THE FUTURE OF NON THERMAL ABLATION:IS THE FUTURE OF ENDOVENOUS ABLATION
STEVE ELIAS MD FACS DIRECTOR, CENTER FOR VEIN DISEASE
DIRECTOR, WOUND CARE CENTERENGLEWOOD HOSPITAL AND MEDICAL CENTER NJ
Disclosures
• Covidien Inc. – Medical Advisory Board
• Vascular Insights LLC – Medical Advisory Board
• Le Maitre Vascular – Consultant
• VVT Medical - Consultant
“SO WE BEAT ON, BOATS AGAINST THE CURRENT,
BORNE BACK CEASELESSLY INTO THE PAST”
F. SCOTT FITZGERALD “THE GREAT GATSBY”
GSV/SSV/AAGSV incompetence (anything straight)
Replaced stripping of great or small saphenous vein
Local/IV Sedation
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
New Technologies: Two New Categories*
• TT (Thermal, Tumescent)
• NTNT (Non Thermal, Non Tumescent)
*Elias S. Emerging Endovenous Technologies. Endovasc Today. March 2014.
Thermal Tumescent: TT
• Laser – HSLW, WSLW, radial/jacketed
• Radiofrequency – Closurefast, RFITT
• Steam – SVS, Veneti
Non Thermal, Non Tumescent: NTNT
• Mechanochemical – ClariVein
• Cyanoacrylate glue – Sapheon
• Polidocanol Endovenous Microfoam – BTG
• V Block – VVT Medical
CAG (Cyanoacrylate): NTNT
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
Pollak JS, JVIR, 2001Levrier 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
CAG: TREATMENT
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
DR 30At 6 month:
28/30 (93%) closed 2 re-canalized > 5 cm
X= 1.12cc
DR 8All original 8 closed at 1-yearX= 1.58cc
CAG Efficacy
Almeida JI, AVF 2012
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 veinincompetence. J Vasc Surg:Venous and Lym Dis 2013;1:174-80.
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
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 oncyanoacrylate embolization of incompetent great saphenous veins. UIP 2013.
• 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
PEM: Polidocanol Endovenous MicrofoamVarithena™
• 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
PEM: Phase 3 Clinical TrialVANISH 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
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
• Vanish 1 9.23 -5.44 (SE 0.29) 59% ↓p<0.0001
• Vanish 2 8.67 -5.53 (SE 0.33) 64% ↓p<0.0001
VV Sym Q: Symptoms
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<0.0001Vanish 2 3.54 -1.82(SE 0.09) 51% p<0.0001
• 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
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
MOCA:NTNT
Position: Wire 1 cm SFJ
MOCA: Mechanism of action
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.
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. Mechanochemicalablation: status and results. Phlebology 2013 Supp. 1:28;10-14. .
Complications
• No DVT
• No nerve injury
• No skin injury
• Bruising 3 pts. - 2° caught on vein wall
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 ofgreat 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
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 smallsaphenous vein insufficiency using the ClariVeindevice: One-year results of a prospective series. EJVES2012.
MOCA vs. RFMOCA
• 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 endovenousablation of incompetent great saphenous veins. J VascSurg 2012.
MOCA:Contraindications
• GSV/SSV – post SVT
• Synechiae – can place but wire snags
• Large veins - >15mm. (19mm)
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
V BLOCK: NTNT
V Block
•Endovenous SFJ ligation
•Dual syringe system to deliver liquid sclerosant and empty vein
•Results - early
V Block: SFJ Occlusion
V Block: Dual Syringe
V Block: Technique
V Block: US Post insertion
V Block: Early Results
• 50 patients
• 4.6 month avg. follow up
• 100% occlusion (46 pts.)
• Kolvenbach R. VEITH 2013
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
• Minimal nerve/skin injury
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
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?
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)
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
Before NTNT : mid 2000’s
Edward Hopper, Early Sunday Morning
After NTNT: Last 5 years
Jackson Pollock, Number 1, 1949.
“THE FUTURE OF NON THERMAL ABLATION:IS THE FUTURE OF ENDOVENOUS ABLATION”
“Time will tell just who fellAnd 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.