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The term critical limb ischemia refers to a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene in one or both legs attributable to objectively proven arterial occlusive disease. Critical limb ischemia implies chronicity and is to be distinguished from acute limb ischemia. Its incidence is approximately 500 to 1000 per million year, with the highest rates among older subjects, smokers and diabetics. The rate of primary amputation ranges from 10% to 40%, and was performed only when no graftable distal vessels were present, or in neurologically impaired or hopelessly nonambulatory patients. Contrarily, in some highly specialized and aggressive centres about 90% of patients with CLI had an attempted revascularization. Furthermore, patients with critical limb ischemia have an elevated risk of future myocardial infarction, stroke and vascular death, 3-fold higher than patients with intermittent claudication. Therefore, due to its negative impact on the quality of life and the poor prognosis both in terms of limb salvage and survival, critical limb ischemia is a critical public health issue.

Residual vein thrombosis (RVT) indicates a prothrombotic state and is useful for evaluating the optimal duration of oral anticoagulant treatment (OAT). Patients with a first episode of deep vein thrombosis, treated with OAT for 3 months, were managed according to RVT findings. Those with RVT were randomized to either stop or continue anticoagulants for 9 additional months, whereas in those without RVT, OAT was stopped. Outcomes were recurrent venous thromboembolism and/or major bleeding. Residual thrombosis was detected in 180 (69.8%) of 258 patients; recurrent events occurred in 27.2% of those who discontinued (25/92; 15.2% person-years) and 19.3% of those who continued OAT (17/88; 10.1% person-years). The relative adjusted hazard ratio (HR) was 1.58 (95% confidence interval [CI], 0.85-2.93; P = .145). Of the 78 (30.2%) patients without RVT, only 1 (1.3%; 0.63% person-years) had a recurrence. The adjusted HR of patients with RVT versus those without was 24.9 (95% CI, 3.4-183.6; P = .002). One major bleeding event (1.1%; 0.53% person-years) occurred in patients who stopped and 2 occurred (2.3%; 1.1% person-years) in those who continued OAT. Absence of RVT identifies a group of patients at very low risk for recurrent thrombosis who can safely stop OAT. This trial was registered at http://www.ClinicalTrials.gov as no. NCT00438230.

Background. The optimal duration of Oral Anticoagulant Therapy (OAT) for Deep Vein Thrombosis (DVT) can be tailored by Residual Vein Thrombosis (RVT) (Siragusa S et al. Blood2003;102(11):OC183), a marker able to assess the individual risk for recurrent thrombosis. However, in patients with idiopathic DVT the safety of early interruption of OAT, because of absence of RVT, is still debated. Objective of the study. In the present study, we evaluated the safety of withholding OAT, in patients with idiopathic DVT and without RVT, three months after the index thrombotic episode. Study design. Prospective controlled study with two groups: patients without RVT stopped OAT after 3 months while those with RVT continued for additional 3 months. Materials and Methods. Consecutive patients with a first episode of idiopathic DVT of the lower limbs; patients with cancer or known thrombophilia were excluded. At the third months of OAT, RVT was assessed as previously described; briefly, RVT was considered absent when a clot occupying less than 40% of the vein lumen was detected by compression ultrasonography. Events, classified as recurrent DVT and/or Pulmonary Embolism (PE) and/or major and minor bleeding were evaluated; all patients were followed-up for at least 12 months after OAT discontinuation. Results. During the period 1999–2006, 518 patients were included in the study. In 206 (39.7%) RVT was considered absent (RVT negative group) and they stopped OAT; the remaining 312 patients continued anticoagulants for additional 3 months (RVT positive group). Total duration of follow-up (FU) was 184.7 years for RVT negative group (with a mean FU of 3.0 ± 0.83 years) and 191.3 years for RVT positive group (with a mean FU of 3.1 ± 0.89 years). The rate and type of events during FU is reported in table and figure. Conclusions. This investigation shows that in patients without RVT, three months of OAT are safe even after an episode of idiopathic DVT. This hold for at least 30% of the entire DVT population and has an important clinical impact; in fact, it is possible to select a group of patients with a very low risk for recurrences over a period of 3 years. This approach carries also a negligible risk for bleeding. Events between RVT Negative and Positive Groups Outcomes RVT Neg. group (206) RVT Pos. group (312) "p" value *After OAT discontinuation, **During OAT Recurrences, n/total (%)* 2/206 (0.9) 63/312 (20.2)

Aim of the study is to evaluate the effects of Prostaglandin E-1 (PGE-1) in patients with peripheral arterial disease (PAD) at the 2nd b stage Fontaines classification. The study, controlled, single blinded, enrolled 123 patients with intermittent claudication that were randomised in two groups; the first group received a treatment with PGE-1 while the second one received a pentoxifylline-buflomedil association by venous infusion. We evaluated: Pain Free Walking Distance (PFWD), Maximum Walking Distance (MWD), Rest Flow (RF), Peak Flow (PF), Basal (BVR) and Minimal Vascular Resistance (MVR) with a strain gauge plethysmograph, Resting Flow (RF), Peak Flow (PF), time to reach the Peak Flow (tPF) and time to recovery of the base values (tRF) with laser Doppler flowmeter. After a four weeks treatment, we observed an increase of 370% about PFWD and of 260% in the MWD in patients treated with PGE-1; the other group showed an increase of 110% and 118% respectively. Moreover, the patients of the first group showed a significant increase regarding the plethysmographic Peak Flow (from 9.75±1.37 to 16.21±1.75, p < 0.001), greater than the one observed in the second group (from 9.53±1.41 to 13.47±1.53, p < 0.05); also the laser Doppler parameters showed a significant reduction, more evident in the first group (tPF from 23.0±7.5 to 10.5±4.9, p < 0.001; tRF from 73.5±22.7 to 48.3±13.5, p < 0.001) than in the second one. In conclusion, our study shows the efficacy of PGE-1 in patients with 2nd b stage Fontaine PAD; PGE-1 improves the microcirculation and the haemodynamics in peripheral districts and determines an increase in the pain free walking distance and in maximum walking distance.

Objectives: to evaluate the clinical efficacy and the effects on the quality of life of Iloprost, a prostacyclin analogue, used, according to a new protocol, in patients with Raynaud’s phenomenon secondary to Systemic Sclerosis. Methods: in this randomized study we treated 30 patients with Iloprost given by intravenous infusion, at progressively increasing doses (starting from 0.5 ng/Kg/min up 2 ng/Kg/min) over a period of 6 hours a day for ten days in two consecutive weeks, with repeated cycles at regular intervals of three months for 18 months. The results were compared with those obtained in 30 other patients, who had received the same drug but with different posologic schemes. Results: the total average daily duration of the attacks, the average duration of a single attack and the average daily frequency of the attacks were reduced significantly in all groups of treatment, but the comparison between the groups demonstrated significant differences between patients treated with the new protocol and the others at later times (T12 and T18). The effects on the quality of life, evaluated by SF-36, demonstrate, in the group treated with the new protocol, a marked improvement both regarding the scale relative to the physical aspect of the illness, and especially regarding the scale relative to the mental aspect. Conclusions: in SSc patients, cyclic intravenous Iloprost infusion is efficacious in the treatment of Raynaud’s phenomenon. The protocol that we used, compared with others, is able to determine not only favourable clinical effects but also a marked improvement in the quality of life.

There are only a few published studies on the association between subclavian steal syndrome and ischemic heart disease. The objective of this report is to evaluate the efficacy of subclavian stenoocclusion treatment in patients with subclavian steal syndrome (SSS) and previous cor- onary bypass. Over the last 8 years we observed 207 patients who underwent left internal mammary artery–intraventricular artery (LIMA–IVA) bypass graft. Of these, 31 patients were affected by steno-occlusion of the homolateral subclavian artery. Ten patients (group 1) showed latent vertebral-SSS and were pharmacologically treated. Seven patients (group 2) had an intermittent vertebral-SSS; four patients were treated with angioplasty and stent application and three were pharmacologically treated. Fourteen patients (group 3) with complete vertebral-SSS were treated with angioplasty and stent application or carotid-subclavian bypass graft. All pa- tients were followed up every 3 months for a period of 5 years after the diagnosis. The first group of patients showed no angina and no sign of subclavian restenosis. In the second group only two patients, who were affected by angina, showed subclavian restenosis at angiography. In the third group only one patient underwent further angioplasty for restenosis. The results of this study show that the SSS may be an adverse event in patients with a LIMA-IVA bypass graft. Identification of the steal is essential to choose an appropriate therapeutic approac

