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The Registro Italiano per lo Stenting Carotideo (RISC, Italian Registry for Carotid Stenting) has been organized by Italian specialists from different disciplines directly involved in the prevention of stroke due to carotid plaques through stenting of carotid lesions. The Registry has been endorsed by the national societies of 4 different specialties: vascular surgery, interventional cardiology, radiology, and neuroradiology. Each society contributed in he planning stage.The basis for the registry is to collect data on carotid stenting procedures performed by different specialists with different techniques in a 'real-world' setting without the limitations of a randomized clinical trial. The Registry was funded to enroll at least 1200 patients over a minimum period of 36 months. The results will be analyzed using the intention-to-treat principle and are anticipated in late 2006. Primary endpoints of the registry are the 30-day combined death and stroke rate and the occurrence of restenosis and ipsilateral neurological deficit at 12 and 24 months. Considerable attention has been paid to the registry's quality control program to ensure scientific validation. An online database facilitates the collection of data with speed and accuracy. [ABSTRACT FROM AUTHOR]

Objective: The aim of the present study was to comprehensively evaluate systemic and local inflammation as well as progression of vascular inflammation in normal and mechanically injured vessels in a large animal model of mild hypercholesterolemia. Our aim was also to test the effect of high-dose statin treatment on these processes., Methods: Pigs were kept for 120 days on a standard diet (SD, n=7), high-cholesterol diet (HCD, n=7) or high-cholesterol diet with Atorvastatin starting after 50 days (STATIN, n=7). Left carotid artery balloon injury was conducted in all groups after 60 days of diet treatment. Biochemical analysis together with evaluation of blood and tissue markers of vascular injury and inflammation were performed in all groups at the end of experiment., Results: HCD compared to SD induced systemic inflammation demonstrated by increased number of circulating monocytes and lymphocytes. HCD compared to SD induced also local inflammation demonstrated by adipocyte hypertrophy and infiltration of T-lymphocytes in abdominal white adipose tissue, activation of hepatic stellate cells with infiltration of T- and B-lymphocytes and macrophages in the liver and increased macrophage content in lung parenchyma. These changes were accompanied by increased Intima/Media thickness, stenosis, matrix deposition and activated T-cell infiltrates in injured but not in uninjured contralateral carotid artery as we previously reported. The treatment with high-dose statin attenuated all aspects of systemic and local inflammation as well as pathological changes in injured carotid artery., Conclusions: Diet related mild hypercholesterolemia induce systemic and local inflammation in the liver, lung and adipose tissue that coincide with enhanced inflammation of injured vessel but is without deleterious effect on uninjured vessels. High dose statin attenuated systemic and local inflammation and protected injured vessels. However, finding exact role of reduced systemic and remote inflammation in vascular protection requires further studies.

Heme oxygenase-1 (HO-1, encoded by the HMOX1 gene) and inducible nitric oxide synthase (iNOS) have been implicated in vascular disease; however the role of these genes remains unclear. Therefore, we studied the mechanism by which iNOS-derived nitric oxide (NO) affects the intimal hyperplasia (IH) formation in relation to HO-1. We show, in a model of balloon injury in rats, that the suppression of vascular smooth muscle cells (VSMC) proliferation by NO required HO-1, while induction of apoptosis of the VSMC by NO does not involve HO-1. To better clarify the molecular mechanism of this finding, we used Hmox1(+/+) and Hmox1(-/-) VSMC exposed to NO. In Hmox1(+/+) VSMC, NO is antiproliferative (up to 34% inhibition) and it is associated to an increase of apoptosis (up to 35%) due to a decrease of X-linked inhibitor of apoptosis protein (XIAP) expression level and to the activation of caspase-3. In the absence of HO-1 (Hmox1(-/-) VSMC) apoptosis was significantly greater (69% p<0.01 vs. Hmox1(+/+) VSMC) demonstrating that HO-1 attenuated the pro-apoptotic effect of NO on VSMC. In the context of IH, the pro-apoptotic effect of NO on VSMC is increased in the absence of HO-1 and exerts therapeutic effects with a significant reduction in IH.

