Debate: Should persistent incompetent truncal veins be treated immediately? The case in support of the statement

Introduction

The management of varicose veins has evolved considerably in recent years but debate still remains over the best method of management. In particular, whether removal of saphenous trunks is required in order to address the symptoms and cosmetic consequences of varicose veins.

Lessons from the treatment of superficial varices by surgical methods

Sclerotherapy versus surgery

Sclerotherapy has been used by many physicians for over 100 years. However, Professor George Fegan created a method of treatment, based on the earlier work of Sigg ⁴ and Tournay, which was widely used from the 1960s until the 1980s in the UK and Ireland. ⁵ The essence of this method was to treat all superficial varices and ‘leak points’. He did not systematically treat the saphenous trunks which usually remained patent but incompetent. He showed using phlebography that once superficial venous reflux had been controlled by sclerotherapy the diameter of the saphenous trunks diminished substantially and concluded that his treatment had controlled the source of the varicose veins. ⁶

Hobbs randomised a series of patients to surgical stripping or sclerotherapy using Fegan’s techniques. By 1974, Hobbs ⁷ had reviewed the results of surgical treatment and sclerotherapy of varicose veins over a six-year follow up. The group size was 250 patients in each of the surgery and sclerotherapy groups. In total 404 legs had been treated by injection and 275 legs by surgery. The results revealed that whilst injection sclerotherapy was superior to surgery up to two years post-treatment, the failure rate increased over the next four years to achieve a level greater than that seen following surgery.

Fegan had originally claimed low recurrence rates for his techniques which were based on the clinical outcome at one year. However, Hobbs showed that reliance on clinical outcomes requires a follow-up period of at least six years for objective comparison between groups. Studies in which clinical outcome measures have been used with shorter periods of follow-up may be misleading since they underestimate the long-term risk of recurrence.

Hobbs demonstrated that in patients with truncal saphenous reflux, sclerotherapy was much less effective than surgical stripping at achieving a good long term clinical outcome. The sclerotherapy technique that he used had limited or no efficacy in ablating saphenous trunks. However, in patients with saphenous varices alone in whom the saphenous trunk had been removed or treated previously, sclerotherapy achieved good outcomes since it is very effective in ablating saphenous tributaries and varices.

21st century treatments

The new treatments for varicose veins developed in the last 15–20 years have mainly concentrated on ablation of the saphenous trunk as a way of addressing the problem of varicose veins. This includes radiofrequency ablation, endovenous laser ablation, ultrasound guided foam sclerotherapy, mechanochemical endovenous ablation and the Sapheon® Glue system.

In 2008 Luebke published a review comparing the outcome of radiofrequency ablation, endovenous laser ablation and foam sclerotherapy. ⁸ The authors concluded that endovenous laser was the most effective treatment, radiofrequency ablation with more early complications and foam sclerotherapy the least effective in obliterating the great saphenous vein (GSV). Subsequently, van den Bos has published a review in which surgery is compared to the endovenous treatments for varicose veins, including foam sclerotherapy, endovenous laser ablation and radiofrequency ablation. ⁹ The outcomes reported from the studies included in this meta-analysis were based on duplex ultrasound assessment of saphenous vein obliteration rather than clinical criteria or measures of quality of life. The authors assessed the outcome of surgery and endovenous treatments after three years. They found that surgery, radiofrequency ablation and foam sclerotherapy were equally effective at achieving a successful outcome as assessed by duplex ultrasound imaging (success range 77–84)% but that endovenous laser ablation was slightly more effective (94% success). The conclusions from these analyses are based on the surrogate outcome measure of ultrasound obliteration of the saphenous veins rather than the presence of clinically apparent varices or on quality of life measures.

Subsequently, a limited number of randomised clinical trials (RCTs) have been published.^10,11 The authors of these studies found similar clinical recurrence and patient-reported outcomes in all groups despite the differences in recanalisation rate shown on duplex ultrasound imaging. These studies demonstrate that the efficacy of saphenous ablation alone measured by duplex ultrasound imaging is not an accurate predicator of clinical recurrence.

A recent report of a clinical series discusses the reasons for recurrence after thermal ablation procedures for varicose veins. ¹² In 2010, 2380 patients were seen at seven participating centres for evaluation of symptomatic venous disease. Of the total patients seen, 164 were identified as having recurrent venous disease after a previous thermal ablation and these patients form the basis of this study.

Of the recurrences, 47 patients (29%) had either partial or total recanalisation of the GSV. Twenty-three patients (14%) had new saphenous insufficiency in previously unablated GSV segment. For those patients with recanalisation, the aetiology was either tributary or perforator inflow. New reflux in the anterior accessory great saphenous vein (AAGSV) occurred in 40 patients (24%) of the 164 in this study undergoing prior GSV ablation. New small saphenous vein (SSV) insufficiency occurred in 27 patients (16%).

The authors conclude that 40% of recurrences were attributable to new AAGSV or SSV reflux. The corollary of this appears to be that any untreated or incompletely treated segment of saphenous trunk, accessory vein or tributary that remains after treatment has the ability to develop into a recurrent varicose vein. Better and more extensive treatment of the GSV trunk and its tributaries may help in avoiding recurrence arising from previously untreated sections of vein.

Saphenous vein sparing procedures

In some centres preservation of the saphenous vein is emphasised with treatment based on modification of the blood flow in the superficial saphenous system (CHIVA technique) or on phlebectomy alone (ASVAL). Pittaluga has reported follow-up in a group patients undergoing treatment by phlebectomy alone using the ASVAL technique, with a total of 811 limbs. ¹³ He noted that clinical freedom from varices was present in 88% of patients at four years. Symptoms were also abolished in most patients. Caradina has reported a series of patients treated by the CHIVA method which avoids stripping the saphenous trunk, although the sapheno-femoral junction is ligated in some patients. A total of 150 patients were entered into the study and 26 were lost to follow-up. Patients were randomised to either CHIVA or conventional surgical treatment by saphenous stripping. Ten years later 18% of patients in the CHIVA group and 35% of patients in the surgery group had clinical evidence of recurrent varices.

The limitation of these studies is that the results have not been replicated in similar clinical trials in other centres. Convincing data should be achievable in other centres using these methods before it can be concluded that these techniques offer equivalent outcomes to methods in which saphenous trunks are ablated.

Conclusions

The author considers that there is a great deal to learn from the studies referenced earlier which can be applied to 21st century phlebology. Fegan’s method of treatment was based on the extensive work of Sigg and Tournay who had used sclerotherapy over several decades to treat varicose veins and who had reported satisfactory outcomes. Fegan and his predecessors had to rely on clinical outcome measures which have paradoxically become more important in the 21st century as indicators of efficacy. In varicose veins the disadvantage of using clinical indicators is that several years follow-up are required in order to establish the rate of clinical recurrence. Hobbs found that after one year the outcome from Fegan’s sclerotherapy was comparable with that of surgery but after six years the recurrence rate was substantially higher following sclerotherapy than with surgical stripping of saphenous trunks. Ablation of saphenous trunks by surgery significantly improved the outcome of treatment. Sclerotherapy achieved a less durable outcome. This was effective in treating the varices but did not achieve abolition of reflux in the saphenous trunks, even though it could be shown radiologically that the diameter of the saphenous veins had decreased after sclerotherapy. Winterborn has also found that abolition of the saphenous trunk by surgical stripping leads to a reduced rate of recurrence in patients with truncal saphenous incompetence. ³

Most surgeons do not have the patience to wait six years to assess the outcome of surgical treatments and in recent years duplex ultrasound imaging has assisted in evaluation of the new endovenous ablation methods for treating varicose veins. De Maeseneer has shown that in some patients, recurrent venous reflux can be demonstrated by duplex ultrasound imaging as early as 1 year following surgical stripping. In these patients clinical recurrence of varices can be seen at a later stage. This shows the value of duplex ultrasonography in predicting the long term outcome of varicose veins treatment. ¹⁴ However, data from clinical trials show that better efficacy of saphenous ablation, as assessed by duplex ultrasonography, in the van der Bos review ⁹ does not necessarily translate into a better clinical outcome. This review showed that ultrasound assessed efficacy was better in patients treated with laser ablation than with other modalities of treatment. However, in a randomised clinical trial laser ablation had very similar clinical and patient-reported outcomes to foam sclerotherapy, radiofrequency ablation and surgical saphenous stripping. ¹⁰ Successful saphenous trunk ablation alone is insufficient to ensure a good long-term outcome following varicose veins treatment.

Available evidence suggests that recurrence arises in residual saphenous trunks, accessory veins and other tributaries. ¹² Treatments which systematically eliminate all these potential sources of reflux are likely to lead to a better long-term outcome with reduced likelihood of recurrence. Any superficial vein left in the region of varicose veins treatment appears to have the potential to develop into further varices with the passage of time.