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.

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.

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.

Diagnosis of chronic venous disease of the lower extremities: the "CEAP" classification.

OBJECTIVE: To test a new classification of chronic venous disease (CVD)--based on clinical, etiologic, anatomic, and pathophysiologic data (the CEAP system)--in a series of patients by using objective tests to establish all diagnoses. MATERIAL AND METHODS: The CEAP classification was applied to 102 extremities in 70 consecutive patients with CVD. Diagnoses were based on objective testing with continuous-wave Doppler studies, duplex scanning, plethysmography, venous pressure, and phlebography, which were applied selectively (the more invasive methods were reserved for cases of greater severity). RESULTS: Use of this classification provided an organized categorization of the key elements of the venous abnormalities in each case and clarified the interrelationships among the clinical manifestations, cause of the process, and anatomic distribution of involvement. For example, in this series of 102 extremities, 79% had primary venous disease, 18% had secondary disease, and 3% had congenital abnormalities. Ulcers were found in 7% of extremities with primary CVD and 44% with secondary CVD. Of the cases with ulceration, 43% were due to primary incompetence and 57% to postthrombotic disease. Reflux was the pathophysiologic problem in 86% of the total series and in 80% of ulcer cases. Similar relationships can be delineated for cases with varicose veins, edema, or skin changes. Study of the specific facets of the CEAP classification provided precise information about the cause and the effect of venous abnormalities that could be compared with cases in other series. CONCLUSION: Use of the CEAP classification with diagnoses determined by objective testing accurately identifies categories of CVD. The objective date provide a clear description of the abnormalities in each case and may be used for analyses of meaningful relationships between categories of CVD. Adoption of this objective method of classifying CVD will facilitate interinstitutional studies.

Axillofemoral bypass reconstructions in sixty-one patients with leg ischemia.

During a 5-year period, 61 axillofemoral bypass operations have been performed in patients regarding as poor risks for conventional bifurcations procedures with arteriosclerotic occlusive disease and in patients with graft infections. Velour-Dacron grafts and expanded polytetrafluoroethylene (PTFE)-grafts have been used. The results are encouraging with a 3 year graft patency rate of 75% and a 3 year limb salvage rate of 90%. The expanded PTFE graft is a suitable graft for this purpose, and the use of axillofemoral bypass grafting is recommended as an alternative to the conventional aortoiliac/femoral bypass graft when dealing with high risk patients and patients with graft infections.

Revascularization of popliteal and below-knee arteries with polytetrafluoroethylene.

The expanded polytetrafluoroethylene (PTFE) graft (Gore-tex) is the most frequently used synthetic graft when an alternative to autologous saphenous vein is required. Early results have been encouraging. In the present paper we report on 6 years of results from 153 above-knee (AK) femoropopliteal bypass grafts, 74 below-knee (BK) femoropopliteal bypass grafts, and 54 femorotibial/peroneal bypass grafts. The main indication for the vascular reconstruction was severe ischemia. Preventive antibiotics were given to 95% of the patients. Minimum observation time was 1 year after implantation. There was no operative death. Graft infection was seen in less than 5% of patients. The 6-year cumulative limb salvage rate was 87% for patients with severe ischemia in the AK femoropopliteal bypass group, 59% for those in the BK femoropopliteal bypass group, and 57% for those in the femorotibial/peroneal bypass group. The graft patency rate was 88% at 2 years and 78% at 6 years for the AK femoropopliteal bypass group, for whom the operative indication was disabling claudication, and 81% and 68%, respectively, when the indication for the vascular procedure was severe ischemia. The cumulative graft patency rate was 53% and 43% at 2 and 6 years, respectively, after implantation of BK femoropopliteal bypass grafts and 43% and 39% for femorotibial/peroneal bypass procedures. The expanded PTFE (Gore-tex) graft seems therefore to be a good alternative when an autologous vein is not available, even for reconstructions well below the knee joint.

Intramuscular pressure, blood flow, and skeletal muscle metabolism in patients with venous claudication.

