Advanced Testing for Cardiovascular Disease Joseph P. McConnell, Ph.D., DABCC Joseph P. McConnell, Ph.D., DABCC Laboratory Director and Chief Medical Officer Laboratory Director and Chief Medical Officer Health Diagnostic Laboratory Health Diagnostic Laboratory National Lipid Association Meeting New York, NY New York, NY May 20, 2011 May 20, 2011
Health Diagnostic Laboratory Inc. (HDL Inc.) History Health Diagnostic Laboratory, Inc. (HDL) was founded in 2008. Capital acquired in July of 2009 November 2009: Accreditation from the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) The Founders collectively have over 70 years of experience in the field of Laboratory Medicine holding key positions in renowned and respected medical, educational, and industrial institutions including: The Mayo Clinic University of Washington, Northwest Lipid Research Center Indiana University Medical Center Berkeley Heart Laboratory Wako Diagnostics
Our Founders
The HDL Mission � To identify through laboratory testing why cardiovascular disease is occurring in each individual , and tailor therapy to halt or reverse disease progression, extending the quality and length of life . Live healthy until you die! ☺
The HDL Business Approach The goal is prevention. HDL is solutions focused and not technology driven � bent on outcomes Through strategic partnerships with industry, researchers, and physician/medical educators , we use a team approach to understanding where an individual is on the disease continuum and tailor therapies to achieve a diagnosis of health.
Advanced CVD Risk Testing The cost of laboratory tests make up about 3-5% of total health care costs, but are responsible for about 75-85% of medical treatment decisions. By performing low cost advanced testing, we can decrease the large downstream costs of catastrophic events like MI, stroke, DVT and PE, and interventions (CABG, etc.) saving $$$ in medical care cost.
Physicians customize testing panels Physicians customize testing panels
Physicians customize testing panels Physicians customize testing panels
Case Studies
Case #1: 45 yr Male: Family History � Maternal Grandfather died at age 57, two years after his first stroke (significant morbidity). � Maternal Grandmother died at age 61 of MI, apparently in her sleep. � Paternal Grandfather died at age 63, massive coronary. � Paternal grandmother died of a stroke at age 62. � Father survived first MI at age 61, died following 2 nd MI at age 62.
Case #2: A Concerned Young Woman A healthy 38 years old female is interested in a cardiovascular evaluation because her seemingly healthy father in his early 60s just had a myocardial infarction followed by triple vessel coronary bypass surgery. She appears quite healthy with a BMI of 24 (5 � 6 inches and 150 lbs) and is normotensive. There is no history of smoking. She has two children ages 3 and 5 and there was no gestational diabetes.
Case #2: A Concerned Young Woman
Case#3: 50 year old Male 124
Different Inflammatory Markers: Different Roles Adapted from: Rader D. N Engl J Med . 2000
Additive Risk for Incident CHD for LDL <130 by Lp-PLA 2 and hsCRP Tertiles 5 (95% CI 1.7-10.3, p=0.001) 4 4.2 Risk 3 Ratios 1.4 2 Lp-PLA2 top 1 Lp-PLA2 bottom 1.2 1.0 0 hsCRP hsCRP top bottom Adjusted for demographics, current smoking status, blood pressure, diabetes, and HDL Ballantyne et al., Circulation 2004
Case #4: 36 year old Female � Father: MI at age 45 � Significant hyperlipidemia resistant to therapy � Has had numerous stents placed over the years. � Patient presents with known hyperlipidemia � Current Meds: Rosuvastatin (Crestor 20) � Previously on crestor 40 but complained of myalgias � Concerned about hyperlipidemia � Therapeutic lifestyle changes
Case #4: 36 year old Female � Interpretive comment: � The elevated LDL cholesterol is consistent with heterozygosity for familial hypercholesterolemia. Family studies are recommended. � Familial Hypercholesterolemia � Most common genetically inherited disorder that we can treat in the US � Frequency estimated 1:500 in the US
NLA Launching Campaign on Awareness of Familial Hypercholesterolemia (FH) � Recommended LDL cholesterol cut points for identification of individuals likely to have FH. � < 20 years old: LDL-C > 160 mg/dL � 20-29 years old: LDL-C > 190 mg/dL � > 29 years old: LDL-C > 200 mg/dL � � FH: It � s Relative � Know Your Family Cholesterol History � � � Ask your relatives to be screened as well �
Elevated LDL Cholesterol in ca. 200,000 HDL Inc. Patients � < 20 years old with LDL-C > 160 mg/dL � 2.26%, total N = 886; or 20 possible FH � 20-29 years old with LDL-C > 190 mg/dL � 0.87%, total N = 5493; or 48 possible FH � > 29 years old: LDL-C > 200 mg/dL or > 220 mg/dL � LDL-C > 200: 0.87%, total N = 194483; 1692 possible FH � LDL-C >220: 0.32%, total N = 194483; 622 possible FH
NLA Launching Campaign on Awareness of Familial Hypercholesterolemia (FH) � We congratulate the NLA on this needed effort! � We are willing to help participate in identification of FH patients. � Also planning to help with such efforts as patient registries and generation of family trees, etc.
