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Endovascular Management of PAD in the Female Patient

Richard C Kovach, MD, FACC, FSCAI, FACP Division Director, Intervention Cardiology Medical Director, Cardiac Catheterization Laboratory Assistant Director, Interventional Cardiology Fellowship Program

Deborah Heart and Lung Center, Browns Mills, NJ Clinical Professor of Medicine

Philadelphia College of Osteopathic Medicine Philadelphia, Pennsylvania

Associate Director, Cardiovascular Institute of Philadelphia Philadelphia, Pennsylvania

Associate Editor, Vascular Disease Management Chairman Elect

Horizons International Peripheral Group

10/1/16

Disclosures

•  Spectranetics Corporation: Medical advisory board, consultant, speaker, educational grants, trainer, investigator

•  Boston Scientific: Medical advisory board, speaker, fellow training faculty, educational grants, trainer, investigator

•  Abbott: Medical advisory board, speaker, research funding, educational grants, trainer, investigator

•  Medtronic Corporation: speaker, educational grants, investigator •  St Jude: investigator •  Avinger: investigator •  Gore: investigator •  Bard: Medical Advisory Board, Continuum Study Clinical Events Committee •  Ostialcorp: Medical Advisory Board; stock holder •  Asia Pacific Medical Technologies: Stock Holder •  Endoshape, Inc.: Stock Holder

Risk Factors of PAD

Hirsch  AT,  et  al.  ACC/AHA  2005  Prac9ce  Guidelines  for  the  Management  of  Pa9ents  with  Peripheral  Arterial  Disease  (Lower  Extremity,  Renal,  Mesenteric,  and  Abdominal  Aor9c)  J  Am  Coll  Cardiol.  2006;  47:e1-­‐e192  

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Smoking Smoking is the #1 correctible risk factor of developing PAD1 Smokers are 3 to 6 times more likely to develop PAD than nonsmokers.2 Smokers have poor PAD survival rates, as well as a higher risk of developing CLI leading to amputation.3

American Indians/Alaska Natives (29%), Whites (18%), and Blacks (17%) have the highest smoking rates in the United States.4

1.  Heather  L.  Gornik,  Joshua  A.  Beckman.  Cardiology  Pa9ent  Page,  Peripheral  Artery  Disease.  Circula/on.  2005  2.  Hirsch  AT,  Criqui  MH,  Treat-­‐Jacobson  D,  et  al.  Peripheral  arterial  disease  detec9on,  awareness,  and  treatment  in  primary  care.  JAMA  2001  3.       Olin,  Sealove.  Peripheral  Artery  Disease:  Current  Insight  Into  the  Disease  and  Its  Diagnosis  and  Management.  Mayo  Clin  Proc.  2010  4.  Centers  for  Disease  Control  and  Preven9on.  Current  Cigare\e  Smoking  Among  Adults—United  States,  2005–2014.  Morbidity  and  Mortality  Weekly  Report  2015  5.  Center  for  Disease  Control  and  Preven9on,  MMWR.  Racial/Ethnic  Differences  Among  Youths  in  Cigare\e  Smoking  and  Suscep9bility  to  Start  Smoking  -­‐-­‐-­‐  US,  2002—2004.  

%  of  Youths  12-­‐17  who  smoked  within  the  last  30  days5  

White   14.9  

Black   6.5  

AI/AN   23.1  

Asian   4.3  

La9no   9.3  

Diabetes

•  Intermittent Claudication is twice as common in diabetics than non-diabetics2

•  40%-50% increased risk of PAD w/insulin resistance2

•  Major amputation rate 5-10 times higher in diabetics2

American Diabetic Association recommends referring patients with significant claudication or a positive ABI for further vascular assessment3

1.  American Diabetes Association, Peripheral Arterial Disease (PAD). 2014 2.  Falconer, Travis M, et al. Management of peripheral arterial disease in the elderly: focus on cilostazol.