Nine patients with chronic iliac vein obstruction and venous claudication were investigated. Intramuscular pressure was measured in the anterior tibial and the deep posterior compartments in both legs at rest and during exercise. The pressures were significantly higher in the leg with iliac vein obstruction (39 +/- 10 mm Hg) than in the contralateral leg (26 +/- 12 mm Hg) at rest as well as during exercise (60 +/- 16 mm Hg and 41 +/- 15 mm Hg, respectively) in the deep posterior compartment. Similar changes were observed in the anterior tibial compartment. Muscle water content was higher (P less than 0.01) in the obstructed leg and contributes to the explanation for the high intramuscular pressure in this leg. Muscle blood flow, adenosine triphosphate, phosphocreatine, and lactate were determined in the gastrocnemius muscles at rest and at exercise. Muscle blood flow, measured with the 133xenon clearance technique, was lower in the obstructed leg (17.5 ml/min, 100 gm) than in the control leg (28.1 ml/min, 100 gm) during exercise. Lactate increased more (P less than 0.05) in the obstructed leg. It is suggested that pain in venous claudication is caused by the high intramuscular pressure, and therefore fasciotomy may be useful in the treatment of this disorder.

Iliofemoral venous thrombectomy followed by percutaneous closure of the temporary arteriovenous fistula.

Iliofemoral venous thrombosis treated by anticoagulants alone almost invariably results in postthrombotic sequelae with deep venous reflux alone or combined with an outflow obstruction. This study evaluates the result of iliofemoral venous thrombectomy with temporary proximal arteriovenous fistula (AVF) performed on 48 consecutive patients. In 10 patients the thrombus extended in the inferior vena cava, and the thrombectomy was combined with inferior vena cava interruption. The AVF closed spontaneously in 8 of 48 patients (patency rate, 84%). An attempt to close the AVF by placing a detachable balloon percutaneously under radiographic control was made 6 to 12 weeks later (success rate, 87%; complications, rare). A preclosure arteriovenography of the femoro-iliaco-caval segment revealed 34 of 38 segments open (patency rate, 89%). Four patients had severe stenosis of the iliac segment, and a transvenous percutaneous dilatation was successfully performed in three of the four patients, keeping the fistula. At AVF closure 4 weeks later the arteriovenography showed sustained dilatation in only two patients. Thirty-seven patients were followed for 3 to 48 months (median, 24 months) and 30 of 37 patients (81%) who had no symptoms were not using compression stockings. Doppler investigation revealed patent and competent femoral and popliteal veins and normal photoplethysmography in 56% of the patients. Four iliac veins were occluded (patency rate, 88%). No recurrence of fistula had occurred. Venous iliofemoral thrombectomy seems to better preserve valve function. The percutaneous balloon closure of the AVF has decreased the complication rate, facilitated venographic evaluation of the result, and made possible the performance of percutaneous interventions under the protection of the AVF.

Streptokinase treatment of deep venous thrombosis and the postthrombotic syndrome. Follow-up evaluation of venous function.

The conditions of 35 patients with deep venous thrombosis treated with streptokinase were reevaluated after a mean of 29 months with clinical examination, venous plethysmography, foot volumetry, phlebography (28 patients) and femoral vein pressure measurement (24 patients). At follow-up, 25 patients (71%) had symptoms and 22 (63%) had signs of venous insufficiency. Plethysmography was abnormal in 29 patients (83%) and foot volumetry in 25 (72%). Only two (6%) of the patients had normal plethysmography and foot volumetry and were free from symptoms and signs. No leg ulcer or severe postthrombotic syndrome was found. Phlebography showed that no patient had a normal deep venous system. Six of earlier thrombotic iliac veins (38%) and femoral veins 14 (48%), respectively, remained occluded. Increased femoral venous pressure, more pronounced during and after exercise, was found when iliac vein was diseased. Our results emphasize the importance of functional evaluation of the patient with a postthrombotic leg.

Indications for surgical treatment of iliofemoral vein thrombosis.

The goals of treatment of acute iliofemoral DVT should be prevention of fatal PE, reduction of pain and swelling of the involved leg, trying to stop the development of phlegmasia cerulea dolens and venous gangrene, prevention of disabling PTS by early removal of the blood clot, avoiding proximal venous obstruction, preserving normal, functioning valves in the leg veins, and preventing reflux. The authors recommend an aggressive approach with rapid removal of the occluding thrombus in the leg veins extending up into the iliac veins in active patients with a short history of symptomatic DVT, usually less than 7 days. This approach is not justified in chronically ill, bedridden, high-risk, or aged patients, or those with serious intercurrent disease or limited life expectancy. In these patients, such interventions can only be indicated for limb salvage in phlegmasia cerulea dolens when conservative treatment does not prevent the development of an acute compartment syndrome with venous gangrene. The preferred means of accomplishing early and quick removal of the thrombus is CDITT. Most of the authors' positive experience with thrombolysis is based on the use of urokinase. The Food and Drug Administration (FDA) has put this drug on temporary hold for almost 1 year. The alternative drugs (e.g., tissue plasminogen activator [tPA]) have not been tested for CDITT of DVT, and tPA is not FDA-approved for this indication. When there are contraindications or failure of thrombolysis, TE with a temporary AVF is a valid alternative.

Risk factors for venous thromboembolism following prolonged air travel. Coach class thrombosis.

Venous thromboembolism (VTE) in legs and lungs is a potentially life-threatening condition. The incidence of VTE associated with air travel is still unknown, but it may have increased. Most travelers who develop symptoms do so within 24 hours after their flight takes off. Predisposing risk factors may be divided into patient-related and cabin-related factors, both of which are described. It is emphasized that better information and better inflight precautions can minimize these risk factors.

Arteriovenous fistulas as an adjunct to venous surgery.

The objectives of the temporary arteriovenous fistula (AVF) are to increase blood flow in the thrombectomized segment to prevent immediate thrombosis and to allow time for healing of the endothelium. After complete thrombectomy of the iliac vein, confirmed by intraoperative venogram, the AVF is constructed using the divided long saphenous vein end-to-side to the superficial femoral artery. After 6 to 8 weeks, the patency of the AVF and the deep venous system is assessed by duplex scan, followed by an arteriovenogram from the opposite femoral artery, evaluating the anatomy of the AVF, common femoral vein, iliac vein, and the inferior vena cava (IVC). The AVF is closed using coils.

The functional long-term value of different types of treatment for saphenous vein incompetence.

OBJECTIVE: To compare the long-term value of different forms of treatment for primary varicose veins with saphenous vein insufficiency. EXPERIMENTAL DESIGN: A prospective, partially randomized study with 5-year follow-up. SETTING: Ambulatory day-case care. PATIENTS AND INTERVENTIONS: The study includes 211 patients (214 lower limbs), who received compression sclerotherapy (CST; n = 78), radical operation (OP; n = 74) or CST combined with high tie under local anesthesia (HT + CST; n = 63). MEASURES: The patient's subjective opinion, objective finding by the surgeon and functional (foot-volumetric) assessment were obtained just after treatment and 6 months, 1, 3 and 5 years later. RESULTS: Subjectively the result started to deteriorate in both the CST and HT + CST groups after one year. The patient satisfaction was greatest in the OP group throughout the study period. Objectively the CST group cure rate fell markedly after 6 months and at 5 year follow-up the failure rate reached 51%, while the OP group still had a high rate of cured (60%) and improved (35%) patients. The HT + CST treatment seemed to hold well for three years followed by increasing failure rate with only 16% objectively cured after 5 years. The foot-volumetric parameters expelled volume (= calf pump function) and refilling flow ratio (= venous reflux) increased 51-79% respectively decreased 8-29% post-treatment in all groups. After 5 years these parameters had returned to pre-treatment levels in the CST and HT + CST groups, while the OP group was still significantly improved. CONCLUSIONS: Radical surgery is superior to compression sclerotherapy alone or in combination with high tie in the treatment of varicose veins with saphenous vein incompetence. The foot-volumetric assessment correlated well with and supported objective findings as a whole but could not replace the clinical examination of each individual patient.

