Assessing the impact of distal protection filter design characteristics on 30-day outcomes of carotid artery stenting procedures.

OBJECTIVE: This study aims to review retrospectively the records of patients treated with carotid artery stenting (CAS) to investigate the potential correlations between clinical variables, distal protection filter (DPF) type and characteristics, and 30-day peri-/postprocedural outcomes. METHODS: This is a multicenter, single-arm, nonrandomized retrospective study of patients who underwent filter-protected CAS in the Pittsburgh, Pennsylvania, region between July 2000 and May 2011. Analysis of peri-/postprocedural complications included myocardial infarction, transient ischemic attacks (TIA), stroke, death, and a composition of all adverse events (AEs). Filter characteristics for Accunet (Abbott Vascular, Santa Clara, Calif; n = 429 [58.8%]), Angioguard (Cordis Endovascular, Miami Lakes, Fla; n = 114 [15.6%]), FilterWire (Boston Scientific, Natick, Mass; n = 113 [15.5%]), Spider (ev3 Endovascular, Plymouth, Minn; n = 45 [6.2%]), and Emboshield (Abbott Vascular; n = 24 [3.3%]) were previously determined in vitro and were used to find correlations with CAS procedural outcomes. Both univariate and multivariate analyses were performed, as well as goodness-of-fit tests to find multivariate correlations with procedural outcomes. RESULTS: In total, 731 CAS procedures using six different DPFs were analyzed. Peri-/postprocedural AEs included 19 TIAs (2.6%), 38 strokes (5.2%), one myocardial infarction (0.1%), 19 deaths (3.6%), and a total of 61 patients with complications (8.3%). Univariate analysis for filter design characteristics showed that the composite of AE was negatively associated with both vascular resistance (P = .01) and eccentricity (P = .02) and was positively associated with porosity (P = .0007), number of pores (P = .005), and pore density (P = .001). Multivariate analysis and the goodness-of-fit test revealed that patients with a history of congestive heart failure, stroke, and TIA (each with odds ratio >1) led to a good-fit model P value of .72 for peri-/postprocedural AEs. Multivariate analysis was inconclusive for all filter design characteristics. CONCLUSIONS: The following filter design characteristics are independently significant for minimizing peri-/postprocedural AEs: higher vascular resistance, concentric in shape, greater capture efficiency, lower porosity, lower number of pores, and lower pore density. Lower porosity and smaller wall apposition were also found to be independently significant for minimization of peri-/postprocedural TIAs. This information can be used when considering the desirable design characteristics of future DPFs.).

Successful recanalization of a left common iliac artery chronic total occlusion adjacent to an ectopic renal artery at the aortoiliac bifurcation.

Ectopic kidneys are rare and usually present incidental findings during invasive or non-invasive angiography. Their parenchyma is not more susceptible to disease and symptoms occur mainly due to alteration of the anatomic relations. The main renal artery of the ectopic kidney derives invariably from the aorta; however, accessory renal arteries may originate from almost any arterial branch adjacent to the ectopic kidney. Knowledge of the common anatomic variations is important during complex peripheral interventions. We present the case of a 46-year-old male with symptoms of claudication secondary to left common iliac artery occlusion. He was diagnosed as occlusion of the left common iliac artery at the aortoiliac bifurcation in close proximity to the ectopic renal artery by peripheral angiography, and percutaneous intervention of the left common iliac artery was successful. Percutaneous intervention led to resolution of the patient's symptoms of claudication as well as preservation of the ectopic renal artery. In such cases, renal ectopy and aberrant arteries should be promptly recognized in order to avoid vascular or renal complications.

A comparative analysis of bench-top performance assessment of distal protection filters in transient flow conditions.

PURPOSE: To compare the performance in vitro of 6 distal protection filters (DPFs) on the basis of filtration ability and effects on pressure gradient and vascular impedance in a flow model of the internal carotid artery (ICA). METHODS: Six DPFs (Accunet, Angioguard, FilterWire, Gore Embolic Filter, NAV6, and SpiderFX) were evaluated in a physiologically realistic flow loop. A blood analog was heated to body temperature and circulated by a pulsatile pump outputting a time-varying flow rate representative of the ICA. The ICA flow model was a highly curved tube representing a challenging site for filter deployment. The DPFs were deployed at the apex of the curved segment, and 2 sizes of microspheres (143 and 200 µm) were injected to simulate embolization. The capture efficiency, pressure gradient, normalized pressure gradient, and vascular impedance were calculated. RESULTS: The Gore filter had high capture efficiency (143 µm: 99.97%; 200 µm: 100.00%) with relatively small increases in pressure gradient (143 µm: +27%; 200 µm: +20%) and vascular impedance (143 µm: +23.4%; 200 µm: +6.1%) after particles were injected. Spider had the lowest capture efficiency (143 µm: 1.50%; 200 µm: 19.34%, p<0.0005), while NAV6 (143 µm: +916%, p<0.0005) and Accunet (200 µm: +179%, p<0.0005) yielded the largest pressure gradient increases. CONCLUSION: A bench-top flow apparatus exhibiting physiologically realistic conditions was developed by combining pulsatile flow and a body temperature blood analog. Using microspheres larger than the pore size of most of the DPFs, the device-wall apposition has an important effect on the overall filter performance and the global fluid dynamics in the flow model.

Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at increased surgical risk: results from the SAPPHIRE trial.

OBJECTIVES: To evaluate the cost-effectiveness of carotid stenting vs. carotid endarterectomy using data from the SAPPHIRE trial. BACKGROUND: Carotid stenting with embolic protection has been introduced as an alternative to carotid endarterectomy for prevention of cerebrovascular and cardiovascular events among patients at increased surgical risk. METHODS: Between August 2000 and July 2002, 310 patients with an accepted indication for carotid endarterectomy but at high risk of complications were randomized to and subsequently underwent either carotid stenting (n = 159) or endarterectomy (n = 151). Clinical outcomes, resource use, costs, and quality of life were assessed prospectively for all patients over a 1-year period. Life expectancy, quality-adjusted life expectancy, and health care costs beyond the follow-up period were estimated for patients alive at 1 year, based on observed clinical events during the first year of follow-up. RESULTS: Although initial procedural costs were significantly higher for stenting than for endarterectomy (mean difference: $4,081/patient; 95% CI, $3,849-$4,355), mean post-procedure length of stay was shorter for stenting (1.9 vs. 2.9 days; P < 0.001) with significant associated cost offsets. As a result, initial hospital costs were just $559/patient higher with stenting (95% CI, $3,470 less to $2,289 more). Neither follow-up costs after discharge nor total 1-year costs differed significantly. The incremental cost-effectiveness ratio for stenting compared with endarterectomy was $6,555 per quality-adjusted life year (QALY) gained, with over 98 percent of bootstrap estimates < $50,000/QALY gained. CONCLUSIONS: Although carotid stenting with embolic protection is more costly than carotid endarterectomy, by commonly accepted standards, stenting is an economically attractive alternative to endarterectomy for patients at high surgical risk.

In vitro performance assessment of distal protection filters: pulsatile flow conditions.

PURPOSE: To evaluate in vitro the capture efficiency of a distal protection filter (DPF) used during carotid artery stenting and examine the longitudinal vascular impedance in the presence of a DPF. METHODS: Four approved DPFs (Spider RX, FilterWire EZ, RX Accunet, and FiberNet) were evaluated in a physiologically realistic in vitro setup. A pulsatile programmable piston pump circulated a blood analog at a time-varying flow rate representative of the human common carotid artery. A silicone carotid bifurcation having average human dimensions was used for the carotid flow model. Microspheres ranging from 40 to 900 microm were injected to simulate embolization. The longitudinal vascular impedance was calculated as the ratio of the time-varying pressure gradient across the DPF to the time-varying flow rate in the internal carotid artery. RESULTS: RX Accunet had the highest capture efficiency (99.4%) and Spider RX the lowest (78.1%). Spider RX increased the longitudinal vascular impedance the least after deployment (+23%), while FilterWire EZ increased the longitudinal vascular impedance the least after particles were injected (+29%). FiberNet increased longitudinal vascular impedance the most (+84%). CONCLUSION: This investigation, unique for examining the effects of physiologically realistic pulsatile flow on DPF performance, can aid in the development of future generations of novel DPFs.

Endovascular Therapy for Acute Ischemic Stroke: A Comprehensive Review of Current Status.

Stroke remains among the leading causes of disability and death worldwide. Fibrinolytic therapy is associated with poor patency and functional outcomes. Recently, multiple randomized trials have been published that have consolidated the role of endovascular therapy for ischemic stroke due to large vessel occlusion in the anterior cerebral circulation. This manuscript reviews the current understanding of the endovascular management of acute stroke including technical aspects and current evidence base.

Vascular resistance in the carotid artery: an in vitro investigation of embolic protection filters.

PURPOSE: To assess in vitro performance of four embolic protection filters (EPFs) with a varying mass of injected particles. Evaluation is based on capture efficiency, pressure gradient, flow rate, and vascular resistance. MATERIALS AND METHODS: A bench-top flow apparatus was used for in vitro testing of four devices (Spider RX, FilterWire EZ, RX Accunet, and Emboshield). A silicone phantom with average human carotid artery dimensions and a 70% symmetric internal carotid artery (ICA) stenosis was used to model the carotid bifurcation. A blood-mimicking solution (glycerol/deionized water) was circulated at the time-averaged mean peak velocity for the common carotid artery. Five and 10 mg of 200- or 300-mum-diameter microspheres were injected into the ICA to evaluate the capture efficiency of the devices. The normalized pressure gradient, flow rate, and vascular resistance in the ICA were calculated from measured values of pressure and flow rate. RESULTS: The Spider RX captured the most particles (99.9% for 5 mg, 98.4% for 10 mg) and was associated with the slightest increase in pressure gradient (+8%, +15%) for both masses of microspheres injected. The Spider RX and FilterWire EZ were associated with the slightest decreases in flow rate (Spider RX, -1.9% and -12.1%; FilterWire EZ, -3.5% and -8.2%) and the slightest increases in vascular resistance (Spider RX, +10.1% and +33.0%; FilterWire EZ, +20.5% and +32.7%). The device-specific porosity was calculated, and the Spider RX was found to have the greatest at 50.4%; the Emboshield had the lowest at 2.2%. CONCLUSIONS: The Spider RX and FilterWire EZ had the best overall performances. Design features such as porosity and pore density are important parameters for improving the effectiveness of EPFs. Vascular resistance in the ICA is a flow-derived variable indicative of device performance and affected by the filter design features.

Treatment of asymptomatic carotid disease with stenting: pro.

The assumptions upon which the decisions to treat asymptomatic patients are founded on landmark studies, such as the Asymptomatic Carotid Atherosclerotic Study (ACAS), the Veterans Affairs Cooperative Study (VA), and the Asymptomatic Carotid Surgical Trial (ACST). In total, these trials randomized more than 5,000 patients to surgical vs. medical therapy. These trials were based on 60% stenosis and basically "no-risk" entry criteria. The carotid stent trials and registries, however, were based on 80% stenosis and all high-risk entry criteria. With a wide range of operator experience, and patient enrollment based on surgical risk criteria, Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events II (CAPTURE) II, Emboshield and Xact Post Approval Carotid Stent Trial (EXACT), and the Carotid Artery Revascularization Using the Boston Scientific EPI FilterWire EX/EZ and the EndoTex NexStent (CABERNET) trials were able to meet the American Heart Association guidelines of 3% procedural events in the asymptomatic subset. Carotid stenting is presently in the first and second generation of devices, and as the technology improves, procedural event rates should also improve. An understanding of the plaque composition and presence or absence of plaque vulnerability will separate those patients best suited for stenting versus endarterectomy. Asymptomatic patients cannot be grouped, but rather require individualization. Those patients with anatomical risks, preocclusive stenosis, and an incomplete Circle of Willis with a poorly collateralized hemisphere, are best managed with stenting versus endarterectomy or best medical management. Those patients, however, with

Protected carotid-artery stenting versus endarterectomy in high-risk patients.

BACKGROUND: Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease. METHODS: We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year--a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy. RESULTS: The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, -7.9 percentage points; 95 percent confidence interval, -16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). CONCLUSIONS: Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy.

First Clinical Experience With Targeted REnal Nerve Demodulation (TREND-1) Using a Neurotropic Agent for the Treatment of Sympathetic Hypertension.

AIMS: To evaluate the feasibility and safety of a novel targeted neuromodulatory treatment for sympathetic hypertension involving a one-time local injection of neurotropic agents near renal nerves. METHODS AND RESULTS: Seven patients suffering from uncontrolled hypertension per ESH-ESC guidelines were treated using a single dose of NW2013, a neurotropic Na+/K+ ATPase antagonist. A microneedle catheter was used to administer 1.2 mL of NW2013 (0.6 mL per artery) to the perivascular space surrounding renal arteries using percutaneous endovascular procedures under fluoroscopic guidance. All patients were successfully treated without any procedural complications. Patients were followed for 12 months post procedure, and office and 24-hour ambulatory blood pressure measurements were made. Both office and ambulatory blood pressures were lower at 24 hours, 1 month, and 3 months after treatment. The decrease in office blood pressure was greater than the decrease in ambulatory blood pressure. A reduction in medication regimen was also observed in 2 patients. One patient suffered a cerebrovascular event after 6-month follow-up and died from stroke, unrelated to the treatment. Overall, the reduction in office and ambulatory blood pressure was sustained over the course of 12 months. CONCLUSIONS: Treatment of hypertension using local administration of NW2013 near renal nerves appears to be feasible and safe. Large, controlled, randomized, and blinded clinical studies with monitoring of patient compliance to daily oral medication are recommended to further establish the efficacy of this novel treatment.

Usefulness of optical coherent reflectometry with guided radiofrequency energy to treat chronic total occlusions in peripheral arteries (the GRIP trial).

Optical coherent reflectometry, a forward-looking, fiberoptic-guided device was used in 72 patients to direct radiofrequency energy across the central intraluminal portion of 75 chronic total occlusions in peripheral arteries (iliac, femoral, and popliteal) that failed attempts with conventional guidewires. The system was successful in crossing 76% of the chronic total occlusions with no clinical perforations or distal embolizations, and complications consisted of a single dissection greater than or equal to grade C.

CaRESS: carotid revascularization using endarterectomy or stenting systems.

The primary objective of the CaRESS Phase I trial is to determine the sample size needed to reliably test the hypothesis that carotid stenting systems with distal embolic protection (CAS) is equivalent to carotid endarterectomy (CEA) in the treatment of symptomatic and asymptomatic carotid artery disease in a broad-risk population. A total of 397 patients were treated at 14 clinical centers. The primary endpoint results of combined all-cause mortality and stroke at 30-days and 1-year are presented. The CaRESS Phase I study was able to closely resemble clinical practice and results suggest equivalence between treatment groups.

Common Cervical and Cerebral Vascular Variants.

Successful open and endovascular carotid artery intervention depends on a thorough foundational knowledge of cervical and intracranial vascular anatomy. It is essential for the carotid interventionist to be familiar with the common and rare variants of the cervical and intracranial vasculature, and to understand the implications of these variants for the performance of carotid intervention with protection of the distal circulation. This article provides interventionists with a basic description of the normal and relevant variant vascular anatomy from the aortic arch to the circle of Willis, and outlines the potential difficulties that specific variants may present for endovascular therapy.

Carotid artery stenting update.

Stroke is the third leading cause of death and the most common cause of long-term disability in the USA. Approximately 25% of strokes are due to carotid artery disease. The mechanisms of stroke include thrombotic occlusion, thrombus embolism, atheroembolism and dissection or subintimal hematoma. Today, endarterectomy is the standard of care for management of significant carotid artery disease. The SAPPHIRE trial has proved the noninferiority of carotid artery stenting versus carotid endarterectomy in 'high-risk' patients, which led to the US FDA approval of carotid stent for high-risk patients. The CREST trial is the largest randomized trial comparing stenting versus endarterectomy and showed no significant difference in death, stroke or myocardial infarction. Over the last 15 years, the accumulation of experience, the improvement of stent platforms and embolic protection devices, and the strong demand from patients for a less invasive alternative to carotid endarterectomy has made carotid artery stenting an equally efficient and safe procedure for the prevention of stroke.

Optical coherence tomography imaging in asymptomatic patients with carotid artery stenosis.

Assessment and treatment plan for asymptomatic patients with carotid stenosis are based on angiography at the present time. However, angiography or other imaging modalities are limited with their resolution to detect high-risk plaque features. Intravascular optical coherence tomography (IVOCT) recently emerged as a novel imaging modality with a unique resolution to identify vulnerable plaque characteristics. We report use of IVOCT in two separate asymptomatic patients with carotid stenosis with two different plaque types.

Reproducibility of IVUS border detection for carotid atherosclerotic plaque assessment.

Plaque composition is a potentially important diagnostic feature for carotid artery stenting (CAS). The purpose of this investigation is to evaluate the reproducibility of manual border correction in intravascular ultrasound with virtual histology (VH IVUS) images. Three images each were obtained from 51 CAS datasets on which automatic border detection was corrected manually by two trained observers. Plaque was classified using the definitions from the CAPITAL (Carotid Artery Plaque Virtual Histology Evaluation) study, listed in order from least to most pathological: no plaque, pathological intimal thickening, fibroatheroma, fibrocalcific, calcified fibroatheroma, thin-cap fibroatheroma, and calcified thin-cap fibroatheroma. Inter-observer variability was quantified using both weighted and unweighted Kappa statistics. Bland-Altman analysis was used to compare the cross-sectional areas of the vessel and lumen. Agreement using necrotic core percentage as the criterion was evaluated using the unweighted Kappa statistic. Agreement between classifications of plaque type was evaluated using the weighted Kappa statistic. There was substantial agreement between the observers based on necrotic core percentage (κ=0.63), while the agreement was moderate (κ(quadratic)=0.60) based on plaque classification. Due to the time-consuming nature of manual border detection, an improved automatic border detection algorithm is necessary for using VH IVUS as a diagnostic tool for assessing the suitability of patients with carotid artery occlusive disease for CAS.

Stroke intervention: catheter-based therapy for acute ischemic stroke.

The majority (>80%) of the three-quarters of a million strokes that will occur in the United States this year are ischemic in nature. The treatment of acute ischemic stroke is very similar to acute myocardial infarction, which requires timely reperfusion therapy for optimal results. The majority of patients with acute ischemic stroke do not receive any form of reperfusion therapy, unlike patients with acute myocardial infarction. Improving outcomes for acute stroke will require patient education to encourage early presentation, an aggressive expansion of qualified hospitals, and willing providers and early imaging strategies to match patients with their best options for reperfusion therapy to minimize complications.