Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.

BACKGROUND: In patients at urgent need for cardiac surgery coexisting with increased-stroke-risk carotid stenosis, any staged intervention increases the risk of complications from the primarily unaddressed pathology. In this challenging cohort, we assessed safety and feasibility of endovascular carotid revascularization under open-chest extracorporeal circulation (ECC) combined with cardiac surgery (hybrid-room true simultaneous treatment). METHODS: Per-protocol (PP), after general anesthesia induction, chest-opening and ECC stand-by installation, carotid stenting (CAS) was performed (femoral/radial or direct carotid access) with ad-hoc/on-hand switch to ECC cardiac surgery. RESULTS: Over 78 months, 60 patients (70.7±6.9years, 85% male, all American Society of Anesthesiology grade IV) were enrolled. All were at increased carotid-related stroke risk (ipsilateral recent stroke/transient ischemick attack, asymptomatic cerebral infarct, increased-risk lesion morphology, bilateral severe stenosis). Majority of study procedures involved CAS+coronary bypass surgery or CAS+valve replacement±coronary bypass. 45 (75%) patients were PP- and 15 (25%) not-PP (NPP-) managed (context therapy). CAS was 100% neuroprotected (transient flow reversal-64.4%, filters-35.6%) and employed micronet-covered plaque-sequestrating stents with routine post-dilatation optimization/embedding. 4 deaths (6.7%) and 7 strokes (11.7%) occurred by 30-days. Despite CAS+surgery performed on aspirin and unfractionated heparin-only (delayed clopidogrel-loading), no thrombosis occurred in the stented arteries, and 30-days stent patency was 100%. NPP-management significantly increased the risk of death/ipsilateral stroke (OR 38.5; P<0.001) and death/any stroke (OR 12.3; P=0.002) by 30-days. CONCLUSIONS: In cardiac unstable patients at increased carotid-related stroke risk who require urgent cardiac surgery, simultaneous cardiac surgery and CAS with micronet-covered stent lesion sequestration is feasible and safe and shows efficacy in minimizing stroke risk. Larger-scale, multicentric evaluation is warranted. (SIMGUARD NCT04973579).

Imaging modality-dependent carotid stenosis severity variations against intravascular ultrasound as a reference: Carotid Artery intravasculaR Ultrasound Study (CARUS).

PURPOSE: Different non-invasive and invasive imaging modalities are used to determine carotid artery stenosis severity that remains a principal parameter in clinical decision-making. We compared stenosis degree obtained with different modalities against vascular imaging gold standard, intravascular ultrasound, IVUS. METHODS: 300 consecutive patients (age 47-83 years, 192 men, 64% asymptomatic) with carotid artery stenosis of " ≥ 50%" referred for potential revascularization received as per study protocol (i) duplex ultrasound (DUS), (ii) computed tomography angiography (CTA), (iii) intraarterial quantitative angiography (iQA) and (iv) and (iv) IVUS. Correlation of measurements with IVUS (r), proportion of those concordant (within 10%) and proportion of under/overestimated were calculated along with recipient-operating-characteristics (ROC). RESULTS: For IVUS area stenosis (AS) and IVUS minimal lumen area (MLA), there was only a moderate correlation with DUS velocities (peak-systolic, PSV; end-diastolic, EDV; r values of 0.42-0.51, p < 0.001 for all). CTA systematically underestimated both reference area and MLA (80.4% and 92.3% cases) but CTA error was lesser for AS (proportion concordant-57.4%; CTA under/overestimation-12.5%/30.1%). iQA diameter stenosis (DS) was found concordant with IVUS in 41.1% measurements (iQA under/overestimation 7.9%/51.0%). By univariate model, PSV (ROC area-under-the-curve, AUC, 0.77, cutoff 2.6 m/s), EDV (AUC 0.72, cutoff 0.71 m/s) and CTA-DS (AUC 0.83, cutoff 59.6%) were predictors of ≥ 50% DS by IVUS (p < 0.001 for all). Best predictor, however, of ≥ 50% DS by IVUS was stenosis severity evaluation by automated contrast column density measurement on iQA (AUC 0.87, cutoff 68%, p < 0.001). Regarding non-invasive techniques, CTA was the only independent diagnostic modality against IVUS on multivariate model (p = 0.008). CONCLUSION: IVUS validation shows significant imaging modality-dependent variations in carotid stenosis severity determination.

