slide

Vein Disease Published Research

 

Below are just some examples of the many publications devoted to various minimally-invasive treatment methods for venous disease and the results obtained from these treatment methods:

Varicose Vein Treatment With Endovenous Laser Therapy

Author: Neil M Khilnani, MD; Weill Cornell Vascular, New York, NY; Associate Professor of Clinical Radiology, Weill Medical College of Cornell University
Updated: Jul 2, 2012

Overview

Chronic venous disorders (CVD) of the lower extremity are common problems caused by venous hypertension.
Venous hypertension is usually the result of incompetent valves in one or more of the saphenous veins and their primary tributaries. In patients with saphenous vein incompetence, regardless of CVD stage, treatment begins with the elimination of these incompetent pathways. Until recently, the best way to accomplish this was with ligation of the saphenous vein at its deep vein junction and removal of the abnormal saphenous vein segments; this procedure is known as high ligation and stripping (HL/S).

Over the last 10 years, HL/S has been replaced by endovenous thermal ablation. Two types of thermal ablation procedures exist: endovenous laser ablation (ELA) and radiofrequency ablation (RFA). Both procedures are associated with high success and low complication rates. The procedures are generally performed on an ambulatory basis with local anesthetic and typically require no sedation. The patients are fully ambulatory following treatment and the recovery time is short. In this article we review ELA.

Target veins

ELA has been successfully and safely used to ablate the great and small saphenous veins, the anterior and posterior accessory great saphenous vein, the superficial accessory saphenous vein, the anterior and posterior circumflex veins of the thigh as well as the thigh extension of the small saphenous vein, including the vein of Giacomini. ELA has been used to treat long straight competent tributary veins outside the superficial fascia, particularly in patients who are obese and who either sclerotherapy or microphlebectomy would be difficult, time consuming, or prone to side effects.

Indications

The selection of candidates for ELA involves a directed history, physical examination, and duplex ultrasound (DUS) examination. Indications for endovenous treatment are listed below:

Symptoms affecting quality of life
  • Aching
  • Throbbing
  • Heaviness
  • Fatigue
  • Restlessness
  • Night cramps
  • Pruritus
  • Spontaneous hemorrhage
Skin changes associated with chronic venous hypertension
  • Corona phlebectasia, eczema, and pigmentation
  • Lipodermatosclerosis
  • Atrophie blanche
  • Healed or active ulceration
  • Edema
  • Superficial phlebitis (SVT) in varicose veins
Anatomical indications
  • Significant reflux documented on DUS examination (reflux >0.5 seconds)
  • Straight vein segment
  • Reflux responsible for venous hypertension leading to the clinical abnormalities

Results of ELA

  • General comments ELA is safely and effectively performed using local anesthesia in an office setting requiring about 45–90 minutes of room time to be perform. Procedure times are dependent on the number of concurrent treated veins, length of segment(s) treated, and whether ancillary procedures, such as ambulatory phlebectomy, are carried out. Patient satisfaction has been reported to be very high.

Anatomical success rates Anatomic success following ELA should result in the treated vein having no lumen and either shrink to a fibrous cord < 2.5 mm in diameter or become sonographically absent 6-12 months after treatment. Anatomical success with ELA of the GSV has been reported between 93–100%. The follow-up for these evaluations varies from 3 months to 4 years. Fewer data are published following SSV with ELA but the results are qualitatively similar to that found with GSV ablations.

Evaluation of Clinical Outcomes

Several studies have documented significant and durable improvements in validated assessments of quality of life following ELA, which were at least as good as or better than the improvements seen following HL/S in one study). Evaluation of the effectiveness of ELA in CEAP 4-6 patients was performed in a retrospective review of patients 6 weeks after they were treated with RFA and laser; 85% vein occlusion was noted overall, with significant improvements in the Venous Clinical Severity Scores (VCSS), and air plethysmography (APG).
The correction in VFI (venous filling index) on the APG has been correlated with long-term symptomatic relief in surgical series. Improvement in APG at 8 weeks following ELA has been documented.

Ulcer healing has been induced after ELT. One report documented an 84% success rate with ulcer healing with a combination of either RFA or laser and microphlebectomy with 77% of these healing within 2 weeks of the procedure.

