6/1/2017

1

Mechanico-Chemical Ablation

ROBERT W. VORHIES, M.D., F.A.C.S.

VASCULAR AND ENDOVASCULAR SURGERY

ENDOVENOUS THERAPY AND VEIN AESTHETICS

FERRELL-DUNCAN CLINIC, COX HEALTH SYSTEMS

Cox Health Venous Symposium June 2-3, 2017

Non-thermal, Non-tumescent Venous Ablation Therapy

MOCA ?

Disclaimer

Descriptions of brand name devices will be used during this

presentation but do not imply endorsement of any particular

device.

Descriptions of billing codes are intended for reference only and

should not be used for actual clinical use. Please refer to your own

billing and collections departments for details.

You are to be commended if you have stayed through the entire

conference and still have the motivation to read this disclaimer all

the way to the finish.

6/1/2017

2

What is the problem?

Varicose veins are the

result of poorly selecting one’s

grandparents. -Sir William Osler, MD

What is the problem?

6

CEAP Classification for Chronic Venous Disorders

Images courtesy of Jennifer Heller, M.D.

C1: Telangiectasia or Reticular Veins

C2: Varicose Veins C3: Edema

6/1/2017

3

7

CEAP Classification for Chronic Venous Disorders

Images courtesy of Gordon Gibbs, M.D. and Jennifer Heller, M.D

C4a: Pigmentationor Eczema

C4b: Lipodermatoscleros

is or Atrophie

Blanche

C5: Healed Venous Ulcer

C6: Active Venous Ulcer

What are the solutions?

Conservative

Therapies

Exercise

Leg elevation

Compression stockings

Unna boot

Surgical Stripping

Phlebectomy

Thermal Ablation

Radiofrequency Ablation

Laser Ablation

9

1

0

Current Treatment Disadvantages

Thermal TherapiesSurgery

Manually removes the vein

segment from the leg

General anesthesia required

Long incision scar

Extended post procedure discomfort and wound care

2-3 weeks recovery

Compression stockings

Hyperpigmentation

Scarring

Endothermal heat-induced

thrombus (EHIT)

Hematoma

Thrombophlebitis

Nerve injury

Compression stockings

Zahn H. & Bush R. A review of the current management and treatment options for superficial venous insufficiency. World J Surg

(2014) 38:2580-2588 p.2584

6/1/2017

4

1

1

Complications of Thermal Ablation

Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons

(Veith Symposium) New York City; November 19, 2013

Complications1 Week(N=395)

3 Months(N=371)

1 Year(N=350)

5 Years(N=279)

Ecchymosis 5.8% 0.0% 0.0% 0.0%

Erythema 1.3% 0.0% 0.0% 0.0%

Hematoma 1.0% 0.3% 0.0% 0.0%

Infection 0.0% 0.0% 0.0% 0.0%

Pain 1.8% 0.0% 0.6% 0.0%

Paresthesia 1.5% 2.4% 0.3% 0.7%

1

2

More Recent Treatment Options

Non-thermal, Non-tumescent

Mechanochemical

Foam Sclerotherapy

Non-thermal, Non-tumescent, Non-sclerosant

Cyanoacrylate

adhesive

Chemical Ablation:

Ultrasound Guided Foam Sclerotherapy (UGFS)

6/1/2017

5

1

4

Polidocanol Endovenous Microfoam:

VANISH 2 Study

Patient-reported improvement in

symptoms, as measured by the

change from baseline to week 8 in the

7-day average VVSymQTM* score.

Primary Endpoints

Secondary Endpoints

Included the improvement in

appearance of varicosities from

baseline to week 8, as measured by

patients (using PA-V) and by a

physician review panel (IPR-V).

Improvement in VCSS, VEINES-QOL

and occlusion/reflux were also

assessed at week 8 as tertiary

endpoints.

Randomized, multi-center

Patients injected with polidocanol

endovenous microfoam (PEM)

232 patients were randomized

to:

Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of

polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013

Jul 17

Placebo

PEM 0.125%

125

58

PEM 1.0%

PEM 0.5%

6057

VANISH 2 Study – Results

Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol

endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17

10.5% 12.3% 5.0%Pain in extremity 15.5%

The most commonly reported adverse events in %:

Placebo PEM 0.125% PEM 0.5% PEM 1.0%

0 10.5% 11.7%Retained coagulum 27.6%

1.8% 7.0% 13.3%Thrombophlebitis

superficial

3.4%

0 0 0Deep vein thrombosis 8.6%

0 3.5% 3.3%CFVTE3 6.9%

0 0 1.7%Tenderness 6.9%

1.8% 59.6% 83.3%1Duplex responders

Placebo PEM 0.125% PEM 0.5% PEM 1.0%

86.2%2

Duplex ultrasound response at 8 weeks:

1 P < 0.05

2 P < 0.001 compared to PEM 0.125%

3 CFVTE – Common Femoral Vein Thrombus Extension. This is non-occlusive thrombi starting in the superficial vein and extending into

the common femoral vein (similar to EHIT).

1

6

VANISH 2 Study – Summary

Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of

polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013

Jul 17

Percentage of patients treated with the 1.0%

polidocanol solution experienced the following mild to moderate adverse events:

Experienced retained coagulum

(blood trapped in varicosities)

Reported pain

Experienced a DVT

15.5%

27.6%

8.6%

CFVTE 6.9%

Closure

Rate

Duration

86.20%

8 Weeks

6/1/2017

6

1

7

How do the VANISH 2 Study Results Compare to RFA?*

1 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques,

Horizons (Veith Symposium) New York City; November 19, 2013

2 Proebstle et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great

saphenous vein with or without treatement of calf varicosities. Journal of Vascular Surgery; 20113 Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of

polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology;

2013 Jul 17

*ClosureFast long-term data is shown for perspective only and not meant to imply that the data can be used in a head-to-head

comparison with the data from the Vanish 2 study.

VANISH 2 Study3Proebstle Study1,2

Multi-center Multi-center

326 patients 232 patients

99.6% occlusion at 6 months 87.9% occlusion at 8 weeks

90.0% occlusion at 5 years No data at 5 years

vs

Summary: UGFS

Non tumescent

Non thermal

Less effective

More side effects

Mechanico- Chemical Ablation (MOCA):

Non-thermal

Non-tumescent

MOCA combines mechanical damage to the endothelium of the

vein wall with the infusion of a sclerosant. (1)

1. van Eekeren, Doeke Boersma, Vincent Konijn, Jean Paul P. M. de Vries, and Michel M. J. P. Reijnen, Arnhem and Nieuwegein, The

Netherlands. “Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of

incompetent great saphenous veins.” J Vasc Surg 2013; 57: 445-50.

6/1/2017

7

MOCA Mechanical damage:

Promotes coagulation activation by minimal mechanical damage to the endothelium

Induces vasospasm that reduces the diameter of the vein,

Increases the action of sclerosant by an increase in surface.

Ensures an even distribution of the sclerosant at the endothelium.

Chemical Ablation

Liquid sclerosant produces irreversible damage to the venous endothelium.

Cellular membranes of the endothelium are damaged, creating endofibrosis.

This causes venous obliteration and thrombus development.

Damage of the endothelium depends on the concentration of sclerosant.

How does ClariVeinTM work?

ClariVeinTM

6/1/2017

8

How well does it work?

2

5

Mechanochemical Tumescentless Endovenous Ablation (MOCA): Elias Study

Safety (measured through adverse

events).

Closure rate at 6 months.

Primary Endpoints

Secondary Endpoints

Procedural pain, post procedural

pain, pain medication use, and

degree of ecchymosis.

Prospective, single-center

30 GSVs in 29 patients

Treated with ClariVeinTM*

catheter

Avg. diameter was

8.1mm

Avg. length of treated

segment was 37.5cm

Avg. total procedure time

was 14 minutes

Follow-ups were 1 week,

1 month, 3 months, and 6

months post-procedure

Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology

2012;27:67-72

*Trademark of its respective owner.

2

6

Elias Study – Results

Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology

2012;27:67-72

Closure

Rate

Duration

96.70%

260 days

6/1/2017

9

2

8

Summary of Clinical Efficacy

Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping

for great saphenous varicose veins. BJS 2011;98:1079-1087

Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith

Symposium) New York City; November 19, 2013

Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanolendovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17

2-8

Weeks

3-6

Months

1 Year 5 Years

0.9970.986

0.952

0.9

94.2%

0.967

87.9% 87.3%

82.5%

90.0%

97.5%

105.0%

Perc

ent

Occlu

sio

n

CLF

EVLA

MOCA

UGFS

What is the code for MOCA?

36473 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous,

mechanochemical; first vein treated

✚36474 subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)

(Use 36474 in conjunction with 36473)

(Do not report 36474 more than once per extremity)

(Do not report 36473, 36474 in conjunction with

29581, 29582, 36000, 36002, 36005,

36410, 36425, 36475, 36476, 36478, 36479,

37241, 75894, 76000, 76001, 76937, 76942,

76998, 77022, 93970, 93971 in the same

surgical field)

(For catheter injection of sclerosantwithout concomitant endovascular mechanical disruption of the vein intima, use 37799)

(For catheter injection of an adhesive, use 37799)

Summary- MOCA

Non Thermal

Non Tumescent

Very few adverse side effects

Safe and efficacious

Reimbursement is available

6/1/2017

10

What else is coming out ?

3

3

Current Treatment Disadvantages

Thermal TherapiesSurgery

Manually removes the vein

segment from the leg

General anesthesia required

Long incision scar

Extended post procedure discomfort and wound care

2-3 weeks recovery

Compression stockings

Hyperpigmentation

Scarring

Endothermal heat-induced

thrombus (EHIT)

Hematoma

Thrombophlebitis

Nerve injury

Compression stockings

Zahn H. & Bush R. A review of the current management and treatment options for superficial venous insufficiency. World J Surg

(2014) 38:2580-2588 p.2584

3

4

Opportunities for Improvement

Elimination of:

Tumescent anesthesia

Post-procedure compression

stockings

Post-procedure pain and bruising

6/1/2017

11

Cyanoacrylate: Venaseal™

Non-tumescent

Non-thermal

Non-sclerosant

3

7

Safety of Cyanoacrylate Adhesives

Widely used medical tissue

adhesive.1

Antimicrobial effect against gram-

positive organisms.2

Used safely on millions of patients

with no reported carcinogenicity in

humans (1986 study).2

1 Lawson et al. Sapheon: the solution? Phlebology 2013, 28 Suppl 1:2-9, p3

2 Quinn J., Tissue Adhesives in Clinical Medicine, 2nd ed.(2005) p 34-35

3

9

Properties of Ideal Cyanoacrylate forVenous Closure

Ideal viscosity

Polymerize quickly

Soft and elastic

Maintains a strong

bond

Eliminate need for

compression stockings*

*Some patients may benefit from compression stockings post procedure.

6/1/2017

12

4

1

How does it work?

When cyanoacrylate (CA) comes in contact

with blood or plasma, it begins to

polymerize.

The body encapsulates the polymer as a

foreign body.

CA triggers inflammatory reaction in the

vessel wall resulting in occlusion.

Almeida J. et.al. Cyanoacrylate adhesive for the closure of truncal veins: 60 day swine model results. Vasc and Endovasc Surg

(2011) 000(00) 1-5. DOI 10.1177/1538574411413938 http://ves.sagepub.com p.1

4

2

Features of the VenaSeal™ Procedure

Eliminates need for

tumescent anesthesia.

No risk of thermal injury.

No post treatment

compression stockings

needed.1,2*

Rapid return to normal

activities.2

Procedure Features

1 Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein

incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014.

2 Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesive embolization with radiofrequency ablation for

treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology, 2014.*Some patients may benefit from compression stockings post procedure.

4

6

VeClose (U.S. pivotal trial)

1 No adjunctive treatments for 3 months

Study Design

Purpose

Closure Rates1

Prospective, randomized 1:1 comparing the VenaSeal™ system (VSCS) to RFA (ClosureFast™ catheter).

Demonstrate safety and effectiveness of the VenaSeal™

closure system (VSCS) for the treatment of lower extremity

truncal reflux by showing non-inferiority at three months to

RFA using the ClosureFast™ system.

3-Months:

RFA: 94.3%

VSCS: 98.9%

Gibson, K. A Randomized, Controlled Study Comparing Cyanoacrylate Adhesive Embolization With Radiofrequency Ablation For

Treatment Of Incompetent Great Saphenous Veins VeClose Study. German Society of Phlebology, 2014.

6-Months:

RFA: 94.3%

VSCS: 98.9%

6/1/2017

13

Summary: VenaSeal ™

Non Thermal

Non Tumescent

Non Sclerosant

Non compression stockings

Safe and effective

Very few adverse effects

No distinct coding reimbursement at this time.

Conclusions:

Thermal ablation is effective but has shortcomings that interfere with

complete patient satisfaction.

Safety and efficacy of ClariVein and VenaSeal is well supported,

ultrasound guided foam sclerotherapy is not.

Reimbursements are evolving to include these new techniques.

Eliminating heat and the need for tumescent anesthesia and

reducing or eliminating the need for compression stockings without

compromising procedural success is another promising advance in

the treatment of chronic venous diease.

References: Beebe-Dimmer Jl, Pfeifer JR, Engle, JS, et al. The Epidemiology of Chronic Venous Insufficiency and Varicose Veins. Ann Epidemiol. 2005;15(3):175-184.

Zahn H. & Bush R. A rev iew of the current management and treatment options for superficial venous insufficiency. World J Surg (2014) 38:2580-2588 p.2584

Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013

Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17

Proebstle et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatement of calf varicosities. Journal of Vascular Surgery; 2011

van Eekeren, Doeke Boersma, Vincent Konijn, Jean Paul P. M. de Vries, and Michel M. J. P. Reijnen, Arnhem and Nieuwegein, The Netherlands. “Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical

endovenous ablation of incompetent great saphenous veins.” J Vasc Surg 2013; 57: 445-50.

Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72

Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98:1079-1087

Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72

Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013

Zahn H. & Bush R. A rev iew of the current management and treatment options for superficial venous insufficiency. World J Surg (2014) 38:2580-2588 p.2584

Quinn J., Tissue Adhesives in Clinical Medicine, 2nd ed.(2005) p 34-35

Lawson et al. Sapheon: the solution? Phlebology 2013, 28 Suppl 1:2-9, p3

Almeida J. et.al. Cyanoacrylate adhesive for the closure of truncal veins: 60 day swine model results. Vasc and Endovasc Surg (2011) 000(00) 1-5. DOI 10.1177/1538574411413938 http://ves.sagepub.com p.1

Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014.

Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesive embolization with radiofrequency ablation for treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology, 2014.

6/1/2017

14

51Venous Symposium Wrap Up

Chronic Venous Insufficiency and Varicose Veins are extremely common and remarkably under treated.

Evaluation of lymphedema, varicose veins, and venous disease in general, relies on listening carefully to the history, examining the extremities, and obtaining a thorough venous duplex ultrasound with reflux testing.

A multi-specialty approach, including conservative therapy, wound care, and procedures, is essential for the successful treatment of chronic venous disease and it’s complications.

Deep vein interventions and central venous pathology continue to be challenging, and Venous stasis ulcers require a lifelong commitment to maintenance compression therapy.

Overall, treatment modalities for venous disease have evolved tremendously and continue to improve the patient’s outcomes with less risk and less morbidity.

Summary-Venous Symposium

Overview

Robert Vorhies, MD

Anatomy and Physiology

John Waites, MD

Ultrasound Evaluations

Brent Wilkinson, RDMS

Conservative therapies

Julie Highfill, PA-C

Laura Ross, PA-C

Lymphedema

Jan Weiss, PT, DHS, CLT-LANA

Deep vein interventions

Randy Mullins, MD

Venous stasis and ulcers

John Waites, MD

Pelvic congestion

Randy Mullins, MD

Varicose vein procedures

Zak Schmittling, MD

Mechanico-Chemical Ablation

Robert Vorhies, MD

Thank you Planning Committee

Lisa Boyer

Triesa Massey

Kristen Richner

Bryan Wiliams

Becky Watts

Leah Cook

Steve Shoemaker

Cathy Adams

Julie Highfill

Laura Ross

Vascular Ultrasonographers

Brent Wilkinson

Lauren Tennison

Maddie Manes

Javona Killion

Steve Shoemaker

Vein Center Nursing staff

Sam Williams

Nina Mann

Kelley Everett

Brad Hampton

Kathryn Pallister

Tina Johnson

Kayla Scantlin

Vein Center Office staff

Sarah Myers

Lauren Chumbley

Marsha Maggi

Brittney Cook

Vein Center Office Nurses

Crystal Price

Cindy White

Glenda Bostic

Cassie Lawrence

Lori Davis

6/1/2017

15

2nd Annual

MAY 4-5,

2018