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.

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.

Endovascular prevention and treatment of stroke related to extracranial carotid artery disease.

Acute ischemic stroke (AIS) is the leading cause of premature mortality and morbidity worldwide for both men and women. Extracranial carotid artery stenosis/occlusion is responsible for approximately 11.5% of ischemic strokes, whereas extracranial large vessel disease comprises roughly 16.6% of ischemic strokes. Carotid artery disease has been the source of significant debate among neurovascular and cardiovascular specialists, as well as vascular surgeons, as to the best method of revascularization, surgical reconstruction versus endovascular recanalization. There are different treatment modalities and techniques related to AIS and extracranial carotid artery disease based on the different etiologies, and these include acute internal carotid artery occlusion (thrombectomy versus carotid stenting/angioplasty), tandem occlusions (stenting and thrombectomy), and non-emergent carotid stenting/angioplasty for chronic internal carotid artery stenosis. The continuing development of new endovascular technology has led to a major shift in treatment to a minimally invasive endovascular approach. Distal filter devices, proximal protection devices, balloon-guided catheters, open- or closed-cell stents, and flow-reversal stenting are some of the technologies that are now available. The latest treatment techniques, indications, and studies are discussed in this review.

Acute stroke endovascular treatment: tips and tricks.

Acute ischemic stroke is a leading cause of death and disability in the United States, responsible for 1 of every 20 deaths. The efficacy of intravenous tissue plasminogen activator (tPA) alone for recanalization of large-vessel occlusion (LVO) is low. Several randomized trials have now established endovascular treatment of LVO as a standard of care. Endovascular techniques continue to evolve at a rapid pace. This review seeks to report recent advances in endovascular technology, discuss the correlation between speed of reperfusion and patient outcomes, and present mobile stroke care, shortcoming of the recent technology (such as clot fragmentation), and potential solutions to overcome these drawbacks, as well as anesthetic considerations and cost-effectiveness.

Submaximal angioplasty for symptomatic intracranial atherosclerosis: a prospective Phase I study.

OBJECTIVE Intracranial atherosclerotic disease (ICAD) accounts for approximately 10% of ischemic strokes. The recent Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study demonstrated a high incidence of perioperative complications (15%) for treatment of ICAD with stenting. Although the incidence of stroke was lower in the medical arm, recurrent stroke was found in 12% of patients despite aggressive medical management, suggesting that intervention may remain a viable option for ICAD if perioperative risk is minimized. Angioplasty without stenting represents an alternative and understudied revascularization treatment for ICAD. Submaximal angioplasty limits the risks of thromboembolism, vessel perforation, and reperfusion hemorrhage that were frequently reported with stenting in the SAMMPRIS trial. The authors conducted a prospective Phase I trial designed to assess the safety of submaximal angioplasty in patients with symptomatic ICAD. METHODS This study was approved by the local institutional review board. Demographic and clinical data were prospectively collected. Angioplasty was performed with a balloon undersized to approximately 50%-70% of the nondiseased vessel diameter in patients with symptomatic ICAD who had angiographically significant stenosis of ≥ 70%. The primary outcome measure was the incidence of periprocedural complications (combined rate of death, stroke, and hemorrhage occurring within 30 days and at 1 year). RESULTS Among the 65 patients with symptomatic ICAD who were screened, 24 had significant angiographic stenosis that met the inclusion criteria of this study. The mean age was 64.08 years (median 65 years; SD ± 11.24 years), most were men (62.5%), and most were white (66.67%). Many patients had concomitants of vascular disease, including hypertension (95.8%), hyperlipidemia (70.83%), smoking history (54.1%), and diabetes mellitus (50.0%). Coronary artery disease (41.66%) and previous stroke or transient ischemic attack (45.83%) were frequently present. Most patients (75%) had anterior circulation stenosis. The mean preprocedure stenosis was 80.16% (median 80%, range 70%-95%). Submaximal angioplasty was performed in patients who met the inclusion criteria, with a mean postangioplasty stenosis rate of 54.62% (median 55.5%, range 31%-78%). Rates of ischemic stroke in the territory of the treated artery were 0% within 30 days and 5.55% (in the only patient who presented with recurrent stroke) at 1 year. The mortality and hemorrhage rates in this series were 0%. CONCLUSIONS This study demonstrates the safety of the submaximal angioplasty technique, with no permanent periprocedural complications in 24 treated patients.

Experience with vertebral artery origin stenting and ostium dilatation: results of treatment and clinical outcomes.

