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5/15/2017
1
ENDOVENOUS LASER
THERAPY FOR VARICOSE
VEINS
LOWELL S. KABNICK, MD
NYU LANGONE MEDICAL CENTER
ANGIODYNAMICS
AMSEL
BARD
BTG
VASCULAR INSIGHTS
VENITI
FREE ITEMS
AS ABOVE, MEDTRONIC, BSN JOBST, JANSEN, MEDI,
SIGVARIS,ETC
Disclosure Slide
EndoVenous Laser
Procedure
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Endovenous Laser Ablation
Preoperative Planning
Preparation of the Patient
Percutaneous Insertion Supplies
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Access Methods
•19 g thin walled needle with 035 system long or
short sheath
•18 g needle with 035 system long or short sheath
system
•18g wire long sheath system
•18g wire short sheath system and direct fiber
insertion
•21g 018 micropuncture system
Local Anesthesia
Insertion of 21 g Needle
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4
Insertion of Micropuncture 018” Wire
Image courtesy of
Olivier Pichot, MD
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Insertion of Micropuncture Sheath
Laser Kit Dilator Removal
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035 Wire Insertion
Removal of Microsheath
4 Fr Sheath Back-Loaded
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Sheath and Covered Fiber
Fiber Position >2cm from the SFJ
SFJ
Tumescent Anesthesia
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Contents of the Saphenous Compartment
Saphenous Eye
Tumescent Anesthesia
Tumescent Halo
•10 mm diameter around vein
•10 mm between target vein & skin
•10cc/cm
10mm
10mm
500cc of Normal Saline
Remove 55cc of fluid
Add 50cc of 1% Lidocaine with epinephrine 1:100,000
Add 5cc of Sodium Bicarbonate
Purpose of Local Anesthesia
•Protect against thermal skin injury
•Provide local anesthesia along the treatment
vein pathway
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Manual Tumescent Anesthesia
Tumescent Anesthesia
Tumescent Anesthesia
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Laser Pull Back
•5-7 W 30-50J/cm
Small Saphenous Vein
Small Saphenous Vein Procedure
ssv
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DUS SSV
Skin Anesthesia
21 Gauge Needle Insertion
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018 wire
Micropuncture sheath
Upsize 035 wire
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4 Fr Sheath
Placement of Sheath and Covered Fiber
Fiber
just before the SSV
“dives” to the popliteal
vein
2-3cms from the
Junction
Tumescent Anesthesia
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Pull Back
•Watts 5-7 W
•LEED 30-50 J/cm
•6W ~50J/cm
•8 secs/cm
Laser Perforator
Procedure
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SPOT WELD
Laser set at 5W
5 sec X 2~50J/cm
Weld in two places
.5 cms
So What Do We Know
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18
Hemoglobin based wavelengths produce
more short term side effects than longer
wavelengths
Kabnick L. Outcome of different endovenous laser wavelengths for great saphenous vein ablation. J
Vasc Surg. 2006 Jan;43(1):88-93.
Proebstle TM, Moehler T, et al. Endovenous treatment of the great saphenous vein using a1320 nm
Nd:YAG laser causes fewer side effects than using a 940 nm diode laser. Dermatol Surg. 2005
Dec;31(12):1678-83.
Less side effects (pain, bruising) with 1320nm at 5
watts than at 8 watts
Less side effects (pain, bruising) with 980nm than
810nm at the same watts
Laser side effects
•Most likely caused by laser induced vein wall
perforation with extravasation of blood into the
surrounding tissue
•Perforations are more common with;
•HSLW, higher power (watts), greater LEEDs
Proebstle TM, Gul D, et al. Infrequent early recanalization of greater saphenous
vein after endovenous laser treatment. J Vasc Surg 2003;38:511–516.
Goldman MP, Mauricio M, et al. Intravascular 1320-nm laser closure of the great
saphenous vein: a 6- to 12-month follow-up study. Dermatol Surg. 2004;30:1380-
1385.
Mundy L, Merlin TL, et al. Systematic review of endovenous laser treatment for
varicose veins. Br J Surg 2005;92:1189–1194.
EVLT: So What Else Do We Know?
