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Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement

Zaidat, Osama O; Yoo, Albert J; Khatri, Pooja; Tomsick, Thomas A; von Kummer, Rudiger; Saver, Jeffrey L; Marks, Michael P; Prabhakaran, Shyam; Kallmes, David F; Fitzsimmons, Brian-Fred M; Mocco, J; Wardlaw, Joanna M; Barnwell, Stanley L; Jovin, Tudor G; Linfante, Italo; Siddiqui, Adnan H; Alexander, Michael J; Hirsch, Joshua A; Wintermark, Max; Albers, Gregory; Woo, Henry H; Heck, Donald V; Lev, Michael; Aviv, Richard; Hacke, Werner; Warach, Steven; Broderick, Joseph; Derdeyn, Colin P; Furlan, Anthony; Nogueira, Raul G; Yavagal, Dileep R; Goyal, Mayank; Demchuk, Andrew M; Bendszus, Martin; Liebeskind, David S
PMCID:4160883
PMID: 23920012
ISSN: 0039-2499
CID: 825662

A multicenter study of stent-assisted coiling of cerebral aneurysms with a Y configuration

Fargen, Kyle M; Mocco, J; Neal, Dan; Dewan, Michael C; Reavey-Cantwell, John; Woo, Henry H; Fiorella, David J; Mokin, Maxim; Siddiqui, Adnan H; Turk, Aquilla S; Turner, Raymond D; Chaudry, Imran; Kalani, M Yashar S; Albuquerque, Felipe; Hoh, Brian L
BACKGROUND: Stent-assisted coiling with 2 stents in a Y configuration is a technique for coiling complex wide-neck bifurcation aneurysms. OBJECTIVE: We sought to provide long-term clinical and angiographic outcomes with Y-stent coiling, which are not currently established. METHODS: Seven centers provided deidentified, retrospective data on all consecutive patients who underwent stent-assisted coiling for an intracranial aneurysm with a Y-stent configuration. RESULTS: Forty-five patients underwent treatment by Y-stent coiling. Their mean age was 57.9 years. Most aneurysms were basilar apex (87%), and 89% of aneurysms were unruptured. Mean size was 9.9 mm. Most aneurysms were treated with 1 open-cell and 1 closed-cell stent (51%), with 29% treated with open-open stents and 16% treated with 2 closed-cell stents. Initial aneurysm occlusion was excellent (84% in Raymond grade I or II). Procedural complications occurred in 11% of patients. Mean clinical follow-up was 7.8 months, and 93% of patients had a modified Rankin Scale score of 0 to 2 at last follow-up. Mean angiographic follow-up was 9.8 months, and 92% of patients had Raymond grade I or II occlusion on follow-up imaging. Of those patients with initial Raymond grade III occlusion and follow-up imaging, all but 1 patient progressed to a better occlusion grade (83%; P < .05). Three aneurysms required retreatment because of recanalization (10%). There was no difference in initial or follow-up angiographic occlusion, clinical outcomes, incidence of aneurysm retreatment, or in-stent stenosis among open-open, open-closed, or closed-closed stent groups. CONCLUSION: In a large multicenter series of Y-stent coiling for bifurcation aneurysms, there were low complication rates and excellent clinical and angiographic outcomes.
PMID: 23756744
ISSN: 0148-396x
CID: 825682

Physical factors effecting cerebral aneurysm pathophysiology

Sadasivan, Chander; Fiorella, David J; Woo, Henry H; Lieber, Baruch B
Many factors that are either blood-, wall-, or hemodynamics-borne have been associated with the initiation, growth, and rupture of intracranial aneurysms. The distribution of cerebral aneurysms around the bifurcations of the circle of Willis has provided the impetus for numerous studies trying to link hemodynamic factors (flow impingement, pressure, and/or wall shear stress) to aneurysm pathophysiology. The focus of this review is to provide a broad overview of such hemodynamic associations as well as the subsumed aspects of vascular anatomy and wall structure. Hemodynamic factors seem to be correlated to the distribution of aneurysms on the intracranial arterial tree and complex, slow flow patterns seem to be associated with aneurysm growth and rupture. However, both the prevalence of aneurysms in the general population and the incidence of ruptures in the aneurysm population are extremely low. This suggests that hemodynamic factors and purely mechanical explanations by themselves may serve as necessary, but never as necessary and sufficient conditions of this disease's causation. The ultimate cause is not yet known, but it is likely an additive or multiplicative effect of a handful of biochemical and biomechanical factors.
PMCID:3679262
PMID: 23549899
ISSN: 0090-6964
CID: 825722

Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial

Becske, Tibor; Kallmes, David F; 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; Nelson, Peter K
PURPOSE: To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. MATERIALS AND METHODS: The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. RESULTS: PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). CONCLUSION: PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.
PMID: 23418004
ISSN: 0033-8419
CID: 425262

IN VITRO QUANTIFICATION OF THE SIZE DISTRIBUTION OF INTRASACCULAR VOIDS LEFT AFTER ENDOVASCULAR COILING OF CEREBRAL ANEURYSMS

Sadasivan, Chander; Brownstein, Jeremy; Patel, Bhumika; Dholakia, Ronak; Santore, Joseph; Al-Mufti, Fawaz; Puig, Enrique; Rakian, Audrey; Fernandez-Prada, Kenneth D; Elhammady, Mohamed S; Farhat, Hamad; Fiorella, David J; Woo, Henry H; Aziz-Sultan, Mohammad A; Lieber, Baruch B
Endovascular coiling of cerebral aneurysms remains limited by coil compaction and associated recanalization. Recent coil designs which effect higher packing densities may be far from optimal because hemodynamic forces causing compaction are not well understood since detailed data regarding the location and distribution of coil masses are unavailable. We present an in vitro methodology to characterize coil masses deployed within aneurysms by quantifying intra-aneurysmal void spaces. Eight identical aneurysms were packed with coils by both balloon- and stent-assist techniques. The samples were embedded, sequentially sectioned and imaged. Empty spaces between the coils were numerically filled with circles (2D) in the planar images and with spheres (3D) in the three-dimensional composite images. The 2D and 3D void size histograms were analyzed for local variations and by fitting theoretical probability distribution functions. Balloon-assist packing densities (31+/-2%) were lower (p=0.04) than the stent-assist group (40+/-7%). The maximum and average 2D and 3D void sizes were higher (p=0.03 to 0.05) in the balloon-assist group as compared to the stent-assist group. None of the void size histograms were normally distributed; theoretical probability distribution fits suggest that the histograms are most probably exponentially distributed with decay constants of 6-10 mm. Significant (p<=0.001 to p=0.03) spatial trends were noted with the void sizes but correlation coefficients were generally low (absolute r<=0.35). The methodology we present can provide valuable input data for numerical calculations of hemodynamic forces impinging on intra-aneurysmal coil masses and be used to compare and optimize coil configurations as well as coiling techniques.
PMCID:3653595
PMID: 23687520
ISSN: 1869-408x
CID: 825702

Stenting in acute stroke: point

Fiorella, David; Woo, Henry H
PMID: 22933734
ISSN: 1759-8478
CID: 825762

Should neurointerventional fellowship training be suspended indefinitely? [Editorial]

Fiorella, David; Hirsch, Joshua A; Woo, Henry H; Rasmussen, Peter A; Shazam Hussain, Muhammad; Hui, Ferdinand K; Frei, Donald; Meyers, Phil M; Jabbour, Pascal; Gonzalez, L Fernando; Mocco, J; Turk, Aquilla; Turner, Raymond D; Arthur, Adam S; Gupta, Rishi; Cloft, Harry J
PMID: 22933732
ISSN: 1759-8478
CID: 825772

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

White, Christopher J; Avula, Surendra B; Mintz, Randy T; Iskander, Ayman; Chervu, Arun; Feldman, Robert L; Schermerhorn, Marc L; Woo, Henry H; Hopkins, L Nelson
BACKGROUND: Continuous improvement in carotid artery stenting (CAS) outcomes, especially for periprocedural death and stroke in high-surgical-risk patients, have been seen in recent randomized trials of CAS versus carotid endarterectomy and CAS registries. However, these studies use stringent inclusion/exclusion criteria for patient, institution, and physician selection. The Carotid Stenting Boston Scientific Surveillance Program (CABANA) study was initiated to evaluate periprocedural outcomes with modern versions of the Carotid Wallstent and FilterWire EZ System for operators with a wide range of clinical specialties, CAS experience and training levels, in patients with a broad range of high-surgical-risk conditions and lesion types. METHODS: This prospective, single-arm study enrolled 1,097 subjects with 1,098 carotid artery lesions at 99 study centers. Investigators were grouped into one of three tiers according to whether they had a high, medium, or low level of previous CAS experience and were also categorized by their CAS-credential-based training requirements for the CABANA study. Follow-up at 30 days includes clinical evaluation and independent neurological and NIH stroke scale assessments. The primary endpoint rate of 30-day composite stroke, death, and MI, as well as the rates of these individual events, will be evaluated across the overall study, by physician experience tier, and by physician training tier. DISCUSSION: The evaluation of periprocedural CAS safety in a real-world environment with modern devices in high-surgical-risk patients treated by physicians with a broad range of training and experience will better inform treatment decisions in the future.
PMID: 21805584
ISSN: 1522-1946
CID: 825972

U.S. Wingspan Registry: 12-month follow-up results

Fiorella, David J; Turk, Aquilla S; Levy, Elad I; Pride, G Lee Jr; Woo, Henry H; Albuquerque, Felipe C; Welch, Babu G; Niemann, David B; Aagaard-Kienitz, Beverly; Rasmussen, Peter A; Hopkins, L Nelson; Masaryk, Thomas J; McDougall, Cameron G
BACKGROUND AND PURPOSE: The purpose of this study is to present 12-month follow-up results for a series of patients undergoing percutaneous transluminal angioplasty and stenting with the Gateway-Wingspan stenting system (Boston Scientific) for the treatment of symptomatic intracranial atherostenosis. METHODS: Clinical and angiographic follow-up results were recorded for patients from 5 participating institutions. Primary end points were stroke or death within 30 days of the stenting procedure or ipsilateral stroke after 30 days. RESULTS: During a 21-month study period, 158 patients with 168 intracranial atherostenotic lesions (50% to 99%) were treated with the Gateway-Wingspan system. The average follow-up duration was 14.2 months with 143 patients having at least 3 months of clinical follow-up and 110 having at least 12 months. The cumulative rate of the primary end point was 15.7% for all patients and 13.9% for patients with high-grade (70% to 99%) stenosis. Of 13 ipsilateral strokes occurring after 30 days, 3 resulted in death. Of these strokes, 76.9% (10 of 13) occurred within the first 6 months of the stenting procedure and no events were recorded after 12 months. An additional 9 patients experienced ipsilateral transient ischemic attack after 30 days. Most postprocedural events (86%) could be attributed to interruption of antiplatelet medications (n=6), in-stent restenosis (n=12), or both (n=1). In 3 patients, the events were of uncertain etiology. CONCLUSIONS: After successful Wingspan percutaneous transluminal angioplasty and stenting, some patients continued to experience ipsilateral ischemic events. Most of these ischemic events occurred within 6 months of the procedure and were associated with the interruption of antiplatelet therapy or in-stent restenosis.
PMID: 21636812
ISSN: 0039-2499
CID: 826012

Thromboembolic events associated with endovascular treatment of cerebral aneurysms

Altay, Tamer; Kang, Hee I; Woo, Henry H; Masaryk, Thomas J; Rasmussen, Peter A; Fiorella, David J; Moskowitz, Shaye I
OBJECTIVE: To evaluate the rate of peri-procedural thromboembolic events after the endovascular treatment of cerebral aneurysms. The rate of diffusion-positive lesions was assessed in relation to selected procedural and technical factors. METHODS: 184 patients treated with coil embolization (198 total procedures) between July 2004 and February 2007 were included. In 65, the procedure was coiling alone; in 55, coiling with balloon remodeling; in 48, coiling with Neuroform stenting; and in 30, coiling, Neuroform stenting and balloon remodeling. All patients underwent a routine diffusion weighted magnetic resonance imaging (DWI) within the 72 h after the intervention for the detection of ischemic complications. RESULTS: Regardless of the technique used, thromboembolic complications were more common (p<0.0001) in patients with ruptured aneurysms (33/65, 51%) than in those with unruptured aneurysms (40/133, 30%). Balloon remodeling tended to be associated with a lower rate of DWI positivity than the other techniques. Younger patients (
PMID: 21990807
ISSN: 1759-8478
CID: 825952