The relative position of paired valves at venous junctions suggests their role in modulating three-dimensional flow pattern in veins.

PURPOSE: The aim of the study is to investigate the relative position of orifices of two valves within the most proximal segments of the great saphenous vein (GSV), and the femoral vein (FV). METHODS: A total of 15 volunteers with no signs or symptoms of venous disease and 13 unaffected limbs of patients with unilateral primary chronic venous disease (CVD) were included. Two most proximal valves of the GSV and the FV were identified. The angle between the two valves, and the distance between the valves were measured. RESULTS: The mean distance between the two valves in the GSV was 3.8 ± 0.4 cm, and in the FV was 4.6 ± 0.3 cm. In one limb, the distance between the FV valves was 1 cm less than GSV valves, and in two limbs the distances were equal. In the remaining 12 limbs available for comparison, the valves in the FV were 1-2 cm further apart compared to the GSV (P = 0.002, paired t-test). All studied pairs of valves were positioned at a minimum 60° angle to each other. The mean angle between the two valves was 84.3 ± 8.4° in the GSV, and 88.3 ± 6.7° in the FV (P = 0.24). The angle between the two valves correlated with the distance between the valves (r = 0.68, P = 0.000005). No significant relations were found between the diameter of the studied vein, and the angle between the two valves. There was no difference in valve orientation between volunteers and unaffected limbs of the patients with CVD. CONCLUSION: When two valves are present in the areas of venous junctions, they consistently positioned at a significant angle to each other. A hypothesis that venous valves at the junctions increase efficiency of venous return by creating a helical flow pattern can be postulated and deserves further investigation.

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.

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.

Venous severity scoring: An adjunct to venous outcome assessment.

Some measure of disease severity is needed to properly compare the outcomes of the various approaches to the treatment of chronic venous insufficiency. Comparing the outcomes of two or more different treatments in a clinical trial, or the same treatment in two or more reports from the literature cannot be done with confidence unless the relative severity of the venous disease in each treatment group is known. The CEAP (Clinical-Etiology-Anatomic-Pathophysiologic) system is an excellent classification scheme, but it cannot serve the purpose of venous severity scoring because many of its components are relatively static and others use detailed alphabetical designations. A disease severity scoring scheme needs to be quantifiable, with gradable elements that can change in response to treatment. However, an American Venous Forum committee on venous outcomes assessment has developed a venous severity scoring system based on the best usable elements of the CEAP system. Two scores are proposed. The first is a Venous Clinical Severity Score: nine clinical characteristics of chronic venous disease are graded from 0 to 3 (absent, mild, moderate, severe) with specific criteria to avoid overlap or arbitrary scoring. Zero to three points are added for differences in background conservative therapy (compression and elevation) to produce a 30 point-maximum flat scale. The second is a Venous Segmental Disease Score, which combines the Anatomic and Pathophysiologic components of CEAP. Major venous segments are graded according to presence of reflux and/or obstruction. It is entirely based on venous imaging, primarily duplex scan but also phlebographic findings. This scoring scheme weights 11 venous segments for their relative importance when involved with reflux and/or obstruction, with a maximum score of 10. A third score is simply a modification of the existing CEAP disability score that eliminates reference to work and an 8-hour working day, substituting instead the patient's prior normal activities. These new scoring schemes are intended to complement the current CEAP system.

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.

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.

Venous bypass and valve reconstruction: long-term efficacy.

Palma and Esperon described the first femoro-femoral cross-over bypass for iliac vein obstruction in 1958, and Kistner performed the first valve reconstruction for deep vein reflux in 1968. Such surgical development has stimulated better diagnostic methods that now form the foundation for a classification of chronic venous disease, and surgery has been supported by, and sometimes replaced by, the rapid progress in endovascular procedures with angioplasty and stenting. The ability now exists to relieve obstruction and repair reflux in the deep veins, and the results in the successful cases demonstrate the improvement that follows correction of the physiologic abnormalities. The detail in workup required to achieve an accurate diagnosis that is adequate enough to guide surgical treatment in these cases has set a new standard for the diagnosis of chronic venous disease that incorporates the clinical state, etiology, pathophysiology and anatomic distribution of the venous problem, and is incorporated in the CEAP (clinical, etiologic, anatomic, pathophysiologic) classification. The challenge at this time is to produce a reliable set of data that demonstrate the results of treatment in patients with chronic venous disease by conventional methods of bandaging, rest and elevation as well as specific surgical correction of venous obstruction and reflux and to follow these cases over a significant period of time.

The natural history of calf vein thrombosis: lysis of thrombi and development of reflux.

PURPOSE: Although the fact is well accepted that deep venous thrombosis (DVT) of the iliac, femoral, and popliteal veins can lead to the post-thrombotic (postphlebitic) syndrome, the significance of isolated calf DVT on the development of late venous sequelae and physiologic calf dysfunction is unknown. The purpose of this study was to review the outcome of 58 limbs with isolated calf DVT and report the clinical, physiologic, and imaging results up to 6 years after the onset of DVT. METHODS: The study consisted of 58 limbs of 54 patients in whom isolated calf vein DVT was diagnosed between 1990 and 1995. Proximal propagation of clot, lysis of thrombi, and development of symptomatic pulmonary emboli were examined. Of the patients, 28 received anticoagulation therapy, and 26 did not, but they had follow-up with serial duplex scans. At late follow-up 1 to 6 years later (median, 3 years), 23 patients were examined for the post-thrombotic syndrome, and all 23 underwent clinical examination, color-flow duplex scanning, and air plethysmography. RESULTS: Proximal propagation of DVT from the calf veins into the popliteal or thigh veins occurred in 2 of 49 cases (4%) within 2 weeks of diagnosis. No patient had clinically overt pulmonary emboli develop regardless of whether anticoagulation therapy was received or not. The most common site for calf DVT was the peroneal vein (71%). Complete lysis of calf thrombi was found in 88% of the cases by 3 months. At 3 years, 95% of the patients were either asymptomatic or mildly symptomatic, and 5% had discoloration of the limb. No ulcers occurred. By air plethysmography, physiologic abnormalities were found in 27% of the cases, which was not significantly different from normal controls. Valvular reflux by duplex scanning of the calf vein segment with DVT was found in 2 of 23 cases (9%). However, reflux in at least one venous segment not involved with DVT was found in 7 of 23 cases (30%), which was higher than, but not statistically different from, normal controls, with reflux occurring in 5 of 26 cases (19%). CONCLUSIONS: Isolated calf vein DVT leads to few early complications (ie, clot propagation, pulmonary emboli) and few adverse sequelae at 3 years. The peroneal vein is most commonly involved and should be a part of the routine screening for DVT. Lysis of clot usually occurs by 3 months. Although valvular reflux rarely is found in the affected calf vein at 3 years, reflux may be found in adjacent uninvolved veins in approximately 30% of the cases. The question of whether this will lead to future sequelae, such as ulceration, will require longer follow-up.

Stent-graft arteriovenous fistula: an endovascular technique in hemodialysis access.

PURPOSE: To determine the feasibility and safety of a new endovascular technique for creating an arteriovenous (AV) fistula utilizing catheter-directed techniques and stents. METHODS: Stent-graft AV fistulas were offered on an experimental basis to 8 patients who had a history of multiple failed access procedures or very small arm veins unsuitable for standard vascular access techniques. The device consisted of a balloon-expandable Palmaz stent attached to the designated venous end of a polytetrafluoroethylene graft. The balloon-mounted stent-graft was inserted into the brachial vein through an arteriotomy and advanced over a guidewire into the axillary vein. After the stent-graft was deployed, the arterial anastomosis was completed in standard surgical fashion using an end-to-side anastomosis of the graft to the brachial artery. RESULTS: The stent-graft was inserted successfully in all patients, but there were two early failures. The first resulted from a steal phenomenon secondary to high flows through the stent-graft, necessitating ligation of the fistula. Another stent-graft was placed too peripherally in the upper arm, and the stainless steel stent was crushed by external compression. Three of the 6 remaining grafts were patent for over 1 year, and 2 grafts are still functioning at 22 and 13 months. CONCLUSIONS: Endoluminal stent-grafts can be successfully inserted into the axillary vein for creation of an AV fistula and remain patent for 2 years or more. This method may be most useful in patients with very small, unusable arm veins or multiple failed AV grafts.

Safety, feasibility, and early efficacy of subfascial endoscopic perforator surgery: a preliminary report from the North American registry.

PURPOSE: The North American Subfascial Endoscopic Perforator Surgery (NASEPS) Registry was established to evaluate the safety, feasibility, and efficacy of minimally invasive endoscopic Linton operations for treatment of chronic venous insufficiency. METHODS: Retrospective analysis was performed on the clinical data of 151 patients who underwent attempt at 158 SEPS in 17 medical centers in the United States and Canada between June 1993 and February 1996. RESULTS: SEPS was completed on 155 limbs of 148 patients, 81 male and 67 female (mean age, 56 years; range, 27 to 87 years). Three procedures were aborted. Seven patients had bilateral procedures (data from one limb were analyzed). One hundred four limbs (70%) had active ulcers, and 22 (15%) had healed ulcers. A single endoscopic port without insufflation was used in 66 procedures (45%) and laparoscopic instrumentation, with two or three ports, in 82 (55%), with CO2 insufflation in 78 (53%). A tourniquet was used on 112 patients (76%). Concomitant venous procedures were performed in 106 patients (72%; saphenous stripping in 71, high ligation in 17, varicosity avulsion in 85). No early deaths or thromboembolism occurred. Complications included wound infections (9), superficial thrombophlebitis (5), cellulitis (4), and saphenous neuralgia (10). Seven patients with wound infection had open ulcers; nine of 10 with neuralgia had concomitant procedures. A roll-on tourniquet caused skin necrosis in one patient. The clinical score improved from 9.4 to 2.9 after surgery (p < 0.0001). Mean follow-up was 5.4 months; 31 patients had > or = 6 months follow-up. Ulcers healed in 88% (75 of 85); recurrence or new ulcer was reported in 3% (4 of 120). CONCLUSIONS: The SEPS modified Linton operation appears safe, with no postoperative deaths or early thromboembolism. Wound infection after SEPS remains important. Early results indicate rapid ulcer healing. Prospective evaluation of long-term results is warranted.

Venous thromboembolism in association with prolonged air travel.

OBJECTIVE: To study risk factors for the development of air travel-related acute venous thromboembolism. METHODS: A retrospective study of 254 patients admitted from 1988 to 1993 under the diagnosis of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) identified 44 patients who developed symptoms during or after air flight. RESULTS: There were 24 males and 20 females with a mean age of 63 years. Flight times were 5-17 hours. Twenty-eight patients (63.6%) had DVT only, five patients (11.4%) PE only, and 11 patients (25%) DVT and PE. Ninety-five percent had extension of the thrombus above the calf: popliteal vein, 10 patients; superficial femoral vein, 13 patients; common femoral vein, six patients; and iliac vein, eight patients. Five patient-related risk factors were identified: history of previous DVT (34%), presence of chronic disease or malignancy (25%), hormone therapy (16%), recent lower limb injury (11%), and recent surgery or femoral catheterization (9%). CONCLUSIONS: We can speculate about the role of seven cabin-related risk factors: low humidity, hypoxia, diuretic effect of alcohol, insufficient fluid intake, smoking, "coach" position, and immobilization. In travelers with patient-related risk factors, the cabin-related risk factors are superimposed and may increase the risks for air travel-related acute venous thromboembolism. Active prophylaxis is recommended.

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.