INTRODUCTION —
Radiofrequency ablation (RFA) is a minimally invasive percutaneous technique using thermal energy to ablate incompetent veins. The device is used primarily to treat insufficiency of the axial veins (ie, great, small, accessory saphenous veins), but perforator veins can also be treated with a specialized radiofrequency stylet.
Alternative approaches to the treatment of superficial venous reflux using other thermal (eg, laser) and nonthermal (open surgery or liquid, foam, or glue sclerotherapy) ablation techniques, and open surgical ligation and stripping, are discussed separately.
ANATOMY
Venous anatomy — The veins of the lower extremity are divided into superficial, perforator, and deep veins (figure 1A-B). The superficial veins lie superficial to the muscle fascia. The perforator veins cross the fascia and connect the superficial veins to the deep veins that are located beneath the fascia.
The main superficial veins of the lower extremity include the great and small saphenous veins. These and the accessory saphenous veins are collectively referred to as the axial veins. (See "Classification of lower extremity chronic venous disorders", section on 'Superficial venous system (As)'.)
●The great saphenous vein is the longest vein in the body and originates on the medial aspect of the dorsal foot. It crosses anterior to the medial malleolus and ascends along the medial aspect of the leg and thigh. Just below the inguinal ligament, it enters the fossa ovalis and terminates in the common femoral vein at the saphenofemoral junction. Anatomic variations in the great saphenous vein have implications for great saphenous venous ablation (figure 2). (See 'Great saphenous vein' below.)
●The small saphenous vein originates laterally from the dorsal venous arch of the foot, crosses posterior to the lateral malleolus, and ascends in the posterior calf (figure 1A-B). In the upper calf, the small saphenous vein passes through the deep muscle fascia and terminates in the popliteal vein; however, the anatomy at the saphenopopliteal junction is variable (figure 3) [1-4]. The small saphenous vein can join a superficial cephalad extension in the posterior thigh (vein of Giacomini), connect to both the popliteal vein and the posterior thigh vein, or join the popliteal vein with no major tributaries near the junction (figure 3). Anatomic variations in the small saphenous vein have implications for small saphenous venous ablation [4]. (See 'Small saphenous vein' below.)
●The accessory saphenous veins are any of several venous segments that ascend parallel to the great saphenous vein. Anterior accessory saphenous veins are located anteriorly and can be found in the thigh or leg (figure 1A-B) [5].
The deep veins of the lower extremity are contained within the deep muscle compartments bounded by the muscle fascia (figure 4). (See "Classification of lower extremity chronic venous disorders", section on 'Deep venous system (Ad)'.)
Perforator veins are those veins that traverse the muscular fascia to connect superficial veins with the deep veins. They are located anteriorly, posteriorly, laterally, and medially in both the thigh and calf. The normal flow in the perforator veins is from superficial to deep; however, many perforator veins demonstrate bidirectional flow. When the perforator veins are incompetent, flow is from deep to superficial. The most clinically significant perforator veins connect the posterior arch vein to the posterior tibial vein. These veins, termed posterior tibial perforators, were formerly known as Cockett's perforators. (See "Classification of lower extremity chronic venous disorders" and "Classification of lower extremity chronic venous disorders", section on 'Perforator veins (Ap)'.)
Associated nerves
Saphenous nerve — The saphenous nerve (figure 5A-B) is a terminal branch, and the largest cutaneous branch, of the femoral nerve and provides sensory innervation to the medial aspect of the lower leg. It passes through the adductor canal, after which it becomes superficial and closely related to the saphenous vein. The saphenous nerve is most vulnerable to injury in the distal calf, where it is adherent to the saphenous vein [6]. (See 'Nerve injury' below.)
Sural nerve — The sural nerve is a cutaneous nerve coursing along the small saphenous vein and traversing posterior to the lateral malleolus toward the fifth toe (figure 6). Identification of the relative anatomy of the sural nerve to the small saphenous vein is important to avoid thermal injury to the sural nerve during radiofrequency ablation. (See 'Nerve injury' below.)
In an autopsy study, the sural nerve was noted to be separated from the small saphenous vein by the deep muscular fascia above the inferior border of the gastrocnemius muscle; however, below the inferior border of the gastrocnemius muscle, the sural nerve perforates the deep fascia and runs in close proximity to the small saphenous vein, where it can easily be injured [7]. The sural nerve can vary in its course from the usual anatomy in up to one-half of patients and can usually be identified using ultrasound [8].
Tibial nerve — The tibial nerve provides nerves to the muscles of the lower leg and foot. The distal tibial nerve provides sensation to the calcaneus and plantar surface (sole) of the foot. The tibial nerve may be near the small saphenous vein near the saphenopopliteal junction, especially when the saphenopopliteal junction is high; however, the location of the saphenopopliteal junction is extremely variable.
INDICATIONS —
The indications for radiofrequency ablation (RFA) are the same as for other venous ablation techniques [9]. In brief, patients with persistent symptoms and signs of superficial venous disease and documented axial venous reflux (ie, retrograde flow >500 ms for superficial or perforator veins) are candidates for treatment. The patient's symptoms should directly correlate to the incompetent veins being treated. For patients with ulceration who are refractory to medical management or have recurrent ulceration, RFA of perforator veins may help heal ulcers and prevent recurrence. (See 'Specific anatomic sites' below and "Overview of lower extremity chronic venous disease", section on 'Symptomatic' and "Approach to treating symptomatic superficial venous insufficiency", section on 'Candidates for venous intervention'.)
