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Objective: To develop an accurate and reproducible measure of vertical integration between physicians and hospitals (defined as hospital or health system employment of physicians), which can be used to assess the impact of integration on healthcare quality and spending. Data Sources and Study Setting: We use multiple data sources including from the Internal Revenue Service, the Centers for Medicare and Medicaid Services, and others to determine the Tax Identification Numbers (TINs) that hospitals and physicians use to bill Medicare for services, and link physician billing TINs to hospital‐related TINs. Study Design: We developed a new measure of vertical integration, based on the TINs that hospitals and physicians use to bill Medicare, using a broad set of sources for hospital‐related TINs. We considered physicians as hospital‐employed if they bill Medicare primarily or exclusively using hospital‐related TINs. We assessed integration status for all physicians who billed Medicare from 1999 to 2019. We compared this measure with others used in the existing literature. We conducted a simulation study which highlights the importance of accurately identifying integrated physicians when study the effects of integration. Data Collection/Extraction Methods: We extracted physician and hospital‐related TINs from multiple sources, emphasizing specificity (a small proportion of nonintegrated physicians identified as integrated). Principal Findings: We identified 12,269 hospital‐related TINs, used for billing by 546,775 physicians. We estimate that the percentage of integrated physicians rose from 19% in 1999 to 43% in 2019. Our approach identifies many additional physician practices as integrated; a simpler TIN measure, comparable with prior work, identifies only 30% (3877) of the TINs we identify. A service location measure, used in prior work, has both many false positives and false negatives. Conclusion: We developed a new measure of hospital‐physician integration. This measure is reproducible and identifies many additional physician practices as integrated. [ABSTRACT FROM AUTHOR]

Background: Using DAs for preference‐sensitive decisions is an evidence‐based way to improve patient‐centered decisions. Reimbursement mandates have increased the need for DAs in ICD care, although none have been formally evaluated. The objectives were to develop and pilot implantable cardioverter‐defibrillator (ICD) decision aids (DAs) for patients considering primary prevention ICDs. Methods: Development Phase: An expert panel, including patients and physicians, iteratively developed four DAs: a one‐page Option GridTM conversation aid, a four‐page in‐depth paper tool, a 17‐minute video, and an interactive website. Trial Phase: At three sites, patients with heart failure who were eligible for primary prevention ICDs were randomly assigned 2:1 to intervention (received DAs) or control (usual care). We conducted a mixed‐methods evaluation exploring acceptability and feasibility. Results: Twenty‐one eligible patients enrolled (15 intervention). Most intervention participants found the DAs to be unbiased (67%), helpful (89%), and would recommend them to others (100%). The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than chart review. Although the main goals were to measure acceptability and feasibility, intervention participants trended towards increased concordance between longevity values and ICD decisions (71% concordant vs. 29%, p =.06). Participants preferred the in‐depth paper tool and video DAs. Access to a nurse during the decision‐making window encouraged questions and improved participant‐perceived confidence. Conclusions: Participants felt the DAs provided helpful, balanced information that they would recommend to other patients. Further exploration of this larger context of DA use and strategies to promote independent use related to electrophysiology (EP) visits are needed. [ABSTRACT FROM AUTHOR]

