Varicose Veins Radiofrequency Ablation Therapy

Article Author:
Bhalaghuru Chokkalingam Mani
Article Editor:
Gabriel Delgado
Updated:
3/24/2020 6:18:07 AM
For CME on this topic:
Varicose Veins Radiofrequency Ablation Therapy CME
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Varicose Veins Radiofrequency Ablation Therapy

Introduction

Venous disease has a very high prevalence among adults ranging from 40% to 80%, and the highest prevalence is in Western countries.[1] In the United States alone, greater than 30% of adults are affected by chronic venous insufficiency and varicose veins. Chronic venous insufficiency can result in pain, loss of workdays, and thereby result in significant morbidity.[2] Treatment of venous insufficiency includes non-invasive and invasive methods. Invasive methods include surgery and endovenous techniques. Most frequently used minimally invasive techniques include radiofrequency and laser therapy.

Anatomy and Physiology

Lower extremity varicose veins are defined as enlarged subcutaneous veins that measure greater than 3 mm in diameter. The lower extremity venous system comprises of superficial veins, perforators, and deep veins. Superficial veins are those that lie underneath the skin and superficial to the muscles of the leg. The primary superficial veins of the leg are the great saphenous vein and the short saphenous vein abbreviated as GSV and SSV, respectively. The GSV arises in the medial aspect of the foot and runs along the medial border of the tibia. In the thigh, it runs on the medial aspect and drains into the saphenofemoral junction in the inguinal region. The saphenofemoral junction also drains the superficial circumflex iliac, superficial epigastric, external pudendal veins. There are anterior and posterior accessory great saphenous veins in the calf and thigh that drain into the primary GSV. The thigh portion of the GSV may be duplicated in up to 20% of cases.[3][4]

The short saphenous vein or the SSV is a posterior superficial vein localized to the calf. It originates in the lateral aspect of the foot and drains most frequently into the popliteal vein, just distal to the popliteal fossa. An anatomical variant in which the SSV continues through to the thigh as a distinct branch tributary to then drain in the GSV in the thigh or directly in the saphenofemoral junction is known as the vein of Giacomini.[3]

The deep veins in the leg run alongside the named major arteries of the leg. The calf veins in the leg are paired and include anterior tibial, posterior tibial, peroneal, all of which join together to form the popliteal vein. The thigh veins include popliteal and femoral veins. The soleal veins generally drain into the posterior tibial veins. The gastrocnemius veins drain directly into the popliteal vein.[3]

Perforators include perforators of the foot, ankle perforators, perforators of the leg, perforators of the knee, perforators of the thigh, perforators of the gluteal muscles. Perforator veins serve to connect superficial and deep veins. There are many groups of perforators, depending on the location. For example, perforators in the leg are medial, anterior, posterior, and lateral leg perforators. Medial leg perforators, in turn, are the posterior tibial perforators and paratibial perforators. The posterior tibial perforators connect the posterior accessory GSV with the posterior tibial vein. The paratibial perforators connect the primary GSV with the posterior tibial veins. Similarly, in the thigh, there are 4 groups of perforators, namely medial thigh, lateral thigh, anterior thigh, posterior thigh perforators. In the medial thigh, the femoral canal perforators and the inguinal perforators connect the main GSV to the femoral vein.[3]

Superficial and deep veins of the lower limb have unidirectional valves that help drain the leg against gravity towards the right heart. Venous insufficiency of a superficial vein or a perforator is defined as the presence of flow reversal greater than 500 milliseconds on ultrasound, in the upright position with distal compression. For deep veins, namely the femoral and popliteal veins, reflux greater than 1000 milliseconds is considered significant. In general, proximal veins should be tested during an increase in intra-abdominal pressure or with the Valsalva maneuver. Distal veins can be tested with distal compression by hand or by pressure cuff.[2]

Indications

Symptomatic superficial insufficiency of veins greater than 3 mm in diameter that is refractory to compression stockings therapy in individuals greater than 18 years of age is an indication for treatment. Usually, this is limited to the GSV and SSV. Perforator veins can be treated if they are greater than 3.5 mm in diameter with greater than 500 milliseconds of reflux, and the perforator happens to run beneath a healed or active venous ulcer.[2]

Symptoms generally include throbbing discomfort, burning pain, pruritus, leg swelling, leg heaviness, fatigue, spontaneous bleeding from varicosities. Advanced venous disease may present as poorly healing ulcers. Chronic venous disease may present with skin changes such as eczema, corona phlebectatica, lipodermatosclerosis, or diffuse hyperpigmentation of the lower legs.[2]

Corona phlebectatica (ankle flare or malleolar flare) is a term that indicates short sized veins occurring in a fan-shaped pattern in the medial or the lateral aspects of the foot next to the malleoli.[5]

Lipodermatosclerosis describes thickened bound skin involving the tissues below the knee.[6]

Contraindications

Relative contraindications include an incompetent superficial vein diameter of less than 2 mm, history of extensive deep vein thrombosis (DVT) in the same leg, active superficial vein thrombosis in the vein to be treated, history of a prior surgical or endovenous treatment of the same leg, pregnancy, known malignancy.[7]

Other relative contraindications include more systemic conditions such as overall poor health, frailty, immobility, and known bleeding or clotting disorders.[8]

Equipment

Radiofrequency ablation or RFA is a minimally invasive procedure that was approved by the FDA in 1999 for treatment of varicose veins. The commercially available radiofrequency catheters are built with a heating element at its tip that uses thermal energy to destroy the endothelium of the vein. The length of the heating element is variable based on the manufacturer.[7]

Personnel

Radiofrequency ablation is an image-guided minimally invasive procedure that can be performed in the outpatient setting. It can be performed with local anesthesia and does not require general anesthesia. A performing operator, a nursing assistant, and a trained ultrasound technician are the required personnel for this procedure.[9]

Preparation

Antibiotic prophylaxis is not routinely recommended before or after the procedure.[10] Patients are generally placed in the supine position and the affected leg is prepared and draped using sterile technique.

Technique

Access to the refluxing superficial vein is obtained with a 16 or 18 F needle under ultrasound guidance at the lowest point of its incompetence. In general, the point of access is limited to 15 cm distal to the knee joint. The radiofrequency ablation catheter is then advanced under ultrasound guidance and placed at least 2 cm distal to the saphenofemoral junction. Once the catheter is in place, a tumescent anesthetic solution is injected around the vein under ultrasound guidance along the entire course of the vein. The tumescent anesthetic solution usually contains epinephrine, bicarbonate, and lidocaine. An example of tumescent anesthetic would be a combination of 0.5 mg adrenaline or epinephrine, 4.2 mg bicarbonate, and 35 ml lidocaine diluted in 500 ml 0.9 percent saline.

This serves to insulate the surrounding soft tissue, nerves, deep vessels from heat injury. It also helps compress the target vein, thereby increasing contact of the heating element on the RFA catheter with the vein walls. The RF generator is then activated, which results in segmental heat energy of 120 degrees Celsius being applied. The RF generator is activated in 20-second intervals until the entire length of the vein is treated.

At the end of the procedure, hemostasis is achieved by manual compression at the site of venous access and catheter entry. Compression bandages and stockings are then applied on the treated leg for 1 to 3 days to reduce post-procedure bruising, tenderness. Patients are encouraged to walk after the procedure. Follow up protocols vary by institutions. In general, between 1 and 3 days, patients undergo repeat venous ultrasound. This is to ensure successful occlusion of the treated vein and to confirm the absence of deep venous injury. The patient then also undergoes repeat clinical evaluation in 1 to 3 weeks.[7][9]

After radiofrequency therapy of varicose veins, compression stockings are recommended for continued regular use. The duration of compression stocking is guided by clinical judgment.[11]

Complications

Overall, the rate of adverse effects has been reported to be as low as 4.4% to as high as 40%. However, pain is the most common adverse effect that contributes to greater than 95% of the higher reported rates.[8] Rate of bruising and thrombophlebitis are around 10%. Access site infection rate is as low as 0 to 5%. The rate of major adverse events such as nerve injury, pulmonary embolism, DVT, etc is less than 1%.[7][12]

Clinical Significance

In comparative studies, radiofrequency ablation has been shown to have the lowest rates of adverse events and complications. Patients also report greater symptom improvement and quality of life during follow up, up to one year.[7][8]

Enhancing Healthcare Team Outcomes

Chronic venous disease has a high prevalence. However, it is under-recognized and therefore undertreated. Initial recognition begins at the level of the primary care physician or a primary care provider. Often lower extremity venous stasis changes are mistakenly treated for cellulitis or dermatologic conditions. It is important to refer the patient to an appropriate vascular specialist where definitive evaluation can occur. Vascular technologists who are trained in performing venous reflux studies should be involved in the testing of patients presenting with chronic venous disease. In particular, it is important to follow testing protocols as recommended by the Society of Vascular Surgery guidelines.[2]

The Society of Vascular Surgery and the American Venous Forum have developed guidelines for the treatment of varicose veins, venous insufficiency, and chronic venous disease. The current guidelines were developed after an exhaustive review of the existing literature, including randomized trials, registries, meta-analyses, etc. The level of evidence for the use of Radiofrequency ablation in treating varicose veins has been graded as moderate by the society of vascular surgery. [Level 2]


References

[1] Davies AH, The Seriousness of Chronic Venous Disease: A Review of Real-World Evidence. Advances in therapy. 2019 Mar;     [PubMed PMID: 30758738]
[2] Gloviczki P,Comerota AJ,Dalsing MC,Eklof BG,Gillespie DL,Gloviczki ML,Lohr JM,McLafferty RB,Meissner MH,Murad MH,Padberg FT,Pappas PJ,Passman MA,Raffetto JD,Vasquez MA,Wakefield TW, The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. Journal of vascular surgery. 2011 May;     [PubMed PMID: 21536172]
[3] Caggiati A,Bergan JJ,Gloviczki P,Jantet G,Wendell-Smith CP,Partsch H, Nomenclature of the veins of the lower limbs: an international interdisciplinary consensus statement. Journal of vascular surgery. 2002 Aug;     [PubMed PMID: 12170230]
[4] Padavinangadi A,Kumar N,Swamy RS,Satheesha NB,Mohandas Rao KG, Unilateral Double Great Saphenous Vein: A Clinically Significant Case Report. Journal of cardiovascular echography. 2015 Oct-Dec;     [PubMed PMID: 28465950]
[5] Uhl JF,Cornu-Thénard A,Carpentier PH,Widmer MT,Partsch H,Antignani PL, Clinical and hemodynamic significance of corona phlebectatica in chronic venous disorders. Journal of vascular surgery. 2005 Dec;     [PubMed PMID: 16376209]
[6] Bruce AJ,Bennett DD,Lohse CM,Rooke TW,Davis MD, Lipodermatosclerosis: review of cases evaluated at Mayo Clinic. Journal of the American Academy of Dermatology. 2002 Feb;     [PubMed PMID: 11807428]
[7] Almeida JI,Kaufman J,Göckeritz O,Chopra P,Evans MT,Hoheim DF,Makhoul RG,Richards T,Wenzel C,Raines JK, Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). Journal of vascular and interventional radiology : JVIR. 2009 Jun;     [PubMed PMID: 19395275]
[8] Hamann SAS,Timmer-de Mik L,Fritschy WM,Kuiters GRR,Nijsten TEC,van den Bos RR, Randomized clinical trial of endovenous laser ablation versus direct and indirect radiofrequency ablation for the treatment of great saphenous varicose veins. The British journal of surgery. 2019 Jul;     [PubMed PMID: 31095724]
[9] Endovascular radiofrequency ablation for varicose veins: an evidence-based analysis. Ontario health technology assessment series. 2011;     [PubMed PMID: 23074413]
[10] Chehab MA,Thakor AS,Tulin-Silver S,Connolly BL,Cahill AM,Ward TJ,Padia SA,Kohi MP,Midia M,Chaudry G,Gemmete JJ,Mitchell JW,Brody L,Crowley JJ,Heran MKS,Weinstein JL,Nikolic B,Dariushnia SR,Tam AL,Venkatesan AM, Adult and Pediatric Antibiotic Prophylaxis during Vascular and IR Procedures: A Society of Interventional Radiology Practice Parameter Update Endorsed by the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Association for Interventional Radiology. Journal of vascular and interventional radiology : JVIR. 2018 Nov;     [PubMed PMID: 30274857]
[11] Lurie F,Lal BK,Antignani PL,Blebea J,Bush R,Caprini J,Davies A,Forrestal M,Jacobowitz G,Kalodiki E,Killewich L,Lohr J,Ma H,Mosti G,Partsch H,Rooke T,Wakefield T, Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. Journal of vascular surgery. Venous and lymphatic disorders. 2019 Jan;     [PubMed PMID: 30554745]
[12] Shepherd AC,Gohel MS,Brown LC,Metcalfe MJ,Hamish M,Davies AH, Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins. The British journal of surgery. 2010 Jun;     [PubMed PMID: 20473992]