Love your legs again
Header

Great question.  I’m glad you asked.  Many vascular surgical groups do fine work in the diagnosis and treatment of peripheral arterial disease, carotid arterial disease, and abdominal aortic aneurysms, but often approach venous reflux disease as a peripheral (pardon the pun) aspect of their clinical practice.  As a result, they will often focus on the catheter-based techniques that are useful in treating the refluxing great and small saphenous veins, but not focus on the diagnosis and treatment of associated refluxing accessory and tributary veins, which are often treated with ultrasound-guided foam sclerotherapy or endovenous laser.

If the patient only undergoes procedures that treat the refluxing great and small saphenous veins, the patient will often be left with significant residual symptoms of their chronic venous insufficiency, as they have only been “partially treated”.

At CVR, we pride ourselves on performing complete bilateral venous ultrasound in the standing position in order to identify ALL the refluxing veins that are responsible for the patient’s clinical presentation.  In addition, whenever possible, we also perform visual sclerotherapy on the residual spider veins that often also contribute to the patient’s symptoms. Furthermore, our detailed 1 month and 6 month follow-up consultations, which include standing venous ultrasound, often identify additional underlying venous reflux disease that has been “unmasked” with prior treatment or has appeared since the initial evaluation.

Finally, because we are a large physician-owned group (25 centers and counting) that focuses SPECIFICALLY on the treatment of symptomatic venous insufficiency, we have accumulated and published clinically-significant data on the best treatment algorithms for these patients.

 

We always appreciate the hard work of physical therapists who help patients overcome pain issues.  Often times, we see patients referred from orthopedic surgeons, neurosurgeons, physiatrists, and physical therapists.  These patients frequently have musculoskeletal issues addressed with various treatment modalities including an intensive physical therapy regimen.  The musculoskeletal symptoms can include pain localized to hip, knee, and ankle joints, shooting sciatic pain radiating from the lower back, and tightness of muscles groups.  If patients continue to experience pain such as tired, achy, itchy, or heavy legs associated with swelling or pain, we feel that they should have an ultrasound evaluation to assess for venous insufficiency.  Further, if patients have any visual stigmata of venous insufficiency such as spider veins, varicose veins, phlebitis, or hyperpigmentation, a venous evaluation is warrented.

Understanding Vulvar Varicosities

March 20th, 2014 | Posted by CenterForVein in vulvar varicosities - (Comments Off)

Theresa M. Soto, MD  FACOG, FACS

dr-theresa-soto

As patients and clinicians are becoming more familiar and comfortable with the examination, diagnosis and treatment of varicose veins of the lower extremities, vulvar varicosities remain an enigma. The more delicate nature of the issue, lack of understanding of the disease process, as well as the limited availability of diagnostic/treatment centers contributes to the lack of attention to this disorder. Vulvar varicosities are dilated veins found in the labia majora and minora; more commonly in pregnant women as opposed to the non-pregnant population. While as many as one in ten pregnant women experience these troublesome veins and OB/GYN physicians easily diagnose this condition, there is little work up or treatment of this condition once the pregnancy is completed. Vulvar varicosities typically present in the second or third trimester of pregnancy and quite often they are asymptomatic, especially in a woman’s first pregnancy. When symptomatic however, they may present with discomfort during walking, a sense of “swelling,” “vulvar pressure,” pruritis, pain, a palpable “lump” or dyspareunia. Excessive bleeding at the time of vaginal delivery in association with a perineal laceration, episiotomy or vaginal wall laceration may result in the formation of a pelvic sidewall or labial hematoma, but spontaneous bleeding from the varicosities is unusual. The presence of vulvar varicosities alone is not an indication for cesarean delivery. Thrombosis of one of these veins can occur, but this is a rare phenomenon as well.

The venous drainage of the vulva is via pudendal and perineal veins which then depend on competence of the ovarian, iliac and great saphenous veins. The majority of varicose veins of the vulva are caused by reflux in the pelvic veins; ovarian vein reflux, internal iliac vein reflux or a combination thereof. Incompetence of the great saphenous vein is often diagnosed in the setting of pelvic vein incompetence. Extension of varicosities into the medial thigh is a common finding in patients with varicosities of the vulva. During pregnancy the rise in estrogen and progesterone production in combination with the increasing physical load of pregnancy contribute to venous insufficiency and symptomatic varicosities. With each subsequent pregnancy, symptoms typically present earlier in the course of gestation and are more significant.

