mechanico-chemical ablation - cox college...mechanico- chemical ablation (moca): non-thermal...
Post on 18-Jun-2020
7 Views
Preview:
TRANSCRIPT
6/1/2017
1
Mechanico-Chemical Ablation
ROBERT W. VORHIES, M.D., F.A.C.S.
VASCULAR AND ENDOVASCULAR SURGERY
ENDOVENOUS THERAPY AND VEIN AESTHETICS
FERRELL-DUNCAN CLINIC, COX HEALTH SYSTEMS
Cox Health Venous Symposium June 2-3, 2017
Non-thermal, Non-tumescent Venous Ablation Therapy
MOCA ?
Disclaimer
Descriptions of brand name devices will be used during this
presentation but do not imply endorsement of any particular
device.
Descriptions of billing codes are intended for reference only and
should not be used for actual clinical use. Please refer to your own
billing and collections departments for details.
You are to be commended if you have stayed through the entire
conference and still have the motivation to read this disclaimer all
the way to the finish.
6/1/2017
2
What is the problem?
Varicose veins are the
result of poorly selecting one’s
grandparents. -Sir William Osler, MD
What is the problem?
6
CEAP Classification for Chronic Venous Disorders
Images courtesy of Jennifer Heller, M.D.
C1: Telangiectasia or Reticular Veins
C2: Varicose Veins C3: Edema
6/1/2017
3
7
CEAP Classification for Chronic Venous Disorders
Images courtesy of Gordon Gibbs, M.D. and Jennifer Heller, M.D
C4a: Pigmentationor Eczema
C4b: Lipodermatoscleros
is or Atrophie
Blanche
C5: Healed Venous Ulcer
C6: Active Venous Ulcer
What are the solutions?
Conservative
Therapies
Exercise
Leg elevation
Compression stockings
Unna boot
Surgical Stripping
Phlebectomy
Thermal Ablation
Radiofrequency Ablation
Laser Ablation
9
1
0
Current Treatment Disadvantages
Thermal TherapiesSurgery
Manually removes the vein
segment from the leg
General anesthesia required
Long incision scar
Extended post procedure discomfort and wound care
2-3 weeks recovery
Compression stockings
Hyperpigmentation
Scarring
Endothermal heat-induced
thrombus (EHIT)
Hematoma
Thrombophlebitis
Nerve injury
Compression stockings
Zahn H. & Bush R. A review of the current management and treatment options for superficial venous insufficiency. World J Surg
(2014) 38:2580-2588 p.2584
6/1/2017
4
1
1
Complications of Thermal Ablation
Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons
(Veith Symposium) New York City; November 19, 2013
Complications1 Week(N=395)
3 Months(N=371)
1 Year(N=350)
5 Years(N=279)
Ecchymosis 5.8% 0.0% 0.0% 0.0%
Erythema 1.3% 0.0% 0.0% 0.0%
Hematoma 1.0% 0.3% 0.0% 0.0%
Infection 0.0% 0.0% 0.0% 0.0%
Pain 1.8% 0.0% 0.6% 0.0%
Paresthesia 1.5% 2.4% 0.3% 0.7%
1
2
More Recent Treatment Options
Non-thermal, Non-tumescent
Mechanochemical
Foam Sclerotherapy
Non-thermal, Non-tumescent, Non-sclerosant
Cyanoacrylate
adhesive
Chemical Ablation:
Ultrasound Guided Foam Sclerotherapy (UGFS)
6/1/2017
5
1
4
Polidocanol Endovenous Microfoam:
VANISH 2 Study
Patient-reported improvement in
symptoms, as measured by the
change from baseline to week 8 in the
7-day average VVSymQTM* score.
Primary Endpoints
Secondary Endpoints
Included the improvement in
appearance of varicosities from
baseline to week 8, as measured by
patients (using PA-V) and by a
physician review panel (IPR-V).
Improvement in VCSS, VEINES-QOL
and occlusion/reflux were also
assessed at week 8 as tertiary
endpoints.
Randomized, multi-center
Patients injected with polidocanol
endovenous microfoam (PEM)
232 patients were randomized
to:
Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of
polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013
Jul 17
Placebo
PEM 0.125%
125
58
PEM 1.0%
PEM 0.5%
6057
VANISH 2 Study – Results
Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol
endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17
10.5% 12.3% 5.0%Pain in extremity 15.5%
The most commonly reported adverse events in %:
Placebo PEM 0.125% PEM 0.5% PEM 1.0%
0 10.5% 11.7%Retained coagulum 27.6%
1.8% 7.0% 13.3%Thrombophlebitis
superficial
3.4%
0 0 0Deep vein thrombosis 8.6%
0 3.5% 3.3%CFVTE3 6.9%
0 0 1.7%Tenderness 6.9%
1.8% 59.6% 83.3%1Duplex responders
Placebo PEM 0.125% PEM 0.5% PEM 1.0%
86.2%2
Duplex ultrasound response at 8 weeks:
1 P < 0.05
2 P < 0.001 compared to PEM 0.125%
3 CFVTE – Common Femoral Vein Thrombus Extension. This is non-occlusive thrombi starting in the superficial vein and extending into
the common femoral vein (similar to EHIT).
1
6
VANISH 2 Study – Summary
Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of
polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013
Jul 17
Percentage of patients treated with the 1.0%
polidocanol solution experienced the following mild to moderate adverse events:
Experienced retained coagulum
(blood trapped in varicosities)
Reported pain
Experienced a DVT
15.5%
27.6%
8.6%
CFVTE 6.9%
Closure
Rate
Duration
86.20%
8 Weeks
6/1/2017
6
1
7
How do the VANISH 2 Study Results Compare to RFA?*
1 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques,
Horizons (Veith Symposium) New York City; November 19, 2013
2 Proebstle et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great
saphenous vein with or without treatement of calf varicosities. Journal of Vascular Surgery; 20113 Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of
polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology;
2013 Jul 17
*ClosureFast long-term data is shown for perspective only and not meant to imply that the data can be used in a head-to-head
comparison with the data from the Vanish 2 study.
VANISH 2 Study3Proebstle Study1,2
Multi-center Multi-center
326 patients 232 patients
99.6% occlusion at 6 months 87.9% occlusion at 8 weeks
90.0% occlusion at 5 years No data at 5 years
vs
Summary: UGFS
Non tumescent
Non thermal
Less effective
More side effects
Mechanico- Chemical Ablation (MOCA):
Non-thermal
Non-tumescent
MOCA combines mechanical damage to the endothelium of the
vein wall with the infusion of a sclerosant. (1)
1. van Eekeren, Doeke Boersma, Vincent Konijn, Jean Paul P. M. de Vries, and Michel M. J. P. Reijnen, Arnhem and Nieuwegein, The
Netherlands. “Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of
incompetent great saphenous veins.” J Vasc Surg 2013; 57: 445-50.
6/1/2017
7
MOCA Mechanical damage:
Promotes coagulation activation by minimal mechanical damage to the endothelium
Induces vasospasm that reduces the diameter of the vein,
Increases the action of sclerosant by an increase in surface.
Ensures an even distribution of the sclerosant at the endothelium.
Chemical Ablation
Liquid sclerosant produces irreversible damage to the venous endothelium.
Cellular membranes of the endothelium are damaged, creating endofibrosis.
This causes venous obliteration and thrombus development.
Damage of the endothelium depends on the concentration of sclerosant.
How does ClariVeinTM work?
ClariVeinTM
6/1/2017
8
How well does it work?
2
5
Mechanochemical Tumescentless Endovenous Ablation (MOCA): Elias Study
Safety (measured through adverse
events).
Closure rate at 6 months.
Primary Endpoints
Secondary Endpoints
Procedural pain, post procedural
pain, pain medication use, and
degree of ecchymosis.
Prospective, single-center
30 GSVs in 29 patients
Treated with ClariVeinTM*
catheter
Avg. diameter was
8.1mm
Avg. length of treated
segment was 37.5cm
Avg. total procedure time
was 14 minutes
Follow-ups were 1 week,
1 month, 3 months, and 6
months post-procedure
Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology
2012;27:67-72
*Trademark of its respective owner.
2
6
Elias Study – Results
Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology
2012;27:67-72
Closure
Rate
Duration
96.70%
260 days
6/1/2017
9
2
8
Summary of Clinical Efficacy
Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping
for great saphenous varicose veins. BJS 2011;98:1079-1087
Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72 Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith
Symposium) New York City; November 19, 2013
Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanolendovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17
2-8
Weeks
3-6
Months
1 Year 5 Years
0.9970.986
0.952
0.9
94.2%
0.967
87.9% 87.3%
82.5%
90.0%
97.5%
105.0%
Perc
ent
Occlu
sio
n
CLF
EVLA
MOCA
UGFS
What is the code for MOCA?
36473 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous,
mechanochemical; first vein treated
✚36474 subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
(Use 36474 in conjunction with 36473)
(Do not report 36474 more than once per extremity)
(Do not report 36473, 36474 in conjunction with
29581, 29582, 36000, 36002, 36005,
36410, 36425, 36475, 36476, 36478, 36479,
37241, 75894, 76000, 76001, 76937, 76942,
76998, 77022, 93970, 93971 in the same
surgical field)
(For catheter injection of sclerosantwithout concomitant endovascular mechanical disruption of the vein intima, use 37799)
(For catheter injection of an adhesive, use 37799)
Summary- MOCA
Non Thermal
Non Tumescent
Very few adverse side effects
Safe and efficacious
Reimbursement is available
6/1/2017
10
What else is coming out ?
3
3
Current Treatment Disadvantages
Thermal TherapiesSurgery
Manually removes the vein
segment from the leg
General anesthesia required
Long incision scar
Extended post procedure discomfort and wound care
2-3 weeks recovery
Compression stockings
Hyperpigmentation
Scarring
Endothermal heat-induced
thrombus (EHIT)
Hematoma
Thrombophlebitis
Nerve injury
Compression stockings
Zahn H. & Bush R. A review of the current management and treatment options for superficial venous insufficiency. World J Surg
(2014) 38:2580-2588 p.2584
3
4
Opportunities for Improvement
Elimination of:
Tumescent anesthesia
Post-procedure compression
stockings
Post-procedure pain and bruising
6/1/2017
11
Cyanoacrylate: Venaseal™
Non-tumescent
Non-thermal
Non-sclerosant
3
7
Safety of Cyanoacrylate Adhesives
Widely used medical tissue
adhesive.1
Antimicrobial effect against gram-
positive organisms.2
Used safely on millions of patients
with no reported carcinogenicity in
humans (1986 study).2
1 Lawson et al. Sapheon: the solution? Phlebology 2013, 28 Suppl 1:2-9, p3
2 Quinn J., Tissue Adhesives in Clinical Medicine, 2nd ed.(2005) p 34-35
3
9
Properties of Ideal Cyanoacrylate forVenous Closure
Ideal viscosity
Polymerize quickly
Soft and elastic
Maintains a strong
bond
Eliminate need for
compression stockings*
*Some patients may benefit from compression stockings post procedure.
6/1/2017
12
4
1
How does it work?
When cyanoacrylate (CA) comes in contact
with blood or plasma, it begins to
polymerize.
The body encapsulates the polymer as a
foreign body.
CA triggers inflammatory reaction in the
vessel wall resulting in occlusion.
Almeida J. et.al. Cyanoacrylate adhesive for the closure of truncal veins: 60 day swine model results. Vasc and Endovasc Surg
(2011) 000(00) 1-5. DOI 10.1177/1538574411413938 http://ves.sagepub.com p.1
4
2
Features of the VenaSeal™ Procedure
Eliminates need for
tumescent anesthesia.
No risk of thermal injury.
No post treatment
compression stockings
needed.1,2*
Rapid return to normal
activities.2
Procedure Features
1 Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein
incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014.
2 Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesive embolization with radiofrequency ablation for
treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology, 2014.*Some patients may benefit from compression stockings post procedure.
4
6
VeClose (U.S. pivotal trial)
1 No adjunctive treatments for 3 months
Study Design
Purpose
Closure Rates1
Prospective, randomized 1:1 comparing the VenaSeal™ system (VSCS) to RFA (ClosureFast™ catheter).
Demonstrate safety and effectiveness of the VenaSeal™
closure system (VSCS) for the treatment of lower extremity
truncal reflux by showing non-inferiority at three months to
RFA using the ClosureFast™ system.
3-Months:
RFA: 94.3%
VSCS: 98.9%
Gibson, K. A Randomized, Controlled Study Comparing Cyanoacrylate Adhesive Embolization With Radiofrequency Ablation For
Treatment Of Incompetent Great Saphenous Veins VeClose Study. German Society of Phlebology, 2014.
6-Months:
RFA: 94.3%
VSCS: 98.9%
6/1/2017
13
Summary: VenaSeal ™
Non Thermal
Non Tumescent
Non Sclerosant
Non compression stockings
Safe and effective
Very few adverse effects
No distinct coding reimbursement at this time.
Conclusions:
Thermal ablation is effective but has shortcomings that interfere with
complete patient satisfaction.
Safety and efficacy of ClariVein and VenaSeal is well supported,
ultrasound guided foam sclerotherapy is not.