Clin Interv Aging. 2008 3.  American Diabetes Association. Standards of Medical Care in Diabetes-2015

About  1  in  3  people  with  diabetes  over  the  age  of  50    also  have  PAD1  

Good diabetes management can help

reduce your risk – need slide on what good

management is

Many people are not even aware that they have

diabetes

Hypertension and Hypercholesterolemia

Hypertension (HTN) About 69% of people who have a first heart attack, 77% who have a first stroke, and 74% who have congestive heart failure have HTN, i.e. higher than 140/90 mm Hg.1

Nearly 55% of PAD patients also have HTN2

High Cholesterol When levels of bad (LDL) cholesterol are 130 mg/dl or higher there is a higher risk of developing peripheral artery disease and other vascular complications.1

1.  American  Heart  Associa9on.  What  Your  Cholesterol  Levels  Mean.  2.  Singer  DR,  Kite  A.  Management  of  hypertension  in  peripheral  arterial  disease:  does  the  choice  of  

drugs  ma\er?.  Euro  Journal  of  Vascular  and  Endovascular  Surgery.  2008    

Pressure  exerted  by  blood  

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Obesity and Diabetes

Amputation Rates per State in Medicare Patients

Goodney,  Holman,  Henke,  et  al.  Regional  intensity  of  vascular  care  and  lower  extremity  amputa9on  rate.  J  Vasc  Surg.  2013  

Number  of  Amputa9ons  in  Each  Hospital  Referral  Region  (per  10,000  Medicare  Pa9ents)  

Amputa=on  rates  vary  by  region  

PAD General Outcomes

Ultrasound   Angiogram   PVR  tracing  

•  27.5%  people  on  dialysis  have  PVD1  

•  54%  of  all  amputa9ons  are  due  to  PAD  and  diabetes2  •  Individuals  with  low  ABIs  have  significantly  elevated  3-­‐year  CVD  mortality  (RR:  4.3,  p=0.01)  

compared  to  those  without  PAD3  

•  Pa9ents  with  PAD  and  diabetes  die  nearly  9  years  before  nondiabe9cs.4  •  Opera9ve  mortality  for  AAA  is  increased  in  diabe9cs  (OR  1.26;  p=0.0008)5  

Methods  of  Detec9on  

1.  Rajagopalan,  Sanjay.  et  al.  Peripheral  Artery  Disease  in  Pa9ents  With  End-­‐Stage  Renal  Disease  –  Observa9ons  From  the  Dialysis  Outcomes  and  Prac9ce  Pa\erns  Study  (DOPPS).  Circula/on  2006  

2.  Ziegler-­‐Graham  K,  et  al.  Es9ma9ng  the  Prevalence  of  Limb  Loss  in  the  United  States:  2005  to  2050.  Archives  of  Physical  Medicine  and  Rehabilita/on  2008  3.  Criqui,  Michael  H.  et  al.  Progression  of  Peripheral  Arterial  Diseae  Predicts  Cardiovascular  Disease  Morbidity  and  Mortality.  J  Am  Coll  Cardiol.  2008  4.  Jude,  Edward  B.  et  al.  Peripheral  Arterial  Disease  in  Diabe9c  and  Nondiabe9c  Pa9ents  –  A  comparison  of  severity  and  outcome.  ADA  2001  5.  Rango,  Farchioni,  et  al.  Diabetes  and  abdominal  aor9c  aneurysms.  Eur  J  Vac  Endovasc  Surg.  2014    

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Prevalence and Ethnicity

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Whites   Blacks   La9nos   Asians  

Frac=o

n  of  Pop

ula=

on  with

 PAD

  About  8.5  million  Americans  ages  ≥40  are  affected  by  peripheral  arterial  disease.1    The  highest  prevalence  of  PAD  is  among  the  elderly,  Blacks,  and  American  Indians/Alaska  Na9ves1    Blacks  are  most  likely  to  have  PAD  followed  by  American  Indians/Alaska  Na9ves,  Whites,  Hispanics  and  Asians.2    

Only…1  •  ~10%  of  pa9ents  show  signs  of  intermi\ent  

claudica9on  •  ~40%  do  not  complain  of  any  leg  pain  •  ~50%  have  a  variety  of  leg  symptoms  different    from  

IC  

1.  American  Heart  Associa9on,  Heart  Disease  and  Stroke  Sta9s9cs,  2015  update  2.  Criqui,  Aboyans.  Peripheral  Artery  Disease  Compendium,  Epidemiology  of  Peripheral  Artery  Disease.  Circ.  2015  3.  Criqui,  Vargas,  Denenberg,  Ho,  et  al.  Ethnicity  and  Peripheral  Arterial  Disease.  The  San  Diego  Popula9on  Study.  Circ.  2005  

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Eslami.  H  Mohammad,  et  al;  The  adverse  effect  of  race,  insurance  status,  and  low  income  on  the  rate  of  amputa9on  in  pa9ents  present  with  lower  extremity  ischemia;  the  New  England  Society  for  Vascular  Surgery;  January  2007.  

Revasculariza=on  Techniques:  Percutaneous  and  Surgical    

Demographics of men and women

•  Women live longer (therefore more live long after loss of spouses) There are more women than men in the US 1.  At age 75 – 3:2 Females alive 2.  At age 80 – 2:1 Females alive

•  Less women smoke (at the time of prior publications) •  Women have slightly higher incidence of diabetes •  By 2060 1 in 4 > age 65 (100,000,000)

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The Heart of the Matter Heart disease is the leading cause of death for women and men, regardless of race and ethnicity

Black American Males 46%  

Black American Females 48.3%  

White Males 36.1%  

White Females 31.9%  

Hispanic/Latino Males 48.3%  

32.4%  Hispanic/Latino Females

85.6 Million American Adults Have Heart Disease

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0%

Mozaffarian D, et al; on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015;131:e29–e322

Disease Predilection

•  AAA 4:1 Male (However must question definitions as women’s aorta’s are normally much smaller at baseline and small AAA’s in women more apt to rupture 3 x >)

•  Popliteal art aneurysm 20:1 Male •  Gut ischemia 2:1 Female •  Carotid Disease 6% of Males 4% Females > 60

–  (Pattern of disease different – women more common carotid and men internal carotid)

* But what about PAD?? Largely under-diagnosed and under-treated in both men and women: As with CAD, after menopause incidence of PAD in women catches up very quickly to men

Factors affecting prognosis in females

•  Women typically present at a later stage of disease –  More CLI than claudication. –  More likely ruptured aneurysm –  More likely to be on hormonal replacement (worse

prognosis) •  Typically present at an older age •  Awareness of vascular disease in women is low in both

patients and primary care physicians

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Factors Affecting Prognosis (cont)

•  Women are more likely to adhere to medical regimes and get follow-up, BUT------

•  Women often delay seeking medical help for the problem, leading to a higher rate of advanced disease (CLI) at the time of diagnosis.

•  Because they present late, are more likely than men to receive an amputation.

•  When treated surgically (bypass), they are more likely than men to develop a wound infection.

More Factors Affecting Prognosis

•  Over 80% of female patients are asymptomatic or have atypical symptoms

•  Paradoxically, women appear to have a lower calf muscle hemoglobin oxygen saturation in response to exercise, which contributes to a lower absolute claudication distance

•  Women have higher mortality rates with open surgical procedures (yet fewer women are offered the endovascular option

Size Matters

•  Women have smaller peripheral arteries in general –  Sheaths more apt to be occlusive –  Vascular rupture more common with dilation –  May need different rules in AAA (small iliac vessels

may preclude endovascular options) –  SFA Self expanding stents are designed for larger

vessels (chronic outward force may be deleterious-present stents may be too large for women’s SFA’s)

–  Many devices require large bore catheters. –  Smaller vessels are associated with higher

restenosis rates

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Leg Ischemia

•  With similar amounts of PAD women are much less likely to experience claudication. (even men only experience typical claudication only 1/3 of the time.)

