Effect of cerebral embolic protection devices on CNS infarction in surgical aortic valve replacement

A randomized clinical trial

Cardiothoracic Surgical Trials Network (CTSN)

Research output: Contribution to journalArticle

21 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)536-547
Number of pages12
JournalJAMA - Journal of the American Medical Association
Volume318
Issue number6
DOIs
StatePublished - Aug 8 2017

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Embolic Protection Devices
Aortic Valve
Surgical Instruments
Suction
Infarction
Central Nervous System
Randomized Controlled Trials
Delirium
Control Groups
Stroke
Mortality
Acute Kidney Injury
Nervous System Trauma
Ambulatory Surgical Procedures
Cognition
Cardiac Arrhythmias
Outcome Assessment (Health Care)
Equipment and Supplies

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of cerebral embolic protection devices on CNS infarction in surgical aortic valve replacement : A randomized clinical trial. / Cardiothoracic Surgical Trials Network (CTSN).

In: JAMA - Journal of the American Medical Association, Vol. 318, No. 6, 08.08.2017, p. 536-547.

Research output: Contribution to journalArticle

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title = "Effect of cerebral embolic protection devices on CNS infarction in surgical aortic valve replacement: A randomized clinical trial",
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.",
author = "{Cardiothoracic Surgical Trials Network (CTSN)} and Mack, {Michael J.} and Acker, {Michael A.} and Gelijns, {Annetine C.} and Overbey, {Jessica R.} and Parides, {Michael K.} and Browndyke, {Jeffrey N.} and Groh, {Mark A.} and Moskowitz, {Alan J.} and Jeffries, {Neal O.} and Gorav Ailawadi and Thourani, {Vinod H.} and Moquete, {Ellen G.} and Alexander Iribarne and Pierre Voisine and Perrault, {Louis P.} and Bowdish, {Michael E.} and Michel Bilello and Christos Davatzikos and Mangusan, {Ralph F.} and Winkle, {Rachelle A.} and Smith, {Peter K.} and Michler, {Robert E.} and Miller, {Marissa A.} and O’Sullivan, {Karen L.} and Taddei-Peters, {Wendy C.} and Rose, {Eric A.} and Weisel, {Richard D.} and Furie, {Karen L.} and Emilia Bagiella and Moy, {Claudia Scala} and O'Gara, {Patrick T.} and Mess{\'e}, {Steven R.}",
year = "2017",
month = "8",
day = "8",
doi = "10.1001/jama.2017.9479",
language = "English (US)",
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pages = "536--547",
journal = "JAMA - Journal of the American Medical Association",
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TY - JOUR

T1 - Effect of cerebral embolic protection devices on CNS infarction in surgical aortic valve replacement

T2 - A randomized clinical trial

AU - Cardiothoracic Surgical Trials Network (CTSN)

AU - Mack, Michael J.

AU - Acker, Michael A.

AU - Gelijns, Annetine C.

AU - Overbey, Jessica R.

AU - Parides, Michael K.

AU - Browndyke, Jeffrey N.

AU - Groh, Mark A.

AU - Moskowitz, Alan J.

AU - Jeffries, Neal O.

AU - Ailawadi, Gorav

AU - Thourani, Vinod H.

AU - Moquete, Ellen G.

AU - Iribarne, Alexander

AU - Voisine, Pierre

AU - Perrault, Louis P.

AU - Bowdish, Michael E.

AU - Bilello, Michel

AU - Davatzikos, Christos

AU - Mangusan, Ralph F.

AU - Winkle, Rachelle A.

AU - Smith, Peter K.

AU - Michler, Robert E.

AU - Miller, Marissa A.

AU - O’Sullivan, Karen L.

AU - Taddei-Peters, Wendy C.

AU - Rose, Eric A.

AU - Weisel, Richard D.

AU - Furie, Karen L.

AU - Bagiella, Emilia

AU - Moy, Claudia Scala

AU - O'Gara, Patrick T.

AU - Messé, Steven R.

PY - 2017/8/8

Y1 - 2017/8/8

N2 - 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.

AB - 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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U2 - 10.1001/jama.2017.9479

DO - 10.1001/jama.2017.9479

M3 - Article

VL - 318

SP - 536

EP - 547

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 6

ER -