Calciphylaxis is a severe “vascular ossification–calcification,” associated with a very high mortality rate that involvesarterial wall, venular wall, and nerves resulting in ischemia and necrosis of skin, subcutaneous fat, visceral organs,and skeletal muscles. Sodium thiosulfate has recently been used as a novel treatment option for calciphylaxisbecause of its dual role as an antioxidant and a chelator. Multiple case reports demonstrated that such therapy hasresulted in pain relief and healing of skin ulceration. We report a case of calciphylaxis of large severity that had anambiguous response to sodium thiosulfate treatment (improvement of symptomatology and skin lesions, improve-ment of blood parameters, worsening of general conditions, and consciousness until death)

Background We evaluated the prevalence of intima-media thickening (IMT) and asymptomatic carotid plaque (ACP) in a group of subjects with or without traditional and/or emerging risk factors (RF). Methods There were 631 subjects (313 male and 318 female) aged between 19 and 97 years, asymptomatic for cerebro- and cardiovascular diseases. The following measurements were used: anamnesis, physical examination, height and sitting blood pressure. Biochemistry variables were also considered: total cholesterol, HDL-C, LDL-C, triglycerides, fibrinogen, high sensitive C-reactive protein, IgG antibodies for Helicobacter pylori (HP), cytotoxic HP, cytomegalovirus and Chlamydia pneumoniae . Finally, an echo color Doppler examination of the carotid arteries was performed. We subdivided the population studied in normotensive and hypertensive subjects and evaluated in each group the frequency of IMT and ACP in relation to age. Results We showed that IMT + ACP was significantly more frequent in patients >65 years in comparison with those p p Conclusions IMT and ACP of carotid arteries are significantly more frequent in patients >65 years vs. those

Background. Venous ulcers represent an important medical problem due to their high prevalence and consequent sanitary costs. In this study we evaluated the effect of Prostaglandin E-1 (PGE-1), a drug that improves district ischemia, on the healing of venous ulcers. Methods. We performed a randomized, placebo-controlled, single blind study, in which 87 patients, carriers of venous leg ulcers, homogeneous for dimensions and characteristics, were treated for 20 days an with infusion of Prostaglandin E-1 or placebo, in association with a topic therapy. The dimension and the number of the ulcers were determined at the beginning of the treatment and then every 20 days up to 4 months or until total recovery. The main outcome of the study was the recovery percentage of the ulcers at the end of the period of observation (120 days) and the referred healing time. The reduction in the extension of ulcers from the baseline measurement to the last observation was also evaluated. Results. The baseline characteristics in the two groups were similar. The reduction in the size of the ulcers was faster in the group of patients treated with PGE-1. In this group 100% of the ulcers healed after 100 days, while in the placebo group only 84.2% did so by the end of the observation period (120 days) (P

Context Patients with suspected deep vein thrombosis ( DVT) of the lower extremities are usually investigated with ultrasonography either by the proximal veins ( 2-point ultrasonography) or the entire deep vein system ( whole- leg ultrasonography). The latter approach is thought to be better based on its ability to detect isolated calf vein thrombosis; however, it requires skilled operators and is mainly available only during working hours. No randomized comparisons are yet available evaluating the relative values of these 2 strategies. Objective To assess if the 2 diagnostic strategies are equivalent for the management of symptomatic outpatients with suspected DVT of the lower extremities. Design, Setting, and Patients A prospective, randomized, multicenter study of consecutive symptomatic outpatients ( n= 2465) with a first episode of suspected DVT of the lower extremities who were randomized to undergo 2- point or whole- leg ultrasonography. Data were taken from ultrasound laboratories of 14 Italian universities or civic hospitals between January 1, 2003, and December 21, 2006. Patients with normal ultrasound findings were followed up for 3 months, with study completion on March 20, 2007. Main Outcome Measure Objectively confirmed 3- month incidence of symptomatic venous thromboembolism in patients with an initially normal diagnostic workup. Results Of 2465 eligible patients, 345 met 1 or more exclusion criteria and 22 refused to participate; therefore, 2098 patients were randomized to either 2- point ( n= 1045) or whole- leg ( n= 1053) ultrasonography. Symptomatic venous thromboembolism occurred in 7 of 801 patients ( incidence, 0.9%; 95% confidence interval [ CI], 0.3%1.8%) in the 2- point strategy group and in 9 of 763 patients ( incidence, 1.2%; 95% CI, 0.5%- 2.2%) in the whole- leg strategy group. This met the established equivalence criterion ( observed difference, 0.3%; 95% CI, - 1.4% to 0.8%). Conclusion The 2 diagnostic strategies are equivalent when used for the management of symptomatic outpatients with suspected DVT of the lower extremities. Trial Registration clinicaltrials. gov Identifier: NCT00353093