 ICDs (95% CI, 1249 to 1741) absolute decrease in volume at nonsettlement hospitals (P < .001 for both; P for interaction < .001), with more modest decreases or slight increases in secondary prevention ICD volume. These patterns were similar when examining ICD utilization among non-Medicare beneficiaries.Conclusions and Relevance: From 2007 through 2015, the volume of primary prevention implantable cardioverter-defibrillators and the proportion of devices not meeting the Centers for Medicare & Medicaid Services National Coverage Determination criteria decreased at all hospitals with substantially larger decreases at hospitals that reached settlements in the US Department of Justice investigation. These patterns extended to implantable cardioverter-defibrillators placed in non-Medicare beneficiaries, which were not the focus of the US Department of Justice investigation. [ABSTRACT FROM AUTHOR]

Background: Publicly reported hospital risk-standardized mortality rates (RSMRs) for acute myocardial infarction (AMI) are calculated for Medicare beneficiaries. Outcomes for older patients with AMI may not reflect general outcomes.Objective: To examine the relationship between hospital 30-day RSMRs for older patients (aged ≥65 years) and those for younger patients (aged 18 to 64 years) and all patients (aged ≥18 years) with AMI.Design: Retrospective cohort study.Setting: 986 hospitals in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-Get With the Guidelines.Participants: Adults hospitalized for AMI from 1 October 2010 to 30 September 2014.Measurements: Hospital 30-day RSMRs were calculated for older, younger, and all patients using an electronic health record measure of AMI mortality endorsed by the National Quality Forum. Hospitals were ranked by their 30-day RSMRs for these 3 age groups, and agreement in rankings was plotted. The correlation in hospital AMI achievement scores for each age group was also calculated using the Hospital Value-Based Purchasing (HVBP) Program method computed with the electronic health record measure.Results: 267 763 and 276 031 AMI hospitalizations among older and younger patients, respectively, were identified. Median hospital 30-day RSMRs were 9.4%, 3.0%, and 6.2% for older, younger, and all patients, respectively. Most top- and bottom-performing hospitals for older patients were neither top nor bottom performers for younger patients. In contrast, most top and bottom performers for older patients were also top and bottom performers for all patients. Similarly, HVBP achievement scores for older patients correlated weakly with those for younger patients (R = 0.30) and strongly with those for all patients (R = 0.92).Limitation: Minority of U.S. hospitals.Conclusion: Hospital mortality rankings for older patients with AMI inconsistently reflect rankings for younger patients. Incorporation of younger patients into assessment of hospital outcomes would permit further examination of the presence and effect of age-related quality differences.Primary Funding Source: American College of Cardiology. [ABSTRACT FROM AUTHOR]

Background: The direct oral anticoagulants (DOACs) reduce the risk of stroke in moderate to high-risk patients with non-valvular atrial fibrillation (AF). Yet, concerns remain regarding its routine use in real world practice. We sought to describe adherence patterns and the association between adherence and outcomes to the DOACs among outpatients with AF.Methods: We performed a retrospective cohort study of patients in the VA Healthcare System who initiated pharmacotherapy with dabigatran, rivaroxaban, or apixaban between November 2010 and January 2015 for non-valvular AF with CHA2DS2-VASc score ≥ 2. Adherence was determined using pharmacy refill data and estimated by the proportion of days covered (PDC) over the first year of therapy. Clinical outcomes, including all-cause mortality and stroke, were measured at 6 months and used to assess measures of adherence for each DOAC.Results: A total of 2882 patients were included. Most were prescribed dabigatran (72.7%), compared with rivaroxaban (19.8%) or apixaban (7.5%). The mean PDC was 0.84 ± 0.20 for dabigatran, 0.86 ± 0.18 for rivaroxaban, and 0.89 ± 0.14 for apixaban (p < 0.01). The proportion of non-adherent patients, PDC <0.80, was 27.6% for all and varied according DOAC. Lower adherence to dabigatran was associated with higher risk of mortality and stroke (HR 1.07; 1.03-1.12 per 0.10 decline in PDC).Conclusions: In a real-world VA population being prescribed anticoagulation for AF, more than one quarter had sub-optimal adherence. Lower adherence was associated with a higher risk of mortality and stroke. Efforts identifying non-adherent patients, and targeted adherence interventions are needed to improve outcomes. [ABSTRACT FROM AUTHOR]

Objective: Patients with chronic kidney disease (CKD) have higher risk of sudden cardiac death; however, they may not receive implantable cardioverter defibrillators (ICDs), in part due to higher risk of complications. We evaluated whether CKD is associated with greater risk of device-delivered shocks/antitachycardia pacing (ATP) therapies among patients receiving a primary prevention ICD.Methods: We studied participants in the observational Cardiovascular Research Network Longitudinal Study of Implantable Cardioverter Defibrillators. CKD was defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Outcomes included all delivered shocks/ATPs therapies and type of shock/ATP therapies (inappropriate or appropriate, determined by physician adjudication) within the 3 years. We evaluated the associations between CKD and time to first device therapy, burden of device therapy, and inappropriate versus appropriate device therapy, adjusting for demographics, comorbidity, laboratory values and medication use.Results: Among 2161 participants, 1066 (49.3%) had CKD (eGFR 44±11 mL/min/1.73 m2) at ICD implantation. During mean of 2.26±0.89 years, 9.8% and 18.5% of participants had at least one inappropriate and appropriate shock/ATP therapies, respectively. CKD was not associated with time to first shock/ATP therapies (adjusted HR 0.87, 95% CI 0.73 to 1.05), overall burden of shock/ATP therapies (adjusted relative rate 0.93, 95% CI 0.74 to 1.17) or inappropriate versus appropriate shock/ATP therapies (adjusted relative risk 0.88, 95% CI 0.68 to 1.14) compared with not having CKD.Conclusions: In adults receiving a primary prevention ICD, mild-to-moderate CKD was not associated with the timing, burden or appropriateness of subsequent device therapy. Potential concern for inappropriate ICD-delivered therapies should not preclude ICDs among eligible patients with CKD. [ABSTRACT FROM AUTHOR]

