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Author Notes:

Corresponding Author: Annetine C. Gelijns, PhD, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029 (annetine.gelijns@mssm.edu).

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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.

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Research Funding:

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.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Medicine, General & Internal
  • General & Internal Medicine
  • CARDIAC-SURGERY
  • THORACIC-SURGEONS
  • BRAIN-LESIONS
  • STROKE
  • DELIRIUM
  • SOCIETY
  • BYPASS
  • RISK
  • DECLINE
  • IMPACT

Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement A Randomized Clinical Trial

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Journal Title:

Journal of the American Medical Association

Volume:

Volume 318, Number 6

Publisher:

, Pages 536-547

Type of Work:

Article | Final Publisher PDF

Abstract:

Stroke is a major complication of surgical aortic valve replacement (SAVR). OBJECTIVE: 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. INTERVENTIONS: 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. RESULTS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02389894.

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© 2017 American Medical Association. All rights reserved.

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