By: Steve Elias, MD, FACS Visit VeinGlobal at http://www.veinglobal.com/ for more presentations and videos on this topic, or for more information on venous disease news, education and research.

1. THE FUTURE OF NON THERMAL ABLATION:
IS THE FUTURE OF ENDOVENOUS ABLATION
STEVE ELIAS MD FACS
DIRECTOR, CENTER FOR VEIN DISEASE
DIRECTOR, WOUND CARE CENTER
ENGLEWOOD HOSPITAL AND MEDICAL CENTER NJ

2. Disclosures
• Covidien Inc. – Medical Advisory Board
• Vascular Insights LLC – Medical Advisory Board
• Le Maitre Vascular – Consultant
• VVT Medical - Consultant

3. “SO WE BEAT ON,
BOATS AGAINST THE CURRENT,
BORNE BACK CEASELESSLY INTO THE
PAST”
F. SCOTT FITZGERALD
“THE GREAT GATSBY”

4. GSV/SSV/AAGSV incompetence (anything
straight)
Replaced stripping of great or small
saphenous vein
Local/IV Sedation
Endovenous Ablation 2014:
Laser, RF, Mechanochemical, Foam,
Glue, Steam, V Block

5. New Technologies: Two New Categories*
• TT (Thermal, Tumescent)
• NTNT (Non Thermal, Non Tumescent)
*Elias S. Emerging Endovenous Technologies. Endovasc
Today. March 2014.

6. Thermal Tumescent: TT
• Laser – HSLW, WSLW, radial/jacketed
• Radiofrequency – Closurefast, RFITT
• Steam – SVS, Veneti

7. Non Thermal, Non Tumescent: NTNT
• Mechanochemical – ClariVein
• Cyanoacrylate glue – Sapheon
• Polidocanol Endovenous Microfoam – BTG
• V Block – VVT Medical

8. CAG (Cyanoacrylate): NTNT

9. Pollak JS, JVIR, 2001
Permitted for use in endovascular procedures in Europe for
several decades
FDA approved in U.S. 2000 Trufill CA (Cordis, Miami, FL)
clearance for treatment of cerebral AVMs
CAG: NTNT

10. Pollak JS, JVIR, 2001
Levrier O, J Neuroradiol 2003
Anionic substances such as plasma or blood polymerization
of the adhesive upon contact, leading to occlusion
When introduced within a vessel triggers an acute
inflammatory reaction in the wall and surrounding tissues
The resultant polymerization damages the vascular intima
and induces immunological responses
CAGCAG: NTNT

11. CAG: TREATMENT

12. Mean max SFJ diameter was 8.0 mm
(range 4.1 – 12.0) before treatment
Mean length ablated GSV 33cm (range
15-52)
Mean treatment time 20.3 minutes (range
11 – 33)
Mean volume of CA 1.3 ml
(range 0.63 - 2.25)
CAG Dominican Republic: Almeida
Almeida JI, AVF 2012

13. DR 30
At 6 month:
28/30 (93%) closed
2 re-canalized > 5 cm
X= 1.12cc
DR 8
All original 8 closed at 1-year
X= 1.58cc
CAG Efficacy
Almeida JI, AVF 2012

14. CAG: First Results
• 38 pts.
• No compression/No tumescence
• 1° Endpoint – safety/efficacy
• 2° Endpoint – adverse events/VCSS change
Almeida JI, Javier JJ, Mackay E et al. First human use of
cyanoacrylate adhesive for treatment of saphenous vein
incompetence. J Vasc Surg:Venous and Lym Dis 2013;1:174-80.

15. Results
• 1 year – 92% occlusion
• Volume – 1.3 ml.
• Phlebitis – 15%
• Thrombus extension – 21% (self limited) (5 cm back
now)
• VCSS – 6.1 to 1.5

16. Most Recent Results:
European Multicenter Study
• 70 GSV – No tumescence – No compression
• 7 Centers
• 94% occlusion at 6 months
• VCSS – 4.3 to 1.3
Proebstle T et al. One year follow up of the European Multicenter Study on
cyanoacrylate embolization of incompetent great saphenous veins. UIP 2013.

17. • Pharmaceutical-grade microfoam has been under
development in Europe and the US for >12 years.
• Microfoam and the deliberate injection of gas into the venous
circulation has presented unique challenges in demonstrating
fundamental safety.
• A proprietary company has provided the experimental and
trial data to answer important questions in relation to their
specific microfoam O2, CO2, and trace N2
PEM: NTNT

18. PEM: Polidocanol Endovenous Microfoam
Varithena™
• Status of trials- safe
• Status of results – 75- 85%
• GSV/SSV/VV/VM
• Approved in US 12/13
• Available in US momentarily
Polidocanol
liquid
CO2/O2 gas
Microfoam
generation
mechanism

19. PEM: Phase 3 Clinical Trial
VANISH II
• 235 pts. – PLD .125%, .5%, 1% (176 pts.)
– Placebo (59 pts.)
• PLD – 85% occlusion SFJ or GSV at 1 year
• Placebo – 20%
• Primary endpoint – pt. reported outcomes (VV SymQ)
• FDA approved QoL measure

20. Primary Endpoint: VV SymQ - Patient reported outcome
for
symptoms
Secondary Endpoints: PA-V3
Patient reported assessment
of varicose vein appearance
IPR-V3
Independent physician
photographic assessment of
appearance
(Both endpoints are new and have been developed to most recent FDA standards and
outcome tested for clinically meaningfulness.)
Tertiary endpoint : Duplex closure (regarded as a surrogate
endpoint )
VANISH II

21. • Vanish 19.23 -5.44 (SE 0.29) 59% ↓
p<0.0001
• Vanish 28.67 -5.53 (SE 0.33) 64% ↓
p<0.0001
VV Sym Q: Symptoms

22. Results IPR-V3 (Independent MD)
Vanish 1 2.07 -0.81 (SE 0.05) 39% p<0.0001
Vanish 2 2.11 -0.86 (SE 0.06) 41% p<0.0001
Results PA-V3 (Patient reported  VV)
Vanish 1 3.54 -1.58 (SE 0.09) 45% p<0.0001
Vanish 2 3.54 -1.82(SE 0.09) 51% p<0.0001

23. • Duplex response = elimination of SFJ reflux
and /or closure of all incompetent veins
• Vanish 1 VV015, single treatment 75%
• Vanish 2 VV016, up to 2 treatments 85%
Closure Rates

24. Proximal DVT 1.7%
•Dist CFV extension (EHIT 2 equivalent) 2.9%
– all completely resolved
• (50% anticoagulated)
Distal DVT 1.1%
IGSVT isolated gastroc/soleal 1.4%
•No PE dx
•No cerebrovascular neurological adverse events
Complications

25. MOCA:NTNT

26. Position: Wire 1 cm SFJ

28. MOCA: Mechanism of action

29. Elias FIM: Clinical Trial 2/09*
• 30 limbs
• GSV only (no SSV, VV, 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 2012;27:67-72.

30. Completed Trial and Non Trial*
•>2 years – 27/28 (96%) ( 1 died, 1 lost F/U)
•>2 years non trial – 29/30 (96%) (random pts.)
•VCSS – significant improvement at > 2 years
*Elias S, Lam YL, Wittens CHA. Mechanochemical
ablation: status and results. Phlebology 2013 Supp. 1:28;10-14. .

31. Complications
• No DVT
• No nerve injury
• No skin injury
• Bruising 3 pts. - 2° caught on vein wall

32. GSV Results: Dutch series
• 224 GSV’s
• 6 weeks – 182/185 (98% closed)
• 6 months – 40/42 (95% closed)
• 1 year – 95% occlusion rate
• No nerve/skin injury or DVT
*Ramon RJP, van Eekeren MD et al. Endovenous mechanochemical ablation of
great saphenous vein incompetence using the ClariVein device: a safety study.
J Endovasc Ther 2011; 18:328-334.
*Reijnen M. One year results of MOCA. Charing Cross Meeting 2014. London

33. SSV: 50 pts
• 1 yr. – 94% occlusion
• VCSS – 3 to 1
• No DVT, no nerve injury
Boersma D, van Eekeren RRJP, Werson DAB, et al.
Mechanochemical endovenous ablation of small
saphenous vein insufficiency using the ClariVein
device: One-year results of a prospective series. EJVES
2012.

34. MOCA vs. RF
MOCA
• 14 day pain – 8.6 (100)
• RTW – 3.3 days
• RT Activity – 1.2 days
• QoL - equal
RF
• 14 day pain – 14.8 (100)
• RTW – 5.6 days
• RT Activity – 2.8 days
• QoL - equal
van Eekeren et al. Postoperative pain and early quality of life
after radiofrequency ablation and mechanochemical endovenous
ablation of incompetent great saphenous veins. J Vasc
Surg 2012.

35. MOCA:Contraindications
• GSV/SSV – post SVT
• Synechiae – can place but wire snags
• Large veins - >15mm. (19mm)

36. Summary: MOCA
• >20,000 cases worldwide (GSV/SSV/AAGSV)
• > 90% occlusion rate – various intervals
• QoL – improves as any successful EVA
• DVT - < 0.5% worldwide
• No nerve injury

37. V BLOCK: NTNT

38. V Block
•Endovenous SFJ ligation
•Dual syringe system to deliver liquid sclerosant
and empty vein
•Results - early

39. V Block: SFJ Occlusion

40. V Block: Dual Syringe

41. V Block: Technique

42. V Block: US Post insertion

43. V Block: Early Results
• 50 patients
• 4.6 month avg. follow up
• 100% occlusion (46 pts.)
• Kolvenbach R. VEITH 2013

44. NTNT: Special Considerations
• SSV, BK GSV, suprafascial – can go to
malleolus
• C5 –C6 – antegrade (ankle) or retrograde
tumescence hard to
place
• AK GSV or AAGSV – of course

45. Endovenous Ablation: MEEVA
• Percutaneous, outpatient, local anesthesia
• TT:
• RF/Laser - 95% ablation rate @ 4yrs
• Steam - >90% at 1 year (Europe)
• NTNT :
• MOCA – 95% ablation at >2 years
• Foam – 85% at 2 years
• Glue – 95% at 1 or less years
• V Block – 100% at 4 months

46. TT vs. NTNT (need both)
TT (10-15%)
• Big veins
• Good F/U
• Nerve - concern
• Patient comfort
NTNT (85-90%)
• Most GSV/SSV/C6/BK
• Shorter F/U
• Nerve – no issue
• Patient comfort: better?

47. NTNT vs. TT:
Eliminating Tumescence Is The Future
•TT – 14 years – time for something new
•NTNT – nerve/skin risk less/patient comfort
•Treat to malleolus/SSV
•C5, C6 – tumescence difficult in lower leg
•More complete treatment?
•NTNT – The future (probably for 90% of EVA)

48. THE END
• All new technologies positive impact QoL
• Simplify procedure = better for pt. and MD
• Current new technology: eliminate
tumescence
• Future new technology: completely non
invasive

49. Before NTNT : mid 2000’s
Edward Hopper, Early Sunday Morning

50. After NTNT: Last 5 years
Jackson Pollock, Number 1, 1949.

51. “THE FUTURE OF NON THERMAL ABLATION:
IS THE FUTURE OF ENDOVENOUS ABLATION”

52. “Time will tell just who fell
And who will be left behind
When you go your way and I go mine”
Dylan B. Most Likely To Go Your Way
And I’ll Go Mine.