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Going beyond traditional cardiovascular health assessment

Recent research shows that following current cholesterol treatment guidelines to lower LDL-C reduces a patient’s risk for cardiovascular events by an average of 25%. This means standard therapy fails to address 75% of a patient’s residual risk for CVD events.1,2,3

New cholesterol lowering therapies were recently approved for clinical use that could lower a patient’s residual risk of CVD events. These new therapies target PCSK9 and appear to be a promising clinical strategy for further lowering LDL-C levels and CVD risk. Large scale outcome trials are now underway in patients at high cardiovascular risk on statin therapy, to evaluate whether these substantial reductions in LDL-C levels result in reduction in cardiovascular events.

Creating an effective CVD prevention or disease regression plan in at-risk patients should include the application of guidelines and the latest clinical data in conjunction with risk stratification and the use of appropriate CVD diagnostics to help characterize disease and to individualize treatment. Boston Heart solutions help you select the best mono or combination therapy for your patients who may need LDL-C lowering or who are already taking medication. Our diagnostic insights help you individualize treatment far beyond what is possible with a standard lipid panel and help engage your patients using highly personalized reports and lifestyle management services. Our solutions are designed to help you improve your patients’ health and wellbeing.

State-of-the-art CVD characterization—individualized to each patient

Through our expertise in cardiovascular disease and health management we have developed a comprehensive, CVD focused test menu. At the core of Boston Heart’s CVD characterization and clinical considerations are our exclusive tests: Boston Heart HDL Map®, Boston Heart Cholesterol Balance®, Boston Heart Statin Induced Myopathy (SLCO1B1) Genotype, Boston Heart Prediabetes Assessment®, and Boston Heart Fatty Acid Balance™. These tests reveal essential, specific information about HDL subpopulations, sources of LDL-C, patient specific treatment considerations to help mitigate the risk of statin induced myopathy, a patient’s 10-year risk of developing diabetes, and help to optimize the fatty acids in your patient’s diet.

These advanced tests, available exclusively from Boston Heart, enable you to better identify your patients’ specific CVD risk, individualize their treatment and engage them in their heart health. The goal: better patient management.

Boston Heart HDL Map® Test

The HDL Map provides information that helps you develop an effective personalized treatment strategy as well as monitor response to targeted therapy. This unique test identifies HDL subpopulations using a proprietary electrophoresis technique, distinguishing between very large alpha (α) particles (associated with reduced CVD risk) and the very small prebeta 1 (preβ-1) particles most associated with increased CVD risk.

The HDL Map offers a more refined analysis, specifically:

    • Analyzes HDL particle profiles not identifiable with any other analytical method—helps explain the causes of a patient’s disease.
    • Facilitates diagnosis of patients with rare genetic disorders, such as Tangier disease (ABCA-1 deficiency) or Fish Eye disease (LCAT deficiency).
    • Enables healthcare providers to prescribe an effective treatment strategy—from therapeutic lifestyle changes to various medications.
    • Allows evaluation of treatment strategy after only 8 weeks—a valuable monitoring tool.
    • Provides a visual aid to document problem areas in HDL metabolism—helps motivate patients and increases compliance with therapy.

Learn more about the science behind the Boston Heart HDL Map test

Boston Heart Cholesterol Balance® Test

Patients respond very differently to treatments that lower LDL-C. Knowing how an individual patient produces and absorbs cholesterol can help determine the most effective therapy.

Boston Heart’s proprietary Cholesterol Balance test measures the key production and absorption markers most associated with circulating total cholesterol—lathosterol, desmosterol, beta-sitosterol and campesterol.

  • The Cholesterol Balance test:
    • Determines whether the patient currently is an under-, normal- or over-producer or absorber of cholesterol—helps explain the causes of an elevated total cholesterol and LDL-C.
    • Enables you to prescribe the most effective protocol for lowering LDL-C in alignment with the National Cholesterol Education Program—dietary changes and statin monotherapy or a combination with a cholesterol absorption inhibitor.
    • Tailors therapy based on patient results—studies show that patients with the highest cholesterol synthesis get the greatest benefit from statin therapy in terms of LDL-C lowering and heart disease risk reduction, while those with elevated cholesterol absorption get the least.
    • Provides a physiologic rationale for patients who are unresponsive to statin or ezetimibe therapy.

Learn more about the science behind the Boston Heart Cholesterol Balance test

Boston Heart Statin Induced Myopathy (SLCO1B1) Genotype Test

SLCO1B1 genotyping helps you identify patients who are at higher risk for statin induced myopathy due to a variation in their SLCO1B1 gene, and prescribe the right statin type and dose with the least probability of causing myopathy accordingly.

  • The benefits of SLCO1B1 genotyping are:
    • Advanced identification of those patients who are at higher risk for statin induced myopathy due to:
      • Reduced ability to metabolize statins
      • Higher blood levels after dosing
    • Ability to prescribe the right type of drugs in the right doses according to a patient’s SLCO1B1 genotype.
      • For patients with the T/C or C/C genotypes, healthcare providers should consider using lower doses of water-soluble statins. Combination therapy including ezetimibe or colesevelam to augment LDL-C lowering response if needed should also be considered.
    • Reduced time and expense in achieving optimal therapeutic outcomes.
    • Other factors associated with risk of statin induced myopathy
      • Clinical Conditions
        • Diabetes
        • Creatine >1.0 mg/dL
        • Hypothyroidism
        • Use of calcium channel blockers
        • Use of amiodorone
      • Other Causes:
        • Age >65 years
        • Female gender
        • Physical activity

Learn more about the science behind the Boston Heart Statin Induced Myopathy (SLCO1B1) Genotype test

New Data: PCSK9 Inhibitor Approved by FDA; Demonstrates LDL-C Lowering Promise

On July 24, 2015 the Food and Drug Administration (FDA) approved the use of Praluent®(alirocumab), the first agent in the class of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent was approved in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (FH) or patients with clinical atherosclerosic cardiovascular disease (CVD) such as heart attacks or strokes, who require additional lowering of LDL-C. Another PCSK9 inhibitor’s application, Repatha™ (evolocumab), received FDA approval August 27, 2015.

Researchers are hopeful that PCSK9 inhibition provides a key element to reducing the residual cardiovascular risk that persists in high risk patients whose clinical needs are not met with current lipid lowering therapy.

PCSK9 inhibition demonstrated marked reductions in LDL cholesterol in people with FH. In addition, treatment with a PCSK9 inhibitor was effective in dyslipidaemic patients receiving background intensive lipid management with a statin, with or without other lipid-modifying therapies. Common mutations in the PCSK9 gene are associated with lower LDL cholesterol and a reduced frequency of adverse cardiovascular events. Sequencing the PCSK9 gene and other integral genes involved in diagnosing and treating FH could prove to be clinically relevant tools for lowering CVD risk.

With its existing exclusive product portfolio, Boston Heart is uniquely positioned to optimize clinical and therapeutic understanding for guideline-recommended LDL-C lowering—statins and diet and exercise—and potential utilization of PCSK9 inhibitors. Today, we can identify causes and risk factors for statin intolerance which include an abnormal SLCO1B1 genotype, other genetic variants, hypothyroidism, vitamin D deficiency, co-enzyme Q10 deficiency, age > 65 years, renal insufficiency, female gender, and use of amiodorone or calcium channel blockers. In active development are next-generation sequencing to help determine the genetic cause of high LDL-C (> 190 mg/dL off medications) in patients at five different gene loci, and also whether such patients will respond to PCSK9 inhibitors.

Boston Heart Prediabetes Assessment®

The Boston Heart Prediabetes Assessment gives a patient’s ten year risk of developing diabetes with a 92% accuracy. If a patient has borderline or high risk, lifestyle changes may prevent or delay the onset of type 2 diabetes.

Learn more about the science behind the Prediabetes Assessment

Boston Heart Fatty Acid Balance™ Test

Fatty acids are essential to heart health. Knowing a patient’s fatty acid balance can help healthcare providers make informed recommendations to decrease the risk of heart disease. The benefits of having an optimal balance of fatty acids are:

    • Improved balance of cholesterol
    • Improved immune system function
    • Reduced inflammation
    • Reduced rates of heart disease and atherosclerosis

Learn more about the science behind the Fatty Acid Balance test

Other Advanced Cardiovascular Tests

Beyond these five exclusive tests, you have access to the most advanced, clinically relevant, cardiovascular testing, providing you deeper insight into your patients’ risk of specific cardiovascular events. Our offering includes, but is not limited to:

    • Lipid, lipoprotein, and apolipoprotein tests: Total cholesterol, triglycerides, direct LDL-C, HDL-C, small dense LDL-C, apoB, Lp(a), apoA-I, non-HDL-C, VLDL-C
    • Metabolic tests: hemoglobin A1c (HbA1c), insulin resistance (HOMA-IR), glucose, insulin, adiponectin and glycated serum protein (GSP)
    • Inflammation tests: Myeloperoxidase (MPO), high sensitivity C-reactive protein (hs-CRP), lipoprotein associated-phospholipase A2 (LpPLA2), and; fibrinogen
    • Genetic tests: Boston Heart Statin Induced Myopathy (SLCO1B1)Genotype, apoE Genotype, Clopidogrel Response (CYP2C19) Genotype, Factor V Leiden Genotype, Factor II Genotype, and MTHFR Genotype
    • Liver, kidney, muscle and other tests:
      • Liver: alkaline phosphatase, alanine aminotransferase (ALT), aspartate amino transferase (AST)
      • Kidney: blood urea nitrogen (BUN), creatinine, BUN/Creatinine, estimated glomerular filtration rate (eGFR)
      • Muscle: creatine kinase (CK), homocysteine, N-terminal pro-brain natriuretic peptide (NT-proBNP), uric acid
      • Thyroid: Total T4, Free T4, Total T3, Free T3, thyroid stimulating hormone (TSH)
      • Other: albumin, sex hormones and 25-OH vitamin D

Please visit our test menu to learn more about the role of our advanced tests in identifying and stratifying cardiovascular risk and improving treatment options.

1. Sachdeva A, Cannon CP, Deedwania PC, et al; for The Get With The Guidelines Steering Committee and Hospitals. Lipid levels in patients hospitalized with coronary artery disease: an analysis of 136,905 hospitalizations in Get With The Guidelines. Am Heart J. 2009;157(1):111-117.e2.
2. Cannon CP et al, for the PROVE IT-TIMI 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes.
N Engl J Med. 2004;350:1495-1504.
3. LaRosa JC, Grundy SM, Waters DD, et al, for the TNT Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005; 352: 1425-1435.
4. Pedersen TR, Faergeman O, Kastelein JJP,et al, for the IDEAL Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction. The IDEAL Study: A randomized controlled trial. JAMA. 2005;294:2437-2445.
5. Libby P. The forgotten majority: unfinished business in cardiovascular risk reduction. J Am Coll Cardiol. 2005;46:1225–1228.
6. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143–3223.

Disease Management

  • Did you know?
    • Despite major advances in therapy, there is significant residual risk for death and acute events.5
    • A 1% decrease in LDL-C reduces CHD risk by 1%. A 1% increase in HDL-C reduces CHD risk by 2–3%. A 1% increase in HDL α-1 reduces CHD risk by 26%.6
  • Test Menu
    • For a complete listing and description of tests performed in our laboratory, see our Test Menu.