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Introduction: The aim of this study is to describe our experience in the treatment of femoropopliteal occlusive disease with percutaneous transluminal angioplasty (PTA) followed by stenting with S.M.A.R.T. Flex vascular stent system., Materials and Methods: From June 2014 to October 2018, 80 patients were treated at our Institution for intermittent claudication, critical, or acute limb ischemia due to total occlusion or long diffused lesions of the femoropopliteal segment. Main study end points are primary patency, target lesion revascularization, and stent fractures; secondary end points are major amputation rate, procedure-related bleeding, incidence of intrastent restenosis, and primary assisted patency after reintervention., Results: Mean follow-up time was 21 months (range 2-48 months). Primary patency rate was 80% (64 patients of 80), with mean covered lesion length of 8.2 cm. The deployment of a single stent was obtained for 57 (89%) patients, with a mean stent length of 9.86 cm. Of 80 patients, 2 (2.5%) had early stent occlusion within first 48 hours after the procedure, while 4 (5%) of 80 patients experienced stent occlusion within first 6 months. Of 80 patients, 6 (7.5%) had an intrastent restenosis detected at duplex ultrasound with a primary-assisted patency after simple re-PTA procedures of 83.3% at 12 months., Discussion: In the literature, primary patency after PTA and stenting of the femoropopliteal trunk seems to be related to several variables, such as number of stents used, specific stent length, diameters, type and length of lesions, type of pathology (if acute or chronic), and number of preoperatory patent below-the-knee vessels. In this study, we try to analyze each single factor in order to understand their role in predisposing specific stent restenosis., Conclusions: S.M.A.R.T. Flex vascular stent system has shown good results in terms of primary patency in the treatment of calcified lesions both at SFA and at popliteal level. However, in our experience, stent patency seems to be significantly poorer in patients presenting with acute limb ischemia associated with chronic atherosclerotic disease as well as for lesions located in the mid-distal part of the popliteal artery and both when number of stents increases or number of runoff vessel decreases.

Aim: Carotid revascularization is an established theurapeutic modality in preventing stroke and death among patients with severe carotid stenosis. Although carotid endarterectomy remains as the primary option, carotid stenting is accepted as an alternative for patients with high risk for carotid endarterectomy. Recently published reports have better results with proximal protection devices when compared with distal protection devices. These studies have revealed less microembolic signals and less periprocedural new ischemic lesions on diffusion weighted magnetic resonance imaging. Stent choice may be also important for these procedures as open cell stent design has advantage of better flexibility whereas closed cell systems have an advantage of better scaffolding. Hybrid stents which are composed of open cells in the proximal and distal part and closed cells in the middle may carry both advantages. The aim of this study is to demonstrate whether combination of proximal protection devices with hybrid stents can be a safe alternative for carotid stenting in terms of periprocedural and 30-day outcomes., Methods: Here we retrospectively evaluated 68 symptomatic carotid stenosis patients undergoing carotid stenting with hybrid stent (Cristallo Ideale®, Invatec s.r.l., Medtronic, Italy) and proximal protection device (MO.MA®, Invatec s.r.l., Medtronic, Italy)., Results: Our results showed only 1 minor stroke in the periprocedural period and during the first 30-day after stenting, with no death or myocardial infarction., Conclusion: Although our case number is not large, we propose that carotid stenting may be safer with utilization of proximal protection system and hybrid type carotid stents.

According to the World Health Organization, every year, 5 million peoples die for stroke and another 5 million are permanently disabled. Although there are many causes of acute stroke, a common treatable cause of acute stroke is atheromatous narrowing at the carotid bifurcation. Carotid endarterectomy is still the standard of car, even if carotid artery stenting (CAS) has become an effective, less invasive alterantive. Unfortunately, CAS procedure is not yet perfect; regardless the use of an embolic protection device (EPD), percutaneous treatment has been correlated with a risk of cerebral ischemic events related to distal embolization. The objective of the IRON-Guard Registry is to evaluate the clinical outcome of treatment by means of stenting with the C-Guard (InspireMD, Boston, MA, USA) in subjects requiring CAS due to significant extracranial carotid artery stenosis with a physician-initiated, Italian, prospective, multicenter, single-arm study. A total of 200 enrolled subjects divided over different centers are planned to be enrolled. CAS will performed by implanting of C-Guard stent. Procedure will be performed according to the physician's standard of care. Standard procedures will be followed based on the Instructions for Use, for the C-Guard device of Inspire. The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any periprocedural (≤30 days postprocedure) death, stroke or myocardial infarction. Secondary endpoints are rate of late ipsilateral stroke (31 through 365 days), system technical success, device malfunctions, major adverse events (MAEs), serious device-related and procedure-related adverse events, target lesion revascularization, and in-stent restenosis rates.

