VEnous INtervention VEIN Project by ps94506

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									VENOUS FORUM OF THE ROYAL SOCIETY OF MEDICINE




VEnous INtervention
VEIN Project
VEnous INtervention (VEIN) Project

Venous Forum of The Royal Society of Medicine

The VEIN project was                         about how and when to employ them.
                                             The VEIN Project was conceived
conceived and supervised by:                 to define how services should be
David Berridge
                                             provided for patients with symptomatic,
Tim Lees
                                             uncomplicated varicose veins, and the
Jonathan Michaels
                                             way the interventions should be delivered.
Alun Davies
                                             Standardisation of facilities and methods
Jonothan Earnshaw
                                             is expected to produce optimal results
                                             from all the interventions.
Supported by
A grant from the Venous Forum of the         The VEIN Project is a collection of six
Royal Society of Medicine                    evidence-based articles concerning
                                             interventions for uncomplicated varicose
Endorsed by                                  veins, and the methods currently
The Councils of the Venous Forum of          available. This summary document
the Royal Society of Medicine and the        uses these papers to define the various
Vascular Society of Great Britain and        interventions and standards for their
Ireland in February 2009.                    use. It is envisaged that the project
                                             documents will be used by healthcare
Introduction:                                professionals, commissioning groups, and
Varicose veins affect up to 25% of the       even patients to influence the provision of
adult population in the United Kingdom.      varicose vein treatment in their hospitals.
Their management comprises a significant     Readers of this summary document
proportion of the workload of most           are strongly encouraged to refer to the
vascular specialists. In the last decade a   complete articles which are published in
variety of new treatments have become        a supplement of the journal Phlebology
available, yet there remains controversy     2009.



The VEIN Project
Bachoo P Interventions for uncomplicated
         .                                   Gohel M, Davies AH. Radiofrequency
varicose veins. Phlebology 2009; 24 suppl    ablation for uncomplicated varicose veins.
1: 3-12.                                     Phlebology 2009; 24 suppl 1: 42-49.

Palfreyman S. A systematic review of         Darwood R, Gough M. Endovenous laser
compression hosiery for uncomplicated        treatment for uncomplicated varicose
varicose veins. Phlebology 2009; 24 suppl    veins. Phlebology 2009; 24 suppl 1: 50-61.
1: 13-33.
                                                               .
                                             Coleridge Smith P Foam and liquid
Perkins J. Standard varicose vein surgery.   sclerotherapy for varicose veins.
Phlebology 2009; 24 suppl 1: 34-41.          Phlebology 2009; 24 suppl 1: 62-73.

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    VEnous INtervention (VEIN) Project

