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Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial

Becske, Tibor; Brinjikji, Waleed; Potts, Matthew B; Kallmes, David F; Shapiro, Maksim; Moran, Christopher J; Levy, Elad I; McDougall, Cameron G; Szikora, Istvan; Lanzino, Giuseppe; Woo, Henry H; Lopes, Demetrius K; Siddiqui, Adnan H; Albuquerque, Felipe C; Fiorella, David J; Saatci, Isil; Cekirge, Saruhan H; Berez, Aaron L; Cher, Daniel J; Berentei, Zsolt; Marosfoi, Miklos; Nelson, Peter K
BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded. RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores
PMID: 28362885
ISSN: 1524-4040
CID: 2509042

Smoking Does Not Affect Occlusion Rates and Morbidity-Mortality after Pipeline Embolization for Intracranial Aneurysms

Rouchaud, A; Brinjikji, W; Cloft, H J; Lanzino, G; Becske, T; Kallmes, D F
BACKGROUND AND PURPOSE: Smoking is a major risk factor for patients with intracranial aneurysms, yet the effects of smoking on outcomes of aneurysm with flow-diverter treatment remain unknown. We studied the impact of smoking on long-term angiographic and clinical outcomes after flow-diverter treatment of intracranial aneurysms. MATERIALS AND METHODS: We retrospectively reviewed data from patients treated with the Pipeline Embolization Device and included in the International Retrospective Study of the Pipeline Embolization Device, the Pipeline for Uncoilable or Failed Aneurysms Study, and the Aneurysm Study of Pipeline in an Observational Registry. Patients were stratified according to smoking status into 3 groups: 1) never smoker, 2) current smoker, and 3) former smoker. We studied angiographic and clinical outcomes. Outcomes were compared by using chi2 and Student t tests. A multivariate analysis was performed to determine whether smoking was independently associated with poor outcomes. RESULTS: Six hundred sixteen patients with 694 aneurysms were included. Current smokers had a smaller mean aneurysm size compared with the other 2 groups (P = .005) and lower rates of multiple Pipeline Embolization Device use (P = .015). On multivariate analysis, former smokers (OR, 1.08; 95% CI, 0.43-2.71; P = .57) and current smokers (OR, 0.70; 95% CI, 0.27-1.77; P = .38) had similar odds of long-term angiographic incomplete occlusion compared with never smokers. Former smokers (OR, 1.27; 95% CI, 0.64-2.52; P = .25) and current smokers (OR, 0.74; 95% CI, 0.37-1.46; P = .22) had similar odds of major morbidity and neurologic mortality compared with never smokers. CONCLUSIONS: These results suggest that smoking is not associated with angiographic and clinical outcomes among patients treated with the Pipeline Embolization Device. Nonetheless, patients with intracranial aneurysms should continue to be counseled about the risks of tobacco smoking.
PMID: 26797135
ISSN: 1936-959x
CID: 2009782

Posterior Spinal Artery Aneurysm Presenting with Leukocytoclastic Vasculitis

Hill, Travis C; Tanweer, Omar; Thomas, Cheddhi; Engler, John; Shapiro, Maksim; Becske, Tibor; Huang, Paul P
Rupture of isolated posterior spinal artery (PSA) aneurysms is a rare cause of subarachnoid hemorrhage (SAH) that presents unique diagnostic challenges owing to a nuanced clinical presentation. Here, we report on the diagnosis and management of the first known case of an isolated PSA aneurysm in the context of leukocytoclastic vasculitis. A 53-year-old male presented to an outside institution with acute bilateral lower extremity paralysis 9 days after admission for recurrent cellulitis. Early magnetic resonance imaging was read as negative and repeat imaging 15 days after presentation revealed SAH and a compressive spinal subdural hematoma. Angiography identified a PSA aneurysm at T9, as well as other areas suspicious for inflammatory or post-hemorrhagic reactive changes. The patient underwent a multilevel laminectomy for clot evacuation and aneurysm resection to prevent future hemorrhage and to establish a diagnosis. The postoperative course was complicated by medical issues and led to the diagnosis of leukocytoclastic vasculitis that may have predisposed the patient to aneurysm development. Literature review reveals greater mortality for cervical lesions than thoracolumbar lesions and that the presence of meningitic symptoms portents better functional outcome than symptoms of cord compression. The outcome obtained in this case is consistent with outcomes reported in the literature.
PMCID:4842908
PMID: 27114966
ISSN: 2234-8565
CID: 2091992

Foreign Body Emboli following Cerebrovascular Interventions: Clinical, Radiographic, and Histopathologic Features

Shapiro, M; Ollenschleger, M D; Baccin, C; Becske, T; Spiegel, G R; Wang, Y; Song, X; Raz, E; Zumofen, D; Potts, M; Nelson, P K
Foreign material emboli following cerebral, cardiac, and peripheral catheterizations have been reported since the mid-1990s. Catheter coatings have been frequently implicated. The most recent surge of interest in this phenomenon within the neurointerventional community is associated with procedures using flow-diversion devices for the treatment of cerebral aneurysms. Following coil-supported Pipeline embolization in 4 cases and stent-supported coiling in 1, 5 patients developed multiple subcentimeter enhancing lesions, usually with surrounding edema and variable magnetic susceptibility in the vascular territories of the treated aneurysms. Conventional angiography findings were unrevealing. Laboratory work-up showed mild CSF protein elevation with no leukocytosis. Brain biopsy in 2 cases revealed granulomatous angiitis encasing foreign material, identical in stain appearance to a polyvinylpyrrolidone catheter coating. Corticosteroid administration typically produced clinical improvement. A heterogeneous radiographic and clinical course was noted, with rise and fall in the number of enhancing lesions in 2 patients and persistence in others. The etiology may be related to widespread adoption of increasingly sophisticated catheterization techniques.
PMID: 26294650
ISSN: 1936-959x
CID: 1732492

Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results

Sahlein, Daniel H; Fouladvand, Mohammad; Becske, Tibor; Saatci, Isil; McDougall, Cameron G; Szikora, Istvan; Lanzino, Giuseppe; Moran, Christopher J; Woo, Henry H; Lopes, Demetrius K; Berez, Aaron L; Cher, Daniel J; Siddiqui, Adnan H; Levy, Elad I; Albuquerque, Felipe C; Fiorella, David J; Berentei, Zsolt; Marosfoi, Miklos; Cekirge, Saruhan H; Kallmes, David F; Nelson, Peter K
OBJECT Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). METHODS The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. RESULTS In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. CONCLUSIONS Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.
PMID: 26162031
ISSN: 1933-0693
CID: 1668552

Use of Pipeline Embolization Devices for treatment of a direct carotid-cavernous fistula

Nossek, E; Zumofen, D; Nelson, E; Raz, E; Potts, M B; Desousa, K G; Tanweer, O; Shapiro, M; Becske, T; Riina, Howard A
BACKGROUND: The use of minimally porous endoluminal devices (MPEDs) such as the Pipeline Embolization Device (PED) has been described for the treatment of brain aneurysms. The benefit of using MPEDs to assist embolization of a direct high-flow carotid cavernous fistula resulting from a ruptured cavernous carotid artery aneurysm is not well documented. METHODS: We describe our experience with deploying a tailored multidevice PED construct across the cavernous internal carotid artery (ICA) wall defect in combination with transarterial coil embolization using the "jailed microcatheter" technique. RESULTS: A 59-year-old woman presented with acute left-sided ophthalmoplegia. Diagnostic cerebral angiography demonstrated a ruptured giant cavernous carotid aneurysm with fistulous outflow via the ipsilateral left superior ophthalmic vein and into the pterygoid venous plexi bilaterally. Via the Marksman microcatheter, a total of three PEDs measuring 4.5 mm x 18 mm, 4.5 mm x 20 mm, and 4.75 mm x 16 mm were telescoped within the ICA across the aneurysm neck. Coiling of the aneurysm fundus and cavernous sinus via the "jailed" Rapidtransit microcatheter was subsequently achieved. A 2-year follow-up digital subtraction angiography (DSA) demonstrated stable obliteration of the aneurysm and the fistula, coincident with complete resolution of the patient's symptoms. CONCLUSIONS: Based on our long-term clinical and angiographic results, we advocate that the presented method be a valid treatment option for selected cases.
PMID: 25981434
ISSN: 0942-0940
CID: 1630972

Endoluminal Reconstruction for Nonsaccular Aneurysms of the Proximal Posterior Cerebral Artery with the Pipeline Embolization Device

Zumofen, D W; Shapiro, M; Becske, T; Raz, E; Potts, M B; Riina, H A; Nelson, P K
BACKGROUND AND PURPOSE: Treatment options for nonsaccular posterior cerebral artery aneurysms include a range of surgical and endovascular reconstructive and deconstructive methods. However, no truly satisfactory treatment option is available to date for lesions arising from the P1 and P2 segments. The purpose of the present case series is to investigate both the efficacy and safety of the Pipeline Embolization Device in treating these challenging aneurysms. MATERIALS AND METHODS: We present a series of 6 consecutive patients who underwent endoluminal reconstruction with the Pipeline Embolization Device for nonsaccular P1 or P2 segment aneurysms between January 2009 and June 2013. RESULTS: Aneurysm location included the P1 segment in 2 patients and the P2 segment in 4 patients. Mean aneurysm diameter was 23 mm (range, 5-44 mm). Mean length of the arterial segment involved was 10 mm (range, 6-19 mm). Clinical presentation included mass effect in 4 patients and perforator stroke and subacute aneurysmal subarachnoid hemorrhage in 1 patient each. Endovascular reconstruction was performed by using 1 Pipeline Embolization Device in 5 patients and 2 overlapping Pipeline Embolization Devices in the remaining patient. Angiographic aneurysm occlusion was immediate in 1 patient, within 6 months in 4 patients, and within 1 year in the remaining patient. Index symptoms resolved in 4 patients and stabilized in the remaining 2. No new permanent neurologic sequelae and no aneurysm recurrence were recorded during the mean follow-up period of 613 days (range, 540-725 days). CONCLUSIONS: Endovascular reconstruction with the Pipeline Embolization Device for nonsaccular aneurysms arising from the P1 and P2 segments compares favorably with historical treatment options in terms of occlusion rate, margin of safety, and neurologic outcome.
PMID: 25792531
ISSN: 1936-959x
CID: 1669452

Anterior Choroidal Artery Patency and Clinical Follow-Up after Coverage with the Pipeline Embolization Device

Raz, E; Shapiro, M; Becske, T; Zumofen, D W; Tanweer, O; Potts, M B; Riina, H A; Nelson, P K
BACKGROUND AND PURPOSE: Endoluminal reconstruction with the Pipeline Embolization Device is an effective treatment option for select intracranial aneurysms. However, concerns for the patency of eloquent branch arteries covered by the Pipeline Embolization Device have been raised. We aimed to examine the patency of the anterior choroidal artery and clinical sequelae after ICA aneurysm treatment. MATERIALS AND METHODS: We prospectively analyzed all patients among our first 157 patients with ICA aneurysms treated by the Pipeline Embolization Device who required placement of at least 1 device across the ostium of the anterior choroidal artery. The primary outcome measure was angiographic patency of the anterior choroidal artery at last follow-up. Age, sex, type of aneurysm, neurologic examination data, number of Pipeline Embolization Devices used, relationship of the anterior choroidal artery to the aneurysm, and completeness of aneurysm occlusion on follow-up angiograms were also analyzed. RESULTS: Twenty-nine aneurysms requiring placement of at least 1 Pipeline Embolization Device (median = 1, range = 1-3) across the anterior choroidal artery ostium were identified. At angiographic follow-up (mean = 15.1 months; range = 12-39 months), the anterior choroidal artery remained patent, with antegrade flow in 28/29 aneurysms (96.5%), while 24/29 (82.7%) of the target aneurysms were angiographically occluded by 1-year follow-up angiography. Anterior choroidal artery occlusion, with retrograde reconstitution of the vessel, was noted in a single case. A significant correlation between the origin of the anterior choroidal artery from the aneurysm dome and failure of the aneurysms to occlude following treatment was found. CONCLUSIONS: After placement of 36 Pipeline Embolization Devices across 29 anterior choroidal arteries (median = 1 device, range = 1-3 devices), 1 of 29 anterior choroidal arteries was found occluded on angiographic follow-up. The vessel occlusion did not result in persistent clinical sequelae. Coverage of the anterior choroidal artery origin with the Pipeline Embolization Device, hence, may be considered reasonably safe when deemed necessary for aneurysm treatment.
PMID: 25572948
ISSN: 0195-6108
CID: 1432982

Rapid aneurysm growth and rupture in systemic lupus erythematosus

Graffeo, Christopher S; Tanweer, Omar; Nieves, Cesar Fors; Belmont, H Michael; Izmirly, Peter M; Becske, Tibor; Huang, Paul P
BACKGROUND: Subarachnoid hemorrhage (SAH) due to intracranial aneurysm rupture is a major neurosurgical emergency associated with significant morbidity and mortality. Rapid aneurysm growth is associated with rupture. Systemic lupus erythematosus (SLE) is a multi-system autoimmune disorder whose complications can include cerebral vasculitis and vasculopathy. Intracranial aneurysms are not known to occur more frequently in SLE patients than the general population; however, aneurysm growth rates have not been studied in SLE. CASE DESCRIPTION: We present a 43-year-old female with SLE on prednisone, hydroxychloroquine, and azathioprine with moderate disease activity who presented with severe, acute-onset headache and was found to have Hunt and Hess grade II SAH due to rupture of an 8 mm saccular anterior communicating artery (ACoA) aneurysm. The patient developed severe vasospasm, re-ruptured, and was taken for angiography and embolization, which was challenging due to a high degree of vasospasm and arterial stenosis. Review of imaging from less than 2 years prior demonstrated a normal ACoA complex without evidence of an aneurysm. CONCLUSION: We review the literature and discuss the risk factors and pathophysiology of rapid aneurysm growth and rupture, as well as the pathologic vascular changes associated with SLE. Although SLE patients do not develop intracranial aneurysm at an increased rate, these changes may predispose them to higher incidence of growth and rupture. This possibility-coupled with increased morbidity and mortality of SAH in SLE-suggests that SAH should be considered in SLE patients presenting with headache, and advocates for more aggressive treatment of SLE patients with unruptured aneurysms.
PMCID:4310132
PMID: 25657862
ISSN: 2152-7806
CID: 1456852

Impact of aneurysm size on the complication rate associated with flow diverter treatment of intracranial aneurysms. A composite analysis of three large scale multicenter studies [Meeting Abstract]

Szikora, I; Becske, T; Kallmes, D; Lylyk, P; Boccardi, E; Nelson, P
Purpose: Flow Diverter Treatment (FDT) of intracranial aneurysms has been reportedly associated with excellent morphological results and a varying rate of periprocedural complications. The purpose of this work was to study the incidence of complications and safety outcomes in relation to aneurysm size through a composite analysis of three large scale multicenter studies. Methods: A total of 1221 aneurysms in 1092 patients were included from the PUFS single arm prospective trial, and the ASPIRE prospective and IntrePED retrospective registries. In PUFS and the US ASPIRE sites, the indication was restricted to wide-neck aneurysms larger than 10 mm, located on the intracranial internal carotid artery from the petrous to the superior hypophyseal segments. All aneurysms treated prior to study initiation were included in IntrePED without restrictions in anatomy, size or ruptured status. All adverse events were evaluated by an independent event adjudication committee. Complications were considered major if symptoms lasted longer than 7 days and were classified as ipsilateral ischemic stroke (IIS) or ipsilateral intracranial hemorrhage (IIH). The major complications are reported below. Results: The incidence of IIS and IIH for the entire population was 3,7% and 2,0%, respectively. The IIS rate was 2,4%, 3,3% and 9,4% while IIH rate was 1,2%, 2,5% and 2,8% for small, large and giant aneurysms respectively. The composite incidence of morbidity defined as major ISS and major IIH was 5,7% and the rate of neurological mortality was 3,3%. The combined morbidity-neurological mortality rate was 7,1% for the entire cohort including ruptured aneurysms, and 4,4%, 7,2% and 17,0% for small, large and giant aneurysms respectively. Conclusion: The rate of periprocedural IIS and subsequent major morbidity and neurological mortality following FDT correlates with aneurysm size. Small aneurysms were associated with better outcomes than the large and giant aneurysms
EMBASE:72097810
ISSN: 1591-0199
CID: 1905712