Relative contraindications — RFA generally should not be performed in patients who have signs of acute venous thrombosis (superficial, deep). However, case reports have documented potential benefits from early endovenous ablation in patients with superficial vein thrombosis (SVT) of the distal great saphenous vein with a thrombus-free segment proximally [10,11]. In such circumstances, the catheter is never passed through the clot burden. The Insights-SVT study documented that the risk of venous thromboembolism remains high for 3 to 12 months after an acute superficial vein thrombosis event [12]. This suggests that early endovenous ablation may be associated with an increased risk of venous thromboembolism.
Pregnant patients should defer treatment until after delivery.
Patients with mixed arterial/venous ulcers are difficult to manage, and the patient should be referred to a vascular specialist. When severe arterial disease and coexisting venous disease is identified, the arterial disease may need to be addressed first. (See "Lower extremity peripheral artery disease: Clinical features and diagnosis".)
To successfully perform RFA, the treated vein should generally have a diameter exceeding 5 mm to facilitate vessel access and to easily accommodate the device. Large veins are a relative contraindication to RFA. While vein diameter greater than 10 to 12 mm may have a higher risk of nonclosure or thrombotic complications [13-16], alterations in technique (eg, additional cycles) can be usually used to safely manage larger veins. In a comparative review, two cycles of RFA when treating the great saphenous vein achieved quicker and greater vein shrinkage without an increase in side effects compared with a single treatment cycle [17]. (See 'Large veins' below and 'Ablation-related thrombus extension' below.)
A very large diameter (>20 mm) at the saphenofemoral junction or in the proximal saphenous vein represents a venous aneurysm and is best managed with high ligation and resection of the aneurysm. The remainder of the incompetent great saphenous vein in the thigh can then be ablated using standard techniques.
PATIENT COUNSELING —
The decision to offer radiofrequency ablation (RFA) depends upon symptoms, response to initial medical therapy, extent of lower extremity venous disease, and patient expectations. The patient should be made aware that:
●Unforeseen anatomic issues may result in technical failure (ie, the inability to perform an endovenous procedure), in which case the patient may need to be rescheduled for a repeat or alternative procedure.
●Despite the successful technical application of the RFA device, nonclosure of the vein (primary failure) or late secondary failure (ie, vein recanalization) can occur. When this happens, RFA may be repeated, or an alternative procedure can be performed. (See 'Saphenous ablation' below.)
●Whether to perform simultaneous phlebectomy or sclerotherapy at the same time as RFA versus delayed treatment of any residual veins should be discussed, as well as the benefits and risks of each approach. The advantages and disadvantages of each approach are discussed separately. (See 'Perform supplemental procedures' below.)
●Associated varicosities that were not treated at the time of RFA should become less noticeable but may not completely disappear. Additional treatment (eg, phlebectomy, sclerotherapy) may be required to achieve the desired cosmetic result [18,19].
●Other risks of the procedure include bleeding, infection, phlebitis, endovenous heat-induced thrombosis (EHIT), deep venous thrombosis, and cutaneous nerve injury. (See 'Complications' below.)
Alternatives to RFA include no therapy, compression therapy, sclerotherapy, laser ablation, chemical ablation, mechanochemical ablation, or surgical removal of refluxing superficial veins. (See "Injection sclerotherapy techniques for the treatment of telangiectasias, reticular veins, and small varicose veins" and "Techniques for endovenous laser ablation for the treatment of lower extremity chronic venous disease" and "Approach to treating symptomatic superficial venous insufficiency", section on 'Intervention for axial vein reflux'.)
PATIENT PREPARATION —
The evaluation of the patient includes a careful history and physical examination and noninvasive vascular laboratory studies. A venous duplex ultrasound of the affected lower extremity should evaluate the deep veins, great saphenous vein, accessory saphenous veins, if present, and small saphenous vein for patency as well as for reflux. The clinical evaluation of lower extremity chronic venous insufficiency is discussed elsewhere. (See "Clinical manifestations of lower extremity chronic venous disorders" and "Diagnostic evaluation of lower extremity chronic venous disease".)
Antithrombotic therapies — Aspirin, antiplatelet agents, and nonsteroidal anti-inflammatory drugs are sometimes discontinued to limit postoperative bruising. However, when these medications are continued, the success of the vein closure has not been affected.
The need for therapeutic medical anticoagulation is not a contraindication to endovenous ablation. Endovenous ablation can be undertaken safely with successful outcomes in fully anticoagulated patients [20-22]. Alternatively, warfarin may also be temporarily discontinued or bridging anticoagulation initiated. (See "Perioperative management of patients receiving anticoagulants".)
Radiofrequency ablation (RFA) in the face of direct oral anticoagulants (DOACs) has not been studied, but we would similarly expect no significant alterations in vein closure rates. DOACs are typically held 48 hours prior to a procedure and reinitiated the evening of the procedure or the day after depending upon whether concurrent phlebectomy was performed.
Prophylactic antibiotics — Prophylactic antibiotics are generally not necessary. However, if RFA is combined with vein excisions, particularly in those with a higher risk for surgical site infection due to a risk for hematoma formation (eg, obese patient), antimicrobial prophylaxis may be elected even though these are clean cases [23]. (See "Antimicrobial prophylaxis for prevention of surgical site infection in adults".)
Thromboprophylaxis — Thromboprophylaxis is generally not administered prior to RFA.
