TY - JOUR
AU - Hiller, J E
AB - Abstract Background The safety and effectiveness of endovenous laser treatment (EVLT) for varicose veins are not yet fully evaluated. Methods Medical bibliographic databases, the internet and reference lists were searched from January 1966 to September 2004. Only case series were available for inclusion in the review. Results Thirteen studies met the inclusion criteria. Self-limiting features, such as pain, ecchymosis, induration and phlebitis, were commonly encountered after treatment. Deep vein thrombosis and incorrect placement of the laser in vessels were uncommon adverse events. No study has yet assessed the effectiveness of laser therapy in comparison to saphenofemoral junction ligation with saphenous vein stripping. Occlusion of the saphenous vein and abolition of venous reflux occurred in 87·9–100 per cent of limbs, with low rates of re-treatment and recanalization. Conclusion From the low-level evidence available it seems that EVLT benefits most patients in the short term, but rates of recanalization, re-treatment, occlusion and reflux may alter with longer follow-up. The lack of such data, in addition to the small numbers of patients in the available studies, demonstrates the need for a randomized clinical trial of EVLT versus conventional surgery. Introduction Varicose veins are common, with a prevalence of between 10·4 and 23·0 per cent in men, and 29·5 and 39·0 per cent in women1–3. Several treatment options are available when there is no reflux, including sclerotherapy, hand-held lasers applied externally, ablation with echosclerotherapy and ambulatory phlebectomy for varicose veins4–8. Radiofrequency wavelengths may also be used to generate heat within the varicose vein, causing it to collapse9,10, and foam sclerotherapy is gaining popularity. When reflux is present, the standard intervention is saphenofemoral junction ligation with saphenous vein stripping11. Perforate invagination is a modification of this technique that inverts the vein with the aim of avoiding the trauma of conventional stripping12. Endovenous laser treatment (EVLT) is a relatively new and minimally invasive method of treating refluxing varicose veins; it may be done in an outpatient setting using local anaesthesia. Access to the great or small saphenous vein is achieved at the ankle or just below the knee, by either needle puncture or the stab wound–Mueller hook approach. A guidewire or cannula is introduced into the vein and manoeuvred towards its junction with the deep vein under ultrasonographic guidance. A catheter is then introduced over the guidewire, which is removed. Perivascular tumescent infiltration of local anaesthetic along the length of the vein to be treated dissipates the heat generated during the procedure, reducing tissue damage. A diode laser fibre is inserted into the catheter to approximately 1–2 cm below the saphenofemoral or saphenopopliteal junction, the position being confirmed by ultrasonography. Thermal laser energy is applied along the length of the vein by withdrawing the laser fibre in 3–5-mm increments over time. Compression is applied to achieve vein wall apposition. Once the laser fibre and catheter have been removed, the wound is cleaned and dressed. Graduated compression stockings are applied and patients are instructed to walk immediately. Tributary varicosities cannot be treated during the EVLT process, meaning that patients always require follow-up treatment with sclerotherapy or multiple phlebectomy and this is usually done 4–6 weeks later13,14. Several follow-up visits are often required. This paper summarizes the results of a systematic review assessing the safety and effectiveness of EVLT for the treatment of varicose veins. Methods The literature was searched to identify studies describing EVLT over the period from January 1966 to September 2004. The full search strategy is available on request from the authors. Included papers provided data on patients over the age of 18 years with clinically documented primary venous reflux, confirmed by duplex ultrasonography, of the great or small saphenous veins in whom sclerotherapy alone would be unlikely to be successful. Papers included for the assessment of safety and effectiveness described the treatment of varicose veins using equipment sourced from Diomed (Cambridge, UK). The primary outcomes for assessing safety were mortality and morbidity, including laser-related adverse events, postoperative infection, thrombotic events, pain, bleeding complications, ecchymosis, paraesthesia, induration and phlebitis. Effectiveness was assessed by the abolition of reflux, rate of re-treatment, recanalization or neovascularization, reduction of symptoms and quality of life. Assessment of quality The evidence presented in the selected studies was assessed using the dimensions of evidence defined by the National Health and Medical Research Council of Australia15. The appraisal of study quality was undertaken using a checklist for the appraisal of case series developed by Young et al.16, with a maximum quality score (QS) of 3·0 indicating the highest quality. Data extraction Data were extracted from the included articles by a single researcher, and confirmed by an independent assessor, using tables and outcome definitions developed a priori by the investigation team. Descriptive statistics were extracted or calculated, where possible, for all safety and effectiveness outcomes, and a qualitative synthesis of the results was undertaken. Differences in the frequency of each variable before and after treatment were calculated using McNemar's χ2 test, with P < 0·050 being considered statistically significant. All statistical calculations were undertaken using the biostatistical computing software package, Stata for Windows® version 7.0 (Stata Corporation, College City, Texas, USA). Results After the application of inclusion criteria, 75 papers were retrieved for full text appraisal; of these, 13 case series were included in the review. Duplication of patients may have occurred in a number of studies by the same authors13,17–21. Several abstracts from conference proceedings were also identified but they did not contain enough information to be critically appraised. The profiles of the included studies are shown in Table 1. No study compared EVLT with junction ligation (with or without stripping) and so data pertaining to the safety and effectiveness of EVLT alone are presented here. Table 1 Profiles of case series included in assessment Reference . Year . Quality score . Follow-up (months)* . No. of patients (limbs) . Min et al.13† 2001 3·0  6 (1–9) 84 (90 GSV) Proebstle et al.20‡ 2004 3·0  3 77 (106 GSV) Proebstle18‡ 2002 3·0 n.a. 77 (95 GSV) Proebstle et al.21‡ 2002 3·0  1 26 (31 GSV) Oh et al.22 2003 3·0  3 12 (15 GSV) Min et al.17† 2003 2·5 17 (1–39) 423 (504 GSV) Proebstle et al.23 2003 2·5  6 (3–12) 33 (41 SSV) Proebstle et al.19‡ 2003 2·5 12 85 (109 GSV) Boné and Navarro24 2001 2·0 12 105 (125 GSV) Chang and Chua25 2002 2·0 19 (12–28) 149 (252 GSV) Gérard et al.26 2002 2·0  1 20 (20 GSV) Navarro et al.14 2001 2·0  4 (0·25–14) 33 (40 GSV) Perkowski et al.27 2004 2·0 12 165 (154 GSV, 37 SSV, 12 acc)§ Reference . Year . Quality score . Follow-up (months)* . No. of patients (limbs) . Min et al.13† 2001 3·0  6 (1–9) 84 (90 GSV) Proebstle et al.20‡ 2004 3·0  3 77 (106 GSV) Proebstle18‡ 2002 3·0 n.a. 77 (95 GSV) Proebstle et al.21‡ 2002 3·0  1 26 (31 GSV) Oh et al.22 2003 3·0  3 12 (15 GSV) Min et al.17† 2003 2·5 17 (1–39) 423 (504 GSV) Proebstle et al.23 2003 2·5  6 (3–12) 33 (41 SSV) Proebstle et al.19‡ 2003 2·5 12 85 (109 GSV) Boné and Navarro24 2001 2·0 12 105 (125 GSV) Chang and Chua25 2002 2·0 19 (12–28) 149 (252 GSV) Gérard et al.26 2002 2·0  1 20 (20 GSV) Navarro et al.14 2001 2·0  4 (0·25–14) 33 (40 GSV) Perkowski et al.27 2004 2·0 12 165 (154 GSV, 37 SSV, 12 acc)§ * Values are mean (range). There was possible duplication of patients in studies by †Min and ‡Proebstle. § Only 35 patients were enrolled in the study for sufficient time for 1-year follow-up. GSV, great saphenous vein; SSV, small saphenous vein; acc, accessory saphenous veins; n.a., data not available. Open in new tab Table 1 Profiles of case series included in assessment Reference . Year . Quality score . Follow-up (months)* . No. of patients (limbs) . Min et al.13† 2001 3·0  6 (1–9) 84 (90 GSV) Proebstle et al.20‡ 2004 3·0  3 77 (106 GSV) Proebstle18‡ 2002 3·0 n.a. 77 (95 GSV) Proebstle et al.21‡ 2002 3·0  1 26 (31 GSV) Oh et al.22 2003 3·0  3 12 (15 GSV) Min et al.17† 2003 2·5 17 (1–39) 423 (504 GSV) Proebstle et al.23 2003 2·5  6 (3–12) 33 (41 SSV) Proebstle et al.19‡ 2003 2·5 12 85 (109 GSV) Boné and Navarro24 2001 2·0 12 105 (125 GSV) Chang and Chua25 2002 2·0 19 (12–28) 149 (252 GSV) Gérard et al.26 2002 2·0  1 20 (20 GSV) Navarro et al.14 2001 2·0  4 (0·25–14) 33 (40 GSV) Perkowski et al.27 2004 2·0 12 165 (154 GSV, 37 SSV, 12 acc)§ Reference . Year . Quality score . Follow-up (months)* . No. of patients (limbs) . Min et al.13† 2001 3·0  6 (1–9) 84 (90 GSV) Proebstle et al.20‡ 2004 3·0  3 77 (106 GSV) Proebstle18‡ 2002 3·0 n.a. 77 (95 GSV) Proebstle et al.21‡ 2002 3·0  1 26 (31 GSV) Oh et al.22 2003 3·0  3 12 (15 GSV) Min et al.17† 2003 2·5 17 (1–39) 423 (504 GSV) Proebstle et al.23 2003 2·5  6 (3–12) 33 (41 SSV) Proebstle et al.19‡ 2003 2·5 12 85 (109 GSV) Boné and Navarro24 2001 2·0 12 105 (125 GSV) Chang and Chua25 2002 2·0 19 (12–28) 149 (252 GSV) Gérard et al.26 2002 2·0  1 20 (20 GSV) Navarro et al.14 2001 2·0  4 (0·25–14) 33 (40 GSV) Perkowski et al.27 2004 2·0 12 165 (154 GSV, 37 SSV, 12 acc)§ * Values are mean (range). There was possible duplication of patients in studies by †Min and ‡Proebstle. § Only 35 patients were enrolled in the study for sufficient time for 1-year follow-up. GSV, great saphenous vein; SSV, small saphenous vein; acc, accessory saphenous veins; n.a., data not available. Open in new tab Adverse events Results of safety outcomes are presented in Table 2. Two studies reported the death of a patient from a mesenteric infarction 6 weeks after treatment19,23. It was not stated whether this death was associated directly or indirectly with the procedure. No other study reported treatment-related death. Table 2 Adverse events associated with endovenous laser treatment Reference . Laser related . Thrombosis . Ecchymosis . Paraesthesia . Induration . Phlebitis . Min et al.13‡ — — 90 of 90 (100)* 1 of 84 (1)† — — Proebstle et al.20§ — — — — — — Proebstle18§ — — 95 of 95 (100)* 1 of 95 (1)* 95 of 95 (100)* 3 of 95 (3)* Proebstle et al.21§ — — 31 of 31 (100)* — 26 of 26 (100)† 2 of 26 (8)† Oh et al.22 — — — — — 1 of 12 (8)† Min et al.17‡ — — — — — 21 of 423 (5·0)† Proebstle et al.23 1 of 41 (2)* 1 of 41 (2)* 17 of 41 (41)* 4 of 41 (10)* 14 of 41 (34)* 3 of 41 (7)* Proebstle et al.19§ — — — — 47 of 85 (55)† 10 of 85 (12)† Boné and Navarro24 — — 125 of 125 (100)* — 105 of 105 (100)† — Chang and Chua25¶ 12 of 252 (4·8)* — 58 of 252 (23·0)* 92 of 252 (36·5)* — 4 of 252 (1·6)* Gérard et al.26 1 of 20 (5)*† — — — — — Navarro et al.14 — — 33 of 33 (100)† — 33 of 33 (100)† — Perkowski et al.27 — — — — — — Reference . Laser related . Thrombosis . Ecchymosis . Paraesthesia . Induration . Phlebitis . Min et al.13‡ — — 90 of 90 (100)* 1 of 84 (1)† — — Proebstle et al.20§ — — — — — — Proebstle18§ — — 95 of 95 (100)* 1 of 95 (1)* 95 of 95 (100)* 3 of 95 (3)* Proebstle et al.21§ — — 31 of 31 (100)* — 26 of 26 (100)† 2 of 26 (8)† Oh et al.22 — — — — — 1 of 12 (8)† Min et al.17‡ — — — — — 21 of 423 (5·0)† Proebstle et al.23 1 of 41 (2)* 1 of 41 (2)* 17 of 41 (41)* 4 of 41 (10)* 14 of 41 (34)* 3 of 41 (7)* Proebstle et al.19§ — — — — 47 of 85 (55)† 10 of 85 (12)† Boné and Navarro24 — — 125 of 125 (100)* — 105 of 105 (100)† — Chang and Chua25¶ 12 of 252 (4·8)* — 58 of 252 (23·0)* 92 of 252 (36·5)* — 4 of 252 (1·6)* Gérard et al.26 1 of 20 (5)*† — — — — — Navarro et al.14 — — 33 of 33 (100)† — 33 of 33 (100)† — Perkowski et al.27 — — — — — — Values in parentheses are percentages. Incidence of complications is expressed with respect to *limbs or †patients. There was possible duplication of patients in studies by ‡Min and §Proebstle. ¶ Ligation was used in addition to laser treatment. Open in new tab Table 2 Adverse events associated with endovenous laser treatment Reference . Laser related . Thrombosis . Ecchymosis . Paraesthesia . Induration . Phlebitis . Min et al.13‡ — — 90 of 90 (100)* 1 of 84 (1)† — — Proebstle et al.20§ — — — — — — Proebstle18§ — — 95 of 95 (100)* 1 of 95 (1)* 95 of 95 (100)* 3 of 95 (3)* Proebstle et al.21§ — — 31 of 31 (100)* — 26 of 26 (100)† 2 of 26 (8)† Oh et al.22 — — — — — 1 of 12 (8)† Min et al.17‡ — — — — — 21 of 423 (5·0)† Proebstle et al.23 1 of 41 (2)* 1 of 41 (2)* 17 of 41 (41)* 4 of 41 (10)* 14 of 41 (34)* 3 of 41 (7)* Proebstle et al.19§ — — — — 47 of 85 (55)† 10 of 85 (12)† Boné and Navarro24 — — 125 of 125 (100)* — 105 of 105 (100)† — Chang and Chua25¶ 12 of 252 (4·8)* — 58 of 252 (23·0)* 92 of 252 (36·5)* — 4 of 252 (1·6)* Gérard et al.26 1 of 20 (5)*† — — — — — Navarro et al.14 — — 33 of 33 (100)† — 33 of 33 (100)† — Perkowski et al.27 — — — — — — Reference . Laser related . Thrombosis . Ecchymosis . Paraesthesia . Induration . Phlebitis . Min et al.13‡ — — 90 of 90 (100)* 1 of 84 (1)† — — Proebstle et al.20§ — — — — — — Proebstle18§ — — 95 of 95 (100)* 1 of 95 (1)* 95 of 95 (100)* 3 of 95 (3)* Proebstle et al.21§ — — 31 of 31 (100)* — 26 of 26 (100)† 2 of 26 (8)† Oh et al.22 — — — — — 1 of 12 (8)† Min et al.17‡ — — — — — 21 of 423 (5·0)† Proebstle et al.23 1 of 41 (2)* 1 of 41 (2)* 17 of 41 (41)* 4 of 41 (10)* 14 of 41 (34)* 3 of 41 (7)* Proebstle et al.19§ — — — — 47 of 85 (55)† 10 of 85 (12)† Boné and Navarro24 — — 125 of 125 (100)* — 105 of 105 (100)† — Chang and Chua25¶ 12 of 252 (4·8)* — 58 of 252 (23·0)* 92 of 252 (36·5)* — 4 of 252 (1·6)* Gérard et al.26 1 of 20 (5)*† — — — — — Navarro et al.14 — — 33 of 33 (100)† — 33 of 33 (100)† — Perkowski et al.27 — — — — — — Values in parentheses are percentages. Incidence of complications is expressed with respect to *limbs or †patients. There was possible duplication of patients in studies by ‡Min and §Proebstle. ¶ Ligation was used in addition to laser treatment. Open in new tab Three studies reported laser-related adverse events23,25,26. The better quality study (QS 2·5) reported that treatment could not be completed in one of 33 patients owing to the incorrect placement of the laser into the popliteal vein instead of the small saphenous vein23. This patient received low molecular weight heparin for 10 days after treatment. A lower-quality study (QS 2·0) reported incorrect positioning of the laser in the superficial femoral vein instead of the great saphenous vein26. Despite this serious operator error, there was no long-term harmful effect. Only one study described superficial laser-related burns (in 12 (4·8 per cent) of 252 limbs), which healed by the end of follow-up (mean 19 months)25. One paper described deep vein thrombosis in a patient 5 weeks after treatment of the saphenous vein23. This patient, who had thrombophilic polycythaemia vera and had previously experienced thrombotic events, was probably a poor choice for EVLT. Seven studies13,14,18,21,23–25 reported ecchymosis or discoloration beneath the skin during the early period after EVLT, with an incidence of 23·0–100 per cent. This was generally self-limiting, with a duration of 1–4 weeks, but one patient still had hyperpigmentation visible at the end of a 28-day follow-up21. A lower-quality study25 (QS 2·0) reported hyperpigmentation in two legs persisting beyond 6 months. Four studies13,18,23,25 reported saphenous paraesthesia in 1 per cent18 to 36·5 per cent25 of limbs. In one low-quality study paraesthesia affected 2·8 per cent of limbs even after 6 months, but this resolved by the end of follow-up25. Six reports14,18,19,21,23,24 mentioned induration along the length of the saphenous vein in 55–100 per cent of patients, but this was of limited duration, typically 3–4 weeks. Phlebitis after EVLT was reported in seven studies17–19,21–23,25 in 1·6 per cent of limbs25 to 12 per cent of patients21. Most were prescribed diclofenac and symptoms resolved by the end of follow-up. Low to moderate pain was reported in seven of the 13 studies13,17,19,21,22,23,26, with rates ranging from 6 per cent (QS 3·0)13 to 100 per cent (QS 3·0 and 2·0)21,26 of patients. Patients required analgesics in four studies13,19,23,26. Two lower-quality studies (QS 2·0) recorded the development of a haematoma immediately after treatment in 4·8 per cent25 and 100 per cent26 of limbs. Bruising was reported in two better-quality studies17,22 in 24–100 per cent of limbs, resolving in 3–4 weeks. Effectiveness of treatment Effectiveness outcomes are shown in Table 3. The main treatment outcome was the abolition of reflux in the saphenous vein, demonstrated by its complete occlusion or obliteration, and confirmed by Doppler and colour duplex ultrasonography. Following the procedure, reflux was generally assessed in the saphenous vein but not in other veins of the leg. Table 3 Effectiveness of endovenous laser treatment . Occlusion . . . Reference . After EVLT . End of follow-up . Recanalization . Re-treatment . Min et al.13* 87 of 90 (97) 26 of 27 (96) 3 of 90 (3) — Proebstle et al.20† — 95 of 106 (89·6) — — Proebstle18† — 92 of 95 (97) — — Proebstle et al.21 — 30 of 31 (97) — — Oh et al.22 — 15 of 15 (100) — — Min et al.17* 490 of 504 (97·2) 113 of 121 (93·4) 9 of 504 (1·8) — Proebstle et al.23 — 37 of 39 (95) — 0 of 39 (0) Proebstle et al.19†‡ — 94 of 107 (87·9) — 5 of 107 (4·7) Boné and Navarro24 — 119 of 125 (95·2) — 6 of 125 (4·8) Chang and Chua25§ — 244 of 252 (96·8) — 0 of 252 (0) Gérard et al.26 — 18 of 20 (90) — — Navarro et al.14 — 40 of 40 (100) — 0 of 40 (0) Perkowski et al.27 — 159 of 165 (96) — 6 of 165 (3·6)¶ . Occlusion . . . Reference . After EVLT . End of follow-up . Recanalization . Re-treatment . Min et al.13* 87 of 90 (97) 26 of 27 (96) 3 of 90 (3) — Proebstle et al.20† — 95 of 106 (89·6) — — Proebstle18† — 92 of 95 (97) — — Proebstle et al.21 — 30 of 31 (97) — — Oh et al.22 — 15 of 15 (100) — — Min et al.17* 490 of 504 (97·2) 113 of 121 (93·4) 9 of 504 (1·8) — Proebstle et al.23 — 37 of 39 (95) — 0 of 39 (0) Proebstle et al.19†‡ — 94 of 107 (87·9) — 5 of 107 (4·7) Boné and Navarro24 — 119 of 125 (95·2) — 6 of 125 (4·8) Chang and Chua25§ — 244 of 252 (96·8) — 0 of 252 (0) Gérard et al.26 — 18 of 20 (90) — — Navarro et al.14 — 40 of 40 (100) — 0 of 40 (0) Perkowski et al.27 — 159 of 165 (96) — 6 of 165 (3·6)¶ Values in parentheses are percentages. Rates are expressed with respect to patients in reference 27 and with respect to limbs in the other studies. References 13 and 17 contain results from a longitudinal study; only 27 of 90 limbs were available for follow-up at 9 months13 and 121 of 504 limbs were evaluated at the end of 24-month follow-up17. There was possible duplication of patients in studies by *Min and †Proebstle. †, ‡ One patient (two limbs) died. § Ligation was used in addition to laser treatment. ¶ Two patients removed compression bandages owing to discomfort, resulting in recanalization. EVLT, endovenous laser treatment. Open in new tab Table 3 Effectiveness of endovenous laser treatment . Occlusion . . . Reference . After EVLT . End of follow-up . Recanalization . Re-treatment . Min et al.13* 87 of 90 (97) 26 of 27 (96) 3 of 90 (3) — Proebstle et al.20† — 95 of 106 (89·6) — — Proebstle18† — 92 of 95 (97) — — Proebstle et al.21 — 30 of 31 (97) — — Oh et al.22 — 15 of 15 (100) — — Min et al.17* 490 of 504 (97·2) 113 of 121 (93·4) 9 of 504 (1·8) — Proebstle et al.23 — 37 of 39 (95) — 0 of 39 (0) Proebstle et al.19†‡ — 94 of 107 (87·9) — 5 of 107 (4·7) Boné and Navarro24 — 119 of 125 (95·2) — 6 of 125 (4·8) Chang and Chua25§ — 244 of 252 (96·8) — 0 of 252 (0) Gérard et al.26 — 18 of 20 (90) — — Navarro et al.14 — 40 of 40 (100) — 0 of 40 (0) Perkowski et al.27 — 159 of 165 (96) — 6 of 165 (3·6)¶ . Occlusion . . . Reference . After EVLT . End of follow-up . Recanalization . Re-treatment . Min et al.13* 87 of 90 (97) 26 of 27 (96) 3 of 90 (3) — Proebstle et al.20† — 95 of 106 (89·6) — — Proebstle18† — 92 of 95 (97) — — Proebstle et al.21 — 30 of 31 (97) — — Oh et al.22 — 15 of 15 (100) — — Min et al.17* 490 of 504 (97·2) 113 of 121 (93·4) 9 of 504 (1·8) — Proebstle et al.23 — 37 of 39 (95) — 0 of 39 (0) Proebstle et al.19†‡ — 94 of 107 (87·9) — 5 of 107 (4·7) Boné and Navarro24 — 119 of 125 (95·2) — 6 of 125 (4·8) Chang and Chua25§ — 244 of 252 (96·8) — 0 of 252 (0) Gérard et al.26 — 18 of 20 (90) — — Navarro et al.14 — 40 of 40 (100) — 0 of 40 (0) Perkowski et al.27 — 159 of 165 (96) — 6 of 165 (3·6)¶ Values in parentheses are percentages. Rates are expressed with respect to patients in reference 27 and with respect to limbs in the other studies. References 13 and 17 contain results from a longitudinal study; only 27 of 90 limbs were available for follow-up at 9 months13 and 121 of 504 limbs were evaluated at the end of 24-month follow-up17. There was possible duplication of patients in studies by *Min and †Proebstle. †, ‡ One patient (two limbs) died. § Ligation was used in addition to laser treatment. ¶ Two patients removed compression bandages owing to discomfort, resulting in recanalization. EVLT, endovenous laser treatment. Open in new tab Rates of vein occlusion ranged from 87·9 per cent19 to 100 per cent14,22,25 at the end of follow-up; two studies reported limbs that required re-treatment13,17. Follow-up data are reported for a mean of 28 days21,26 to 19 months25 (Table 1). A good-quality study with the largest patient group (504 limbs) and longest follow-up (mean 17 (range 1–39) months)17 presented preliminary results of a longitudinal study, probably building on the results of a previous study published in 200113. Owing to the nature of enrolment, however, results were reported for only 121 limbs at 24 months' follow-up. At the 1- and 24-month follow-up, 490 (97·2 per cent) of 504 and 113 (93·4 per cent) of 121 limbs were successfully occluded. One study used ligation in addition to EVLT, resulting in 244 (96·8 per cent) of 252 limbs being completely occluded at 6 months' follow-up25. Eight limbs with partial occlusion were treated with sclerotherapy, resulting in 100 per cent complete occlusion at the end of the follow-up period. In the literature there is considerable variation in defining recurrent varicose veins. Many papers do not state explicitly whether the recurrent varicose veins are true recurrences, residual incompetent veins, or new incompetent veins that were previously normal. The EVLT procedure does not treat tributary varicosities, which will always require follow-up treatment with sclerotherapy approximately 4–6 weeks after the procedure. This follow-up sclerotherapy is not reported in the EVLT studies as re-treatment. None of the EVLT studies explicitly reported the rate of recurrent varicose veins. However, after initial follow-up examination with duplex ultrasonography, two studies13,17 reported that 1·8–3 per cent of saphenous veins were only partially occluded and so still had reflux. These veins were eligible for re-treatment. One good-quality study reported that 89 per cent of greater saphenous veins were successfully occluded after re-treatment17. Six studies reported recanalization rates ranging from zero14,23,25 to 4·8 per cent24. Three studies described the reduction of symptoms associated with varicose veins after EVLT. Only one study noted a statistically significant improvement in the CEAP severity score after EVLT combined with ligation (P < 0·050)25. CEAP (clinical, etiology, anatomy, pathophysiology) is a stratified classification system developed to distinguish between morphological and functional aspects of varicose veins28. The remaining two studies23,27 reported clinically relevant improvements in symptoms after EVLT, such as alleviation of oedema, pain, pruritus and ulceration, but statistical analysis was not performed. Of 35 patients available for 1-year follow-up in one study, two had symptoms that had not changed after EVLT27. No study reported quality of life as an outcome. Only one paper commented on the time taken to return to normal activities26. No cessation of work was required for any patient with employment. In all studies patients were advised to resume normal activities as soon as possible after treatment, but activity data were not presented. Two studies considered the length of operating time for EVLT25,26. The procedure took a mean of 122 (range 95–175) min in one study25 that combined EVLT with ligation of the great saphenous vein. The other study reported that the procedure took 60 min when EVLT alone was performed26. Discussion There are no controlled studies available that assess the effectiveness of EVLT in comparison to saphenofemoral ligation with saphenous vein stripping. From the low-level evidence available it appears that EVLT benefits most patients in the short term; good-quality data are not available to assess its comparative safety. Pain, ecchymosis, induration, haematoma and phlebitis are common adverse events associated with EVLT but in most cases they are self-limiting. The most serious adverse events are deep vein thrombosis and incorrect positioning of the laser within the wrong vessel. Deep vein thrombosis has been described in only one patient. Despite ultrasonographic guidance, incorrect laser placement occurred in two patients, representing serious operator error. Although no long-term harmful effects occurred, the potential for significant damage was real. Occlusion of the saphenous vein with abolition of reflux was achieved in 87·9–100 per cent of limbs in those studies that carried out EVLT on the great saphenous vein; one study on the small saphenous vein reported an occlusion rate of 95 per cent. The combined treatment of EVLT plus ligation of the great saphenous vein resulted in 100 per cent occlusion at the end of follow-up. Re-treatment was reported in only two of the 13 studies, and rates were low (1·8 and 3 per cent of limbs). Similar low rates for recanalization were also noted. Clinically relevant reduction in the symptoms associated with varicose veins, such as pain and oedema, was also achieved with EVLT. The above notwithstanding, there is a lack of long-term follow-up data in the studies assessed for this review; few studies provided follow-up of more than 6 months for all treated limbs. Occlusion, recanalization and reflux may change over time. Although EVLT seems beneficial, its effectiveness cannot be properly appreciated without comparative data. A new procedure may be evaluated initially without controls to determine its safety but after this randomized clinical trials are needed. Uncontrolled studies are inevitably affected by bias and are potentially misleading. To make a sound comparison of EVLT and conventional operation, patients should be selected in the same way, operations should occur under similar conditions and in the same time period, and clinical outcomes should be assessed in the same manner29. Such a randomized clinical trial of EVLT versus conventional surgery was scheduled to begin in June 2003 in Leeds, UK30. Until its results become available, EVLT should be considered as an experimental treatment. Acknowledgements This review was commissioned and funded by the Commonwealth Department of Health and Ageing on behalf of the Medical Services Advisory Committee (MSAC). 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TI - Systematic review of endovenous laser treatment for varicose veins
JF - British Journal of Surgery
DO - 10.1002/bjs.5142
DA - 2005-09-20
UR - https://www.deepdyve.com/lp/oxford-university-press/systematic-review-of-endovenous-laser-treatment-for-varicose-veins-9TCKFS4D5R
SP - 1189
EP - 1194
VL - 92
IS - 10
DP - DeepDyve
ER -