Reduction in Serum LDL Cholesterol Using a Nutrient Compendium in Hyperlipidemic Adults Unable or Unwilling to Use Statin Therapy: A Double-Blind Randomized Crossover Clinical Trial.

BACKGROUND: Many hyperlipidemic patients prescribed ß-hydroxy-ß-methylglutaryl coenzyme A reductase inhibitors (statins) are unable or unwilling to take them. A hedonically acceptable snack-based solution formulated from cholesterol-lowering food ingredients could represent a therapeutic alternative but has not been tested in this population. OBJECTIVES: To evaluate the effect of snacks containing a compendium of functional bioactives on fasting LDL cholesterol in statin candidates unwilling to use or intolerant to ≥1 statin drug. Secondary outcomes included changes in circulating total cholesterol (TC), triglycerides, HDL cholesterol, fasting glucose, insulin, and high-sensitivity C-reactive protein concentrations, as well as effects of single-nucleotide polymorphisms (SNPs) on outcome. METHODS: This multicenter, randomized, double-blind, free-living crossover study was composed of 2 regimented phases of 4 wk each, separated by a 4-wk washout. Eighteen men and 36 women, with a mean ± SD age of 49 ± 12 y and mean ± SD LDL cholesterol of 131 ± 32.1 mg/dL,  were instructed to ingest a variety of ready-to-eat snacks twice daily as a substitute for something they were consuming already. Other behavior changes were actively discouraged. Treatment products provided ≥5 g fiber, 1000 mg ω-3 (n-3) fatty acids, 1000 mg phytosterols, and 1800 µmol antioxidants per serving. Control products were calorie-matched like-items drawn from the general grocery marketplace. Serum lipids were measured at baseline and the end of each phase and compared using the ANOVA model. Compliance to study foods was confirmed by serum 18:3n-3 concentration assessment. RESULTS: Comparing intervention phase endpoints, LDL cholesterol was reduced a mean ± SD of 8.80 ± 1.69% (P < 0.0001), and TC was reduced a mean ± SD of 5.08 ± 1.12% (P < 0.0001) by treatment foods compared with control foods, whereas effects on other analytes did not differ between treatments. SNPs were not significantly related to outcomes (P ≥ 0.230). Compliance with study foods was 95%. CONCLUSIONS: Consumption of hedonically acceptable snacks containing a compendium of cholesterol-lowering bioactive compounds can rapidly and meaningfully reduce LDL cholesterol in adult patients unable or unwilling to take statin drugs. This trial was registered at clinicaltrials.gov as NCT02341924.

Healthcare Cost Implications of Utilizing a Dietary Intervention to Lower LDL Cholesterol: Proof of Concept Actuarial Analysis and Recommendations.

PURPOSE OF REVIEW: To determine if subsidizing the cost of a food-based intervention for managing hyperlipidemia could be cost-effective under commercial insurance and/or Medicare coverage scenarios. RECENT FINDINGS: A large number of patients eligible for pharmaceutical treatment of hyperlipidemia either cannot or will not use lipid lowering drugs, leaving them at increased cardiovascular risk. Lipid levels can be modified by diet, but food has never enjoyed covered benefit status. We evaluated the financial implications of providing insurance coverage for a specifically formulated suite of food products previously documented to yield statistically significant lipid reductions, using multiple product uptake and lipid impact scenarios in both commercially covered and Medicare-covered populations. Even after controlling for multiple confounders, we noted positive payback on subsidizing the cost of lipid-lowering foods under all scenarios. Addressing a root cause of hyperlipidemia by directly encouraging dietary modification provides a cost-effective alternative for cholesterol management, especially for statin intolerant or statin unwilling patients.

The Essential Role of Educator Development: 10 Years of the ACC Emerging Faculty Program.

The American College of Cardiology Emerging Faculty program was developed in 2005 to promote a systematic approach to "educate the educators" through training and mentorship. A primary focus of the program is the biennial Teaching Skills Workshop, which has had 130 participants since its inception and is focused on the concepts of effective adult learning, curriculum design, and optimization of presentation skills. A survey of participants (80 respondents of 130 total participants) found that the majority stated that participation in the program had a large impact on their ability to apply instructional design principles (49%) and present in face-to-face settings (47%), and it had a moderately large to large positive impact on their personal careers. Thus, the Emerging Faculty program combines several elements of the College's strategic plan in a single program that provides member value to early career professionals and sustained benefit for the cardiovascular community and patients.

Quantitation of regional ejection fractions using gated tomographic imaging with 99mTc-sestamibi.

BACKGROUND: Gated single photon emission CT (SPECT) sestamibi imaging allows the simultaneous assessment of myocardial perfusion and left ventricular function. OBJECTIVE: The purpose of this study was to evaluate a technique for quantitative regional wall motion assessment using gated SPECT (99m)Tc-sestamibi imaging. PATIENTS AND INTERVENTIONS: Fourteen subjects without cardiac pathology and 25 patients who had experienced myocardial infarction (MI) were studied. After tomographic reconstruction of gated short-axis slices, the identification of endocardial borders was made using a standard edge-detection program in systole and diastole in each of five selected slices. Regional ejection fraction (EF) and myocardial perfusion were determined for five regions within each slice. Ten patients underwent echocardiographic regional wall-motion analysis, the results of which were compared to corresponding regional EF results. RESULTS: High interobserver reproducibility in the assessment of regional EFs was found, with r values ranging from 0.94 to 0.98. In patients with anterior and inferior MIs, the regional EFs were abnormal in the anterior and septal regions, and the inferior and lateral regions, respectively. The regional EFs correlated significantly with regional perfusion in the anterior walls (r = 0.71; p = 0.0001), the lateral walls (r = 0.66; p = 0.0001), and inferior walls (r = 0.54; p = 0.0004). There was a significant association between the regional EFs and the echocardiographic regional wall motion assessment at the base (p < 0.0001), mid-ventricle (p = 0.0004), and apex (p = 0.0003). CONCLUSIONS: Gated SPECT images obtained (99m)Tc-sestamibi can provide reproducible quantitative, segmental regional EFs for multiple left ventricular slices that are significantly associated with subjective regional wall motion assessment by echocardiography.

Prognostic significance of ischemic electrocardiographic changes during vasodilator stress testing in patients with normal SPECT images.

BACKGROUND: Patients with ischemic electrocardiographic (ECG) findings during exercise stress testing but normal perfusion images generally have a low risk of cardiac death or myocardial infarction (<1% per year). During vasodilator stress testing, however, the prognostic significance of the combination of normal perfusion images and ischemic ECG changes is unknown. METHODS AND RESULTS: Among 5526 patients who underwent vasodilator stress single photon emission computed tomography (SPECT), 49 (0.9%) had normal images but ischemic ECG changes. A unique feature of this population was that 43 (88%) were women with a mean age of 67 +/- 10 years. Ischemic ECG changes occurred at a mean heart rate of 101 +/- 15 beats per minute and persisted for 6.8 +/- 4.7 minutes after termination of drug infusion. During follow-up of 28 +/- 20 months, cardiac death occurred in 2 patients and nonfatal myocardial infarction in 4 patients. The rate of cardiac death or nonfatal myocardial infarction was 4% at 1 year, 10% at 2 years, and 14% at 3 years. Of the 12 patients who underwent coronary angiography or autopsy during follow-up, 11 had multivessel coronary artery disease, indicating that these patients likely had false-negative SPECT image results. Eight patients required coronary revascularization. CONCLUSIONS: The finding of ischemic ECG changes with normal SPECT images during vasodilator infusion is uncommon, occurs primarily in older women, and is associated with a higher subsequent cardiac event rate than is customarily associated with normal images.