[Severe intermittent claudication: PGE1 treatment. A 40-week registry, efficacy and costs]. / Claudicatio intermittens severa: trattamento con PGE1. Registry, follow up (40 settimane), efficacia e costi.

AIM: Intermittent claudication (IC) in peripheral vascular disease is characterized by lower limb pain appearing on effort. Treatment with PGE1 has been successfully used to manage IC patients. This registry has evaluated safety and costs of PGE1 in the management of IC. METHODS: In this study a long-term treatment protocol (LTP), a short-term protocol (STP) and an outpatient (OP), "on-demand" treatment have been compared. A treadmill effort test has been used to evaluate walking distance. The follow up for these three protocols was 40 weeks. PGE1 treatment was associated to a risk reduction plan and to an exercise program. RESULTS: The final analysis has included 252 LTP patients, 223 STP patients and 284 OP patients (total 659 valid cases). A group of 171 comparable patients not treated with PGE1 was used for a parallel comparison. Cardiovascular mortality and morbidity has been evaluated in 731 PGE1 patients completing 24 months of follow up. All protocols have been well tolerated. No side effects were observed. The lower cost has been observed for OP patients. In the long term, mortality and morbidity were lower in patients treated with PGE1 in comparison with patients not treated with PGE1. CONCLUSION: Considering costs and results (increase in walking distance) and improvement in Karnofsky scale the STP plan appears to be better than LTP for IC patients. The OP, "on-demand" treatment offers further improvements. This last treatment plan is simpler; the plan allows better timing for exercise. The treatment can be used even in non-specialized centers.

[Medical treatment of chronic venous disease: evolution or involution?]. / Trattamento medico della malattia venosa cronica: evoluzione o involuzione?

Chronic venous disease (CVD) is an important clinical condition with substantial epidemiological implications and socio-economic repercussions. In the Western world the consequences of its high prevalence, the costs of diagnosis and therapy, the significant loss of working hours and the repercussions on patients'quality of life are well known. Pharmacotherapy for CVD has greatly developed over the last 40 years and largely used in the symptomatic treatment of CVD together with compression therapy and to make patients more comfortable. The clinical efficacy on the symptoms (feeling of heaviness, pain, paresthesia, heat and burning sensations, night cramps, etc.) has long been confirmed by Level III, IV and V evidence, but there are now Level I and II trials on specific drugs. For the bioflavonoids double-blind, randomised trials have used micronized purified flavonoid fraction; rutosides; escin; anthocyanosides; and synthetic calcium dobesilate. It was therefore surprising some recent difficulties in the use of this important treatment in health national system in Italy. In this up-date we use the method on evidence-based medicine from the medical literature. We have started a governance and economic analysis of the problem in Italy. Particular consideration was given to the evidence set out in review, meta-analysis, guidelines and Consensus Statements in this field. The evidence for pharmacological agents in the treatment of CVD suggests today a wide use in all CEAP classes.

Management of superficial vein thrombosis and thrombophlebitis: status and expert opinion document.

Superficial vein thrombosis is characterized by clotting of superficial veins (ie, following direct trauma) with minimal inflammatory components. Superficial thrombophlebitis is a minimally thrombotic process of superficial veins associated with inflammatory changes and/or infection. Treatments generally include analgesics, elastic compression, anti-inflammatory agents, exercise and ambulation, and, in some cases, local or systemic anticoagulants. It is better to avoid bed rest and reduced mobility. Topical analgesia with nonsteroidal, anti-inflammatory creams applied locally to the superficial vein thrombosis/superficial thrombophlebitis area controls symptoms. Hirudoid cream (heparinoid) shortens the duration of signs/symptoms. Locally acting anticoagulants/antithrombotics (Viatromb, Lipohep, spray Na-heparin) have positive effects on pain and on the reduction in thrombus size. Intravenous catheters should be changed every 24 to 48 hours (depending on venous flow and clinical parameters) to prevent superficial vein thrombosis/superficial thrombophlebitis and removed in case of events. Low molecular weight heparin prophylaxis and nitroglycerin patches distal to peripheral lines may reduce the incidence of superficial vein thrombosis/superficial thrombophlebitis in patients with vein catheters. In case of superficial vein thrombosis/superficial thrombophlebitis, vein lines should be removed. In neoplastic diseases and hematological disorders, anticoagulants may be necessary. Exercise reduces pain and the possibility of deep vein thrombosis. Only in cases in which pain is very severe is bed rest necessary. Deep vein thrombosis prophylaxis should be established in patients with reduced mobility. Antibiotics usually do not have a place in superficial vein thrombosis/superficial thrombophlebitis unless there are documented infections. Prevention of superficial vein thrombosis should be considered on the basis of patient's history and clinical evaluation.

Management of Varicose Veins and Chronic Venous Insufficiency in a Comparative Registry with Nine Venoactive Products in Comparison with Stockings.

The aim of this registry study was to compare products used to control symptoms of CVI. Endpoints of the study were microcirculation, effects on volume changes, and symptoms (analogue scale). Pycnogenol, venoruton, troxerutin, the complex diosmin-hesperidin, Antistax, Mirtoselect (bilberry), escin, and the combination Venoruton-Pycnogenol (VE-PY) were compared with compressions. No safety or tolerability problems were observed. At inclusion, measurements in the groups were comparable: 1,051 patients completed the registry. Best performers : Venoruton, Pycnogenol, and the combination VE-PY produced the best effects on skin flux. These products and the combination VE-PY better improved PO 2 and PCO 2 . The edema score was decreased more effectively with the combination and with Pycnogenol. Venoruton; Antistax also had good results. Considering volumetry, the best performers were the combination PY-VE and the two single products Venoruton and Pycnogenol. Antistax results for edema were also good. The best improvement in symptoms score were obtained with Pycnogenol and compression. A larger decrease in oxidative stress was observed with Pycnogenol, Venoruton, and with the VE-PY combination. Good effects of Antistax were also observed. Parestesias were lower with Pycnogenol and with Antistax. Considering the need for interventions, the best performers were Pycnogenol, VE-PY, and compression. The efficacy of Pycnogenol and the combination are competitive with stockings that do not have the same tolerability in warmer climates. A larger and more prolonged evaluation is suggested to evaluate cost-efficacy (and non-interference with drugs) of these products in the management of CVI. The registry is in progress; other products are in evaluation.

The first 1000 cases of Italian Endovenous-laser Working Group (IEWG). Rationale, and long-term outcomes for the 1999-2003 period.

AIM: The innovations for disease management need to be thoroughly evaluated so that their benefits and potential downsides can be compared with the already existing approaches. Endovascular laser (EVL) treatment for varicose veins offers today several advantages over surgical standard stripping. The Italian Endovenous-laser Working Group (IEWG) is a homogeneous group of surgeons and phlebologists who have been using EVL since 1999 and has undertaken to examine EVL in a multicenter study starting from a well defined rationale, with the benefit of a single protocol to use. METHODS: In a cooperative, multicenter, clinical study, 1076 limbs in 1050 patients, mean age of 54.5 years, 241 males and 809 females affected by chronic venous insufficiency (CVI) were considered eligible for surgery and stratified by CEAP classification in a four-year period (January 1999 December 2003). Inclusion criteria were insufficiency of the great and/or small saphenous vein at various levels, beyond those accessory saphenous trunks with incompetence in the saphenofemoral junction. In all cases truncular reflux apparead up on duplex scan examination, with or without associated varicosities. All the patients underwent a surgery on the basis of the clinical assessment. All the centres involved performed treatment in conformity with the Food and Drug Administration (FDA) validated procedure, using an endo-laser venous system kit with a 810-980 nm diode. Duplex scan was performed in all patients after 36 months with very few lost to follow-up cases. RESULTS: In the immediate postoperative period the results have been impressive, with a very effective closure of incompetent great saphenous vein and the other treated varicose veins (the early occlusion rate has been 99%). Major complications have not been detected: in particular, no deep venous thrombosis (DVT) evaluated duplex ultrasound. The patients' acceptability and satisfaction regarding the procedure, have been measured by means of a questionnaire on the quality of life, and the result was 96.7%. After 36 months, the total occusion rate of saphenous trunks has been 97%. CONCLUSIONS: The first important Italian experience with EVL based on preoperative, perioperative and postoperative duplex control and which is also based on the patients' satisfaction at mid/long-term has indicated some advantages over the standard treatment with the stripping method. In terms of reduced postoperative pain, shorter sick leave, a faster resumption of the normal activities, and, in particular, the total absence of DVT, we can conclude that EVL is a good solution for all patients with anatomic and hemodinamic patterns for saphenous vein surgery.