However, patients with a known thrombophilia or at high risk for venous thromboembolism should receive periprocedural thromboprophylaxis according to their risk. (See "Prevention of venous thromboembolic disease in adult nonorthopedic surgical patients".)
Periprocedural prophylactic anticoagulation (eg, low-molecular-weight heparin, warfarin, direct oral anticoagulants) does not appear to affect the success of vein closure [20].
Vein mapping/marking — Prior to the procedure, the veins to be ablated are evaluated and mapped (ie, marked with indelible ink) with duplex ultrasound to confirm the presence of reflux and to identify vein size and depth, any large perforator veins, any existing superficial or deep venous thrombosis, or any significant anatomic variations (eg, duplication, low or high entrance of the vein into the deep venous system) [24]. (See 'Anatomy' above.)
Any associated varicose veins that will be excised after ablation need to be marked preoperatively. These are marked with the patient in a standing position.
Scheduled follow-up — In patients at risk for thrombosis, a prescheduled appointment should be made for two to three days following the procedure for clinical examination and duplex ultrasound to rule out deep vein thrombosis. Patients at average risk do not require routine follow-up; however, the development of any symptoms concerning for deep vein thrombosis should prompt duplex ultrasound examination. (See 'Postoperative duplex ultrasound' below and 'Ablation-related thrombus extension' below and 'Deep venous thrombosis' below.)
RADIOFREQUENCY DEVICES —
Radiofrequency ablation (RFA) gained early attention in the 1990s for the treatment of tumors but subsequently achieved wider application to treat other conditions (eg, cardiac dysrhythmias, Barrett's esophagus), including venous disease. RFA devices create a focal closed-loop high-frequency (in the radio range of frequencies, 300 kHz to 1 MHz) alternating current that is transmitted through an electrode. The resultant energy heats the vein wall adjacent the probe to a prespecified temperature, ultimately inducing thermal damage to the vein wall endothelium [17,25].
The first radiofrequency device (ie, ClosurePlus) was approved for use in the United States in 1999. This first-generation device used a collapsible bipolar electrode to deliver the energy but was slow to use and had high recanalization rates. Later, the ClosureFAST radiofrequency catheter was approved for use in the United States and introduced clinically in 2007; subsequent modifications have improved its effectiveness. Once the vein has been accessed, the ClosureFast catheter (65 or 100 cm length) is introduced into the vein using a 6 or 7 French sheath. Energy is delivered through either a 3, 7, or 8 cm catheter segment that heats up to 120º Celsius over a 20-second interval. The catheter is withdrawn in a series of 3, 7, or 8 cm steps with the number of steps depending upon the length of the vein being treated; pullback times are generally faster compared with the earlier catheters. Another RFA catheter available in the United States is the Venclose. This catheter also has a segmental heating element; however, the operator can vary the length of the heating element from 2.5 cm to 10 cm during the procedure, offering flexibility in treating the vein. Other radiofrequency devices (EVRF, VeinClear) are available in the United Kingdom and Europe.
Specialized catheters that are designed to treat perforator veins (ClosureRFS stylet, RFiTT) are shorter and have smaller catheter diameters. They are introduced through a sheath or by direct puncture [20,26-29].
PROCEDURE —
Radiofrequency ablation (RFA) can be performed in the office setting (appropriately equipped operative suite) or ambulatory surgery center under sterile conditions. Although some surgeons will perform bilateral saphenous venous ablation in a single session, we prefer not to perform bilateral procedures due to increased postoperative pain and discomfort that might impair ambulation.
The procedure is typically performed in an office setting with local anesthesia and often with an oral anxiolytic agent. In extremely rare cases, general anesthesia may be appropriate due to lidocaine allergy or extreme patient anxiety.
An oral anxiolytic can be given approximately one hour prior to the procedure to help the patient relax. (See "Acute procedural anxiety and specific phobia of clinical procedures in adults: Treatment overview", section on 'Benzodiazepines as first-line medication'.)
Preparation
Equipment
●Duplex ultrasound machine.
●Endovenous device – Check the machine for proper functioning; calibrate if necessary.
●Roller pump for tumescent anesthesia (eg, Klein pump).
●Table with Trendelenburg and reverse Trendelenburg positions.
Medications
●Local anesthetic for puncture sites – 1% lidocaine.
●Tumescent anesthetic – The tumescent anesthetic mixture (saline, lidocaine with epinephrine, and bicarbonate) should be mixed just prior to the procedure [30,31]. Cold saline solution may be an alternative for patients with allergy to local anesthesia or who are at risk for toxicity (eg, impaired liver function) [32].
●EMLA – Topical eutectic mixture of local anesthetics (EMLA) is useful for reducing pain associated with various types of medication injection including local anesthetic. A trial randomly assigned 62 patients undergoing RFA to receive EMLA two to three hours before tumescent injection or no EMLA [33]. Patients who received EMLA reported lower pain scores at the completion of tumescent anesthesia, but not at later time points (at the end of RFA, at discharge). Patients also reported less pain during needle puncture at EMLA pretreated areas compared with non-pretreated areas. Complication rates were similar between the groups. An earlier trial did not report improved pain scores; however, the duration of EMLA application was much shorter (20 minutes before the procedure), and it is likely the EMLA absorption was not complete. Given that EMLA does not add significantly to the cost of the procedure, we suggest pretreatment when EMLA is available. In our experience, it should be applied at least 30 minutes before the procedure.
●Saline (0.9%) for irrigation.
