Peripheral Vascular Disease - aamsc.org file• Acute inferior STEMI was suspected and pt was rushed...

Peripheral Vascular Disease

“Save a Life-Save a Leg”

Harry Balian, MD, FACC, FSCAI

Armenian Medical Society

Saturday Sept 12, 2015

Las Vegas Convention

Recent Updates in Treatments of Vascular Disease

Harry Balian, MD FACC, FSCAI

Chairman of Cardiology

Director of Cardiac Cath Lab

Glendale Adventist Heart & Vascular Institute

Saturday May 5th, 2018

Objectives

• Definition of Peripheral Vascular Disease

(PVD)

• Aortic Dissection and Treatment

• Epidemiology of PVD

• Modalities of diagnosis of PVD

• Treatment and Lifestyle Modification

• Recent Updates in Treatment of PVD

• Inflammatory Vascular Disease

• Final Remarks

Aortic Dissection

• Mr M is a 57 y/o Korean speaking male with hx of 1 ppd smoker, dyslipidemia, presented to the ER with crushing chest pain partially radiating to the back that started an hour prior to presentation. Ptappeared cold and clammy upon initial evaluation

• His right radial pulse was bounding but left radial pulse thready and weak

• Pt had been given aspirin 325 mg on the

field.

• Acute inferior STEMI was suspected and

pt was rushed to cath lab

CT scan of aorta with contrast(chest/abdomen/pelvis)

• Ascending aortic angio showed Type I aortic dissection

• Stat CT angio of the aortic root was obtained

The patient was noted to have a type A dissection

The dissection involved the Celiac artery and the right

renal artery.

Pt also had large amounts of retroperitoneal fluid that

c/w contained rupture of the descending aorta

Pt was rushed to OR

TEE can be helpful when the patient has renal insufficiency and CT angio of the chest can further compromise the kidneys

Aortic Dissection

• Diagnosis

– Angiography • “Gold standard”

• Shows all anatomy and involvement

• 94% specific

• 88% sensitive

– TEE• 97-100% sensitive

• 97-99% specific

• Esophageal dz contraindication

Aortic Dissection• In contrast to ruptured AAA,

SUSPECTED DISSECTIONS MUST BE CONFIRMED RADIOLOGICALLY PRIOR TO SENDING TO OR!!!

Open surgery-for repair of asc ao

dissection

TEVAR for descending ao

dissection

CASE #2

Mr V

• 44 y/o Armenian gentleman who has been

suffering of severe L calf pain worsening

over the last 6 months. He has been 22

pack year smoker but has quit over the

last 3 months.

• His left leg ABI is 0.5

• His right is 0.95

• Arterial duplex of the lower extremites

shows total occlusion of the left popliteal

artery

• There is faint flow of the left posterior tibial

artery that is supplying blood flow to the

left foot.

• LE angiogram was proposed

©2014 MFMER | Slide-30

Acute arterial occlusion

• Presentation

• Pain, pulselessness, pallor, paresthesias, pokilothermy, paralysis

• Admit to intensive care

• Initiate IV heparin

• CBC, creatinine, ECG, Echo, TEE

• Ultrasound, Doppler

• Angiography

• We restored three vessel runoff to the foot

• By end of case-pt had bounding DP and

PT pulses

• He was discharged home two days later

with ABI of 0.99 on left foot and completely

asymptomatic

Epidemiology

• Lower extremity arterial disease (PAD) affects 10 to 15% of community-dwelling older men and women

• PAD affects 25 to 30% of men and women aged 50 years and older in primary care medical practices

• Intermittent claudication is the most classic symptom of PAD

• However, many pts with PAD are asx

Prevalence of Claudication

• Claudication

increases w/ age-

• <1% in 30 y/o men

• 3% in 55 to 59 y/o

men

• 3-7% in 60 to 69 y/o

men

• >7% in > 70 y/o men

0% 5% 10% 15% 20% 25% 30% 35%

29%

6%

Prevalence of PAD

PARTNERS

Aged >70 years, or 50–69 years with a history diabetes or smoking

San Diego

Mean age 66 years

Diehm

Aged 65 years

Rotterdam

Aged >55 years

NHANES

Aged 70 years

NHANES

Aged >40 years

NHANES=National Health and Nutrition Examination Study

PARTNERS=PAD Awareness, Risk, and Treatment: New Resources for Survival [program]

