Varicose Vein Treatment With Endovenous Laser Therapy 

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 Over the last 10 years, HL/S has been replaced by endovenous thermal ablation.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 in detail.

ELA mechanism of action

The underlying goal for all thermal ablation procedures is to deliver sufficient thermal energy to the wall of an incompetent vein segment to produce irreversible occlusion, fibrosis, and ultimately disappearance of the vein. The mechanism of vein wall injury after ELA is controversial. It has been postulated to be mediated both by direct effect and indirectly via laser-induced steam generated by the heating of small amounts of blood within the vein.^[1] Adequately damaging the vein wall with thermal energy is imperative to obtain effective ablation. Some heating may occur by direct absorption of photon energy (radiation) by the vein wall, as well as by convection from steam bubbles and conduction from heated blood. However, these later mechanisms are unlikely to account for most of the impact on the vein.

The maximum temperature of blood is 100°C. Laser treatment has been found to produce carbonization of the vein wall.^[2] Carbonization of the laser tip, which occurs at approximately 300°C, is noted following ELA and seems to occur regardless of the wavelength used. Carbonization of the laser fiber tip creates a point heat source and essentially reduces light penetration into tissue to zero.

Mordon et al state "The steam produced by absorption of laser energy by the blood is a tiny fraction of the energy necessary to damage the vein wall and cannot be the primary mechanism of injury to the vein with endovenous laser. The carbonization and tract within the vein walls seen by histology following endovenous laser can only be the result of direct contact between the laser fiber tip and the vein wall."^[3] Dr Rox Anderson, director of The Wellman Center for Photomedicine at Massachusetts General Hospital, reported that carbon appears to be a secondary but key chromophore that is probably independent of wavelength.^[4] An ex vivo study on human vein segments supports this concept.^[5] See the image below.

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.^[6]

The selection of candidates for ELA involves a directed history, physical examination, and duplex ultrasound (DUS) examination. The details of the clinical and DUS examination have been discussed in other chapters. 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
• Cosmetic (restorative) concerns
• Anatomical indications

  • Significant reflux documented on DUS examination (reflux >0.5 seconds)
  • Straight vein segment
  • Intrafascial or epifascial vein segment meeting other anatomical criteria that can be pushed away from the skin with tumescent anesthetic
  • Reflux responsible for venous hypertension leading to the clinical abnormalities
• Ambulatory patient without contraindication

The contraindications to endovenous treatment are listed below.

• Patients who are pregnant or breastfeeding (concerns related to anesthetic use and heated blood effluent that may pass through the placenta to the fetus)
• Obstructed deep venous system inadequate to support venous return after ELA
• Liver dysfunction or allergy making it impossible to use a local anesthetic (cold saline may be useful as an alternative)
• Allergy to both amide and ester local anesthetics (cold saline may be an alternative)
• Severe uncorrectable coagulopathy (ELA is safe with warfarin use if INR < 2)
• Severe hypercoagulability syndromes (where risk of treatment outweighs potential benefits despite prophylactic anticoagulants)
• Inability to wear compression stockings secondary to inadequate arterial circulation, hypersensitivity to the compressive materials, or musculoskeletal or neurologic limitations to donning the stocking itself
• Inability to adequately ambulate after the procedure
• Sciatic vein reflux
• Thrombus or synechiae in the vein or tortuous vein making passage of an endovenous device impossible (unless multiple access points are chosen)

Treatment of incompetent superficial truncal veins in patients with previous deep vein thrombosis requires a careful assessment of the adequacy of the patent segments of the deep venous system. It also requires a risk stratification of postprocedural thrombosis. ELA is appropriate if the deep system is adequate enough to support venous drainage and the superficial venous incompetence is responsible for symptoms or skin changes. If the patient has any ongoing risk for thrombosis, ELA may still be appropriate if that risk can be decreased with prophylactic anticoagulants. If saphenous reflux is seen with venous ulcers with an adequate deep venous system, ELA of the causative veins is necessary to minimize the risk of a recurrent ulceration.

