DISEASE EDUCATION SUPERFICIAL VEIN THERAPIES

Information about venous reflux disease

VENOUS REFLUX DISEASE

Venous reflux disease or chronic venous insufficiency (CVI) is a progressive medical condition that may worsen over time and affects the veins and vessels in the leg that carry oxygen-poor blood back toward the heart. Signs and symptoms may include pain, swelling and fatigue of the legs as well as skin damage and ulcers. CVI is often preceded by varicose veins.¹

Symptoms2

  • Varicose veins
  • Aching
  • Swelling
  • Cramping
  • Heaviness or tiredness
  • Itching
  • Restlessness
  • Open skin sores

Risk Factors3

  • Age 40+
  • Gender
  • Family history
  • Heavy lifting
  • Smoking
  • Prolonged standing
  • Obesity or excessive weight
  • Multiple pregnancies

With proper treatment, the progressive symptoms of venous reflux disease are preventable.

Without treatment, signs and symptoms may progress and significantly impact quality of life, and lead to venous leg ulcers.


Identifying Venous Leg Ulcers

Venous leg ulcers can be caused by chronic venous insufficiency (CVI).4 This can be caused by reflux in any of the venous systems — superficial, perforator, or deep — when the valves of the veins have failed or the vein has become obstructed.

2014 SVS/AVF venous leg ulcer guidelines recommend comprehensive venous duplex ultrasound examination of the lower extremity in all patients with a suspected venous leg ulcer to identify the cause.6

STEP 1: DIFFERENTIATE ARTERIAL ULCER FROM VENOUS ULCER

CHARACTERISTIC ARTERIAL ULCER VENOUS ULCER

Location

Toes or foot

Malleolus or metatarsal

Appearance

Irregular margin,
cool cyanotic

Typically sloped edges, may have exudate, irregular shape

Foot temperature

Cold

Warm

Pain

Usually severe

Mild

Sensation

Variable, often decreased

Present, variable
(pain, temperature)

 

Arterial Pulses

Absent

Present, variable
(pain, temperature)

Veins

Collapsed

Dilated, varicosities, edema

Arterial Ulcer

Arterial Ulcer

Venous Ulcer

Venous Ulcer

Ulcer appearance together with the medical history and physical exam should be used to determine the different diagnosis and see if a venous leg ulcer is suspected.

STEP 2: TEST FOR CHRONIC VENOUS INSUFFICIENCY (CVI)

Comprehensive Venous Duplex Ultrasound Examination of the lower extremity should be performed in all patients with a suspected venous leg ulcer in order to identify the cause. The Society of Vascular Surgery (SVS) and the American Venous Forum (AVF) 2014 venous leg ulcer guidelines provide a strong recommendation for conducting this exam.

STEP 3: IDENTIFY THE UNDERLYING CAUSE

Venous leg ulcers can be caused by chronic venous insufficiency (CVI)1, a more serious form of venous reflux disease which can cause reflux in any of the venous systems — superficial, perforatoror deep.  Ultrasound testing will help define the underlying cause of this disease and help in determining the right treatment for patients.


EARLY ENDOVENOUS INTERVENTION IS KEY

Treating patients with venous ulcers is not easy. It is important to not only treat the wound but also identify the cause — enabling your patients to live without the discomfort of these wounds.

Patients with less than 40% wound closure at four weeks are unlikely to achieve complete wound healing and may benefit from alternative or advanced interventions.7

DID YOU KNOW?

  • 70% – 90% of all lower extremity ulcers are venous.6,8
  • 1 million people in the U.S. are affected by venous leg ulcers.9
  • More than half of venous ulcers treated are recurrent ulcerations.10

QUALITY OF LIFE

Due to pain, mobility limitations and other consequences, venous leg ulcers have been associated with increased rates of depression and substantial decreases in patient quality of life.11-13

COST OF CARE

  • Each year U.S. payers spend a combined $14.9 billion on managing venous leg  ulcers8.
  • A venous leg ulcer patient costs payers $6,000 – $7,000 more each year than a  matched non-venous leg ulcer patient6.

Compared to compression therapy alone, minimally invasive treatments addressing the underlying cause of venous ulcers may:

  • Aid in ulcer healing in patients with chronic venous insufficiency14
  • Reduce ulcer recurrence15
  • Improve quality of life14,15

SVS/AVF Guidelines for Venous Leg Ulcers

The 2014 Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) provide comprehensive guidelines on venous leg ulcers for clinical practices. Please refer to the guidelines below for further information regarding assessment and recommendations for venous leg ulcer management and treatment.6

GUIDELINE GRADE

Venous Duplex Ultrasound

3.9: We recommend comprehensive venous duplex ultrasound examination of the lower extremity in all patients with suspected venous leg ulcer

1 B

Ablation:
Prevent Recurrence

6.2: In a patient with a venous leg ulcer (C6) and incompetent superficial veins that have axial reflux directed to the bed of the ulcer, we recommend ablation* of the incompetent veins in addition to standard compressive therapy to prevent recurrence.

 

1 B

Ablation:
Ulcer Healing

6.1: In a patient with a venous leg ulcer (C6) and incompetent superficial veins that have axial reflux directed to the bed of the ulcer, we suggest ablation* of the incompetent veins in addition to standard compressive therapy to improve ulcer healing.

2 C

Ablation:
Prevent Ulceration

6.4: In a patient with skin changes at risk for venous leg ulcer (C4b) and incompetent superficial veins that have axial reflux directed to the bed of the affected skin, we suggest ablation* of the incompetent superficial veins in addition to standard compressive therapy to prevent ulceration.

2 C

Venous Angioplasty and Stent Recanalization:
Ulcer Healing, and Prevent Recurrence

6.14: In a patient with inferior vena cava or iliac vein chronic total occlusion or severe stenosis, with or without lower extremity deep venous reflux disease, that is associated with skin changes at risk for venous leg ulcer (C4b), healed venous leg ulcer (C5), or active venous leg ulcer (C6), we recommend venous angioplasty and stent recanalization in addition to standard compression therapy to aid in venous ulcer healing and to prevent recurrence.

1 C

GRADE DESCRIPTION OF RECOMMENDATION METHODOLOGIC QUALITY OF SUPPORTING EVIDENCE

1 B

Strong recommendation, moderate-quality evidence

RCTs with important limitations or exceptionally strong evidence from observational studies

1 C

Strong recommendation, low quality or very-low-quality evidence

Observational studies or case series

2 C

Weak recommendation, low quality or very-low-quality evidence

Observational studies or case series


*

Regarding the choice of method of saphenous ablation there are multiple RCTs showing strong and consistent evidence that modern open surgery radiofrequency and laser ablation are equivalent in effect and safety


1

Eberhardt, R., Raffetto, J. Chronic Venous Insufficiency. Circulation. 2005;111:2398-2409.

2

Venous Disease Coalition. “Chronic Venous Insufficiency | Venous Disease Coalition.” Venous Disease Coalition | Promoting Public Health Professional Awareness of Venous Disease. Venous Disease Coalition, 19 June 2010. Web. 09 Aug. 2011.

3

Chronic Venous Insufficiency.” Vascular Web. Society For Vascular Surgery, Jan. 2011. Web. 17 Aug. 2011. http://www.vascularweb.org/vascularhealth/Pages/chronic-venous-insufficiency.aspx.

4

Kanth, A., Khan, S., Gasparis, A., Labropoulos, N., et al. The Distribution and Extent of Reflux and Obstruction in Patients with Active Venous Ulceration. Phlebology. 2015; 30(5): 350-6.

5

Sufian, S., Lakhanpal, S., Marquez, J., et al. Superficial Vein Ablation for the Treatment of Primary Chronic Venous Ulcers. Phlebology. 2011; 26:301-6.

6

O’Donnell Jr, T.F., et al. Management of Venous Leg Ulcers: Clinical Practical Guidelines of the Society for Vascular Surgery and the American Venous Forum. J VascSurg. 2014; 60:3S-59S.

7

Howard M., et al. An Evidence-Based Algorithm for Treating Venous Leg Ulcers Utilizing the Cochrane Database of Systematic Reviews. WOUNDS. 2013; 25(9):242-250.

8

Rice, J. Burden of Venous Leg Ulcers in the United States. Journal of Medical Economics. 2014; 17(5): 347-356.

9

Internal data; Dymedex Study.

10

The Outpatient Wound Clinic Market: 2013 Report and Analytics. Net Health Analytics. 2010-2012 Claims Data.

11

Valencia I.C., Falabella A, Kirsner RS, et al. Chronic Venous Insufficiency and Venous Leg Ulceration. J Am Acad Dermatol. 2001; 44:401-21.

12

Phillips, T., Stanton, B., Provan, A., et al. A Study of the Impact of Leg Ulcers on Quality of Life: Financial, Social and Psychologic Implications. J Am Acad Dermatol. 1994; 31:49-53.

13

Green, J., Jester, R. Health-related Quality of Life and Chronic Venous Leg Ulceration: Part 1. Wound Care. 2009; December: S12-S17.

14

Harlander-Locke, et al. The Impact of Ablation of Incompetent Superficial and Perforator Veins on Ulcer Healing Rates. J Vasc Surg. 2012; 55:458-64.

15

Harlander-Locke, et al. Combined Treatment with Compression Therapy and Ablation of Incompetent Superficial and Perforating Veins Reduces Ulcer Recurrence in Patients with CEAP 5 Venous Disease. J Vasc Surg; 55:446-50 (2012).