Objectives: The aim of this study was to identify predictors of occlusion intolerance (OI) developing during proximal protected carotid artery stenting (CAS)., Background: The use of proximal embolic protection devices, such as endovascular occlusion, during CAS has been demonstrated to be particularly safe and effective. However, endovascular occlusion can expose the ipsilateral hemisphere to hypoperfusion and produce transient neurological symptoms (OI)., Methods: From March 2010 to March 2012, 605 consecutive patients underwent proximal protected CAS at our institution. To identify independent predictors of OI, a multivariate logistic regression model was developed that included all patients' clinical/angiographic and procedural characteristics., Results: OI developed in a total of 184 patients (30.4%). Compared with patients in whom OI did not develop, those who experienced OI had lower occlusion pressure (OP) (42.3 ± 12.7 mm Hg vs. 61.9 ± 15.4 mm Hg, p < 0.001). Receiver-operating characteristic curve analysis demonstrated that OP was the most consistent predictor of OI with a C-statistic of 0.85 (95% confidence interval [CI]: 0.82 to 0.88) with best cutoff being ≤40 mm Hg (sensitivity, 68.5%; specificity, 93.3%). By logistic regression analysis, the most powerful independent predictor of OI developing was an OP ≤40 mm Hg (odds ratio: 33.2, 95% CI: 19.1 to 57.7) and the most powerful clinical predictor of such OP was the presence of contralateral internal carotid artery occlusion (odds ratio: 3.1, 95% CI: 1.5 to 6.2)., Conclusions: OI may occur in as many as one-third of the patients undergoing proximal protected CAS. This event is more common in those patients with an OP ≤40 mm Hg. Patients presenting with concomitant occlusion of the contralateral internal carotid artery more frequently have an OP ≤40 mm Hg., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Carotid artery stenting (CAS) is currently considered a valid alternative to carotid endarterectomy (CEA) for the prevention of stroke in high-risk patients. One of the most important issues for both of these techniques is carotid restenosis. The aim of our study was to evaluate the incidence of post-CEA and post-CAS restenosis in a large cohort of patients in a single high-volume center., Methods: Between December 2000 and December 2010, 2453 CEA and 2628 CAS procedures were performed in the Vascular and Endovascular Surgery Unit at our institution. The mean age of patients was 73.8 years (range 55‒89 years), 78% of whom were men. Indications for carotid revascularization were: presence of symptomatic carotid artery stenosis of >70%, or asymptomatic stenosis of at least 80%, especially in patients with vulnerable plaques., Results: Mild and long-term results after CEA and CAS were similar. The overall perioperative neurologic complication rate (minor and major stroke) was similar in the 2 groups. At 1-year follow-up the restenosis rate after CEA was 1.58%. In-stent restenosis after CAS occurred in 1.67% of the procedures. All but 3 arteries had been treated for postsurgical restenosis. All lesions were approached secondarily with endovascular procedures. Statistical analysis demonstrated that post-CEA restenosis was the most important predictive factor for the development of in-stent restenosis after CAS., Conclusions: This review of our 10-year experience confirms that patients who develop restenosis after CEA are also prone to developing in-stent restenosis after CAS., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Purpose: To evaluate the safety and efficacy of urgent carotid artery stenting (CAS) with technical modifications in patients with recent (<24 hours) initial or recurrent (≥2 episodes in 24 hours) transient ischemic attacks (TIA) or with minor stroke., Methods: A single-center, prospective, observational study was begun in March 2005 to assess an urgent CAS protocol for the treatment of selected high-risk patients with carotid artery disease who presented within 24 hours of an initial or recurrent TIA or minor stroke. Up to June 2011, 78 patients (59 men; mean age 76 years) with TIA (n=57) or minor stroke (n=21) underwent urgent CAS (within 48 hours) for severe internal carotid artery stenosis. Outcome measures were major adverse cardiac and cerebrovascular events (MACCE), modifications in the National Institutes of Health Stroke Scale (NIHSS) values for minor stroke patients, and postoperative stroke and death rates., Results: Technical and procedural success rates were 100% and 97.4%, respectively; 1 intraoperative minor stroke occurred due to stent thrombosis. At 30 days, 2 patients had recurrent minor stroke; one subsequently died after a hemorrhagic brain infarction. The MACCE rate was 3.8%. There were no cases of myocardial infarction or access-related complications. Of the 20 surviving minor stroke patients, 14 showed improvement in neurological deficit on the NIHSS scale at 30 days, while 5 remained stable and one was neurologically impaired., Conclusion: Urgent CAS in selected patients with symptomatic carotid stenosis was satisfactory in preventing the recurrence of TIA and stroke in this study. Urgent CAS with careful patient selection, contemporary tools (medical and technical), and expert technique may represent a possible solution for some patients with recent or recurrent TIA or minor stroke.

Background: Invasive management of patients ≥80 years of age with carotid stenosis may be questionable. The higher likelihood of stroke needs to be balanced with the increased perioperative risk and the reduced life expectancy of this ageing population. The purpose of this study was to evaluate the clinical relevance of carotid stenosis revascularisation in octogenarians., Methods: All patients ≥80 years of age who received carotid revascularisation in 2001-2010 were reviewed for perioperative and 5-year outcomes. The experience was comprehensive of carotid endarterectomy (CEA) and carotid stenting (CAS) performed during the training frame when age was not a contraindication for this procedure. Mortality rates were compared to those of octogenarians of the same geographical territory according to all-cause and stroke-related mortality national statistics datasets., Results: A total of 348 procedures performed in ≥80-year-old patients (272 males) were reviewed: 162 (46.6%) were by CAS and 169 (48.6%) were for symptomatic disease. Perioperative stroke/death rate was 5.5% and was non-significantly higher for symptomatic disease (7.1% vs. 3.9% asymptomatic; p = 0.24), after CAS (6.2% vs. 4.8% CEA; p = 0.64) and in females (6.6% vs. 5.1% males; p = 0.57). At median follow-up of 36.18 months, 95 deaths and 21 new ischaemic strokes (12 fatal) occurred with 5-year Kaplan-Meier freedom from stroke of 84.8% (78.7%, symptomatic vs. 90.3% asymptomatic; p = 0.003). According to national datasets, in 80-85-year-old resident population 5-year mortality was 29.9% (23.4% females, 40.6% males) and ischaemic stroke-related mortality was 14.9% (16.8% females, 13.0% males). Corresponding figures from treated population showed a 5-year mortality of 49.4%, higher in males (39.5% females, 52.5% males) and ischaemic stroke-related mortality of 20.2%, higher in females (40.0% females, 15.6% males). Comparing data from the study population with residents' figures, ischaemic stroke-related mortality hazard was significantly higher in the study females: odds ratio (OR) 3.2, 95% confidence interval (CI) 1.16-9.17; p = 0.029 (for males: OR 0.97, 95%CI 0.89-1.10; p = 0.99)., Conclusions: Despite perioperative stroke/death risks being lower compared with CAS, the benefit of surgical carotid revascularisation in old patients remains controversial due to limited life expectancy and high fatality of stroke in this ageing population. Invasive treatment of carotid stenosis may not be warranted in most patients ≥80 years of age with carotid stenosis, especially when female and asymptomatic., (Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Aim: The aim of this preliminary study is to evaluate the feasibility and efficacy of CAS as treatment option to endarterectomy when carotid shunt cannot be used safely., Methods: The medical records concerning 469 carotid stenosis treated between January 2006 and December 2009 were retrospectively reviewed, focusing on cross-clamp intolerance during CEA. Patients with cross-clamping intolerance were divided in two groups. Group 1: those that concluded the open procedure with the use of a shunt, and Group 2: those who experience immediate brain intolerance and coma and were immediately converted to an endovascular procedure. Mortality and neurological adverse event rate were compared between shunted CEA and cross-clamping intolerant cases converted into CAS. The secondary end-point was long-term survival., Results: Carotid cross-clamp intolerance occurred in 30 cases (8.7%). CEA with Pruitt-Inahara's shunt was performed in 17 cases with a perioperative neurological adverse event rate of 23.5%. In 13 cases limitations to shunting due to quick onset of coma and/or an unfavorable anatomy were encountered. In these 13 cases the open intervention was immediately converted into endovascular procedure. Technical success was achieved in all the converted to CAS cases (100%), with a perioperative neurological adverse event rate of 7.7% (P=0.35 between the two groups). No significant difference emerges comparing patient's survival between the cases, Conclusion: Nevertheless, the small dimension of this survey, immediate conversion to CAS resulted feasible with a lower risk of neurological adverse events if compared to CEA with shunt, and could be considered as an alternative to CEA when carotid shunt cannot be used safely.

Background: Diabetes is prevalent in most patients undergoing carotid revascularization and is suggested as a marker of poor outcome after carotid endarterectomy (CEA). Data on outcome of diabetic patients undergoing carotid artery stenting (CAS) are limited. The aim of this study was to investigate early and 6-year outcomes of diabetic patients undergoing carotid revascularization with CAS and CEA., Methods: The database of patients undergoing carotid revascularization for primary carotid stenosis was queried from 2001 to 2009. Diabetic patients were defined as those with established diagnosis and/or receiving oral hypoglycemic or insulin therapy. Multivariate and Kaplan- Meier analyses, stratified by type of treatment, were performed on perioperative (30 days) and late outcomes., Results: A total of 2196 procedures, 1116 by CEA and 1080 by CAS (29% female, mean age 71.3 years), were reviewed. Diabetes was prevalent in 630 (28.7%). Diabetic patients were younger (P < .0001) and frequently had hypertension (P = .018) or coronary disease (P = .019). Perioperative stroke/death rate was 2.7% (17/630) in diabetic patients vs 2.3% (36/1566) in nondiabetic, (P = .64); the rate was 3.4% in diabetic CEA group and 2.1% in diabetic CAS group (P = .46). At multivariate analyses, diabetes was a predictor of perioperative stroke/death in the CEA group (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.05-7.61; P = .04) but not in the CAS group (P = .72). Six-year survival was 76.0% in diabetics and 80.8% in nondiabetics (P = .15). Six-year late stroke estimates were 3.2% in diabetic and 4.6% in nondiabetic patients (P = .90). The 6-year risk of restenosis was similar (4.6% % vs 4.2%) in diabetic and nondiabetic patients (P = .56). Survival, late stroke, and restenosis rates between diabetics and nondiabetics were similar in CAS and CEA groups., Conclusions: Diabetic patients are not at greater risk of perioperative morbidity and mortality or late stroke after CAS, however, the perioperative risk can be higher after CEA. This may help in selecting the appropriate technique for carotid revascularization in patients best suited for the type of procedure., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: S-100 protein is a family of low molecular weight proteins found in vertebrates characterized by two calcium binding sites of the helix-loop-helix ("EF-hand type") conformation. There are at least 21 different types of S-100 proteins. The name is derived from the fact that the protein is 100% soluble in ammonium sulfate at neutral pH. Protein S-100B was investigated as a marker of brain ischemic damage after treatment of carotid stenoses., Methods: Between December 1, 2009 and December 1, 2010, S-100B protein was monitored in 76 patients after carotid artery stenting (CAS) and in 24 patients after carotid endarterectomy (CEA). In each patient, multiple samples were taken: before the procedure (basal sample), immediately after CAS or CEA, 60 minutes after CAS or CEA, and daily during the hospital stay. Evaluation of S-100B was carried out by blind assessment. Patients underwent pre- and postoperative diffusion-weighted magnetic resonance imaging or computed tomographic scan., Results: An S-100B coefficient of variation higher than the established cut-off was detected in 16 patients: three affected by postoperative stroke, two patients with minor stroke, and one patient with fatal stroke; 12 patients presented with uneventful neurological outcome and positive brain imaging; and there was one false positive case. No false negative cases occurred. The postoperative protein S-100B level lowered to basal level in 15 patients: within 24 hours in the 12 patients with the uneventful outcome (and positive brain imaging) and in the false positive case; and after 120 and 144 hours, respectively, in the two patients with minor stroke. In the patient with fatal stroke, protein S-100B never returned to the preoperative level., Conclusions: In patients with an increased S-100B coefficient of variation, the diffusion-weighted magnetic resonance imaging was positive for ischemic brain lesions, except for one patient who was reported as a false positive case. The postoperative S-100B protein level decreased within 24 hours in the uneventful neurological cases and in the false positive case, whereas long-lasting postoperative increased values of the S-100B protein were observed in patients with poor neurological outcomes., (Copyright © 2011 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

Aim: The aim of this study was to retrospectively compare early and one-year results of open surgery (OS) for critical limb ischemia (CLI) in patients who underwent primary surgery and in patients operated after a previous failure of endovascular treatment (EV)., Methods: Between January 2004 and December 2007, 460 patients (304 males, 156 females) aged between 46 and 95 (average age 72) underwent OS or EV for CLI. We performed 273 EV (47%) and 307 OS (53%) procedures. In 98 patients (21.3%) the procedures were bilateral. EV procedures were intraluminal, subintimal or both, with selective stenting. OS procedures were distal bypass grafts. OS involved 34 dialysed patients, 159 patients with CLI non-dialysed and not previously submitted to EV treatment (group 1, control group) and 114 patients with failure of previous EV treatment (group 2), frequently performed in different and non surgical centers, 8% of EV failure in our series in this time. We retrospectively compared the early and one-year results in the last two groups of patients in terms of level of revascularization, primary patency, amputation and mortality., Results: By-pass grafts were autologous vein in 94% and PTFE in 6%. Revascularizations have been directed to the tibial or to the plantar arteries at the ankle or foot. Those directed to the plantars were respectively 54% (52% dorsalis pedis, 36% retromalleolar posterior tibial, 12% medial plantar artery) in the control group and 76% (66% dorsalis pedis, 18% retromalleolar posterior tibial, 16% medial plantar artery) in patients with previous failed PTA (P<0.001). Early primary patency, mortality and amputation free survival were respectively in the control group and in patients with previous failure of PTA: 93.7% vs. 76.3% (P<0.001), 2.5% vs. 3.5% (P>0.5), 95% vs. 93% (P>0.5). One-year primary patency, mortality and amputation free survival were respectively in the control group and patients with previous failure of PTA: 86.03% vs. 70.87% (P>0.25), 14.93% vs. 17.56% (P>0.5), 78.1% vs. 68.5% (P>0.1)., Conclusion: After failure of EV therapy, the subsequent open surgery was more distal and technically demanding. Its results were significantly worse when compared with standard CLI patients, with an increase rate of redo. Our data suggest that EV should not be attempted as the first choice in every patient affected by CLI, and we believe that OS still is the primary treatment for the most advanced clinical situations.

Aim: The literature continues reporting a high complication rate for carotid artery stenting (CAS) during the learning-curve phase (LCP). The aim of this study was to report a simple and reproducible method designed to improve CAS results during the LCP., Methods: Between February 2007 and December 2009, a qualified vascular surgeon ran a proctorship program for CAS. The program was divided into four practical phases: in the teaching phase (a) the first 20 CAS were performed by the proctor assisted by a trainee surgeon; in the training phase (b) for the 21st to the 50th CAS the trainee surgeon was supervised by the proctor; in the skilled phase (c), between the 51st and the 80th procedure, a trainee surgeon performed CAS while the proctor was scrubbed-in but operating only on demand; in the final phase (d), following the 81st CAS, the procedure was performed without the proctor's presence. The inclusion criterion was carotid stenosis ≥70% and patient selection was performed for the first 40 cases based on patient and lesion characteristics. The procedure for CAS was standardized., Results: Four trainees performed 604 CASs in two centers. The procedural success rate of CAS was 98.8% (N.=594/604) without any differences among the four trainees (P=0.902). The overall TIA, myocardial infarction, minor, major and fatal stroke rate at 30 days was respectively 1.7% (N.=10), 0.8% (N.=5), 1.2% (N.=7), 0.64% (N.=4) and 0.3% (N.=2). The effectiveness of this program was demonstrated by a significant decrease in the proctor's intervention between phase b and phase c (P<0.001) and by a similar trend in the complication rate achieved by the four trainees, in all phases and centers (P=0.075 and 0.788, respectively)., Conclusion: This preliminary experience of a proctorship program in the LCP, together with patient selection and standardization of the procedure and materials used, seems to be safe and reproducible. Moreover, possibly randomized, studies comparing different CAS training techniques are needed in order to validate our findings.

Objectives: To investigate the role of renal stenting in selected patients with chronic ischemic heart disease and renal artery stenosis., Methods: Consecutive patients, with chronic ischemic heart disease and severe hypertension and/or impaired renal function undergoing renal stenting, were prospectively enrolled. Mid-term (at least 2 years) follow-up was performed to assess both changes in renal function [serum creatinine and estimated glomerular filtrate rate (eGFR)] and blood pressure (BP) control (number of required drugs) and to record the incidence of clinical major adverse events. Moreover, in the first consecutive 24 patients, out-of-range pressure values at 24-hr BP monitoring and GFR at renal scintigraphy were measured at baseline and 1 month after stenting., Results: Seventy patients treated by stenting on 86 renal arteries entered the study. Procedural success rate was 99% and no major complication occurred. At 2-year follow-up, both mean serum creatinine (-0.1 +/- 0.7 mg/dl at follow-up compared to baseline, P = 0.6) and eGFR (+3.7 +/- 23.5 ml/min/1.73m(2) at follow-up compared to baseline, P = 0.2) did not significantly change while the number of drugs required to control BP significantly decreased (2.7 +/- 0.8 to 2.2 +/- 0.7, P < 0.0001). In the subset of 24 patients evaluated at 1 month, GFR significantly increased (62 +/- 20 ml/min to 67 +/- 21 ml/min; P = 0.008) and the rate of the out-of-range systolic pressure values at 24-hr monitoring significantly decreased (51-33%, P = 0.005). Elevated baseline creatinine values and the presence of global renal ischemia were identified as predictors of poor outcome at the multivariate analysis., Conclusions: In selected patients with chronic ischemic heart disease and hypertension and/or renal insufficiency, renal stenting may be performed with very low periprocedural complications and results in unchanged renal function and improved BP control., ((c) 2010 Wiley-Liss, Inc.)

Background: Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians., Purpose: The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high-volume centers by experienced operators., Methods: From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days., Results: 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In-hospital complications: Two minor and two major strokes (2.02%) occurred. No device-related complications and no serious access site complication were noted. Between discharge and 30-day follow-up, one patient died due to a cardiac arrest. The overall 30-day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender., Conclusion: This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines., ((c) 2010 Wiley-Liss, Inc.)

Aims: We aimed to determine the success, safety and long-term durability of carotid artery stenting (CAS) in stroke prevention for all-comers managed with mandatory neuroprotection and a tailored-approach to intervention., Methods and Results: From our CAS registry (beginning July 1997) all procedures up to September 2007 with intention-to-treat by stenting under distal filter or proximal occlusion neuroprotection devices were analysed (N=1523; mean age 72 years [237 >or=80 years, 15.5%]). Indications included symptomatic stenoses >or=50% (366, 24.1%) and asymptomatic stenoses >or=80% (1157, 75.9%). CAS success was 99.6% and the 30-day all-stroke/death rate was 1.5% (minor stroke 11 [0.7%], major stroke 8 [0.5%], death 5 [0.3%]). The risk was 1.2% for asymptomatic patients and 2.7% for symptomatic patients (p=0.042). Regarding octogenarians this risk was 2.1% versus 1.5% for patients or=80 1.2%, symptomatic or=80 4.5%. The event free survival rates from all strokes or stroke-related deaths at eight years were 96% for asymptomatic and 92% for symptomatic patients., Conclusions: Results from this large cohort show that carotid stenting in a real-world setting is safe and efficacious, and durable in the long-term prevention of stroke.

Purpose: To assess the impact of diabetes, patient age, and gender on major periprocedural (30-day) complications (major and minor strokes, all-cause deaths) following carotid artery stenting (CAS)., Methods: An exploratory analysis was performed of 695 patients (516 men; mean age 69.9+/-8.4 years) enrolled consecutively between September 1999 and September 2002 in a multicenter Italian/German registry of routine CAS using cerebral protection devices. There were 535 nondiabetic patients and 160 diabetic patients in the analysis., Results: Logistic regression analysis revealed that diabetes and age, but not gender, impacted the cumulative 30-day incidence of any stroke and death (OR 2.1, 95% CI 1.0 to 4.8, p = 0.068 and OR 1.06, 95% CI 1.01 to 1.12, p = 0.031, respectively), as well as the 30-day incidence of major strokes and deaths (OR 5.9, 95% CI 1.6 to 21.8, p = 0.007 and OR 1.13, 95% CI 1.02 to 1.25, p = 0.018, respectively). According to receiver-operating characteristic analysis, age had no discriminatory power to predict complications in nondiabetic patients, but an age of 75 years was identified as the optimal cut point to predict complications in diabetic patients. Compared with nondiabetic patients, diabetics > or =75 years had a 4.3 greater risk of experiencing any stroke or death (95% CI 1.3 to 12.3, p = 0.016) and a 12.0 greater risk of a major stroke or death (95% CI 2.1 to 66.5, p = 0.005). Diabetics <75 years had no increase in risk over that of nondiabetic patients., Conclusion: Diabetic patients > or =75 years carry a significantly increased risk for strokes or death after protected CAS. The findings should be taken into consideration when treating elderly diabetic patients.