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By Robert C. Kiser, DO, MSPH

Restless legs syndrome (RLS) – also called Willis Ekborn Disease – was first described by Chinese physicians in 15291, and 1763 by French physicians2. The condition was first suggested to be associated with venous insufficiency Dr Karl A Ekbom in 1944.3  RLS is characterized by unpleasant or painful sensations (dysesthesias or paresthesias) in the legs and an urge to move the legs. Symptoms occur when the patient is relaxing, inactive or at rest, and can increase in severity during the night or latter part of the patient’s wake period. Moving the legs reduces and may relieve the discomfort. The discomfort and constant need to move the legs disturbs sleep and can lead to impairment of function in daily life.

Epidemiology

Restless legs syndrome affects approximately 10 percent of adults in the United States.4 RLS may begin at any age, including childhood, and affects approximately twice as many women as men. 80% of those affected by RLS also experience Periodic Limb Movement Disorder during sleep, in which the patient has brief “jerks” of the legs or arms while sleeping.

 

Causes and Associations

Restless Legs Syndrome may have genetic causes, and has been associated with low iron storage in the brain as well as diminished dopamine in the basal ganglia (the brain area also associated with Parkinson’s disease). RLS is associated with Parkinson’s disease, diabetes, renal insufficiency, iron deficiency anemia, peripheral neuropathy,5  and multiple sclerosis6. The focus of this article is the association between RLS and venous insufficiency. RLS occurring secondarily from a chronic disease can often be improved or cured by adequately treating the associated condition.  For instance, Restless legs syndrome caused by iron deficiency anemia can be treated by normalizing iron levels. This relationship has been established so strongly that some medical insurers require that a ferritin level be drawn on any patient before initiating another treatment for RLS.

 

Treatments

Treatment for RLS depends upon the cause. If a primary condition is responsible, then optimizing treatment for the associated condition may help the symptoms. Frequently, however, no clearly associated condition is known and the RLS is “idiopathic,” or treatment of the underlying condition does not adequately resolve the symptoms. In these cases treatment is directed to the proximate known cause, which is a decrease in dopamine in areas of the basal ganglia. Anti-Parkinsonian medications such as carbidopa-levodopa, pergolide, bromocriptine,and ropinirole will often ease the symptoms.

 

The Association of RLS with Venous Insufficiency

Those who treat varicose veins have long heard from their patients’ descriptions of throbbing, buzzing, creepy-crawly, pains in the lower extremities – symptoms that sound very similar to those of RLS. Restless legs syndrome has long been accepted as a symptom of venous insufficiency by phlebologists.  It was McDonagh, et al., in 2007 who published the paper, “Restless legs syndrome in patients with chronic venous disorders: an untold story.” This case-control study found a significant difference (at p < 0.05) between the cases (36% prevalence of RLS) and controls (19% prevalence). The clinical difference found between the two groups was a higher prevalence of cramping symptoms in the group with both RLS and venous insufficiency when compared to the control group that had RLS without venous insufficiency.7

 

The association begs the question as to whether treatment of venous insufficiency (VI) in those who have both RLS and VI, will improve both conditions.  In 2008, Clint Hayes and John Kingsley, et al., published their ground-breaking paper “The effect of endovenous laser ablation on restless legs syndrome,” in the journal Phlebology. This cohort study took patients with ultrasound-proven venous insufficiency and RLS (by NIH criteria) and separated them into operative and non-operative cohorts. The operative cohort received endovenous laser ablation and sclerotherapy. The results: correcting the SVI decreased the mean IRLS score 80%. Also, 89% of patients had a decrease in their score of > or =15 points. Fifty-three percent indicated their symptoms “had been largely alleviated” and 31% reported complete relief of their RLS symptoms. Hayes et al. concluded that patients with diagnosed RLS should be sent for ultrasound evaluation for venous insufficiency prior drug therapy being initiated or continued. 3

 

Summary

Restless legs syndrome is a common disorder with a known association with venous insufficiency. RLS is commonly treated with dopaminergic drugs, but these drugs have numerous short and long-term side effects. When RLS co-exists with venous insufficiency, treating the venous insufficiency can provide substantial improvement in the patient’s symptoms and subsequently the patient’s quality of life.