BACKGROUND: The vertebral artery (VA) ostium (VAO) is a common stenosis site. Most patients with VAO stenosis refractory to medical treatment are treated endovascularly using stenting. To optimally cover the ostial plaque, which frequently extends into the adjacent subclavian artery, part of the stent must overhang in the subclavian artery. This configuration makes subsequent VA access very challenging in cases of in-stent or distal vertebrobasilar pathology; it also obstructs the distal subclavian artery. OBJECTIVE: To determine whether angioplasty at the ostium with a dual balloon (Flash Ostial) specially designed to allow the subclavian end of the stent to flare might circumvent these problems and, most importantly, provide optimal plaque coverage around the vertebral ostium. METHODS: Between June 2012 and July 2014, 11 patients with symptomatic VAO stenosis refractory to best medical therapy were treated with stenting and dual balloon Flash angioplasty. Demographics, results, and outcomes were reviewed. RESULTS: A total of 12 VAO stenting-dual balloon angioplasty procedures were performed (mean stenosis, 83.6%; range, 78-90%). Nine patients had mild-to-moderate (40-60%) contralateral VAO stenosis. The initial average modified Rankin Scale (mRS) score was 1.25. In all cases, immediate postangioplasty angiography showed excellent stent apposition against the VA and around the ostium in the subclavian artery. No permanent perioperative complications or deaths occurred. At a mean follow-up of 10.8 months (range 2-24), all patients had symptom resolution and no evidence of symptomatic restenosis on neuroimaging/Doppler studies; the average mRS score was 0.66. Three patients continued to have previously diagnosed mid-cervical VA stenosis; one of them had postprocedure dissection and an asymptomatic in-stent stenosis at 8 months. CONCLUSIONS: Safety and feasibility were demonstrated using the Ostial Flash system for VAO stenting and angioplasty. No permanent perioperative complications were seen.

The fate of cranial neuropathy after flow diversion for carotid aneurysms.

OBJECTIVE: The authors sought to determine whether flow diversion with the Pipeline Embolization Device (PED) can approximate microsurgical decompression in restoring function after cranial neuropathy following carotid artery aneurysms. METHODS: This multiinstitutional retrospective study involved 45 patients treated with PED across the United States. All patients included presented between November 2009 and October 2013 with cranial neuropathy (cranial nerves [CNs] II, III, IV, and VI) due to intracranial aneurysm. Outcome analysis included clinical and procedural variables at the time of treatment as well as at the latest clinical and radiographic follow-up. RESULTS: Twenty-six aneurysms (57.8%) were located in the cavernous segment, while 6 (13.3%) were in the clinoid segment, and 13 (28.9%) were in the ophthalmic segment of the internal carotid artery. The average aneurysm size was 18.6 mm (range 4-35 mm), and the average number of flow diverters placed per patient was 1.2. Thirty-eight patients had available information regarding duration of cranial neuropathy prior to treatment. Eleven patients (28.9%) were treated within 1 month of symptom onset, while 27 (71.1%) were treated after 1 month of symptoms. The overall rate of cranial neuropathy improvement for all patients was 66.7%. The CN deficits resolved in 19 patients (42.2%), improved in 11 (24.4%), were unchanged in 14 (31.1%), and worsened in 1 (2.2%). Overtime, the rate of cranial neuropathy improvement was 33.3% (15/45), 68.8% (22/32), and 81.0% (17/21) at less than 6, 6, and 12 months, respectively. At last follow-up, 60% of patients in the isolated CN II group had improvement, while in the CN III, IV, or VI group, 85.7% had improved. Moreover, 100% (11/11) of patients experienced improvement if they were treated within 1 month of symptom onset, whereas 44.4% (12/27) experienced improvement if they treated after 1 month of symptom onset; 70.4% (19/27) of those with partial deficits improved compared with 30% (3/10) of those with complete deficits. CONCLUSIONS: Cranial neuropathy caused by cerebral aneurysm responds similarly when the aneurysm is treated with the PED compared with open surgery and coil embolization. Lower morbidity and higher occlusion rates obtained with the PED may suggest it as treatment of choice for some of these lesions. Time to treatment is an important consideration regardless of treatment modality.

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.

Thrombus density predicts successful recanalization with Solitaire stent retriever thrombectomy in acute ischemic stroke.