Background: In the United States 2018 bradycardia guideline, the current class III recommendation that patients with permanent pacemaker (PPM) indications and high multimorbidity burden may not have meaningful clinical benefit from PPM therapy is based on limited data. Methods: Observational study (January 1, 2008–December 31, 2015) of adults ≥65 years (N = 16,678) who underwent PPM implantation. Exposure variable: Elixhauser comorbidity number (ECN, 29 well‐validated conditions). Primary outcome: ≤1‐year mortality; secondary outcome: > 1‐year mortality. Results: Those who died ≤1‐year were older, had a lower body mass index (BMI), and higher ECN (p <.001). Cumulative survival at 1‐year was 92.3% (95% confidence interval [CI]: 91.9–92.7). One‐year survival decreased by increasing ECN—with a difference at 1‐year between lowest and highest ECN category of 17.3% (ECN 0–1: 97.1% [95% CI: 96.3–97.7]; ECN ≥8: 79.8% [95% CI: 77.9–81.5]). For those who survived the first year, cumulative survival at 8‐years was 51.2% (95% CI = 49.8–52.6) with a difference between ECN 0–1 and ≥8 of 43.4%. Increasing ECN was associated equally with ≤1‐year (HR 1.28 [95% CI: 1.25–1.30]) and >1‐year (HR 1.19 [95% CI: 1.17–1.20]) mortality. A predictive model including age, sex, BMI, PPM type, race, and ECN had greater discriminative ability (p <.0001) than a bedside model (age, sex) for the primary outcome. Conclusion: Across the heterogeneity of indications for PPM placement, multimorbidity is increasingly common. The association of multimorbidity to mortality (≤1‐year, >1‐year) should be routinely discussed during the shared decision‐making process as an important prognostic geriatric domain variable. [ABSTRACT FROM AUTHOR]

Background: CMS reimbursement guidelines for implantable cardioverter‐defibrillators (ICDs) include mandated shared decision making (SDM), but without any manner of assessing the quality of decisions made. We developed and tested a scale meant to assess patients' knowledge of and preferences specific to ICDs. Such a tool would assess these constructs in the clinical environment, targeting resources and support for patients considering a primary prevention ICD. Methods: Development of the ICD decision quality (ICD‐DQ) scale included (1) item creation, (2) content validation using surveys of patients (n = 23) and clinicians (n = 31), and (3) examination of validity and reliability using a survey of patients who previously received an ICD (n = 295, response rate = 72%). Results: The final scale consists of 12 knowledge and 8 preference items. With respect to content validity, clinician and patient respondents agreed on the importance of 19 of 24 candidate knowledge items (79%), and 9 of 11 treatment preference items (81%). Knowledge items exhibited moderate internal validity (α = 0.62, 1 factor), strong test‐retest reliability (mean % correct at first administration = 59%, 62% at follow‐up, P >.1) and discriminant validity (59% correct for patients, 93% among cardiologists). Short versions of the ICD‐DQ were developed for clinical settings, the scores from both of which correlated with the long version in this cohort (11‐item (r = 0.90) and a 5‐item (r = 0.75)). Conclusions: : The ICD‐DQ fills a critical gap in measuring the quality of patients' ICD decisions. They may be used to evaluate the effectiveness of patient decision aids or the quality of SDM in clinical practice. [ABSTRACT FROM AUTHOR]

Importance: Little is known about the association between industry payments and medical device selection.Objective: To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D).Design, Setting, and Participants: In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated.Exposures: Manufacturers' payments to physicians who performed an ICD or CRT-D implantation.Main Outcomes and Measures: The primary outcome of the study was the manufacturer of the device used for the implantation.Results: Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D.Conclusions and Relevance: In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually. [ABSTRACT FROM AUTHOR]

Objective: We aimed to estimate the current use of secondary prevention drugs and identify its associated individual characteristics among those with established cardiovascular diseases (CVDs) in the communities of China.Methods: We studied 2 613 035 participants aged 35-75 years from 8577 communities in 31 provinces in the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project, a government-funded public health programme conducted from 2014 to 2018. Participants self-reported their history of ischaemic heart disease (IHD) or ischaemic stroke (IS) and medication use in an interview. Multivariable mixed models with a logit link function and community-specific random intercepts were fitted to assess the associations of individual characteristics with the reported use of secondary prevention therapies.Results: Among 2 613 035 participants, 2.9% (74 830) reported a history of IHD and/or IS, among whom the reported use rate either antiplatelet drugs or statins was 34.2% (31.5% antiplatelet drugs, 11.0% statins and 8.3% both). Among the 1 530 408 population subgroups, which were defined by all possible permutations of 16 individual characteristics, reported use of secondary prevention drugs varied substantially (8.4%-60.6%). In the multivariable analysis, younger people, women, current smokers, current drinkers, people without hypertension or diabetes and those with established CVD for more than 2 years were less likely to report taking antiplatelet drugs or statins.Conclusions: The current use of secondary prevention drugs in China is suboptimal and varies substantially across population subgroups. Our study identifies target populations for scalable, tailored interventions to improve secondary prevention of CVD. [ABSTRACT FROM AUTHOR]

Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice.Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices.Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017.Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only.Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding.Results: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI.Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To use patient‐level clinical variables to develop and validate a parsimonious model to predict hospital readmissions from home healthcare (HHC) in Medicare fee‐for‐service beneficiaries. DESIGN: Retrospective analysis using multivariable logistic regression and gradient boosting machine (GBM) learning to develop and validate a predictive model. SETTING/PARTICIPANTS/MEAUREMENTS: A 5% national sample of patients, aged 65 years or older, with Medicare fee‐for‐service who received skilled HHC services within 5 days of hospital discharge in 2012 (n = 43 407). Multiple data sets were merged, including Medicare Outcome and Assessment Information Set, Home Health Claims, Medicare Provider Analysis and Review, and Master Beneficiary Summary Files, to extract patient‐level variables from the first HHC visit after discharge and measure 30‐day readmission outcomes. RESULTS: Among 43 407 patients with inpatient hospitalizations followed by HHC, 14.7% were readmitted within 30 days. Of the 53 candidate variables, seven remained in the final model as individually predictive of outcome: Elixhauser comorbidity index, index hospital length of stay, urinary catheter presence, patient status (ie, fragile health with high risk of complications or serious progressive condition), two or more hospitalizations in prior year, pressure injury risk or presence, and surgical wound presence. Of interest, surgical wounds, either from a total hip or total knee arthroplasty procedure or another surgical procedure, were associated with fewer readmissions. The optimism‐corrected c‐statistics for the full model and parsimonious model were 0.67 and 0.66, respectively, indicating fair discrimination. The Brier score for both models was 0.120, indicating good calibration. The GBM model identified similar predictive variables. CONCLUSION: Variables available to HHC clinicians at the first postdischarge HHC visit can predict readmission risk and inform care plans in HHC. Future analyses incorporating measures of social determinants of health, such as housing instability or social support, have the potential to enhance prediction of this outcome. J Am Geriatr Soc 67:2505–2510, 2019 [ABSTRACT FROM AUTHOR]

Background: In 2012, nearly one-third of adults 65 years or older with Medicare discharged to home after hospitalization were referred for home health care (HHC) services. Care coordination between the hospital and HHC is frequently inadequate and may contribute to medication errors and readmissions. Insights from HHC nurses could inform improvements to care coordination.Objective: To describe HHC nurse perspectives about challenges and solutions to coordinating care for recently discharged patients.Design/participants: We conducted a descriptive qualitative study with six focus groups of HHC nurses and staff (n = 56) recruited from six agencies in Colorado. Focus groups were recorded, transcribed, and analyzed using a mixed deductive/inductive approach to theme analysis with a team-based iterative method.Key Results: HHC nurses described challenges and solutions within domains of Accountability, Communication, Assessing Needs & Goals, and Medication Management. One additional domain of Safety, for both patients and HHC nurses, emerged from the analysis. Within each domain, solutions for improving care coordination included the following: 1) Accountability-hospital physicians willing to manage HHC orders until primary care follow-up, potential legislation allowing physician assistants and nurse practitioners to write HHC orders; 2) Communication-enhanced access to hospital records and direct telephone lines for HHC; 3) Assessing Needs & Goals-liaisons from HHC agencies meeting with patients in hospital; 4) Medication Management-HHC coordinating directly with clinician or pharmacist to resolve discrepancies; and 5) Safety-HHC nurses contributing non-reimbursable services for patients, and ensuring that cognitive and behavioral health information is shared with HHC.Conclusions: In an era of shared accountability for patient outcomes across settings, solutions for improving care coordination with HHC are needed. Efforts to improve care coordination with HHC should focus on clearly defining accountability for orders, enhanced communication, improved alignment of expectations for HHC between clinicians and patients, a focus on reducing medication discrepancies, and prioritizing safety for both patients and HHC nurses. [ABSTRACT FROM AUTHOR]

Aims: To assess the association of body mass index (BMI) with heart failure (HF) outcomes after cardiac resynchronization therapy with defibrillator (CRT-D) implantation.Methods and Results: Medicare beneficiaries with HF aged ≥ 65 years (n = 18 922) undergoing first-time CRT-D from the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter-Defibrillator Registry between 2010 and 2013, were followed for 3 years post-implantation. Survival curves and covariate adjusted hazard ratio (aHR) or odds ratio were used to assess the risks for death, readmission, and device-related complications by BMI status. Of 18 922 HF patients receiving CRT-D, 5265 (27.8%) were normal weight, 6896 (37%) were overweight, 6318 (33.4%) were obese, and 353 (1.8%) were underweight. Compared to those of normal weight (BMI 18.5-24.9 kg/m2 ), underweight patients had a higher 3-year post-device implantation risk of death [aHR: 1.34 (95% confidence interval 1.09-1.65); P < 0.001] and of readmission [sub-aHR: 1.25 (1.09-1.42); P < 0.001]. The corresponding 3-year aHRs for death were 0.83 (0.77-0.89) for overweight, 0.74 (0.67-0.82) for obesity class I (BMI 30-34.9 kg/m2 ), 0.78 (0.68-0.90) for obesity class II (BMI 35-39.9 kg/m2 ), and 0.75 (0.60-0.93) for obesity class III (BMI ≥ 40 kg/m2 , P for all categories < 0.001). Individuals with class III obesity had a higher risk of readmission [sub-aHR: 1.17 (1.06-1.30)]. There were no differences in rates of device-related complications within 90 days across BMI categories.Conclusion: Most elderly patients with HF receiving CRT-D were overweight or obese. While being underweight was associated with greater risks of death and hospitalization, overweight and obese patients were at lower risk of death after CRT-D. [ABSTRACT FROM AUTHOR]

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]

Objective: To assess the association between educational attainment and acute myocardial infarction (AMI) outcomes in China to inform future healthcare interventions.Methods: We used data from the China Patient-centred Evaluative Assessment of Cardiac Events-Prospective AMI study of 3369 consecutive patients hospitalised with AMI from 53 hospitals. Educational attainment was categorised as: high (senior high school, college or postgraduate degree), intermediate (junior high school) or low (primary school or illiterate). We used survival models to assess the relationship between education and 1-year major adverse cardiovascular events (MACE), all-cause mortality, both unadjusted and after adjustment for demographic characteristics and cardiovascular risk factors.Results: The median participant age was 61 (52, 69) years, 23.2% were women, and 33.3% had high, 32.4% intermediate and 34.3% low educational attainment. In unadjusted analysis, compared with high educational attainment, low educational attainment was associated with a higher 1-year risk of MACE (HR 2.41, 95% CI 1.72 to 3.37) and death (HR for low vs high education 3.09, 95% CI 1.69 to 5.65). In risk-adjusted analyses, the association between education and death was attenuated and no longer statistically significant (adjusted HR 1.41, 95% CI 0.74 to 2.69, p=0.30). However, the risk of 1-year MACE (adjusted HR 1.68, 95% CI 1.18 to 2.41, p=0.004) remained significantly greaterin low educational attainment group.Conclusions: In a national Chinese cohort of patients hospitalised with AMI, low educational attainment was associated with a higher risk of adverse events in the year following discharge. This association highlights the need to consider interventions to improve AMI outcomes in adults with low levels of education.Clinical Trial Registration: NCT01624909; Results. [ABSTRACT FROM AUTHOR]

Caring for older adults with multiple chronic conditions (MCCs) is challenging. The American Geriatrics Society (AGS) previously developed The AGS Guiding Principles for the Care of Older Adults With Multimorbidity using a systematic review of the literature and consensus. The objective of the current work was to translate these principles into a framework of Actions and accompanying Action Steps for decision making for clinicians who provide both primary and specialty care to older people with MCCs. A work group of geriatricians, cardiologists, and generalists: (1) articulated the core MCC Actions and the Action Steps needed to carry out the Actions; (2) provided decisional tips and communication scripts for implementing the Actions and Action Steps, using commonly encountered situations: (3) performed a scoping review to identify evidence‐based, validated tools for carrying out the MCC Actions and Action Steps; and (4) identified potential barriers to, and mitigating factors for, implementing the MCC Actions. The recommended MCC Actions include: (1) identify and communicate patients' health priorities and health trajectory; (2) stop, start, or continue care based on health priorities, potential benefit vs harm and burden, and health trajectory; and (3) align decisions and care among patients, caregivers, and other clinicians with patients' health priorities and health trajectory. The tips and scripts for carrying out these Actions are included in the full MCC Action Framework available in the supplement (www.GeriatricsCareOnline.org). J Am Geriatr Soc 67:665–673, 2019. [ABSTRACT FROM AUTHOR]

Background: As cardiovascular risk increases in China, interest in strategies to mitigate it is growing. However, national information about the prevalence and treatment of high cardiovascular disease (CVD) risk is limited.Objective: To assess the prevalence and treatment of high CVD risk as well as variations in risk across population subgroups.Design: National project of CVD screening and management.Setting: 141 county-level regions in all 31 provinces of China.Participants: Local residents aged 35 to 75 years.Measurements: Rates of high CVD risk were assessed both in the overall study population and by age, sex, body mass index, geographic region, and socioeconomic status. Multivariable mixed models were fitted to assess the associations between individual characteristics and high CVD risk. Statin and aspirin use was evaluated among persons at high risk for CVD.Results: Among 1 680 126 participants, 9.5% (95% CI, 9.5% to 9.6%) had high risk for CVD. Mixed models identified persons who were of Han ethnicity, had medical insurance, were currently using alcohol, or were obese as more likely to be at high risk for CVD. Of those with high CVD risk, only 0.6% (CI, 0.5% to 0.6%) and 2.4% (CI, 2.3% to 2.5%) reported using statins and aspirin, respectively. Among persons with high CVD risk and hypertension, 31.8% were receiving antihypertensive medications.Limitation: Samples were not nationally representative.Conclusion: Of the 1.7 million participants, 1 in 10 had a high risk for CVD; among those at high risk, fewer than 3% were receiving statins or aspirin. An immense opportunity exists for risk mitigation in this substantial population.Primary Funding Source: Ministry of Finance and National Health Commission, China. [ABSTRACT FROM AUTHOR]

Aims: To compare the management of patients with diabetes and heart failure with reduced ejection fraction (HFrEF) in the United States and Asia to understand variations in treatment patterns across different healthcare systems. Materials and methods: Our cohort included patients with diabetes and HFrEF (ejection fraction <40%) from a US‐based registry of adults with diabetes (2013‐2016, electronic health records) and a multi‐national Asian registry of adults with heart failure (2010‐2016, prospective registry). Asian countries were categorized as high income (HI) or low income (LI), according to the United Nations classification. Rates of use of guideline‐directed medical therapies (determined through review of active medication lists) were compared across regions. Results: Patients with diabetes and HFrEF in the United States (n = 28 877) were older, had higher body mass indices, and were more likely to have coronary disease than those in Asia (n = 2235). Compared with US patients, the use of guideline‐directed medical therapy for HFrEF was lower in patients in LI Asian countries (angiotensin‐converting enzyme inhibitors/angiotensin II receptor blockers: patients in the United States, 77% vs. patients in HI Asian countries, 76% vs patients in LI Asian countries, 69%; β‐blockers: patients in the United States, 91% vs. patients in HI Asian countries, 87% vs. patients in LI Asian countries, 69%; P < 0.001 for both). Insulin was used more commonly in the United States (44% vs. 24% vs. 25%, respectively; P < 0.001), whereas sulphonylureas were more often prescribed in Asian countries (42% vs. 52% vs. 54%; respectively, P < 0.001). Thiazolidinediones were prescribed in 6% of US patients compared with <1% of patients in Asia. The use of newer diabetes medications was <5% in all. Conclusion: In both the United States and Asia, opportunities for improvement in the use of evidence‐based therapies exist for patients with both diabetes and HFrEF. Effective tools to guide medication choices for these complex, high‐risk patients could have substantial impact on quality and outcomes. [ABSTRACT FROM AUTHOR]

Background: The current acute kidney injury (AKI) risk prediction model for patients undergoing percutaneous coronary intervention (PCI) from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) employed regression techniques. This study aimed to evaluate whether models using machine learning techniques could significantly improve AKI risk prediction after PCI.Methods and Findings: We used the same cohort and candidate variables used to develop the current NCDR CathPCI Registry AKI model, including 947,091 patients who underwent PCI procedures between June 1, 2009, and June 30, 2011. The mean age of these patients was 64.8 years, and 32.8% were women, with a total of 69,826 (7.4%) AKI events. We replicated the current AKI model as the baseline model and compared it with a series of new models. Temporal validation was performed using data from 970,869 patients undergoing PCIs between July 1, 2016, and March 31, 2017, with a mean age of 65.7 years; 31.9% were women, and 72,954 (7.5%) had AKI events. Each model was derived by implementing one of two strategies for preprocessing candidate variables (preselecting and transforming candidate variables or using all candidate variables in their original forms), one of three variable-selection methods (stepwise backward selection, lasso regularization, or permutation-based selection), and one of two methods to model the relationship between variables and outcome (logistic regression or gradient descent boosting). The cohort was divided into different training (70%) and test (30%) sets using 100 different random splits, and the performance of the models was evaluated internally in the test sets. The best model, according to the internal evaluation, was derived by using all available candidate variables in their original form, permutation-based variable selection, and gradient descent boosting. Compared with the baseline model that uses 11 variables, the best model used 13 variables and achieved a significantly better area under the receiver operating characteristic curve (AUC) of 0.752 (95% confidence interval [CI] 0.749-0.754) versus 0.711 (95% CI 0.708-0.714), a significantly better Brier score of 0.0617 (95% CI 0.0615-0.0618) versus 0.0636 (95% CI 0.0634-0.0638), and a better calibration slope of observed versus predicted rate of 1.008 (95% CI 0.988-1.028) versus 1.036 (95% CI 1.015-1.056). The best model also had a significantly wider predictive range (25.3% versus 21.6%, p < 0.001) and was more accurate in stratifying AKI risk for patients. Evaluated on a more contemporary CathPCI cohort (July 1, 2015-March 31, 2017), the best model consistently achieved significantly better performance than the baseline model in AUC (0.785 versus 0.753), Brier score (0.0610 versus 0.0627), calibration slope (1.003 versus 1.062), and predictive range (29.4% versus 26.2%). The current study does not address implementation for risk calculation at the point of care, and potential challenges include the availability and accessibility of the predictors.Conclusions: Machine learning techniques and data-driven approaches resulted in improved prediction of AKI risk after PCI. The results support the potential of these techniques for improving risk prediction models and identification of patients who may benefit from risk-mitigation strategies. [ABSTRACT FROM AUTHOR]

Purpose: To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. Methods: We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. Results: At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. Conclusions: Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates. [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]