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1. Mid-term safety and efficacy in small intracranial aneurysm coiling: results from TARGET® nano prospective independent core lab adjudicated multicenter registry

Author

Yazan Ashouri, Alexandra R. Paul, Ajit Puri, Nicholas Liaw, Aniel Majjhoo, Asif Taqi, Ansaar Rai, Aamir Badruddin, Amer Alshekhlee, Bharath Naravetla, Mahmoud Rayes, Matthew Lawson, Batool Al Masaid, Claire Langerford, Qaisar Shah, Karen Beaty, Eugene Lin, Tanner Gray-Duvall, Jasmine Olvany, Hannah Slight, Varun Chaubal, Saif Bushnaq, Benedict Tan, Mohammad Al Majali, Lucas Elijovich, Peter Sunenshine, and Osama O. Zaidat

Subjects
intracranial aneurysm, coiling, TARGET, nano coils, safety, efficacy, Neurology. Diseases of the nervous system, RC346-429
Abstract

BackgroundThe primary objective is to evaluate the safety and effectiveness of Stryker second generation Target® Nano Coils in the treatment of ruptured and unruptured small (

Published
2024
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2. The WOVEN trial: Wingspan One-year Vascular Events and Neurologic Outcomes

Author

Alexander, Michael J, Zauner, Alois, Gupta, Rishi, Alshekhlee, Amer, Fraser, Justin F, Toth, Gabor, Given, Curtis, Mackenzie, Larami, Kott, Brian, Hassan, Ameer E, Shownkeen, Harish, Baxter, Blaise W, Callison, R Charles, and Yu, Wengui

Subjects
Neurosciences, Clinical Research, Brain Disorders, Clinical Trials and Supportive Activities, Stroke, Aged, Cohort Studies, Constriction, Pathologic, Female, Follow-Up Studies, Humans, Intracranial Arteriosclerosis, Male, Middle Aged, Mortality, Nervous System Diseases, Stents, Treatment Outcome, stent, stenosis, atherosclerosis, intervention, stroke
Abstract

BackgroundPrior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate.ObjectiveThis WOVEN study assesses the 1-year follow-up from this cohort.MethodsTwelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis.ResultsIn the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up.ConclusionsThe WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.

Published
2021

3. Abstract 011: Endovascular therapy for acute ischemic stroke utilizing SOFia Aspiration System as first line Technique (SOFAST)

Author

Dheeraj Gandhi, Daniel Sahlein, Syed Zaidi, Lucian Maidan, Kenneth Kreitel, Timothy Miller, Scott Rahimi, Amer Alshekhlee, Henry Woo, Gabor Toth, Clemens Schirmer, Vince Loh, and David Fiorella

Subjects
Neurology. Diseases of the nervous system, RC346-429, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction Mechanical thrombectomy using stent retrievers and aspiration techniques has emerged as the standard of care for patients with acute ischemic stroke (AIS) secondary to emergent large vessel occlusion (LVO). This study intended to collect real‐world clinical evidence on the safety and effectiveness of endovascular treatment of AIS using the SOFIA Flow Plus 6F aspiration catheter. The primary endpoint was the proportion of subjects achieving mTICI ≥2b. Secondary endpoints included good functional outcomes (mRS 0‐2) at Day 90, revascularization time, first line and first pass mTICI ≥2b, occurrence of procedure‐related SAEs, vasospasm involving the accessed vascular tree, embolization to new territories (ENTs), symptomatic intracerebral hemorrhage (sICH) within 24 hours and mortality at Day 90. Methods SOFAST was a prospective, multicenter, single‐arm, observational post‐market study. The enrolled subjects were ≥21 and ≤85 years with large vessel (ICA or MCA) proximal occlusion, pre‐morbid mRS ≤1, baseline NIHSS ≥5, and for whom groin puncture was within 8 hours of symptom onset. A total of 108 patients were enrolled and treated using aspiration thrombectomy with SOFIA 6F as the first line treatment device. Patients were followed at 24 hours, 7 days/discharge, and 90 days post‐procedure. Cerebral angiography was performed pre‐ and post‐procedure. Clinical assessments included the NIHSS and mRS scales. All neurological, device‐related, and procedure‐related AEs and deaths were adjudicated by independent medical reviewers. Angiographic and other imaging data was adjudicated by an independent core laboratory. Results A total of 108 subjects were enrolled (mean age 62.7 years, 50% men) with a median NIHSS of 15.5. Of 108 subjects, 97.2% (105/108), 85.2% (92/108) and 55.6% (60/108) achieved mTICI ≥2b, ≥2c and =3 revascularization, respectively. With first line aspiration using SOFIA 6F, 87.0%, 79.6% and 52.8% achieved mTICI ≥2b, ≥2c and =3 revascularization, respectively. Median number of passes was one (range 1‐3). First pass rate of mTICI 2c or 3 using SOFIA 6F was 70.4%, of which 50.9% patients achieved mTICI score of 3. Mean duration from groin puncture to initial clot contact was 13.0 min and to successful revascularization was 17.9 min. Good functional outcome was achieved in 66.7% (72/108) of subjects at Day 90 (mRS 0‐2), procedure‐related SAEs occurred in 2.8% (3/108) of subjects and sICH in 0.9% (1/108) of subjects within 24 hours. Procedural vasospasm was recorded in in 9.3% (10/108) of subjects, and mortality in 7.4% (8/108) subjects at Day 90 (none related to the study device). No ENTs occurred. Conclusion In SOFAST study, mTICI ≥2b revascularization was achieved in the majority of patients at the end of all procedures (97.2%) and with first line treatment (87.0%) with a large fraction of these subjects achieving mTICI ≥2c following the first SOFIA 6F pass (70.4%). Durations from groin puncture to clot contact and successful revascularization were relatively short. The study presented high rates of good functional outcome at Day 90 and low rates of safety events. In summary, the study provides encouraging evidence of the safety and effectiveness of the SOFIA 6F device for aspiration thrombectomy in acute ischemic stroke subjects.

Published
2023
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4. Pivotal Trial of the Neuroform Atlas Stent for Treatment of Anterior Circulation Aneurysms

Author

Zaidat, Osama O, Hanel, Ricardo A, Sauvageau, Eric A, Aghaebrahim, Amin, Lin, Eugene, Jadhav, Ashutosh P, Jovin, Tudor G, Khaldi, Ahmad, Gupta, Rishi G, Johnson, Andrew, Frei, Donald, Loy, David, Malek, Adel, Toth, Gabor, Siddiqui, Adnan, Reavey-Cantwell, John, Thomas, Ajith, Hetts, Steven W, Jankowitz, Brian T, Gross, Bradley, Ducruet, Andrew, Panczkowski, David, Shoirah, Hazem, Al-Bayati, Alhamza, Weiner, Greg, Kenmuir, Cynthia, Tadi, Prasanna, Walker, Gregory, Johnson, K, Frei, Don, Bellon, Richard, Atchie, Benjamin, Kaminsky, Ian, Huddle, Dan, Bain, Mark, Rasmussen, Peter, Hussain, M Shazam, Moore, Nina, Masaryk, Thomas, Elgabaly, Mohamed, Cerejo, Russell, Hardman, Julian, John, Seby, Bauer, Andrew, Peih-Chir Tsai, Jenny, Levy, Elad, Snyder, Kenneth, Davies, Jason, Ogilvy, Christopher, Rivet, Dennis, Alexander, Michael, Moser, Franklin, Maya, Marcel, Schiraldi, Michael, Eboli, Paula, Caplan, Justin, Jiang, Bowen, Bender, Matthew, Colby, Geoffrey, Satti, Sudhakar, Sivapatham, Thinesh, Kung, David, Pukenas, Bryan, Hurst, Robert, Smith, Michelle J, Puri, Ajit, Massari, Francesco, Rex, David, Fraser, Justin, Grupke, Stephen, Alhajeri, Abdulnasser, Klucznik, Richard, Diaz, Orlando, Britz, Gavin, Zhan, Yi, Spiotta, Alejandro, Lena, Jonathan, Turk, Aquilla, Chaudry, Mohamad, Fargen, Kyle, Turner, Raymond, Kan, Peter, Duckworth, Edward, Asif Taqi, Muhammad, Hou, Samuel, Arthur, Adam S, Elijovich, Lucas, Hoit, Daniel, Nickele, Christopher, Vachhani, Jay, Thomas Doss, Vinodh, Crowley, Richard, Lopes, Demetrius, Chen, Michael, Hallam, Danial, Ghodke, Basavaraj, Kim, Louis, Callison, Richard, Alshekhlee, Amer, and Kale, Sushant

Subjects
Bioengineering, Stroke, Assistive Technology, Neurosciences, Clinical Research, Clinical Trials and Supportive Activities, Brain Disorders, Adult, Aged, Embolization, Therapeutic, Endovascular Procedures, Female, Humans, Intracranial Aneurysm, Male, Middle Aged, Stents, Treatment Outcome, angiography, intracranial aneurysm, middle cerebral artery, retreatment, stent, ATLAS Investigators, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Neurology & Neurosurgery
Abstract

Background and purposeStent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented.MethodsATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio 50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee.ResultsA total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%-90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%-8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death.ConclusionsIn the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and

Published
2020

6. Thrombectomy for Stroke With Large Infarct on Noncontrast CT: The TESLA Randomized Clinical Trial.

Author

Yoo, Albert J., Zaidat, Osama O., Sheth, Sunil A., Rai, Ansaar T., Ortega-Gutierrez, Santiago, Given II, Curtis A., Zaidi, Syed F., Grandhi, Ramesh, Cuellar, Hugo, Mokin, Maxim, Katz, Jeffrey M., Alshekhlee, Amer, Taqi, Muhammad A., Ansari, Sameer A., Siddiqui, Adnan H., Barazangi, Nobl, English, Joey D., Maud, Alberto, Kirmani, Jawad, and Gupta, Rishi

Subjects
INTRACRANIAL hemorrhage, MEDICAL care, ENDOVASCULAR surgery, SUBARACHNOID hemorrhage, STROKE
Abstract

Key Points: Question: Does endovascular thrombectomy improve functional outcome in patients with a large infarct on noncontrast computed tomographic (CT) scan within 24 hours of stroke onset? Findings: In this randomized trial of 300 patients, thrombectomy did not significantly improve 90-day functional outcome compared with medical management alone for the primary end point (adjusted difference in utility-weighted modified Rankin Scale score, 0.63). Meaning: Among patients with large infarct detected by noncontrast CT and presenting within 24 hours, thrombectomy did not significantly improve functional outcome at 90 days. Importance: Recent large infarct thrombectomy trials used heterogeneous imaging modalities and time windows for patient selection. Noncontrast computed tomographic (CT) scan is the most common stroke imaging approach. It remains uncertain whether thrombectomy is effective for patients with large infarcts identified using noncontrast CT alone within 24 hours of stroke onset. Objective: To evaluate the effect of thrombectomy in patients with a large infarct on a noncontrast CT scan within 24 hours of onset. Design, Setting, and Participants: Open-label, blinded–end point, bayesian-adaptive randomized trial with interim analyses for early stopping (futility or success) or population enrichment, which was conducted at 47 US academic and community-based stroke thrombectomy centers. Three hundred patients presenting within 24 hours with anterior-circulation, large-vessel occlusion and large infarct on noncontrast CT scan, with Alberta Stroke Program Early CT Scores of 2 to 5, were randomized to undergo thrombectomy or usual care. Enrollment occurred July 16, 2019 to October 17, 2022; final follow-up, January 25, 2023. Intervention: The intervention patients (n = 152) underwent endovascular treatment using standard thrombectomy devices and usual medical care. Control patients (n = 148) underwent usual medical care alone. Main Outcomes and Measures: The primary efficacy end point was improvement in 90-day functional outcome measured using mean utility-weighted modified Rankin Scale (UW-mRS) scores (range, 0 [death or severe disability] to 10 [no symptoms]; minimum clinically important difference, 0.3). A bayesian model determined the posterior probability that the intervention would be superior to usual care; statistical significance was a 1-sided posterior probability of.975 or more. The primary adverse event end point was 90-day mortality; secondary adverse event end points included symptomatic intracranial hemorrhage and radiographic intracranial hemorrhage. Results: The trial enrolled 300 patients (152 intervention, 148 control; 138 females [46%]; median age, 67 years), without early stopping or enrichment; 297 patients completed the 90-day follow-up. The mean (SD) 90-day UW-mRS score was 2.93 (3.39) for the intervention group vs 2.27 (2.98) for the control group with an adjusted difference of 0.63 (95% credible interval [CrI], −0.09 to 1.34; posterior probability for superiority of thrombectomy,.96). The 90-day mortality was similar between groups: 35.3% (53 of 150) for the intervention group vs 33.3% (49 of 147) for the control group. Six of 151 patients (4.0%) in the intervention group and 2 of 149 (1.3%) in the control group experienced 24-hour symptomatic intracranial hemorrhage. Fourteen patients of 148 (9.5%) in the intervention group vs 4 of 146 (2.7%) in the control group experienced parenchymal hematoma type 1 hemorrhages; 14 (9.5%) in the intervention group vs 5 (3.4%) in the control group experienced parenchymal hematoma type 2 hemorrhages; and 24 (16.2%) in the intervention group vs 9 (6.2%) in the control group experienced subarachnoid hemorrhages. Conclusions and Relevance: Among patients with a large infarct on noncontrast CT within 24 hours, thrombectomy did not demonstrate improvement in functional outcomes. But the width of the credible interval around the effect estimate includes the possibility of both no important effect and a clinically relevant benefit, so the potential role of thrombectomy with this imaging approach and time window will likely require additional study. Trial Registration: ClinicalTrials.gov Identifier: NCT03805308 This clinical trial evaluates whether endovascular thrombectomy and usual medical care vs medical care alone improves functional outcomes among patients who present within 24 hours after symptom onset with anterior-circulation, large-vessel occlusion, and large infarct detected by noncontrast CT scan. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Mid-term safety and efficacy in small intracranial aneurysm coiling: results from TARGET® nano prospective independent core lab adjudicated multicenter registry

Author

Ashouri, Yazan, primary, Paul, Alexandra R., additional, Puri, Ajit, additional, Liaw, Nicholas, additional, Majjhoo, Aniel, additional, Taqi, Asif, additional, Rai, Ansaar, additional, Badruddin, Aamir, additional, Alshekhlee, Amer, additional, Naravetla, Bharath, additional, Rayes, Mahmoud, additional, Lawson, Matthew, additional, Al Masaid, Batool, additional, Langerford, Claire, additional, Shah, Qaisar, additional, Beaty, Karen, additional, Lin, Eugene, additional, Gray-Duvall, Tanner, additional, Olvany, Jasmine, additional, Slight, Hannah, additional, Chaubal, Varun, additional, Bushnaq, Saif, additional, Tan, Benedict, additional, Al Majali, Mohammad, additional, Elijovich, Lucas, additional, Sunenshine, Peter, additional, and Zaidat, Osama O., additional

Published
2024
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9. Long-term effect of thymectomy plus prednisone versus prednisone alone in patients with non-thymomatous myasthenia gravis: 2-year extension of the MGTX randomised trial

Author

Cutter, Gary, Aban, Inmaculada, Minisman, Greg, Feese, Michelle, Kuo, Hui-Chien, Newsom-Davis, John, Wolfe, Gil, Kaminski, Henry, Jaretzki, Alfred, Sonett, Joshua, Mazia, Claudio, Saluto, Valeria, Rosenberg, Moises, Alvarez, Valeria, Rey, Lisa, King, John, Butzkueven, Helmut, Goldblatt, John, Carey, John, Pollard, John, Reddel, Stephen, Handel, Nicholas, McCaughan, Brian, Pallot, Linda, Waddington-Cruz, Márcia, Novis, Ricardo, Boasquevisque, Carlos, Dias-Tosta, Elza, Morato-Fernandez, Rubens, Ximenes, Manoel, Werneck, Lineu, Scola, Rosana, Soltoski, Paulo, Chalk, Colin, Moore, Fraser, Mulder, David, Wadup, Lisa, Oger, Joel, Mezei, Michele, Evans, Kenneth, Jiwa, Theresa, Schaffar, Anne, White, Chris, Toth, Cory, Gelfand, Gary, Wood, Susan, Pringle, Elizabeth, Zwicker, Jocelyn, Maziak, Donna, Shamji, Farid, Sundaresan, Sudhir, Seely, Andrew, Cea, Gabriel, Verduga, Renato, Aguayo, Alberto, Jander, Sebastian, Zickler, Philipp, Klein, Michael, Marx, Alexander, Ströbel, Philipp, Weis, Cleo-Aron, Melms, Arthur, Bischof, Felix, Aebert, Hermann, Ziemer, Gerhard, Nix, Wilfred, Thümler, Björn, Wilhem-Schwenkmezger, Thomas, Mayer, Eckhard, Schalke, Berthold, Pöschel, Peter, Hieber, Gisela, Wiebe, Karsten, Antonini, Giovanni, Clemenzi, Alessandro, Ceschin, Vanessa, Rendina, Erino, Venuta, Federico, Morino, Stefania, Bucci, Elisabetta, Durelli, Luca, Tavella, Alessia, Clerico, Marinella, Contessa, Giulia, Borasio, Piero, Evoli, Amelia, Servidei, Serenella, Granone, Pierluigi, Mantegazza, Renato, Berta, Emilia, Novellino, Lorenzo, Spinelli, Luisa, Motomura, Masakatsu, Matsuo, Hidenori, Nagayasu, Takeshi, Yoshikawa, Hiroaki, Takamori, Masaharu, Oda, Makoto, Matsumoto, Isao, Furukawa, Yutaka, Noto, Daisuke, Motozaki, Yuko, Iwasa, Kazuo, Yanase, Daisuke, Garcia Ramos, Guillermo, Cacho, Bernardo, de la Garza, Lorenzo, Kostera-Pruszczyk, Anne, Lipowska, Marta, Kwiecinski, Hubert, Potulska-Chromik, Anna, Orlowski, Tadeusz, Silva, Ana, Feijo, Marta, Freitas, António, Heckmann, Jeannine, Frost, Andrew, Pan, Edward, Tucker, Lawrence, Rossouw, Johan, Drummond, Fiona, Illa, Isabel, Diaz, Jorge, Leon, Carlos, Yeh, Jiann-Horng, Chiu, Hou-Chang, Hsieh, Yei-San, Witoonpanich, Rawiphan, Tunlayadechanont, Supoch, Attanavanich, Sukasom, Verschuuren, Jan, Straathof, Chiara, Titulaer, Maarten, Versteegh, Michel, Pels, Arda, Krum, Yvonne, Buckley, Camilla, Leite, M. Isabel, Vincent, Angela, Hilton-Jones, David, Ratnatunga, Chandi, Farrugia, Maria, Petty, Richard, Overell, James, Kirk, Alan, Gibson, Andrew, McDermott, Chris, Hopkinson, David, Lecky, Bryan, Watling, David, Marshall, Dot, Saminaden, Sam, Davies, Deborah, Dougan, Charlotte, Sathasivam, Siva, Page, Richard, Sussman, Jon, Ealing, John, Krysiak, Peter, Amato, Anthony, Salajegheh, Mohammad, Jaklitsch, Michael, Roe, Kristen, Ashizawa, Tetsuo, Smith, Robert Glenn, Zwischenberg, Joseph, Stanton, Penny, Barboi, Alexandru, Jaradeh, Safwan, Tisol, William, Gasparri, Mario, Haasler, George, Yellick, Mary, Dennis, Cedric, Barohn, Richard, Pasnoor, Mamatha, Dimachkie, Mazen, McVey, April, Gronseth, Gary, Dick, Arthur, Kramer, Jeffrey, Currence, Melissa, Herbelin, Laura, Belsh, Jerry, Li, George, Langenfeld, John, Mertz, Mary Ann, Benatar, Michael, Harrison, Taylor, Force, Seth, Usher, Sharon, Beydoun, Said, Lin, Frank, DeMeester, Steve, Akhter, Salem, Malekniazi, Ali, Avenido, Gina, Crum, Brian, Milone, Margherita, Cassivi, Stephen, Fisher, Janet, Ciafaloni, Emma, Heatwole, Chad, Watson, Thomas, Hilbert, James, Smirnow, Alexis, Distad, B. Jane, Weiss, Michael, Wood, Douglas, Haug, Joanna, Ernstoff, Raina, Cao, Jingyang, Chmielewski, Gary, Welsh, Robert, Duris, Robin, Gutmann, Laurie, Pawar, Gauri, Graeber, Geoffrey Marc, Altemus, Patricia, Nance, Christopher, Gutmann, Ludwig, Jackson, Carlayne, Grogan, Patrick, Calhoon, John, Kittrell, Pamela, Myers, Deborah, Hayat, Ghazala, Naunheim, Keith, Eller, Susan, Holzemer, Eve, Katirji, Bashar, Alshekhlee, Amer, Robke, Jason, Karlinchak, Brenda, Katz, Jonathan, Miller, Robert, Roan, Ralph, Forshew, Dallas, Kissel, John, Elsheikh, Bakri, Ross, Patrick, Chelnick, Sharon, Lewis, Richard, Acsadi, Agnes, Baciewicz, Frank, Masse, Stacey, Massey, Janice, Juel, Vern, Onaitis, Mark, Lowe, James, Lipscomb, Bernadette, Mozaffar, Tahseen, Thai, Gaby, Milliken, Jeffrey, Martin, Veronica, Karayan, Ronnie, Muley, Suraj, Parry, Gareth, Shumway, Sara, Oh, Shin, Claussen, Gwen, Lu, Liang, Cerfolio, Robert, Young, Angela, Morgan, Marla, Pascuzzi, Robert, Kincaid, John, Kesler, Kenneth, Guingrich, Sandy, Michaels, Angi, Phillips, Lawrence, Burns, Ted, Jones, David, Fischer, Cindy, Pulley, Michael, Berger, Alan, D'Agostino, Harry, Smith, Lisa, Rivner, Michael, Pruitt, Jerry, Landolfo, Kevin, Hillman, Demetric, Shaibani, Aziz, Sermas, Angelo, Ruel, Ross, Ismail, Farah, Sivak, Mark, Goldstein, Martin, Camunas, Jorge, Bratton, Joan, Tandan, Rup, Panitch, Hill, Leavitt, Bruce, Jones, Marilee, Muppidi, Srikanth, Vernino, Steven, Nations, Sharon, Meyer, Dan, Gorham, Nina, Wolfe, Gil I, Kaminski, Henry J, Aban, Inmaculada B, Cea, J Gabriel, Heckmann, Jeannine M, King, John O, Beydoun, Said R, Chalk, Colin H, Barboi, Alexandru C, Amato, Anthony A, Shaibani, Aziz I, Lecky, Bryan R F, Pulley, Michael T, Rivner, Michael H, Kostera-Pruszczyk, Anna, Pascuzzi, Robert M, Jackson, Carlayne E, Verschuuren, Jan J G M, Massey, Janice M, Kissel, John T, Werneck, Lineu C, Barohn, Richard J, Silvestri, Nicholas J, Conwit, Robin, Sonett, Joshua R, Jaretzki, Alfred, III, and Cutter, Gary R

Published
2019
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10. Abstract 011: Endovascular therapy for acute ischemic stroke utilizing SOFia Aspiration System as first line Technique (SOFAST)

Author

Gandhi, Dheeraj, primary, Sahlein, Daniel, additional, Zaidi, Syed, additional, Maidan, Lucian, additional, Kreitel, Kenneth, additional, Miller, Timothy, additional, Rahimi, Scott, additional, Alshekhlee, Amer, additional, Woo, Henry, additional, Toth, Gabor, additional, Schirmer, Clemens, additional, Loh, Vince, additional, and Fiorella, David, additional

Published
2023
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16. First Pass Effect in Patients Treated With the Trevo Stent-Retriever: A TRACK Registry Study Analysis

Author

Maxim Mokin, Christopher T. Primiani, Alicia C. Castonguay, Raul G. Nogueira, Diogo C. Haussen, Joey D. English, Sudhakar R. Satti, Jennifer Chen, Hamed Farid, Candace Borders, Erol Veznedaroglu, Mandy J. Binning, Ajit Puri, Nirav A. Vora, Ron F. Budzik, Guilherme Dabus, Italo Linfante, Vallabh Janardhan, Amer Alshekhlee, Michael G. Abraham, Randall Edgell, Muhammad Asif Taqi, Ramy El Khoury, Aniel Q. Majjhoo, Mouhammed R. Kabbani, Michael T. Froehler, Ira Finch, Sameer A. Ansari, Roberta Novakovic, Thanh N. Nguyen, and Osama O. Zaidat

Subjects
stroke, Ischemia—reperfusion, endovascualar treatment, thrombectomy, brain, Neurology. Diseases of the nervous system, RC346-429
Abstract

Background and Objective: The first pass effect (FPE; achieving complete recanalization with a single thrombectomy device pass) has been shown to be associated with higher rates of good clinical outcomes in patients with acute ischemic stroke. Here, we investigate clinical and radiographic factors associated with FPE in a large U.S. post-marketing registry (TRACK, Trevo Stent-Retriever Acute Stroke).Methods: We analyzed the TRACK database (multicenter registry of 634 patients from 23 centers from March 2013 through August 2015), which 609 patients were included in the final analysis. FPE was defined as a single pass/use of device, TICI 2c/3 recanalization, and no use of rescue therapy. Analysis of individual patient data from TRACK were performed to analyze clinical and radiographic characteristics associated with FPE as well-compared clinical outcomes defined as modified Rankin Scale (mRS) score at 30 and 90 days from hospital discharge to the non-FPE group.Results: The rate of FPE in TRACK was 23% (140/609). There was no association between patient demographics and FPE, including age (p = 0.36), sex (p = 0.50), race (p = 0.50), location of occlusion (p = 0.26), baseline NIHSS (p = 0.62), or past medical history. There was no difference in the use of a balloon-guide catheter or general anesthesia (49 and 57% with FPE vs. 47 and 64%, p = 0.63 and p = 0.14, respectively). Clinical outcomes were significantly associated with FPE; 63 vs. 44% in non-FPE patients achieved mRS 0–2 at 90 days (p = 0.0004).Conclusion: Our study showed that achieving complete recanalization with a single thrombectomy pass using the Trevo device was highly beneficial. The most common clinical factors that are used to determine eligibility for endovascular therapy, such as NIHSS severity, location of occlusion or patient age were not predictive of the ability to achieve FPE.

Published
2020
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17. Site Experience and Outcomes in the Trevo Acute Ischemic Stroke (TRACK) Multicenter Registry: Higher Volumes Translate in Better Outcomes

Author

Nogueira, Raul G., Haussen, Diogo C., Castonguay, Alicia, Rebello, Leticia C., Abraham, Michael, Puri, Ajit, Alshekhlee, Amer, Majjhoo, Aniel, Farid, Hamed, Finch, Ira, English, Joey, Mokin, Maxim, Froehler, Michael T., Kabbani, Mo, Taqi, Muhammad A., Vora, Nirav, Khoury, Ramy El, Edgell, Randall C., Novakovic, Roberta, Nguyen, Thanh, Janardhan, Vallabh, Veznedaroglu, Enrol, Prabhakaran, Shyam, Budzik, Ron, Frankel, Michael R., Nordhaus, Brittany L., and Zaidat, Osama O.

Published
2019
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18. TARGET® Intracranial Aneurysm Coiling Prospective Multicenter Registry: Final Analysis of Peri-Procedural and Long-Term Safety and Efficacy Results

Author

Osama O. Zaidat, Alicia C. Castonguay, Ansaar T. Rai, Aamir Badruddin, William J. Mack, Amer K. Alshekhlee, Qaisar A. Shah, Syed I. Hussain, Mouhammed R. Kabbani, Ketan R. Bulsara, Asif M. Taqi, Vallabh Janardhan, Mary S. Patterson, Brittany L. Nordhaus, Lucas Elijovich, and Ajit S. Puri

Subjects
aneurysm, coiling, ruptured aneurysm, occlusion, target coils, target registry, Neurology. Diseases of the nervous system, RC346-429
Abstract

Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils.Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes.Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1–67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0–6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0–2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3–41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients.Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT01748903

Published
2019
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19. Intraarterial Treatment Versus No Intraarterial Treatment within 24 Hours in Patients with Ischaemic Stroke and Large Infarct on Noncontrast CT (TESLA): A Multicentre, Open-Label, Blinded-Endpoint, Randomised, Controlled, Phase 3 Trial

Author

Yoo, Albert J., primary, Zaidat, Osama O., additional, Al Kasab, Sami, additional, Sheth, Sunil A., additional, Rai, Ansaar T., additional, Ortega-Gutierrez, Santiago, additional, Given, Curtis A., additional, Zaidi, Syed F., additional, Grandhi, Ramesh, additional, Cuellar, Hugo, additional, Mokin, Maxim, additional, Katz, Jeffrey M., additional, Alshekhlee, Amer, additional, Taqi, Muhammad A., additional, Ansari, Sameer A., additional, Siddiqui, Adnan H., additional, Barazangi, Nobl, additional, English, Joey D., additional, Maud, Alberto, additional, Kirmani, Jawad, additional, Gupta, Rishi, additional, Yavagal, Dileep, additional, Tarpley, Jason, additional, Pandya, Dhruvil J., additional, Cress, Marshall C., additional, Dharmadhikari, Sushrut, additional, Asif, Kaiz, additional, Kass-Hout, Tareq, additional, Puri, Ajit S., additional, Janjua, Nazli, additional, Majjhoo, Aniel, additional, Badruddin, Aamir, additional, Edgell, Randall C., additional, Khatri, Rakesh, additional, Morgan, Larry, additional, Razak, Anmar, additional, Zha, Alicia, additional, Khandelwal, Priyank, additional, Mueller-Kronast, Nils H., additional, Rivet, Dennis J., additional, Wolfe, Thomas, additional, Snelling, Brian, additional, Sultan-Qurraie, Ali, additional, Lin, Shao-Pow, additional, Khangura, Rajkamal, additional, Spiotta, Alejandro, additional, Bhuva, Parita, additional, Salazar-Marioni, Sergio, additional, Lin, Eugene, additional, Tarabishy, Abdul R., additional, Samaniego, Edgar A., additional, Kolikonda, Murali, additional, Jumaa, Mouhammad A., additional, Reddy, Vivek K., additional, Sharma, Pankaj, additional, Berkhemer, Olvert A., additional, van Doormaal, Pieter Jan, additional, van Es, Adriaan C.G.M, additional, van Zwam, Wim H., additional, Emmer, Bart J., additional, Beenen, Ludo, additional, Buderer, Nancy, additional, Detry, Michelle A., additional, Bosse, Anna, additional, Graves, Todd L., additional, Saunders, Christina, additional, Elijovich, Lucas, additional, Jadhav, Ashutosh, additional, Brown, Scott, additional, Nguyen, Thanh N., additional, Gress, Daryl, additional, Patterson, Mary, additional, Slight, Hannah, additional, Below, Kristine, additional, Dippel, Diederik W.J., additional, Smith, Wade S., additional, and Investigators, TESLA, additional

Published
2023
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21. Predictors of Outcomes in Patients With Mild Ischemic Stroke Symptoms: MaRISS

Author

Jose G. Romano, Hannah Gardener, Iszet Campo-Bustillo, Yosef Khan, Sofie Tai, Nikesha Riley, Eric E. Smith, Ralph L. Sacco, Pooja Khatri, Heather M. Alger, Brian Mac Grory, Deepak Gulati, Navdeep S. Sangha, Jeffrey M. Craig, Karin E. Olds, Curtis G. Benesch, Adam G. Kelly, Scott S. Brehaut, Amit C. Kansara, Lee H. Schwamm, Mayumi Oka, Christina Roels, Cherylee W. J. Chang, Jennifer Moran, Nicholas Lanciano, Charles E. Romero, David Salvatore, Neel Shah, Rodney Leacock, Angel Rochester, Jerry C. Martin, Vikas Grover, Maheen Malik, William R. Logan, Muhib A Khan, Arun Babu, Jestin Carlson, Gabriel Vidal, Jennifer Lynch, Kathryn Kirchoff, Jennifer Rasmussen-Winkler, Gary Thompson, Stephen Martino, Gillian L. Gordon-Perue, Kasey Gildersleeve, Timothy C. Parsons, John W. Chen, David Lombardi, Amer Malik, Amy Guzik, Robert Hoesch, Dorothea Altschul, Miran Salgado, Indrani Acosta, Terry A. Neill, Abhineet Chowdhary, Jose Rafael Romero, Refat Assad, Rebecca Sugg, Muhammad M. Alvi, Jonathan Hartman, Ankur Garg, Curtis Given, Jeffrey Hilburn, Christopher Commichau, Changsoo Hahm, Angel Pulido, Nima Ramezan-Arab, Anna Khanna, Armistead Williams, Ratna Reddy, Bhupat Desai, Laurence Ufford, Keith O. Jones, Elizabeth H. Wise, Gauhar Chaudhary, Joseph Hanna, Franklin Marden, Ajay Arora, Raymond Reichwein, Kelly Matmati, Kumiko Owada, Ashish Masih, Larry Shepherd, Stephen Gancher, Matthew Smith, Joseph Mazzola, Edward Plyler, James Napier, Amer Alshekhlee, Tarakad Ramachandran, Michael Jorolemon, David, Padalino Collin Maloney, Laxmi P. Dhakal, Truman J. Milling, Harish Shownkeen, Paul A. Cullis, Sajjad Mueed, Steven R. Levine, Kanwal Nayyar, Rose Dotson, Elisheva Coleman, Rajan Gadhia, Paul W. Lewis, Rehan Sajjad, Angelos Katramados, Rashmikant Kothari, Fen Lei Chang, Kinjal Desai, Gary Reese, Ashu Jadhav, Jeffrey Saver, Janice A. Miller, and Matthew S. Tenser

Subjects
Male, medicine.medical_specialty, Sex Factors, Risk Factors, Internal medicine, medicine, Humans, In patient, Prospective Studies, cardiovascular diseases, Stroke, Aged, Ischemic Stroke, Aged, 80 and over, Advanced and Specialized Nursing, business.industry, Age Factors, Middle Aged, medicine.disease, Ischemic Attack, Transient, Tissue Plasminogen Activator, Ischemic stroke, Quality of Life, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business
Abstract

Background and Purpose: Although most strokes present with mild symptoms, these have been poorly represented in clinical trials. The objective of this study is to describe multidimensional outcomes, identify predictors of worse outcomes, and explore the effect of thrombolysis in this population. Methods: This prospective observational study included patients with ischemic stroke or transient ischemic attack, a baseline National Institutes of Health Stroke Scale (NIHSS) score 0 to 5, presenting within 4.5 hours from symptom onset. The primary outcome was a 90-day modified Rankin Scale score of 0 to 1; secondary outcomes included good outcomes in the Barthel Index, Stroke Impact Scale-16, and European Quality of Life. Multivariable models were created to determine predictors of outcomes and the effect of alteplase. Results: A total of 1765 participants were included from 100 Get With The Guidelines-Stroke participating hospitals (age, 65±14; 42% women; final diagnosis of ischemic stroke, 90%; transient ischemic attack, 10%; 57% received alteplase). At 90 days, 37% were disabled and 25% not independent. Worse outcomes were noted for older individuals, women, non-Hispanic Blacks and Hispanics, Medicaid recipients, smokers, those with diabetes, atrial fibrillation, prior stroke, higher baseline NIHSS, visual field defects, and extremity weakness. Similar outcomes were noted for the alteplase-treated and untreated groups. Alteplase-treated patients were younger (64±13 versus 67±1.4) with higher NIHSS (2.9±1.4 versus 1.7±1.4). After adjusting for age, sex, race/ethnicity, and baseline NIHSS, we did not identify an effect of alteplase on the primary outcome but did find an association with Stroke Impact Scale-16 in the restricted sample of baseline NIHSS score 3–5. Few symptomatic intracerebral hemorrhages were recorded ( Conclusions: A large proportion of stroke patients presenting with low NIHSS have a disabled outcome. Baseline predictors of worse outcomes are described. An effect of alteplase on outcomes was not identified in the overall cohort, but a suggestion of efficacy was noted in the NIHSS 3–5 subgroup. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02072681.

Published
2021

22. Hospital Mortality Associated with Stroke in Southern Iran

Author

Afshin Borhani-Haghighi, Rasool Safari, Seyed Taghi Heydari, Faroq Soleimani, Maryam Sharifian, Sara Yektaparast Kashkuli, Mahsa Nayebi Khayatghuchani, Mahbube Azadi, Abdolhamid Shariat, Anahid Safari, Kamran Bagheri Lankarani, Amer Alshekhlee, and Salvador Cruz-Flores

Subjects
Stroke, Cerebrovascular disease, Cerebrovascular accident, Mortality, Sex, Medicine (General), R5-920
Abstract

Background: Unlike the western hemisphere, information about stroke epidemiology in southern Iran is scarce. The aim of this study was to determine the main epidemiological characteristics of patients with stroke and its mortality rate in southern Iran. Methods: A retrospective, single-center, hospital-based longitudinal study was performed at Nemazee Hospital in Shiraz, Southern Iran. Patients with a diagnosis of hemorrhagic and ischemic strokes were identified based on the International Classification of Diseases, 9th and 10th editions, for the period between 2001 and 2010. Demographics including age, sex, area of residence, socioeconomic status, length of hospital stay, and discharge destinations were analyzed in association with mortality. Results: 16351 patients with a mean age of 63.4 years (95% CI: 63.1, 63.6) were included in this analysis. Men were slightly predominant (53.6% vs. 46.4%). Forty-seven percent of the total sample was older than 65,17% were younger than 45, and 2.6% were children younger than 18. The mean hospital stay was 6.3 days (95% CI: 6.2, 6.4). Among all types of strokes, the overall hospital mortality was 20.5%. Multiple logistic regression revealed significantly higher in-hospital mortality in women and children (P

Published
2013

24. Risk for Major Bleeding in Patients Receiving Ticagrelor Compared With Aspirin After Transient Ischemic Attack or Acute Ischemic Stroke in the SOCRATES Study (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes)