•Efficacy and Safety Profile:
•Benchmark 97-99% efficacy
•Randomized Control Trials:
•VCSS scores improved
•QOL improved
•Murad et al; J Vasc Surg 2010
•Shepherd et al, Br J Surg 2010
5/15/2017
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6 Randomized Controlled Trials
•1 EVLA, RFA, sclerotherapy, surgery
•1 EVLA, sclerotherapy
•2 EVLA, sclerotherapy, surgery
•1 RFA, glue embolization
•1 RFA, mechanochemical (MOCA)
treatment
580 limbs, 500 patients
Inclusion criteria
•Symptomatic varicose veins with GSV
reflux
•C2–C4
Exclusion criteria
•Previous DVT
•Axial deep venous reflux
Br J Surg. 2011
Primary Endpoint
GSV Closure
Patent GSV with Reflux
EVLA
N=144
n(%)
RFA
N=148
n(%)
UGFS
N=144
n(%)
Stripping
N=142
n(%)
Pvalue
3 days
0 (0) 0 (0) 3 (2.1) 4 (2.8) .053
1 month
1 (0.7) 0 (0) 2 (1.4) 3 (2.2) .20
1 year
7 (5.8) 6 (4.8) 20 (16) 4 (4.8) <.001
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20
30-day Complications
EVLA
N=144 RFA
N=148 UGFS
N=144
Stripping
N=142
Major
Deep vein thrombosis
0 0 1 1
Pulmonary embolism
0 0 1 0
Minor
Phlebitis*
412 17 5
Infection
0 1 4 1
Paraesthesia
3 6 2 5
Hyperpigmentation
3 8 8 6
Haemorrhage
1 0 1 1
* P=.006
Disease Specific Quality of Life
(AVVSS)
P=NS
WHICH IS MORE IMPORTANT FOR
POSTOPERATIVE RECOVERY?
LASER WAVELENGTH
FIBERS
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21
Hb H2O
Endovenous Laser Ablation
810-nm
940-nm
980-nm
1319/1320-nm
1470-nm
What Do We Know About Fibers?
Bare Covered Fiber
Courtesy AngioDynamics
Power density
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The use of a JT fiber appeared to be more significant in reducing pain and bruising
as compared to a longer wavelength. Moreover, the results appeared additive, and
the cohort using 1470 nm with a JT fiber produced the best treatment outcomes.
Additional study is required to confirm the efficacy and durability of the various
iterations evaluated; however, these data should be taken into consideration when
undertaking treatment with endovenous laser ablation.
2016
Presented at the Twenty-fourth Annual Meeting of the American Venous Forum, Orlando, Fla,
February 8-11, 2012.
Lowell S. Kabnick, MD, RPhS, FACS, Mikel Sadek, MD, FACS
NYU Langone Medical Center, Division of Vascular Surgery, New York, NY
What is More Important?
•Wavelength is Important
•Fiber Type is Important
•The Type of Fiber seems to be more
important than the Laser Wavelength
Concluding Remarks
•Laser ablation is very versatile including
spot welding
•There is no significant difference between laser
and RF in terms of
•Efficacy
•QOL
•Safety profile
•Clinical Equipoise
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Non-contact fibers:
maybe the great equalizer in postoperative
recovery between endothermal devices and
wavelengths.j/cm? Is
higher energy
better?
Together 1470nm and covered fibers have
a superior postoperative safety profile.
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1
Micro-foam Therapy for
Treatment of Superficial Venous
Disease
Paramjit “Romi” Chopra, MD
Associate Professor, RUSH University,
Midwest Institute for Minimally Invasive Therapies (MIMIT), Chicago, IL
Disclosures
SUPERFICIAL VENOUS DISEASE
IS NOT UNCOMMON
IS NOT BENIGN
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healthy strong, good
looking legs without pain or
discomfort
WHAT DO WE WANT?
Normal Anatomy & Physiology
Venous Anatomy-
Lower Extremity Venous Pump
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Anatomy
PATHOPHYSIOLOGY
•Pathologic:
Valvular
incompetence of the
venous system.
•Physiologic:
Leaky valve syndrome,
superficial valvular reflux
Venous
Hypertension
Venous Reflux
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Obstruction V/S valvular Incompetence
Reflux leading to Venous hypertension
Foundational Principle
•Regardless of the
size or type of the
vein
Find the underlying
source of the venous
hypertension
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Foundational Principle
Foundational principle
Create a Map of venous hypertension
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Leaking perforators- Varicose veins
www.themimit.com
CEAP = clinical, etiologic, anatomy, pathophysiologic classification of venous disorders
Medically Significant Venous Incompetence
Disease Progression
1. Eklöf , B et al. Revis ion of t he CEAP class ificat ion f or chronic v enous disorders: Cons ensus statement . Journal of Vasc ular Surgery . 2004 40(6): 1248-1252..
2. Labropoulos N, Leon L, Kwon S, et al. Study of the v enous reflux progress ion. J Vasc Surg. 2005;41(2):291-295
3. Kaplan RM, et al. Quality of lif e in patients with chronic v enous disease: San Diego population study . J Vasc Surgery . 2003; 37:1047-53
4. Callam MJ et al., Chronic ulcer of the leg: clinical hist ory. Britis h Medical Journal. 1987; 294:1389-1391.
CEAP Classification1
C6:
Active ulcer
C5:
Healed ulcer
C2:
Varicose veins
C1:
Telangiectasia C3:
Edema
C4:
Lipodermatosclerosis
or hyperpigmentation
Create a Map of venous hypertension
C2
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Treatment Options
•Relief of the hypertension
•Conservative
•Thermal Tumescent
PLANNING AND COUNSELING
•Planning the therapy
–Detailed discussion
–What’s the baseline
–Establish the Goals of treatment
•Healing a wound
•Relief of symptoms
–Pain, swelling etc
•Cosmetic
–Conservative therapy first
•Counseling
–Timeline of therapy
–Realistic expectations
–Cost issues
–Long term follow-up
Graduated Compression Therapy
•is the cornerstone of the modern
treatment of venous insufficiency
•Properly fitted gradient compression
stockings provide 30-40 or 40-50 mm
Hg of compression at the ankle
•sufficient to restore normal venous
flow patterns in many or most patients
with superficial venous reflux and to
improve venous flow, even in patients
with severe deep venous
incompetence.
5/15/2017
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www.mimit.org
Graduated Compression
•Graduated compression
of superficial veins
•Allows blood to drain
upwards
•Decrease venous
hypertension in legs
Interventions
•Move to interventions if compression therapy not meeting the goals of
therapy
•Important to establish goals of therapy and timeline of expected
improvement
•The patient reached this degree of problem over a prolonged period
–Important to emphasize that this will not all magically disappear
www.mimit.org
MICROFOAM THERAPY
5/15/2017
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www.themimit.com
Polidocanol injectable foam is a Comprehensive
Above and Below the Knee Intervention1
PCF = physician-compounded foam
1. Todd et al,. Phlebology. 2013;1-11.
2. Glov iczki P, et al. J Vasc Surg. 2011; 539(suppl 5): 2S-48S.
Above Knee2
(Proximal GSV)
•Endovenous thermal ablation
•Stripping and ligation
•(polidocanol injectable foam)
Below Knee2
(Distal GSV)
•PCF sclerotherapy
•Some endovenous thermal ablation
•Varithena®
Visible Varicosities2
(GSV tributaries)
•Ambulatory phlebectomy
•PCF/Liquid sclerotherapy
•(polidocanol injectable foam)
Primary cause
of symptoms
CEAP 2
Medial thigh and leg
Before After
Lower leg
Before After
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CEAP 6
CASE STUDY
MICRO-FOAM THERAPY
www.themimit.com
Polidocanol injectable foam Endovenous Microfoam
Ablation Procedure
Catheter based endovascular procedure performed under ultrasound
guidance
•FDA approved as first line treatment for GSV Incompetence
•Not adjunctive or subsequent to surgical ligation or thermal
ablation
•Does not require tumescent anesthesia
•Physician performed18 step procedure
•Procedure requires ≥ 2 professionals
FDA agreed upon physician training Risk Management Plan (RMP)
•Physician prerequisite of ≥ 100 vein cases within past two years &
attestation of experience
•Must complete four online training modules
•Documented proficiency (exam)
•Must successfully complete training program to gain access to product
• BTG clinical specialist support is required for each physician’s initial
cases
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Addressing a History of Decreased Efficacy with Physician
Compounded Foam (PCF)
•Historically, physician compounded foam has yielded poor
performance in large diameter vessels such as the Great
Saphenous Vein (GSV)1
•Why?
–Variability in foam
(differing compositions)
–Low stability of foam
1. Rasmussen et al, British Journal of Surgery 2011; 98: 1079-1087.
2. Carugo et al, Phlebology , June 2015.
www.themimit.com
1. Asclera Full Perscribing Inf ormation , p. 1
Polidocanol injectable foam
FDA approved
•Manufactured drug/device under Good Manufacturing Practice (GMP) standards
•Endovenous Microfoam Chemical Ablation Agent
•Stable, low density, sterile, cohesive microfoam provides a two-step mechanism of
action
oDisplace blood from vein to be treated
oChemically ablates endothelial layer
•Nitrogen Content <0.8%
o65% O2/ 35% CO2
o1:7 Liquid to gas ratio by volume
•Small consistent narrow bubble size
oMedian bubble size <100 μm
oNo bubble >500 μm
oLittle to no remaining surfactant after bubbles take their effect
Chemical Ablative Properties
Polidocanol
injectable foam
®
PCF
Physician compounded foam (PCF)
•Not FDA approved
•Non-GMP
•Extemporaneously compounded in the physician office setting
using a variety of techniques, gases, active agents, and
concentrations
•Final product is highly variable and operator dependent
Polidocanol Liquid
•FDA approved
•Manufactured via GMP
•Liquid Sclerosing Agent
•Indicated for uncomplicated spider and reticular veins (< 3 mm in diameter)1
Adverse Events Associated with PCF
1. Ceulen et al, New England Journal of Medicine, 2008: 358;14
2. Murad et al. J Vasc Surg. 2011; 53 (suppl):49S; 2. Sarvananthan et al. J Vasc Surg. 2012;55:243;
3. Bush et al. Phlebology . 2008;23:189
4. Eckmann, Dermatol Surgery, 2005: 31;636-343
Significant Adverse Events
have been reported with
physician compounded
foam1,2,3
Why?