Revision stapes surgery for recurrent transmissional hearing loss after stapedectomy and stapedotomy for otosclerosis.

A total of 20 stapedotomy and 24 stapedectomy cases were retrospectively reviewed to establish the causes of failure, and to evaluate hearing results after revision surgery. Our series included 23 male and 21 female patients. Mean age at revision time was 42 years, and the mean interval from primary surgery and revision stapes surgery was 27 months. The retrospective review of our data, revealed that the most common cause for revision surgery was a displaced prosthesis (47.7%). After revision surgery, the mean post-operative air-bone gap was 14.78 dB. A mean post-operative air-bone gap within 10 dB occurred in 24 patients (54.5%), in 14 patients (31.5%) this was between 11 and 20 dB, in 5 patients (11.5%) between 21 and 30 dB, and in one patient (2.5%) > 30 dB. There were no "dead ears" in this series. Our results compare to other reported series, and confirm that after revision stape surgery, an air-bone gap closure within 10 dB is difficult to obtain. In the present series, the use of the total ossicular replacement prosthesis resulted in the poorest functional hearing results.

Analysis of the effects of micronized purified flavonoid fraction versus placebo on symptoms and quality of life in patients suffering from chronic venous disease: from a prospective randomized trial.

AIM: The aim was to investigate the effect of micronized purified flavonoid fraction (MPFF; Daflon® 500 mg, Laboratoires Servier, France) versus placebo, on pain and quality of life (QoL) in patients with symptomatic chronic venous disease (CVD). METHODS: A large randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate treatment effects on vesperal oedema using water displacement volumetry (WDV). Other criteria were leg pain\heaviness assessed by Visual Analog Scale (VAS) and Quality Of Life Questionnaire (CIVIQ-20). Study treatments were administered once a day for 4 months. The tolerance to the study treatments was assessed based on spontaneously reported adverse events, coded using the MedDRA dictionary. The present post-hoc analysis focuses on the subgroup of symptomatic patients having a baseline VAS>4 cm. RESULTS: The main study included 1137 patients classified C3 or C4 according to CEAP classification, with 592 in the symptomatic subgroup: 296 randomized to MPFF and 296 to placebo. Patient demographics and medical history were well-balanced at baseline. The main study was inconclusive on WDV for methodological reasons. In the symptomatic subgroup, MPFF treatment was associated with a greater reduction in VAS score than on placebo treatment (between-group difference =-0.5 cm; P=0.031) and greater improvement in CIVIQ score (between-group difference =3.1%; P=0.040). CONCLUSION: A 4-month treatment with MPFF significantly reduced leg pain/heaviness and improved QOL when compared to placebo and was well tolerated.

Double-blind comparison of nimesulide and diclofenac in the treatment of superficial thrombophlebitis with telethermographic assessment.

A total of 60 patients with acute varicophlebitis or acute superficial thrombophlebitis of the lower limbs were recruited to this randomised double-blind comparative study, which evaluated the efficacy and tolerability of oral nimesulide (100mg twice daily) with those of diclofenac (50 mg/kg twice daily) over a period of < or = 20 days (average duration 13.6 days for nimesulide and 12.6 days for diclofenac). The analgesic effect of both drugs was rapid. Spontaneous pain disappeared within 3 to 5 days of commencing therapy, and pain on palpation within 7 days. Reduced inflammation was observed after approximately 15 days, and total resolution of redness and swelling was observed by day 20. Telethermographic assessment showed a reduction in local temperature, either in absolute terms or in the extent of inflammation. Indeed, 93% of patients showed complete recovery while 7% of patients showed a partial reduction in hyperthermia. For these latter patients, medical treatment was extended, although the subjective symptoms of the disease were no longer present. The comparison between nimesulide and the reference drug, diclofenac sodium, showed no significant difference for any of the considered parameters. Both drugs were well tolerated and no patient reported an adverse event.

Observations on the Raynaud's disease.

During the last 25 years, owing to the improvement of the diagnostic means, the cases of "Raynaud's phenomenon" with well known etiology have been increasing and according to some authors they should be considered clearly prevailing. Through a right prevention and a medical and surgical therapy it is possible to obtain significant results. Consequently it is important to carry out a diagnostic screening. A study concerns 68 cases have been carried out in the Institute of Vascular Surgery, University of Milan, during the period 1971-1974. The cases are divided in two groups: idiopathic forms (disease) and forms connected to identifiable etiologies (syndrome). Many of the clinical parameters studied are examined. The so-called idiopathic forms: 47 cases (69%) with an average age of 45 years and a clear female prevalence (33 against 14). The forms with an identifiable etiology: 21 (31%) with an average age of 31 years and a clear male prevalence (16 against 5). It is therefore observed that the idiopathic Raynaud's disease is still prevailing and particularly in women. In idiopathic forms brachial angiography shows in most of the cases X-ray evidence of digital artery occlusion.

Bypass procedures in the management of juxtarenal aortic occlusion.

Juxtarenal aortic occlusion is one of the most important though less frequent atherosclerotic lesions. The indications for surgical treatment using bypass techniques, are well known. However, controversy remains about the pathogenesis of the lesion; from either a thrombosis developing on an atherosclerotic lesion of the terminal aorta, or a primary atherosclerosis of the subrenal aorta. In our series of 1,180 patients submitted to surgery for aorto-iliac occlusive disease, we encountered 91 cases (7.7%) of juxtarenal occlusion. Apart from the different angiographic pictures, the patients were grouped on the operative finding of either thrombosis or atheroma. An aortobifemoral bypass graft was implanted on all but three of the cases; in these three we performed an axillo-bifemoral bypass. A different technique was used, for juxtarenal disobliteration, using a different (end-to-end, or end-to-side) suture of the proximal anastomosis. The operative indications and results are discussed.

Optimal site for proximal and distal anastomoses in AAAs repair.

The replacement of straight graft for vascular aortic reconstruction, in the elective treatment of aortic and aorto-iliac aneurysms, is advisable and requires only two anastomoses and a low surgical risk. In our report we have tried to identify the simplest vascular reconstruction for juxtarenal involvement (15% in our experience), reducing the surgical time and the operative (or postoperative) injuries. The decision to employ the tube or the bifurcated reconstruction depends on the surgeon's assessment of the degree of common iliac dilatation, the presence of an iliac aneurysm or the concomitance of occlusive disease of the iliac-femoral district. Some authors extend the bifurcated repair to prevent the possible future occlusive events or iliac dilatation. We have much information about the natural history of aortic aneurysms but we have also to define the indications for a valuable surgical reconstruction. We have considered a consecutive series of 20 patients who underwent elective aortic and aorto-iliac aneurysm repair in S. Rita private hospital; in 13 patients (65%) the aneurysms were treated with tube grafts, the other patients received bifurcate grafts: 3 (15%) aorto-bisiliac, 2 (10%) aorto-bifemoral and 2 (10%) right aorto-iliac and left aortofemoral bypass procedure. We employed Crawford's inclusion in the juxtarenal involvements, generally without the reimplantation of renal arteries, extending the tube repair in the aorto-iliac dilatation, obtaining a simplification of the surgical procedures. The use of straight graft allows a sensible decrease of surgical operating time, a reduction of hematic loss and a very low incidence of postoperative injuries; this solution became possible also in some selected forms of aneurysmatic involvement of renal arteries.(ABSTRACT TRUNCATED AT 250 WORDS)

Thrombectomy for late graft limb occlusion: our experience in 182 consecutive cases.