Author

Easton, J. Donald, Aunes, Maria, Albers, Gregory W., Amarenco, Pierre, Bokelund-Singh, Sara, Denison, Hans, Evans, Scott R., Held, Peter, Jahreskog, Marianne, Jonasson, Jenny, Minematsu, Kazuo, Molina, Carlos A., Wang, Yongjun, Wong, K.S. Lawrence, Johnston, S. Claiborne, Ameriso, Sebastiá F., Donnan, Geoffrey, Lemmens, Robin, Massaro, Ayrton, Titianova, Ekaterina, Hill, Michael D., Lavados, Pablo, Skoloudik, David, Röther, Joachim, Norbert, Szegedi, Agnelli, Giancarlo, Bornstein, Natan, Tanahashi, Norio, Góngora, Angel Arauz, Pretell, Edwin, San Jose, Maria Cristina Z., Czlonkowska, Anna, Bajenaru, Ovidiu, Stakhovskaya, Ludmila, Brozman, Miroslav, Kim, Jong-Sung, Wahlgren, Nils, Michel, Patrik, Lee, Tsong Hai, Suwanwela, Nijasri Charnnarong, Kutluk, Kursad, Moskovko, Sergii, Kasner, Scott, Laskowitz, Daniel, Clark, Wayne, Nguyen, Huy Thang, Ameriso, Sebastian, Lepera, Sandra, Romano, Marina, Paulon, David, Ioli, Pablo, Zurru, Cristina, Bruera, Guadalupe, Jure, Lorena, Klein, Francisco, Povedano, Guillermo, Levi, Christopher, Phan, Thanh, Markus, Romesh, Anderson, Craig, Sabet, Arman, Davis, Stephen, Lee, Andrew, Kleinig, Timothy, Wong, Andrew, Krause, Martin, Jannes, Jim, Wijeratne, Tissa, Lemmens, Robin, Hemelsoet, Dimitri, Peeters, André, Tack, Philippe, Vanacker, Peter, Laloux, Patrice, Van Landegem, William, Vanhooren, Geert, Desfontaines, Philippe, Van Orshoven, Marc, Oliveira, Fabio, Friedrich, Mauricio, Brondani, Rosane, Gagliardi, Rubens, Fabio, Soraia, Dracoulakis, Marianna, Bazan, Rodrigo, Marrone, Luiz, Pontes Neto, Octavio, Silva, Gisele, Kowacs, Pedro, Titianova, Ekaterina, Stamenova, Paraskeva, Daskalov, Marin, Staikov, Ivan, Baldaranov, Dimo, Maslarov, Dimitar, Lilovski, Hristo, Petkov, Plamen, Petrova, Neli, Mavrov, Radoslav, Markova, Veska, Petrova, Valeria, Beleva, Tanya, Kralev, Borislav, Sotirov, Nikolay, Lekova, Veska, Hristov, Dimcho, Ermenkova, Vera, Mateev, Lyudmil, Mitkova, Rumeliya, Haralanov, Liybomir, Ikonomov, Rosen, Mihailova, Margarita, Georgiev, Ivan, Shuaib, Ashfaq, Hachinski, Vladimir, Boulanger, Jean-Martin, Mann, Sharan, Hassan, Ayman, Mackey, Ariane, Menon, Bijoy, Minuk, Jeffrey, Siddiqui, Muzaffar, Eustace, Marsha, Vieira, Lucia, Selchen, Daniel, Beaudry, Michel, Stotts, Grant, Lavados, Pablo, Castro, Angel, Gasic, Kristo, Rivas, Rodrigo, Sanchez, Pablo, Roldan, Andres, Grossmann, Ingrid, Figueroa, Christian, Li, Jimei, Xu, Xiaolin, Chen, Huisheng, Li, Xiaohong, Yang, Yi, Zhang, Chunsheng, Wang, Baojun, Li, Guanglai, Wang, Dong, Lin, Hong, Tang, Yamei, Xu, Anding, Wang, Yanjiang, Hong, Wenke, Song, Zhi, Zhang, Xu, Jin, Xiaoping, Xu, Yun, Yan, Fuling, Zheng, Weihong, Wang, Xiaoping, Dong, Qiang, Zhao, Zhongxin, Zhang, Baorong, Zhong, Wangtao, Wen, Guoqiang, Xu, Jun, Li, Guozhong, Dong, Xueshuang, Tian, Xiangyang, Zhang, Zhaohui, Xu, En, Liu, Kaixiang, Chen, Jun, Skoda, Ondrej, Skoloudik, David, Ehler, Edvard, Vaclavik, Daniel, Sanak, Daniel, Klimosova, Sylva, Vitkova, Eva, Fiksa, Jan, Mikulik, Robert, Neumann, Jiri, Plny, Richard, Leys, Didier, Sibon, Igor, Mas, Jean-Louis, Alamowitch, Sonia, Pico, Fernando, Hosseini, Hassan, Mahagne, Marie-Hélène, Touze, Emmanuel, Vadot, Wilfried, Vannier, Stéphane, Nighoghossian, Norbert, Samson, Yves, Garnier, Pierre, Ellie, Emmanuel, Guillon, Benoît, Timsit, Serge, Giroud, Maurice, Philippeau, Frédéric, Bagan-Triquenot, Aude, Wolff, Valérie, Raposo, Nicolas, Obadia, Michel, Debiais, Severine, Grimaud, Jérôme, Illouz, Stéphane, Smadja, Didier, Urbanczyk, Cédric, Röther, Joachim, Berrouschot, Jörg, Weimar, Christian, Gahn, Georg, Soda, Hassan, Klimpe, Sven, Nabavi, Darius, Glahn, Jörg, Köhrmann, Martin, Krause, Lars, Terborg, Christoph, Urban, Peter, Steiner, Thorsten, Ferbert, Andreas, Dziewas, Rainer, Seidel, Günter, Thomalla, Götz, Li, Richard, Fong, Wing Chi, Cheung, Raymond, Szegedi, Norbert, Pozsegovits, Krisztián, Valikovics, Attila, Pánczél, Gyula, Rózsa, Csilla, Németh, László, Diószeghy, Péter, Óváry, Csaba, Csányi, Attila, Kerényi, Levente, Nagy, Valéria, Komoly, Sámuel, Bereczki, Dániel, Molnár, Sándor, Kondákor, István, Tanne, David, Raphaeli, Guy, Telman, Gregory, Bornstein, Natan, Leker, Ronen, Lampl, Yair, Agnelli, Giancarlo, Corea, Francesco, Ricci, Stefano, Guidetti, Donata, Malferrari, Giovanni, Marcheselli, Simona, Micieli, Giuseppe, Zini, Andrea, Di Lazzaro, Vincenzo, Gandolfo, Carlo, Salmaggi, Andrea, Tassi, Rossana, Rasura, Maurizia, Orlandi, Giovanni, Comi, Giancarlo, Ricci, Stefano, Mancuso, Michelangelo, Delodovici, Marialuisa, Bovi, Paolo, Consoli, Domenico, Utsugisawa, Kimiaki, Fujita, Tsuneo, Kurihara, Hideyuki, Maruki, Chikashi, Hayashi, Takeshi, Ogiichi, Tsuneaki, Kumagai, Morio, Takenaka, Katsunobu, Toyoda, Kazunori, Takamatsu, Kazuhiro, Ogami, Ryo, Kin, Shigenari, Aoki, Takeshi, Takizawa, Katsumi, Omori, Shigehiro, Umezawa, Takehiko, Toba, Yasuyuki, Nonoyama, Yutaka, Nakagawa, Hidemitsu, Naka, Takashi, Morimoto, Masanori, Matsumoto, Shuichi, Hitotsumatsu, Tsutomu, Shingaki, Tatsuya, Okuda, Satoshi, Ota, Mamoru, Sakai, Nobuyuki, Yamada, Takeshi, Niwa, Jun, Fujita, Hitoshi, Moriki, Akihito, Yoshino, Kimihiro, Fukushima, Yoshihisa, Mori, Takahisa, Sato, Atsushi, Kusano, Yoshikazu, Kubo, Michiya, Yamazaki, Masashi, Ooasa, Takao, Nishizaki, Takafumi, Kitagawa, Naoki, Yasaka, Masahiro, Manabe, Yasuhiro, Yoshioka, Akira, Ishihara, Masayuki, Kagawa, Takato, Ichihashi, Toshikazu, Matsuoka, Hideki, Ito, Yasuhiro, Yamasaki, Masahiro, Takaba, Hitonori, Saito, Hisatoshi, Sato, Masahiro, Fukuda, Kazumasa, Endo, Sumio, Kidooka, Minoru, Umemura, Toshitaka, Kikkawa, Yuriko, Toru, Shuta, Yamada, Kentaro, Sakai, Hideki, Asari, Jun, Ezura, Masayuki, Nitta, Hisashi, Nagano, Keiko, Ochiai, Jun, Sakai, Keiichi, Kobayashi, Yasutaka, Yoshii, Yasuhiro, Miake, Hirotomo, Takita, Tomohiro, Taniguchi, Hidekazu, Kuroki, Kazuhiko, Mizota, Takamitsu, Yamamoto, Kenichi, Nakane, Hiroshi, Iwanaga, Takeshi, Chiba, Kei, Yoshimoto, Tetsuyuki, Torii, Tsuyoshi, Kitagawa, Takeo, Takashima, Hiroshi, Shirasaki, Naoki, Dehara, Makoto, Wada, Naomichi, Hamada, Kensuke, Kato, Noriyuki, Go, Yoshinori, Izumi, Ichiro, Ninomiya, Hirotomo, Kumai, Junichiro, Nakajima, Yoshikazu, Kaku, Yasuhiko, Isayama, Yukihiro, Kawanishi, Masahiro, Noda, Shinya, Yamamoto, Kazuhide, Hazama, Takanori, Takahashi, Hiroshi, Tanaka, Yohei, Hata, Takashi, Kazekawa, Kiyoshi, Furui, Eisuke, Hondo, Hideki, Sato, Nobuyuki, Kusunoki, Katsusuke, Nanri, Kazunori, Abe, Satoshi, Sasaoka, Noboru, Kuroyanagi, Takayuki, Suzuki, Hisahiko, Fukuyama, Kouzou, Nakahara, Kimihiro, Gongora, Fernando, Góngora, Angel Arauz, Cantú Brito, Carlos, Villarreal Careaga, Jorge, Vazquez Alfaro, Rosalia, Aguayo Leytte, Geronimo, Berrospi, Percy, Chavez, Carlos, Pretell, Edwin, Rodriguez, Liliana, Custodio, Nilton, Castañeda, Cesar, Perez, Julio, San Jose, Maria Cristina, Baroque, Alejandro, Collantes, Epifania, Aquino, Abdias, Díaz, Alejandro, Roxas, Artemio, Jr, Lokin, Johnny, Advincula, Joel, Calderon, Emerito, Navarro, Jose, Hiyadan, John, Surdilla, Arturo, Czlonkowska, Anna, Ryglewicz, Danuta, Krychowiak, Grzegorz, Fryze, Waldemar, Sobolewski, Piotr, Nowak, Ryszard, Fiszer, Urszula, Papierowska, Beata, Zielińska-Turek, Justyna, Lasek-Bal, Anetta, Kołodziejska, Ewa, Kamińska, Anna, Adamkiewicz, Bożena, Tutaj, Andrzej, Szkopek, Dorota, Musiatowicz, Krzysztof, Bąk, Zbigniew, Brzozowski, Sławomir, Brola, Waldemar, Ferens, Antoni, Zalisz, Marek, Rejdak, Konrad, Rudzińska, Monika, Bajenaru, Ovidiu, Panea, Cristina, Simu, Mihaela, Balasa, Rodica, Cuciureanu, Iulian, Popescu, Bogdan, Sabau, Monica, Roman-Filip, Corina, Pimenov, Leonid, Gekht, Alla, Milto, Anna, Shchukin, Ivan, Parfenov, Vladimir, Stakhovskaya, Liudmila, Arkhipov, Mikhail, Sokolova, Nadezhda, Bogdanov, Enver, Esin, Radiy, Khasanova, Dina, Golikov, Konstantin, Melnikova, Elena, Zaslavskiy, Leonid, Voznyuk, Igor, Nazarov, Alexander, Akhmadeeva, Leila, Iakupova, Aida, Shamalov, Nikolay, Belskaya, Galina, Chuprina, Svetlana, Denisova, Olga, Drozdova, Ekaterina, Karakulova, Yuliya, Sholomov, Ilya, Spirin, Nikolay, Vostrikova, Elena, Mordvintseva, Elena, Grigoryeva, Vera, Zateyshchikov, Dmitry, Gorbachev, Vladimir, Chefranova, Zhanna, Dudarev, Mikhail, Nilk, Rostislav, Rozhdestvenskiy, Alexey, Gurcik, Ladislav, Dvorak, Miloslav, Krastev, Georgi, Kurca, Egon, Vyletelka, Juraj, Brozman, Miroslav, Kim, Jong Sung, Bae, Hee-Joon, Kim, Yong-Won, Kim, Joon-Tae, Cha, Jae-Kwan, Nam, Hyo Suk, Chang, Dae-Il, Lee, Yong-Seok, Oh, Kyungmi, Yu, Sung-Wook, Sohn, Sung-Il, Lee, Jun, Cho, Han Jin, Kim, Eung-Gyu, Rha, Joung-Ho, Kim, Seo Hyun, Molina Cateriano, Carlos, Serena Leal, Joaquín, Vivancos Mora, José, Rodríguez Yañez, Manuel, Roquer González, Jaume, Purroy García, Francisco, Gomis Cortina, Meritxell, Masjuan Vallejo, Jaime, Arenillas Lara, Juan, Segura Martín, Tomás, Herrero, José Antonio Egido, Tembl Ferrairó, Jose Ignacio, Gállego Culleré, Jaime, Moniche Álvarez, Francisco, Steinberg, Anna, Callander, Margarita, Laska, Ann Charlotte, Bokemark, Lena, Mooe, Thomas, Käll, Tor-Björn, Welin, Lennart, Sjöblom, Lars, Hambraeus, Joakim, Teichert, Jörg, Wannberg, Hans, Sanner, Johan, Ramströmer, Bo, Ziedén, Bo, Hau, Stefan Olsson, Gustafsson, Claes, Michel, Patrik, Kahles, Timo, Lyrer, Philippe, Arnold, Marcel, Liesch, Martin, Medlin, Friedrich, Cereda, Carlo, Kägi, Georg, Luft, Andreas, Carrera, Emmanuel, Lee, Tsong-Hai, Po, Helen L., Chern, Chang-Ming, Lien, Li-Ming, Chan, Lung, Liu, Chung-Hsiang, Wu, Shey-Lin, Lee, Jiann-Der, Chen, Chih-Hung, Lin, Huey-Juan, Lin, Ruey-Tay, Chen, Wei-Hsi, Sun, Yu, Suwanwela, Nijasri Charnnarong, Tantirittisak, Tasanee, Muengtaweepongsa, Sombat, Nilanont, Yongchai, Tiamkao, Somsak, Udommongkol, Chesda, Watcharasaksilp, Kanokwan, Jantararotai, Witoon, Kutluk, Kursad, Sirin, Hadiye, Ince, Birsen, Asil, Talip, Arsava, Murat, Incesu, Tulay Kurt, Tireli, Hulya, Kucukoglu, Hayriye, Ak, Fikri, Unal, Ali, Ozturk, Serefnur, Uzuner, Nevzat, Chmyr, Galyna, Lebedynets, Volodymyr, Nikonov, Vadym, Shulga, Lyudmyla, Smolanka, Volodymyr, Moskovko, Sergii, Khavunka, Marta, Yavorska, Valentyna, Tomakh, Nataliya, Kozyolkin, Olexandr, Litovaltseva, Galyna, Lansberg, Maarten, Bernstein, Richard, Brown, David, Clark, Wayne, Dissin, Jonathan, Graffagnino, Carmelo, Harris, Jonathan, Hicks, William, Kasner, Scott, Katzan, Irene, Kramer, Jeffrey, Willey, Joshua, Silliman, Scott, Starkman, Sidney, Thaler, David, Tremwel, Margaret, Concha, Mauricio, Rajamani, Kumar, Dandapani, Bhuvaneswari, Silver, Brian, Deal, Nathan, Chang, Ira, Hassan, Ameer, Rudolph, Steven, Fischer, Kenneth, Kirshner, Howard, Logan, William, Mallenbaum, Sidney, Hefzy, Hebah, Latorre, Julius, Levine, Steven, Ciabarra, Anthony, Dafer, Rima, Anyanwu, Benjamin, Cherian, Laurel, Panezai, Spozhmy, Khanna, Anna, Dodds, Jodi, Torbey, Michel, Gebel, James, Woo, Henry, Chiu, David, Androulakis, Xiao, Burgin, William, Pineda, Maria, Yilmaz, Engin, Altafullah, Irfan, Boutwell, Christine, Cruz-Flores, Salvador, Sapkota, Biggya, Fayad, Pierre, Jacoby, Michael, Rafiq, Shahid, Salgado, Efrain, Lafranchise, Eugene, Felton, Warren, Madhavan, Ramesh, Zaidat, Osama, Pieper, Connie, Riviello, Ralph, Burnett, Aaron, Fischer, Michelle, Gentile, Nina, Calder, Christopher, Dietrich, Dennis, Cross, Jonathan, Blankenship, Larry, Dafer, Rima, Montoya, Liliana, Grogan, Wendell, Young, Mark, Khan, Farrukh, Campbell, Duane, Daboul, Nizar, Espinoza, Andrey, Cullis, Paul, Concepcion, Gilberto, Wulff, John, Afzal, Haider, Jaffrani, Naseem, Reiter, William, Arshad, Tamjeed, Lukovits, Timothy, Welker, James, Chang, Fen Lei, Badruddin, Aamir, Babikian, Viken, Menon, Ravi, Sander, James, Springer, Mellanie, Nanda, Ashish, Mas, Luis, Rajan, Raj, Silverman, Bruce, Hefzy, Hebah, Huang, David, Carpenter, David, Clark, Joni, Ching, Marilou, Santhakumar, Sunitha, Gould, Jeffrey, Bansal, Vibhav, Vidal, Gabriel, Mikesell, Timothy, Brick, John, French, William, Shah, Qaisar, Holmstedt, Christine, Ishag-Osman, Nadir, Kostis, John, Shehadeh, Abbas, Sethi, Pramodkumak, Imam, Asher, Mccomas, Carl, Tran, Duc, Gebreyohanns, Mehari, Wiseman, Brian, Malik, Maheen, Schwarcz, Aron, Altschul, Dorothea, Castaldo, John, Alshekhlee, Amer, Gancher, Stephen, Krish, Nagesh, Nguyen-Huynh, Mai, Tremwell, Margaret, Sharma, Jitendra, Lee, Lance, Neil, William, Siddiqui, Fazeel, Malek, Ali, Romero, Charles, Huy, Thang Nguyen, Hoang, Hoa, Nguyen, Thang, Nguyen, Anh, and Nguyen, Hung

Published
2017
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25. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Author

Zaidat, Osama O., primary, Fifi, Johanna T., additional, Nanda, Ashish, additional, Atchie, Benjamin, additional, Woodward, Keith, additional, Doerfler, Arnd, additional, Tomasello, Alejandro, additional, Tekle, Wondwossen, additional, Singh, Inder Paul, additional, Matouk, Charles, additional, Thalwitzer, Jörg, additional, Jargiełło, Tomasz, additional, Skrypnik, Dmitry, additional, Beuing, Oliver, additional, Berge, Jérôme, additional, Katz, Jeffrey M., additional, Biondi, Alessandra, additional, Bonovich, David, additional, Sheth, Sunil A., additional, Yoo, Albert J., additional, Hassan, Ameer E., additional, Piotin, Michel, additional, Blanc, Raphaël, additional, Desilles, Jean-Philippe, additional, Ciccio, Gabriele, additional, Smajda, Stanislas, additional, Marnat, Gaultier, additional, Barreau, Xavier, additional, Ménégon, Patrice, additional, Gariel, Florent, additional, Dörfler, Arnd, additional, Engelhorn, Tobias, additional, Gölitz, Philipp, additional, Schmidt, Manuel, additional, Lang, Stefan, additional, Mühlen, Iris, additional, Rösch, Julie, additional, Knott, Michael, additional, Lücking, Hannes, additional, Hoelter, Philip, additional, Schramm, Peter, additional, Neumann, Alexander, additional, Eckey, Thomas, additional, Boppel, Tobias, additional, Krah, Mike, additional, Schwarze, Jens, additional, Manikowski, Bettina, additional, Ladig, Philipp, additional, Albert, Nathanael, additional, Otto, Carmen, additional, Lemme, Anne, additional, Brandt, Silvio, additional, Bohner, Georg, additional, Kleine, Justus, additional, Siebert, Eberhard, additional, Bauknecht, Hans-Christian, additional, Wiener, Edzard, additional, Donitza, Aneta, additional, Górnik, Michał, additional, Pyra, Krzysztof, additional, Roman, Tomasz, additional, Szajner, Maciej, additional, Ficek, Remigiusz, additional, Prus, Katarzyna, additional, Stachowicz, Sylwia, additional, Wojczal, Joanna, additional, Sojka, Michał, additional, Buraczyńska, Kinga, additional, Luchowski, Piotr, additional, Anisimov, Kirill, additional, Sukhanova, Ekaterina, additional, Shloydo, Eugene, additional, Kravchenko, Kirill, additional, Golikov, Konstantin, additional, Sergeev, Aleksey, additional, Udovichenko, Anna, additional, Georgiev, Roman, additional, Gasparyan, Eduard, additional, Malov, Svyatoslav, additional, Ploschenkov, Eugeny, additional, Tomasello Weitz, Alejandro, additional, Ribó, Marc, additional, Hernández, David, additional, Rodriguez-Luna, David, additional, García-Tornel, Álvaro, additional, Rubiera, Marta, additional, Juega, Jesús, additional, Muchada, Marian, additional, Villatoro, Noelia Rodríguez, additional, Boned Riera, Sandra, additional, Pagola, Jorge, additional, Deck Román, Matías, additional, Piñana Plaza, Carlos, additional, Zamarro Parra, Joaquín, additional, Parrilla, Guillermo, additional, Espinosa de Rueda Ruiz, Mariano, additional, García-Villalba Navaridas, Blanca, additional, Díaz Pérez, José, additional, Hellinger, Frank, additional, Gandhi, Ravi, additional, Bellew, Michael, additional, Bellon, Richard, additional, Frei, Do, additional, Kaminsky, Ian, additional, Arias, Eric, additional, Katz, Jeffrey, additional, Woo, Henry, additional, Molina, Ina Teron, additional, Patel, Anand, additional, Libman, Richard, additional, Arora, Rohan, additional, Hixson, Harry, additional, Graham, Cole, additional, Moftakhar, Roham, additional, Diaz, Orlando, additional, Klucznik, Richard, additional, Alexander, Michael, additional, Jackson, Robert, additional, Padrick, Matthew, additional, Dumitrascu, Oana, additional, Schlick, Konrad, additional, Olivas, Edgar, additional, Song, Shlee, additional, Barnard, Zachary, additional, Madarang, Ernest John, additional, Reeves, Alan, additional, Paul Singh, Inder, additional, Fifi, Johanna, additional, Shoriah, Hazem, additional, Yaeger, Kurt, additional, Majidi, Shahram, additional, DeLacey, Reade, additional, Keller, Christopher, additional, Shigematsu, Tomoyoshi, additional, Yaniv, Gal, additional, Oxley, Thomas, additional, Georgiadis, Alexandros, additional, Hassan, Ameer, additional, Herber, Ryan, additional, Bahrassa, Farhad, additional, Johnson, Michele, additional, Hawk, Harris, additional, Quarfordt, Steven, additional, Nichols, Michael, additional, Calvert, Justin, additional, Starke, Robert, additional, Yavagal, Dileep, additional, Peterson, Eric, additional, Altschul, Dorothea, additional, Sattar, Ahsan, additional, Ali Aziz-Sultan, Mohammed, additional, Large, Daniel, additional, Patel, Nirav, additional, Chen, Karen, additional, Ziayee, Habibullah, additional, Du, Rose, additional, Frerichs, Kai, additional, Patel, Akshal, additional, Monteith, Stephen, additional, Loh, Yince, additional, Aref, Mohammed, additional, Tjoumakaris, Stavropoula, additional, Herial, Nabeel, additional, Jabbour, Pacal, additional, Rosenwasser, Robert, additional, Reid Gooch, Michael, additional, Zarzour, Hekmat, additional, Taqi, Muhammad, additional, Hoit, Daniel, additional, Arthur, Adam, additional, Elijovich, Lucas, additional, Nickele, Christopher, additional, Inoa, Violiza, additional, Goyal, Nitin, additional, Torabi, Radmehr, additional, Dornbos, David, additional, Peterson, Jeremy, additional, Maidan, Lucian, additional, Luh, George, additional, Kale, Sushant, additional, Alshekhlee, Amer, additional, Farid, Hamed, additional, Bress, Aaron, additional, Senturk, Cagin, additional, Milburn, Jim, additional, Vidal, Gabriel, additional, Gulotta, Paul, additional, Valle-Giler, Edison, additional, Turkel-Parrella, David, additional, Gordon, David S., additional, Liff, Jeremy, additional, Arcot, Karthik, additional, Farkas, Jeffrey, additional, Adamczyk, Peter, additional, Zaidat, Osama, additional, Lin, Eugene, additional, Ezzeldin, Mohammad, additional, Sultan-Qurraie, Ali, additional, Alenzi, Badar, additional, Teleb, Mohamed, additional, Abuawad, Mazen, additional, Viktoria Totoraitis, Ruta, additional, and Richard, Paul, additional

