Visual Sclerotherapy (VS)

Visual Sclerotherapy is a technique used by vein doctors to treat dilated varicose veins and spider veins (telangiectasias).   It involves the needle application of a chemical caustic to the interior of veins, leading to obliteration and eventual resolution.

Sclerotherapy has been used in the treatment of spider veins and varicose veins for over 150 years. Attempts at treating varicose veins have been documented as early as the 4th century BCE. The writings of Hippocrates include a mention of treatment of varicose veins by thrombosis with a metal instrument. Hippocrates reports an ulcer being healed after a thrombosis, perhaps due to iatrogenic infection, in the affected vein.

Highlights from 1600-1800

  • In 1667, Sigismund Eisholtz made repeated attempts to use a hollow bone to cannulate a vein in order to introduce pharmacological substances. The first injection of distilled plantain water via an enema syringe into a branch of the crural vein.
  • The introduction of a lachrymal syringe by Anel in 1713 led to the development of the hypodermic syringe by Rynd and its subsequent modification by Pravaz.
  • In 1682, Zollikofer in Switzerland injected an acid into a vein to induce thrombus formation
  • Great saphenous veinstripping performed by Madelung in 1844.
  • Debout and Cassaignaic reported success in treating varicose veins by injecting perchlorate of iron in 1853
  • Desgranges in 1854 cured 16 cases of varicose veins by injecting iodine and tannin into the veins.

However, due to high rates of side-effects with the drugs used at the time, sclerotherapy was practically abandoned by 1894. With the improvements in surgical techniques and anaesthetics over that time, stripping became the treatment of choice.

Highlights from 1900- Present

  • Stripping of the long and short saphenous vein was introduced by Mayo in 1906, the process involved a rigid external stripper.
  • In 1954, Myers introduced the flexible intraluminal stripper
  • Alternative sclerosants continued in the early 20th century. Some of those tried were carbolic acid and perchlorate of mercury. Whilst these showed some effect in obliterating varicose veins, side-effects also caused them to be abandoned.
  • Professor Sicard and other French doctors developed the use of sodium carbonate and then sodium salicylate during and after the First World War.
  • Coppleson’s book in 1929 advocated the use of sodium salicylate or quinine as the best choice of sclerosant.
  • Sclerotherapy was introduced to the United States in 1939 by McCausland, who reported an astounding series of 10,000 patients.
  • Further work on improving the technique and development of safer and more effective sclerosants continued through the 1940s and 1950s. Of particular note was the development of sodium tetradecyl sulfate(STS) in 1946, a product still widely used up to today.
  • In Australia by the early 1950s the flexible intraluminal stripper had become popular, however low ligation of the long saphenous vein was still done very frequently, and consequently groin recurrences were very common.
  • One of the innovative work which laid the groundwork for subsequent investigation and treatment of venous disease, Australian Professor John Ludbrook, whose landmark studies on venous physiology, the measurement of venous pressures, and work on the musculo-venous pump of the leg and the origin of primary great saphenous varicose, still stands today as important research into venous physiology.
  • In the late 1950s, Peter Halliday had returned to join John Loewenthal’s developing vascular unit at Royal Prince Alfred Hospital in the late 1950s and apart from doing arterial surgery, tackled venous surgery on a specific basis by doing a large number of investigative venograms.
  • George Fegan in the 1960s reported treating over 13,000 patients with sclerotherapy, significantly advancing the technique by focussing on fibrosis of the vein rather than thrombosis, concentrating on controlling significant points of reflux, and emphasizing the importance of compression of the treated leg. The procedure became medically accepted in mainland Europe during that time.
  • In 1975, the Australian and New Zealand Society of Phlebology was founded.
  • The next major development in the evolution of sclerotherapy was the advent of duplex ultrasonographyin the 1980s and its incorporation into the practice of sclerotherapy later that decade. Knight was an early advocate of this new procedure and presented it at several conferences in Europe and the United States.
  • In 1986, Australia was formally admitted as a member nation of the International Union of Phlebology, represented by the Australian and New Zealand Society of Phlebology.

Sclerotherapy has, in many ways, evolved enormously yet in other ways has changed little. Today it is unquestionably the treatment of choice for spider veins in the legs. It is also used to treat veins in the face, arms, back, breasts and other areas. And recently, the use of ultrasound and foam has opened up fantastic possibilities in the treatment of varicose veins, perforator veins and in some cases even the great saphenous vein.

References:

Ultrasound Venous Mapping

Ultrasound Mapping (Pre-treatment)

Duplex venous scanning is the essential pre-treatment investigation prior to either sclerotherapy or ultrasound-guided sclerotherapy of major varicose veins and truncal incompetence.  Through duplex scanning, patterns of venous incompetence will be found to be extremely variable and often unexpected.

Duplex examination is able to provide an accurate anatomical and physiological map of superficial and deep venous incompetence and localise points of reflux from the deep to superficial venous system.

Spider veins (telangiectasias) or milder vein disease often don’t involve larger structure and therefore obviate the need for full venous mapping.

Ultrasound Guided Sclerotherapy

Ultrasound Guided Sclerotherapy (UGS) is a trusted, non-surgical solution for varicose veins, eliminating the appearance and discomfort of affected veins and returning healthy blood flow to affected legs. Ultrasound imaging is used to guide a needle into the abnormal vein and deliver medication to destroy the lining of the blood vessel and seal it shut. Ultrasound guided sclerotherapy is primarily used to treat large veins beneath the surface of the skin.  UGS was developed in Australia, USA, Canada and France in the late 1980’s. Generally only relatively strong sclerosants are used in this procedure.  In an international survey of forty-four phlebologists who were known to use UGS extensively, 95% used sodium tetradecyl sulfate (STS; Fibrovein; STD Pharmaceuticals Hereford, England), and 5% used 3% polidocanol (POL; Aethoxysclerol; Kreusler Pharma, Wiesbaden, Germany).

Background

  • Stegall and Rushmer in 1961 described the first Doppler instrument and the basis for its practical use for ultrasound in venous medicine.
  • Sigel and co-workers in 1967 made a refinement of the Doppler techniques for venous investigations.
  • Evans and Cockett, and Sumner and Strandness a year later furnished the fundamentals of Doppler investigation of deep venous thrombosis.
  • Folse and Alexander in 1970 deeply investigated the technique to evaluate valvular competence.
  • In 1976, the history of venous echotomography started when Day focused the possible role of B-mode imaging of venous thrombi.
  • Szendro, Nicolaides, Myers, Malouf et al., and Luizy, Franceschi and Franco in 1986 proposed duplex scanning for the diagnosis of venous disorders.
  • In 1989 the method of ultrasonic guidance of injection into the superficial venous system was first published (The method was initially used for treatment of incompetent saphenous axes).
  • In 1992 the method of injecting incompetent perforating veins associated with post-surgical recurrences was described.
  • Kanter and Thibault in 1996 reported the medium-term results of saphenofemoral junction (SFJ) incompetence treated by UGS.
  • In the late 1990s, several practitioners around the world began using sclerosant foam injection using ultrasound guidance.
  • Cabrera in 2000 the first medium-term results were reported.

Adverse Effects of Ultrasound Guided Sclerotherapy (UGS)

Varcoe performed a survey of forty-four experienced UGS phlebologists from seven countries and reported on their experience with adverse effects from Ultrasound Guided Sclerotherapy. In this survey, side effects were grouped into “minor” or “major” reactions.

Minor reactions:

  • Phlebitis
  • Pigmentation
  • Edema
  • Pain
  • Minor (asymptomatic) DVT
  • Minor allergic reaction

Major reactions: incidence were all less than 0.1%

  • Major DVT
  • Pulmonary embolus
  • Severe allergic reaction

There are a number of studies in medical literature documenting the effectiveness of UGS. Most of these studies have examined the results of treating Great saphenous vein (GSV) incompetence, although there are several now published on SSV incompetence.

  • Kanter and Thibault – first reported objective ultrasound results of SFJ and GSV incompetence treated with UGS
  • Cavezzi and Frullini
  • Myers et al
  • Chapman-Smith
  • Barrett et al
  • Padbury and Benveniste

References:

 

MOCA (Mechanico-Chemical Ablation): ClariVein

CLARIVEIN

ClariVein is a special infusion catheter with a rotating wire tip designed for the controlled 360-degree dispersion of physician-specified agents to the targeted treatment area. The ClariVein device is a slim, thin catheter (tube) that your doctor temporarily inserts into the peripheral vasculature (veins) through a pin-sized entry point. ClariVein is several times smaller than other devices used in peripheral vascular treatments allowing the entrance point to be smaller. The ClariVein infusion catheter (Vascular Insights) received FDA approval (K071468) on March 20, 2008. The ClariVein device is safe and efficacious to ablate long and short saphenous varicose veins on a walk-in, walk-out basis. The procedure can be expanded to bilateral procedures and multiple veins in the same leg, which are well tolerated. There is a high satisfaction rate, and periprocedural pain is low.

On April 21, 2010—Vascular Insights LLC (Madison, CT) announced results from the initial clinical trial of its ClariVein catheter for the treatment for varicose veins. The device combines mechanical and chemical modalities to accomplish vein treatment in an in-office setting. Vascular Insights has received 510(k) clearance from the US Food and Drug Administration to market ClariVein for infusion of physician-specified agents in the peripheral vasculature. Principal investigator Steve Elias, MD, stated, “Results were excellent. The initial success rate is equal to that from radiofrequency or laser treatment of great saphenous vein disease.”

“The main advantage of this new technique in comparison to older endovenous therapies is that it does not require tumescent anesthesia infusion, saving significant time and decreasing patient discomfort,” commented Dr. Elias. “In addition, a generator is not required, and therefore capital and maintenance cost is reduced. This in-office procedure takes about 15 minutes to perform and patients resume normal activity that day, including exercise.”

In a pilot study, Van Eekeren et al. (2011) evaluated the feasibility and safety of endovenous MOCA for the treatment of great saphenous vein (GSV) incompetence. Initial technical success, complications, patient satisfaction and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment. Initial technical success of MOCA was 100%. There were no major adverse events. The authors concluded that endovenous MOCA is feasible and safe in the treatment of GSV incompetence.

Elias and Raines (2012) assessed the safety and efficacy of the ClariVein® system for mechanochemical ablation of the great saphenous vein (GSV). Thirty GSVs in 29 patients were treated. At six-month follow-up, the primary closure rate was 96.7% with no adverse events reported. The authors concluded that mechanochemical ablation appears to be safe and efficacious.

Van Eekeren et al. (2013) evaluated postoperative pain and quality of life after radiofrequency ablation (RFA) and MOCA for great saphenous vein (GSV) incompetence. Patients treated with MOCA reported significantly less postoperative pain than patients treated with RFA during the first 14 days after treatment. The lower postoperative pain score was associated with a significantly earlier return to normal activities and work. At 6 weeks, patients in both groups perceived an improved change in health status and an improved disease-specific quality of life.

Vun et al. (2015) assessed the efficacy of the ClariVein system for the treatment of superficial vein incompetence. Fifty-one great saphenous veins and six small saphenous veins were treated. Duplex showed a technical success rate of 91%. Comparison with 50 RFA and 40 EVLA procedures showed procedure times were significantly less for ClariVein than for either RFA or EVLA. Median pain scores were significantly lower for ClariVein than for RFA and EVLA. No major complications or deep vein thrombosis were reported.

Advantages to ClariVein:

  • Only micro-incision required – no large cuts or stitches
  • Painless procedure
  • Reduced risk to surrounding tissue including nerves and other veins
  • Less bruising compared to some other procedures
  • Short treatment time
  • Clinically Proven
  • Non Thermal
  • No Tumescent Anesthesia Required
  • Minimises bruising 

Contraindications to ClariVein:

  • Tortuous Veins
  • Patients with history of deep vein thrombosis (DVT)
  • Allergy to the sclerosing chemical

Post-Op Instructions:

  • Walk for 15 minutes immediately after treatment.
  • Arrange for someone to drive you home or go home by taxi or public transport – it is essential that patients do not drive on the day of treatment. Driving can resume on the following day.
  • Walk for 30 minutes each day.
  • No vigorous activities for 1 week.
  • Wear the medical-grade support stockings continuously (and to bed). Continue this for 3 weeks is mandatory to assist the body’s process of closing the veins off.
  • Maintain normal daytime activities and avoid standing still for long periods.
  • Avoid flights of greater than 4 hours duration for 4 weeks after treatment. If travel is unavoidable, then the flight should be covered by subcutaneous heparin injections given before departure and after arrival.
  • Return for a check ultrasound scan within a few days after treatment to ensure that the treated vein is occluded, determine whether any further veins require treatment, and exclude the small risk of deep vein occlusion.
  • Bring your compression garments to every follow-up visit.

Possible Complications:

  • Deep vein thrombosis
  • Allergic reaction
  • Pigmentation along the treated veins

REFERENCES

* http://evtoday.com/2010/04/trial-results-announced-for-vascular-insights-clarivein-to-treat-varicose-veins

* http://phl.sagepub.com/content/early/2016/02/22/0268355516630154.full

* http://www.veinandlasercenterofnj.com/2015-09-30-new-procedure-for-treating-varicose-veins-introduced

* https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Medical%20Policies/Surgical_Ablative_Venous_Insuff_Varicose_Veins.pdf

* http://clarivein.com/clarivein-ous/for-patients/why-clarivein/

* http://www.theveininstitute.com/clarivein.php

* http://www.victoriaveinclinic.com.au/clarivein-sclerotherapy.html