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Venous Ulcers

Venous Insufficiency: An Under-Recognized Cause of Chronic, Nonhealing Wounds

Michael Shao, MD

Keywords
June 2017

Providers in the outpatient clinic have a responsibility to refer patients to specialists when venous insufficiency is present. This article offers education on signs and symptoms, as well as suggestions for when to refer.

 

Editor’s Note: Patient names in this article are pseudonyms.

 

Amelia, 68, could not have been a more frustrated patient. Four months prior, she had developed a chronic right medial ankle ulcer after a period of pruritis in the area. The ulcer was ultimately complicated by an episode of cellulitis requiring intravenous antibiotics and inpatient hospital admission. The wound had healed somewhat after she underwent endovenous thermal ablation of the great saphenous vein (GSV), but then stalled. Upon presentation to the wound care center, she had a medial ankle ulcer measuring 3.5 x 2.0 x 0.2 cm and a second ulcer measuring 0.5 x 0.4 x 0.1 cm. Her medical history included a similar posterior calf venous stasis ulcer six years prior that took about one year to heal with local wound care and compression therapy. During her initial visit to the wound center, venous duplex ultrasound showed successful closure of the proximal GSV, but persistent, tortuous refluxing GSV tributaries from the proximal calf to the distal calf in the vicinity of the ulcers. The tributaries were ablated with the sclerosing agent Varithena® (polidocanol endovenous microfoam [PEM]) and the ulcers went on to heal about four weeks later.  

Barry, 63, had a history of rheumatoid arthritis requiring multiple immunosuppression medications that impair wound healing. This contributed to chronic, recurrent bilateral lower-leg ulcers persisting for much of the past 11 years. He had previously undergone thermal ablation of the bilateral GSVs and small saphenous veins (SSVs), as well as multiple grafting procedures including xenogeneic, allogeneic, and autologous grafts. Barry had been receiving care at an outpatient wound care center 80 miles from his home. As with Amelia’s situation, he referred himself to this author’s wound care center for a second opinion after becoming frustrated with the lack of progress in healing over the years. He presented with a left medial calf ulcer (11.0 x 4.2 x 0.2 cm) and a right medial ankle ulcer (5.0 x 2.6 x 0.2 cm). He too underwent the Varithena chemical ablation of refluxing bilateral medial calf and ankle GSV tributaries identified on venous duplex ultrasound in November 2016. Now, five months later, the right ankle ulcer has healed to 2.2 x 1.3 x 0.1 cm and the left calf ulcer has shrunk and split into two smaller ulcers (2.0 x 2.2 x 0.2 cm and 1.0 x 0.7 x 0.2 cm).

These two patient examples illustrate the importance of treating a wound’s underlying venous hypertension. Without this, these wounds would have little likelihood of healing. Both patients could have been spared months of pain, frustration, repeated dressing changes, and ineffective treatment had they been immediately referred to a vascular specialist to evaluate for superficial venous incompetence. This article will discuss the signs and symptoms of venous insufficiency and educate clinicians in the outpatient setting about when it may be helpful to refer to a vascular specialist.  

Signs Of Venous Insufficiency

Some primary care physicians and even some wound care specialists may not always recognize the signs of venous insufficiency. These providers may not be aware that untreated venous hypertension will stall wound healing and result in a high rate of ulcer recurrence. Some physicians may attempt to rule out venous disease by asking patients about the classic symptoms of venous reflux: leg heaviness, leg fatigue, and a dull, aching discomfort that is exacerbated by prolonged leg dependence and improves with leg elevation. However, patients living with chronic venous ulcers may not necessarily report these symptoms. Barry, for example, had noted the onset of large varicose veins many years prior, but did not remember how his leg used to feel before he developed venous reflux. It was only after undergoing venous ablation that he noticed significant improvement in symptoms of leg throbbing, pain, heaviness, and fatigue (to which he had become accustomed). Another misconception is that venous insufficiency can only be present when there are visible, bulging varicose veins. Significant venous reflux can occur in the main superficial truncal veins, namely the GSV and the SSV, which lie deep to the saphenous fascia and may not feed refluxing tributaries extending to the skin surface. The only way to diagnose venous insufficiency is by duplex ultrasound, which assesses venous valvular function by measuring reflux time — the time that it takes for the valves to close and for retrograde flow to stop. Duplex ultrasound maps out the anatomic distribution of refluxing venous segments and can trace refluxing tributaries that often extend to pathologic varicosities in the vicinity of ulcers or even directly beneath the ulcer bed.

