Disclosure Information

1
Disclosure Information

• Dan Varga, MD discloses that he has nothing to
  disclose.

2
The ABCs of Vascular Disease

• What is it?

3
Agenda

• Peripheral Vascular Disease (PVD) defined
• What is PAD (Peripheral Artery Disease)?
• PAD Risk Factors
• Signs Symptoms of Advanced PAD
• PVD Conditions
• Symptomatic Asymptomatic PAD
• CLI (Critical Limb Ischemia)
• Amputation Impact
• Vascular Screening Recommendations
• Vascular Tests Diagnosis of PAD
• Non-invasive
• Invasive
• The MultidisciplinaryTeam
• PAD Treatment Options
• Vascular Center Organization Chart
• Conclusion

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What is Peripheral Vascular Disease?

• Peripheral Vascular Disease (PVD) refers to
  diseases of blood vessels outside the heart and
  brain. It's often a narrowing of vessels that
  carry blood to the legs, arms, stomach or
  kidneys. There are two types of these circulation
  disorders
• Functional peripheral vascular diseases don't
  have an organic cause. They don't involve defects
  in blood vessels' structure. They're usually
  short-term effects related to "spasm" that may
  come and go. Raynaud's disease is an example. It
  can be triggered by cold temperatures, emotional
  stress, working with vibrating machinery or
  smoking.
• Organic peripheral vascular diseases are caused
  by structural changes in the blood vessels, such
  as inflammation and tissue damage. Peripheral
  artery disease is an example. It's caused by
  fatty buildups in arteries that block normal
  blood flow.

PVD definition is from the American Heart
Association
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Peripheral Artery Disease (PAD)

• PAD is most commonly caused by atherosclerotic
  plaque build up in the arteries. The plaque
  causes obstruction to blood flow in the
  extremities of the body, such as the legs.
• PAD affects 12-20 of Americans age 65 and older.
• Only 25 of PVD patients are in treatment.
• 14-18 million have PAD (in the US)
• 3x greater risk for diabetics over the age of 50
• 4x-5x higher risk of dying from a cardiovascular
  event

Period Change 28
Source Meditech Insights U.S. Markets for
Interventional Peripheral Vascular Products
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PAD Risk Factors

• NON-MODIFIABLE RISKS
• Age. The risk of limb loss due to PAD increases
  with age. People 65 or older are two to three
  times more likely to have an amputation.
• Gender. Men with PAD are twice as likely to
  undergo an amputation as women.
• Race/ethnicity. Some racial and ethnic groups
  have a higher risk of amputation (i.e., African
  Americans, Latino Americans, and Native
  Americans). This is because they are at increased
  risk for diabetes and cardiovascular disease.
• Family history of heart disease. A family history
  of cardiovascular disease is an indicator for
  risk at developing PAD.
• MODIFIABLE RISKS
• Cigarette smoking.  Smoking is a major risk
  factor for PAD. Smokers may have four times
  the risk of PAD than nonsmokers. 
• Obesity. People with a Body Mass Index (BMI) of
  25 or higher are more likely to develop heart
  disease and stroke even if they have no other
  risk factors. 
• Diabetes mellitus.  Having diabetes puts
  individuals at greater risk of developing PAD as
  well as other cardiovascular diseases. 
• Physical inactivity.  Physical activity increases
  the distance that people with PAD can walk
  without pain and also helps decrease the risk of
  heart attack or stroke. Supervised exercise
  programs are one of the treatments for PAD
  patients. 
• High blood cholesterol.  High cholesterol
  contributes to the build-up of plaque in the
  arteries, which can significantly reduce the
  blood's flow. This condition is known as
  atherosclerosis. Managing cholesterol levels is
  essential to prevent or treat PAD.
• High blood pressure. When blood pressure remains
  high, the lining of the artery walls becomes
  damaged. Many PAD patients also have high blood
  pressure.
• High levels of Homocysteine. This is an amino
  acid found in plasma (blood). Some recent studies
  show higher levels are associated with PAD.

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Signs Symptoms of Advanced PAD

• Pain in the toes or feet. This is called rest
  pain and occurs because the body is unable to
  deliver enough blood to the feet at rest. Rest
  pain usually worsens when the legs are elevated,
  and may be relieved by lowering the legs. When
  the legs are unable to get the nutrition needed
  for growth and repair, gangrene or death of the
  tissue can occur.
• Decreased hair growth on the legs
• Paleness of the leg or foot when elevated
• Blue/red discoloration of the foot when hanging
  down
• Absence of pulses in the foot
• Numbness, tingling, or pain in the foot, toes or
  leg
• Decreased ability to spread the toes and move the
  foot
• Cool temperature of the foot and leg
• A sore on the foot that does not heal
• Fatigue in legs which may require may require
  patient to stop and rest while walking.
• Slow or shuffled gait having difficulty keeping
  up with others.
• Impotence may be a sign of iliac disease and may
  see some relief with sildenafil citrate.

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Vascular Conditions

• Abdominal Aneurysm 
• Aortoiliac Disease 
• Upper Extremity Disease 
• Carotid Artery Disease 
• Claudication
• Deep Vein Thrombosis 
• Diabetic Problems 
• Hyperlipidemia
• Lymphedema 

• Mesenteric Ischemia
• Peripheral Aneurysm 
• Peripheral Arterial Disease 
• Pulmonary Embolism 
• Renovascular Conditions 
• Thoracic Aneurysm 
• Thoracic Outlet Syndrome 
• Varicose Veins 
• Venous Insufficiency 

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Symptomatic Asymptomatic PAD
Hirsh AT et al. JAMA. 2001 289 1317-1324
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Does Asymptomatic PAD Really Matter?

• Coronary Artery Surgery Study (CASS) in patients
  with known CAD the presence of PAD increased
  Cardiovascular mortality by 25 during a 10-year
  follow-up (J AM Coll Cardiol 1994231091-5)
• PAD, symptomatic or asymptomatic, is a powerful
  independent predictor of CAD and CVD (Vasc.
  Med. 3, 241, 1998)

PAD severity ABI Mortality Rate / CAD Death (10 year)
None WNL 11
Mild to Moderate 0.9 - 0.6 40
Moderate to Severe lt 0.6 60
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Critical Limb Ischemia (CLI)

• CLI affects 2 million Americans who are at risk
  for amputation of the toes, feet legs
• 40 of amputees die within 2 years
• CLI causes persistently recurring rest pain
  requiring regular analgesia
• CLI is a non-healing ulceration or gangrene of
  the foot or toes. Threatened limb loss or tissue
  loss
• Rutherford Becker Categories 4 6
• 4 Ischemic rest pain
• 5 minor tissue loss, e.g. non-healing ulcer,
  focal gangrene
• 6 major tissue loss, i.e. above transmet level

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CLI Vascular Compromise (Impact Mortality)

• Often due to diffuse, multi-level arterial
  involvement
• Frequently involves infra-popliteal arteries with
  sever diffuse disease and/or total occlusion
• Diabetics often have entirely infra-popliteal
  disease

Mortality rates for CLI patients at Mortality rates for CLI patients at
One year 25.0
Two years 31.6
Three years 60.0
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Amputation Impact

• International Diabetes Federation estimates that
  somewhere in the world, a leg is lost to diabetes
  every 30 seconds
• The risk of leg amputation is 15-40 times greater
  for a person with diabetes
• Each year there are 150,000 lower extremity
  amputations with a 270 million price

Source American Cancer Society, American Heart
Association, Alzheimer's Disease Education /
Referral Center, American Diabetes Association,
SAGE Group.
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Does Asymptomatic PAD Really Matter?
15
Vascular Screening Recommendations

• ADA Consensus Panel recommends ABI Screening for
• Patients over the age of 50 years who have
  diabetes
• Patients with diabetes younger than 50 years of
  age who have other PAD risk factors (i.e.
  smoking, hypertension, hyperlipidemia, diabetes
  more than 10 years)
• ABI should be repeated in 5 years if normal
• If ABI is abnormal, then patient should be
  referred

• TASC II recommends ABI Screening for
• All patients who have exertional leg symptoms
• All patients between the age of 50-69 and who
  have a cardiovascular risk factor
• All patients age greater than 70 years regardless
  of risk factor status
• All patients with a Framingham risk score of
  10-20

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Vascular Tests Diagnosis of PAD

• Non-invasive techniques
• ABI (Ankle/Brachial Index)
• Exercise Test
• Segmental Pressures
• Segmental Volume Plethysmography
• Duplex Ultrasonography
• CT Angiogram
• MRA (Magnetic Resonance Arteriography)
• Carotid Doppler identifies patients who are at
  risk for stroke
• Vascular ultrasound

• Invasive techniques
• Peripheral Angiograms
• CT Angiograms
• MR Angiograms

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PAD Diagnosic TestABI (Ankle-Brachial Index)
Medicare Reimbursement of CPT Code 93922 97 -
165 (depending on location)

• Simple, reliable means for diagnosing PAD.  Blood
  pressure measurements are taken at the arms and
  ankles using a Doppler.
• The ABI test is simple enough to be performed in
  any doctor's office.
• Inexpensive equipment and reimbursable tests.
• Please note Blood-flow waveform analysis must be
  included for Medicare reimbursement. CPT 93922
  provides coverage for a single-level lower
  extremity physiologic study. Test must be
  diagnosed as medically necessary (e.g. leg pain
  when walking).
• Sample vendors that meet reimbursement criteria
• LifeDop ABI (2,000)
• PADnet (22,000 auto transmission)

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Normal ABI Exceptions

• Normal resting ABI does not exclude PAD in
  patients with symptoms of PAD
• Exercise induced claudication
• Patients with diabetes with arterial claudication
• Toe pressures

19
PAD Diagnostic Test Segmental Pressures

• Similar to the ABI plus 2 or 3 additional blood
  pressure cuffs. These additional cuffs are placed
  just below the knee and one large cuff or two
  narrow cuffs are placed above the knee and at the
  upper thigh. These cuffs are then inflated above
  your normal systolic blood pressure, and then
  slowly deflated.
• Using the Doppler instrument, a significant drop
  in pressure between two adjacent cuffs indicates
  a narrowing of the artery or blockage along the
  arteries in this portion of your leg. This allows
  the physician to identify more precisely the
  location of such blockages in the arteries of
  your leg.

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PAD Diagnostic TestDuplex Scanning

• Duplex Scanning a combination of real-time and
  Doppler ultrasonography
• Purpose to evaluate arterial and venous
  disorders noninvasively.
• The most common application for the examination
  is to determine the presence of deep vein
  thrombosis (DVT) in the extremity, usually
  because of leg swelling.
• The deep veins are examined every 1-2 cm and
  gentle pressure is applied with the scan head to
  demonstrate that the walls of the vein can be
  easily collapsed. When thrombus is present there
  is little if any compressibility. The flow
  patterns are also assessed with Doppler
  recording. The presence or absence of venous
  valve insufficiency is assessed with compression
  maneuvers of the extremity.

• TYPES OF DUPLEX SCANS
• Extracranial Cerebrovascular
• Abdominal
• Renal
• Aortoiliac
• Mesenteric Arterial
• Venous Duplex Scan Upper and Lower Extremities

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The Team
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The Team

• Podiatry
• Care directly for patients with CLI
• Wound Care Medication, Debridement, HBO, Skin
  Grafting, Limited Amputation
• Identify Patients who may benefit from
  revascularizationfor claudication as well as for
  CLI
• Serve as Gate Keeper/PCP as 70 of patients
  with PAD also have CAD , Carotid Disease, other
  vascular disease (AAA, RAS)

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The Multidisciplinary Team

• Interventional Cardiology
• Committed to Endovascular Revascularization
• Management of Dyslipidemia
• Screening for CAD nuclear stress testing
• Evaluation of carotid disease stenting vs. CEA
• Interventional Radiology
• Committed to Endovascular Revascularization
• Experts in Vascular Imaging
• Screening for Vascular Disease in other areas
• Experts in Endovascular Therapy for other
  Vascular areas
• Surgery
• Committed to Endovascular Revascularization
• Experts in Vascular Disease
• Screening for Vascular Disease in other areas
• Can offer both Open and Endovascular
  Revascularization
• Experts in Vascular Imaging
• MOST PATIENTS WITH PAD DIE FROM MI OR STROKE

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PAD Treatment Options

• Medical
• Risk Factor Modification
• Exercise Therapy
• Drug Therapy
• Endovascular Therapy
• Peripheral Transluminal Therapy
• Peripheral Stenting
• Angioplasty
• Laser
• Cryoplasty
• Atherectomy
• Thrombolic Therapy (adjunctive)
• Surgery
• Bypass Grafts
• Amputation
• Endarterectomy

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AAA Screening

• Medicare now pays for this!
• Class 1 Indication Current or prior
• Smoking history, male, age 65-75
• Ultrasound, CT or MRA all acceptable, but
• cost argues for ultra sound

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Medical Care of the PAD Patient

• Remember You are treating a systemic disease

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Medical Care of the PAD Patient

• Most PAD patients will die of cardiovascular
  disease distant from the affected limb.
• Five year MI risk of mild claudicants exceeds
  that of a MI survivor!
• CLI patients have an exceptionally poor
  prognosisaverage survival less than one year in
  some series.

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Medical Care of the PAD Patient

• Antiplatelet agents
• --ASA or Clopidogrel both in high risk patients
  only
• Lipid lowering agents
• --PAD is a CAD risk equivalent LDL target is
  ,100
• --Statins are the preferred agent
• Blood Pressure targets are also secondary
  prevention targets

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Vascular Center Organizational Chart
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Thank you.