Late occlusion of an aortofemoral bypass graft is usually caused by fibrointimal hyperplasia or progressive atherosclerosis. Several surgical approaches have been advocated in order to minimize the operative risk, to correct the impaired inflow and to provide a satisfactory outflow. In the last 16 years, in the Institute of Vascular Surgery and Angiology of the University of Milan, we have operated upon 182 consecutive thrombosed grafts. Inflow was restored by performing a graft limb thrombectomy using a Fogarty balloon catheter and simultaneously employing an endarterectomy ring stripper to dislodge tenaciously adherent fibrinous material and thrombotic plug. As the superficial femoral artery was generally occluded, usually a good outflow was achieved by profundaplasty in 101 cases (55.5%) or direct bypass (interposition graft), to a more distal segment of the profunda femoris artery in 55 cases (30.2%). Concomitant popliteal or tibial revascularization was done in the remaining 26 cases (14.3%) when pre-operative or intra-operative findings suggested an inadequate collateral network through the profunda femoris artery. Early re-occlusion, which occurred in 14 cases (7.6%), generally due to insufficient outflow, was corrected by additional intervention in 7 cases (3.8%), while 7 legs were amputated for extensive atherosclerotic disease. Six patients died giving a mortality rate of 3.3%. This low rate in a high risk population is probably related to our policy of operating under loco-regional anaesthesia. Long term results, with a patency rate of 62.0% at 3 years and 60.2% at 5 years (life table method), prove that this operation is a durable procedure for correction of graft limb thrombosis.

Femoral noninfected anastomotic aneurysms. A report of 56 cases.

Fifty-six femoral non infected anastomotic false aneurysms (FAAs) were observed in 49 patients admitted to the Institute of Vascular Surgery, University of Milan, from 1975 to 1988; in 6 patients they were bilateral. These aneurysms developed after primary revascularization procedures at a mean interval of 66 months (range 12 to 156 months); one recurred after reparative surgery. Forty-four FAAs (78.6%) were asymptomatic, whereas 3 (5.3%) were complicated by acute expansion and 9 (16.1%) by thrombosis. Host vessel degeneration was the cause of aneurysm formation in most cases. A history of hypertension was present in 30% of the patients. All anastomotic aneurysms were operated upon except for one small aneurysm that was asymptomatic. In 5 patients aneurysm resection was carried out on both sides. The surgical technique was endoaneurysmectomy in all the cases with insertion of an interposition graft in 48 cases, a fabric patch in 2 cases and prosthesis re-anastomosis in 5 cases. One case of peripheral embolization occurring in the early postoperative period was successfully treated and there was no operative mortality. In our opinion elective repair of these aneurysms should be recommended whenever possible because of their propensity to develop serious complications and the operative morbidity is low.

Slow release nifedipine in the treatment of Raynaud's phenomenon.

An ever increasing interest is shown towards calcium-antagonist drugs and in particular to nifedipine in the treatment of Raynaud's Phenomenon (R.P.) On this matter a randomized double-blind study with 40 mg/die slow release nifedipine versus placebo was carried out for 30 days on 24 patients affected by R.P.-idiopathic in 16 cases and secondary in the remaining 8 cases. The evaluation of the clinical situation (hand ischemic attacks, pain, skin trophism) and the structural one (capillaroscopy of the finger nail bed and strain-gauge digital plethysmography) could be performed on 17 patients since 7 dropped out. From the clinical point of view an improvement was observed especially in the reduction of the ischemic attacks (88.8% of patients treated with nifedipine vs. 25.0% treated with placebo). Capillaroscopic results showed an improvement in 100% of the cases treated with nifedipine vs. 12.5% with placebo (p less than 0.001), as well as an improvement of the basal digit blood pressure values and after cold test in 88.8% of patients treated with nifedipine vs. 12.5% treated with placebo (p less than 0.005) and (p less than 0.0025) respectively.

The role of regional nerve block anesthesia for carotid endarterectomy: an experimental comparison with previous series with the use of general anesthesia and barbiturates for cerebral protection.

A retrospective analysis was performed on a consecutive series of 60 cases divided into two groups given carotid endarterectomy (C.E.) for atherosclerotic disease. In the first group general anesthesia and barbiturate cerebral protection were employed; in group two, loco-regional anesthesia. Indications and risk factors were similar in the two groups; the surgical procedure was identical. The differences in the results are reported and factors contributing to cerebral protection or reduction in the risk of stroke are analyzed. The analysis indicates that loco-regional anesthesia for C.E. is a reliable method for detecting cerebral ischemia and guaranteeing cerebral protection by means of a temporary shunt when strictly necessary.

Tissue response to an expanded polytetrafluoroethylene external valve support device: a histologic study in dogs.

Expanded polytetrafluoroethylene (ePTFE) external valve support devices (EVS) have been used successfully in patients to restore valve function in leg veins with incompetent valves when incompetence is due to dilatation of the vein walls or elongation of the valve leaflet edges. To assess tissue response to these devices, the authors implanted 12 of them in dogs, wrapping the devices around veins in the head and neck. The dogs recovered from the implantation procedure uneventfully, and the veins remained patent on color flow Doppler scanning. Gross and histologic evaluations of vein segments and attached EVS devices after sacrifice of the dogs 30 days postoperatively showed that the ePTFE devices did not affect vein patency or the cellular composition or architecture of vein walls. There were no adverse tissue reactions to the EVS and no thrombus formation in the veins to which the EVS had been applied. Tissue attachment to the EVS was apparent in all specimens. These histologic results support clinical experiences indicating that the ePTFE EVS device is safe to use in external valvuloplasty for the treatment of venous incompetence.

Treatment of long-distance intermittent claudication with pentoxifylline: a 12-month, randomized trial.

The efficacy, safety, and cost of pentoxifylline (PXF) in long-range (>400 m interval) intermittent claudication was studied comparing PXF and placebo in a 12-month study. A standardized treadmill test was performed at inclusion and at 6 and 12 months. A training plan based on walking was associated with the control of risk factor levels. Of the 194 included patients, 135 completed the study: 75 in the PXF group and 60 in the placebo group. There were 59 dropouts (due to low compliance). The authors observed a 148% increase in total walking distance (TWD) at 6 months with PXF (vs 110% with placebo; p<0.05); at 12 months, the increase was 170% with PXF (vs 131% with placebo; p<0.02). There was a 38% difference at 6 months and 39% at 12 months in favor of PXF. Treatment was well tolerated. In conclusion, PXF improved walking distance significantly better than placebo.

Treatment of intermittent claudication with pentoxifylline: a 12-month, randomized trial--walking distance and microcirculation.

The efficacy, safety and cost of pentoxifylline (PXF) in severe intermittent claudication was studied comparing PXF and placebo in a 12-month study. A treadmill test and microcirculatory evaluation with laser Doppler flowmetry were performed at inclusion and at the end of 6 and 12 months. A physical training plan (based on walking) and reduction in risk factor levels plan was used in both groups. Of the 120 included patients, 101 completed the study: 56 in the PXF group and 45 in the placebo group. There were 19 dropouts (due to low compliance). The two groups were comparable for age, sex distribution, walking distance, and the presence of risk factors and smoking. Intention-to-treat analysis indicated a 268% increase in walking distance in the PXF group (vs 198% in the placebo group; p<0.05) at 6 months and an increase of 404% (vs 280% in the placebo group; p<0.02) at 12 months. The absolute and percent increase in pain-free walking distance (PFWD) was greater in the PXF group (p<0.05). Treatment was well tolerated. No serious drug-related side effects were observed. Microcirculatory evaluation indicated an increase in flux (p < 0.05) in the PXF group (not significant in the placebo group); the after-exercise flux (AEF) was increased (p<0.05) in both groups at 6 months but the increase in AEF was greater in the PXF group at 12 month. In conclusion, between-group analysis favors PXF considering walking distance and microcirculatory parameters. Results indicate good efficacy and tolerability.

'Real' epidemiology of varicose veins and chronic venous diseases: the San Valentino Vascular Screening Project.

