Use Of Embolic Protection Devices Research Articles

Clinical Effectiveness of Endovascular Therapy for Total Occlusion of the Subclavian Arteries: A Study of 67 Patients

Endovascular therapy is a feasible option for total occlusion of the subclavian artery. The purpose of this study was to evaluate the effectiveness of stenting therapy bycomparing it with that of surgical treatment in patients with total subclavian artery occlusion. Between May 2007 and October 2013, 52 stents were placed in 67 patients who underwent endovascular therapy for the treatment of total atherosclerosis subclavian artery occlusion. During the same period, 21 patients underwent bypass surgery. All patients were followed at 3, 6, and 12months after treatment and annually thereafter. Technical success was achieved in 77.6% patients in the endovascular group, while clinical success was achieved in 74.6%. Technical failure was noted in 15 patients, while the symptoms failed to resolve in 2. The rate of primary patency was 98.2% at 12months, 94.3% at 24months, and 92.1% at 3years. Significant recurrent obstruction developed in 5 patients. No complications were observed in 5 patients with right side occlusion in whom embolic protection filters were used. Meanwhile, the technical success rate was 100% in the surgery group. One patient developed a major ischemic stroke during surgery (4.8%). The rate of primary patency was 100% at 12months, 96.3% at 24months, and 93.1% at 3years. When performed by skilled surgeons, percutaneous revascularization with primary stenting is a safe and effective therapy for symptomatic total occlusion of the proximal subclavian artery. However, we recommend the use of embolic protection devices during the treatment of right side occlusions. Otherwise, surgery may be the best choice.

Carotid stenting versus endarterectomy for the treatment of carotid artery stenosis: Contemporary results from a large single center study.

To compare the complication rates associated with carotid endarterectomy (CEA) versus carotid artery stenting (CAS). Carotid stenosis is a well-known cause of stroke and increased mortality. The safety of carotid revascularization may be related to symptom status, medical comorbidities, use of embolic protection devices, as well as operator experience and these factors may vary across patient populations within a single operating center. We retrospectively analyzed patients with carotid artery stenosis admitted to our hospital for carotid revascularization between January 1, 2007 and December 1, 2013. The primary end point was a composite endpoint of periprocedural death, stroke, and myocardial infarction (MI). Of the 718 patients admitted for carotid revascularization 525 (73.1%) underwent CEA and 193 (26.9%) underwent CAS. Both groups demonstrated similar rates of the composite endpoint, MI, and death; the stenting group demonstrated a higher rate of stroke (4.2% vs. 1.3%; P = 0.020). Adjusting for baseline medical comorbidities and symptom status mitigated this difference (P = 0.091 and 0.113, respectively). When stratified by department performing CAS, there was a significant difference in the occurrence of stroke (P = 0.033), which likewise disappeared in the multivariate regression analysis. The risk of the composite endpoint did not differ significantly between those undergoing CAS versus CEA. The stenting group demonstrated a higher rate of periprocedural stroke, which was also apparent when patients were stratified by stenting department. These differences were likely driven by variation in baseline medical comorbidities and symptom status. © 2016 Wiley Periodicals, Inc.

VESS21. Mesenteric Artery Stenting Using Embolic Protection Device for Treatment of Acute or Chronic Mesenteric Ischemia

This study reports the feasibility and results of mesenteric artery stenting (MAS) using embolic protection devices (EPD) to treat acute (AMI) and chronic mesenteric ischemia (CMI). We retrospective reviewed all patients who underwent MAS with EPDs from 2007 to 2016. EPDs were used selectively in patients with occlusions, severe calcification, or acute thrombus. A two-wire technique with SpiderRX 0.014-inch Filter-Wire (Medtronic, Minn) combined with a 0.018-inch wire was used to provide support and facilitate filter retrieval. Presence of macroscopic debris in the EPD was recorded and graded as minor (minimal debris) or major (large thrombus or plaque). End points were technical success, presence of EPD debris, embolization, and early morbidity and mortality. A total of 179 patients underwent MAS, of which 65 patients (36%) had EPDs. There were 49 female patients (75%), with mean age of 73 ± 11 years. Clinical presentation was CMI in 48 patients (74%) and AMI in 17 (26%). Brachial access was used in 59 patients (91%). Indications for EPD were severe calcification in 22 patients (34%), acute thrombus in 18 (28%), and total occlusion in 16 (25%). Bare-metal stents were used in 33 patients, covered stents in 26, and both types in six. Adjunctive therapy included thrombolysis in seven patients, thrombectomy in four, and atherectomy in three. Technical success was 100%. Embolization was noted in four patients (6%), of which two had AMI. All large emboli were treated using catheter aspiration devices, but one small distal emboli was left untreated, with no clinical consequences. There were no arterial injuries caused by the EPD. Two patients had vessel spasm treated by nitroglycerin. Macroscopic debris was noted in 43 patients (66%) and was major in 21 (49%; Fig) or minor in 22 (51%). Of the patients with AMI, five (29%) required exploratory laparotomy, and four (23%) had bowel resection. Eight additional patients (12%) had early complications (5 CMI, 3 AMI), including cardiac, brachial hematoma, acute cholecystitis, and ARDS in two patients each. There were no deaths among CMI patients and two early deaths (12%) among those who had AMI. Embolic protection during MAS is safe using the two-wire technique, with no instances of filter wire retention or arterial trauma induced by filter wire manipulation. Macroscopic debris was noted in two-thirds of the patients when EPDs were used selectively in patients with acute symptoms, occlusions or severely calcified lesions. Despite the use of EPD, distal embolization in 6% of patients was successfully treated using catheter aspiration devices.

Embolic protection device use and its association with procedural safety and long-term outcomes following saphenous vein graft intervention: An analysis from the British Columbia Cardiac registry.

Embolic protection devices (EPDs) have been designed and introduced to reduce distal embolization and peri-procedural myocardial infarction during saphenous vein graft (SVG) intervention. Current guidelines give a class I recommendation to EPD use during SVG intervention when technically feasible. However, the routine use of these devices has recently been debated. We analyzed 1,359 patients undergoing isolated SVG intervention between 2008 and 2013 in the British Columbia Cardiac Registry. We analyzed (a) post-procedural TIMI flow; and (b) target vessel revascularization (TVR) and mortality at 1 and 2 years. EPD use was an independent predictor of post-procedural TIMI 2/3 flow (OR = 2.38, 95% CI: 1.51-3.74, P < 0.001). At 1 year, EPD use was an independent predictor for lower TVR (HR = 0.35, 95% CI: 0.14-0.85, P = 0.021) and a trend towards lower mortality (HR = 0.45, 95% CI: 0.18-1.10, P = 0.082). These associations were lost at 2 years where EPD use was not predictive of mortality (HR = 0.62, 95% CI: 0.33-1.17, P = 0.144) or TVR (HR = 0.70, 95% CI: 0.41-1.17, P = 0.176). These findings were confirmed in propensity-matched and inverse probability treatment weighted analyses. In this analysis of patients undergoing SVG intervention, EPD use was a strong predictor for improved post-procedural TIMI flow. Whilst EPD use was associated with lower TVR and a trend for lower mortality at 1 year, these associations were lost at 2 years. These findings would appear to support the use of EPD for SVG intervention. © 2015 Wiley Periodicals, Inc.

TCT-790 Safety and Effectiveness of the Nav-6 Filter in Preventing Distal Embolization during JetStream Atherectomy of Infrainguinal Peripheral Artery Lesions

The risk of distal embolization (DE) during infrainguinal peripheral artery interventions (PAI) is often mitigated with the use of embolic protection devices. There is limited data on the use of filters with the Jetstream (JS) atherectomy device, a rotational cutter with aspiration capacity. The Nav

Plaque morphology (the PLAC Scale) on CT angiography: predicting long-term anatomical success of primary carotid stenting.

Carotid angioplasty and stenting has emerged as an alternative to carotid endarterectomy for the treatment of atherosclerotic carotid stenosis. Primary carotid stenting, performed using self-expanding stents alone without deliberate use of embolic protection devices and balloon angioplasty, has been shown to be effective and faster, cheaper, and potentially safer than conventional techniques. However, the long-term morphological results of this technique have not been established. The aim of this study was to determine whether preprocedural carotid plaque imaging at the site of maximal stenosis by using CT angiography (CTA) could predict the long-term morphological outcome of primary carotid stenting. One hundred eighty-one patients were treated over an 11-year period. Preprocedural CTA was performed in 102 of these. A morphological scale (the Predicting Long-term outcome with Angioplasty of the Carotid artery [PLAC] Scale), with grades from 0 to 4 and A or B, was used to evaluate the circumferential degree of plaque calcification, and the presence or absence of soft plaque. All patients were followed using duplex carotid ultrasound and plain radiographs. Satisfactory morphological outcome was defined as a peak systolic velocity < 120 cm/s and internal carotid artery/common carotid artery ratio < 1.4. The average follow-up duration was 29.7 months (median 24.5 months, range 0.3-87 months). Univariate logistic regression demonstrated that a low calcification grade (p < 0.001), less thick calcification (p < 0.001), and moderate amounts of soft plaque (p < 0.001) are factors that are highly associated with good long-term outcome. Multivariate analyses confirmed that these factors are independent of each other in predicting outcome. The long-term morphological outcome of primary carotid stenting was predicted with considerable accuracy by using a straightforward CTA carotid plaque grading scale.

My approach to a SVG graft with total occlusion: Illustrated with a case

Management of a patient with acute coronary syndrome after coronary artery bypass grafting (CABG) is challenging. Increasing age, associated co-morbidities, and progressive deterioration in left ventricular function make the scenario even worse. The escalation of ongoing medical treatment is usually the first step. Re-CABG is often not an option. Then, this becomes a compelling situation for an interventional cardiologist to perform an intervention to relieve the symptoms and sometimes repeated interventions. Conventionally, two types of interventions are described in this situation, either the intervention on native coronaries or intervention on graft vessels. Percutaneous revascularization is associated with higher rates of in-stent restenosis, target vessel revascularization, myocardial infarction, and death compared with native coronary arteries. Use of embolic protection devices is a Class I indication to decrease the risk of distal embolization. Nonetheless, these devices are underused. Most evidence supports treatment with drug-eluting stents. We illustrate the management with a case. This case used a thrombus aspiration device prior to stent deployment in saphenous vein graft to get optimal results without any slow-flow or no-flow.

Technique and clinical evidence of neuroprotection in carotid artery stenting

Carotid artery stenting has been advocated as an effective alternative to carotid endarterectomy. Periprocedural embolization of debris during endovascular treatment of carotid artery disease may result in neurological deficit. Different strategies are being developed and evaluated for their ability to minimize the clinical embolic risk. Distal filter devices, proximal and distal balloon occlusion systems are increasingly used in carotid artery stenting, because they seem to be safe and effective in preventing distal embolization, according to several uncontrolled studies. However the use of embolic protection devices is a subject of controversy and no data on their benefit are available from randomized controlled multi-center trials. The technique and clinical evidence of cerebral protection systems during carotid angioplasty and stenting for stroke prevention are reviewed.

Cardioprotective effect of high‐dose intragraft adenosine infusion on microvascular function and prevention of no‐reflow during saphenous vein grafts intervention

Despite the use of embolic protection devices, no-reflow can still occur during saphenous vein grafts (SVGs) intervention. High-dose intracoronary adenosine infusion preconditions the myocardium, improves coronary flow, and prevents no-reflow. The role of high-dose intragraft adenosine infusion on protection of microvascular function and prevention of no-reflow has not been investigated We investigated the cardioprotective effect of high-dose intragraft adenosine infusion, compared with placebo, on microvascular function and prevention of no-reflow during SVGs intervention. We randomized 22 patients with SVGs stenoses to receive either a 10-min intragraft adenosine infusion (200 μg/min; total dose = 2,000 μg) or normal saline prior to stenting. Average peak velocity (APV), coronary flow velocity reserve (CVR), thrombolysis in myocardial infarction (TIMI) frame count (TFC), TIMI myocardial perfusion grade (TMPG), and the rate of no-reflow were compared between the two groups before adenosine or saline infusions and after stenting After stenting, hyperemic APV, CVR, and TMPG were significantly higher in the adenosine-treated group than in the control group (60 ± 18 vs. 35 ± 10 cm/sec; 2.6 ± 0.54 vs. 1.8 ± 0.47; and 2.8 ± 0.90 vs. 2.1 ± 0.80, respectively; P < 0.05. TFC was significantly lower in the adenosine-treated group than in the control group (14 ± 3.0 vs. 26 ± 13; P < 0.05). In the control group, four patients (36%) developed no-reflow compared to none in the adenosine-treated patient; P < 0.05 CONCLUSIONS: This study provides the first evidence that high-dose intragraft adenosine infusion compared with placebo protects microvascular function and prevents no-reflow during SVGs intervention.

The protective effect of clopidogrel and atorvastatin in patients undergoing carotid stenting

Over the last few years, the advance in operator’s experience, the improvement in technology and the strong demand from patients for a less-invasive alternative to surgery has made carotid artery stenting (CAS) an equally efficient and safe procedure to carotid endarterectomy for the treatment of carotid artery stenosis [1–3]. The introduction of mechanical cerebral protection systems can be considered the cornerstone in the evolution of CAS; these devices aim to prevent emboli from reaching the brain, and their introduction in the majority of procedures is responsible for better outcomes reported in recent clinical trials and registries. Therefore, guidelines strongly recommend the use of embolic protection devices in all procedures [4]. Despite progress in CAS, periprocedural stroke rate remains significant, and has an important physical, mental and social impact on patients’ lives. Therefore, indication for treatment of asymptomatic patients is one of the most debatable issues in the literature. In particular, incidence of microembolization, during and after CAS, persists despite the use of cerebral protection devices. Diffusion-weighted MRI (DW-MRI) has been shown to be a sensitive tool in identifying new ischemic cerebral lesions that are caused by emboli during CAS. Cerebral ischemic lesions are observed by DW-MRI in 15–78% of patients after CAS, and most of them are not associated with acute neurological symptoms [5–7]. Clinical implication and impact on prognosis of asymptomatic cerebral microembolism is still debated. Recently, a large study analyzing the role of asymptomatic cerebral ischemic lesions after CAS on prognosis in terms of major adverse cardiac and cerebrovascular event (death, stroke and myocardial infarction) demonstrated that a positive DW-MRI after CAS was not an

Carotid Revascularization: A Systematic Review of the Evidence

The aim of this study is to provide an evidence-based review of the periprocedural safety and long-term effectiveness of carotid artery stenting (CAS) compared to carotid endarterectomy (CEA), with particular attention paid to the use of embolic protection devices and patients at high risk for CEA. Electronic databases (Ovid Medline, Cochrane central register of controlled trials, Pubmed, and Embase) were searched to identify: (1) randomized controlled trials (RCT) comparing outcomes of CEA and CAS, and (2) prospective clinical trials assessing the safety of CAS in patients at high surgical risk. Pooled incidence rates and one-sided 95% confidence interval for the periprocedural and long-term composite end-point of stroke, myocardial infarction, or death among high surgical risk patients were generated and compared to objective performance criteria (OPC) reported by previous trials. Six RCTs and 14 prospective clinical trials met our search criteria. Selected RCTs showed inconsistency in reported periprocedural and long-term outcome rates. Pooled incidence rates of the periprocedural and long-term composite end-point of stroke, myocardial infarction or death in high surgical risk candidates were 5.59% and 7.92%, respectively. These results were noninferior to selected OPCs (P-value <0.001). CAS represents a safe and effective stroke prevention strategy in high surgical risk patients when compared with CEA. The inconsistent results from the RCTs and the improved outcomes in the prospective clinical trials are likely related to variability in operator experience, use of embolic protection devices, and patient selection strategies.

Proteção cerebral em pacientes idosos durante implante de stent carotídeo

BACKGROUND: The type of cerebral protection used during carotid stenting in the elderly is controversial. Our objective was to evaluate the results of proximal and distal cerebral embolic protection devices (EPDs), in patients > 70 years through diffusion-weighted magnetic resonance imaging (DW-MRI). METHODS: Between 2008 and 2011, 60 patients with indication for carotid stenting were randomized to EPD with Mo.Ma® or Angioguard®, of which 26 patients were > 70 years of age. Results of DW-MRI performed before and 48 hours after the procedure were evaluated by an independent neurologist blinded to the type of EPD used. New ischemic lesions, their localization and size were analyzed. RESULTS: New cerebral ischemic lesions were found in 8/12 (66.7%) patients in the Mo.Ma® group and 12/14 (85.7%) patients in the Angioguard® group (P = 0.37). The vast majority of the lesions (> 90%) were ipsilateral to the treated artery in both groups and the size of the lesions was < 0.5 cm in most cases. The number of lesions per patient was lower with the Mo.Ma® device (median [variation]: 3 [1 to 8] lesions vs 15 [2 to 76] lesions; P < 0.001). All of the patients with more than 40 lesions were in the Angioguard® group. CONCLUSIONS: Despite the use of EPDs (proximal or distal), new ischemic lesions were observed in both groups in elderly patients. A proportionately larger number of patients with Angioguard® had new ischemic lesions when compared to those with Mo.Ma®. The Mo.Ma® device seems to decrease the number of lesions per patient.

Clinical effectiveness of secondary interventions for restenosis after renal artery stenting

Secondary interventions for renal artery restenosis (RAS) after renal artery stenting are common, despite limited data about their effectiveness. This study was designed to evaluate the outcomes of endovascular treatment of recurrent RAS. We conducted a retrospective review of patients who underwent renal artery stenting between 2001 and 2011 at Dartmouth-Hitchcock Medical Center. Patients who required secondary interventions were compared with control patients who underwent only primary interventions for RAS. Multivariate regression models were used to identify factors associated with successful outcomes, as measured by changes in blood pressure, estimated glomerular filtration rate, and number of antihypertensive medications required. Sixty-five secondary (57 patients) renal interventions were undertaken for recurrent RAS associated with progressive hypertension or renal dysfunction and compared with outcomes after 216 primary (180 patients) renal artery stenting procedures. Patients undergoing primary vs secondary interventions did not differ significantly in the number of preoperative antihypertensive medications used, comorbid conditions, or blood pressure. All primary and secondary interventions were performed with stents and showed no difference in procedural complications. At a mean follow-up of 23 months (range, 1-128 months), similar improvements in renal function and blood pressure were found between patients undergoing primary and secondary interventions, and there was no difference in rates of restenosis or survival between cohorts. Regression models showed that the use of embolic protection devices was associated with improved renal function after primary (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.1-3.8; P < .05) and secondary (OR, 4.7; 95% CI, 1.7-12.5; P < .05) interventions, whereas statin therapy was associated with improved renal (OR, 2.0; 95% CI, 1.3-3.2; P < .05) and blood pressure response (OR, 4.1; 95% CI, 1.1-14.9; P < .05) after secondary interventions. Patients undergoing secondary interventions for recurrent RAS have outcomes that are comparable with those for primary interventions. These data suggest that repeated endovascular procedures for RAS can be undertaken with similar expectations for clinical improvement and may be further improved by routine use of embolic protection devices and statin therapy.

