Prevention and treatment of venous thromboembolism--International Consensus Statement.

The aim of this document is to provide a clear and concise account of the evidence regarding efficacy or harm for various methods available to prevent and manage venous thromboembolism (VTE).

Reprinted article "Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up".

PURPOSE: To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial. METHODS: Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire. RESULTS: The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment. CONCLUSION: The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.

Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins.

BACKGROUND: This randomized trial compared four treatments for varicose great saphenous veins (GSVs). METHODS: Five hundred consecutive patients (580 legs) with GSV reflux were randomized to endovenous laser ablation (980 and 1470 nm, bare fibre), radiofrequency ablation, ultrasound-guided foam sclerotherapy or surgical stripping using tumescent local anaesthesia with light sedation. Miniphlebectomies were also performed. The patients were examined with duplex imaging before surgery, and after 3 days, 1 month and 1 year. RESULTS: At 1 year, seven (5.8 per cent), six (4.8 per cent), 20 (16.3 per cent) and four (4.8 per cent) of the GSVs were patent and refluxing in the laser, radiofrequency, foam and stripping groups respectively (P < 0.001). One patient developed a pulmonary embolus after foam sclerotherapy and one a deep vein thrombosis after surgical stripping. No other major complications were recorded. The mean(s.d.) postintervention pain scores (scale 0-10) were 2.58(2.41), 1.21(1.72), 1.60(2.04) and 2.25(2.23) respectively (P < 0.001). The median (range) time to return to normal function was 2 (0-25), 1 (0-30), 1 (0-30) and 4 (0-30) days respectively (P < 0.001). The time off work, corrected for weekends, was 3.6 (0-46), 2.9 (0-14), 2.9 (0-33) and 4.3 (0-42) days respectively (P < 0.001). Disease-specific quality-of-life and Short Form 36 (SF-36(®)) scores had improved in all groups by 1-year follow-up. In the SF-36(®) domains bodily pain and physical functioning, the radiofrequency and foam groups performed better in the short term than the others. CONCLUSION: All treatments were efficacious. The technical failure rate was highest after foam sclerotherapy, but both radiofrequency ablation and foam were associated with a faster recovery and less postoperative pain than endovenous laser ablation and stripping.

Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years.

OBJECTIVE: This study aims to compare the outcome 2years after treatment of varicose veins by endovenous laser ablation (EVLA) or surgery by assessing recurrence, venous clinical severity score (VCSS) and quality of life. METHODS: A total of 121 patients (137 legs) were randomised to either EVLA or saphenofemoral ligation and stripping of the great saphenous vein (GSV). Follow-up included clinical and duplex ultrasound examinations, VCSS and quality of life questionnaires. RESULTS: A total of 18 (26%) and 25 patients (37%) in the EVLA and surgery group, respectively, developed recurrent varicose veins (not significant (NS) between groups). The source of reflux was not significantly different between the groups. Technical failure occurred in three EVLA and two surgery patients, reflux in the anterior accessory GSV, the groin, thigh and calf perforators was found in six, two, four, and three EVLA patients, and in three, three, nine and six surgery patients. VCSS, Aberdeen Varicose Vein Severity Score and several domains of the Medical Outcomes Study Short Form 36 (SF36) quality of life score improved significantly in both groups. CONCLUSIONS: No significant differences in clinical or ultrasound recurrences were found between EVLA and surgery groups. Our study also shows that similar improvements in clinical severity scores and quality of life were gained in both treatments.

Traveller's thrombosis: international consensus statement.

In 2001, consensus meetings on traveller's thrombosis were held in Vienna and Berlin. The results of these conferences were subsequently published in VASA 2002. In 2006 a follow-up conference was organized in Hall, Tirol, Austria, in order to review new and emerging data and to update the conclusions and recommendations of the 2001 meetings. Prior to the conference key papers from peer-reviewed journals were pre-circulated to all participants. The consensus group discussed the data and drafted an updated statement. Thereafter, the writing group summarised the results including the pre-circulated material and additional papers identified by a formal literature search up to December 2007. In this article current knowledge on the incidence, pathophysiology and prevention of traveller's thrombosis is summarised. The assessment of individual risk is described and recommendations for prevention of traveller's thrombosis are given, based upon the conclusions of the Hall Conference.

CEAP classification and implications for investigations.

Classification of diseases is a basic instrument for uniform diagnosis and meaningful communication about the disease. The credo of the American Venous Forum (AVF) is that "The cornerstone for management of chronic venous disorders (CVD) is a proper diagnosis and accurate classification of the underlying venous problem, which creates the base for correctly directed treatment". In CVD reliance for too long has been placed on the clinical appearance of the superficial effects of CVD, such as spider veins, varicose veins, swelling, skin changes, and ulcerations, without requiring accurate objective testing of the venous system to substantiate the diagnosis. This practice has caused errors of diagnosis and has been largely responsible for the poor correlation of results between treatment methods. There have been several classifications in the past that have added to our understanding of CVD, but all lack the completeness and objectivity needed for scientific accuracy.

Association of venous volume and diameter of incompetent perforator veins in the lower limb--implications for perforator vein surgery.

PURPOSE: To define the association between venous volume as measured with air-plethysmography and the duplex ultrasound measured diameter of incompetent perforator of the lower limb. PATIENTS AND METHODS: Thirty-six patients with chronic venous disease were investigated with air-plethysmography and duplex ultrasound. Venous volume and venous filling time was measured. Venous filling index was calculated. The findings were correlated with the diameter of the largest incompetent perforator vein of the lower limb. RESULTS: Twenty-six patients with venous volume in the normal range (80-170 ml) had a median perforator diameter of 3.5 mm (IQR 3.2-4.3). Ten patients with venous volume above 170 ml had median perforator diameter of 5.5 mm (IQR 4.6-7.7). (p=0.001, Mann-Whitney). There was a correlation between the venous volume and diameter of the largest incompetent perforator vein. (Pearson correlation factor 0.69, p=0.01). CONCLUSION: Limb volume correlates to the diameter of the largest incompetent perforator of the calf. Increase in venous limb volume could be partly responsible for an increase in the size of calf perforators thereby promoting incompetence.

Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up.

PURPOSE: To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial. METHODS: Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire. RESULTS: The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment. CONCLUSION: The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.

Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).

PURPOSE: This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure). METHODS: Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit. RESULTS: Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12; P =.02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (P <.01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (P <.05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months. CONCLUSIONS: In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping.