Endovenous ablation with laser for great saphenous vein insufficiency and tributary varices: A retrospective evaluation
Article Outline
Background
Endovenous laser ablation (EVLA) is a minimally invasive technique for treating great saphenous vein (GSV) reflux for several years. We report our experience with EVLA and evaluate its effectiveness.
Methods
A consecutive series of patients (639 women [60%] and 421 men [40%], age 23 to 79 years) were treated by EVLA for GSV reflux and tributary varices at our institution. A questionnaire was used to assess preoperative and postoperative symptoms. The primary outcomes for assessing safety were mortality and morbidity, including laser-related adverse events, postoperative infection, thrombotic events, etc. Effectiveness was assessed by the obliteration of the vein, disappearance of varicosities, and so on.
Results
All patients tolerated the procedure well, recovered uneventfully, and returned to daily activities and work 3 days and 10 to 14 days, respectively, after the operation. Treatment with EVLA plus ligation of the GSV resulted in occlusion in all cases at 2 weeks follow-up and in 1169 of 1186 (99%) at 6-month follow-up; the rate of retreatment was low (36/1186). Complications were minor and improved quickly.
Conclusions
EVLA can reduce and relieve symptoms associated with varicose veins and achieve cosmetic goals. Vein emptying before exposure to laser energy and compression treatment afterwards may improve results.
Varicose veins are common in men (prevalence, 10.4% to 23.0%) and women (29.5% to 39.0%).1, 2 In most people, varicose veins are associated with aching, itching, heavy legs, edema, lipodermatosclerosis, or even frank ulceration, and some people, especially young patients, seek treatment for cosmetic goals because they find varicose veins unsightly.
Great saphenous vein (GSV) reflux is the most common underlying cause of symptomatic varicose veins. Traditional treatment of GSV reflux has been surgical removal of the GSV. Tributary varicosities require multiple phlebectomy or follow-up treatment with sclerotherapy. Although surgical ligation and stripping of the GSV has been the most dependable treatment, it is associated with significant perioperative morbidity. There are recognized morbidities associated with surgery, and patients require 2 to 3 weeks to return to normal activity. Potential complications include cutaneous neurosensory loss, wound infection, hematoma, and, more rarely, lymph leak and deep vein thrombosis. Despite improvements in technique, recurrence remains a problem after surgery.3, 4 In view of these less than satisfactory outcomes and to reduce morbidity and recovery time, minimally invasive techniques have been developed as alternatives to conventional surgery in recent years. Endovenous laser ablation (EVLA) is the most promising of these new techniques. However, most surgeons only use endovenous laser ablation for GSV reflux because they believe tributary varicosities cannot be treated with EVLA and will require follow-up treatment with sclerotherapy or multiple phlebectomy sometimes.5, 6
From June 2001 to April 2006, 1060 patients were successfully treated by EVLA in our hospital. This report recounts our experiences with EVLA in the treatment of GSV reflux and tributary varices and evaluates the effectiveness of this treatment option.
Methods
Patient selection
This is a retrospective, consecutive-enrollment study of patients receiving endovenous laser ablation for incompetent GSV and tributary varices. Directed history and physical examination, including duplex ultrasound (US) evaluation of the superficial and deep venous system, were performed on limbs of subjects with varicose veins. Duplex ultrasound was performed in the upright position to map incompetent sources of venous reflux. Venous reflux was defined as reverse flow of more than 0.5 seconds.7 Ascending venography was performed to confirm the diagnosis and further exclude postthrombotic syndrome with total recanalization and the May-Thurner syndrome, which may be missed on ultrasonography. Presence of incompetent perforators was not routinely evaluated.
Study inclusion criteria included varicose veins caused by saphenofemoral junction (SFJ) incompetence with GSV reflux (as demonstrated by duplex US imaging); age of at least 20 years; completed written informed consent form acknowledging awareness of the alternative treatments available, risks involved, and other issues that conform to the standard of care for informed consent practices; and ability to return for scheduled follow-up examinations for at least 12 months after EVLA. Exclusion criteria included nonpalpable pedal pulses; inability to ambulate; previous deep venous thrombosis; the May-Thurner syndrome; congenital malformations; axial deep venous reflux, from groin through popliteal vein; general poor health; pregnancy, or plans to become pregnant during the course of participation in the investigation; acute superficial thrombophlebitis, and venous ulceration larger than 2.0 cm in diameter.
Description of the technique
All patients were treated by EVLA combined with high ligation of the GSV in accordance with a four-step standard protocol. In the first step, the GSV was disconnected from and ligated at the saphenofemoral junction (SFJ). In the second step, the GSV was punctured at the ankle level with an 18-gauge needle under ultrasound-guidance or after wrapping a strip above the ankle to achieve hemostasis. A 5F introducer sheath (Cook, Bloomington, Ind) was placed into the GSV; a catheter was inserted into the distal GSV and advanced to the SFJ using a 0.035-inch diameter J guidewire. If catheter could not be advanced to the SFJ, it would be inserted from the GSV stump to ankle level using a 0.035-inch diameter J guidewire. In the third step, the varicose branches were punctured using an 18-gauge needle, and the intraluminal position of the needle within the varicosities was confirmed by aspiration of nonpulsatile venous blood. A 0.035-inch diameter mini guidewire was placed into the varicose vein, and a 5F introducer dilator was inserted as far as possible. A laser fiber was then inserted in the dilator and the dilator was withdrawn. The laser was fired as it was withdrawn at a rate of 1-3 mm/s with manual pressure being applied to achieve venous wall apposition around the laser fiber tip. The laser fiber was directly inserted and fired if the mini guidewire and dilator could not be placed into the tributary varices, and the treated area would be compressed manually several minutes. If varicosities were very close or adhered to the dermis, then subcutaneous injection of tumescent saline over the treated vein was indicated, to form a protective barrier between varicosities and the skin. This compressed the vein to ensure vein wall apposition to the fiber and limited heat conduction to perivenous tissues, thus minimizing the possibility of heat-related damage to adjacent tissues.8 Quick withdrawal was important as well. In the fourth step, a laser fiber was inserted via a catheter into the distal GSV and advanced to the SFJ. The tip position of the laser fiber was confirmed by direct visualization of its red aiming beam through the skin and GSV stump. The catheter was then withdrawn 3 cm, exposing the distal end of the bare-tipped laser fiber and positioning it 1-2 cm below the GSV stump. The wound was cleaned and dressed, and a near bloodless field in the vein (to be treated) was created by wrapping the limb with elastic compressive bandage and placing the patient in the Trendelenburg position. The catheter and optical fiber were pulled back together from the proximal GSV stump, preferably at a rate of 1-2 mm second (a retraction speed that is adaptable to changes in the venous diameter and inner vessel surface). The energy of the laser beam was 12 watts, and exposures were either pulsed (1-second pulses separated by 1-second intervals during withdrawal) or continuous as the fiber was withdrawn. If the GSV was too tortuous to allow a catheter to pass, multiple puncture was indicated, and ultrasound-guided catheterization was used if necessary.
Antibiotics were used for 1 to 3 days and anticoagulants for one time routinely after operation in order to avoid infection and deep venous thrombosis. A compression bandage was worn at least for 3 days following treatment, and a class II (30-40 mm Hg) full-thigh graduated support stocking or panty hose was worn for at least 1 month at all times during follow-up, except to sleep or to shower. Patients were instructed to ambulate and resume their normal daily activities as soon as possible after treatment. Two weeks after EVLA, patients returned for follow-up. Physical examination of the treated area, bidirectional Doppler and duplex US examinations were performed to check for GSV occlusion. Similar evaluations were performed at each follow-up visit. Clinical and duplex US follow-up was obtained at 2 weeks, 3, 6, and 12 months, and then yearly. Tumescent anesthetic solution was not routinely injected around the saphenous vein before treatment in this series.
Study endpoints and definitions
The primary outcomes for assessing safety were mortality and morbidity, including laser-related adverse events, postoperative infection, thrombotic events, pain, skin burn injury, leg swelling, bleeding complications, ecchymosis, paraesthesia, induration, and phlebitis. Effectiveness was assessed by evaluating the obliteration of the vein, disappearance of varicosities, rate of retreatment, reduction of symptoms and pigmentation, or other skin changes secondary to chronic venous insufficiency.
Efficacy of vein obliteration was categorized as: (1) totally occluded (TO) (ie, veins with no evidence of flow), (2) partially occluded (PO) (ie, no evidence of flow in a vein trunk except for a vein segment [5 cm or less in length]), and (3) inefficiently occluded (IO) (ie, flow in a segment greater than 5 cm in length).
Varicose veins were defined as any visible abnormally dilated, tortuous vein. Symptom severity, limb pain, fatigue, and edema were each ranked as absent (0), moderate (1), or severe (2). The total score for each limb ranged from zero (asymptomatic) to six (severe pain, fatigue, and edema).9 The surgeon assessing the patient rated and recorded these scores in the clinical notes.
Results
Patient characteristics
We treated 1060 patients (including 1186 limbs; 639 women (60%), 421 men (40%), age 23-79 years, mean age 56 years) with endovenous laser ablation over a 50-month period. Of the 1186 limbs, 15 had had previous sclerotherapy and another 21 had GSV and varicose vein ablation. Follow-up ranged from 12 to 48 months (mean 27 months ±SD of 11 months). Overall, slightly more left legs (n = 676, 57%) were treated, and 126 patients (12%) were treated for bilateral GSV reflux and tributary varices. The disease course was 1.8 to 42 years (mean 13.4 years). According to the CEAP (clinical, etiological, anatomical, and pathological grade) classification, all involved lower limbs had superficial varicose veins, and 54% had a class 4 or higher clinical stage.10 Patients' demographic data and CEAP grades are listed in Table I.
Table I. Demographic characteristics and CEAP classification for 1060 patients (1186 limbs) treated with EVLA
| Variable | Data |
|---|---|
| History | |
 Mean age, y (range) | 56.17(23-79) |
| Women/men | 639/421(60.28%/39.72%) |
| Limb (right/left) | 676/510 |
| Course of disease, y (range) | 13.4(1.8-42) |
| Previous treatment | |
| Sclerotherapy | 15(1.26%) |
| Ablation | 21(1.77%) |
| CEAP classification | |
| Clinical | |
| Class 2 | 173(14.59%) |
| Class 3 | 367(30.94%) |
| Class 4 | 423(35.67%) |
| Class 5 | 127(10.71%) |
| Class 6 | 96(8.09%) |
| Etiology | |
| Primary | 1186(100%) |
| Secondary | 0 |
| Anatomy/pathology | |
| Superficial reflux | 796(67.12%) |
| Deep reflux | 390(32.88%) |
Therapeutic effects
Percutaneous access and endovenous placement of laser fibers were achieved in all patients. All patients tolerated the procedure well and recovered uneventfully. They were encouraged to return to ambulatory activities, normal daily activities, and work 1 day, 3 days, and 10 to 14 days, respectively, after the operation. The diode laser fiber in the treatment of GSV and superficial varicosities was normally 600 μm in diameter, and a wavelength of 810 nm was chosen in our series. Pulses ranging in duration from 80 to 600 seconds (mean 245) were used throughout the procedure. Depending on the severity of the varicosities, the entire procedure took 40 to 120 minutes (mean 55) to perform.
Use of EVLA plus ligation of the great saphenous vein resulted in GSV occlusion in all cases at 2 weeks follow-up with no flow detectable by duplex US interrogation (Table II). At 6 months follow-up, 1169 of 1186 (99%) GSVs remained closed. Of the 17 GSVs that opened, 12 were partially occluded (PO) and five were inefficiently occluded (IO); these patients had recurrent calf varicose veins. Another 19 patients also had local recurrent varicose veins, which were successfully treated with multiple puncture EVLA under local anesthesia. The rate of retreatment was 3% (36/1186); no recurrence was seen in other patients after 6 months follow-up. At 6 to 9 months follow-up visit, GSV occlusion was substantial (>50% reduction in diameter) and at 1 year and beyond, GSV disappeared completely or existed as minimal residual fibrous cords with no flow detectable. Most of the treated vein segments became fibrose and proved to be difficult to identify. No great saphenous veins regained patency after 1 year.
Table II. Obliteration of GSV by DUS assessment
| Outcome | Follow-up time | |||
|---|---|---|---|---|
| 2 wk | 6 mos | 9 mo | 12 mo or longer | |
| N | 1186 | 1186 | 1186 | 1186 |
| Total occluded | 1186 | 1169 | 1184 | 1186 |
| Partial occluded | 0 | 12 | 2 | 0 |
| Inefficiently occluded | 0 | 5 | 0 | 0 |
Analysis of questionnaire data on preoperative and postoperative venous symptoms found that EVLA reduced symptoms associated with varicose veins, such as limb pain, fatigue, and edema (Table III). Ninety-six patients had gaiter ulcerations, which healed in 2 to 8 weeks after the procedure. By 6 months after initial treatment, pigmentation and pruritus were greatly improved or resolved in all treated limbs.
Table III. Mean symptom severity scores
| Follow-up time period | N | Mean pretreatment score | Mean posttreatment score |
|---|---|---|---|
| Pretreatment | 1186 | 3.56 | N/A |
| 3 mo | 1186 | 3.56 | 0.7 |
| 6 mo | 1186 | 3.56 | 0.23 |
| 9 mo | 1186 | 3.56 | 0.12 |
| 12 mo | 1186 | 3.56 | 0.17 |
| 24 mo | 878 | 3.61 | 0.13 |
| 36 mo | 523 | 3.55 | 0.12 |
| 48 mo | 135 | 3.58 | 0.08 |
Complications
Pain, ecchymosis, induration, and phlebitis are common adverse events associated with EVLA, but in most cases they are self-limiting. During the early period after EVLA, 532 limbs (44.86%) experienced ecchymosis or discoloration beneath the skin along the course of treated veins, but this symptom usually abated in 2 to 4 weeks. In addition, 450 limbs (38%) had string-like indurations over the treated veins that caused slight or moderate pain and resolved in 3 to 6 weeks. Only 19 patients required treatment with over-the-counter analgesics (ibuprofen) for 1 to 2 weeks. Five percent of patients developed superficial phlebitis, but most cases required no treatment. Spot skin burn injuries occurred in 12 limbs (1.01%) and resolved in 2 to 4 weeks. Postoperative infection occurred in seven limbs (0.59%). Paresthesia in the gaiter area was noted in 65 limbs (5.48%) but disappeared in 1 to 3 months. No other potential minor or major complications such as deep vein thrombosis (DVT), pulmonary embolism (PE), allergic reactions, or hematoma developed, and all of the above-mentioned minor complications resolved without sequelae.
Discussion
Percutaneous methods for treating incompetent GSVs are not new. Duplex-guided sclerotherapy for treatment of GSV reflux has been attempted, but long-term studies have failed to prove long-term benefit comparable to that resulting from surgery.11, 12 Initial attempts at damaging vein walls by electrocoagulation involved creation of a thrombus within the vessel lumen, but the occluded vessels ultimately recanalized.13, 14 Early methods of intraluminal delivery of high-frequency alternating-current radiofrequency (RF) energy to treat GSV reflux were complicated by skin burns, saphenous nerve and peroneal nerve injury, phlebitis, and wound infection.15, 16 In 1999, Boné17 first reported on delivery of endoluminal laser energy. Since then, a method for treating the entire incompetent GSV segment has been described.5, 6 Sufficient heating of the vein wall is necessary to cause collagen contraction and destruction of the endothelium. This stimulates vein wall thickening, eventual luminal contraction, and fibrosis of the vein.18 An inverse relation exists between fluence (ie, energy density) and area of irradiated surface, suggesting that different venous diameters require variable exposure times at the same wattage to deliver the same fluence.19 For this study, the optical fiber retraction speed was changed (in different venous segments of differing diameter and surface area) rather than the watts delivered. This was practically much easier to accomplish with the same effect. An adequate fluence should be achievable in veins of varying diameter and inner surface area by adjusting retraction speed, thereby maximizing the efficacy of the treatment.19
Most people with varicose veins experience symptoms of venous reflux (ie, restless legs, pain, edema, eczema, pigmentation, and ulceration). Our results demonstrated that EVLA could reduce and relieve these symptoms. However, for some patients, especially younger women, cosmetic reasons for treatment are also important. In the literature, most authors have only used endovenous laser ablation for GSV reflux, not for tributary varicosities. Although symptomatic resolution and significant improvement in the appearance of the leg is usually noted after endovenous laser ablation alone, full restoration usually requires additional complementary procedures (ie, sclerotherapy or phlebectomy).5, 6, 20 Our results revealed that EVLA occludes both the venous trunk and tributary varicosities. During the procedure, tributary varicosities are treated by multiple puncture using a mini guidewire and dilator. This add-on procedure increases treatment efficacy and reduces recurrent varicose veins. Manual compression is applied over the red aiming beam to achieve vein wall apposition around the laser fiber tip during firing, and the treated area is compressed several minutes after the laser fiber is withdrawn. Longer exposure (obtained by slowing optical fiber retraction or by repeating the laser irradiation two or three times) can be used successfully in larger diameter tributary varicosities and extensive varicose masses. So EVLA can achieve both therapeutic and cosmetic goals.
Endovenous laser irradiation of the GSV combined with surgical interruption of the saphenofemoral junction is recommended.20 High ligation of the GSV was used to decrease the risk of thrombus formation in the deep vein and recanalization of the GSV caused by SFJ reflux and to facilitate thrombosis and fibrosis throughout the GSV. Clinically apparent DVT or PE was absent in our patient cohort. In this study, all recurrences were noted before 6 months, with the majority seen by 3 months. This may indicate that these were not true recurrences but rather the result of inadequate initial treatment. Twelve skin burn injuries occurred at an early stage in our series. Because subcutaneous injections of tumescent saline and quick withdrawal were used, such complications were seldom seen.
The endovenous diode laser exerts its effect on contact. We suggest that before emission of the laser energy, the involved limbs be elevated or the treated area be compressed to fully empty venous blood and collapse the venous wall. This should facilitate fiber endothelial contact and reduce the postoperative thrombophlebitis and the formation of indurations. Superficial thrombophlebitis with thrombosis in the GSV would result in recanalization of the vein.5 The higher rate of painful thrombophlebitis and cellulitis with the EVLA technique is probably due to incomplete vein emptying, an intraluminal thrombus, and surrounding inflammation.21 Indurations along the course of the GSV or over the treated varicose veins will cause local pain. Such a tissue reaction is most distinct 1 to 2 weeks postoperatively and then gradually subsides and diminishes in 3 to 6 weeks. The more complete the emptying of the vein lumen, the weaker the intensity of the tissue reaction, and the better the results achieved. Therefore, we recommend creating a near bloodless field inside the GSV by wrapping the limb with an elastic compressive bandage and placing the patient in the Trendelenburg position. In addition, compression bandaging or compression stockings are most important postoperatively to avoid early recanalization and enhance the therapeutic effect. Although we did not monitor closely compliance with postoperative compression, we believe that this may be a contributing factor for recurrences and some complications. Because most of our patients had varices in the calf region and more frequent advanced skin changes in the gaiter area than previously reported, we treated the entire incompetent GSV from groin to ankle (not from groin to knee) in all cases. To avoid thermal injury to the saphenous nerve during the procedure, a relatively quick withdrawal of the catheter and the optical fiber (in 3- to 5-mm increments) was performed in the GSV from the knee to ankle level.
Our results with EVLA have been impressive: very effective closure of incompetent GSV and varicose veins, reduction and relief of patient symptoms associated with varicose veins, achievement of cosmetic goals, and lower rates of complications. Since this technique is continually developing, the future outlook for its extensive application is favorable. Vein emptying before the emission of laser energy and compression treatment after EVLA may be important measures.
Author contributions
References
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Supported by the National Natural Science Funds of China (30772104).
Competition of interest: none.
PII: S0741-5214(08)00627-7
doi:10.1016/j.jvs.2008.04.017
© 2008 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
