Vitrified medical wastes bottom ash in cement clinkerization. Microstructural, hydration and leaching characteristics.

The present investigation focuses on the utilization of medical wastes incineration bottom ash (MBA), vitrified with soda lime recycled glass (SLRG), as an alternative raw material in cement clinkerization. Bottom ash is recovered from the bottom of the medical wastes incineration chamber, after being cooled down through quenching. It corresponds to 10-15 wt% of the initial medical wastes weight and since it has been classified in the category of hazardous wastes, its safe management has become a major environmental concern worldwide. MBA glasses of various syntheses were initially obtained during the MBA vitrification simultaneously with various amounts of silica scrap (20, 25 and 30 wt% correspondingly). The produced MBA glasses were in turn used for the production of Portland cement clinker, after sintering at 1400 °C, thus substituting traditional raw materials. Both evaluation of vitrification and sintering products was carried out by chemical and mineralogical analyses along with microstructure examination. The final cements were prepared by clinkers co-grinding in a laboratory ball mill with appropriate amounts of gypsum (≈5.0 wt%) and the evaluation of their quality was carried out by determining setting times, standard consistency, expansibility and compressive strength at 2, 7, 28 and 90 days. Finally, the leaching behaviour of the vitrified MBA and hydrated cements, together with the corresponding of the "as received" MBA, was further examined using the standard leaching tests of the Toxicity Characteristic Leaching Procedure (TCLP) and the EN 12457-2. According to the obtained results, the quality of the produced cement clinkers was not affected by the addition of the vitrified MBA in the raw meal, with the trace elements detected in all leachates measured well below the corresponding regulatory limits.

Descending phlebography in patients with venous ulceration: hemodynamic implications.

AIM: The aim of this paper is to report on the hemodynamic significance of the various degrees reflux as demonstrated on descending phlebography, by comparing the phlebographic findings with ambulatory venous pressure (AVP) measurements. METHOD: Thirty-two patients (45 affected limbs) with active or healed venous ulceration were admitted to the study. Descending phlebography with grading of reflux (0-4 using Herman's grading), AVP and refilling time 90 (RT90) were performed in all patients. In addition, the presence of deep to superficial reflux into the great saphenous vein at the sapheno-femoral junction, thigh incompetent perforating veins, small saphenous vein at the saphenopopliteal junction and incompetent calf perforating veins was recorded using ascending functional phlebography. The examined limbs were separated into two groups according to the Grade of reflux. Group I consisted of limbs in which popliteal valve incompetence was not demonstrated on descending phlebography, i.e., Grades 0-2 (18 limbs). Group II consisted of limbs with popliteal reflux as demonstrated by descending venography, i.e., grades 3 and 4 (27 limbs). RESULTS: In Group I the mean AVP ± SD was 47.2 ± 9.3 mmHg (range 31-67 mmHg). After the application of the ankle tourniquet to exclude the effects of the superficial venous incompetence on the pressure recordings, the mean AVP ± SD became 28.1 ± 9.9 mmHg (range 11-44) (paired t test: P < 0.001). In Group II (limbs with incompetent popliteal valves) the mean AVP ± SD was 71.6 ± 12.7 mmHg (range 49-95 mmHg) before the tourniquet. This was significantly higher than in Group I (t test: P < 0.001). The application of the ankle tourniquet in this group produced a small but significant decrease in the AVP (mean AVP ± SD: 66 ± 14.5 mmHg) (paired t test: P < 0.001). CONCLUSION: Incompetence of the femoral valves in the presence of competent popliteal valves adds very little to the hemodynamic abnormality produced by superficial venous reflux. In the majority of these patients, there is co-existing reflux from deep to superficial veins with associated superficial valve incompetence which is responsible for the venous hypertension, skin changes and ulceration. The hemodynamic changes which in the past had been associated with deep venous insufficiency (AVP >45 mmHg and RT90 < 14 seconds despite the application of an ankle tourniquet) occur only when there is popliteal incompetence.

Safe carotid artery angioplasty and stenting in patients unsuitable for transfemoral approach.

AIM: The aim of this study was to use the maximum of all the protective measures to make carotid angioplasty and stenting (CAS) a safe procedure. METHODS: Twenty patients with severe carotid disease have been treated. These patients were considered as high risk for carotid endarterectomy and not suitable for transfemoral CAS for anatomic reasons. Transcervical approach to the common carotid (CCA) and the internal jungular vein (IJV) has been used. The vessels were cannulated with introducing sheaths and the flow in the internal carotid (ICA) was reversed by occluding the proximal CCA and creating a fistula with the IJV by connecting the two sheaths. The carotid lesion was crossed under retrograde flow and a filter was positioned and opened in the distal ICA. Antegrade flow was then resumed and CAS was performed. RESULTS: All procedures were successful and uneventful with the exception of transient hypotension in 3 patients. The mean time of flow reversal was less than 1.5 min. Seventeen patients were discharged the following morning and 3 on the subsequent day, because of hypotension. CONCLUSION: The results of this preliminary study indicate that the combination of several protective measures for CAS is effective. Further series are required to confirm our findings.

Hemodynamic follow-up of iliofemoral venous thrombosis.

AIM: The aim of this pilot study was to assess the venous hemodynamic changes after deep venous thrombosis (DVT) using air-plethysmography (APG) and to study the rate and magnitude of these changes in relation to those associated with the post-trombotic syndrome. METHODS: Twenty limbs of 19 patients with acute iliofemoral thrombosis have been followed up with APG and Duplex scanning for 24 months. Patients were treated with anticoagulation and elastic stockings. The air-plethysmographic measurements of venous outflow and functional venous volume were measured on admission. These measurements, as well as venous reflux and calf muscle pump ejecting capacity, have been performer after one week, one month and 3, 6, 12, 18 and 24 months. The results were compared with similar measurements of 10 normal limbs and 10 post-thrombotic limbs with chronic venous ulcers. Duplex scanning was performed on admission, in six and 24 months. RESULTS: Plethysmographic parameters showed a dramatic improvement in the first month, fast improvement after three months and slower improvement thereafter, with the exception of the development of marked venous reflux in five of the 20 limbs studied, in the first three months. Popliteal reflux was diagnosed in these limbs. Elastic compression protected the patent veins from overdistention and incompetence and contributed to the relatively good calf muscle pump function during the first year after DVT. By the end of the study no patient had post-thrombotic changes, but four patients needed elastic stockings in order to avoid edema. CONCLUSIONS: The most important hemodynamic alterations occurred during the first three months after DVT. This is the crucial period during which conservative treatment needs to be improved. Further work is required in this field to study the effect of various newly emerging methods. The air-plethysmographic measurements described may become surrogate endpoints for testing different therapies.

S-shaped ilio-mesenteric bypass in a young high risk patient.

Symptomatic chronic mesenteric ischemia is a rare condition. Several surgical and endovascular techniques have been described, but treatment is individualized according to the conditions of each patient. We report a successful superior mesenteric artery revascularization by using an S-shaped retrograde polytetrafluoroethylene ilio-mesenteric bypass graft in a young overweight patient with a history of two abdominal vascular operations and several comorbidities.

Helix formation in linear achiral dendronized polymers: a computer simulation study.

We present a molecular simulation study of the structure of linear dendronized polymers. We use excluded volume interactions in the context of a generic coarse grained molecular model whose geometrical parameters are tuned to represent a poly(paraphenylene) backbone with benzyl ether, Frechet-type dendrons. We apply Monte Carlo sampling in order to investigate the formation of packing-induced chiral structures along the polymer backbone of these chemically achiral systems. We find that helical structures can be formed, usually with defects consisting of domains with reversed helical handedness. Clear signs of helical arrangements of the dendrons begin to appear for dendritic generation g=4, while for g=5 these arrangements dominate and perfect helices can be observed as equilibrium structures obtained from certain types of starting configurations.

'On-line' alterations of contralateral jugular blood gas profile during carotid clamping.

The aim of this work was to record the metabolic status of the brain (pH, PCO(2) and PO(2)) during carotid endarterectomy (CEA), with the use of an intravascular multiparameter sensor (Paratrend 7) via retrograde catheterization of the contralateral jugular vein. Twenty-four patients with ASA grades II and III scheduled for CEA were included in the study. After induction of anesthesia, the contralateral internal jugular vein was punctured retrogradely and the sensor was introduced. During clamping, pH became persistently more acidotic (7.34-7.31; p < 0.05), PCO(2) was elevated (43.2-46.8 mm Hg; p < 0.05) while most of the patients showed a non-significant decrease in PjvO(2)/SjvO(2) (jv = jugular venous). Correlation with clamping time or stump pressure was not significant. Unclamping was followed by a short period (5- 9 min) of decrease in pH and elevation of PCO(2) (7.30-7.22; p < 0.05, and 48.0-52.5 mm Hg; p < 0.05, respectively). PjvO(2) was significantly elevated (51.8-58.0 mm Hg; p < 0.001) after the restoration of flow. The study suggests that local CO(2) creates conditions for compensation of flow after the application of a carotid clamp. We consider that this monitoring technique, after further validation, may provide useful information.

Foam-sclerotherapy, surgery, sclerotherapy, and combined treatment for varicose veins: a 10-year, prospective, randomized, controlled, trial (VEDICO trial).

The study compared, by a prospective, randomized method, 6 treatment options: A: Sclerotherapy; B: High-dose sclerotherapy; C: Multiple ligations; D: Stab avulsion; E: Foam-sclerotherapy; F: Surgery (ligation) followed by sclerotherapy. Results were analyzed 10 years after inclusion and initial treatment. Endpoints of the study were variations in ambulatory venous pressure (AVP), refilling time (RT), presence of duplex-reflux, and number of recurrent or new incompetent venous sites. The number of patients, limbs, and treated venous segments were comparable in the 6 treatment groups, also comparable for age and sex distribution. The occurrence of new varicose veins at 5 years varied from 34% for group F (surgery + sclero) and ligation (C) to 44% for the foam + sclero group (E) and 48% for group A (dose 1 sclero). At 10 years the occurrence of new veins varied from 37% in F to 56% in A. At inclusion AVP was comparable in the different groups. At 10 years the decrease in AVP and the increase in RT (indicating decrease in reflux), was generally comparable in the different groups. Also at 10 years the number of new points of major incompetence was comparable in all treatment groups. These results indicate that, when correctly performed, all treatments may be similarly effective. "Standard," low-dose sclerotherapy appears to be less effective than high-dose sclero and foam-sclerotherapy which may obtain, in selected subjects, results comparable to surgery.

[Treatment of severe intermittent claudication: ORACLE-PGE1 short term study. A randomised 40-week study. Evaluation of efficacy and costs]. / Trattamento della claudicatio intermittens severa: studio ORACLE-PGE1 short term. Registry e studio randomizzato a 40 settimane, valutazione di efficacia e costi.

BACKGROUND: The efficacy and cost of prostaglandin E1 (PGE1) in severe intermittent claudication was studied comparing a long-term protocol (LTP) with a short-term protocol (STP) in a randomised 40-week study. METHODS: Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. Treatment was performed with 2-hour infusions (60 micro g PGE1, 5 days each week for 4 weeks. In phase 3 (4-week interval period), PGE1 was administered twice a week (same dosage). In phase 4 (40 weeks), no PGE1 were used. In STP, phase 2 treatment was performed in two days by a 2-hour infusion (60 micro g PGE1 twice a day in 2 days). The same cycle was repeated every 4 weeks. A treadmill test was performed at inclusion, at the beginning of each phase and at the end of weeks 12, 16, 20 32 and 40. A progressive training plan (walking) and reduction in risk factors plan was used in both groups. RESULTS: Out of the 1276 included patients 1165 completed the study (606 in LTP group; 559 in the STP). Drop-outs were 111. The two groups were comparable in distribution, risk factors and smoking. Intention-to-treat analysis indicated an increase in pain free walking distance (PFWD). The absolute and percent increase in pain-free walking distance (PFWD) was comparable in both LTP and STP groups with a significative increase in TWD at 4 weeks. At 20 and 40 weeks increase was up to 219% in the LTP and 460% in the STP group (p<0.02). Comparable results concerning PFWD were obtained in the two groups. Both treatments were well tolerated. No side effect was observed. Local effects were observed in 8.5% of the treated subjects in the LTP and 4% in the STP. The average cost of the LTP protocol was 8786 Euro. For STP the costs was 946 (10.8% of LTP). For both protocols the cost of the infusion was 24% of the total for the LTP and 35% in the STP. Therefore 75% of the cost is not drug-related. CONCLUSIONS: In conclusion between-group-analysis favours STP considering walking distance and costs. Results indicate good efficacy and tolerability of PGE1 treatment particularly STP.

