Anatomy of a SuccessfulPrevention Practice

A Case Study for Providers

Prevention is common sense...but is it profitable?

“The doctor of the futurewill give no medicines, butwill interest his patients inthe care of the humanframe, in diet, and in thecauses and prevention ofdisease.”

Thomas Edison, 1847-1931

“Today’s risky behaviors becometomorrow’s risk factors, and today’srisk factors become tomorrow’scardiovascular events.”

Dr. K. Srinath ReddyPresident of the

World Heart Federation

Strategic Goals• Simplify Your Practice• Streamline and Standardize care with Best Science

• Improve Patient Outcomes• Pay for Performance metrics achieved

• Enhance Revenue Generation• Patient Retention and Ancillary Services

• Reclaim Leadership Role for Primary Care Providers• Become a Center of Excellence

Clinic/Practice Model

• Private medical practice in a major suburban environment

• 15-year database of clinical results

• 800+ patients

Clinic/Practice Strategy: Prevention

• Identify risk and disease – arteriology focus

• Lipid status• Oxidative stress evaluation• Inflammation status• Metabolic factors• Genetics• Nutritional factors• RAAS system

Clinic/Practice Program

• RISK STRATIFICATION ALGORITHM

• EVALUATION ALGORITHM

• TREATMENT ALGORITHM

• OPTIMAL GOALS ESTABLISHED

• EDUCATIONAL SUPPORT SYSTEM

Advanced Technologies

ENDOTHELIAL FUNCTION TESTING

PLAQUE DETECTION

CAROTID INTIMA MEDIA THICKNESS TESTING (CIMT)

ANKLE-BRACHIAL INDEX

Advanced Biomarker Testing

ADVANCED LIPIDS

INFLAMMATION ASSESSMENT

INSULIN RESISTANCE

MYOCARDIAL FUNCTION

Clinic/Practice Algorithm FlowInitialPre-

Screen (online or

paper)

Initial Intake Visit

&Blood Draw

Testing

Plan Delivery

Visit

Continual Follow-up

Visits

Monitor Testing

Practice DemographicsDisease

Management Practice

Prevention Clinic

Wellness Center

After 25+ years, the M.D.’s patients are aging with him...

• Patients 100 years or older: 2• Patients 90 years or older: 51• Patients age 85 to 89 years: 74• Patients age 80 to 85 years: 195`

Practice DemographicsDisease

Management Practice

Prevention Clinic

Wellness Center

Revenue by payer type:

Medicare: 47.6%BCBS: 28.4%Commercial: 22.1%Misc.: 1.8%

Practice Mortality Statistics2001 - 2011

• Total Deaths: 163

• CAD/CVA: 30 (18.4%)

• All Others: 133 (81.6%)

• CVD Rate at <65: 17%

• CVD Rate at >80: 16%

• CVD Deaths > 80: 50%

Personalized Prevention Plans

• Medication changes• Weight loss goals• Exercise goals• Dietary plans• Diagnostic plans• Follow-up visits with

– FNP– Dietician– Wellness Center staff– Disease Management

Practice– Diabetes Store Classes

Used the available evidence, the data, to predict and prevent the onset of disease

Leading Causes of Death...and Heart Disease, Stroke, and Diabetes

1990 - 2010

Diet is #1

Weight is #3

Inactivity is #6

ObesityCDC's Behavioral Risk Factor Surveillance System (BRFSS) available at http://www.cdc.gov/obesity/data/trends.html

Diabetes

Diabetes Epidemic Predicted by CDC

• Currently 8.3% of U.S. adults (26 million people)suffer from diabetes.

• By 2050, 33% (more than 100 million people) will havea form of diabetes.

• 5,000 new cases every day over the next 40 years

• 80% of diabetics die of heart attack (60%) or stroke(20%)

Heart Disease

Arterial Biology

“A man is as old as his arteries.”

Thomas Sydenham, 1624-1689Father of English Medicine

CIMT FINDS DISEASE

Belcaro, G., et. al. (2001). “Carotid and femoral ultrasound morphology screening and cardiovascular events in low risk subjects: a 10-year follow-up study (the CAFES-CAVEstudy).” Atherosclerosis 156: 379-387.

The Utility and Promise of

Correlates with ASCVD Risk Factor levels Directly related to risk of Vascular

Events Correlates with ASCVD elsewhere

Reflects Pathophysiology of Entire Arterial Vasculature

Rate of Change is Measurable Reflective of Atherosclerotic Process

Progression Regression

Modifiable with Treatment Reflects Cardiovascular Risk

CarotidIntimaMedia ThicknessUltrasound(CIMT)

Cholesterol: Truth or Myth?

“If my cholesterol is normal I won’t have a heart attack.”

Truth: More than half of all heart attacksoccur in people with normal cholesterol. Thereare tests to find those at risk.

Cholesterol: Truth or Myth?

“If I take a statin drug and lower my LDLcholesterol, I wont have a heart attack.”

Truth: Statin drugs only prevent about 1 out 3heart attacks – the other two will still occurunless action is taken.

Cholesterol: Truth or Myth?

“Everyone in my family dies of a heart attack, so Iknow it’s inevitable.”

Truth: Family history is predictive, not destiny.There are several genetic tests now availableto uncover some of the causes.

Cholesterol: Truth or Myth?

“My doctor told me my HDL cholesterol is so high I’ll never have a heart attack.”

Truth: We now know that not all HDL isprotective – and there are tests to help decidethis.

Standard Lipid Levels in Heart Attack

• Get With The Guidelines Database*

• 136,905 hospitalized with CAD• 70% ACS• 30% Chest pain and known CAD• 83% LDL < 130 mg/dl• 50% LDL < 100 mg/dl• 18% LDL < 70 mg/dl

• At most, 25% of premature heart disease was attributable to elevated LDL

*Sachdeva A, et al. Am Heart J. 2009;157:111-7.

• Get With The Guidelines Database*

• 136,905 hospitalized with CAD• 70% ACS• 30% Chest pain and known

CAD• 45% HDL > 40 mg/dl*Sachdeva A, et al. Am Heart J. 2009;157:111-7.

Standard Lipid Levels in Heart Attack

Standard Lipid Levels in Heart Attack• Get With The Guidelines

Database*• 136,905 hospitalized with CAD

• 70% ACS• 30% Chest pain and known CAD• 70% Trigs < 150 mg/dl

*Sachdeva A, et al. Am Heart J. 2009;157:111-7.

Russell Ross’s response to injury hypothesis

1976

Injury

CholesterolApproximately

50% of individuals who experience heart attack or

stroke have normal lipids

Response

Inflammation

Vascular InflammationMyeloperoxidase (MPO)Inflammation outside the vessel wall – in the bloodstream – dueto the WBC response to arterial damage or vulnerable plaqueLp-PLA2 (The PLAC® Test)Inflammation inside the vessel wall due to cholesterolaccumulation

Endothelial Damage

Urinary MicroalbuminEndothelial damage in the kidneys that may indicate riskof endothelial damage in other parts of the body andrisk for cardiovascular disease

General InflammationhsCRPAn acute phase – or short-term – protein produced by theliver in response to body damage or infection. Also,associated with the presence of cardiovascular disease.

Oxidation/LifestyleOxidized LDLLDL cholesterol – or “bad” cholesterol – may become damaged dueto oxidation and identifies increased risk of metabolic syndromeF2-IsoprostanesFormed in your body due to red meat intake, smoking or lack ofexercise and place you at risk for cardiovascular disease

Endothelial health is key

Risk of Disease

Presence of Disease

Disease Activity

Endothelial Damage

Cholesterol Accumulation

Plaque activity/rupture/event

Biomarkers to Better Define Patients at Risk

Long-TermRisk

Mid-Term Risk

Near-Term Risk

Life Long Decade(s) YearsStandard

Lipid Panel

Advanced Lipid

Testing

InflammatoryMarkers

Inflammation TestingOxidation

Disease initiation/Plaque growth

Plaque maturation/Vulnerable plaque Acute coronary syndrome

LOW RISK

RISK OF DISEASE

MODERATERISK

PRESENCEOF DISEASE

HIGHRISK

DISEASE ACTIVITY

Why Monitor Inflammation?Studies continue to show the value of assessing the degree of inflammation in a patient

Younger Patient Older Patient

Plaque formation

Healthy Vulnerable plaque

Adverse events (MI, stroke, death)

hsCRP is a more reliable predictor ofcardiovascular events in women thanLDL-C

Women’s Health Study

28,345 women (8 yrs.; 15,745 were not on HRT)

hsCRP and LDL-C measured at baseline

Ridker PM et al. Comparison of C-reactive protein and low-density lipoproteincholesterol levels in the prediction of first cardiovascular events. N Engl J Med.2002; 347: 1557-1565.

The Two Sides of Vulnerable Plaque

Outside the vessel wallMPO can be used to tell us ifcirculating white blood cells are beingactivated in response to fissures,erosions or warming plaque increasingthe risk of vulnerable plaque rupture

Inside the vessel wallLp-PLA2 can be used to tell us if there is active inflammation within the vessel wall that could contribute to vulnerable plaque formation

MPO & CRP have combined utility in predicting cardiovascular mortality risk in patients with angiographic

evidence of CAD

Patients with either a high MPO or high CRP elevated had 5.3-foldhigher mortality risk

Patients with high levels of both MPO and CRP had a 4.3-fold risk vs. patients with only one elevated

marker

MPO CRPLow and Low

High or High

High and High

Log-rank test: p<0.001 for trend

Modified from Heslop CL et al. Myeloperoxidase and C-reactive protein have combined utility for long-term prediction ofcardiovascular mortality after coronary angiography. J Am Coll Cardiol . 2010; 55:1102-1109.

The Two Sides of Vulnerable Plaque

Outside the vessel wallMPO can be used to tell us if circulating white blood cells are being activated in response to fissures, erosions or warming plaque increasing the risk of vulnerable plaque rupture

Inside the vessel wallLp-PLA2 can be used to tell us if there is active inflammation within the vessel wall that could contribute to vulnerable plaque formation

High Lp-PLA2 and Low MPO

Interpretation: Active artery wall,but a stable collagen cap

Management of Lp-PLA2 Levels

Assess LDL-C• Initiate/titrate statin therapy, if

medically necessaryUtilize 10-yr. ACC/AHA CV risk calculator

Lp-PLA2

≤200 >200

Monitor every 6 mo.

Assess diet/lifestyleAssess blood pressureAssess insulin sensitivityAssess dental health

Assess presence of CAD w/ imaging (CIMT/CACS)If clinically appropriate, consider dual platelet inhibition

Assess risk for pre-diabetes/diabetesIf pre-diabetic/ diabetic, consider insulin sensitizing therapy

Assess CoQ10 levelsIf low, consider supplementation for its cardioprotective benefits

With the aforementioned ruled out, consider Hashimoto’s thyroiditis or serious liver issues which may result in the overproduction of Lp-PLA2.

The Two Sides of Vulnerable Plaque

Outside the vessel wallMPO can be used to tell us if circulating white blood cells are being activated in response to fissures, erosions or warming plaque increasing the risk of vulnerable plaque rupture

Inside the vessel wallLp-PLA2 can be used to tell us if there is active inflammation within the vessel wall that could contribute to vulnerable plaque formation

Low Lp-PLA2 and High MPO

Interpretation: Less active artery wall, but an unstable collagen cap

Management of MPO LevelsAssess LDL-C• Initiate/titrate statin therapy, if

medically necessaryUtilize 10-yr. ACC/AHA CV risk calculator

MPO

<470 470-539 or ≥539

Monitor every 6 mo.

in the absence of chest pain

Assess diet/lifestyleAssess blood pressureAssess insulin sensitivityAssess dental health

Assess presence of CAD w/ imaging (CIMT/CACS)• If clinically

appropriate, consider dual platelet inhibition

Assess risk for pre-diabetes/diabetes

• If pre-diabetic/ diabetic, consider insulin sensitizing therapy

Assess CoQ10 levels

• If low, consider supplementation for its cardioprotective benefits

With the aforementioned ruled out, consider the presence of inflammatory conditions (RA, systemic lupus erythematosus, Crohn’s disease, or vasculitis) or the presence of bone marrow dyscrasias. Also, assess extreme exercise levels.

Inflammation TestingTest Identifies

Risk of DiseaseF2-Isoprostanes Oxidation

Oxidized LDL Metabolic Syndrome Risk

Presence of DiseasehsCRP General InflammationMicroalbumin Endothelial Dysfunction

Disease ActivityLp-PLA2 (The PLAC® Test) Vulnerable Plaque Risk

(Active Necrotic Core)

Myeloperoxidase Vulnerable Plaque Risk(Luminal aspect of artery)

Insulin Resistance• More than 70% of Coronary Artery Disease/Acute Coronary Syndrome

sufferers are insulin resistant (Diabetes Care 2008; 31:1955-1959/Lancet 2007; 370:667-675)

• Every 18mg/dl above 140mg/dl at 2-hour plasma glucose increases cardiovascular and all-cause death rates by 26% over 6-7 years (Diabetes Care 2009; 32:1721-1726)

• Hgb A1C cut points were designed for microvascular complication prediction, NOT Cardiovascular Disease...(Diabetes Care 2009; 32:1721-1726/NEJM 2010; 362:800-811)

– A1C >5.5% AND <6.5% IS A RISK FACTOR FOR CVD:– 5.5 TO <6% 1.23 x HAZARD RATIO– 6 TO < 6.5% 1.95 x HAZARD RATIO

• 2 HOUR PLASMA GLUCOSE BETA CELL FUNCTION100-119mg/dl DECLINE STARTS120-139mg/dl 40-50% LOSS140-200mg/dl >50% LOSS

Diagnosis of Insulin Resistance

• Metabolic Syndrome is 90% IR specific; 10%false positive

• 50% with IR do not have Metabolic Syndrome;50% sensitivity

• Fasting Plasma Glucose > 100 mg/dl• 1 hour post glucose load > 125 mg/dl• 2 hour post glucose load > 120 mg/dl• Hgb A1C > 6.5%--definite; > 5.7% suspiciousDiabetes Care 2004; 27:978-983

Diagnosis• Metabolic Syndrome• Presence of 3 of 5 following risk factors:

Risk Factor MEN WOMEN

Waist Circumference >40” >35”

HDL Cholesterol <40mg/dl <50mg/dl

Triglycerides >150mg/dl >150mg/dl

Blood Pressure >130 systolic OR >85 diastolic

Fasting Plasma Glucose 100mg/dl 100mg/dl

Oral Glucose Tolerance TestFindings through January 2012

Normal Results 141 22.8%Insulin Resistant 441 71.3%Diabetes 36 5.8%Total Patients Tested 618

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“Changing ingrained behavior isdifficult. When sciencechallenges existing paradigms,we need effective strategiesto overcome lingering, stronglyheld beliefs.”

Frederick Masoudi, MD 2011

Implementation Barriers to Prevention

• I’m already swamped with acute care and complex chronic disease problems!

• I’m already managing their diabetes/cholesterol/blood pressure/etc.

• I’m following the guidelines already.• Insurance reimbursements aren’t adequate.• How do I keep up with the rapidly changing science?

