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Can cerebral embolic protection devices reduce the incidence of stroke after surgical aortic valve replacement?
In this randomized clinical trial that included 383 patients, there was no significant difference in freedom from central nervous system infarction between suction-based extraction and a standard aortic cannula (32.0% vs 33.3%, respectively) or between intra-aortic filtration and a standard aortic cannula (25.6% vs 32.4%, respectively).
The incidence of central nervous system infarction after surgical aortic valve replacement was not altered by either of the 2 cerebral embolic protection devices.
Stroke is a major complication of surgical aortic valve replacement (SAVR).
To determine the efficacy and adverse effects of cerebral embolic protection devices in reducing ischemic central nervous system (CNS) injury during SAVR.
Design, Setting, and Participants
A randomized clinical trial of patients with calcific aortic stenosis undergoing SAVR at 18 North American centers between March 2015 and July 2016. The end of follow-up was December 2016.
Use of 1 of 2 cerebral embolic protection devices (n = 118 for suction-based extraction and n = 133 for intra-aortic filtration device) vs a standard aortic cannula (control; n = 132) at the time of SAVR.
Main Outcomes and Measures
The primary end point was freedom from clinical or radiographic CNS infarction at 7 days (± 3 days) after the procedure. Secondary end points included a composite of mortality, clinical ischemic stroke, and acute kidney injury within 30 days after surgery; delirium; mortality; serious adverse events; and neurocognition.
Among 383 randomized patients (mean age, 73.9 years; 38.4% women; 368 [96.1%] completed the trial), the rate of freedom from CNS infarction at 7 days was 32.0% with suction-based extraction vs 33.3% with control (between-group difference, −1.3%; 95% CI, −13.8% to 11.2%) and 25.6% with intra-aortic filtration vs 32.4% with control (between-group difference, −6.9%; 95% CI, −17.9% to 4.2%). The 30-day composite end point was not significantly different between suction-based extraction and control (21.4% vs 24.2%, respectively; between-group difference, −2.8% [95% CI, −13.5% to 7.9%]) nor between intra-aortic filtration and control (33.3% vs 23.7%; between-group difference, 9.7% [95% CI, −1.2% to 20.5%]). There were no significant differences in mortality (3.4% for suction-based extraction vs 1.7% for control; and 2.3% for intra-aortic filtration vs 1.5% for control) or clinical stroke (5.1% for suction-based extraction vs 5.8% for control; and 8.3% for intra-aortic filtration vs 6.1% for control). Delirium at postoperative day 7 was 6.3% for suction-based extraction vs 15.3% for control (between-group difference, −9.1%; 95% CI, −17.1% to −1.0%) and 8.1% for intra-aortic filtration vs 15.6% for control (between-group difference, −7.4%; 95% CI, −15.5% to 0.6%). Mortality and overall serious adverse events at 90 days were not significantly different across groups. Patients in the intra-aortic filtration group vs patients in the control group experienced significantly more acute kidney injury events (14 vs 4, respectively; P = .02) and cardiac arrhythmias (57 vs 30; P = .004).
Conclusions and Relevance
Among patients undergoing SAVR, cerebral embolic protection devices compared with a standard aortic cannula did not significantly reduce the risk of CNS infarction at 7 days. Potential benefits for reduction in delirium, cognition, and symptomatic stroke merit larger trials with longer follow-up.
clinicaltrials.gov Identifier: NCT02389894
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Corresponding Author: Annetine C. Gelijns, PhD, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029 (email@example.com).
Accepted for Publication: July 6, 2017.
Author Contributions: Ms Overbey and Dr Parides had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Mack and Acker are both first authors.
Concept and design: Mack, Acker, Gelijns, Parides, Browndyke, Moskowitz, Ailawadi, Thourani, Moquete, Iribarne, Perrault, Bowdish, Davatzikos, Winkle, Miller, Taddei-Peters, Rose, Weisel, Furie, Bagiella, Moy, O’Gara.
Acquisition, analysis, or interpretation of data: Mack, Acker, Gelijns, Overbey, Parides, Browndyke, Groh, Moskowitz, Jeffries, Ailawadi, Moquete, Iribarne, Voisine, Perrault, Bilello, Davatzikos, Mangusan, Smith, Michler, O'Sullivan, Taddei-Peters, Rose, Weisel, Bagiella, O'Gara, Messé.
Drafting of the manuscript: Mack, Acker, Gelijns, Overbey, Browndyke, Moskowitz, Moquete, Iribarne, Bowdish, O'Sullivan, Bagiella, O'Gara.
Critical revision of the manuscript for important intellectual content: Mack, Acker, Gelijns, Overbey, Parides, Browndyke, Groh, Jeffries, Ailawadi, Thourani, Moquete, Iribarne, Voisine, Perrault, Bowdish, Bilello, Davatzikos, Mangusan, Winkle, Smith, Michler, Miller, Taddei-Peters, Rose, Weisel, Furie, Bagiella, Moy, O'Gara, Messé.
Statistical analysis: Overbey, Parides, Browndyke, Jeffries, Iribarne, Perrault, Smith, Rose, Bagiella.
Obtained funding: Gelijns, Parides, Ailawadi, Bowdish, Michler, Miller, Rose, Weisel, Moy.
Administrative, technical, or material support: Acker, Browndyke, Iribarne, Voisine, Bowdish, Bilello, Michler, Miller, O'Sullivan, Taddei-Peters, Rose, Weisel.
Supervision: Mack, Acker, Gelijns, Parides, Groh, Moskowitz, Ailawadi, Thourani, Moquete, Perrault, Winkle, Michler, O'Sullivan, Weisel, O'Gara, Messé.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Mack reported having prior uncompensated research relationships with Edwards LifeSciences and Abbott Vascular; and serving on an executive board for Medtronic (uncompensated). Dr Browndyke reported receiving personal fees from Claret Medical Inc. Dr Bowdish reported receiving personal fees from Edwards Lifesciences. Dr Messé reported receiving personal fees from Claret Medical Inc; and receiving personal fees from the Yale Cardiovascular Research Group for serving on a clinical event committtee. No other disclosures were reported.
Funding/Support: The trial was supported by cooperative agreement U01 HL088942 funded by the National Institute of Neurological Disorders and Stroke, the National Heart, Lung, and Blood Institute, and the Canadian Institutes for Health Research. Additional support was provided by grant R01 AG014971 from the National Institutes of Health (Dr Davatzikos). Training in use of the Embol-X (Edwards Lifesciences) and CardioGard (CardioGard) devices was provided by the companies but they did not provide financial support for the study.
Role of the Funder/Sponsor: The representatives from the National Institutes of Health were involved in study design, management, and review of the manuscript. Edwards Lifesciences and CardioGard had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript or the decision to submit for publication.
Group Information: The members of the Cardiothoracic Surgical Trials Network (CTSN) are Dennis Buxton, Nancy L. Geller, Catherine Burke, Albert Lee, and Tyrone Smith (National Heart, Lung, and Blood Institute); Ilana Kogan Gombos (Canadian Institutes of Health Research); Kinjal Shah, Stephanie Pan, Alishba Aslam, Helena Chang, Melissa Chase, Kayla Dellefratte, Seth Goldfarb, Lopa Gupta, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Andrea Ratner, Milerva Santos, Nancy Sledz-Joyce, and Xia Ye (International Center for Health Outcomes and Innovation Research at Icahn School of Medicine at Mount Sinai; data coordinating center); Amanda Fenlon, Katherine Harrington, Kelly Hutcheson, Melissa Johnson, Jessica Jones, Megan Kolb, Sarah Lam, Lucy Miranda, Jackie Ward, Renessa Whitman, Brittany Zingler, William Ryan, Robert L. Smith, Pedro Nosnik, and Justin Whisenant (Baylor Research Institute); Edward G. Soltesz, Stephanie Mick, Irene Katzan, Brian Strippy, Shoi Smith, Michelle Garcia, and Mary Alice Bowman (Cleveland Clinic Foundation); Michael Argenziano (primary investigator), Michael Borger, Hiroo Takayama, Lyn Goldsmith, Nadia Sookraj, Talaya McCright-Gill, and Sowmya Sreekanth (Columbia University); Jock N. McCullough (primary investigator), Joseph P. DeSimone, Anthony W. DiScipio, Henry Stokes, Amanda St Ivany, Gaylin Petty, and Jim Hart (Dartmouth-Hitchcock Medical Center); John H. Alexander, Carmelo A. Milano, Donald D. Glower, Stacey Welsh, Sarah Casalinova, Victoria Johnson, Derek Smith, and Greg Tipton (Duke University); Robert Guyton, Omar Lattouf, Michael Halkos, Kim Baio, Tamara Prince, Natascha Cook, and Alexis A. Neill (Emory University); François Dagenais, Robert Laforce Jr, Kim O’Connor, Gladys Dussault, Manon Caouette, Hugo Tremblay, Nathalie Gagne, and Patricia Landry (Hôpital Laval); John G. Short, Reid D. Taylor, Tracy Nanney, Holly Aubart, Kristin Cross, Leslie McPeters, Christina Riggsbee, and Lucy Rixey (Mission Hospital); Joseph J. DeRose Jr, Daniel J. Goldstein, Ricardo A. Bello, William Jakobleff, Kathryn Kirchoff, Richard Zampolin, Rebecca Meli, Juan Garcia, Jon Goldenberg, and Lauren Kealy (Montefiore-Einstein Heart Center); Denis Bouchard, Michel Carrier, Jean François Tanguay, Pierre Pagé, Céline Odier, Filippo Codemartiri, Jonathan Lacharité, and Sophie Robichaud (Montreal Heart Institute); Keith A. Horvath (primary investigator), Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Greg Kumkumian, Mark Milner, and Zurab Nadareishvili (National Institutes of Health Heart Center at Suburban Hospital); Bryan A. Whitson (primary investigator), Juan Crestellano, Xuan Nguyen, Mohit Datta, Asia McDavid, and Denise Fadorsen (Ohio State University Medical Center); Maral Ouzounian (primary investigator), Terry Yau, Cheryl Jaigobin, Narinder Paul, Walter Kucharczyk, Nishit Fumakia, and Shakira Christie (Toronto General Hospital); John C. Mullen (primary investigator), Asvina Bissonauth, and Alexandra Hripko (University of Alberta Hospital); Bradley Taylor (primary investigator), James Gammie, John Cole, Robert Morales, Kristen Mackowick, Stephanie Deasey, and Julia Collins (University of Maryland); Jesse Raiten, Cen Zhang, Mary Lou Mayer, Caitlin McDonald, Holley Fok, Breanna Maffei, Stephen Cresse, and Christine Gepty (University of Pennsylvania); Vaughn A. Starnes, David Shavalle, Christi Heck, Amy Hackmann, Craig Baker, Fernando Fleischman, Mark Cunningham, Meng Law, Edward Lozano, Michelle Hernandez, and Sylvia Ramos (University of Southern California); Irving L. Kron, Karen Johnston, Ravi K. Ghanta, Leora Yarboro, Joe Carrera, Nicole Chiota-McCollum, Sandra Burks, Mike Cosner, China Green, Samantha Loya, Helen Kim, Jennifer Phillips, and Rachel Simon (University of Virginia).
Additional Contributions: We thank David A. Bull (chair), Patrice Desvigne-Nickens (executive secretary), Dennis O. Dixon, Rebecca Gottesman, Mark Haigney, Richard Holubkov, Constantino Iadecola, Alice Jacobs, Eric M. Meslin, John M. Murkin, and John A. Spertus (protocol review committee); Frank Sellke (chair), Cheryl L. McDonald (executive secretary), John Canty, Neal Dickert, Dennis O. Dixon, John S. Ikonomidis, Kyung Mann Kim, David O. Williams, Clyde W. Yancy, Seemant Chaturvedi, and Marc Chimowitz (data and safety monitoring board); James C. Fang and Wayne Richenbacher (medical monitors); Vivek Rao (chair), Rachel Miller, Jennifer Cook, David D’Alessandro, Frederick Han, Sean Pinney, and Mary N. Walsh (overall event adjudication committee); David Greer (chair), Koto Ishida, and Christian Stapf (events adjudication committee neurology subcommittee); Judy Hung, Xin Zeng, David Hung, and Sudarat Satitthummanid (echo core laboratory at Massachusetts General Hospital); Guray Erus, Lauren Karpf, and Lisa Desiderio (MRI core laboratory at the University of Pennsylvania); Joseph P. Mathew, Michael L. James, Yanne Toulgoat-Dubois, and Rachele Brassard (neurocognitive core laboratory at Duke University Medical Center); and Renu Virmanu, Maria E. Romero, and Ryan Braumann (histopathology core laboratory at CVPath Institute).
Disclaimer: The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the US Department of Health and Human Services.
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