'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.

Continuous contralateral jugular acid-base and blood gas monitoring during carotid endarterectomy.

BACKGROUND: The aim of this study is to evaluate the intravascular multiparameter sensor Paratrend 7 (P7) for continuous acid-base and blood gas monitoring after retrograde jugular catheterization during carotid endarterectomy. PATIENTS AND METHODS: We studied 11 patients with history of smoking (72.7%), coronary artery disease (72.7%), hypertension (100%), diabetes mellitus (55.5%) and TIA's and/or nondisabling stroke (90.9%). The contralateral internal jugular vein was punctured retrogradely and the calibrated P7 sensor was introduced. The sensor was removed after surgery. The P7 provides continuous graphical display of pH, pCO2, and pO2, while temperature, oxygen saturation, HCO3 concentration and base excess are displayed numerically. RESULTS: Mean duration of carotid cross-clamping was 17.0 +/- 6.2 min. Mean stump pressure was 50.2 +/- 12.9 mmHg. Intraluminal shunting was not used in any operation. All sensors were easily inserted. During clamping, pH became persistently more acidic (7.31 to 7.28; p < 0.05), pCO2 was elevated (44.7 to 49.8 mmHg; p < 0.05) while, in the majority of the patients, there was a non significant decrease in pjvO2/SjvO2. Declamping was followed by a short period of decrease of pH and elevation of pCO2 reminiscent of wash out phenomena. PjvO2 was significantly elevated (53.8 +/- 5.2 to 59.0 +/- 5.8 mmHg; p < 0.001) after the restoration of flow. In one case, P7 was diagnostic for unsuccessful endarterectomy. CONCLUSIONS: P7 is useful during carotid endarterectomy providing continuous and "on-line" information on brain metabolism. It is a simple and powerful technique, which should be further investigated.

Nomograms used to define the short-term treatment with PGE(1) in patients with intermittent claudication and critical ischemia. The ORACL.E (Occlusion Revascularization in the Atherosclerotic Critical Limb) Study Group. The European Study.

Infusional, cyclic PGE1 treatment is effective in patients with intermittent claudication and critical limb ischemia (CLI). One of the problems related to chronic PGE1 treatment in vascular diseases due to atherosclerosis is to evaluate the variations of clinical conditions due to treatment in order to establish the number of cycles per year or per period (in severe vascular disease reevaluation of patients should be more frequent) needed to achieve clinical improvement. In a preliminary pilot study a group of 150 patients (mean age 67+/-12 years) with intermittent claudication (walking range from 0 to 500 m) and a group of 100 patients with CLI (45% with rest pain, and 55% gangrene; mean age 68 +/-11 years) the number of PGE1 cycles according to the short-term protocol (STP) needed to produce significant clinical improvement was preliminarily evaluated. Considering these preliminary observations, the investigators established a research plan useful to produce nomograms indicating the number of cycles of PGE1-STP per year needed to improve the clinical condition (both in intermittent claudication and CLI). A significant clinical improvement was arbitrarily defined as the increase of at least 35% in walking distance (on treadmill) and/or the disappearance of signs and symptoms of critical ischemia in 6 months of treatment in at least 75% of the treated patients. With consideration of the results obtained with the preliminary nomograms a larger validation of the nomograms is now advisable. A cost-effectiveness analysis is also useful to define the efficacy of treatment on the basis of its costs. The publication of this report in two angiological journals (Angeiologie and Angiology) will open the research on nomograms to all centers willing to collaborate to the study. The data are being collected in the ORACL.E database and will be analyzed within 12 months after the publication of this report.

PGE(1) treatment of severe intermittent claudication (short-term versus long-term, associated with exercise)--efficacy and costs in a 20-week, randomized trial.

The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe intermittent claudication was studied comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study. The study included 980 patients (883 completed the study) with an average total walking distance of 85.5 +/-10 m (range 22-119). Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. In the LTP, treatment was performed with 2-hour infusions (60 microg PGE1, 5 days each week for 4 weeks. In phase 3 (4-week interval period) PGE1 was administered twice a week (same dosage). In phase 4 (monitoring lasting 3 months, from week 9 to 20) no drugs were used. In STP phase 2 treatment was performed in 2 days by a 2-hour infusion (first day: morning 20 microg, afternoon 40 microg; second day morning and afternoon 60 microg). The reduced dosage was used only at the first cycle (week 0) to evaluate tolerability or side effects. Full dosage (60 microg bid) was used for all other cycles. The same cycle was repeated at the beginning of weeks 4, 8, and 12. The observation period was between weeks 12 and 20. A treadmill test was performed at inclusion, at the beginning of each phase, and at the end of 20th week. A similar progressive physical training plan (based on walking) and a reduction in risk factors levels plan was used in both groups. Intention-to-treat analysis indicated an increase in walking distance, which improved at 4 weeks and at 20 weeks in the STP more than in the LTP group. At 4 weeks the variation (increase) in pain-free walking (PFWD) was 167.8% (of the initial value) in the LTP group and 185% in the STP group (p<0.05). At 4 weeks the variation (increase) in total walking distance (TWD) was 227.6% of the initial value in the LTP group and 289% in the STP group (p<0.05). At 20 weeks the increase in PFWD was 496% of the initial value in the LTP group vs 643% in the STP group (147% difference; p<0.02). The increase in TWD was 368% in the LTP group and 529% in the STP group (161% difference; p<0.02). In both groups there was a significant increase in PFWD and TWD at 4 and 20 weeks, but results obtained with STP are better considering both walking distances. No serious drug-related side effects were observed. Local, mild adverse reactions were seen in 6.3% of the treated subjects in the LTP and 3% in the STP. Average cost of LTP was 6,664 Euro; for STP the average costs was approximately 1,820 E. The cost to achieve an improvement in walking distance of 1 m was 45.8 E with the LTP and 8.5 E with the STP (18% of the LTP cost; p<0.02). For an average 100% increase in walking distance the LTP cost was 1,989 E vs. 421 E with STP (p<0.02). Between-group analysis favors STP considering walking distance and costs. Results indicate good efficacy and tolerability of PGE, treatment. With STP less time is spent in infusion and more in the exercise program. STP reduces costs, speeds rehabilitation, and may be easily used in a larger number of nonspecialized units.

Endovascular sclerotherapy, surgery, and surgery plus sclerotherapy in superficial venous incompetence: a randomized, 10-year follow-up trial--final results.

The study was planned to evaluate efficacy and costs of endovascular sclerotherapy (ES) in comparison with surgery and surgery associated with sclerotherapy in a prospective (10-year follow-up), good-clinical-practice study. Patients with varicose veins and pure, superficial venous incompetence were included. Of the patients randomized into the three groups 39 (group A) were treated with ES, 40 (B) with surgery + sclerotherapy, and 42 with surgery only (C). Surgery consisted of ligation of the SFJ (saphenofemoral junction) and of incompetent veins detected with color duplex. Of the preselected 150 patients, 121 subjects entered the study; 96 completed the 10-year follow-up (mean age 52.6 +/- 6 years; 51 men, 45 women). Dropouts were due to nonmedical problems. At 10 years no incompetence was observed in subjects treated with SPJ ligation (B and C). In the ES group 18.8% of the SFJs were patent and incompetent and in 43.8% of limbs the distal (below-knee) venous system was still incompetent [16.1% in the surgery + sclerotherapy group (p < 0.05) and 36% in the group treated with surgery only (p < 0.05 vs B and 0.05 vs A)]. Color duplex of the long saphenous vein indicated atrophy or obstruction of a segment (average 6.7 cm) after SFJ ligation (4.2 cm after ES). The cost of ES was 68% of surgery while the cost of surgery and sclerotherapy was 122% of surgery only. Endovascular sclerotherapy is an effective, cheaper treatment option, but surgery after 10 years is superior.

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.

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 $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.

External femoral vein valvuloplasty with limited anterior plication (LAP): a 10-year randomized, follow-up study.

