Update on endovenous therapy for venous

Update on endovenous therapy for venous insufficiency Julian J Javier, MD, FSCAI, FACC, FCCP. Voluntary Assistant professor University of Miami School of Medicine. Adjunct professor of Medicine Nova Southeastern University. 1168 Goodle@e Frank rd. Naples, FL Naples Vein Center Naples, Florida JULIAN J. JAVIER, M.D.
Cardiac & Vascular Specialist
Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/
arrangement or affiliaMon with the organizaMon(s) listed below. AffiliaMon/Financial RelaMonship • 
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Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit
Company • 
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None
None
None
None
Vascular Device Partners
None
None
Prevalence and Etiology of
Venous Insufficiency
Venous Reflux Disease
Coronary Heart Disease
Peripheral Arterial Disease
<2% of 30MM patients with CVI are treated Congestive Heart Failure
Annual U.S. Incidence Stroke
U.S. Prevalence Cardiac Arrhythmias
Heart Valve Disease
0
5
10
15
20
25
30
35
Millions of patients Only 1.9 million of the more than 30 million Americans who
suffer from varicose veins or CVI seek treatment1,2,3
Photos courtesy of Rajabrata Sarkar, MD, PhD. Treatments
!  Surgery •  Manually removes the vein segment from the leg •  General anesthesia •  Permanent scarring •  Extended post-­‐procedure discomfort •  2-­‐3 weeks recovery !  AblaMon Therapies •  Relies on heat energy to burn and destroy vein segment •  Tumescent anesthesia •  ParMal pain and bruising •  Extended post-­‐procedure discomfort •  2-­‐3 days recovery Abla6on Techniques
Compression Stockings Pain & Bruising Tumescent Anesthesia 6 Why not use Thermal Abla6on?
•  It is time consuming.
•  Delivery is tedious.
•  Multiple injections, quite
uncomfortable for patients.
•  Post procedure pain and bruising
•  Learning curve for novice operators
and abla6on
Thermal Non-­‐thermal Radiofrequency Covidien MOCA Radiofrequency FP-­‐system Varythema WSWL/HSLA Laser Cyanoacrilate Steam AblaMon Vblock* Endovenous Tusmecent* Balloon Occlusion Sclerotherapy " mechanical occlusive
chemical ablation or MOCA.
" Varythema.
" Cyanoacrilate Glue. (UE, not US)
" V block occlusive device (UE, not US)
Pharmaco-mechanical ablation
or MOCA
ClariVein™ is a Percutaneous, 2 2/3 Fr (0.035")
infusion catheter that contains a
rotating wire driven by a motor activated from a
DC battery-powered handle.
MOCA
Pharmaco-mechanical ablation
•  Procedure time averaged 14 min.
•  GSV size 2cm from SFJ was 8.1mm (5.5-12mm) with an average
treatment length of 36cm.
•  At 1 month, 3 months and 6 month, 29 of the 30 veins treated
were successfully closed. Only vein that did not respond was that
of the first patient. Subsequent to the trial, to date 22 other
patients have had the ClariVein procedure, with all being
successful.
Dr Steve Elias,,Mount Sinai and Englewood Hospital , New York, 2009.
Complications
•  No DVT
•  No Nerve Injury
•  No Skin Injury
•  Brusising 3 pts.
Elias S, Lam YL, Wittens. Mechanical Ablation Status and results. Plebology
2013 (28 Supp 1) 10-14.
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.
MOCA 2013
•  13,000 cases worldwide (GSV/SSV)
•  95% of GSV/SSV
•  > 90% occlusion rate – various intervals
•  Reproducible results
•  QoL – improves as any successful EVA
•  DVT - < 1% worldwide
•  Unique advantages – certain situations
MOCA
Pros •  No tumescent. •  Safe. •  Immediate recovery. •  No analgesics post period. Cons •  Long term data. •  Reimbursement. •  Cost. •  Tortuous Veins. " mechanical occlusive chemical
ablation or MOCA.
" Varithema.
" Cyanoacrilate Glue. (UE, not US)
" V block occlusive device (UE, not
US)
Varithema (Previously called varisol)
# Polidocanol endovenous microfoam. # Highly concentrated CO2 and O2 very li@le nitrogen. # Approved in the US in 12/2013. Vanish I and Vanish II
# Large Veins C3 to C6. # 1ry end-­‐point paMents benefit. # Ultrasound closure was terMary benefit. # 1333 paMents in 12 clinical trials. # PASTE 2.9 % # neuro events 2.7 % vs. 4.5 % in placebo group # DVT 1 % Kenneth L Todd III1 DI Wright for the VANISH-­‐2 Inves>gator Group Varithena: Pros • Works well. • Safe. • Immediate recovery. • J-­‐code reimburse for drug. Cons •  High cost US $ 71/cc, average tx 12 cc. •  Reimbursement, using code 37799 (unlisted procedure), however company going to great extend to help with reimbursement. " mechanical occlusive chemical ablation or
MOCA.
" Varithema
" Cyanoacrilate Glue. (UE, not US)
" V block occlusive device (UE, not US)
Venaseal Procedure
VDP – Sapheon animal trial
CONCLUSION:
Injection of CA is feasible for closure of superficial veins in animal models.
Vein closure is achieved via an inflammatory process which ultimately leads to
fibrosis
Almeida JI, et al. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results.
Vasc Endovascular Surg 2011;45:631-5
Feasibility study
Conducted 2 phases of a single clinical study – Phase 1: First in Humans, n=8, December 2010 (DR-­‐1) – Phase 2: ConMnuaMon of Protocol, n=30, July 2011 (DR-­‐2) – Four invesMgators, 3 US, 1 German Almeida, JI; Javier, JJ et al, First Human use of cyanoacrilate adhesive for treatment of Saphenous vein incompetence J of Vasc Surg:Venous & Lym Dis 2013;1:174-­‐80 Two-­‐year follow-­‐up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence Jose I Almeida1, Julian J Javier2, Edward G Mackay3, Claudia BauMsta4, Daniel J Cher5 and Thomas M Proebstle6 Phlebology April,2014 Abstract ObjecMves: To evaluate the safety and effecMveness of endovenous cyanoacrylate-­‐based embolizaMon of incompetent great saphenous veins. Methods: Incompetent great saphenous veins in 38 paMents were embolized by cyanoacrylate bolus injecMons under ultrasound guidance without the use of perivenous tumescent anesthesia or graduated compression stockings. Follow-­‐up was performed over a period of 24 months. Result: Of 38 enrolled paMents, 36 were available at 12 months and 24 were available at 24 months follow-­‐up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all paMents except for one complete and two parMal recanalizaMons observed at, 1, 3 and 6 months of follow-­‐up, respecMvely. Kaplan-­‐Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836–1.0) at 24 months follow-­‐up. Venous Clinical Severity Score improved in all paMents from a mean of 6.1±2.7 at baseline to 1.3±1.1, 1.5±1.4 and 2.7±2.5 at 6, 12 and 24 months, respecMvely (p<.0001). Edema improved in 89% of legs (n1⁄434) at 48 hours follow-­‐up. At baseline, only 13% were free from pain. At 6, 12 and 24 months, 84%, 78% and 64% were free from leg pain, respecMvely. Conclusions: The first human use of endovenous cyanoacrylate for closure of insufficient great saphenous veins proved to be feasible, safe and effecGve. Clinical efficacy was maintained over a period of 24 months. Visual Comparison of Ultrasound and Histology
Fibrosis With Small Adhesive Spaces InMmal Hyperplasia & Fibrosis with Adhesive & Old Thrombus in the Lumen Fibrosis and Adhesive Spaces Histology and ultrasound images are simulated matches delivered under ultrasound observa6on
Treated Saphenofemoral Junc6on
Cyanoacrylate Glue Advantages
#  No tumescent anesthesia
#  No capital equipment
#  No risk of thermal nerve
damage
#  No compression stockings
29
29 " mechanical occlusive chemical
ablation or MOCA.
" Varythema
" Cyanoacrilate Glue. (UE, not US)
" V block occlusive device (UE,
not US)
V-block
# Occlusive device compose of
a nitinol frame and anchoring
hooks.
# Percutaneously deployed at
SFJ.
# 12 Sheeps device deployed, 4
tx with adjuntive liquid
sclerotherapy. US at 30, 60 and
90 days.
# Histopathologic showed Vblock
lodge in the GSV sorrounded by
fibrous tissue
# Obliteration of the GSV,
widespread intimal loss and
multifocal medial smooth
muscle loss was noted
Farber A, et al Boston Medical Ctr, Phlebology November 2012.
Phlebology. 2014 Feb;29(1):16-­‐24. doi: 10.1258/phleb.2012.012003. Epub 2013 May 6. The evalua>on of a novel technique to treat saphenous vein incompetence: preclinical animal study to examine safety and efficacy of a new vein occlusion device. Farber A1, Belenky A, Malikova M, Brenner O, Brandeis Z, Migdal M, Orron D, Kim D. Abstract OBJECTIVES: We tested a novel technique to treat great saphenous vein (GSV) incompetence in an animal model. METHODS: V-­‐block (VVT Medical Ltd, Kfar Saba, Israel), an occlusion device composed of a niMnol frame and anchoring hooks, was percutaneously deployed at the saphenofemoral juncMon in 12 sheep. Four of the 12 sheep were treated with adjuncMve liquid sclerotherapy. Animals underwent duplex ultrasound, venography and histopathological evaluaMon immediately posMmplantaMon at 30, 60 and 90 days. RESULTS: V-­‐block was successfully deployed in all animals without adverse events. There was no device migraMon at follow-­‐up. Histopathological analysis demonstrated V-­‐block to be lodged within the GSV and surrounded by fibrous Mssue in all samples. ObliteraMon of the GSV lumen, widespread inMmal loss and mulMfocal medial smooth muscle loss was noted. CONCLUSIONS: In this animal study V-­‐block was deployed without complicaMons, remained in stable posiMon and led to GSV occlusion. This device has promise for future use in humans. V-­‐block
IniMal trial results in humans. Fisy paMents were studied; Early occlusion rate of 90 %. 46 followed to an average of 4.6 months. •  There was 100% occlusion at this early stage. •  No DVT reported, and 1 paMent had superficial thrombophlebiMs. •  Device sMll in very early development, and further studies are planned • 
• 
• 
• 
Dr. Ralf Kolvenbach at the 2013 VEITH symposium • Endovenous Laser AblaMon Treatment EVLT • Steam AblaMon. • Radiofrequency. • Endoluminal Tusmecent Anesthesia Delivery JET Laser •  Wavelength. •  Tips. Wavelength
# Wavelength 810, 940, 980 nm diode laser Hb specific. # 1064, 1320 nm YAG Laser # 1470 nm water-­‐based diode laser. # Not yet established 1310 nm diode and 2100 nm Holmium Laser Saphenous Laser Ablation at 1470 nm Targets the
Vein Wall, Not Blood
•  We demonstrated that the 1470-nm wavelength
endovenous laser system could not close saphenous
veins without use of anesthesia.
•  Closure with a dramatic reduction in energy when compared to a
980-nm wavelength control demonstrated a marked reduction in
postoperative pain and ecchymosis; this implies that vein-wall
perforations are minimized with this system.
Vascular and Endovascular Surgery 2009 1-­‐6 iO 2009 Jose Almeida, Edward Mackay, Julian J Javier, John Mauriello, and OJ Jeffrey Raines 10.1 177/1 Water Specific Laser
Not in the USA. Dr. Mendez Mexico 1470 nm 7 to 10 w water based. 1970 nm 5 to 6 wa@s water based. Goal:
Avoid carbonizaMon of the Mp which may lead to perforaMon of the vein. Ceramic Tulip Bare Metal radial •  Endovenous Laser AblaMon Treatment EVLT •  Steam AblaGon. •  Radiofrequency. •  Endoluminal Tusmecent Anesthesia Delivery JET Generator Veni RF Plus
Generator
Pedal
Tube and
siringe60 ml
Disposable catheter
Confidencial
Veni RF Plus System
• 
0.9 % Saline solution runs trough caheter.
• 
Steam is given 5 cm /q 10 sec/segment based on a potency of 2 mlmin at 60 W.
• 
Low pressure system <10 PSI.
• 
Salinity closes the circuit via the electrodes and the energy heats up saline.
• 
Steam comes out via the lateral ports.
• 
Steam comes in contact with venous wall and releases energy at condensation.
• 
About 60 j /cm
Despite early success of tumescent-less
therapies, Thermal Injury with RF and EVLA has
shown to be:
•  Effective.
•  Low risk of complication.
•  Proven track record.
•  Long term use has optimized the thermal injury
technique.
Why mess with success?
Endovenous Tusmecenst
Summary
• New evolving technique are designed to eliminate the need for Tumescent anesthesia. • Thermal remains as a safe and effecMve means of venous insufficiency treatment. • Complex venous anatomy demands mulMple tools available. What does the future hold?
THERMAL
NONTHERMAL
OR
medicine
baseball
to be determine!
Thanks Veins Hands On course: Santo Domingo, Dom Rep,September 2014. JulianJavier@JulianJaviermd.com www.veinshandson.com 239-­‐692-­‐4197