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Background CMS reimbursement guidelines for implantable cardioverter-defibrillators (ICDs) include mandated shared decision making, 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 shared decision making in clinical practice. This article is protected by copyright. All rights reserved.

Background: Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction. Without novel approaches to improve prescribing, the cumulative benefits of heart failure with reduced ejection fraction treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. Methods: The EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) trial randomized patients with heart failure with reduced ejection fraction from a diverse health system to usual care versus patient activation tools—a 3-minute video and 1-page checklist—delivered electronically 1 week before, 3 days before, and 24 hours before a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to “make one positive change” in heart failure with reduced ejection fraction prescribing. The primary endpoint was the percentage of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days after, compared with usual care during the same period. Results: EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient activation tools and 145 were controls. The median age of patients was 65 years; 29% were female, 11% were Black, 7% were Hispanic, and the median ejection fraction was 32%. Preclinic data revealed significant GDMT opportunities, with no patients on target doses of β-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days after, 49.0% in the intervention and 29.7% in the control experienced an initiation or intensification of their GDMT ( P =0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths and no significant differences in hospitalization or emergency department visits at 30 days between groups. Conclusions: A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03334188.

Background: New medical technologies and advancements in care quality have transformed care of patients hospitalized with incident acute myocardial infarction (AMI). While some advances may impact short-term mortality (e.g., mechanical circulatory support), others may take much longer to impact mortality (e.g., cardiac rehabilitation). Little is known about trends in time-incremental AMI mortality rates. Methods: We identified all patients hospitalized with incident AMI using a 5% sample of Medicare fee-for-service beneficiaries from 2008 to 2017. We used a three-year look back to exclude patients with a prior AMI hospitalization. We calculated unadjusted in-hospital, 30-day, 1-year, 2-year, and 3-year mortality rates by dividing the total number of all-cause deaths during each period by the corresponding number of patients who were hospitalized. We used logistic regression models to adjust mortality rates for patient demographics (age, sex, race/ethnicity) and a variety of comorbid conditions. Using 2008 as the baseline, we calculated annual incremental mortality rates for each time period. We performed subgroup analyses among AMI patients with ST-segment and non-ST-segment elevation. Results: From 2008 to 2017, we identified 42,567 patients hospitalized with incident AMI (mean age 81 years, 44% male, 86% white). The largest incremental declines in mortality rates were observed for the in-hospital (2.9% [CI 2.7 to 3.1%]), 30-day (2.1% [CI 1.9 to 2.3%], and 1-year (2.9% [CI 2.6 to 3.2%] time periods. Mortality declines were smaller but persisted for the 2-year (1.5% [CI 1.2 to 1.8%]), and 3-year (0.5% [CI 0.2 to 0.8%]; Figure) time periods. Similar patterns were observed among both ST-segment and non-ST-segment elevation AMI patients. Conclusions: For patients hospitalized with incident AMI, advances in care have led to incremental declines in mortality across time periods spanning the hospital stay through 3 years after discharge.

ImportanceMany physicians believe that most medical malpractice claims are random events. This study assessed the association of prior paid claims (including a single prior claim) with future paid claims; whether public disclosure of prior paid claims affects future paid claims; and whether the association of prior and future paid claims decayed over time.ObjectiveTo examine the association of 1 or more prior paid medical malpractice claims with future paid claims.Design, Setting, and ParticipantsThis study assessed the association between prior paid claims (including a single prior claim) with future claims; whether public disclosure of prior claims affects future paid claims; and whether the association of prior and future paid claims decayed over time. This retrospective case-control study included all 881 876 licensed physicians in the US. All data analysis took place between July, 2018 and January, 2023.ExposurePaid medical malpractice claims.Main Outcome and MeasuresAssociation between a prior paid medical malpractice claim and likelihood of a paid claim in a future period, compared with simulated results expected if paid claims are random events. Using the same outcomes, we also assessed whether public disclosure of paid claims affects future paid claim rates.ResultsThis study included all 881 876 physicians licensed to practice in the US at the time of the study. Overall, 3.3% of the 841 961 physicians with 0 paid claims in the prior period had 1 or more claims in the future period vs 12.4% of the 34 512 physicians with 1 paid claim in the prior period; 22.4% of the 4189 physicians with 2 paid claims in the prior period; and 37% of the 1214 physicians with 3 paid claims in the prior period. The association between prior claims and future claims was similar for high-medical-malpractice-risk and lower-risk specialties; 1 prior-period claim was associated with a 3.1 times higher likelihood of a future-period claim for high-risk specialties (95% CI, 2.8-3.4) vs a 4.2 times higher likelihood for lower-risk specialties (95% CI, 3.8-4.6). The predictive power of a prior paid claim for future claims declined gradually as the time since the prior claim increased, for prior or future periods up to 10 years. Public disclosure did not affect the association between prior and future paid claims.Conclusions and RelevanceIn this study of paid medical malpractice claims for all US physicians, a single prior paid claim was associated with substantial, long-lived higher future claim risk, independent of whether a physician was practicing in a high- or low-risk specialty, or whether a state publicly disclosed paid claims. Timely, noncoercive intervention, including education, has the potential to reduce future claims.

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.

Background Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. Methods The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.Discussion The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding) and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse health care systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement and planning for dissemination and sustainment.Trial registration The study was funded by the NIH grant number is 4UH3HL144163-02 issued 4/5/19. The Clinicaltrial.gov identifier number is NCT03973931 which was registered on 6/4/2019. URL: https://clinicaltrials.gov/ct2/show/NCT03973931

Background Quality of care incentives and reimbursements for cardiovascular testing differ between insurance providers. We hypothesized that there are differences in the use of guideline‐concordant testing between Medicaid versus commercial insurance patients Methods and Results Using data from the Colorado All‐Payer Claims Database from 2015 to 2018, we identified patients eligible to receive a high‐value test recommended by guidelines: assessment of left ventricular function among patients hospitalized with acute myocardial infarction or incident heart failure, or a low‐value test that provides minimal patient benefit: stress testing prior to low‐risk surgery or routine stress testing within 2 years of percutaneous coronary intervention or coronary artery bypass graft surgery. Among 145 616 eligible patients, 37% had fee‐for‐service Medicare, 18% Medicare Advantage, 22% Medicaid, and 23% commercial insurance. Using multilevel logistic regression models adjusted for patient characteristics, Medicaid patients were less likely to receive high‐value testing for acute myocardial infarction (odds ratio [OR], 0.84 [0.73–0.98]; P =0.03) and heart failure (OR, 0.59 [0.51–0.70]; P P P Conclusions Guideline‐concordant testing was less likely to occur among patients with Medicaid compared with commercial insurance, and more likely to occur among patients with Medicare Advantage compared with fee‐for‐service Medicare. Insurance plan features may provide valuable targets to improve guideline‐concordant testing.