Materials
●Preparation materials – Skin antiseptic, sterile gloves.
●Draping materials – Sterile drapes, bag for foot.
●Roller pump tubing.
●Echogenic 21-gauge micropuncture needle.
●10 mL syringe with 16- to 20-gauge needle to draw up anesthetic, 27- to 30-gauge needle to inject.
●Catheter sheath kit – 0.035" wire, dilator/sheath (6 or 7 French) flushed with saline. Micropuncture sheath kit: 0.018" micropuncture wire, dilator/sheath (5 French), flushed with heparinized saline, as needed.
●Glidewire (0.025", 260 cm length).
●Wound dressing – Self-adhesive strips, or transparent film dressing.
General technique — RFA is performed according to the device manufacturer's instructions for use (ie, IFU). The general technique is described below.
Following sterile preparation of the lower extremity, the patient is placed in reverse Trendelenburg position to facilitate identification of the veins for sheath placement.
Place the device sheath — The patient is placed in reverse Trendelenburg position to assure maximal dilation of the target vein.
●Great saphenous vein – The great saphenous vein is typically cannulated in the proximal calf or distal thigh segment. Data support treatment of the proximal calf. In one comparative study, including the proximal great saphenous vein lead to greater improvement in symptoms and a reduced need for additional procedures compared with ablation of the above knee great saphenous vein only [34]. Thermal ablation of the mid-to-distal calf great saphenous vein is not generally done due to the proximity to the saphenous nerve and risk for nerve injury.
●Small saphenous vein – The small saphenous vein is typically cannulated at the inferior border of the gastrocnemius muscle. Thermal ablation is not performed below the inferior border of the gastrocnemius muscle due to the proximity of the sural nerve to the vein [7].
After anesthetizing the skin, with ultrasound guidance, an echogenic needle is used to access the chosen vein with single wall puncture, and the dilator/sheath combination is placed using the modified Seldinger technique. The inner dilator of the sheath is removed and the position checked with ultrasound. Blood return is confirmed prior to introduction of the catheter through the sheath. On occasion, the vein is unable to be accessed percutaneously. In this case, the needle is withdrawn and pressure is applied to control bleeding, as needed. Percutaneous access can be reattempted, by moving more proximally, or access can be achieved by performing a small cutdown and introducing the sheath directly into the vein (figure 7).
Position the catheter — The radiofrequency catheter is placed through the sheath and advanced under ultrasound guidance to the saphenofemoral or saphenopopliteal junction. The catheter often advances through the vein with ease; however, tortuosity or the presence of large perforator veins may necessitate the need for a guidewire. If needed, a long, floppy wire can be placed through the sheath and advanced to the proximal vein under ultrasound guidance. Once the position of the wire is confirmed, the catheter is passed over the guidewire and positioned in the proximal vein, and the wire is removed. The tip of the catheter is positioned at least 2.5 to 3 cm distal to the saphenofemoral junction or at the fascia curve if treating the small saphenous vein [35]. The patient is then placed in Trendelenburg position to empty the vein. (See 'Great saphenous vein' below and 'Small saphenous vein' below.)
Instill tumescent anesthesia — Under ultrasound guidance, tumescent anesthesia is instilled directly into the saphenous sheath through a series of punctures along the target vein to completely envelop the vessel in tumescent fluid. The tumescent anesthesia limits heat transfer to tissues beyond the vein, anesthetizes these tissues to decrease pain, and causes venoconstriction, which places the vein in close apposition to the ablation catheter, which is critical for closure of the vein when using radiofrequency. The use of an echogenic micropuncture/spinal needle and ultrasound facilitates tumescent needle placement, and a motorized pump may help lessen pain during the delivery of tumescent anesthesia into the saphenous sheath.
Ablate the vein — The position of the tip of the catheter is reevaluated with ultrasound since the installation of tumescent anesthesia tends to straighten the vein and can push the tip of the catheter cephalad. Venous ablation is carried out according to the manufacturer's instructions for use (ie, IFU) for the type of catheter chosen. The device is activated, transferring energy to the vein wall, resulting in immediate intimal injury and subsequent thrombosis as the probe is sequentially withdrawn. Vein wall thickening, inflammatory change, and, ultimately, fibrotic closure of the vein occurs with time analogous to that seen with laser ablation [36]. Compression of the vein (with ultrasound) during the ablation procedure is commonly performed to assure vein wall contact with the device and to maintain a correct level of electrical impedance.
Perform completion ultrasound — A completion ultrasound is performed to evaluate closure of the vein. Following RFA, the treated vein has thickened walls (ie, appears as a hyperechoic doughnut) with thrombus in the lumen and no identifiable venous flow. The junction of the treated vein with the deep venous system is also imaged to evaluate for the presence of thrombus. The proximal vein at the junction should be compressible and hypoechoic and without the presence of any intraluminal debris, which would appear hyperechoic. The patency of the adjacent deep veins should also be evaluated at the conclusion of the procedure. (See 'ARTE treatment and follow-up' below and 'Deep venous thrombosis' below.)
Perform supplemental procedures — If concurrent phlebectomy is to be performed, the veins must be marked prior to the procedure. They cannot be evaluated after vein closure due to compression by tumescent anesthesia and also Trendelenburg positioning. For small veins (<6 mm), supplemental procedures may be delayed as many of these will reduce in size over time. However, larger veins and those located on the thigh are less likely to respond to elimination of reflux, and we prefer to manage these concurrently with the ablation procedure. (See "Injection sclerotherapy techniques for the treatment of telangiectasias, reticular veins, and small varicose veins" and "Approach to treating symptomatic superficial venous insufficiency", section on 'Ambulatory phlebectomy' and "Approach to treating symptomatic superficial venous insufficiency", section on 'Treatment timing'.)
Anatomic considerations — The technical aspects of the RFA procedure vary with the anatomic site. Venous anatomy is described above. (See 'Anatomy' above.)
Large veins — Very large diameter at the saphenofemoral junction (>20 mm) likely represents venous aneurysm and is best treated with high ligation and vein resection prior to ablation of the more distal incompetent vein. (See 'Relative contraindications' above.)
Veins with a diameter greater than 10 to 12 mm may have a higher risk of nonclosure or thrombotic complications (eg, deep vein thrombosis, endovenous heat-induced thrombus) [13-16], but successful closure of veins with larger diameters has been reported [17,37]. (See 'Ablation-related thrombus extension' below and 'Complications' below.)
With alterations in technique, including providing additional tumescent and compression, and increasing the linear energy density (Joules/cm) by double or triple heating the segment, larger veins can be managed safely [17]. In a retrospective review that evaluated the treatment of smaller veins (4 to 11 mm) compared with larger veins (12 to 21 mm), the rates of closure at 1, 6, and 12 months were similar [38]. There was no difference in the rate of adverse events between the groups. (See 'General technique' above and 'Saphenous ablation' below.)
Specific anatomic sites
Great saphenous vein — Great saphenous venous ablation is performed with the catheter tip positioned 2.5 to 3 cm distal to the saphenofemoral junction. The optimal closure level is below the origin of the superficial epigastric vein to preserve flow into the proximal great saphenous vein [14]. The anatomy of the veins in the region of the saphenofemoral junction can be quite variable (figure 2), and identification of the tip of the catheter using ultrasound is essential.
The sheath may safely be placed in the great saphenous vein in the proximal calf. Treatment in the proximal below-knee great saphenous vein often improves long-term outcomes when there is reflux in this segment [34], but care must be taken to avoid excessive heating of the great saphenous vein around the knee due to the proximity of the saphenous nerve. Thermal ablation of the more distal RFA is generally not done due to the proximity of the saphenous nerve to the great saphenous vein and the risk for nerve injury (figure 8) [39]. (See 'Saphenous nerve' above and 'Nerve injury' below.)
Accessory saphenous vein — Accessory saphenous venous ablation is performed in a similar manner as the great saphenous vein, as described above. (See 'General technique' above.)
Compared with the great and small saphenous veins, the accessory saphenous veins have a shorter straight segment, with tortuous tributary varicosities. The straight portion of the vein can be ablated with the radiofrequency device and the more tortuous segments subsequently managed with phlebectomy. The catheter tip is positioned 2.5 to 3 cm distal to the saphenofemoral junction. Adequate tumescent anesthesia is important since these veins can be more superficial and often do not have a well-defined saphenous sheath.
Small saphenous vein — For small saphenous venous ablation, the sheath is placed at the inferior border of the gastrocnemius muscle, and not below this level, to avoid thermal injury to the medial cutaneous sural nerve (figure 6) [7]. The catheter tip is positioned at the fascial curve. Tumescent anesthesia is instilled, as with the great saphenous vein, and the procedure is performed with the patient in Trendelenburg position. Instillation of the tumescent anesthesia is extremely important in small saphenous venous ablation because of the proximity of the vein to the sural nerve. (See 'General technique' above and 'Sural nerve' above and 'Nerve injury' below.)
The anatomy of the saphenopopliteal junction is highly variable (figure 3) [4,7]. If the saphenopopliteal junction is high, care should be taken to identify the location of the tibial nerve relative to the saphenopopliteal junction, and to use tumescent anesthesia to push it away from the vein (figure 9).
Perforator veins — Incompetent perforator veins can also be closed with RFA but require a specialized stylet [26,27]. The procedure is performed with ultrasound guidance. The perforator is accessed either directly or with the Seldinger technique. The catheter is positioned 1 to 2 mm below the deep fascia but at least 5 mm superficial to the deep veins to avoid thermal injury to the deep veins. The tumescent or local anesthesia is administered both above and below the fascia while the catheter is held in place. With the patient in Trendelenburg position, the ablation is performed according to the manufacturer's instructions for use (ie, IFU) for the chosen device. The catheter is removed and completion ultrasound performed.
FOLLOW-UP CARE
Pain management — Nonsteroidal anti-inflammatory drugs (NSAIDs) are generally used in all patients without a contraindication to minimize a significant phlebitic reaction. Patients who have a contraindication to nonsteroidal anti-inflammatory medications may require stronger analgesics (eg, codeine) for a short period of time. An ice pack can also be applied to the affected areas for comfort and to decrease inflammation. (See "NSAIDs: Therapeutic use and variability of response in adults" and "Nonopioid pharmacotherapy for acute pain in adults", section on 'Nonsteroidal anti-inflammatory drugs'.)
Patient instructions — Postoperatively, we instruct patients to:
●Ambulate normally. Make an effort on the first postoperative day to walk every hour before bedtime and then daily for 15 to 30 minutes.
●Avoid prolonged standing and sitting with the leg in a dependent position; when seated, elevate the treated extremity.
●Avoid heavy lifting and exercise for two weeks.
●Resume normal job duties within three to four days; however, jobs requiring prolonged standing/heavy lifting may require additional time off.
●Maintain the postoperative dressing and elastic bandages/compression stockings until the postoperative duplex examination, which should occur within two to three days following the procedure.
●Reinforce any areas of bleeding that occur through the dressing, but call their clinician if excessive bleeding occurs. This is more commonly associated with vein excisions performed at the same time as the endovenous ablation.
●Wear their bandages/compression stockings continuously for the first 48 hours, and if concurrent phlebectomies have been performed, continue to wear them during the day for the next two weeks. While the form of compression and duration of treatment remain debated, the downsides of compression are minimal [40-42]. (See 'Post-procedure compression' below.)
●Not be alarmed at the development of a pulling/tugging sensation along the course of the treated vein. This is due to fibrosis and contraction of the ablated vein. Gentle stretching exercises may help.
●Call their clinician if they notice numbness, tingling, coolness, or discoloration of the toes of the treated extremity. The postoperative compression bandages/stockings may be too tight and may need to be removed.
●Call their clinician promptly if they experience swelling or excessive pain not relieved with the prescribed nonsteroidal anti-inflammatory medications, because this may be a symptom of deep vein thrombosis.
Post-procedure compression — Our approach is to have the patient wear compression stockings (eg, thigh-high or pantyhose) for the first two days following RFA, and then during the daytime for at least two weeks if concurrent phlebectomies have been performed. Patients are prescribed 15 to 20 mmHg or a higher level of compression (table 1), which they may have already been using prior to the scheduled procedure. (See "Approach to treating symptomatic superficial venous insufficiency", section on 'Response to initial measures'.)
The need for and, when used, the optimal duration of compression following RFA for saphenous reflux (in the absence of venous ulceration) is debated [40-45]. A systematic review identified four trials comparing compression therapy with no compression therapy after RFA [43]. In a meta-analysis of three trials that used a visual analog scale to assess pain (552 patients), while postoperative scores were lower in the compression group, the difference did not appear to be clinically significant. Also, among trials that evaluated other outcomes, occlusion rates, complication rates, and Aberdeen Varicose Vein Questionnaire scores were similar between the groups.
If a patient with mild arterial disease is a candidate for and is treated with an endovenous procedure, eccentric rather than circumferential compression should be used postprocedure. Eccentric compression involves placing a bolster over the treated vein and taping it into place. A light bandage can be used to hold the bolster in place, if needed.
Resumption of normal activities — The low incidence of adverse effects and complications with RFA results in a significantly lower number of days to return to normal activities and work compared with vein stripping (1.5 versus 3.9 days, 4.7 versus 12.4 days) [46,47].
Multiple randomized trials have also shown that immediate postoperative quality-of-life measures (pain, ecchymosis, tenderness) are significantly better following treatment of the saphenous vein using RFA compared with laser methods [46-51]. However, it is important to note that many of these studies used lower-wavelength lasers, which are used less frequently compared with the higher-wavelength lasers. Higher laser wavelengths (eg, 1470 nm) have been associated with fewer postoperative symptoms [52]. (See "Comparison of methods for endovenous ablation for chronic venous disease", section on 'Quality of life'.)
Postoperative duplex ultrasound — The need for routine follow-up duplex ultrasound is debated. In the earlier experience with RFA, a routine study was nearly always performed; however, as technology and techniques have improved, the incidence of ablation-related thrombus extension (ARTE) has decreased such that guidelines suggest follow-up duplex ultrasound only for those at risk for deep vein thrombosis [53].
When elected, follow-up duplex ultrasound is most often performed within two to three days of the procedure [9,53-55]. The main purpose of the postoperative duplex study is to carefully evaluate the proximal extent of the ablated vein for thrombus and to determine whether any thrombus extends into the deep veins.
The most common duplex finding following ablation of the great saphenous vein in the groin is an open, competent saphenofemoral junction with less than 5 cm of patent terminal vein segment and vein wall thickening and thrombus in the distal vein. Prograde flow is seen from the saphenous tributaries into the proximal saphenous vein [56,57]. Thrombus may also be identified at the saphenofemoral/saphenopopliteal junction, extending up to, but not into, the deep vein. If the initial ultrasound demonstrates no thrombus in the deep vein, repeat ultrasound is not required unless the patient develops new symptoms.
When patients treated with RFA for advanced venous disease (edema, skin changes, venous ulceration) develop recurrence, we reevaluate them with duplex ultrasound to identify any residual/recurrent superficial venous reflux. In the absence of significant superficial venous reflux, we consider obtaining a computed tomography (CT) venogram to evaluate for obstruction of the iliac veins or inferior vena cava. (See "Overview of iliocaval venous obstruction".)
Ablation-related thrombus extension — Although thrombus extension from the saphenous vein into the proximal deep vein cephalad to the level of the ablation is uncommon, it can occur and has been termed ARTE (for thermal ablation technique, formerly known as endovenous heat-induced thrombus [EHIT]) [53]. ARTE is classified similarly to EHIT (I-IV). The term ARTE will be used, when possible, but EHIT will still be used for studies specifically reporting this as an outcome.
The incidence of ARTE after RFA is low at less than one percent, and the incidence appears to be similar to that following endovenous laser ablation (EVLA) [58-61]. Repeat duplex examination is usually performed within a week to evaluate for any propagation. Patients identified to have occlusive common femoral thrombus are treated accordingly. (See 'Deep venous thrombosis' below.)
In an early review of 500 patients, a great saphenous vein diameter >8 mm at the level of the saphenofemoral junction, or a history of deep vein thrombosis, increased the risk for thrombus extension into the femoral vein following venous ablation (ie, EHIT) [14]. A later review of 312 patients undergoing great saphenous venous ablation (various methods) also reported an increased incidence of EHIT for a large proximal great saphenous vein diameter [60]. Patients who developed EHIT had a mean great saphenous vein diameter of 13.1 mm, and 11 percent had saphenofemoral junction incompetence. By comparison, those who did not develop EHIT had a mean diameter of 8.4 mm, and only 0.44 percent had saphenofemoral junction incompetence. A review of over 4000 ablation treatments (RFA or EVLA) supports the notion that increasing the distance of the laser tip from the saphenofemoral junction reduces the risk of EHIT [35]. In this study, there was a trend toward a decreased incidence of EHIT when the tip of the catheter was >2.5 cm compared with 2 cm from the junction (2.3 versus 1.3 percent). However, a separate review that included 519 great or anterior saphenous venous ablation procedures (RFA or EVLA) did not identify vein diameter, short distance of the catheter tip to saphenofemoral junction, type of endovenous ablation (RFA versus EVLA), concomitant treatments (sclerotherapy, phlebectomy), or perioperative anticoagulation as risk factors for EHIT [59]. Rather, on multivariate analysis, only male sex and Caprini thrombosis risk factor assessment score (table 2) were significant risk factors.
Classification — A classification of ARTE provides an accurate description of the level of proximal great saphenous thrombus for the purpose of guiding clinical therapy and further research [14].
This classification scheme, and a similar but simplified classification that may be more clinically useful [62,63], are described and illustrated in the figures (figure 10A-C).
ARTE treatment and follow-up — The natural history of ARTE is not well defined.
●For patients with ARTE I or II, no treatment is necessary.
●For patients diagnosed with thrombus within the deep veins (ARTE class III, IV; Lawrence: Level V, VI; Kabnick: class 3, 4) (figure 10A-C), anticoagulation is initiated. A follow-up duplex ultrasound should be obtained within 7 to 10 days [53]. In some cases of ARTE following great saphenous venous ablation, thrombus contraction occurs and thrombus is no longer apparent within the common femoral vein, at which point anticoagulation may be discontinued.
Persistence of thrombus in the common femoral vein (ie, deep vein thrombosis) is managed according to standard protocols. (See "Overview of the treatment of lower extremity deep vein thrombosis (DVT)".)
LOCAL ADVERSE REACTIONS —
Significant pain is not typical following radiofrequency ablation (RFA) even when vein excisions are performed concurrently, though some patients may have a mild phlebitic reaction. Rupture of the treated vein with ecchymosis or hematoma formation is uncommon. Skin burns, hyperpigmentation, and telangiectatic matting are also infrequent with this technique (<1 percent).
A mild phlebitic/inflammatory reaction is anticipated along the course of the ablated vein, but retrograde extension into neighboring tributaries may cause pain and inflammation in regions that appear remote from the ablation procedure [64]. The reported incidence of this symptomatic phlebitic reaction following RFA ranges from 0 to 5.2 percent and does not appear to be related to whether concomitant phlebectomy was performed [65-70]. Higher rates have been reported in studies that have included concomitant phlebectomy [71].
This phlebitic reaction is managed conservatively and can be ameliorated by preemptively using nonsteroidal anti-inflammatory drugs (NSAIDs). Thrombosed vein segments that are painful and tender postprocedure can also be treated with cold compresses. (See 'Pain management' above.)
More significant signs or symptoms of pain or edema warrant ultrasound examination to evaluate for the presence of proximal clot extension. (See 'Postoperative duplex ultrasound' above.)
COMPLICATIONS —
Complications associated with radiofrequency ablation (RFA) primarily include cutaneous nerve injury and deep venous thrombosis. The development of an arteriovenous (AV) fistula has been reported following perforator ablation [26].
Nerve injury — Sensory abnormalities are reported in 0 to 22 percent of patients following ablation of the great saphenous vein and are usually transient.
Saphenous nerve injury may be more likely when the sheath is placed below the level of the midcalf, due to the adherence of the saphenous nerve to the saphenous vein in the distal third of the calf (figure 8) [6].
Small saphenous venous ablation may be associated with sural nerve paresthesias (figure 6). Injury to the common fibular (peroneal) nerve has also been reported but is more likely related to concurrent vein excisions in proximity to the lateral fibular head where this nerve becomes extremely superficial (figure 11) [72]. Tibial nerve injury can also occur, particularly if the saphenopopliteal junction is high (figure 9) [7,72].
Deep venous thrombosis — Deep vein thrombosis and pulmonary embolism have been reported following RFA; however, at experienced centers, the risk is <1 percent [54,58,73,74]. Direct thermal injury to the deep veins can occur due to catheter malposition, but the majority of thromboses occurring following RFA appear to be related to extension of clot from thrombus induced in the ablated vein, a mechanism referred to as ablation-related thrombus extension (ARTE; formerly known as endovenous heat-induced thrombus [EHIT]), which generally has a benign course. This is discussed above. (EHIT), which generally has a benign course. This is discussed above. (See 'Ablation-related thrombus extension' above.)
Patients with occlusive thrombus in the common femoral vein or femoral vein are treated accordingly. (See "Overview of the treatment of lower extremity deep vein thrombosis (DVT)".)
Other complications — Although uncommon, the loss of radiographic guidewires/sheath components into the circulation has been reported. Ensuring that wires are at least twice the length of the catheter/sheath into which they are introduced minimizes the likelihood of this complication.
Device components should be examined carefully after they are removed from the patient to ensure their integrity. If there is any question about the possible loss of a device, radiographs should be obtained.
CLOSURE RATES AND RECURRENCE —
Outcomes specific to radiofrequency ablation (RFA) are briefly reviewed below. A comparison of radiofrequency with other venous ablation techniques is provided separately. (See "Comparison of methods for endovenous ablation for chronic venous disease".)
Closure rates with RFA have improved with operator experience and later-generation technologies. Immediate closure rates are higher for the saphenous veins compared with perforator veins (>90 versus 70 to 82 percent) [27,67,75-79].
Saphenous ablation — In two meta-analyses evaluating anatomic vein closure, immediate closure rates were between 89 and 94 percent for great saphenous venous ablation using earlier continuous pullback catheters [78,80]. Alterations in closure technique, increasing probe temperature, and increased ablation time have resulted in immediate occlusion rates as high as 99.6 percent; however, long-term data are not available for later-generation devices [81,82]. Immediate closure rates for the small saphenous vein are similar to those of the great saphenous vein [83,84].
Symptoms and appearance of varicose veins as reflected by venous clinical severity scales (VCSS) are also significantly improved following RFA of the saphenous vein [46,75,85]. In a retrospective review, the VCSS in 256 extremities improved (ie, less severe) from 3.9±2.1 before RFA of the great saphenous vein to 0.9±1.5 at three months, and the VCSS was maintained at <1.0 for up to two years [85].
Following initially successful ablation, duplex ultrasound may later show procedural failure. In the meta-analyses, reopening of the previously occluded vein occurred in 15 to 19 percent of veins at three years and in 26 to 30 percent of veins at three- to five-year follow-up [78,80,86]. Despite this, some of these patients may still have clinical improvement as reflected that is maintained long term [75,87]. Anatomic failure is a useful term to distinguish these patients from those with clinical failure (ie, recurrent clinical symptoms and/or varicose veins). Anatomic failure is classified as type I, II, or III, depending on the timing of failure and etiology (table 3) [37]:
Following RFA, varicose vein recurrence can occur in up to one third of patients, which was similar to other ablation methods in a meta-analysis comparing RFA, saphenous stripping, and laser ablation [88].
Perforator ablation — Minimally invasive techniques including RFA are associated with fewer complications compared with surgical management of refluxing perforators (ie, subfascial endoscopic perforator surgery [SEPS]) [89-91]. Clinical trials comparing RFA with other therapies for the management of venous ulceration and standardization of the radiofrequency perforator ablation technique are needed [26,92]. (See "Comparison of methods for endovenous ablation for chronic venous disease", section on 'Ulcer healing'.)
Immediate occlusion of perforator veins following RFA occurs in 70 to 82 percent of treated veins [27,28,79]. In one prospective study, at five-year follow-up, recurrent reflux developed in 19 percent of perforators previously confirmed closed [26]. Interestingly, of the total number of perforators identified with reflux, 19 percent were new [26]. In a retrospective review, RFA of perforator veins was more successful in the proximal calf and ankle regions compared with the middle and distal calf [93].
RFA reliably ablated perforator venous reflux after failed ultrasound-guided foam sclerotherapy (UGFS) [20]. Body mass index >50 predicted failure of perforator closure in all groups. Failure of UGFS as an initial treatment increased the success of perforator closure when thermal ablation was used as a secondary technique.
SOCIETY GUIDELINE LINKS —
Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Chronic venous disorders".)
SUMMARY AND RECOMMENDATIONS
●Candidates – Candidates for radiofrequency ablation (RFA), a minimally invasive thermal venous ablation technique, are patients with persistent symptoms/signs of chronic venous disease and documented venous reflux (ie, retrograde flow >0.5 second duration) as a source of their symptoms. Patients with reflux in the great saphenous vein without signs or symptoms of chronic venous disease do not require venous ablation. (See 'Introduction' above.)
●Treated veins – RFA is used to primarily treat venous insufficiency of the axial veins (ie, great, small, accessory saphenous veins). A specialized stylet is available for treating incompetent perforator veins. (See 'Radiofrequency devices' above.)
●RFA devices – RFA devices transmit a high-frequency alternating current through an electrode that heats the vein wall, altering its intrinsic protein structure and effecting closure of the vein. (See 'Radiofrequency devices' above.)
●Procedure – RFA is performed in an office-based or ambulatory surgery setting in a stepwise fashion with local tumescent anesthetic and oral anxiolytic medication, as needed. (See 'Procedure' above.)
●Follow-up duplex ultrasound – Routine follow-up duplex ultrasound is performed within two to three days of the procedure in patients with risk factors for deep vein thrombosis to evaluate for ablation-related thrombus extension (ARTE; formerly referred to as endovenous heat-induced thrombus [EHIT]). Any symptoms concerning for deep vein thrombosis should also prompt evaluation. We repeat duplex ultrasound within a week if thrombus is identified at the saphenofemoral/saphenopopliteal junction, extending up to, or into, the deep vein. (See 'Postoperative duplex ultrasound' above and 'ARTE treatment and follow-up' above and 'Deep venous thrombosis' above.)
●Complications – Complications following RFA are uncommon and include nerve injury and, rarely, deep vein thrombosis. (See 'Complications' above.)