Objective: To assess patient- and hospital-level factors associated with home health care (HHC) referrals following nonelective U.S. patient hospitalizations in 2012.Data Source: The 2012 National Inpatient Sample (NIS).Study Design: Retrospective, cross-sectional multivariable logistic regression modeling to assess patient- and hospital-level variables in patient discharges with versus without HHC referrals.Data Collection: Analysis included 1,109,905 discharges in patients ≥65 years with Medicare.Principal Findings: About 29.2 percent of discharges were referred to HHC, which were more likely with older age, female sex, urban location, low income, longer length of stay, higher severity of illness scores, diagnoses of heart failure or sepsis, and hospital location in New England (referent: Pacific).Conclusions: As health policy changes influence postacute HHC, defining specific diagnoses and regional patterns associated with HHC is a first step to optimize postacute HHC services. [ABSTRACT FROM AUTHOR]

Background When patients are not adequately engaged in decision making, they may be at risk of decision regret. Our objective was to explore patients' perceptions of their decision-making experiences related to implantable cardioverter defibrillators (ICDs). Methods Cross-sectional, mailed survey of 412 patients who received an ICD without cardiac resynchronization therapy for any indication between 2006 and 2009. Patients were asked about decision participation and decision regret. Results A total of 295 patients with ICDs responded (72% response rate). Overall, 79% reported that they were as involved in the decision as they wanted. However, 28% reported that they were not told of the option of not getting an ICD and 37% did not remember being asked if they wanted an ICD. In total, 19% reported not wanting their ICD at the time of implantation. Those who did not want the ICD were younger (<65 years; 74% vs 43%, P < 0.001), had higher decision regret (31/100 vs 11/100, P < 0.001), and reported less participation in decision making (the doctor 'totally' made the decision, 9% vs 3%; P < 0.001). Conclusions A considerable number of ICD recipients recalled not wanting their ICD at the time of implantation. While these findings may be prone to recall bias, they likely identify opportunities to improve ICD decision making. [ABSTRACT FROM AUTHOR]

Objectives To determine the prognostic value of slow gait in predicting outcomes 1 year after acute myocardial infarction ( AMI). Design Observational cohort with longitudinal follow-up. Setting Twenty-four U.S. hospitals participating in the Translational Research Investigating Underlying disparities in recovery from acute Myocardial infarction: Patients' Health status Registry. Participants Older adults (≥65) with in-home gait assessment 1 month after AMI (N = 338). Measurements Baseline characteristics and 1-year mortality or hospital readmission adjusted using Cox proportional hazards regression in older adults with slow (<0.8 m/s) versus preserved (≥0.8 m/s) gait speed. Results Slow gait was present in 181 participants (53.6%). Those with slow gait were older, more likely to be female and nonwhite, and had a higher prevalence of heart failure and diabetes mellitus. They were also more likely to die or be readmitted to the hospital within 1 year than those with preserved gait (35.4% vs 18.5%, log-rank P = .006). This association remained significant after adjusting for age, sex, and race (slow vs preserved gait hazard ratio ( HR) = 1.76, 95% confidence interval ( CI)=1.08-2.87, P = .02) but was no longer significant after adding clinical factors ( HR = 1.23, 95% CI=0.74-2.04, P = .43). Conclusion Slow gait, a marker of frailty, is common 1 month after AMI in older adults and is associated with nearly twice the risk of dying or hospital readmission at 1 year. Understanding its prognostic importance independent of comorbidities and whether routine testing of gait speed can improve care requires further investigation. [ABSTRACT FROM AUTHOR]

Importance: Little contemporary information is available about comparative performance between Veterans Affairs (VA) and non-VA hospitals, particularly related to mortality and readmission rates, 2 important outcomes of care.Objective: To assess and compare mortality and readmission rates among men in VA and non-VA hospitals.Design, Setting, and Participants: Cross-sectional analysis involving male Medicare fee-for-service beneficiaries aged 65 years or older hospitalized between 2010 and 2013 in VA and non-VA acute care hospitals for acute myocardial infarction (AMI), heart failure (HF), or pneumonia using the Medicare Standard Analytic Files and Enrollment Database together with VA administrative claims data. To avoid confounding geographic effects with health care system effects, we studied VA and non-VA hospitals within the same metropolitan statistical area (MSA).Exposures: Hospitalization in a VA or non-VA hospital in MSAs that contained at least 1 VA and non-VA hospital.Main Outcomes and Measures: For each condition, 30-day risk-standardized mortality rates and risk-standardized readmission rates for VA and non-VA hospitals. Mean aggregated within-MSA differences in mortality and readmission rates were also assessed.Results: We studied 104 VA and 1513 non-VA hospitals, with each condition-outcome analysis cohort for VA and non-VA hospitals containing at least 7900 patients (men; ≥65 years), in 92 MSAs. Mortality rates were lower in VA hospitals than non-VA hospitals for AMI (13.5% vs 13.7%, P = .02; -0.2 percentage-point difference) and HF (11.4% vs 11.9%, P = .008; -0.5 percentage-point difference), but higher for pneumonia (12.6% vs 12.2%, P = .045; 0.4 percentage-point difference). In contrast, readmission rates were higher in VA hospitals for all 3 conditions (AMI, 17.8% vs 17.2%, 0.6 percentage-point difference; HF, 24.7% vs 23.5%, 1.2 percentage-point difference; pneumonia, 19.4% vs 18.7%, 0.7 percentage-point difference, all P < .001). In within-MSA comparisons, VA hospitals had lower mortality rates for AMI (percentage-point difference, -0.22; 95% CI, -0.40 to -0.04) and HF (-0.63; 95% CI, -0.95 to -0.31), and mortality rates for pneumonia were not significantly different (-0.03; 95% CI, -0.46 to 0.40); however, VA hospitals had higher readmission rates for AMI (0.62; 95% CI, 0.48 to 0.75), HF (0.97; 95% CI, 0.59 to 1.34), or pneumonia (0.66; 95% CI, 0.41 to 0.91).Conclusions and Relevance: Among older men with AMI, HF, or pneumonia, hospitalization at VA hospitals, compared with hospitalization at non-VA hospitals, was associated with lower 30-day risk-standardized all-cause mortality rates for AMI and HF, and higher 30-day risk-standardized all-cause readmission rates for all 3 conditions, both nationally and within similar geographic areas, although absolute differences between these outcomes at VA and non-VA hospitals were small. [ABSTRACT FROM AUTHOR]

Background: Geriatric conditions may influence outcomes among patients receiving implantable cardioverter-defibrillators (ICDs). We sought to determine the prevalence of frailty and dementia among older adults receiving primary prevention ICDs and to determine the impact of multimorbidity on mortality within 1 year of ICD implantation.Methods and Results: The cohort included 83 792 Medicare patients from the National Cardiovascular Data Registry ICD Registry who underwent first primary prevention ICD implantation between 2006 and 2009. These data were merged with Medicare analytic files to determine the prevalence of frailty, dementia, and other conditions before ICD implantation, as well as 1-year mortality. A validated claim-based algorithm was used to identify frail patients. Mutually exclusive patterns of chronic conditions were examined. The association of each pattern with 1-year mortality was assessed using logistic regression models adjusted for selected patient characteristics. Approximately 1 in 10 Medicare patients with heart failure receiving a primary prevention ICD had frailty (10%) or dementia (1%). One-year mortality was 22% for patients with frailty, 27% for patients with dementia, and 12% in the overall cohort. Several multimorbidity patterns were associated with high 1-year mortality rates: dementia with frailty (29%), frailty with chronic obstructive pulmonary disease (25%), and frailty with diabetes mellitus (23%). These patterns were present in 8% of the cohort.Conclusions: More than 10% of Medicare beneficiaries with heart failure receiving primary prevention ICDs have frailty or dementia. These patients had significantly higher 1-year mortality than those with other common chronic conditions. Frailty and dementia should be considered in clinical decision-making and guideline development. [ABSTRACT FROM AUTHOR]

Heart failure disproportionately affects the older population. Approximately 80% of all cases of heart failure in the United States occur in persons aged 65 years and older. It is associated with very poor long-term survival, with a minority surviving 5 years after diagnosis. In the older population, heart failure accounts for more hospital admissions than any other single condition. Following hospitalization for heart failure, older persons are at high risk for re-hospitalization: nearly half are readmitted within 6 months. The economic impact of the condition is thus dramatic. Despite the importance of heart failure in the older population, there is a dearth of research specifically targeting this group. This review highlights the importance of heart failure in the older population and identifies the specific areas where research and policy initiatives may be instrumental in reducing the impact of the condition. [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: Despite calls to expand measurement of acute myocardial infarction (AMI) outcomes to include symptom burden, little has been done to describe hospital-level variation in this patient-centered outcome, or its association with mortality. Understanding the relationship between symptoms and longer-term mortality could inform the importance of these outcomes for monitoring quality of care.Methods and Results: Among 4316 patients with AMI treated at 24 hospitals participating in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) study, we assessed risk-standardized 1-year symptom burden as measured by the Seattle Angina Questionnaire Angina Frequency Score and mortality attributed to the hospital that provided AMI care. Median odds ratios were used to assess outcome variation and reflect the relative odds of an outcome for 2 patients with identical covariates at different, randomly selected, hospitals. We then evaluated the correlation between hospital-level mortality and angina. Finally, we determined the extent to which variation in mortality and angina was explained by achievement of AMI performance measures. We observed hospital variation in risk-adjusted 1-year mortality (range, 4.9%-8.6%; median odds ratio, 1.30; P=0.01) and angina (range, 17.7%-29.4%; median odds ratio, 1.34; P<0.001). At the hospital level, mortality and angina at 1 year were weakly correlated (r=0.40; 95% confidence interval, 0.00-0.68; P=0.05). Accounting for the quality of AMI care did not attenuate variation in risk-adjusted 1-year mortality or angina.Conclusions: Symptom burden and mortality vary at the hospital level after AMI and are only weakly correlated. These findings suggest that symptom burden should be considered a separate quality domain that is not well captured by current quality metrics. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this report was to characterize the patients, participating centers, and measures of quality of care and outcomes for 5 NCDR (National Cardiovascular Data Registry) programs: 1) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry–GWTG (Get With The Guidelines) for acute coronary syndromes; 2) CathPCI Registry for coronary angiography and percutaneous coronary intervention; 3) CARE (Carotid Artery Revascularization and Endarterectomy) Registry for carotid revascularization; 4) ICD Registry for implantable cardioverter defibrillators; and the 5) PINNACLE (Practice INNovation And CLinical Excellence) Registry for outpatients with cardiovascular disease (CVD). Background: CVD is a leading cause of death and disability in the United States. The quality of care for patients with CVD is suboptimal. National registry programs, such as NCDR, permit assessments of the quality of care and outcomes for broad populations of patients with CVD. Methods: For the year 2011, we assessed for each of the 5 NCDR programs: 1) demographic and clinical characteristics of enrolled patients; 2) key characteristics of participating centers; 3) measures of processes of care; and 4) patient outcomes. For selected variables, we assessed trends over time. Results: In 2011 ACTION Registry–GWTG enrolled 119,967 patients in 567 hospitals; CathPCI enrolled 632,557 patients in 1,337 hospitals; CARE enrolled 4,934 patients in 130 hospitals; ICD enrolled 139,991 patients in 1,435 hospitals; and PINNACLE enrolled 249,198 patients (1,436,328 individual encounters) in 74 practices (1,222 individual providers). Data on performance metrics and outcomes, in some cases risk-adjusted with validated NCDR models, are presented. Conclusions: The NCDR provides a unique opportunity to understand the characteristics of large populations of patients with CVD, the centers that provide their care, quality of care provided, and important patient outcomes. [Copyright &y& Elsevier]

