Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial.

BACKGROUND: Innovative restructuring of cardiac rehabilitation (CR) delivery remains critical to reduce barriers and improve access to diverse populations. Destination Cardiac Rehab is a novel virtual world technology-based CR program delivered through the virtual world platform, Second Life, which previously demonstrated high acceptability as an extension of traditional center-based CR. This study aims to evaluate efficacy and adherence of the virtual world-based CR program compared with center-based CR within a community-informed, implementation science framework. METHODS: Using a noninferiority, hybrid type 1 effectiveness-implementation, randomized controlled trial, 150 patients with an eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. Participants will be randomized 1:1 to either the 12-week Destination Cardiac Rehab or the center-based CR control groups. The primary efficacy outcome is a composite cardiovascular health score based on the American Heart Association Life's Essential 8 at 3 and 6 months. Adherence outcomes include CR session attendance and participation in exercise sessions. A diverse patient/caregiver/stakeholder advisory board was assembled to guide recruitment, implementation, and dissemination plans and to contextualize study findings. The institutional review board-approved randomized controlled trial will enroll and randomize patients to the intervention (or control group) in 3 consecutive waves/year over 3 years. The results will be published at data collection and analyses completion. CONCLUSIONS: The Destination Cardiac Rehab randomized controlled trial tests an innovative and potentially scalable model to enhance CR participation and advance health equity. Our findings will inform the use of effective virtual CR programs to expand equitable access to diverse patient populations. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05897710.

Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool).

Background There is a scarcity of validated rapid dietary screening tools for patient use in the clinical setting to improve health and reduce cardiovascular risk. The Healthy Eating Index (HEI) 2015 measures compliance with the 2015 to 2020 Dietary Guidelines for Americans but requires completion of an extensive diet assessment to compute, which is time consuming and impractical. The authors hypothesize that a 19-item dietary survey assessing consumption of common food groups known to affect health will be correlated with the HEI-2015 assessed by a validated food frequency questionnaire and can be further reduced without affecting validity. Methods and Results A 19-item Eating Assessment Tool (EAT) of common food groups was created through literature review and expert consensus. A cross-sectional survey was then conducted in adult participants from a preventive cardiology clinic or cardiac rehabilitation and in healthy volunteers (n=661, mean age, 36 years; 76% women). Participants completed an online 156-item food frequency questionnaire, which was used to calculate the HEI score using standard methods. The association between each EAT question and HEI group was analyzed by Kruskal-Wallis test. Linear regression models were subsequently used to identify univariable and multivariable predictors for HEI score for further reduction in the number of items. The final 9-item model of Mini-EAT was validated by 5-fold cross validation. The 19-item EAT had a strong correlation with the HEI score (r=0.73) and was subsequently reduced to the 9 items independently predictive of the HEI score: fruits, vegetables, whole grains, refined grains, fish or seafood, legumes/nuts/seeds, low-fat dairy, high-fat dairy, and sweets consumption, without affecting the predictive ability of the tool (r=0.71). Conclusions Mini-EAT is a 9-item validated brief dietary screener that correlates well with a comprehensive food frequency questionnaire. Future studies to test the Mini-EAT's validity in diverse populations and for development of clinical decision support systems to capture changes over time are needed.

Ceramides improve atherosclerotic cardiovascular disease risk assessment beyond standard risk factors.

Ceramides are bioactive lipids that act as secondary messengers for both intra- and inter-cellular signaling. Elevated plasma concentrations of ceramides are associated with multiple risk factors of atherosclerotic cardiovascular diseases and comorbidities including obesity, insulin resistance and diabetes mellitus. Furthermore, atherosclerotic plaques have been shown to be highly enriched with ceramides. Increases in ceramide content may accelerate atherosclerosis development by promoting LDL infiltration to the endothelium and aggregation within the intima of artery walls. Thus, ceramides appear to play a key role in the development of cardiometabolic disease due to their central location in major metabolic pathways that intersect lipid and glucose metabolism. Recently published data have shown that ceramides are not only of scientific interest but may also have diagnostic value. Their independent prognostic value for future cardiovascular outcomes over and above LDL cholesterol and other traditional risk factors have consistently been shown in numerous clinical studies. Thus, ceramide testing with a mass spectrometer offers a simple, reproducible and cost-effective blood test for risk stratification in atherosclerotic cardiovascular diseases.

How Low to Go With Lipid-Lowering Therapies in a Cost-effective and Prudent Manner.

The 2013 American College of Cardiology/American Heart Association guideline on the treatment of blood cholesterol was a landmark document guiding health care professionals around the globe on how to administer lipid-lowering therapies. Those guidelines were primarily focused on statin therapy benefit groups. The writing committee found insufficient evidence for specific low-density lipoprotein cholesterol (LDL-C) treatment targets. There have been many important updates in the lipid literature since the publication of that document. Most importantly, clinical trials have provided definitive evidence for the pivotal role of LDL-C in atherogenesis and the improvement in clinical outcomes by means of aggressive LDL-C reduction. Ezetimibe, evolocumab, and alirocumab treatment resulted in substantial reductions in major adverse cardiovascular outcomes. These data encourage a discussion on whether LDL-C targets are warranted in primary and/or secondary prevention, and if so, how low should those targets be. In order to answer such questions, the costs and safety of such therapies, as well as the safety of very low levels of LDL-C need to be addressed. This review discusses the relationship between LDL-C lowering and cardiovascular risk reduction, the efficacy, safety, and cost-effectiveness of high-intensity lipid-lowering therapies, and the recommendations from the most recent lipid guidelines.

Cholesterol Management in the Era of PCSK9 Inhibitors.

PURPOSE OF REVIEW: Cholesterol management in the current era is discussed. Aggressive reduction of low density lipoprotein (LDL) cholesterol plays a key role in primary and secondary prevention of heart disease. Statins are the recommended first-line therapy in patients with hyperlipidemia; however, additional complementary approaches are frequently needed for patients who fail to reach their target LDL. RECENT FINDINGS: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are novel drugs that provide dramatic lowering of LDL and promise outcome benefit. Despite great enthusiasm about their cardiovascular benefit, concerns have been raised regarding their cost and added value to the healthcare system. Although cost-effectiveness studies have yielded inconclusive results, analyses suggest that the current cost of PCSK9 inhibitors is disproportionately high and must be significantly reduced to add positive net benefit to healthcare system. PCSK9 inhibitors significantly lower LDL cholesterol. Further outcome data and cost-effectiveness analyses are needed to overcome the current barriers with PCSK9 inhibitors that patients, physicians, and payers face.

Comparative Trends and Downstream Outcomes of Coronary Computed Tomography Angiography and Cardiac Stress Testing in Emergency Department Patients With Chest Pain: An Administrative Claims Analysis.

OBJECTIVES: Coronary computerized tomography angiography (CCTA) is a rapidly emerging technology for the evaluation of chest pain in the emergency department (ED). We assessed trends in CCTA use and compared downstream healthcare utilization between CCTA and cardiac stress testing modalities. METHODS: Using administrative claims data (Optum Labs Data Warehouse) from over 100 million geographically diverse privately insured and Medicare Advantage enrollees across the United States, we identified 2,047,799 ED patients from January 2006 to December 2013 who presented with chest pain and had a CCTA or cardiac stress test within 72 hours. Cohorts were established based on CCTA or functional stress testing (myocardial perfusion scintigraphy [MPS], stress echocardiogram [SE], or treadmill exercise electrocardiogram [TMET]) performed within 72 hours of the ED visit. We tracked subsequent invasive cardiac procedures (invasive coronary angiography [ICA], percutaneous coronary intervention [PCI], and coronary artery bypass grafting [CABG]), repeat noninvasive testing, return ED visits, hospitalization, and the rate of acute myocardial infarction (AMI) within 30 days. We used propensity-score matching to adjust for coronary artery disease (CAD) risk factors, Charlson-Deyo comorbidity index, and baseline differences between patients selected for CCTA or cardiac stress testing. Logistic regression was used to measure adjusted associations between testing modality and outcomes. RESULTS: During the study period, CCTA use increased from 0.8% to 4.5% of all cardiac testing within 72 hours, a change of 434% (p-value for trend < 0.001), while rates of other cardiac stress testing modalities decreased (-22% for TMET [p < 0.001]; -11% for SE [p = 0.11]; -6% for MPS [p = 0.04]. After matching, there was no difference in the 30-day rate of AMI between testing modalities. Compared to MPS, CCTA was associated with higher rates of PCI (odds ratio [OR] = 1.25, 95% confidence interval [CI] = 1.04 to 1.51), and CABG (OR = 1.47; 95% CI = 1.03 to 2.13). Compared to SE and treadmill stress testing, CCTA was associated with more invasive procedures, hospitalizations, return ED visits, and repeat noninvasive testing. CONCLUSIONS: CCTA use increased fourfold during the study period and was associated with higher rates of PCI, CABG, repeat noninvasive testing, hospitalization, and return ED visits. The authors have no relevant financial information or potential conflicts to disclose.

A perspective on the New American College of Cardiology/American Heart Association guidelines for cardiovascular risk assessment.

The recently published American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for cardiovascular risk assessment provide equations to estimate the 10-year and lifetime atherosclerotic cardiovascular disease (ASCVD) risk in African Americans and non-Hispanic whites, include stroke as an adverse cardiovascular outcome, and emphasize shared decision making. The guidelines provide a valuable framework that can be adapted on the basis of clinical judgment and individual/institutional expertise. In this review, we provide a perspective on the new guidelines, highlighting what is new, what is controversial, and potential adaptations. We recommend obtaining family history of ASCVD at the time of estimating ASCVD risk and consideration of imaging to assess subclinical disease burden in patients at intermediate risk. In addition to the adjuncts for ASCVD risk estimation recommended in the guidelines, measures that may be useful in refining risk estimates include carotid ultrasonography, aortic pulse wave velocity, and serum lipoprotein(a) levels. Finally, we stress the need for research efforts to improve assessment of ASCVD risk given the suboptimal performance of available risk algorithms and suggest potential future directions in this regard.

A summary and critical assessment of the 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: filling the gaps.

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines has recently released the new cholesterol treatment guideline. This update was based on a systematic review of the evidence and replaces the previous guidelines from 2002 that were widely accepted and implemented in clinical practice. The new cholesterol treatment guideline emphasizes matching the intensity of statin treatment to the level of atherosclerotic cardiovascular disease (ASCVD) risk and replaces the old paradigm of pursuing low-density lipoprotein cholesterol targets. The new guideline also emphasizes the primacy of the evidence base for statin therapy for ASCVD risk reduction and lists several patient groups that will not benefit from statin treatment despite their high cardiovascular risk, such as those with heart failure (New York Heart Association class II-IV) and patients undergoing hemodialysis. The guideline has been received with mixed reviews and significant controversy. Because of the evidence-based nature of the guideline, there is room for several questions and uncertainties on when and how to use lipid-lowering therapy in clinical practice. The goal of the Mayo Clinic Task Force in the assessment, interpretation, and expansion of the ACC/AHA cholesterol treatment guideline is to address gaps in information and some of the controversial aspects of the newly released cholesterol management guideline using additional sources of evidence and expert opinion as needed to guide clinicians on key aspects of ASCVD risk reduction.

An assessment by the Statin Muscle Safety Task Force: 2014 update.

The National Lipid Association's Muscle Safety Expert Panel was charged with the duty of examining the definitions for statin-associated muscle adverse events, development of a clinical index to assess myalgia, and the use of diagnostic neuromuscular studies to investigate muscle adverse events. We provide guidance as to when a patient should be considered for referral to neuromuscular specialists and indications for the performance of a skeletal muscle biopsy. Based on this review of evidence, we developed an algorithm for the evaluation and treatment of patients who may be intolerant to statins as the result of adverse muscle events. The panel was composed of clinical cardiologists, clinical lipidologists, an exercise physiologist, and a neuromuscular specialist.

Principles and process in the development of the Mayo Clinic's individual and institutional conflict of interest policy.

In 1995, federal regulations required all academic medical centers to implement policies to manage individual financial conflict of interest. At the Mayo Clinic, all staff are salaried, and all medically related intellectual property from the staff belongs to the clinic. Hence, it was necessary to develop a policy for institutional conflict of interest to complement the policy for individual conflicts of interest. This article addresses the principles and process that led to the development of the Mayo Clinic's policies that guide the management of conflict of interest of individuals and of the institution. Empowered by the Bayh-Dole Act, the Mayo Clinic participates in technology transfer through its entity Mayo Medical Ventures. Individual conflicts of interest arising from such technology transfer are associated with Institutional conflicts because all individual intellectual property belongs to the institution, per clinic policy. This policy addresses conflicts of interest that arise in research, leadership, clinical practice, investments, and purchasing. Associated with the statutory annual disclosure on personal consulting and other relationships with Industry, which are guided by federal regulations, all research protocols or grant applications require financial disclosure on initial submission and in annual progress reports. The clinic's Conflict of Interest Review Board was established to review each disclosure and recommend management of individual and institutional conflicts of interest according to policy.

Continuous 12-lead electrocardiographic monitoring in an emergency department chest pain unit: an assessment of potential clinical effect.

STUDY OBJECTIVES: Continuous 12-lead serial ECG monitoring has been proposed to assist in the evaluation of patients with acute coronary syndrome and nondiagnostic ECG in an emergency department chest pain unit. However, the ability of serial ECG to detect acute coronary syndrome and its benefit in addition to a standard protocol has not been established. We evaluate the ability of continuous 12-lead ECG to detect acute coronary syndrome, assess the incremental benefit of the serial ECG in association with a set protocol in an ED chest pain unit, and evaluate whether serial ECG changes could be considered as prognostic factors. METHODS: Patients who met Agency for Health Care Policy and Research guidelines for intermediate risk for short-term cardiovascular event unstable angina were prospectively studied in the chest pain unit. Patients were monitored with the Mortara Instruments ELI 100 STM continuous 12-lead ECG system with ST-segment analysis. ST-segment changes of greater than 100 microV in 2 or more contiguous leads or greater than 200 microV in 1 lead were considered positive. Data were compared with serial serum cardiac markers, cardiac function study results, angiographic results, and 30-day outcome results. RESULTS: One hundred nineteen patients had serial ECG applied. The median duration of monitoring was 4.2 hours. Forty patients were given a diagnosis of acute coronary syndrome. Chest pain unit protocol detected 52 patients, and 23 were given a diagnosis of acute coronary syndrome (sensitivity 58%; specificity 63%). Sixteen patients had ST-segment changes of greater than 100 microV or greater than 200 microV, and 9 were given a diagnosis of acute coronary syndrome. The addition of the serial ECG to the chest pain unit protocol increased the sensitivity to 65% and decreased the specificity to 58%. Two patients with ST-segment changes but none without ST-segment changes had an adverse cardiac event, yielding a sensitivity of 100% and a specificity of 88%. CONCLUSION: Serial ECG is of limited value in the diagnostic evaluation of intermediate-risk patients managed in the chest pain unit with a standard protocol. However, when ST-segment changes are present, they indicate an increased likelihood for an adverse cardiac event.