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1.
Stroke ; 55(5): 1438-1448, 2024 May.
Article in English | MEDLINE | ID: mdl-38648281

ABSTRACT

ARISE (Aneurysm/AVM/cSDH Roundtable Discussion With Industry and Stroke Experts) organized a one-and-a-half day meeting and workshop and brought together representatives from academia, industry, and government to discuss the most promising approaches to improve outcomes for patients with chronic subdural hematoma (cSDH). The emerging role of middle meningeal artery embolization in clinical practice and the design of current and potential future trials were the primary focuses of discussion. Existing evidence for imaging, indications, agents, and techniques was reviewed, and areas of priority for study and key questions surrounding the development of new and existing treatments for cSDH were identified. Multiple randomized, controlled trials have met their primary efficacy end points, providing high-level evidence that middle meningeal artery embolization is a potent adjunctive therapy to the standard (surgical and nonsurgical) management of neurologically stable cSDH patients in terms of reducing rates of disease recurrence. Pooled data analyses following the formal conclusion and publication of these trials will form a robust foundation upon which guidelines can be strengthened for cSDH treatment modalities and optimal patient selection, as well as delineate future lines of investigation.


Subject(s)
Hematoma, Subdural, Chronic , Humans , Consensus , Embolization, Therapeutic/methods , Hematoma, Subdural, Chronic/therapy , Randomized Controlled Trials as Topic
2.
Stroke ; 55(5): 1428-1437, 2024 May.
Article in English | MEDLINE | ID: mdl-38648283

ABSTRACT

BACKGROUND: Intracranial aneurysms (IAs) remain a challenging neurological diagnosis associated with significant morbidity and mortality. There is a plethora of microsurgical and endovascular techniques for the treatment of both ruptured and unruptured aneurysms. There is no definitive consensus as to the best treatment option for this cerebrovascular pathology. The Aneurysm, Arteriovenous Malformation, and Chronic Subdural Hematoma Roundtable Discussion With Industry and Stroke Experts discussed best practices and the most promising approaches to improve the management of brain aneurysms. METHODS: A group of experts from academia, industry, and federal regulators convened to discuss updated clinical trials, scientific research on preclinical system models, management options, screening and monitoring, and promising novel device technologies, aiming to improve the outcomes of patients with IA. RESULTS: Aneurysm, Arteriovenous Malformation, and Chronic Subdural Hematoma Roundtable Discussion With Industry and Stroke Experts suggested the incorporation of artificial intelligence to capture sequential aneurysm growth, identify predictors of rupture, and predict the risk of rupture to guide treatment options. The consensus strongly recommended nationwide systemic data collection of unruptured IA radiographic images for the analysis and development of machine learning algorithms for rupture risk. The consensus supported centers of excellence for preclinical multicenter trials in areas such as genetics, cellular composition, and radiogenomics. Optical coherence tomography and magnetic resonance imaging contrast-enhanced 3T vessel wall imaging are promising technologies; however, more data are needed to define their role in IA management. Ruptured aneurysms are best managed at large volume centers, which should include comprehensive patient management with expertise in microsurgery, endovascular surgery, neurology, and neurocritical care. CONCLUSIONS: Clinical and preclinical studies and scientific research on IA should engage high-volume centers and be conducted in multicenter collaborative efforts. The future of IA diagnosis and monitoring could be enhanced by the incorporation of artificial intelligence and national radiographic and biologic registries. A collaborative effort between academic centers, government regulators, and the device industry is paramount for the adequate management of IA and the advancement of the field.


Subject(s)
Intracranial Aneurysm , Humans , Aneurysm, Ruptured/therapy , Aneurysm, Ruptured/diagnostic imaging , Consensus , Endovascular Procedures/methods , Endovascular Procedures/standards , Intracranial Aneurysm/therapy , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/diagnosis
3.
Stroke ; 55(5): 1449-1463, 2024 May.
Article in English | MEDLINE | ID: mdl-38648282

ABSTRACT

Brain arteriovenous malformations (bAVMs) are complex, and rare arteriovenous shunts that present with a wide range of signs and symptoms, with intracerebral hemorrhage being the most severe. Despite prior societal position statements, there is no consensus on the management of these lesions. ARISE (Aneurysm/bAVM/cSDH Roundtable Discussion With Industry and Stroke Experts) was convened to discuss evidence-based approaches and enhance our understanding of these complex lesions. ARISE identified the need to develop scales to predict the risk of rupture of bAVMs, and the use of common data elements to perform prospective registries and clinical studies. Additionally, the group underscored the need for comprehensive patient management with specialized centers with expertise in cranial and spinal microsurgery, neurological endovascular surgery, and stereotactic radiosurgery. The collection of prospective multicenter data and gross specimens was deemed essential for improving bAVM characterization, genetic evaluation, and phenotyping. Finally, bAVMs should be managed within a multidisciplinary framework, with clinical studies and research conducted collaboratively across multiple centers, harnessing the collective expertise and centralization of resources.


Subject(s)
Intracranial Arteriovenous Malformations , Humans , Cerebral Hemorrhage/therapy , Endovascular Procedures/methods , Intracranial Arteriovenous Malformations/therapy , Radiosurgery/methods
4.
Circ Res ; 130(8): 1230-1251, 2022 04 15.
Article in English | MEDLINE | ID: mdl-35420919

ABSTRACT

The treatment of acute ischemic stroke continues to advance. The mainstay of treatment remains intravenous thrombolysis with alteplase. Recent studies demonstrated that later treatment with alteplase is beneficial in patients selected with advanced imaging techniques. Tenecteplase has been evaluated as an alternative thrombolytic drug and evidence suggests that it is as least as effective as alteplase and may lyse large vessel clots more effectively. Endovascular therapy with mechanical thrombectomy has now been shown to be beneficial up to 24 hours after stroke onset in carefully selected patients with proximal, large vessel occlusions. Ongoing studies are evaluating the effectiveness of thrombectomy in patients with more distal vessel occlusions and patients with proximal large vessel occlusions with larger ischemic core volumes and also in patients with milder neurological deficits. Cytoprotection is another potential acute stroke therapy that has not demonstrated efficacy in prior clinical trials. It should be reconsidered as an adjunct to reperfusion and a variety of new clinical trials can be envisioned to evaluate the potential benefits of cytoprotection in patients before and after reperfusion.


Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Brain Ischemia/diagnostic imaging , Brain Ischemia/drug therapy , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Fibrinolytic Agents/adverse effects , Humans , Stroke/diagnostic imaging , Stroke/drug therapy , Tenecteplase/therapeutic use , Thrombectomy/adverse effects , Thrombectomy/methods , Thrombolytic Therapy/adverse effects , Thrombolytic Therapy/methods , Tissue Plasminogen Activator , Treatment Outcome
5.
J Neurol Neurosurg Psychiatry ; 93(4): 360-368, 2022 04.
Article in English | MEDLINE | ID: mdl-35078916

ABSTRACT

BACKGROUND: To analyse the clinical characteristics of COVID-19 with acute ischaemic stroke (AIS) and identify factors predicting functional outcome. METHODS: Multicentre retrospective cohort study of COVID-19 patients with AIS who presented to 30 stroke centres in the USA and Canada between 14 March and 30 August 2020. The primary endpoint was poor functional outcome, defined as a modified Rankin Scale (mRS) of 5 or 6 at discharge. Secondary endpoints include favourable outcome (mRS ≤2) and mortality at discharge, ordinal mRS (shift analysis), symptomatic intracranial haemorrhage (sICH) and occurrence of in-hospital complications. RESULTS: A total of 216 COVID-19 patients with AIS were included. 68.1% (147/216) were older than 60 years, while 31.9% (69/216) were younger. Median [IQR] National Institutes of Health Stroke Scale (NIHSS) at presentation was 12.5 (15.8), and 44.2% (87/197) presented with large vessel occlusion (LVO). Approximately 51.3% (98/191) of the patients had poor outcomes with an observed mortality rate of 39.1% (81/207). Age >60 years (aOR: 5.11, 95% CI 2.08 to 12.56, p<0.001), diabetes mellitus (aOR: 2.66, 95% CI 1.16 to 6.09, p=0.021), higher NIHSS at admission (aOR: 1.08, 95% CI 1.02 to 1.14, p=0.006), LVO (aOR: 2.45, 95% CI 1.04 to 5.78, p=0.042), and higher NLR level (aOR: 1.06, 95% CI 1.01 to 1.11, p=0.028) were significantly associated with poor functional outcome. CONCLUSION: There is relationship between COVID-19-associated AIS and severe disability or death. We identified several factors which predict worse outcomes, and these outcomes were more frequent compared to global averages. We found that elevated neutrophil-to-lymphocyte ratio, rather than D-Dimer, predicted both morbidity and mortality.