Telemedicine allows the remote exchange of medical data between patients and healthcare professionals. It is used to increase patients’ access to care and provide effective healthcare services at a distance. During the recent coronavirus disease 2019 (COVID-19) pandemic, telemedicine has thrived and emerged worldwide as an indispensable resource to improve the management of isolated patients due to lockdown or shielding, including those with hypertension. The best proposed healthcare model for telemedicine in hypertension management should include remote monitoring and transmission of vital signs (notably blood pressure) and medication adherence plus education on lifestyle and risk factors, with video consultation as an option. The use of mixed automated feedback services with supervision of a multidisciplinary clinical team (physician, nurse, or pharmacist) is the ideal approach. The indications include screening for suspected hypertension, management of older adults, medically underserved people, high-risk hypertensive patients, patients with multiple diseases, and those isolated due to pandemics or national emergencies.

BackgroundNearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.MethodsThe Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.DiscussionThe primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment.Trial registrationClinicalTrials.govNCT03973931. Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.

The 2020 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care is based on the extensive evidence evaluation performed in conjunction with the International Liaison Committee on Resuscitation. The Adult Basic and Advanced Life Support, Pediatric Basic and Advanced Life Support, Neonatal Life Support, Resuscitation Education Science, and Systems of Care Writing Groups drafted, reviewed, and approved recommendations, assigning to each recommendation a Class of Recommendation (ie, strength) and Level of Evidence (ie, quality). The 2020 Guidelines are organized in knowledge chunks that are grouped into discrete modules of information on specific topics or management issues. The 2020 Guidelines underwent blinded peer review by subject matter experts and were also reviewed and approved for publication by the AHA Science Advisory and Coordinating Committee and the AHA Executive Committee. The AHA has rigorous conflict-of-interest policies and procedures to minimize the risk of bias or improper influence during development of the guidelines. Anyone involved in any part of the guideline development process disclosed all commercial relationships and other potential conflicts of interest.

1. Newborn resuscitation requires anticipation and preparation by providers who train individually and as teams. 2. Most newly born infants do not require immediate cord clamping or resuscitation and can be evaluated and monitored during skin-to-skin contact with their mothers after birth. 3. Inflation and ventilation of the lungs are the priority in newly born infants who need support after birth. 4. A rise in heart rate is the most important indicator of effective ventilation and response to resuscitative interventions. 5. Pulse oximetry is used to guide oxygen therapy and meet oxygen saturation goals. 6. Chest compressions are provided if there is a poor heart rate response to ventilation after appropriate ventilation corrective steps, which preferably include endotracheal intubation. 7. The heart rate response to chest compressions and medications should be monitored electrocardiographically. 8. If the response to chest compressions is poor, it may be reasonable to provide epinephrine, preferably via the intravenous route. 9. Failure to respond to epinephrine in a newborn with history or examination consistent with blood loss may require volume expansion. 10. If all these steps of resuscitation are effectively completed and there is no heart rate response by 20 minutes, redirection of care should be discussed with the team and family. It is estimated that approximately 10% of newly born infants need help to begin breathing at birth,1–3 and approximately 1% need intensive resuscitative measures to restore cardiorespiratory function.4,5 The neonatal mortality rate in the United States and Canada has fallen from almost 20 per 1000 live births6,7 in the 1960s to the current rate of approximately 4 per 1000 live births. The inability of newly born infants to establish and sustain adequate or spontaneous respiration contributes significantly to these early deaths and to the burden of adverse neurodevelopmental outcome among survivors. Effective and timely resuscitation …

Survival after cardiac arrest requires an integrated system of people, training, equipment, and organizations working together to achieve a common goal. Part 7 of the 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care focuses on systems of care, with an emphasis on elements that are relevant to a broad range of resuscitation situations. Previous systems of care guidelines have identified a Chain of Survival, beginning with prevention and early identification of cardiac arrest and proceeding through resuscitation to post–cardiac arrest care. This concept is reinforced by the addition of recovery as an important stage in cardiac arrest survival. Debriefing and other quality improvement strategies were previously mentioned and are now emphasized. Specific to out-of-hospital cardiac arrest, this Part contains recommendations about community initiatives to promote cardiac arrest recognition, cardiopulmonary resuscitation, public access defibrillation, mobile phone technologies to summon first responders, and an enhanced role for emergency telecommunicators. Germane to in-hospital cardiac arrest are recommendations about the recognition and stabilization of hospital patients at risk for developing cardiac arrest. This Part also includes recommendations about clinical debriefing, transport to specialized cardiac arrest centers, organ donation, and performance measurement across the continuum of resuscitation situations.

Background: Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. Methods: The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions. Discussion: The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding) and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse health care systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement and planning for dissemination and sustainment. Trial registration: The study was funded by the NIH grant number is 4UH3HL144163-02 issued 4/5/19. The Clinicaltrial.gov identifier number is NCT03973931 which was registered on 6/4/2019. URL: https://clinicaltrials.gov/ct2/show/NCT03973931

RESEARCH OBJECTIVE: In 2017, the Centers for Medicare & Medicaid Services launched the Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model with the aim to reduce first‐time heart attacks and strokes among high‐risk Medicare fee‐for‐services (FFS) beneficiaries within 5 years. This large‐scale randomized trial pays providers to assess each of their Medicare patient’s risk of a heart attack or stroke and then makes additional payment if they reduce CVD risk among their high‐risk cohort. We assess whether, during its first two years, the model increased use of CVD medications, reduced incidence of heart attacks and strokes, and reduced Medicare spending. STUDY DESIGN: A pragmatic, cluster‐randomized trial. CMS enrolled 516 organizations (primary and specialty practices, health centers, and hospitals) throughout the country and assigned half to the intervention group. For the 313 organizations that enrolled beneficiaries in 2017, we linked enrollment and clinical data with Medicare claims and estimated impacts as intervention‐control differences (regression adjusted) in outcomes. POPULATION STUDIED: 300,550 Medicare FFS beneficiaries, 18% of whom were high risk (≥30% or higher risk of a heart attack or stroke in the next 10 years) and 40% were medium risk (15‐30% risk) in both groups. Intervention and control group beneficiaries were similar at enrollment in demographics, CVD risk factors, and recent utilization and spending. PRINCIPAL FINDINGS: Among the high‐risk group, almost 40% of CVD risk at baseline was modifiable, mainly from elevated blood pressure and cholesterol. High‐risk intervention group enrollees were 4 percentage points more likely than the control group (28 vs 24%, P

Background Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. Hypothesis Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies. Design The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools—a 3-minute video and 1-page checklist—delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with Summary The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.

Introduction: The Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model pays providers for measuring cardiovascular risk among their Medicare beneficiaries and for reducing risk among their high-risk patients. The Centers for Medicare and Medicaid Services (CMS) is testing whether this model can improve cardiovascular care and reduce the incidence of first-time heart attacks and strokes over 5 years. This study assesses whether, in its first 2 years, the model (1) increased use of CVD medications among those with elevated blood pressure or cholesterol, and (2) increased provider awareness of CVD risks among their patients. Methods: In this pragmatic, cluster-randomized trial, CMS enrolled 516 organizations (primary and specialty practices, health centers, and hospitals) throughout the country and assigned half to the intervention group. Organizations enrolled beneficiaries (age 40-79 without a prior CVD event) during routine office visits. We linked enrollment and clinical data with Medicare Part D claims and estimated impacts as intervention-control differences in outcomes. We surveyed one randomly selected provider in each organization about their use of risk CVD stratification (70% response rate). Results: The intervention and control organizations enrolled 300,550 Medicare beneficiaries. In both groups, 18% of enrollees were high risk per CMS definitions (≥30% or higher risk of a heart attack or stroke in the next 10 years), 40% were medium risk (15-30% risk), and the remainder were low risk ( Conclusions: The Million Hearts model significantly improved use of CVD medications among high-risk enrollees, mainly through intensification, and had positive spillover to the much larger medium risk group. These improvements were likely driven, at least partly, by providers become more aware of their patients’ CVD risk through greater use of risk stratification.

OBJECTIVES To assess multimorbidity burden and its association with clinical outcomes in adults with heart failure (HF) according to sex, age, and HF type. DESIGN Retrospective cohort study. SETTING Five healthcare delivery systems across the United States. PARTICIPANTS Adults with HF (N=114,553). MEASUREMENTS We characterized participants with respect to the presence of 26 chronic conditions categorized into quartiles based on overall burden of comorbidity (

AIMS: This study examined whether the association between hemoglobin A1c (HbA1c) and short-term clinical outcomes is moderated by CAD severity. METHODS: We studied 17,394 US Veterans with type 2 diabetes who underwent elective cardiac catheterization between 2005 and 2013. CAD severity was categorized as obstructive, non-obstructive, or no CAD. Using multivariable Cox proportional hazards regression, we assessed associations between time-varying HbA1c and two-year all-cause mortality and non-fatal MI, with an interaction term between HbA1c and CAD severity. RESULTS: 61%, 22%, and 17% of participants had obstructive, non-obstructive, and no CAD, respectively. CAD severity modified the relationship between HbA1c and each outcome (interaction p-value 0.0005 for mortality and

IMPORTANCE: The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model pays provider organizations for measuring and reducing Medicare patients’ cardiovascular risk. OBJECTIVE: To assess whether the model increases the initiation or intensification of antihypertensive medications or statins among patients with blood pressure or low-density lipoprotein (LDL) cholesterol levels above guideline thresholds for treatment intensification. DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of a cluster-randomized, pragmatic trial included primary care and cardiology practices, health care centers, and hospital-based outpatient departments across the US. Participants included Medicare patients who were enrolled into the model in 2017 by participating organizations and who were at high risk and at medium risk of a myocardial infarction or stroke in 10 years. Patient outcomes were analyzed for 1 year postenrollment (through December 2018) using an intent-to-treat design. Analysis began November 2019. INTERVENTIONS: US Centers for Medicare & Medicaid Services paid organizations for risk stratifying Medicare patients and reducing CVD risk among high-risk patients through discussing risk scores, developing individualized risk reduction plans, and following up with patients twice yearly. MAIN OUTCOMES AND MEASURES: Initiating or intensifying statin or antihypertensive therapy within 1 year of enrollment, measured in Medicare Part D claims, and LDL cholesterol and systolic blood pressure levels approximately 1 year after enrollment, measured in usual care and reported to Centers for Medicare & Medicaid Services via a data registry (data complete for 51% of high-risk enrollees). The study’s primary outcome (incidence of first-time myocardial infarction and stroke) is not reported because the trial is ongoing. RESULTS: A total of 330 primary care and cardiology practices, health care centers, and hospital-based outpatient departments and 125 436 Medicare patients were included in this analysis. High-risk patients in the intervention group had a mean (SD) age of 74 (4.1), 15 213 (63%) were male, 21 657 (90%) were receiving antihypertensive medication at baseline, and 16 558 (69%) were receiving statins. Almost all (21 791 [91%]) high-risk intervention group patients had above-threshold systolic blood pressure level (>130 mm Hg), LDL cholesterol level (>70 mg/dL), or both. Patients in the intervention group with these risk factors were more likely than control patients (8127 [37.3%] vs 4753 [32.4%]; adjusted difference in percentage points, 4.8; 95% CI, 2.9-6.7; P

Objectives To assess the clinical effectiveness of beta-blocker therapy in individuals with heart failure (HF) and chronic lung disease and of angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin II receptor blockers (ARBs) in individuals with HF and chronic kidney disease. Design Retrospective cohort study. Setting Community. Participants Individuals with HF with reduced ejection fraction (HFrEF) or HF with preserved ejection fraction (HFpEF). Methods We undertook separate new-user cohort studies to assess the effectiveness of beta-blocker therapy in treating HF and chronic lung disease and ACE-Is and ARBs in treating HF and chronic kidney disease (CKD). Individuals with a chronic lung disease diagnosis were included in the group with HF and chronic lung disease (International Classification of Diseases, Ninth Revision, codes 490–496, 518). Individuals with an estimated glomerular filtration rate less than 60 mL/min per 1.73 m2 were included in the group with HF and CKD. The clinical outcomes of interest were death from any cause, hospitalization for HF, and hospitalization for any reason. We fitted pooled logistic marginal structural models using inverse probability weighting, stratified according to HF type. Results For individuals with HFrEF with chronic lung disease, beta-blocker therapy was protective against death (relative risk (RR) = 0.58, 95% confidence interval (CI) = 0.44–0.77) and hospitalization for HF (RR = 0.78, 95% CI = 0.60–1.00). For those with HFpEF, no statistically significant associations between beta-blocker therapy use and any of the outcomes were observed. We found ACE-I and ARB use to be protective against all three outcomes of interest in individuals with HFrEF (death from any cause: RR = 0.60, 95% 0.40–0.91; hospitalization for HF: RR = 0.43, 95% CI = 0.28–0.67; hospitalization for any reason: RR = 0.63, 95% CI = 0.45–0.89, respectively) and those with HFpEF (death from any cause: RR = 0.52, 95% CI = 0.33–0.81; hospitalization for HF: RR = 0.35, 95% CI = 0.18–0.68; hospitalization for any reason: RR = 0.67, 95% CI = 0.47–0.95). Conclusion Large observational studies may allow for identification of important subgroups of individuals with HF that might benefit from existing treatment approaches. Our findings may also better inform the design of more-definitive future observational studies and randomized trials.

Objective To develop a model to predict hypertension risk among children with incident elevated blood pressure (BP); to test the external validity of the model. Methods A retrospective cohort study was conducted in 3 organizations: Kaiser Permanente Colorado was the model derivation site; HealthPartners of Minnesota and Kaiser Permanente Northern California served as external validation sites. During study years 2006 through 2012, all children aged 3 through 17 years with incident elevated BP in an outpatient setting were identified. The predictor variables were demographic and clinical characteristics collected during routine care. Cox proportional hazards regression was used to predict subsequent hypertension, and diagnostic statistics were used to assess model performance. Results Among 5598 subjects at the derivation site with incident elevated BP, 160 (2.9%) developed hypertension during the study period. Eight characteristics were used to predict hypertension risk: age, sex, race, BP preceding incident elevated BP, body mass index percentile, systolic BP percentile, diastolic BP percentile, and clinical setting of the incident elevated BP. At the derivation site, the model discriminated well between those at higher versus lower risk of hypertension (c-statistic = 0.77). At external validation sites, the observed risk of hypertension was higher than the predicted risk, and the model showed poor discrimination (c-statistic ranged from 0.64 to 0.67). Conclusions Among children with incident elevated BP, a risk model demonstrated good internal validity with respect to predicting subsequent hypertension. However, the risk model did not perform well at 2 external validation sites, which might limit transportability to other settings.

IMPORTANCE: To control spending, the Centers for Medicare & Medicaid Services reduced Medicare fee-for-service (FFS) payments for noninvasive cardiac tests (NCTs) performed in provider-based office settings (ambulatory offices not administratively affiliated with hospitals) starting in 2005. Contemporaneously, payments for hospital-based outpatient testing increased. The association between differential payments by site and test location is unknown. OBJECTIVES: To quantify trends in differential Medicare FFS payments for NCTs performed in hospital-based and provider-based settings, determine the association between the hospital-based outpatient testing to provider-based office testing payment ratio and the proportion of hospital-based NCTs, and to examine trends in test location between Medicare FFS and 3 Medicare Advantage health maintenance organizations for which Centers for Medicare & Medicaid Services payments do not depend on testing location. DESIGN, SETTING, AND PARTICIPANTS: This observational claims-based study used Medicare FFS claims from 1999 to 2015 (5% random sample) and Medicare Advantage claims from 3 large health maintenance organizations (2005-2015) among Medicare FFS beneficiaries aged 65 years or older and a health maintenance organization control group. Statistical analysis was performed from May 1, 2017, to July 15, 2019. EXPOSURES: The weighted mean payment ratio of Medicare FFS hospital-based outpatient testing to provider-based office testing for outpatient NCTs. MAIN OUTCOMES AND MEASURES: Proportion of outpatient NCTs performed in the hospital-based setting and Medicare FFS costs. RESULTS: The data included a mean of 1.72 million patient-years annually in Medicare FFS (mean age, 75.2 years; 57.3% female in 2015) and a mean of 142 230 patient-years annually in the managed care control group (mean age, 74.8 years; 56.2% female in 2015). The Medicare payment ratio of FFS hospital-based outpatient testing to provider-based office testing increased from 1.05 in 2005 to 2.32 in 2015. The FFS hospital-based outpatient testing proportion increased from 21.1% in 2008 to 43.2% in 2015 and was correlated with the payment ratio (correlation coefficient with a 1-year lag, 0.767; P

This cohort study assesses whether changes in overall rates of use of diagnostic cardiovascular tests were associated with changes in high-value testing recommended by guidelines and low-value testing that is expected to provide minimal benefits among a 5% national sample of Medicare beneficiaries between 2000 and 2006., Key Points Question Are changes in annual rates of diagnostic cardiovascular tests associated with changes in rates of high- and low-value testing? Findings In this cohort study of a 5% national sample of Medicare beneficiaries, annual rates of overall testing appeared to increase from 2000 to 2008 and then declined until 2016. Rates of low-value tests (preoperative stress testing and routine stress testing after coronary revascularization) appeared to have increased and then decreased, whereas rates of high-value tests (assessing left ventricular systolic function among patients hospitalized with acute myocardial infarction and heart failure) appeared to increase throughout the study period. Meaning Payment changes intended to reduce spending on overall testing may not have adversely affected testing recommended by guidelines., Importance Owing to a rapid increase in rates of diagnostic cardiovascular testing in the 1990s and early 2000s, the Centers for Medicare & Medicaid Services implemented a series of payment changes intended to reduce overall spending on fee-for-service testing. Whether guideline-concordant testing has been subsequently affected is unknown to date. Objective To determine whether changes in overall rates of use of diagnostic cardiovascular tests were associated with changes in high-value testing recommended by guidelines and low-value testing that is expected to provide minimal benefits. Design, Setting, and Participants This retrospective cohort study assessed a national 5% random sample of Medicare fee-for-service beneficiaries aged 65 to 95 years from January 1, 1999, through December 31, 2016. Data were analyzed from February 15, 2018, through August 15, 2019. Exposures Eligibility to receive high-value testing (assessment of left ventricular systolic function among patients hospitalized with acute myocardial infarction or heart failure) and low-value testing (stress testing before low-risk noncardiac surgery and routine stress testing within 2 years of coronary revascularization not associated with acute care visits). Main Outcomes and Measures Age- and sex-adjusted annual rates of overall, high-value, and low-value diagnostic cardiovascular testing. Results Mean (SD) age was similar over time (75.57 [7.32] years in 2000-2003; 74.82 [7.79] years in 2012-2016); the proportion of women slightly declined over time (63.23% in 2000 to 2003; 57.27% in 2012 to 2016). The rate of overall diagnostic cardiovascular testing per 1000 patient-years among the 5% sample of Medicare beneficiaries increased from 275 in 2000 to 359 in 2008 (P

BACKGROUND Studies have shown that self-monitoring of blood pressure (BP) is effective when combined with co-interventions, but its efficacy varies in the presence of some co-morbidities. This study examined whether self- monitoring can reduce clinic BP in patients with hyper tension-related co-morbidity. METHODS A systematic review was conducted of articles published in Medline, Embase, and the Cochrane Library up to January 2018. Randomized controlled trials of self-monitoring of BP were selected and individual patient data (IPD) were requested. Contributing studies were prospectively categorized by whether they examined a low/ high-intensity co-intervention. Change in BP and likelihood of uncontrolled BP at 12 months were examined according to number and type of hypertension-related co-morbidity in a one-stage IPD meta-analysis. RESULTS A total of 22 trials were eligible, 16 of which were able to provide IPD for the primary outcome, including 6,522 (89%) participants with fol low-up data. Self-monitoring was associated with reduced clinic systollc BP compared to usual care at 12-month follow-up, regardless of the number of hypertension-related co-morbidities (-3.12 mm Hg, [95% confidence intervals -4.78, -1.46 mm Hg]; P value for interaction with number of morbidities = 0.260). Intense interventions were more effective than low-intensity interventions in patients with obesity (P < 0,001 for ail outcomes), and possibly stroke (P < 0,004 for BP control outcome only), but this effect was not observed in patients with coronary heart disease, diabetes, or chronic kidney disease. CONCLUSIONS Self-monitoring lower BP regardless of the number of hypertensic related co-morbidities, but may only be effective in conditions such obesity or stroke when combined with high-intensity co-interventions., This research was funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR number 267) and via an National Institute for Health Research Professorship (NIHR-RP-02-12-015). JS holds a Wellcome Trust/Royal Society Sir Henry Dale Fellowship (ref 211182/Z/18/Z). RM, KT and JS have, or previously received funding from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust. JM and RMcM are NIHR Senior Investigators. HB received funds from NHLBI (R01 HL070713). KM received funds from National Heart, Lung, and Blood Institute (NHLBI) (R01 HL090965). FDRH acknowledges part support from the NIHR School for Primary Care Research (SPCR), the NIHR Collaboration for Leadership in Applied Research in Health and Care (CLARHC) Oxford, and the NIHR Biomedical Research Centre (BRC), Oxford. RM has received research funding in terms of BP monitors from Omron. RM leads a programme of research around self-monitoring/management in stroke with BMc, funded by the Stroke Association and British Heart Foundation. BMc is the clinical lead for the Scottish Government's National programme for scaling up tele-monitoring in Scotland. HB receives research funds from Otsuka pharmaceuticals, Novo Nordisk, and Sanofi, but none of these studies are related to the current study. NH is now an employee of Bristol-Myers Squibb. The authors declare no other conflicts of interest. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

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 (

Previous studies have shown an association between cost and poor asthma control. However, longitudinal studies of general populations are lacking.To examine the cost of poor asthma control and exacerbations across a broad spectrum of asthma patients.The Observational Study of Asthma Control and Outcomes (OSACO) was a prospective survey of persistent asthma patients in Kaiser Colorado in 2011-2012. Patients received a survey 3 times in one year, which included the Asthma Control Questionnaire (ACQ) and questions on exacerbations. Self-reported exacerbations were compared to actual oral corticosteroid (OCS) use. Regression analyses examined the association of control (ACQ-5 scores) and exacerbations with healthcare expenditures, controlling for sociodemographics and smoking. Analyses of expenditures used Generalized Linear Models (GLM) with log-link.2681 individuals completed at least one survey; 1799 completed all three. ACQ-5 scores were associated with higher all-cause and asthma-specific expenditures across all categories of costs (medical, outpatient, ER, pharmacy) except for inpatient expenditures. Each 1-point increase in the ACQ-5 score (i.e., worse control) was associated with a corresponding increase in all-cause annual healthcare and asthma-specific expenditures of $1443 and $927 ($US 2013). Asthma exacerbations with documented OCS use were associated with an increase of $3014 and $1626 over 4 months, while self-reported exacerbations were $713 and $506.Results demonstrate that poor asthma control and exacerbations are strongly associated with higher healthcare expenditures. Results also confirm that collection of validated measures of control such as the ACQ-5 may provide valuable information toward improving clinical and economic outcomes.

Author(s): Writing Group Members; Mozaffarian, Dariush; Benjamin, Emelia J; Go, Alan S; Arnett, Donna K; Blaha, Michael J; Cushman, Mary; Das, Sandeep R; de Ferranti, Sarah; Despres, Jean-Pierre; Fullerton, Heather J; Howard, Virginia J; Huffman, Mark D; Isasi, Carmen R; Jimenez, Monik C; Judd, Suzanne E; Kissela, Brett M; Lichtman, Judith H; Lisabeth, Lynda D; Liu, Simin; Mackey, Rachel H; Magid, David J; McGuire, Darren K; Mohler, Emile R; Moy, Claudia S; Muntner, Paul; Mussolino, Michael E; Nasir, Khurram; Neumar, Robert W; Nichol, Graham; Palaniappan, Latha; Pandey, Dilip K; Reeves, Mathew J; Rodriguez, Carlos J; Rosamond, Wayne; Sorlie, Paul D; Stein, Joel; Towfighi, Amytis; Turan, Tanya N; Virani, Salim S; Woo, Daniel; Yeh, Robert W; Turner, Melanie B; American Heart Association Statistics Committee; Stroke Statistics Subcommittee

Introduction Guideline Directed Medical Therapy (GDMT) recommends a combined regimen of beta blockers, ACE-I/ARB/ARNI, and mineralocorticoid receptor agents for optimal treatment of patients with Heart Failure with Reduced Ejection Fraction (HFrEF). Unfortunately, data from numerous heart failure registries show that HFrEF patients by-and-large continue to remain on suboptimal therapy. Interventions to improve medication plans often target either patient adherence or provider prescribing methods, with mixed results. This suggests that a more novel approach—in which provider and patient are equally involved—may be necessary to incite change. Hypothesis Aspects of Direct-to-Consumer (DTC) methods and Shared Decision Making models can be harnessed to encourage patients to engage providers in HFrEF prescribing decisions. This in turn may improve use of guideline-directed medical therapies. Methods Using DTC and Shared Decision Making models as our framework (Figure 1), we developed a user-friendly patient activation intervention—a 3-minute video and a HFrEF medication checklist—to encourage patients to discuss with their provider “one thing” that can be done to improve their medication plan. Patients were enrolled across three medical centers within the UCHealth medical system, and randomized to either intervention or control arms. Data on HFrEF medication prescribing and dosing was collected at enrollment, at time of intervention, and at 1-and-6 months from intervention. Results 305 patients were enrolled in total. At time of enrollment, 8.5% were on GDMT at suboptimal doses; only one patient (.3%) was on GDMT at target doses. Conclusions Our baseline results highlight the clear need for effective interventions to improve HFrEF prescribing. If successful, our intervention is simple enough to be adapted and implemented across a multitude of settings.

BACKGROUND: Little is known about what determines strategy implementation around quality improvement (QI) in small- and medium-sized practices. Key questions are whether QI strategies are associated with practice readiness and practice characteristics. OBJECTIVE: Grounded in organizational readiness theory, we examined how readiness and practice characteristics affect QI strategy implementation. The study was a component of a larger practice-level intervention, Heart of Virginia Healthcare, which sought to transform primary care while improving cardiovascular care. DESIGN: This observational study analyzed practice correlates of QI strategy implementation in primary care at 3 and 12 months. Data were derived from surveys completed by clinicians and staff and from assessments by practice coaches. PARTICIPANTS: A total of 175 small- and medium-sized primary care practices were included. MAIN MEASURES: Outcome was QI strategy implementation in three domains: (1) aspirin, blood pressure, cholesterol, and smoking cessation (ABCS); (2) care coordination; and (3) organizational-level improvement. Coaches assessed implementation at 3 and 12 months. Readiness was measured by baseline member surveys, 1831 responses from 175 practices, a response rate of 73%. Practice survey assessed practice characteristics, a response rate of 93%. We used multivariate regression. KEY RESULTS: QI strategy implementation increased from 3 to 12 months: the mean for ABCS from 1.20 to 1.59, care coordination from 2.15 to 2.75, organizational improvement from 1.37 to 1.78 (95% CI). There was no statistically significant association between readiness and QI strategy implementation across domains. Independent practice implementation was statistically significantly higher than hospital-owned practices at 3 months for ABCS (95% CI, P = 0.01) and care coordination (95% CI, P = 0.03), and at 12 months for care coordination (95% CI, P = 0.04). CONCLUSION: QI strategy implementation varies by practice ownership. Independent practices focus on patient care–related activities. FQHCs may need additional time to adopt and implement QI activities. Practice readiness may require more structural and organizational changes before starting a QI effort.

Background Primary prevention implantable cardioverter‐defibrillators (ICDs) reduce mortality in selected patients with left ventricular systolic dysfunction by delivering therapies (antitachycardia pacing or shocks) to terminate potentially lethal arrhythmias; inappropriate therapies also occur. We assessed device therapies among adults receiving primary prevention ICDs in 7 healthcare systems. Methods and Results We linked medical record data, adjudicated device therapies, and the National Cardiovascular Data Registry ICD Registry. Survival analysis evaluated therapy probability and predictors after ICD implant from 2006 to 2009, with attention to Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups: left ventricular ejection fraction, 31% to 35%; nonischemic cardiomyopathy Conclusions In this community cohort of primary prevention patients receiving ICD, therapy delivery varied across demographic and clinical characteristics, but did not differ meaningfully for Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups.

Importance Chronic kidney disease (CKD) is common in adults with heart failure and is associated with an increased risk of sudden cardiac death. Randomized trials of participants without CKD have demonstrated that implantable cardioverter defibrillators (ICDs) decrease the risk of arrhythmic death in selected patients with reduced left ventricular ejection fraction (LVEF) heart failure. However, whether ICDs improve clinical outcomes in patients with CKD is not well elucidated. Objective To examine the association of primary prevention ICDs with risk of death and hospitalization in a community-based population of potentially ICD-eligible patients who had heart failure with reduced LVEF and CKD. Design, Settings, and Participants This noninterventional cohort study included adults with heart failure and an LVEF of 40% or less and measures of serum creatinine levels available from January 1, 2005, through December 31, 2012, who were enrolled in 4 Kaiser Permanente health care delivery systems. Chronic kidney disease was defined as an estimated glomerular filtration rate of less than 60 mL/min/1.73 m 2 . Patients who received and did not receive an ICD were matched (1:3) on CKD status, age, and high-dimensional propensity score to receive an ICD. Follow-up was completed on December 31, 2013. Data were analyzed from 2015 to 2017. Exposures Placement of an ICD. Main Outcomes and Measures All-cause death, hospitalizations due to heart failure, and any-cause hospitalizations. Results A total of 5877 matched eligible adults with CKD (1556 with an ICD and 4321 without an ICD) were identified (4049 men [68.9%] and 1828 women [31.1%]; mean [SD] age, 72.9 [8.2] years). In models adjusted for demographics, comorbidity, and cardiovascular medication use, no difference was found in all-cause mortality between patients with CKD in the ICD vs non-ICD groups (adjusted hazard ratio, 0.96; 95% CI, 0.87-1.06). However, ICD placement was associated with increased risk of subsequent hospitalization due to heart failure (adjusted relative risk, 1.49; 95% CI, 1.33-1.60) and any-cause hospitalization (adjusted relative risk, 1.25; 95% CI, 1.20-1.30) among patients with CKD. Conclusions and Relevance In a large, contemporary, noninterventional study of community-based patients with heart failure and CKD, ICD placement was not significantly associated with improved survival but was associated with increased risk for subsequent hospitalization due to heart failure and all-cause hospitalization. The potential risks and benefits of ICDs should be carefully considered in patients with heart failure and CKD.

Supplemental Digital Content is available in the text., Background— Treatment for symptomatic peripheral artery disease includes lower extremity bypass surgery (LEB) and peripheral endovascular interventions (PVIs); however, limited comparative effectiveness data exist between the 2 therapies. We assessed the safety and effectiveness of LEB and PVI in patients with symptomatic claudication and critical limb ischemia. Methods and Results— In a community-based clinical registry at 2 large integrated healthcare delivery systems, we compared 883 patients undergoing PVI and 975 patients undergoing LEB between January 1, 2005 and December 31, 2011. Rates of target lesion revascularization were greater for PVI than for LEB in patients presenting with claudication (12.3±2.7% and 19.0±3.5% at 1 and 3 years versus 5.2±2.4% and 8.3±3.1%, log-rank P

Summary Background Although paediatric growth charts are recommended for weight assessment prior to age 20, many teenagers transition earlier to adult care where absolute body mass index (BMI) is used. This study examines concordance of weight classification in older teenagers using paediatric percentiles and adult thresholds. Methods BMI from 23 640 US teens ages 18–19 years were classified using paediatric BMI percentile criteria for underweight (

Background In US clinical practice, many patients who undergo placement of an implantable cardioverter‐defibrillator ( ICD ) for primary prevention of sudden cardiac death receive dual‐chamber devices. The superiority of dual‐chamber over single‐chamber devices in reducing the risk of inappropriate ICD shocks in clinical practice has not been established. The objective of this study was to compare risk of adverse outcomes, including inappropriate shocks, between single‐ and dual‐chamber ICD s for primary prevention. Methods and Results We identified patients receiving a single‐ or dual‐chamber ICD for primary prevention who did not have an indication for pacing from 15 hospitals within 7 integrated health delivery systems in the Longitudinal Study of Implantable Cardioverter‐Defibrillators from 2006 to 2009. The primary outcome was time to first inappropriate shock. ICD shocks were adjudicated for appropriateness. Other outcomes included all‐cause hospitalization, heart failure hospitalization, and death. Patient, clinician, and hospital‐level factors were accounted for using propensity score weighting methods. Among 1042 patients without pacing indications, 54.0% (n=563) received a single‐chamber device and 46.0% (n=479) received a dual‐chamber device. In a propensity‐weighted analysis, device type was not significantly associated with inappropriate shock (hazard ratio, 0.91; 95% confidence interval, 0.59–1.38 [ P =0.65]), all‐cause hospitalization (hazard ratio, 1.03; 95% confidence interval, 0.87–1.21 [ P =0.76]), heart failure hospitalization (hazard ratio, 0.93; 95% confidence interval, 0.72–1.21 [ P =0.59]), or death (hazard ratio, 1.19; 95% confidence interval, 0.93–1.53 [ P =0.17]). Conclusions Among patients who received an ICD for primary prevention without indications for pacing, dual‐chamber devices were not associated with lower risk of inappropriate shock or differences in hospitalization or death compared with single‐chamber devices. This study does not justify the use of dual‐chamber devices to minimize inappropriate shocks.

Background Self-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension. Methods and findings Medline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (9June 2016). Two reviewers independently assessed articles for eligibility and the authors of eligible trials were approached requesting IPD. Of 2,846 articles in the initial search, 36 were eligible. IPD were provided from 25 trials, including 1 unpublished study. Data for the primary outcomes-change in mean clinic or ambulatory BP and proportion controlled below target at 12 months-were available from 15/19 possible studies (97,138/8,292 [86%] of randomised participants). Overall, self-monitoring was associated with reduced clinic systolic blood pressure (9sBP) compared to usual care at 12 months (-3.2 mmHg, [95% CI -4.9, -1.6 mmHg]). However, this effect was strongly influenced by the intensity of co-intervention ranging from no effect with self-monitoring alone (-1.0 mmHg [-3.3, 1.2]), to a 6.1 mmHg (-9.0, -3.2) reduction when monitoring was combined with intensive support. Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg. No differences in efficacy were seen by sex or by most comorbidities. Ambulatory BP data at 12 months were available from 4 trials (91,478 patients), which assessed selfmonitoring with little or no co-intervention. There was no association between self-monitoring and either lower clinic or ambulatory sBP in this group (9clinic -0.2 mmHg [-2.2, 1.8]; ambulatory 1.1 mmHg [-0.3, 2.5]). Results for diastolic blood pressure (9dBP) were similar. The main limitation of this work was that significant heterogeneity remained. This was at least in part due to different inclusion criteria, self-monitoring regimes, and target BPs in included studies. Conclusions Self-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (9including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counselling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions., This research was funded by the Institute for Health Research School for Primary Care Research (NIHR SPCR number 112) and via an NIHR Professorship for RM (NIHR-RP-02-12-015). JS holds a Medical Research Council (MRC) Strategic Skills Postdoctoral Fellowship (MR/K022032/1). FDRH is part funded as Director of the National Institute for Health Research (NIHR) School for Primary Care Research (SPCR), Theme Leader of the NIHR Oxford Biomedical Research Centre (BRC), and Director of the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Oxford. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Objectives To describe changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and body mass index (BMI) associated with initiation and continued use of combined oral contraceptives (COCs) in healthy adolescents. Study design This observational, matched cohort study was conducted in 2 large health systems. Utilizing claims and electronic medical records, we identified adolescents 14-17.9 years of age initiating medium-dose COCs (containing 30 or 35 (μg of ethinyl estradiol or equivalent and a progestin) between July 1, 2007 and December 31, 2009 with a baseline and at least 1 follow-up blood pressure (BP) and BMI. COC-users were matched 1:2 by age, race/ethnicity, and site to controls (COC-nonusers). All BPs and BMIs recorded during outpatient visits starting 1 month prior to COC initiation (index date for controls), through December 31, 2010 were collected. Mixed model linear regression with random intercepts and slopes were then used to estimate changes in SBP, DBP, and BMI over time. Results The 510 adolescent COC-users and 912 controls did not differ significantly by age, race/ethnicity, insurance, and baseline SBP, DBP, or BMI. After adjusting for baseline values, over a median of 18 months follow-up, COC-users had an decrease in SBP of 0.07 mm Hg/mo, and controls had an increase of 0.02 mm Hg/mo ( P = .65). Similarly, DBP decreased by 0.007 mm Hg/mo in COC-users vs 0.006 mm Hg/mo in controls ( P = .99). BMI increased by 0.04 (kg/m 2 )/mo in COC-users vs 0.025 (kg/m 2 )/mo in controls ( P = .09). Conclusions These data should provide reassurance to patients and providers regarding the lack of significant associations between COC-use and BMI or BP changes in adolescents.

Purpose To assess the impact of personalised physician learning (PPL) interventions using simulated learning cases on control of hypertension and dyslipidaemia in primary care settings. Methods A total of 132 primary care physicians, 4568 eligible patients with uncontrolled hypertension, and 15 392 eligible patients with uncontrolled dyslipidaemia were cluster-randomised to one of three conditions: (a) no intervention, (b) PPL-electronic medical record (EMR) intervention in which 12 PPL cases were assigned to each physician based on observed patterns of care in the EMR in the previous year, or (c) PPL-ASSESS intervention in which 12 PPL cases were assigned to each physician based on their performance on four standardised assessment cases. General and generalised linear mixed models were used to account for clustering and to model differences in patient outcomes in the study arms. Results Among patients with uncontrolled hypertension at baseline, 49.1%, 46.6% and 47.3% (p=0.43) achieved blood pressure (BP) targets at follow-up. Among patients with uncontrolled dyslipidaemia at baseline, 37.5%, 37.3% and 38.1% (p=0.72) achieved low density lipoprotein cholesterol targets at follow-up in PPL-EMR, PPL-ASSESS and the control group, respectively. Although systolic (BP) (p

The current paradigm of bystander cardiopulmonary resuscitation (CPR) blankets a community with training. Recently, the authors have found that high-risk neighborhoods can be identified, and CPR training can be targeted in the neighborhoods in which it is most needed. This article presents a novel method and pilot implementation trial for the HANDDS (identifying High Arrest Neighborhoods to Decrease Disparities in Survival) program. The authors also seek to describe example methods in which the HANDDS program is being implemented in Denver, Colorado. The HANDDS program uses a simple three-step approach: identify, implement, and evaluate. This systematic conceptual framework uses qualitative and quantitative methods to 1) identify high-risk neighborhoods, 2) understand common barriers to learning and performing CPR in these neighborhoods, and 3) implement and evaluate a train-the-trainer CPR Anytime intervention designed to improve CPR training in these neighborhoods. The HANDDS program is a systematic approach to implementing a community-based CPR training program. Further research is currently being conducted in four large metropolitan U.S. cities to examine whether the results from the HANDDS program can be successfully replicated in other locations.

Background— Integrated guidelines on cardiovascular health and risk reduction in children issued in 2011 newly recommended universal screening for dyslipidemia in children at 9 to 11 years and 17 to 21 years. Methods and Results— We determined the frequency and results of lipid testing in 301 080 children and adolescents aged 3 to 19 enrolled in 3 large US health systems in 2007 to 2010 before the 2011 guidelines were issued. Overall, 9.8% of the study population was tested for lipids. The proportion tested varied by body mass index percentile (5.9% of normal weight, 10.8% of overweight, and 26.9% of obese children) and age (8.9% of 9- to 11-year olds and 24.3% of 17- to 19-year olds). In normal weight individuals, 2.8% of 9- to 11-year olds and 22.0% of 17- to 19-year olds were tested. In multivariable models, age and body mass index category remained strongly associated with lipid testing. Sex, race, ethnicity, and blood pressure were weakly associated with testing. Abnormal lipid levels were found in 8.6% for total cholesterol, 22.5% for high-density lipoprotein-cholesterol, 12.0% for non–high-density lipoprotein-cholesterol, 8.0% for low-density lipoprotein-cholesterol, and 21% for triglycerides (age, 10–19 years). There was a strong and graded association of abnormal lipid levels with body mass index, particularly for high-density lipoprotein-cholesterol and triglycerides (2- to 6-fold higher odds ratio in obese when compared with that in normal weight children). Conclusions— Lipid screening was uncommon in 9- to 11-year olds and was performed in a minority of 17- to 19-year olds during 2007 to 2010. These data serve as a benchmark for assessing change in practice patterns after the new recommendations for pediatric lipid screening and management.

Objectives This study aimed to characterize the use of cardiovascular testing for patients with incident heart failure (HF) hospitalization who participated in the National Heart, Lung, and Blood Institute sponsored Cardiovascular Research Network (CVRN) Heart Failure study. Background HF is a common cause of hospitalization, and testing and treatment patterns may differ substantially between providers. Testing choices have important implications for the cost and quality of care. Methods Crude and adjusted cardiovascular testing rates were calculated for each participating hospital. Cox proportional hazards regression models were used to examine hospital testing rates after adjustment for hospital-level patient case mix. Results Of the 37,099 patients in the CVRN Heart Failure study, 5,878 patients were hospitalized with incident HF between 2005 and 2008. Of these, evidence of cardiovascular testing was available for 4,650 (79.1%) patients between 14 days before the incident HF admission and ending 6 months after the incident discharge. We compared crude and adjusted cardiovascular testing rates at the hospital level because the majority of testing occurred during the incident HF hospitalization. Of patients who underwent testing, 4,085 (87.9%) had an echocardiogram, 4,345 (93.4%) had a systolic function assessment, and 1,714 (36.9%) had a coronary artery disease assessment. Crude and adjusted testing rates varied markedly across the profiled hospitals, for individual testing modalities (e.g., echocardiography, stress echocardiography, nuclear stress testing, and left heart catheterization) and for specific clinical indications (e.g., systolic function assessment and coronary artery disease assessment). Conclusions For patients with newly diagnosed HF, we did not observe widespread overuse of cardiovascular testing in the 6 months following incident HF hospitalization relative to existing HF guidelines. Variations in testing were greatest for assessment of ischemia, in which testing guidelines are less certain.

The purpose of this study was to examine the relationship between the presence of clinical depression and persistence to drug therapy treatment for depression with early nonpersistence to antihypertensive therapies in a large, diverse cohort of newly treated hypertension patients. Using a hypertension registry at Kaiser Permanente Northern California, the authors conducted a retrospective cohort study of 44,167 adults (18 years and older) with hypertension who were new users of antihypertensive therapy in 2008. We used multivariate logistic regression analysis to model the relationships between the presence of clinical depression and early nonpersistence (defined as failing to refill the first prescription within 90 days after the end of the first fill days' supply) to antihypertensive therapies, controlling for sociodemographic and clinical risk factors. Within the group of 1484 patients who had evidence of clinical depression in the 12 months prior to the initiation of antihypertensive therapy, the authors examined the relationship between drug therapy treatment for depression and 6-month persistence with antidepressant therapy with early nonpersistence with antihypertensive therapies. No association was found between the presence of clinical depression and early nonpersistence to antihypertensive therapies after adjustment for individual demographic and clinical characteristics and neighborhood-level socioeconomic status. However, among the subset of 1484 patients with documented evidence of clinical depression in the 12 months prior to the initiation of antihypertensive therapy, being prescribed and persistence with antidepressant therapy was strongly associated with lower odds of early nonpersistence to antihypertensive medications (odds ratio, 0.64; confidence interval, 0.42-0.96). In an integrated delivery system, the authors found that treatment for depression was associated with higher levels of antihypertensive persistence. Improving quality of depression care in patients with comorbid hypertension may be an important strategy in decreasing cardiovascular disease risk in these patients.

Few studies have directly investigated the association of clinicians' implicit (unconscious) bias with health care disparities in clinical settings.To determine if clinicians' implicit ethnic or racial bias is associated with processes and outcomes of treatment for hypertension among black and Latino patients, relative to white patients.Primary care clinicians completed Implicit Association Tests of ethnic and racial bias. Electronic medical records were queried for a stratified, random sample of the clinicians' black, Latino and white patients to assess treatment intensification, adherence and control of hypertension. Multilevel random coefficient models assessed the associations between clinicians' implicit biases and ethnic or racial differences in hypertension care and outcomes.Standard measures of treatment intensification and medication adherence were calculated from pharmacy refills. Hypertension control was assessed by the percentage of time that patients met blood pressure goals recorded during primary care visits.One hundred and thirty-eight primary care clinicians and 4,794 patients with hypertension participated. Black patients received equivalent treatment intensification, but had lower medication adherence and worse hypertension control than white patients; Latino patients received equivalent treatment intensification and had similar hypertension control, but lower medication adherence than white patients. Differences in treatment intensification, medication adherence and hypertension control were unrelated to clinician implicit bias for black patients (P = 0.85, P = 0.06 and P = 0.31, respectively) and for Latino patients (P = 0.55, P = 0.40 and P = 0.79, respectively). An increase in clinician bias from average to strong was associated with a relative change of less than 5 % in all outcomes for black and Latino patients.Implicit bias did not affect clinicians' provision of care to their minority patients, nor did it affect the patients' outcomes. The identification of health care contexts in which bias does not impact outcomes can assist both patients and clinicians in their efforts to build trust and partnership.