    1. Components of a                           interventions. A tilting treatment couch
                                                 capable of Trendelenburg and reverse
       venous service                            Trendelenburg positions is necessary
                                                 for foam sclerotherapy and endovenous
    1.1 Assessment. Every patient referred       thermal ablation techniques. The room
    with uncomplicated varicose veins            should be large enough for the laser or
    should undergo a formal assessment           radiofrequency generator, the infusion
    that includes: history (including severity   pump, duplex machine, disposables,
    of symptoms), clinical examination           sclerotherapy equipment, drugs and
    and investigation. Assessment should         dressings. It will need to accommodate
    include examination with hand-held           the operator and up to two assistants.
    Doppler (HHD) by a clinician trained in      It needs to be well illuminated and
    the technique, and who can interpret         ventilated, but have the capacity to dim
    the findings. There is some evidence         the light (blinds or dimmer switch) to
    that duplex imaging should be a routine      see the duplex monitor screen easily.
    part of the investigation of every           Separate secure patient and staff
    patient with varicose veins, particularly    changing facilities also need to be close
    if they are to undergo intervention. It      by. For laser therapy it is mandatory that
    is necessary as part of both selection       the facilities are inspected and signed off
    and control during foam sclerotherapy,       by the institution’s laser safety officers
    laser and radiofrequency ablation.           (usually part of the Medical Physics
    Preoperative duplex has been shown           / Radiation Safety Department of a
    in a randomised trial to improve the         Hospital).
    outcome from standard varicose vein
    surgery. Where clinicians choose to          1.3 Training Standard varicose vein
    employ the investigation selectively         surgery is currently a core activity
    before standard surgery, the following       taught to all vascular surgical specialists
    are specific indications for preoperative    during their training, and monitored
    duplex imaging: recurrent varicose veins,    through logbooks, training review and
    reflux in the popliteal fossa on HHD (all    RITAs. Established consultants should
    small saphenous varicose veins) and past     consider adding their procedures to a
    history of deep vein thrombosis (DVT).       database such as the Venous Registry
                                                 (www/host.e-dendrite.com/CSP/IVF/
    1.2 Facilities. The major change in          Frontpages/ivrfront.csp) to monitor
    the delivery of venous intervention in       outcome and performance. For trained
    the last decade has been the move            vascular specialists who wish to develop
    away from treatment under general            a new service such as endovenous laser
    anaesthesia in a sterile operating theatre   ablation therapy (EVLT), radiofrequency
    to ambulant outpatient treatment. For        ablation (RFA) or foam sclerotherapy (FS),
    optimal delivery this requires a dedicated   training and mentoring are essential.
    venous intervention room, which may          This should comprise training in the
    be situated in outpatients. The area         theoretical aspects of the technique, the
    should be easily cleaned, and stocked        equipment required and the technique
    with all the equipment needed for the        itself. All of the new methods require
2
duplex ultrasound imaging skills, and      segment (cm), settings of the laser / RFA
duplex-guided venous cannulation, which    generator, or dose and type of sclerosant.
should be learned before undertaking       A record should also be kept of the efficacy
any new intervention. This process         of the technique and any complications.
should be agreed with the relevant         All procedures should only be undertaken
hospital authorities, and documented       according to current guidance at the time
by the individuals. Only when all these    from the National Institute of Health and
components have been achieved and          Clinical Excellence (NICE).
competence has been demonstrated
should the vascular specialist undertake   1.5 Vascular specialists should only offer
the procedure independently.               treatments that they are trained and able
                                           to deliver, but they should be able to
1.4 Documentation. The indications         inform patients about the available range
for any venous intervention should be      of alternative treatments. Most current
documented clearly in the medical notes.   specialists will offer an alternative to
Consent to the treatment should be taken   standard surgery. Patients who choose an
by a member of the team trained to take    intervention that is not available at their
consent and written information sheets     referral hospital should have the opportunity
should be given to each patient before     to transfer to a centre where it is available.
the intervention. For each technique       Information sheets describing the risks and
there should be an accurate record         benefits of the available treatments should
of the operator, site(s) of cannulation,   be available to patients before they decide
energy used (Joules), length of treated    what to have done.




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    VEnous INtervention (VEIN) Project

    2. Indications for intervention               2.5 New thermal ablation techniques
                                                  for treating varicose veins all show a
    2.1 There exist evidence-based                consistent improvement in disease-
    treatments for patients with complications    specific quality of life after intervention.
    from their varicose veins such as leg         Compared to standard surgery, the trials
    ulceration and thrombophlebitis. This         suggest a reduction in pain and earlier
    document specifically examines the            return to normal activity.
    potential advantage of treating patients
    with symptomatic, uncomplicated               3. Compression Hosiery
    varicose veins.
                                                  3.1 There are five different systems
    2.2 Varicose veins are associated with a      applied to the categorisation of
    negative effect on the physical domains       compression stockings. United Kingdom
    of quality of life measurement. A large       (UK) hospitals use the European Standard,
    prospective cohort collaborative study        whereas community pharmacists use
    involving 5,688 subjects over 5 years,        the UK Standard. As such, a patient
    concluded that the reduction in quality       wearing Class II stockings using the UK
    of life (both generic and disease-specific)   Standard will have a pressure range of
    was directly linked to the severity of the    approximately 18-24 mm of mercury
    varicose veins. This has been confirmed in    compared to 23-32 mm of mercury for
    a number of other studies.                    the Class II prescribed according to the
                                                  European Standard. Clinicians must be
    2.3 In the REACTIV trial (Michaels et         aware of the different systems, and be
    al, 2006), which compared surgery or          sure that their patients are prescribed
    conservative treatment for symptomatic,       the appropriate strength; patients with
    uncomplicated varicose veins, 57% of          uncomplicated varicose veins usually
    patients randomised to conservative           need Class II UK Standard hosiery.
    treatment expressed unhappiness and
    over half sought surgical intervention.       3.2 Skin necrosis can occur with badly
    Patients who had surgery for their veins      fitting stockings. The risk increases in
    had a marked improvement in quality           patients with impaired blood supply
    of life; the cost per quality adjusted life   and/or impaired sensation, especially
    year (QALY) was £1864, well below the         diabetics. Rolling down of the stockings
    acceptable threshold of £30,000 for           can effectively cause a tourniquet on the
    treatments within the National Health         leg. In the absence of easily palpable
    Service.                                      foot pulses, ankle brachial pressure index
                                                  (ABPI) should be measured to exclude
    2.4 In the same study, liquid sclerotherapy   arterial disease before compression
    was lower cost, but also produced lower       hosiery is prescribed. In general,
    QALY gains. Liquid sclerotherapy has          compression hosiery should not be
    a higher recurrence rate than surgery         prescribed when the ABPI is less than
    (Belcaro et al, 2003; Einarrson at el,1993;   0.9.
    and Rutges and Kitslaar, 1994).

