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.
N1 - Publisher Copyright:
© 2017 American Medical Association. All rights reserved.
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
C2 - 28787505
AN - SCOPUS:85027525529
SN - 0098-7484
VL - 318
SP - 536
EP - 547
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 6
ER -