Spontaneous improvement in the appearance of vulvar varicosities is typically seen within six to eight weeks post partum. While symptoms typically ease as well, there often remains a sense of “fullness,” “swelling,” and/or general “discomfort” beyond the post partum recovery period. Treatment during pregnancy is symptomatic with the use of compression garments, ice and topical anti-pruritics. As vulvar varicosities are rarely an isolated finding, a combined evaluation for venous insufficiency by Center for Vein Restoration and Center for Vascular Medicine is indicated twelve weeks post delivery. Pelvic sonography and venography are the methods of choice for evaluation of the pelvic and vulvar venous systems while duplex ultrasound scanning of the lower extremities will provide information on the competence of the superficial system that includes the great saphenous veins.

With the diagnosis of ovarian vein reflux, a coil or chemical sclerosant can be placed into the ovarian vein resulting in closure of the vein with eradication of reflux in this vessel. Selective catheterization and foam sclerotherapy of the obturator vein and/or internal pudendal tributary veins may also be accomplished as indicated. Once the pelvic vein reflux has been treated, the patient returns for a follow-up scan at six weeks to evaluate her response to therapy. If the intervention has been successful; there is resolution of the pelvic vein reflux, the vulvar varicose veins may then be approached with foam sclerotherapy injections. A period of observation (six to twelve months) is typically warranted prior to moving on to sclerotherapy as many vulvar varicosities will improve significantly after suppression of the pelvic vein reflux. When indicated, sclerotherapy may be injected either directly into the vulvar varicose veins or under ultrasound guidance pending their visibility. It is just as important to manage the underlying venous incompetence prior to directly treating the visible varicosities as it is in treatment of venous insufficiency manifestations of the lower extremities.

Many women are hesitant to initiate a conversation on vulvar varicosities. This issue is often discovered in the course of discussing symptoms of pelvic pain, pelvic congestion syndrome or varicosities of the legs. Soliciting this information is vital in order to properly direct a woman’s evaluation and treatment. As with venous insufficiency and varicosities of the lower extremities, this is a medical problem, not simply a cosmetic concern. Presenting the condition in such a manner can reassure a patient that her issue is not simply an embarrassment, but a medical disorder that warrants attention. Due to the chronic nature of venous insufficiency, recurrence is possible and these patients should be followed at regular intervals for return of symptoms or physical findings.

 

By ROB KISER, DO

Often physicians fall into the trap of philosophical “Essentialism.” We believe, as we were taught, that each disease entity is a specific thing, a rigid constellation of symptoms. We expect the anatomy of each patient to be that of our textbooks, and should it not, we consider it anomalous for diverging from the “essence” of “proper human anatomy.” Such an erroneous view is a philosophical hold-over from  Platonism and the notion of Platonic Ideals. In brief, Plato described mundane reality as a casting of shadows made by the true objects of reality, ideals, which are in essence perfect examples of their types. The concept of Platonic Ideals has permeated teaching in many ways, and certainly in medicine we are taught to expect that livers should look exactly as we are taught and that disease should present with rigid constellations of signs and symptoms. This is a pedagogical tool that helps us learn basic categories such as organs and disease by matching the object or entity presented to us with that list of descriptions which we know and which we may thereby apply a label. Taken to an extreme or misunderstood as describing how reality is actually structured, however, essentialism blinds us to the numerous variations in how disease may present in an individual patient. In the words of Sir William Osler, “It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has.” and “The good physician treats the disease; the great physician treats the patient who has the disease.” The following is based on an interview with a real person whose life was changed by deep vein thrombosis (DVT) and the treatment thereof.

Meet Teri: DVT Survivordvt-blog-post2

dvt-3

Teri is a 36 year-old woman living in Chicago. In 2004, at the age of 27, she was flying home from a stay in Europe. The night before she had experienced vomiting and diarrhea. At the Amsterdam airport she stopped at the nurses’ station and diagnosed with food poisoning. She was given an antidiarrheal, an antiemetic and “a sedative.” She had a window seat in economy class, and slept most of 9 hour trip home. She recovered from her gastrointestinal distress, but in two days she began to notice a new symptom. “Two days after I landed in Chicago I had what felt like a leg cramp in my left leg. I thought it was because I had done a lot of walking and touring in Europe, but it didn’t get better,” she said. “Three or four days later, I couldn’t put any weight on it, it hurt just to get out of bed, it was very painful. I couldn’t walk or drive.” A friend drove her to a local hospital and there she was seen in the Emergency Department. She was informed that she had three deep vein thromboses in her left leg and that she would need to be admitted. She was admitted, started on a heparin drip, fitted with graduated compression stockings and put at complete bed rest. Teri says, “At that point I was pretty scared.”