In a primary care

population defined by age

and common risk factors,

the prevalence of PAD was

approximately one in three

patients

ACCF/AHA PAD slide set


ABI and mortality

Ankle brachial index

JAMA 2008; 300(2):201

0.5

1.0

2.0

4.0

8.0

Hazard

ratio

£0.6

0

0.6

1-0

.70

0.7

1-0

.80

0.8

1-0

.90

0.9

1-1

.00

1.0

1-1

.10

1.1

1-1

.20

(r

efe

rence

)

1.2

1-1

.30

1.3

1-1

.40

>1

.40

Men (n=24,955) Women (n=23,339)

Additional PAD facts

• Prevalence of PAD- 12%

• Risk of PAD increases two to threefold for

every 10 year increase in age after 40

years

• 60% of pts with PAD have significant

multivessel CAD

Natural History of PAD

• 5 year mortality in pts with intermittent

claudication is about 30%

• 5% major lower extremity amputation rate

over 5 years

• 10 fold increase in the risk for major

amputation in tobacco users and 2x

increase in mortality

Risk Factors for PAD

• Male gender

• Older age

• Hyperhomocysteinemia

• Lp(a)

• Tobacco

• High TG level

• DM

• HTN

Management of PAD

• History- Listen to your pt

• Physical- inspect, palpate, auscultate

• Treatment

– Exercise therapy

– Medical therapy (Pletal, statins, ACEI,

glycemic control, aggressive BP lowering)

– Endovascular management (PTA, stent,

atherectomy, laser, calcium cutter)


Functional impairment in PAD

Coutinho T, et al. Vasc Med 2011

History

“ The patient will always tell you the right

diagnosis. You have to listen, give them the

opportunity to state their problem in their own

words and be smart enough to ask the right

questions to come up with the right diagnosis”

Ted Booden-July 2nd, 1993, 1st lecture in medical

school at the University of Chicago


Ankle-brachial index (ABI)

Normal ABI = 1.0-1.3

PAD ≤0.9

Severe <0.5

Moderate, 0.5-0.7

Post exercise ABIs

Non-compressible ≥1.4

Normal ABI tracings across the lower extremities

ABI tracings in a pt with severe PVD

Physical Exam

• Inspect-

– Absence of hair

– Nailbed disease/onychomycosis

– Pallor

– Ulcerations (deep, painful ulcers in lateral

surface of foot)

ARTERIAL INSUFF

ULCERS-DEEP

CRATERS WITH

SMOOTH EDGES

VENOUS STASIS ULCER

ARTERIOLAR ULCERS-VERY

PAINFUL

NEUROTRPHIC ULCERS-SEEN

IN DIABETICS

BASAL CELL CA-ROLLED

EDGES, SMOOTH SURFACE

Treatment of PAD

• Treatment

– Exercise therapy

– Medical therapy (Pletal, statins, ACEI,

glycemic control, aggressive BP lowering)

– Endovascular management (PTA, stent,

atherectomy, laser, calcium cutter)


Treatment of claudication: Therapeutic Choice & Evidence

Intervention Limitations

Indicated in

Exercise Availability Motivation

50-85%

Cilostazol CHF

Side effects ?

Angioplasty Restenosis 10-15%

Surgery Graft failure

Morbidity, mortality <5%


Surgical options

80-90%

Vein Syn

65% 50%

65% 35%

65% 25%

Patency rates

Revascularization

• Lesions might be better treated surgically

if:

– Long segments

– Multi focal stenoses

– Long segment occlusions

– Eccentric, calcified lesions

64 y/o diabetic male w/ acute R thigh/buttock pain with pulseless R leg

s/o PTA and Stenting of the common iliac artery-pt’s sxs resolved

New Technology

• 1. Drug Eluting Peripheral stents-Zilver

PTX

• 2. Drug Coated Balloon for PVD

• 3. Supera-high tensile strength stent that

works well for junction points (ie,

popliteal/common femoral artery)

• Zontivity-antiplatelet that targets the

thrombin receptor of the platelet (reduction

of future vascular events by 20-25%)

Drug Eluting Stent for lower

extremities

How drug elution works

1. Release 2. Absorption 3. Inhibiting

The drug paclitaxel is

released from the polymer-

free Zilver PTX stent within

72 hours.2 Cook Medical’s

proprietary coating process

eliminates the potential risks

of adverse reactions that are

associated with polymers.

Paclitaxel is eluted into the

vessel wall and remains in

arterial walls for up to 56

days.2

Inside the cell, paclitaxel binds

to structures (microtubules) and

inhibits proliferation (mitosis),

which is a cellular response to

the trauma of angioplasty and

stenting that, when excessive,

can prompt a reintervention.

1. Refer to IFU for full prescribing information, including indications, contraindications, warnings, precautions, and clinical data.

2. Dake MD, Van Alstine WG, Zhou Q, et al. Polymer-free paclitaxel-coated Zilver PTX Stents—evaluation of pharmacokinetics and comparative

safety in porcine arteries. J Vasc Interv Radiol. 2011;22(5):603-610.

Normal cell cycle

The short animation below illustrates how a cell divides during a normal cell cycle. As soon as a cell divides, the two new cells immediately begin the cycle again, thus perpetuating cell proliferation.


Cell cycle with paclitaxel

In this version, you see how paclitaxel acts on a cell. Paclitaxel stops the cell cycle in phase M (mitosis), preventing the cell from dividing.


The proven drug effect of Zilver

PTX

Paclitaxel is the drug of choice in combination-therapy devices in the SFA.

Paclitaxel helps maintain patency by inhibiting restenosis.

Paclitaxel is the drug for the superficial femoral artery.

Rendering of

paclitaxel molecule

• Taxol® – Liquid formulation of paclitaxel for treating cancer

• Liquid formulation is not used in PTX coating.

• Active ingredient (paclitaxel) is used in PTX coating; it does not require a polymer coating to adhere to the stent, and therefore, does not exhibit the issues associated with polymers.

• Dose of paclitaxel in PTX (3 μg/mm2) is at least 200 times lower than a systemic dose of Taxol.

Basics of paclitaxel


Zilver PTX drug-eluting

peripheral stent

• New generation SFA Stent

• Available in over 50 countries

• Approved in EU, Japan, and US

• Scaffold plus drug

– Mechanical scaffold:

Zilver Flex® Stent Platform

– Drug therapy: Paclitaxel only

• No polymer or binder

• 3 µg/mm2 dose density

• Sponsor: Cook Medical

Uncoated

PTX Coated

5-year Clinical Benefit IndexProvisional Zilver PTX vs. BMS

81.8%

63.8%

Provisional Zilver PTX

Provisional BMS

p = 0.02log-rank

At 5 years, Zilver PTX has a superior rate of freedom from persistent or worsening claudication, rest pain, ulcer, or tissue loss

Conclusions for 5-year Zilver PTX

RCT

• As the first randomized controlled SFA device trial with

5-year follow-up, these results with the Zilver PTX stent

provide important insights regarding long-term outcomes

for endovascular treatment

• 5-year data for Zilver PTX versus standard care

– Greater than 40% reduction in reintervention and restenosis

– Superior clinical benefit

– These benefits increase with time – results with Zilver PTX

continue to diverge from standard care over 5 years with no late

catch-up

• 5-year results confirm long-term superiority

of Zilver PTX versus bare metal stents

Drug Eluting Balloon

IN.PACT Admiral DCB is a drug-based therapy that can reduce

tissue growth in a treated vessel for sustained clinical benefit,

delivered on a familiar PTA balloon catheter

Admiral PTA balloon

Diameters: 4.0 mm – 7.0 mm

Lengths: 40,60,80,120 mm

Hydrophobic, lipophilic, proven

anti-proliferative drug,

3.5 µg/mm2

Facilitates drug transfer to

vessel wall. Hydrophilic,

naturally occurring, non-toxic

Reliable, scalable, uniform drug

coating process

PTA

Paclitaxel

Urea

Medtronic

Platform

Drug

Excipient

Coating

process

The combination of the drug and excipient work together to promote drug uptake in the tissue,

providing a sustained clinical result.

127 UC201505033 EN © Medtronic, Inc. 2015. All Rights Reserved. For Distribution in the USA only. 01/15

IN.PACT Admiral’s proprietary coating facilitates the

transfer of paclitaxel deep into vessel tissue

IN.PACT Admiral

balloon matrix coating:

• Paclitaxel

• Urea - excipient that

controls drug release

DCB inflation:

• Matrix coating contact with

the blood

• Urea hydrates causing the

release of paclitaxel

• Paclitaxel binds to the wall

due to its hydrophobic and

lipophilic properties

Paclitaxel penetration:

• Through vessel wall deep

into the media and adventitia

• Interferes with the causes of

restenosis

• Can remain in the vessel wall

for over 180 days at

therapeutic levels1

128

1Data on file at Medtronic (GLP Study FS208; GLP Study PS516)

UC201505033 EN © Medtronic, Inc. 2015. All Rights Reserved. For Distribution in the USA only. 01/15

IN.PACT SFA demonstrated the highest reported primary

patency results at 12 months

129

Primary patency at 12 months is the primary endpoint for the study

.

1. IN.PACT SFA defines primary patency as freedom from clinically-driven TLR and freedom from restenosis determined by DUS PSVR<2.4

p<0.001

UC201505033 EN © Medtronic, Inc. 2015. All Rights Reserved. For Distribution in the USA only. 01/15

CSI Atherectomy

Harry Balian M.D.

CSI Atherectomy Case

Ms S.D.

67 yr. old female with CAD, prior CABG 6 years ago with

LIMA to the LAD, SVG to LCx and SVG to the RCA.

She presented with a nonhealing wound of the left big toe

that worsened despite broad spectrum antibiotic coverage.

Arterial duplex showed L SFA occlusion and poor signal

one vessel runoff to the L foot.

Left Big Toe Non Healing

Calcified SFA debulked with a 2.25 Solid Crown.

50-75% of the Calcium/Plaque removed to change the

Vessel compliance. Followed by a low pressure balloon

No Stent.

Patient started with a single vessel Anterior Tib Runoff. Initially there was slow

reflow in the AT after the SFA was treated with the

2.25 Solid Crown. We successfully cleared emboli within the anterior tibial artery

We then angioplastied the Peroneal to give the patient 2 vessel runoff.

Within two weeks, pt’s L toe wound healed

Distal

Supera Stent

Indications

• Junction points-

• Popliteal stenosis

• Areas that will be exposed to shear stress

due to bending

• Possibly Common femoral artery lesions if

endarterectomy is not an option

2

©2014 Abbott. All rights reserved. AP2939964-US Rev. C

The Supera ® Vascular Mimetic Implant Provides

Natural Movement For Durable Outcomes

Maintains a round,

open lumen for normal,

healthy blood flow in

challenging anatomy2

•The Supera® implant mimics the natural

structure and movement of the anatomy1,2

An innovative, interwoven nitinol design

creates an implant that supports rather than

resists the vessel

Resists kinking and fracture with minimal

chronic outward force3

Supports the natural movement of the vessel

for high patency rates1

Angio image courtesy of Dr. Hans Biemans, Rivas Hospital Gorinchem, the Netherlands.

1. Scheinert, et al., Real world perspectives of treating complex SFA-Pop lesions, Results from the SUPERA-500 Registry, LINC 2013.

2. Characteristically round lumens supported by Arena, F.J., Arena, F.A. Intravascular Ultrasound Evaluation of Interwoven Nitinol Stents at Implant. J Vasc Med Surg. 2013:1;116. Data on file at Abbott Vascular.