The aim of this study was to evaluate the prevalence and incidence of venous diseases and the role of concomitant/risk factors for varicose veins (VV) or chronic venous insufficiency (CVI). The study was based in San Valentino in Central Italy and was a real whole-population study. The study included 30,000 subjects in eight villages/towns evaluated with clinical assessment and duplex scanning. The global prevalence of VV was 7%; for CVI, the prevalence was 0.86% with 0.48% of ulcers. Incidence (new cases per year) was 0.22% for VV and 0.18% for CVI; 34% of patients with venous disease had never been seen or evaluated. The distribution of VV and CVI in comparison with duplex-detected incompetence (DI) indicates that 12% of subjects had only VV (no DI), 2% had DI but no VV, 7.5% had DI associated with VV, 2% apparent CVI without DI, 3% DI only (without CVI), and 1.6% both CVI and DI. VV associated with DI are rapidly progressive and CVI associated with DI often progresses to ulceration (22% in 6 years). VV without significant DI (3%) and venous dilatation without DI tend to remain at the same stage without progression for a lengthy time. New cases per year appear to have a greater increase in the working population (particularly CVI) possibly as a consequence of trauma during the working period. In older age (>80 years), the incidence of CVI tends to decrease. Ulcers increase in number with age. Only 22% of ulcers can be defined as venous (due to venous hypertension, increased ambulatory venous pressure, shorter refilling time, obstruction and DI). Medical advice for VV or CVI is requested in 164 subjects of 1,000 in the population. In 39 of 1,000, there is a problem but no medical advice is requested and in only 61 of 1,000, the venous problem is real. In VV in 78% of limbs, there is only reflux, in 8% only obstruction, and in 14% both. In CVI, 58% of limbs have reflux, 23% obstruction, and 19% both. In conclusion, VV and CVI are more common with increasing age. The increase with age is linear. There was no important difference between males and females. These results are the basis for future real, whole population studies to evaluate VV and CVI.

Superficial vein valve repair with a new external valve support (EVS). The IMES (International Multicenter EVS Study).

The aim of this international multicenter trial was to evaluate the effects of a new surgical device (Gore External Valve Support-EVS) and technique for external valvuloplasty of the long saphenous vein (LSV). Patients with superficial venous disease and venous hypertension due to pure superficial venous incompetence were randomized into two treatment groups, the first treated with "conventional treatment" (ligation or stripping) and the second with external valvuloplasty with the EVS. Patients with uncomplicated varicose veins within the age range of 35-65 years were included. Incompetence with presence of functional cusps at the saphenofemoral junction (SFJ), with vein dilatation were the main inclusion criteria. The EVS comprised of a GORE-TEX patch material (including a nitinol frame) that is placed around the vein, producing a reduction in the caliber of the vein. Also the vein section becomes elliptical. These combined actions are aimed to reduce incompetence, allowing a better closure of the cusps. The EVS was placed at the SFJ after limited dissection of the vein and ligation of collaterals. The procedure was randomized as an alternative to simple ligation or stripping (according with the procedure commonly used in the center). The associated ligation of distal incompetent veins was allowed. The main outcome measures of the study were evaluated by color-duplex (morphologic findings and evaluation of reflux) and with ambulatory venous pressure (AVP) or air-plethysmography (APG). Main endpoints of the first year of the study and main subject of this report (mainly concerning safety within the first year of follow-up) were considered presence/absence of reflux; patency of the veins; mobility/function of vein cusps; occurrence of thrombosis; tolerability of the device; and increased complexity and operating time needed for the EVS. At 1 year 30 patients had been randomized (14 EVS implanted, 16 controls). Reflux was absent in all EVS patients, all treated veins were patent, and all cusps were mobile. No thrombosis had been observed and the tolerability of the device was very good. The increased complexity required by placing the EVS was limited (5-12 minutes more). In conclusion results of the first year show efficacy and tolerability of the EVS. In selected patients (superficial LSV incompetence, reflux-dilatation, functional SFJ cusps, incompetence mainly due to enlargement of the vein), the EVS could be an effective alternative to "destructive" ligation and/or stripping of the vein. Prolonged follow-up will indicate the clinical potentials of the EVS.