Guidelines for clinical studies with compression devices in patients with venous disorders of the lower limb.

OBJECTIVES: The scientific quality of published clinical trials is generally poor in studies where compression devices have been assessed in the management of venous disease. The authors' aim was to establish a set of guidelines which could be used in the design of future clinical trials of compression treatments for venous diseases. DESIGN: Consensus conference leading to a consensus statement. METHODS: The authors form a expert consensus group known as the International Compression Club (ICC). This group obtained published medical literature in the field of compression treatment in venous disease by searching medical literature databases. The literature was studied by the group which attended a consensus meeting. A draft document was circulated to ICC members and revised until agreement between contributors was reached. RESULTS: The authors have prepared a set of guidelines which should be given consideration when conducting studies to assess the efficacy of compression in venous disease. CONCLUSIONS: The form of compression therapy including the comparators used in the clinical study must be clearly characterised. In future studies the characteristics of the material provided by the manufacturer should be described including in vivo data on pressure and stiffness of the final compression system. The pressure exerted on the distal lower leg should be stated in mmHg and the method of pressure determination must be quoted.

Results of a questionnaire regarding improvement of 'C' in the CEAP classification.

BACKGROUND: One of the shortcomings of the CEAP classification is that some of the clinical conditions in the original version were not defined and, therefore, were used in different ways by those who work with CEAP. AIM: To clarify the definitions of the seven clinical classes in the CEAP classification and to improve universal understanding of these in phlebology. METHODS: The authors prepared a short questionnaire regarding the 'C' part of CEAP with five main questions, dealing with definitions of clinical items: telangiectases, corona phlebectatica, reticular veins, varicose veins and the use of CEAP. The questionnaire was translated into 11 different languages and sent around the world by means of International Venous Digest by fax. Two hundred and six answers were received from 67 countries out of 3681 faxes sent (5.6%). RESULTS: There were a wide variety of opinions returned thus demonstrating that the same term is used with various meanings by different physicians. All physicians classify telangiectases of thigh and foot as class C1, but discrepant answers were obtained concerning the differences between reticular veins and reticular varicose veins as well as the diameter of small and large varicose veins. Sixty per cent of physicians answering this survey use the CEAP classification. CONCLUSION: Further clarification and refinement of the CEAP classification are necessary. The authors hope that this will result in broader acceptance of CEAP.

Pregnancy-induced changes in lower extremity superficial veins: an ultrasound scan study.

OBJECTIVE: The purpose of this study was to follow changes in superficial veins of the lower extremities during pregnancy and the postpartum period in women with varicose veins. METHODS: This was a prospective study with the use of duplex scanning during the first and third trimesters of pregnancy and postpartum period. Competent veins were defined as veins with an absence of reflux, and incompetent veins were defined as veins with reflux. The diameter of the competent or incompetent greater saphenous vein (GSV) and lesser saphenous vein (LSV) was measured. The diameter of the largest varicose dilatations was measured in all three networks: GSV and its tributaries, LSV and its tributaries, and nonsaphenous varicose veins. RESULTS: Sixty-six women were studied prospectively (mean age, 32.2 +/- 4 years; 85 affected extremities). The diameter of competent and incompetent GSVs and competent LSVs increased between the first and third trimester (P <.001) and decreased between the third trimester and the postpartum period (P <.001). The diameter of the largest varicose dilatations of the GSV and its tributaries and nonsaphenous networks increased between the first and third trimester (P <.001) and decreased between the third trimester and the postpartum period (P <.001). No statistically significant variation of the diameter was demonstrated for any of these veins between the first trimester and the postpartum period. CONCLUSION: The diameters of competent and incompetent superficial veins increased during pregnancy and decreased during the postpartum period to return to their baseline values.

Sclerotherapy. Continuous wave Doppler-guided injections.

BACKGROUND: The usual method of injection of sclerosing agents is based simply on clinical recognition and visualization of the varicose vein. OBJECTIVE: The authors present an original technique for sclerosing injections, named Doppler sclerotherapy. The purpose is to allow more accurate sclerotherapy in situations where varicose veins (usually greater than 4-5 mm) are not palpable in the supine position, but palpable when standing. METHODS: This technique consists of injecting the sclerosing agent using an uncomplicated continuous wave Doppler, a syringe, and a needle, according to a method consisting of four well-defined steps ensuring avoidance of arterial vessels and constant appreciation of the varicose vein to be treated, even during the injection. It requires no assistants and allows the treating physician's gaze to remain at the injection site while listening for very specific Doppler sounds of aspiration and injection. RESULTS: In our multicenter study of 220 patients (approximately 1,400 injections) all but 18 injections were successful for intravascular localization. No serious complications were noted. CONCLUSIONS: The principal indication is the treatment of varicose veins that are palpable while standing but impalpable in the supine position. In addition varicose veins in the groin region, lower third of the thigh, and along the axis of the small saphenous vein may be treated with this technique. In these situations it is a more accessible, faster, and economical technique, although it does not replace duplex ultrasound-guided injections.

Importance of the familial factor in varicose disease. Clinical study of 134 families.

BACKGROUND: The role of heredity in the development of varicose veins of the lower limbs has been raised many times in the literature. When evaluating this role, most authors only question the patients, without examining their relatives. As shown in other papers, the subjectivity of this type of data throws doubt on the results. OBJECTIVE: This problem was evaluated by means of a prospective study based on clinical examination of all immediate family members. METHODS: In the case-control study, the female or male patients had to satisfy the following criteria: 1. Varicose veins in their legs. 2. Age between 30 and 40 years (meaning that, in most cases, their parents were still alive). 3. No history of deep vein thrombosis. To limit the influence of certain confusing factors (diet, life-style), the control group was composed of the patients' spouses, who were not suffering from varicose veins. The parents of the cases and the parents of the controls were also examined. For each case-control couple and for the four parents, we recorded the history of venous disease, the life-style, and the results of clinical examination, including the results of palpation and percussion of the various varicose vein territories. RESULTS: One hundred and thirty-four families were examined: 67 patients and their parents and 67 controls and their parents. A total of 402 subjects were examined. The results demonstrated a prominent role of heredity in the development of varicose veins (P < .001). The risk of developing varicose veins for the children was 90% when both parents suffered from this disease, 25% for males and 62% for females when one parent was affected, and 20% when neither parent was affected.

Evaluation of different systems for clinical quantification of varicose veins.

One hundred twenty-five lower limbs with varicose veins were studied clinically, essentially by palpation. Two specialists in venous pathology scored the severity of the varicose veins from 0 to 20. Comparison between the different clinical parameters and the scores of the specialists showed that two systems of clinical quantification gave good results and were easy to use. One system is the maximum diameter of the largest varicose vein; the other system is the sum of maximum diameters over 7 sections (3 for thigh, 3 for leg, 1 for foot). This latter system gives a more precise evaluation of the clinical severity of the varicose veins.