Object: The pathogenesis of carotid artery stenosis (CAS) as well as the mechanisms underlying the different localisation of the atherosclerotic lesions remains poorly understood. We used microarray technology to identify novel systemic mediators that could contribute to CAS pathogenesis. Moreover, we compared gene-expression profile of CAS with that of patients affected by abdominal aortic aneurysm (AAA), previously published by our group., Methods and Results: By global gene-expression profiling in a pool of 10 CAS patients and 10 matched controls, we found 82 genes differentially expressed. Validation study in pools used for profiling and replication study in larger numbers of CAS patients (n = 40) and controls (n = 40) of 14 genes by real-time polymerase chain reaction (RT-PCR) confirmed microarray results. Fourteen out of 82 genes were similarly expressed in AAA patients. Gene ontology analysis identified a statistically significant enrichment in CAS of differentially expressed transcripts involved in immune response and oxygen transport. Whereas alteration of oxygen transport is a common tract of the two localisations, alteration of immune response in CAS and of lipid metabolic process in AAA represents distinctive tracts of the two atherosclerotic diseases., Conclusions: We describe the systemic gene-expression profile of CAS, which provides an extensive list of potential molecular markers., (Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determine whether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-knee bypass grafting., Methods: Patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial disease (PAD) were enrolled 2 to 4 days after surgery and were randomly assigned to clopidogrel 75 mg/day plus ASA 75 to 100 mg/day or placebo plus ASA 75 to 100 mg/day for 6 to 24 months. The primary efficacy endpoint was a composite of index-graft occlusion or revascularization, above-ankle amputation of the affected limb, or death. The primary safety endpoint was severe bleeding (Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries [GUSTO] classification)., Results: In the overall population, the primary endpoint occurred in 149 of 425 patients in the clopidogrel group vs 151 of 426 patients in the placebo (plus ASA) group (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.78-1.23). In a prespecified subgroup analysis, the primary endpoint was significantly reduced by clopidogrel in prosthetic graft patients (HR, 0.65; 95% CI, 0.45-0.95; P = .025) but not in venous graft patients (HR, 1.25; 95% CI, 0.94-1.67, not significant [NS]). A significant statistical interaction between treatment effect and graft type was observed (P(interaction) = .008). Although total bleeds were more frequent with clopidogrel, there was no significant difference between the rates of severe bleeding in the clopidogrel and placebo (plus ASA) groups (2.1% vs 1.2%)., Conclusion: The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk., (Copyright © 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Most strategies against intimal hyperplasia developed in several preclinical models failed in terms of clinical application, often due to a discrepancy between animal and human disease. The aim of this study was to setup for the first time a porcine vascular injury model with mild hypercholesterolemia able to significantly increase the degree of stenosis resembling human settings and investigate the pathogenetic role of hypercholesterolemia on protective genes and inflammatory response affecting matrix deposition and cell proliferation., Methods: Pigs were fed with standard (SD, n=7) or high-cholesterol diet (HCD, n=7) for 120 days. A balloon angioplasty injury was induced in carotid arteries., Results: Hypercholesterolemia induced a mild significant increase of total and LDL cholesterolemia. HCD significantly increased the degree of stenosis (48+/-3% vs. 13+/-4%, p=0.001), with induction of cell proliferation, matrix deposition, TGF-beta1/TGFbetaRII and MMP2 expression and reduction of collagen. The reduced expression of the protective gene heme oxygenase-1 and inducible-nitric oxide synthase in HCD was associated to a systemic inflammation with a significant increase in circulating leukocytes, serum IFN-gamma and TNF-alpha and a local inflammatory response with an increase of CD3-positive cell infiltrates. There was a significant correlation between CD3 infiltrates and the degree of stenosis., Conclusion: We developed for the first time a porcine vascular injury model with mild hypercholesterolemia able to significantly increase the degree of stenosis and showed the pathogenetic role of hypercholesterolemia on intimal hyperplasia. New therapeutical strategies to prevent restenosis can be tested in this preclinical hypercholesterolemic model resembling human disease.