Aims: The NCDR CathPCI Registry collects detailed clinical, process-of-care and outcomes data for patients undergoing coronary angiography and percutaneous coronary intervention (PCI) in the USA. The registry contributes to quality of care by providing data feedback on a wide range of performance metrics to participating centres and by facilitating local and national quality improvement efforts. Interventions: No treatments are mandated, participating centres receive routine quality-of-care and outcomes performance feedback reports and access to a quality dashboard for personalized performance reports. Population: Patients undergoing cardiac catheterization and PCI are retrospectively identified. No informed consent is required, as data are anonymised. From inception in 1998, more than 12 million records have been submitted from 1577 participating US centres. Baseline data: Approximately 250 fields encompassing patient demographics, medical history and risk factors, hospital presentation, initial cardiac status, procedural details, medications, laboratory values, and in-hospital outcomes. Linkages with outside sources of data have permitted longitudinal outcomes assessment in some cases. Centre personnel enter the data into the registry, in some cases facilitated by software vendors. There are non-financial incentives for centre participation. Data completeness is noteworthy with most fields missing at rates less than 5%. A comprehensive data quality program is employed to enhance data validity. Endpoints: Main outcome measures include quality process metrics and in-hospital patient outcomes. Data are available for research by application to: http://www. ncdr.com [ABSTRACT FROM AUTHOR]

Heart failure (HF) is a major cause of mortality and morbidity, representing a leading cause of death and hospitalization among U.S. Medicare beneficiaries. Advances in science have generated effective interventions to reduce adverse outcomes in HF, particularly in patients with reduced left ventricular ejection fraction. Unfortunately, effective therapies for heart failure are often not utilized in an effective, safe, timely, equitable, patient-centered, and efficient manner. Further, the risk of adverse outcomes for HF remains high. The last decades have witnessed the growth of efforts to measure and improve the care and outcomes of patients with HF. This paper will review the evolution of quality measurement for HF, including a brief history of quality measurement in medicine; the measures that have been employed to characterize quality in heart failure; how the measures are obtained; how measures are employed; and present and future challenges surrounding quality measurement in heart failure. [ABSTRACT FROM AUTHOR]

The article investigates acculturation and outcomes among patients with heart failure (HF) in the U.S. The authors note that cultural and language differences may be important determinants of health outcomes among minority patients with chronic conditions like HF, requiring frequent healthcare system interactions. Results showed that patients with HF who are foreign-born and do not speak English have a greater rehospitalization risk independent of clinical factors and race or ethnicity.

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

The article discusses the relevance of percutaneous coronary intervention (PCI), which is performed in about 600,000 cases in the U.S. per year and costs a total of 12 billion U.S. dollars. In a study conducted by the authors to understand the need for the procedure, they use data from the National Cardiovascular Data Registry between July 1, 2009 and September 30, 2010 with an aim of finding the proportion of appropriate, uncertain or inappropriate PCI. They conclude that most PCIs done in the U.S. were appropriate with only 12% being tagged as inappropriate.

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.

A reprint of the report "AACVPR/ACCF/AHA 2010 Update: Performance Measures on Cardiac Rehabilitation for Referral to Cardiac Rehabilitation /Secondary Prevention Services," by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Task Force on Performance Measures, is presented. It focuses on the leadership role taken by these associations in developing measures of the quality of care for cardiovascular disease (CVD).

The article discusses the findings of a research which validated risk score for in-hospital mortality in patients with heart failure from the American Heart Association's Get With the Guidelines-Heart Failure program. The identified independent predictors of in-hospital death were age, admission systolic blood pressure, blood urea nitrogen, heart rate, sodium, the presence of chronic obstructive pulmonary disease, and non-African American race. Results showed that the predicted risk of in-hospital death varied by greater than 24-fold across deciles.

The article focuses on an observational study which estimated hospital-level 30-day risk-standardized mortality rates (RSMRs) for patients discharged with acute myocardial infarction (AMI). Administrative data and a validated risk model were used to evaluate 3,195,672 discharges in 2,755,370 patients discharged from nonfederal acute care hospitals in the U.S. between January 1, 1995 to December 31, 2006. A significant decrease was observed in the risk-standardized hospital mortality rate for Medicare patients discharged with AMI, as well as between-hospital variation.

The article presents a study which examines the glucose normalization among patients with acute myocardial infarction in the U.S. It states that high blood glucose levels on hospital admission have connection with increased mortality in patients with acute myocardial infarction. It concludes that glucose normalization after hospital admission is associated with better survival in hyperglycemic patients with acute myocardial infarction whether or not they receive insulin therapy. It highlights the need for effective strategy on intentional glucose lowering with insulin therapy.

Background: Although it is known that reperfusion therapy for ST-elevation myocardial infarction (STEMI) is underused, the reasons for the failure to provide this potentially life-saving treatment are not well described. Methods: In a cohort of 2215 consecutive patients presenting with acute myocardial infarction to 5 emergency departments in Colorado and California between 2000 and 2002, patients with ischemic symptoms and ST-segment elevation on electrocardiogram without documented guideline-based contraindications to therapy were identified as eligible reperfusion candidates. Multivariable logistic models were constructed to identify factors associated with the failure to receive reperfusion. The emergency department records of patients not receiving reperfusion were reviewed to categorize the reasons therapy was not provided. Results: Of 460 eligible patients, 102 (22%) did not receive reperfusion therapy. Patient factors associated with failure to receive reperfusion therapy included older age, peripheral vascular disease, and absence of chest pain; patients seen by both resident and attending physicians were more likely to receive treatment than those seen by an attending alone. In cases where reperfusion was not provided, ST-segment elevation was not identified in 34% (n = 35), left bundle-branch block was not considered as an indication in 13% (n = 13), there was documentation of a reason for withholding therapy not supported by guidelines in 34% (n = 35), and there was no documentation of reasons for withholding reperfusion in 19% (n = 19). Conclusions: Initiatives to improve electrocardiogram interpretation and evidence-based patient selection may reduce gaps in the delivery of reperfusion therapy to eligible candidates and thereby potentially improve STEMI outcomes. [ABSTRACT FROM AUTHOR]

Background Polypharmacy—the concurrent prescription of multiple medications—is a salient consideration in the care of older patients with heart failure. Little is known, however, about the complexity and financial burden of medical therapy in this population. Methods This is a study of the chronic medications prescribed at hospital discharge to patients 65 years or older hospitalized for heart failure in 2 cohorts separated by 27 months (April 1998–March 1999, n = 31 602; July 2000–June 2001, n = 30 774). Three utilization measures were assessed: the number of drugs, the estimated number of doses per day, and the estimated annual costs using the same cost standard (2003 average wholesale prices) for both samples. Utilization associated with population characteristics and between time frames was assessed in multivariable models. Results In 1998-1999, the mean number of drugs was 6.8, representing 10.1 doses daily at a cost of $3142/y, increasing to 7.5 drugs, 11.1 doses daily and $3823/y in 2000-2001 (P<.001 for all comparisons). After adjustment, the number of drugs increased by 12% and costs by 24% between samples. Factors associated with greater complexity and cost included diabetes (1.6 additional drugs and $1094/y additional cost), prior revascularization (1.3 drugs, $1154/y), and chronic lung disease (1.2 drugs, $814/y). Younger age and white race were also associated with more drugs and higher costs. Conclusions The drug treatment of older patients with heart failure is characterized by rapidly increasing complexity and cost. Efforts should be directed toward optimizing the complex drug regimens of elderly patients with heart failure and multiple comorbidities. [ABSTRACT FROM AUTHOR]

Purpose: Racial differences in the treatment of patients with myocardial infarction are often presented as nationally consistent patterns of care, despite known regional variations in quality of care. We sought to determine whether racial differences in myocardial infarction treatment vary by U.S. census region.Methods: We conducted a retrospective analysis of medical record data from 138,938 elderly fee-for-service Medicare beneficiaries hospitalized with myocardial infarction between 1994 and 1996. Patients were evaluated for the use (admission, discharge) of aspirin and beta-blockers, and cardiac procedures (cardiac catheterization, any coronary revascularization) within 60 days of admission.Results: Nationally, black patients had lower crude rates of aspirin and beta-blocker use, cardiac catheterization, and coronary revascularization than did white patients. Racial differences in treatment, however, varied by region. Black patients in the Northeast had rates of aspirin use that were similar to those of white patients on admission (50.6% vs. 49.8%, P = 0.58) and at discharge (77.5% vs. 74.2%, P = 0.07), whereas racial differences were observed in the South (admission: 43.7% vs. 48.8%, P <0.001; discharge: 69.5% vs. 73.2%, P <0.001), Midwest (admission: 48.4% vs. 52.3%, P = 0.004), and West (admission: 49.2% vs. 56.2%, P <0.001; discharge: 70.7% vs. 76.2%, P = 0.02). Racial differences in beta-blocker use were comparable across regions (admission: P = 0.59, discharge: P = 0.89). There were no differences in cardiac catheterization use among black and white patients in the Northeast (38.9% vs. 40.5%, P = 0.24), as opposed to the Midwest (43.3% vs. 48.9%, P <0.001), South (39.2% vs. 48.5%, P <0.001), and West (38.3% vs. 48.6%, P <0.001). Similarly, racial differences in any coronary revascularization use were smallest in the Northeast (22.1% vs. 26.7%, P <0.001), greater in the Midwest (24.7% vs. 33.5%, P <0.001), and largest in the South (20.7% vs. 32.0%, P <0.001) and West (22.9% vs. 33.7%, P <0.001). Regional variations in racial differences persisted after multivariable adjustment for aspirin on admission (P = 0.09) and any coronary revascularization (P = 0.10).Conclusion: Racial differences in the use of some therapies for myocardial infarction in patients hospitalized between 1994 and 1996 varied by region, suggesting that national evaluations of racial differences in health care use may obscure potentially important regional variations. [ABSTRACT FROM AUTHOR]

