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

被引:54
作者
Mack, Michael J. [2 ]
Acker, Michael A. [3 ]
Gelijns, Annetine C. [1 ,4 ]
Overbey, Jessica R. [4 ]
Parides, Michael K. [4 ]
Browndyke, Jeffrey N. [5 ]
Groh, Mark A. [6 ]
Moskowitz, Alan J. [4 ]
Jeffries, Neal O. [7 ]
Ailawadi, Gorav [8 ]
Thourani, Vinod H. [9 ]
Moquete, Ellen G. [4 ]
Iribarne, Alexander [10 ]
Voisine, Pierre [11 ]
Perrault, Louis P. [12 ]
Bowdish, Michael E. [13 ]
Bilello, Michel [14 ]
Davatzikos, Christos [14 ]
Mangusan, Ralph F. [6 ]
Winkle, Rachelle A. [2 ]
Smith, Peter K. [15 ]
Michler, Robert E. [16 ]
Miller, Marissa A. [17 ]
O'Sullivan, Karen L. [4 ]
Taddei-Peters, Wendy C. [17 ]
Rose, Eric A. [18 ]
Weisel, Richard D. [19 ,20 ,21 ]
Furie, Karen L. [22 ,23 ]
Bagiella, Emilia [4 ]
Moy, Claudia Scala [24 ]
O'Gara, Patrick T. [25 ]
Messe, Steven R. [26 ]
机构
[1] Icahn Sch Med Mt Sinai, One Gustave L Levy Pl,POB 1077, New York, NY 10029 USA
[2] Baylor Scott & White Hlth, Baylor Res Inst, Dept Cardiothorac Surg, Plano, TX USA
[3] Univ Penn, Sch Med, Dept Surg, Div Cardiovasc Surg, Philadelphia, PA 19104 USA
[4] Icahn Sch Med Mt Sinai, Int Ctr Hlth Outcomes & Innovat Res, Dept Populat Hlth Sci & Policy, New York, NY 10029 USA
[5] Duke Univ, Med Ctr, Dept Psychiat & Behav Sci, Div Geriatr Behav Hlth, Durham, NC USA
[6] Mission Hlth & Hosp, Cardiovasc & Thorac Surg, Asheville, NC USA
[7] NHLBI, Off Biostat Res, Bldg 10, Bethesda, MD 20892 USA
[8] Univ Virginia, Sch Med, Div Thorac & Cardiovasc Surg, Charlottesville, VA 22908 USA
[9] Emory Univ, Sch Med, Div Cardiothorac Surg, Clin Res Unit, Atlanta, GA 30322 USA
[10] Dartmouth Hitchcock Med Ctr, Cardiac Surg, Lebanon, NH 03766 USA
[11] Inst Univ Cardiol Quebec, Hop Laval, Quebec City, PQ, Canada
[12] Univ Montreal, Montreal Heart Inst, Montreal, PQ, Canada
[13] Univ Southern Calif, Keck Sch Med, Dept Surg, Los Angeles, CA USA
[14] Univ Penn, Dept Radiol, Philadelphia, PA 19104 USA
[15] Duke Univ, Med Ctr, Dept Surg, Div Cardiovasc & Thorac Surg, Durham, NC 27710 USA
[16] Montefiore Med Ctr, Albert Einstein Coll Med, Dept Cardiothorac Surg, New York, NY USA
[17] NHLBI, Div Cardiovasc Sci, Bldg 10, Bethesda, MD 20892 USA
[18] Mt Sinai Hlth Syst, Dept Cardiac Surg, New York, NY USA
[19] Peter Munk Cardiac Ctr, Toronto, ON, Canada
[20] Univ Hlth Network, Toronto Gen Hosp, Div Cardiovasc Surg, Toronto, ON, Canada
[21] Univ Toronto, Div Cardiac Surg, Toronto, ON, Canada
[22] Brown Univ, Rhode Isl Hosp, Dept Neurol, Miriam Hosp, Providence, RI 02903 USA
[23] Brown Univ, Bradley Hosp, Warren Alpert Med Sch, Providence, RI 02912 USA
[24] NINDS, Div Clin Res, Bldg 36,Rm 4D04, Bethesda, MD 20892 USA
[25] Brigham & Womens Hosp, Div Cardiovasc, 75 Francis St, Boston, MA 02115 USA
[26] Univ Penn, Sch Med, Dept Neurol, Philadelphia, PA 19104 USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2017年 / 318卷 / 06期
基金
美国国家卫生研究院;
关键词
CARDIAC-SURGERY; THORACIC-SURGEONS; BRAIN-LESIONS; STROKE; DELIRIUM; SOCIETY; BYPASS; RISK; DECLINE; IMPACT;
D O I
10.1001/jama.2017.9479
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 pointwas 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.
引用
收藏
页码:536 / 547
页数:12
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