•Large bubbles migrate in
vasculature and block vessels
downstream to treatment area
•Large bubble migration is
associated with Nitrogen content of
the gas mixture used4
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Polidocanol injectable foam Safety Profile
1. Regan et al, Journal of Vascular Surgery 2011; 53: 131-138
•60 high risk patients with confirmed right to left shunt treated
with Polidocanol injectable foam
•No evidence of lesion on diffusion weighted MRI sequence
•No neurological symptoms
•No elevation in cardiac troponin levels
Summary
•Newer Non-thermal Non tumescent treatment options
available
•FDA approved
•Safe
•Effective
•Faster and Better
•Reimbursed by Insurance
•Cost-effective
5/15/2017
1
VenaSealSapheonClosureSystem vs
Radiofrequency Ablation for Incompetent
Great Saphenous Veins (VeClose)
36 Month Results and update
Nick Morrison, MD, FACPh, FACS, RPhS
President, International Union of Phlebology
Morrison Vein Institute
Phoenix, AZ, USAAntelope Canyon, AZ, USA
30 April
10:20-10:35
Now 5 min at
moderate pace
w/o video
Disclosures
Medtronic
Research Grant
Speakers Bureau/Consultant
Pierre Fabre
Speakers Bureau
Medi
Educational Grant
Speakers Bureau
Morrison Training Institute
Medical Director
Sedona, AZ, USA
The procedure
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4
Position catheter 5 cm from SFJ Compress cephalad to catheter
VenaSeal™closure system
VENASEAL™CLOSURE SYSTEM: PROCEDURE
Access GSV using catheter technique
5
Inject 0.10 cc adhesive into the vein, pull
back 1 cm, inject 0.10 cc pull back 3 cm
Inject 0.10 cc, pull back 3 cm, compress
for 30 seconds
Compress 3 minutes
Repeat process throughout vein
VENASEAL™CLOSURE SYSTEM: PROCEDURE
6
VenaSeal™catheter
during administration of
adhesive
VenaSeal™
catheter image
ULTRASOUND VIEW OF VENASEAL™CATHETER
Images courtesy of Dr. R. Raabe
5/15/2017
3
7
VenaSeal™Procedure Closure RFA Procedure Closure
Images courtesy of Dr. R. Raabe
ULTRASOUND IMAGES 8 WEEKS POST TREATMENT
8
Eliminates need for tumescent anesthesia
No risk of thermal injury
No post treatment compression stockings needed1,2*
Rapid return to normal activities
No capital equipment
FEATURES OF THE VENASEAL™PROCEDURE
1. Almeida JI, et al. Two-year follow-upof first humanuse of cyanoacrylateadhesive for treatment of sa phenousvei n incompetence. Phlebology / Venous
Forum ofthe Royal S ociety of Medicine 2014.
2. Proebstle TM, etal . The European mult icenter cohortstudy on cyanoacrylate embolizationof refluxinggreat saphenous veins. J ournal of VascularSurgery:
Venousand Lymphatic Disorders2015;3:2-7.
*Some patients maybenefitfrom compression stockingspost procedure.
VeClose Study Overview
Title
naSeal ClosureSystem vs. Radiofrequency Ablation for
Purpose
VenaSeal
truncal
ClosureFAST system)
Study Design
-center, randomized controlled IDE study. The
-inferiority approach to effectiveness for
Enrollment /
Sites
-in and 222 randomized) subjects enrolled at 10
Follow
-up
-up visits at 3 days post-procedure, 1, 3, 6
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
5/15/2017
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VeClose Primary Endpoint
Primary
Endpoint
Complete
closure of the target vein at 3 months
after index proce
dure as judged by the core
laboratory. Complete closure is defined as Doppler
ultrasound examination showing closure along
entire treated target vein segment with no discrete
segments of patency exceeding 5 cm.
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
Secondary
Endpoints
Intraoperative Pain evaluation :
Following procedure, self rated pain experienced during 2 phases of the
treatment procedure on a 0
-10 NRS
•
Phase 1: From initial local anesthesia injection at the access site to
venous access with the micro-access catheter
•
Phase 2: From introduction of the RFA or CAC catheter to completion of
vein treatment and device removal
Ecchymosis at Day 3:
Investigator assessment of ecchymosis along the treated area using a 0
-5
point grading scale
0
-none
1
- involving <25% of the treatment area
2
- 25%-50%
3
- 50%-75%
4
-75%-100%
5
- extension above or below the treatment segment
CAC, cyanoacrylate closure; NRS, numeric rating scale; RFA, radiofrequency ablation
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
Additional Endpoints
Assessments related to venous disease severity:
Change in VCSS scores
Change in CEAP scores
Assessments related to QoL:
Change in AVVQ scores
Change in EQ-5D TTO scores
Comparison of adverse event rates related to target GSV
AVVQ, aberdeen varicose vein questionnaire; CEAP, clinical-etiology-anatomy-pathophysiology classification; GSV, great
saphenous vein; EQ-5D, euro quality of life-5D; QoL, quality of life; TTO, time trade-off; VCSS, vein clinical severity score.
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
5/15/2017
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VeClose - Sites & Enrollments
Site # Site Name PI Location # Enrolled
Roll-in
Randomized
11
Morrison Vein Institute
Morrison
Scottsdale, AZ
214
12
Vein Clinics of America
King,
Hlavcek
Oakbrook Terrace, IL
219
13
Inovia
Vein Specialty Center
Jones
Bend, OR
244
14
Lake Washington Vascular
Gibson
Bellevue, WA
258
16
Radiology Imaging Associates
Spencer
Greenwood Village,
CO
2 4
17
GBK Cosmetic Laser Dermatology
Goldman
San Diego, CA
224
18
Prairie Education & Research
Cooperative
Kolluri
, Matos
Springfield, IL
2 9
19
Maryland Laser Skin & Vein Institute
Weiss
Hunt Valley, MD
217
20
Vein Center of Virginia/Sentara
Vascular Specialists
McEnroe
Virginia Beach, VA
224
22
Venous Institute of Buffalo
Vasquez
Amherst, NY
2 9
20 222
242
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
VeClose Study Design
Enrolled (N=242)
RFA (n=114)
CAC (n=108)
Evaluation of perioperative parameters
Randomized (1:1) and Treated
Subjects (N=222)
Follow up at Day 3; and at 1,3,6, 12, 24, 36, 60 months
CAC Roll-In group
Subjects (N=20)
Baseline
Assessments
Intraoperative
pain
Ecchymosis
Reevaluation of clinical assessments and adverse events
CAC –Cyanoacylate Closure; RFA, radiofrequency ablation
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
15
Baseline Characteristics
CAC
(N=108)
RFA
(N=114) P-value
Age (years)
49.0 50.5 0.34
Body
Mass Index
27.0 27.0 0.95
Mean GSV diameter
(mm)
Proximal
6.3 6.6 0.15
Mid-
thigh
4.9 5.1 0.28
Mean Treatment Length
(cm)
32.8 (108) 35.1 (114) 0.17
Mean VCSS
5.5 ± 2.6 5.6 ± 2.6 0.99
Mean AVVQ
18.9 ± 9.0 19.4 ± 9.9 0.72
Mean EQ-
5D TTO
0.935 ± 0.113
0.918
±
0.116
0.29
Demographics and Baseline Characteristics
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
5/15/2017
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CAC
(N=108)
RFA
(N=114) P-value
Tumescent
Anesthesia
Volume (mL)
Not
applicable 272 -
Lidocaine Use During
Procedure (mL)
1.6 2.7 0.1
Cyanoacrylate
delivered,
(mL)
1.2 N/A -
Intraoperative pain
During Vein Access
1.6 2.0 0.13
During Treatment
2.2 2.4 0.11
VeClose Pain Scores
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
Total Dose of NSAIDs and Narcotic Use in First 24 Hrs
Assessed at Day 3
Medication Use
VenaSeal
N (%)
RFA
N (%) P-Value
No medication
86
(79.6%) 90 (78.9%) 1.00
Narcotic
Hydrocodone
0 1 (0.9%) 1.00
NSAIDs
Ibuprofen
17 (15.7%)
22 (19.3%) 0.60
Aspirin
1 (0.9%)
0 0.49
Naproxen
1 (0.9%)
1 (0.9%) 1.00
Other
3 (2.8%)
1 (0.9%) 0.36
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
67.6
26.9
2.8 1.9 0.9
48.2
33.3
14.0
3.5 0.9
0
10
20
30
40
50
60
70
80
90
100
None <25% 25-50% 50-75% 75-100%
Assessed by investigators with a 5-point scale on Day 3
Secondary Endpoint : Ecchymosis at Day 3
Subjects treated with VenaSeal™system had significantly less
ecchymosis at Day 3 compared to RFA (p< 0.01).
VenaSeal
ClosureFast
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
5/15/2017
7
Proportion of closure
CAC (N=104)
RFA (N=108)
Roll-in (N=19)
Complete occlusion, n (%)
103 (99.0) 103 (95.4) 19 (100)
Incomplete occlusion, n (%)
1 (1) 5 (4.6) 0 (0)
No. of patients lost during
follow up, n (total)
4 (108) 6 (114) 1 (20)
Primary Endpoint: Rate of GSV closure at Month 3
Complete closure defined as Doppler ultrasound examination showing closure along entire treated target
vein segment with no discrete segments of patency exceeding 5 cm. This includes compressible segments
with and without flow. Ultrasound exams used 2D imaging, color Doppler and pulsed Doppler.
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and RF ablation for incompetent GSV (VeClose).J Vasc Surg 2015.61.985-94.
Timepoint VenaSeal RFA
Day 3
100% (108) 99.1% (114)
Month 1
100% (105) 87.3% (110)
Month 3*
99% (104) 95.4% (108)
Month 6
99% (101) 96.2% (105)
Month 12
96.8% (95) 95.9% (97)
Month 24
95.3% (86) 94% (84)
Month 36
94.4% (72) 91.9% (74)
VeClose Primary Endpoint –Complete Closure
94.4% closure rates, demonstrating long term durability at 36 months; and continued,
non-inferiority results to RFA (P=0.005) through 36 months.
*Complete closure based on clinical site assessment. The month 3 core lab assessment with LOCF rates are 99.1% for VSCS and 95.6% for RFA
with non-inferiority p-value of <.0001.
0 1 3 6 12 24 36
2
4
6
8
Follow-up Months
VCSS, Mean (SE)
108
114
105
110
104
108
95
97
87
84
72
74
101
105
108
114
RFA 1.69 ±2.42
VS 1.25 ±1.60
p-value =
0.5643*
VCSS demonstrated statistically significant improvement out to 6 months
and sustained through 12, 24, and 36 month time points.
36 Month -Venous Clinical Severity Score (VCSS)
Treatment
VenaSeal
RFA
VCSS : an evaluative instrument that is responsive to changes in disease severity over time and in res ponse to treatment
p-value c omparing change scores between VSCS and RFA was based on repeated measures analysis of variance.
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0
5
10
15
20
25
0 1 3 6 12 24 36
107
111
102
109
104
108
100
105
95
95
86
84
71
73
Follow-up Months
AWQ, Mean (SE)
RFA 8.21 ± 7.76
VS 7.33 ± 6.19
p-value = 0.6778*
36 Month - Aberdeen Varicose Vein Questionnaire
Subjects experienced statistically significant improvement from baseline and
improvement (decreasing total AVVQ score) over time through 36 months.
Treatment
VenaSeal
RFA
AVVQ: a 13-question survey addres sing physical symptoms, pain, ankle edema, ulcers, compression therapy use, and
limitations on daily activities are examined, as well as the cosmetic effect of varicose veins and social issues.
p-value c omparing change scores between VSCS and RFA was based on repeated measures analysis of variance.
0 1 3 6 12 24 36
70
80
100
Follow-up Months
EQ-5D Health Thermometer, Mean (SE)
108
114
105
110
104
108
99
105
95
97
87
84
72
74
VS 89.69 ± 12.00
RFA 88.09 ± 11.69
p-value = 0.8024*
Treatment
VenaSeal
RFA
36 Month - EQ5D Results
Subjects experienced statistically significant improvement from baseline and
improvement over time through 36 months.
The EQ-5D includes single item measures of: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Eachitem is
coded using 3-levels (1 = no problems; 2 = some problems; 3 = severe problems).
p-value c omparing change scores between VSCS and RFA was based on repeated measures analysis of variance.
Adverse Events Reported between 12 and 24 Months
Adverse Events
Reported
Device Related
Procedure Related
#
Reported
Not Related to
the Device
Uncertain
Not Related
Uncertain
VenaSeal
8 6 2* 51*
RFA
4 4 0 4 0
Roll
-In 2 2 0 2 0
*Erythema was reported in the medial thigh for 2 patients and a shin splint reported by 1 patient with VenaSeal.
Etiology of these events could not be determined and/or directly related to treatment or device.
The majority of adverse events reported in the 12-24 month time period were
determined to be unrelated to the treatment or the device across all groups.
