Annals of Vascular Surgery
Volume 20, Issue 4 , Pages 451-457, July 2006

A Nonrandomised Controlled Trial of Endovenous Laser Therapy and Surgery in the Treatment of Varicose Veins

Academic Vascular Surgery Unit, Hull Royal Infirmary, Hull, United Kingdom

Article Outline

Endovenous laser therapy (EVLT) is a minimally invasive treatment for varicose veins. This study compares early quality-of-life (QoL) outcomes following EVLT and surgery. Two non-randomized groups were studied: an EVLT group with 70 patients, median age 49 (interquartile range [IQR] 35–58) years, and a surgery group with 62 patients, median age 49 (IQR 35–61) years. Patients were assessed prior to and at 1, 6, and 12 weeks following the procedure using the Short Form 36 (SF-36), the Aberdeen Varicose Veins Questionnaire (AVVQ), and the Venous Clinical Severity Score (VCSS). Follow-up at 1, 6, and 12 weeks was 100%, 77%, and 70% following EVLT and 100%, 85%, and 47% following surgery. SF-36 scores were significantly better in the EVLT group at 1 week (Physical Functioning, Role Physical, Bodily Pain, Vitality, and Social Functioning domains) and at 6 weeks (Physical Functioning and Role Physical). At 12 weeks, no significant differences were evident between the groups. AVVQ scores were significantly better in the EVLT group at 6 and 12 weeks. VCSS scores were significantly improved in both groups at 12 weeks. EVLT and surgery provide similar QoL improvements in patients with varicose veins. EVLT, however, removes the QoL limitations experienced by patients in the early postoperative period.

 

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INTRODUCTION 

Varicose veins are common, affecting 20–25% of women and 10–15% of men.1 Although patients may be asymptomatic, frequent symptoms include aching, discomfort, pruritus, and muscle cramps. Complications include edema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding.2, 3, 4 Varicose veins also negatively affect patients' quality of life (QoL),5, 6, 7, 8 which is rectified by successful surgical treatment.7, 8

Recently, minimally invasive options have been developed for the treatment of varicose veins. Endovenous laser therapy (EVLT) is a local anesthetic procedure with impressive long saphenous vein (LSV) ablation rates at 5-year follow-up.3, 9 Successful treatment should, however, not be interpreted only in the context of ablation rates but also in respect of total patient well-being. Health-related QoL is the patient-perceived functional effect of an illness and its consequent therapy.10 It has been proposed that QoL measures should be standard in studies involving patients with venous diseases.10

The aim of this study was to compare early QoL outcomes following EVLT and surgery in the treatment of patients with varicose veins.

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PATIENTS AND METHODS 

This trial was designed as a nonrandomized pilot study, whose results would be utilized in a power calculation for a future randomized controlled trial with QoL measures as primary outcome.

Patient Selection 

Immediately prior to commencement of EVLT at our institution, consecutive consenting patients undergoing surgery for varicose veins were recruited into the surgery group. When EVLT commenced, all suitable consenting patients were recruited into the EVLT group.

Two groups of patients undergoing treatment for unilateral symptomatic varicose veins attributable to isolated saphenofemoral junction (SFJ) incompetence and LSV reflux on preoperative duplex ultrasound scan were studied. All patients had patent and competent deep venous systems. Perforators were not specifically examined as they are not routinely laser-ablated or ligated.

Surgery group. There were 62 patients – 19 men; median age 49 years (interquartile range [IQR] 35–61); clinical, etiological, anatomical, and pathophysiological (CEAP) classifications C2 = 41, C3 = 3, C4 = 16, C5 = 2 – who underwent SFJ ligation, inversion stripping of the LSV to knee level, and multiple stab phlebectomies, performed under general anesthesia. Local anesthetic (10 mL 1% lignocaine) was infiltrated into the groin wound.

EVLT group. There were 70 patients – 33 men; median age 49 years (IQR 35–58); CEAP classifications C2 = 45, C4 = 24, C5 = 1 – who underwent EVLT with concomitant multiple stab phlebectomies performed under local anesthesia. Using duplex ultrasound, the SFJ and LSV in the thigh were marked preoperatively. Skin preparation and draping were performed prior to percutaneous perigenicular cannulation of the LSV with the patient in the reverse Trendelenburg position. A 5F catheter was introduced into the LSV using the Seldinger technique, and its tip was accurately positioned at the SFJ using ultrasound. The patient was then put in the Trendelenburg position, and perivenous local anesthetic (0.2% lignocaine with 1:200,000 adrenaline) was infiltrated along the LSV and varicosities. Total local anesthetic did not exceed the recommended maximum safe dose per patient. A sterile baretipped 600 μm laser fiber was introduced via the catheter for laser ablation of the LSV. Laser energy was delivered endovenously using an 810 nm diode laser generator (Diomed, Cambridge, UK) at 14 W power, continuous mode. Stab incisions of 1–2 mm were made over varicose tributaries, and the veins were avulsed using mosquito artery forceps or vein hook.

In both groups, stab incisions were closed with steristrip, and Panelast® (Lohmann & Rauscher International GmbH & Co. KG) elastic adhesive bandage was applied to the limb and remained in situ for 1 week, when it was replaced by a class II (30–40 mm Hg) full-length graduated support stocking for a further 5 weeks. All patients were prescribed Diclofenac, 50 mg three times a day. Success of EVLT was confirmed by duplex ultrasound scanning at 1 and 12 weeks.

Assessments 

Patients were assessed prior to intervention and at 1, 6, and 12 weeks postprocedure, using the medical outcomes Short Form 36 (SF-36) health survey, the Aberdeen Varicose Veins Questionnaire (AVVQ), and the Venous Clinical Severity Score (VCSS).

The SF-36 is a widely used generic QoL instrument that has been demonstrated to be valid, reliable, and sensitive.6, 7, 8, 11 It consists of 36 individual items aggregated to form eight domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).12 Each domain is scored from 0 (worst score) to 100 (best score).

The AVVQ is a validated specific QoL instrument for lower limb venous disease. Its 13 questions cover all aspects of varicose vein clinical presentation, including distribution, symptomatology, complications, and management (analgesia and compression).13 It produces a single disease-specific index scored from 0 (no venous symptoms) to 100 (extreme venous symptoms).

The VCSS is the American Venous Forum's modification of the clinical score of the CEAP classification of chronic venous disease. It was designed to be a quantifiable measure of disease severity, sufficiently dynamic to measure change in response to treatment.14 It scores nine clinical characteristics of chronic venous disease in varying grades of severity and has been validated for severity scoring in varicose vein surgery.15 VCSS assessment was performed prior to and at 12 weeks following treatment.

Statistical Analysis 

Data were collected prospectively and entered into a specifically designed database. Statistical analysis was performed with SPSS for Windows, version 12 (SPSS Inc., Chicago, IL). Intergroup analysis was performed using the Mann-Whitney test and intragroup analysis, using the Friedman test (across all time points) and Wilcoxon's ranked sum test (two time points). Adjustment for baseline differences between the groups was done by analysis of covariance (ANCOVA). Results are expressed as median (IQR), and p < 0.01 was considered statistically significant.

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RESULTS 

All procedures in the surgery group were successfully carried out as day cases, except for five patients who were admitted overnight (two for social reasons and three for postoperative pain requiring parenteral analgesia). All procedures in the EVLT group were performed successfully as day cases under local anesthetic with no admissions. There were no major complications in either group. At 1 and 12 weeks, SFJ occlusion rates on duplex ultrasound were 97% and 96%, respectively. LSV occlusion rates at the same time points were 99% and 96%.

Follow-up 

At the time of data compilation, follow-up at 1, 6, and 12 weeks was 100%, 85%, and 47% following surgery and 100%, 77%, and 70% following EVLT.

Baseline Parameters 

The groups were well matched for age, gender, and SF-36 domains except PF, BP, and VT, where the surgery group had significantly lower baseline scores. The surgery group also had higher baseline AVVQ and VCSS scores (Table I).

Table I. Baseline parameters
Age (years)SexPFRPBPGHVTSFREMHAVVQVCSS
Surgery49 (35, 61)M = 19 F = 4380 (55, 91)75 (50, 100)52 (51, 74)77 (70, 87)60 (40, 80)88 (62, 100)100 (66, 100)84 (67, 92)16.6 (12.6, 20.6)6 (4, 8)
EVLT49 (35, 48)M = 33 F = 3790 (80, 100)100 (25, 100)74 (51, 84)82 (62, 92)73 (60, 80)100 (75, 100)100 (100, 100)88 (76, 92)11.1 (8.9, 17.4)4 (3, 5)
p*0.6710.0830.0030.6300.0090.1420.0090.0570.4860.2390.0010.000

Baseline median values; values in parentheses are 25th, 75th percentiles.

* Mann-Whitney test; p values in bold type are significant.

SF-36 Results 

Surgery group. At 1 week, there was a statistically significant deterioration in the SF-36 domains of PF, RP, BP, and SF. Over the total study period, all domain scores equaled or surpassed baseline scores with statistically significant improvement in the PF, RP, BP, VT, SF, and MH domains (Table II).

Table II. QoL outcomes following surgery
MeasurePreop1 weekp* (preop to 1 week)6 weeks12 weeksp** (across all time points)
AVVQ16.6 (12.6–20.6)22 (18.1–26.7)0.00113.2 (7.9–17.7)4.4 (1.8–9.9)0.000
VCSS6 (4–8) 0 (0–1)0.000
PF80 (55–91)40 (18–75)0.00085 (60–95)95 (87–100)0.000
RP75 (50–100)0 (0–25)0.000100 (0–100)100 (100–100)0.000
BP52 (51–74)41 (31–62)0.00074 (62–100)74 (52–100)0.000
GH77 (70–87)80 (66–87)0.48382 (67–93)82 (64–91)0.132
VT60 (40–80)55 (38–70)0.06965 (50–80)70 (55–85)0.000
SF88 (62–100)63 (37–75)0.000100 (68–100)100 (87–100)0.000
RE100 (66–100)100 (66–100)0.551100 (66–100)100 (100–100)0.869
MH84 (67–92)84 (68–92)0.87388 (72–92)88 (80–100)0.001

Values are median (IQR). p values in bold type are significant.

* Wilcoxon signed rank test.

** Friedman test.

EVLT group. There was no significant deterioration seen in any domain at 1 week. Over the total study period, all domain scores equaled or surpassed baseline scores with statistically significant improvement in the PF, RP, BP, GH, VT, and SF domains (Table III).

Table III. QoL outcomes following EVLT
MeasurePreop1 weekp* (preop to 1 week)6 weeks12 weeksp** (across all time points)
AVVQ11.1 (8.9–17.4)15.7 (12.6–22.3)0.0004.70.6 (0–4.4)0.000
VCSS4 (3–5) 0 (0–1)0.000
PF90 (80–100)90 (90–100)0.070100 (90–100)100 (86–100)0.001
RP100 (25–100)75 (0–100)0.037100 (75–100)100 (81–100)0.000
BP74 (51–84)72 (42–84)0.10684 (73–100)92 (72–100)0.000
GH82 (62–92)82 (72–92)0.22786 (74–97)82 (73–97)0.007
VT73 (60–80)70 (55–80)0.37075 (60–90)75 (60–85)0.001
SF100 (75–100)88 (75–100)0.033100 (75–100)100 (75–100)0.008
RE100 (100-100)100 (100-100)0.439100 (100-100)100 (100-100)0.039
MH88 (76–92)88 (76–92)0.99688 (80–92)90 (70–96)0.167

Values are median (IQR). p values in bold type are significant.

* Wilcoxon signed rank test.

** Friedman test.

Intergroup comparison. At 1 week, scores in the PF, RP, BP, and SF domains were significantly worse in the surgery group. At 6 weeks, scores in the PF and RP domains remained significantly worse in the surgery group; however, at 12 weeks, there were no differences in any of the SF-36 domains between groups (Fig. 1, Fig. 2, Fig. 3, Fig. 4).

AVVQ Results 

Surgery group. At 1 week, there was a significant deterioration in AVVQ. Over the total study period, a significant improvement in AVVQ score was observed, falling to a median value of 4.4 at 12 weeks, representing a 74% improvement from baseline (Table II).

EVLT group. At 1 week, there was a significant deterioration in AVVQ. Over the total study period, a significant improvement in AVVQ score was observed, falling to a median value of 0.6 at 12 weeks, representing a 95% improvement from baseline (Table III).

Intergroup analysis. At 1 week, there was no significant difference in AVVQ scores between the two groups. At 6 and 12 weeks, the EVLT group demonstrated significantly better AVVQ scores than the surgery group (Fig. 5).

VCSS Results 

Scores were assessed in both groups at baseline and at 12 weeks.

Surgery group. Significant improvement was observed, with VCSS scores falling from 6 (4–8) at baseline to 0 (0–1) at 12 weeks (Table II).

EVLT group. Significant improvement was observed, with VCSS scores falling from 4 (3–5) at baseline to 0 (0–1) at 12 weeks (Table III).

Intergroup analysis. Intergroup analysis demonstrated no difference in scores between groups at 12 weeks (Fig. 6).

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DISCUSSION 

EVLT is a relatively new treatment for varicose veins. The main aim of treatment for varicose veins is to improve QoL and prevent/treat complications. The benefit of any new treatment must be gauged against the current gold standard, which in this case is surgery. While current evidence supporting EVLT for varicose veins provides acceptable LSV occlusion rates and patient acceptability, QoL outcomes are lacking. Successful treatment must take into account patients' perception of benefit, assessed by QoL measures or satisfaction surveys.16 This is the first study to analyze QoL outcomes following EVLT and to compare them to QoL outcomes following current gold standard treatment.

As this was a nonrandomized trial, baseline intergroup differences were not unexpected. ANCOVA, a technique that reduces bias in comparative studies, was performed to adjust for these baseline differences.17

A significant decline in QoL was observed in the surgery group at 1 week postprocedure. No such decline was observed following EVLT. Also, intergroup comparisons demonstrated significant QoL differences at the 1- and 6-week time points, particularly in the physical SF-36 domains. This suggests that the deleterious effects of surgery for varicose veins on patients' early QoL are not seen following EVLT. This is supported by EVLT case series, which have shown almost immediate return to normal activities. Thus, the early physical benefits following minimally invasive EVLT are clear in comparison with surgery.

Many of the generic QoL scores in both groups improved significantly at 6 and 12 weeks. This demonstrates that the QoL benefits following varicose vein surgery are also seen following EVLT, with no difference at 12 weeks.

The disease-specific QoL analysis demonstrated some important variation in comparison with the generic QoL analysis. The decline in QoL at 1 week was statistically significant in both groups, whereas the decline in SF-36 domain scores at 1 week following EVLT did not reach statistical significance. This difference is perhaps not unexpected. The AVVQ is a disease-specific instrument and, therefore, generally accepted to be more responsive to change in varicose vein status. In addition, the AVVQ ascribes points for compression therapy. All patients in this study were advised to wear compression stockings for 6 weeks postintervention, potentially artificially increasing the AVVQ score. The routine prescription of pain-relieving tablets may also have contributed to the increased AVVQ scores.

As seen in the SF-36 analysis, both groups experienced significant improvement in overall QoL following treatment for their disease. This adds to the body of evidence that varicose vein treatment improves patients' QoL. It has to be said, however, that the EVLT group experienced a higher AVVQ improvement at 12 weeks. This may indicate that, as far as disease-specific QoL assessment is concerned, EVLT is better than surgery. However, the surgery group had higher AVVQ scores at baseline, and the difference between the groups at 12 weeks may represent residual venous insufficiency in this group, which had more symptomatic disease to begin with.

The improvement of our patients was not limited to QoL outcomes. As seen by the VCSS, there was a significant improvement in the severity of disease. This improvement was similar at 12 weeks in both groups and highlights the efficacy of both modalities of treatment. The majority of our patients in both groups had uncomplicated varicose veins (C2 CEAP classification), and specifically, none had active ulceration. However, in a series of 23 patients with varicose ulcers, EVLT without long-term compression resulted in ulcer healing in 22 patients in a median time of 4 months.18 There is therefore potential for EVLT to be effective in treating more severe disease.

Our results must be interpreted in light of some limitations. Although an ANCOVA was performed to adjust for baseline differences, it is appreciated that this technique may not completely eliminate all bias. Also, only about half of 62 patients in the surgery group had 12-week follow-up. Whether or not this proportion was representative of the group can only be speculated.

In conclusion, this study highlights, firstly, that both surgery and EVLT for varicose veins improve QoL, an important consideration for medical managers and policy makers during decision making regarding resource allocation and service provision: varicose veins are not just a cosmetic problem. Secondly, in the early postintervention period, EVLT has a QoL advantage over surgery. Although this advantage becomes progressively reduced with time, it may have significant implications in terms of early return to normal lifestyle and activities. Even given this study's limitations, we believe it highlights important findings that need to be further investigated by a randomized clinical trial with prolonged follow-up.

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 Financial support was provided by the Academic Vascular Surgery Unit, Hull Royal Infirmary, and the Hull and East Yorkshire Hospitals NHS Trust, Hull UK.

PII: S0890-5096(06)61461-1

doi:10.1007/s10016-006-9095-y

Annals of Vascular Surgery
Volume 20, Issue 4 , Pages 451-457, July 2006

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