Red-Flag Assessment• Obstructive Sleep Apnea• Sleep Deprivation, any cause• Metabolic Syndrome• Psoriasis• Sjogren’s Syndrome• Systemic Lupus• Migraine• Periodontal Disease• Hypothyroidism• Hyperuricemia/Gout• Polycystic Ovarian Syndrome• Miscarriages• Gestational Diabetes, history• Preeclampsia• Kidney Stones• Elevated GGT

• Erectile Dysfunction• First Responder work types• TV viewing time > 2 hours daily• Short Height (April 2015 NEJM

article)• Caffeine in slow metabolizers• Chronic Kidney Disease• Ear Lobe Creases under 40yo• Xanthelasma• Trigeminal Neuralgia• Second Hand Smoke• Hispanic/Latino ethnicity• Spouse Caregivers of Cancer Patient• Low Vitamin D• Sitting (6 hours a day = smoking 1

ppd)

Lowering My Risk• American Heart Association “Simple 7’s”• Less than 1% of us do all seven

Lowering My Risk1. Never smoked, or quit more than a year ago.2. Having a body mass index of less than 25 kg/m2.3. Exercising at a moderate level for at least 150

minutes, or at an intense level for 75 minutes perweek.

4. Meeting four to five of the key components of ahealthy diet in line with current AHA guidelines.

5. Having a total cholesterol of less than 200 mg/dL.6. Blood pressure below 120/80 mm Hg.7. Fasting blood glucose below 100 mg/dL.

Diabetes PreventionLose 7% of weight

150 min aerobic activity weekly• ~30mins 5 days a week• High-intensity interval training• Discuss with your doctor

Muscle resistance training 3 days/week

Metformin therapy? Discuss with your doctor

Treatment Options Beyond Statins

• Insulin Resistance Therapies• Metformin, Pioglitazone, Acarbose• Inflammation• Search for Causes, Statin adjustment, Omega 3, Insulin

Resistance• RAAS blockade—HOPE Trial• Cholesterol Absorption Blockade

Treatment Options Beyond Statins

• Apo E Dietary Implications

• Apo E2: Low Carb, Higher Fat (35%), alcohol allowed

• Apo E3: Neutral effect of carb/fat/alcohol

• Apo E4: Low Fat (20%), More Carbs, No alcohol

• Vitamin D Repletion

• Exercise Prescription

• High Intensity-Interval Training (HIIT)

• Obstructive Sleep Apnea

Treatment OptionsBeyond Statins

• Niacin—lp(a), LDL particle size, HDL particle size, Apo B, Triglycerides, Inflammation

• HATS

• Arbiter 2

• Arbiter 6-HALTS

• AIM-HIGH

• HPS2-THRIVE

Diabetes Projections for One Company

• 35,000 employees (15,000 under 45; 20,000 over 45)

• 2975 known diabetics, 1115 diabetics not yet diagnosed

• 4090 total diabetics -- 294 new diabetics every year• 80% will have a stroke or heart attack at least once

in their lives...• ...and they are already costing their employers 20

cents of every dollar of healthcare spend JUST for their diabetes

ACS Hidden & Long-Term Costs are Significant

• About 47% of patients with ACS in the US areyounger than the eligibility age for Medicare

• Enhanced focus on ACS prevention should yieldgreater-than-expected savings

• Economic benefit of avoiding ACS should beincentive for employers to expand coverage ofprevention efforts

Dr. Robert L. Page (University of Colorado School of Pharmacy, Aurora) 11/5/2012 American Heart Association (AHA) 2012 Scientific Sessions.

ACS Hidden & Long-Term Costs are Significant

• 37,340 employees of service companies with ACS claims; 95% were younger than 65

• Direct out of pocket first year cost to patient ~$8,170

• Short term (~2mos.) disability cost: $2,263 to pt.; $7,943 to employer

• Long term (~398 days) disability cost: $20,609 to pt.; $52, 473 to employer

Dr. Robert L. Page (University of Colorado School of Pharmacy, Aurora) 11/5/2012 American Heart Association (AHA) 2012 Scientific Sessions.

The Ancient Science of Prevention

“Superior doctors prevent the disease.Mediocre doctors treat the disease before itis evident. Inferior doctors treat the full-blown disease.”

Huang Dee Nai-Chang, from the first known Chinese medical text, ca. 2600 B.C.

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