In many ways, other than her youth, Teri’s profile shows several risk factors for DVT. She was a smoker, she was on birth control, and she had just experienced a long flight with immobility in a seated position. The hospital felt this was sufficient explanation for her DVTs, and did not run additional thrombophilia laboratories. She was in hospital for one week and discharged on warfarin with instructions to follow-up with a hematologist on staff who had briefly seen her in hospital (and may have had labs drawn).  Unfortunately, the hematologist to whom she had been referred was out of network with her insurance, and so a different hematologist was sought. In the interim she had to see yet another hospital’s anticoagulation clinic. She experienced side effects from the warfarin, including orthostatic hypotension, vertigo and a sort of motion sickness; “watching a train go by or copies coming out of the copy machine made me feel nauseated.” She wanted to know how long she would be on anticoagulants, what the long-term effects would be and what her prognosis would be. When she finally met with the new hematologist and asked these questions she was told, “Well, with your genetic problem you will never be off of warfarin.” This was the first she had been told that thrombophilia labs had been run and that she was found to have Factor V Leiden mutation. “I had never heard of it before then.” It was a lot to take in, and there were implications for her future. She had just been told, at age 27, that she had a genetic ailment that predisposed her to getting blood clots and that she was facing a lifetime of taking medication. “Also I had just gotten married, and if we decided to have kids I would have to go off the coumadin and give myself daily heparin shots in the belly.” She was given very little other information or genetic counseling, and so sought out information from the internet. She continued on warfarin and, because of difficulties stabilizing her INR, she had frequent lab draws.

Meet Teri: DVT Treatment Survivor

One year later Teri attended a work Christmas party. She left the party about 11 p.m. On the train home she began to feel nauseated, “I didn’t think I had drunk that much, so I thought maybe I had gotten food poisoning again.” By the time she reached her home, “I was really starting to feel sick.” She attempted to sleep, but she began to develop pain in her neck, upper back, lower back and abdomen. “It was the worst pain I’ve ever experienced.” She got up to use the bathroom and passed out, hitting her head on the sink, “I woke up in a pool of blood.” She once again called a friend who drove her to a local hospital emergency department around 7 a.m. Teri was diagnosed with a ruptured ovarian cyst. Because she had been anticoagulated, the ruptured cyst had bled profusely into the peritoneum, resulting in excruciating pain, hemorrhage and shock. Teri says, “It was absolutely terrifying; I still have nightmares about it.” She was given three units of plasma, underwent emergency open laparotomy with partial oophorectomy, “I had 33 staples,” she noted. Her two-week hospital stay was further complicated by pneumonia and a bowel obstruction. Years later she continues to have pain from the incisions and adhesions.

Teri remained on warfarin for more than a year after the ruptured ovarian cyst. At that point, she decided it was time to stop anticoagulants. “Mostly I was just worried that I would get another cyst, bleed out and die.” She has now been off of all anticoagulants for over six years, and had had no recurrent venous thromboembolism. She does now avoid hormonal birth control and walks frequently during long flights or sedentary activity. Asked what she would like physicians to know about her experience she says, “A lot of the care I got was compassionate and caring, but I do wish there had been more patient education, more take-home literature… more patient education would have helped.”

Summary

Teri’s case provides an important example of why the risks and benefits of treatment must be carefully weighed. In particular the benefits of indefinite anticoagulation treatment for a single episode of provoked DVT have not been shown to outweigh the risk of major bleeding, even for those with thrombophilia. Her case also demonstrates how multiple factors in Virchow’s “triad” interact and can be present in a given instance of venous thromboembolism. Even if there are “adequate” provoking factors to explain a VTE, an underlying thrombophilia may be present. Finally, as Teri stresses, thorough and compassionate patient education can be helpful in providing information, guidance, comfort, and hope for the newly diagnosed patient.


The Danger of DVT’s (Deep Vein Thrombosis)

January 27th, 2014 | Posted by CenterForVein in Deep Vein Thrombosis | DVT - (Comments Off)

Dangerous blood clots form in the leg veins of over 2.5 million Americans each year. According to the American Heart Association, about 600,000 people in the United States are hospitalized each year for a deep vein thrombosis (DVT), in which a blood clot forms in a leg vein. DVT, with its risk of pulmonary embolism (PE), may be the most preventable cause of death among people hospitalized today in the United States. Deep venous thrombosis (DVT) is a blood clot that forms in a vein deep inside a part of the body. It mainly affects the large veins in the lower leg and thigh. DVTs are most common in adults over age 60, but can occur at any age. Blood is more likely to clot in someone who has conditions or habits like:

  • Cancer
  • Autoimmune disorders such as lupus
  • Cigarette smoking
  • Taking estrogens or birth control pills
  • Pregnancy

DVT is a major cause of secondary venous insufficiency. Thus, individuals that have a history of DVT have a high likelihood of having concomitant superficial venous disease. Evaluation by a vein specialist is recommended if they experience continued swelling, pain, heaviness or fatigue in their legs. Chronic venous insufficiency that develops as a result of DVT is also known as post-thrombotic syndrome. As many as 30 percent of people with DVT will develop this problem within 10 years after diagnosis. Post-thrombotic syndrome (PTS) may develop following DVT in up to two thirds of those affected. Pain and leg swelling often limit normal activities. Chronic venous insufficiency can cause varicose veins, leg edema, leg pain, chronic skin changes and non-healing ulcers. These problems may make it difficult to sit or stand for long periods, and make it difficult to work at home or on the job.

DVT  

Air travel and DVT’s:

One large group identified as “at risk” are airline passengers. The U.S. Department of Transportation’s Bureau of Transportation Statistics (BTS) reported that 815.3 million scheduled passengers traveled on U.S. airlines and on foreign airlines serving the United States in 2012. Air passengers are at risk even if they are only on short flights lasting just a few hours, research reveals. DVT, the so-called “economy class syndrome”, occurs when travelers are immobile for many hours, often in cramped conditions.

Reducing the risk of travel-related DVT’s

During your trip

  • Exercise calf and foot muscles regularly.
  • Drink plenty of water to avoid dehydration.
  • Limit alcohol consumption.
  • Elastic compression stockings can help to prevent travel-related DVT in people who have a high to moderate risk. Stockings (or ‘flight socks’) can be purchased from pharmacies, or online from retailers that sell travel-related clothing and accessories.

Be tested, to be safe

Physicians can diagnose DVT’s by examining a patient’s health, medical history, and symptoms, as well as performing a physical exam. However, because DVT symptoms are shared by many other conditions, a special test – Duplex Ultrasound – can rule out other problems or confirm a diagnosis. During this test, high-frequency sound waves produce images of blood vessels and sometimes the blood clots, as well. Painless and noninvasive, ultrasound tests require no radiation, and are performed by the Vascular Technicians at Center for Vein Restoration to obtain accurate results.

 

 

 

 

 

What is the difference between DVT and EHIT?

January 27th, 2014 | Posted by CenterForVein in DVT | vein-center - (Comments Off)

Endovenous thermal ablation is an accepted method of treatment for superficial vein reflux with a relatively low incidence of procedure-related complications.  Deep venous thrombosis (DVT) is the formation of a thrombus within the deep venous system and is a recognized complication associated with less than 1% of endovenous ablation procedures.  Endovenous heat induced thrombus (EHIT) is and expected result of endovenous ablation of an incompetent superficial vein.  During the thermal ablation, the endothelial lining of the vein is damaged, thus causing an inflammatory reaction.  Thrombotic occlusion subsequently occurs, which then leads to fibrosis and effective closure within the superficial venous system.  In less than 0.5% of endovenous ablation procedures, the thrombus produced propagates in close proximity to or extends into the deep venous system and the EHIT is then classified according to the thrombus extension.  The classification for EHIT propagation within a superficial vein to a deep vein is as follows:

  • Class I: Venous thrombosis to superficial deep junction (SFJ of SPJ), but not extending into deep system.
  • Class II: Non-occlusive venous thrombosis, with an extension into deep system of a cross sectional area less than 50%.
  • Class III: Non-occlusive venous thrombosis, with an extension into deep system of a cross sectional area greater than 50%.
  • Class IV: Occlusive deep vein thrombosis of common femoral /popliteal vein.

All patients at Center for Vein Restoration undergo routine duplex imaging within 2-7 days post endovenous ablation procedure.  If EHIT I or II is identified, serial duplex imaging weekly with observation will be performed until thrombus regression into superficial vein is noted.  Antiplatelet therapy may be initiated, with Plavix most probable in case of EHIT II.  If EHIT III or IV is identified on duplex scan, low molecular weight heparin (LMWH) is initiated and continued, along with weekly duplex imaging and evaluation, until thrombus regression to EHIT I or complete resolution.  The potential for further thrombus propagation after the initial post procedure documentation of EHIT is low.  In most patients, the thrombus usually remains stable initially and regresses or completely resolves within 10-14 days.  Larger superficial vein diameters, concomitant multiple phlebectomy and thermal tip position appear to be associated with EHIT propagation, but further investigation of risk factors continues.

EHIT appears to behave differently than a spontaneous occurring deep vein thrombus (DVT) and may be an ultrasound finding without clinical significance.  However, Center for Vein Restoration, all patients presently undergo post endovenous ablation procedure duplex imaging within 2-7 days per protocol to identify an EHIT or DVT potentially requiring observation or intervention.

As with all medical and surgical practice, expertise arises from education, dedication, fascination, and specialization. While there are certainly practitioners who are excellent at treating many aspects of venous disease, CVR is dedicated to the treatment of venous disease.  Because of this, we have all of the necessary tools (radiofrequency, laser, sclerosants) to treat virtually any condition.  Most practices invest in a single modality and don’t have the flexibility to treat what we do. CVR provides complete vein treatment. In addition, CVR invests heavily in peer review to assure that all patients are treated appropriately according to the most recent guidelines recommended by the Society for Vascular Surgery and the American Venous Forum. In addition, our staff is continually trained in the latest diagnostic techniques and specializes in venous disease. We work closely with many specialties to provide the best venous care. In fact, some vascular specialists choose to send their patients to us.  These are a few of the reasons we are a national authority in vein treatment. In addition to CVR’s ability to comprehensively treat venous hypertension in the lower extremities, CVR also is capable of the evaluation and treatment of lymphatic disease and supra-inginual vein disease.

Restless Leg Syndrome (RLS)

January 24th, 2014 | Posted by CenterForVein in Restless Legs Syndrome - (Comments Off)

Restless legs syndrome (RLS) is a condition in which your legs feel extremely uncomfortable, typically in the evenings while you’re sitting or lying down. It makes you feel like getting up and moving around.  RLS can begin at any age and generally worsens as you age. Restless legs syndrome can disrupt sleep — leading to daytime drowsiness — and make traveling difficult. Moving the legs reduces and may relieve the discomfort. The constant need to move the legs disturbs sleep and can lead to impairment of function in daily life.

The condition was first suggested to be associated with venous insufficiency Dr. Karl A Ekbom in 1944. Doctors 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.   When RLS co-exists with venous insufficiency, treating the venous insufficiency can provide substantial improvement in symptoms and subsequently the quality of life.

Restless legs syndrome affects approximately 10 percent of adults in the United States. 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 (PLMD) during sleep, in which the patient has  brief “jerks” of the legs or arms while sleeping.

PLMD causes you to involuntarily flex and extend your legs while sleeping — without being aware you’re doing it. Hundreds of these twitching or kicking movements may occur throughout the night. If you have severe RLS, these involuntary kicking movements may also occur while you’re awake. PLMD is common in older adults;  4 out of 5 people with RLS also experience PLMD.

Venous insufficiency not only causes varicose veins, it can be the underlying cause for a multiple conditions, including lower extremity cellulitis, leg cramps and restless legs syndrome. When patients present with venous insufficiency symptoms, physicians often only check some of the obvious explanations and do not delve deeper to look for the possibility of venous reflux as an underlying cause. Unfortunately, there is a large percentage of people walking around with venous problems who aren’t getting the evaluation or treatment they need. Symptoms of restless legs syndrome may vary from person to person but often include burning, tingling, creeping sensations and the uncontrollable urge to move the legs. This is generally worse at night when laying down and is usually relieved by movement or walking. The symptoms of venous insufficiency and restless leg syndrome are almost interchangeable and many patients with documented severe superficial venous insufficiency and restless leg syndrome will have resolution of their restless leg syndrome after successful vein treatment.

Treating the cause, not just the symptoms

Studies show that the treatment of venous insufficiency can relieve symptoms of restless leg syndrome. According to a study in the journal Phlebology, in patients with restless leg syndrome and venous insufficiency, 98% of patients experienced relief from restless legs syndrome symptoms by treating their venous insufficiency, and 80% had long-term relief.

Given the results of the recent studies, it is recommended that, before patients start taking prescription medication for restless leg syndrome, they request a consult by a qualified vein specialist who can perform ultrasound evaluation to identify whether there is significant underlying venous insufficiency which may be causing or contributing to their problem. There is no downside to getting an ultrasound – there is no radiation involved, no needles, no pain, and it is a physiologic test which reveals which veins are leaking and how much they are leaking. Venous ultrasound for insufficiency is conservative, noninvasive, and it accurately identifies which patients are most likely to benefit from treatment.

 

Venotonics, also known as venotropics or phlebotropics, are a class of medicinals that have effect on veins and are used to alleviate venous diseases and disorders and particularly venous insufficiency. No venotonic has been shown to cure venous insufficiency or to be as effective as surgical ablation to improve the symptoms of venous insufficiency, but several have been shown to reduce the symptoms of venous insufficiency to a clinically significant degree.

Venotonics can be useful before, during and after venous ablation and can be used in addition to compression. Each of the available compounds exert effects on noradrenergic receptors in the vein wall. This causes prolonged contraction of the vein, reducing the luminal diameter and hence reducing the volume of blood in the “varicose reservoir.” Venotonics may exert their effect on larger veins, but some also have their effect at the microcirculatory level, helping to reduce the effects of chronic venous hypertension on capillary end organs, in particular, skin. This leads to a reduction in transcapillary movement of fluids and thus reduced edema.

Butcher’s Broom Extract (Ruscus aculeatus)

Butcher’s Broom Extract (BBE) appears to reduce the diameter of varicose veins in vitro. BBE is available in the United States without a prescription as an herbal supplement. It is hypothesized that the mechanism of action for BBE may be via increasing cyclic adenosine monophosphate (cAMP) levels within the veins. Because of its ability to increase vein tone, it may have some benefit as a treatment for orthostatic hypotension. Symptomatic improvement in heaviness, fatigue and altered sensations in patients taking butcher’s broom of venous insufficiency is correlated with reduced volume of blood within the varicosities.

Horse Chestnut Seed Extract

Horse chestnut seed extract (HCSE) has been used in traditional medicine as a treatment for varicose veins. In their 2002 systematic review of previous studies for the Cochrane Collaboration, Pittler and Ernst found that there was evidence, based on placebo controlled studies, that HCSE reduced the symptoms of venous insufficiency and that HSCSE is a reasonable short-term treatment for venous insufficiency.  The mechanism of action of HCSE is believed to be via alteration of the transcapillary filtration in a manner favoring edema reduction.

There is one case report of a patient with renal angiomyolipoma (AML), a condition known to spontaneously rupture and bleed, who was taking HCSE. The patient experienced a potentially life-threatening rupture of her AML, and her emergency physician felt this was potentially a side effect of the patient’s use of HCSE. It is not clear that HCSE has the anticoagulant effect the author claims.

Diosmin, Diosmiplex, (Vasculera)

Diosmin glycoside is a flavonoid occurring naturally in citrus plants and can also be derived from hesperidin, a constituent found primarily in oranges. Internationally it is available as a highly purified flavonoid fraction. In the United States it is available as a prescription medication (brand name Vasculera). The generic name for Vasculera is diosmiplex and it is a highly purified flavonoid fraction combined with Alka4-complex, an alkalinizing agent. The addition of the alkalinizing agent is thought to buffer stomach acid and blood pH and thereby combat metabolic acidosis within varicose veins.

Diosmiplex is classified as a “medical food.” The classification of “medical foods” was established by the 1988 Orphan Drug Act and is defined as “a food which is formulated to be consumed or administered enterally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” (source: 21 U.S.C. sec. 360ee(b)(3). — [from the Orphan Drug Act, 1988]). Because the constituents are derived from commonly eaten foods, the medicine is Generally Recognized as Safe (GRAS). The most common side effect of diosmin is dyspepsia, and this is likely another reason for the addition of the Alka4-complex to the product.