Case #5: A 26 Year old female
Factor V Leiden and Prothrombin G20210A Mutations � Associated with Venous Thromboembolism � DVT = Deep Venous Thrombosis � PE = Pulmonary Embolism
Factor V Leiden and Prothrombin G20210A Testing � Heterozygous carriers of factor V Leiden have approximately 5 fold increased risk for DVT/VTE � Homozygous carriers have as much 80 to 100 fold increased risk. � Compound heterozygotes of Factor V and Prothrombin mutations have significantly increased risk for DVT/VTE (50 � 100 fold).
Estimated Prevalence of VTE in the USA � As many as 450,000 cases of DVT annually � Approx. 250,000 cases PE � 40-45% fatal
Deep Venous Thrombosis
Clots Surgically Removed
14 y-o female in for cervix biopsy. PE at the bifurcation of the pulmonary artery 2 days later. (Biopsy was benign).
Good News � Most DVTs are avoidable � Maintain good circulation � Anti-coagulate during surgical procedures � Consider alternative birth control to oral contraceptives � Control homocysteine elevations (30X risk) � Watch fibrinogen levels
Current Recommendations for Use � After a patient has had a VTE (DVT, PE, etc) � Test to see if person is predisposed � If positive test family members � Not recommended for screening purposes � Why not?
Reflex to Warfarin Sensitivity Testing? � If patient is predisposed to VTE, reflex to warfarin sensitivity testing: � CYP2Cp and VKORC1 testing � Determine proper warfarin loading and maintenance doses.
Patient Medical Information Card
Advanced CVD Risk Testing The cost of laboratory tests make up about 3-5% of total health care costs, but are responsible for about 75-85% of medical treatment decisions. By performing low cost advanced testing, we can eliminate the large downstream costs of catastrophic events like MI, stroke, DVT and PE, saving $$$ in medical care cost.
Advanced CVD Risk Testing Laboratory testing can make a difference! Almost everyone has disease, but our individual diseases may have a different root causes. Lab testing can find the root cause of disease. By addressing the root cause, we can halt or reverse disease, leading to a diagnosis of health.
Health Diagnostic Laboratory, Inc. Advanced Testing for Cardiovascular Disease � Cardiovascular disease is preventable and progression can be halted or even reversed. � Together � .through teamwork � with education, research and a united message � We can beat CVD!!!
Thank You! Thank You! Please join us at the HDL, Inc. booth Please join us at the HDL, Inc. booth (numbers 10 and 12) tomorrow, Saturday (numbers 10 and 12) tomorrow, Saturday May 21 st st , for a May 21 , for a book signing book signing featuring Dr. featuring Dr. Thomas Dayspring, Dr. Michael Richman, Thomas Dayspring, Dr. Michael Richman, and Russ Warnick, Chief Scientific Officer and Russ Warnick, Chief Scientific Officer at HDL, Inc. at HDL, Inc.
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