Mechanochemical Ablation: MOCA2 year follow up, lessons learned

Steve Elias MD FACS FACPhDirector, Division of Vascular Surgery Vein ProgramsColumbia University and Medical Center, NY

Assistant Professor of SurgeryColumbia University

Disclosure:

Vascular Insights LLC – Advisory Board

Covidien Inc. – Advisory Board

What Is It? MOCA

How Does It Work:

Combination – endovenous mechanical and chemical

Mechanical – wire > rotates > intimal damage

Chemical – liquid > penetrates > scar

End result – venous occlusion

Mechanical Component

Chemical Component

Mechanochemical Together

Access: MOCA

Percutaneous ultrasound guided

4 fr. micropunture sheath

18 gauge IV access

No further wires or larger sheath exchange

Position: Wire exposed

Position: Wire 2 cm SFJ

Treat: MOCA Pullback 1.o – 1.5 mm. per second

Inject during pullback

Sodium tetradecyl sulfate 1.5% liquid (or equivalent sclerosant)

Volume dependent on size/length

Treat SFJ: Rotate and Inject

Treat Mid GSV: Wire/Sclerosant Mix

Treat: Injection & Pullback

MOCA: Mechanism of action

Elias FIM: Clinical Trial 2/09* 30 limbs GSV only C2 – 24 C3 – 2 C4 – 4 Avg. 55 years Treat GSV only (no treatment VV or

IPV) 1 yr. follow up to complete trial No tumescence or sedation

*Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial.Phlebology;27:67-72.

Procedure Statistics: MOCA GSV size – 8.1 mm.

GSV length treated – 36 cm.

GSV treatment time – 5 min.

Overall treatment time - 14 min

Completed Trial *

All closed except 1st patient – btw 3-6mos

6 month – 29/30 (96%)

12 month – 29/30 (96%)

24 month – 27/28 (96%) ( 1 died, 1 no US yet)

*Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial.Phlebology;27:67-72.

Complications

Subcutaneous ecchymoses – 3 pts.

Side branch tear?

No DVT

No nerve injury

No skin injury

224 GSV’s

C2 (13%) C3 (67%) C4 (20%)

GSV diameter 7 mm

GSV length 41 cm

treatment time 16 min

GSV Results: Dutch seriesMichel Reijnen/ Jean Paul DeVries

Ramon RJP, van Eekeren MD et al. Endovenous mechanochemical ablation ofgreat saphenous vein incompetence using the ClariVein device: a safety study.J Endovasc Ther 2011; 18:328-334.

Dutch MOCA: Results

6 weeks – 182/185 closed 98%

6 months – 40/42 closed 95%

No nerve/skin/DVT

MOCA 2012: Results Summary

6,000 cases worldwide (GSV/SSV) > 90% occlusion rate – various

intervals Chaloner – 92% at 1 yr. QoL – improves as any successful

EVA DVT - < 1% No nerve/skin injury No tumescence – longest part of

short procedure

What We Have Learned: Technique

Rotate 1st (spasm/vortex) then inject slow

Catheter ON = Catheter MOVING

Two handed technique – 1 pulls – 1 injects

Tendency: Pull too fast, inject too slow

What We Have Learned: Volume Volume originally 12 cc (1.5%STD)

for all

Volume now based on diameter/length

Volume tends to be less

Table available

GSV – 6-10 cc SSV – 2-4 cc PPV – 1cc

What We Have Learned: Concentration

Stronger is better

STD 1.5% - 2% 93-96% 1% < 90% (Chaloner UK)

PLD – 2 – 3 % (volume based on weight)

Lower volume, maximum concentration

What We Have Learned: Duplex Slower contraction and scarring

No flow but appears sponge like (color flow)

Can take up to 1 year for contraction

If some flow – reimage 3 months

Post MOCA 1 month

Advantages: MOCA

No thermal injury – nerves, skin

SSV, BK GSV, PPV

Ulcers – retrograde

Eliminates tumescence – patient and MD

Conclusions MOCA: 2012

It works, It is safe – 96% at 2 years

Learning curve - 5 – 8 cases

No tumescence – the future, only one now Glue, PEM, TAHOE (RF)

Another good option for ablation (95% pts.)

Words To Live By:

Respect the elders, Embrace the new,

Encourage the improbable and impractical

Without bias