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JAMA. 2017 Aug 8;318(6):536-547. doi: 10.1001/jama.2017.9479.

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

Author information

1
Department of Cardiothoracic Surgery, Baylor Research Institute, Baylor Scott & White Health, Plano, Texas.
2
Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia.
3
International 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.
4
Division of Geriatric Behavioral Health, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.
5
Cardiovascular and Thoracic Surgery, Mission Health and Hospitals, Asheville, North Carolina.
6
Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, Maryland.
7
Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville.
8
Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia.
9
Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
10
Institut Universitaire de Cardiologie de Québec, Hôpital Laval, Quebec, Quebec, Canada.
11
Montréal Heart Institute, University of Montréal, Montreal, Quebec, Canada.
12
Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles.
13
Department of Radiology, University of Pennsylvania, Philadelphia.
14
Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina.
15
Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York.
16
Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.
17
Department of Cardiac Surgery, Mount Sinai Health System, New York, New York.
18
Peter 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.
19
Department of Neurology, Rhode Island Hospital, Miriam Hospital and Bradley Hospital, Warren Alpert Medical School, Brown University, Providence, Rhode Island.
20
Division of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.
21
Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
22
Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia.

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.

PMID:
28787505
PMCID:
PMC5808875
DOI:
10.1001/jama.2017.9479
[Indexed for MEDLINE]
Free PMC Article

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