Published
2022
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26. Abstract TP161: Embolization Of Intracranial Aneurysms Using WAVE Extra Soft Coils, A Part Of The Penumbra SMART COIL System: An Interim Analysis Of The SURF Study

Author

Clemens Schirmer, Kimberly Kicielinski, Albert J Yoo, Ian Kaminsky, Amer Alshekhlee, Andrew Nicholson, Osama Zaidat, Henry H Woo, Bradley Bohnstedt, Marios Psychogios, and Alejandro M Spiotta

Subjects
Advanced and Specialized Nursing, Neurology (clinical), Cardiology and Cardiovascular Medicine
Abstract

Introduction: Initial clinical evidence has shown that coiling with the SMART COIL System (Penumbra, Inc.) is a safe and durable treatment option for intracranial aneurysms. The SURF study is a post-market, prospective, multicenter, single-arm, observational study to assess the utility of the WAVE Extra Soft Coil (WAVE) as fill and finishing coil to support adequate occlusion of intracranial aneurysms. Methods: Enrollment began November 5, 2019; this analysis includes data as of July 20, 2021. Patients undergoing embolization of intracranial aneurysms with WAVE as the final finishing coil and Penumbra SMART COIL System accounting for at least 75% of the total number of coils implanted were enrolled consecutively at 34 centers globally. Post-procedure Raymond Roy Occlusion Classification (RROC) was assessed by a core lab. The estimated enrollment will be 800 patients. Results: This analysis includes 346 patients, mean age 60.1 (SD 13.03), 73.1% female. Of the target aneurysms, 39.8% (135/339) were ruptured, and 80.5% (269/334) were saccular, and 11.5% (39/338) were previously treated. Post-procedure, 89.2% (206/231, 95% CI 85.2%, 93.2%) of aneurysms were RROC I or II. Device-related SAEs occurred in 1.5% (5/346, 95% CI 0.2%, 2.7%) of patients up to 7 days or discharge. The rate of major ipsilateral stroke was 0.6% (2/346), and the intra-procedural rupture rate was 0.6% (2/346). Conclusions: We report interim outcomes from the SURF study. This post-market registry evaluates the safety and performance of the Penumbra SMART COIL System, including WAVE as fill and finishing coil, in the treatment of intracranial aneurysms.

Published
2022

29. Abstract TP161: Embolization Of Intracranial Aneurysms Using WAVE Extra Soft Coils, A Part Of The Penumbra SMART COIL System: An Interim Analysis Of The SURF Study

Author

Schirmer, Clemens, primary, Kicielinski, Kimberly, additional, Yoo, Albert J, additional, Kaminsky, Ian, additional, Alshekhlee, Amer, additional, Nicholson, Andrew, additional, Zaidat, Osama, additional, Woo, Henry H, additional, Bohnstedt, Bradley, additional, Psychogios, Marios, additional, and Spiotta, Alejandro M, additional

Published
2022
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30. Abstract 1122‐000113: Periprocedural Safety of Intracranial Aneurysm Embolization with Extra Soft Coils: Interim Analysis of SURF Study

Author

Clemens Schirmer, Kimberly Kicielinski, Albert Yoo, Ian Kaminsky, Amer Alshekhlee, Andrew Nicholson, Osama Zaidat, Henry Woo, Bradley Bohnstedt, Marios Psychogios, and Alejandro Spiotta

Abstract

This meeting abstract was removed due to the OA licensing requirements of this journal. The full abstract is listed here : https://www.svin.org/files/SVIN_2021_Abstracts_for_Web.pdf

Published
2021

31. Frequency and Prognostic Significance of Clinical Fluctuations Before Hospital Arrival in Stroke

Author

Jose G. Romano, Hannah Gardener, Eric E. Smith, Iszet Campo-Bustillo, Yosef Khan, Sofie Tai, Nikesha Riley, Ralph L. Sacco, Pooja Khatri, Heather M. Alger, Brian Mac Grory, Deepak Gulati, Navdeep S. Sangha, Karin E. Olds, Curtis G. Benesch, Adam G. Kelly, Scott S. Brehaut, Amit C. Kansara, Lee H. Schwamm, Scott Moody, Weiping Ye, Vena Sobhawongse, Jeffrey M. Craig, Heloisa Pearson, Deborah Summers, Christine Boerman, Christy Rice, Robin Kintner, Mayumi Oka, Sarah Baran, Christina Roels, Maureen Dosunmu, Cherylee W. J. Chang, Jennifer Moran, Denise Ditrich, Nicholas Lanciano, Aimee Mann, Charles E. Romero, Becky Thiele, David Salvatore, Annette Taylor, Neel Shah, Rodney Leacock, Angel Rochester, Fanny Guillerminet, Jerry C. Martin, Johnny Jones, Nicol Brandon, Vikas Grover, Maryika Gibson, Maheen Malik, Carol Mechem, William R. Logan, Camilla Cook, Muhib A Khan, Christa Rood, Arun Babu, Leah Steinig, Jestin Carlson, Melanie Henderson, Gabriel Vidal, Bethany Jennings, Jennifer Lynch, Jessica Ratcliff, Kathryn Kirchoff, Khadean Moncrieffe, Jennifer Rasmussen-Winkler, Leigh Allen, Gary Thompson, Christopher Firek, Stephen Martino, Baher Georgy, Gillian L. Gordon-Perue, Nina Vekima, Kasey Gildersleeve, Marian Skewes, Christina Valdovinos, Timothy C. Parsons, Cynthia Marques, John W. Chen, David Lombardi, Brenda Perez, Amer Malik, Kathy Hesse, Amy Guzik, Sandra E. Norona, Robert Hoesch, Jacki Anderson, Dorothea Altschul, Farah Fermin, Miran Salgado, Jonathan Muller, Indrani Acosta, Brooke Hartwell, Terry A. Neill, Carrie Hundley, Abhineet Chowdhary, Tina Fortney, Jose Rafael Romero, Brandon Finn, Refat Assad, Maggie Ellithorpe, Rebecca Sugg, Susan Hetzel, Muhammad M. Alvi, Jay Sherman, Jonathan Hartman, Tashia Orr, Ankur Garg, Melissa Turner, Curtis Given, Sara Renfrow, Jeffrey Hilburn, Ellen Looney, Christopher Commichau, Paul Jarvis, Changsoo Hahm, Melissa Mccaulley, Angel Pulido, Sergio Michel, Nima Ramezan-Arab, Françoise Toussaint- Jones, Anna Khanna, Esther Olasoji, Armistead Williams, Elizabeth Purrington, Ratna Reddy, Renee Potter, Bhupat Desai, Karen Tse-Chang, Laurence Ufford, Leslie Drager, Keith O. Jones, Teresa Ellebusch, Michelle Dobrzynski, Elizabeth H. Wise, Ann Jerde, Gauhar Chaudhary, Robyn McLean, Joseph Hanna, Dana Cook, Franklin Marden, Jennifer Orde, Ajay Arora, Shawna Miller, Raymond Reichwein, Deborah Hoffman, Kelly Matmati, Nabil Matmati, Kumiko Owada, Laura Murphy, Ashish Masih, Bethany Fife, Larry Shepherd, Matthew Holzmann, Stephen Gancher, Sabrina Enoch, Matthew Smith, Denise Goings, Joseph Mazzola, Edward Plyler, Lisa Landers, James Napier, Laura Thoreson, Amer Alshekhlee, Michelle Raymond, Tarakad Ramachandran, Michael Jorolemon, David Padalino, Collin Maloney, Jenny Rae Mott, Laxmi P. Dhakal, Cindy Murphy, Truman J. Milling, Patrick Lawrence, Harish Shownkeen, Kathy Hansen, Paul A. Cullis, Lynne Froehlich, Sajjad Mueed, Ryan Pavolka, Steven R. Levine, Nadege Gilles, Laura LaChance, Kanwal Nayyar, Karen Klein, Rose Dotson, Kristopher Rowe, Elisheva Coleman, Emily Sayles, Rajan Gadhia, Jason Lee, Paul W. Lewis, Jenny Nunley, Rehan Sajjad, Carol Halliday, Angelos Katramados, Theresa Holmes, Rashmikant Kothari, Linda Mader, Fen Lei Chang, Kelly Western, Kinjal Desai, Colleen Kehr, Gary Reese, Ashu Jadhav, Mackenzie Steinbach, Jeffrey Saver, Gilda Avila, Janice A. Miller, Alicia Gneiting, Matthew S. Tenser, and Sarah Burke

Subjects
Male, medicine.medical_specialty, Emergency Medical Services, Quality of life, Fibrinolytic Agents, medicine, Humans, Stroke, Aged, Ischemic Stroke, Advanced and Specialized Nursing, Aged, 80 and over, business.industry, Middle Aged, medicine.disease, Prognosis, Quality Improvement, Treatment Outcome, Tissue Plasminogen Activator, Emergency medicine, Ischemic stroke, Quality of Life, Female, Neurology (clinical), Guideline Adherence, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract

Background and Purpose: Clinical fluctuations in ischemic stroke symptoms are common, but fluctuations before hospital arrival have not been previously characterized. Methods: A standardized qualitative assessment of fluctuations before hospital arrival was obtained in an observational study that enrolled patients with mild ischemic stroke symptoms (National Institutes of Health Stroke Scale [NIHSS] score of 0–5) present on arrival to hospital within 4.5 hours of onset, in a subset of 100 hospitals participating in the Get With The Guidelines–Stroke quality improvement program. The number of fluctuations, direction, and the overall improvement or worsening was recorded based on reports from the patient, family, or paramedics. Baseline NIHSS on arrival and at 72 hours (or discharge if before) and final diagnosis and stroke subtype were collected. Outcomes at 90 days included the modified Rankin Scale, Barthel Index, Stroke Impact Scale 16, and European Quality of Life. Prehospital fluctuations were examined in relation to hospital NIHSS change (admission to 72 hours or discharge) and 90-day outcomes. Results: Among 1588 participants, prehospital fluctuations, consisting of improvement, worsening, or both were observed in 35.5%: 25.1% improved once, 5.3% worsened once, and 5.1% had more than 1 fluctuation. Those who improved were less likely and those who worsened were more likely to receive alteplase. Those who improved before hospital arrival had lower change in the hospital NIHSS than those who did not fluctuate. Better adjusted 90-day outcomes were noted in those with prehospital improvement compared to those without any fluctuations. Conclusions: Fluctuations in neurological symptoms and signs are common in the prehospital setting. Prehospital improvement was associated with better 90-day outcomes, controlling for admission NIHSS and alteplase treatment. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT 02072681.

Published
2021

33. Abstract 1122‐000113: Periprocedural Safety of Intracranial Aneurysm Embolization with Extra Soft Coils: Interim Analysis of SURF Study

Author

Schirmer, Clemens, primary, Kicielinski, Kimberly, additional, Yoo, Albert, additional, Kaminsky, Ian, additional, Alshekhlee, Amer, additional, Nicholson, Andrew, additional, Zaidat, Osama, additional, Woo, Henry, additional, Bohnstedt, Bradley, additional, Psychogios, Marios, additional, and Spiotta, Alejandro, additional

Published
2021
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34. Frequency and Prognostic Significance of Clinical Fluctuations Before Hospital Arrival in Stroke

Author

Romano, Jose G., primary, Gardener, Hannah, additional, Smith, Eric E., additional, Campo-Bustillo, Iszet, additional, Khan, Yosef, additional, Tai, Sofie, additional, Riley, Nikesha, additional, Sacco, Ralph L., additional, Khatri, Pooja, additional, Alger, Heather M., additional, Mac Grory, Brian, additional, Gulati, Deepak, additional, Sangha, Navdeep S., additional, Olds, Karin E., additional, Benesch, Curtis G., additional, Kelly, Adam G., additional, Brehaut, Scott S., additional, Kansara, Amit C., additional, Schwamm, Lee H., additional, Moody, Scott, additional, Ye, Weiping, additional, Sobhawongse, Vena, additional, Craig, Jeffrey M., additional, Pearson, Heloisa, additional, Summers, Deborah, additional, Boerman, Christine, additional, Rice, Christy, additional, Kintner, Robin, additional, Oka, Mayumi, additional, Baran, Sarah, additional, Roels, Christina, additional, Dosunmu, Maureen, additional, Chang, Cherylee W. J., additional, Moran, Jennifer, additional, Ditrich, Denise, additional, Lanciano, Nicholas, additional, Mann, Aimee, additional, Romero, Charles E., additional, Thiele, Becky, additional, Salvatore, David, additional, Taylor, Annette, additional, Shah, Neel, additional, Leacock, Rodney, additional, Rochester, Angel, additional, Guillerminet, Fanny, additional, Martin, Jerry C., additional, Jones, Johnny, additional, Brandon, Nicol, additional, Grover, Vikas, additional, Gibson, Maryika, additional, Malik, Maheen, additional, Mechem, Carol, additional, Logan, William R., additional, Cook, Camilla, additional, Khan, Muhib A, additional, Rood, Christa, additional, Babu, Arun, additional, Steinig, Leah, additional, Carlson, Jestin, additional, Henderson, Melanie, additional, Vidal, Gabriel, additional, Jennings, Bethany, additional, Lynch, Jennifer, additional, Ratcliff, Jessica, additional, Kirchoff, Kathryn, additional, Moncrieffe, Khadean, additional, Rasmussen-Winkler, Jennifer, additional, Allen, Leigh, additional, Thompson, Gary, additional, Firek, Christopher, additional, Martino, Stephen, additional, Georgy, Baher, additional, Gordon-Perue, Gillian L., additional, Vekima, Nina, additional, Gildersleeve, Kasey, additional, Skewes, Marian, additional, Valdovinos, Christina, additional, Parsons, Timothy C., additional, Marques, Cynthia, additional, Chen, John W., additional, Lombardi, David, additional, Perez, Brenda, additional, Malik, Amer, additional, Hesse, Kathy, additional, Guzik, Amy, additional, Norona, Sandra E., additional, Hoesch, Robert, additional, Anderson, Jacki, additional, Altschul, Dorothea, additional, Fermin, Farah, additional, Salgado, Miran, additional, Muller, Jonathan, additional, Acosta, Indrani, additional, Hartwell, Brooke, additional, Neill, Terry A., additional, Hundley, Carrie, additional, Chowdhary, Abhineet, additional, Fortney, Tina, additional, Romero, Jose Rafael, additional, Finn, Brandon, additional, Assad, Refat, additional, Ellithorpe, Maggie, additional, Sugg, Rebecca, additional, Hetzel, Susan, additional, Alvi, Muhammad M., additional, Sherman, Jay, additional, Hartman, Jonathan, additional, Orr, Tashia, additional, Garg, Ankur, additional, Turner, Melissa, additional, Given, Curtis, additional, Renfrow, Sara, additional, Hilburn, Jeffrey, additional, Looney, Ellen, additional, Commichau, Christopher, additional, Jarvis, Paul, additional, Hahm, Changsoo, additional, Mccaulley, Melissa, additional, Pulido, Angel, additional, Michel, Sergio, additional, Ramezan-Arab, Nima, additional, Toussaint- Jones, Françoise, additional, Khanna, Anna, additional, Olasoji, Esther, additional, Williams, Armistead, additional, Purrington, Elizabeth, additional, Reddy, Ratna, additional, Potter, Renee, additional, Desai, Bhupat, additional, Tse-Chang, Karen, additional, Ufford, Laurence, additional, Drager, Leslie, additional, Jones, Keith O., additional, Ellebusch, Teresa, additional, Dobrzynski, Michelle, additional, Wise, Elizabeth H., additional, Jerde, Ann, additional, Chaudhary, Gauhar, additional, McLean, Robyn, additional, Hanna, Joseph, additional, Cook, Dana, additional, Marden, Franklin, additional, Orde, Jennifer, additional, Arora, Ajay, additional, Miller, Shawna, additional, Reichwein, Raymond, additional, Hoffman, Deborah, additional, Matmati, Kelly, additional, Matmati, Nabil, additional, Owada, Kumiko, additional, Murphy, Laura, additional, Masih, Ashish, additional, Fife, Bethany, additional, Shepherd, Larry, additional, Holzmann, Matthew, additional, Gancher, Stephen, additional, Enoch, Sabrina, additional, Smith, Matthew, additional, Goings, Denise, additional, Mazzola, Joseph, additional, Plyler, Edward, additional, Landers, Lisa, additional, Napier, James, additional, Thoreson, Laura, additional, Alshekhlee, Amer, additional, Raymond, Michelle, additional, Ramachandran, Tarakad, additional, Jorolemon, Michael, additional, Padalino, David, additional, Maloney, Collin, additional, Mott, Jenny Rae, additional, Dhakal, Laxmi P., additional, Murphy, Cindy, additional, Milling, Truman J., additional, Lawrence, Patrick, additional, Shownkeen, Harish, additional, Hansen, Kathy, additional, Cullis, Paul A., additional, Froehlich, Lynne, additional, Mueed, Sajjad, additional, Pavolka, Ryan, additional, Levine, Steven R., additional, Gilles, Nadege, additional, LaChance, Laura, additional, Nayyar, Kanwal, additional, Klein, Karen, additional, Dotson, Rose, additional, Rowe, Kristopher, additional, Coleman, Elisheva, additional, Sayles, Emily, additional, Gadhia, Rajan, additional, Lee, Jason, additional, Lewis, Paul W., additional, Nunley, Jenny, additional, Sajjad, Rehan, additional, Halliday, Carol, additional, Katramados, Angelos, additional, Holmes, Theresa, additional, Kothari, Rashmikant, additional, Mader, Linda, additional, Chang, Fen Lei, additional, Western, Kelly, additional, Desai, Kinjal, additional, Kehr, Colleen, additional, Reese, Gary, additional, Jadhav, Ashu, additional, Steinbach, Mackenzie, additional, Saver, Jeffrey, additional, Avila, Gilda, additional, Miller, Janice A., additional, Gneiting, Alicia, additional, Tenser, Matthew S., additional, and Burke, Sarah, additional

Published
2021
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35. Interventional Stroke Management in a Patient With COVID-19

Author

Kevin Yeboah, Joseph Conway, R Edgell, and Amer Alshekhlee

Subjects
Mechanical ventilation, medicine.medical_specialty, education.field_of_study, Health professionals, Coronavirus disease 2019 (COVID-19), business.industry, medicine.medical_treatment, Population, Case, medicine.disease, Stroke treatment, Respiratory failure, Emergency medicine, Medicine, In patient, Neurology (clinical), business, education, Stroke
Abstract

In patients with COVID-19, acute stroke management may need to be limited to patients with viable outcomes, perhaps younger population with fewer comorbidities, and patients without respiratory failure requiring mechanical ventilation. Protecting healthcare professionals must be kept at the forefront if aggressive stroke treatment is used.

Published
2020

36. Site Experience and Outcomes in the Trevo Acute Ischemic Stroke (TRACK) Multicenter Registry

Author

Randall C. Edgell, Shyam Prabhakaran, Ramy El Khoury, Diogo C Haussen, Joey English, Alicia C. Castonguay, Leticia C Rebello, Michael G. Abraham, Michael T. Froehler, Roberta Novakovic, Maxim Mokin, Hamed Farid, Nirav Vora, Ajit S. Puri, Amer Alshekhlee, Osama O. Zaidat, Vallabh Janardhan, Brittany L. Nordhaus, Aniel Q. Majjhoo, Raul G Nogueira, M Taqi, Ira J. Finch, Mo Kabbani, Enrol Veznedaroglu, Thanh N. Nguyen, Michael Frankel, and Ron Budzik

Subjects
Advanced and Specialized Nursing, medicine.medical_specialty, Stroke scale, business.industry, Odds ratio, medicine.disease, Brain ischemia, Interquartile range, Modified Rankin Scale, Internal medicine, Occlusion, Cardiology, Medicine, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, Acute ischemic stroke, Stroke
Abstract

Background and Purpose— It remains unclear how experience influences outcomes after the advent of stent retriever technology. We studied the relationship between site experience and outcomes in the Trevo Acute Ischemic Stroke multicenter registry. Methods— The 24 sites that enrolled patients in the Trevo Acute Ischemic Stroke registry were trichotomized into low-volume (4 cases/month). Baseline features, imaging, and clinical outcomes were compared across the 3 volume strata. A multivariable analysis was performed to assess whether outcomes were influenced by site volumes. Results— A total of 624 patients were included and distributed as low- (n=188 patients, 30.1%), medium- (n=175, 28.1%), and high-volume (n=261, 41.8%) centers. There were no significant differences in terms of age (mean, 66±16 versus 67±14 versus 65±15; P =0.2), baseline National Institutes of Health Stroke Scale (mean, 17.6±6.5 versus 16.8±6.5 versus 17.6±6.9; P =0.43), or occlusion site across the 3 groups. Median (interquartile range) times from stroke onset to groin puncture were 266 (181.8–442.5), 239 (175–389), and 336.5 (221.3–466.5) minutes in low-, medium-, and high-volume centers, respectively ( P =0.004). Higher efficiency and better outcomes were seen in higher volume sites as demonstrated by shorter procedural times (median, 97 versus 67 versus 69 minutes; P P ≤0.0001), and higher rates of good outcome (90-day modified Rankin Scale [mRS], ≤2; 39% versus 50% versus 53.4%; P =0.02). There were no appreciable differences in symptomatic intracranial hemorrhage or 90-day mortality. After adjustments in the multivariable analysis, there were significantly higher chances of achieving a good outcome in high- versus low-volume (odds ratio, 1.67; 95% CI, 1.03–2.7; P =0.04) and medium- versus low-volume (odds ratio, 1.75; 95% CI, 1.1–2.9; P =0.03) centers, but there were no significant differences between high- and medium-volume centers ( P =0.86). Conclusions— Stroke center volumes significantly influence efficiency and outcomes in mechanical thrombectomy.

Published
2019

37. Real-World Impact of Retrievable Stents for Acute Ischemic Stroke on Disability Utilizing the National Inpatient Sample

Author

Eric S. Armbrecht, Eric Adjei Boakye, Amer Alshekhlee, Anit Behera, Jahnavi Trivedi, and Randall C. Edgell

Subjects
Original Paper, medicine.medical_specialty, business.industry, Mortality rate, medicine.medical_treatment, Stent, Logistic regression, 030218 nuclear medicine & medical imaging, Odds, law.invention, Mechanical thrombectomy, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Surgery, Neurology (clinical), Intravenous tissue plasminogen activator, Cardiology and Cardiovascular Medicine, business, Acute ischemic stroke, 030217 neurology & neurosurgery
Abstract

Purpose: We assess the impact of retrievable stent (RS) compared to first-generation devices on in-hospital mortality and disability in patients with acute ischemic stroke (AIS). Methods: Using the National Inpatient Sample, data were obtained for patients with a primary diagnosis of AIS who underwent mechanical thrombectomy (MT) and were admitted to US hospitals between 2010 and 2014. Two time periods were compared: 2010–2012 (pre-RS Food and Drug Administration [FDA] approval) and 2013–2014 (post-RS FDA approval). Disability level was used to classify outcomes as minimal disability, moderate to severe disability, or in-hospital mortality. Weighted, multivariable logistic regression was used to assess the association between MT device type and disability. Results: A total of 2,443,713 weighted patients admitted with AIS were identified; 148,923 (4.9%) of these received intravenous tissue plasminogen activator; and 23,719 (0.8%) underwent MT. In multivariable logistic regression analysis, the odds of in-hospital mortality decreased (OR 0.69, 95% CI 0.59–0.82) in the post-RS time-period compared with pre-RS time. The odds of moderate-to-severe disability decreased (OR 0.88, 95% CI 0.73–1.06) compared with minimal disability. In-hospital mortality rates decreased successively over the 4 years in the MT-treated patients (p < 0.001). Conclusions: The FDA approval of RS technology after 2012 was associated with decreased in-hospital mortality when compared with the 3-year interval prior. These findings provide an indication that the RCT data on the efficacy of RS technology are translating into improved real-world outcomes.

Published
2018

40. The WOVEN trial: Wingspan One-year Vascular Events and Neurologic Outcomes

Author

Wengui Yu, Brian Kott, Larami Mackenzie, Curtis A. Given, Rishi Gupta, Amer Alshekhlee, Gábor Tóth, Justin F. Fraser, Ameer E Hassan, Michael J. Alexander, R Charles Callison, Harish Shownkeen, Blaise Baxter, and Alois Zauner

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Constriction, Pathologic, Cohort Studies, medicine, Humans, cardiovascular diseases, Mortality, Patient group, Stroke, Wingspan, intervention, Aged, business.industry, Mortality rate, stenosis, Stent, General Medicine, Middle Aged, Intracranial Arteriosclerosis, medicine.disease, stroke, Surgery, Stenosis, Treatment Outcome, Cohort, Wingspan stent, Female, Stents, stent, Neurology (clinical), Nervous System Diseases, atherosclerosis, business, Follow-Up Studies
Abstract

BackgroundPrior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate.ObjectiveThis WOVEN study assesses the 1-year follow-up from this cohort.MethodsTwelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis.ResultsIn the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up.ConclusionsThe WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.

Published
2021

41. Predictors of Outcomes in Patients With Mild Ischemic Stroke Symptoms: MaRISS

Author

Romano, Jose G., primary, Gardener, Hannah, additional, Campo-Bustillo, Iszet, additional, Khan, Yosef, additional, Tai, Sofie, additional, Riley, Nikesha, additional, Smith, Eric E., additional, Sacco, Ralph L., additional, Khatri, Pooja, additional, Alger, Heather M., additional, Mac Grory, Brian, additional, Gulati, Deepak, additional, Sangha, Navdeep S., additional, Craig, Jeffrey M., additional, Olds, Karin E., additional, Benesch, Curtis G., additional, Kelly, Adam G., additional, Brehaut, Scott S., additional, Kansara, Amit C., additional, Schwamm, Lee H., additional, Grory, Brian Mac, additional, Oka, Mayumi, additional, Roels, Christina, additional, Chang, Cherylee W. J., additional, Moran, Jennifer, additional, Lanciano, Nicholas, additional, Romero, Charles E., additional, Salvatore, David, additional, Shah, Neel, additional, Leacock, Rodney, additional, Rochester, Angel, additional, Martin, Jerry C., additional, Grover, Vikas, additional, Malik, Maheen, additional, Logan, William R., additional, Khan, Muhib A, additional, Babu, Arun, additional, Carlson, Jestin, additional, Vidal, Gabriel, additional, Lynch, Jennifer, additional, Kirchoff, Kathryn, additional, Rasmussen-Winkler, Jennifer, additional, Thompson, Gary, additional, Martino, Stephen, additional, Gordon-Perue, Gillian L., additional, Gildersleeve, Kasey, additional, Parsons, Timothy C., additional, Chen, John W., additional, Lombardi, David, additional, Malik, Amer, additional, Guzik, Amy, additional, Hoesch, Robert, additional, Altschul, Dorothea, additional, Salgado, Miran, additional, Acosta, Indrani, additional, Neill, Terry A., additional, Chowdhary, Abhineet, additional, Romero, Jose Rafael, additional, Assad, Refat, additional, Sugg, Rebecca, additional, Alvi, Muhammad M., additional, Hartman, Jonathan, additional, Garg, Ankur, additional, Given, Curtis, additional, Hilburn, Jeffrey, additional, Commichau, Christopher, additional, Hahm, Changsoo, additional, Pulido, Angel, additional, Ramezan-Arab, Nima, additional, Khanna, Anna, additional, Williams, Armistead, additional, Reddy, Ratna, additional, Desai, Bhupat, additional, Ufford, Laurence, additional, Jones, Keith O., additional, Wise, Elizabeth H., additional, Chaudhary, Gauhar, additional, Hanna, Joseph, additional, Marden, Franklin, additional, Arora, Ajay, additional, Reichwein, Raymond, additional, Matmati, Kelly, additional, Owada, Kumiko, additional, Masih, Ashish, additional, Shepherd, Larry, additional, Gancher, Stephen, additional, Smith, Matthew, additional, Mazzola, Joseph, additional, Plyler, Edward, additional, Napier, James, additional, Alshekhlee, Amer, additional, Ramachandran, Tarakad, additional, Jorolemon, David, Michael, additional, Collin Maloney, Padalino, additional, Dhakal, Laxmi P., additional, Milling, Truman J., additional, Shownkeen, Harish, additional, Cullis, Paul A., additional, Mueed, Sajjad, additional, Levine, Steven R., additional, Nayyar, Kanwal, additional, Dotson, Rose, additional, Coleman, Elisheva, additional, Gadhia, Rajan, additional, Lewis, Paul W., additional, Sajjad, Rehan, additional, Katramados, Angelos, additional, Kothari, Rashmikant, additional, Chang, Fen Lei, additional, Desai, Kinjal, additional, Reese, Gary, additional, Jadhav, Ashu, additional, Saver, Jeffrey, additional, Miller, Janice A., additional, and Tenser, Matthew S., additional

Published
2021
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42. Syncopal migraine

Author

Curfman, David, Chilungu, Michael, Daroff, Robert B., Alshekhlee, Amer, Chelimsky, Gisela, and Chelimsky, Thomas C.

Published
2012
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48. E-241 A prospective, multicenter study assessing the embolization of intracranial aneurysms using wave™ extra soft coils, a part of the penumbra smart coil® system: study protocol for SURF

Author

Cedric Schirmer, Amer Alshekhlee, I Kaminsky, O. O. Zaidat, M Chaudry, M Taqi, and P Ramakrishnan

Subjects
medicine.diagnostic_test, business.industry, Penumbra, medicine.medical_treatment, Digital subtraction angiography, medicine.disease, Magnetic resonance angiography, Aneurysm, Electromagnetic coil, Occlusion, medicine, Embolization, Nuclear medicine, business, Computed tomography angiography
Abstract

Introduction/Purpose Initial clinical evidence has shown that coiling with the SMART COIL® System (Penumbra, Inc.) is a safe and durable treatment option for intracranial aneurysms.1–5 The WAVE™ Extra Soft Coil (WAVE) is part of the SMART Coil System and is specifically designed as a fill and finish coil. The primary objective of the SURF study, a post-market registry, is to assess the utility of WAVE as a fill and finish coil to support adequate occlusion at one year follow-up. A secondary objective is to compare the ability of digital subtraction angiography (DSA) and magnetic resonance angiography (MRA) to detect incomplete occlusion in the coiled aneurysms. Materials and Methods SURF is a post-market, prospective, multicenter, single-arm, observational study that will enroll approximately 800 consecutive patients at up to 50 centers in North America. Patients age ≥ 18 years, having embolization of intracranial aneurysms, with WAVE as the final finishing coil and Penumbra SMART COIL System accounting for at least 75% of total number of coils implanted, will be included. All subjects will be followed for approximately 1 year. The primary efficacy endpoint is adequate occlusion defined as Raymond-Roy Occlusion Class I and II at final follow-up. The primary safety endpoints are serious adverse events (SAE) within 24 hours post-procedure and device-related SAE up to 7 days or discharge. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates at follow-up. Imaging modalities include DSA, computed tomography angiography (CTA), and/or MRA. A comparative analysis between imaging modalities will be performed for patients with DSA and MRA. Results The trial is currently recruiting. Enrollment began November 2019 and the estimated date for study completion is June 2023. Imaging and clinical data collection and core laboratory review are ongoing. Conclusion We report the design of the SURF study, a post-market registry that evaluates the safety and performance of the Penumbra SMART COIL System, including WAVE as a fill and finish coil, in the treatment of intracranial aneurysms. References Daniel B, Henrik S, Ioannis T, Veit R, Marios-Nikos P. SMART coils for intracranial aneurysm repair - a single center experience. BMC Neurol. 2020 Jan 29;20(1):38. Sokolowski JD, Ilyas A, Buell TJ, Taylor DG, Chen CJ, Ding D, Raper DMS, Liu KC. SMART coils for intracranial aneurysm embolization: Follow-up outcomes. J Clin Neurosci 2019 Jan;59:93–97. Ilyas A, Buell TJ, Chen CJ, Ding D, Raper DMS, Taylor DG, Sokolowski JD, Liu KC. SMART coils for intracranial aneurysm embolization: Initial outcomes. Clin Neurol Neurosurg 2018 Jan;164:87–91. Spiotta AM, Fargen KM, Lena J, Chaudry I, Turner RD, Turk AS, Huddle D, Loy D, Bellon R, Frei D. Initial Technical Experience with the SMART Coil for the Embolization of Intracranial Aneurysms. World Neurosurg 2017 Jan;97:80–85. Stapleton CJ, Torok CM, Patel AB. Early experience with the Penumbra SMART coil in the endovascular treatment of intracranial aneurysms: Safety and efficacy. Interv Neuroradiol 2016 Dec;22(6):654–658. Disclosures C. Schirmer: None. I. Kaminsky: None. M. Chaudry: None. O. Zaidat: None. A. Alshekhlee: None. P. Ramakrishnan: None. M. Taqi: None.

Published
2020

49. Pivotal Trial of the Neuroform Atlas Stent for Treatment of Anterior Circulation Aneurysms: One-Year Outcomes

Author

Osama O. Zaidat, Ricardo A. Hanel, Eric A. Sauvageau, Amin Aghaebrahim, Eugene Lin, Ashutosh P. Jadhav, Tudor G. Jovin, Ahmad Khaldi, Rishi G. Gupta, Andrew Johnson, Donald Frei, David Loy, Adel Malek, Gabor Toth, Adnan Siddiqui, John Reavey-Cantwell, Ajith Thomas, Steven W. Hetts, Brian T. Jankowitz, Bradley Gross, Andrew Ducruet, David Panczkowski, Hazem Shoirah, Alhamza Al-Bayati, Greg Weiner, Cynthia Kenmuir, Prasanna Tadi, Gregory Walker, K. Johnson, Don Frei, Richard Bellon, Benjamin Atchie, Ian Kaminsky, Dan Huddle, Mark Bain, Peter Rasmussen, M. Shazam Hussain, Nina Moore, Thomas Masaryk, Mohamed Elgabaly, Russell Cerejo, Julian Hardman, Seby John, Andrew Bauer, Jenny Peih-Chir Tsai, Elad Levy, Kenneth Snyder, Jason Davies, Christopher Ogilvy, Dennis Rivet, Michael Alexander, Franklin Moser, Marcel Maya, Michael Schiraldi, Paula Eboli, Justin Caplan, Bowen Jiang, Matthew Bender, Geoffrey Colby, Sudhakar Satti, Thinesh Sivapatham, David Kung, Bryan Pukenas, Robert Hurst, Michelle J. Smith, Ajit Puri, Francesco Massari, David Rex, Justin Fraser, Stephen Grupke, Abdulnasser Alhajeri, Richard Klucznik, Orlando Diaz, Gavin Britz, Yi Zhan, Alejandro Spiotta, Jonathan Lena, Aquilla Turk, Mohamad Chaudry, Kyle Fargen, Raymond Turner, Peter Kan, Edward Duckworth, Muhammad Asif Taqi, Samuel Hou, Adam S. Arthur, Lucas Elijovich, Daniel Hoit, Christopher Nickele, Jay Vachhani, Vinodh Thomas Doss, Richard Crowley, Demetrius Lopes, Michael Chen, Danial Hallam, Basavaraj Ghodke, Louis Kim, Richard Callison, Amer Alshekhlee, Sushant Kale, Michael Froehler, Matt Fusco, and Rohan Chitale

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Original Contributions, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, Clinical and Population Sciences, 0302 clinical medicine, Atlas (anatomy), medicine.artery, medicine, Humans, angiography, Coil embolization, Aged, Advanced and Specialized Nursing, middle cerebral artery, medicine.diagnostic_test, business.industry, Endovascular Procedures, Stent, Intracranial Aneurysm, Middle Aged, Embolization, Therapeutic, medicine.anatomical_structure, Treatment Outcome, Angiography, Middle cerebral artery, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Female, Stents, stent, Neurology (clinical), Radiology, Cardiology and Cardiovascular Medicine, business, retreatment, 030217 neurology & neurosurgery
Abstract

Supplemental Digital Content is available in the text., Background and Purpose: Stent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented. Methods: ATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio 50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee. Results: A total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%–90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%–8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death. Conclusions: In the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and

Published
2020

50. Risk factors associated with death in in-hospital pediatric convulsive status epilepticus.

Author

Tobias Loddenkemper, Tanvir U Syed, Sriram Ramgopal, Deepak Gulati, Sikawat Thanaviratananich, Sanjeev V Kothare, Amer Alshekhlee, and Mohamad Z Koubeissi

Subjects
Medicine, Science
Abstract

To evaluate in-patient mortality and predictors of death associated with convulsive status epilepticus (SE) in a large, multi-center, pediatric cohort.We identified our cohort from the KID Inpatient Database for the years 1997, 2000, 2003 and 2006. We queried the database for convulsive SE, associated diagnoses, and for inpatient death. Univariate logistic testing was used to screen for potential risk factors. These risk factors were then entered into a stepwise backwards conditional multivariable logistic regression procedure. P-values less than 0.05 were taken as significant.We identified 12,365 (5,541 female) patients with convulsive SE aged 0-20 years (mean age 6.2 years, standard deviation 5.5 years, median 5 years) among 14,965,571 pediatric inpatients (0.08%). Of these, 117 died while in the hospital (0.9%). The most frequent additional admission ICD-9 code diagnoses in addition to SE were cerebral palsy, pneumonia, and respiratory failure. Independent risk factors for death in patients with SE, assessed by multivariate calculation, included near drowning (Odds ratio [OR] 43.2; Confidence Interval [CI] 4.4-426.8), hemorrhagic shock (OR 17.83; CI 6.5-49.1), sepsis (OR 10.14; CI 4.0-25.6), massive aspiration (OR 9.1; CI 1.8-47), mechanical ventilation >96 hours (OR9; 5.6-14.6), transfusion (OR 8.25; CI 4.3-15.8), structural brain lesion (OR7.0; CI 3.1-16), hypoglycemia (OR5.8; CI 1.75-19.2), sepsis with liver failure (OR 14.4; CI 5-41.9), and admission in December (OR3.4; CI 1.6-4.1). African American ethnicity (OR 0.4; CI 0.2-0.8) was associated with a decreased risk of death in SE.Pediatric convulsive SE occurs in up to 0.08% of pediatric inpatient admissions with a mortality of up to 1%. There appear to be several risk factors that can predict mortality. These may warrant additional monitoring and aggressive management.

Published
2012
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