Guidelines from the Society for Vascular Surgery, American Venous Forum, and American College of Phlebology recommend venous ablation in addition to standard compressive therapy and local wound care to help improve ulcer healing and to reduce the risk of ulcer recurrence.1 Venous insufficiency leads to hemosiderin deposition, which results in chronic inflammation and skin damage. Minor trauma, such as a scratch or a bump, can cause the damaged skin to break down and develop into a chronic ulcer. Venous ulcers are typically located at the medial aspect of the ankle if fed by the GSV, but can also be found at the lateral aspect of the ankle if fed by the SSV. Typical signs of skin damage include erythema indicative of venous stasis dermatitis or hyperpigmented, thickened, leathery skin indicative of lipodermatosclerosis. Patients living with clinical category 4-6 on the Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification scale for chronic venous disorders should be referred immediately to a vascular specialist for venous ablation without first undergoing a course of conservative therapy with compression. CEAP Category 4 is venous stasis dermatitis or lipodermatosclerosis. Category 5 is a history of a previously healed venous ulcer. Category 6 is an active venous stasis ulcer. Treating venous disease with minimally invasive outpatient interventions such as thermal ablation and foam sclerotherapy speeds ulcer healing and reduces the ulcer recurrence rate by about half.2 Clinical experience has found that nonthermal ablation modalities, such as chemical ablation, show promise in treating Category 5 venous disease (healed ulcer) and Category 6 venous disease (active ulcer) by directly targeting venous tributaries feeding the ulcer bed. New clinical evidence is expected in the near term from studies underway. Signs of venous hypertension in the periwound skin should mandate a venous duplex ultrasound to evaluate for venous insufficiency. Additionally, a patient should also be evaluated for venous disease if he or she has a history of slow-to-heal venous stasis ulcers, with the aim of reducing ulcer recurrence.

Evaluating Venous Disease

It is important that a venous study be performed by a skilled vascular ultrasound technician accustomed to scanning legs with open wounds, preferably in a wound care center. Hospital radiology departments may not be the optimal setting for wound care patients to undergo duplex ultrasound due to a potential lack of advanced dressing supplies or nursing staff onsite to redress wounds. Consequently, hospital staff members may be reluctant to remove wound dressings when performing the study, resulting in a limited study that may miss identifying refluxing venous tributaries directly feeding the ulcer bed. At a wound care center, an experienced vascular ultrasound technician can scan the periwound skin directly over the ulcer bed itself to identify the underlying pathology. The standard venous insufficiency study includes scanning of the superficial venous system, the deep venous system, and the perforators that connect the superficial and deep systems (with the patient in the standing position). The focus is first directed toward the superficial truncal veins — the GSV and the SSV. Technicians should also trace and assess reflux in named tributaries, such as the anterior accessory saphenous vein and the posterior accessory saphenous vein, as well as smaller unnamed tributaries, to determine if they are extending toward an ulcer. In addition, the study should examine the deep system to evaluate for deep vein thrombosis (DVT) and deep venous reflux. A completely occlusive DVT is a contraindication to ablation of the superficial system because this may result in closing the only venous outflow from the leg and cause massive leg edema. A chronic DVT that is partially occlusive and recanalized, however, may provide enough venous return to still safely perform ablation if the goal is ulcer healing, but this requires caution and judgment. Likewise, in the presence of significant peripheral arterial disease, venous ablation should not be performed because the truncal veins may be needed as a future bypass conduit.    

Venous Ablation Therapies

Often, patients living with venous ulcers have diffuse reflux along the entire length of the vein, from the saphenofemoral junction to the ankle in the GSV, and from the saphenopopliteal junction to the ankle in the SSV. To close refluxing truncal segments above the knee, many specialists typically use catheter-based thermal ablation modalities due to their excellent medium-term closure rates of approximately 93-94% at 3 years.3,4 For refluxing veins below the knee, a nonthermal modality is often preferred in order to avoid the risk of saphenous nerve or sural nerve paresthesia, which are known complications of thermal ablation below the mid-calf. Thermal damage to these nerves can cause permanent numbness in the ankle area or neurogenic pain. PEM is useful for ablating tortuous refluxing tributaries, which cannot be accessed by rigid, straight catheter-based therapies. It may also be well suited to treat pathologic varicose networks that surround a venous ulcer. For those venous ulcers with truncal venous reflux, ablation of the affected truncal vein is generally the first step. In some cases, closing the truncal vein will eliminate tributary reflux and the wound will heal. If wound healing does not progress quickly, however, consider repeating the venous duplex to identify any persistent refluxing tributaries. Venous ablation procedures carry small risks; the risk of DVT is 1-2% for thermal ablation procedures.5 

In pooled clinical trials, the rate of DVT following PEM treatment was 2.3%. Proximal DVT was 1.7% and proximal symptomatic DVT was <1%. Other minor complications of venous ablation and foam sclerotherapy include superficial thrombophlebitis, which is self-limited and can be treated with nonsteroidal anti-inflammatory drugs. Other infrequent complications include skin necrosis due to thermal injury to the skin from catheter ablation or from extraluminal infiltration of sclerosant. For many venous ulcers, the ulcer will start to show signs of healing within 48 hours of ablation with markedly decreased drainage and diminished periwound pain and pruritis. Some patients will also report that their legs feel “lighter” and that it is easier to walk.

Where to Refer

Any patient living with an active venous ulcer and/or with a history of a healed venous ulcer, venous stasis dermatitis, or lipodermatosclerosis should be considered for referral to a reputable vascular specialist. This requires vetting among the many practitioners who provide this care, and there can be considerable variability among these individuals. For instance, the vein center should only perform venous ablation when there is significant reflux. A reputable vascular specialist will thoughtfully and selectively treat venous insufficiency. (Note that Novitas Inc., a Medicare Administrative Contractor [MAC], recently proposed a draft local coverage determination [LCD] regarding treatment of varicose veins of the lower extremities6 and that the Centers for Medicare & Medicaid Services convened a panel of the Medicare Evidence Development and Coverage Advisory Committee in July 2016 that examined the scientific evidence underpinning the benefits and risks of existing treatments for lower extremity chronic venous disease in the Medicare population. The meeting also identified evidence gaps that exist related to lower extremity chronic venous disease.7) Wound care professionals should monitor the Medicare Coverage Database website to see if Novitas posts a future effective LCD to follow the draft LCD.8 Patients living with nonhealing wounds experience considerable pain, impaired quality of life, loss of wages, and represent a huge financial burden to the healthcare system. Wound care clinicians owe it to these patients to identify and address chronic venous insufficiency when it exists to progress chronic venous ulcers to healing. 

 

Michael Shao is a vascular surgeon who practices with the Swedish Covenant Medical Group, Chicago, IL, and at the Swedish Covenant Hospital Wound Care Center. He is also a consultant and speaker for BTG International Ltd., West Conshohocken, PA, and for Vascular Insights LLC, Quincy, MA.

 

References

1. O’Donnell TF Jr, Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2014;60(2 Suppl):3S-59S.

2. Alden PB, Lips EM, Zimmerman KP, et al. Chronic venous ulcer: minimally invasive treatment of superficial axial and perforator vein reflux speeds healing and reduces recurrence. Ann Vasc Surg. 2013;27(1):75-83.

3. Proebstle TM, Alm J, Göckeritz O, et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg. 2011;54(1):146-52.

4. van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009; 49(1):230-9.

5. Mozes G, Kalra M, Carmo M, Swenson L, Gloviczki, P. Extension of saphenous thrombus into the femoral vein: a potential complication of new endovenous ablation techniques. J Vasc Surg. 2005;41(1):130-5.

6. Proposed/Draft Local Coverage Determination: Treatment of Varicose Veins of the Lower Extremities (DL34924). CMS. Accessed online: www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=37169

7. MEDCAC Meeting 7/20/2016 - Lower Extremity Chronic Venous Disease. CMS. Accessed online: www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=72

8. Medicare Coverage Database. CMS. Accessed online: www.cms.gov/medicare-coverage-database

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