On the day of the RFA procedure, the patient should be well hydrated to achieve maximum distention of the leg veins. In preparation for the procedure, duplex ultrasonography is performed to mark the skin overlying the target treatment vein.²⁷ A surgical marking pen is used to avoid accidental tattooing of the skin. With use of duplex ultrasonography, the highest point of reflux is marked; it serves as a guide during the RFA procedure. It is advisable to heat the ultrasound gel before placing it on the patient’s leg because cold gel could cause venospasm. Similarly, the patient should be kept warm and comfortable in the procedure room to further avoid venospasm. Mild sedation such as alprazolam (Xanax), diazepam (Valium), or lorazepam (Ativan) may be prescribed for patients who exhibit anxiety.

Radiofrequency Ablation Procedure

An access site that will allow successful treatment of all possible diseased segments of the target vein is identified ultrasonographically. For ablation of the GSV, access is routinely initiated at or just below the popliteal area. With the patient in the reverse Trendelenburg position, lidocaine is administered at the selected site, and a percutaneous technique with a 21-gauge needle is used to gain access under ultrasound guidance. A small cutdown may be used but is not the preferred technique because of cosmetic concerns. A 0.018-inch guide wire is inserted into the GSV, and the needle is removed.

Next, a 7F × 7-cm or 11-cm sheath is advanced over the wire, the 0.018-inch wire is removed, and the 7F ClosureFAST catheter is inserted. The catheter is advanced to the predetermined point at which treatment will begin. If the catheter does not advance easily, a 0.025-inch guide wire may be back-loaded into the device to assist in passage. When the GSV is being treated, optimal positioning of the catheter tip is 2 cm peripheral to the SFJ.²⁸ After correct placement of the catheter tip is confirmed by ultrasound, perivenous tumescent anesthesia is administered under ultrasound guidance along the entire target treatment length to create a fluid layer around the GSV. Proper administration of tumescent anesthesia is a critical component of the procedure, because it not only serves as an anesthetic but also compresses the vein around the catheter and protects the surrounding tissue from heat damage.^28,29 Sufficient tumescent anesthesia should be instilled to create a 10-mm diameter around the vein, hence forming a distance of 10 mm between the targeted vein and the skin (Fig. 58-3). The amount of anesthesia required depends on the length of the vessel to be treated. A representative mixture includes 50 mL of 1% lidocaine with epinephrine in 450 mL of normal saline, neutralized with 5 to 10 mL of 8.4% sodium bicarbonate.²⁷ Caution should be exercised to observe the safe limits for tumescent lidocaine administration, described by Klein³⁰ to be 35 mg per kg body weight.

The type of needle used is based on user preference; popular choices include a 25-gauge hypodermic needle and a 22-gauge spinal needle. The needle is connected to a 20-mL syringe, 20-mL refillable syringe, or specialized tubing that is used in conjunction with an infusion pump. Many physicians prefer to use the pump delivery system because it decreases the time needed for administration of local anesthetic as well as the number of needle punctures. However, during the learning curve for the procedure, manual delivery of tumescent anesthesia enables the proceduralist to more effectively develop the skill set used for ultrasound guidance. Ideal needle positioning for delivery of the tumescent anesthetic is within the saphenous compartment to achieve maximum compression of the vein. After administration of the tumescent anesthetic, the patient should be placed in the Trendelenburg position to assist in vein collapse, apposition, and exsanguination.²⁹ The sheath is withdrawn next, while catheter position is maintained, until the sheath is aligned with the index line on the catheter.²⁹ Positioning of the catheter tip should be reconfirmed with ultrasound before treatment is commenced.

In addition to tumescent anesthesia, a technique that is crucial for success of the procedure is apposite compression.³¹ In the instructions for use of the Covidien ClosureFAST system, it is recommended that compression be applied with the ultrasound transducer positioned longitudinally over the heating element, as well as with two fingers distal to the transducer.²⁹ When the proceduralist is prepared to begin, the generator is turned on and the unit is ready to use. With the segmental ablation technique of the ClosureFAST system, each 7-cm segment is treated independently for a 20-second treatment interval. Radiofrequency energy is delivered by a press of the button located on the handle of the catheter; once a 20-second interval is complete, delivery of energy automatically stops. The initial treatment segment 2 cm inferior to the SFJ requires two 20-second cycles to ensure successful ablation. Additionally, aneurysmal or large-diameter segments may be treated twice at the user’s discretion.²⁸ For each 20-second cycle, the temperature must reach 120° C within 5 seconds after the initiation of delivery of the energy; if this temperature is not achieved within the stated time frame, the segment must undergo another 20-second treatment cycle.²⁹ The generator monitors all parameters during the treatment cycle and alerts the user if the parameters are not successfully met. A segment should not undergo more than three treatment cycles.²⁹

On completion of each 7-cm segment, the catheter is repositioned to the contiguous segment through the use of the 6.5-cm stepped markers on the catheter shaft. The 6.5-cm spacing allows 0.5-cm overlap of each pair of segments to ensure that no untreated areas are left between them. This process is repeated until the desired vessel length is treated, and the procedure can last from 1 to 5 minutes, depending on the length of the vessel and the number of repeated segments.^28,32 When positioning the catheter for the final segment, the user should avoid pulling the heating element into the sheath because it may melt the sheath. After treatment, duplex ultrasonography is used to assess the treated vein for absence of reflux and evidence of occlusion.

Discharge and Follow-up

Postoperative compression with a 30– to 40–mm Hg graduated stocking is recommended for a period of at least 1 week.^29,32,33 Patients are instructed to ambulate after the procedure before leaving the facility to assist in occlusion of the vessel.³³ A duplex ultrasound follow-up examination is advised at 72 hours after the procedure to inspect for extension of thrombus into the deep system and to assess the treated veins.³³ Further follow-up evaluations are performed according to physician preference; experts advocate examinations at 3 months, 6 months, and 1 year after ablation.^28,34

Complications

Potential complications of RFA include vessel perforation, thrombosis, pulmonary embolism (PE), phlebitis, infection, nerve injury, and skin burns or discoloration.²⁹ Proebstle et al²⁸ initially reported comprehensive findings from 6-month data showing a low rate of side effects: ecchymosis 6.4%, paresthesia 3.2%, hyperpigmentation 2.0%, hematoma 1.6%, erythema 1.6%, and phlebitis 0.8%. Thermal skin injury and DVT were not observed in the trial²⁸; however, during the first year of use of the ClosureFAST in 2007, numerous adverse events related to DVT were reported to the U.S. Food and Drug Administration (FDA).³⁵ The FDA MAUDE Adverse Event Database contains 15 reports of DVT in 2007 from use of a ClosureFAST catheter for endothermal ablation.³⁵ In addition, four PEs were reported along with one skin burn.³⁴ It is unclear at this point whether the segmental ablation technique poses an increased risk for DVT over the original ClosurePLUS device. A 4-year prospective study of the ClosurePLUS catheter by Merchant et al³³ revealed that 4 of 858 limbs (0.5%) had localized thrombus formation in the SFJ that did not extend more than 10% into the common femoral vein, as well as another 4 of 858 limbs (0.5%) in which DVT developed. Conversely, a 2004 study by Hingorani et al³⁶ reported that DVT subsequently developed in 16% of limbs treated with the ClosurePLUS catheter.

The European Closure Fast Clinical Study Group reported on the 3-year European follow-up on the ClosureFAST device.³⁷ The incidence of complications was low, the majority of which manifested and subsided within the first week of treatment. During the first week of treatment the following complications occurred: ecchymosis 5.8%, erythema 2.0%, hematoma 1.4%, and phlebitis 1.0%. Complications that persisted beyond the first week included paresthesias at an initial rate of 3.4% that declined to 0.4% at 36 months, and pigmentation at an initial rate of 2.4% that also declined to 0.4% at 36 months. There were no reported cases of DVT or PE.

Clinical Results

In addition to low complication rates, early data for ClosureFAST have demonstrated a high degree of efficacy during its first year of use. Before U.S. approval, an initial trial in Europe demonstrated a 100% success rate in 223 patients 6 months after the procedure³¹ and a 96.7% success rate at 1 year.³⁸ The initial U.S. data used the Kaplan-Meier method to determine efficacy; ultrasonography at 3 days, 3 months, and 6 months showed successful closure in 99.6% of limbs.²⁸ The results of an additional multicenter prospective study, presented by Dietzek,³⁹ indicated a 96.2% vein occlusion rate 1 year after treatment. This result is comparable to that of several 1-year Closure studies, which have yielded success rates ranging from 86% to 99%.^33,40–42 A large-scale study of the original ClosurePLUS device by Merchant et al³³ demonstrated 2-, 3-, and 4-year efficacy rates of 86.2%, 84.2%, and 88.8%, respectively.

Once again, the European Closure Fast Clinical Study Group reported on the mid-term efficacy of the ClosureFAST device.³⁷ The probability of continued occlusion of the treated truncal vein at 3 years was 92.6%. In addition to anatomic procedural success, the 3-year midterm analysis evaluated other surrogate variables in order to assess clinical efficacy. For example, the Venous Clinical Severity Score (VCSS) improved from an average of 3.9 before treatment to an average of 0.9 at 3 months after treatment (P < .0001), and the low average Venous Clinical Severity Score persisted for the duration of the study. With regards to the clinical component of the Clinical, Anatomic, Etiologic, Pathophysiologic classification system, 74.1% of patients demonstrated an improvement at 36 months. Substratification of the clinical score did demonstrate a differential in the clinical results such that patients with stages C3 and C4 disease accounted for 46% of the patient population before treatment but for only 8% of the population at the conclusion of the study. The proportion of patients with C2 disease dropped to less than 10% at 1 year; however, there was a linear increase such that at 3 years, 33.3% of the patients exhibited C2 disease.

Laser Wavelengths

Numerous different endovenous laser wavelengths have been used to generate endothelial destruction of varicose veins, including 810, 940, 980, 1064, 1319, 1320, and 1470 nm.⁴⁶ Since the advent of endovenous lasers, several theories centered around the efficacy of wavelengths absorbed by water and hemoglobin have been offered. Research on the optical properties of blood has shown that different wavelengths have variable absorption characteristics⁴⁷:

A limited number of studies have been conducted to evaluate these various wavelengths for both efficacy and adverse events. The first, published by Proebstle et al⁵² in 2005, compared the 940- and 1320-nm wavelengths. The study concluded that the wavelengths were equally efficacious but that ecchymosis and pain occurred significantly less often in limbs treated with the 1320-nm laser.⁵² In a similar study, an analysis of the 810-nm wavelength versus the 980-nm wavelength also favored the higher wavelength.⁴⁸ There was no significant difference in success of treatment between the two wavelengths; however, at 1-week and 4-month follow-up, less bruising and lower postprocedure pain intensity were noted with the 980-nm wavelength.⁴⁸ Mackey et al⁵³ performed a study comparing the 810-nm wavelength and the 1320-nm wavelength, with follow-up 3 days after the procedure. They reported analogous findings and concluded that the 1320-nm wavelength was associated with less postoperative pain and bruising. Mauriello et al⁵⁴ performed a retrospective review in 50 patients treated using the 1470-nm wavelength, which demonstrated treatment efficacy with low rates of pain and bruising. Current research suggests that the various laser wavelengths are likely equally efficacious, but there is a trend toward less pain and bruising with the higher-wavelength lasers.

As with RFA, for the treatment of the GSV, the target access site is at or slightly below the popliteal area. Experienced physicians may attempt to gain access lower on the leg if the vein exhibits reflux distally; however, doing so adds risk to the procedure because the saphenous nerve lies adjacent to the GSV within the saphenous compartment in the lower part of the leg. Ablating the GSV in the lower leg region may increase the risk for paresthesia as a result of the proximity of the saphenous nerve. A micro-access set (21-gauge needle, 0.018-inch wire, and microsheath) is used to initiate access.⁴⁸ An 18-gauge needle or a cutdown is also effective but not preferred because of the increased risk for trauma to the vessel or venospasm. Once the microsheath is inserted into the GSV, the distance from the access site to the SFJ is measured. The inner dilator of the microsheath is removed and a 0.035-inch guide wire is advanced through the microsheath to the SFJ under ultrasound guidance. The microsheath is removed and a long sheath is selected on the basis of the measured distance from the SFJ to the access site. The sheath selected, most commonly 45 cm in length, is exchanged over the guide wire to a point just distal to the superficial epigastric vein.⁴⁸ Once in place, the inner dilator and guide wire are removed and a 600-µm bare-tipped or jacket-tipped fiber is advanced into the sheath. The fiber is then connected to the generator and the aiming beam turned on to help visualize the fiber tip under the skin. While the fiber is held in place, the sheath is withdrawn to the locking mechanism of the fiber and locked in place, with the tip of the fiber exposed approximately 2 cm past the end of the sheath. Positioning is reconfirmed with ultrasound, and preparation is made to administer tumescent anesthesia. As with RFA, tumescent anesthesia is injected perivenously^48,55,56 with the goal to create a target diameter of fluid around the vein of 10 mm. Positioning of the laser fiber tip is then reconfirmed before the procedure is commenced.

Discharge and Follow-up

Discharge and follow-up instructions for ELA are identical to those for RFA.

Complications

The incidence of procedure-related complications with ELA has been relatively low with the use of endovenous lasers in the continuous mode. Potential complications include but are not limited to vessel perforation, thrombosis, PE, phlebitis, hematoma, infection, skin pigmentation, neovascularization, paresthesia, complications from tumescent anesthesia, irradiation of nontarget tissue, hemorrhage, necrosis, skin burns, and pain.⁶² Min et al⁵⁵ published results of the first large-scale study (499 limbs) using a laser with an 810-nm wavelength and noted that 24% of treated patients experienced bruising; notably absent were any cases of skin burns, paresthesia, and DVT. Another broad study using the 810-nm laser reported the following complications: DVT 0.3%, hematoma 0.3%, superficial phlebitis 1.8%, and local transient paresthesia 3.0%.⁶³ Similarly, Kim and Paxton⁶⁴ observed no DVT, PE, skin burns, or permanent nerve injury in their prospective study using a 980-nm laser. Minor complications in this study included hematoma at the entry site 0.3%, thrombophlebitis 0.3%, and ecchymosis 27%. With regard to postprocedural complications, the rates vary widely in the literature: DVTs 0% to 5.7%, skin burns less than 1%, nerve injury 0% to 22%, and superficial thrombophlebitis 0% to 25%.^65,66 A rare complication that has been reported in both RFA- and ELA-treated patients is the development of an arteriovenous fistula, commonly occurring where the external pudendal artery crosses posterior to the GSV.⁶⁷ The natural history of these arteriovenous fistulae is still being elucidated, but the majority of patients remain asymptomatic.

As discussed earlier, some evidence suggests that higher-wavelength lasers produce less pain and bruising; however, a prospective, large-scale study evaluating all the wavelengths is needed to further substantiate these initial findings. The mechanism of the ELA procedure that causes pain and bruising remains unclear, although some experts speculate that the complications are due to perforation of the vein wall by laser energy.^52,68 Aside from laser wavelengths, a novel adaptation to laser fibers that has shown a beneficial effect on perforation of the vein wall is the newly introduced jacket-tipped fibers. This technology features either a stainless steel or a ceramic jacket that completely covers the tip of the fiber, with the end of the tip being recessed within the jacket.^69,70 This design prevents the flat emitting face of the fiber tip from coming in contact with the vein wall.^69,70 Kabnick et al⁶⁸ carried out a pilot study to evaluate the efficacy and complications of jacket-tipped fibers versus bare-tipped fibers. At 72 hours after the procedure, both treatment groups demonstrated 100% success; however, in the group treated by jacket-tipped fiber, pain and bruising scores were lower.⁶⁸ Because vessel perforation has been directly linked to bruising,⁵² the study concluded that the lower bruising scores achieved in the jacket-tipped fiber group could be attributed to fewer perforations.⁶⁸ In order to assess the use of a jacket-tipped fiber in a higher-wavelength laser, Maurins et al⁷¹ evaluated a 1470-nm laser and compared treatments using a bare-tipped fiber, a jacket-tipped fiber, and a radial-emitting tip fiber. All demonstrated similar efficacy in ablation with corresponding reductions in vein diameter. It turned out that the radial-emitting fiber had the lowest LEED requirement, resulting in less postprocedural pain than in the other two groups.

Clinical Results

In addition to the low rate of complications demonstrated by ELA, treatment outcomes and success rates of ELA are at least equivalent to those of all other modalities. The paramount trial for establishing ELA as an efficacious treatment was published by Min et al⁵⁵ in 2003. Initial treatment results with an 810-nm laser showed a 98.2% success rate and an ensuing closure rate of 93.4% at 2 years.⁵⁵ Since this study, numerous trials have been conducted for all the wavelengths currently used. Proebstle et al⁵² performed a study evaluating 1320- and 940-nm (15- and 30-W) lasers and reported favorable efficacy rates at 3 months of 90.3% (940 nm, 15 W), 100% (940 nm, 30 W), and 97% (1320 nm).⁵² A large-scale prospective trial involving the use of a 980-nm laser on 500 limbs was published in 2007.⁶¹ A 98% closure rate was reported at the 1-week follow-up and remained constant; closure rate was 97.1% at the 4-year follow-up.⁶¹

More recently, the International Endovenous Laser Working Group evaluated long-term outcomes using ELA for the treatment of patients with truncal reflux. The international registry evaluated 1020 limbs that were treated using a 980-nm bare-tip laser. The durability of the procedure was confirmed, given that the treatment success rates were 92.3% at 1 year and 86.9% at 2 years with no additional treatment failures at 3 years.⁷² As the data indicate, ELA for the treatment of venous reflux is a well-tolerated, efficacious, and durable treatment option.