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5/15/2017

ENDOVENOUS LASER
THERAPY FOR VARICOSE
VEINS

LOWELL S. KABNICK, MD

NYU LANGONE MEDICAL CENTER

Disclosure Slide

ANGIODYNAMICS
AMSEL
BARD
BTG
VASCULAR INSIGHTS
VENITI
FREE ITEMS
AS ABOVE, MEDTRONIC, BSN JOBST, JANSEN, MEDI,
SIGVARIS,ETC

EndoVenous Laser
Procedure

5/15/2017

Endovenous Laser Ablation

Preoperative Planning

Preparation of the Patient

Percutaneous Insertion Supplies

5/15/2017

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

5/15/2017

Insertion of Micropuncture 018” Wire

I mage courtesy of
Oliv ier Pichot, MD

5/15/2017

Insertion of Micropuncture Sheath

Laser Kit

Dilator Removal

5/15/2017

035 Wire Insertion

Removal of Microsheath

4 Fr Sheath Back-Loaded

5/15/2017

Sheath and Covered Fiber

Fiber Position >2cm from the SFJ

SFJ

Tumescent Anesthesia

5/15/2017

Contents of the Saphenous Compartment

Saphenous Eye

Tumescent Anesthesia

500cc of Normal Saline
Remove 55cc of fluid
Add 50cc of 1% Lidocaine with epinephrine 1:100,000
Add 5cc of Sodium Bicarbonate

Tumescent Halo

10mm

• 10 mm diameter around vein
• 10 mm between target vein & skin
• 10cc/cm

10mm

Purpose of Local Anesthesia
•Protect against thermal skin injury
•Provide local anesthesia along the treatment
vein pathway

5/15/2017

Manual Tumescent Anesthesia

Tumescent Anesthesia

5/15/2017

Laser Pull Back
•5-7 W 30-50J/cm

Small Saphenous Vein

Small Saphenous Vein Procedure

ssv

5/15/2017

DUS SSV

Skin Anesthesia

21 Gauge Needle Insertion

5/15/2017

018 wire

Micropuncture sheath

Upsize 035 wire

5/15/2017

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

5/15/2017

Pull Back

• Watts 5-7 W
•LEED 30-50 J/cm
•6W ~50J/cm
•8 secs/cm

Laser Perforator
Procedure

5/15/2017

SPOT WELD
Laser set at 5W
5 sec X 2~50J/cm
Weld in two places
.5 cms

So What Do We Know

5/15/2017

Hemoglobin based wavelengths produce
more short term side effects than longer
wavelengths
Less side effects (pain, bruising) with 980nm than
810nm at the same watts
Less side effects (pain, bruising) with 1320nm at 5
watts than at 8 watts
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.

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;30:13801385.
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

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

Br J Surg. 2011

580 limbs, 500 patients
Inclusion criteria
• Symptomatic varicose veins with GSV
reflux
• C2 – C4

Exclusion criteria
• Previous DVT
• Axial deep venous reflux

Primary Endpoint
GSV Closure
Patent GSV with Reflux

3 days

EVLA
N=144
n(%)

RFA
N=148
n(%)

UGFS
N=144
n(%)

Stripping
N=142
n(%)

P value

.053

0 (0)

3 (2.1)

4 (2.8)

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

5/15/2017

30-day Complications
EVLA
N=144

RFA
N=148

UGFS
N=144

Stripping
N=142

Deep vein thrombosis

Pulmonary embolism

Phlebitis*

Infection

Paraesthesia

Hyperpigmentation

Haemorrhage

Major

Minor

* P=.006

Disease Specific Quality of Life
(AVVSS)

P=NS

WHICH IS MORE IMPORTANT FOR
POSTOPERATIVE RECOVERY?
LASER WAVELENGTH

FIBERS

5/15/2017

Endovenous Laser Ablation
H2O
1319/1320-nm

940-nm
980-nm

810-nm

1470-nm

What Do We Know About Fibers?

Bare

Covered Fiber

Power density

Courtesy AngioDynamics

5/15/2017

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

2016

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.