•  When they do experience symptoms, caregivers attribute these to other etiologies such as osteoporosis, arthritis, etc

•  PAD develops later in life for women •  Risk for PAD increases quickly after menopause. •  Women much more likely to present first as critical limb

ischemia.

Leg Ischemia (cont)

•  Occlusive PAD – Multiple series show similar patency outcomes but more women go from intervention to long term care (possibly later disease and possible no spouse to care for them)

Carotid disease in women

•  Slightly less prevalent then in men (4% vs 6%) •  Surgical studies under represent women

–  NASCET 30% women –  VA cooperative 0% women –  ACAS 33% women

•  Disease pattern different •  Prognosis may be different with medical therapy •  Smaller carotid arteries require less plaque volume to

create significant disease.

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AAA (more common in men…but)

•  Women more likely to present with rupture 21 vs 16% •  Higher acute rupture 3X. •  Rupture frequently occurs at much smaller size. •  AAA expansion rate 40-80% faster than men. •  Much higher endoleaks (short necks) following EVAR •  Small vessels may preclude EVAR •  Even with EVAR, women have a higher LOS, readmission

rate and mortality than men. •  SHOULD WE RE-DEFINE WHEN IT IS APPRPRIATE TO

INTERVENE ON WOMEN?

•  SHOULD SCREENING BE LIMITED ONLY TO MEN WHO ARE > 65 YO AND HAVE BEEN SMOKERS?

LUCY Study

•  1st prospective study evaluating endovascular repair of AAA in women (Currently enrolling at DHLC)

•  Designed to evaluate the clinical outcomes and benefits using the Ovation™ abdominal stent graft system in men and women

•  Assess access-related vascular complications, mortality rates, and eligibility rates, even in patients with small access vessels and challenging neck anatomy.

•  Ovation™ (Trivascular/Endologix Corporation) is a low profile (14F) system employing a polymer filled main body graft instead of the typical nitinol framework

Alternative/Exotic Access

•  Higher failure rate in gaining pedal access in women (smaller vessels ofter no larger than micro-stick needle)

•  Once access is successful crossing success the same as men

Cook  Pedal  Access  Registry  

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So, Where Do We Stand With Rx?

•  Both men and women are being treated with endovascular treatment more commonly, especially since device French sizes have decreased significantly.

•  Good?? •  Most data shows similar patency rates with

matched disease and vessel size. •  Overall, however, data is severely lacking for

endovascular treatment options and outcomes in women

Case Example

•  History: -65 y/o female, Rutherford 3 right, 4 left (rest pain) -CAD (prior stents), DJD, HTN, hyperlipidemia, low plts,50-60% left carotid -SMOKER!!—smoked 1 pk in parking lot to calm down before adm -on Lyrica: had a referral to see a neurologist before another astute primary physician picked up on the PAD diagnosis •  Physical Exam -small stature, cachectic body habitus -left carotid bruit, absent pedal pulses, legs painful to touch

Summary

•  Men and women are different in symptomatic presentation, age at typical presentation, size of vessels, and potential complications.

•  Reduction in profile of interventional devices has now made endovascular intervention an option for more female patients, particularly AAA

•  Numerous technologies are available for addressing obstructive peripheral vascular disease, including chronic total occlusions (subject for a completely separate presentation)

•  Interventional and surgical patencies are similar when vessel size and outflow status is similar.

•  Data on treatments and outcomes for vascular disease in women is still lacking.

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Suggested Reading:

•  AHA Scientific Statement

A Call to Action: Women and Peripheral Artery Disease Circulation March 20, 2012, Volume 125, Issue 11

•  Peripheral Artery Disease in Women Journal of Vascular Surgery April 2013 Volume 57, Issue 4 18S-26S