Editor's Choice - Carotid Stenosis Treatment: Variation in International Practice Patterns.

OBJECTIVES: The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR). METHODS: Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country. RESULTS: Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7). CONCLUSIONS: Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world.

Endovascular Treatment of Isolated Dissection of Superior Mesenteric Artery.

Isolated spontaneous dissection of the superior mesenteric artery is extremely rare. In December 2012, a 45-year-old man, without significant comorbidities, presented at the emergency room of another hospital with abdominal pain. The patient was treated with medical therapy and discharged on resolution of the pain. Three months later he returned to the emergency room with a new onset of pain. CT-angiography (CTA) showed an isolated SMA dissection associated with aneurysmal dilatation. The patient was referred to our attention. We attempted endovascular exclusion of the dissecting aneurysm in May 2013. We deployed a self-expandable nitinol stent (BostonSC Adapt 4-9×32 mm) in order to simultaneously repair the dissection, preserve the branches and exclude the aneurysm. Postoperative course was uneventful and the patient was discharged on postoperative day 2. At 10-month follow-up CTA showed excellent positioning of the stent, patency of the visceral branches and shrinkage of the aneurysm.

Treatment of peripheral arterial disease in diabetes: a consensus of the Italian Societies of Diabetes (SID, AMD), Radiology (SIRM) and Vascular Endovascular Surgery (SICVE).

Diabetic foot (DF) is a chronic and highly disabling complication of diabetes. The prevalence of peripheral arterial disease (PAD) is high in diabetic patients and, associated or not with peripheral neuropathy (PN), can be found in 50% of cases of DF. It is worth pointing out that the number of major amputations in diabetic patients is still very high. Many PAD diabetic patients are not revascularised due to lack of technical expertise or, even worse, negative beliefs because of poor experience. This despite the progress obtained in the techniques of distal revascularisation that nowadays allow to reopen distal arteries of the leg and foot. Italy has one of the lowest prevalence rates of major amputations in Europe, and has a long tradition in the field of limb salvage by means of an aggressive approach in debridement, antibiotic therapy and distal revascularisation. Therefore, we believe it is appropriate to produce a consensus document concerning the treatment of PAD and limb salvage in diabetic patients, based on the Italian experience in this field, to share with the scientific community.

Optical coherence tomography after carotid stenting: rate of stent malapposition, plaque prolapse and fibrous cap rupture according to stent design.

OBJECTIVES: This study aims to evaluate the rate of stent malapposition, plaque prolapse and fibrous cap rupture detected by optical coherence tomography (OCT) imaging according to carotid stent design. DESIGN: It was a prospective single-centre study. MATERIALS AND METHODS: Forty consecutive patients undergoing protected carotid artery stenting (CAS) and high-definition OCT image acquisition were enrolled in the study. OCT frames were analysed off-line, in a dedicated core laboratory by two independent physicians. Cross-sectional OCT images within the stented segment of the internal carotid artery were evaluated at 1-mm intervals for the presence of strut malapposition, plaque prolapse and fibrous cap rupture according to stent design. RESULTS: Closed-cell design stents (CC) were used in 17 patients (42.5%), open-cell design stents (OC) in 13 (32.5%) and hybrid design stents (Hyb) in 10 (25%). No procedural or post-procedural neurological complications occurred (stroke/death 0% at 30 days). On OCT analysis the frequencies of malapposed struts were higher with CC compared to OC and Hyb (34.5% vs 15% and 16.3%, respectively; p < 0.01). Plaque prolapse was more frequent with OC vs CC (68.6% vs 23.3%; p < 0.01) and vs Hyb stents (30.8%; p < 0.01). Significant differences were also noted in the rates of fibrous cap rupture between CC and OC (24.2% vs 43.8%; p < 0.01), and between CC and Hyb (24.2% vs 39.6%; p < 0.01), but not between OC and Hyb stents (p = 0.4). CONCLUSION: Intravascular OCT after CAS revealed that micro-defects after stent deployment are frequent and are related to the design of implanted stents. Stent malapposition is more frequent with CC stents, while plaque prolapse is more common with OC stents. It remains, however, unknown whether these figures now detected with OCT are of any clinical and prognostic significance.

The wonders of a newly available post-analysis CT software in the hands of vascular surgeons.

INTRODUCTION: Endovascular treatment of abdominal aortic aneurysms has become a widespread and accepted practice in most Vascular Surgery centres. The optimal method to identify and characterise complications still awaits assessment. CASE REPORT: An 83-year-old woman was admitted to our Institution for volumetric expansion of the aneurysm sac due to a suspected type II endoleak. Post-analysis, using OsiriX, revealed the presence of a hole at the distal portion of the main body in the docking zone near the flow divider. CONCLUSION: OsiriX is an image processing software and an attractive alternative to dedicated workstations and allows rendering and analysis of numerous medical imaging modalities.

Surveillance imaging modality does not affect detection rate of asymptomatic secondary interventions following EVAR.

OBJECTIVES: Literature reports that surveillance imaging following endovascular aortic aneurysm repair (EVAR) gives rise to asymptomatic secondary interventions (SI) in 1.4-9% of cases. This retrospective study aimed to evaluate whether the modality of surveillance imaging influences the detection rate of asymptomatic SI. MATERIALS AND METHODS: Two EVAR surveillance protocols were compared at the same vascular centre. Protocol I, performed from January 2003 to December 2006, consisted of colour duplex ultrasound scan (CDU) plus CT angiography (CTA) 1 month after procedure and every 6 months thereafter. Protocol II, performed from January 2007 to June 2010, consisted of CDU plus CTA 1 month after operation and CDU plus plain abdominal films (XR) every 6 months thereafter. In the second protocol, CTA was carried out only during follow-up in specific conditions. The term 'asymptomatic SI' was used when the necessity for SI was detected by imaging alone on an elective basis, prior to development of any symptoms. RESULTS: Enrolment included 376 and 341 consecutive patients with a mean follow-up of 1148 days (range 1-3204 days) and 942 days (range1-1512 days) in Protocols I and II, respectively (p < 0.001). Freedom rates from aneurysmal rupture, freedom from SI and detection rate for asymptomatic SI at 3 years were 98.3% and 98.7% (p = 0.456), 82% and 83.5%(p = 0.876) and 8.8% (n = 33/376) and 8.5%(n = 25/341) (p = 0.49) in Protocols I and II, respectively. Estimated comparison of the costs, radiation exposure and contrast used at 3 years in Protocol I versus Protocol II showed that Protocol II allowed for a three-, four- and six fold reduction in overall costs, radiation exposure and contrast used, respectively (p < 0.0001). CONCLUSIONS: The detection rate of asymptomatic SI following EVAR is not affected by the type of surveillance imaging. A surveillance schedule based primarily on CDU and XR appears to be justified.

Benefit of revascularisation to critical limb ischaemia patients evaluated by a patient-oriented scoring system.

OBJECTIVES: The concept of patency and limb salvage are physician-oriented endpoints in critical limb ischaemia (CLI). These endpoints have failed to enhance function after revascularisation. The aim of this study was to create a scoring system to predict 1-year functional status and to assess the benefit to patients possible by revascularisation. MATERIALS AND METHODS: During the period 2007-2009, 480 consecutive patients (mean age ± SD, 83.2 ± 8.7 years) underwent repair for CLI. Preoperative, operative and functional status characteristics and post-operative outcomes were recorded. The following patient-oriented outcomes were investigated pre- and postoperatively: basic and instrumental activities of daily living (BADL and IADL) and ambulatory and living status. Statistical analysis was performed to assess predictors of functional benefit from revascularisation. The variables significant on multivariable analysis were used to generate a scoring system to pre and postoperatively grade individual patient risk of losing baseline functional status at 1 year (CLI functional score). RESULTS: Ninety-three of 480 patients (19.3%) were in Rutherford class IV, 208 (43.3%) in class V and 179 (37.4%) in class VI. Surgical, endovascular and hybrid operations were performed in 108 (22.5%), 319 (66.5%) and 53 (11%) patients, respectively; mean follow-up was 408 ± 363 days. Improved or unchanged functional status was observed in 276 patients (57.5%). Preoperative mean ± SD BADL and IADL (4.26 ± 1.98 and 3.92 ± 2.69, respectively) were modified from mean values at 1-year follow-up (4.19 ± 2.06 and 4.12 ± 3, respectively) (p = 0.401 and p < 0.05, respectively). In the same time interval, mortality was 50%, limb salvage 50.4%, CLI-related new hospitalisations 50.8%, relief of symptoms 18.5% and tissue healing 14.5%. A CLI functional score of >80% indicates that patients are likely to lose functional abilities and require assistance for ambulation or ADL, as well as risking outcomes such as major amputation, new CLI-related hospitalisation or re-operation (p < 0.001). Preoperative poor living status, dependence in daily activities, advanced local disease (lesion >2 cm, infection and poor tibial runoff), American Society of Anesthesiologists (ASA) score > II, previous cerebrovascular event and heart disease were the strongest pre-operative negative predictors of losing baseline functional status. Major amputation was the only negative post-operative predictor. CONCLUSIONS: Considering patient-oriented outcomes, our study showed that revascularisation could be worthwhile in nearly 60% of CLI patients. A non-revascularisation strategy such as primary amputation or palliation could be indicated in patients with a poor pre-operative living status, dependence for daily activities, advanced local disease, extensive comorbid conditions and a score >80%. To make our findings generalisable, the score needs to be validated in independent cohorts at different centres before it can be recommended for application.