Cerebral Protection in Elderly Patients during Carotid Stenting

The type of cerebral protection used during carotid stenting in the elderly is controversial. Our objective was to evaluate the results of proximal and distal cerebral embolic protection devices (EPDs), in patients > 70 years through diffusion-weighted magnetic resonance imaging (DW-MRI). Between 2008 and 2011, 60 patients with indication for carotid stenting were randomized to EPD with Mo.Ma® or Angioguard®, of which 26 patients were > 70 years of age. Results of DW-MRI performed before and 48 hours after the procedure were evaluated by an independent neurologist blinded to the type of EPD used. New ischemic lesions, their localization and size were analyzed. New cerebral ischemic lesions were found in 8/12 (66.7%) patients in the Mo.Ma® group and 12/14 (85.7%) patients in the Angioguard® group (P = 0.37). The vast majority of the lesions (> 90%) were ipsilateral to the treated artery in both groups and the size of the lesions was < 0.5 cm in most cases. The number of lesions per patient was lower with the Mo.Ma® device (median [variation]: 3 [1 to 8] lesions vs 15 [2 to 76] lesions; P < 0.001). All of the patients with more than 40 lesions were in the Angioguard® group. Despite the use of EPDs (proximal or distal), new ischemic lesions were observed in both groups in elderly patients. A proportionately larger number of patients with Angioguard® had new ischemic lesions when compared to those with Mo.Ma®. The Mo.Ma® device seems to decrease the number of lesions per patient. Proteção Cerebral em Pacientes Idosos durante Implante de Stent Carotídeo O tipo de proteção cerebral utilizado durante o implante de stent carotídeo é controverso em idosos. Nosso objetivo foi avaliar os resultados dos dispositivos de proteção embólica cerebral (PEC), proximal e distal, em pacientes > 70 anos de idade, por meio da ressonância magnética ponderada de difusão (RM-PD). Entre 2008 e 2011, 60 pacientes com indicação de stent carotídeo foram randomizados para PEC com Mo.Ma® ou Angioguard®, dos quais 26 tinham > 70 anos de idade. Os resultados da RMPD realizada antes e 48 horas após o procedimento foram avaliados por neurologista independente e cego para o tipo de PEC utilizado. Foram analisados o número de novos focos isquêmicos, sua localização e o tamanho. Novos focos isquêmicos cerebrais foram encontrados em 8/12 (66,7%) pacientes do grupo Mo.Ma® e em 12/14 (85,7%) pacientes do grupo Angioguard® (P = 0,37). A maioria das lesões (> 90%) era ipsilateral à artéria tratada em ambos os grupos, e o tamanho das lesões foi < 0,5 cm na maioria dos casos. O número de lesões por paciente foi menor com o dispositivo Mo.Ma® (mediana [variação]: 3 [1 a 8] lesões vs. 15 [2 a 76] lesões; P < 0,001). Todos os pacientes que tiveram mais de 40 lesões pertenciam ao grupo Angioguard®. Mesmo utilizando PEC (proximal ou distal), novas lesões isquêmicas foram observadas em ambos os grupos em pacientes idosos. Proporcionalmente maior número de pacientes com Angioguard® teve novos focos isquêmicos se comparados aos pacientes do grupo Mo.Ma®. O dispositivo de PEC Mo.Ma® parece diminuir o número de lesões por paciente.

In‐Hospital and 1‐year outcomes with drug‐eluting versus bare metal stents in saphenous vein graft intervention: A report from the EVENT registry

To compare outcomes of patients receiving drug-eluting stents (DES) versus bare metal stents (BMS) during percutaneous coronary intervention (PCI) of saphenous vein bypass grafts (SVG). Long-term benefits of DES versus BMS are well established for native vessel PCI. Benefit in patients undergoing SVG intervention is less certain. We used data from a multicenter registry (evaluation of drug eluting stents and ischemic events, EVENT) to compare outcomes among patients treated with DES versus BMS 1-year following SVG interventions. Between July 2004 and December 2007, 684 patients in EVENT underwent SVG PCI (515 DES only, 169 BMS only). The primary endpoint was a composite of death, myocardial infarction (MI), and target lesion revascularization between hospital discharge and 1-year follow-up. Propensity score stratification was used to adjust for differences between groups. Baseline demographic and clinical characteristics of patients treated with DES and BMS were similar. The DES group had fewer men and a higher prevalence of prior PCI. Patients receiving DES had less angiographic thrombus, less frequent use of embolic protection devices, greater total stent length, and smaller maximum stent diameters. Unadjusted outcomes between discharge and 1-year follow-up did not differ between the groups. After risk adjustment, the primary outcome was less frequent among patients treated with DES (adjusted HR = 0.48, 95% CI = 0.27-0.84, P < 0.01) with similar relative benefits across the individual endpoints. Among patients undergoing SVG PCI in a "real world" registry analyzed using propensity score stratification, treatment with DES compared with BMS was associated with reduced MACE at 1 year following PCI.

Advances in Stroke

Carotid artery stenting (CAS) has not been shown to be as safe as carotid endarterectomy for treatment of symptomatic extracranial carotid artery stenosis in the immediate postoperative period. However, beyond the postoperative period, data continues to support a role for CAS in selected patients. A large systematic review of 206 individual studies (54 713 total patients) undergoing CAS found the cumulative 30-day risk of stroke or death to be 7.6% in symptomatic and 3.3% in asymptomatic patients.1 Factors associated with increased risk of adverse outcomes in both groups were age 75 years (relative risk [RR] 1.88), hypertension (RR 1.86), and coronary artery disease (RR 1.41). Use of embolic protection devices significantly reduced the risk of stroke or death (RR 0.57). Although reports of adverse events vary widely in the literature, there has been a trend toward overall reduction in risk over the past several years, suggesting that use of embolic protection devices, careful patient selection, and increasing operator experience may be important factors in minimizing risk. The vast majority of these data (97%) are outside the standards of a randomized controlled trial (RCT), emphasizing the need for data from the trials that are currently enrolling patients. Among the larger studies currently enrolling patients are the Carotid Stenting for High Risk Surgical Patients (CHOICE, Abbott Vascular, target 5000 patients), Asymptomatic Carotid Surgery Trial-2 (ACST-2, target 5000 patients), and Stent-Protected Angioplasty in Asymptomatic Carotid Artery Stenosis versus Endarterectomy trial (SPACE-2, target 3640 patients). This year, we received our first update from the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the largest RCT to date comparing the periprocedural safety and long-term (4 years) efficacy of CAS versus carotid endarterectomy.2 Data from the lead-in phase demonstrated an overall 30-day stroke and death rate of 4.4%. Restenosis rates in the lead-in phase were reported to be 13% with 1.2% of patients requiring repeat revascularization by 1-year follow-up. These numbers compare to restenosis rates of 10.7% and 4.6% in patients undergoing CAS and carotid endarterectomy, respectively, in the SPACE trial3 and 19% of CAS patients in the Stenting and Angioplasty with Protection in Patients at High Risk of Endarterectomy (SAPPHIRE) study. 4 The Carotid Revascularization Using Endarterectomy

Strategies and Outcomes for Proximal and Distal Embolic Protection Devices – A Review

Both carotid endarterectomy (CEA) and carotid artery stenting (CAS) are associated with small, but clinically important and discrepant, rates of procedural complications, including cerebral and myocardial ischaemic events, cranial nerve injury and access site haematoma. Embolic protection devices (EPDs) may lower the rate of ipsilateral ischaemic events during CAS and are considered by the majority of interventionists to be mandatory during CAS, although there are no available data from randomised trials based on clinical outcomes to support this practice (perhaps because many thousands of patients would be required to adequately power a trial based on stroke and death endpoints). A recent systematic review of non-randomised data supports the use of EPDs. Worldwide experience demonstrates that all available protection strategies will capture macroemboli generated during endovascular manipulation of carotid bifurcation plaque, thus clearly implying an added level of protection for the brain when these systems are employed, but different philosophies of protection manage the microembolic burden of CAS (i.e. those particles less than 1 mm in diameter) in very different ways. These differences may be assessed by the evaluation of microembolic signals (MES) on transcranial Doppler (TCD) and of new hyperintensities (‘new white lesions’) on diffusion-weighted magnetic resonance imaging (DWMRI) of the brain. Differences between proximal and distal systems may assume clinical relevance, but further work is required before definitive conclusions can be drawn. This article focuses on the clinical and subclinical differences between protection strategies and provides a pragmatic treatment paradigm to support clinical decision-making.

Distal Protection Device-Induced Slow- or Stop-Flow Phenomenon During Carotid Stenting and the Use of Aspiration to Decrease Periprocedural Events

The phenomenon of slow flow (significant reduction in antegrade flow in the internal carotid artery [ICA]) or stop flow (cessation of antegrade flow in the ICA) during carotid artery stenting (CAS) caused by distal embolic protection devices (EPDs), specifically the Angioguard XP filter, was evaluated in the article by Sorimachi et al. (12) in this issue of WORLD NEUROSURGERY. Although this is not a well-discussed topic in the literature, it could have very important implications with respect to the acceptance of CAS because this acceptance depends on the equivalent effectiveness of CAS when compared to its operative counterpart, carotid endarterectomy, in preventing periprocedural stroke. CAS has been criticized for its higher periprocedural event rates when compared to carotid endarterectomy. These events mainly occur during stent placement and angioplasty, although they have been shown to occur up to 18 hours after the procedure (13). The use of a distal EPD can potentially reduce the incidence of intracranial embolization observed during CAS, decreasing periprocedural event rates. The literature includes multiple studies that show lower stroke rates with distal EPDs as well as studies that show no statistical difference when they are used, such as the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) trial (5). However, the most recent trial published, the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), which was a multicenter randomized North American trial that compared the efficacy of carotid endarterectomy with that of CAS, performed with the aid of an EPD in the prevention of stroke, myocardial infarction, and death in symptomatic and asymptomatic patients, showing a very low 30-day composite rate of stroke and death for symptomatic (6.1%) and asymptomatic (3.8%) CAS patients (3). Other studies have looked at the slow-flow phenomenon during CAS, such as Casserly et al. (4), who used multivariate logistic regression analysis to evaluate 71 CAS procedures. Their analysis showed that increased age, history of transient ischemic attack or stroke within 6 months of the procedure, and large stent diameter were predictive of slow flow during CAS. Slow flow was noted predominantly after balloon dilatation, although 25% of the cases occurred after stent deployment (4). The underlying etiology of slow flow is uncertain, but it is known that once the filter is retrieved, normal flow is restored. This isolates the filter as the problem and, thus, likely the occlusion of the pores of the filter as the reason for the slow-flow state. Histopathologic analysis of the filter debris has shown amorphous material derived from the core of atherosclerotic plaque (1). This correlates with the findings of slow flow being related to stent deployment and balloon angioplasty, as well as symptomatic lesions and increased stent diameter being independent predictors of slow-flow states. Casserly et al. (4) found that the 30-day incidence of stroke and/or death among patients with slow flow was 9.5%, compared to 2.9% in patients with normal flow. All the strokes occurred the same day as the procedure and were noted after retrieval of thefilter. These risk factors of slowflow have also been shown to be general risk factors of neurologic events associated with CAS. The CREST trial showed that patients older than age 79 years had higher 30-day stroke and death rates (11.9%) (8). Both the CREST (3) and the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

A novel approach to aortocoronary saphenous venous graft percutaneous treatment

Evaluation of: Abizaid A, Weiner B, Bailey SR, Londero H: Use of a self-expanding super-elastic all-metal endoprosthesis; to treat degenerated SVG lesions: the SESAME first in man trial. Catheterization and cardiovascular interventions. J. Soc. Cardiac Angiogr. Interv. 76(6), 781–786 (2010). Saphenous veins remain an important conduit in coronary artery bypass surgery. However, owing to accelerated atherosclerosis, approximately 50% of grafts are occluded by 10 years making the percutaneous treatment the preferable approach. Previously, the results of percutaneous treatment of saphenous vein grafts (SVGs) were affected by the high rates of periprocedural myocardial infarction and restenosis/occlusion. These unfavorable results were supplanted, in part, by the use of embolic protection devices (EPDs). However, less than 25% of SVG lesions have the anatomical criteria for the use of EPDs. Moreover, their use adds complexity to the procedure and requires training. This first-in-man study describes a novel na...

A Role for Embolic Protection in the Management of Acute Limb Ischemia

Distal embolization is a complication during lower-extremity revascularization procedures that may occur when intervening on acute or subacute lesions. Several studies have demonstrated the safety and feasibility of using embolic protection devices (EPD) and some interventionalists have adapted this technology for use in infrainguinal revascularization procedures. At present, there are no randomized trials to indicate the benefit, safety, and cost-effectiveness of EPD for this application and its use in the United States is considered off-label. However, based on our experience and a review of the published literature, we consider the use of EPD in acute lower-extremity ischemia a reasonable strategy.