CONTENTS  •  Volume 9  Number 1 1994

In this issue of Phlebology a number of authors investigate the efficacy of existing and new methods of treatment for varicose veins. Sclerotherapy continues to be a popular modality for the treatment of varices, and the ‘Australian polidocanol study’ shows that this drug has been used successfully during its first months in Australia, when used to treat dermal flares and small varices. However, sclerotherapy is demonstrated to be ineffective in permanently obliterating the main saphenous trunk. The paper by Biegeleisen using the most advanced technology available (angioscopy) to guide the delivery of sclerosant and to follow-up the effect of treatment shows invariable failure to control valvular incompetence of the main saphenous trunk after a I-year period. Although this has been observed previously, it has never been shown that sclerotherapy fails even when treatment has been correctly applied to the vein concerned. This important finding must clearly have implications for the growing enthusiasm with which ‘echo-sclerotherapy’ is used, i.e. ultrasound-guided sclerotherapy, to obliterate the main trunks of the long or short saphenous vein. No study has reported the long-term follow-up of such treatment, but clearly this information will be essential to determine the likely efficacy of echosclerotherapy.

The search for improved methods of treatment is not confined to sclerotherapy. The paper by Schanzer reports the efficacy of external compression of deep and superficial veins using a Dacron cuff to constrain valvular incompetence. This is certainly a much less invasive procedure than open valvuloplasty, and may well have a place in the management of patients with deep vein incompetence. In the superficial veins I am less certain of the applicability of this technique. A number of authors have now reported reconstructive procedures instead of ablative surgery for incompetence of the superficial veins. The rationale appears to he that the veins may he preserved for coronary artery surgery and that a less extensive operation may he carried out. These are ideal aims, hut such surgery must be shown to he as long-lasting and safe as more conventional procedures.

Design: A review of the results of randomized controlled trials of LMWHs in which LMWH was compared with placebo, dextran or unfractionated heparin.

Methods: Published data from journals indexed in Index Medicus (Medline CD Rom) since 1984 or found in the reference lists of such journals.

Main outcome measures: Incidence of DVT as assessed by isotope scanning and/or venography and the incidence of PE and bleeding complications.

Results: Prophylaxis with LMWH causes a significant reduction in the incidence of DVT compared with placebo, dextran and unfractionated heparin in high-risk patients undergoing orthopaedic operations, but there is no conclusive evidence that they are better than unfractionated heparin in general surgery. There was inconclusive evidence that LMWHs reduced the incidence of PE compared with dextran or unfractionated heparin. LMWHs were at least as safe as unfractionated heparin in terms of major haemorrhage or postoperative blood loss.

Conclusions: Current evidence suggests the use of LMWHs in high-risk orthopaedic patients as a means of thromboprophylaxis is cost-effective. More trials are necessary to justify the use of LMWHs over unfractionated heparin in general surgery.

Design: Prospective study in a group of patients with severe venous insufficiency. One patient (one extremity) was lost to follow-up.

Setting: Tertiary care teaching hospital.

Patients: Twelve patients (13 extremities) with severe or moderate venous insufficiency.

Interventions: Correction of valvular incompetence by narrowing a valvular ring with an external band. Twenty-seven bands were fitted to incompetent valves of 13 extremities.

Main outcome measures: Abolition of reflux and improvement of muscle pump measured by clinical, plethysmographic and venographic criteria.

Results: Symptomatic improvement was found in 10 extremities (77%) and complete correction of reflux on venography in eight extremities (67%). Plethysmographically measured reflux improved in 6 extremities (50%) and muscle pump function improved in 7 extremities (51%). No correlation was found between plethysmographic and clinical or venographic outcome.

Conclusion: Perivalvular handing can correct reflux and alleviate clinical symptoms of chronic venous stasis in patients with primary valvular incompetence. Selection of patients, valves to be corrected, necessary degree of valvular ring narrowing and need for additional interventions should he further investigated.

Design: Single patient group study of patients who received surgical treatment for varicose veins 10 years earlier.

Setting: Department of Surgery, University Hospital of Tampere. Finland.

Patients: All men and a randomly picked sample of women were invited to attend for a follow-up examination; 81% (52 men, 74 women) participated.

Intervention: Long saphenous vein stripping in all patients.

Main outcome measures: The presence of visible varicose veins as graded in four categories by clinical examination.

Results: Seventy per cent of the operated legs in women free of varicosities or showed only minor varicose veins compared with 51% in men; 28% of the patients required further treatment (mostly sclerotherapy) for varicose veins.

Conclusions: Long saphenous vein stripping combined with additional procedures results in a relatively low rate of severe recurrent varicose veins in 10 years.

Design: A single-arm prospective study of polidocanol complications and its effectiveness as a sclerosant. This was compared with each investigator’s previous experience with other sclerosing agents.

Setting: Multiple investigators in both private practices and hospital settings.

Patients: Patients had either varicose veins or venule ectasias and/or spider veins (telangiectasia). A total of 8177 limbs were injected by 75 investigators.

Interventions: Sclerotherapy was performed with 0.5% or 1% polidocanol for telangiectasias or spider veins, and with 3% polidocanol for varicose veins. The effectiveness of the sclerotherapy and any complications were reported during a 12-month period.

Results: There were very few complications reported with polidocanol. There were no reported deaths or anaphylaxis. The investigators with previous experience of other sclerosants considered that the effectiveness of polidocanol was superior to STD (77%) and hypertonic saline (75%). Ninety-one per cent of investigators considered that polidocanol had less frequent complications than STD, and 96% considered that these were less severe. Sixty-nine per cent considered that polidocanol had fewer side-effects than hypertonic saline, and 71% considered that these were less severe.

Conclusions: Polidocanol is an effective sclerosant that has few complications.

Design: Single group study of patients with incompetence of the long saphenous vein.

Setting: All treatments were performed in a private office setting.

Patients: Sixteen patients with untreated varicosities limited to the greater saphenous vein, which was 10 mm in diameter at the saphenofemoral junction in all cases.

Interventions: Angioscopically guided sclerosis of the long saphenous vein.

Main outcome measures: Colour-flow ultrasound was used to establish the presence of residual reflux after angioscopic treatment.

Results: Total obliteration of saphenofemoral reflux was obtained in 12 veins with angioscopic sclerotherapy. All veins on which follow-up was available (nine veins in seven patients) had undergone substantial recanalization by 12 months after treatment.

Conclusion: Angioscopically controlled sclerotherapy effectively obliterates the saphenophemoral junction. Recanalization of the sclerosed segment of vein occurs invariably within 12 months of treatment.

Design: Prospective single patient study.

Setting: Departments of Vascular Surgery. Radiology and Angiology, Jean Kunlin Unit of Vascular Pathology, Clinique du Grand-Large, Declines Charpieu. France.

Patients: Eighteen consecutive patients with venous reflux in the popliteal fossa as demonstrated by hand-held Doppler insonation.

Interventions: All limbs were investigated by DS and DPP before undergoing surgical exploration of the popliteal fossa.

Main outcome measures: The findings of the two modes of investigation were compared with the operative findings.

Results: Both tests showed good specificity (98% DPP, 96% DS), but only moderate sensitivity (83% DPP, 87.5% DS). Both tests were wrong in two limbs.

Conclusion: Phlebography can be reserved for cases where duplex scanning is inconclusive. Unsuspected anomalies will occasionally be found at operation despite exhaustive investigation.

Design: Prospective study.

Setting: Second Department of Surgery, Tottori University School of Medicine, Yonago, Japan.

Patients: Twenty-one lower extremities in 16 patients and 23 lower extremities in 13 healthy control subjects.

Intervention: Application of standard compression elastic stockings (30—40 mmHg compression at the ankle) and high compression elastic stockings (40—50 mmHg at the ankle) (Sigvaris, Sweden).

Main outcome measures: Comparison of expelled volume measured by ambulatory strain-gauge plethysmography.

Results: Calf pump function after deep vein thrombosis was classified into three grades (normal, compensated and failed) by the expelled volume. The expelled volume increased from 0.4 ml/dl (SD 0.2) to 0.9 ml/dl (SD 0.5) following the application of strong compression.

Conclusion: Compression therapy is haemodynamically effective only when using strong compression (40—50 mmHg) in patients with post-thrombotic syndrome.

Methods: Six drug preparations used in phlebology and extracts of hop and valerian were tested for neuronal and mitochondrial BZ receptor binding activity in vitro. In addition, plasma samples of volunteers who ingested phlebotropic drugs for 3 weeks were assayed for the presence of BZ-like activity.

Results: All phlebotropic drug preparations interacted weakly with central and/or peripheral BZ receptors in vitro. Their diazepam-equivalent concentrations were, however, too low to be of pharmacological relevance. No binding activity was recovered in the blood of volunteers pretreated with phlebotropic drugs.

Conclusion: The positive influence of so-called ‘phlebotropic’ drugs on the subjective symptoms of venous disease is not mediated through BZ receptors.

Design: Prospective, open cross-over study.

Patients: Twenty-nine patients with established unilateral deep venous insufficiency of at least 12 months duration, and a history of venography-proven deep venous thrombosis in the affected leg.

Interventions: On entering the study, patients were randomly assigned to receive either 1-lidrosmina (Venosmil, FAES SA, Spain) 6(X) mg daily. or 0-(ß-hydroxyethyl)-rutosides (Venoruton, Zyma SA, Switzerland) 900 mg daily. The drugs were taken for 6 months. At the end of this period, the drug was discontinued, and patients taking Hidrosmina changed to rutosides, or vice versa, for a further 6-month period. Finally, both drugs were discontinued, and patients were re-examined 3 and 6 months later.

Results: During the first 6-month period, 12 out of 29 patients showed reduced tiredness and/or pain in the leg in comparison to the control visit. Furthermore, a slight reduction was found in mean circumferences of both the ankle and calf during this study period. During the second 6-month period of therapy, six additional patients improved their subjective symptoms, but there were three patients in whom these symptoms had increased. Six months after discontinuation of therapy, subjective symptoms increased in 10 out of 29 patients, and mean circumferences of both the ankle and calf returned to baseline values.

Conclusions: In this pilot study our findings demonstrate that venoactive drugs may improve both objective and subjective symptoms in patients with post-thrombotic syndrome, and that these effects disappear after drug therapy is discontinued.

Design: Immunohistochemical localization of FXIIIa and immunofluorescent histological labelling of fibrin in patients' biopsies and in control specimens.

Procedure: Twenty-five biopsies were taken from granulation tissue of venous ulcers. Specimens of unimpaired wound healing (n = 10) served as controls. Concentrations of FXIIIa and fibrin were estimated in all biopsies. Additionally, 11 biopsies from ulcer edges were stained with FXIIIa.

Results: The fibrin uptake in ulcer tissue exceeded the amount found in control biopsies. Specimens taken from the ulcer edges contained the greatest amount of FXIIIa in both pericapillary and interstitial regions, followed by the controls. Granulation tissue taken from venous ulcers showed less FXIIIa around capillaries and in the interstitium than specimens of both other groups.

Conclusion: Local FXIIIa deficiency in ulcer tissue may contribute to impaired wound healing. Sclerosis found in ulcer edges may be the morphological correlate of the high enzymatic Concentrations found in specimens from this area.