Temporary extracorporeal perfusion of the splanchnic circulation dependent on the Riolan anastomosis.

A thorough investigation of a hypertensive 25 year old male was undertaken due to the finding of an absent right radial pulse. This work-up revealed widespread, largely asymptomatic arterial disease characterised by a combination of multiple sites of stenosis and occlusion, aneurysmal dilatation and extensive vessel wall calcification. The findings included a right renal artery stenosis, an abdominal aortic aneurysm and a splanchnic vasculature completely supplied by the inferior mesenteric artery. Consequently it was thought that a prolonged clamping time during the aortic repair would possibly result in ischemic injury. Therefore, the splanchnic organs were perfused by a paediatric oxygenator and pump during the aortic cross-clamping. This case report discusses the etiology of the disease and the technical aspects of splanchnic perfusion.

Embolic brain infarction: a rare complication of thoracic outlet syndrome. A report of two cases.

The thoracic outlet syndrome is known to cause brachial neuropathy. Pressure on the subclavian artery causing post-stenotic dilatation with intraluminal thrombosis is not a common complication. This may lead to antegrade embolisation and ischemic changes in the upper limb. In right sided thoracic outlet syndrome the thrombus may extend retrogradely. From this an embolus may detach to the right hemisphere of the brain resulting in left sided hemiplegia. This is a rare but serious complication from a neglected, relatively benign, curable condition. This report describes two cases of a right sided thoracic outlet syndrome due to cervical rib compression with retrograde embolisation.

The late results after axillo-femoral bypass grafts in patients with leg ischaemia.

The late results--up to six years--after axillo-femoral bypass reconstruction are reported for 85 patients with leg ischaemia who were regarded as poor-risk patients for aortic bypass surgery, or who had aortic graft infection. Velour-Dacron grafts and expanded polytetrafluoroethylene (PTFE, Gore-Tex)--grafts have been used. The cumulative patency rate (life table) six years after graft implantation was 64% (PTFE-grafts) and 58% (Velour-Dacron grafts). The corresponding cumulative limb salvage rate six years after graft implantation was 88% when PTFE grafts were used and 77% when Velour-Dacron grafts were used. Our results demonstrate that axillo-femoral reconstruction is a useful procedure with a good patency rate 6 years after implantation. This procedure should be considered when dealing with poor risk patients with severe leg ischaemia.

Etiologic spectrum in acute iliofemoral venous thrombosis.

To identify common etiologies and allow a selective and effective management of acute iliofemoral venous thrombosis, 128 patients treated surgically (97 cases) or medically (31 patients) were analysed regarding possible underlying conditions. Chart review revealed that prolonged immobilization (25%), recent surgery (20%), and neoplasm (16%) were the most frequent etiologic factors. No underlying cause was detected in 34% of the patients, but more than one possible etiology were recorded in 29% of the patients. Chronic compression of the iliac vein was present in at least 13% of the operated cases. The multifactorial etiologic spectrum in iliofemoral thrombosis is basically the same as in calf vein thrombosis. Iliac vein compression, childbearing and perhaps estrogen intake seem to be more often associated with iliofemoral thrombosis. Initial survey regarding underlying causes permits tailored management for the individual patient. Surgical treatment is often successful but thrombi that develop secondary to chronic vein obstruction or neoplasm are preferably treated conservatively.

Thrombectomy and temporary AV-fistula in iliofemoral vein thrombosis. Technical considerations and early results.

Seventy patients with iliofemoral vein thrombosis were operated on with thrombectomy and a temporary arteriovenous fistula (AVF). Diagnosis was always verified with a three-stage venography. The result of the treatment was evaluated with arteriovenography before closing the AVF at a second operation. The AVF stayed patent in 85% and occluded in 15% of the evaluated 60 legs. In patients with patent AVF the common femoral and iliac veins were normal in 37% and in 51% there was a stenosis in either of these veins. Occlusion of the veins in spite of patent AVF was found in 12%. No major pulmonary embolism occurred. The most common complication was wound infection (26%). Technical details of the operative procedure experienced from this study are stressed in the paper.