A nonrandomized, consecutive treatment comparison of conventional HL/S with general anesthesia and laser ablation of the GSV using tumescent anesthesia has been performed. The authors demonstrated that with the 36-Item Short Form Health survey (SF-36) at 1 and 6 weeks, the patients treated with laser did not suffer the decrease in quality of life seen in the surgical group at the same time. By 12 weeks, both groups had similar improvements in quality of life and in an objective assessment of the severity of their venous disease. The VCSS improvement was significant compared with the pretreatment assessment and similar for both groups of patients.

A randomized comparison of 118 limbs treated with laser and microphlebectomy and 124 with conventional HL/S and microphlebectomy compared the quality of life of the post-procedure period of both procedures. The study demonstrated significantly less postoperative morbidity for the laser procedure using the Chronic Venous
Insufficiency Questionnaire (CIVIQ). In addition, patient satisfaction, analgesia use, and the duration of days before return to work was significantly better for the laser-treated group.

Summary

In the decade since its introduction, ELA has become an important procedure to eliminate saphenous vein reflux. ELA and other thermal ablation techniques have essentially replaced HL/S for GSV and HL for SSV reflux elimination. The procedure has been validated to result in reliable elimination of saphenous vein reflux, is safe, well tolerated, and durable. ELA can be performed in an office setting with local anesthetic and is associated with a quicker recovery than HL/S.

Restless Legs Syndrome & Chronic Venous Disorders

The conclusion of this study was that patients who suffer from Restless Legs Syndrome typically have other venous leg disorders such as venous insufficiency and chronic venous disorders.

Restless legs syndrome in patients with chronic venous disorders: an untold story McDonagh B*, King T , Guptan RC *Illinois Phlebology group; Indiana Phlebology; The Department of Clinical Research, Venous Research Foundation, Schaumburg, IL, USA.

Objective

To perform a prospective study of the occurrence of Restless Legs Syndrome (RLS) in patients who are evaluated in a phlebology practice.

Method

A prospective questionnaire and clinical evaluation were used. In total, 174 consecutive patients and 174 matched controls were included in the study. The International RLS Study Group (IRLSSG) 4-point criteria were used to objectively establish the diagnosis of RLS. The symptom severity of those who had RLS was assessed with the 10-point IRLSSG severity questionnaire. Detailed history, physical, and Duplex ultrasound evaluations were performed to establish the presence or absence of venous insufficiency (reflux > 0.5 seconds on compression/augmentation) and chronic venous disorder (CVD), according to current clinical, etiologic, anatomic, and pathologic (CEAP) criteria.

Results

Of the 174 consecutive patients studied (22M: 152F), 63 (36%) met the clinical criteria for having RLS. This compared with only 34 of 174 (19%) in the control group (P<0.05). In the RLS-positive study group, 62 of 63 (98%) were found to have venous insufficiency and CVD. By comparison, 31 of 34 (91%) of the RLS-positive control group were found to have CVD. Thus, the prevalence of CVD in both the RLS-positive study and control groups was similar; however, this was significantly more than the prevalence of CVD in the RLS-negative controls (P<0.01). There were only 3 (9%) of the RLS-negative controls who had CVD. RLS-positive patients were typically women (P<0.01 vs. men) who were more than 40 years of age (P<0.01 vs. less than 40). It should be noted that a history of leg cramps was significantly more common in the RLS-positive patients (P<0.01). It should also be noted that none of the RLS patients gave a history of anemia, chronic renal failure, or had an established psychiatric or neurologic disorder that others have described as being highly associated with the diagnosis of RLS.

Conclusion

RLS appears to be a clinical syndrome that commonly overlaps in patients with venous insufficiency and CVD. Prospective, blinded therapeutic trials are underway to evaluate the effect of definitive treatment for CVD on sequential RLS scores.

Radiofrequency Ablation Therapy for Varicose Veins

Author: Margaret Weiss, MD; Chief Editor: Dirk M Elston, MD
Updated: Jan 23, 2012

Overview

Venous insufficiency resulting from superficial reflux because of varicose veins is a serious problem that usually progresses inexorably if left untreated. When the refluxing circuit involves failure of the primary valves at the saphenofemoral junction, treatment options for the patient are limited, and early recurrences are the rule rather than the exception.

In the historical surgical approach, ligation and division of the saphenous trunk and all proximal tributaries are followed either by stripping of the vein or by avulsion phlebectomy. Proximal ligation requires a substantial incision at the groin crease. Stripping of the vein requires additional incisions at the knee or below and is associated with a high incidence of minor surgical complications. Avulsion phlebectomy requires multiple 2- to 3-mm incisions along the course of the vein and can cause damage to adjacent nerves and lymphatic vessels.

Endovenous ablation has replaced stripping and ligation as the technique for elimination of saphenous vein reflux. One of the endovenous techniques is a radiofrequency-based procedure. Newer methods of delivery of radiofrequency were introduced in 2007. Endovenous procedures are far less invasive than surgery and have lower complication rates. The procedure is well tolerated by patients, and it produces good cosmetic results.

Excellent clinical results are seen at 4-5 years, and the long-term efficacy of the procedure is now known with 10 years of experience. Endovenous techniques (endovenous laser therapy, radiofrequency ablation, and endovenous foam sclerotherapy) clearly are less invasive and are associated with fewer complications compared with more invasive surgical procedures, with comparable or greater efficacy.

Technology

The original radiofrequency endovenous ablation system worked by thermal destruction of venous tissues using electrical energy passing through tissue in the form of high-frequency alternating current. This current was converted into heat, which causes irreversible localized tissue damage. Radiofrequency energy is delivered through a special catheter with deployable electrodes at the tip; the electrodes touch the vein walls and deliver energy directly into the tissues without coagulating blood. The newest system, called ClosureFast, delivers infrared energy to vein walls by directly heating a catheter tip with radiofrequency energy.

Immediately after treatment, biopsy specimens show a significant reduction in the size of the vein lumen, with denudation of endothelium, thrombus formation, thickened vessel walls, loss of collagen birefringence, and inflammatory changes. The zone of thermal damage is limited to 2 mm beyond the point of contact with the electrodes.

In more than 90% of patients, biopsy specimens demonstrate complete occlusion of the vein lumen 6 weeks after treatment. The lumen is completely ablated in most areas, with some portions of the vessel demonstrating a small residual lumen containing organized fibrous thrombi. Birefringence is present, and new collagen growth is evident.

Outcomes

Published results show a high early success rate with a very low subsequent recurrence rate up to 10 years after treatment. Early and mid-range results are comparable to those obtained with other endovenous ablation techniques. The authors’ overall experience has been a 90% success rate, with rare patients requiring a repeat procedure in 6-12 months. Overall efficacy and lower morbidity have resulted in endovenous ablation techniques replacing surgical stripping. Patient satisfaction is high and downtime is minimal, with 95% of patients reporting they would recommend the procedure to a friend.

Stasis Dermatitis

Author: Scott L Flugman, MD; Chief Editor: Dirk M Elston, • MD more...
Updated: Aug 30, 2012

Background

Stasis dermatitis is a common inflammatory skin disease that occurs on the lower extremities. It is usually the earliest cutaneous sequela of chronic venous insufficiency with venous hypertension and may be a precursor to more problematic conditions, such as venous leg ulceration and lipodermatosclerosis. Stasis dermatitis typically affects middle-aged and elderly patients, rarely occurring before the fifth decade of life. An exception would be patients with acquired venous insufficiency due to surgery, trauma, or thrombosis.

Prognosis

Complications of chronic stasis dermatitis include cellulitis and nonhealing venous ulcers. Direct consequences of stasis dermatitis include an increased incidence of allergic contact dermatitis, lower-extremity ulceration, lipodermatosclerosis, and id reaction (autoeczematization). Patients should be educated regarding the underlying cause of their stasis dermatitis and the permanent nature of venous valvular insufficiency.

Etiology

Stasis dermatitis occurs as a direct consequence of venous insufficiency. Disturbed function of the 1-way valvular system in the deep venous plexus of the legs results in a backflow of blood from the deep venous system to the superficial venous system, with accompanying venous hypertension. This loss of valvular function can result from an age-related decrease in valve competency.

Alternatively, specific events, such as deep venous thrombosis, surgery (eg, vein stripping, total knee arthroplasty, harvesting of saphenous veins for coronary bypass), or traumatic injury, can severely damage the function of the lower-extremity venous system.

Epidemiology

Occurrence in the United States

Although not nearly as prevalent as skin cancer, dermatophytosis, or xerosis, stasis dermatitis affects a significant proportion of the elderly population. No conclusive investigations into morbidity and mortality in stasis dermatitis have been undertaken, but studies have estimated an approximately 6-7% prevalence of the condition in patients older than 50 years. This would translate into approximately 15-20 million patients older than 50 years with stasis dermatitis in the United States. This finding makes stasis dermatitis twice as prevalent as psoriasis and only slightly less prevalent than seborrheic dermatitis.

Sex-and age-related demographics

A slight female preponderance has been reported in stasis dermatitis. This is most likely due to the fact that pregnancy results in significant stress on the lower-extremity venous system, with many women experiencing earlier and more severe derangement of lower-extremity valvular function. The risk of developing stasis dermatitis steadily increases with each passing decade; when considering only adults older than 70 years, the prevalence of stasis dermatitis may be greater than 20%. The well-publicized aging of the population will undoubtedly result in a significant increase in cases of stasis dermatitis over the next few decades.

Varicose Veins: Achieving Optimal Outcomes With Minimally Invasive Therapies

Robert A. Weiss, MD Released: 05/26/2011

Varicose veins are an extremely common medical concern, with documentation of the condition and various interventions dating back thousands of years. They are often unsightly, and cosmetic concern is "the most common reason patients seek consultation."[2] Beyond their appearance, varicose veins are associated with numerous health concerns because they are the visible surface manifestation of some degree of venous insufficiency syndrome. Patients may present with symptoms ranging from aches and cramps to visible ulceration and hemorrhage. Even very small varicose veins may be of more than cosmetic concern because the outward signs of venous disease often do not match the significance of the underlying pathology.

As in most areas of medicine, the treatment of varicose veins continues to evolve toward increasingly less invasive interventions. Less invasive therapies are associated with a number of benefits, including reduced treatment time, lower costs, fewer serious side effects, and improved treatment efficiency. These benefits, however, must be balanced against efficacy.

CEAP

The clinical, etiologic, anatomical, and pathologic elements (CEAP) classification system was developed to provide a "comprehensive objective classification" of the severity of venous disease. The classification system considers the clinical symptoms of chronic venous insufficiency but also factors in the etiology, anatomic distribution, and pathogenic mechanism to produce a CEAP score of disease severity. This system is useful for the classification of severe venous disease but has limited utility in the assessment of mild-to-moderate disease of mostly cosmetic concern.

Noninvasive Diagnostic Techniques

The development of noninvasive diagnostic techniques for evaluating venous disease revolutionized the field of vascular medicine. Doppler ultrasound is the most practical instrument for evaluating patients with venous disease. Color-flow duplex imaging technology superimposes color-coded flow information over a gray structural image, providing a visual demonstration of reflux. This technology has become the gold standard for noninvasive diagnosis and has allowed greater insight into the pathophysiology of the disease.

Introduction

The information gathered from patient evaluation and assessment guides the development of an appropriate treatment strategy. When saphenous system reflux, or reverse flow, is detected, it should be treated by endovenous radiofrequency or laser ablation. Sclerotherapy, laser therapy, intense pulsed-light therapy, radiofrequency or laser ablation, and ambulatory phlebectomy are all part of the contemporary algorithm for varicose vein treatment once any underlying saphenous reflux is addressed. Each approach has benefits and limitations, and many patients will benefit from the combination of multiple modalities.

Sclerotherapy

Sclerotherapy is the most commonly used intervention for smaller varicose veins and telangiectasias. It is widely considered the gold standard for treatment of veins < 4 mm in diameter. In this procedure, a solution (sclerosant) is injected into abnormal veins, destroying the lining and causing the vein to collapse and eventually be absorbed. It is important to note that sclerotherapy of superficial veins will not be successful unless the points of reflux, or reverse flow, through incompetent valves leading to the visible veins have been identified and treated. Sclerotherapy is the primary minimally invasive approach to treating varicose veins.

Endovenous Procedures

Advances in technology have enabled the development of minimally invasive alternatives to surgery for the management of incompetent great saphenous vein and small saphenous vein segments. Endovenous laser ablation and radiofrequency ablation have become important options for the contemporary treatment of varicose veins. These procedures are performed in the office using localized tumescent anesthesia and have largely replaced traditional saphenectomy (surgical removal of the great saphenous vein) by ligation and stripping.

Surgery

The most common surgical procedure in current use is ambulatory phlebectomy, also known as stab-avulsion. This procedure enables removal of short segments of varicose and reticular veins. It is useful for treating residual clusters following saphenectomy and for removing nontruncal tributaries when the saphenous vein is competent. Phlebectomy is not the recommended technique when significant reflux at the saphenofemoral and saphenopopliteal junctions is present. Laser/radiofrequency ablation are better initial approaches in this case.

Venous Insufficiency

Author: Robert Weiss, MD; Chief Editor: William D • James, MD.
Updated: Nov 21, 2012

Background

In venous insufficiency states, venous blood escapes from its normal antegrade path of flow and refluxes backward down the veins into an already congested leg. Venous insufficiency syndromes are most commonly caused by valvular incompetence in the low-pressure superficial venous system but may also be caused by valvular incompetence in the high-pressure deep venous system (or, rarely, both). In addition, they may result from the congenital absence of venous valves.

Untreated venous insufficiency in the deep or superficial system causes a progressive syndrome (chronic venous insufficiency [CVI]). In addition to poor cosmesis, CVI can lead to chronic life-threatening infections of the lower extremities. Pain, especially after ambulation, is a hallmark of the disease. CVI causes characteristic changes, called lipodermatosclerosis, to the skin of the lower extremities, which lead to eventual skin ulceration.

Anatomy

The venous network in the lower extremities commonly affected by CVI is divided into the following 3 systems:

  • Superficial veins (including the great saphenous vein [GSV], the small saphenous vein [SSV], and their tributaries)
  • Deep veins (including the anterior tibial, posterior tibial, peroneal, popliteal, deep femoral, superficial femoral, and iliac veins)
  • Perforating veins of lower leg.

 

Etiology

CVI can be caused by congenital absence of or damage to venous valves in the superficial and communicating systems. It can also be caused by venous incompetence due to thrombus formation as favored by the Virchow triad (venous stasis, hypercoagulability, and endothelial trauma). Varicose veins rarely are associated with the development of CVI. Most cases of venous insufficiency are related to reflux through the superficial veins. Chronic nonhealing wounds of the lower extremity have many different potential causes, but most chronic lower extremity ulcers are of venous etiology. The majority of venous ulcers are caused by venous reflux that is purely or largely confined to the superficial venous system; only a minority are caused by chronic DVT or by valvular insufficiency in the deep veins.

Superficial venous insufficiency

In superficial venous insufficiency, the deep veins are normal, but venous blood escapes from a normal deep system and flows backwards through dilated superficial veins in which the valves have failed. More than 80% of varicose veins seen on the leg are caused by venous insufficiency or a leaky valve in the GSV, which terminates near the inguinal ligament as it joins the common femoral vein.
The initial valve failure may occur at any level between the groin and the ankle, but the saphenofemoral junction is the high point of reflux in most patients with severe superficial venous insufficiency. Valve failure can be spontaneous in patients with congenitally weak valves. Congenitally normal valves can fail as a consequence of direct trauma, thrombosis, hormonal changes, or chronic environmental insult (eg, prolonged standing).

Deep venous insufficiency

Deep venous insufficiency can be due to congenital valve or vessel abnormalities, but it most commonly occurs when the valves of the deep veins are damaged as a result of DVT. With no valves to prevent deep system reflux, the hydrostatic venous pressure in the lower extremity increases dramatically.

Epidemiology

United States statistics

CVI is a significant public health problem in the United States. It has been estimated that 2-5% of all Americans have some changes associated with CVI. Published estimates of the prevalence of varicosities range from 7% to 60% in the adult population, with most studies demonstrating clinical varicose reflux in about 40% of the population. Venous stasis ulcers affect approximately 500,000 people. The mean incidence of hospital admission for CVI is 92 per 100,000 admissions.

Age-related demographics

The prevalence of venous insufficiency increases with age. Peak incidence occurs in women aged 40-49 years and in men aged 70-79 years.

The incidence and prevalence of deep and superficial venous disease depend on the age and sex of the population, but at any age, such disease is more common in women than in men. In younger men, the incidence is lower than 10%, compared with 30% in similarly aged women. In men older than 50 years, the incidence is 20%, compared with 50% in similarly aged women.[7]

Prognosis

The syndromes of venous hypertension and reduced venous clearance are important causes of morbidity and disability in patients with varicose venous disease. Without correction of the underlying cause, venous insufficiency is inexorably progressive. Subjective symptoms usually worsen over time.

In many patients, the skin eventually breaks down and nonhealing ulcers develop. Chronic nonhealing leg ulceration can be debilitating. Approximately 1 million Americans have an ulceration due to superficial venous disease, and approximately 100,000 are disabled because of their condition.

Tissue atrophy and staining are usually not reversible. Patients have an increased lifetime risk of DVT and pulmonary embolism. As many as 50% of patients with untreated varicose veins develop superficial thrombophlebitis at some time. This is of grave concern, because unrecognized DVT is present in as many as 45% of patients with what appears to be purely superficial phlebitis.

The risk of DVT is 3 times higher in patients with superficial varicosities than in the general population. Phlebitis develops in 60% of hospitalized patients with clinically evident superficial venous insufficiency, and in nearly one half of cases, the condition progresses to DVT. Approximately one half of patients with DVT have detectable pulmonary embolism, and the death rate in this group exceeds 1 in 3. Venous insufficiency syndromes can also lead to death from hemorrhage. Bleeding from lower-extremity varicosities can be fatal.

Venous Leg Ulcer

Phlebology 2005; 20:2 (The official Journal of the Venous Forum of the Royal Society of Medicine and Societas Phlebologica Scandinavica, Members of the Union Internationale de Phlebologie)
B. McDonagh1, S. Sorenson1, A. Cohen1, T. Eaton1, D.E. Huntley1, M. Schul1, C. Martin1, C. Gray1, P. Putterman1, T. King1, J.L. Harry1, R.C. Guptan2 1Illinois Phlebology Group, Chicago, Illinois, USA and 2Department of Clinical Research, Venous Research Foundation, Schaumburg, Illinois, USA

Objective

Venous stasis ulcer is a major public health problem in the U.S. Subcutaneous endoscopic perforator surgery, tissue graft, hyperbaric oxygen and granulocyte-macrophage colony-stimulating factor therapy have remained experimental. There is a need for effective minimally invasive therapies. Non-elastic, ambulatory, below knee (BK) compression aggressively counters the impact of reflux on venous pump failure and is complemented by sequential duplex ultrasound-guided sclerotherapy.

Methods

Eighteen U.S. centers were studied retrospectively. 1,142 leg ulcer cases from 1984 to 2004 were available. Inclusion: CEAP class 6, evidence of chronic venous insufficiency, photograph, treated with non-elastic, ambulatory, BK compression and sequential duplex ultrasound-guided sclerotherapy. Exclusion: Arterial disease, DM and varicose surgery. 
Outcomes assessment: CEAP classification, sustained healing (>6 months), DVT and amputation incidence. Comprehensive objective mapping (Phlebology 2003; 4:173-185) was used to quantify reflux.

Results

To date, data from 123 patients is available (62M: 61F). The sexes were comparable in age. The mean duration of ulceration was 4.98 months. Most ulcers, 101 (82%), were in the gaiter area. Non-elastic, BK, ambulatory compression was applied every 2.7 days for 4.7 months. In a majority of active ulcers, 75/103 (73%) showed evidence of healing after compression. After 5 sclerotherapy treatments 86/103 (83%) had sustained healing. None had DVT or required amputation at the last follow up but 23/103 (22%) had recurrent reflux, which required sequential duplex ultrasound-guided sclerotherapy.

Conclusion

Non-elastic, BK, ambulatory compression with sequential duplex ultrasound-guided sclerotherapy appears to be highly efficacious in venous stasis ulcer management. A detailed survey is planned to estimate long-term outcomes.