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Biomedical subjects

D Christopoulos

Publications and source records attributed to D Christopoulos.

At least 19 recordsLinked to original sources
PubMed2002

[Treatment of severe intermittent claudication: ORACLE-PGE1 short term study. A randomised 40-week study. Evaluation of efficacy and costs].

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.

Alprostadil↗
PubMed2000

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.

Acid-Base Equilibrium↗
PubMed2000

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.

Adult↗
PubMed2000

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.

Aged↗
PubMed2000

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.

Aged↗
PubMed1999

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.

Adult↗
PubMed1999

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.

Ambulatory Care↗
PubMed1998

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.

Alprostadil↗
PubMed1993

The effect of iloprost in patients with rest pain.

Thirty-four patients with ischaemic rest pain in 42 limbs and ankle pressure equal to or less than 50 mmHg have been treated with intravenous infusion of synthetic prostacyclin (iloprost) for eight days. Leg blood flow was measured with air plethysmography before treatment, on day 4 and day 8 of treatment. Total relief of pain for at least 6 weeks occurred in 91% of patients with leg blood flow > or = 40 ml/min, in 18% with leg flow 30-39 ml/min and in 11% with leg flow < 30 ml/min. Complete relief of pain for at least 6 weeks occurred in 92% of patients in whose limbs the blood flow on day 8 was greater than 50 ml/min but only in 6% with blood flow less than 50 ml/min. These results indicate that iloprost increases leg blood flow and that patients likely to respond can be identified from the baseline air plethysmographic measurement of leg blood flow.

Arteriosclerosis↗
PubMed1993

The relation of venous ulceration with ambulatory venous pressure measurements.

Two hundred thirty-six limbs of 220 unselected patients who were admitted with venous problems (83 with ulcers) were studied with continuous-wave Doppler ultrasonography, duplex scanning, and ambulatory venous pressure measurements. Patients with evidence of deep venous disease because of reflux or obstruction in the deep veins on Doppler and duplex ultrasonic examination or with an ambulatory venous pressure greater than 45 mm Hg despite the ankle cuff had venography. One hundred fifty-three limbs had superficial venous disease (reflux in the superficial veins with competent popliteal valves), and 83 limbs had deep venous disease (popliteal reflux on duplex examination or deep venous obstruction on venography). No ulceration occurred in limbs with ambulatory venous pressure < 30 mm Hg, and there was a 100% incidence with ambulatory venous pressure > 90 mm Hg. A linear increase occurred from 14% in limbs with ambulatory venous pressure between 31 and 40 mm Hg to 100% in limbs with ambulatory venous pressure greater than 90 mm Hg (r = 0.79). In the groups studied, an increased incidence of ulceration was associated with an increase in ambulatory venous pressure irrespective of whether the venous problem was the result of superficial or deep venous disease. Ambulatory venous pressure has both diagnostic and prognostic significance in patients with venous disease.

Blood Flow Velocity↗
PubMed1993

Noninvasive tests in venous insufficiency.

Chronic venous insufficiency (CVI) is the result of outflow obstruction, reflux or a combination of both. Noninvasive tests detect an quantify obstruction and reflux if present and define the anatomic localisation of the abnormality. In evaluating CVI noninvasive tests combine physiologic and imaging techniques. These tests are widely available, simple, quick and cost-effective and therefore they are the methods of choice for initial objective evaluation. Different tests provide answers to different questions. The optimum clinically useful information can be now obtained using only three instruments: pocket Doppler, duplex or color duplex scanner and air plethysmography. The value of ambulatory venous pressure, photoplethysmography and light reflection reography, air plethysmography, duplex and color duplex scanning to assess reflux and the value of tests to assess out-flow obstruction are presented. Pooled data collected from large studies are also presented for reference. Qualitative and quantitative assessment of CVI are useful both for clinical assessment and to evaluate the effect of treatments.

Chronic Disease↗
PubMed1992

The combination of liquid crystal thermography and duplex scanning in the diagnosis of deep vein thrombosis.

One hundred patients with clinically suspected deep vein thrombosis (DVT) were studied by liquid crystal thermography (LCT), duplex scanning and venography. Liquid crystal thermography was found to have a negative predictive value of 97% if performed within 1 week of the onset of symptoms. Duplex scanning had a sensitivity of 93% and specificity of 91% for all thrombi (proximal and calf). On the basis of these results a plan of investigation has been formulated that would avoid duplex scanning and venography in 39 of the 100 patients. Duplex scanning alone would be appropriate in 56 of the remaining 61 patients. Only six patients would be unsuitable for duplex scanning because of a very tense tender leg and require venography. The plan would miss one calf thrombus and result in treating three patients unnecessarily. This policy would be not only effective but also cost-effective.