Subject(s)
Brain Ischemia , COVID-19 , Ischemic Stroke , Stroke , Brain Ischemia/epidemiology , Brain Ischemia/etiology , Brain Ischemia/virology , COVID-19/complications , Humans , Ischemic Stroke/epidemiology , Ischemic Stroke/etiology , Ischemic Stroke/virology , Middle Aged , Retrospective Studies , SARS-CoV-2 , Stroke/epidemiology , Stroke/etiology , Stroke/virology , Thrombectomy , Treatment Outcome
6.
Stroke ; 50(6): 1473-1479, 2019 06.
Article in English | MEDLINE | ID: mdl-31084335

ABSTRACT

Background and Purpose- To evaluate the safety and effectiveness of the Surpass Flow Diverter (Surpass; Stryker Neurovascular, Fremont, CA) in the treatment of large or giant wide-neck intracranial aneurysms at one year, we hypothesize that treatment with Surpass meets or improves on historical safety and efficacy end points. Methods- SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms) is a multicenter, prospective, single-arm, nonrandomized, interventional trial of the Surpass Flow Diverter for uncoilable or previously treated but failed aneurysms of the intracranial internal carotid artery extending from the petrous segment to the carotid terminus at its bifurcation into anterior and middle cerebral arteries. For enrollment in SCENT, target aneurysms had to be wide-neck (≥4 mm) and large or giant size (≥10 mm). Study results are compared with performance goals derived from a thorough review of the medical literature. The primary effectiveness end point included 3 components: complete aneurysm occlusion, absence of significant parent artery stenosis (≥50%), and no retreatment at 12 months. The primary safety end point was major ipsilateral stroke (increase in National Institutes of Health Stroke Scale score of ≥4) or neurological death within 12 months. Results- At 26 medical centers, 180 patients with 180 target aneurysms were enrolled in the modified intention-to-treat cohort. Per angiographic core lab assessment, there were 15 (8.3%) fusiform, 164 (91.1%) saccular aneurysms, and 1 (0.6%) blister aneurysm. Mean aneurysm size was 12.0 mm. Thirteen (7.4%) aneurysms were giant (≥25 mm). Fifty-eight (32.2%) aneurysms were located in the supraclinoid and distal (including posterior communicating artery) segments of the internal carotid artery. Mean procedure duration was 53.6 minutes. The device was successfully implanted in 97.8% of patients with a mean of 1.1 devices per patient. SCENT met both primary safety and effectiveness end points: 12-month primary effectiveness rate was 62.8% [(113/180); 95% CI, 55.3-69.9] and 12-month major ipsilateral stroke or neurological death rate was 8.3% [(15/180); 95% CI, 4.7-13.4]. Conclusions- Surpass provides safe and effective flow diversion of large or giant, wide-neck, intracranial internal carotid artery aneurysms. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01716117.


Subject(s)
Carotid Artery, Internal/surgery , Intracranial Aneurysm/surgery , Stents , Adult , Aged , Aged, 80 and over , Carotid Stenosis/prevention & control , Carotid Stenosis/surgery , Female , Humans , Intracranial Aneurysm/mortality , Male , Middle Aged , Neck/surgery , Prospective Studies
7.
Neuroradiology ; 58(3): 267-75, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26700827

ABSTRACT

INTRODUCTION: Flow diversion is being increasingly used to treat cerebral aneurysms. We present our experience using these stents to treat aneurysms distal to the circle of Willis with parent arteries smaller than 2.5 mm. METHODS: Aneurysms treated with a Pipeline Embolization Device in vessels less than 2.5 mm between June 2012 and August 2014 were included. We evaluated risk factors, family history of aneurysms, aneurysm characteristics, National Institute of Health Stroke Scale (NIHSS), and modified Rankin scale (mRS) on admission and angiography and clinical outcome at discharge, 6 months, and 1 year. RESULTS: We included seven patients with a mean age of 65 years. The parent vessel size ranged from 1.5 to 2.3 mm; mean 1.9 mm. Location of the aneurysms was as follows: two aneurysms centered along the pericallosal artery (one left, one right), one on the right angular artery, one aneurysm at the anterior communicating artery (ACom), one at the ACom-right A2 anterior cerebral artery (ACA), one at the lenticulostriate artery, and one at the A1-A2 ACA artery. Aneurysms ranged from 1 to 12 mm in diameter. All aneurysms were treated with a single Pipeline Embolization Device (PED). No peri- or post-procedural complications or mortality occurred. The patients were discharged with no change in NIHSS or mRS score. Angiographic follow-up was available in six patients. Angiography showed complete aneurysm occlusion in all. NIHSS and mRS remained unchanged at follow-up. CONCLUSION: Our preliminary results show that flow diversion technology is an effective and safe therapy for aneurysms located on small cerebral arteries. Larger studies with long-term follow-up are needed to validate our promising results.


Subject(s)
Blood Vessel Prosthesis , Embolization, Therapeutic/instrumentation , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Stents , Aged , Embolization, Therapeutic/methods , Equipment Failure Analysis , Female , Follow-Up Studies , Humans , Longitudinal Studies , Male , Middle Aged , Prosthesis Design , Treatment Outcome
8.
Stroke ; 46(12): 3507-13, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26493676

ABSTRACT

BACKGROUND AND PURPOSE: The goal of this study is to combine temporary endovascular bypass (TEB) with a novel shear-activated nanotherapeutic (SA-NT) that releases recombinant tissue-type plasminogen activator (r-tPA) when exposed to high levels of hemodynamic stress and to determine if this approach can be used to concentrate r-tPA at occlusion sites based on high shear stresses created by stent placement. METHODS: A rabbit model of carotid vessel occlusion was used to test the hypothesis that SA-NT treatment coupled with TEB provides high recanalization rates while reducing vascular injury. We evaluated angiographic recanalization with TEB alone, intra-arterial delivery of soluble r-tPA alone, or TEB combined with 2 doses of intra-arterial infusion of either the SA-NT or soluble r-tPA. Vascular injury was compared against stent-retriever thrombectomy. RESULTS: Shear-targeted delivery of r-tPA using the SA-NT resulted in the highest rate of complete recanalization when compared with controls (P=0.0011). SA-NT (20 mg) had a higher likelihood of obtaining complete recanalization as compared with TEB alone (odds ratio 65.019, 95% confidence interval 1.77, >1000; P=0.0231), intra-arterial r-tPA alone (odds ratio 65.019, 95% confidence interval 1.77, >1000; P=0.0231), or TEB with soluble r-tPA (2 mg; odds ratio 18.78, 95% confidence interval 1.28, 275.05; P=0.0322). Histological analysis showed circumferential loss of endothelium restricted to the area where the TEB was deployed; however, there was significantly less vascular injury using a TEB as compared with stent-retriever procedure (odds ratio 12.97, 95% confidence interval 8.01, 21.02; P<0.0001). CONCLUSIONS: A novel intra-arterial, nanoparticle-based thrombolytic therapy combined with TEB achieves high rates of complete recanalization. Moreover, this approach reduces vascular trauma as compared with stent-retriever thrombectomy.


Subject(s)
Arterial Occlusive Diseases/pathology , Arterial Occlusive Diseases/therapy , Endovascular Procedures/methods , Nanoparticles/administration & dosage , Shear Strength , Animals , Cattle , Combined Modality Therapy , Female , Male , Nanoparticles/chemistry , Rabbits , Treatment Outcome
9.
J Neurol Neurosurg Psychiatry ; 86(9): 1029-35, 2015 Sep.
Article in English | MEDLINE | ID: mdl-25344064

ABSTRACT

BACKGROUND: Dantrolene is neuroprotective in animal models and may attenuate cerebral vasospasm (cVSP) in human aneurysmal subarachnoid haemorrhage (aSAH). We evaluated safety, feasibility and tolerability of intravenous dantrolene (IV-D) in patients with aSAH. METHODS: In this single-centre, randomised, double blind, placebo-controlled trial, 31 patients with aSAH were randomised to IV-D 1.25 mg every 6 h for 7 days (n=16) or equiosmolar free water/5% mannitol (placebo; n=15). Primary safety end points were incidence of hyponatraemia (sNa≤132 mmol/L) and liver toxicity (proportion of patients alanine transaminase, aspartate aminotransferase and AlkPhos >5× upper-limit-of-normal). Secondary end points included tolerability, systemic hypotension and intracranial hypertension. Efficacy was explored for clinical/radiological cVSP, delayed cerebral ischaemia (DCI), and 3-month functional outcomes. Quantitative analyses of angiograms and daily transcranial Doppler (TCD) were performed. RESULTS: Between IV-D versus placebo, no differences were observed in the primary outcomes (hyponatremia 44% vs 67% (p=0.29); liver toxicity 6% vs 0% (p=1.0)). Three patients in the IV-D versus two in the placebo group had severe adverse events possibly attributable to infusion and reached stop criteria: one IV-D patient developed liver toxicity; two patients in each group developed brain oedema requiring osmotherapy. The majority of adverse events were not related to infusion (17 vs 5 (RR 2.2; 95% CI 0.7 to 6.7; p=0.16) in IV-D vs placebo). No differences in any categorical cVSP outcomes, DCI, 3-month outcomes or quantitative angiogram and TCD analyses were seen in this small safety trial not powered to detect efficacy. CONCLUSIONS: In this small trial, IV-D after aSAH was feasible, tolerable and safe. TRIAL REGISTRATION NUMBER: http://clinicaltrials.gov NCT01024972.


Subject(s)
Dantrolene/therapeutic use , Muscle Relaxants, Central/therapeutic use , Subarachnoid Hemorrhage/complications , Vasospasm, Intracranial/drug therapy , Adult , Aged , Dantrolene/adverse effects , Double-Blind Method , Female , Humans , Male , Middle Aged , Muscle Relaxants, Central/adverse effects , Treatment Outcome , Vasospasm, Intracranial/etiology
12.
Stroke ; 45(5): 1474-7, 2014 May.
Article in English | MEDLINE | ID: mdl-24713525

ABSTRACT

BACKGROUND AND PURPOSE: Noninvasive imaging identifying a predictive biomarker of the bleeding risk of unruptured intracranial aneurysms (UIAs) is needed. We investigated a potential biomarker of UIA instability, myeloperoxidase, in human aneurysm tissue. METHODS: Human brain aneurysms were harvested after clipping and were histologically and biochemically evaluated for the presence of myeloperoxidase. Of the tissue collected, 3 were from ruptured aneurysms and 20 were from UIAs. For each UIA, its 5-year aneurysm rupture risk was determined using the Population, Hypertension, Age, Size of Aneurysm, Earlier Subarachnoid Hemorrhage From Another Aneurysm and Site of Aneurysm (PHASES) model. RESULTS: All ruptured aneurysms were myeloperoxidase positive. Of the UIAs, half were myeloperoxidase positive. The median 5-year aneurysm rupture risk was higher for myeloperoxidase-positive UIA (2.28%) than myeloperoxidase-negative UIA (0.69%), and the distributions were statistically different (P<0.005, Wilcoxon-Mann-Whitney test). The likelihood for myeloperoxidase-positive UIA was significantly associated (P=0.031) with aneurysm rupture risk (odds ratio, 4.79; 95% confidence limits, 1.15-19.96). CONCLUSIONS: Myeloperoxidase is associated with PHASES estimated risk of aneurysm rupture and may potentially be used as an imaging biomarker of aneurysm instability.


Subject(s)
Aneurysm, Ruptured/metabolism , Intracranial Aneurysm/metabolism , Peroxidase/metabolism , Adult , Aged , Aneurysm, Ruptured/enzymology , Aneurysm, Ruptured/pathology , Biomarkers/metabolism , Female , Humans , Intracranial Aneurysm/enzymology , Intracranial Aneurysm/pathology , Male , Middle Aged , Models, Statistical , Pilot Projects , Risk , Time Factors
13.
Stroke ; 44(6): 1567-77, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23686973

ABSTRACT

BACKGROUND AND PURPOSE: In patients harboring intracranial aneurysms, the major goal in treatment is to prevent bleeding. A new generation of an endoluminal device (Surpass Flow Diverter [Surpass]) was developed to reconstruct parent artery and occlude the aneurysm. We present our clinical and angiographic single-center experience. METHODS: Patients with a wide range of complex unruptured aneurysms were treated with the Surpass placed in the parent artery and bridging the aneurysm. Clinical and angiographic follow-up were performed at 6 months. Data were prospectively collected. RESULTS: Thirty seven patients (mean age, 56 years; range, 32-79), harboring 49 unruptured aneurysms were treated at our center. All except 1 patient were treated with a single device. Successful delivery of the device was achieved in all patients. All 35 nonbifurcation aneurysm necks were covered completely, whereas 14 bifurcation aneurysms were only partially covered. There was no major periprocedural morbidity or mortality. During follow-up, 4 patients (10.4%) experienced transient neurological deficit. One patient (3%) developed a minor stroke at 4-month follow-up with persistent neurological deficit. Twelve patients had neurological symptoms related to their aneurysm and 7 showed improvement of these symptoms during follow-up. At 6-month follow-up, 29 of 31 aneurysms studied that had complete neck coverage showed a complete occlusion (94%) including 1 case with a 95% to 100% occlusion, whereas 5 of the 10 bifurcation aneurysms were occluded. CONCLUSIONS: Our study shows high safety and efficacy profile of a new generation endoluminal device in treatment of complex intracranial aneurysms. Long-term studies of treated bifurcation aneurysms are needed.


Subject(s)
Endovascular Procedures/instrumentation , Endovascular Procedures/methods , Equipment and Supplies , Intracranial Aneurysm/therapy , Adult , Aged , Cerebral Angiography , Equipment Design , Equipment Safety , Female , Follow-Up Studies , Humans , Intracranial Aneurysm/diagnostic imaging , Male , Middle Aged , Netherlands , Prospective Studies , Retrospective Studies , Treatment Outcome
14.
Stroke ; 44(5): 1396-401, 2013 May.
Article in English | MEDLINE | ID: mdl-23493730

ABSTRACT

BACKGROUND AND PURPOSE: To evaluate the impact of proximal flow control on efficacy and safety of mechanical thrombectomy in an in vitro middle cerebral artery occlusion. METHODS: Three independent variables, including clot type, device (Merci Retriever, Solitaire FR, and Trevo devices), and use of a balloon guide catheter, were used to ascertain the impact of proximal flow control on the size and number of distal emboli generated during thrombectomy. Secondary end points were the recanalization rate and amount of flow restored. RESULTS: Use of the balloon guide catheter during thrombectomy of the fragile, hard clot significantly reduced the formation of large distal emboli with a diameter >1 mm, regardless of the device used (P<0.01). Applying aspiration via the balloon guide catheter in place of the conventional guide catheter resulted in a significant increase of flow reversal (P<0.0001). Prior to thrombectomy, deployment of the stent-trievers produced immediate flow restoration through the soft and hard clot occlusions, 69.2 ± 27.3 and 45.5 ± 22.8 mL/min, respectively, that was preserved after the balloon inflation because of collateral flow via the posterior communication artery. After deployment but before thrombectomy, no flow was restored when using the Merci Retriever. After thrombectomy, complete flow restoration was achieved in a majority of cases. The Merci Retriever required more thrombectomy attempts to achieve hard clot removal compared with the stent-trievers when the conventional guide catheter was used (1.5 versus 1.1). CONCLUSIONS: The risk of distal embolization was significantly reduced with the use of the balloon guide catheter.


Subject(s)
Infarction, Middle Cerebral Artery/surgery , Models, Anatomic , Stroke/surgery , Thrombectomy/methods , Catheterization , Humans , Stents , Thrombectomy/instrumentation , Treatment Outcome
15.
J Neurointerv Surg ; 15(7): 679-683, 2023 Jul.
Article in English | MEDLINE | ID: mdl-35551072

ABSTRACT

BACKGROUND: The Surpass flow diverter was developed to treat intracranial aneurysms not amenable to standard treatment. Indications for use allow placement in the internal carotid artery to the terminus, including the communicating artery segment. METHODS: The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT) trial is an international, multicenter, prospective, non-randomized trial comparing the outcomes of Surpass flow diverter treatment with historic control designed to evaluate the effectiveness and safety of Surpass for the treatment of wide neck (≥4 mm) large or giant intracranial aneurysms ≥10 mm. The primary effectiveness endpoint is the percentage of subjects with 100% aneurysm occlusion without significant stenosis of the parent artery and without retreatment of the target aneurysm at 12 months. The primary safety endpoint is the percentage of subjects experiencing neurologic death or major ipsilateral stroke at 12 months. We report the effectiveness and safety of flow diversion in the subgroup of posterior communicating artery (PComA) aneurysms. RESULTS: Of the 180 patients treated, 38 harbored a PComA aneurysm. Mean aneurysm size was 12.2 mm and mean neck width was 4.8 mm. The mean number of Surpass devices used was 1.1 per procedure, with 94.7% of aneurysms treated with one flow diverter. The 12 month primary effectiveness rate was 73.7% (28/38). At 36 months, 68.4% (26/38) of aneurysms remained completely occluded. The 12 month major ipsilateral stroke or neurological death rate was 10.5%. No patients with PComA occlusion after flow diverter placement (54.5%) had clinical sequelae. CONCLUSIONS: SCENT demonstrated acceptable 12 month effectiveness of flow diversion in PComA aneurysms. Despite associated PComA occlusions in many cases, arterial occlusions were clinically silent. TRIAL REGISTRATION NUMBER: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT01716117.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Stroke , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Prospective Studies , Odorants , Embolization, Therapeutic/methods , Stroke/therapy , Treatment Outcome , Stents
16.
J Neurointerv Surg ; 15(11): 1084-1089, 2023 Nov.
Article in English | MEDLINE | ID: mdl-36375835

ABSTRACT

BACKGROUND: To report the 3-year safety and effectiveness of the Surpass Streamline flow diverter in the SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms). METHODS: The Surpass Streamline flow diverter device was evaluated in a multicenter, prospective, single-arm, non-randomized interventional trial including patients with uncoilable or previously treated but failed aneurysms of the intracranial internal carotid artery. 3-year outcomes were tabulated with descriptive statistics and compared with 1-year outcomes. RESULTS: Of 180 patients in the modified intent-to-treat (mITT) cohort, 36-month clinical and angiographic follow-up was available in 134 and 117 cases, respectively. Effectiveness endpoint of complete aneurysm occlusion without clinically significant stenosis or retreatment was met in 71.8% (79/110, 95% CI 62.4% to 80.0%) of cases. Safety composite endpoint was 12.2% (22/180) over the 3-year period, with two major safety events (ipsilateral ischemic strokes) occurring between 12-36 months. Complete aneurysm occlusion was noted in 77.8% (91/117), and 99.1% (116/117) of the patients demonstrated adequate aneurysm occlusion (complete occlusion or neck residual). There were four cases (2.2%) of aneurysm rupture, all occurring within the first month of the index procedure. Target aneurysm retreatment rate was 2.8% (5/180). CONCLUSION: The present findings support the long-term safety and effectiveness of the Surpass Streamline flow diverter device. TRIAL REGISTRATION: NCT01716117.

17.
Neurosurgery ; 93(4): 764-772, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37171169

ABSTRACT

BACKGROUND: Flow diverters (FDs) have demonstrated a safe and effective profile. However, the use of FDs for posterior communicating artery (PComA) aneurysms remains controversial. OBJECTIVE: To evaluate the safety and effectiveness of FDs for PComA aneurysms using a systematic review and meta-analysis of the literature. METHODS: We performed a systematic search from inception until June 2022 for flow diversion in PComA aneurysms. Primary effectiveness was the rate of complete aneurysm occlusion defined by Raymond-Roy class 1. Primary safety outcomes were treatment-related ischemic/hemorrhagic (composite) events causing morbidity and mortality. Secondary safety was PComA patency at follow-up. Random-effects meta-analyses were used to calculate proportions, and statistical heterogeneity was assessed. RESULTS: A total of 13 studies with 397 patients harboring 403 aneurysms were included. Mean age was 48 years, and the mean aneurysm size was 5.3 mm. Most aneurysms were unruptured (65%). Complete occlusion at final follow-up was 73% (CI 66%-79%), and adjunctive coils were used in 10% of aneurysms. Retreatment rate was 2% (CI 0%-9%). The primary safety composite outcome was 4% (CI 3%-7%), and mortality was 1%. PComA patency at final follow-up was 76% (CI 57%-89%). Subgroup analysis, patients with fetal PComAs had a lower complete occlusion rate (42% fetal PComA vs 77%, psubgroupdifference = <.01). CONCLUSION: The performance of FDs in PComA aneurysms is comparable with outcomes found in other subtypes of supraclinoid aneurysms. Effectiveness was acceptable and safety favorable. However, effectiveness was suboptimal in patients with fetal-type PComAs; alternative treatments should be considered in these cases.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Humans , Middle Aged , Retrospective Studies , Intracranial Aneurysm/surgery , Circle of Willis , Retreatment , Treatment Outcome , Stents
18.
J Neurointerv Surg ; 15(7): 655-663, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36190965

ABSTRACT

BACKGROUND: Dolichoectatic vertebrobasilar fusiform aneurysms (DVBFAs) have poor natural history when left untreated and high morbimortality when treated with microsurgery. Flow diversion (FD) with dual-antiplatelet therapy (DAPT) is feasible but carries high risk of perforator occlusion and progression of brainstem compression. Elaborate antithrombotic strategies are needed to preserve perforator patency while vessel remodeling occurs. We compared triple therapy (TT (DAPT plus oral anticoagulation)) and DAPT alone in patients with DVBFAs treated with FD. METHODS: Retrospective comparison of DAPT and TT in patients with DVBFAs treated with FD at eight US centers. RESULTS: The groups (DAPT=13, TT=14) were similar in age, sex, clinical presentation, baseline disability, and aneurysm characteristics. Radial access use was significantly higher in the TT group (71.4% vs 15.3%; P=0.006). Median number of flow diverters and adjunctive coiling use were non-different between groups. Acute ischemic stroke rate during the oral anticoagulation period was lower in the TT group than the DAPT group (7.1% vs 30.8%; P=0.167). Modified Rankin Scale score decline was significantly lower in the TT group (7.1% vs 69.2%; P=0.001). Overall rates of hemorrhagic complications (TT, 28.6% vs DAPT, 7.7%; P=0.162) and complete occlusion (TT, 25% vs DAPT, 54.4%; P=0.213) were non-different between the groups. Rate of moderate-to-severe disability at last follow-up was significantly lower in the TT group (21.4% vs 76.9%; P=0.007). CONCLUSIONS: Patients with DVBFAs treated with FD in the TT group had fewer ischemic strokes, less symptom progression, and overall better outcomes at last follow-up than similar patients in the DAPT group.


Subject(s)
Intracranial Aneurysm , Ischemic Stroke , Humans , Platelet Aggregation Inhibitors , Ischemic Stroke/drug therapy , Retrospective Studies , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/drug therapy , Intracranial Aneurysm/surgery , Anticoagulants , Treatment Outcome
19.
Interv Neuroradiol ; 29(5): 589-598, 2023 Oct.
Article in English | MEDLINE | ID: mdl-35934939

ABSTRACT

BACKGROUND AND PURPOSE: Flow diversion has established as standard treatment for intracranial aneurysms, the Surpass Streamline is the only FDA-approved braided cobalt/chromium alloy implant with 72-96 wires. We aimed to determine the safety and efficacy of the Surpass in a post-marketing large United States cohort. MATERIALS AND METHODS: This is a retrospective multicenter study of consecutive patients treated with the Surpass for intracranial aneurysms between 2018 and 2021. Baseline demographics, comorbidities, and aneurysm characteristics were collected. Efficacy endpoint included aneurysm occlusion on radiographic follow-up. Safety endpoints were major ipsilateral ischemic stroke or treatment-related death. RESULTS: A total of 277 patients with 314 aneurysms were included. Median age was 60 years, 202 (73%) patients were females. Hypertension was the most common comorbidity in 156 (56%) patients. The most common location of the aneurysms was the anterior circulation in 89% (279/314). Mean aneurysm dome width was 5.77 ± 4.75 mm, neck width was 4.22 ± 3.83 mm, and dome/neck ratio was 1.63 ± 1.26. Small-sized aneurysms were 185 (59%). Single device was used in 94% of the patients, mean number of devices per patient was 1.06. At final follow-up, complete obliteration rate was 81% (194/239). Major stroke and death were encountered in 7 (3%) and 6 (2%) cases, respectively. CONCLUSION: This is the largest cohort study using a 72-96 wire flow diverter. The Surpass Streamline demonstrated a favorable safety and efficacy profile, making it a valuable option for treating not only large but also wide-necked small and medium-sized intracranial aneurysms.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Female , Humans , Middle Aged , Male , Intracranial Aneurysm/therapy , Intracranial Aneurysm/surgery , Cohort Studies , Stents , Retrospective Studies , Endovascular Procedures/methods , Treatment Outcome
20.
Cerebrovasc Dis ; 33(6): 525-31, 2012.
Article in English | MEDLINE | ID: mdl-22538962

ABSTRACT

BACKGROUND: To date limited information regarding outcome-modifying factors in patients with acute intracranial large artery occlusion (ILAO) in the anterior circulation is available. Leukoaraiosis (LA) is a common finding among patients with ischemic stroke and has been associated with poor post-stroke outcomes but its association with ILAO remains poorly characterized. This study sought to clarify the contribution of baseline LA and other common risk factors to 90-day outcome (modified Rankin Scale, mRS) after stroke due to acute anterior circulation ILAO. METHODS: We retrospectively analyzed 1,153 consecutive patients with imaging-confirmed ischemic stroke during a 4-year period (2007-2010) at a single academic institution. The final study cohort included 87 patients with acute ILAO subjected to multimodal CT imaging within 24 h of symptom onset. LA severity was assessed using the van Swieten scale on non-contrast CT. Leptomeningeal collaterals were graded using CT angiogram source images. Hemorrhagic transformation (HT) was determined on follow-up CT. Multivariate logistic regression controlling for HT, treatment modality, demographic, as well as baseline clinical and imaging characteristics was used to identify independent predictors of a poor outcome (90-day mRS >2). RESULTS: The median National Institutes of Health Stroke Scale (NIHSS) at baseline was 15 (interquartile range 9-21). Twenty-four percent of the studied patients had severe LA. They were more likely to have hypertension (p = 0.028), coronary artery disease (p = 0.015), poor collaterals (p < 0.001), higher baseline NIHSS (p = 0.003), higher mRS at 90 days (p < 0.001), and were older (p = 0.002). Patients with severe LA had a uniformly poor outcome (p < 0.001) irrespective of treatment modality. Poor outcome was independently associated with higher baseline NIHSS (p < 0.001), worse LA (graded and dichotomized, p < 0.001), reduced leptomeningeal collaterals (graded and dichotomized, p < 0.001), presence of HT (p < 0.001), presence of parenchymal hemorrhages (p = 0.01), baseline mRS (p = 0.002), and older age (p = 0.043). The association between severe LA (p = 0.0056; OR 13.86; 95% CI 1.94-∞) and baseline NIHSS (p = 0.0001; OR 5.11; 95% CI 2.07-14.49 for each 10-point increase) with poor outcome maintained after adjustment for confounders in the final regression model. In this model, there was no significant association between presence of HT and poor outcome (p = 0.0572). CONCLUSION: Coexisting LA may predict poor functional outcome in patients with acute anterior circulation ILAO independent of other known important outcome predictors such as comorbid state, admission functional deficit, collateral status, hemorrhagic conversion, and treatment modality.


Subject(s)
Arterial Occlusive Diseases/complications , Leukoaraiosis/complications , Neuroimaging , Stroke/complications , Aged , Aged, 80 and over , Arterial Occlusive Diseases/pathology , Cohort Studies , Female , Humans , Leukoaraiosis/diagnosis , Male , Middle Aged , Neuroimaging/methods , Predictive Value of Tests , Retrospective Studies , Risk Factors , Severity of Illness Index , Stroke/pathology , Tomography, X-Ray Computed , Treatment Outcome
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