Object: Abdominal aortic aneurysm (AAA) pathogenesis remains poorly understood. This study investigated the gene expression profile of peripheral blood from patients with AAA using microarray technology., Methods and Results: We determined gene expression profiles in pooled RNA from 10 AAA patients and 10 matched controls with arrays representing 14,000 transcripts. Microarray data for selected genes were confirmed by real-time PCR in two different AAA (n=36) and control (n=36) populations and integrated with biochemical data. We identified 91 genes which were differentially expressed in AAA patients. Gene Ontology analysis indicated a significant alteration of oxygen transport (increased hemoglobin gene expression) and lipid metabolism [including monoglyceride lipase and low density lipoprotein receptor-related protein 5 (LRP5) gene]. LRP5 expression was associated inversely with serum lipoprotein(a) [Lp(a)] concentration., Conclusions: Increased expression of hemoglobin chain genes as well as of genes involved in erythrocyte mechanical stability were observed in the AAA RNA pools. The association between low levels of LRP5 gene expression and increased levels of Lp(a) in AAA patients suggests a potential role of LRP5 in Lp(a) catabolism. Our data underline the power of microarrays in identifying further molecular perturbations associated with AAA.

Endovascular procedures have emerged as an attractive alternative technique for the repair of abdominal aortic aneurysms with an increasing popularity and diffusion. Even if technology progresses are developing more and more efficient grafts and devices, at the moment the endovascular treatment is still not applicable to all patients. The most common reason for patient exclusion remains an unsuitable proximal implantation site. Endografts with suprarenal fixation were studied for solving the problem of the proximal neck but results seem to be not so encouraging. At the moment pararenal aortic aneurysms, involving ostia of renal or visceral arteries, are usually excluded from endovascular treatment. The solution could be a custom-made graft for each single patient, with fenestrations or branches for renal and visceral arteries. The first clinical use of a fenestrated graft was by Park in 1996 and some groups are now studying different kinds of grafts, both in experimental and clinical studies, which are opening attractive new possibilities. At present results are only preliminary but this would be the first step towards the potential substitution of the entire aorta through endovascular techniques.

Carotid artery stenting (CAS) is used widely to treat carotid lesions. Indication to CAS is mostly based, both in trial and in clinical practice, on the percentage of stenosis and the presence or absence of preprocedural neurologic symptoms, whereas the features of the plaque are somehow disregarded and ignored. The most severe complication of CAS is stroke, related to cerebral embolization from carotid plaque. Several studies showed that echolucent plaques generate a higher number of embolic particles following carotid stenting. Echolucency can be measured using the gray scale median, which is an objective and quantitative computer-assisted grading of the echogenicity of carotid plaques. As previously demonstrated in the ICAROS study, carotid plaque echolucency is an independent risk factor for stroke in carotid stenting. Carotid plaque echolucency is one of the parameters that should be mandatory to be considered for indication to treatment.

Purpose: This paper examines the clinical results of a 9-year experience in which the incidence of major (stroke and death) perioperative events and of recurrent stenosis (>60%) after carotid endarterectomy performed with a direct suture (DS) of the arteriotomy versus bovine pericardium patch angioplasty (BPPA) are compared., Methods and Materials: A total of 517 carotid endarterectomies were included in this nonrandomized study and were divided into two groups: group DS with 194 procedures and group BPPA with 323 procedures. All patients were entered in a follow-up program that ranged from 1 to 108 months (mean, 56.4 months) and included color duplex scan examinations at 1, 3, 6, and 12 months after surgery and every year thereafter., Results: The number of major (stroke and death) perioperative cerebrovascular accidents was eight (4.1%) in the DS Group and five (1.5%) in the BPPA group (P =.066). One death occurred in the DS group, and three occurred in the BPPA Group (P =.517). The four deaths in both groups were the result of strokes. No statistically significant difference was found in terms of early neurologic complications between the two groups. During the first year of follow-up study, the rate of restenosis >60% and occlusion was significantly lower in the BPPA group. Thereafter, the difference was not significant., Conclusion: In our experience, the use of BPPA or DS during carotid endarterectomy procedure does not cause a significantly different rate of perioperative major events (stroke or death) in the two groups. The incidence rate of restenosis is lower in the first year after surgery with BPPA, but in subsequent years, no significant difference in restenosis is seen. The early and late postoperative results with BPPA compare favorably with the reported data from literature with the use of other patch materials.

Objective: to evaluate whether perioperative haemodynamic optimisation influences outcome from infrarenal abdominal aortic aneurysm repair., Methods: a consecutive series of 100 eligible patients were randomised to either haemodynamic optimisation through the use of a pulmonary artery catheter (CI > 3.0 l/min/sqm, PWP > 10 and <18 mmHg, SVR <1450 dyne/sec/cm(-5), DO(2)> 600 ml/min/sqm) or conventional treatment., Results: there were no differences in terms of in-hospital mortality, cardiovascular morbidity, postoperative renal failure or duration of hospital stay between the groups., Conclusions: in this study perioperative haemodynamic optimisation was not beneficial., (Copyright 2002 Elsevier Science Ltd.)

Purpose: To describe a case of improved renal function and renovascular hypertension after percutaneous treatment of a renal artery aneurysm., Case Report: A 72-year-old hypertensive woman with a hilar saccular aneurysm of the right renal artery underwent percutaneous coil embolization under local anesthesia. Four individual, soft, detachable platinum embolization coils were successfully inserted in the aneurysm with incomplete aneurysm exclusion. Nonetheless, the patient's blood pressure and renal function returned to normal. The arteriogram at 3 months demonstrated complete exclusion of the lesion and good renal perfusion. The patient remains normotensive with documented improved renal function at 18 months after treatment., Conclusions: Superselective coil embolization is an effective treatment for renal artery aneurysms that display proper morphological features. The long-term outcome of this less invasive therapy still must be assessed, but it appears plausible that embolotherapy of renal artery aneurysms can correct secondary hypertension and deteriorating renal function.

ICAROS (Imaging in Carotid Angioplasties and Risk Of Stroke) is a multicenter international registry of carotid artery stenting designed to determine the criteria for identifying patients at higher or lower risk of periprocedural stroke and restenosis at 1 year. The aim of the registry is to improve patient selection and consequently reduce the risk of cerebral embolization during carotid stenting. The registry is open to all interventionists performing carotid stenting, and the participants are free to apply their own endovascular techniques and devices, including cerebral protection mechanisms. All cerebral ischemic events following the procedure will be reported. Follow-up surveillance to 1 year will include periodic duplex scanning and neurological examinations. Echographic plaque images will be standardized for comparison, processed for echodensity, and analyzed by computer at the Registry Center. Correlation will be investigated between the echographic index (gray-scale median) and the risk of embolism and outcome of carotid stenting.

This is a report of a prospective study to evaluate the safety and efficacy of the Medtronic AneuRx stent-graft. Patients with an infrarenal aneurysm with a proximal neck length of greater than 10 mm and a neck diameter not greater than 26 mm and iliac artery diameters of at least 6 mm were accepted for endovascular repair using the Medtronic AneuRx modular stent-graft. A total of 104 patients were included in the study. Transfemoral placement of the bifurcated stent-graft was successful in 102 of 104 patients. Two conversions were performed. The mean operating time was 148 min (range 75-480) and the mean blood loss was 605 ml (range 100-2900). The mean follow-up was 15 months (range 12-21). Complications were rare and no kinking or migration occurred. At follow-up, four endoleaks persisted after 12 months. The Medtronic AneuRx stent-graft is a safe and efficacious alternative to open abdominal aortic aneurysm repair with excellent early results.

Objectives: to confirm that plaque echogenicity evaluated by computer analysis, as suggested by preliminary studies, can identify plaques associated with a high incidence of strokes., Materials and Methods: a series of 96 patients with carotid stenosis in the range of 50-99% were studied retrospectively (41 with TIAs and 55 asymptomatic). Carotid plaque echogenicity was evaluated using a computerised measurement of the median grey scale value (GSM). All patients had a CT brain scan to determine the presence of infarction in the carotid territory., Results: the incidence of ipsilateral brain CT infarctions was 16% in the asymptomatic and 32% in the symptomatic plaques (p =0.076). It was 20% for <70% stenosis and 25% for >70% stenosis (p =0.52). It was 9% for plaques which had a GSM >50 and 40% in those with GSM <50 (p <0.001) with a relative risk of 4.6 (95% CI 1.8 to 11.6)., Conclusions: the results confirm that computer analysis of plaque echogenicity is better than the degree of stenosis in identifying plaques associated with an increased incidence of CT brain-scan infarction and consequently useful for identifying individuals at high risk of stroke. What is required is a form of image standardisation in order to apply this method to natural history studies with stroke as the endpoint., (Copyright 1999 W.B. Saunders Company Ltd.)