Context: According to package inserts, metformin is contraindicated in diabetic patients receiving drug treatment for heart failure therapy, and thiazolidinediones are not recommended in diabetic patients with symptoms of advanced heart failure. Little is known about patterns of use of these antihyperglycemic drugs in diabetic patients with heart failure. Objective: To determine the proportions of patients hospitalized with heart failure and concomitant diabetes treated with metformin or thiazolidinediones. Design: Serial cross-sectional measurements using data from retrospective medical record abstraction. Setting: Nongovernmental acute care hospitals in the United States. Patients: Two nationally representative samples of Medicare beneficiaries hospitalized with the primary diagnosis of heart failure and concomitant diabetes between April 1998 and March 1999 and between July 2000 and June 2001. Main Outcome Measures: The prescription of either metformin or a thiazolidinedione at hospital discharge. Results: In the 1998-1999 sample (n = 12 505), 7.1% of patients were discharged with a prescription for metformin, 7.2% with a prescription for a thiazolidinedione, and 13.5% with a prescription for either drug. In the 2000-2001 sample (n = 13 158), metformin use increased to 11.2%, thiazolidinedione use to 16.1%, and use of either drug to 24.4% (P<.001 for all comparisons). Similar increases were seen among patients of all age groups, all races, and both sexes. Conclusions: The use of metformin and thiazolidinediones is common and has increased rapidly in Medicare beneficiaries with diabetes and heart failure in direct contrast with explicit warnings against this practice by the Food and Drug Administration. Further studies to establish the safety and effectiveness of this practice are needed to ensure optimal care of patients with diabetes and heart failure. [ABSTRACT FROM AUTHOR]

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

The author reflects on the work of the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Task Force on performance measurement in cardiovascular disease. He claims that clinicians recognize the variability in care and outcomes that characterizes clinical practice in the U.S. He believes that clinician engagement is viable with rigorous supporting methodology. He mentions the development of measures such as the use of composite measures to characterize processes of care.

A letter to the editor is presented which discusses home health care (HHC) referrals upon hospital discharge in the U.S. between 2001 and 2012.

Background: Over the past 2 decades, guidelines for digoxin use have changed significantly. However, little is known about the national-level trends of digoxin use, hospitalizations for toxicity, and subsequent outcomes over this time period.Methods: To describe digoxin prescription trends, we conducted a population-level, cohort study using data from IQVIA, Inc.'s National Prescription Audit (2007-2014) for patients aged ≥65 years. Further, in a national cohort of Medicare fee-for-service beneficiaries aged ≥65 years in the United States, we assessed temporal trends of hospitalizations associated with digoxin toxicity and the outcomes of these hospitalizations between 1999 and 2013.Results: From 2007 through 2014, the number of digoxin prescriptions dispensed decreased by 46.4%; from 8,099,856 to 4,343,735. From 1999 through 2013, the rate of hospitalizations with a principal or secondary diagnosis of digoxin toxicity decreased from 15 to 2 per 100,000 person-years among Medicare fee-for-service beneficiaries. In-hospital and 30-day mortality rates associated with hospitalization for digoxin toxicity decreased significantly among Medicare fee-for-service beneficiaries; from 6.0% (95% confidence interval [CI], 5.2-6.8) to 3.7% (95% CI, 2.2-5.7) and from 14.0% (95% CI, 13.0-15.2) to 10.1% (95% CI, 7.6-13.0), respectively. Rates of 30-day readmission for digoxin toxicity decreased from 23.5% (95% CI, 22.1-24.9) in 1999 to 21.7% (95% CI, 18.0-25.4) in 2013 (P < .05).Conclusion: While digoxin prescriptions have decreased, it is still widely prescribed. However, the rate of hospitalizations for digoxin toxicity and adverse outcomes associated with these hospitalizations have decreased. These findings reflect the changing clinical practice of digoxin use, aligned with the changes in clinical guidelines. [ABSTRACT FROM AUTHOR]

Discusses whether prescribing aspirin and ibuprofen to patients being discharged after myocardial infarction is associated with an increased risk of death. Use of the database compiled by the Cooperative Cardiovascular Project in the United States; Number of Medicare patients in the study; Finding that the two drugs did not interact adversely; Possible bias in this research; Limitations of another study that concluded patients who received combined therapy were at an increased risk of death.

