Emiliano Chisci

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.

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.

Subintimal Angioplasty with the Aid of a Re-entry Device for TASC C and D Lesions of the SFA

AIM The aim of this prospective study was to assess the clinical effectiveness and related midterm patency of subintimal angioplasty (SAP) in patients suffering from critical limb ischaemia (CLI) in a single tertiary care university centre. The secondary aim was to evaluate the safety and clinical effectiveness of using a re-entry device when re-canalisation by SAP was unsuccessful. METHODS From January 2005 to December 2007, consecutive patients suffering from CLI (Rutherford clinical categories: 4-6) were treated with SAP. All patients included in the study had occluded SFA (TASC C and D) and underwent clinical and ultrasound follow-up examinations at day 30 and at 3, 6, 9 and 12 months, and then yearly. A re-entry device (Outback, Cordis Corporation, Miami Lakes, Florida, USA in all cases) was only used when re-canalisation by simple SAP was unsuccessful, and stenting was used when residual stenosis was >30% or there was a flow-limiting dissection. Factors that could modify the outcome were analysed. RESULTS In this study, 145 patients were treated, with a technical success rate of 83.5% (121 of 145) for simple SAP. Stenting was performed in 43% (n=62) of successful SAP procedures. No death occurred in the perioperative period, while the 30-day mortality was 4.8% (7 of 145). The re-entry device (Outback) was used in 24 cases (16.5%). The technical success of the re-entry device was 79% (19 of 24), with a 90% success rate of stent placement at the site of re-entry. Complications occurred in 6.2% of all procedures (n=9) (three arterial perforations (2.1%), three distal embolisations (2.1%), two femoral artery pseudo-aneurysms (1.4%) and one arterio-venous fistula (0.7%)). Factors capable of independently affecting the patency were renal insufficiency (p=0.03), current smoking (p=0.01) and diabetes (p=0.04). The primary patency at 1 and 3 years was 70% and 34% and the secondary patency at 1 and 3 years was 77% and 43%, respectively. At the same time intervals, the limb-salvage rate was 88% and 49%. CONCLUSIONS SAP with the aid of a re-entry device for TASC C and D lesions of the SFA seems to be safe and clinically effective in patients suffering from CLI, according to the experience at our centre. Further follow-up and more data are necessary to confirm these findings.

The AAA with a Challenging Neck: Outcome of Open versus Endovascular Repair with Standard and Fenestrated Stent-Grafts

Purpose: To compare the outcome of endovascular aneurysm repair (EVAR) versus conventional open repair (OR) in patients with a short, angulated or otherwise challenging proximal neck. Methods: The definition of a challenging proximal neck was based on diameter (≥28 mm), length (≤15 mm), angulation (≥60°), shape (reverse tapered or bulging), and thrombus lining (>50%). Between January 2005 and December 2007, 187 consecutive patients (159 men; mean age 73 years, range 48–92) operated for asymptomatic abdominal aortic aneurysm (AAA) were identified as having challenging proximal neck morphology. Of these, 61 patients were treated with OR at center I (group A), 71 with standard EVAR (group B; 45 center I, 29 center II) and 52 with fenestrated EVAR (group C) at center II. Clinical examination and computed tomography were performed at 1 month and yearly thereafter. Results: There was no statistically significant difference between groups A, B, and C regarding primary technical success rate, 30-day mortality, or late AAA-related mortality. The mean length of follow-up was 19.5 months (range 0–40). Freedom from reintervention at 3 years was 91.8%, 79.7%, and 82.7% for groups A, B, and C, respectively (p=0.042). The only statistically significant difference between standard and fenestrated EVAR was a higher incidence of late sac expansion [9 (12.2%) versus 1 (1.9%), p=0.036] in the standard stent-graft group. Reinterventions were more frequent after EVAR (p=NS), but open reinterventions were more common after OR. Reinterventions after EVAR were related to the presence of an angulated (p=0.039) or short neck (p=0.024). Conclusion: The results of EVAR and OR were similar for AAAs with a challenging proximal neck. Endovascular reinterventions were more frequent after EVAR, particularly in patients with an angulated or short neck. Open reinterventions were more common after OR. More patients and long-term data are needed to confirm these findings.

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.

Carotid Artery Stenting in Recently Symptomatic Patients: A Single Center Experience

BACKGROUND The effective and early management of patients with acute symptoms due to carotid stenosis remains the subject of debate. The inability to predict who is at higher early risk of a recurrent stroke after a cerebrovascular event (transient ischemic attack [TIA] or stroke) may explain the variation in management of acute strokes from physician to physician and institution to institution. The aim of this study is to evaluate the clinical outcome of recently symptomatic patients with carotid stenosis treated with urgent or deferred carotid artery stenting (CAS) on the basis of a preidentified protocol in a single center. METHODS From January 2006 to October 2008, 43 patients with symptomatic carotid stenosis greater than 70% underwent urgent or deferred CAS (26 TIA, 17 minor stroke). The exclusion criteria were major stroke, cerebral ischemic lesion greater than 2.5 cm as documented by a computed tomography scan, loss of consciousness, and signs of intracranial hemorrhage. Patients who had a TIA underwent urgent CAS within 24 hours of the cerebral event, while patients who had had a minor stroke underwent deferred CAS, performed within a short space of time from the event (treatment within 1 to 30 days from the onset of symptoms, according to the stabilization of cerebral symptoms: mean time, 6.5 days; range, 2 to 28 days). RESULTS Successful stent implantation was achieved in all cases (100%), respecting the use of a cerebral protection device (filter device: 76%, proximal occlusion device: 24%). The new adverse events in the TIA patients at 1 month were 1 non-neurological death (3.8%) and 1 TIA (3.8%). In the minor stroke group, at 1 month, 10 of 17 patients (58.8%) experienced an improvement in their initial neurological deficit (decrease in National Institutes of Health Stroke Scale less than 2), while in 35.3% of patients (6 of 17), the deficit remained stable, and only one patient had a neurological impairment. CONCLUSION Our study demonstrated that early treatment with protected carotid stenting is both feasible and safe in selected patients with first episode or recurrent TIA or minor stroke. This preliminary study in a limited series of patients revealed that an urgent endovascular approach is associated with a satisfactory outcome considering the very high-risk profile of the patient population.

Deferred Urgency Carotid Artery Stenting in Symptomatic Patients: Clinical Lessons and Biomarker Patterns from a Prospective Registry

INTRODUCTION The aim of this prospective observational registry was to study the outcome of symptomatic patients presenting with recent TIA or minor stroke and severe carotid stenosis, submitted to early percutaneous treatment by stenting. A secondary aim was to evaluate the biological activity of the symptomatic carotid plaques by serial serum and urinary markers (PAPP-A, hs-CRP, MMP-2/MMP-9, IL-6/IL-8, TNF alpha, CD40L) measured by enzyme-linked immunosorbent assay before and after treatment. METHODS From May 2005 to June 2006, 57 patients were enrolled in this prospective registry. All patients underwent carotid stenting using a concentric filter for cerebral protection. The procedure was performed within 24-48hrs of the last attack in patients with TIA (n=24, 42%) and between 14 and 30 days in patients with stroke (n=33, 58%). RESULTS Successful stent implantation was achieved in all cases (100%). Adverse events at 1 month were 1 death (1.7%) and 2 TIAs (3.5%). Some of the vulnerability markers, in particular those reflecting an active systemic inflammatory process of the plaque (PAPP-A, hs-CR, and IL-6), were significantly elevated at the time of enrolment, increased after stenting and decreased after 30 days. CONCLUSION Deferred CAS is feasible and safe in selected patients with symptomatic carotid stenosis. This preliminary study in a limited series of patients with unstable carotid plaques revealed that endovascular treatment has a satisfactory outcome considering the very high risk profile of the patient population. The evaluation of some biomarkers suggested an inflammatory role in the process of an unstable carotid plaque generating an acute cerebral event.

A Case of Contrast-Induced Encephalopathy Using Iodixanol

Purpose To document a heretofore unreported complication of the contrast agent iodixanol during an endovascular procedure. Case Report A 76-year-old woman with a history of coronary artery disease was admitted to the emergency department for recurrent transient ischemic attacks. Before combined percutaneous transluminal coronary angioplasty and carotid artery stenting (CAS) using iodixanol, the patient suffered from concomitant unstable angina and recurrent transient ischemic attacks. The total amount of iodixanol used during the CAS procedure was 300 mL. Contrast-induced encephalopathy, which manifested as aphasia, stupor, and full hemiparesis immediately after the combined procedure, was diagnosed by urgent computed tomography. Treatment was based on anti-edema drugs, and the patient made a complete recovery within 48 hours, without any neurological sequelae. Conclusion Although previously reported in relation to other types of contrast media, contrast-induced encephalopathy has never been described as a complication of an endovascular procedure using iodixanol.

How To Diagnose and Manage Infected Endografts after Endovascular Aneurysm Repair

The prevalence of endograft infections (EI) after endovascular abdominal aortic aneurysm repair is below 1%. With the growing number of patients with aortic endografts and the aging population, the number of patients with EI might also increase. The diagnosis is based on an association of clinical symptoms, imaging, and microbial cultures. Angio-computed tomography is currently the gold-standard technique for diagnosis. Low-grade infection sometimes requires nuclear medicine imaging to make a correct diagnosis. There is no good evidence to guide management so far. In the case of active gastrointestinal bleeding, pseudoaneurysm, or extensive perigraft purulence involving adjacent organs, an invasive treatment should always be attempted. In the other cases (the majority), when there is not an immediate danger to the patients life, a conservative management is started with a proper antimicrobial therapy. Any infectious cavity can be percutaneously drained. Management depends on the patients condition and a tailored approach should always be offered. In the case of a patient who is young, has a good life expectancy, or in whom there is absence of significant comorbidities, a surgical attempt can be proposed. Surgical techniques favor, in terms of mortality, patency, and reinfection rate, the in situ reconstruction. Choice of technique relies on the center and the operators experience. Long-term antibiotic therapy is always required in all cases, with close monitoring of the C-reactive protein.