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SummaryA randomised, prospective, double-blind trial was performed, to compare the safety and efficacy of a new low-molecular-weight heparin (LMWH) Bemiparin and standard unfractionated heparin (UFH), for the prophylaxis of postoperative venous thromboembolism. 300 patients scheduled to undergo elective hip arthroplasty were included. The principal outcome measures were the incidence of thromboembolic events and bleeding complications. 149 patients received 3,500 anti-Xa IU of bemiparin plus a placebo injection daily and 149 patients received 5,000 IU of UFH twice a day.The two groups were similar with respect to factors likely to affect the risk of developing post-operative venous thromboembolism (VTE) and risk of bleeding events. During the post-operative period, 34 patients developed VTE complications; 9 (7.2%) in the bemiparin group and 25 (18.7%) in the UFH group. VTE in the two groups was statistically significant (OR of 2.96; 95% CI 1.32-6.62 and p = 0.01).There were no significant differences in the frequency of bleeding complications: major bleeding requiring discontinuation of prophylaxis, (OR 1.21; 95% CI 0.36-4.05; p = 1.00), the measured median operative blood loss (p = 0.77) or the median postoperative drain loss (p = 0.97), and the number of patients who developed wound haematoma (OR 0.87; 95% CI 0.31-2.46; p = 1.00).A comparison of coagulation parameters on the preoperative day with post-operative day 2 ± 1, day 6 ± 1 and day of discharge showed a significantly higher AT concentration, anti-factor Xa activity and TFPI levels in the bemiparin group when compared with UFH.This study demonstrates that bemiparin, in a single daily subcutaneous dose of 3,500 anti-Xa IU in high risk patients undergoing hip arthroplasty is more effective than UFH administered twice daily at a dose of 5,000 IU in the prevention of postoperative VTE. Both agents are equally safe.List of participants, their affiliations and current addresses are listed in the appendix on p. 528

The aim of the study was to evaluate any correlation between the circulating oestrogenic hormone 17β-oestradiol and haemostatic factors in healthy postmenopausal women. In keeping with this objective, the correlations were evaluated irrespective of whether the source of the hormone was purely endogenous or exogenous as well. Accordingly, a univariate correlation adjusted for age, body mass index, and duration of menopause was determined in 42 healthy postmenopausal women aged 47–78 years, 19 of whom were self-reported users of hormone replacement therapy. The rest were self- reported never users. Serum 17β-oestradiol exhibited a direct correlation with endogenous thrombin potential extrinsic pathway (R = 0.42, p = 0.01) and prothrombin fragments 1 and 2 (R = 0.37, p = 0.03) and an inverse correlation with antithrombin III (R = –0.36, p = 0.03) and α2-antiplasmin (R = –0.45, p = 0.005). The observations suggest an association of this hormone with net thrombin generation on the one hand and improved fibrinolysis on the other.

Objective: Myocardial areas distal to complete coronary artery occlusion are poorly protected by antegrade cardioplegia. Hence, retrograde cardioplegia becomes an important adjunct in myocardial protection. An aim of the study was to compare both methods prospectively. Methods: 158 coronary artery bypass grafting (CABG) patients were randomly assigned to two groups according to myocardial protection technique: 89 patients to group 1-retrograde cold blood cardioplegia (RCBC); and 69 patients to group 2-antegrade cold blood cardioplegia (ACBC). Preoperative parameters were similar but cross-clamp time and volume of cardioplegia needed were higher in the retrograde group. The results were assessed on the basis of: (I) clinical outcome; (2) ECG and enzymatic parameters of ischemia; (3) assessment of early systolic function by means of cardiac output (CO), stroke work index (SWI), left ventricular stroke work index (LVSWI) and right ventricular stroke work index (RVSWI) taken before, and 1 and 5 h after coming off bypass; (4) late systolic and diastolic function by echo assessment of segmental contractility of 17 segments and indexes of peak transmitral flow (TMI) taken 7 days and 6 months after operation. Results: Ischemic events, inotropes and ventricular fibrillation on reperfusion were significantly more frequent in the antegrade group. Sinus rhythm at an early stage postoperatively was found more frequently in the retrograde group. All these parameters became comparable 24 h after operation. Early myocardial recovery was better in the retrograde group where intraoperative improvement in CO and SWI was significant. At the same time, SWI decreased significantly in the antegrade group. RVSWI changes were similar in both groups. There were no differences in mortality and perioperative MI. Late myocardial performance by segmental contractility and diastolic transmitral flow were similar in both groups. Conclusions: Retrograde continuous blood cardioplegia reduces ischemic injury and permits better early recovery of myocardial function. There is no difference, however, regarding long-term assessment of myocardial recovery.

This study compared all-cause medication discontinuation (any switch, augmentation or medication discontinuation) in matched cohorts of patients with schizophrenia who were initiated on depot or oral antipsychotics. Other objectives included between-group comparisons of resource use, and clinical and functional outcomes.This post hoc analysis of a one-year, multicentre, prospective, observational study included outpatients with schizophrenia who required a change in their antipsychotic medication because of a physician-perceived risk of medication non-adherence. Patients were matched 1 : 1 using an optimal algorithm with rank-based Mahalanobis distances. All-cause medication discontinuation was compared using the Klein and Moeschberger test for survival and hazard ratios (HR) with 95% confidence intervals (CI) were calculated using a Cox proportional hazards model, stratifying on matched pairs.Forty patients who initiated a depot antipsychotic could be matched to patients who initiated an oral antipsychotic. Fewer depot-treated patients discontinued their antipsychotic medication at least once compared with oral-treated patients [20% (8/40) vs. 40% (16/40)]. Depot-treated patients discontinued their medication later (Klein and Moeschberger test p = 0.025) and were less likely to discontinue their initial antipsychotic medication [HR = 0.33 (95% CI, 0.12-0.92), p = 0.033] than oral-treated patients. There were few differences in resource use and no differences in clinical and functional outcomes between cohorts.In this matched-cohort analysis, patients with schizophrenia who were considered to be non-adherent with their prior oral antipsychotics were less likely to discontinue their medication for any cause if they were initiated on depot compared with oral antipsychotics.

Stentless bioprostheses are anticipated to cause improved hemodynamics and increased longevity over stented bioprosthesis. We have compared echocardiographic analysis of stented bioprosthesis "Freestyle" with stented "Mosaic" bioprosthesis. Because of similar technology (0 pressure fixation, anticalcification) any differences may relate to stent.Twenty-eight patients undergoing AVR were randomly assigned to receive either stented or stentless. Echocardiograms, by means of M-mode and Doppler were performed early, 3-6 months and 1 year postoperatively.The peak flow velocity was significantly lower in the stentless group, especially 1 week and 6 months after surgery. Mean transvalvular gradient dropped significantly in stentless group and did not change in stented group. EOA did not change significantly in either of groups. AoV velocity time integral was increasing in stentless group. LV mass had fallen significantly in both groups but degree of mass reduction was comparable.There are marked improvements of stentless valves hemodynamics. However it is not necessary equal to higher degree of LV mass reduction during 1 year follow-up.

We report the mid-term results of a prospective trial of a new bioprosthetic valve. The Mosaic bioprosthesis consists of porcine aortic valve that has been cross linked ed in glutaraldehyde solution under zero-pressure fixation and treated with alpha amino oleic acid to reduce the potential for calcification.Mosaic bioprosthetic valve replacement was performed in 67 consecutive patients between January 1995 and August 1998. There were 37 patients having aortic valve replacement (AVR) and 30 having mitral valve replacement (MVR) who entered this study. The patients age ranged 56 to 86 years (mean 74.9); 38 were female and 29 were male; 44 were in NYHA grade 3 and 21 were NYHA grade 4. All mitral valve replacements were performed with total preservation of subvalvular apparatus. Echocardiographic assessment of valve and LV function were performed on 7th day, 6 months 1,2 and 3 years.There was no hospital mortality. 3 year survival was 85.9+/-5.9% for AVR and 100% for MVR. Freedom from antithromboembolic related haemorrhage has been 96.7% for MVR and 91.9% for AVR. Freedom from the transient neurological event was 96.7+/-3.3% for MVR and 100% for AVR Freedom from structural valve failure, permanent thromboembolism, thrombosis or endocarditis has been 100% for both AVR and MVR. In AVR group left ventricle mass, left ventricle mass index significantly decreased, when cardiac index and effective orifice area increased significantly during study period. Transvalvular gradient did not change. In MVR group transvalvular gradient, effective orifice area and cardiac index did not change.The valve was user friendly. The early results are very satisfactory. Echocardiography measurements after aortic valve replacement are showing very marked late postoperative remodelling of left ventricle. After mitral valve replacement there were exceptionally low transvalvular gradients, no left ventricle outflow tract obstruction.

To evaluate the homeostasis of myocardium during simultaneous continuous retrograde and antegrade cardioplegia vs retrograde continuous cardioplegia.40 patients who underwent elective operation of coronary arteries bypass grafting were randomly assigned to 2 groups: group one consisted of 24 patients who received retrograde continuous blood cardioplegia; group two consisted of 16 patients who received simultaneous continuous ante/retrograde cardioplegia. The following measurements were taken: acidosis, oxygen content, oxygen extraction and oxygen consumption; they were taken before and after cross-clamp releasing from coronary sinus effluent and from arterial line. Incidence of low cardiac output, ventricular fibrillation, raised cardiac enzymes and ischemic changes on ECG was noted.In simultaneous group such parameters as acidosis, oxygen content, oxygen extraction and myocardial oxygen consumption recovered after cross-clamping and changes of their values were respectively: 0.0005, 0.87 ml/100 ml, 0.098 and 1.4 ml/min. The same parameters didn't recovered in retrograde group and changes were respectively: 0.05 - p=0.2; 3.7 ml/100 ml - p=0.006, 0.29 p=0.006 and 7.4 ml/min - p=0.03. These changes were significant between groups.Metabolic viability of myocardium measured with oxygen utilisation is better preserved with simultaneous antegrade and retrograde cardioplegia.

The association between obesity and risk of coronary artery disease is well established. The distribution of body fat was shown to be related to serum lipids and lipoproteins in a group of healthy men, but the association between body fat and haemostatic factors is less clear. The aim of the present study was to determine the association of overall adiposity (OVRAD, percent total fat mass contributing to body weight) and body mass index (BMI, weight/height2) with lipids and haemostatic factors in order to evaluate which of these was more associated with circulating procoagulant factors. The total fat mass was estimated by dual-energy X-ray absorptiometry (DEXA) and OVRAD computed for 28 male and 36 healthy female subjects, whose median age were 44.2 years and 48.4 years respectively. In addition, the BMI was computed for each of them from their weight and height measurements. Fasting samples were analysed for serum lipids (total, HDL- and LDL-cholesterol and triglyceride) and plasma fibrinogen, factor VII coagulant (FVII:C) activity, tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1) activities. The men and women had similar median BMI (23.9 kg/m2 and 23.1 kg/m2 respectively), but the median fat mass of women (19.6 kg) was higher than that of men (16.9 kg). Age, BMI and OVRAD exhibited statistically significant correlations with lipids and haemostatic factors in both men and women. However, when BMI was adjusted for age and OVRAD, the statistically significant associations were no longer apparent in men or women. In contrast, OVRAD adjusted for age and BMI still exhibited statistically significant associations with FVII:C activity (R = 0.38, p = 0.05), triglyceride (R = 0.51, p = 0.008), LDL-cholesterol (R = 0.45, p = 0.02) and HDL/Total cholesterol ratio (R = -0.63, p0.001). It is concluded that OVRAD, a fat mass-based index, rather than BMI, a weight-height based index, is better associated with circulating coronary risk factors.

1. A prospective study has been carried out, and 68 patients with hypercholesterolaemia have been investigated to study the effects of central cooling on serum lipid levels. 2. Central cooling was obtained by the exposure of the whole body to cold water. All patients were trained to gradually reduce the water temperature from 22 to 14 degrees C and to increase the time of exposure from 5 to 20 min over a period of 90 days. The 33 male and 35 female patients were aged between 40 and 60 years at entry with total cholesterol of 6.0 mmol/l or greater and low-density lipoprotein (LDL)-cholesterol of 4. 0 mmol/l or greater. Thyroid-stimulating hormone, free thyroxine (FT4), total T3, total cholesterol, LDL-cholesterol, high-density lipoprotein (HDL)-cholesterol, triacylglycerols and total fat mass (determined by dual-energy X-ray absorptiometry scan) were obtained at baseline and after 3 months treatment with hydrotherapy. 3. Central cooling obtained by hydrotherapy results in a median fall in tympanic temperature from 0.2 degrees C (P0.001) to 0.8 degrees C (P0.001). We have observed in these patients a significant reduction in total cholesterol (-0.2 mmol/l, P=0.006) and LDL-cholesterol (-0.2 mmol/l, P=0.004). Serum FT4 level was higher than baseline results in 30 of these hypercholesterolaemic patients (15.5 pmol/l to 17.3 pmol/l) and there was no significant change in serum thyroid-stimulating hormone and total T3. 4. In conclusion, in our patients with hypercholesterolaemia we have observed a significant reduction of total cholesterol and LDL-cholesterol after body temperature regulation.

To evaluate the results of mechanical prosthetic valve replacement for active endocarditis 71 patients were reviewed. They were treated surgically between 1988 and 1993 in our institution. Mechanical valves were used in 54 patients (group 1) and bioprosthetic valves were used in 17 patients (group 2). In terms of demographic, clinical and surgical variables prior to operation groups were statistically the same. Follow up ranged from 2-63 months averaged 21 months. This study was carried out to: asses cardiac status postoperatively and assess the rate of mortality, recurrency and reoperations.Evaluation of cardiac status was assessed on the basis of symptoms and findings by examination, ECG, X-ray, echocardiography, and laboratory tests. Data analysis was done by means of statistical tests like: Student's "t"-test, Fisher exact test, one sided test of difference between two percentages, Kaplan Meyer survival analysis and Cox test.4-year mortality was 20% in group 1 comparing to 28,6% in group 2, when early mortality were 13% in group 1 comparing to 17% in group 2. These differences were not significant. The recurrency rate was 8,5% in group 1 comparing to 28,6% in group 2 which was statistically significant (p=0.028). Especially early recurrency rates differed significantly between groups and were 4,2% in group 1 comparing to 21% in group 2 (p=0.022). The reoperations rate was 4,2% in group 1 comparing to 21% in group 2 which was statistically significant (p=0.022). Clinical status showed satisfactory values and significant improvement in both groups, slightly better after mechanical valve replacement.It is concluded that mechanical valve is recommended for valve replacement in active valvular endocarditis first of all due to low recurrency and reoperation rate.