Purpose: To emphasize the importance of diagnostic imaging: a) in the selection of patients to be treated with the transluminal approach b) during stent-graft positioning c) in the follow-up of treated patients., Material and Methods: From January 1997 to May 1998, twenty-five patients with abdominal aortic aneurysms (AAA) were treated with transfemoral stent-grafts (AneuRx Medtronic). All patients were submitted to a preoperative study including digital angiography (DSA) and Spiral CT. Intraoperatively they underwent DSA and intravascular ultrasound (IVUS). Follow-up was performed with Spiral CT., Results: Twenty-four bifurcated and one straight device were inserted in twenty-five patients with AAA. In two cases it was impossible to position the endoprosthesis due to narrow or tortuous artery access. Following the intention to treat criteria, the technical success rate was 92.5%. All the stents were patent and no dislodgement was observed at follow-up. Partial thrombosis of the stent was observed in three patients. Owing to incomplete distal covering, early endoleak occurred in one patient with an aortoiliac aneurysm; the positioning of two cuffs allowed a successful outcome. CT examination performed 6 months after positioning revealed the presence of endoleaks in three patients, due to persistence of lumbar and inferior mesenteric artery patency. The AAA was no more appreciable in five of the ten patients submitted to CT follow-up one year after the procedure. In three of ten cases it was reduced in size and in two patients there was no change., Discussion: Spiral CT plays a basic role in the selection of patients because it helps assess the length and diameter of the proximal neck, thus permitting to choose the device to be inserted. Preoperative DSA is mandatory in the evaluation of size and tortuosity of the iliac arteries. IVUS allows to monitor the site of delivery during the maneuver and to make the final measurements while DSA plays a role in checking the correct positioning of the device and excluding the presence of endoleaks at the end of the procedure. Late follow-up with Spiral CT aims at demonstrating possible malfunctioning of the endoprosthesis and confirms the definitive exclusion of AAA., Conclusions: Diagnostic imaging plays a basic role in the endovascular treatment of AAA, much more than that required for traditional surgical treatment. In particular, pretreatment planning is critical and requires sophisticated imaging including Spiral CT with 3D reconstruction and angiographic evaluation using catheters with calibrated markers.

Objective: Transfemoral endoluminal repair of AAA, introduced for the first time in the early 90's, has become a very promising alternative to conventional open repair and more and more centers are reporting satisfactory postoperative results in a high percentage of cases. Straight and bifurcated grafts represent the devices available on the market at present and aortic, as well as iliac aneurysmal lesions can be safely treated through a transfemoral approach. The possibility to indicate an endovascular AAA repair is related to the configuration (length and size) of the proximal and distal necks, tortuosity and calcification of the access arteries and to vascular and non-vascular comorbidities, which afflict the patients. The objective of our study was to evaluate the early and late postoperative results in a series of patients affected by infrarenal AAA, who underwent endoluminal repair., Materials and Methods: From December 1996 to 31 October 1997 in 5 different European Centers, 100 Medtronic AneuRx bifurcated stent grafts were implanted for infrarenal abdominal aortic aneurysms. The diameter of the AAA varied from 33 to 77 mm (average 64 mm) and the mean age of the patients was 70.8 years (51-87 years). In one patient with a 33 mm diameter of the aneurysm, the surgical procedure was indicated because the size of the aneurysm had increased by 5 mm, compared to the previous control made 2 months before. In addition the aneurysm became symptomatic. There were 92 male and 8 female patients. The average time of the surgical procedure was 150 minutes (75-480 minutes) with an average blood loss of 570 ml (100-2,600 ml).