BACKGROUND: Thrombus characteristics, including Hounsfield unit (HU) value to measure density and thrombus volume and length, can predict successful recanalization following IV thrombolysis with recombinant tissue plasminogen activator. Conflicting and limited data exist regarding the value of assessing thrombus properties in acute stroke cases treated with endovascular IA approaches. METHODS: We retrospectively reviewed cases of anterior circulation acute ischemic stroke in which a Solitaire stent retriever (ev3-Covidien) was the primary treatment device. We measured the following thrombus characteristics: absolute and corrected HU values; thrombus length and volume; clot burden score; and vessel bifurcation involvement. Fisher's exact test and the t test were used to study the association between these clot characteristics and successful recanalization (Thrombolysis in Cerebral Infarction (TICI) score 2b-3). RESULTS: We identified 41 patients with anterior circulation stroke treated with the Solitaire stent retriever as the primary treatment device. Successful recanalization (TICI score 2b-3) was achieved in 59% of cases. Higher absolute and corrected HU values were strongly predictive of successful recanalization (49.9±7.6 vs 43.8±6.6, p=0.01 for absolute HU values and 1.2±0.2 vs 1.0±0.1, p=0.03 for HU ratio in TICI 2b-3 and TICI 0-2a groups, respectively). There was no significant difference between recanalization and non-recanalization groups in the other thrombus characteristics studied. CONCLUSIONS: In acute stroke treated with Solitaire stent retriever thrombectomy, higher thrombus HU values are predictive of successful recanalization. Such information can be used in decision making when estimating recanalization success rate with different endovascular treatment approaches.

Carotid artery stenting in nonagenarians: are there benefits in surgically treating this high risk population?

BACKGROUND: Carotid angioplasty and stenting (CAS) is considered desirable treatment for patients at high risk for carotid endarterectomy. Despite a growing elderly population, scant data exist on CAS in nonagenarians. Nonagenarians represent a high risk population for open and endovascular interventions due to unique anatomic and physiologic characteristics presenting significant challenges to anesthesiologists and surgeons. Studies have quantified that symptomatic and asymptomatic patients should survive 2 and 5 years, respectively, to gain benefit from revascularization; thus doubt exists on the value of CAS in nonagenarian patients because of their extreme age and unique risk factors. We therefore evaluated CAS safety and efficacy in our hospital's nonagenarian population. METHODS: CAS cases performed in patients aged ≥ 90 years between April 2005 and January 2013 were retrospectively examined. Relevant demographic and medical data were reviewed. Rates of perioperative complications and complications until end of follow-up (including stroke, myocardial infarction, death) were compiled. RESULTS: Among 21 nonagenarian cases of stent placement performed in 20 patients (11 symptomatic, nine asymptomatic), two patients suffered perioperative stroke after undergoing CAS and one died during the perioperative period. 50% of symptomatic patients were alive at 19 months; 50% of asymptomatic patients were alive at 47 months. CONCLUSIONS: CAS in nonagenarian patients carried increased risk of perioperative ischemic events, compared with contemporary trial results in symptomatic and asymptomatic patients. Further, mean survival time postprocedure fell short of guidelines for receiving procedural benefit. Although larger scale multicenter research is needed, we recommend careful consideration of overall health status when contemplating stenting in nonagenarians.

Direct carotid artery puncture access for endovascular treatment of acute ischemic stroke: technical aspects, advantages, and limitations.

BACKGROUND: Challenging anatomy for carotid artery access can result in a delay to achieve successful recanalization in patients with acute ischemic stroke. Our objective was to study emergent direct percutaneous carotid artery puncture as an alternative access approach for acute endovascular stroke interventions. METHODS: We reviewed cases of acute ischemic stroke in which direct carotid artery puncture was used for access. We also reviewed current literature relevant to this subject. RESULTS: We describe the technical aspects, limits, and potential complications associated with direct carotid artery puncture for intracranial acute ischemic stroke interventions, and present cases to illustrate the utility of this access approach. CONCLUSIONS: Direct carotid artery puncture is a feasible alternative to transfemoral artery access in cases of stroke with difficult anatomy, including unfavorable arch type, carotid tortuosity, or an ostial lesion.

Early carotid angioplasty and stenting may offer non-inferior treatment for symptomatic cases of carotid artery stenosis.

OBJECTIVE: Early intervention is desirable in patients presenting with stroke or transient ischemic attack (TIA) referable to carotid artery stenosis because of the high incidence of recurrent ischemic events within 48 h post-ictus. However, the optimal timing of performing carotid angioplasty and stenting (CAS) in these patients remains unclear amid concerns for an elevated risk of perioperative complications. The primary outcome of this study was the combined incidence of major perioperative complications (stroke, myocardial infarction (MI), death) based on timing of CAS relative to symptom onset. METHODS: A prospectively maintained database of all neuroendovascular procedures at our hospital was searched for consecutive cases of extracranial internal CAS procedures performed for symptomatic atherosclerotic carotid stenosis between January 2009 and January 2012. Rates of perioperative complications including 30-day stroke, MI and death were assembled in a total of 221 patients. RESULTS: The primary outcome was not statistically different among groups stratified based on intervention timing, with a combined incidence of stroke, MI or death of 7.1% in patients treated within 2 days, 4.5% in patients treated between days 3 and 7, 2.8% in patients treated between days 8 and 14 and 3.7% in patients treated between days 15 and 90 (p=0.749, Fisher exact test). CONCLUSIONS: Our results support the conclusion that early CAS (within 2 days) carries no additional risks compared with CAS after 2 days or any other timing of the intervention up to 90 days. Early CAS may represent a reasonable option for acute revascularization to minimize the risk of perioperative stroke and overall perioperative complications.

Outcomes in patients with acute ischemic stroke from proximal intracranial vessel occlusion and NIHSS score below 8.

OBJECTIVE: Acute ischemic stroke due to proximal intracranial vessel occlusion is associated with poor prognosis and neurologic outcomes. Outcomes specifically in patients with stroke due to these occlusions and lower National Institutes of Health Stroke Scale (NIHSS) scores (0-7 range) have not been described previously. METHODS: We retrospectively reviewed discharge outcomes (reported in our 'Get With the Guidelines-Stroke' database) in patients with an admission NIHSS score of 0-7 due to proximal intracranial large vessel occlusion (based on CT angiography results) who were excluded from receiving intravenous (IV) thrombolysis with recombinant tissue plasminogen activator and endovascular intra-arterial (IA) stroke interventions. RESULTS: Among the 204 patients included in our analysis, younger age and lower admission NIHSS score (0-4 range) were strong predictors of good outcome (defined as ability to ambulate independently) at discharge whereas female sex was a predictor of poor outcome. There was no significant difference between cerebrovascular risk factors, specific sites of occlusion, or presenting symptoms and outcomes at discharge. There was great variability in functional outcomes at discharge and discharge disposition (home versus acute or subacute facility or nursing home versus death/hospice) with a trend toward worse outcomes in patients with higher (5-7 range) NIHSS scores on admission. CONCLUSIONS: Patients with acute stroke due to large vessel occlusion and low admission NIHSS scores (0-7 range) may have poor functional outcomes at discharge. These patients, if not eligible for IV thrombolysis, might benefit from IA revascularization therapies.

Carotid artery stenting outcomes: do they correlate with antiplatelet response assays?

OBJECTIVE: Limited data exist regarding the use of antiplatelet response assays during neuroendovascular intervention. We report outcomes after carotid artery stenting (CAS) based on aspirin and P2Y12 assays. METHODS: We retrospectively identified patients who had aspirin and P2Y12 assays at the time of stenting. Aspirin (325 mg) and clopidogrel (75 mg) were started 7-10 days pre-intervention. If not possible, aspirin (650 mg) and clopidogrel (600 mg) loading doses were given pre-intervention. Assays were checked on postoperative day 0/1. Outcomes included neurological ischemic sequela at 30 days, 1 and 2 years, as well as 30 day death/hemorrhage/myocardial infarction. RESULTS: 449 patients were included. Mean P2Y12 reaction unit (PRU) values were higher in patients with an ipsilateral ischemic event (stroke/transient ischemic attack (TIA)) or stroke (alone) at 1 and 2 years than in patients with no events: ischemic event versus no event at 1 year, 252 vs 202 (p=0.008); stroke versus no stroke at 1 year, 252 versus 203(p=0.029); ischemic event versus no event at 2 years, 244 vs 203 (p=0.047); stroke versus no stroke at 2 years, 243 versus 203 (p=0.082). Ischemic event free survival (stroke/TIA, p=0.0268) and overall survival (p=0.0291) post-CAS were longer in patients with PRU ≤198 compared with an initial threshold of PRU ≤237. Mean PRU values were higher in patients who died from all causes at 30 days than in survivors (p=0.031). No correlation was found between lower PRU values and hemorrhage. Aspirin reaction units did not correlate with outcome. CONCLUSIONS: PRU ≤198 may be associated with a lower incidence of ischemic neurological sequela and death post-CAS. Prospective studies are needed to validate the relationship between antiplatelet assays and outcomes post-CAS.

Understanding risk factors for perioperative ischemic events with carotid stenting: is patient age over 80 years or is unfavorable arch anatomy to blame?

OBJECTIVE: Several studies have reported increased perioperative risk after carotid artery stenting (CAS) for patients ≥80 years of age; however, most have not considered unfavorable anatomic features noted more frequently in this population as a confounding variable. The purpose of this study was to show a correlation between poor aortic arch anatomy and perioperative ischemic complications after CAS. METHODS: Our prospectively maintained database was queried for all CAS procedures performed on symptomatic patients between 2009 and 2011. Retrospective analysis of consecutive CAS procedures was performed. The primary endpoint was perioperative (within 30 days) ischemic events (stroke, transient ischemic attack (TIA)). Event incidence was compared between groups dichotomized by age and anatomical features. Incidence of unfavorable arch (acute angle between aortic arch and treated common carotid artery) was compared between age groups. RESULTS: Perioperative ischemic events included four ischemic strokes and three TIAs (all events ipsilateral to the treated vessel). Event incidence was more frequent in patients with unfavorable arch anatomy (7.9%) than in those with favorable aortic arch features (0.7%) (p=0.0073). Event incidence in patients ≥80 years of age (4.5%) was not statistically different than that in patients <80 years (2.3%) (p=0.428). Unfavorable aortic arch anatomy was increased in frequency in patients aged 80 years and over (<80 years, 29%; ≥80 years, 52%; p<0.001). CONCLUSIONS: In the present series, the incidence of perioperative complications was increased in patients with unfavorable aortic arch anatomy but not in patients ≥80 years. CAS represents a revascularization option for patients of all ages; however, patients with unfavorable aortic arch anatomy may represent a group at relatively high risk for periprocedural ischemic events.

Primary stenting for acute ischemic stroke using the Enterprise vascular reconstruction device: early results.

OBJECTIVE: Primary stenting for acute ischemic stroke (AIS) using the Wingspan stent delivery system has been reported. Major technical limitations in that study were difficulties in delivering the device and a few cases in which the Enterprise vascular reconstruction device (stent) was used as a bailout procedure. The Enterprise, which has relatively less radial force and more flexibility than other intracranial stents, is an ideal device for revascularization as it is easily delivered through tortuous intracranial vessels. We tested the safety and effectiveness of this stent as the primary revascularization device for AIS in an FDA-approved investigational device exemption prospective cohort study. METHODS: Twenty patients presenting with AIS due to confirmed intracranial large vessel occlusion within 8 h of onset of stroke symptoms were treated with the Enterprise as the primary revascularization device. The primary outcome was recanalization to Thrombolysis In Myocardial Infarction (TIMI) flow of ≥2. Perioperative safety was measured by major complication incidence within 30 days of stent revascularization. A secondary measure of outcome was 30-day modified Rankin Scale (mRS) score. RESULTS: Recanalization to TIMI 2 (n=6) or 3 (n=12) flow was achieved in 18 patients (90% revascularization rate). Three major complications were noted (15%) including one myocardial infarction, one symptomatic intracranial hemorrhage and one ischemic stroke in a distribution other than the qualifying vessel. Good outcome (mRS ≤2) was obtained in 10 patients (50%). CONCLUSIONS: In this prospective study the Enterprise stent was found to be a safe and effective revascularization tool in the setting of AIS.

Perioperative complications after carotid artery stenting: a contemporary experience from the university at buffalo neuroendovascular surgery team.

BACKGROUND: Technological advances have resulted in diminishing perioperative complications reported during carotid artery stenting (CAS) trials. Because trial experience lags behind technological advances, an understanding of the incidence of perioperative complications after CAS remains in flux. OBJECTIVE: In this single-arm, observational study, a contemporary experience of CAS at a high-volume academic training center for neuroendovascular surgeons was reviewed to assess perioperative morbidity. METHODS: A prospectively maintained database of all neuroendovascular procedures was queried for all CAS procedures performed for stenotic atherosclerotic disease between 2009 and 2011. Each case was assessed for major perioperative (30 day) adverse events, including new acute ischemic stroke, postoperative symptomatic intracranial hemorrhage, myocardial infarction (MI), and mortality. RESULTS: A total of 474 patients were identified. Perioperative adverse events were noted in 13 patients (2.7%). These included 4 ischemic strokes, 4 intracranial hemorrhages, 3 MIs, and 5 deaths. Most perioperative events occurred in symptomatic patients (10 of 239 symptomatic patients with events, 4.2% event incidence), whereas these events occurred rarely in asymptomatic patients (3 of 235 asymptomatic patients with events, 1.3% event incidence). CONCLUSION: In this retrospective analysis of consecutive patients treated with CAS, the perioperative incidence of stroke (0.9%), MI (0.6%), and death (1.1%) was favorable.