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

Publication ,  Journal Article
Mack, MJ; Acker, MA; Gelijns, AC; Overbey, JR; Parides, MK; Browndyke, JN; Groh, MA; Moskowitz, AJ; Jeffries, NO; Ailawadi, G; Thourani, VH ...
Published in: JAMA
August 8, 2017

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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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

August 8, 2017

Volume

318

Issue

6

Start / End Page

536 / 547

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Risk Factors
  • Postoperative Complications
  • Male
  • Incidence
  • Humans
  • Heart Valve Prosthesis Implantation
  • Heart Valve Prosthesis
  • General & Internal Medicine
  • Female
 

Citation

APA
Chicago
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Mack, M. J., Acker, M. A., Gelijns, A. C., Overbey, J. R., Parides, M. K., Browndyke, J. N., … Cardiothoracic Surgical Trials Network (CTSN), . (2017). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA, 318(6), 536–547. https://doi.org/10.1001/jama.2017.9479
Mack, Michael J., Michael A. Acker, Annetine C. Gelijns, Jessica R. Overbey, Michael K. Parides, Jeffrey N. Browndyke, Mark A. Groh, et al. “Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial.JAMA 318, no. 6 (August 8, 2017): 536–47. https://doi.org/10.1001/jama.2017.9479.
Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, et al. Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536–47.
Mack, Michael J., et al. “Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial.JAMA, vol. 318, no. 6, Aug. 2017, pp. 536–47. Pubmed, doi:10.1001/jama.2017.9479.
Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, Groh MA, Moskowitz AJ, Jeffries NO, Ailawadi G, Thourani VH, Moquete EG, Iribarne A, Voisine P, Perrault LP, Bowdish ME, Bilello M, Davatzikos C, Mangusan RF, Winkle RA, Smith PK, Michler RE, Miller MA, O’Sullivan KL, Taddei-Peters WC, Rose EA, Weisel RD, Furie KL, Bagiella E, Moy CS, O’Gara PT, Messé SR, Cardiothoracic Surgical Trials Network (CTSN). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536–547.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

August 8, 2017

Volume

318

Issue

6

Start / End Page

536 / 547

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Risk Factors
  • Postoperative Complications
  • Male
  • Incidence
  • Humans
  • Heart Valve Prosthesis Implantation
  • Heart Valve Prosthesis
  • General & Internal Medicine
  • Female