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Original Investigation
August 8, 2017

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

Author Affiliations
  • 1Department of Cardiothoracic Surgery, Baylor Research Institute, Baylor Scott & White Health, Plano, Texas
  • 2Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia
  • 3International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York
  • 4Division of Geriatric Behavioral Health, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina
  • 5Cardiovascular and Thoracic Surgery, Mission Health and Hospitals, Asheville, North Carolina
  • 6Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, Maryland
  • 7Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville
  • 8Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia
  • 9Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
  • 10Institut Universitaire de Cardiologie de Québec, Hôpital Laval, Quebec, Quebec, Canada
  • 11Montréal Heart Institute, University of Montréal, Montreal, Quebec, Canada
  • 12Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles
  • 13Department of Radiology, University of Pennsylvania, Philadelphia
  • 14Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina
  • 15Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York
  • 16Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland
  • 17Department of Cardiac Surgery, Mount Sinai Health System, New York, New York
  • 18Peter Munk Cardiac Centre and Division of Cardiovascular Surgery, Toronto General Hospital, University Health Network and the Division of Cardiac Surgery, University of Toronto, Toronto, Ontario, Canada
  • 19Department of Neurology, Rhode Island Hospital, Miriam Hospital and Bradley Hospital, Warren Alpert Medical School, Brown University, Providence, Rhode Island
  • 20Division of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland
  • 21Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts
  • 22Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia
JAMA. 2017;318(6):536-547. doi:10.1001/jama.2017.9479
Key Points

Question  Can cerebral embolic protection devices reduce the incidence of stroke after surgical aortic valve replacement?

Findings  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).

Meaning  The incidence of central nervous system infarction after surgical aortic valve replacement was not altered by either of the 2 cerebral embolic protection devices.

Abstract

Importance  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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