Mechanical-Chemical Ablation Mechanism of Use with Venous Ulcers

A R I E L D . S O F F E R , M D , FA C CA S S O C I AT E C L I N I C A L P R O F E S S O R O F M E D I C I N E F L O R I D A I N T E R N AT I O N A L U N I V E R S I T Y

• Fellow of the American College of Cardiology since 1998 with training at Cedars-Sinai, Beverly Hills, USC/UCLA, and Harvard Business School.

• Professor at Florida International University School of Medicine. Published the first article on the importance of venous insufficiency in the cardiovascular practice, Endovascular Today, 2007.

• Founder of "Soffer Vein & Vascular" (Cardiovascular-Based Multi-Specialty private practice with 8 offices throughout South Florida), and the Vein Experts Training Academy (www.vetavein.com)

• Co-Founder of AppwoRx™ - Patented clinical photography applications used heavily in the venous space.

Dr. Ariel David Soffer-BioNCVH Vein Forum

Relevant Disclosures

BTG Paid Consultant

Sigvaris Paid Consultant

Alma Lasers Paid Consultant

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Venous Ulcers

Venous ulcers, or stasis ulcers, account for 80% of lower extremity ulcerations.

Less common etiologies for lower extremity ulcerations include:

• arterial insufficiency

• prolonged pressure

• diabetic ulcers and neuropathy

Venous Ulcers

1-2% of the world population.

Debilitating for patients.

The financial burden of venous ulcers is estimated to be $2 billion per year in the United States.

Treatment options

Limited• Compression

• Stripping/Thermal ablation of proximal refluxing veins

• Foam sclerotherapy

• Hyperbaric Chamber

Historically poor healing and high recurrence.

Ulcer effect on the patient

Devastating condition• Infection

• Foul smell

• Chronic pain and swelling

• Depression

• Disability

Diagnosis

Clinical• Shallow, painful ulcer located over bony

prominences, particularly over medial malleolus. granulation tissue and fibrin present

Ultrasound• Venous insufficiency evaluation a must

• GSV, SSV, perforators, Deep system

Pathophysiology of venous ulcers

Controversial:1. Venous hypertension causing activation of

inflammatory process• Leukocyte activation, endothelial damage, platelet

aggregation, and intracellular edema contribute to venous ulcer development.

2. ISCHEMIC. High venous pressure in the venoules below the ulcer bed prevents adequate arterial supply.

Treatment of the ulcer bed venules/venous pools is essential!

Mechanical-Chemical Ablation

Largely painless

Distal access (Foot/retrograde)

No nerve damage

Ability to treat below ulcer

Unique mechanism-collateral damage

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MOCA™

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MOCA™

Typical ulcer case

The Mechanical Chemical Ablation treats the tributaries, venous pools and venules below the ulcer

Ultrasound

Ulcer bed before treatment Ulcer bed immediately after treatment

Mechanical Chemical Ablation Recent Trial

• MARADONA Trial (Mechanicochemical endovenous Ablation verses RADiOfrequeNcy Ablation)

• Netherlands study with 460 Patients • Endpoint was comparability to RFA

with less discomfort

• Showed equal results at 1 year with less procedural and post-procedural pain

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Typical case #1

• 79 y.o. male with greater than 20 year history of bilateral skin discoloration below the knees

• Recurring right ankle ulcer for 4 years

• Previously treated by primary care, dermatology, vascular surgery, podiatry and wound care

• Referred by wound care center

• Has difficulty with transportation

Case #1

Case #1

• Venous duplex ultrasound – bilateral GSV reflux distal thigh to ankle. Right greater than left

• Right GSV coursed below the ulcer

• Retrograde approach from distal thigh to ankle

Post treatment (10/23/12)• Pre-treatment (11/3/11)

Case #2

• 65 y.o. male with history of DM

• Former smoker

• History of right heel ulcer for 2 years with pain.

• History of right 2nd toe ulcer and discoloration for 6 months

SSV reflux

Pre treatment (9/26/11) Post treatment 5 mo Post treatment 9 mo

Case #3

68 y.o female with 16 year history of ulcers

Described instances of “ruptured veins”

Constant pain with limited mobility

Cannot drive due to the pain

Used to be very social and “wants to go dancing again”

Had been told that she would have to “live with this for the rest of her life”

Case #3

SSV insufficiency with tributary to ulcer

GSV normal

Treated SSV in with Mechanical Chemical Ablation

Case #3

Pre-treatment Post 6 months

Case #4

59 y.o. Male with a history of LLE persistent ulcer(s) since 2003

Prior history of EVLT in 2004 and phlebectomies

Multiple failed skin grafts in 2005

Being treated by wound care center

Duplex still shows patent and refluxing left GSV and SSV

RFA left GSV and SSV 2010

Case #4

2011 Duplex US demonstrates patent and refluxing left GSV below the knee to the ankle

GSV courses below ulcer

Case #4

Pre –treatment Post 11 mo

Summary

Venous ulcers are a big public health problem with limited treatment options.

Mechanical Chemical Ablation offers a unique mechanism that seems to be beneficial in the treatment of venous stasis ulcer amongst other possible indications.

Closing Remarks / Thank You

Mechanical-Chemical Ablation Mechanism of Use with Venous Ulcers

A R I E L D . S O F F E R , M D , FA C CA S S O C I AT E C L I N I C A L P R O F E S S O R O F M E D I C I N E F L O R I D A I N T E R N AT I O N A L U N I V E R S I T Y