Carlo Setacci

Protected Carotid Stenting: Clinical Advantages and Complications of Embolic Protection Devices in 442 Consecutive Patients

Background and Purpose— Periprocedural embolization of debris during carotid stenting interventions may result in neurological deficit. This study was designed to evaluate in-hospital and 30-day adverse events in patients percutaneously treated for carotid artery disease with embolic protection devices. Methods— From 1999 to June 2002, a total of 442 consecutive patients underwent percutaneous angioplasty and/or stenting of the extracranial carotid artery. The endovascular procedure was conducted under embolic protection devices. Results— The percutaneous procedure was successful in 440 of 442 patients (99.5%). No periprocedural death occurred with any embolic protection device. All in-hospital stroke/death and 30-day ipsilateral stroke/death rate was 1.1%. The overall complication rate was 3.4%. Major adverse events included 1 major stroke (0.2%), 4 intracranial hemorrhages (0.9%), 1 carotid artery wall fissuration (0.2%), and 1 diffuse cardioembolism (0.2%). Minor adverse events included 4 minor strokes (0.9%) and 4 transient ischemic attacks (0.9%). The cerebral protection device–related complications were 4 (0.9%): 1 case of abrupt closure of the internal carotid artery because of spiral dissection (0.2%), 1 case of trapped guide wire (0.2%), and 2 cases of intimal dissection (0.5%). Transient loss of consciousness, tremors, and fasciculations were present in 6 of 40 patients (15%) in whom occlusive protection devices were used. Conclusions— Our data suggest that percutaneous stenting of the carotid artery when a cerebral protection device is used is feasible and effective but not without potential complications. However, a long learning curve may exist for the proper use of some embolic protection devices.

Carotid Artery Stenting First Consensus Document of the ICCS-SPREAD Joint Committee

Background and Purpose— The prevention of stroke and the correct treatment of carotid artery stenosis represent today a major debate in cardiovascular medicine. Beside carotid endarterectomy, carotid angioplasty and stenting is becoming more widely performed for the treatment of severe carotid obstructive disease, and is now accepted as a less invasive technique that may provide an alternative for selected patients, particularly those with significant comorbidities. An Italian multidisciplinary task force, in which converged the most representative scientific societies involved in carotid treatment, was created to provide neurologists, radiologist, cardiologists, vascular surgeons, and all those involved in prevention and treatment of carotid disease with a simple, clear and updated evidence-based consensus document. Summary of Review— This First Consensus Document of the ICCS (Italian Consensus Carotid Stenting)/SPREAD group addressed the main issues related to methodology, definition of symptomatic and asymptomatic carotid stenosis, indication and procedures for carotid artery stenting, including the use of devices for preventing procedural embolic complications. Special attention was paid to credentials and competency for physicians qualifications to perform vascular angioplasty and stent placement, including training, acceptable complication rates and certification. Conclusions— As any guideline or consensus statement, also this document is valid as long as the evidence on which it is based remains up-to-date. In such a fast-evolving field of medicine as the management of carotid stenosis, it is mandatory to stimulate a continuous and fruitful discussion among all the professionals involved in this very evolutionary field.

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.

Grading Carotid Intrastent Restenosis: A 6-Year Follow-Up Study

Background and Purpose— The accuracy of carotid ultrasound has not been well established in predicting intrastent restenosis (ISR) after carotid artery stenting (CAS). The aim of this study is to determine different degrees of ISR using ultrasound velocity criteria compared to percentage of stenosis at angiography. Methods— This is a 6-year prospective study. After CAS procedure, each patient underwent angiography for measuring ISR (NASCET method) which was compared to peak systolic velocity (PSV), end diastolic velocity (EDV), and the ratio between PSV of internal carotid artery and common carotid artery (ICA/CCA). This was done within 48 hours, thus creating a baseline value. Ultrasound (US) examination was performed at day 30, at 3, 6, 9, and 12 months, and then yearly. Patients with an increase in PSV greater than 3 times the baseline value or in presence of PSV ≥200 cm/s underwent angiography. Results— 814 CAS procedures, 6427 US examinations, and 1123 angiographies were performed. ISR ≥70% and ISR ≥50% was detected, respectively, in 22 patients and in 73 patients. We defined velocity criteria for grading carotid ISR: PSV ≤104 cm/s, if <30% stenosis; PSV:105 to 174 cm/s if 30% to 50% stenosis; PSV:175 to 299 cm/s if a 50% to 70% stenosis; PSV ≥300 cm/s, EDV ≥140 cm/s, and ICA/CCA ≥3.8 if a ≥70% stenosis. Receiver operator characteristic (ROC) curves for ISR ≥70% were, respectively, for PSV, EDV, and ICA/CCA: 0.99, 0.98, and 0.99. Conclusions— US grading of carotid ISR can guarantee a correct follow-up after CAS if new customized velocity criteria are validated by skilled operators using a specific protocol of follow-up in a certified laboratory.

Is carotid artery stenting in octogenarians really dangerous

Purpose: To evaluate (1) whether carotid artery stenting (CAS) performed in octogenarians increases the procedure-related risk and (2) the incidence of complex anatomy of the aortic arch and supra-aortic vessels in patients >80 years old, which can increase the technical difficulty of CAS. Methods: Between December 2000 and September 2005, 1053 patients (903 men; mean age 72±2.2 years, range 46–90) underwent 1222 CAS procedures in 2 centers for de novo (n=1192) and restenotic (n=30) lesions (139 staged bilateral procedures). Indications for treatment were the presence of a symptomatic carotid artery stenosis ≥70% (n=798, 65.3%) or an asymptomatic stenosis of at least 80%. The patients were separated into 2 age categories: under 80 (n=1078 procedures, 88.2%) and 80 or older (n=144 procedures, 11.8%) for this analysis. Data analysis included death and stroke rate at discharge and at 30 days. Anatomical characteristics evaluated were aortic arch elongation, arch and supra-aortic vessel calcification and tortuosity, anatomical tortuosity of the lesion, and carotid plaque composition. Results: Three lesions in octogenarians could not be treated because of failure to access the vessel in 1 case and extremely tortuous arteries in 2. The overall death and stroke rate at 30 days was 2.12% in the older group (2 fatal strokes, 1 minor stroke) and 1.11% in the younger group (3 deaths, 3 major strokes, 6 minor strokes); the difference was not statistically significant (p=0.40). Significantly higher frequencies of tortuosity and calcification of the arch and supra-aortic vessels and of type III aortic arch were observed in the older group (p<0.001). Conclusion: In our experience, CAS has proven to be safe and effective in elderly patients. Different age-related anatomical features can represent an adjunctive technical challenge, but these difficulties can be successfully managed without increased perioperative risk if CAS is performed in high-volume centers by highly skilled operators.

Carotid artery stenting versus surgery: adequate comparisons?

A moratorium on carotid artery stenting (CAS) has been recently proposed. Current randomised evidence supports the notion that carotid endarterectomy (CEA) is better than CAS. A meta-analysis of the randomised trials compared the two strategies and included data from the recent International Carotid Stenting Study (ICSS). This meta-analysis indicated that patients who received CAS had a signifi cant increased risk of 30-day death or stroke compared with patients who received CEA (odds ratio 1·60; 95% CI 1·26–2·02). As randomised clinical trials are the gold standard of clinical investigation, it seems unwise to challenge them. However, for the comparison of CAS versus CEA, most of the randomised trials should be considered not only scientifi cally but also ethically questionable because the endovascular experience required for interventionalists to be eligible for the studies was minimal (table). As a consequence, patients allocated to CAS might have been exposed to unnecessary risk and the assessment of safety and effi cacy of the endovascular approach confounded. In the French Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) study, a lifetime experience of at least 12 CAS interventions was required. Alternatively, a minimum of fi ve CAS procedures was deemed to be suffi cient if the interventionalist had a lifetime experience of at least 30 stenting procedures in supraaortic vessels. The rationale for this adjustment is diffi cult to understand given that subclavian and carotid interventions diff er substantially. For investigators who did not comply with these minimum requirements, the EVA-3S protocol allowed the procedure “under the supervision of an experienced tutor”, defi ned in the protocol as “a clinician who qualifi ed to perform stenting in this study”. In later correspondence, the investigators acknowledged that only 16% of the 265 patients treated with stenting were managed by operators who had done more than 50 CAS procedures in their lifetime and that 39% of patients were treated by physicians in training. Although such a track record can hardly be defi ned as good clinical practice or trial conduct, the information was not thought to be suffi ciently relevant to be reported in any of the EVA-3S publications. Concerns about CAS safety in the EVA-3S trial were raised after the enrolment of 80 patients in the endovascular arm. The safety committee recommended stopping the performance of CAS without the use of embolic protection devices, because the 30-day rate of stroke among patients undergoing un protected CAS was 26·7%, which was 3·9 times higher than that of patients treated with embolic protection (8·6%). However, in the clinical alert published by the EVA-3S investigators, the experience of the interventionalists was not questioned because “a learning eff ect is also unlikely to explain the diff erent complications rates, since protected CAS is a more complex technique than unprotected CAS”. This quote reveals a fundamental gap in understanding of the CAS procedure. In real-life practice, the use of embolic protection devices is widely embraced by experienced CAS interventionalists, whereas those with less expertise might be reluctant to use these devices. Additional evidence of the little endovascular experience among the investigators of EVA-3S is derived from the high rate of emergent conversion from CAS to CEA (5%). The fact that CAS was never reimbursed in France did not help the investigators to gain exposure to the procedure. According to the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study, a minimum of 25 successful consecutive CAS procedures was needed to participate as an investigator. However, a subsequent report revealed that, during the course of the trial, the protocol was amended to allow for tutoring of physicians who had only undertaken ten CAS procedures. Finally, in ICSS, a minimum of 50 total stenting procedures was required as long as at least ten of these involved the carotid artery. Tutor-assisted procedures were allowed for investigators with insuffi cient experience, again raising the concern of adequacy of training. The inexperience of the EVA-3S, SPACE, and ICSS investigators might have exposed the endovascular patients to an increased risk, not only because of insuffi cient operator skills, but also (and equally important) owing to inappropriate selection of patients. Interventions in patients with complex anatomy at the level of the aortic arch and supra-aortic vessels require more catheter manipulation than in patients with less tortuous or diseased vessels and place patients at increased risk of periprocedural stroke.

Siena Carotid Artery Stenting Score. A Risk Modelling Study for Individual Patients

Background and Purpose— Carotid artery stenting (CAS) still entails a considerable peri-interventional risk of serious neurological adverse events. The aim of this study was to generate a score to grade this risk for CAS in individual patients. Methods— This is a 9-year prospective study. Consecutive patients with ≥70% carotid artery stenosis were treated with a standardized CAS procedure. All patients included underwent independent neurological evaluation before and after the procedure and at 30 days. The rates of transient ischemic attack and minor, major, and fatal stroke were recorded. Stroke predictors were analyzed and a score system was generated using Arabic numerals for all variables to preoperatively grade the individual patient risk of stroke. Results— Two thousand one-hundred twenty-four successful CAS procedures were performed. The transient ischemic attack and minor, major, and fatal stroke rates at 30 days were, respectively, 2.72% (n=60), 1.55% (n=33), 1.18% (n=25), and 0.61% (n=13). Multiple regression analysis showed that the following significantly predicted the 30-day risk of treatment-related stroke: cardiac disease, symptomatic patient, diabetes, calcification or ulceration at the level of the lesion, native and ostial lesion, lesion length >15 mm, the need for predilatation, type III arch, bovine arch, arch calcification, procedure time >30 minutes, and the operators experience of <50 CAS procedures. The operators experience of >100 CAS procedures was the only protective factor against the development of stroke at 30 days (odds ratio, 0.81; confidence interval, 0.67–0.95). The Siena CAS score was developed from these variables and predicted the risk of CAS within the 3 categories of low risk (<1%; CAS I), medium risk (1% to 3%; CAS II), and high risk (>3%; CAS III), with a sensitivity of 0.82 and specificity of 0.79. Conclusions— The Siena CAS risk score seems to be a useful tool to help predict stroke after CAS but needs to be validated in independent cohorts at a variety of centers before it can be recommended for application, preferably in a randomized comparison with carotid endarterectomy.

Determinants of In-Stent Restenosis after Carotid Angioplasty: A Case-Control Study

PURPOSE To report a retrospective study that sought to identify clinical factors contributing to the development of in-stent restenosis in the carotid arteries, to profile the patients at greatest risk, and to review the treatment modalities evolved from our experience. METHODS Between December 2000 and April 2003, 195 carotid angioplasty/stenting (CAS) procedures (12 bilateral) were performed in 183 patients (131 men; median age 65.9 years, interquartile range 55.2-72.7). Stenting for de novo stenoses was performed in 119 (61%) carotid arteries; 76 (39%) vessels were treated for postsurgical restenosis. Nearly two thirds of the patients (117, 64%) were symptomatic. Patients were evaluated at 3 and 6 months and at 6-month intervals thereafter with duplex ultrasonography. Angiography was used to confirm any recurrent lesion detected on the ultrasound scan. RESULTS Overall perioperative neurological complications included 4 (2.2%) minor strokes, 1 (0.5%) intracranial hemorrhage, and 1 (0.5%) major stroke; both patients with major neurological complications died at 5 and 12 days, respectively, after the procedure. During the 12.5-month follow-up (range 0-27.2), 3 non-procedure-related late deaths and another 9 (4.9%) neurological events occurred (2 strokes and 7 transient ischemic attacks). In-stent restenosis after CAS was present in 10 (5.2%) of 193 carotid arteries (9/181 patients) in follow-up; all but 1 artery had been treated for postsurgical restenosis. All lesions were treated secondarily with endovascular procedures. Statistical analysis demonstrated that postsurgical restenosis was the only predictive factor for the development of in-stent restenosis (OR 15.5, 95% CI 2.05 to 125.6, p=0.001) in this cohort. CONCLUSIONS The present study, far from being exhaustive on the subject, indicates that patients who develop restenosis after carotid endarterectomy are also prone to develop restenosis after CAS; moreover, although strongly recommended for postsurgical restenosis, CAS carries a greater risk of in-stent restenosis in this subgroup, thus reducing the benefits of this procedure.

Editor's Choice – Management of Descending Thoracic Aorta Diseases : Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS)

Editors Choice - Management of Descending Thoracic Aorta Diseases : Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS).