the purpose of this study was to identify significant morphological and hemodynamic parameters that discriminate intracranial aneurysm rupture status using 3-dimensional angiography and computational ...fluid dynamics.
one hundred nineteen intracranial aneurysms (38 ruptured, 81 unruptured) were analyzed from 3-dimensional angiographic images and computational fluid dynamics. Six morphological and 7 hemodynamic parameters were evaluated for significance with respect to rupture. Receiver operating characteristic analysis identified area under the curve (AUC) and optimal thresholds separating ruptured from unruptured aneurysms for each parameter. Significant parameters were examined by multivariate logistic regression analysis in 3 predictive models-morphology only, hemodynamics only, and combined-to identify independent discriminants, and the AUC receiver operating characteristic of the predicted probability of rupture status was compared among these models.
morphological parameters (size ratio, undulation index, ellipticity index, and nonsphericity index) and hemodynamic parameters (average wall shear stress WSS, maximum intra-aneurysmal WSS, low WSS area, average oscillatory shear index, number of vortices, and relative resident time) achieved statistical significance (P<0.01). Multivariate logistic regression analysis demonstrated size ratio to be the only independently significant factor in the morphology model (AUC, 0.83; 95% CI, 0.75 to 0.91), whereas WSS and oscillatory shear index were the only independently significant variables in the hemodynamics model (AUC, 0.85; 95% CI, 0.78 to 0.93). The combined model retained all 3 variables, size ratio, WSS, and oscillatory shear index (AUC, 0.89; 95% CI, 0.82 to 0.96).
all 3 models-morphological (based on size ratio), hemodynamic (based on WSS and oscillatory shear index), and combined-discriminate intracranial aneurysm rupture status with high AUC values. Hemodynamics is as important as morphology in discriminating aneurysm rupture status.
Stroke is a catastrophic event for patients and their families. Given the frequency of approximately 750,000 events annually with their associated morbidity and mortality, stroke has assumed ...increasing importance. Scientific study has identified several diseases categorized under the broad term of "stroke" that form the rationale for current treatment strategies. This paper reviews new information, especially on ischemic stroke (particularly large-vessel occlusions), which identifies the potential for new approaches that can dramatically improve outcome but will require the need to enhance and embrace the care team required to deliver optimal care and address current unmet clinical needs.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
In this randomized comparison of stenting and endarterectomy as treatment for carotid-artery stenosis, there was no significant difference in the rate of the composite primary end point of stroke, ...myocardial infarction, or death (7.2% and 6.8%, respectively; P=0.51). Stroke was more common with carotid-artery stenting than carotid endarterectomy; myocardial infarction was more common with carotid endarterectomy. The 4-year rate of stroke or death was 6.4% for carotid-artery stenting and 4.7% for carotid endarterectomy (P=0.03).
In this randomized comparison of stenting and endarterectomy as treatment for carotid-artery stenosis, there was no significant difference in the rate of the composite primary end point of stroke, myocardial infarction, or death (7.2% and 6.8%, respectively).
Carotid-artery atherosclerosis is an important cause of ischemic stroke.
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Carotid endarterectomy has been established as effective treatment for both symptomatic patients and asymptomatic patients.
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Carotid-artery stenting is another option for treatment. The results of randomized trials comparing carotid-artery stenting and carotid endarterectomy for use in symptomatic patients are conflicting.
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The primary aim of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) was to compare the outcomes of carotid-artery stenting with those of carotid endarterectomy among patients with symptomatic or asymptomatic extracranial carotid stenosis.
Methods
Study Design
CREST is a randomized, controlled trial with blinded end-point adjudication. Ethics review . . .
The pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment.
To report early postmarket results with the PED.
This study was a prospective registry ...of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.
Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty.
Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.
The use of flow-diverting stents has gained momentum as a curative approach in the treatment of complex proximal anterior circulation intracranial aneurysms. There have been some reported attempts of ...treating formidable lesions in the posterior circulation. Posterior circulation giant fusiform aneurysms have a particularly aggressive natural history. To date, no one approach has been shown to be comprehensively effective or low risk. The authors report the initial results, including the significant morbidity and mortality encountered, with flow diversion in the treatment of large or giant fusiform vertebrobasilar aneurysms at Millard Fillmore Gates Circle Hospital.