4
3.3 Compression hosiery can improve           however, that there was no difference
symptoms in patients with uncomplicated       between Class I and Class II stockings.
varicose veins. Of 23 clinical studies        Both European Class I and II stockings
included in the systematic review             were shown to improve leg symptoms
(Palfreyman, 2009), only three were           compared with controls by Cochlan et al,
randomised trials. Hosiery improved pain      2001. Wearing stockings during pregnancy
and discomfort compared to no stockings,      does not affect the progression of
but only while the stockings were actually    varicose veins (Thaler et al, 2001).
worn; there was no long-term benefit.
                                              3.6 There is no evidence to suggest
3.4 A combination of exercise and             that long leg stockings have any
compression stockings can improve             advantage over below knee length
symptoms more than stockings alone.           hosiery, either for symptom control or
Compliance with compression hosiery is        treatment. Nor is there any evidence
often poor. In one study there was a 39%      that wearing compression stockings
withdrawal rate (Chant et al, 1989). Raju     prevents progression of varicose veins or
et al 2007 in a large cohort study of 3,144   recurrence after treatment.
patients reported that only 37% had full,
or even partial compliance.                   3.7 Compliance remains a fundamental
                                              issue, and vascular teams should include
3.5 There remains controversy over            an individual (usually a specialist nurse)
the value of compression hosiery              with responsibility for optimising the use
during pregnancy. Two randomised              of compression hosiery: providing advice
studies explored the value of Class I         and support to patients and general
compression tights, but concluded they        practice, keeping updated with industry
were not suitable. It was also noticed,       advances and stocking aids.




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    VEnous INtervention (VEIN) Project

    4. Standard Varicose                              use of a barrier (prosthetic patch) at the
                                                      SFJ is not yet supported by controlled
       Vein Surgery                                   trials for either primary or recurrent veins.
    4.1 Conventional surgery remains                  4.5 Due to the variable anatomy at the
    the most common form of varicose                  saphenopopliteal junction (SPJ), pre-
    vein intervention in the NHS. All new             operative duplex imaging is advised,
    techniques must be assessed against this          with marking of the junction an option.
    previously gold standard.                         This allows for accurate placement of the
                                                      skin incision, but has not been shown to
    4.2 In the NHS, surgery for varicose              improve the clinical outcome. The results
    veins is limited to those with significant        of small saphenous varicose vein surgery
    symptoms and/or complications (NICE               are not as good as GSV surgery, with
    guidance, 2001). Surgical intervention for        higher rates of persistent reflux in up to
    uncomplicated varicose veins improves             25% (Rashid et al, 2002, van Rij et al,
    quality of life and symptom relief                2003). It is not clear whether flush SPJ
    compared to conservative treatment                ligation and/or stripping can optimise the
    (Michaels et al, 2006). Indeed, many              outcome for SSV surgery, though more
    patients get long term satisfaction after 10      surgeons now routinely expose the SPJ
    years, associated with relief or improved         than in 2004 (10% vs. 67%) (Winterborn
    symptoms (Campbell et al, 2003).                  et al, 2004, Campbell 2007). There is
                                                      early evidence that stripping the SSV to
    4.3 Although there is evidence that               mid calf can improve the haemodynamic
    routine duplex imaging can improve the            result, and does not appear to increase
    accuracy of varicose vein surgery, it is still    the rate of sural nerve damage.
    acceptable that surgery is planned on the
    basis of HHD alone in selected patients           4.6 The additional value of perforating
    (experienced surgeon, typical great               vein surgery for primary varicose veins
    saphenous veins).                                 has not been demonstrated convincingly.
                                                      Traditional open operation was associated
    4.4 The single evidence based component           with significant wound problems.
    of standard surgery is routine stripping of
                                                      Sub-facial endoscopic perforator
    the great saphenous vein (GSV) to knee
    level. There is no obvious advantage to
                                                      surgery (SEPS) reduced the rate of wound
                                                      complications and was associated with
    any particular brand of stripping device,
                                                      fewer incompetent perforator veins at 1
    but inversion stripping appears to cause
                                                      year, but had no effect on recurrence or
    the least associated trauma (Durkin et al,
                                                      quality of life (Kianiford et al, 2007).
    1999). Stripping can reduce recurrence
    and reoperation rates. Other suggested
                                                      4.7 Multi stab phlebectomies causes
    practice techniques are: clear dissection
                                                      less postoperative bruising and pain than
    of the saphenofemoral junction (SFJ);
                                                      transluminated-powered phlebectomy
    division of all tributaries at the SFJ, closure
                                                      (TIPP). (Chetter et al, 2006).
    of the cribriform fascia, the use of a thigh
    tourniquet to minimise bleeding. Routine

6
4.8 Serious complications are few after      The majority of vascular surgeons in a
varicose vein surgery. Injury to the         postal questionnaire did not give routine
saphenous nerve injury occurs after 7%       prophylaxis ten years ago (Lees et al,
of procedures, but does not usually affect   1999). However, the failure to perform a
quality of life (Holme, 1990). Major nerve   risk assessment and provide prophylaxis
injuries such as sural nerve and common      in high risk patients is potentially
peroneal nerve damage resulting in foot      negligent (Scurr and Scurr, 2007). All
drop are rare (2-4% Atkin et al, 2007).      patients undergoing varicose vein surgery
All patients undergoing varicose vein        should have a risk assessment, and
surgery should be counselled about these     thromboprophylaxis is mandatory in high
potential complications as part of the       risk patients (see NICE Guidelines CG46 –
consent process.                             www.nice.org.uk). It is justified to exclude
                                             thromboprophylaxis in young, fit patients
4.9 DVT is also rare after varicose vein     undergoing varicose vein surgery that
surgery; the rate of pulmonary embolus       lasts for less than 1h.
is approximately 0.6% (Critchley et al,
1997). There remains controversy about
whether all patients undergoing varicose
vein surgery require thromboprophylaxis.




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    VEnous INtervention (VEIN) Project

    5. Radiofrequency Ablation                      consensus on the ideal regimen. Delayed
                                                    sclerotherapy or phlebectomies may be
    5.1 Radiofrequency ablation (RFA) for           used to deal with residual veins after the
    the treatment of superficial venous             truncal veins have been treated with RFA.
    reflux was introduced in 1998, and has
    evolved significantly. RFA uses a bipolar       5.5 The main reported complications
    endovenous catheter that generates              following RFA include skin burns, nerve
    temperatures of 85-120°c at the vein            damage and deep vein thrombosis,
    wall. This is controlled locally by inbuilt     although all these are rare. Patients
    feedback using vein wall impedance.             also need to be counselled about the
                                                    possibility of residual, or recurrent veins
    5.2 The method was originally designed          (since long term outcome data are
    as a continuous pull back technique             lacking).
    (VNUS Closure ™, VNUS Medical
    Technologies, San Jose, California, USA).       5.6 A systematic review (Gohel and
    However in 2006, VNUS introduced the            Davies, 2009) identified 23 published
    Closure Fast™ technique allowing 7 cm           reports comprising 3 randomised studies,
    segments to be treated in 20 seconds.           2 meta-analyses and 15 prospective
    Another RFA device (the Olympus Celon           observational studies. Only one study
    RFITT™, (Olympus Medical Systems,               involved the VNUS ClosureFast™ system.
    Hamburg, Germany) is also available.            Initial vein occlusion rates were 89%
                                                    at 3 months, reducing to 80% after
    5.3 Tumescent local anaesthesia is              5 years (van den Boss et al, 2008). In
    common to both RFA and endovenous               a prospective international registry
    laser ablation (EVLA). Surrounding the          (Merchant and Pichot, 2005) suggested
    vein to be treated with fluid reduces the       late occlusion rates of 87 .2% at 5 years.
    risk that healthy tissues will suffer thermal
    damage. Some authors use normal saline          5.7 The newer VNUS ClosureFast™
    alone, others use Hartman’s solution in         system was reported to have an occlusion
    combination with local anaesthetic to give      rate of 99.6% within 2 years in a single
    additional anaesthesia/analgesia. Dilute        prospective series (Proebstle et al, 2008).
    epinephrine may be added to reduce local
    bleeding. General anaesthesia is only           5.8 Quality of life appears to be improved
    required if multiple phlebectomies are          after both RFA and EVLA, with no
    done at the same time.                          significant difference between the two in
                                                    the medium term in comparative studies.
    5.4 The vein to be treated is cannulated        RFA is suitable for the office outpatient
    under duplex ultrasound control; accurate       environment with subsequent reduction
    positioning is essential. The RFA probe         in costs. Both techniques also enable a
    should be sited 2cm below to the                more rapid return to work than standard
    refluxing junction (SFJ or SPJ). After          surgery.
    the treatment, Class I or II graduated
    compression stockings are employed              5.9 There is a learning curve to the
    for 1-2 weeks, although there is no             RFA technique. There is no substitute

8
for appropriate training, mentorship            local anaesthetic, unless they are in a high
and continued audit to ensure that              risk category. Similarly phlebitis (2.9%)
complication rates are kept to the              and skin burn (1.2%) occur occasionally,
minimum. Operators should be familiar           though the majority were reported before
with the equipment used, particularly the       the use of tumescence became routine
energy generator and the RFA catheters.
They must also be competent to use              5.11 As with the other new endovenous
duplex ultrasound imaging for monitoring        techniques, the intervention should
the RFA process.                                only be undertaken according to current
                                                NICE guidelines. It is important to collect
5.10 Although a rate of DVT as high as          outcome data including occlusion and
16% was reported in one study (Hingorani        complication rates. Medium and long
et al, 2004), the overall DVT rate is usually   term outcome data are also important to
less than 1% (Merchant et al, 2005). For        ensure that late recurrence is a rare event.
this reason thromboprophylaxis is not
required in patients having RFA under




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     VEnous INtervention (VEIN) Project

     6. Endovenous Laser Ablation                   Trendelenberg position to maximise
                                                    vein diameter. Thus a tilting table is
     6.1 Endovenous laser ablation (EVLA)           recommended. Once the fibre is correctly
     involves insertion of a laser fibre into the   positioned the table is moved to the
     incompetent truncal vein (usually great or     Trendelenberg position to empty the vein
     small saphenous vein) with subsequent          of blood before ablation. EVLA does not
     thermal ablation of the vein. Laser is         require an operating theatre and may be
     an acronym for “light amplification            performed in an outpatient setting.
     by stimulated emission of radiation”   .
     Monochromatic light is emitted from a          6.5 A randomised controlled trial
     laser medium (both diodes and Nd:YAG           comparing above-knee EVLA alone
     are used for EVLA) and amplified by            with above and below knee EVLA (from
     mirrors. Lasers with wavelengths from          the lowest point of reflux) in patients
     808 nm to 1320 nm have been used for           with below-knee GSV incompetence
     EVLA. Wavelength is a determinant of           has confirmed a superior symptomatic
     laser penetration and absorption but there     outcome from below-knee EVLA,
     is no evidence that wavelength affects         with only 17% of patients having
     clinical outcome.                              residual varicosities requiring delayed
                                                    sclerotherapy (versus 61% for above-knee
     6.2 Although EVLA was initially used to        ablation).
     treat great saphenous vein (GSV) reflux
     there are several large series describing      6.6 The “dose” of laser energy delivered
     successful small saphenous vein and            can be expressed as joules (J)/cm vein,
     anterior saphenous vein ablation. There        sometimes called linear endovenous
     are also isolated reports of treatment         energy density (LEED) or as fluence,
     of incompetent perforating veins and           which is laser energy delivered for a given
     varicosities themselves. Generally,            surface area (J/cm2). Optimum occlusion
     the vein needs to be straight to allow         rates are achieved with a minimum laser
     the passage of the laser fibre, though         energy of 60J/cm. Withdrawal of the laser
     more tortuous veins can be treated by          fibre at a rate of 1cm/5 seconds using
     experienced practitioners.                     14W power allows easy and accurate
                                                    delivery of 70J/cm. The fibre may be
     6.3 EVLA is usually performed using            withdrawn in a stepped or continuous
     tumescent local anaesthesia which              fashion and the laser fired continuously
     provides analgesia, compresses the vein        or with 1 second exposures. Continuous
     thus enhancing contact between the             withdrawal now appears to be favoured.
     vein wall and laser fibre, and protects        This reduces treatment times and perhaps
     surrounding tissues from thermal               perforation and bruising.
     damage. Techniques for anaesthesia are
     similar for EVLA and RFA.                      6.7 Randomised controlled trials suggest
                                                    that abolition of GSV reflux, improvements
     6.4 The vein for ablation is cannulated        in quality of life, patient satisfaction and
     percutaneously under ultrasound                cosmesis are similar for surgery and
     guidance with the patient in the reverse       EVLA. Three studies also show that post-

10
treatment discomfort was no different          complications include hyperpigmentation,
for either technique. Case series of EVLA      arteriovenous fistula and thread vein
with 1-3 year duplex follow-up have            formation, and skin burns.
reported truncal vein ablation rates of 93-
99%, with most recanalisations appearing       6.10 The clinician undertaking EVLA
within the first year.                         should assess the patient following
                                               referral to confirm that treatment is
6.8 Five studies which have used the           indicated. They should be experienced in
Aberdeen Varicose Vein Symptom                 assessing patients with venous disease
Questionnaire have shown an                    and understand the benefits and risks of
improvement in quality of life following       different treatment modalities. Training
truncal vein ablation. There are no good       for EVLA includes developing ultrasound
data regarding the cost-effectiveness          skills (unless the assistance of a trained
of EVLA. Three studies have used a             ultrasonographer is sought), knowledge
patient-completed visual analogue score        about laser safety issues and training in the
(which may be subject to positive skew)        EVLA technique. The clinician performing
indicating satisfaction with cosmetic          EVLA should be able undertake follow-up,
outcome after EVLA.                            provide any further treatment that may be
                                               required and manage complications.
6.9 Post-treatment discomfort or
tenderness over the treated vein is usually    6.11 New guidance was issued in April of
termed phlebitis, with symptoms maximal        this year on the safe use of lasers by the
5-7 days after treatment. Estimates of         MHRA (DB 2008(03)) and can be accessed
frequency range from 0-33% of patients.        via their website (www.mhra.gov.uk).
This appears more common with higher           The procedure should be undertaken in
laser doses perhaps reflecting thermal         accordance with NICE guidelines, and after
injury rather than a true phlebitis. Routine   local agreement with the hospital Trust.
prescription of non-steroidal analgesia for    Suitable mechanisms should be in place for
3-5 days post-EVLA may lessen the pain         clinical governance and audit. In addition
and inflammation. Some bruising seems          to the information recorded for all invasive
common in the majority of patients             procedures/surgery power and energy
secondary to either administration of          delivery should be recorded together with
tumescent anaesthesia or vein wall             follow-up data on occlusion rates and
perforation by the laser. The incidence        adverse events. Adverse incidents relating
of cutaneous nerve injury is between           to laser use should be reported to the
1-10% with the majority being temporary.       MHRA.
The incidence of DVT is low. Other rare




