Download National Medical Policy

National Medical Policy
Subject:
Varicose Veins Surgical Interventions
Policy Number:
NMP148
Effective Date*: September 2003
Updated:
July 2016
Please contact the Medical Policy Department for an archive of
this policy
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document
For Medicaid Plans: Please refer to the appropriate State’s Medicaid
manual(s), publication(s), citation(s), and documented guidance for
coverage criteria and benefit guidelines prior to applying Health Net
Medical Policies
The Centers for Medicare & Medicaid Services (CMS)
For Medicare Advantage members please refer to the following for coverage
guidelines first:
Use
X
Source
National Coverage Determination
(NCD)
National Coverage Manual Citation
Local Coverage Determination
(LCD)*
Article (Local)*
Other
None
Reference/Website Link
Treatment of Varicose Veins of Lower Extremity;
Noninvasive Peripheral Venous Studies;
Varicose Veins of Lower Extremities, Treatment
of:
http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
Noridian LCD 34182
Use Health Net Policy
Instructions
 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members
in ALL regions.
Varicose Vein Surgical Interventions Jul 16
1



Medicare LCDs and Articles apply to members in specific regions. To access your
specific region, select the link provided under “Reference/Website” and follow the
search instructions. Enter the topic and your specific state to find the coverage
determinations for your region. *Note: Health Net must follow local coverage
determinations (LCDs) of Medicare Administration Contractors (MACs) located
outside their service area when those MACs have exclusive coverage of an item
or service. (CMS Manual Chapter 4 Section 90.2)
If more than one source is checked, you need to access all sources as, on
occasion, an LCD or article contains additional coverage information than
contained in the NCD or National Coverage Manual.
If there is no NCD, National Coverage Manual or region specific LCD/Article,
follow the Health Net Hierarchy of Medical Resources for guidance.
Please note that prior authorization requirements for photographs differ
between regional Health Net plans
If photographs are required*:
1. Recent color photographic documentation of medium- (> 6mm or > ¼ inch in diameter) to
large-sized (> 10mm or > 3/8 inch in diameter) elongated, tortuous, superficial varicosities of
the branches (tributaries) of the saphenous veins must be provided; and
2. Recent color photographic documentation of the varicosities must be taken in the
Provider’s office under the provider’s direction and the picture must contain a ruler by the
varicosity to measure the size of the vessel, patient identification, and identify the body
location (e.g., right thigh, left ankle, etc.). If requests for subsequent procedures are
made (e.g., phlebectomy following EVLT), photos must be from at least 3 months
after the initial procedure.
Current Policy Statement
Health Net, Inc. considers surgical treatment medically necessary when the patient
has one or more medical complications attributed to the varicose veins AND the
criteria for selective treatments for varicose veins of the lower extremities are met:
Medical Complications Attributed To Varicosities
Health Net, Inc. considers one or more of the following medical complications
attributed to varicosities is documented in the patient’s medical record (for example,
sequential office visits over at least a 3 month period of time):
1. Persistent symptoms/signs severe enough to impair mobility or activities of daily
living (e.g., unable to walk or stand for periods of time necessary to fulfill
essential job functions, shopping, etc.), such as one or more of the following:




Discomfort, aching, throbbing, heaviness, and/or dull pain in the leg; or
Development of venous stasis dermatitis*; or
Lipodermatosclerosis**; or
Chronic painful edema as evidenced by a > 2 cm increase in circumference as compared to the contralateral leg; or
Varicose Vein Surgical Interventions Jul 16
2
NOTE - The term varicose vein disease does not apply to small (<3 mm
diameter) superficial reticular veins and/or telangiectasias (spider veins) or
CEAP classification <2. While abnormal in appearance, these veins typically
are not associated with any symptoms, such as pain or heaviness, and
their treatment is considered cosmetic in nature.
*Note - Venous stasis dermatitis is characterized by an itchy red, brown or purplish
rash on the lower legs which can be dry and scaly or can weep and form crusts and
is usually associated with indurated edema of the subcutaneous tissue.
**Note - Lipodermatosclerosis is characterized by inflammation and hardening of
the layer of fat underneath the skin (woody induration) associated with a brownish
discoloration to the skin which is typically bound down to the tissues just underneath
the skin making it look like an inverted champagne bottle.
2.
Severe venous insufficiency with nonhealing or recurrent venous stasis
ulceration; or

A trial of conservative therapy MAY include a trial of six weeks of
nonoperative management including, but not limited to walking,
avoidance of prolonged standing, frequent elevation of affected leg(s)
and use of compression stockings.
3.
More than one episode of minor hemorrhage from a ruptured superficial
varicosity OR a single significant hemorrhage from a ruptured superficial
varicosity, especially if transfusion of blood is required; or
4.
Two or more episodes of significant superficial thrombophlebitis OR persistent
superficial thrombophlebitis that is not responsive to > 4 weeks of conservative
therapy, including nonsteroid anti-inflammatory drugs (NSAIDS); and graduated
compression hosiery. Appropriate treatment of superficial thrombophlebitis
includes graduated compression hose, since most patients with this diagnosis
note less pain with support hose.
Selective Treatments for Varicose Veins
Saphenous Vein Ligation/Division/Stripping, VNUS, ELAS, Microfoam
Chemical Ablation (MCA)
Health Net, Inc. considers *Great Saphenous Vein or Small Saphenous Vein
ligation/division /stripping, endoluminal radiofrequency ablation (ERFA - also known
as VNUS Closure System) or endoluminal laser ablation of the saphenous vein (ELAS
- also known as endovenous laser treatment [EVLT]) or Endovenous Microfoam
medically necessary, in patients who meet all of the following:
1. The patient has a significant medical complication attributed to the varicosities as
stated above; and
2. Duplex scan or ultrasound (not a hand-held Doppler) with pretreatment mapping
of varicosities to document significant venous incompetence (i.e., insufficiency,
reflux) of any of the following:
o
The saphenofemoral junction;
Varicose Vein Surgical Interventions Jul 16
3
Great saphenous vein in the thigh;
saphenopopliteal junction;
The Small saphenous vein in the calf;
Perforators that remain incompetent only after ablation of the
incompetent saphenous system and all the following criteria are met:
 Perforator vein size is 3.5mm or greater; and
 Outward flow duration is ≥500 milliseconds; and
 Perforating vein is located underneath a healed or active
venous stasis ulcer (CEAP class C5-C6).
Note: There can be no justification for ablating perforators based on apparent
incompetence at the time of the original scan, since most of these “incompetent”
perforators will become competent following ablation of the incompetent saphenous
system.
o
o
The
The


3. Adequate patency of the deep veins of the leg is documented by duplex doppler
ultrasonography.
*Note: Endovenous ablation is a minimally invasive alternative to surgical ligation
and stripping for varicosities that occur as a result of Great or Small Saphenous Vein
reflux.
Endovenous laser ablation (EVLA), known as endovenous laser treatment (EVLT), or
endoluminal radio frequency ablation (ERFA), known as VNUS Closure System, are
forms of endovenous ablation.
It is considered inappropriate to do both ligation/division/stripping of the great or
short saphenous vein, as well as ablation on the same vein, during the same surgical
procedure.
Repeat Procedures:
Repeated procedures for venous ablation (i.e. VNUS, ELAS, etc.), performed more
than twice, on the same area of the same vein, in separate surgical procedures, are
considered not medically necessary.
Not Medically Necessary:
Health Net, Inc. considers the following not medically necessary:
1.
Saphenous vein ligation/division/stripping, VNUS, ELAS for asymptomatic,
unsightly varicose veins as this is cosmetic in nature.
Contraindications to saphenous vein ligation/division/stripping, VNUS, ELAS
include:
1.
2.
3.
4.
5.
6.
7.
8.
9.
During pregnancy and for 3 months after delivery (most times varicosities recede
after delivery)
Acute febrile illness
Local or general infection
Severe distal arterial occlusive disease (ankle-brachial index 0.4 or less)
Critical limb ischemia/arterial ulcer(s)/gangrene
Obliteration of deep venous system
Recent deep venous thrombosis
Acute deep venous thrombophlebitis or acute superficial thrombophlebitis.
General poor health/inability to ambulate
Varicose Vein Surgical Interventions Jul 16
4
10. Tortuosity of the Great saphenous vein severe enough to impede catheter
advancement
Primary Sclerotherapy/Ambulatory Stab Avulsion Phlebectomy/TIPP
(TriVex System)
We consider sclerotherapy using high dose sclerosants or foamed sclerosing agents,
ambulatory stab avulsion phlebectomy, or transilluminated powered phlebectomy
(TIPP - TriVex System) medically necessary when all of the following are met:
1. Duplex scan (not a hand-held Doppler) documents no significant
incompetence (i.e., insufficiency, reflux) of the saphenofemoral junction, the
saphenopopliteal junction, the Great saphenous vein in the thigh and/or the
Small saphenous vein;
2. Adequate patency of the deep veins of the leg is documented by duplex
doppler ultrasonography;
3. The patient has a significant medical complication attributed to the
varicosities as stated above.
Note: Sclerotherapy sessions usually last about 30 to 60 minutes depending on the
patient, the extent of the condition and the strength of the sclerosing solution. Best
results tend to be seen with at least 3 to 5 treatment sessions performed about 2
weeks apart.
Post-Procedural Sclerotherapy/Ambulatory Stab Avulsion
Phlebectomy/TIPP (TriVex System)
Health Net, Inc. considers sclerotherapy using high dose sclerosants or foamed
sclerosing agents, ambulatory stab avulsion phlebectomy, or transilluminated
powered phlebectomy (TIPP - TriVex System) medically necessary when all of the
following are met:
1. Patient has had an initial successful procedure to eliminate reflux at the
saphenofemoral junction (saphenous vein ligation/division/stripping, VNUS,
ELAS);
a. Note: Very recent studies have shown that obliteration of the primary
source of incompetence at the saphenofemoral junction results in
spontaneous regression of residual varicose veins in the leg with
resolution of symptoms such that most patients can forego
postadjunctive definitive treatment using sclerotherapy, stab avulsion
phlebectomy, or TIPP. At this time, there is sufficient evidence in the
peer-reviewed medical literature to support a postprocedural delay for
at least 3 months at which time the patient can be reassessed for
subsequent treatment for persistently symptomatic veins. A trial of
conservative management is unlikely to be successful in this situation.
2. Adequate patency of the deep veins of the leg is documented by duplex
doppler ultrasonography; or
3. The patient has a significant medical complication attributed to the
varicosities as stated above
Investigational
Varicose Vein Surgical Interventions Jul 16
5
Health Net, Inc. considers the following investigational, because although there are
ongoing studies, the results are not conclusive, and additional peer-reviewed studies
are necessary:
1.
Additional injections of sclerotherapy for documented recanalization or failure of
vein closure, as symptomatic improvement is the primary goal and indicator of a
satisfactory outcome.
2.
Mechanicochemical ablation (MOCA) (Eg. ClariVein Occlusion Catheter,
Nonthermal Vein Ablation System).
3.
VenaSeal Closure System (i.e., uses cyanoacrylate embolization [CAE])
Not Medically Necessary:
Health Net, Inc considers the following not medically necessary, since there are no
ongoing studies to support them:
1.
Sclerotherapy in patients with asymptomatic varicose veins because this is
considered cosmetic in nature; or
2.
Sclerotherapy in the presence of reflux anywhere in the proximal great or small
saphenous veins, not just at the junction; or
3.
Sclerotherapy for the treatment of secondary varicose veins resulting from deep
vein thrombosis or arteriovenous fistulae; or
4.
Sclerotherapy of the anterior accessory saphenous vein in patients with
documented reflux. (It is not uncommon for patients to have reflux isolated to
the anterior accessory saphenous vein without involvement of the great
saphenous vein itself); or
5.
The COMPASS procedure, an acronym for comprehensive objective mapping,
precise image guided injection, antireflux positioning and sequential
sclerotherapy, represents a distinct sclerotherapy protocol for the treatment of
saphenofemoral valvular incompetence of the Great or Small saphenous venous
system; or
6.
All of the following treatments of small (< 3mm) superficial reticular veins,
superficial dermal spider veins (telangiectasias < 1mm in diameter) and reticular
veins (blue veins < 2mm in diameter) because these veins do not have any
significant negative health impact, and their treatment is considered cosmetic in
nature:






Sclerotherapy
Laser therapy/flash lamp therapy
Transdermal Nd:YAG laser
Photothermal sclerosis (also referred to as an intense pulsed light
source, e.g., the PhotoDerm, VeinLase, VascuLight)
Cryosurgery
Pinpoint electrocauterization ("electric needle”)
Contraindications to sclerotherapy include:
1. During pregnancy and for 3 months after delivery (most times varicosities
recede after delivery)
Varicose Vein Surgical Interventions Jul 16
6
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Patients who are breast feeding
Severe lymphedema
Acute febrile illness
Local or general infection
Severe distal arterial occlusive disease (ankle–brachial index 0.4 or less)
Critical limb ischemia
Obliteration of deep venous system
Recent deep venous thrombosis
Acute deep venous thrombosis or acute superficial thrombophlebitis;
Allergy to sclerosant
Advanced collagen vascular disease
General poor health/inability to ambulate.
Subfascial Endoscopic Perforator Vein Surgery (SEPS)
Health Net, Inc. considers subfascial endoscopic perforator vein surgery (SEPS) for
the treatment of advanced chronic venous insufficiency (CVI) secondary to primary
valvular incompetence (PVI) of perforating veins medically necessary when
conservative management has failed and the patient has any of the following:
1. Lipodermatosclerosis (see definition above); or
2. Healed or active ulceration on the medial aspect of the lower leg (limbs with
lateral ulcerations should be managed by open interruption of lateral or posterior
perforators where appropriate)
Absolute contraindications include:
1. Severe associated arterial occlusive disease
2. Infected ulcer
3. A medically high-risk patient
Relative contraindications include:
1. Diabetes
2. Renal failure
3. Liver failure
4. Morbid obesity
5. Ulcers in patients with rheumatoid arthritis or scleroderma
6. Presence of deep venous obstruction at the level of the popliteal vein or higher
on preoperative imaging
7. Circumferential large ulcers
8. Recent DVT
9. Severe lymphedema
10. A nonambulatory patient
Varicose Vein Surgical Interventions Jul 16
7
Definitions
CVD
CVU
UGFS
NS
GSV
SSV
PTPV
IPV
IPVA
GSVA
PA
ICPV
RCT
RFA
MOCA
Chronic venous diseases
Chronic venous ulcer
Ultrasound-guided foam sclerotherapy
Not significant
Great saphenous vein
Small saphenous vein
Perforator posterior tibial veins
Incompetent perforating veins
Incompetent perforating vein ablation
Great saphenous vein ablation
Perforator ablation
Incompetent perforating veins
Randomized controlled trial
Radiofrequency ablation
Mechanicochemical ablation
Codes Related To This Policy
NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in
this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and
medical necessity criteria. This list of codes may not be all inclusive.
On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and
inpatient procedures have been replaced by ICD-10 code sets.
ICD-9 Codes
448.0448.1
448.9
454
454.0
454.1
454.2
454.9
459.10459.19
459.81
Hereditary hemorrhagic telangiectasia
Nevus, non-neoplastic
Other and unspecified capillary diseases
Varicose veins of the lower extremities (excludes that complicating
pregnancy, childbirth, or the puerperium)
Varicose veins of the lower extremities, with ulcer
Varicose veins of the lower extremities, with inflammation
Varicose veins of the lower extremities, with ulcer and inflammation
Asymptomatic varicose veins
Postphlebetic syndrome without complications - Postphlebetic syndrome
with complications
Venous insufficiency, unspecified
ICD-10 Codes
I78.0-I78.9
Disease of capillaries
I83.001-I83.93
Varicose veins of lower extremities
I87.001-I87.9
Other disorders of veins
CPT Codes
36468
36469
Sngl/Mx Inj Sclerosing solutions, spider veins (telangiectasia); limb or
trunk
Sngl/Mx Inj Sclerosing solutions, spider veins; face (Code deleted in
Varicose Vein Surgical Interventions Jul 16
8
36470
36471
36475
36476
36478
36479
37700
37718
37722
37735
37760
37761
37765
37766
37780
37785
37799
93965
93970
93971
2014)
Injection of sclerosing solution; single vein (should be used when only one
vein is injected on a given date of service)
Injection of sclerosing solution; multiple veins, same leg (should be used
when multiple veins in the same leg are injected on a given date of
service)
Endovenous ablation therapy of incompetent vein, extremity, inclusive of
all imaging guidance and monitoring, percutaneous, radiofrequency; first
vein treated
; second and subsequent veins treated in a single extremity, each through
separate access sites
Endovenous ablation therapy of incompetent vein, extremity, inclusive of
all imaging guidance and monitoring, percutaneous, laser; first vein
treated
; second and subsequent veins treated in a single extremity, each through
separate access sites
Ligation and division of long saphenous vein at saphenofemoral junction,
or distal interruptions
Ligation/Division/Stripping, short Saphenous Vein
Ligation/Division/Strip-long (Great) Saphenous Vein
Ligation and division and complete stripping of long or short saphenous
veins with radical excision of ulcer and skin graft and/or interruption of
communicating veins of the lower leg, with excision of deep fascia
Ligation of perforators, subfascial, radical (Linton type), with or without
skin graft, open
Ligation of perforator vein(s), subfascial, open, including ultrasound
guidance, when performed, 1 leg
Stab Phlebectomy of varicose veins; 1 Extremity; 10-20 Stab Incisions
Stab Phlebectomy of varicose veins; 1 Extremity; more than 20 incisions
Ligation and division of short saphenous vein at saphenopopliteal junction
(separate procedure)
Ligation, division, and/or excision of recurrent or secondary varicose veins
(clusters), one leg
Unlisted procedure, vascular surgery (May be used for VNUS and ELAS)
Non-invasive physiologic studies of extremity veins, complete bilateral
study (e.g., Doppler waveform analysis with responses to compression
and other maneuvers, phleborheography, impedance plethysmography)
Duplex scan of extremity veins including responses to compression and
other maneuvers; complete bilateral study
Duplex scan of extremity veins including responses to compression and
other maneuvers; unilateral or limited study
HCPCS Codes
N/A
Scientific Rationale – Update February 2016
Embolotherapy or embolization has developed in recent years and now represents a
part of interventional radiology practice. Embolotherapy is the percutaneous
endovascular application of one or more of a variety of agents or materials to
accomplish vascular occlusion.
Medical conditions treated by using embolization can be grouped as follows:
Varicose Vein Surgical Interventions Jul 16
9
1.
2.
3.
Vascular anomalies (eg, AVM, AVF, venous malformation [VM], lymphatic
malformation [LM], and hemangioma), occlusion of congenital or acquired
aneurysms (eg, cerebral, visceral, extremities), pseudoaneurysms.
Hemorrhage (eg, pseudoaneurysms and GI tract, pelvic, posttraumatic,
epistaxis, and hemoptysis bleeding)
Other conditions (eg, tumors, varicoceles, and organ ablation)
In the 'Guidelines for Peripheral and Visceral Vascular Embolization Training' (2010),
and in Medscape (2015) there is a section on 'Vascular Lesion Embolization Imaging',
and neither mentions vascular embolization for varicose veins. There are no specific
Clinical Trials on vascular embolization for varicose veins.
The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF)
guidelines for the care of patients with varicose veins and associated chronic venous
diseases provided a Grade 2B recommendation in favor of coil embolization, plugs, or
transcatheter sclerotherapy for treatment of pelvic congestion syndrome (PCS). A
Grade 2B recommendation is defined as a weak recommendation based on medium
quality evidence.
VenaSeal Closure System received FDA pre-market approval on February 20, 2015
to permanently treat varicose veins of the legs by sealing the affected superficial
veins using an adhesive agent. This system uses cyanoacrylate embolization (CAE)
and does not require tumescent anesthesia. A cyanoacrylate adhesive is injected into
the vein via a catheter inserted through the skin under ultrasound, the vein is
compressed, and the adhesive material changes into a solid to seal the varicose vein.
Although this modality has been approved or cleared for marketing by the FDA, peer
reviewed evidence supporting it is minimal. Morrison et al. (2015) published the
early results of a RCT evaluating CAE, using the VenaSeal Closure System (n=108)
versus radiofrequency ablation (n=114) for the treatment of varicose veins. The
study’s primary endpoint was closure of the target vein at month 3 as assessed by
duplex ultrasound. Statistical testing focused on showing non-inferiority with a 10%
delta conditionally followed by superiority testing. By use of the predictive method
for imputing missing data, 3-month closure rates were 99% for CAE and 96% for
RFA. All primary end point analyses, which used various methods to account for the
missing data rate (14%), showed evidence to support the study’s non-inferiority
hypothesis (all P < .01). Some of the analyses supported a trend toward superiority
(P = .07 in the predictive model). Pain experienced during the procedure was mild
and similar between treatment groups (2.2 and 2.4 for CAE and RFA, respectively,
on a 10-point scale; P = .11) and there was less ecchymosis in the treated region on
day 3 following CAE compared with RFA (P < .01). In the authors opinion, CAE was
non-inferior to RFA for the treatment of incompetent great saphenous veins (GSVs)
at three month follow-up. The authors noted the results will be monitored for 3 years
to determine long-term success rates, rates of recanalization, and chronic venous
disorder (CVD) progression.
Scientific Rationale – Update January 2016
Traditionally, foam sclerosants used for the treatment of varicose veins are
physician-compounded agents created at the time of treatment. The liquid
sclerosant (polidocanol or sodium tetradecyl sulphate [STS]) is mixed with room air,
which has a nitrogen content of approximately 78%. Issues with these homemade
compounds include lack of standardization and dosage as well as other factors that
can affect the quality of the foam sclerosant as the optimal protocol for preparation
and administration.
Varicose Vein Surgical Interventions Jul 16
10
Sclerotherapy performed with manually created foam was shown to be generally
safe; however, it was associated with rare but serious complications such as
pulmonary emboli (PE) and neurologic complications, especially in patients with a
patent foramen ovale (PFO). These issues led to the development of standardized
polidocanol microfoam for use in endovenous procedures for ablating varicosities.
Varithena™ (previously known as Varisolve, BTG PLC, London) was approved by the
FDA in November 2013) for the treatment of patients with incompetent veins and
visible varicosities of the great saphenous vein (GSV) system above of below the
knee.
Varithena is a proprietary microfoam-generating canister that delivers a 1% solution
of polidocanol with a controlled density. The concentration of nitrogen is very low,
the gas mixture is physically resolvable, and the bubble size is uniform. The
concentration of Varithena in the systemic circulation is clinically insignificant, and
the drug was not associated with neurological adverse events (AEs) or PEs in clinical
trials. It is administered on an outpatient basis by a vascular surgeon or other
qualified physician who has received training. Local anesthetic may be used at the
access site, but tumescent anesthesia is not required. To treat a varicosity, the vein
is compressed distal to the access site and the foam is injected under ultrasonic
guidance. If needed, additional treatment sessions may be performed at intervals of
5 days. Compression bandages are used for 2 weeks after treatment.
HAYES (2015) reported on a search of the literature that identified 4 studies
including 2 randomized controlled trials (RCTs); 1 cross-sectional study; and 1
prospective uncontrolled study that evaluated the efficacy and safety of Varithena
standardized 1% polidocanol foam, or its precursor Varisolve, for treatment of
symptomatic ultrasound (US)-confirmed varicose veins. The studies included 82 to
710 patients and had follow-up times of 28 days, 8 weeks (reported thus far of a
planned 5 years), and 12 months. All of the studies received manufacturer funding
and/or one or more authors had a financial relationship with the company. Outcomes
in the RCTs included US-confirmed venous occlusion and elimination of reflux,
perioperative pain, symptom reduction, return to normal activities, and
complications. The 2 uncontrolled studies evaluated the incidence of cerebral bubble
embolization and neurological complications in patients undergoing endovenous foam
sclerotherapy with Varisolve.
In a multicenter phase III RCT, Wright et al. (2006) compared the safety and
efficacy of Varisolve (1% polidocanol microfoam sclerosant) with alternative
treatments in 710 adults with incompetence of the GSV or SSV with reflux for > 1
second and < 7 seconds on duplex US. The study was designed to assess the
noninferiority of Varisolve to alternative treatments. After clinical assessment,
patients were assigned to 2 treatment cohorts: surgery or sclerotherapy. Within each
of these 2 cohorts, patients were then randomized in a 2:1 allocation to receive
Varisolve or the alternative treatment. The 2 independently randomized cohorts
(Varisolve/surgery and Varisolve/sclerotherapy) were analyzed separately.
Alternative treatments were not further specified; surgeons could treat patients
randomized to alternative treatment with any surgical procedure or sclerosant.
Patients treated with Varisolve used compression stockings for 14 days after
treatment and were advised to walk hourly.
In the Varisolve/surgery cohort, there were 178 patients treated with Varisolve and
94 with surgery. In the Varisolve/sclerotherapy cohort, there were 259 patients
Varicose Vein Surgical Interventions Jul 16
11
treated with Varisolve and 125 with sclerotherapy. Across both cohorts, the mean
age of patients treated with Varisolve was 50.4 ± 12.4 years and 67.5% were
women. Most had primary disease of the GSV (70.9%) and had C2 disease (74.8%).
There were some differences in the severity of the venous diseases based on CEAP
classification. Outcomes were assessed at 3 months and at one year. The primary
endpoint was occlusion of the vein at 3 months and elimination of reflux as
determined by duplex US. A responder was defined as occlusion (or for surgery,
absence of the vein) and absence of junctional reflux. Secondary endpoints were
perioperative pain (days 1 to 6 assessed by a VAS), time to return to normal
activities, number of treatment sessions required, and response rates at 1 year.
At 3 months, in both cohorts combined, 83.4% of the Varisolve group responded
(i.e., showed venous occlusion and elimination of reflux) versus 88.1% of the
controls who had standard sclerotherapy or surgery. At 1 year, the response rate
was 78.9% of the Varisolve group versus 80.4% of surgery/sclerotherapy group.
Varisolve was deemed to be noninferior to alternative treatments. However, in the
Varisolve versus surgery cohort, surgery was more efficacious than Varisolve at 3
months (87.2% versus 68.2%) and at 1 year (86.2% versus 63.1%). In the
Varisolve/sclerotherapy cohort, Varisolve demonstrated noninferiority compared with
sclerotherapy at 3 months (93.8% versus 88.8%) and at 1 year (89.6% versus
76.0%) (P<0.001). At 3 months in the Varisolve/surgery cohort, Varisolve was
significantly less painful than surgery (P<0.01) and the time to resumption of normal
activities was shorter (P<0.01). There were no differences in these outcomes for
Varisolve versus sclerotherapy.
The incidences of DVT were 2.5% in patients treated with Varisolve, 0.8% in those
treated with sclerotherapy, and 0% in the surgery group. No patient had a PE. The
most common adverse events in the Varisolve group were mild contusion (62.9%),
skin discoloration (49.7%), and limb pain (34.3%). Transient neurological symptoms
observed within 24 hours of treatment included paresthesias and visual and speech
disorders.
Several limitations were noted in this study. In the alternative treatment arms,
treatments were not further specified, so the treatments were heterogeneous. Most
patients in the surgery arm were treated with high ligation and stripping rather than
more contemporary endovenous thermal procedures. Patients in the alternative
sclerotherapy arm were treated with a variety of sclerosants and the method of
administration and preparation of the foam was not standardized.
The authors concluded that Varisolve was non-inferior to alternative treatments as it
caused less pain and patient returned to normal more quickly, though surgery was
more efficacious in the long term.
Todd, et al. (2014) reported on a RCT (VANISH-2) to determine efficacy and safety
of polidocanol endovenous microfoam in treatment of symptoms and appearance in
patients with saphenofemoral junction incompetence due to reflux of the great
saphenous vein or major accessory veins. Patients were randomized equally to
receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam
1.0% or placebo. The primary efficacy endpoint was patient-reported improvement
in symptoms, as measured by the change from baseline to Week 8 in the 7-day
average electronic daily diary VVSymQ™ score. (VVSymQ™ score is a patientreported outcome measure of varicose vein symptom burden). The co-secondary
Varicose Vein Surgical Interventions Jul 16
12
endpoints were the improvement in appearance of visible varicosities from baseline
to Week 8, as measured by patients and by an independent physician review panel.
The authors reported that in the 232 treated patients, polidocanol endovenous
microfoam 0.5% and polidocanol endovenous microfoam 1.0% were superior to
placebo, with a larger improvement in symptoms VVSymQ (-6.01 and-5.06,
respectively, versus -2.00; P < 0.0001) and greater improvements in physician and
patient assessments of appearance (P < 0.0001). These findings were supported by
the results of duplex ultrasound and other clinical measures. Of the 230 polidocanol
endovenous microfoam-treated patients (including open-label patients), 60% had an
adverse event compared with 39% of placebo; 95% were mild or moderate. No
pulmonary emboli were detected and no clinically important neurologic or visual
adverse events were reported. The most common AEs in patients treated with 1%
polidocanol were retained coagulum (27.6%), leg pain (17.2%), and DVT (8.6%).
Most AEs were related to treatment and resolved without sequelae. Most thrombi
were small; 50% of patients with thrombi were managed with anticoagulation, and
others with nonsteroidal anti-inflammatory drugs or compression and observation.
The median time to resolution of thrombi was 29 days.
The authors concluded that polidocanol endovenous microfoam provided clinically
meaningful benefit in treating symptoms and appearance in patients with varicose
veins. Polidocanol endovenous microfoam was an effective and comprehensive
minimally invasive treatment for patients with a broad spectrum of vein disease
(clinical, etiology, anatomy, pathophysiology clinical class C2 to C6) and great
saphenous vein diameters ranging from 3.1 to 19.4 mm. Treatment with polidocanol
endovenous microfoam was associated with mild or moderate manageable side
effects.
The 2 uncontrolled studies evaluated the incidence of cerebral bubble embolization in
patients undergoing endovenous foam sclerotherapy with Varisolve (Wright et al.,
2010; Regan et al., 2011).
In the Wright et al (2010) study, among 221 patients, 130 (58.8%) were found to
have a shunt, indicating a higher prevalence of patent foramen ovale (PFO)
compared with the general population. Of the 82 patients treated with Varisolve, 61
of whom had a shunt, evidence of bubble emboli in the MCA was observed in more
patients with than without a shunt (89% versus 29%) although no patients had signs
or symptoms of cerebral embolization. The authors noted that the high prevalence
of R-L shunt in patients with GSV incompetence is clinically significant since these
patients may be at risk of cerebral bubble embolization during foam sclerotherapy
and also note that additional studies are needed to better characterize the outcomes
of patients with shunts following foam sclerotherapy. This study is limited by the lack
of reporting of outcomes data regarding the varicosities and the lack of follow-up
after Varisolve therapy.
Regan et al. (2011) evaluated the efficacy and safety of polidocanol 1% endovenous
microfoam (Varisolve) in 82 patients with SFJ incompetence and GSV reflux (≥ 1.0
second) with symptomatic venous disease recruited from 5 centers. The incidence of
neurological complications in 82 patients undergoing treatment with Varisolve was
evaluated and showed that despite the presence of bubble emboli in the MCA of 60
patients, no changes occurred in brain MRI scans, and none of these shunt-positive
patients had new neurological signs or symptoms after Varisolve therapy despite the
Varicose Vein Surgical Interventions Jul 16
13
presence of bubble emboli (Regan et al, 2011). In these patients, complete occlusion
of the GSV occurred in 71 (88%) and elimination of reflux in 73 (90%) by day 28.
Common adverse events included mild contusion, hyperpigmentation, skin
discoloration, skin inflammation, limb pain, coagulum, superficial thrombophlebitis,
and ecchymosis. Migraine, deep vein thrombosis (DVT), and PE were reported but
were uncommon.
Preliminary evidence from these studies suggests that US-guided endovenous foam
sclerotherapy using Varithena may be efficacious for treating symptomatic varicose
veins; however, additional studies are needed for confirmation and the optimal
patient selection criteria have not been established. According to HAYES, the quality
of the overall evidence is low. There is a paucity of published evidence on the
efficacy of Varithena and the available studies are short in duration, lack
comparisons with other minimally invasive therapies for varicose veins, and are
supported by the manufacturer.
Proebstle et al. (2015) reported 5-year results of a prospective European multicenter
cohort study on radiofrequency segmental thermal ablation (RFA) for incompetent
great saphenous veins ( GSVs) using a catheter with an integrated heating element.
A total of 225 subjects had 295 GSVs treated with RFA. At 5 years post treatment,
177 subjects with 236 treated limbs completed follow-up exams for a study
completion rate of 78.7%. Varicose veins were present in 98.6% of legs at baseline
with 52.2 originating from the GSV. At 3 months post treatment, only 15.2% of the
treated limbs had varicose veins present. The number of legs with varicose veins
increased to 40.7% at 5 years. An initial vein occlusion rate of 100% was reported.
Kaplan-Meier analyses showed a GSV occlusion rate of 91.9% and a reflux-free rate
of 94.9% at 5 years. Among the 15 GSVs noted with reflux at follow-up, only 3
showed full recanalization of the GSV at 1 week, 6 months and 3 years. Of the 12
legs with partial recanalization, reflux originated at the saphenofemoral junction in
10, with a mean length of the patent segment of 5.8 cm; only 6 subjects were
symptomatic. A total of 192.4 of the treated limbs were reported to be pain-free at
the 5-year follow-up visit. Retreatment was required in 15.3% by 5 years. The
authors concluded that comprehensive follow-up for other methods to 5 years are
required to establish the optimal treatment for varicose veins.
Scientific Rationale – Update January 2015
Samuel et al. (2013) Patients with unilateral, primary saphenopopliteal junction
incompetence and SSV reflux were randomized equally into parallel groups receiving
either surgery or EVLA. Patients were assessed at baseline and weeks 1, 6, 12, and
52. Outcomes included successful abolition of axial reflux on duplex, visual analog
pain scores, recovery time, complication rates, Venous Clinical Severity Score, and
quality of life profiling. A total of 106 patients were recruited and randomized to
surgery (n = 53) or EVLA (n= 53). Abolition of SSV reflux was significantly higher
after EVLA (96.2%) than surgery (71.7%) (P<0.001). Postoperative pain was
significantly lower after EVLA (P<0.05), allowing an earlier return to work and
normal function (P<0.001). Minor sensory disturbance was significantly lower in the
EVLA group (7.5%) than in surgery (26.4%) (P = 0.009). Both groups demonstrated
similar improvements in Venous Clinical Severity Score and quality of life.
EVLA produced the same clinical benefits as conventional surgery but was more
effective in addressing the underlying pathophysiology and was associated with less
Varicose Vein Surgical Interventions Jul 16
14
periprocedural morbidity allowing a faster recovery. (Registration number:
NCT00841178.).
Scientific Rationale – Update January 2014
The ClariVein Infusion Catheter received marketing clearance through the 510(k)
process in 2008 (K071468). It is used for mechanochemical ablation. Predicate
devices were listed as the Trellis Infusion System (K013635) and the Slip-Cath
Infusion Catheter (K882796). The system includes an infusion catheter, motor drive,
stopcock and syringe and is intended for the infusion of physician-specified agents in
the peripheral vasculature.
The ClariVein Infusion Catheter, also known as the ClariVein-IC, is an endovascular
catheter system used for the treatment of peripheral venous reflux disease. This
device is introduced percutaneously into the vein under ultrasound guidance, and the
tip is positioned near the saphenofemoral junction. Infusion is through an opening at
the distal end of the catheter and fluid delivery is enhanced by the use of a rotating
dispersion wire to mix and disperse the infused fluid in the blood stream and on the
vessel wall. This wire, connected to a cartridge for connection to the motorized
handle, extends through the catheter lumen. Prior to drug infusion the catheter
sheath is inserted into the vasculature and once the catheter tip is positioned at the
treatment site, the sheath is retracted to expose the dispersion wire tip. Wire
rotation is controlled by a 9 Volt DC motorized Handle Unit. This handle unit provides
a grip and syringe holder to facilitate physician-controlled infusion.
Per NICE (2013) information on ‘Endovenous mechanochemical ablation for varicose
veins’ was noted and included the following information:
“Varicose veins are veins that have become wider than normal and are unable
to transport blood properly so that blood collects in them. This can cause
heaviness, aching, throbbing, itching, cramps and fatigue in the legs. In severe
cases, patients may develop skin discoloration or inflammation, and skin ulcers.
In endovenous mechanochemical ablation (Eg. ClariVein Occlusion Catheter), a
tube with a rotating hollow wire at its tip is inserted into the affected vein in the
leg. As the tube is pulled back out of the vein, the wire is rotated, damaging the
lining of the vein. At the same time, a chemical is injected through the hollow
wire into the vein. This causes the varicose vein to become inflamed, then
shrivel and close”.
The NICE guidance noted above does not cover whether or not the NHS should
fund a procedure. Decisions about funding are taken by local NHS bodies
(primary care trusts and hospital trusts) after considering how well the
procedure works. NICE has produced this guidance because the procedure is
quite new. This means that there is not a lot of information yet about how well
it works, how safe it is and which patients will benefit most from it.
Kendler et al. (2013) completed a study regarding endovenous treatment modalities
that are used to treat varicose veins. The ClariVein catheter is a new endoluminal
mechanico-chemical obliteration technique which can be used without tumescent
anesthesia. It is still unclear what changes the mechanical tip of the catheter has on
the walls of the vein. Five great saphenous vein specimens were obtained
atraumatically by crossectomy. Then the veins were treated ex vivo with the
ClariVein catheter without sclerotherapy. The activated catheter rotating tip (3 500
U/min) was steadily withdrawn at 1-2 mm per second. Subsequently, histological
Varicose Vein Surgical Interventions Jul 16
15
and immunohistochemical investigations of treated (cv) and untreated specimens
(plain) were performed. A 4-point score was calculated to compare the results.
The mechanical part of the catheter caused a subtle incomplete destruction of the
endothelium (endothelium cv: 2.2 vs. plain: 1, p = 0.04). Changes in the media or
adventitia were not seen. Immunohistochemical presentation of the endothelium of
the intima was demonstrated with antibodies against CD31 (cv: 3.4 vs. plain: 2.8),
CD34 (cv: 3.8 vs. plain: 3.2) and factor VIII (cv: 2.2 vs. plain: 1, p = 0,004).
The mechanical part of the ClariVein catheter caused a subtle incomplete destruction
of endothelium, which was confirmed histologically and immunohistochemically. The
reduced expression of factor VIII in the treated vein could be caused by the release
of preformed factor VIII granules due to the minimal mechanical irritation.
Boersma et al. (2013) completed a prospective cohort study that evaluated the
feasibility, safety and 1-year results of mechanochemical endovenous ablation
(MOCATM) of small saphenous vein (SSV) insufficiency. Fifty consecutive patients
were treated for primary SSV insufficiency with MOCATM using the ClariVein device
and polidocanol. Initial technical success, complications, patient satisfaction and
visual analogue scale (VAS) pain score were assessed. Anatomic and clinical success
was assessed at 6 weeks and at 1 year. Initial technical success of MOCATM was
100%. At the 6-week assessment, all treated veins were occluded. The 1-year
follow-up duplex showed anatomic success in 94% (95% confidence interval, 0.871). Venous clinical severity score (VCSS) decreased significantly from 3.0
(interquartile range (IQR) 2-5) before treatment to 1.0 (IQR 1-3, P < 0.001) at 6
weeks and to 1.0 (IQR 1-2, P < 0.001) at 1 year. Median procedural VAS score for
pain was 2 (IQR 2-4). No major complications were observed, especially no nerve
injury. MOCATM is proposed as a safe, feasible and efficacious technique for
treatment of SSV insufficiency. One-year follow-up shows a 94% anatomic success
rate and no major complications. However, although the results of this study are
promising, it only included 50 patients with a 1-year follow-up, with no comparison
to other techniques. Additional, larger, comparative studies are needed with longer
follow-up periods to assess the long-term safety and efficacy of this technique.
Elias et al. (2012) reported an industry-sponsored safety and efficacy study of the
ClariVein system. Thirty greater saphenous veins in 29 patients were treated with
this device. Greater saphenous veins with diameters greater than 12 mm were
excluded. In this series 77% of veins were Clinical, Etiology, Anatomy, Physiology
(CEAP) class 2 with 7% in class 3 (i.e., varicose veins and edema) and 16% in class
4a (i.e., varicose veins with skin changes). At 6-month follow-up 1 vein had
recanalized, for a primary closure rate of 96.7%. No pain or adverse events during
the procedure were reported. Controlled studies with longer follow-up are needed.
There is a Clinical Trial on ‘Early Outcome of Mechanochemical Endovenous Ablation
(ClariVein-2)’, which is ongoing but not currently recruiting participants. This was
last updated on September 2, 2013, with the clinicaltrials.gov identifier of
NCT0145263. Mechanochemical endovenous ablation is a new tumescent-less
technique, that combines mechanical endothelial damage using a rotating wire with
the infusion of a liquid sclerosant. The current study aims at evaluating short and
long term outcome after mechanochemical endovenous ablation. The estimated
primary completion date is December 2017.
Scientific Rationale – Update November 2012
Perforating veins connect the superficial to the deep venous system. They pass
through the deep fascia that separates the superficial compartment from the deep.
Varicose Vein Surgical Interventions Jul 16
16
An association between incompetent perforating veins and venous ulcers was
established more than a century ago.
Clinical practice guidelines of the Society for Vascular Surgery and the American
Venous Forum on the care of patients with varicose veins and associated chronic
venous diseases (May 2011) make the following recommendations:

We recommend that in patients with varicose veins or more severe chronic
venous diseases (CVD), a complete history and detailed physical examination
are complemented by duplex ultrasound scanning of the deep and superficial
veins (GRADE 1A).

We recommend that the CEAP classification is used for patients with CVD
(GRADE 1A) and that the revised Venous Clinical Severity Score is used to
assess treatment outcome (GRADE 1B).

We suggest compression therapy for patients with symptomatic varicose veins
(GRADE 2C) but recommend against compression therapy as the primary
treatment if the patient is a candidate for saphenous vein ablation (GRADE 1B).

We recommend compression therapy as the primary treatment to aid healing of
venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we
recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A). For treatment of the incompetent great
saphenous vein (GSV), we recommend endovenous thermal ablation
(radiofrequency or laser) rather than high ligation and inversion stripping of the
saphenous vein to the level of the knee (GRADE 1B).

We recommend phlebectomy or sclerotherapy to treat varicose tributaries
(GRADE 1B) and suggest foam sclerotherapy as an option for the treatment of
the incompetent saphenous vein (GRADE 2C).

We recommend against selective treatment of perforating vein incompetence in
patients with simple varicose veins (CEAP class C2; GRADE 1B), but we suggest
treatment of pathologic perforating veins (outward flow duration ≥500 ms, vein
diameter ≥3.5 mm) located underneath healed or active ulcers (CEAP class C5C6; GRADE 2B).

We suggest treatment of pelvic congestion syndrome and pelvic varices with coil
embolization, plugs, or transcatheter sclerotherapy, used alone or together
(GRADE 2B).
Note:
Recommendations of the Venous Guideline Committee are based on the Grading of
Recommendations Assessment, Development, and Evaluation (GRADE) system as
strong (GRADE 1) if the benefits clearly outweigh the risks, burden, and costs. The
suggestions are weak (GRADE 2) if the benefits are closely balanced with risks and
burden. The level of available evidence to support the evaluation or treatment can be
of high (A), medium (B), or low or very low (C) quality.
Alden et al (2012) retrospectively reviewed and analyzed eighty-six patients with
chronic venous ulcer (CVU) with 95 active ulcers (Clinical, Etiology, Anatomy,
Physiology-CEAP clinical class 6) presenting to a multispecialty wound clinic. All
Varicose Vein Surgical Interventions Jul 16
17
patients underwent duplex scanning for venous insufficiency. Ulcer dimensions at
each visit were recorded and used to calculate healing rates. Presence or absence of
ulcer recurrence at 1-year follow-up was recorded. Ulcers treated with compression
alone ("compression group") were compared with those treated with compression
and minimally invasive interventions, such as thermal ablation of superficial axial
reflux and ultrasound-guided foam sclerotherapy (UGFS) of incompetent perforating
veins and varicosities ("intervention group"). The average age in the intervention
and compression groups was 67 and 71 years, respectively (P = not significant
[NS]). Body mass index was 32.4 ± 9.5 and 33.6 ± 11.8 kg/m(2), in the
compression and intervention groups, respectively (P = not significant [NS]). Ulcers
were recurrent in 42% of the intervention group and 26% of the compression group
(P = NS). In the intervention group, 33% had radiofrequency ablation of axial reflux,
31% had UGFS of perforators, and 29% had both treatments. The only complication
of intervention was a single case of cellulitis requiring hospitalization. Compared with
the compression group, the ulcers in the intervention group healed faster (9.7% vs.
4.2% per week; P = 0.001) and showed fewer recurrences at 1-year follow-up
(27.1% vs. 48.9 %; P < 0.015). Multivariate analysis showed use of intervention
was the strongest determinant of healing with a coefficient of variation of 7.432, SE
2.406, P = 0.003. Analysis of just the intervention group before and after
intervention using matched pairs showed acceleration of healing after intervention
from ranging from a median of 1.2% (interquartile range [IQR], 14.3) to 9.7% (IQR,
11.3) per week (P ≤ 0.001). Reviewers concluded minimally invasive ablation of
superficial axial and perforator vein reflux in patients with active CVU is safe and
leads to faster healing and decreased ulcer recurrence when combined with
compression alone in the treatment of CVU.
Harlander-Locke et al (2012) assessed the impact of endovenous ablation of
incompetent superficial (great saphenous [GSV] and small saphenous [SSV]) and
perforator (posterior tibial [PTPV]) veins on the healing rate of venous ulcers in
patients who had failed conventional compression therapy. Patients with CEAP 6
ulcers were treated with weekly compression in a dedicated wound care center. Ulcer
size and depth were tracked prospectively. Those ulcers that showed no measurable
improvement after >5 weeks of compression therapy underwent ablation of at least
one incompetent vein. 140 consecutive endovenous ablation procedures (74
superficial and 66 perforator) were performed on 110 venous ulcers in 88 limbs.
Ulcers had been present for 71 ± 6 months with an initial ulcer area of 23 ± 6
cm(2). Following successful ablation, the healing rate for healed ulcers improved
from + 1.0 ± .1 cm(2)/month to -4.4 ± .1 cm(2)/month (P > .05). Ulcer healing rate
for healed ulcers, based on the last vein ablated, was GSV = 6.4 cm(2)/month, SSV
= 4.8 cm(2)/month, and PTPV = 2.9 cm(2)/month. After a minimum observation
period of 6 months (mean follow up, 12 ± 1.25 months), 76.3% of patients healed in
142 ± 14 days. Twelve patients with 26 ulcers did not heal: two patients died from
unrelated illnesses, six patients are still actively healing, and four patients have been
lost to follow up. Of the healed ulcers, four patients with six ulcers (7.1%) recurred;
two have rehealed. Investigators concluded there is measurable and significant
reduction in ulcer size and ultimate healing following ablation of incompetent
superficial and perforator veins in patients who have failed conventional compression
therapy.
Harlander-Locke et al (2012) also examined the effect of closing incompetent
superficial and/or perforating veins on ulcer recurrence rates in patients with CEAP 5
who have progressive lipodermatosclerosis and impending ulceration. Endovenous
ablation was performed on patients with CEAP 5 disease and incompetent superficial
Varicose Vein Surgical Interventions Jul 16
18
and/or perforator veins and increasing lipodermatosclerosis and/or progressive
malleolar pain. A minimum of 3 months of compressive therapy was attempted
before endovenous ablation of incompetent veins. Demographic data, risk factors,
CEAP classification, procedural details, and postoperative status were all recorded.
Patients underwent duplex ultrasound scans before ablation to assess for deep,
superficial, and perforator venous incompetence as well as postoperatively to confirm
successful ablation. Twenty-eight endovenous ablation procedures (superficial = 19;
perforator = 9) were performed on 20 patients (limbs = 21). The mean patient age
was 73 years old (range, 45-93 years) and the mean body mass index was 29.5
(18.9-58.4). Ninety-five percent of patients previously wore compression stockings
(20-30 mm Hg = 9; 30-40 mm Hg = 10; none = 1) for a mean time of 23.3 months
(range, 3-52 months) since the prior ulcer healed. Indications for venous ablation
were increasing malleolar pain (55%) and/or lipodermatosclerosis (70%). Technical
success rates for the ablation procedures were 100% for superficial veins and 89%
for perforators (96.4% overall). All patients underwent closure of at least one
incompetent vein. Postoperatively, 95% of patients were compliant with wearing
compression stockings (20-30 mm Hg = 8; 30-40 mm Hg = 11; none = 1). Ulcer
recurrence rates were 0% at 6 months and 4.8% at 12 and 18 months. These data
compare with prior studies showing an ulcer recurrence rate up to 67% at 12 months
with compression alone. Investigators concluded patients with CEAP 5 healed
venous ulcers that undergo endovenous ablation of incompetent superficial and
perforating veins and maintain compression have reduced ulcer recurrence rates
compared with historical controls that are treated with compression alone.
Park et al (2011) compared two methods of treating incompetent thigh perforator
and GSV. Patients with varicose veins of CEAP C2 and C3 with incompetent
perforating veins (IPVs) in the thigh without evidence of saphenofemoral reflux and
with obvious venous reflux from IPVs into the GSV distal to IPVs were included.
Endovenous laser ablation was done using two methods (IPV ablation (IPVA) versus
GSV ablation: GSVA). Their technical success rate, clinical success rate, and
complications were compared at 1 week, and 1, 3, 6, and 12 months. Sixty-nine
consecutive patients were randomized to IPVA (n = 34) or GSVA (n = 35). Technical
success was significantly lower with IPVA than GSVA (p = .002). Clinical success,
defined as continued closure of treated veins, was similar with IPVA and GSVA
(96.1% vs 100% at 1 week, 100% vs 97.1% at 1 month, and 100% for both at 3, 6,
and 12 months, respectively). Investigators concluded IPVA has clinical results and
complications similar to those of GSVA in individuals with C2 and C3 chronic venous
disease with IPVs in the thigh combined with incompetent GSV, but its higher
technical failure rate makes it difficult to choose it as the primary treatment method.
Lawrence et al (2011) reported their experience with perforator ablation (PA) with
venous ulcers unresponsive to prolonged compression therapy. Patients with
nonhealing venous ulcers of >3 months' duration underwent duplex ultrasound to
assess their lower extremity venous system for incompetence of superficial,
perforating, and deep veins. Patients who had either no saphenous incompetence or
persistent ulcers after saphenous ablation underwent PA of incompetent perforating
veins >3 mm that demonstrated reflux; initial treatment was performed on the
perforator vein adjacent to the ulcer with additional incompetent veins treated if
ulcer healing failed. Seventy-five ulcers with 86 associated incompetent perforating
veins were treated with PA in 45 patients with CEAP 6 recalcitrant venous ulcers.
Treated incompetent perforator veins were located in the medial ankle (61%), calf
(37%), and lateral ankle (2%). Initial success of PA, assessed by postprocedure
duplex ultrasound, was 58%; repeat ablation was 90% successful and 71% had
Varicose Vein Surgical Interventions Jul 16
19
eventual successful perforator closure. No complications (skin necrosis, infection, or
nerve injury) occurred. Failure of ulcer healing with successful perforator closure
occurred in 10% and was due to intercurrent illness, patient noncompliance, and
patient death due to unrelated causes. Of patients who healed their ulcers, the
healing occurred at a mean of 138 days; an average PA of 1.5 incompetent veins per
ulcer was required for healing. Ninety percent of ulcers healed when at least one
perforator was closed; no ulcer healed without at least one perforator being closed.
Investigators concluded the experience demonstrates both the feasibility and
effectiveness of PA for a selected group of patients with venous ulcers who fail
conventional therapy with compression.
O'Donnell et al (2008) reported superficial venous hypertension has been cited as
the putative etiologic factor in advanced chronic venous insufficiency with venous
ulcer (CEAP C 5/6). For over a century, influenced by this belief, surgeons have
ablated the superficial venous system as a treatment for venous ulcer. Incompetent
perforating veins (ICPVs) have become a particular focus of this therapeutic
strategy. This review examines the evidence for the surgical approach. A MEDLINE
search of the literature identified only four randomized controlled trials (RCTs)
directed at the surgical reduction of superficial venous hypertension. Risk ratios for
ulcer healing and prevention of recurrence were calculated to determine benefits for
these four RCTs, while mortality and morbidity, where available, was used to
determine risk from the procedure. In addition, the quality of the trials (design and
outcomes) was assessed. While two trials compared ICPV ligation to compression,
the GSV was also treated in many of these limbs, which confounds the results. By
contrast, two RCTs, which compared treatment of the GSV alone to compression,
demonstrated a significant reduction in the incidence of ulcer recurrence. Case series
that employed hemodynamic or surrogate outcomes showed little effect on the
addition of ICPV treatment to GSV stripping, while GSV ablation alone was associated
with a reduction in the number of ICPVs in several studies. This review suggests a
grade 1A recommendation for the treatment of venous ulcer by GSV ablation to
reduce ulcer recurrence. The role of ICPV ablation alone or concomitant with GSV
treatment awaits results of properly conducted RCTs.
van den Bos et al (2009) described the procedure of radiofrequency ablation (RFA) of
IPV and to evaluate its short-term effectiveness and safety. In a clinical pilot study,
14 IPV in 12 patients were treated with a radiofrequency stylet. After three months,
ultrasound (US) examination was used to assess anatomical success rate and
exclude deep venous thrombosis. Also, self-reported side-effects were investigated.
Of the 14 treated IPV, nine (64%) were obliterated on US examination and the
others showed remaining reflux. Two patients reported localized paresthesia, but no
deep venous thrombosis was recorded. Investigators concluded RFA of IPV may be a
promising procedure, but patient and incompetent perforator vein selection is
important and further standardization of the procedure is required. Comparative
clinical trials between RFA and other therapies are warranted.
Hingorani et al (2009) evaluated potential predictive factors associated with success
or failure of incompetent perforating veins (IPVs) treated with radio-frequency stylet
(RFS). Over the last 12 months in this observational study, 38 consecutive patients
with various degrees of venous insufficiency and IPVs underwent 48 office-based
radio-frequency ablation procedures (1 - C 3; 7 - C 4; 10 - C 5; 30 - C 6) in 44
limbs. There were 21 females and 17 males with a mean age of 67 +/- 17 years (3893 years) who had a total of 93 IPVs (40 calf; 53 ankle). Eighteen patients (47%)
had ipsilateral GSV radio-frequency closures performed prior to current procedure.
Varicose Vein Surgical Interventions Jul 16
20
The venous flow pattern was classified by spectral waveform analysis as "normal"
(spontaneous with respiratory phasicity) in 33 patients and "pulsatile" (with
bidirectional cardiac phasicity) in five patients. Follow-up duplex scans were
performed from 3 to 7 days postprocedure. Statistical analyses were performed for
determining correlation between the various factors such as, age, pulsatile flow,
CEAP class, prior GSV ablation, vein diameter, reflux, and patency. The mean
number of ablated IPVs was 1.94 +/- 0.38 ranging from 1-3. Immediate success rate
was 88% (82 cases, 32 patients). IPVs had a duplex measured mean diameter of 3.8
+/- 1.1 mm (2-6.6 mm). Eleven IPVs remained patent in six patients. There was no
significant difference between the patent and the obliterated IPV groups concerning
age (P = 0.75), prior GSV ablation (P = .19), IPV diameter (P = .08) and CEAP
classification. Conversely, four of the five procedures (80%) performed in patients
with "pulsatile" venous flow failed, while only two of the remaining 43 procedures
(4.7%) in patients with "normal" venous flow failed (P < .001). Investigators
concluded the data show that a pulsatile venous flow pattern is a significant predictor
of failure following RFS for IPVs.
Scientific Rationale – Update April 2012
Endovenous laser ablation (EVLA)
EVLA is contraindicated in patients with acute deep vein thrombosis and in pregnant
patients, due to the risk of developing a new DVT. We prefer to wait a minimum of
six weeks after delivery in pregnant patients before performing EVLA.
Relative contraindications to EVLA for a given vein segment include:




Chronic or recurrent phlebitis in the target vein, since formation of synechiae in
the vein can prevent passage of the laser sheath.
Severe tortuosity in which passage of the device may not be possible.
Target veins that are not at least 1 cm deep to the skin dermis after tumescent
anesthesia is administered. Ablation of veins closer to the skin may lead to skin
burns.
Target vein segments that are aneurysmal (>2.5 cm in diameter). These have a
greater risk of failure.
The indications for EVLA are the same as for other vein ablation therapies including
radiofrequency ablation, sclerotherapy and open surgical stripping. Venous ablation
is indicated in patients with symptoms and signs of venous disease that persist in
spite of three months of medical management, and documented reflux in the target
vein (ie, retrograde flow >0.5 seconds). The patient’s symptoms should directly
relate to the incompetent veins being treated.
Selective Treatments for Varicose Veins, Saphenous Vein Ligation/Division/
Stripping, VNUS, ELAS
Due to the risk for saphenous nerve injury, surgical stripping of the saphenous vein
in the mid- to distal calf is no longer recommended. For similar reasons, we prefer
not to extend ablation of the GSV below the mid- to upper-calf.
A systematic review of 20 studies (including NASEPS registry) involving 1140 limbs,
found ulcer healing in 88 percent of limbs treated with SEPS, with a 13 percent
recurrence rate at a mean of 21 months [16]. Risk factors for nonhealing and ulcer
recurrence were similar and included the presence of postoperative incompetent
perforators, larger ulcer size (>2 cm), and secondary venous insufficiency (eg,
postthrombotic syndrome).
Varicose Vein Surgical Interventions Jul 16
21
Saphenous vein ablation is a minimally-invasive treatment, generally an outpatient
procedure, performed using ultrasound guidance. After applying local anesthetic to
the vein, the surgeon inserts a thin catheter into the vein and guides it up the great
saphenous vein in the thigh. Then laser or radiofrequency energy is applied to the
inside of the vein. This heats the vein and seals the vein closed. Reflux within the
great saphenous vein leads to pooling in the visible varicose veins below. By closing
the great saphenous vein, the twisted and varicosed branch veins, which are close to
the skin, shrink and improve in appearance. Once the diseased vein is closed, other
healthy veins take over to carry blood from the leg, re-establishing normal flow.
Patients with combined deep and superficial venous insufficiency are often not good
candidates for ablation therapy due to coexisting medical issues. In this population,
varicose vein recurrence and ulcer recurrence rates following intervention are much
higher. Because of this and potential for the development of non-healing ulcers,
dilated veins in patients with isolated deep venous reflux are rarely treated with
surface laser, sclerotherapy or phlebectomy. These patients are managed medically.
Patients found to have significant venous reflux, as well as patients with
complications (including ulceration, hemorrhage, or recurrent superficial
thrombophlebitis) should be referred to a vein specialist for further evaluation and
management.
Under established guidelines, individuals with reflux should be treated with ligation,
division and stripping of the junction, VNUS, or ELAS prior to sclerotherapy to reduce
the risk of varicose vein recurrence.
However, in several studies, deep venous reflux was noted to resolve following
saphenous ablation and aggressive management should be considered in patients
with refractory symptoms or skin changes, persistent ulcer, or recurrent ulcer.
Rasmussen et al. (2011) This randomized trial compared four treatments for varicose
great saphenous veins (GSVs). Five hundred consecutive patients (580 legs) with
GSV reflux were randomized to endovenous laser ablation (980 and 1470 nm, bare
fibre), radiofrequency ablation, ultrasound-guided foam sclerotherapy or surgical
stripping using tumescent local anaesthesia with light sedation. Miniphlebectomies
were also performed. The patients were examined with duplex imaging before
surgery, and after 3 days, 1 month and 1 year. At 1 year, seven (5.8 per cent), six
(4.8 per cent), 20 (16.3 per cent) and four (4.8 per cent) of the GSVs were patent
and refluxing in the laser, radiofrequency, foam and stripping groups respectively (P
< 0.001). One patient developed a pulmonary embolus after foam sclerotherapy and
one a deep vein thrombosis after surgical stripping. No other major complications
were recorded. The mean (s.d.) postintervention pain scores (scale 0-10) were
2.58(2.41), 1.21(1.72), 1.60(2.04) and 2.25(2.23) respectively (P < 0.001). The
median (range) time to return to normal function was 2 (0-25), 1 (0-30), 1 (0-30)
and 4 (0-30) days respectively (P < 0.001). The time off work, corrected for
weekends, was 3.6 (0-46), 2.9 (0-14), 2.9 (0-33) and 4.3 (0-42) days respectively
(P < 0.001). Disease-specific quality-of-life and Short Form 36 (SF-36) scores had
improved in all groups by 1-year follow-up. In the SF-36 domains bodily pain and
physical functioning, the radiofrequency and foam groups performed better in the
short term than the others. All treatments were efficacious. The technical failure rate
was highest after foam sclerotherapy, but both radiofrequency ablation and foam
Varicose Vein Surgical Interventions Jul 16
22
were associated with a faster recovery and less postoperative pain than endovenous
laser ablation and stripping.
Subfascial endoscopic perforator surgery (SEPS)
Subfascial endoscopic perforator surgery (SEPS), described by Hauer in 1985, may
be indicated for patients with refractory symptoms or ulceration, or recurrent
ulceration associated with perforator reflux. This technique has largely been
abandoned in favor of lesser invasive technique.
A systematic review of 20 studies (including NASEPS registry) involving 1140 limbs,
found ulcer healing in 88 percent of limbs treated with SEPS, with a 13 percent
recurrence rate at a mean of 21 months. Risk factors for nonhealing and ulcer
recurrence were similar and included the presence of postoperative incompetent
perforators, larger ulcer size (>2 cm), and secondary venous insufficiency (eg,
postthrombotic syndrome).
Post-Procedural Sclerotherapy/Ambulatory Stab Avulsion Phlebectomy/
TIPP (TriVex System)
Sclerotherapy for treatment of secondary varicose veins resulting from deep
vein thrombosis or Arteriovenous fistulae
Lower-extremity venous insufficiency is a common medical condition. Venous
insufficiency typically results from primary valvular incompetence or less commonly
from previous deep venous thrombosis. Venous insufficiency may result in varicose
veins that may be of cosmetic concern or cause symptoms such as discomfort,
extremity swelling, skin discoloration, skin induration, or ulceration. Affected veins
may thrombose or bleed. Venous insufficiency most commonly results from reflux
originating from the great saphenous vein (GSV). Other sources of venous
insufficiency include superficial veins, such as the small saphenous vein (SSV), the
anterior thigh circumflex vein, the posterior thigh circumflex vein, and the anterior
accessory GSV. Treatment of venous insufficiency is intended to alleviate symptoms
and reduce the risk of complications. Conventional management of GSV reflux has
been surgical removal of the saphenous vein from the level of the saphenofemoral
junction to the level of the knee or ankle (stripping), along with ligation of the
saphenous branches in the groin. An alternative to ligation and stripping of the
saphenous vein is endovenous ablation of the vein using laser energy,
radiofrequency-generated thermal energy, or a chemical sclerosing agent. Treatment
is aimed at relief of symptoms, prevention of progression of venous insufficiency,
prevention of complications, and improvement in cosmesis. Sclerotherapy has no
long-term effectiveness for large veins, such as the GSV.
Adjunctive treatments may be required to help eliminate venous insufficiency.
Patients with venous insufficiency and associated venous occlusion or stenosis of the
common iliac vein (e.g., May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return. Patients
with pelvic venous insufficiency may require percutaneous embolization of the
ovarian veins. Patients with deep venous thrombosis are typically treated with
anticoagulation to reduce the risk of thrombus propagation, embolization, and
postthrombotic syndrome. One study suggested that endovenous ablation of the
saphenous vein can be considered as a viable treatment alternative in patients with
venous insufficiency and previous deep venous thrombosis.
Recanalization
Varicose Vein Surgical Interventions Jul 16
23
Randomized trials suggest that sclerotherapy is less effective than surgery for larger
veins. Recurrence rates following saphenous vein sclerotherapy are significant (up to
65 percent) and related to saphenous recanalization. Foam sclerotherapy is
associated with lower rates of recanalization compared with liquid sclerotherapy;
however, for either therapy, recurrence of clinical symptoms may be less.
In one prospective trial, saphenous vein recanalization occurred in 27 and 64 percent
of patients treated at one and five years, respectively. However, 70 percent of
patients did not have worsened clinical symptoms. Repeat UGFS treatment was
performed in 16.5 percent of patients between one and two years, and fewer than 10
percent in subsequent years (up to five years).
Ultrasound-Guided Sclerotherapy
Chapman-Smith et al. (2009) The purpose of this study was to determine the longterm efficacy, safety and rate of recurrence for varicose veins associated with great
saphenous vein (GSV) reflux treated with ultrasound-guided foam sclerotherapy
(UGFS). A five-year prospective study was performed, recording the effect on the
GSV and saphenofemoral junction (SFJ) diameters, and reflux in the superficial
venous system over time. UGFS was the sole treatment modality used in all cases,
and repeat UGFS was performed where indicated following serial annual ultrasound.
No serious adverse outcomes were observed, specifically no thromboembolism,
arterial injection, anaphylaxis or nerve damage. There was a 4% clinical recurrence
rate after five years, with 100% patient acceptance of success. Serial annual duplex
ultrasound demonstrated a significant reduction in GSV and SFJ diameters,
maintained over time. There was ultrasound recurrence in 27% at 12 months, and in
64% at five years, including any incompetent trunkal or tributary reflux even 1 mm
in diameter being recorded. Thirty percent had pure ultrasound recurrence, 17% new
vessel reflux and 17% combined new and recurrent vessels on ultrasound. Of all,
16.5% required repeat UGFS treatment between 12 and 24 months, but less than
10% in subsequent years. The safety and clinical efficacy of UGFS for all clinical,
aetiological, anatomical and pathological elements classes of GSV reflux was
excellent. The popularity of this outpatient technique with patients reflects ease of
treatment, lower cost, lack of downtime and elimination of venous signs and
symptoms. Patients accept that UGFS can be repeated readily if required for
recurrence in this common chronic condition. The subclinical ultrasound evidence of
recanalization or new vein incompetence needs to be considered in this light.
Scientific Rationale – Update September 2009
First-line treatment of varicose veins includes conservative methods such as
exercise, weight reduction, elevation of the legs, avoidance of prolonged
immobility, or compression therapy. When these measures fail, medium to large
incompetent veins may be treated with surgical stripping, ligation, sclerotherapy,
endovenous laser therapy (EVLT), or endoluminal radiofrequency ablation
(ERFA). EVLT involves ultrasonography to evaluate the veins, infiltration of the
area to be treated with local anesthetic, and passage of an optical fiber into and
along the length of the Great Saphenous Vein or Small Saphenous Vein.
The fundamental principle of totally removing varicose clusters from the circulation
remains firmly established. However, methods of accomplishing this have changed
and continue to change. Failure of a valve protecting a tributary vein from the
pressures of the GSV allows a cluster of varicosities to develop. Surgical treatment
may be used to remove clusters with varicosities greater than 4 mm in diameter.
Ambulatory phlebectomy may be performed using the stab avulsion technique with
preservation of the great saphenous vein and the small saphenous vein, if they are
Varicose Vein Surgical Interventions Jul 16
24
unaffected by valvular incompetence. When saphenous incompetence is present, the
removal of clusters is preceded by stripping or limited removal of the saphenous
vein. Stripping techniques are best done from above, in a downward motion, to avoid
lymphatic and cutaneous nerve damage. More recently hook phlebectomy and clamp
phlebectomy have replaced open dissection and tributary ligation.
The findings on physical examination will determine whether the great saphenous
vein will require ligation and stripping or endovenous ablation. Although “ligation”
and/or “stripping” of the saphenous vein are the traditional methods for removing
the diseased vein from circulation, the newer, less-invasive techniques such as
endovenous laser ablation and radiofrequency ablation, present a less invasive
alternative.
More recently, endoluminal radiofrequency ablation (ERFA) and endoluminal laser
ablation have been developed as minimally invasive alternatives to sclerotherapy and
to surgical ligation and stripping for varicosities that occur as a result of GSV reflux.
These procedures are designed to damage the intimal wall of the vein resulting in
fibrosis and subsequent ablation of the lumen segment of the vessel. Both
procedures utilize specially designed catheters inserted through a small incision in
the distal thigh and advanced, often under ultrasound guidance, nearly to the
saphenofemoral junction. The catheter is then slowly withdrawn while controlled
radiofrequency or laser energy is applied. This is followed by external compression of
the treated segment.
Reflux within the GSV leads to pooling in the visible varicose veins below. By closing
the GSV with ERFA, also known as the ‘Closure Procedure’, the twisted and varicosed
branch veins which are near the skin, shrink and improve in appearance.
Confirmation of closure is obtained with post procedure duplex at the conclusion of
the intervention. Advantages of these procedures are :



They are percutaneous and are performed on an outpatient basis.
No anesthesia is necessary.
Patients can return to baseline activities within a day or so.
Risks of the procedures include potential development of a deep venous thrombosis
or pulmonary embolism, skin burn, thrombophlebitis, paresthesias, and recurrence.
A 2-year follow-up study compared endovenous radiofrequency closure with ligation
and vein stripping. The findings of this study revealed similar closure rates of the
greater saphenous vein. Interestingly, the authors did not find that ligation of the
vein at the saphenofemoral junction improved long-term outcome. The patients’
quality of life index was superior in the endovenous radiofrequency group.
Leopardi et al. (2009) performed a systematic review to compare the safety and
efficacy of varicose vein treatments, including conservative therapy, sclerotherapy,
phlebectomy, endovenous laser therapy, radiofrequency ablation, and surgery
involving saphenous ligation and stripping. Seventeen studies, published between
2003 and 2007, were included in this review. All treatments displayed levels of
effectiveness depending on the extent of the vein in question. Short-term
advantages appeared to be associated with sclerotherapy and endovenous
treatments, and long-term effectiveness was more apparent following surgical
intervention. Sclerotherapy and phlebectomy may also be more appropriate in
patients with minor superficial varicose veins not related to reflux of the saphenous
system or as a post- or adjunctive treatment to other procedures, such as surgery.
Varicose Vein Surgical Interventions Jul 16
25
Current evidence suggests endovenous laser therapy and radiofrequency ablation are
as safe and effective as surgery, particularly in the treatment of saphenous veins.
Most importantly, the type of varicose vein should govern the intervention of choice,
with no single treatment universally employed.
Since its inception in 1998, it is estimated that over 250,000 radiofrequency ablation
procedures have been performed. As with many industry-driven technologic
procedures, hard data are somewhat lacking. Early trials demonstrated an
unacceptably high rate of cutaneous skin burns, but this problem has largely been
eliminated with the technique of tumescent anesthesia. An immediate closure rate of
approximately 85% is commonly quoted, but long-term follow-up is poor. When
subjected to Kaplan-Meyer analysis, most failures (recanalization) occur within the
first year or so, and long-term outcome after this is generally satisfactory.
Although initial findings are promising in both the radiofrequency and endovenous
laser therapies, to date, there are minimal prospective randomized trials to compare
these modalities, to stripping/ligation procedures.
Scientific Rationale – Update September 2008
Please note that the International Union of Phlebology has designated the terms
Great Saphenous Vein (instead of the formerly used “Great” or “long”), and Small
Saphenous Vein (instead of the formerly used “short” or “lesser”).
Moll et al. (2008) The mechanism of action of endovenous laser is attributed to laser
induced endovenous steam bubble formation, indirectly heating the vein wall over a
large area of the lumen, and partly direct heating of the vein wall as a consequence
of closer contact between the fiber tip and the wall itself.
The American College of Phlebology (ACP)
The American College of Phlebology (ACP) was founded in 1985 and is a newly
recognized specialty of the American Medical Association (AMA) that was also added
to the list of the American Osteopathic Association. The mission of the ACP is to
improve the standards of practice and patient care related to venous disorders. The
American Board of Phlebology was launched in December 2007 to improve the
quality of medical practitioners and the care of patients related to venous disorders
through rigorous testing, reliable certification, and improved educational standards.
The ACP Guidelines for Varicose Vein Surgery
With the advent of minimally invasive techniques for the treatment of varicose veins
and venous reflux, the decision-making process for determination of medical
necessity has changed. When the only option for treatment was surgical high ligation
and stripping, it was reasonable to consider all available alternatives prior to this
type of invasive procedure. Patients undergoing vein stripping typically experience
significant post operative pain and require a prolonged recover period of two to four
weeks. Recent studies have shown that the five year recurrence rate after vein
stripping is 50 to 65% often due to neovascularization that can occur after ligation
and division of the saphenofemoral junction. Surgical stripping also carries the risk
of side effects related to general anesthesia and prolonged immobility that is not
present with newer, endovenous methods.
In comparison, endovenous techniques (endovenous thermal ablation and
endovenous chemical ablation) do not require hospitalization, general anesthesia, or
a prolonged recovery period. Patients typically experience minimal pain and recover
Varicose Vein Surgical Interventions Jul 16
26
within a day or two. The five-year recurrence rate has been reported to be only 8 to
10%.
While the use of compression stockings may be useful for the relief of symptoms,
they are poorly tolerated by most patients, especially in warmer climates.
Compression stockings are impossible for those who work in hot environments, and
are only palliative in all cases. Elderly patients and those with arthritis and other
neuromuscular disease have great difficulty putting the hose on. If the stockings do
not fit properly they may cause pressure sores, venous or lymphatic outflow
obstruction, and even vascular compromise in patients with arterial insufficiency. The
bottom line is that they do not eliminate venous reflux, which is the root cause of
progressive chronic venous disease.
When high ligation and stripping was the principle option for definitive treatment,
long term use of graduated compression hose was a more reasonable alternative to
venous surgery when considering the poor long-term success rate and risk of
complications associated with surgical procedures. However, now that minimally
invasive treatments are widely available, long-term use of compression stockings is
no longer a viable option as definitive treatment.
In the practice of Phlebology, use of compression hose is useful for the following
situations:






Post treatment compression;
Symptomatic treatment in patients when surgical or endovenous treatment is
contraindicated due other medical problems;
To assist in determining whether pain is related to venous reflux (2 weeks is
usually ample time);
For control of dependent edema;
For treatment of deep venous insufficiency; or
For treatment of lymphedema.
A requirement for prolonged use of compression hose prior to any treatment
(endovenous thermal or chemical ablation) is not supported by any evidence based
medicine, is of questionable medical benefit for this correctable problem and does
not represent the standard of care. In cases where the source of venous reflux can
be treated effectively using endovenous methods, the patient is best served by
proceeding directly to definitive treatment which is supported by evidence medicine
with improved quality of life, decrease of symptoms and return to normal function
with activities and work. This represents the current standard of care.
The elimination of varicosities that are a consequence of truncal reflux is often
needed to adequately treat the affected patient. These varicosities are often
responsible for many of the patient’s symptoms, particularly when the reflux source
is short and a long chain of superficial varicosities are present. Endovenous
treatment of the reflux source will decompress these varicosities but will not
eliminate them. The elimination of these symptomatic varicosities may be
accomplished by phlebectomy or sclerotherapy. In general phlebectomy is better
suited to larger varicosities but sclerotherapy can be used effectively. The aim of
sclerotherapy is to eliminate reflux in the superficial venous system and thereby
eliminate the visible and non-visible source components or incompetent tributaries
via ultrasound guidance.
Varicose Vein Surgical Interventions Jul 16
27
The decision as to when to perform these adjunctive procedures is dependent on the
patient’s specific clinical situation. As an example, large varicosities which extend
from a refluxing segment of the upper great saphenous vein (GSV) to a refluxing
segment of the lower GSV may thrombose if endovenous ablation (EVA) of the entire
GSV is performed because all blood flow to this isolated group of varicosities is
stopped. There is usually more than one source of reflux in the varicose tributaries
and they rarely fibrose. They do diminish in size so they may not be visible on the
skin surface, but they are always visible by ultrasound, and they are the primary
source for eventual “recurrent” varicosities.
If thrombosis occurs, the resulting phlebitis can be very painful and this pain can last
for weeks to months. In this scenario eradication of these varicosities at the same
time EVA is done would prevent this from occurring. There are many other clinical
and anatomical situations where the simultaneous eradication of the truncal reflux
source and the varicosities are in the best clinical interest of the patient. Therefore it
is the recommendation of the American College of Phlebology that adjunctive
varicosity treatment at the time of EVA be left to the clinical judgment of the treating
physician.
CEAP Classification
Venous disease of the legs can be classified according to the severity, cause, site and
specific abnormality using the CEAP classification. Use of such a classification
improves the accuracy of the diagnosis and improves communication between
specialists. The elements of the CEAP classification are:




Clinical severity
Etiology or cause
Anatomy
Pathophysiology
Patients with CEAP grade C3, C4, C5 and C6 demonstrate an increased severity of
chronic venous insufficiency, have a functional abnormality of the venous system,
and are at the most risk of chronic ulceration.
Patients with CEAP grade C2 disease may be considered for one of the applicable
venous procedures if there is a noted perforator or junctional reflux (saphenofemoral
or saphenopopliteal), in order to prevent disease progression.
For the initial assessment of a patient, the clinical severity is the most important and
can be made by simple observation and does not need special tests. There are seven
grades of increasing clinical severity:
Grade
CO
C1
C2
C3
C4
C5
C6
Description
No evidence of venous disease
Superficial spider veins (reticular veins) only
Simple varicose veins only
Ankle edema of venous origin (not foot edema)
Skin pigmentation in the gaiter area (lipodermatosclerosis)
A healed venous ulcer
An open venous ulcer
Air plethysmography (APG) and Photoplethysmography (PPG)
Varicose Vein Surgical Interventions Jul 16
28
Air plethysmography (APG) is a test of overall venous function, and does not
distinguish well between deep and superficial venous disease. The equipment for
performing APG is difficult to find today as it is considered outmoded by most
technologists. Photoplethysmography (PPG) is a sensitive method of detecting reflux,
but the specificity is poor, and PPG refill times cannot accurately predict the location
of reflux.
Duplex Ultrasound
Duplex ultrasound is the current standard noninvasive examination of the venous
system in the lower extremities. Preoperative duplex scanning defines the venous
anatomy and can directly visualize areas of reflux in the deep, perforating, and
superficial systems. Duplex has been shown to be sensitive (0.92 to 0.95) in
identifying the competence of the saphenofemoral and saphenopopliteal junctions,
but less sensitive in identifying incompetent perforators (0.4 to 0.63).
The duplex ultrasound has become the most useful tool for workup and has replaced
many of the physical examination maneuvers and physiological tests once used for
the diagnosis of varicose veins. In most cases, once the initial vein mapping is
performed, it is not essential that follow-up scanning be done for subsequent
sclerotherapy sessions. It has not been demonstrated in the published medical
literature that repeat Duplex studies are essential for the successful outcome of the
procedure when performed as part of a series of sclerotherapy sessions.
These diagnositic studies can also eliminate the more easily managed superficial or
perforator disease as the cause of the symptoms. Abnormality in the superficial and
perforator veins can usually be eliminated by procedures such as vein removal,
sclerotherapy or perforator ligation before deep venous repair is even considered.
Generally, significant obstructive disease within the deep venous system is also
repaired before procedures for valvular reflux are necessary.
Scientific Rationale – Update June 2007
Duplex scanning combines an image and a Doppler signal. Color units indicate flow
from the heart in red and toward the heart in blue. Color flow duplex scanning has
become the “gold standard” for varicose vein assessment by allowing the operator to
locate and identify specific structures using real-time imaging and then obtain
information on the presence, direction and velocity of blood flow from a specific
location or vessel within the image. The femoral, popliteal, deep calf veins and
perforating veins can be specifically and individually tested as well as determining
the involvement of the long and short saphenous veins and their tributaries. It has
also been recommended that color duplex should be the investigation of choice for all
patients presenting with varicose veins, even recurrent varicose veins. A hand-held
Doppler is inadequate for detecting incompetency at the saphenofemoral junctions
because it has high sensitivity but low specificity, it cannot detect the exact site of
reflux, it is not accurate in localizing incompetent perforating veins, it is unreliable in
the assessment of veins in the popliteal fossa.
The general indications for treatment of varicose veins are to relieve symptoms and
to prevent complications related to venous disease (especially venous ulcer).
Treatment of varicose veins not accompanied by skin changes or great discomfort
would largely be for cosmetic reasons. There is scant evidence showing how many
patients with asymptomatic or mild varicose veins progress on to more severe forms
of venous insufficiency, and so it is extremely difficult either to support or refute the
argument of prophylactic surgery. Conversely, there is general agreement that skin
Varicose Vein Surgical Interventions Jul 16
29
changes and ulceration represent an indication for treatment. Symptoms of
discomfort reported by the patient are variably interpreted as indications for
treatment. Moderate and severe (clearly symptomatic) varicose veins are generally
thought to be worthy of surgical treatment, however, a thorough assessment is
needed prior to surgery to define whether surgery is likely to be effective and at
what sites to intervene to maximize long-term outcome and reduce recurrence rates.
Conservative treatment in the form of compression therapy is the preferred form of
treatment if surgical intervention is not sufficiently indicated, or if the patient is seen
as unfit for general anesthesia. In addition, when varicose veins are severely
complicated by deep vein incompetence, the only form of treatment offered may be
compression therapy. Compression therapy can also be used as a therapeutic test; if
symptoms improve with stockings, it is likely that they are due to varicose veins and
so surgery maybe of value. Compression may also help heal and prevent the
recurrence of ulcers and helps to prevent the deterioration of skin changes. It is the
mainstay of venous ulcer treatment, acting to reduce vein caliber, capillary filtration
and venous reflux while improving venous pumping. These effects increase venous
return, improve lymphatic drainage and decrease edema. Materials used for
compression include elastic and inelastic bandages (Unna boot), and elastic
stockings. There are many ways of applying compression such as single layers of
bandaging, multiple layers of bandaging, compression stockings or a combination of
bandages and stockings, which are usually used to treat the more severe end of the
spectrum.
It is now recommended to graduate the external compression with the amount of
external pressure being greatest at the ankle and lower at the knee. This has been
shown to increase blood velocity within the deep venous system. The most suitable
amount of pressure to apply to the leg is generally accepted to depend on the
severity of the condition. It is important to note that before undertaking compression
therapy the ankle brachial pressure index (ABPI) should be assessed. This is because
patients with peripheral arterial disease with poor arterial circulation can develop
ischemia if compression is too high. The precise ABPI below which compression is
contraindicated is often quoted as 0.8.
Levels Of Compression Stockings
Class
Compression
Severity of Varicose Veins
I
Light support, 14-17mmHg at
the ankle
Medium support, 18-24mmHg
at the ankle
Mild varicose veins, venous
hypertension in pregnancy
Mild edema, moderate to severe
varicose veins, prevention of ulcer
recurrence in lesser, light people
Treatment of severe varicose veins and
prevention of venous ulcers, large heavy
legs
II
III
Strong support, 25-35mmHg
at the ankle
Armstrong S, Woollons S. Compression Hoisery. Professional Nurse 1998; 14: 49-59.
Surgery is the established treatment and treatment of choice for saphenofemoral
vein incompetence and long saphenous vein varicosity. The effectiveness of the
different forms of management for varicose veins can be assessed by the amount of
reduction in the presenting symptoms and signs, and in the long term, by the
volume of need for further treatment, particularly venous ulcer care. The goal of
Varicose Vein Surgical Interventions Jul 16
30
interventional procedures has been said to be to normalize venous physiology. A
major problem with varicose vein surgery is the high risk of recurrence, which is a
common, complex and costly problem. The frequency of recurrent veins is stated to
be between 20 and 80%, depending on the definition, method of assessment,
duration of follow-up, initial case mix and quality of surgery. A consensus meeting on
recurrent varicose veins in 1998 decided to adopt a definition: the presence of
varicose veins in a lower limb previously operated on for varices. Whilst some
recurrence is inevitable due to the development of new varicose veins, some may be
due to inadequate assessment and initial surgery. Up to 20% of varicose vein
surgery is for recurrence. The insufficiency of perforating veins is thought to be
crucial in the pathogenesis of varicose and postphlebitic ulcers as well as
postoperative varicose vein recurrence.
There are a number of new treatments for varicose veins that claim advantages over
conventional surgery by reducing operative trauma and bruising and speeding up
postoperative recovery. The methods all close off the long saphenous vein under
duplex ultrasound control. Endoluminal radiofrequency ablation (thermal heating)
(VNUS Closure System) is based on the principle of treating reflux disease by control
of the point of reflux and isolation of the refluxing saphenous vein from the
circulation. The current evidence suggests that this procedure has success rates
similar to those reported for surgical ligation and stripping with less postoperative
pain and faster postoperative recovery. The level of evidence supporting this
conclusion includes randomized controlled clinical trials. Currently, the published
data regarding endovenous laser ablation (Endovenous Laser Treatment or EVLT) of
the Great saphenous vein is composed of two large-scale case series studies and
several lesser case series studies. These studies demonstrate lower relapse rates
when compared to ligation and stripping, as well as comparable symptom relief and
complication rates similar to endoluminal radiofrequency ablation. With respect to
long-term outcomes and head-to-head comparison to other therapies, including
ligation and stripping or radiofrequency ablation, the data is not adequate to make
sufficient comparisons. Both methods require a duplex ultrasound machine with a
skilled operator.
The surgical management of venous ulcer can be considered once venous
hypertension is established as the cause of the ulcer and the possible venous
abnormalities have been demonstrated. In the 50% of venous ulcers that have
superficial reflux as the main component, appropriate ligation can heal the ulcer. The
role of perforator ligation is thought to be limited apart from in a group of patients
with primary deep incompetence, in whom ulceration persists in spite of saphenous
ligation. Skin grafts are used by some clinicians in order to stimulate healing of
venous ulcers. The skin grafts may be taken from the patient's own uninjured skin
(e.g., thigh), may be grown from the patient's skin cells into a dressing, (autografts)
or applied as a sheet of bioengineered skin grown from donor cells (allograft).
Preserved skin from other animals (e.g., pigs) has also been used and these are
known as xerografts. They can give immediate relief for patients with very painful
ulcers, but they often fail after a period of time.
Recurrence is frequently used as a measure of effectiveness, although it is extremely
difficult to measure and classify, as there is always difference of opinion between
observers on what constitutes a recurrence. When using recurrence as a measure of
effectiveness, it is important to distinguish between residual veins, recurrent veins
and recanalized veins. Residual veins are veins that were not treated at the original
operation because they were not detected pre-operatively, not found during the
Varicose Vein Surgical Interventions Jul 16
31
operation, were deliberately left untreated or were incompletely treated. A failure to
remove the full length of a tortuous vein is the most common cause of residual
varicosities, but short saphenous vein incompetence may only become obvious when
long saphenous vein incompetence has been treated, especially if it has not been
carefully excluded before the first operation. Recurrent varicose veins are veins,
which have become varicose after the original treatment, having been considered
normal at the time of that treatment. This often occurs when all the visible
varicosities were treated but the underlying physiological abnormalities were not
corrected; the remaining normal veins therefore continue to be subjected to
abnormal pressures and subsequently dilate. The role of incompetent thigh
perforating veins has become recognized as a common cause of recurrence (39% of
patients with recurrent varicose veins have incompetent thigh perforating veins
demonstrated by venography).
Sclerotherapy is the injection of an irritant solution into an empty vein, resulting in
an endothelial reaction, fibrosis and complete venous destruction. The aim of
sclerotherapy is to eliminate reflux in the superficial venous system and thereby
eliminate visible varicose veins. The sclerotherapy process works such that a
sclerosant causes damage to the endothelial and sub-endothelial layers, resulting in
an inflammatory reaction of the venous wall, which evolves to fibrosis over a period
ranging from 6 months to several years. The aim of sclerotherapy is fibrotic
obliteration and not thrombosis of the varicose vein. Different sclerosants have been
experimented with; sodium tetradecyl sulphate is a popular choice, along with
iodine, polidocanol and sodium salicylate. Compression must accompany
sclerotherapy to aid the occlusion of the lumen by making opposing surfaces stick
together without any intervening thrombus. In conclusion, sclerotherapy especially
has a role to play in isolated varicose veins, particularly those missed by surgery. A
novel application of sclerotherapy where a sclerosant is mixed forcibly with air to
produce a foam that spreads rapidly and widely through the veins after injection.
In the REACTIV clinical trial (2006), a total of 1009 patients were recruited. Thirtyfour patents with minor varicose veins with no reflux were randomized between
conservative treatment and sclerotherapy (Group 1), 77 patients with moderate
varicose veins with reflux were randomized between surgery and sclerotherapy
(group 2) and 246 patients with severe varicose veins with reflux were randomized
between conservative treatment and surgery. The remaining 652 patients formed the
observational part of the study. Main outcome measures included health-related
quality of life (HRQoL), symptomatic relief, anatomical extent, patient satisfaction
and the incidence of complications. Results showed that only in the Group 3 arm did
surgery produce better outcomes than conservative treatment. Clinical outcomes of
surgery and sclerotherapy showed significant improvement in the extent of varicose
veins, symptomatic and HRQoL parameters. The researchers concluded that standard
surgical treatment of varicose veins by saphenofemoral ligation, stripping and
multiple phlebectomies is a clinically effective treatment for varicose veins. Injection
sclerotherapy produces less overall benefit for patients with superficial venous reflux.
In minor varicose veins without reflux, sclerotherapy is likely to provide a lesser
average benefit.
Recent studies have emerged supporting a delay of definitive treatment of residual
varicose veins in the leg after a successful endovascular ablation procedure. The
thinking is that obliteration of the primary source of incompetence at the
saphenofemoral junction eliminates backwash pressure and causes the superficial
varicose tributaries to recede or even disappear over time. At this time, there is
Varicose Vein Surgical Interventions Jul 16
32
sufficient evidence in the peer-reviewed medical literature to support the use of
sclerotherapy or phlebectomy for the treatment of residual or recurrent symptomatic
varicosities only after waiting a period of at least 3 months after surgical ligation and
stripping, VNUS or ELAS. The level of evidence supporting this conclusion includes
randomized clinical trials.
Welch (2006) studied the clinical approach of performing radiofrequency ablation
(RFA) alone as initial treatment for varicose veins. He performed a retrospective
review of the initial 184 procedures in a series from June 2002 through February
2005, allowing for a 9-month follow-up period. Postoperative duplex scans showed
total occlusion or partial patency of <10 cm in 155 limbs. Seven (4.5%) had
concomitant stab phlebectomy, seven subsequently had sclerotherapy, and 39
(25.2%) underwent subsequent stab phlebectomy of persistent symptomatic
varicosities. In 101 limbs (65.1%), symptoms resolved and had no further therapy,
and 24 limbs had a GSV that was patent for >10 cm on postoperative duplex
imaging. Nine limbs had no further therapy (37.5%), eight (33.3%) had subsequent
stab phlebectomy, and three had stripping of the GSV and stab phlebectomy. The
author concluded that endovenous ablation of the GSV can be performed safely and
effectively as the initial treatment for lower extremity varicose veins. Because most
patients show clinical improvement after RFA, an algorithm of reassessment of the
limb and branch varicose veins several months post-RFA allows most patients to
defer stab phlebectomy. Chandler (2004) also came to the conclusion that
radiofrequency endovenous obliteration (RFO) eliminates the GSV as a refluxing
conduit in >90% of limbs and that only 7.9% of 63 limbs studied required
postadjunctive phlebectomy at 2-years follow-up.
Monahan (2005) designed a study to observe the clinical sequelae of varicose veins
after great saphenous vein (GSV) ablation and to assess possible predictability of
spontaneous varicose vein regression. Fifty-four limbs in 45 patients with
symptomatic varicose veins secondary to GSV insufficiency were treated with
radiofrequency ablation (RFA). Up to five of the largest varicose veins in each limb
were mapped, sized, and documented before RFA. No varicose vein was treated
either at the time of RFA or within 6 months postoperatively. A total of 222 varicose
veins were documented before RFA with an average size of 11.4 +/- 3.7 mm. During
the follow-up period, complete resolution of visible varicose veins was seen in 13%
of limbs after RFA alone, and 63 (28.4%) varicose veins spontaneously resolved. A
further 88.7% (141/159) of varicose veins decreased in size an average of 34.6%
(4.3 +/- 3.4 mm). Preoperatively, 19.4% of varicose veins were above the knee and
75.7% were below the knee. Complete varicose vein resolution was 41.9% (18/43)
above the knee and 25.6% (43/168) below the knee. Resolution rates of the 168
below-knee varicose veins were 30.6% (33/108) of medial, 23.1% (6/26) of
anterior, 20.0% (3/15) of lateral, and 5.3% (1/19) of posterior. This paper came to
the conclusion that Great saphenous vein ablation resulted in subsequent resolution
or regression of many lower-limb visible varicose veins and that with further study
the predictability of varicose vein regression may perhaps be increased, which can
then direct the treatment strategy to further leverage the advantages of minimally
invasive endovenous procedures.
van Neer et al (2006) conducted a prospective study in 59 consecutive patients (74
limbs) to investigate the occurrence of residual varicose veins (visible and ultrasonic)
at the below-knee level after short-stripping the great saphenous vein (GSV). A
preoperative color flow duplex imaging was performed preoperatively and at 6
months after surgery. Dissection of the saphenofemoral junction and short-stripping
Varicose Vein Surgical Interventions Jul 16
33
of the GSV from the groin to just below the knee level was performed without
additional stab avulsions on the lower leg. Preoperative varicosities in the GSV below
the knee were visible in 62 limbs (70%) and were visible after surgery in 12 limbs
(16%). This study shows that reflux in the GSV below knee level after the shortstripping procedure persists in all below-knee GSV branches. Approximately 20% of
patients with visible varicose veins in the GSV area below the knee level will have
visible varicose veins in this area 6 months after the short-strip procedure.
Scientific Rationale - Initial
The venous drainage of the lower extremity is accomplished through two parallel
systems, the superficial and deep venous systems. These channels meet at the
saphenofemoral and the saphenopopliteal junctions and are connected in the legs by
perforating veins that transverse the muscle fascia. Veins in all three components
are equipped with unidirectional bicuspid valves that direct all flow toward the deep
system and cephalad. Calf muscle contraction provides the main pumping force that
propels blood toward the heart. The superficial veins (Great and lesser saphenous
veins) run within the subcutaneous tissues and the deep veins lie within various
muscular compartments of the leg, are paired, and run next to arteries. There are
more than 90 perforating veins in the lower part of each leg. At the medial malleolus,
the perforating veins are not surrounded by deep or superficial fascia and are directly
in contact with the skin. Increased deep venous pressure, as seen in chronic venous
insufficiency, is directly transmitted through the perforating vein to the skin surface,
thereby leading to superficial varicosities and the edematous, eczematous, crusted,
and often ulcerated conditions known as venous stasis dermatitis, venous
insufficiency ulcers, and lipodermatosclerosis. The Great saphenous vein (GSV) and
the lesser saphenous vein (LSV) lie deep to the superficial fascia, whereas their
tributaries lie relatively unsupported superficial to the superficial fascia, accounting
for early varicose transformation of clusters of tributary veins.
The term varicose vein is used to designate abnormally enlarged and tortuous veins
that develop when the thin flaps of the venous valves no longer meet in the midline,
allowing blood to reflux backwards. This valve incompetence leads to increased
hydrostatic pressure transmitted to the unsupported superficial vein system,
ultimately resulting in varicosities. Large varicose veins protrude above the surface
of the skin and typically are related to valve incompetence either at the saphenofemoral or saphenopopliteal junction. As the venous pressure in the deep system is
generally Great than that of the superficial system, clusters of varicosities may also
appear at the site of perforating vessels. In some instances, the valvular
incompetence may be isolated to a single perforator vein. These varicosities are
often not associated with saphenous vein incompetence since the perforating veins in
the lower part of the leg do not communicate directly with the saphenous vein.
Although many varicose veins are asymptomatic, untreated varicose veins can
progress toward significant morbidity. Varicose veins initially present as a cosmetic
concern, but can become clinically important when symptoms such as itching,
heaviness, cramping, pain, peripheral edema, hemorrhage, superficial thrombophlebitis, venous ulceration, and chronic skin changes come to the forefront. The
term telangiectasias (spider veins) is used to designate minute, visible blood vessels
that are permanently dilated.
Treatment of varicose veins may be conservative or surgical. Conservative measures
include rest and leg elevation, exercises, and pressure gradient elastic supportive
Varicose Vein Surgical Interventions Jul 16
34
stockings (> 30 mm Hg compression is recommended if there is no associated
arterial insufficiency). Diseases loosely grouped together under the heading varicose
veins are fundamentally different and require different management. It is extremely
important to make an effort to determine the nature and the location of the underlying pathology in every case before commencing treatment. Once a decision is
made to begin treatment of symptomatic varicose veins, the underlying principles
are simple. Under established guidelines, the basic tenet of successful treatment is to
eliminate the primary and secondary sources of the reflux. Under established
guidelines, long-term success in the treatment of truncal and significant branch leg
varicosities depends on the following principles, which, when observed, result in very
effective treatment:

Elimination of the most proximal point of high-grade reflux, typically at the
saphenofemoral junction (SFJ), as identified by preoperative Doppler
ultrasonography or Duplex scanning.

Isolation of the refluxing Great saphenous vein (GSV) from the circulation. The
most typical strategy for isolation is vein stripping, which is always preceded by
high ligation and division. Both VNUS and ELAS have recently gained popularity
and have been found to have similar results.

Removal of varicose tributaries. Strategies for this removal include stab
avulsion or injection sclerotherapy, either at the time of the initial treatment, or
subsequently.

If studies do not show reflux present at the major junctions, then symptomatic
varicosities of the venous tributaries can be treated by sclerotherapy or stab
avulsion.
Ligation and division of the saphenofemoral and/or saphenopopliteal junction is
indicated when reflux is demonstrated by Doppler examination or Duplex scanning.
The literature states that operative excision of varicose veins in the leg(s) should be
reserved for those that are very large (> 6 mm), extensive in distribution, or occur
in large clusters. Stripping of the Great and/or lesser saphenous vein, performed in
conjunction with ligation and division of their respective junctions, is indicated when
the saphenous veins themselves show varicose changes, usually > 1 cm in diameter.
Treatment of the proximal point of reflux is typically followed by ambulatory
phlebectomy or sclerotherapy of the remaining branches. Varicose vein surgery
and/or sclerotherapy during pregnancy is not appropriate because dilatation of veins
in the legs is physiologic and will revert to normal after delivery, at which time a
more accurate appraisal can be made.
Endoluminal radiofreqency ablation (RFA) uses a catheter containing a specifically
designed electrode that generates controlled RF energy to heat and contract
varicosities of the Great saphenous vein. The catheter is inserted into the affected
vein and advanced to 1 to 2 cm below the saphenofemoral junction. When proper
placement is confirmed by palpation or Doppler ultrasound imaging, the electrodes
are unsheathed and RF energy is delivered to the desired treatment site. The
electrodes are slowly withdrawn, occluding the entire length of the vein. The VNUS
Closure System (manufactured by VNUS Medical Technologies, Inc.) received
approval from the Food and Drug Administration (FDA) in December 1998, as
intended for endovascular coagulation of blood vessels in patients with superficial
vein reflux. Prospective case series extending to 24 months have shown success
Varicose Vein Surgical Interventions Jul 16
35
rates similar to those reported for vein ligation and stripping. Weiss and Weiss
(2002) reported complete disappearance of the treated saphenous vein in 90% of 21
patients followed for 24 months. Chandler, et al. (2000) found no statistically
significant difference in 1-year success rates from endovenous radiofrequency
catheter ablation in 120 limbs treated without saphenofemoral ligation and 120 limbs
treated with saphenofemoral ligation.
With encouraging results of laser photocoagulation treatment of vascular anomalies,
endovenous laser ablation of saphenous vein (ELAS) has been studied as a treatment
alternative to surgical ligation and stripping of the Great saphenous vein. Vein access
for endoluminal placement of a lesser laser fiber through a catheter is achieved by
means of percutaneous or stab wound incision under ultrasound guidance and local
anesthesia. Exact placement of the fiber is determined by direct observation of the
aiming beam through the skin and by ultrasound confirmation. Pulses of laser light
are emitted inside the vein causing the vein to collapse and seal shut. Laser-induced
indirect local heat injury of the inner vein wall by steam bubbles originating from
boiling blood is proposed as the pathophysiological mechanism of action. A bandage
or compression hose is placed on the treated leg following the treatment.
Short and mid-term follow up of up to 37 months has shown that vein occlusion
persists and patient symptoms are markedly reduced following ELAS treatment.
Navarro et al. reported on an uncontrolled case series of 40 limbs in 33 patients with
short term follow up showing a 100% rate of closure. Long-term follow-up is
awaited. In September 2003, Proebstle et al reported on the frequency of
recanalization of the GSV after ELAS. Their study of 104 GSVs in 82 consecutive
patients showed continued occlusion in 90.4% of patients with less than 10% of
GSVs requiring retreatment because of early recanalization after ELAS. Nine
recanalized vessels (8.6%) required further treatment with high ligation and
stripping. The histopathologic pattern mimics recanalization after thrombophlebetic
occlusion. In October 2001, Min and colleagues published the preliminary results of
ELAS treatment in 90 limbs in 84 patients with reflux at the sapheno-femoral
junction. At a mean follow up of 6 months, 99% of the Great saphenous veins
remained closed with no visible flow, as assessed by ultrasonography. Only one
recurrence was detected after 2 months. As a continuation of this study, in August
2003, they reported long-term follow-up results of endovenous laser treatment for
great saphenous vein (GSV) reflux caused by saphenofemoral junction (SFJ)
incompetence. Four hundred ninety-nine GSVs in 423 subjects with varicose veins
were treated over a 3-year period with 810-nm diode laser energy delivered
percutaneously into the GSV via a 600- micro m fiber. Patients were evaluated
clinically and with Duplex scanning at 1 week, 1 month, 3 months, 6 months, 1 year,
and yearly thereafter to assess treatment efficacy and adverse reactions.
Compression sclerotherapy was performed in nearly all patients at follow-up for
treatment of associated tributary varicose veins and secondary telangiectasis.
Successful occlusion of the GSV, defined as absence of flow on color Doppler
imaging, was noted in 490 of 499 GSVs (98.2%) after initial treatment. One hundred
thirteen of 121 limbs (93.4%) followed for 2 years have remained closed, with the
treated portions of the GSVs not visible on duplex imaging. Of note, all recurrences
have occurred before 9 months, with the majority noted before 3 months. Bruising
was noted in 24% of patients and tightness along the course of the treated vein was
present in 90% of limbs. There have been no skin burns, paresthesias, or cases of
deep vein thrombosis. The authors concluded that long-term results available in 499
limbs treated with ELAS demonstrate a recurrence rate of less than 7% at 2-year
follow-up. These results are comparable or superior to those reported for the other
Varicose Vein Surgical Interventions Jul 16
36
options available for treatment of GSV reflux, including surgery, US-guided
sclerotherapy, and radiofrequency ablation (VNUS), and that endovenous laser
appears to offer these benefits with lower rates of complication and avoidance of
general anesthesia. The most recent data seems to indicate that ELAS appears to be
an extremely safe technique that yields impressive short- and long-term results.
Since the advent of bypass grafting of coronary and peripheral arteries, every effort
is made to preserve the saphenous veins. Physicians who believe that surgery is the
treatment of choice recommend that the saphenous veins be stripped only if
diseased throughout from ankle to groin. Those who recommend extensive surgery
strip the long and sometimes the short saphenous veins and, by dissection, remove
as many of the tortuous and saccular varices as possible. The patient must be
forewarned that isolated varices may persist but can often be treated by injection
therapy.
Ambulatory phlebectomy (also known as microphlebectomy) is a minimally invasive
procedure performed under local anesthesia, and is an accepted outpatient therapy
for the removal of varicose veins. Veins most readily treated with phlebectomy
include branch varicosities of the Great saphenous vein, pudendal veins in the groin,
and varices in the popliteal fold or lateral part of the thigh. This treatment permits
removal of nearly any incompetent vein below the saphenofemoral and
saphenopopliteal junctions and almost all of the large varicose veins, except the
proximal long saphenous vein which is better-managed by stripping. After making a
microincision over the vessel using a tiny blade or a large needle, a phlebectomy
hook is introduced and the vein is delivered through the incision. Using traction on
the vein, as long a segment as possible is pulled out of the body, tearing it loose
from its tributaries and other attachments. When the vein breaks or cannot be pulled
any further, another microincision is made and the process is begun again and
repeated along the entire length of the vein to be extracted. Patients can ambulate
immediately after ambulatory phlebectomy. Complications associated with
ambulatory phlebectomy may include blister formation, localized thrombophlebitis,
skin necrosis, hemorrhage, and persistent edema. The use of broad compression
pads following ambulatory phlebectomy reduces hemorrhage and enhances
resorption.
Phlebectomy can also be used as an immediate treatment for lesser segments of
superficial phlebitis because the intravascular coagulum is expressed and the
involved vein segment can be extracted through the same incision. Typically,
varicose veins recur when the source of venous reflux is missed. Sometimes, the
cause may not be apparent until the phlebectomy is performed, particularly when
many varicose veins are present.
The TriVex System (transilluminated powered phlebectomy) is an alternative to
ambulatory phlebectomy. This entails endoscopic resection and ablation of the
superficial veins using an illuminator and a "powered vein rejector". In this
procedure, veins are marked with a magic marker in order to enhance visualization
of the veins, a bright light is introduced into the leg through a tiny incision. This
unique illumination feature allows the surgeon to quickly and accurately target and
remove the vein and then visually confirm its complete extraction. The powered vein
rejector, which has a powered oscillating end, is then introduced to cut and dislodge
the veins. The pieces of vein are then gently retrieved by suction down a tube.
Transilluminated powered phlebectomy is usually performed in the hospital on an
outpatient basis and under general anesthesia or using local anesthesia with
Varicose Vein Surgical Interventions Jul 16
37
sedation. The manufacturer claims that this method makes varicose vein removal
more effective, complete and less traumatic for patients, by reducing the number of
incisions required to perform the procedure and the duration of surgery. The
manufacturer also claims that this method not only reduces the pain associated with
varicose vein removal but also reduces the potential for post-operative infection.
Although the potential advantages of the TriVex System over standard ambulatory
phlebectomy have not been proven by studies published in the peer-reviewed
medical literature, it has become a generally accepted method.
The objective of sclerotherapy is to destroy the endothelial lining of the target vessel
by injecting an irritant solution (either a detergent, osmotic solution, or a chemical
irritant), ultimately resulting in the complete obliteration of the vessel secondary to
fibrous occlusion. Too little destruction leads to thrombosis without fibrosis and
ultimate recanalization. Too much destruction leads to vascular dehiscence. The
success of the treatment depends on accurate injection of the vessel, an adequate
injectant volume and concentration of sclerosant, and post-procedure compression.
Compression theoretically results in direct apposition of the treated vein walls to
provide more effective fibrosis and may decrease the extent of the thrombosis
formation. The risk of complications depends on the agent used, its concentration
and the quantity injected. Of note is the fact that perforators should not be treated
with sclerotherapy. Published long-term randomized controlled clinical studies have
demonstrated that surgery plus sclerotherapy is more effective than surgery alone
for treatment of varicosities associated with incompetence of the saphenofemoral
junction. However, it behooves one to wait for at least 6 months after vein ligation
and stripping because one may be surprised that all or the vast majority of lesser to
moderate size (< 6 mm) residual varicosities scattered throughout the leg(s) may
disappear after the backwash pressure has been eliminated. Visible subcuticular
veins (i.e., spider angiomas, and telangiectasias) less than 2 mm in size do not
cause symptoms and their treatment is purely cosmetic.
Application of injection sclerotherapy to the Great or lesser saphenous vein has been
investigated as a minimally invasive alternative to vein stripping, either with or
without ligation. Since the saphenous vein is not visible with the naked eye, injection
is typically guided by ultrasonography, and the combined procedure may be referred
to as "echosclerotherapy”. Since the Great saphenous vein is larger and deeper than
telangiectatic dermal veins, sclerotherapy of this vein raises issues regarding
appropriate volume and concentration of the sclerosant, and the ability to provide
adequate volume and concentration of the sclerosant, and the ability to provide
adequate postprocedure compression. Moreover, the use of sclerotherapy, as
opposed to the physical removal of the vein and stripping, raises the issue of
recurrence due to recanalization. Long-term recurrence rates are higher after
sclerotherapy than after surgery for the treatment of varicose veins. The use of
injection sclerotherapy for trunk varices has fallen in recent years, partly because of
concerns about complications such as skin staining and ulceration and also because
up to 65% of patients treated by sclerotherapy develop recurrent varicose veins
within five years, much below that seen for GSV ligation and stripping Sclerotherapy
alone is rarely if ever used as definitive therapy for very large (>1 cm) or tortuous
varicosities.
In recent years several proposals have been done for treatment of varicose veins
with a detergent sclerosing solution transformed in a foam. This is thought provide
several advantages as opposed to liquid solution due to the different behavior of the
drug when injected as a foam: (1) enhanced adhesiveness of the sclerosant to the
Varicose Vein Surgical Interventions Jul 16
38
vein inner wall; (2) compactness with poor initial mixing with blood, thus providing
better predictability of concentration obtained in the vein segment to be treated; (3)
longer persistence of the foam, hence different variables have to be considered in
choosing the right amount and concentration of drug; (4) visibility at duplex
scanning due to the air (or different gases) present in the foam; (5) enhancement of
sclerosing power and of spasm occurrence; and (6) reduction of drug doses because
from 0.5 ml of liquid it is possible to produce at least 2-3 ml of foam.
Telangiectasias and/or varicose veins are present in about 33% of adult women and
15% of adult men. Although they may be only of cosmetic concern, superficial
varices often cause significant symptoms such as pain, aching, heaviness, and
pruritus. Venous ulceration is commonly caused solely by superficial venous
insufficiency. Superficial thin-walled veins may rupture and hemorrhage.
Sclerotherapy is a nonsurgical procedure that can be used to treat both lesser and
large varices of the superficial venous system and perforators. This involves injecting
a sclerosant intraluminally to cause fibrosis and eventual obliteration of a vein. The
most common sclerosants used in the U.S. include sodium tetradecyl sulfate,
polidocanol, 23.4% saline, and a combination of 25% dextrose with 10% saline.
Treatment generally proceeds from proximal to distal and largest to the smallest
vein, based on a reflux map developed from physical examination, Doppler, and
duplex ultrasound. Sclerotherapy results can be optimized and the risk of
complications minimized by choosing the proper sclerosant, sclerosant concentration,
sclerosant volume, and injection sites for the vein(s) being treated. Post-treatment
instructions, particularly compression and ambulation, are designed to improve the
results and safety of sclerotherapy. Adequate understanding of an appropriate
history and physical, ultrasound evaluation, anatomy, pathophysiology, knowledge of
sclerosing solutions, patient selection, and post-treatment care, as well as the ability
to prevent, recognize, and treat complications are required before embarking on
treatment.
There is little evidence, in the form of randomized prospective clinical trials, to
support the belief that sclerotherapy of the GSV or LSV alone is as effective as
saphenous vein ligation and/or striping, VNUS or ELAS, even when ultrasound is
used to guide the injection of sclerosing agent. Since the saphenous vein is not
visible with the naked eye, injection is typically guided by ultrasonography, and the
combined procedure may be referred to as "echosclerotherapy”. In fact, there is also
no proof that ultrasound makes a significant difference in optimizing outcome or
decreasing complications from sclerotherapy for varicose veins, when compared to
non-ultrasound-guided techniques. A structured evidence review conducted by the
Alberta Heritage Foundation for Medical Research (AHFMR - 2003) concluded that
“the reviewed evidence does not adequately address the questions; which sclerosant
is superior and which technique with or without ultrasound guidance is most
efficacious.”
Since the saphenous vein is not visible with the naked eye, injection is typically
guided by ultrasonography, and the combined procedure may be referred to as
"echosclerotherapy." Injection sclerotherapy or ligation of incompetent perforator
veins can prevent or arrest the breakdown of the tributaries of the varicose veins.
The dermatitis component usually responds to mid-strength topical steroid
ointments. Topical antibiotics should be avoided unless specific cultures warrant their
use, because these patients have a high rate of contact sensitization. Lipodermatosclerosis responds to support stockings alone but may require adjunctive therapy
with pentoxifylline or stanazolol.
Varicose Vein Surgical Interventions Jul 16
39
Subfascial endoscopic perforator vein surgery (SEPS) is a minimally invasive
endoscopic procedure that eliminates the need for the traditional open surgical
treatment (the Linton procedure). It is designed to interrupt incompetent medial calf
perforating veins to reduce venous reflux and decrease ambulatory venous
hypertension in critical areas above the ankle where tissue destruction and venous
ulcers most frequently develop. Available evidence confirms the superiority of SEPS
over open perforator ligation, but does not address its role in the surgical treatment
of advanced chronic venous insufficiency and venous ulceration. Because ablation of
superficial reflux by high ligation and stripping of the Great saphenous vein with
avulsion of branch varicosities is concomitantly performed in the majority of patients
undergoing SEPS, the clinical and hemodynamic improvements attributable to SEPS
alone thus are difficult to ascertain. As with open perforator ligation, clinical and
hemodynamic results are better in patients with primary valvular incompetence than
in those with the post-thrombotic syndrome. Until prospective, randomized,
multicenter clinical studies are performed to address lingering questions regarding
the effectiveness of SEPS, the procedure is recommended in patients with advanced
CVI secondary to PVI of superficial and perforating veins, with or without deep
venous incompetence. The performance of SEPS in patients with post-thrombotic
syndrome remains controversial.
Review History
September 2003
April 2006
June 2007
December 2007
March 2008
April 2008
September 2008
November 2008
February 2009