3. Data on file at Abbott Vascular.

3


Supera® is a New Class of SFA Technology

Unlike Standard Nitinol Stents (SNS), Supera’s Vascular Mimetic Technology offers

unparalleled strength and flexibility.

Kink Compression

Standard

Nitinol

Stents

Supera®

Fracture

>4x compression

resistance

vs. SNS1

Zero fractures at 1

year across

1400+

patients2

Greatest kink

resistance of

any SFA

stent1

1. Flexibility is defined as kink resistance. Supera® implant demonstrated lowest kink resistance for 5.5 and 6.5 x 100 mm implants as compared to 6 x 100 mm standard nitinol stents in a tube. Data on file at Abbott Vascular.

2. 1,152 patients analyzed retrospectively, see Scheinert, et al., Real world perspectives of treating complex SFA-Pop lesions, Results from the SUPERA-500 (including Leipzig SFA,

Leipzig Popliteal and S500 LL) Registry, LINC 2013, 495 patients; Goverde, et al., AURORRAregistry: Experience with high radial force interwoven nitinol stents in femoropopliteal arteries, LINC 2013, 117 patients; Molenaar,

et al., Interwoven self-expanding nitinol stents for long complex SFA and popliteal lesions CWZ, LINC 2012, 178 patients; Goltz, et al., Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients with Critical

Limb Ischemia, J Endovasc Ther 2012;19:450-456, 40 patients; Chan, et al., HK Single-centre Results of Femoro-popliteal Revascularization using Helical Interwoven Nitinol Stents, LINC 2013, 75 patients; Pacanowski, et al.,

RESTORE: Interwoven Stents in the Real World, The Initial United States Experience with the Use of the Supera Stent in the SFA and Popliteal Artery, LINC 2013, 147 patients; Kovach, R., SAKE, Supera Interwoven Nitinol

Stent Outcomes in Above-Knee Interventions: A Single Center Experience, LINC 2013, 100 patients.

Angio photos courtesy of Dr. Dierk Schienert (top row) and SUPERB study (bottom row). IVUS images courtesy of Dr. Dierk Scheinert and Dr. Frank Arena. Kink photos on file at Abbott Vascular.

11


Clinical data on file at Abbott Vascular.

Supera® Has Strong Clinical

Outcomes in Calcification at 3 Years

SUPERB Data - Severe Calcification

% of Lesions with Severe

Calcification (SUPERB Trial) 45% (n=118)

Patency (VIVA 12 months) 89%

95% 92% 88%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

12 months 24 months 36 months

Freedom from TLR % Over Time in Severe Calcium


Acute arterial occlusion Etiology

• No known vascular disease: • Atrial fibrillation

• Recent myocardial infarction

• Dissection

• Arterial trauma

• DVT (paradoxical embolism)

• Known vascular disease:

• Atherosclerosis

• Aneurysm (eg, aortic, popliteal)

• Prior lower extremity bypass or angioplasty/stent


Acute arterial occlusion

• Presentation

• Pain, pulselessness, pallor, paresthesias, pokilothermy, paralysis

• Admit to intensive care

• Initiate IV heparin

• CBC, creatinine, ECG, Echo, TEE

• Ultrasound, Doppler

• Angiography


Viable Threatened Non-viable

Motor deficit None Partial Complete

Sensory deficit None Partial Complete

Arterial Doppler Audible Inaudible Inaudible

Venous Doppler Audible Audible Inaudible

Treatment

Intrarterial thrombolysis if

onset <14 d, otherwise

surgery

Emergency surgery

Amputation

Management of acute arterial occlusion

Modified from Rutherford RB, Semin Vasc Surg 1992; 5:4

Prognosis of Pts with Acute Limb Ischemia


Inflammatory arteriopathies (Vasculitides)


Large vessel vasculitides

• Giant cell arteritis

• age of onset >50 y, headache, temporal artery tenderness, ESR often >100, granulomatous arteritis on biopsy, visual loss if untreated

• Takayasu’s arteritis

• age of onset <50 y, subclavian artery involvement, claudication, hypertension, may have systemic symptoms


Medium vessel vasculitides

Polyarteritis nodosa

• Weight loss, livedo reticularis, testicular pain, myalgias, polyneuropathy, new onset HTN, renal dysfunction, evidence of HBV infection, characteristic angiographic abnormalities

Kawasaki’s disease

• Prediliction for coronary arteries (aneurysms), usually occurs in children, often associated with a mucocutaneous lymph node syndrome


Small vessel vasculitides

• Churg-Strauss: Eosinophilic granulomatosis, typically involves the arteries of the lung and skin

• Granulomatosis with polyangiitis (Wegener’s): involves respiratory tract and kidneys; ANCA +ve

• Microscopic polyangiitis: similar to above but less respiratory tract typically not involved

• Henoch-Schönlein purpura (IgA vasculitis): palpable purpura, renal dysfunction

• Cryoglobulinemic vasculitis: often due to HCV

• S○ to hypersensitivity, connective tissue disorders, viral

infection


Non-inflammatory arteriopathies

• Dissection • Carotid artery dissection

• Segmental arterial mediolysis

• Spontaneous coronary artery dissection

• Occlusion/stenosis • Fibromuscular dysplasia

• Iliac artery endofibrosis

• Cystic adventitial disease

• Popliteal artery entrapment

Circulation 2011;124:e54-e130


Secondary Raynaud’s

Atheroembolism

• Blue or gangrenous toes

• Livedo reticularis

• Hypertension

• Intact pulses

• Elevated serum creatinine

• Eosinophilia (transient)

• Elevated ESR

• TIA/CVA


Question choices

a) Atheroembolism

b) Vasculitis

c) Drug reaction

d) Buerger’s disease

e) Pernio

Let’s do some questions


Question 1

In calculating ABI, one uses:

Arm BP Ankle BP

a Higher Higher

b Lower Higher

c Higher Lower

d Lower Lower


Question 2

In the CLEVER study, 111 patients with aortoiliac PAD, moderate to severe claudication, were randomized to optimal medical care (OMC) , OMC + supervised exercise or OMC + stenting. The greatest increase in peak walking time at 6 months was seen with:

a) OMC

b) OMC + supervised exercise

c) OMC + stenting


Question Which of the following may be seen in both primary and secondary Raynaud’s phenomenon?

a) Asymmetry of affected digits

b) Involvement of both hands and feet

c) History of connective tissue disease

d) Digital ulcerations

e) Abnormal nailfold capillaries


Question

The week following an LAD stent placement, a 69-year old man calls your office to report a painful right great toe with bluish discoloration. He reports no systemic symptoms or history of thrombophilia. Which of the following is the most likely diagnosis?


Question choices

a) Atheroembolism

b) Vasculitis

c) Drug reaction

d) Buerger’s disease

e) Pernio


Question 40-y old non-diabetic man presents with a 15- year smoking history presents with rest pain. On exam he has a painful left toe ulcer and a red, tender ‘cord’ along the calf. ANA and special coagulation studies are negative. The angiogram is shown. What is the likely diagnosis?


Question choices What is the most likely diagnosis?

a) Atherosclerosis

b) Vasculitis

c) Buerger’s disease

d) System Lupus Erythematosis

Conclusion

• Lower extremity arterial disease (PAD)

affects 10 to 15% of community-dwelling

older men and women

• PAD affects 25 to 30% of men and women

aged 50 years and older in primary care

medical practices

• 60% of pts with PAD have at least one

vessel CAD

Conclusion-cont.

• A careful history and physical is crucial in

the diagnosis of PAD

• Treatment modalities include

– Exercise therapy- 150% increase in walking

distance

– Med therapy- Smoking cessation, statins,

ACEI, tight glycemic control, and BP control

– Endovascular therapy- PTA, stenting,

atherectomy, calcium cutting

Questions and comments

Peripheral Vascular Disease - aamsc.org file• Acute inferior STEMI was suspected and pt was rushed...

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