Reimbursements are evolving to include these new techniques.
Eliminating heat and the need for tumescent anesthesia and
reducing or eliminating the need for compression stockings without
compromising procedural success is another promising advance in
the treatment of chronic venous diease.
References: Beebe-Dimmer Jl, Pfeifer JR, Engle, JS, et al. The Epidemiology of Chronic Venous Insufficiency and Varicose Veins. Ann Epidemiol. 2005;15(3):175-184.
Zahn H. & Bush R. A rev iew of the current management and treatment options for superficial venous insufficiency. World J Surg (2014) 38:2580-2588 p.2584
Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013
Todd KL 3rd, et. al. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of incompetence. Phlebology; 2013 Jul 17
Proebstle et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatement of calf varicosities. Journal of Vascular Surgery; 2011
van Eekeren, Doeke Boersma, Vincent Konijn, Jean Paul P. M. de Vries, and Michel M. J. P. Reijnen, Arnhem and Nieuwegein, The Netherlands. “Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical
endovenous ablation of incompetent great saphenous veins.” J Vasc Surg 2013; 57: 445-50.
Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72
Rasmussen et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. BJS 2011;98:1079-1087
Elias and Raines Mechanochemical Tumescentless Endovenous Ablation: Final Results of the Initial Clinical Trial. Phlebology 2012;27:67-72
Dietzek A. RF Segmental ablation: 5-year data. Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (Veith Symposium) New York City; November 19, 2013
Zahn H. & Bush R. A rev iew of the current management and treatment options for superficial venous insufficiency. World J Surg (2014) 38:2580-2588 p.2584
Quinn J., Tissue Adhesives in Clinical Medicine, 2nd ed.(2005) p 34-35
Lawson et al. Sapheon: the solution? Phlebology 2013, 28 Suppl 1:2-9, p3
Almeida J. et.al. Cyanoacrylate adhesive for the closure of truncal veins: 60 day swine model results. Vasc and Endovasc Surg (2011) 000(00) 1-5. DOI 10.1177/1538574411413938 http://ves.sagepub.com p.1
Almeida, J et al., Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014.
Gibson, K. A Randomized, controlled study comparing cyanoacrylate adhesive embolization with radiofrequency ablation for treatment of incompetent great saphenous veins VeClose study. German Society of Phlebology, 2014.
6/1/2017
14
51Venous Symposium Wrap Up
Chronic Venous Insufficiency and Varicose Veins are extremely common and remarkably under treated.
Evaluation of lymphedema, varicose veins, and venous disease in general, relies on listening carefully to the history, examining the extremities, and obtaining a thorough venous duplex ultrasound with reflux testing.
A multi-specialty approach, including conservative therapy, wound care, and procedures, is essential for the successful treatment of chronic venous disease and it’s complications.
Deep vein interventions and central venous pathology continue to be challenging, and Venous stasis ulcers require a lifelong commitment to maintenance compression therapy.
Overall, treatment modalities for venous disease have evolved tremendously and continue to improve the patient’s outcomes with less risk and less morbidity.
Summary-Venous Symposium
Overview
Robert Vorhies, MD
Anatomy and Physiology
John Waites, MD
Ultrasound Evaluations
Brent Wilkinson, RDMS
Conservative therapies
Julie Highfill, PA-C
Laura Ross, PA-C
Lymphedema
Jan Weiss, PT, DHS, CLT-LANA
Deep vein interventions
Randy Mullins, MD
Venous stasis and ulcers
John Waites, MD
Pelvic congestion
Randy Mullins, MD
Varicose vein procedures
Zak Schmittling, MD
Mechanico-Chemical Ablation
Robert Vorhies, MD
Thank you Planning Committee
Lisa Boyer
Triesa Massey
Kristen Richner
Bryan Wiliams
Becky Watts
Leah Cook
Steve Shoemaker
Cathy Adams
Julie Highfill
Laura Ross
Vascular Ultrasonographers
Brent Wilkinson
Lauren Tennison
Maddie Manes
Javona Killion
Steve Shoemaker
Vein Center Nursing staff
Sam Williams
Nina Mann
Kelley Everett
Brad Hampton
Kathryn Pallister
Tina Johnson
Kayla Scantlin
Vein Center Office staff
Sarah Myers
Lauren Chumbley
Marsha Maggi
Brittney Cook
Vein Center Office Nurses
Crystal Price
Cindy White
Glenda Bostic
Cassie Lawrence
Lori Davis
6/1/2017
15
2nd Annual
MAY 4-5,
2018
top related