September 2009
January 2010
April 2011
Medical Advisory Council initial approval
Revised – number of sclerotherapy sessions initially authorized
revised from 3 to 6
Policy totally revamped
Added lesser saphenous vein incompetence as a criterion for
VNUS
Code updates
Added photographic documentation of the varicosities must be
taken by the Provider in the Provider’s office, to #4, pg. 2 in
policy statement.
Update. Removed requirement of trial with compression
stockings, removed plethysmography and added photographic
documentation only for sclerotherapy of smaller veins . Added
requirement of duplex ultrasound. Added ‘Great &/or Small’ to
Saphenous Vein verbiage. Added restriction of two separate
procedures only for venous ablation of same area, same vein.
Codes reviewed. A trial of conservative therapy of six weeks of
nonoperative management added for severe venous
insufficiency.
Add optional requirements for photographs in accordance with
regional prior authorization requirements
Added pre-treatment photographs of varicose veins for
sclerotherapy as a local Medicare required service as dictated by
specific local Medicare carriers
Revised policy. It is considered investigational to do saphenous
vein ligation/division/stripping and venous ablation on the same
vein during the same procedure. Codes reviewed.
Added additional verbiage regarding photographs. Codes
reviewed.
Updated – added links to Medicare LCDs
Varicose Vein Surgical Interventions Jul 16
40
April 2012
November 2012
November 2013
January 2014
January 2015
January 2016
February 2016
July 2016
Update. Removed ‘Saphenous vein ligation/division/stripping and
venous ablation done on the same vein during the same
procedure’, from not medically necessary list. Removed ‘Without
recurrent signs or symptoms’ for additional injections of
sclerotherapy for documented recanalization or failure of vein
closure, from investigational list. Removed SEPS from not
medically necessary NOTE.
Added medically necessary criteria for the treatment of
pathologic perforating veins to the policy statement
Update – no revisions. Codes Updated.
Update. Added mechanicochemical ablation (MOCA) (Eg.
ClariVein Occlusion Catheter, Nonthermal Vein Ablation System)
as investigational. Codes Updated.
Update – no revisions. Codes Updated.
Added Varithena as investigational. Codes updated.
Added VenaSeal Closure System (i.e., uses cyanoacrylate
embolization [CAE]) as investigational since there is a paucity of
peer-reviewed literature to support it.
Removed Varithena as investigational
This policy is based on the following evidenced-based guideline:
1.
The American Academy of Dermatology. Guidelines of Care for Sclerotherapy
Treatment of Varicose and Telangiectatic Leg Veins. 1996.
2. The National Institute for Clinical Excellence (NICE). Radiofrequency ablation of
varicose veins. IP Guidance Number: IPG0008. London, UK: NICE; September
24, 2003.
3. Alberta Heritage Foundation for Medical Research (AHFMR). Sclerotherapy for
varicose veins of the legs. Technote. TN 40. AHFMR; October 2003.
4. No authors listed. Position statement: Endovenous ablation. Society of
Interventional Radiology, Fairfax, VA. December 2003.
5. National Institute for Clinical Excellence (NICE). Ultrasound-guided foam
sclerotherapy for varicose veins. Interventional Procedure Consultation
Document. London, UK: NICE; July 2004.
6. The American Academy Of Cosmetic Surgery: 2003 Guidelines for Sclerotherapy
7. No authors listed. Recommendations and medical references of ANAES.
Indications for surgical treatment of primary varicosities of the legs. J Mal Vasc.
1998;23(4):297-308.
8. No authors listed. Guidelines of care for sclerotherapy treatment of varicose and
telangiectatic leg veins. American Academy of Dermatology. J Am Acad
Dermatol. 1996;34(3):523-528.
9. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose
veins and associated chronic venous diseases: clinical practice guidelines of the
Society for Vascular Surgery and the American Venous Forum. J Vasc Surg.
2011 May;53(5 Suppl):2S-48S.
10. Hayes. Search & Summary. ClariVein Occlusion Catheter, Nonthermal Vein
Ablation System (Vascular Insights LLC) for Varicose Veins. November 2013.
Archived December 7, 2014.
11. National Institute for Healthcare and Excellence (NICE). Endovenous
mechanochemical ablation for varicose veins. (IPG435). January 2013.
12. Hayes. Health Technology Brief. Endovenous Mechanochemical Ablation (MOCA)
(ClariVein Occlusion Catheter, Nonthermal Vein Ablation System [Vascular
Insights LLC]) for Treatment of Varicose Veins. March 12, 2015.
Varicose Vein Surgical Interventions Jul 16
41
References – Update February 2016
1.
2.
3.
4.
5.
Golzarian J, Sapoval MR, Kundu S, et al. Guidelines for Peripheral and Visceral
Vascular Embolization Training. J Vasc Interv Radiol 2010; 21:436–44.1
Konez O. Vascular Lesion Embolization Imaging. Medscape. October 13, 2015.
Manning WJ. Principles of Doppler echocardiography. UpToDate. January 14,
2015.
Morrison N, Gibson K, McEnroe S. et al. Randomized trial comparing
cyanoacrylate embolization and radiofrequency ablation for incompetent great
saphenous veins (VeClose). J Vasc Surg 2015 Apr;61(4):985-94.
U.S. FDA. VenaSeal. FDA approves closure system to permanently treat varicose
veins. February 15, 2015.
References – Update January 2016
1.
Bootun R, Lane T, Dharmarajah B, Lim C, et al. Intra-procedural pain score in a
randomised controlled trial comparing mechanochemical ablation to
radiofrequency ablation: The Multicentre Venefit versus ClariVein for varicose
veins trial. Phlebology. 2014 Sep 5. [Epub ahead of print].
2. Bond K, Harstall C, Dennett L, et al. Endovenous ablation interventions for
symptomatic varicose veins of the legs. Edmonton, AB: Institute for Health
Economics; September 2014.
3. Brittenden J, Cotton SC, Elders A, et al. A randomized trial comparing
treatments for varicose veins. N Engl J Med. 2014;371(13):1218-1227.
4. Markovic JN, Shortell CK. Varicose vein surgery. Scientific American Surgery,
August 2014.
5. Proebstle TM, Alm BJ, Göckeritz O, et al. Five-year results from the prospective
European multicenter cohort study on radiofrequency segmental thermal
ablation for incompetent great saphenous veins. Br J Surg. 2015; 102(3):212218.
6. Tassie E, Scotland G, Brittenden J, et al. CLASS study team. Cost-effectiveness
of ultrasound-guided foam sclerotherapy, endovenous laser ablation or surgery
as treatment for primary varicose veins from the randomized CLASS trial. Br J
Surg. 2014;101(12):1532-1540.
7. Todd KL 3rd, Wright DI. VANISH-2 Investigator Group. 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 saphenofemoral junction incompetence. Phlebology.
2014;29(9):608-618.
8. Vun S, Rashid S, Blest N, Spark J. Lower pain and faster treatment with
mechanico-chemical endovenous ablation using ClariVein. Phlebology. 2014 Oct
8. [Epub ahead of print]
9. Todd, KL, Wright, DI (2014) VANISH-2 Investigor Group. 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 if saphofemoral junction incompetence. Phlebology 2014:29:608
10. Regan JD, Gibson KD, Rush JE, Shortell CK, Hirsch SA, Wright DD. Clinical
significance of cerebrovascular gas emboli during polidocanol endovenous ultralow nitrogen microfoam ablation and correlation with magnetic resonance
imaging in patients with right-to-left shunt. J Vasc Surg. 2011;53(1):131-137.
11. Wright D, Gobin JP, Bradbury AW, et al. Varisolve polidocanol microfoam
compared with surgery or sclerotherapy in the management of varicose veins in
the presence of trunk vein incompetence: European randomized controlled trial.
Phlebology. 2006;21(4):180-190.
Varicose Vein Surgical Interventions Jul 16
42
12. Wright DD, Gibson KD, Barclay J, Razumovsky A, Rush J, McCollum CN. High
prevalence of right-to-left shunt in patients with symptomatic great saphenous
incompetence and varicose veins. J Vasc Surg. 2010;51(1):104-107. Available
at: http://www.jvascsurg.org/article/S0741-5214(09)01621-8/fulltext.
References – Update January 2015
1.
2.
Rhee SJ, Cantelmo NL, Conrad MF, et al. Factors influencing the incidence of
endovenous heat-induced thrombosis (EHIT). Vasc Endovascular Surg 2013;
47:207.
Samuel N, Carradice D, Wallace T, et al. Randomized clinical trial of endovenous
laser ablation versus conventional surgery for small saphenous varicose veins.
Ann Surg 2013; 257:419.
References – Update January 2014
1.
2.
3.
4.
5.
6.
Boersma D, van Eekeren RR, Werson DA. Mechanochemical endovenous ablation
of small saphenous vein insufficiency using the ClariVein() device: one-year
results of a prospective series. European Journal of Vascular & Endovascular
Surgery. 45(3):299-303, 2013 Mar.
Clinicaltrial.gov. Early Outcome of Mechanochemical Endovenous Ablation
(ClariVein-2). Clinicaltrial.gov identification number NCT01459263. September
2013. Available at:
http://www.clinicaltrials.gov/ct2/show/NCT01459263?term=NCT01459263&rank
=1
Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final
results of the initial clinical trial. Phlebology 2012; 27(2):67-72.
Kendler M. Averbeck M. Simon JC. Histology of saphenous veins after
treatment with the ClariVein device - an ex-vivo experiment. 11(4):348-52,
2013 Apr.
Mueller RL, Raines JK. ClariVein mechanochemical ablation: background and
procedural details. Vascular & Endovascular Surgery. 47(3):195-206, 2013 Apr.
Reijnen M, de Vries JPM. Safety and feasibility of mechano-chemical ablation of
varicose veins: Initial results. St. Antonios Hospital, The Netherlands. 2012.
References – Update November 2013
1.
2.
3.
4.
5.
6.
Alguire PC, Scovell S. Overview and management of lower extremity chronic
venous disease. UpToDate. October 14, 2013.
Bashaw M. Surgical risk factors in geriatric perioperative patients. AORN J - 01JUL-2012; 96(1): 58-74.
Biemans AA, Kockaert M, Akkersdijk GP, et al. Comparing endovenous laser
ablation, foam sclerotherapy, and conventional surgery for great saphenous
varicose veins. J Vasc Surg 2013; 58:727.
Eidt JF. Open surgical techniques for lower extremity vein ablation. UpToDate.
July 29, 2013. Updated November 2013.
Harlander-Locke M, Jimenez JC, Lawrence PF, et al. Endovenous ablation with
concomitant phlebectomy is a safe and effective method of treatment for
symptomatic patients with axial reflux and large incompetent tributaries. J Vasc
Surg 2013; 58:166.
Huang TW, Chen SL, Bai CH, et al. The optimal duration of compression therapy
following varicose vein surgery: a meta-analysis of randomized controlled trials.
Eur J Vasc Endovasc Surg 2013; 45:397.
References – Update November 2012
Varicose Vein Surgical Interventions Jul 16
43
1.
Alden PB, Lips EM, Zimmerman KP, et al. Chronic Venous Ulcer: Minimally
Invasive Treatment of Superficial Axial and Perforator Vein Reflux Speeds
Healing and Reduces Recurrence. Ann Vasc Surg. 2012 Oct 18.
2. Dumantepe M, Tarhan A, Yurdakul I, Ozler A. Endovenous Laser Ablation of
Incompetent Perforating Veins with 1470nm, 400μm Radial Fiber. Photomed
Laser Surg. 2012 Oct 3
3. Harlander-Locke M, Lawrence PF, Alktaifi A, et al. The impact of ablation of
incompetent superficial and perforator veins on ulcer healing rates. J Vasc Surg.
2012 Feb;55(2):458-64.
4. Harlander-Locke M, Lawrence P, Jimenez JC, Rigberg D, et al. Combined
treatment with compression therapy and ablation of incompetent superficial and
perforating veins reduces ulcer recurrence in patients with CEAP 5 venous
disease. J Vasc Surg. 2012 Feb;55(2):446-50.
5. Hingorani AP, Ascher E, Marks N, et al. Predictive factors of success following
radio-frequency stylet (RFS) ablation of incompetent perforating veins (IPV). J
Vasc Surg. 2009 Oct;50(4):844-8.
6. Lawrence PF, Alktaifi A, Rigberg D, et al. Endovenous ablation of incompetent
perforating veins is effective treatment for recalcitrant venous ulcers. J Vasc
Surg. 2011 Sep;54(3):737-42.
7. Marsh P, Price BA, Holdstock JM, Whiteley MS. One-year outcomes of
radiofrequency ablation of incompetent perforator veins using the radiofrequency
stylet device. Phlebology. 2010 Apr;25(2):79-84.
8. Park SW, Hwang JJ, Yun IJ, et al. Randomized Clinical Trial Comparing Two
Methods for Endovenous Laser Ablation of Incompetent Perforator Veins in Thigh
and Great Saphenous Vein Without Evidence of Saphenofemoral Reflux.
Dermatol Surg. 2011 Dec 30. doi: 10.1111/j.1524-4725.2011.02261.x.
9. van den Bos RR, Wentel T, Neumann MH, Nijsten T. Treatment of incompetent
perforating veins using the radiofrequency ablation stylet: a pilot study.
Phlebology. 2009 Oct;24(5):208-12.
10. O'Donnell TF Jr. The present status of surgery of the superficial venous system
in the management of venous ulcer and the evidence for the role of perforator
interruption. J Vasc Surg 2008; 48:1044
References – Update April 2012
1.
2.
3.
4.
5.
6.
7.
Alguire PC, Mathes BM. Post-thrombotic (Postphlebitic) syndrome. UpToDate.
February 14, 2011.
Chapman-Smith P. Prospective five-year study of ultrasound-guided foam
sclerotherapy in the treatment of great saphenous vein reflux. Phlebology.
2009;24 (4):183.
Collins KA. Open surgical techniques for lower extremity vein ablation.
UpToDate. April 13, 2010.
Ihnat DM. Endovenous laser ablation for the treatment of lower extremity
chronic venous disease. UpToDate. September 2011. Updated October 31. 2013.
Pannier F, Rabe E, Maurins U. 1470 nm diode laser for endovenous ablation
(EVLA) of incompetent saphenous veins - a prospective randomized pilot study
comparing warm and cold tumescence anaesthesia. Vasa 2010; 39:249.
Rasmussen LH, Bjoern L, Lawaetz M, et al. Randomised clinical trial comparing
endovenous laser ablation with stripping of the great saphenous vein: clinical
outcome and recurrence after 2 years. Eur J Vasc Endovasc Surg. 2010; 39
(5):630.
Rasmussen LH, Lawaetz M, Bjoern L, et al. Br J Surg. 2011 Aug;98 (8):1079-87.
Randomized clinical trial comparing endovenous laser ablation, radiofrequency
Varicose Vein Surgical Interventions Jul 16
44
8.
ablation, foam sclerotherapy and surgical stripping for great saphenous varicose
veins.
Schanzer H. Endovenous ablation plus microphlebectomy/sclerotherapy for the
treatment of varicose veins: single or two-stage procedure? Vasc Endovascular
Surg 2010; 44:545.
References – Update September 2009
1.
Leopardi D, Hoggan BL, Fitridge RA, et al. Systematic Review of Treatments for
Varicose Veins. Annals of Vascular Surgery. Volume 23, Issue 2, Pages 264-276
(March 2009).
2. Theivacumar NS, Dellagrammaticasa D, Darwooda RJ, et al. Fate of the Great
Saphenous Vein Following Endovenous Laser Ablation: Does Re-canalization
Mean Recurrence? European Journal of Vascular and Endovascular Surgery.
Volume 36, Issue 2, August 2008, Pages 211-215.
3. Singh MJ, Sura C. Endovenous Saphenous and Perforator Vein Ablation.
Operative Techniques in General Surgery - Volume 10, Issue 3 (September
2008).
4. Proebstle TM, et al. Treatment of the incompetent great saphenous vein by
endovenous radiofrequency powered segmental thermal ablation: first clinical
experience. J Vasc Surg - 01-JAN-2008; 47(1): 151-156.
5. Luebke T, et al. Meta-analysis of endovenous radiofrequency obliteration of the
great saphenous vein in primary varicosis. J Endovasc Ther, 01-APR-2008.
6. Hirsch SA, Dillavou E. Options in the management of varicose veins. J Card
Surg 49. 19-26.2008.
7. Harris JE. Radiofrequency ablation of the long saphenous vein without high
ligation versus high ligation and stripping for primary varicose veins: Pros and
cons. Seminars in Vascular Surgery. Available November 19, 2008.
8. Bush R.L., Constanza R.M.: Endovenous saphenous and perforator vein
ablation. Sem Vasc Surg 21. 50-53.2008.
9. Townsend: Sabiston Textbook of Surgery, 18th ed. The Biological Basis of
Modern Surgical Practice. 2007 Saunders, An Imprint of Elsevier.
10. Kundu S, Laurie F, Millward SF. Recommended reporting standards for
endovenous ablation of the treatment of venous insufficiency: Joint statement of
the American Venous Forum and the Society of Interventional Radiology. J Vasc
Inter Rad 18. 1073-1080.2007.
11. Lurie F, Creton D, Eklof B, et al. Prospective randomised study of endovenous
radiofrequency obliteration (closure) versus ligation and vein stripping
(EVOLVeS): two-year follow-up. Eur J Vasc Endovasc Surg. Jan 2005;29(1):6773.
References – Update February 2009
1.
2.
3.
CMS, Centers for Medicare & Medicaid Services. LCD for VARICOSE VEINS OF
THE LOWER Extremity, TREATMENT OF (L25519). National Government
Services, Inc. Revision Effective Date is for services performed on or after
11/14/2008.
CMS, Centers for Medicare & Medicaid Services. LCD for VARICOSE VEINS OF
THE LOWER Extremity, TREATMENT OF (L27596). Contractor Name - Palmetto
GBA. Revision Effective Date: 01/01/2009,
CMS, Centers for Medicare & Medicaid Services. LCD for VARICOSE VEINS OF
THE LOWER Extremity, TREATMENT OF (L25519). National Government
Services, Inc. Contractor number 00660.
Varicose Vein Surgical Interventions Jul 16
45
4.
5.
CMS, Centers for Medicare & Medicaid Services. LCD for VARICOSE VEINS OF
THE LOWER Extremity, TREATMENT OF (L25519). National Government
Services, Inc. Contractor number 13101.
CMS, Centers for Medicare & Medicaid Services. LCD for Varicose Veins of the
Lower Extremity, Treatment of (L25519).
References – Update September 2008
1.
2.
3.
4.
5.
6.
7.
8.
Moll FL, der Kinderen DJ, Verdaasdonk IRM. Endovenous Therapy for Varicose
Veins. 2008. Available at: http://igitur-archive.library.uu.nl/dissertations/20080710-200451/disselhoff.pdf
Rakel & Bope: Conn's Current Therapy 2008, 60th ed. Venous Stasis Ulcers,
Diagnosis and Treatment, Chapter 213.
Brotman DJ. Prevention of Venous Thromboembolism in the Geriatric Patient
Cardiol Clin - 01-MAY-2008; 26(2): 221-34, vi.
Weiss R, Ramelet AA. Varicose Veins Treated With Ambulatory Phlebectomy.
eMedicine. 2007. Available at: http://www.emedicine.com/derm/topic748.htm
Rahma A, Ali F. J. Noninvasive Vascular Diagnosis. 2nd edition. Berlin: Springer
Verlag. 2007.
Gloviczki T, Yao JSt. Handbook of Venous Disorder. 3rd Edition. London, UK:
Arnold, 2007.
Primary Venous Insufficiency. 2007. Townsend: Sabiston Textbook of Surgery,
18th ed.
Eklof B, et al. Revision of the CEAP classification for chronic venous disorders:
Consensus statement. J Vasc Surg 2004; 40:1248-52.
References – Update June 2007
1.
2.
Rakel & Bope: Conn's Current Therapy 2008, 60th ed.
Gibbs S, van den Hoogenband HM, de Boer EM. Wound healing in venous ulcers;
mechanisms, approach and modern developments. Ned Tijdschr Geneeskd. 2007
Mar 17;151(11):635-40.
3. Recek C. Historical review of opinions on the nature of varicose veins and leg
ulcers and their treatment. Rozhl Chir. 2006 Dec;85(12):641-5. .
4. Rajendran S, Rigby AJ, Anand SC. Venous leg ulcer treatment and practice--Part
3: The use of compression therapy systems. J Wound Care. 2007
Mar;16(3):107-9.
5. Lopez P, Dachs R. Effectiveness of dressings for healing venous leg ulcers. Am
Fam Physician. 2007 Mar 1;75(5):649-50.
6. Subramonia S, Lees TA. The treatment of varicose veins. Ann R Coll Surg Engl.
2007 Mar;89(2):96-100.
7. Rajendran S, Rigby AJ, Anand SC. Venous leg ulcer treatment and practice--part
1: the causes and diagnosis of venous leg ulcers. J Wound Care. 2007
Jan;16(1):24-6.
8. Coleridge-Smith P, Labropoulos N, Partsch H, et al. Duplex ultrasound
investigation of the veins in chronic venous disease of the lower limbs--UIP
consensus document. Part I. Basic principles. Vasa. 2007 Feb;36(1):53-61.
9. Do DD, Husmann M. Diagnosis of venous disease. Herz. 2007 Feb;32(1):10-7.
10. Rajendran S, Rigby AJ, Anand SC. Venous leg ulcer treatment and practice--Part
2: Wound management. J Wound Care. 2007 Feb;16(2):68-70.
11. Etufugh CN, Phillips TJ. Venous ulcers. Clin Dermatol. 2007 Jan-Feb;25(1):12130.
Varicose Vein Surgical Interventions Jul 16
46
12. Sadick NS. Advances in the treatment of varicose veins: ambulatory
phlebectomy, foam sclerotherapy, endovascular laser, and radiofrequency
closure. Adv Dermatol. 2006;22:139-56.
13. Sackheim K, De Araujo TS, Kirsner RS. Compression modalities and dressings:
their use in venous ulcers. Dermatol Ther. 2006 Nov-Dec;19(6):338-47.
14. O'Donnell TF Jr, Lau J. A systematic review of randomized controlled trials of
wound dressings for chronic venous ulcer. J Vasc Surg. 2006 Nov;44(5):111825.
15. Alekseev KI, Starkov IuG, Shishin KV. Subfascial endoscopic dissection of knee
perforant veins in the treatment of chronic venous insufficiency. Khirurgiia
(Mosk). 2006;(9):71-5.
16. Tisi PV, Beverley C, Rees A. Injection sclerotherapy for varicose veins. Cochrane
Database Syst Rev. 2006 Oct 18;(4):CD001732.
17. Recek C. Impact of the calf perforators on the venous hemodynamics in primary
varicose veins. J Cardiovasc Surg (Torino). 2006 Dec;47(6):629-35.
18. Marchiori A, Mosena L, Prandoni P. Superficial vein thrombosis: risk factors,
diagnosis, and treatment. Semin Thromb Hemost. 2006 Oct;32(7):737-43.
19. Welch HJ. Endovenous ablation of the great saphenous vein may avert
phlebectomy for branch varicose veins. J Vasc Surg. 2006 Sep;44(3):601-5.
20. Hach-Wunderle V, Hach W. Invasive therapeutic options in truncal varicosity of
the great saphenous vein. Vasa. 2006 Aug;35(3):157-66.
21. Palfreyman SJ, Nelson EA, Lochiel R, Michaels JA. Dressings for healing venous
leg ulcers. Cochrane Database Syst Rev. 2006 Jul 19;3:CD001103.
22. Stirling M, Shortell CK. Endovascular treatment of varicose veins. Semin Vasc
Surg. 2006 Jun;19(2):109-15.
23. Carr SC. Current management of varicose veins. Clin Obstet Gynecol. 2006
Jun;49(2):414-26.
24. Michaels JA, Campbell WB, Brazier JE, et al. Randomised clinical trial,
observational study and assessment of cost-effectiveness of the treatment of
varicose veins (REACTIV trial). Health Technol Assess. 2006 Apr;10(13):1-196,
iii-iv.
24. Vowden KR, Vowden P. Preventing venous ulcer recurrence: a review. Int Wound
J. 2006 Mar;3(1):11-21.
25. Chandler JG, Pichot O, Kabnick LS, et al. Duplex ultrasound scan findings two
years after great saphenous vein radiofrequency endovenous obliteration. J Vasc
Surg. 2004 Jan;39(1):189-95.
26. Monahan DL. Can phlebectomy be deferred in the treatment of varicose veins? J
Vasc Surg. 2005 Dec;42(6):1145-9. Links
27. van Neer P, Kessels A, de Haan E, et al. Residual varicose veins below the knee
after varicose vein surgery are not related to incompetent perforating veins. J
Vasc Surg. 2006 Nov;44(5):1051-4.
28. Kavuturu S, Girishkumar H, Ehrlich F. Endovenous laser ablation of saphenous
vein is an effective treatment modality for lower extremity varicose veins. Am
Surg. 2006 Aug;72(8):672-5; discussion 675-6.
References – Revision April 2006
1. Chong TW, Bott MJ, Kern JA, et al. Subfascial endoscopic perforating vein surgery
(SEPS) for the treatment of venous ulcers. Ostomy Wound Manage. 2005
Sep;51(9):26-31.
2. Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser
treatment for varicose veins. Br J Surg. 2005 Oct;92(10):1189-94.
3. Min RJ, Khilnani NM. Endovenous laser ablation of varicose veins. J Cardiovasc
Surg (Torino). 2005 Aug;46(4):395-405.
Varicose Vein Surgical Interventions Jul 16
47
4. Sadick NS. Advances in the treatment of varicose veins: ambulatory
phlebectomy, foam sclerotherapy, endovascular laser, and radiofrequency
closure. Dermatol Clin. 2005 Jul;23(3):443-55.
5. Rass K. Modern aspects of varicose vein surgery. Hautarzt. 2005 May;56(5):44856.
6. Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May
10;111(18):2398-409.
7. Tisi P. Varicose veins. Clin Evid. 2004 Dec;(12):309-16.
8. Bartholomew JR, King T, Sahgal A, Vidimos AT. Varicose veins: newer, better
treatments available. Cleve Clin J Med. 2005 Apr;72(4):312-4, 319-21, 325-8.
9. Cheatle T. The long saphenous vein: to strip or not to strip? Semin Vasc Surg.
2005 Mar;18(1):10-4.
References - Initial
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Schadeck M. Current status of sclerotherapy of varicose veins. Hautarzt. 2003
Nov;54(11):1065-72.
Barrett JM, et al. Microfoam ultrasound-guided sclerotherapy of varicose veins in
100 legs. Dermatol Surg 2004; 30(1): 6-12
Belcaro G, et al. Foam-sclerotherapy, surgery, sclerotherapy, and combined
treatment for varicose veins: a 10-year, prospective, randomized, controlled,
trial (VEDICO trial). Angiology 2003; 54(3): 307-15
Hsu TS. Foam sclerotherapy: a new era. Arch Dermatol 2003; 139(11): 1494-6
Hamel-Desnos C. Evaluation of the efficacy of polidocanol in the form of foam
compared with liquid form in sclerotherapy of the Great saphenous vein: initial
results. Dermatol Surg 2003; 29(12): 1170-5; discussion 1175
Alonzo U, Ruffolo F, Leonardi L, et al: Ambulatory phlebectomy. Literature
review and personal experience. Minerva Cardioangiol 1997 Apr; 45(4): 121-9.
Cohn MS, Seiger E, Goldman S: Ambulatory phlebectomy using the tumescent
technique for local anesthesia. Dermatol Surg 1995 Apr; 21(4): 315-8.
De Roos KP, Neumann HA: Muller's ambulatory phlebectomy for varicose veins
of the foot. Dermatol Surg 1998 Apr; 24(4): 465-70.
Ferrara G, Meloni V, Annessi M, et al: Ambulatory phlebectomy with Muller
procedure in the treatment of lower limb varices. Indications, technique and
long-term results. Minerva Chir 1995 Jul-Aug; 50(7-8): 681-5.
Garde C: Ambulatory phlebectomy. Dermatol Surg 1995 Jul; 21(7): 628-30.
Weiss RA, Weiss MA: Ambulatory phlebectomy compared to sclerotherapy for
varicose and telangiectatic veins: indications and complications. Adv Dermatol
1996; 11: 3-16; discussion 17.
Chandler J, Pichot O, Sessa C, et al. Treatment of primary venous insufficiency
by endovenous saphenous vein obliteration. Vascular Surgery. 2000: 34(3):
201-214.
Goldman M. Closure of the Great saphenous vein with endoluminal
radiofrequency thermal heating of the vein wall in combination with ambulatory
phlebectomy: preliminary 6-month follow-up. Dermatol Surg 2000: 26(5): 452456.
Dixon PM. Duplex ultrasound in the pre-operative assessment of varicose veins.
Australas Radiol. 1996;40(4):416-421.
Campbell WB, Halim AS, Aertssen A, et al. The place of duplex scanning for
varicose veins and common venous problems. Ann R Coll Surg Engl.
1996;78(6):490-493.
Fronek A. Non-invasive examination of the venous system in the leg:
Presclerotherapy evaluation. J Dermatol Surg Oncol. 1992;15(2):170-171.
Varicose Vein Surgical Interventions Jul 16
48
17. Houghton AD, Panayiotopoulos Y, Taylor PR. Practical management of primary
varicose veins. Br J Clin Pract. 1996;50(2):103-105.
18. Neglen P, Einarsson E, Eklof B. The functional long-term value of different types
of treatment for saphenous vein incompetence. J Cardiovasc Surg.
1993;34(4):295-301.
19. Goldman MP, Weiss RA, Bergan JJ. Diagnosis and treatment of varicose veins: A
review. J Am Acad of Dermatol. 1994:31(3 Pt 1):393-413.
20. DeGroot WP. Treatment of varicose veins: Modern concepts and methods. J
Dermatol Surg. 1989;15(2):191-198.
21. Zimmet SE. Venous leg ulcers: Modern evaluation and management. Dermatol
Surg. 1999;25(3):236-241.
22. Dortu JA, Constancias-Dortu I. Treatment of varicose veins of the lower limbs by
ambulatory phlebectomy (Muller's method): Technique, indications and results.
Ann Chir. 1997;51(7):761-772.
23. Goldman MP, Eckhouse S. Photothermal sclerosis of leg veins. Dermatol Surg.
1996;22(4):323-330.
24. Ricci S. Ambulatory phlebectomy. Principles and evolution of the method.
Dermatol Surg. 1998;24(4):459-464.
25. Otley CC, Mensink LM. The phlebectomy probe: A new and useful instrument for
ambulatory phlebectomy. Dermatol Surg. 1999;25(7):573-575.
26. Olivencia JA. Pitfalls in ambulatory phlebectomy. Dermatol Surg.
1999;25(9):722-725.
27. Goldman MP. Closure of the Great saphenous vein with endoluminal
radiofrequency thermal heating of the vein wall in combination with ambulatory
phlebectomy: Preliminary 6-month follow-up. Dermatol Surg. 2000;26(5):452456.
28. Weiss R. Commentary on endovenous laser. Dermatol Surg. 2001;27(3):326327.
29. Min RJ, Zimmet SE, Isaacs MN, et al. Endovenous laser treatment of the
incompetent Great saphenous vein. J Vasc Interv Radiol. 2001;12(10):11671171.
30. Navarro L, Min RJ, Bone C. Endovenous laser: A new minimally invasive method
of treatment for varicose veins -- preliminary observations using an 810 nm
diode laser. Dermatol Surg. 2001;27(2):117-122.
31. Tisi PV, Beverley CA. Injection sclerotherapy for varicose veins (Cochrane
Review). In: The Cochrane Library, Issue 1, 2002. Oxford, UK: Update Software.
32. Michaels JA, Kendall RJ. Surgery for varicose veins (Protocol for a Cochrane
Review). In: The Cochrane Library, Issue 1, 2002. Oxford, UK: Update Software.
33. Weiss RA. Endovenous techniques for elimination of saphenous reflux: A
valuable treatment modality. Dermatol Surg. 2001;27(10):902-905.
34. Manfrini S, Gasbarro V, Danielsson G, et al. Endovenous management of
saphenous vein reflux. Endovenous Reflux Management Study Group. J Vasc
Surg. 2000;32(2):330-342.
35. Goldman MP, Amiry S. Closure of the Great saphenous vein with endoluminal
radiofrequency thermal heating of the vein wall in combination with ambulatory
phlebectomy: 50 patients with more than 6-month follow-up. Dermatol Surg.
2002;28(1):29-31.
36. Weiss RA, Weiss MA. Controlled radiofrequency endovenous occlusion using a
unique radiofrequency catheter under duplex guidance to eliminate saphenous
varicose vein reflux: A 2-year follow-up. Dermatol Surg. 2002;28(1):38-42.
37. Bergan, J.J., et al. Surgical and Endovascular Treatment of Lower Extremity
Venous Insufficiency.
38. Journal of Vascular and Interventional Radiology. June 2002; 13(6):563-8.
Varicose Vein Surgical Interventions Jul 16
49
39. Bergan, J.J. Endovenous Saphenous Vein Ablation. Advances in Vascular
Surgery. 2001; Volume 9:123-132.
40. Chandler, J.G., et al. Defining the Role of Extended Saphenofemoral Junction
Ligation: A Prospective Comparative Study. Journal of Vascular Surgery.
November 2000; 32(5): 941-953.
41. Chandler, J.G., et al. Treatment of Primary Venous Insufficiency by Endovenous
Saphenous Vein Obliteration. Vascular Surgery. May / June 2000; 34(3):201214.
42. Fassiadis, N., et al. A Novel Approach to the Treatment of Recurrent Varicose
Veins. International Angiology. September 2002; 21(3):275-6.
43. Fassiadis, N., et al. Ultrasound Changes at the Saphenofemoral Junction and in
the Long Saphenous Vein During the First Year After VNUS Closure.
Interventional Angiology. September 2002; 21(3):272-4.
44. Goldman, M.P., et al. Closure of the Great Saphenous Vein with Endoluminal
Radiofrequency Thermal Heating of the Vein Wall in Combination With
Ambulatory Phlebectomy: 50 Patients with More Than 6-Month Follow-up.
Dermatological Surgery. January 2002; 28(1):29-31.
45. Kabnick, L.S. and Merchant, R.F. Twelve and Twenty-four Month Follow-up after
Endovascular Obliteration of Saphenous Vein Reflux – A Report from the MultiCenter Registry. Journal of Phlebology. October – December 2001; 1(1):17-24.
46. Manfrini, S., et al. Endovenous Management of Saphenous Vein Reflux.
Endovenous Reflux Management Study Group. Journal of Vascular Surgery.
August 2000; 32(2):330-42.
47. Merchant, R.F., et al. Endovascular Obliteration of Saphenous Reflux: A
Multicenter Study. Journal of Vascular Surgery. June 2002; 35(6):1190-1196.
48. Pichot, O, et al. Role of Duplex Imaging in Endovenous Obliteration for Primary
Venous Insufficiency. Journal of Endovascular Therapy. December 2000;
7(6):451-459.
49. Rautio, T., et al. Endovenous Obliteration with Radiofrequency-resistive Heating
for Great Saphenous Vein Insufficiency: A Feasibility Study. Journal of Vascular
and Interventional Radiology. June 2002; 13(6):569-75.
50. Rautio, T., et al. Endovenous Obliteration versus Conventional Stripping
Operation in the Treatment of Primary Varicose Veins: A Randomized Controlled
Trial with Comparison of the Costs. Journal of Vascular Surgery. May 2002;
35(5):958-965.
51. Sybrandy, J.E., et al. Initial Experiences in Endovenous Treatment of Saphenous
Vein Reflux. Journal of Vascular Surgery. December 2002; 36(6):1207-12.
52. Weiss, R.A. and Weiss, M.A. Controlled Radiofrequency Endovenous Occlusion
using a Unique Radiofrequency Catheter under Duplex Guidance to Eliminate
Saphenous Varicose Vein Reflux: A 2-Year Follow-up. Dermatologic Surgery.
January 2002; 28(1):38-42.
53. Proebstle TM, Gul D, Lehr HA, et al. Infrequent early recanalization of Great
saphenous vein after endovenous laser treatment. J Vasc Surg. 2003
Sep;38(3):511-6.
54. Parente EJ, Rosenblatt M. Endovenous laser treatment to promote venous
occlusion. Lasers Surg Med. 2003;33(2):115-8.
55. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein
reflux: longterm results. J Vasc Interv Radiol. 2003 Aug;14(8):991-6.
56. Bush RG. Regarding "Endovenous treatment of the Great saphenous vein with a
940-nm diode laser: thrombolytic occlusion after endoluminal thermal damage
by laser-generated steam bubbles". J Vasc Surg. 2003 Jan;37(1):242; author
reply 242.
Varicose Vein Surgical Interventions Jul 16
50
57. Min RJ, Khilnani NM. Lower-extremity varicosities: endoluminal therapy. Semin
Roentgenol. 2002 Oct;37(4):354-60.
58. Proebstle TM, Gul D, Kargl A, Knop J. Endovenous laser treatment of the lesser
saphenous vein with a 940-nm diode laser: early results. Dermatol Surg. 2003
Apr;29(4):357-61.
59. Proebstle TM, Lehr HA, Kargl A, et al. Endovenous treatment of the Great
saphenous vein with a 940-nm diode laser: thrombotic occlusion after
endoluminal thermal damage by laser-generated steam bubbles. J Vasc Surg.
2002 Apr;35(4):729-36.
60. Chang CJ, Chua JJ. Endovenous laser photocoagulation (EVLP) for varicose
veins. Lasers Surg Med. 2002;31(4):257-62.
61. Bergan JJ, Kumins NH, Owens EL, Sparks SR. Surgical and endovascular
treatment of lower extremity venous insufficiency. J Vasc Interv Radiol. 2002
Jun;13(6):563-8.
62. Gerard JL, Desgranges P, Becquemin JP, et al. Feasibility of ambulatory
endovenous laser for the treatment of Great saphenous varicose veins: onemonth outcome in a series of 20 outpatients. J Mal Vasc. 2002 Oct;27(4):222-5.
63. Min RJ, Zimmet SE, Isaacs MN, Forrestal MD. Endovenous laser treatment of the
incompetent Great saphenous vein. J Vasc Interv Radiol. 2001 Oct;12(10):116771.
64. Navarro L, Min RJ, Bone C. Endovenous laser: A new minimally invasive method
of treatment for varicose veins – preliminary observations using an 810 diode
laser. Dermatol Surg. 2001;27:117-122.
65. Weiss R. Commentary on endovenous laser. Dermatol Surg. 2001;27(3):326327.
Important Notice
General Purpose.
Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering
plan benefits and determining whether a particular procedure, drug, service or supply is medically
necessary. The Policies are based upon a review of the available clinical information including clinical
outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device,
evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select
national health professional organizations. Coverage determinations are made on a case-by-case basis
and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract,
including medical necessity requirements. Health Net may use the Policies to determine whether under the
facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically
necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not
constitute coverage. The member's contract defines which procedure, drug, service or supply is covered,
excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current
criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical
criteria and medical policies provide guidelines for determining the medical necessity criteria for specific
procedures, equipment, and services. In order to be eligible, all services must be medically necessary and
otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all
cases, final benefit determinations are based on the applicable contract language. To the extent there are
any conflicts between medical policy guidelines and applicable contract language, the contract language
prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it
intended to dictate to providers how to practice medicine.
Policy Effective Date and Defined Terms.
The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined
by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for
prior notification. If there is a discrepancy between the policy effective date and legal mandates and
regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior
notice or posting on the website is required before a policy is deemed effective. For information regarding
the effective dates of Policies, contact your provider representative.
The Policies do not include
definitions. All terms are defined by Health Net. For information regarding the definitions of terms used
in the Policies, contact your provider representative.
Varicose Vein Surgical Interventions Jul 16
51
Policy Amendment without Notice.
Health Net reserves the right to amend the Policies without notice to providers or Members.
states, prior notice or website posting is required before an amendment is deemed effective.
In some
No Medical Advice.
The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to
members. Members should consult with their treating physician in connection with diagnosis and
treatment decisions.
No Authorization or Guarantee of Coverage.
The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service
or supply. Members and providers should refer to the Member contract to determine if exclusions,
limitations, and dollar caps apply to a particular procedure, drug, service or supply.
Policy Limitation: Member’s Contract Controls Coverage Determinations.
Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize,
modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary
depending on individual need and the benefits covered under your contract. The determination of
coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is
subject to the facts of the individual clinical case, terms and conditions of the member’s contract, and
requirements of applicable laws and regulations. The contract language contains specific terms and
conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and
other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the
benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s
contract shall govern. The Policies do not replace or amend the Member’s contract.
Policy Limitation: Legal and Regulatory Mandates and Requirements
The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable
legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal
mandates and regulatory requirements, the requirements of law and regulation shall govern.
Reconstructive Surgery
CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery.
“Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body
caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do
either of the following:
(1) To improve function or
(2) To create a normal appearance, to the extent possible.
Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape
normal structures of the body in order to improve appearance.
Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal
improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by
physicians specializing in reconstructive surgery.
Reconstructive Surgery after Mastectomy
California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices
or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy.
Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or
deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and
conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for
medically necessary reasons, as determined by a licensed physician and surgeon.
Policy Limitations: Medicare and Medicaid
Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and
determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid
members shall not be construed to apply to any other Health Net plans and members. The Policies shall
not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.
Varicose Vein Surgical Interventions Jul 16
52