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36 Month Safety - Adverse Events Reported
24
-
36 Month AE Device or Procedure Reporting
Adverse Events
Reported
Device/ Procedure
Related
CAC 2*
RFA 0
*1. late onset of phlebitis, etiology unknown; 2. Scar (access site) device related
VenaSeal AE’s from 0 to 36 months:
No reports of deep vein thrombus
No allergic events reported
No unanticipated adverse events
Most events occurred in the first 30 days, were mild and self-limiting
Delayed adverse events were minimal to non-existent
VeClose 36 Month Results Summary:
▪VenaSeal™ procedure resulted in reported 94.4% closure rates,
demonstrating continued, non-inferiority compared to RFA
(P=0.005) through 36 months.
▪VCSS, AVVQ and EQ-5D outcomes demonstrated statistically
significant improvement from baseline with sustained results
over time; no difference between treatment groups out to 36
months.
•No reported DVT’s, allergic reactions, or other SAE’s in 36
months. Early events were mild and self-limiting; delayed events
were uncommon.
▪The VeClose RCT study, with its high level of clinical evidence and
rigor continued to demonstrate the following for VenaSeal:
•Safe, reliable, non-thermal, non-tumescent treatment
option
•Strong, consistent and durable results through 36 months
The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose
roll-in (training) group treated with CAC by physicians who had received device use training but had
no prior treatment experience with the technique and to compare the outcomes with those from
the randomized RFA and CAC groups.
Results:
Mean procedure time 3 min longer
3-month closure rate –100%
Procedural pain, post-procedural QoL, adverse events similar to randomized group
Conclusions:
“Despite the physician’s lack of prior experience, initial treatment with CAC leads to comparable
efficacy and safety results to RFA and is associated with a relatively short learning period”.
Kolluri R, et al. J Vasc SurgVenous and Lym Dis 2016;4:407-415.
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Aim:
Treatment of patients with large diameter veins (up to 20mm) and multiple incompetent vein segments in
the same session
Methods:
50 pts with GSV, SSV, and/or AASV
No adjunctive tributary Rx
No compression post procedure
RTC 1,4 weeks
Duplex, pain score, VCSS(r), AVVQ, return to work/normal activities
Results:
numerical pain rating scale 2.2 ± 1.8
All treated veins (48 great saphenous vein, 14 accessory saphenous veins, and 8 small saphenous veins) had
complete closure
Return to work/normal activities <1-2+ days
Statistically significant improvement in VCSS, AVVQ
Inflammation 20%
Gibson K, et al. Vascular 2016. Jan 1:1708538116651014. doi: 10.1177/1708538116651014. [Epub ahead of print]
Chan YC, Law J, Cheung G, et al. Phlebology 2017.32(2).99-106
Aim:
Evaluate safety, efficacy, performance of endovenous cyanoacrylate ablate of GSV
Methods:
Primary outcome –GSV obliteration up to one year
Secondary outcomes –VCSS, AVVQ, SF-36,
Diameter of GSV, treatment length, pre-treatment clinical severity of VV used to predict
recanalization
Results:
57 GSVs in 29 pts
Improved VCSS, AVVQ, SF-36 all improved at 1-month
GSV closure rate 78.5% at 1-year
No clinical recurrence at 1-year
GSV diameter ≥ 8mm predictor of recanalization
Almeida J, et al. Abstract. J Vasc Surg2016;3(1):125.
Aim:
Mid-term safety and efficacy of endovenous cyanoacrylate ablation of GSV
Methods:
38 patients
Occlusion by duplex <5cms
VCSS assessments
Results:
94.7% occluded by Kaplan-Meier analysis
2 failures, 4 partial recanalization
VCSS improved
21.1% thrombus extension –no VTE
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Toonder IM, et al. Phlebology 29.49-54
Aim:
Explore feasibility of CAPE
Methods:
33 incompetent perforator veins (IPV) in 27 legs in C3-C6 patients
>0.34sec reflux
≥3mm diameter
Occlusion thigh cuff to 70mmHg
Results:
76% occlusion at 3-months
24% persistent reflux
9% wound infection
No DVT
Lane TRA, et al. J Vasc SurgVenous and Lym Dis 2013;1:298-300.
Aim:
Case report
Methods:
73 y/0 male on Warfarin for Afib –INR 2.3
C4bS Ep As Pr
Bleeding varicosities
Reflux in deep venous system, SFJ, and GSV
GSV 15 mm in diameter
Results:
6-months –significant edema and symptoms
Duplex –GSV recanalized up to 7.2mm diameter
Treated with foam sclerotherapy
Koramaz I, et al. J Vasc SurgVenous and LymDis 2017 Mar;5(2):210-215
Aim:
Comparison of NBCA with EVLA in ablation of GSV
Methods:
Retrospective review of 339 non-randomized patients treated with NBCA or EVLA
Results:
Avg procedure time 7min vs 18min (NBCA vs EVLA)
12-month occlusion rates 98.6% vs 97.3% (NBCA vs EVLA)
Fewer adverse events (pigmentation/phlebitis) with NBCA
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Tekin A, et al. Ann Vasc Surg2016;36:231-5
Aim:
Safety and efficacy of cyanoacrylate adhesive for GSV occlusion
Methods:
single-center prospective study of 62 pts
Local anesthesia
No NSAIDs
Compression wrap for 1 day
Successful occlusion <10cms recanalization
Results:
6-months, 90% occlusion, 3.2% subtotal occlusion, 6.5% no occlusion
<16% phlebitis (exact incidence not specified)
Bozkurt AK, et al. Phlebology 2016;31(1S):106-13.