The Edinburgh Vein Study published in 1999 in the British Medical Journal estimated that over 80% of the total population had reticular varicosities or telangiectasia (spider veins).  However, the prevalence of varicose veins, as reported in studies, has not matched that of reticular varicosities or telangiectasia.  Reported rates of varicose veins in the literature range from 2%-56% in men and from 1%-60% in women.  The prevalence estimates in the literature vary because of differences in the methods of evaluation, criteria for definition, and the geographic regions analyzed.

What we do know is that chronic venous disease is extremely common.  It is estimated that approximately 40-50% of individuals with spider veins have underlying venous disease contributing to the dilated capillary formation.  In the other 50-60% of individuals with spider veins, their disease is limited to the surface telangiectasia and does not represent underlying venous hypertension.  Treatment of these superficial dilated blood vessels can be futile if the underlying disease process is not addressed.  These physical findings should cue doctors in on the possibility that venous disease exists warranting further questioning to see if the individual experiences symptoms in addition to early signs of venous disease.  Any person with spider veins that experience symptoms of burning, itching, aching, heaviness in their legs should be further evaluated by duplex ultrasound. While vein disease signs and symptoms start out as mild, they can progress in severity if left untreated.

 

It is reported that more than 40 percent of pregnant women experience problems with varicose veins of the legs and/or vulva during their pregnancy. Treating patients during pregnancy is not advised due to multiple reasons.  During pregnancy, the lower extremity venous system is constantly changing. The body increases blood volume during pregnancy. It also decreases the speed that blood returns from the legs to the pelvis.  A higher level of the hormone progesterone also contributes to the veins becoming more dilated.  With childbirth, these factors that stress the leg veins are eliminated.  As a result, in a percentage of women, leg veins return to normal function. Furthermore, during pregnancy the body has a higher likelihood of forming blood clots, thus pregnant women are at higher risk for developing deep vein blood clots especially during surgical procedures.  Lastly, certain medications that may be utilized to treat diseased veins have not been proven safe for the fetus in pregnant women.

For the reasons above, we recommend waiting until after pregnancy to be evaluated for venous disease or varicose vein disease. If varicose veins, leg swelling or painful legs persists for 10-12 weeks after pregnancy, it is best to speak with a vein specialist in order to prevent potential complications like painful skin conditions (ulcers) or clotting of the varicose veins (phlebitis).  We recommend scheduling treatments prior to a subsequent pregnancy if possible.  Pregnancy will only worsen the condition once it exists.  Worsening vein disease may require more extensive treatment if it is not addressed prior to the next pregnancy.

Vein stripping is a surgical procedure usually performed under general anesthesia in the hospital setting to remove diseased saphenous veins and their associated varicose veins. The surgery involves making one or more incisions in the groin or leg to gain access to the diseased vessel.  Next, a special wire is inserted into the vein and the vein is then pulled out from the body. The incisions are stitched up and pressure dressings are applied to the incision.  An overnight hospital stay is not uncommon.  Patients may be advised to avoid any physical activity for days or weeks.  Vein stripping has been associated with up to a 8% risk of infection and up to a 25-60% failure rate due to neovascularization. Because of the high failure rates secondary to neovascularization, the relatively high morbidity and recurrences associated with saphenous vein stripping, as well as, the high failure to strip completely in many patients, vein stripping today is rarely performed.

CVR performs endovenous thermal ablations to treat diseased saphenous veins and associated varicose veins.  Endovenous thermal treatments are minimally invasive, office based treatment alternatives to surgical stripping of the great saphenous vein. Instead of removing the saphenous vein, the vein is sealed closed in place by using a heat source generated by either laser or radio-frequency catheter. The skin on the inside of the lower leg is anesthetized and a small fiber or catheter is inserted through a needle stick into the diseased vein. Pulses of heat are delivered inside the vein, which causes the vein to collapse and seal shut. This procedure is done in-office under local anesthesia. Following the procedure a compression bandage is placed on the treated leg. Patients are able to walk immediately after the procedure and most individuals are able to return to work the same day. Endovenous thermal ablation treatments are FDA-approved for the treatment of the greater saphenous vein. These treatments are the first line recommended treatment option for diseased saphenous veins by the Society for Vascular Surgery and the American Venous Forum.

Prior to receiving vein treatments in our clinics, you may take any medications that are part of your normal routine. Blood thinning medications including Aspirin, Plavix, Aggrenox, Coumadin, Pradaxa, to name a few, are all okay to continue. Blood thinning medications should not affect the success of your treatments.  Taking blood thinning medications during treatments may result in more transient bruising but will provide a protective benefit against developing blood clots after treatment.   When taking stronger blood thinners like Coumadin, your physician may choose to treat varicose veins utilizing foam sclerotherapy injection techniques as an alternative to ambulatory microphlebectomies.  Of note, some medications used during treatments including Lidocaine, Polidocanol and Sotradecol can cause allergic reactions or react with other medications.  For example, Polidocanol, a FDA approved sclerosant agent, contains ethyl alcohol as an emulsifier and can cause reactions in individuals taking Antabuse (disulfiram).  It is always wise to let your doctor know all medications and supplements you are taking prior to starting any medical or surgical treatment.

If chronic venous disease is left untreated, it can progress to a more serious form of venous disease. Signs and symptoms of chronic venous disease worsen over time, including pain, swelling, cramping, restlessness and fatigue of the legs, as well as, skin damage and ulcers in more severe cases. Those with the disease may experience symptoms that make walking and everyday tasks painful and difficult.

Symptoms of chronic venous disease are highly variable. Patients report a spectrum of symptoms. Most individuals affected have obvious clinical signs that include spider veins, varicose veins, lower extremity edema, skin discoloration and/or ulcerations. Current estimates show that approximately 70% of leg ulcers in the United States are venous ulcers or of mixed-arterial/ venous etiology.

However, some patients may have NO clinical signs of chronic venous disease but have symptoms ONLY which include tired, heavy, throbbing legs and/ or restless leg, nocturnal cramping or a burning sensation in the extremities. The pain is typically exacerbated by standing, is progressive throughout the day, is typically felt in the muscles in the calf or thigh, and is made better with walking and limb elevation.

As varicose veins are often misunderstood as a cosmetic problem, many people living with them do not seek treatment. The good news is that there are minimally-invasive treatment options available for varicose veins and chronic venous disease that are covered by many insurance plans. These treatments address the condition before it progresses further, allowing for a short, comfortable recovery and a quick return to everyday activities.

STATISTICS

  1. Ten times more people suffer from venous insufficiency than peripheral artery disease in the United States. It affects all age groups.
  2. More than 24 million Americans have varicose veins and 6 million have skin changes associated with Chronic Venous Insufficiency.
  3. Blood clots form in the leg veins of over 2.5 million Americans each year.
  4. 10-35% of adults have leg veins that do not work properly.
  5. Half a million Americans have ulcers on their legs caused by diseased veins.

BENEFITS OF VEIN ABLATION TREATMENT

  1. Each treatment takes less than an hour.
  2. Immediate return to normal activity is common with only minor soreness or bruising, which can be treated with over-the-counter pain relievers.
  3. There are no scars or sutures because the procedure is minimally invasive.
  4. Success rate is high and recurrence rate is low compared to surgery.
  5. The success rate for thermal vein ablation is as high as 98%.
  6. There is no need for general or spinal anesthesia.
  7. Treatments are considered a medical necessity by most insurance carriers.

 
We’re proud to have achieved a 97% patient satisfaction rate, and we hope you’ll refer friends and family. Visit our website and learn more about how we bring relief to people suffering from the pain and discomfort of venous insufficiency.  www.centerforvein.com

 

What happens if the patient is having a bypass and they need the Great Saphenous vein?
Generally, if the Great Saphenous Vein (GSV) is diseased enough that ablation is recommended, then the vein is not suitable for any type of use in a bypass surgery settingeither peripheral arterial bypass or coronary artery bypass grafting (CABG). In this setting, the rendering surgeon will select a different vein, or use an arterial conduit. Rarely, he may choose to use a cadaver vein.

“How do you do a CABG without the Great Saphenous Vein?”
There are multple additional options for bypass grafting. Qualified cardiac surgeons can perform coronary bypass grafting (CABG) surgery without the need for the Great Saphenous. Either other veins, or even other arteries, and sometimes artificial or cadaver grafts can be used. A diseased and dilated Great Saphenous Vein would never be used on the heart. This concern should not be a reason to avoid treating your leg veins, if symptoms are present.

“What medical history issues will exclude a patient from being considered for vein ablation (i.e., clotting issues, etc)?”
Each patient’s individual situation is different. At CVR we take the entire medical history of every patient into account before we make a recommendation for treatment. Cardiac (heart) and pulmonary (lungs) history is very significant as well as other risk factors such as diabetes, hypertension, clotting history, lipid (cholesterol) profile, etc. All of these factors and more will be reviewed with each patient before a recommendation for ablation is made. There are very few factors
that, in and of themselves, will exclude a patient from being a candidate for venous ablation techniques.

Understanding Post Thrombotic Syndrome

July 12th, 2013 | Posted by CenterForVein in DVT | PTS | vein-center - (Comments Off)

By Gautam Shrikhande, MD

In patients with deep venous thrombosis (DVT), the most significant immediate concern is that of pulmonary embolus.  Over the next several months to years, however, development of post thrombotic syndrome (PTS) presents a much more prevalent chronic morbidity.  PTS refers to the signs and symptoms that occur as long term consequences of DVT.  PTS can affect up to 23-60% of patients in the two years following DVT, and up to 10% of these patients may go on to have ulceration.1  The most significant long term sequelae of PTS are a significant loss of quality of life and limitations in the abilities to perform daily activities.2  Signs and symptoms in the leg include swelling, heaviness, aching, cramping, varicose veins, skin discoloration, and ulceration.  The inflammatory response secondary to the thrombus as well as the physical pressure from the thrombus is thought to lead to venous valvular disruption and incompetence.  This valvular incompetence combined with persistent venous obstruction from the thrombus increases the pressure in the veins and leads to a state of venous hypertension.  Risk factors for the development of PTS include proximal DVT, recurrent ipsilateral DVT, persistent DVT symptoms one month after DVT diagnosis, obesity, and inadequate anticoagulation during the first 3 months of DVT treatment.

Understanding Post Thrombotic Syndrome

The most important initial step in the evaluation of PTS after obtaining a history of DVT is obtaining a venous duplex ultrasound.  The key features of this evaluation include the degree of recanalization of the deep venous system, the location of the obstruction (proximal or distal), and the presence of both deep and superficial venous insufficiency.

Initial, conservative treatment options for PTS include appropriate anticoagulation for DVT, leg elevation, weight loss in overweight patients, and the use of elastic compression stockings for up to 2 years post DVT.4 In patients with ulceration development, appropriate wound care and compression bandages are indicated.  Also, in some patients, venous ablation in patients with significant superficial venous reflux may provide symptomatic relief.

In addition, from the American College of Chest Physician Evidence-Based Clinical Practice Guidelines in 2012, there is evidence to suggest that catheter directed thrombolysis (CDT) in the setting of acute DVT may reduce PTS and improve quality of life without being associated with an unacceptable increase in bleeding.  The patients who experience the best results are those who have ileofemoral DVT for less than 14 days.5  CDT involves taking the patient to an angiography suite and infusing thrombolytic therapy, typically tissue plasminogen activator (TPA), directly into the thrombus.  The dissolution of thrombus can prevent the subsequent inflammation of obstruction which occurs secondary to the thrombus and can preserve long term deep venous function.

Lastly, in patients with established PTS, some have shown that venous balloon dilation and stent therapy can be effective treatments for chronic ileofemoral thrombosis.6  With this minimally invasive approach which can be safely and easily accomplished in an angiography suite, patients with PTS can get quick symptomatic relief with minimal morbidity and good patency of the venous system after stenting.    We have had several patients with ulcerations in the setting of PTS who have gone onto complete resolution of this pathology.

In summary, PTS can be a significant source of morbidity in patient with DVT, however with the proper evaluation and treatment selection by a venous specialist, PTS can be either prevented or treated to provide patients with an excellent quality of life.

By Robert C. Kiser, DO, MSPH

Phlebology is a rapidly advancing branch of medicine. It has been Just over 10 years that thermal closure techniques such as radiofrequency and laser ablation were invented, and now they are the standard of care for ablation of superficial venous insufficiency. Thermal closure is extremely effective and safe. It is far less time consuming and has much less down time and associated expense compared with ligation and stripping. Thermal closure has much more reproducible results and is also much more consistently effective in the long term as compared to sclerotherapy alone. However, endovenous thermal closure does have its own requirements, such as disposable catheters, laser fibers, and because it uses heat within the vein it requires the use of tumescent anesthesia around the vein to act as a heat-sink. For the phlebologist, requirements add expense and time to the procedure. For the patient, the more body is penetrated with needles, infused with fluids, or otherwise invaded, the less comfortable the procedure. Newer phlebology treatments focus on providing highly effective treatment methods (>90% success over multiple years) with less bodily invasion, less time and fewer or equal risks.

Supergluing Veins: Sapheon

phlebology

Cyanoacrylate has been used in medicine for many years, primarily to close skin wounds. It also has been  used to close arterio-venous malformations, incompetent ovarian veins and duodenal varicose veins. Cyanoacrylate for saphenous vein closure is not yet available in the United States, although phase 3 trials are underway in the US and the UK. The technique is as follows: A long glue-installation catheter is placed within the vein, much as one would place a thermal catheter. Glue is injected under ultrasound-guidance, starting at 5cm from the saphenofemoral junction. The ultrasound probe compresses the glued vein for 3 minutes. The remaining length of incompetent vein is then glued in a proximal to distal fashion. The effect is a sort of “spot welding” of the vein. The cyanoacrylate causes an acute inflammatory reaction, at the endothelium, that results in fibrotic closure of the vein.

I had the good fortune to speak with Tristan Lane, surgeon  and clinical research fellow at the ImperialCollege, London. Mr. Lane has had the experience of performing more than 100 of these procedures during phase 3 trials. He states he has seen no embolization of glue, no skin pigmentation, no DVT or PE. He did report one case of asymptomatic thrombus extension, which did not recur after changing the starting placement from 3cm to 5cm from the SFJ.  A similar threadlike thrombus extension was noted after Jose Almeida’s series of 38 patients which also resolved spontaneously and asymptomatically.

The major difficulties to consider when using cyanoacrylate intravascularly are the control of viscosity and curing time. If the mixture is not viscous enough, or takes too long to cure, then the glue can migrate to unwanted areas. If the glue cures too quickly then the delivery catheter can become adhered to the vessel walls. The delivery system includes an especially mixed, proprietary blend of cyanoacrylate with additives that affect polymerization. The glue, along with the delivery catheter is made and distributed in a disposable kit by Sapheon, Inc. The entire process is carried out through a single incision, with no tumescent, only a single dot of anesthesia, and no machinery required save for the ultrasound machine. Post-operative care does not mandate compression for this technique.

A New Twist on an Old Therapy: Clarivein Sclerotherapy. 

clariven sclerotherapy treatment

Sclerotherapy for varicose veins has been around for several hundred years. The method has been refined and evolved by many individuals and “schools” of sclerotherapeutic technique. Currently the most widely used and FDA-approved sclerosants are sodium tetradecyl sulfate and polidocanol. These being detergent sclerosants, they are frequently used as a foamed preparation to displace intraluminal blood and increase contact time with the vein wall, thus improving fibrous closure and reducing the amount of retained blood. In the best of hands, sclerotherapy can produce excellent results that yield short and even long-term closure. However, the percentage of veins that reopen some years after sclerotherapy is estimated to be as high as 40% in some studies. This is in likely due to varying techniques, which can lead to inadequate destruction of endothelium and subsequent, inadequate fibrotic closure. Clarivein uses both chemical sclerosant (generally sodium tetradecyl sulfate in the United States) and mechanical agitation of the vein wall. The device is inserted into the vein to be treated (great or small saphenous vein or other straight vein), and positioned below the saphenofemoral junction. The catheter has a thin stainless steel mechanical agitator that runs the length of the catheter to a motor at the hub. An infusion port connects to the lumen surrounding the agitator, and allows the instillation of a sclerosant. Once the agitator is deployed and the motor engaged, the agitator oscillates at 3,500 repetitions per minute in a to-fro motion. This traumatizes the endothelium and causes the vein to spasm. At the same time, the infused sclerosant travels to the tip of the agitator, contacting the traumatized endothelium. This allows for more effective sclerosis of the vein and more robust fibrosis of the lumen.

Because no heat is used, no tumescent anesthesia is needed. Once again, the entire procedure can be done through one small incision, requiring only a dot of anesthesia. Compression is recommended after the procedure, using either compression stocking or bandaging. This is because, unlike the glue method, sclerotherapy does not obstruct the proximal point of reflux, but rather induces an immediate spasm, which then relaxes and allows the admittance of blood into the lumen. Compression is used to reduce the amount of retained blood, which improves the ability of the vein lumen to fibrose and eventually become a fibrous cord.

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Over the course of the last few years, the world of venous care has evolved at a staggering pace. There are more phlebology practices now than ever before, and unfortunately there is significant variance in the quality of vein care provided by the various practitioners. This may be due to the great variability of training or the broad range of treatment modalities.   For this reason, it is more important than ever to examine each practice’s quality related processes and outcomes.

As every field in medicine gets analyzed more closely for over utilization, effectiveness, and patient outcomes, the field of phlebology will also be in the cross hairs.1It is important that everyone who practices venous insufficiency treatment takes on the responsibility of providing the best care available. This can be achieved by establishing medical protocols, continuous evaluation and grading of providers, clinical audits on complication rates, regular reviews of evidence-based treatment plans, and compliance reports.

Evidence-based treatment protocols ensure the most appropriate patient care and are becoming more and more important in every medical field. Because of the wide variation in treatment options in phlebology, medical protocols are necessary. They are a set of predetermined criteria that defines appropriate interventions that articulate or describe situations in which the provider makes judgments relative to a course of action for effective management of the venous patient.     The daily use of protocols has proven to yield better results than in practices that do not utilize them2

Regular evaluation and grading of providers using a “score card system”, which includes criteria such as post-procedure venous closure rates, improvement in Venous Clinical Severity Score (VCSS), as well as physician evaluation skills should be included as part of a continuous evaluation of all providers. This ensures that the quality of care is at or above national standards.   This “score care system” also gives providers and practices a chance to objectively improve on the quality of care, thus always advancing the field.

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