The aim of this study was to evaluate the effects after 10 years of external valvuloplasty of the femoral vein (limited anterior plication or LAP). After informed consent patients with venous hypertension due to deep and superficial venous incompetence were randomized into two treatment groups. Both groups were treated with superficial vein surgery (ligation and section of the major incompetent superficial veins). Group 2 was treated with the same procedure and with LAP. External valvuloplasty of the superficial femoral vein was performed with plication of the anterior vein wall after limited dissection of the vein. Results were evaluated with color-duplex scanning and ambulatory venous pressure (AVP) measurements. Endpoints were AVP, refilling time (RT), presence/absence of reflux at the superficial femoral vein, the variation in the diameter of the vein, and quality of life score (QLS). No complications were observed. All femoral veins treated with LAP were competent after 10 years. Significantly lower AVP and longer RT were observed in the LAP group. Also the average diameter of the vein was smaller in the LAP group. Moreover, QLS was significantly better in the LAP group after 10 years. In conclusion, in selected subjects, with moderate deep venous incompetence, functional cusps, or incompetence mainly due to relative enlargement of the femoral vein, LAP may be an effective alternative to external valvuloplasty.

Treatment of severe intermittent claudication with PGE1--a short-term vs a long-term infusion plan--a 20 week, European randomized trial--analysis of efficacy and costs.

The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe intermittent claudication was studied by comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study. The study included 109 patients (96 completed the study) with an average total walking distance of 65.5 +/- 8 m (range 20-109). Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. In the LTP, treatment was performed with 2-hour infusions (60 microg PGE1, 5 days each week for 4 weeks). In phase 3 (4-week interval period) PGE1 was administered twice a week (same dosage). In phase 4 (monitoring lasting 3 months, from week 9 to 20) no drugs were used. In STP, phase 2 treatment was performed in 2 days by a 2-hour infusion (1st day: morning 20 microg, afternoon 40 microg; 2nd day morning and afternoon 60 microg). The reduced dosage was used only at the first cycle (week 0) to evaluate reduced tolerability or side effects. Full dosage (60 microg b.i.d.) was used for all other cycles. The same cycle was repeated at the beginning of weeks 4, 8, and 12. The observation period was between weeks 12 and 20. A treadmill test was performed at inclusion, at the beginning of each phase, and at the end of the 20th week. A similar progressive physical training plan (based on walking) and a reduction in risk factors levels plan was used in both groups. Intention-to-treat analysis indicated an increase in walking distance, which improved at 4 weeks (101.5% in STP vs 78.3% in LTP), at 8 weeks (260.9% STP vs 107.3% LTP), and at 20 weeks (351% STP vs 242% LTP). Comparable increases in pain-free walking distance were observed in the two groups. No serious drug-related side effects were observed. Local, mild adverse reactions were seen in 7% of the treated subjects in the LTP and 5% in the STP. Average cost of LTP was approximately 6,588 ECU; for STP the average cost was approximately 1,881 ECU. The cost to achieve an improvement in walking distance of 1 m was 35.6 ECU with the LTP and 9.45 ECU with the STP (26% of the LTP cost; p<0.02). For an average 100% increase in walking distance the LTP cost was 1,937 ECU vs 550 ECU with STP (p<0.02). The cost of PGE1 (including infusion and operative costs) was 25% of the total cost for LTP (24.9% for STP). In summary, between-group-analysis favors STP, in terms of walking distance and costs. Results indicate good efficacy and tolerability of PGE1 treatment. With STP less time is spent in infusion and more can be spent in the exercise program. STP reduces costs, speeds up rehabilitation, and may be used in a larger number of nonspecialized units available to follow the protocol.

The hemodynamic effect of venous hypertension in the microcirculation of the lower limb.

Air-plethysmography has been used in order to measure resting arterial inflow in 25 normal limbs and 126 limbs with various grades of venous disease. Twenty five limbs had venous ulcers. Resting arterial inflow was 60-95 ml/min in normal limbs (95% range), 60-110 ml/min in 45 limbs with uncomplicated varicose veins, 65-162 ml/min in limbs with swelling and/or lipodermatosclerosis/pigmentation and 100-235 ml/min in limbs with venous ulceration. There was an increase in the incidence of ulceration with increasing values of arterial inflow. The abnormal increase in resting arterial inflow is considered to reflect the damage in the microcirculation produced by chronic venous hypertension. Therapy should aim to treat or prevent this microangiopathy.