                                                                                               11
     VEnous INtervention (VEIN) Project

     7. Sclerotherapy                              A 5 micron filter placed between the
                                                   air and sclerosant syringes can improve
     7.1 Liquid sclerotherapy has been available   the quality of the foam. Currently
     for use for almost 50 years. Initially        acceptable sclerosants include: Sodium
     popular, controlled trials suggested it was   Tetra Decyl Sulphate STD, Fibro-vein,
     associated with high recurrence rates:        STD Pharmaceuticals, Hereford, UK)
     up to 50% had residual saphenofemoral         or Polidocanol 0.5-3% (Sclero vein™,
     reflux after treatment of truncal veins.      ResinAG, Zurich, Switzerland). A
     Since the introduction of ultrasound-         range of concentrations of sclerosant
     guided foam sclerotherapy (FS) by             should be available for use. Absolute
     Cabrera in 1995 there has been renewed        contraindications to FS include previous
     interest in sclerotherapy. Many case          severe allergy and occluded deep veins,
     series have described good early results      but caution should be exercised in any
     with FS, but few have included follow-up      patient with previous DVT. A resuscitation
     beyond three years.                           box should be available containing rescue
                                                   drugs and equipment for the treatment of
     7.2 Foam sclerotherapy is a new discipline    anaphylaxis.
     that involved skills that most current
     vascular specialists did not acquire during   7.5 All cannulae (venflon or butterfly
     training. It involves diagnostic imaging      needles) should be sited in the vein
     using duplex (though this may be done by      before foam is introduced. At all times it
     a trained vascular scientist), ultrasound-    is vital that the tip of the cannula remains
     guided venous cannulation, and use of         within the vein lumen; regular flushing
     ultrasound imaging during foam injection.     with normal saline will ensure this.
     The two latter parts of the method            Between 2 and 6 cannulae are needed to
     require training before FS is undertaken.     treat one leg.
     Ultrasound cannulation can be practised
     in part using a phantom. Training should      7.6 The leg should be elevated to empty
     be guided as discussed in section 1.3 and     the veins before foam injection. Repeated
     competence must be achieved in all the        ankle dorsiflexion just after injection
     components of FS before independent           should minimise the risk of calf vein
     practice.                                     thrombosis. A maximum of 12ml foam
                                                   is usually employed during one session
     7.3 Foam sclerotherapy should be              (though this may be increased if carbon
     conducted under local anaesthesia since       dioxide is used as the vehicle gas).
     there is a high risk of DVT when foam is
     introduced under general anaesthesia. All     7.7 Compression following sclerotherapy
     patients should receive a full explanation    is variable. Some simply suggest using
     of the risks and benefits of the procedure    compression stockings, others suggest a
     and a relevant information sheet.             short stretch bandage secured with wide
                                                   adhesive tape under a Class II stocking
     7.4 The foam is usually prepared with         for 7-14 days. There is no evidence
     the Tessari technique: a ratio of one part    that there is yet an optimal regimen.
     sclerosant to four parts gas (usually air).   Early ambulation and return to work are

12
encouraged. Patients are advised not to      in the literature. Visual disturbance occurs
drive for 30min after foam treatment, to     in approximately 2% after FS and resolves
ensure that they do not develop visual       in approximately 30 minutes. It is most
symptoms whilst at the wheel of a car.       frequent in those who suffer migraines
                                             and can recur with repeat injection. This
7.8 Most patients develop                    phenomenon remains under investigation.
thrombophlebitis in the successfully         Migraine is not currently a contra-indication
treated vein. If this is excessive, it may   to FS. Other symptoms that are seen
be aspirated under local anaesthetic         include a tight feeling in the chest and
during follow-up, when liquidised.           coughing. Patients should be warned about
Other management includes continued          all these potential side effects during the
compression and anti-inflammatory            consent process.
analgesia. Deep vein thrombosis is very
uncommon after FS (<2%), but should be       7.10 The late results of foam are unknown
excluded by duplex imaging if suspected.     and await detailed follow-up studies, as
Established DVT should be managed            suggested by NICE. Occlusion of truncal
with anticoagulation according to local      veins occurs in about 75-85% of patients
protocols.                                   after 6 to 12 months. Residual skin
                                             pigmentation and lumps can take up to a
7.9 The major potential complication is      year to resolve.
a neurological event, such as a stroke.
This has only occasionally been reported




                                                                                             13
     VEnous INtervention (VEIN) Project

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                                                                                          15
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16
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