Treatment of competent enlarged superficial venous segments has no proven medical benefit and should not be performed. In some cases, the enlarged vein may be functioning as a re-entry or collateral pathway for another source of reflux or deep vein obstruction. The use of ELA to close incompetent perforating veins has been described. At this point the indications and contraindications for use, as well as the success rates and safety of this approach, have only recently begun to be evaluated.

Tumescent anesthetic, when used in phlebology, describes the use of large volumes of dilute anesthetic solutions that are infiltrated into the perivenous space of the veins to be treated. The rationale behind the use of large volume tumescent anesthesia for ELA include its use as a local anesthetic, its ability to empty the vein to maximize the contact of the thermal device and the vein wall for efficient thermal transfer to the vein wall, and providing a protective heat sink around the treated vein to minimize heating of adjacent structures.

ELA is usually performed with a dilute tumescent anesthetic solution of lidocaine in normal saline (a concentration of 0.1% lidocaine is typically used with an average volume of about 5–10 mL/cm of treated vein) with or without epinephrine, often buffered with sodium bicarbonate. This should be delivered with ultrasonographic guidance into the perivenous space (saphenous sheath) of the vein to be treated. It can be injected either manually or with an infusion pump such that upon completion of the process the vein is surrounded along its entire treated length with the anesthetic fluid, as demonstrated in the image below.

Although the maximum safe dosage of lidocaine using tumescent technique for venous procedures is not well studied, 35 mg/kg with epinephrine has been reported as safe in the plastic surgical literature. However, the FDA-reviewed circulars accompanying units of lidocaine state a maximum dose of 5 mg/kg without and 7 mg/kg with epinephrine with each use.

Basic equipment and supplies for ELA are listed below.

• Procedure table that can tilt to Trendelenburg and reverse Trendelenburg
• DUS with at least a 7.5 MHz transducer
• Sterile gowns, gloves, masks, drapes, gauze
• Ultrasound gel, sterile ultrasound probe and cord cover
• Antiseptic preparation fluid
• Local anesthetic
• No. 11 or 15 scalpel blade
• 18- to 21-gauge needle for percutaneous entry
• 21- to 25-gauge needle for administration of tumescent anesthesia
• Syringes
• Normal saline
• Compression stockings

A foot pedal controlled tumescent anesthetic injection pump can be used to infuse the perisaphenous anesthetic as an alternative to hand injection. Venous access kits that allow the use of a less traumatic 21-gauge needle to insert a 0.018-in guidewire are useful when accessing small veins but do add expense to the procedure. These kits include a 4 or 5F sheath with a dilator tapered to the 0.018-in guidewire. After the catheter and dilator are inserted, the dilator and 0.018-in guidewire can be removed to allow the placement of a standard 0.035-in guidewire. These micropuncture kits are marketed by a variety of vendors.

Additional materials required to perform ELA include the laser generator and sterile

laser fiber (see list below) and sheath long enough to cross the abnormal venous segment(s), usually included in a kit along with a guidewire. ELA is usually performed by placing a 4 or 5F sheath into the vein to be treated over a 0.035-in guidewire and then, after inserting a laser fiber into the sheath, withdrawing the sheath to expose the fiber tip. The sheaths are manufactured in multiple lengths and generally the sheath chosen is as long as or longer than the segment(s) to be treated. Sheaths that have a ruler imprinted on them make it easiest to monitor the rate at which they withdrawn. In very straight veins, a laser fiber can be advanced beyond its sheath to the starting point of ablation, but advancement through the sheath is recommended to avoid passing the fiber through the vein wall.

ELA tools

ELA can be performed using multiple wavelengths. Generators and laser fiber kits for use are marketed by multiple vendors, as follows:

Endovenous laser wavelengths commercially available include the following:

• 810 nm (AngioDynamics Queensbury, NY)
• 940 nm (Dornier MedTech Americas, Inc, Kennesaw, Ga)
• 980 nm (Biolitec, Inc, East Longmeadow, Mass)
• 1320 nm (CoolTouch, Roseville, Calif)
• 1470 nm (Biolitec)

Laser has been primarily performed with 600 micron bare-tipped fibers, which are premarked to allow the operator to know when the fiber is tip-to-tip with the end of the sheath and when the they extend a fixed distance beyond the sheath tip. However, some manufacturers have used fibers ranging from 400–1000 micron and 1 vendor uses a fiber with a glass cap on the tip surrounded by a metal cylinder around the cap and distal 2 cm of the fiber. Limited data is available that compares the different configurations at this time. The main chromophore of 1320-nm lasers, at least initially, is water, while other wavelengths used for ELA primarily target hemoglobin. Some investigators have suggested that the choice of wavelength greatly impacts clinical results, but this has not yet been substantiated.

ELA procedure

1. Perform preprocedural DUS to mapping of the venous segments to be treated. Mark the course of the vein(s) to be treated and important anatomical landmarks associated with the ablation on the skin, including the proposed venous access site(s) and deep vein junctions. The access site is ideally at the inferior end of the incompetent segment or segments of the treated vein. In most cases, the entire incompetent segment(s) can be treated with 1 puncture. If microphlebectomy will be performed along with ELA, the veins to be removed should be marked at this time as well.
2. Prepare the operative tray and equipment. Aside from the thermal ablation device and a venous access kit, only basic supplies such as gauze, a sterilizing solution, sterile barriers, and the tumescent solution, with delivery syringes and needle and an ultrasound probe cover, are needed.
3. Carry out sterile preparation and draping of the leg to be treated. Preprocedural antibiotics are not necessary in almost all circumstances as the procedure is performed sterilely and is considered clean.
4. Visualize the access site with DUS. Placing the patient in a reverse Trendelenburg or partly sitting position prior to the venous puncture keeps the vein more distended and may facilitate venous access.
5. Anesthetize the access site. Nick the skin just large enough to facilitate entry of the sheath through the skin.
6. Insert the access needle into the great saphenous vein (GSV) under ultrasonographic guidance. Use of a 21G puncture set, as discussed previously, is preferred particularly when the target vein is < 4 mm in diameter. Cutdown is rarely needed and usually only if percutaneous access fails.
7. Place a 0.035-in guidewire into the vein.
8. Confirm intravenous placement with ultrasonography.
9. Place the introducer sheath over the wire.
10. Position the sheath for ELA to the starting point for ablation. Some physicians typically advance the ELA sheath beyond the starting point and later withdraw it with the laser fiber to the starting spot. The movement of withdrawal helps in to accurately identify the tip and position it at the starting point.
11. Remove the wire and its dilator if one is used with the sheath. Check for venous return by aspirating the syringe attached to the sheath and flush. Recognize that the sheath tip may be against the vein wall and may not aspirate freely. Also realize that when flushing, microbubbles of air introduced into the vein may produce an acoustic shadow that may limit the ability to see venous detail and device positions.
12. Introduce the laser fiber into the sheath so that the fiber reaches the sheath tip. There is generally a mark on the fiber to show this. Then fix the laser fiber and carefully pull back the sheath to expose about 2–3 cm of fiber. Then withdraw the entire sheath-laser fiber to the ablation starting spot.
Fine tune the location of the tip of the laser fiber to just below the superficial epigastric vein, anterior accessory GSV (AAGSV), or other large normal junctional vein for the GSV, and just below the thigh extension junction with the short saphenous vein (SSV) for SSV ablations. Longitudinal (sagittal) duplex ultrasonographic image of the saphenofemoral junction during the positioning of the tip of a laser fiber during an endovenous laser ablation. The laser tip is in the GSV just beyond the SEV origin and is marked by the arrow. FV-femoral vein, SEV-superficial epigastric vein.
13. Connect the laser fiber to its generator and confirm that the tip is in the correct general location by viewing the visible light aiming beam that can be delivered into the laser fiber tip and visualized through the skin. This is an additional way to ensure that the tip of the laser is being visualized accurately and that the laser connections were made appropriately. If the light is not seen in the expected location, troubleshoot the position of the laser or the connection to the laser to understand why.
14. Administer tumescent anesthesia with ultrasonographic guidance after the patient has been placed into the Trendelenburg position to help drain the vein.
15. Place appropriate laser safety goggles on everyone in the procedure room and use other appropriate laser safety measures. Connect the laser fiber to the laser and verify proper laser settings. Setting recommendations vary, but aim to deliver at least 70–80 J/cm length of vein treated: at 14 W this is achieved with a pullback rate of 2 mm/s.
16. Set the laser to continuous mode and select the power to be used. Re-verify placement of the laser tip with ultrasound.
17. Activate the laser and withdraw the fiber and sheath at the speed that is dependent on the amount of energy you wish to deliver at the power setting selected with the laser in continuous mode. Many operators deliver 70-100 J/cm 14 W continuous mode at 810 nm throughout the length of the abnormal vein. For the GSV and AAGSV, the author uses more energy for the first 10-12 cm (140 J/cm) and less as the laser tip progresses lower down the leg (100 J/cm to the knee and 70 J/cm below the knee). This is done to ensure closure of the proximal vein segment just below the deep vein junction, where failure occurs most, and to decrease the risk of nerve injuries lower in the leg. For the SSV, the author uses about 112 J/cm for the first 3-4 cm, then 100 J/cm for the next 3-4 cm, and then 70 J/cm for the remaining vein.
18. Stop laser energy delivery at the distal aspect of the vein and place the laser in standby mode.
19. Remove the fiber/sheath from the vein. Be sure the entire fiber is removed to exclude the possibility of a fracture of the device intravascularly.
20. Record the watts, laser on-time, total joules delivered, and length of the segment treated. Calculate the withdrawal rate and joules delivered per cm to ensure you have reached the targets for successful ablation.

Technique considerations

The amount of thermal energy delivered is correlated to the success of ELA. With laser, energy deposition has been described as either that deposited per centimeter of vein length (J/cm) or as that deposited to the vein wall using a cylindrical approximation of the inner surface area of the vein (J/cm²), which can be considered a fluence equivalent. Durable vein occlusion was demonstrated in an observational series as more likely when the energy delivered exceeded 80 J/cm with a median observation of 30 weeks.^[7] High rates of vein occlusion and ultimate DUS disappearance was noted in a series where the thermal dose in each segment of the GSV was tailored to the diameter in that segment. The ranges of energies used to achieve durable ablation included 50 J/cm for veins ≤4.5 mm and 120 J/cm for veins >10 mm in diameter. No increase in complications was seen with any of the higher energy strategies.^[8]

At this point, a prospective, randomized evaluation of the relationship of the amount of laser energy deposition at a fixed wavelength and its effects on the rate of anatomically successful vein obliteration and complication rates has not been performed. However, other retrospective data cited support the notion of a threshold for high rates of success and that complications and side effects are not increased with energies up to 140 J/cm.

The differences between the current thermal ablation technologies are relatively small. Several retrospective analyses of observational data have demonstrated qualitatively similar occlusion and complication rates with a trend toward quicker treatments and better outcomes with ELA compared with the first generation RFA. In a short-term follow-up study comparing Closure Fast (CF) and ELA, equivalent treatment times and anatomical success at 6 months were seen with slightly less bruising and postprocedure discomfort noted with CF.^[9] At this point, no follow-up is published of the anatomical success of CF beyond 6 months, although there are 2 abstracts that have demonstrated similar anatomical success (vein disappearance) with CF and ELA at 1 year.

ELA bruising and discomfort have been thought to be less with continuous mode laser deposition than with pulsed mode. Limited data suggest that these side effects may be lessened with the use of a laser fiber with its tip covered with a glass cap and metal sleeve as opposed to a bare fiber. This effectively makes the fiber larger and presumably more coagulating than cutting. Long-term evaluation of such fibers is not available at this time.

No differences are apparent in the anatomical success of ELA with different wavelengths in limited evaluations. These studies demonstrated equivalent occlusion rates for the different wavelengths when used at similar rates of energy deposition. No differences were seen in the complication rates in patients treated with different wavelengths but mild differences were described in the side effects of bruising and discomfort.

Adverse events and complications

Adverse events following ELA occur, but almost all are minor. Ecchymosis over the treated segment frequently occurs and normally lasts for 14 days. About one week after ELA, the treated vein may develop a feeling of tightness similar to that after a strained muscle. This transient discomfort, likely related to inflammation in the treated vein segment is self-limited and may be ameliorated with the use of nonsteroidal antiinflammatory drugs (NSAIDs), ambulation and graduated compression stockings. Both of these side effects are more commonly described after ELA using existing laser protocols than for RFA, but the differences in severity are small when studied objectively.^[9]

Superficial phlebitis is another uncommon side effect of ELA, being reported after about 5% of treatments as mentioned previously. There are no published reports of superficial phlebitis after ELA progressing to deep vein thrombosis and it has been managed in most series with NSAIDs, graduated compression hose, and ambulation. Anecdotally, superficial phlebitis seems to be more common in larger diameter tributary varicose veins or in varicose veins that have their inflow and outflow ablated by ELA. Concurrent phlebectomy of these veins at the time of ELA has been recommended to decrease the risk of this side effect, but at this point no data substantiate this claim.

More significant adverse events reported following ELA include neurologic injuries, skin burns, and DVT. The overall rate of these complications has been shown to be higher in low-volume centers than high-volume centers. The nerves at highest risk include the saphenous nerve, adjacent to the GSV below the mid-calf perforating vein, and the sural nerve adjacent to the SSV in the mid and lower calf. Both of these nerves have only sensory components. The most common manifestation of a nerve injury is a paresthesia or dysesthesia, most of which are transient. The nerve injuries can occur with catheter introduction, during the delivery of tumescent anesthesia, or by thermal injury related to heating of the perivenous tissues.

Tumescent anesthesia has been demonstrated to reduce perivenous temperatures with laser and RF ablation. The delivery of the perivenous fluid is felt to be responsible for the low rate of cutaneous and neurologic thermal injuries seen in the series of patients treated using perivenous fluid. Neurologic injuries are seen after truncal vein removal and are related to injury to nerves adjacent to the treated vein. The incidence of these adverse events are related to the degree to which objective testing is performed to identify them. In general, paresthesias caused by ELA are usually temporary with the rate of permanent paresthesias typically reported for GSV and SSV as 0–10%.

The one-week paresthesia rate following RFA was shown to decrease from 15% to 9% after the introduction of tumescent anesthesia. Patients treated with laser ELA performed without tumescent anesthetic infiltrations also demonstrated a high rate of such injuries. Evidence suggests a higher rate of nerve injuries when treating the below knee GSV as compared with the above knee segment and the SSV. Treatment of the below knee GSV or lower part of the SSV may be necessary in many patients to treat to eliminate symptoms or skin disease caused by reflux to the ankle.

A retrospective review demonstrated that below knee laser ablation can be performed with an 8% rate of mild but permanent paresthesias with adequate amounts of tumescent anesthesia. This data also suggests that sparing the treatment of the distal 5–10 cm may have clinical benefit and reduce saphenous nerve injury risk in patients with reflux to the medial malleolus. Skin burns following ELA have been reported. Skin burns are fortunately relatively rare and seem to be avoidable with adequate tumescent anesthesia. The rate of skin burn in 1 series using RFA was 1.7% before and 0.5% after the initiation of the use of tumescent technique during RFA. The early experience had rates as high as 4% that decreased to almost 0% as the use of tumescent anesthesia became a standard of practice.

DVT following ELA is unusual. DVT can occur as an extension of thrombus from the treated truncal vein across the junctional connection into the femoral or popliteal veins. The reported rates of junctional thrombosis following GSV ELA varies widely. This variability may relate to the time of the follow-up examination and the methods used. Most published series using early DUS (around 72 hours or less after ELA) document a proximal extension for the GSV around 1%.

Those performing the DUS later identify a lower rate. Possibly, the rates are different for different operators or the proximal extension of thrombus may be self limited without a clinical event. Pooling data from several sources suggests that the incidence is approximately 0.3% after ELA. This type of DVT is almost universally asymptomatic. The significance of this type of thrombus extension into the femoral vein seems to be different than that found with native GSV thrombosis with extension or when compared with typical femoral vein thrombosis.

The incidence of junctional extension of thrombus after SSV ablation has also been described to be low (0–6%).

In one study, the rate of popliteal extension of SSV thrombus at 2–4 days after ELA was demonstrated to be related to the anatomy of the SPJ. The incidence at 48–72 hours follow-up was 0% when no SPJ existed, 3% when a thigh extension exists, but 11% when no junctional vein could be identified just above the SPJ. Heparin was used to treat identified thrombus extensions and all regressed. No published data is available on conservative management of transjunctional thrombus extension at either the SPJ or SFJ. However, given that popliteal or femoral vein obstruction develops in significantly < 1% of patients, including in those series where DUS is not done until 1 month after ELA, the practice of performing early DUS surveillance and aggressive anticoagulation of such findings is controversial.

Neovascularity at the SFJ after ELA, as a form of recurrence of varicose veins, seems to be rare at 1- to3-year follow-up. Neovascularization was seen in only 2 out of the 1222 limbs followed for up to 5 years in an industry-sponsored registry of patients treated with RFA. Longer follow-up may be necessary to feel confident with this observation. However, neovascularization is common and often an early event following high-ligation and stripping (HL/S). Neovascularization may be less common following endovenous procedures because the junctional tributary flow, which was usually ligated at their confluence with the SFJ is generally not affected with GSV ELA.

Anecdotal reports of laser fiber fracture or retained venous access sheaths have been made to the device manufacturers and a case report exists describing a retained vascular sheath after laser ablation. Respecting the fragile glass laser fibers and being gentle with its handling should help minimize laser fiber fractures. The possibility of a laser fiber fracture should be considered with the removal of the device in each case. Care to deliver thermal energy only beyond the introducer sheath and away from any other parallel placed sheaths when treating 2 veins during the same procedure is essential to avoid severing segments of these catheters. No specific management recommendations of retained intravenous laser fiber or sheath fragments can be made based on the data. However, short segments of the distal end of the laser fiber anecdotally seem to be tolerated without incident and efforts to remove them may be more prone to adverse events than managing them conservatively.

A case report of an arteriovenous fistula (AVF) between a small popliteal artery branch near the SPJ and the SSV exists. Anecdotal references have been made of additional AVFs between the proximal GSV and the contiguous superficial external pudendal artery. Although thought to be related to a heat-induced injury caused by the thermal device, an AVF could be caused by a needle injury during tumescent anesthetic administration. Ways to minimize the risk of these AVFs include careful advancement of the intravascular devices, atraumatic delivery of the tumescent anesthetic, the use of copious amounts of tumescent fluid, and avoidance of treating the subfascial portion of the SSV where popliteal artery branches exist.

Postoperative Care and Instructions

Postoperative care is designed to improve efficacy and minimize side effects and the risk of complications. There is a diversity of opinion about what is necessary as no evidence supports any specific recommendations. Immediately postoperatively, almost all physicians recommend some form of compression. The most common recommendation is for class II compression stockings (30–40 mm Hg) applied immediately after the procedure and worn for 1–2 weeks.

Patients are encouraged to ambulate for at least 30–60 minutes after leaving the procedure room and at least 1–2 hours daily for 1–2 weeks. Hot baths, running, jumping, heavy lifting, and straining are discouraged by many physicians for 1–2 week. NSAIDs may be taken on an as-needed basis for discomfort.

Patients are generally seen at 1 month after the procedure to assess the results by clinical examination and DUS. Some physicians recommend a follow-up DUS 24–72 hours after the procedure as surveillance for junctional thrombus extension from the treated vein into the contiguous deep vein. However, the yield of this early examination for identifying extension of thrombus beyond the deep junction extending into the femoral vein for GSV or popliteal vein for SSV ablation is at most 1%. Moreover, treatment of such nonocclusive extensions is controversial and increasingly conservative. Most physicians agree that repeat DUS at about 9-12 months after the procedure ultimately determines the anatomical success of the ablation.

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.

The total cost (cost of the procedure plus societal cost) of endovenous procedures is likely equal to or better than that of surgery. This is debatable in a hospital setting, but is almost certainly true if the ELA can be performed in a nonspecialized office setting. These techniques are being rapidly adopted and are now being performed more often than traditional HL/S in the United States.

Anatomical success rates

The anatomical outcomes following endovenous treatment include occlusion of the treated segment, early failure (complete or segmental), or late recanalization (complete or segmental). 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.

Table #1. Published Observational Series of Laser Ablation for Truncal Reflux^{[10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34]} (Open Table in a new window)

Fewer data are published following SSV with ELA but the results are qualitatively similar to that found with GSV ablations.

Most ELA recanalizations occur in the first 6 and all in the first 12 months following ELA. This suggests that recanalization may be related to insufficient thermal energy delivery to the target vein with resultant vein thrombosis and recanalization of the thrombus. Late clinical recurrence is extremely unlikely in an occluded vein that has shrunken to a noncompressible cord. Based on this and the surgical data that demonstrate the pathological events that lead to recurrence, which usually take place within 2 years, later clinical recurrences are more likely related to development of incompetence in untreated veins or vein segments (progression of disease in other veins).

To a great extent, late clinical success after ELA is predicated by the natural history of the venous insufficiency in a given patient, the ability of the treating physician to identify refluxing pathways and plan treatment (often described as tactical success) and successfully eliminate all pertinent incompetent pathways (often described as technical success), and the success of the adjunctive procedures used to eradicate any coexistent incompetent tributary veins after ELA.

With ELA, in most cases the first 1–2 cm of the treated vein beyond the SFJ or SPJ remains patent as treatment is begun just below this level. Post-ELA patency of segments < 5 cm long beyond the junction are the most common form of anatomical failure. Clinically, in spite of this, nearly all of these patients benefit from the procedure. However, the patent stump of GSV is usually connected to a saphenous tributary, which, over time, may reflux and be the source of a clinical recurrence.

Post-treatment patency of >5 cm of treated vein segments are much less common and are more likely to be associated with persistent or recurrent symptoms. Less successful closure of the proximal vein segment may be related to insufficient thermal injury to this portion that is generally of larger caliber and less likely to develop spasm during tumescent anesthetic administration and consequently more difficult to empty. As a result, it is less likely to develop good device and vein wall apposition in this segment, which is thought important for optimal vein wall energy deposition to achieve successful ablation.

Patients with a high body mass index have been shown to have a higher rate of failure with laser.^[35] The rationale for this observation is unclear, although it is known that obese patients have higher central venous pressures and a higher frequency of chronic venous disease. ELA success has been demonstrated in retrospective data review to be independent of vein diameter in many studies. However, a prospective confirmation of this conclusion has not been performed.

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).^[36] 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.^[37]

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.^[13]

Several small comparison studies have evaluated the outcomes of laser ablation and surgery. In the first to be published, 20 patients with bilateral GSV reflux were treated with conventional HL/S on one leg and HL and laser in the other and then observed for 3 months.^[38] The patients were not informed on which leg received either therapy, the choice of which technique was used was randomized and all patients were treated with either a spinal or epidural anesthesia. No tumescent anesthetic was used. Early pain was similar for both procedures, although bruising and swelling was worse with surgery. All patients thought the aesthetic improvement was much better in both limbs, but 70% thought the laser limb benefited the most, 20% the surgical limb, and 10% thought they were equal. APG improvements were equivalent in both groups.

A nonrandomized, consecutive treatment comparison of conventional HL/S with general anesthesia and laser ablation of the GSV using tumescent anesthesia has been performed.^[39] 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 postprocedure period of both procedures.^[40] 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.

A randomized trial of 68 limbs treated with HL/S and 62 with laser was performed with both groups only being treated with tumescent anesthesia.^[41] The preliminary report of this ongoing study evaluated the patients up to 6 months after their procedure using a variety of validate instruments, including a visual analogue scale of pain, VCSS, Aberdeen Varicose Vein Severity Score (AVVSS) and SF-36. Initial technical successes were equivalent. In this trial, the early bruising and pain favored laser, but by 3 months both procedures demonstrated significant improvements in all indices compared with pretreatment baselines, but no differences were seen between HL/S and laser.

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.