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SummaryVenous thromboembolism (VTE) is a significant cause of morbidity and mortality in Europe. Data from real-world registries are necessary, as clinical trials do not represent the full spectrum of VTE patients seen in clinical practice. We aimed to document the epidemiology, management and outcomes of VTE using data from a large, observational database. PREFER in VTE was an international, non-interventional disease registry conducted between January 2013 and July 2015 in primary and secondary care across seven European countries. Consecutive patients with acute VTE were documented and followed up over 12 months. PREFER in VTE included 3,455 patients with a mean age of 60.8 ± 17.0 years. Overall, 53.0% were male. The majority of patients were assessed in the hospital setting as inpatients or outpatients (78.5%). The diagnosis was deep-vein thrombosis (DVT) in 59.5% and pulmonary embolism (PE) in 40.5%. The most common comorbidities were the various types of cardiovascular disease (excluding hypertension; 45.5%), hypertension (42.3%) and dyslipidaemia (21.1%). Following the index VTE, a large proportion of patients received initial therapy with heparin (73.2%), almost half received a vitamin K antagonist (48.7%) and nearly a quarter received a DOAC (24.5%). Almost a quarter of all presentations were for recurrent VTE, with >80% of previous episodes having occurred more than 12 months prior to baseline. In conclusion, PREFER in VTE has provided contemporary insights into VTE patients and their real-world management, including their baseline characteristics, risk factors, disease history, symptoms and signs, initial therapy and outcomes.

Introduction: The aim of our study is to identify the assessment of metabolic and dynamic capillaroscopy parameters that may be predictive of the outcome of spinal cord stimulation in patients affected with non-revascularisable chronic critical limb ischemia. Materials and Methods: Forty patients, 16 female and 24 male, average age 69 8, underwent microcirculatory screening with transcutaneous oximetry and dynamic capillaroscopy. Microcirculatory assessment was performed before temporary implantation of the spinal cord stimulation stimulator and after one month. The following metabolic parameters were considered: TcPO2TcPCO2 and with dependent limb, difference between dependent limb and supine values (D TcPO2, D TcPCO2), change in TcPO2-TcPCO2 after stimulation. Dynamic capillaroscopy parameters were recorded. Follow-up visits were scheduled at three, six, and twelve months after implantation. The procedure was performed placing an Octrode (St. Jude Medical, St. Paul, MN, USA) on the dorsal columns of the spinal cord. Results: Two groups were identified on the basis of transcutaneous oximetry measurements: group A (22 patients) and group B (18 patients), responding differently to the postural test. After one month of home testing period, there was an improvement in metabolic parameters, differing from one group to the other. The morphofunctional data provided by capillaroscopy highlighted the percentage of open capillaries poststimulation as being a significant parameter, although not mentioned in previous studies. Conclusions: Spinal neuromodulation is an effective therapy option in the management of patients affected by nonreconstructable chronic critical limb ischemia.

In contrast with extensive information on the management of deep vein thrombosis of the lower extremities, little is known on the most appropriate treatment of the superficial vein thrombosis (SVT). In a multicenter, prospective, controlled, double-blind, double-dummy clinical trial, 164 consecutive patients with acute SVT of the great saphenous vein were randomized to receive the s.c. administration of either fixed prophylactic doses (2850 a-Xa IU) or body-weight adjusted therapeutic doses of nadroparin once daily for 1 month. The main study outcome was to compare the rate of asymptomatic and symptomatic extension of SVT and/or venous thromboembolic (VTE) complications during a 3-month follow-up period. Of the 81 patients randomized to the prophylactic doses, seven [8.6%; 95% confidence interval (CI), 3.5-17.0] developed SVT progression or VTE complications as compared with six of the 83 (7.2%; 95% CI, 2.8-15.1) allocated to the treatment group (absolute difference, 1.4; 96% CI, -6.9 to 9.7; P = 0.74). No patient in either group developed major bleeding. Our findings suggest that therapeutic doses of low-molecular-weight heparin, administered for 1 month in patients with SVT of the greater saphenous vein do not improve results obtained by prophylactic doses, administered for the same period, over a 3-month follow-up period.

Objective To report the 5 year outcome of varicose veins surgery and to establish the factors determining recurrence. Study Design Prospective observational study. Materials and Methods This study reports the outcome in 1326 patients treated in a day surgery centre of an institutional referral centre. Patients were investigated clinically and by colour flow duplex scanning before operation. Treatments used included flush ligation of the sapheno-femoral junction (SFJ) and the sapheno-popliteal junction (SPJ). Incompetence of the great saphenous vein (GSV) and small saphenous vein (SSV) were managed by stripping of these veins. Perforating vein ligation and hook phlebectomy were also used. Patients were evaluated 3 weeks and 5 years following treatment by clinical examination and duplex ultrasonography. Results 412 patients were excluded from the study because they failed to attend for follow-up or did not wear elastic stockings post-operatively. No residual saphenous truncal reflux was found at the initial assessment 3 weeks following surgery. After 5 years, recurrence of varicose veins occurred in 332 patients out of 1326 (25 %). Recurrences arose at the sapheno-femoral junction in 109 out of 862 patients (13%), at the sapheno-popliteal junction in 39 out of 132 patients (30%), in both saphenous regions 38 out of 107 patients (36%) and in 146 out of 225 subjects (65 %) with secondary varicose veins. Conclusion Varicose veins recurred despite technically correct surgery confirmed on post-operative duplex ultrasonography. The likelihood of recurrence increased in the presence of SSV reflux, perforating vein incompetence and post-thrombotic deep vein incompetence.

Defibrotide is a polydeoxyribonucleotide drug known to modulate the endothelial cell release of t-PA, PAI, and PGI-2 and to improve blood flow and perfusion. A double-blind, multicenter, placebo-controlled, dose comparison study was carried out to test the long-term efficacy and safety of defibrotide in patients with PAD (Leriche stage 2). Informed patients suffering from PAD were enrolled, and after a 15-day washout period were randomly allocated in a double-blind fashion to one of the three following treatments: defibrotide 400 mg (1 cps) b.i.d. for 6 months, defibrotide 400 mg o.d., or placebo. Absolute walking distance (AWD, treadmill) and ankle-arm pressure ratio (Winsor Index, WI) were evaluated at the beginning and after 30, 90, and 180 days after therapy. Two hundred twenty seven patients were recruited and 193 patients were included in the final analysis (800 mg: 67; 400 mg: 60; placebo: 66). All treatments brought about an increase in AWD placebo = +17%; 400 mg = +47%, 800 mg = +52%); however, patients treated with defibrotide exhibited a significantly better AWD at the end of treatment in comparison with placebo (p less than 0.01). AWD was not significantly different in the 400-mg and 800-mg groups. There was a trend indicating a possible improvement of WI after defibrotide, with higher WI in 800-mg patients in comparison with placebo (p less than 0.05). However, this difference was partly due to a decrease in arterial blood pressure elicited by the drug. The tolerability in all groups was optimal. These results indicate that orally administered defibrotide exerts symtomatic benefit in PAD patients and daily doses of 400 or 800 mg seem to be equivalent.

SUMMARYLive attenuated influenza vaccine containing the recombinant of A/Victoria/3/75 with A/PR/8/34 virus was administered to healthy adults in a field trial aimed at evaluating protection provided by immunization. The study was designed to measure the effect of vaccination on absenteeism from respiratory disease during a natural influenza epidemic. A total of 2115 male employees of the public transport service of Rome volunteered to participate in the trial, 1050 and 1065 receiving vaccine and placebo respectively, in a randomized blind fashion. Vaccination procedure was completed by the end of December 1976. A small-sized outbreak of influenza, due to a viral strain antigenically homologous to the vaccine, occurred during the month of February 1977. Analysis of absenteeism data, classified according to medical certificate, indicated that morbidity from respiratory disease was reduced in vaccinees compared with controls during the epidemic month; the rate of increase of morbidity compared with that of the preceding month was then three times lower in vaccinees than in controls and the difference in absenteeism between the two groups greatly exceeded the ordinary fluctuation that was observed during non-epidemic periods.

In 103 patients with peripheral arterial disease (PAD) of the lower limbs, coagulation and fibrinolytic parameters were evaluated to identify hemostatic abnormalities characteristic of this patient population. PAD was defined as clinically stable Leriche stage 2 (based on clinical history, peripheral pulses, ankle-arm index, and treadmill test) for at least 3 months, walking distance100 m, and no other major illnesses, rest pain, or trophic lesions. Defibrotide, a polydeoxyribonucleotide derivative with vascular effects, was administered to the patients as part of a multicenter trial. The PAD patients exhibited a prothrombotic state as evidenced by high D-dimer in all but 24% of the patients (average 797 +/- 802 vs. 163 +/- 54 ng/mL normal population; p0.001) and high thrombin-antithrombin III complex (TAT) levels (10.2 +/- 8.9 vs. 2.5 + 1.5 ng/mL; p0.001) with low to normal levels of protein C (86 +/- 25 vs. 102 +/- 18%; p0.01) and plasminogen activator inhibitor-1 (PAI-1) antigen (5.9 +/- 4.5 vs. 1.3 + 0.7 ng/mL; p0.001) were elevated in 79% of the patients. These results suggest that there is ongoing thrombosis in the majority of PAD patients. Differences from normal controls were observed for t-PA, PAI-1, protein C, and protein S; however, it is not certain that the thrombosis in patients with PAD is due to these factors.