Francesco Setacci

Management of Abdominal Aortic Aneurysms Clinical Practice Guidelines of the European Society for Vascular Surgery

Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The Netherlands b Imperial College, London, UK University Hospital Innsbruck, Austria Azienda Ospedaliera di Perugia, Italy Hopital Cardiologique, CHRU de Lille, Lille, France f St Thomas’ Hospital, London, UK g St George’s Vascular Institute, London, UK Yale University School of Medicine, New Haven, Connecticut, USA University of Siena, Siena, Italy University of Poitiers, Poitiers, France

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.

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.

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.

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.

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.

Endovascular treatment of in-stent restenosis after carotid artery stenting: immediate and midterm results.

Purpose: To evaluate the immediate and midterm outcome and analyze the debris captured after repeat endovascular intervention for the treatment of in-stent restenosis after carotid artery stenting (CAS). Methods: Thirty-one consecutive patients (27 men; mean age 63.7±13.0 years, range 53–81) underwent repeat endovascular intervention (balloon angioplasty and provisional stenting) for the treatment of 32 in-stent restenoses following CAS. Results: Procedural success was achieved in all patients. An additional stent was implanted in 10 (31%) cases. No procedural complication was observed. Filter analysis was performed in 17 (53%) procedures; on 12 (71%), macroscopically visible material was captured. The histomorphometric analysis performed on 6 (19%) filters showed fibrin nets entrapping erythrocytes, leucocytes, platelets, and in 2 cases, fibrous hypercellular tissue fragments. At 30 days and during follow-up (mean 17±5 months), no deaths, transient ischemic attacks, or strokes were observed. In 1 (3.1%) patient, asymptomatic recurrence of ISR was found on Doppler ultrasonography and successfully treated with balloon angioplasty. Conclusion: Repeat endovascular intervention using balloon angioplasty with provisional stenting and routine cerebral protection appears to be a feasible, safe, and clinically effective strategy for the treatment of in-stent restenosis after CAS.