Aim:
Prospective comparison of cyanoacrylate vs laser ablation
Methods:
310 pts non-randomized w/o adjunctive therapy
Primary endpoint: occlusion
Secondary endpoints: procedure time, pain, ecchymosis at day 3, changes in VCSS, AVVQ
Results:
Procedure time, pain, and day 3 ecchymosis less with cyanoacrylate
No paresthesia with cyanoacrylate, 2% with laser
1-month closure rates better with cyanoacrylate
12-month 95.8% cyanoacrylate, 92.2% laser
VCSS, AVVQ improved similarly in both
UIP World Congress
4-8 February, 2018
Melbourne, Australia
www.uip2018.com
5/15/2017
13
Thank you for your kind attention
nickmorrison2002@yahoo.com
Canyon Lake, Arizona
5/15/2017
1
What’s new in RF ablation for Superficial
venous disease
Disclosure Statement of Financial Interest
•Grant/Research Support
•Consulting Fees/Honoraria
•Major Stock Shareholder/Equity
•Royalty Income
•Ownership/Founder
•Intellectual Property Rights
•Other Financial Benefit
•Company Names
•Company Names
•Company Names
•Company Names
•Vascular Device Partners
•Company Names
•Company Names
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
Prevalence and Etiology of
Venous Insufficiency
0 5 10 15 20 25 30 35
Heart Valve Disease
Cardiac Arrhythmias
Stroke
Congestive Heart Failure
Peripheral Arterial Disease
Coronary Heart Disease
Venous Reflux Disease
Annual U.S. Incidence
U.S. Prevalence
Millions of patients
<2% of 30MM patients with CVI are treated
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Photos courtesy of Rajabrata Sarkar, MD, PhD.
Leading Competitors in the Venous insufficiency Treatment
Device Market
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Compression
Stockings
Tumescent
Anesthesia
Pain & Bruising
Thermal
Non
-thermal
Radiofrequency
Covidien
MOCA
R
adiofrequency FP-system
Varythema
WSWL/HSLA Laser
Cyanoacrilate
Steam Ablation
Vblock*
VEnclose
Balloon Occlusion
Sclerotherapy
5/15/2017
4
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.
Luebke T, BrunkwallJ J CardiovascSurg (Torino) 2008 Apri;49 (2)
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5
Van Den Bos R, ArendsL, Kockbaert M, et al J Vasc Surg 2009, 49 230-239
Nesbit C, Eifel RK, Coyne P, Badi H et al
Kalluri R,
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6
A. Naymana, , , I. Yildizb, N.
Kocac, S. Denizd, M. Koplaya, L. Oguzkurte
Conclusion
Our results show that pre-procedure diameter of the GSV is the single
risk factor for recanalization after RFA.
European Journal of Vascular and Endovascular Surgery
Volume 52, Issue 2, August 2016, Pages 234–241
S.K. Van der Veldena, , , M. Lawaetzb, M.G.R. De
Maeseneera, L. Hollesteina, T. Nijstena, R.R. van
den Bosa,
Predictors of Recanalization of the Great Saphenous Vein
in Randomized Controlled Trials 1 Year After Endovenous
Thermal Ablation
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•Switchable heating length between 10 cm or 2.5 cm
•Fast treatments with 10 cm vein sections
•2.5 cm for precise treatment of short vein sections
•Small 6F profile
•Flexible, steerable, and easy to navigate
•Fast product setup and generator start up
2.5
cm
10 cm
(default)
Product Features and Benefits
5/15/2017
8
Typical 40cm thigh GSV vein 5cm Tributary plus 40cm GSV
Medtronic ClosureFast™
catheter
7cm heating element, seven 20
-
sec ablations
3cm element 3x, plus
3cm element 17x, total of
twenty 20
-sec ablations
Venclose
EVSRF™
catheter
10cm heating element,
five 20-
sec
ablations
28% faster with Venclose
2.5cm element 3x, plus
10cm element 5x, total of
eight
20-sec ablations
60% faster with Venclose

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