Interdisciplinary management of acute ischaemic stroke: Current evidence training requirements for endovascular stroke treatment. Position Paper from the ESC Council on Stroke and the European Association for Percutaneous Cardiovascular Interventions with the support of the European Board of Neurointervention.

This ESC Council on Stroke/EAPCI/EBNI position paper summarizes recommendations for training of cardiologists in endovascular treatment of acute ischaemic stroke. Interventional cardiologists adequately trained to perform endovascular stroke interventions could complement stroke teams to provide the 24/7 on call duty and thus to increase timely access of stroke patients to endovascular treatment. The training requirements for interventional cardiologists to perform endovascular therapy are described in details and should be based on two main principles: (i) patient safety cannot be compromised, (ii) proper training of interventional cardiologists should be under supervision of and guaranteed by a qualified neurointerventionist and within the setting of a stroke team. Interdisciplinary cooperation based on common standards and professional consensus is the key to the quality improvement in stroke treatment.

Expanding the stroke team to include interventional cardiology.

Team-based care has been emphasized as a strategy to improve and optimize outcomes for broad groups of patients who have presented with often complex medical conditions including large vessel cerebral occlusion. Although neurointerventionalists from different specialties perform mechanical embolectomy, which has become the standard of care for large vessel cerebral occlusion, these specialties are limited by relatively low numbers typically concentrated in a small number of sites. In this single center experience, approximately 50 patients with large vessel stroke were transferred out of an emergency room to other centers despite the availability of an experienced cardiologist with extensive carotid experience. Such transfer strategies typically result in delays in receiving reperfusion and, therefore, may decrease the success rates and substantial improvement that can be obtained by patients in this setting. Trained interventional cardiologists in centers with limited 24/7/365 coverage could achieve rapid revascularization and reperfusion saving lives. In order to accommodate the need for treating these patients, carotid stent trained cardiologists should enter the arena, learn mechanical embolectomy, and be supported by their colleagues from other disciplines on acute stroke care teams.

Factors influencing credentialing of interventionists in the CREST-2 trial.

BACKGROUND: The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a pair of randomized trials assessing the relative efficacy of carotid revascularization in the setting of intensive medical management (IMM) in patients with asymptomatic high-grade atherosclerotic stenosis. One of the trials assesses IMM with or without carotid artery stenting (CAS). Given the low risk of stroke in nonrevascularized patients receiving IMM, it is essential that there be low periprocedural risk of stroke for CAS if it is to show incremental benefit. Thus, credentialing of interventionists to ensure excellence is vital. This analysis describes the protocol-driven approach to credentialing of CAS interventionists for CREST-2 and its outcomes. METHODS: To be eligible to perform stenting in CREST-2, interventionists needed to be credentialed on the basis of a detailed Interventional Management Committee (IMC) review of data from their last 25 consecutive cases during the past 24 months along with self-reported lifetime experience case numbers. When necessary, additional prospective cases performed in a companion registry were requested after webinar training. Here we review the IMC experience from the first formal meeting on March 21, 2014 through October 14, 2017. RESULTS: The IMC had 102 meetings, and 8311 cases submitted by 334 interventionists were evaluated. Most were either cardiologists or vascular surgeons, although no single specialty made up the majority of applicants. The median total experience was 130 cases (interquartile range [IQR], 75-266; range, 25-2500). Only 9% (30/334) of interventionists were approved at initial review; approval increased to 46% (153/334) after submission of new cases with added training and re-review. The median self-reported lifetime case experience for those approved was 211.5 (IQR, 100-350), and the median number of cases submitted for review was 30 (IQR, 27-35). The number of CAS procedures performed per month (case rate) was the only factor associated with approval during the initial cycle of review (P < .00001). CONCLUSIONS: Identification of interventionists who were deemed sufficiently skilled for CREST-2 has required substantial oversight and a controlled system to judge current skill level that controls for specialty-based practice variability, procedural experience, and periprocedural outcomes. High-volume interventionists, particularly those with more recent experience, were more likely to be approved to participate in CREST-2. Primary approval was not affected by operator specialty.

Catheter-based interventions for acute ischaemic stroke.

Catheter-based interventions for acute ischaemic stroke currently include clot removal (usually from the medial cerebral artery) with modern stent-retrievers and in one of five patients (who have simultaneous or stand-alone internal carotid occlusion) also extracranial carotid intervention. Several recently published randomized trials clearly demonstrated superiority of catheter-based interventions (with or without bridging thrombolysis) over best medical therapy alone. The healthcare systems should adopt the new strategies for acute stroke treatment (including fast track to interventional lab) to offer the benefits to all suitable acute stroke patients.

Time From Symptoms to Carotid Endarterectomy or Stenting and Perioperative Risk.

BACKGROUND AND PURPOSE: Prior meta-analysis showed that carotid endarterectomy benefits decline with increasing surgical delay following symptoms. For symptomatic patients in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), we assessed if differences in time between symptoms and carotid endarterectomy or carotid artery stenting are associated with differences in risk of periprocedural stroke or death. METHODS: We analyzed the 1180 symptomatic patients in CREST who received their assigned procedure and had clearly defined timing of symptoms. Patients were classified into 3 groups based on time from symptoms to procedure: <15, 15 to 60, and >60 days. RESULTS: For carotid endarterectomy, risk of periprocedural stroke or death was not significantly different for the 2 later time periods relative to the earliest time period (hazard ratio, 0.74; 95% confidence interval, 0.22-2.49 for 15-60 days and hazard ratio, 0.91; 95% confidence interval, 0.25-3.33 for >60 days; P=0.89). For carotid artery stenting, risk of periprocedural stroke or death was also not significantly different for later time periods relative to the earliest time period (hazard ratio, 1.12; 95% confidence interval, 0.53-2.40 for 15-60 days and hazard ratio, 1.15; 95% confidence interval, 0.48-2.75 for >60 days; P=0.93). CONCLUSIONS: Time from symptoms to carotid endarterectomy or carotid artery stenting did not alter periprocedural safety, supporting early revascularization regardless of modality. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial.

BACKGROUND AND PURPOSE: Post-hoc, we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), increasing experience and improved patient selection with carotid stenting, and to a lesser extent, carotid endarterectomy would contribute to lower periprocedural event rates. METHODS: Three study periods with approximately the same number of patients were defined to span recruitment. Composite and individual rates of periprocedural stroke, myocardial infarction, and death rate were calculated separately by treatment assignment (carotid stenting/carotid endarterectomy). Temporal changes in unadjusted event rates, and rates after adjustment for temporal changes in patient characteristics, were assessed. RESULTS: For patients randomized to carotid stenting, there was no significant temporal change in the unadjusted composite rates that declined from 6.2% in the first period, to 4.9% in the second, and 4.6% in the third (P=0.28). Adjustment for patient characteristics attenuated the rates to 6.0%, 5.9%, and 5.6% (P=0.85). For carotid endarterectomy-randomized patients, both the composite and the combined stroke and death outcome decreased between periods 1 and 2 and then increased in period 3. CONCLUSIONS: The hypothesized temporal reduction of stroke+death events for carotid stenting-treated patients was not observed. Further adjustment for changes in patient characteristics between periods, including the addition of asymptomatic patients and a >50% decrease in proportion of octogenarians enrolled, resulted in practically identical rates. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.

OBJECTIVE: This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS). METHODS: A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30 days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranial nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee. RESULTS: Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit. CONCLUSIONS: The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.

Endovascular management of adjacent tandem intracranial aneurysms: utilization of stent-assisted coiling and flow diversion.

BACKGROUND: Tandem intracranial aneurysms are aneurysms located along a single intracranial vessel. Adjacent tandem aneurysms arise within the same vascular segment and their presence often suggests diffuse parent vessel anomaly. Endovascular management of these rare lesions has not been well studied. In this retrospective observational study, we describe our experience treating adjacent tandem intracranial aneurysms with endovascular embolization. METHODS: We retrospectively reviewed records of patients with these lesions who underwent endovascular treatment between 2008 and 2013. RESULTS: Thirteen patients (mean age 60.8 years; 12 women) with 28 adjacent tandem aneurysms were treated during the study timeframe. Aneurysms were located along the clinoidal, ophthalmic, and communicating segments of the internal carotid artery in 12 patients and at the basilar apex in one patient. Average size was 8.4 mm. Six patients (12 aneurysms) were treated by flow diversion via the Pipeline embolization device (PED) and seven (16 aneurysms) by stent-assisted coiling, with coils successfully placed in 11 aneurysms. Clinical follow-up was available for an average of 26.1 months; postprocedural angiography was performed for 12 patients. Complete occlusion was achieved in nine of ten (90 %) PED-treated aneurysms and eight of 11 (72.7 %) treated by stent-assisted coiling (p = 0.44). Two patients treated by stent-assisted coiling required re-coiling for aneurysm recanalization. Overall, modified Rankin scale scores were 0-1 for 12 patients and 3 for one patient. CONCLUSIONS: Adjacent tandem intracranial aneurysms can be safely and effectively treated by either stent-assisted coiling or flow diversion. We prefer PED flow diversion due to better parent vessel reconstruction and lower recanalization risk.

Carotid artery stenting and patient outcomes: the CABANA surveillance study.

OBJECTIVES: The purpose of the prospective, multicenter, nonrandomized CABANA study was to evaluate periprocedural clinical outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System by a diverse group of clinicians. BACKGROUND: There is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels. METHODS: The study enrolled symptomatic (≥50% carotid artery stenosis) and asymptomatic (≥80% carotid stenosis) patients at high risk for carotid endarterectomy. Study centers were grouped into three tiers based on previous CAS experience while individual operators were grouped by their CAS training. The primary endpoint was the 30-day composite of major adverse events [MAEs; including stroke, death, and myocardial infarction (MI)]. Individual event rates were evaluated across the overall study, and by center experience and physician training tier. RESULTS: Of 1,097 enrolled patients, 1,025 were evaluable for 30-day MAE rate. The stroke rate (3.3%) was a major contributing factor in the overall MAE rate (4.6%). Mortality was 1.3% and the MI rate was 0.5%. There was no statistically significant association between MAE rates among the center experience tiers (P = 0.61) nor among the operator training categories (P = 0.26). CONCLUSIONS: CAS with the Carotid WALLSTENT and FilterWire EZ yielded a low 30-day MAE rate that did not differ significantly across operator experience and training levels. Clinicaltrials.gov identifier: NCT00741091.

Endovascular treatment of acute ischemic stroke: the end or just the beginning?

Various endovascular intraarterial approaches are available for treating patients with acute ischemic stroke who present with severe neurological deficits. Three recent randomized trials-Interventional Management of Stroke (IMS) III, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE), and Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke (SYNTHESIS Expansion)-evaluated the efficacy of endovascular treatment of acute ischemic stroke and, after failing to demonstrate any significant clinical benefit of endovascular therapies, raised concerns and questions in the medical community regarding the future of endovascular treatment for acute ischemic stroke. In this paper, the authors review the evolution of endovascular treatment strategies for the treatment of acute stroke and provide their interpretation of findings and potential limitations of the three recently published randomized trials. The authors discuss the advantage of stent-retriever technology over earlier endovascular approaches and review the current status and future directions of endovascular acute stroke studies based on lessons learned from previous trials.

Stenting versus endarterectomy for treatment of carotid-artery stenosis.

BACKGROUND: Carotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke. METHODS: We randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization. RESULTS: For 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P=0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P=0.84) or sex (P=0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P=0.18), for stroke (4.1% vs. 2.3%, P=0.01), and for myocardial infarction (1.1% vs. 2.3%, P=0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P=0.85). CONCLUSIONS: Among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)

Comparison of intravascular ultrasound with conventional venography for detection of extracranial venous abnormalities indicative of chronic cerebrospinal venous insufficiency.

PURPOSE: To investigate prevalence of extracranial abnormalities in azygos and internal jugular (IJ) veins using conventional venography and intravascular ultrasound (IVUS) in patients with multiple sclerosis (MS) being evaluated for chronic cerebrospinal venous insufficiency, a condition of vascular hemodynamic dysfunction. MATERIALS AND METHODS: PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis) is a venous angioplasty study that enrolled 30 patients with relapsing MS. The patients fulfilled two or more venous hemodynamic extracranial Doppler sonography screening criteria. Phase I of the study included 10 patients and was planned to assess safety and standardize venography, IVUS, and angioplasty and blinding procedures; phase II enrolled 20 patients and further validated diagnostic assessments using the two invasive techniques. Venography was considered abnormal when ≥ 50% lumen-diameter restriction was detected. IVUS was considered abnormal when ≥ 50% lumen-diameter restriction, intraluminal defects, or reduced pulsatility was detected. RESULTS: No venography-related or IVUS-related complications, including vessel rupture, thrombosis, or side effects of contrast media were recorded among the 30 study patients. IVUS-detected venous abnormalities, including chronic, organized, thrombus-like inclusions were observed in 85% of azygos, 50% of right IJ, and 83.3% of left IJ veins, whereas venography demonstrated stenosis of ≥ 50% in 50% of azygos, 55% of right IJ, and 72% of left IJ veins. Sensitivity of venography for detecting IVUS abnormalities was 52.9%, 73.3%, and 80% for the azygos, left IJ, and right IJ veins, respectively. CONCLUSIONS: IVUS assessment of azygos and IJ veins showed a higher rate of venous abnormalities than venography. IVUS provides a diagnostic advantage over conventional venography in detecting extracranial venous abnormalities indicative of chronic cerebrospinal venous insufficiency.

Multimodal noninvasive and invasive imaging of extracranial venous abnormalities indicative of CCSVI: results of the PREMiSe pilot study.

BACKGROUND: There is no established noninvasive or invasive diagnostic imaging modality at present that can serve as a 'gold standard' or "benchmark" for the detection of the venous anomalies, indicative of chronic cerebrospinal venous insufficiency (CCSVI). We investigated the sensitivity and specificity of 2 invasive vs. 2 noninvasive imaging techniques for the detection of extracranial venous anomalies in the internal jugular veins (IJVs) and azygos vein/vertebral veins (VVs) in patients with multiple sclerosis (MS). METHODS: The data for this multimodal imaging comparison pilot study was collected in phase 2 of the "Prospective Randomized Endovascular therapy in Multiple Sclerosis" (PREMiSe) study using standardized imaging techniques. Thirty MS subjects were screened initially with Doppler sonography (DS), out of which 10 did not fulfill noninvasive screening procedure requirements on DS that consisted of ≥2 venous hemodynamic extracranial criteria. Accordingly, 20 MS patients with relapsing MS were enrolled into the multimodal diagnostic imaging study. For magnetic resonance venography (MRV), IJVs abnormal findings were considered absent or pinpoint flow, whereas abnormal VVs flow was classified as absent. Abnormalities of the VVs were determined only using non-invasive testing. Catheter venography (CV) was considered abnormal when ≥50% lumen restriction was detected, while intravascular ultrasound (IVUS) was considered abnormal when ≥50% restriction of the lumen or intra-luminal defects or reduced pulsatility was found. Non-invasive and invasive imaging modality comparisons between left, right and total IJVs and between the VVs and azygos vein were performed. Because there is no reliable way of non-invasively assessing the azygos vein, the VVs abnormalities detected by the non-invasive testing were compared to the azygos abnormalities detected by the invasive testing. All image modalities were analyzed in a blinded manner by more than one viewer, upon which consensus was reached. The sensitivity and specificity were calculated using contingency tables denoting the presence or absence of vein-specific abnormality findings between all imaging modalities used individually as the benchmark. RESULTS: The sensitivity of CV + IVUS was 68.4% for the right and 90% for the left IJV and 85.7% for the azygos vein/VVs, compared to venous anomalies detected on DS. Compared to the venous anomalies detected on MRV, the sensitivity of CV + IVUS was 71.4% in right and 100% in left IJVs and 100% in the azygos vein/VVs; however, the specificity was 38.5%, 38.9% and 11.8%, respectively. The sensitivity between the two invasive imaging techniques, used as benchmarks, ranged from 72.7% for the right IJV to 90% for the azygos vein but the IVUS showed a higher rate of venous anomalies than the CV. There was excellent correspondence between identifying collateral veins on MRV and CV. CONCLUSIONS: Noninvasive DS screening for the detection of venous anomalies indicative of CCSVI may be a reliable approach for identifying patients eligible for further multimodal invasive imaging testing of the IJVs. However, the noninvasive screening methods were inadequate to depict the total amount of azygos vein/VVs anomalies identified with invasive testing. This pilot study, with limited sample size, shows that both a non-invasive and invasive multimodal imaging diagnostic approach should be recommended to depict a range of extracranial venous anomalies indicative of CCSVI. However, lack of invasive testing on the study subjects whose results were negative on the DS screening and of healthy controls, limits further generalizibility of our findings. In addition, the findings from the 2 invasive techniques confirmed the existence of severe extracranial venous anomalies that significantly impaired normal blood outflow from the brain in this group of MS patients.

Results of endovascular treatment of middle cerebral artery aneurysms after first giving consideration to clipping.

BACKGROUND: Middle cerebral artery (MCA) aneurysms are among the more challenging aneurysms for endovascular treatment. We report a contemporary 5-year experience with endovascular therapy for MCA aneurysms at a high-volume neurovascular center. METHODS: Review of prospectively maintained intracranial aneurysm database. RESULTS: Between 2005 and 2009, 148 patients underwent treatment of 149 MCA aneurysms at our hospital, of which 33 patients with 34 aneurysms underwent endovascular therapy. Among these 33 patients, 14 presented with subarachnoid hemorrhage. Eleven patients were treated with stent-assisted coiling, 1 with balloon-assisted coiling, and the remainder with coiling alone. Three patients required repeat endovascular treatment. There were 7 periprocedural complications, including intraprocedural aneurysm rupture resulting in death in 2 patients. Two patients died at later dates from remote aneurysm rehemorrhage. Average follow-up of remaining patients was 17.1 months radiographically, and 20.3 months clinically. Average modified Rankin scale (mRS) score at last follow up was 2.09, with 17 patients with mRS 0/1 and 5 patients with mRS 2. Fifteen patients showed evidence of radiographic residual at last follow up: 13 were simple neck residuals. Unruptured status and saccular aneurysms were associated with mRS 0/1 outcome (each p < 0.05). CONCLUSIONS: At our hospital, MCA aneurysms are being treated with endovascular techniques, but in a minority of patients. Despite the rate of residual neck remnants, few retreatments were necessary and few rehemorrhages occurred. The periprocedural complication rate was not insignificant; therefore, in more recent years and at present, most MCA aneurysms are considered for clipping first at our center.

Cerebral emboli detection and autonomous neuromonitoring using robotic transcranial Doppler with artificial intelligence for transcatheter aortic valve replacement with and without embolic protection devices: a pilot study.

BACKGROUND: Periprocedural ischemic stroke remains a serious complication in patients undergoing transcatheter aortic valve replacement (TAVR). We used a novel robotic transcranial Doppler (TCD) system equipped with artificial intelligence (AI) for real-time continuous intraoperative neuromonitoring during TAVR to establish the safety and potential validity of this tool in detecting cerebral emboli, report the quantity and distribution of high intensity transient signals (HITS) with and without cerebral protection, and correlate HITS occurrence with various procedural steps. METHODS: Consecutive patients undergoing TAVR procedures during which the robotic system was used between October 2021 and May 2022 were prospectively enrolled in this pilot study. The robotic TCD system included autonomous adjustment of the TCD probes and AI-assisted post-processing of HITS and other cerebral flow parameters. Basic demographics and procedural details were recorded. Continuous variables were analyzed by a two-sample Mann-Whitney t-test and categorical variables by a χ2 or Fisher test. RESULTS: Thirty-one patients were prospectively enrolled (mean age 79.9±7.6 years; 16 men (51.6%)). Mean aortic valve stenotic area was 0.7 cm2 and mean aortic-ventricular gradient was 43 mmHg (IQR 31.5-50 mmHg). Cerebral protection was used in 16 cases (51.6%). Significantly fewer emboli were observed in the protection group than in the non-protection group (mean 470.38 vs 693.33; p=0.01). Emboli counts during valve positioning and implantation were significantly different in the protection and non-protection groups (mean 249.92 and 387.5, respectively; p=0.01). One (4%) transient ischemic attack occurred post-procedurally in the non-protection group. CONCLUSION: We describe a novel real-time intraoperative neuromonitoring tool used in patients undergoing TAVR. Significantly fewer HITS were detected with protection. Valve positioning-implantation was the most significant stage for intraprocedural HITS.

Intravenous thrombolysis and endovascular therapy for acute ischemic stroke with internal carotid artery occlusion: a systematic review of clinical outcomes.

BACKGROUND AND PURPOSE: Strokes secondary to acute internal carotid artery (ICA) occlusion are associated with extremely poor prognosis. The best treatment approach to acute stroke in this setting is unknown. We sought to determine clinical outcomes in patients with acute ischemic stroke attributable to ICA occlusion treated with intravenous (IV) systemic thrombolysis or intra-arterial endovascular therapy. METHODS: Using the PubMed database, we searched for studies that included patients with acute ischemic stroke attributable to ICA occlusion who received treatment with IV thrombolysis or intra-arterial endovascular interventions. Studies providing data on functional outcomes beyond 30 days and mortality and symptomatic intracerebral hemorrhage (sICH) rates were included in our analysis. We compared the proportions of patients with favorable functional outcomes, sICH, and mortality rates in the 2 treatment groups by calculating χ(2) and confidence intervals for odds ratios. RESULTS: We identified 28 studies with 385 patients in the IV thrombolysis group and 584 in the endovascular group. Rates of favorable outcomes and sICH were significantly higher in the endovascular group than the IV thrombolysis-only group (33.6% vs 24.9%, P=0.004 and 11.1% vs 4.9%, P=0.001, respectively). No significant difference in mortality rate was found between the groups (27.3% in the IV thrombolysis group vs 32.0% in the endovascular group; P=0.12). CONCLUSIONS: According to our systematic review, endovascular treatment of acute ICA occlusion results in improved clinical outcomes. A higher rate of sICH after endovascular treatment does not result in increased overall mortality rate.

Carotid artery revascularization with distal protection in high-surgical-risk patients in routine clinical practice: rationale and design of the CABANA safety surveillance program.

BACKGROUND: Continuous improvement in carotid artery stenting (CAS) outcomes, especially for periprocedural death and stroke in high-surgical-risk patients, have been seen in recent randomized trials of CAS versus carotid endarterectomy and CAS registries. However, these studies use stringent inclusion/exclusion criteria for patient, institution, and physician selection. The Carotid Stenting Boston Scientific Surveillance Program (CABANA) study was initiated to evaluate periprocedural outcomes with modern versions of the Carotid Wallstent and FilterWire EZ System for operators with a wide range of clinical specialties, CAS experience and training levels, in patients with a broad range of high-surgical-risk conditions and lesion types. METHODS: This prospective, single-arm study enrolled 1,097 subjects with 1,098 carotid artery lesions at 99 study centers. Investigators were grouped into one of three tiers according to whether they had a high, medium, or low level of previous CAS experience and were also categorized by their CAS-credential-based training requirements for the CABANA study. Follow-up at 30 days includes clinical evaluation and independent neurological and NIH stroke scale assessments. The primary endpoint rate of 30-day composite stroke, death, and MI, as well as the rates of these individual events, will be evaluated across the overall study, by physician experience tier, and by physician training tier. DISCUSSION: The evaluation of periprocedural CAS safety in a real-world environment with modern devices in high-surgical-risk patients treated by physicians with a broad range of training and experience will better inform treatment decisions in the future.

A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.

BACKGROUND: The clinical risk predictors for adverse events in carotid stenting using distal embolic protection devices are well established and include patient age and symptomatic status. The risk predictors for adverse events with proximal occlusion devices are not as well established. This study is a meta-analysis of available data on proximal occlusion devices to determine the risk predictors of adverse events in carotid stenting. METHODS: Study-specific results on 2,397 patients from six independent databases of two different proximal occlusion devices were meta-analyzed by an independent statistical analysis organization for predictors of 30-day major adverse clinical events including stroke, myocardial infarction, and death using random effects models. The primary endpoint was the composite of total stroke, myocardial infarction, and death at 30 days. RESULTS: The incidence of stroke was 1.71%. The incidence of myocardial infarction was 0.02%. The incidence of death was 0.40%. The composite primary endpoint at 30 days was 2.25%. Age and diabetic status were found to be the only significant independent risk predictors; however, total stroke rates remained below 2.6% in all subgroups, including symptomatic octogenarians. The other baseline demographic variables including patient gender, symptomatic status, and contralateral carotid occlusion were not found to be independent risk predictors. CONCLUSIONS: A meta-analysis of CAS procedures performed with proximal occlusion devices demonstrated a very low incidence of adverse events at 30 days. The only independent risk predictors were age and diabetes. Patient gender, symptomatic status, and other baseline characteristics were not found to be risk predictors for CAS using proximal occlusion devices.