The authors retrospectively reviewed their prospectively collected endovascular database to identify patients with intracranial aneurysms who underwent treatment with flow-diverting devices and determined that 7 patients had presented with symptomatic large or giant fusiform vertebrobasilar aneurysms. The outcomes of these patients, based on the modified Rankin Scale (mRS), were tabulated, as were the complications experienced.
Among the 7 patients, Pipeline devices were placed in 6 patients and Silk devices in 1 patient. At the last follow-up evaluation, 4 patients had died (mRS score of 6), all of whom were treated with the Pipeline device. The other 3 patients had mRS scores of 5 (severe disability), 1, and 0. The deaths included posttreatment aneurysm ruptures in 2 patients and lack of improvement in neurological status related to presenting brainstem infarcts and subsequent withdrawal of care in the other 2 patients.
Whether flow diversion will be an effective strategy for treatment of large or giant fusiform vertebrobasilar aneurysms remains to be seen. The authors' initial experience suggests substantial morbidity and mortality associated with the treatment and with the natural history. As outcomes data slowly become available for patients receiving these devices for fusiform posterior circulation aneurysms, practitioners should use these devices judiciously.
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract
BACKGROUND AND IMPORTANCE:
The Pipeline Embolization Device (PED) is a flow diverter designed to treat intracranial aneurysms through endoluminal parent vessel reconstruction. The role of ...adjunctive coil embolization is unknown.
CLINICAL PRESENTATION:
This report details the authors' experience with the PED in 2 patients with symptomatic, giant distal intracranial aneurysms (1 basilar artery and 1 M1 segment middle cerebral artery). Both patients had successful parent vessel reconstruction. In the first patient, the basilar artery aneurysm was treated with PEDs alone, and the patient experienced early fatal brainstem hemorrhage from aneurysm rupture. In the second patient, the M1 aneurysm was treated with 2 PEDs along with dense coil embolization, with a good initial angiographic result. This patient experienced acute thrombosis of the PED post-procedure, likely related to mass effect and thrombogenicity of the dense coil mass.
CONCLUSION:
Flow diversion is an evolutionary step in the treatment of giant intracranial aneurysms. However, complete aneurysm occlusion occurs over a delayed period. The authors recommend placement of coils in addition to PED in the treatment of large or giant distal intracranial aneurysms in an attempt to protect the dome. However, robust packing is to be avoided because it can lead to acute PED thrombotic or compressive occlusion.
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.
ABSTRACT
BACKGROUND:
The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study stopped recruiting patients because of ...higher-than-expected perioperative morbidity of primary stenting in patients with symptomatic intracranial stenosis. An alternative treatment, submaximal angioplasty without stenting, performed concurrently with SAMMPRIS, may offer revascularization benefits with a lower incidence of stenting-related risks.
OBJECTIVE:
To present the results of a consecutive case series of primary submaximal angioplasty procedures performed for symptomatic severe atherosclerotic intracranial stenosis refractory to medical treatment.
METHODS:
A database review identified primary submaximal angioplasty procedures performed in 41 patients for the treatment of >70% intracranial stenosis associated with an acute, symptomatic ischemic event in the distribution of the diseased vessel. For results analysis, 30-day events were reported as a percentage of patients treated. One-year periprocedural and ischemic event--free survival was reported as a percentage of all patients treated and displayed graphically with a Kaplan-Meier survival curve.
RESULTS:
Three events in 41 patients included 1 intraprocedural vessel perforation, 1 reperfusion hemorrhage < 24 hours postoperatively, and 1 transient ischemic attack 3 months postprocedurally (30-day event rate, 2 of 41, 4.9%). Median clinical follow-up duration after submaximal angioplasty was 19 months, with ≥ 1 year of follow-up available for 32 patients. One-year perioperative and ischemic event-free survival was high (29 of 32 patients, 91%).
CONCLUSION:
In this series, periprocedural safety of submaximal angioplasty in the setting of acute, symptomatic atherosclerotic intracranial stenosis was demonstrated. Although direct comparison is impossible because many patients were ineligible for stenting procedures, the complication profile compares favorably with rates of identically defined event-free survival for patients randomized to the medical (88%) and surgical (77%) arms of SAMMPRIS despite the absence of aggressive medical management.
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