Clinical Outcomes of Extracranial Carotid Artery-Related Stroke Eligible for Mechanical Reperfusion on Top of Per-Guidelines Thrombolytic Therapy: Analysis from a 6-Month Consecutive Patient Sample in 2 Centers.

BACKGROUND Systemic intravenous thrombolysis and mechanical thrombectomy (MT) are guideline-recommended reperfusion therapies in large-vessel-occlusion ischemic stroke. However, for acute ischemic stroke of extracranial carotid artery origin (AIS-CA) there have been no specific trials, resulting in a data gap. MATERIAL AND METHODS We evaluated referral/treatment pathways, serial imaging, and neurologic 90-day outcomes in consecutive patients, presenting in a real-life series in 2 stroke centers over a period of 6 months, with AIS-CA eligible for emergency mechanical reperfusion (EMR) on top of thrombolysis as per guideline criteria. RESULTS Of 30 EMR-eligible patients (33.3% in-window for thrombolysis and thrombolysed, 73.3% male, age 39-87 years, median Alberta Stroke Program Early Computed Tomography Score (ASPECTS) 10, pre-stroke mRS 0-1 in all, tandem lesions 26.7%), 20 (66.7%) were EMR-referred (60% - endovascular, 6.7% - surgery referrals). Only 40% received EMR, nearly exclusively in stroke centers with carotid artery stenting (CAS) expertise (100% eligible patient acceptance rate, 100% treatment delivery involving CAS±MT with culprit lesion sequestration using micronet-covered stents). The emergency surgery rate was 0%. Baseline clinical and imaging characteristics did not differ between EMR-treated and EMR-untreated patients. Ninety-day neurologic status was profoundly better in EMR-treated patients: mRS 0-2 (91.7% vs 0%; P<0.001); mRS 3-5 (8.3% vs 88.9%; P<0.001), mRS 6 (0% vs 11.1%; P<0.001). CONCLUSIONS In a real-life AIS-CA setting, the referral rate of EMR-eligible patients for EMR was low, and the treatment rate was even lower. AIS-CA revascularization was delivered predominantly in stroke thrombectomy-capable cardioangiology centers, resulting in overwhelmingly superior patient outcome. Large vessel occlusion stroke referral and management pathways should involve centers with proximal-protected CAS expertise. AIS-CA, irrespective of any thrombolysis administration, is a hyperacute cerebral emergency and EMR-eligible patients should be immediately referred for mechanical reperfusion.

Misclassification of carotid stenosis severity with area stenosis-based evaluation by computed tomography angiography: impact on erroneous indication to revascularization or patient (lesion) migration to a higher guideline recommendation class as per ESC/ESVS/ESO/SVS and CMS-FDA thresholds.

Intoduction: Despite a growing understanding of the role played by plaque morphology, the degree of carotid lumen reduction remains the principle parameter in decisions on revascularization in symptomatic and asymptomatic patients. Computed tomography angiography (CTA) is a widely used guideline-approved imaging modality, with "percent stenosis" commonly calculated as %area reduction (area stenosis - AS). Aim: We evaluated the impact of the non-linear relationship between diameter stenosis (DS) and AS (area = π • (diameter/2)2, so that in concentric lesions 51%AS is 30%DS and 75%AS is 50%DS) on stenosis severity misclassification using calculation of area reduction. Material and methods: CTA and catheter quantitative angiography (cQA) were performed in 300 consecutive patients referred to a tertiary vascular centre for potential carotid revascularization (age: 47-83 years, 33.7% symptomatic, 36% female; referral stenosis of ≥ "50%"). CTA-AS was determined by agreement of 2 experienced radiologists; cQA-DS (pivotal trials standard reference, NASCET method) was calculated by agreement of 2 corelab analysts. Results: For symptomatic lesion thresholds, CTA-AS-based calculation reclassified 76% of "< 50%" cQA-DS measurements to the "50-69%" group, and 58% of "50-69%" measurements to the "≥ 70%" group. For asymptomatic lesion thresholds, 78% of "< 60%" cQA-DS measurements were reclassified to the "60-79%" group, whereas 42% of "60-79%" cQA measurements crossed to the "≥ 80%" class. Overall, employing CTA-AS instead of cQA-DS enlarged the "60-79%" and "≥ 80%" lesion severity classes 1.6- and 5.8-fold, respectively, whereas the "≥ 70%" class increased 4.15-fold. Conclusions: Replacing the pivotal carotid trials reference standard cQA-DS "%stenosis" measurement with CTA-AS-based "%stenosis" results in a large-scale lesion/patient erroneous gain of an "indication" to revascularization or migration to a higher revascularization indication class. In consequence, unnecessary carotid procedures may be performed in the absence of cQA verification. Until guidelines rectify the "%stenosis" measurement methods with different guideline-approved imaging modalities (and, where needed, re-adjust decision thresholds), CTA-AS measurement should not be used as a basis for carotid revascularization.

One-day, sequential carotid artery stenting followed by cardiac surgery in patients with severe carotid and cardiac disease.

Optimal management of patients with internal carotid artery (ICA) stenosis concurrent with severe cardiac disease remains undefined. The aim of this study is to evaluate the safety and feasibility of the one-day, sequential approach by carotid artery stenting (CAS) immediately followed by cardiac surgery. The study included 70 consecutive patients with symptomatic > 50% or ⩾ 80% asymptomatic ICA stenosis coexisting with severe coronary/valve disease, who underwent one-day, sequential CAS + cardiac surgery. The majority of patients (85.7%) had CSS class III or IV angina and 10% had non-ST elevation myocardial infarction. The EuroSCORE II risk was 2.4% (IQR 1.69-3.19%). All CAS procedures were performed according to the 'tailored' algorithm with a substantial use of proximal neuroprotection devices of 44.3%. Closed-cell (75.7%) and mesh-covered (18.6%) stents were implanted in most cases. The majority of patients underwent isolated coronary artery bypass grafting (88.6%) or isolated valve replacement (7.1%). No major adverse cardiac and cerebrovascular events (MACCE) occurred at the CAS stage. There were three (4.3%) perioperative MACCE: one myocardial infarction and two deaths. All MACCE were related to cardiac surgery and were due to the high surgical risk profile of the patients. Up to 30 days, no further MACCE were observed. No perioperative or 30-day neurological complications occurred. In this patient series, one-day, sequential CAS and cardiac surgery was relatively safe and did not result in neurological complications. Thus, a strategy of preoperative CAS could be considered for patients with severe or symptomatic ICA stenosis who require urgent cardiac surgery.

Severe, recurrent in-stent carotid restenosis: endovascular approach, risk factors. Results from a prospective academic registry of 2637 consecutive carotid artery stenting procedures (TARGET-CAS).

INTRODUCTION: Optimal management of severe carotid in-stent restenosis remains unknown. Prevalence and risk factors of first and recurrent carotid in-stent restenosis in the multi-stent approach have not been established yet. AIM: To evaluate the safety of different methods of endovascular treatment of carotid in-stent restenosis/recurrent restenosis and to establish its rate and risk factors. MATERIAL AND METHODS: Between January 2001 and June 2016, 2637 neuroprotected carotid artery stenting (CAS) procedures were performed in 2443 patients (men: 67.0%; mean age: 67.9 ±8.8 years, symptomatic: 45.5%). Doppler ultrasound (DUS) evaluation was performed at discharge, after 3-6 months, 12 months, and then annually. Peak systolic velocity of 2-3 and > 3.0 m/s as well as end diastolic velocity of 0.5-0.9 and > 0.9 m/s were DUS criteria for 50-69% and ≥ 70% carotid in-stent restenosis (ISR) respectively. For angiographically confirmed ≥ 70% stenosis balloon re-angioplasty was first line treatment. RESULTS: Out of 95 DUS detected > 50% ISR (95/2637; 3.6%), 53 were confirmed in angiography as ≥ 70% (53/2637; 2.0%, one total occlusion). All patients were treated with bare balloon (n = 19), drug-eluting balloon (n = 27) or stent-supported (n = 6) angioplasty. One procedure was complicated with stroke (1.9%). Angiographic diameter stenosis (DS) was reduced from 83 ±8.3% to 13 ±7.6% (p < 0.001). There were 13 cases of ≥ 70% recurrent ISR. Bilateral and high-grade stenosis were independent risk factors of restenosis. Initial Carotid Wallstent implantation was a risk factor of first and recurrent in-stent restenosis. CONCLUSIONS: Endovascular treatment of carotid in-stent restenosis is safe. Bilateral and high-grade carotid artery stenosis may increase the risk of restenosis. Initial Carotid Wallstent implantation may increase the risk of first and recurrent restenosis.

Intravenous N-acetylcysteine for the PRevention Of Contrast-induced nephropathy - a prospective, single-center, randomized, placebo-controlled trial. The INPROC trial.

INTRODUCTION: Contrast-induced nephropathy (CIN) is a common clinical problem that is growing in importance as an increasing number of tests and procedures which utilize contrast media (CM) are performed. AIM: To evaluate the efficacy of intravenous N-acetylcysteine (NAC) for prevention of CIN after diagnostic and/or interventional procedures requiring CM administration. MATERIAL AND METHODS: In a prospective, single-center, randomized, placebo-controlled trial the preventive effects of N-acetylcysteine were evaluated in 222 patients undergoing elective angiography and/or angioplasty. Patients were randomly assigned to receive either NAC or placebo. All patients received intravenous hydration with normal saline before and after catheterization. Serum creatinine (SCr) and estimated glomerular filtration rate were assessed at baseline, at 48-72 h and 10-15 days after CM administration. Contrast-induced nephropathy was defined as an increase in SCr of at least 44 µmol/l (0.5 mg/dl) or an increase of ≥ 25% of the baseline value 48-72 h after CM administration. RESULTS: Contrast-induced nephropathy occurred in 30 of 222 patients (13.5%): 9 of 108 patients in NAC (8.3%) and 21 of 114 patients in the control group (18.4%; p = 0.0281). The multivariate Cox analysis revealed that elevated SCr at 10-15 days (HR = 2.69; p = 0.018) and baseline SCr level (HR = 1.009; p = 0.015) were independent prognostic variables for adverse events during follow-up. CONCLUSIONS: Our findings suggest that intravenous NAC along with intravenous hydration may help prevent declining renal function after CM exposure. Elevated SCr level 10-15 days after CM administration was associated with increased risk of adverse events in long-term observation, while elevated SCr within 72 h was not. Measuring SCr at least 10 days after exposure to CM may provide a better outcome measure.

Mesh-covered (Roadsaver) stent as a new treatment modality for symptomatic or high-risk carotid stenosis.

INTRODUCTION: Prevention of periprocedural stroke has a crucial role in carotid artery stenting (CAS) procedures. AIM: To assess retrospectively 30-day safety and effectiveness of 41 procedures of internal and common carotid artery stenting using the Roadsaver double nitinol layer micromesh stent in 40 non-consecutive patients with symptomatic or high-risk carotid artery stenosis. MATERIAL AND METHODS: The patients were men (n = 31) and women (n = 9); mean age was 67.8 ±7.9 years. Femoral access was used in 39 cases, whereas radial access was used in 2. Proximal (n = 27) or distal (n = 14) embolic neuroprotection was used. RESULTS: The Roadsaver stents (nominal diameter 7, 8 or 9 mm, length 25 or 30 mm) were implanted successfully in all cases. One minor stroke occurred after common carotid artery intubation with a guiding catheter (before stent deployment) and one transient postprocedural ischemic attack (TIA) of the ipsilateral cerebral hemisphere was observed. Internal/common carotid artery stenosis severity was evaluated by duplex Doppler. Maximal peak systolic velocity (PSV) before CAS was in the range: 2.0-7.0 m/s, mean: 3.9 ±1.0 m/s, at 24-48 h after stenting mean PSV was 1.1 ±0.4 m/s (p < 0.05), and at 30 days 1.1 ±0.3 m/s (p < 0.05). Maximal end-diastolic velocity (EDV) was 0.85-3.5 m/s, mean 1.4 ±0.5 m/s, at 24-48 h after stenting mean EDV was 0.3 ±0.1 m/s (p < 0.05), and at 30 days 0.4 ±0.1 m/s (p < 0.05). No restenosis or thrombosis was observed. Angiographic stenosis decreased from 82.9 ±9.1% (range: 61-97%) to 19.3 ±7.3% (range: 0-34%) (p < 0.05). CONCLUSIONS: The CAS using the Roadsaver stent seems to be safe and effective. Further studies involving larger patient populations and longer follow-up are needed.

Simultaneous vertebral and subclavian artery stenting.

INTRODUCTION: Vertebrobasilar territory ischemia leads to disabling neurological symptoms and may be caused both by vertebral artery (VA) and subclavian artery (SA) stenosis. The coexisting symptomatic ipsilateral VA and proximal SA stenosis should be considered as a true bifurcation lesion for percutaneous treatment. AIM: To evaluate the safety and efficacy of simultaneous angioplasty of vertebral and subclavian stenosis. MATERIAL AND METHODS: Fifteen patients (age 69.5 years, 46.7% men, all symptomatic from posterior circulation (history of stroke, transient ischemic attack, chronic ischemia symptoms)) were scheduled for simultaneous SA/VA angioplasty. Clinical and duplex ultrasound follow-up was conducted 1, 6 and 12 months after the procedure. RESULTS: The technical success rate was 100%. Single balloon-mounted stent angioplasty was performed for all VAs and for 13 (86.7%) SAs. In 4 cases a simultaneous radial and femoral approach was required. The mean North American Symptomatic Carotid Endarterectomy Trial (NASCET) VA stenosis was reduced from 88.7 ±9.7% to 5.7 ±6.8% and SA stenosis from 80 ±12.2% to 11 ±12.3% (p < 0.01). No periprocedural death, stroke, myocardial infarction or transient ischemic attack occurred. During follow-up (range: 6-107 months) in 10 of 15 (66.7%) patients relief of chronic ischemic symptoms was observed. No stroke/TIA occurred. One cardiovascular and 2 non-cardiovascular deaths were recorded. There was 1 symptomatic vertebral and 1 subclavian in-stent restenosis, and 2 cases of asymptomatic VA in-stent occlusion occurred. CONCLUSIONS: Simultaneous vertebral and subclavian artery stenting is safe and effective. The restenosis rate remains at an acceptable level and it may be treated successfully with drug-eluting balloon angioplasty. In selected patients a dual radial and femoral approach may facilitate the procedure.

Invasive treatment for carotid fibromuscular dysplasia.

INTRODUCTION: Fibromuscular dysplasia (FMD) is an infrequent non-inflamatory disease of unknown etiology that affects mainly medium-size arteries. The prevalence of FMD among patients scheduled for endovascular treatment of carotid artery stenosis is unknown. AIM: To evaluate the prevalence and treatment options of carotid FMD in patients scheduled for carotid artery stenting (CAS). MATERIAL AND METHODS: Between Jan 2001 and Dec 2013, 2012 CAS procedures were performed in 1809 patients (66.1% men; age 65.3 ±8.4 years, 49.2% symptomatic). In case of FMD suspicion in Doppler-duplex ultrasound (DUS), computed tomography angiography was performed for aortic arch and extracranial and intracranial artery imaging. For invasive treatment of FMD carotid stenosis, balloon angioplasty was considered first. If the result of balloon angioplasty was not satisfactory (> 30% residual stenosis, dissection), stent placement was scheduled. All patients underwent follow-up DUS and neurological examination 3, 6 and 12 months after angioplasty, then annually. RESULTS: There were 7 (0.4%) (4 symptomatic) cases of FMD. The FMD group was younger (47.9 ±7.5 years vs. 67.2 ±8.9 years, p = 0.0001), with higher prevalence of women (71.4% vs. 32.7%, p = 0.0422), a higher rate of dissected lesions (57.1% vs. 4.6%, p = 0.0002) and less severe stenosis (73.4% vs. 83.9%, p = 0.0070) as compared to the non-FMD group. In the non-FMD group the prevalence of coronary artery disease was higher (65.1% vs. 14.3% in FMD group, p = 0.009). All FMD patients underwent successful carotid artery angioplasty with the use of neuroprotection devices. In 4 cases angioplasty was supported by stent implantation. CONCLUSIONS: Fibromuscular dysplasia is rare among patients referred for CAS. In case of significant FMD carotid stenosis, it may be treated with balloon angioplasty (stent supported if necessary) with optimal immediate and long-term results.

Transradial approach for carotid artery stenting in a patient with severe peripheral arterial disease.

We present a case of a 73-year-old man with critical bilateral internal carotid artery stenosis, recent right-hemisphere stroke and severe peripheral artery disease in whom right internal carotid artery stenting (RICA-CAS) was performed successfully via a right transradial approach.

Carotid artery stenting according to the "tailored CAS" algorithm performed in the very elderly patients: the thirty day outcome.

OBJECTIVES: To assess safety and efficacy of carotid artery stenting (CAS) according to "tailored-CAS" algorithm in the elderly (≥75 years) in relation to younger patients. BACKGROUND: Although CAS has grown as an alternative to carotid endarterectomy the data on safety of CAS in the very elderly are inconsistent. MATERIAL AND METHODS: 1,139 patients with significant carotid stenosis underwent 1,252 CAS procedures in one high-volume center between years 2001-2011. CAS procedures were performed with lesion and patient dependent selection of neuroprotection type ("tailored-CAS"). There were 193 subjects ≥75-years-old (17%) and 946 <75-years-old. No major differences in atherosclerosis risk factors and comorbidities between groups were noted. In both groups the majority of patients were male (70.4% vs. 68.6%, P = NS) and half of the patients were symptomatic (50.2% vs. 55.2%, P = NS). Bilateral carotid stenosis was present in 25% of patients from CAS ≥75 group and 22% from CAS< 75 group, P = NS. Proximal neuroprotection devices use for high risk or symptomatic lesions accounted for 31% in CAS≥ 75 group and 32% in CAS<75 group, P = NS. RESULTS: In symptomatic patients aged ≥75 years 30-day stroke and death rate was 7% versus 1.9% in symptomatic patients aged <75; P = 0.01 and vs. 1.8% in asymptomatic elderly, P = 0.09. No myocardial infarcts were noted. CONCLUSIONS: Symptomatic elderly is a group of highest CAS risk and the use of "tailored CAS" algorithm does not equalize CAS risk in this patients' group. "Tailored CAS" remains a safe procedure for asymptomatic elderly as well as symptomatic and asymptomatic young patients.

Zotarolimus-eluting stent for the treatment of recurrent, severe carotid artery in-stent stenosis in the TARGET-CAS population.

PURPOSE: To evaluate the safety and efficacy of a balloon-mounted drug-eluting stent (DES) for recurrent carotid in-stent stenosis (ISS). METHODS: As part of our targeted carotid artery stenting (TARGET-CAS) protocol, neurological and ultrasound evaluations have been performed at 3, 6, and 12 months and then annually since 2001 in all carotid stent patients. For angiographically-confirmed >70% ISS, balloon angioplasty was performed as a first-line treatment. Recurrent ISS was treated with a 4.0-mm zotarolimus-eluting coronary stent (ZES) that was postdilated according to intravascular ultrasound imaging. Among the 1350 neuroprotected CAS procedures performed between January 2001 and March 2011, there were 7 (0.52%) patients (5 men; ages 51-72 years), all neurologically asymptomatic, with >70% recurrent ISS that occurred at 5 to 11 months after the initial balloon angioplasty treatment for ISS. RESULTS: ZES implantation under distal embolic protection was technically successful and uncomplicated. Angiographic stenosis was reduced from 84.6%±7.5% to 10.7%±3.6% (p<0.01). In 5 patients with ZES implanted fully within the self-expanding carotid stent, duplex ultrasound follow-up (mean 17 months, range 6-36) revealed no evidence of restenosis or stent fracture/deformation. In the 2 other patients, the ZES had been implanted for distal edge ISS such that the ZES protruded beyond the original carotid stent. This protruding segment of the ZES demonstrated deformation/kinking in both; in one, this led to symptomatic stent occlusion. CONCLUSION: The use of coronary ZES in the treatment of recurrent carotid ISS is feasible and appears effective provided the ZES is placed entirely within the original stent. Placement of a coronary ZES outside the carotid stent scaffold should be avoided.

Carotid artery stenting according to the tailored-CAS algorithm is associated with a low complication rate at 30 days: data from the TARGET-CAS study.

BACKGROUND: The rate of early complications of carotid artery stenting (CAS) should not exceed 3% in asymptomatic and 6% in symptomatic patients. However, some recent studies/registries failed to reach this threshold, fueling a debate on the role of CAS in the treatment of patients with carotid artery stenosis. AIM: To evaluate 30-day safety of CAS using different embolic protection devices and different stent types according to the tailored-CAS algorithm and to identify risk factors for complications. METHODS: Between 2002 and 2010, we performed 1176 CAS procedures in 1081 patients (age 38-86 years, mean 66.3 ± 8.4 years, 51.5% symptomatic) according to the tailored-CAS algorithm that included extracranial ultrasound and computed tomography angiography to select the most appropriate embolic protection device (EPD) and stent type. Proximal EPD and closed-cell (CC) stents were preferentially used for high-risk lesions (HR - soft/thrombus-containing/tight/ulcerated, 36.14% of all lesions) and in symptomatic patients. RESULTS: Procedural success rate was 99.8%. In symptomatic patients, proportion of HR lesions was higher (41.1%) than in the asymptomatic group (30.8%, p = 0.001) and the usage of CC stents (76.2% vs 71.7%, p = 0.103) and proximal EPD (P-EPD, 34.8% vs 27.7% among asymptomatic patients, p = 0.010) was more frequent. CC stents were used in 82.4% of CAS procedures involving HR lesions (vs 69.1% for non-HR lesions, p < 0.01), and P-EPD were used in 83.1% of procedures involving HR lesions (vs 2.5% for non-HR lesions, p < 0.001). In-hospital complications included 6 (0.55%) deaths, 1 (0.08%) major stroke and 19 (1.61%) minor strokes. No myocardial infarctions (MI) were noted. Among 7 (0.59%) cases of hyperperfusion syndrome, 2 were fatal. Thirty-day complication rate (death/any stroke/MI) was 2.38%. Age > 75 years was a predictor of death (p = 0.015), and prior neurological symptoms were a predictor of death/stroke (p = 0.030). There were 4 cases of periprocedural embolic cerebral artery occlusion, all treated with combined intracranial mechanical and local thrombolytic therapy. CONCLUSIONS: CAS with EPD and stent type selection on the basis of thorough non-invasive diagnostic work-up (tailored- -CAS) is safe. Advanced age was associated with an increased risk of death and the presence of prior neurological symptoms was a predictor of death/stroke at 30 days. With the tailored-CAS approach, high-risk lesion features (soft/thrombus- -containing/tight/ulcerated) are eliminated as a risk factor. Hyperperfusion syndrome is a severe CAS complication which may lead to intracranial bleeding and death. Acute, iatrogenic embolic cerebral artery occlusion is rare and may be managed by combined intracranial mechanical and local thrombolytic therapy.

Treatment strategies in severe symptomatic carotid and coronary artery disease.

Coexistent carotid artery stenosis (CS) and multivessel coronary artery disease (CAD) is not infrequent. One in 5 patients with multivessel CAD has a severe CS, and CAD incidence reaches 80% in those referred for carotid revascularization. We reviewed treatment strategies for concomitant severe CS and CAD. We performed a literature search (MEDLINE) with terms including carotid artery stenting (CAS), coronary artery bypass grafting (CABG), carotid endarterectomy (CEA), stroke, and myocardial infarction (MI). The main therapeutic option for CS-CAD has been (simultaneous or staged) CEA-CABG. This, however, is associated with a high risk of MI (in those with CEA prior to CABG) or stroke (CABG prior to CEA), and the cumulative major adverse event rate (MAE - death, stroke or MI) reaches 10-12%. With increasing adoption of CAS, a sequential strategy of CAS followed by CABG has emerged. Registries (usually single-centre) indicate an MAE rate of ≈7% for CAS followed by CABG (frequently after >30 days, due to double antiplatelet therapy). Recently, 1-stage CAS-CABG has been introduced. This involves different antiplatelet regimens and, in some centers, preferred off-pump CABG, with a cumulative MAE of 1.4-4.5%. No randomized trial comparing different treatment strategies in CS-CAD has been conducted, and thus far reported series are prone to selection/reporting bias. In addition to the established surgical treatment (CEA-CABG, sequential/simultaneous), hybrid revascularization (CAS-CABG) is emerging as a viable therapeutic option. Larger, preferably multi-centre, studies are required before this can become widely applied.

The use of a novel type of distal protection system (FiberNet®) in the percutaneous management of saphenous vein graft disease.

Percutaneous intervention in saphenous vein grafts is associated with a high risk of distal embolisation by plaque material, 'no flow' phenomenon and clinical complications such as myocardial infarction or death. According to randomised trial evidence, intervention in a degenerated vein graft should be performed using an embolic protection device (EPD), since this strategy significantly reduces periprocedural and 30 day adverse event rate. FiberNet® is a novel distal protection system with unique characteristics of a low crossing profile (0.031'' for vessel size 3.5-5 mm), 'cotton wool'-like three dimensional design and a small pore size (40 µm). The FiberNet® does not require a separate delivery sheath and self-achieves its optimal apposition to the vessel wall; the EPD system also contains a dedicated aspiration catheter. We present the use of FiberNet® in a 77 year-old patient who had undergone coronary artery bypass grafting 20 years ago and currently presented with CCS class III angina due to a significant stenosis of the saphenous vein graft to the marginal branch. The procedure involved the use of a novel mesh-covered stent (MGuard®) designed to 'trap' the plaque material between the stent and the vessel wall. It was technically successful and clinically uncomplicated, and the patient remains well six months later.

Flow reversal for proximal neuroprotection during endovascular management of critical symptomatic carotid artery stenosis coexisting with ipsilateral external carotid artery occlusion.

PURPOSE: To report the utility of proximal brain protection by flow reversal in endovascular management of critical internal carotid artery (ICA) stenosis coexisting with ipsilateral external carotid artery (iECA) occlusion. CASE REPORT: Four patients with a symptomatic, critical ICA stenosis (in-stent restenosis in one) and iECA occlusion were admitted for carotid artery stenting (CAS). In all cases, the stenosis severity and high-risk lesion morphology precluded the use of filter protection. The "tailored" CAS algorithm indicated that a proximal anti-embolism system should be used to maximize the potential for effective neuroprotection. The flow reversal system, which consists of an independent guiding sheath balloon positioned in the common carotid artery (CCA) and an iECA balloon-wire, was employed, using the CCA balloon only. The system was well-tolerated, and the CAS procedures were uneventful. CONCLUSION: Due to a unique design with separate CCA and iECA balloons, the flow reversal system can be used for proximal neuroprotection during CAS in severe, symptomatic ICA lesions coexisting with iECA occlusion.