M.T. De Sanctis

Superficial thrombophlebitis of the legs: a randomized, controlled, follow-up study.

The aim of the present study was to evaluate the effects of different treatment plans (compression only, early surgery, low-dose subcutaneous heparin [LDSH], low- molecular-weight heparin [LMWH], and oral anticoagulant [OC] treatment) in the management of superficial thrombophlebitis (STP), by considering efficacy and costs in a 6-month, randomized, follow-up trial. Patients with STP, with large varicose veins without any suspected/documented systemic disorder, were included. Criteria for inclusion were as follows: presence of varicose veins; venous incompetence (by duplex); a tender, indurated cord along a superficial vein; and redness and heat in the affected area. All patients were ambulatory. Exclusion criteria were obesity, cardiovascular or . neoplastic diseases, bone/joint disease, problems requiring immobilization, and age > 70 years. Patients with superficial thrombophlebitis without varicose veins and patients under treatment with drugs at referral were also excluded. Color duplex (CD) was used to detect concomitant deep vein thrombosis (DVT) and to evaluate the extension or reduction of STP at 3 and 6 months. Venography was not used. Of 562 patients included, 3.5% had had a recent DVT in the same limb affected by SVT and 2.1% in the contralateral limb. In six patients DVT was present in both limbs. These patients were treated with anticoagulants and excluded from the follow-up. After 3 and 6 months the incidence of STP extension was higher in the elastic compression and in the saphenous ligation groups (p < 0.05). There was no significant difference in DVT incidence at 3 months among the treatment groups. Stripping of the affected veins was associated with the lowest incidence of thrombus extension. The cost for compression alone was the lowest and the cost including LMWH was the highest. The average cost was 1,383 US

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

. However the highest social cost (lost working days, inactivity) was observed in subjects treated only with stockings.

Comparison of Low-Molecular-Weight Heparin, Administered Primarily at Home, with Unfractionated Heparin, Administered in Hospital, and Subcutaneous Heparin, Administered at Home for Deep-Vein Thrombosis

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 conclu sion, 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.

Pressure and microcirculatory effects of treatment with lercanidipine in hypertensive patients and in vascular patients with hypertension

In this study, 294 patients with acute proximal DVT (deep venous thrombosis) were randomly assigned to receive intravenous standard heparin in the hospital (98 patients) or low-molecular-weight heparin (LMWH) (nadroparin 0.1 mL [equivalent to 100 AXa IU] per kg of body weight subcutaneously twice daily) administered primarily at home (outpatients) or alternatively in hospital (97 patients) or subcutaneous calcium heparin (SCHep) (99 patients, 0.5 mL bid) administered directly at home. The study design allowed outpatients taking LMWH heparin to go home immediately and hospitalized patients taking LMWH to be discharged early. Patients treated with standard heparin or LMWH received the oral anticoagulant starting on the second day, and heparin was discontinued when the therapeutic range (INR 2-3) had been reached. Anticoagulant treatment was maintained for 3 months. Patients treated with SCHep were injected twice daily for 3 months without oral anticoagulants. Patients were evaluated for inclusion and follow-up with color duplex scanning. Venography was not used. In case of suspected pulmonary embolism (PE) a ventilatory-perfusional lung scan was performed. Endpoints of the study were recurrent or extension of DVT, bleeding, the number of days spent in hospital, and costs of treatments. Of the 325 patients included, 294 completed the study. Dropouts totaled 31 (10.5%); six of the 325 included patients (1.8%) died from the related, neoplastic illness. Recurrence or extension of DVT was observed in 6.1% of patients in the LMWH group, in 6.2% in the standard heparin group, and in 7.1% in the SCHep group. Most recurrences (11/17) were in the first month in all groups. Bleedings were all minor, mostly during hospital stay. Hospital stay in patients treated with LMWH was 1.2 ± 1.4 days in comparison with 5.4 ± 1.2 in those treated with standard heparin. There was no hospital stay in the SCHep group. Average treatment costs in 3 months in the standard heparin group (US

Two-week topical treatment with Essaven gel in patients with diabetic microangiopathy--a placebo-controlled, randomized study.

2,760) were considered to be 100%; in comparison costs in the LMWH group was 28% of the standard heparin and 8% in the SCHep group. This study indicated that LMWH and SCHep can be used safely and effectively to treat patients with proximal DVT at home at a lower cost.

Effects of Shock Waves on the Microcirculation in Critical Limb Ischemia (CLI) (8-Week Study)

The aim of this study was to evaluate the macrocirculatory and microcirculatory effects of treatment with lercanidipine, a new antihypertensive agent acting both on blood pressure and microcirculation in patients with moderate essential hypertension and without vascular disease and in patient with hypertension and vascular disease. In hypertensive subjects target-organ damage associated with high blood pressure may now be objectively documented by noninvasive tests. These alterations constitute a model to evaluate not only the pressure effects of antihypertensive treatment but also the normalization of the peripheral microcirculatory network. With color duplex scanning, flow velocity in the central retinal artery and retinal flow velocity can be measured and with use of laser-Doppler-flowmetry, it is also possible to evaluate microcirculation alterations in hypertensive subjects. These evaluation methods are completely noninvasive and may be used to assess the microcirculatory effects of antihypertensive drugs.

Expanded polytetrafluoroethylene in external valvuloplasty for superficial or deep vein incompetence.

The pulmonic valve is the least commonly involved valve in infective endocarditis. Pulmonic valve endocarditis is usually associated with tricuspid valve endocarditis, and isolated pulmonic valve endocarditis is exceedingly rare. The predisposing factors for developing pulmonic valve endocarditis include a congenitally anomalous pulmonic valve, intravenous drug abuse, and the presence of indwelling intravenous or flow-directed pulmonary artery catheters. More cases of group B streptococcus endocarditis are being reported. The risk factors for group B strepto coccus endocarditis include diabetes mellitus, cancer, alcoholism, malnutrition, immunocom promised status, intravenous drug abuse, postpartum and postabortion states, and underlying valvular disease. The vegetations of this type of endocarditis are usually large and have a higher tendency to result in embolism. The presentation of group B streptococcus endocarditis is usually acute and may result in rapid valve destruction if not treated promptly. A case of isolated pulmonic valve endocarditis caused by group B streptococcus, Streptococcus agalac tiae, is presented that was diagnosed with multiplane transesophageal echocardiography in a 40-year old, alcoholic, malnourished man, who was successfully treated with intravenous peni cillin G. The literature on the isolated pulmonic valve endocarditis caused by group B strepto coccus is reviewed.

Epidemiology and costs of venous diseases in central Italy. The San Valentino Venous Disease Project.

Shock waves (SWs) are used to control and decrease pain in several clinical conditions (eg, painful elbow and shoulder, etc). This clinical effect may be due to cellular stunning of the tissues (particularly nervous components) in the area treated with SW. It may also be the consequence of unknown metabolic actions on tissues, which may include changes in cellular permeability and the liberation of proteins and mediators locally acting on pain and nerve endings. The aim of this study was to evaluate the reduction in pain and the microcirculation improvement induced by SWs treatment in an 8-week study in patients with chronic limb ischemia (CLI). Patients with CLI (15 with rest pain only and 15 with rest pain and limited distal necrosis) were included. The treatment was based on a 30-minute SWs session, three times weekly for 2 weeks. Clinical and microcirculatory evaluation were performed with laser Doppler PO 2 and PCO2 measurements. Pain was measured with an analogue scale line. A Minilith SL1 (Storz Medical, Switzerland) litotriptor was used. The parabolic reflector is coupled to the skin with a silicon water cushion. Focal pressure was adjusted between 6 and 70 Mpa in eight steps. The energy flux density was variable from 0.03 to 0.5 mJ/mm2. Focal diameter and distance were defined (depth of target within the patients foot of about 70 mm). The coded intensity used in this study was between 6 and 8 and the application time was 20 min (at four impulses per second). Twenty-eight of the 30 patients with CLI (15 with rest pain only and 13 with necrosis) completed the study. The treatment was well tolerated. Blood pressure was unchanged after 8 weeks while the increase in laser Doppler flux was significant (p<0.05) (at all measurements after treatment). The ORACLE score at 1 and 8 weeks was decreased (p < 0.05). The same trend was observed with the analogue scale line for pain (p < 0.05). PO2 increased (p < 0.05) and PCO2 decreased (p < 0.05). Tibial pressure did not change. All patients observed an increase in their subjective pain-free walking distance. The improvement was still present after 8 weeks. In a separate subset of 37 patients (mean age 60 ±9 years; males) with CLI, a SWs dose-finding evaluation was performed. Flux changes were measured at the dorsum of the foot. Three treatment plans were used: (a) 20-minute SW treatment only once; (b) 20-minute SWs treatment every 2 days for 1 week; (c) 20 minutes every day for 1 week. Treatments were well tolerated. A different increase in flux was observed on the basis of different treatments. Flux vari ations generally indicated that increased SWs dosage was associated with proportional flux increase. Flux improvement was still present after 4 weeks. SWs treatment in CLI produced changes both in the microcirculation and on pain. These preliminary results are comforting and open new research options to be explored in the near future.