The National Cardiovascular Data Registry is a group of registries maintained by the American College of Cardiology Foundation. These registries are used by a diverse constituency to improve the quality and outcomes of cardiovascular care, to assess the safety and effectiveness of new therapies, and for research. To achieve these goals, registry data must be complete and reliable. In this article, we review the process of National Cardiovascular Data Registry data collection, assess data completeness and integrity, and report on the current state of the data. Registry data are complete. Accuracy is very good but variable, and there is room for improvement. Knowledge of the quality of data is essential to ensuring its appropriate use. [ABSTRACT FROM AUTHOR]

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

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

Background: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.Objectives: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.Methods: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.Results: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare.Conclusions: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials. [ABSTRACT FROM AUTHOR]

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

Background: Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve.Objectives: The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes.Methods: The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events.Results: Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003), and bleeding (p < 0.001) but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57% to 2.15%), bleeding (9.56% to 5.08%), vascular complications (6.11% to 4.20%), and stroke (2.03% to 1.66%). Vascular and bleeding volume-outcome associations were nonlinear with a higher risk of adverse outcomes in the first 100 cases. An association of procedure volume with risk-adjusted outcomes was also seen in the subgroup having transfemoral access.Conclusions: The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume-outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528). [ABSTRACT FROM AUTHOR]

Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements. This review will examine the current landscape of cardiovascular clinical trials in the United States, highlight recently conducted registry-based clinical trials, and discuss the potential attributes of the recently launched pragmatic clinical trial by the Patient-Centered Outcomes Research Institute's National Patient-Centered Clinical Research Network, called the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing the Benefits and Long-term Effectiveness) trial. [ABSTRACT FROM AUTHOR]

Background: Hyperkalemia is common and potentially dangerous in hospitalized patients; its contemporary prevalence and prognostic importance after acute myocardial infarction are not well described.Methods: In 38,689 consecutive patients with acute myocardial infarction from the Cerner Health Facts database, we evaluated the association between maximum in-hospital potassium levels and in-hospital mortality. Patients were stratified by dialysis status and grouped by maximum potassium as follows: <5 mEq/L, 5 to <5.5 mEq/L, 5.5 to <6.0 mEq/L, 6.0 to <6.5 mEq/L, and ≥6.5 mEq/L. Multivariable logistic regression was used to adjust for multiple patient and site characteristics. The relationship between the number of hyperkalemic values and the in-hospital mortality was evaluated.Results: Of 38,689 patients with acute myocardial infarction, 886 were on dialysis. The rate of hyperkalemia (maximum potassium ≥5.0 mEq/L) was 22.6% in patients on dialysis and 66.8% in patients not on dialysis. Moderate to severe hyperkalemia (maximum potassium ≥5.5 mEq/L) occurred in 9.8% of patients. There was a steep increase in mortality with higher maximum potassium levels. In-hospital mortality exceeded 15% once maximum potassium was ≥5.5 mEq/L regardless of dialysis status. The relationship between higher maximum potassium and increased mortality risk persisted after multivariable adjustment. In addition, patients with a greater number of hyperkalemic values (vs a single value) experienced higher in-hospital mortality.Conclusions: Hyperkalemia is common in patients who are hospitalized with acute myocardial infarction. Higher maximum potassium levels and number of hyperkalemic events are associated with a steep mortality increase, with higher risks for adverse outcomes observed even at mild levels of hyperkalemia. Whether more intensive management of hyperkalemia may improve outcomes in patients with acute myocardial infarction merits further study. [ABSTRACT FROM AUTHOR]

Public reporting has been proposed as a strategy to improve health care quality. Percutaneous coronary interventions (PCIs) performed in the United States from July 1, 2009, to June 30, 2011, included in the CathPCI Registry were identified (n = 1,340,213). Patient characteristics and predicted and observed in-hospital mortality were compared between patients treated with PCI in states with mandated public reporting (Massachusetts, New York, Pennsylvania) and states without mandated public reporting. Most PCIs occurred in states without mandatory public reporting (88%, n = 1,184,544). Relative to patients treated in nonpublic reporting states, those who underwent PCI in public reporting states had similar predicted in-hospital mortality (1.39% vs 1.37%, p = 0.17) but lower observed in-hospital mortality (1.19% vs 1.41%, adjusted odds ratio [ORadj] 0.80; 95% confidence interval [CI] 0.74, 0.88; p <0.001). In patients for whom outcomes were available at 180 days, the differences in mortality persisted (4.6% vs 5.4%, ORadj 0.85, 95% CI 0.79 to 0.92, p <0.001), whereas there was no difference in myocardial infarction (ORadj0.97,95% CI 0.89 to 1.07) or revascularization (ORadj1.05,95% CI 0.92 to 1.20). Hospital readmissions were increased at 180 days in patients who underwent PCI in public reporting states (ORadj 1.08,95% CI 1.03 to 1.12, p = 0.001). In conclusion, patients who underwent PCI in states with mandated public reporting of outcomes had similar predicted risks but significantly lower observed risks of death during hospitalization and in the 6 months after PCI. These findings support considering public reporting as a potential strategy for improving outcomes of patients who underwent PCI although further studies are warranted to delineate the reasons for these differences. [ABSTRACT FROM AUTHOR]

The article presents the Statement on Cost/Value Methodology in Clinical Practice Guideline and Performance Measures issued by the American College of Cardiology and the American Heart Association (ACC/AHA). Topics discussed in the statement include the sustainability of the healthcare system in the U.S., the arguments in favor of incorporating resource and value considerations, and the recommendations for value assessment.

To improve hospital performance in door-to-balloon (DTB) times nationally, the American College of Cardiology D2B Alliance recently enrolled approximately 1,000 hospitals that perform percutaneous coronary intervention (PCI) across the United States in a large national quality improvement effort. We evaluated recent changes in DTB times in hospitals within the Get-With-The-Guidelines (GWTG) Coronary Artery Disease (CAD) program, a partner in the D2B Alliance. Within GWTG-CAD participating hospitals, we studied DTB in nontransferred patients with ST-elevation myocardial infarction treated with primary PCI from July 2006 to March 2008. We evaluated the percentage of patients treated within 90 minutes and used multivariable models with generalized estimating equations to examine trends over time after accounting for changes in patients'' characteristics. A total of 5,801 patients at 167 hospitals were included in our analysis, with 3,567 patients at 98 hospitals that joined the D2B Alliance. From July to September 2006, 54.1% of patients received primary PCI within 90 minutes. This number increased significantly during the study period: 335 (74.1%) of 452 patients at GWTG-CAD participating hospitals were treated within 90 minutes from January to March 2008, including 229 of 304 patients (75.3%) treated at hospitals that joined the D2B Alliance and 106 of 148 patients (71.6%) treated at other GWTG-CAD participating hospitals (p <0.001 for all comparisons over time). No statistically significant differences were noted in the rate of change between hospitals that joined the D2B Alliance and other GWTG-CAD participating hospitals. In conclusion, the percentage of patients treated with 90 minutes has dramatically increased at hospitals participating within the GWTG-CAD program, coinciding with the launch of the D2B Alliance. These improvements were broad and not limited to hospitals that joined the D2B Alliance. [Copyright &y& Elsevier]

Background: Left ventricular hypertrophy is a major independent risk factor for cardiovascular mortality. The contribution of left ventricular hypertrophy to racial and ethnic differences in cardiovascular mortality is poorly understood.Methods: We used data from the Third National Health and Nutrition Examination Survey and from the National Death Index to compare mortality for those with an electrocardiographic (ECG) diagnosis of left ventricular hypertrophy to those without left ventricular hypertrophy separately for whites, African Americans, and Latinos. We used Cox proportional hazards regression to control for other known prognostic factors.Results: ECG left ventricular hypertrophy was significantly associated with 10-year cardiovascular mortality in all 3 racial/ethnic groups, both unadjusted and adjusted for other known prognostic factors. The hazard ratio for this association was significantly greater for African Americans (2.31; 95% confidence interval [CI], 1.55-3.42) than for whites and Latinos (1.32; 95% CI, 1.14-1.76 and 2.11; 95% CI, 1.35-3.30, respectively), independent of systolic blood pressure.Conclusions: ECG left ventricular hypertrophy contributes more to the risk of cardiovascular mortality in African Americans than it does in whites. Using regression of ECG left ventricular hypertrophy as a goal of therapy might be a means to reduce racial differences in cardiovascular mortality; prospective validation is required. [ABSTRACT FROM AUTHOR]

Safety-net hospitals are experiencing increasing financial strains, possibly affecting their quality of care. We compare quality at safety-net and non-safety-net urban hospitals for Medicare beneficiaries admitted with acute myocardial infarction (AMI). Although safety-net hospitals had modestly higher risk-standardized thirty-day all-cause mortality rates and modestly lower adherence to quality-of-care performance measures than non-safety-net hospitals, there was much heterogeneity among safety-net hospitals and substantial overlap with non-safety-net hospitals. We examine the implications of these findings for the millions of vulnerable Americans who rely on safety-net hospitals for their care. [ABSTRACT FROM AUTHOR]

Importance: Despite advances in treatment and care quality for patients hospitalized with heart failure (HF), minimal improvement in mortality has been observed after HF hospitalization since 2010., Objective: To evaluate trends in mortality rates across specific intervals after hospitalization., Design, Setting, and Participants: This cohort study evaluated a random sample of Medicare fee-for-service beneficiaries with incident HF hospitalization from January 1, 2008, to December 31, 2018. Data were analyzed from February 2023 to May 2024., Main Outcomes and Measures: Unadjusted mortality rates were calculated by dividing the number of all-cause deaths by the number of patients with incident HF hospitalization for the following periods: in-hospital, 30 days (0-30 days after hospital discharge), short term (31 days to 1 year after discharge), intermediate term (1-2 years after discharge), and long term (2-3 years after discharge). Each period was considered separately (ie, patients who died during one period were not counted in subsequent periods). Annual unadjusted and risk-adjusted mortality ratios were calculated (using logistic regression to account for differences in patient characteristics), defined as observed mortality divided by expected mortality based on 2008 rates., Results: A total of 1 256 041 patients (mean [SD] age, 83.0 [7.6] years; 56.0% female; 86.0% White) were hospitalized with incident HF. There was a substantial decrease in the mortality ratio for the in-hospital period (unadjusted ratio, 0.77; 95% CI, 0.67-0.77; risk-adjusted ratio, 0.74; 95% CI, 0.71-0.76). For subsequent periods, mortality ratios increased through 2013 and then decreased through 2018, resulting in no reductions in unadjusted postdischarge mortality during the full study period (30-day mortality ratio, 0.94; 95% CI, 0.82-1.06; short-term mortality ratio, 1.02; 95% CI, 0.87-1.17; intermediate-term mortality ratio, 0.99; 95% CI, 0.79-1.19; and long-term mortality ratio, 0.96; 95% CI, 0.76-1.16) and small reductions in risk-adjusted postdischarge mortality during the full study period (30-day mortality ratio, 0.88; 95% CI, 0.86-0.90; short-term mortality ratio, 0.94; 95% CI, 0.94-0.95; intermediate-term mortality ratio, 0.94; 95% CI, 0.92-0.95; and long-term mortality ratio, 0.95; 95% CI, 0.93-0.96)., Conclusions and Relevance: In this study of Medicare fee-for-service beneficiaries, there was a substantial decrease in in-hospital mortality for patients hospitalized with incident HF from 2008 to 2018, but little to no reduction in mortality for subsequent periods up to 3 years after hospitalization. These results suggest opportunities to improve longitudinal outpatient care for patients with HF after hospital discharge.