New endovenous ablation methods fall into two categories: thermal tumescent (TT) and non-thermal non-tumescent (NTNT). TT methods like laser, radiofrequency, and steam ablation require tumescent anesthesia while NTNT methods like cyanoacrylate glue, mechanochemical ablation, polidocanol microfoam, and V Block ligation do not. Clinical trials show high occlusion rates of 90-95% at one year for various NTNT techniques with benefits of reduced pain, faster recovery, and ability to treat veins all the way to the ankle without tumescence. NTNT techniques are positioned to become the future standard for treating saphenous vein insufficiency.

1. Endovenous Ablation: New Methods
Where Do We Go From Here?
Steve Elias MD FACS
Director, Vascular Surgery Vein Programs
Columbia University, NY, USA

2. vein disease is an incurable disease
Vein disease is an incurable
disease

3. New Technologies: Two Categories
• TT (Thermal, Tumescent)
• NTNT (Non Thermal, Non Tumescent)

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

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

6. CAG: NTNT

7. 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

8. 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
CAG

9. CAG: TREATMENT

10. 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 JI, AVF 2012

11. 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

12. CAG: Recent 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.

13. 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

14. 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.

15. • 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

16. PEM: Polidocanol Endovenous Microfoam
Varisolve™
• Status of trials- safe
• Status of results – 75- 85%
• GSV/SSV/VV/VM
• It’s coming – Phase 3 completed
Polidocanol
liquid
CO2/O2 gas
Microfoam
generation
mechanism

17. 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

18. 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 )

19. • 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

20. 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

21. • 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

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

23. MOCA:NTNT

24. Position: Wire 1 cm SFJ

26. MOCA: Mechanism of action

27. 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.

28. Completed Trial and Non Trial*
• All closed except 1st
patient – btw 3-6mos
• 1 year – 29/30 (96%)
• 2 years– 27/28 (96%) ( 1 died, 1 lost F/U)
• >2 years non trial – 29/30 (96%) (random pts.)
*Elias S, Lam YL, Wittens CHA. Mechanochemical
ablation: status and results. Phlebology 2013 Supp. 1:28;10-14. .

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

30. GSV Results: Dutch series
• 224 GSV’s
• 6 weeks – 182/185 (98% closed)
• 6 months – 40/42 (95% closed)
• No nerve/ skin injury/ 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.

31. 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.

32. 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.

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

34. Summary: MOCA
• 15,000 cases worldwide (GSV/SSV/AAGSV)
• > 90% occlusion rate – various intervals
• QoL – improves as any successful EVA
• DVT - < 1% worldwide
• No nerve injury

35. V Block
• NTNT
• Endovenous SFJ ligation
• Dual syringe system to deliver sclerosant
• Results pending

36. V Block: SFJ Occlusion

37. V Block: Dual Syringe

38. V Block: Technique

39. V Block: US Post insertion

40. NTNT: Special Considerations
• SSV, BK GSV, suprafascial – can go to
malleolus
• C5 –C6 – retrograde
tumescence hard to place
• Minimal nerve/skin injury

41. Summary: NTNT
• MOCA – 96% (>2yr)
• CAG – 93% (1yr)
• PEM – 85% (1yr)
• V Block – await results

42. Steam: TT

43. • Treatment of saphenous veins and other
varicosities in the lower extremities
• Steam can turn corners, fills voids and at lower
temperature……more possibilities
• Water based therapy – no chemicals and no
staining

44. •SVS steam catheter (1.2 mm) -50% smaller than RFA (2.3
mm)
GSV, SSV, varicose veins, recurrences and venous
malformations
Steam Catheter: TT

45. Physicist calculation:
~ 174 J / pulse of steam (theory)
~ 60 J / pulse @ cath tip (measured) – similar
RF/Laser
The steam produced:
piston pressing a fixed amount of water through a heated element

46. van den Bos , J Vasc Surg 2011

47. 6 months 1 year 2 years 3 years
Nb of patients followed 279 202 95 22
Complete occlusion 96% 92% 92% 94%
8 days 3 months 6 months 12 months
Pain score (0-10 scale, median) 0.75 0.63 0 0
>4,000 GSVs treated with the SVSTM
in
Europe

48. NTNT vs. TT:
Eliminating Tumescence Is The Future
•TT (Steam) – VV advantage (not GSV/SSV)
•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 95% of GSV)

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

50. Vein disease is an incurable
disease