Treatment of Superficial Vein Thrombosis with Standardized Application of Essaven Gel A Placebo-Controlled, Randomized Study

The authors evaluated the long-term safety of expanded polytetrafluoroethylene (ePTFE) implants used in external valvuloplasty for treatment of incompetence of the long saphenous and common and superficial femoral veins. During a 15-year period patients with superficial and/or deep venous disease and hypertension due to pure superficial or deep vein incompetence underwent an external valvuloplasty with ePTFE sutures, or an ePTFE cardiovascular patch placed as a sleeve around the incompetent vein segment, or an ePTFE tubular graft placed around the venous segment. Postoperative follow-up evaluations consisted of clinical examinations, high-resolution ultrasonography, and color duplex scanning, and a complete blood count performed at 1, 3 and 6 months, and repeated for at least 4 years, every 2 years after the procedure. A total of 101 patients (38 men and 63 women; mean [± sd] age, 44 ±12 years) underwent external valvuloplasty between January 1983 and December 1998; 82 of them completed the 4-year follow-up. Forty of the 82 patients had been operated on for superficial vein incompetence, 42 for deep vein incompetence. Overall, the mean follow- up time was 7.8 ± 3.6 years (range, 4 to 13). There were no infections, thromboses, foreign-body reactions to the ePTFE implants, or other prosthesis-related complications requiring explantation. One granuloma (noninfected) developed in association with a tubular ePTFE implant around a long saphenous vein, but it did not necessitate implant removal. Seven patients required (at least after 4 years) a second procedure for recurrent or new venous incompetence. Therefore, in this observational study, ePTFE implants used to treat or correct venous incompetence were well tolerated on a long- term basis.

Treatment of superficial vein thrombophlebitis of the arm with Essaven gel. A placebo-controlled, randomized study

The Prevalence of Early Atherosclerosis study aims to define the prevalence of subclinical atherosclerosis in a typical population of central Italy. A concomitant study evaluates the prevalence of venous diseases. The prevalence of superficial and deep venous disease, the prevalence of venous thrombosis and pulmonary embolism, and the prevalence of the most common venous malformations were studied through use of medical history, a questionnaire, and noninvasive investigations. The costs of venous problems were also considered. Of some 2000 inhabitants, 746 (379 women; mean age 46.3 ±7 years; range eight to nienty-four) have been screened. No significant difference in trend increase of the rela tionship age/percent of subjects with venous problems was observed for superficial venous disease. The increase in the proportion of subjects with lipodermatosclerosis and venous ulcerations appeared to be correlated with age (r=0.543). Evidence accepted for pulmonary embolisms was pulmonary angiogram or evidence on ventilation+perfusion lung scans. According to these criteria the number of documented deep vein thromboses and pulmonary embolisms was very limited with a larger number of suspected disease entities. There was no significant correlation between age and pulmonary embolism or deep venous thrombosis distribution. The number of venous and/or arteriovenous malfor mations was comparable along the age axis in the different age groups. Only a limited number of these malformations (in less that 1% of subjects) had caused a clinical problem. The treatments used for venous problems have been reported in a question naire and subdivided into occasional treatments and chronic treatments (when used for periods longer than twelve months). The percent of subjects using different treatment was also studied. Treatments were divided in: (1) over-the-counter products (or any treatment not requiring prescription); (2) specialized drug (for venous diseases); (3) compression; (4) surgery (any type of surgical treatment); (5) sclerotherapy; (6) combined treatments (ie, sclerotherapy and surgery); (7) alternative treatments (herbal products etc). Finally, the average costs per year for treatment, for investigations, and the costs due to lost working days were recorded. In conclusion some 12% of the evaluated population sample (male population 46%) had or had been affected in the past by a venous problem and 50% of them had received some type of treatment.