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

5/15/2017

Together 1470nm and covered fibers have
a superior postoperative safety profile.
Non-contact fibers:

maybe the great equalizer in postoperative
recovery between endothermal devices and
wavelengths.j/cm? Is

higher energy
better?

5/15/2017

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

5/15/2017

WHAT DO WE WANT?

healthy strong, good
looking legs without pain or
discomfort

Normal Anatomy & Physiology

Venous AnatomyLower Extremity Venous Pump

5/15/2017

Anatomy

PATHOPHYSIOLOGY
• Pathologic:
Valvular
incompetence of the
venous system.

• Physiologic:

Leaky valve syndrome,
superficial valvular reflux

Venous
Hypertension

Venous Reflux

5/15/2017

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

5/15/2017

Foundational Principle

Foundational principle

Create a Map of venous hypertension

5/15/2017

Leaking perforators- Varicose veins

www.themimit.com

Medically Significant Venous Incompetence
Disease Progression

C1 :
Telangiectasia

C2 :
Varicose veins

C3 :
Edema

C4 :
Lipodermatosclerosis
or hyperpigmentation

C5:
Healed ulcer

C6 :
Active ulcer

CEAP Classification1
CEAP = clinical, etiologic, anatomy, pathophysiologic classification of venous disorders

1.
2.
3.
4.

Eklöf , B et al. Rev ision of the CEAP classif ication f or chronic v enous disorders: Consensus statement. Journal of Vascular Surgery . 2004 40(6): 1248-1252..
Labropoulos N, Leon L, Kwon S, et al. Study of the v enous ref lux progression. J Vasc Surg. 2005;41(2):291-295
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
Callam MJ et al., Chronic ulcer of the leg: clinical history . British Medical Journal. 1987; 294:1389-1391.

Create a Map of venous hypertension

5/15/2017

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

• Counseling
–
–
–
–

Timeline of therapy
Realistic expectations
Cost issues
Long term follow-up

– Pain, swelling etc

• Cosmetic

– Conservative therapy first

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

Graduated Compression
• Graduated compression
of superficial veins
• Allows blood to drain
upwards
• Decrease venous
hypertension in legs

www.mimit.org

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

Polidocanol injectable foam is a Comprehensive
Above and Below the Knee Intervention1
www.themimit.com

Above Knee2
(Proximal GSV)
• Endovenous thermal ablation
• Stripping and ligation
• (polidocanol injectable foam)

Visible Varicosities 2
(GSV tributaries)
• Ambulatory phlebectomy
• PCF/Liquid sclerotherapy
• (polidocanol injectable foam)

Primary cause
of symptoms

PCF = physician-compounded foam
1. Todd et al,. Phlebology. 2013;1-11.

Below Knee2
(Distal GSV)
• PCF sclerotherapy
• Some endovenous thermal ablation
• Varithena®

2. Glov iczki P, et al. J Vasc Surg. 2011;539(suppl 5):2S-48S.

CEAP 2
Medial thigh and leg
Before
After

Before

Lower leg
After

5/15/2017

CEAP 6
CASE STUDY
MICRO-FOAM THERAPY

Polidocanol injectable foam Endovenous Microfoam
Ablation Procedure

www.themimit.com

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

5/15/2017

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.
2.

Rasmussen et al, British Journal of Surgery 2011; 98: 1079-1087.
Carugo et al, Phlebology , June 2015.

www.themimit.com

Chemical Ablative Properties
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
o
o

•

o
o

•

65% O2 / 35% CO2
1:7 Liquid to gas ratio by volume

Small consistent narrow bubble size
o
o

Displace blood from vein to be treated
Chemically ablates endothelial layer

Nitrogen Content <0.8%

Median bubble size <100 μm
No bubble >500 μm

Little to no remaining surfactant after bubbles take their effect

Polidocanol Liquid
•
•
•
•
1.

FDA approved
Manufactured via GMP
Liquid Sclerosing Agent
Indicated for uncomplicated spider and reticular veins (< 3 mm in diameter) 1

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

Asclera Full Perscribing Information , p. 1

Adverse Events Associated with PCF
Significant Adverse Events
have been reported with
physician compounded
foam 1,2,3
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
1.
2.
3.
4.

Ceulen et al, New England Journal of Medicine, 2008: 358;14
Murad et al. J Vasc Surg. 2011;53 (suppl):49S; 2. Sarvananthan et al. J Vasc Surg. 2012;55:243;
Bush et al. Phlebology. 2008;23:189
Eckmann, Dermatol Surgery, 2005: 31;636-343

5/15/2017

Polidocanol injectable foam Safety Profile

• 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
1. Regan et al, Journal of Vascular Surgery 2011; 53: 131-138

Summary
• Newer Non-thermal Non tumescent treatment options
available
• FDA approved
• Safe
• Effective
• Faster and Better
• Reimbursed by Insurance
• Cost-effective

5/15/2017

VenaSealSapheonClosureSystemvs
RadiofrequencyAblationforIncompetent
GreatSaphenousVeins (VeClose)
36MonthResults andupdate

30 April
10:20-10:35
Now 5 min at
moderate pace
w/o video
Antelope Canyon, AZ, USA

Nick Morrison, MD, FACPh, FACS, RPhS
President, International Union of Phlebology
Morrison Vein Institute
Phoenix, AZ, USA

Disclosures
Medtronic
Research Grant
Speakers Bureau/Consultant
Pierre Fabre
Speakers Bureau
Medi
Educational Grant
Speakers Bureau

Sedona, AZ, USA

Morrison Training Institute
Medical Director

The procedure

5/15/2017

VENASEAL™ CLOSURE SYSTEM: PROCEDURE

VenaSeal™ closure system

Access GSV using catheter technique

Compress cephalad to catheter

Position catheter 5 cm from SFJ
4

VENASEAL™ CLOSURE SYSTEM: PROCEDURE

Inject 0.10 cc adhesive into the vein, pull
back 1 cm, inject 0.10 cc pull back 3 cm

Compress 3 minutes

Inject 0.10 cc, pull back 3 cm, compress
for 30 seconds

Repeat process throughout vein

ULTRASOUND VIEW OF VENASEAL™ CATHETER

VenaSeal™
catheter image

VenaSeal™ catheter
during administration of
adhesive

Images courtesy of Dr. R. Raabe

5/15/2017

ULTRASOUND IMAGES 8 WEEKS POST TREATMENT
VenaSeal™ Procedure Closure

RFA Procedure Closure

Images courtesy of Dr. R. Raabe

FEATURES OF THE VENASEAL™ PROCEDURE

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
1. Almeida JI, et al. Two-year follow-up of first human use of cyanoacrylateadhesive for treatment of saphenousvein incompetence. Phlebology / Venous
Forum of the Royal Society of Medicine 2014.
2. Proebstle TM, et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. Journal of Vascular Surgery:
Venous and Lymphatic Disorders2015;3:2-7.
*Some patients may benefit from compression stockings post procedure.

VeClose Study Overview
Title

VenaSeal Closure System vs. Radiofrequency Ablation for
Incompetent Great Saphenous Veins

Purpose

Demonstrate the safety and effectiveness of the VenaSeal
Closure System for the treatment of lower extremity truncal
reflux compared to RFA (ClosureFAST system)

Study Design

US multi-center, randomized controlled IDE study. The
study takes a non-inferiority approach to effectiveness for
anatomical closure at 3 months. 36 months effectiveness
assessed and compared across groups.

Enrollment / Sites

242 (20 roll-in and 222 randomized) subjects enrolled at 10
study sites (Sept 2013)

Follow-up

Follow-up visits at 3 days post-procedure, 1, 3, 6, 12, 24 36 , and
60 months.

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

VeClose Primary Endpoint

Primary
Endpoint

Complete closure of the target vein at 3 months
after index procedure 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.

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

Secondary
Endpoints

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

VeClose - Sites & Enrollments
Site #

Site Name

# Enrolled

Location

Roll-in

Randomized

Morrison Vein Institute

Morrison

Scottsdale, AZ

Vein Clinics of America

King, Hlavcek

Oakbrook Terrace, IL

Inovia Vein Specialty Center

Jones

Bend, OR

Lake Washington Vascular

Gibson

Radiology Imaging Associates

Spencer

GBK Cosmetic Laser Dermatology

Goldman

Bellevue, WA
Greenwood Village,
CO
San Diego, CA

Prairie Education & Research
Cooperative

Kolluri, Matos

Springfield, IL

Maryland Laser Skin & Vein Institute

Weiss

Hunt Valley, MD

McEnroe

Virginia Beach, VA

Vasquez

Amherst, NY

20
22

Vein Center of Virginia/Sentara
Vascular Specialists
Venous Institute of Buffalo

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)
CAC Roll-In group

Randomized (1:1) and Treated

Subjects (N=20)

Subjects (N=222)

CAC (n=108)

RFA (n=114)

Evaluation of perioperative parameters
Baseline
Assessments

Intraoperative
pain

Ecchymosis

Follow up at Day 3; and at 1,3,6, 12, 24, 36, 60 months
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.

Demographics and Baseline Characteristics
Baseline Characteristics

CAC
(N=108)
Age (years)
49.0
Body Mass Index
27.0
Mean GSV diameter
(mm)
Proximal
6.3
Mid-thigh
4.9
Mean Treatment Length
32.8 (108)
(cm)
Mean VCSS
5.5 ± 2.6
Mean AVVQ
18.9 ± 9.0
Mean EQ-5D TTO 0.935 ± 0.113

RFA
(N=114)
50.5
27.0

6.6
5.1

P-value
0.34
0.95

0.15
0.28

35.1 (114)

0.17

5.6 ± 2.6
19.4 ± 9.9
0.918± 0.116

0.99
0.72
0.29

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

VeClose Pain Scores
CAC
(N=108)

RFA
(N=114)

P-value

Not
applicable

272

1.6

2.7

0.1

1.2

N/A

During Vein Access

1.6

2.0

0.13

During Treatment

2.2

2.4

0.11

Tumescent Anesthesia
Volume (mL)
Lidocaine Use During
Procedure (mL)
Cyanoacrylate delivered,
(mL)
Intraoperative pain

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

1 (0.9%)

Narcotic

NSAIDs

Hydrocodone
Ibuprofen
Aspirin
Naproxen
Other

17 (15.7%) 22 (19.3%)
1 (0.9%)
0
1 (0.9%)
1 (0.9%)
3 (2.8%)
1 (0.9%)

1.00
0.60
0.49
1.00
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.

Secondary Endpoint : Ecchymosis at Day 3
100
90

Assessed by investigators with a 5-point scale on Day 3

80
70

67.6

60
50

48.2

VenaSeal

33.3

ClosureFast

26.9

30
20

14.0

2.8

1.9 3.5

0.9 0.9

25-50%

50-75%

75-100%

0
None

<25%

Subjects treated with VenaSeal™ system had significantly less
ecchymosis at Day 3 compared to RFA (p< 0.01).
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

Primary Endpoint: Rate of GSV closure at Month 3

Proportion of closure
Complete occlusion, n (%)

CAC (N=104)

RFA (N=108)

Roll-in (N=19)

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)

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.

VeClose Primary Endpoint – Complete Closure
VenaSeal

RFA

Day 3

Timepoint

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)

Month 36

94%

94.4% (72)

(84)

91.9% (74)

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.

36 Month - Venous Clinical Severity Score (VCSS)
VCSS demonstrated statistically significant improvement out to 6 months
and sustained through 12, 24, and 36 month time points.
8

VCSS, Mean (SE)

RFA 1.69 ± 2.42
VS 1.25 ± 1.60
p-value =
0.5643*
4

Treatment
VenaSeal
RFA
2

108 108 105 104
114 114 110 108

101
105

95
97

87
84

72
74

Follow-up Months
VCSS : an evaluative instrument that is responsive to changes in disease severity over time and in response to treatment
p-value comparing change scores between VSCS and RFA was based on repeated measures analysis of variance.

5/15/2017

36 Month - Aberdeen Varicose Vein Questionnaire
Subjects experienced statistically significant improvement from baseline and
25
improvement
(decreasing total AVVQ score) over time through 36 months.

AWQ, Mean (SE)

RFA 8.21 ± 7.76
VS 7.33 ± 6.19
p-value = 0.6778*
15

Treatment
VenaSeal
RFA

107 102 104
111 109 108

100
105

95
95

86
84

71
73

Follow-up Months
AVVQ: a 13-question survey addressing 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 comparing change scores between VSCS and RFA was based on repeated measures analysis of variance.

36 Month - EQ5D Results

EQ-5D Health Thermometer, Mean (SE)

Subjects experienced statistically significant improvement from baseline and
improvement over time through 36 months.
100

VS 89.69 ± 12.00
RFA 88.09 ± 11.69
p-value = 0.8024*

Treatment
VenaSeal
RFA
70

108 105 104
114 110 108

99
105

95
97

87
84

72
74

Follow-up Months
The EQ-5D includes single item measures of: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is
coded using 3-levels (1 = no problems; 2 = some problems; 3 = severe problems).
p-value comparing change scores between VSCS and RFA was based on repeated measures analysis of variance.

Adverse Events Reported between 12 and 24 Months
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.
Adverse Events
Reported

Device Related

#
Reported

Not Related to
the Device

Procedure Related
Uncertain Not Related

Uncertain

VenaSeal

RFA

Roll-In

*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.

5/15/2017

36 Month Safety - Adverse Events Reported
24-36 Month AE Device or Procedure Reporting
Adverse Events
Reported
CAC
RFA

Device/ Procedure
Related
2*
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.

5/15/2017

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]

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
Chan YC, Law J, Cheung G, et al. Phlebology 2017.32(2).99-106

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
Almeida J, et al. Abstract. J Vasc Surg 2016;3(1):125.

5/15/2017

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

Toonder IM, et al. Phlebology 29.49-54

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

Lane TRA, et al. J Vasc SurgVenous and Lym Dis 2013;1:298-300.

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
Koramaz I, et al. J Vasc SurgVenous and Lym Dis 2017 Mar;5(2):210-215

5/15/2017

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)
Tekin A, et al. Ann Vasc Surg 2016;36:231-5

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

Bozkurt AK, et al. Phlebology 2016;31(1S):106-13.

UIP World Congress
4-8 February, 2018
Melbourne, Australia
www.uip2018.com

5/15/2017

Thank you for your kind attention

Canyon Lake, Arizona

nickmorrison2002@yahoo.com

5/15/2017

What’s new in RF ablation for Superficial
venous disease

Disclosure Statement of Financial Interest
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
•
•
•
•
•
•
•

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

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
Stroke

Annual U.S. Incidence
U.S. Prevalence

Cardiac Arrhythmias
Heart Valve Disease
0

Millions of patients

5/15/2017

Photos courtesy of Rajabrata Sarkar, MD, PhD.

Leading Competitors in the Venous insufficiency Treatment
Device Market

5/15/2017

Compression
Stockings

Pain & Bruising

Tumescent
Anesthesia

Thermal

Non-thermal

Radiofrequency Covidien

MOCA

Radiofrequency FP-system

Varythema

WSWL/HSLA Laser

Cyanoacrilate

Steam Ablation

Vblock*

VEnclose

Balloon Occlusion Sclerotherapy

5/15/2017

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 Cardiovasc Surg (Torino) 2008 Apri;49 (2)

5/15/2017

Van Den Bos R, Arends L, Kockbaert M, et al J Vasc Surg 2009, 49 230-239

Nesbit C, Eifel RK, Coyne P, Badi H et al

Kalluri R,

5/15/2017

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.

Predictors of Recanalization of the Great Saphenous Vein
in Randomized Controlled Trials 1 Year After Endovenous
Thermal Ablation
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,

5/15/2017

Product Features and Benefits
• 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
2.5
cm
10 cm
(default)

• Small 6F profile
• Flexible, steerable, and easy to navigate
• Fast product setup and generator start up

5/15/2017

Typical 40cm thigh GSV vein

5cm Tributary plus 40cm GSV

3cm element 3x, plus
3cm element 17x, total of
twenty 20-sec ablations

Medtronic ClosureFast™
catheter

7cm heating element, seven 20sec ablations

Venclose EVSRF™
catheter

10cm heating element, five 20-sec 2.5cm element 3x, plus
10cm element 5x, total of
ablations
eight 20-sec ablations


28% faster with Venclose



60% faster with Venclose

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