AAA with a challenging neck: early outcomes using the Endurant stent-graft system.

OBJECTIVES: The efficacy and safety of endovascular aneurysm repair is disputable in aneurysms with a short, angulated, wide, conical, or thrombus-lined neck making a reliable seal difficult to achieve. The influence of a challenging neck on early results using the Endurant stent-graft system in high risk patients was investigated. MATERIALS AND METHODS: A retrospective study conducted on a prospectively compiled database of 72 elective patients with challenging neck treated with the Endurant system (Endurant Stent Graft, Medtronic AVE, Santa Rosa, CA, USA). These patients were compared to a control group (n = 65) without significant neck problems. Endpoints were early technical and clinical success, deployment accuracy and differences in operative details at one month follow-up. Data are reported as mean and standard deviation or as absolute frequency and percentage (%). Normality distribution and homogeneity of variances were tested by Shapiro-Wilks and Levene tests, respectively. Inter-group comparisons for each variable were made by t-test or χ2-test or Fisher exact test. A p < 0.05 was considered statistically significant. RESULTS: Mean age was 76.12 years; 76.6% were males. Risk factors and pre-operative variables did not differ significantly between the two groups. Mean neck length was 10.56 mm in patients with challenging anatomies and 22.85 mm in controls. Patients with a challenging neck differed significantly (p < 0.001) from controls in terms of mean infrarenal (37.67° vs. 20.12°) and suprarenal angle (19.63° vs. 15.57°); 82% of patients with a challenging neck were ASA III/IV (vs. 86%). Technical success was 100%, with four unplanned proximal extension in challenging group. No type I endoleaks or aneurysm-related deaths occurred in either group; major complications were 1.54% vs. 1.39% (p = 0.942). Operative details were similar in both groups. CONCLUSION: Treatment with the Endurant stent-graft is technically feasible and safe, yielding satisfactory results even in challenging anatomies. Medium- and long-term data are needed to verify durability, but early results are promising.

Chapter II: Diagnostic methods.

Non-invasive vascular studies can provide crucial information on the presence, location, and severity of critical limb ischaemia (CLI), as well as the initial assessment or treatment planning. Ankle-brachial index with Doppler ultrasound, despite limitations in diabetic and end-stage renal failure patients, is the first-line evaluation of CLI. In this group of patients, toe-brachial index measurement may better establish the diagnosis. Other non-invasive measurements, such as segmental limb pressure, continuous-wave Doppler analysis and pulse volume recording, are of limited accuracy. Transcutaneous oxygen pressure (TcPO(2)) measurement may be of value when rest pain and ulcerations of the foot are present. Duplex ultrasound is the most important non-invasive tool in CLI patients combining haemodynamic evaluation with imaging modality. Computed tomography angiography (CTA) and magnetic resonance angiography (MRA) are the next imaging studies in the algorithm for CLI. Both CTA and MRA have been proven effective in aiding the decision-making of clinicians and accurate planning of intervention. The data acquired with CTA and MRA can be manipulated in a multiplanar and 3D fashion and can offer exquisite detail. CTA results are generally equivalent to MRA, and both compare favourably with contrast angiography. The individual use of different imaging modalities depends on local availability, experience, and costs. Contrast angiography represents the gold standard, provides detailed information about arterial anatomy, and is recommended when revascularisation is needed.

Chapter III: Management of cardiovascular risk factors and medical therapy.

Critical limb ischaemia (CLI) is a particularly severe manifestation of lower limb atherosclerosis posing a major threat to both limb and life of affected patients. Besides arterial revascularisation, risk-factor modification and administration of antiplatelet therapy is a major goal in the treatment of CLI patients. Key elements of cardiovascular risk management are smoking cessation and treatment of hyperlipidaemia with dietary modification or statins. Moreover, arterial hypertension and diabetes mellitus should be adequately treated. In CLI patients not suitable for arterial revascularisation or subsequent to unsuccessful revascularisation, parenteral prostanoids may be considered. CLI patients undergoing surgical revascularisation should be treated with beta blockers. At present, neither gene nor stem-cell therapy can be recommended outside clinical trials. Of note, walking exercise is contraindicated in CLI patients due to the risk of worsening pre-existing or causing new ischaemic wounds. CLI patients are oftentimes medically frail and exhibit significant comorbidities. Co-existing coronary heart and carotid as well as renal artery disease should be managed according to current guidelines. Considering the above-mentioned treatment goals, interdisciplinary treatment approaches for CLI patients are warranted. Aim of the present manuscript is to discuss currently existing evidence for both the management of cardiovascular risk factors and treatment of co-existing disease and to deduct specific treatment recommendations.

Chapter I: Definitions, epidemiology, clinical presentation and prognosis.

The concept of chronic critical limb ischaemia (CLI) emerged late in the history of peripheral arterial occlusive disease (PAOD). The historical background and changing definitions of CLI over the last decades are important to know in order to understand why epidemiologic data are so difficult to compare between articles and over time. The prevalence of CLI is probably very high and largely underestimated, and significant differences exist between population studies and clinical series. The extremely high costs associated with management of these patients make CLI a real public health issue for the future. In the era of emerging vascular surgery in the 1950s, the initial classification of PAOD by Fontaine, with stages III and IV corresponding to CLI, was based only on clinical symptoms. Later, with increasing access to non-invasive haemodynamic measurements (ankle pressure, toe pressure), the need to prove a causal relationship between PAOD and clinical findings suggestive of CLI became a real concern, and the Rutherford classification published in 1986 included objective haemodynamic criteria. The first consensus document on CLI was published in 1991 and included clinical criteria associated with ankle and toe pressure and transcutaneous oxygen pressure (TcPO(2)) cut-off levels <50 mmHg, <30 mmHg and <10 mmHg respectively). This rigorous definition reflects an arterial insufficiency that is so severe as to cause microcirculatory changes and compromise tissue integrity, with a high rate of major amputation and mortality. The TASC I consensus document published in 2000 used less severe pressure cut-offs (≤ 50-70 mmHg, ≤ 30-50 mmHg and ≤ 30-50 mmHg respectively). The thresholds for toe pressure and especially TcPO(2) (which will be also included in TASC II consensus document) are however just below the lower limit of normality. It is therefore easy to infer that patients qualifying as CLI based on TASC criteria can suffer from far less severe disease than those qualifying as CLI in the initial 1991 consensus document. Furthermore, inclusion criteria of many recent interventional studies have even shifted further from the efforts of definition standardisation with objective criteria, by including patients as CLI based merely on Fontaine classification (stage III and IV) without haemodynamic criteria. The differences in the natural history of patients with CLI, including prognosis of the limb and the patient, are thus difficult to compare between studies in this context. Overall, CLI as defined by clinical and haemodynamic criteria remains a severe condition with poor prognosis, high medical costs and a major impact in terms of public health and patients' loss of functional capacity. The major progresses in best medical therapy of arterial disease and revascularisation procedures will certainly improve the outcome of CLI patients. In the future, an effort to apply a standardised definition with clinical and objective haemodynamic criteria will be needed to better demonstrate and compare the advances in management of these patients.

Chapter IV: Treatment of critical limb ischaemia.

Recommendations stated in the TASC II guidelines for the treatment of peripheral arterial disease (PAD) regard a heterogeneous group of patients ranging from claudicants to critical limb ischaemia (CLI) patients. However, specific considerations apply to CLI patients. An important problem regarding the majority of currently available literature that reports on revascularisation strategies for PAD is that it does not focus on CLI patients specifically and studies them as a minor part of the complete cohort. Besides the lack of data on CLI patients, studies use a variety of endpoints, and even similar endpoints are often differentially defined. These considerations result in the fact that most recommendations in this guideline are not of the highest recommendation grade. In the present chapter the treatment of CLI is not based on the TASC II classification of atherosclerotic lesions, since definitions of atherosclerotic lesions are changing along the fast development of endovascular techniques, and inter-individual differences in interpretation of the TASC classification are problematic. Therefore we propose a classification merely based on vascular area of the atherosclerotic disease and the lesion length, which is less complex and eases the interpretation. Lesions and their treatment are discussed from the aorta downwards to the infrapopliteal region. For a subset of lesions, surgical revascularisation is still the gold standard, such as in extensive aorto-iliac lesions, lesions of the common femoral artery and long lesions of the superficial femoral artery (>15 cm), especially when an applicable venous conduit is present, because of higher patency and limb salvage rates, even though the risk of complications is sometimes higher than for endovascular strategies. It is however more and more accepted that an endovascular first strategy is adapted in most iliac, superficial femoral, and in some infrapopliteal lesions. The newer endovascular techniques, i.e. drug-eluting stents and balloons, show promising results especially in infrapopliteal lesions. However, most of these results should still be confirmed in large RCTs focusing on CLI patients. At some point when there is no possibility of an endovascular nor a surgical procedure, some alternative non-reconstructive options have been proposed such as lumbar sympathectomy and spinal cord stimulation. But their effectiveness is limited especially when assessing the results on objective criteria. The additional value of cell-based therapies has still to be proven from large RCTs and should therefore still be confined to a research setting. Altogether this chapter summarises the best available evidence for the treatment of CLI, which is, from multiple perspectives, completely different from claudication. The latter also stresses the importance of well-designed RCTs focusing on CLI patients reporting standardised endpoints, both clinical as well as procedural.

Chapter V: Diabetic foot.

Ulcerated diabetic foot is a complex problem. Ischaemia, neuropathy and infection are the three pathological components that lead to diabetic foot complications, and they frequently occur together as an aetiologic triad. Neuropathy and ischaemia are the initiating factors, most often together as neuroischaemia, whereas infection is mostly a consequence. The role of peripheral arterial disease in diabetic foot has long been underestimated as typical ischaemic symptoms are less frequent in diabetics with ischaemia than in non-diabetics. Furthermore, the healing of a neuroischaemic ulcer is hampered by microvascular dysfunction. Therefore, the threshold for revascularising neuroischaemic ulcers should be lower than that for purely ischaemic ulcers. Previous guidelines have largely ignored these specific demands related to ulcerated neuroischaemic diabetic feet. Any diabetic foot ulcer should always be considered to have vascular impairment unless otherwise proven. Early referral, non-invasive vascular testing, imaging and intervention are crucial to improve diabetic foot ulcer healing and to prevent amputation. Timing is essential, as the window of opportunity to heal the ulcer and save the leg is easily missed. This chapter underlines the paucity of data on the best way to diagnose and treat these diabetic patients. Most of the studies dealing with neuroischaemic diabetic feet are not comparable in terms of patient populations, interventions or outcome. Therefore, there is an urgent need for a paradigm shift in diabetic foot care; that is, a new approach and classification of diabetics with vascular impairment in regard to clinical practice and research. A multidisciplinary approach needs to implemented systematically with a vascular surgeon as an integrated member. New strategies must be developed and implemented for diabetic foot patients with vascular impairment, to improve healing, to speed up healing rate and to avoid amputation, irrespective of the intervention technology chosen. Focused studies on the value of predictive tests, new treatment modalities as well as selective and targeted strategies are needed. As specific data on ulcerated neuroischaemic diabetic feet are scarce, recommendations are often of low grade.

Chapter VI: Follow-up after revascularisation.

Structured follow-up after revascularisation for chronic critical limb ischaemia (CLI) aims at sustained treatment success and continued best patient care. Thereby, efforts need to address three fundamental domains: (A) best medical therapy, both to protect the arterial reconstruction locally and to reduce atherosclerotic burden systemically; (B) surveillance of the arterial reconstruction; and (C) timely initiation of repeat interventions. As most CLI patients are elderly and frail, sustained resolution of CLI and preserved ambulatory capacity may decide over independent living and overall prognosis. Despite this importance, previous guidelines have largely ignored follow-up after CLI; arguably because of a striking lack of evidence and because of a widespread assumption that, in the context of CLI, efficacy of initial revascularisation will determine prognosis during the short remaining life expectancy. This chapter of the current CLI guidelines aims to challenge this disposition and to recommend evidentially best clinical practice by critically appraising available evidence in all of the above domains, including antiplatelet and antithrombotic therapy, clinical surveillance, use of duplex ultrasound, and indications for and preferred type of repeat interventions for failing and failed reconstructions. However, as corresponding studies are rarely performed among CLI patients specifically, evidence has to be consulted that derives from expanded patient populations. Therefore, most recommendations are based on extrapolations or subgroup analyses, which leads to an almost systematic degradation of their strength. Endovascular reconstruction and surgical bypass are considered separately, as are specific contexts such as diabetes or renal failure; and critical issues are highlighted throughout to inform future studies.

Open vascular surgery as a starting point for endovascular surgery.

What distinguishes vascular surgeons from other specialists who treat patients with vascular disease is their ability to combine skills in both open and endovascular treatments. Open vascular surgery should be considered the "starting point" for endovascular surgery, since training and practice in vascular surgery require extensive knowledge of the basic science and a thorough education in general surgical techniques. In addition, surgeons must possess detailed specialized knowledge of the anatomy and physiology of arteries, veins and lymphatics and of the pathological processes which may affect them. This scientific and technical background is also imperative for endovascular surgery. Open vascular surgery can also be considered as a potential finishing point of endovascular surgery. In fact, open surgery is still often the only solution for complex cases considered unsuitable for an endovascular approach, or for different types of complications following endovascular treatments. As endovascular surgery is increasingly considered as the initial treatment option for many patients with vascular disease, it is crucial that vascular surgery training programs develop methods to maintain the open surgical skills of their trainees. The only way for vascular surgeons to remain the premier specialists to care for patients with vascular disease is for them to combine skills in both open and endovascular treatments.

A new idea for a safer approach to the supra-aortic trunks: the Piton™ catheter.

Carotid artery disease is among the most common causes of stroke, and stroke is the third leading cause of death in industrialized countries. Thus the personal health and socioeconomic burden of carotid artery disease is significant. Carotid artery disease accounts for approximately 5-12% of new strokes in patients amenable to revascularization therapy. Atherosclerosis is the main reason for stroke and accounts for approximately one third of all cases. Carotid stenting is nowadays considered a valid standard alternative to surgical carotid endarterectomy, especially in patients having a high perioperative risk. The first carotid balloon angioplasty was carried out in 1979 and the first carotid balloon-expandable bare metal stents were implanted 10 years later, in 1989. However, carotid stenting at that time was associated with major complications, due to extrinsic compression and subsequent to the steel stents used. The Piton™ GC (carotid guide catheter) is intended to facilitate the introduction and placement of interventional devices (e.g., guidewires, stent delivery systems, dilation balloons, angiographic- or micro-catheters, etc.) into the human vasculature to treat vascular obstructive disease, including but not limited to the supra-aortic vessels.

Renal aneurysms: surgical vs. endovascular treatment.

Renal artery aneurysms (RAA) are rare (general population incidence is 0.09%). At this time, the appropriateness of the type of intervention ­ surgical or endovascular ­ is based on single center experiences rather than large randomized trials. Endovascular therapy offers less morbidity but surgery has excellent long-term results. In reality, the choice of the treatment relies on the operative risk. A patient with a RAA and good surgical risk should be offered open surgery. If the patient is deemed to be at high risk from surgery then the choice of the type of endovascular treatment (stent grafting, coil/glue embolization, multilayer stenting) should be based on the location and shape of the RAA. RAA should be treated by surgeons/interventionalists who have demonstrated expertise in renal artery procedures.

Proctorship for CAS training: a pilot study of safety and reproducibility.

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.