TY - JOUR
AU - Moll, F L
AB - Abstract Background This was the long-term follow-up of a previously reported randomized clinical trial comparing endovenous laser ablation (EVLA) with cryostripping for great saphenous varicose veins. Methods A total of 120 patients with great saphenous varicose veins were randomized 1:1 to EVLA or cryostripping. Principal outcome measures were freedom from incompetence or neovascularization on duplex imaging, and improvement in Venous Clinical Severity Score (VCSS) and Aberdeen Varicose Vein Severity Score (AVVSS) 5 years after treatment. Results Life-table analysis showed freedom from duplex-derived incompetence and neovascularization at 5 years in 62 (95 per cent confidence interval 50 to 76) per cent after EVLA and in 51 (39 to 66) per cent after cryostripping (P = 0·246). Neovascularization was more common after cryostripping, but incompetent tributaries were more common after EVLA. VCSS and AVVSS values improved significantly after treatment in both groups, and were maintained for 5 years, but with no significant difference between the groups. Conclusion In this study, no significant difference was demonstrated in late outcome after EVLA or cryostripping in patients with great saphenous varicose veins. Registration number: ISRCTN33832691 (http://www.controlled-trials.com). Introduction The standard treatment for varicose veins due to reflux in the great saphenous vein (GSV) is ligation of the vein and its tributaries at the saphenofemoral junction (SFJ), followed by stripping of the GSV from the groin to just below the knee. Since its introduction, the authors have used cryostripping for varicose veins because it is less traumatic, with lower rates of postoperative morbidity and complication rates similar to those of traditional stripping1,2. Minimally invasive procedures, such as endovenous laser ablation (EVLA), have been introduced to eliminate incompetence by obliterating the GSV3. EVLA is performed under local anaesthesia as a day-case procedure and is less invasive than surgical stripping. Patients favour EVLA because of less pain and postoperative morbidity, fewer adverse effects and improved quality of life4,5. A cost-effectiveness comparison of cryostripping and EVLA suggested that, in terms of costs per quality-adjusted life year gained, EVLA provided comparable outcomes at relatively little additional cost6. The relative simplicity and high level of patient satisfaction have made EVLA increasingly popular. Recently published randomized clinical trials did not reveal major differences in the short-term outcome of EVLA compared with standard surgery, but reported a mid-term trend towards a lower incidence of neovascularization in the groin, and possibly a lower recurrence rate, following EVLA5, 7–9. The present report concerned the long-term follow-up of a previously reported randomized clinical trial comparing EVLA with cryostripping for varicose GSVs. Methods Data were collected in an ongoing single-centre randomized clinical trial of consecutive patients with primary varicose veins, treated from June 2003 to July 2005. The study protocol was approved by the regional ethics committee of the Mesos Medical Centre (Utrecht, The Netherlands), and details have been published previously5. In brief, patients with primary symptomatic varicose veins, Clinical Etiologic Anatomic Pathophysiologic (CEAP) clinical class C2 venous disease10, SFJ incompetence, and GSV reflux from the groin to below the knee were eligible. The interventions were performed either as a day-case procedure under general anaesthesia (EVLA 38 patients, cryostripping 49) or on outpatients under local anaesthesia (EVLA 22, cryostripping 11), according to the patient's preference. For EVLA, a 600-µm core bare-tip fibre was inserted into the sheath and connected to a 810-nm diode laser (Diomed, Andover, Massachusetts, USA), and used as described previously5. Cryostripping consisted of flush ligation of the GSV, together with stripping of the GSV using a flexible-tip probe connected to a liquid nitrogen cryostripping unit (Erbe, Tubingen, Germany). All patients wore a long-leg graduated compression stocking (20–30 mmHg) day and night for 1 week, and were prescribed standard analgesia. Patients were instructed to walk immediately after the procedure, and were encouraged to resume normal activities and work as soon as possible. A standard set of information was collected at each follow-up visit. A doctor completed the CEAP classification10 and a research fellow calculated the Venous Clinical Severity Score (VCSS)11. The Aberdeen Varicose Vein Severity Score (AVVSS)12, a disease-specific quality-of-life measure, was reported by the patient. Patients underwent standard duplex imaging. Abolition of GSV reflux was demonstrated by its complete occlusion or obliteration. Recurrent incompetence was classified in accordance with the definitions of Stonebridge and colleagues13. Type 1 recurrence was when there was a residual connection between the superficial and deep systems, at or immediately around the SFJ. This was further subdivided into three mutually exclusive subgroups: type 1a, incompetent GSV (an open section of the treated segment over 5 cm in length, with reflux exceeding 0·5 s); type 1b, incompetent tributaries (bidirectional flow that had not been observed before); and type 1c, neovascularization (serpentine tributaries arising from the ligated SFJ). Type 2 recurrence was when there was no connection at the SFJ; it included type 2a (with cross-groin connections) and type 2b (incompetent thigh perforators). Incompetent tributaries and accessory saphenous veins detected before operation were treated 6 weeks after treatment with liquid sclerotherapy or Müller phlebectomies, with the intention of removing all varicosities. Six months after the procedure, persistent SFJ/GSV incompetence was treated with additional SFJ ligation and was recorded as recurrent varicose veins. In the present study, the principal outcome measures were: freedom from recurrent incompetence and neovascularization on duplex imaging, and changes in VCSS and AVVSS, 5 years after treatment. Statistical analysis Data from the assessments were coded and analyses performed using R version 2.10 for Windows® (http://www.r-project.org) and Microsoft® Excel (Microsoft, Redmond, Washington, USA). Data were presented as mean (range), unless indicated otherwise. The difference in primary outcome for EVLA and cryostripping was assessed by means of the log rank test. Freedom from duplex-confirmed incompetence and neovascularization was calculated by the Kaplan–Meier method, assuming that the event took place exactly halfway between two follow-up visits. Fisher's exact test was used for secondary analysis of categorical data, and Student's t test or Mann–Whitney U test for continuous variables. Multivariable repeated-measures general linear modelling was used to compare VCSS and AVVSS data over time. P < 0·050 was considered statistically significant. Results Perioperative details and results of the 2-year follow-up have been published previously5. Of 681 patients referred with varicose veins, 120 fulfilled the inclusion criteria and were randomized. There were no significant differences between the groups in patient characteristics and duplex outcomes at baseline. There were no conversions and the intended treatment was given to all patients. Concomitant reflux in the small saphenous vein was treated with saphenopopliteal ligation in four (3·3 per cent) of the 120 patients, two in each group. The mean laser energy delivered was 57 (41–86) J per cm of vein. All incompetent tributaries and accessory saphenous veins detected before operation were treated 6 weeks after treatment with liquid sclerotherapy (EVLA 36, cryostripping 33) or Müller phlebectomies (EVLA 1, cryostripping 2). Forty-four patients (36·7 per cent) were lost to follow-up, leaving 41 patients (68 per cent) for analysis in the EVLA group and 35 (58 per cent) in the cryostripping group. There was no significant difference in loss to follow-up between the two groups (P = 0·343). Duplex outcomes After EVLA, the GSV segment was ablated completely in 57 patients (95 per cent). Three patients with a patent GSV underwent saphenofemoral disconnection 6 months later. In the cryostripping group, the introduction of the flexible-tip probe to the below-knee GSV was successful in all 60 patients, and the GSV was stripped completely. Late recanalization and recurrent SFJ/GSV reflux occurred in one patient in the EVLA group, who had been treated with additional saphenofemoral ligation, and none in the cryostripping group. Life-table analysis showed freedom from duplex-derived incompetence and neovascularization (type 1 and type 2) at 5 years in 62 (95 per cent confidence interval 50 to 76) per cent of patients after EVLA and in 51 (39 to 66) per cent after cryostripping (P = 0·246) (Fig. 1). It also showed freedom from GSV incompetence on duplex imaging (type 1a), incompetent tributaries (type 1b) and neovascularization (type 1c) at 5 years in 93 (87 to 100), 85 (76 to 94) and 100 (94 to 100) per cent of patients in the EVLA group, and in 100 (94 to 100), 100 (94 to 100) and 72 (61 to 85) per cent of patients in the cryostripping group (P = 0·043, P = 0·002 and P < 0·001 respectively). Fig. 1 Open in new tabDownload slide Kaplan–Meier life-table analysis of freedom from superficial venous incompetence on duplex imaging after endovenous laser ablation (EVLA) or cryostripping. P = 0·246 (log rank test) Clinical severity and quality of life VCSS values improved significantly after treatment, but the differences between the groups were not significant (Table 1). The most pronounced improvements were in the VCCS components pain and varicosity, and were observed after 6 months (pain: from 1·1 to 0·2 after EVLA and from 1·2 to 0·3 after cryostripping; varicosity: from 2·1 to 0·8 after EVLA and from 2·1 to 0·7 after cryostripping). The VCSS continued to decrease with time, with no differences between the groups. Similarly, AVVSS values decreased to a mean of 5·2 after EVLA and 3·8 after cryostripping, with no significant differences between them either initially or at later follow-up (Table 1). Table 1 Clinical severity and quality-of-life scores to 5 years after endovenous laser ablation or cryostripping . Baseline . 6 months . 12 months . 24 months . 60 months . P* . No. of patients  EVLA 60 60 58 56 41  Cryostripping 60 60 57 55 35 VCSS  EVLA 3·2 (0–6) 1·0 (0–3) 0·7 (0–4) 0·6 (0–4) 1·0 (0–3) 0·23  Cryostripping 3·4 (0–6) 1·0 (0–3) 0·9 (0–2) 0·8 (0–2) 1·0 (0–3) AVVSS  EVLA 15·8 (2–43) 5·6 (0–20) 5·4 (0–27) 5·2 (0–26) 5·4 (0–21) 0·72  Cryostripping 13·6 (1–37) 6·2 (0–29) 7·0 (0–32) 4·5 (0–19) 3·8 (0–18) . Baseline . 6 months . 12 months . 24 months . 60 months . P* . No. of patients  EVLA 60 60 58 56 41  Cryostripping 60 60 57 55 35 VCSS  EVLA 3·2 (0–6) 1·0 (0–3) 0·7 (0–4) 0·6 (0–4) 1·0 (0–3) 0·23  Cryostripping 3·4 (0–6) 1·0 (0–3) 0·9 (0–2) 0·8 (0–2) 1·0 (0–3) AVVSS  EVLA 15·8 (2–43) 5·6 (0–20) 5·4 (0–27) 5·2 (0–26) 5·4 (0–21) 0·72  Cryostripping 13·6 (1–37) 6·2 (0–29) 7·0 (0–32) 4·5 (0–19) 3·8 (0–18) Values are mean (range). EVLA, endovenous laser ablation; VCSS, Venous Clinical Severity Score; AVVSS, Aberdeen Varicose Vein Severity Score. * Versus cryostripping (multivariable repeated-measures general linear modelling; time × treatment interaction). Open in new tab Table 1 Clinical severity and quality-of-life scores to 5 years after endovenous laser ablation or cryostripping . Baseline . 6 months . 12 months . 24 months . 60 months . P* . No. of patients  EVLA 60 60 58 56 41  Cryostripping 60 60 57 55 35 VCSS  EVLA 3·2 (0–6) 1·0 (0–3) 0·7 (0–4) 0·6 (0–4) 1·0 (0–3) 0·23  Cryostripping 3·4 (0–6) 1·0 (0–3) 0·9 (0–2) 0·8 (0–2) 1·0 (0–3) AVVSS  EVLA 15·8 (2–43) 5·6 (0–20) 5·4 (0–27) 5·2 (0–26) 5·4 (0–21) 0·72  Cryostripping 13·6 (1–37) 6·2 (0–29) 7·0 (0–32) 4·5 (0–19) 3·8 (0–18) . Baseline . 6 months . 12 months . 24 months . 60 months . P* . No. of patients  EVLA 60 60 58 56 41  Cryostripping 60 60 57 55 35 VCSS  EVLA 3·2 (0–6) 1·0 (0–3) 0·7 (0–4) 0·6 (0–4) 1·0 (0–3) 0·23  Cryostripping 3·4 (0–6) 1·0 (0–3) 0·9 (0–2) 0·8 (0–2) 1·0 (0–3) AVVSS  EVLA 15·8 (2–43) 5·6 (0–20) 5·4 (0–27) 5·2 (0–26) 5·4 (0–21) 0·72  Cryostripping 13·6 (1–37) 6·2 (0–29) 7·0 (0–32) 4·5 (0–19) 3·8 (0–18) Values are mean (range). EVLA, endovenous laser ablation; VCSS, Venous Clinical Severity Score; AVVSS, Aberdeen Varicose Vein Severity Score. * Versus cryostripping (multivariable repeated-measures general linear modelling; time × treatment interaction). Open in new tab Discussion In this long-term follow-up of a previously reported randomized clinical trial, no significant difference was seen in the outcome after EVLA or cryostripping for varicose GSVs. Although there was less neovascularization after EVLA than after cryostripping, there were more incompetent tributaries. By the 5-year follow-up, VCSS and AVVSS values had improved significantly after both treatments, with no difference between the groups. Cryostripping ablated all GSVs, whereas three GSV segments had reopened by 6 months after EVLA. The occlusion rate of 95 per cent (57 of 60) after EVLA was consistent with published rates of 80–100 per cent4. In the three failed procedures in the EVLA group, the mean amount of energy delivered was 48·3, 50·1 and 47·6 J/cm, lower than the suggested energy threshold of 70 J/cm14. Successful GSV ablation depends on the mode and amount of laser energy delivered, but also on methodological aspects, such as the use of perivenous infiltration, manual compression over the vein during the procedure, and a fibre-tip position 0·5–1 cm below the SFJ15. Late recanalization was observed in one patient after EVLA at 5-year follow-up, which resulted from intraluminal neovascularization after GSV ablation, as described previously by Labropoulos and colleagues16. Incompetent SFJ tributaries such as the anterior accessory saphenous veins (AASVs) are an important cause of recurrence following EVLA or surgery. Garner and co-workers17 described AASV incompetence following surgery in 61 (42·7 per cent) of 143 groin recurrences. In the present study, groin recurrence owing to an incompetent AASV occurred in 15 per cent of patients after EVLA, but in none after cryostripping, in contrast to previous findings4,8. Most AASV recurrence developed after the first 12 months, indicating disease progression. In spite of the relatively high incidence of late reflux in AASVs, it is generally agreed that a competent ASSV does not need treatment because it does not have an adverse effect on the outcome after EVLA15,18. An AASV that becomes incompetent and leads to recurrent varicose veins can be treated with ultrasound-guided foam sclerotherapy or phlebectomy. According to van Rij and colleagues19, neovascularization is the major cause of recurrence of reflux in the groin after adequate surgery. Glass20 described angiogenesis induced by groin surgery as a major source of new channels reconnecting superficial veins to the deep femoral vein around a ligated SFJ. In the present study, groin recurrence due to neovascularization was found in 28 per cent of patients after surgery but in none after EVLA at 5-year follow-up. More recent studies have reported comparable results. Theivacumar and co-workers8 noted that neovascularization was evident in 1 per cent of patients at 12 months after EVLA, compared with 18 per cent of patients after surgery. Rasmussen et al.7 reported a slightly higher rate of neovascularization at 24 months after surgery (EVLA 3 per cent, surgery 4 per cent). In the earlier report5, neovascularization was observed in 18 per cent of patients after cryostripping and in none after EVLA at 2-year follow-up. An incompetent thigh perforator was the cause of recurrence in both groups (EVLA 7, cryostripping 10). None of these incompetent thigh perforators was identified at baseline ultrasonography. This pattern of reflux may occur after incomplete stripping or ablation of the GSV. It is therefore important that treatment of the GSV is performed from the groin to a point distal to the perforating vein. In the past, there was a reluctance to use EVLA for the treatment of incompetence of the GSV below the knee. Limitations of the study were that both groups comprised young, healthy adults with uncomplicated varicose veins. Neither the patients nor the personnel involved in the study could be blinded to the method used; however, the risk of bias was reduced because important outcome variables, such as VCSS and AVVSS, were reported by a research fellow and by the patients. To eliminate technical factors from influencing treatment outcomes, this study was performed by a single consultant surgeon who was equally experienced in both techniques and did not have a preference. A relatively large number of patients were lost to follow-up at 5 years, which could have affected the results, although the dropout rate was similar in the two groups. Both EVLA and cryostripping significantly improved disease-specific quality of life, an effect that lasted at least 5 years21,22. Duplex evaluation of the effects of treatment showed no difference in the outcomes: neovascularization was less common after EVLA but incompetent tributaries were more common. Acknowledgements The authors thank Mrs H. Janmaat for help with duplex imaging, and Mrs J. Pasma for data collection and support. The authors declare no conflict of interest. References 1 Menyhei G , Gyevnar Z, Arato E, Kelemen O, Kollár L. 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Google Scholar Crossref Search ADS PubMed WorldCat Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
TI - Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins
JO - British Journal of Surgery
DO - 10.1002/bjs.7542
DA - 2011-07-01
UR - https://www.deepdyve.com/lp/oxford-university-press/five-year-results-of-a-randomized-clinical-trial-comparing-endovenous-gZB4OGDeSk
SP - 1107
EP - 1111
VL - 98
IS - 8
DP - DeepDyve
ER -