Female↗
PubMed1992

The effect of elastic compression on the venous tone in patients with varicose veins.

The long term effect of elastic compression, with an emphasis on the changes in venous wall elasticity, was studied in 10 limbs with varicose veins. By simultaneously measuring venous volume, using the air plethysmograph (APG), and venous pressure, while the venous outflow was occluded, the pressure/volume (P/V) relationship of the venous system of the leg could be studied and the elastic modulus calculated. These measurements were performed prior to the application of elastic stockings and 6 weeks later, one day after the stockings had been removed. Statistically significant improvements were noted in the APG parameters studied and in the P/V curve derived elastic modulus calculations. The limbs could be divided into two groups based on the response of the P/V curves to elastic stockings and the severity of disease. Those limbs with milder disease tended to shift their P/V curves downward and to the right after compression (giving them a more normal pattern). Limbs with more severe disease showed evidence of a similar pattern of improvement at low but not at high venous pressures.

Bandages↗
PubMed1991

Treatment of superficial venous incompetence with the SAVAS technique--(Section Ambulatoire des Varices avec Sclérothérapie). A 4 year randomised, controlled trial comparing venous hemodynamic and costing after SAVAS, sclerotherapy and the dentist's technique.

Three techniques for treatment of chronic venous incompetence on an out patients basis were compared in a randomised study. One hundred thirty eight limbs (107 patients) with superficial venous incompetence were randomly treated with the dentist's technique (DT) [Group A, 44 limbs], compression sclerotherapy (CS) [Group B, 45 limbs] or the SAVAS (section en Ambulatoire des Varices avec Sclérothérapie) technique [Group C, 49 limbs]. Patients were evaluated and followed up (every year for 4 years) with ambulatory venous pressure (AVP) measurements and Quantum angiodynography (colour duplex scanning). DT consisted in the section under local anesthesia of incompetent veins. CS was done injecting polidocanol 3% with compression applied for 4 weeks. The SAVAS was done with a combination of DT and CS with section of the incompetent veins under local anesthesia and retrograde injection in the distal vein of polidocanol 3%. With this type of injection only incompetent veins were perfused. After 4 years there was a significantly lower refilling time (RT) with AVP in the SAVAS group (21 sec). RT was 13 sec in group B and 16 in A. The number of significantly incompetent residual veins was in average 0.5 in the SAVAS group, significantly lower than in the other two groups. Also the average cost per treated limb was significantly lower in the SAVAS group (917 francs in comparison with 1100 in group A and 1211 in group B). In conclusion considering the four year follow up, the SAVAS technique is a more effective treatment of superficial venous incompetence, its hemodynamic value is superior to sclerotherapy alone and its costs are lower.

Adult↗
PubMed1989

Number and anatomical distribution of incompetent thigh perforating veins.

Although incompetent thigh perforating veins are considered to be a common cause of recurrence of varicose veins after high saphenous ligation, the number and distribution of such incompetent veins have not been reported. The aim of the study was to determine the number and anatomical distribution of incompetent thigh perforating veins. Sixty-five limbs in 48 patients with varicose veins who were found to have incompetent thigh perforating veins on ascending deep to superficial venography were studied. In 80 per cent of patients one incompetent thigh perforating vein was found and in 20 per cent more than one was found. Concomitant incompetent calf perforating veins were found in 92 per cent of the limbs studied. The incompetent thigh perforating veins were found to occur anywhere in the thigh, from the upper edge of the patella to a few centimetres below the saphenofemoral junction. The majority (71 per cent) were found in the middle third of the thigh. All incompetent thigh perforating veins were communicating with the long saphenous vein, including those in five patients with incomplete stripping. The surgeon should be aware of incompetent thigh perforating veins which may be multiple and occur at any site on the medial aspect of the thigh.

Adult↗
PubMed1989

Rupture of a non-aneurysmal salmonella infected aorta.

A 65-year-old man with salmonella bacteraemia developed a retroperitoneal collection as a result of infection and subsequent rupture of the abdominal aorta. Computed tomography (CT) showed the collection but there was no aneurysm on CT or at surgery. The main diagnostic feature of salmonella aortitis is the presence of an aneurysm; this report indicates that a non-aneurysmal infected aorta can rupture. The importance of considering a ruptured aorta as the cause of retroperitoneal collections is emphasised, even when the aorta is of normal calibre.

Aged↗