The medicine is currently FDA approved for chronic venous insufficiency presenting as hemorrhoids and varicose veins. For acute hemorrhoids, diosmiplex is given three times a day for 4 days and twice daily for 9 days. For varicose veins, edema, stasis dermatitis and venous ulcers, diosmiplex is given once daily as a 630mg dose (600mg of diosmin is combined with 30mg of alka4-complex in each tablet). Although improvement may occur within the first week of treatment, 4-8 weeks may be necessary to see clinical improvement.  The mechanism of action for diosmiplex is at several areas of the pathophysiology of venous insufficiency, varicose veins, venous hypertension and the microscopic pathways that lead to the skin changes associated with venous disease.

The alka4-complex is used to address the acidosis in the microvasculature. Diosmin itself helps to increase lymphatic and capillary permeability and reabsorption of fluid, decreasing interstitial fluid and hence edema. Reduction of capillary permeability and inflammation in turn may also decrease healing time for ulcers. Additionally, Diosmin has been shown to affect the metabolism of norepinephrine and prolong the contraction of varicose veins. In one study diosmin was shown to improve clinical signs, quality of life, and CEAP stage in 65 of 80 test subjects with venous insufficiency during a 30-day trial. In vitro, diosmin appears to have antioxidant, anti-inflammatory and antiproliferative effects.

There has been one case report of a patient who was on diosmin (an over-the-counter formulation) for several years and who was subsequently placed on warfarin. Six weeks after initiation of the warfarin, the patient developed a spontaneous interventricular bleed, which the attending physician felt might be related to the combined use of diosmin plus the addition of warfarin.

Medical Therapy as an Adjunct to Surgical Correction

Venous insufficiency is a chronic condition–and therefore medical management alone requires an indefinite period of continuous treatment to maintain improvement. The requirement of prolonged and indefinite medical treatment may be acceptable in some special populations, such as those whose health is frail, those who have deep venous reflux, those who have severe phobia or additional medical considerations contraindicating surgery. For most patients, venotonics can be a useful adjunct to more definite surgical ablation of incompetent veins.

 

 

BREAKING  NEWS   –  The United Kingdom’s National Institute for Health and Care Excellence   (NICE)  has released treatment guidelines for the diagnosis and management of varicose veins. For  the first time, NICE recommends   heat ablation therapy as first line treatment instead of the more invasive and traditional surgical procedures practiced. Furthermore, contrary to what the UK’s National Health Services  and many insurance companies have said before, the new NICE guidelines have recommended that all people with symptomatic primary or recurrent varicose veins should be referred to a vascular specialist for assessment and treatment. The NICE guidelines also state that compression stockings should  not  be  offered to  treat  varicose veins or delay evaluation and treatment, unless interventional treatment is unsuitable.   This recognition welcomes a new era for the management  of patients with varicose veins, who will benefit from a walk-in, walk-out, office-based procedure requiring only local anesthetic and allowing them to return to normal activities the same day.

The National Institute for Health and Care Excellence  (NICE) is a non-departmental public body of the Department of Health serving both the English National Health Service and the Welsh National Health Service.    NICE publishes guidelines in multiple areas, including guidance on the appropriate treatment and care of people with specific diseases and conditions and guidance for  public sector workers on health promotion and ill-health avoidance. These appraisals  are based primarily on evaluations of efficacy and cost-effectiveness in various circumstances. These appraisals must take into account both desired medical outcomes and also economic arguments regarding differing treatments.

The newly  issued  NICE guidelines establish endothermal ablation, which includes endovascular laser and radiofrequency treatment, as the  recommended first  option  in  treating varicose veins. Varicose veins affect up to 3 in 10 adults in the UK, similar to the prevalence in the United States.   Varicose vein disease was found to impact patients’ quality of life comparable with that of congestive heart failure and chronic lung disease. Additionally,  the burden to the National Health Service of managing the impact of untreated varicose veins such as leg ulcers is estimated at billions of dollars annually. Heat ablation is a cheaper therapy associated with less pain and quicker recovery times for patients, compared with traditional surgery such as vein stripping or ligation. Access to appropriate treatment can transform patients’ lives.

Symptoms  of  venous insufficiency, the underlying cause of varicose vein disease, include pain, aching, heaviness, itching, restless leg phenomenon, cramping, hair loss in the lower legs, and skin changes ranging from dryness to extensive dermatitis. Usually these symptoms will worsen as the day progresses and with activities such as prolonged standing or sitting. While these symptoms start out as mild, they can progress in severity if left untreated.

%d bloggers like this: