Wearable Cardioverter-Defibrillator after Myocardial Infarction

被引:205
作者
Olgin, Jeffrey E. [1 ]
Pletcher, Mark J. [2 ]
Vittinghoff, Eric [2 ]
Wranicz, Jerzy [3 ]
Malik, Rajesh [4 ]
Morin, Daniel P. [5 ,6 ]
Zweibel, Steven [7 ,8 ]
Buxton, Alfred E. [9 ]
Elayi, Claude S. [10 ,11 ]
Chung, Eugene H. [12 ]
Rashba, Eric [13 ]
Borggrefe, Martin [14 ,15 ]
Hue, Trisha F. [2 ]
Maguire, Carol [1 ]
Lin, Feng [2 ]
Simon, Joel A. [2 ]
Hulley, Stephen [2 ]
Lee, Byron K. [1 ]
机构
[1] Univ Calif San Francisco, Div Cardiol, Dept Med, UCSF Ctr Prevent Sudden Death, San Francisco, CA 94143 USA
[2] Univ Calif San Francisco, Dept Epidemiol & Biostat, San Francisco, CA 94143 USA
[3] Med Univ Lodz, Dept Electrocardiol, Lodz, Poland
[4] McLeod Reg Med Ctr, Florence, SC USA
[5] Univ Queensland, Sch Med, Ochsner Med Ctr, New Orleans, LA USA
[6] Univ Queensland, Sch Med, Ochsner Clin Sch, New Orleans, LA USA
[7] Hartford Healthcare Heart & Vasc Inst, Hartford, CT USA
[8] Univ Connecticut, Sch Med, Hartford, CT 06112 USA
[9] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Boston, MA USA
[10] Univ Kentucky, Gill Heart Inst, Lexington, KY USA
[11] Vet Affairs Med Ctr, Lexington, KY USA
[12] Univ Michigan, Dept Internal Med, Michigan Med, Ann Arbor, MI 48109 USA
[13] Stony Brook Med, Stony Brook, NY USA
[14] Univ Med Ctr Mannheim, Dept Med Cardiol 1, Mannheim, Germany
[15] DZHK German Ctr Cardiovasc Res, Heidelberg, Germany
基金
美国国家卫生研究院;
关键词
ASSOCIATION TASK-FORCE; LEFT-VENTRICULAR DYSFUNCTION; GUIDELINES WRITING COMMITTEE; SUDDEN CARDIAC DEATH; ACC/AHA; 2007; GUIDELINES; DEVICE-BASED THERAPY; AMERICAN-COLLEGE; FOCUSED UPDATE; RHYTHM ABNORMALITIES; RISK STRATIFICATION;
D O I
10.1056/NEJMoa1800781
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear. METHODS We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death. RESULTS Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P = 0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock. CONCLUSIONS Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control.
引用
收藏
页码:1205 / 1215
页数:11
相关论文
共 35 条
[1]   Sudden Death After Myocardial Infarction [J].
Adabag, A. Selcuk ;
Therneau, Terry M. ;
Gersh, Bernard J. ;
Weston, Susan A. ;
Roger, Veronique L. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 300 (17) :2022-2029
[2]   ACC/AHA 2007 Guidelines for the Management of Patients With unstable Angina/Non-ST-Elevation Myocardial Infarction A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine [J].
Anderson, Jeffrey L. ;
Adams, Cynthia D. ;
Antman, Elliott M. ;
Bridges, Charles R. ;
Califf, Robert M. ;
Casey, Donald E., Jr. ;
Chavey, William E. ;
Fesmire, Francis M. ;
Hochman, Judith S. ;
Levin, Thomas N. ;
Lincoff, A. Michael ;
Peterson, Eric D. ;
Theroux, Pierre ;
Wenger, Nanette Kass ;
Wright, R. Scott ;
Smith, Sidney C. ;
Jacobs, Alice K. ;
Halperin, Jonathan L. ;
Hunt, Sharon A. ;
Krumholz, Harlan M. ;
Kushner, Frederick G. ;
Lytle, Bruce W. ;
Nishimura, Rick ;
Ornato, Joseph P. ;
Page, Richard L. ;
Riegel, Barbara .
CIRCULATION, 2007, 116 (07) :E148-E304
[3]   2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines [J].
Anderson, Jeffrey L. ;
Adams, Cynthia D. ;
Antman, Elliott M. ;
Bridges, Charles R. ;
Califf, Robert M. ;
Casey, Donald E., Jr. ;
Chavey, William E., II ;
Fesmire, Francis M. ;
Hochman, Judith S. ;
Levin, Thomas N. ;
Lincoff, A. Michael ;
Peterson, Eric D. ;
Theroux, Pierre ;
Wenger, Nanette Kass ;
Wright, R. Scott ;
Ettinger, Steven M. ;
Ganiats, Theodore G. ;
Jneid, Hani ;
Philippides, George J. ;
Zidar, James Patrick ;
Jacobs, Alice K. ;
Albert, Nancy ;
Hochman, Judith S. ;
Creager, Mark A. ;
Kushner, Frederick G. ;
Ohman, Erik Magnus ;
Guyton, Robert A. ;
Stevenson, William G. ;
Halperin, Jonathan L. ;
Yancy, Clyde W. .
CIRCULATION, 2011, 123 (18) :E426-E579
[4]  
[Anonymous], 2017, J AM COLL CARDIOL
[5]   2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction - A report of the American college of cardiology/American heart association task force on practice guidelines [J].
Antman, Elliott M. ;
Hand, Mary ;
Armstrong, Paul W. ;
Bates, Eric R. ;
Green, Lee A. ;
Halasyamani, Lakshmi K. ;
Hochman, Judith S. ;
Krumholz, Harlan M. ;
Lamas, Gervasio A. ;
Mullany, Charles J. ;
Pearle, David L. ;
Sloan, Michael A. ;
Smith, Sidney C., Jr. .
CIRCULATION, 2008, 117 (02) :296-329
[6]  
Antman Elliott M., 2004, J Am Coll Cardiol, V44, pE1, DOI 10.1016/j.jacc.2004.07.014
[7]   PROGNOSIS AFTER 1ST MYOCARDIAL-INFARCTION - COMPARISON OF Q-WAVE AND NON-Q-WAVE MYOCARDIAL-INFARCTION IN THE FRAMINGHAM HEART-STUDY [J].
BERGER, CJ ;
MURABITO, JM ;
EVANS, JC ;
ANDERSON, KM ;
LEVY, D .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1992, 268 (12) :1545-1551
[8]   Predicting Persistent Left Ventricular Dysfunction Following Myocardial Infarction The PREDICTS Study [J].
Brooks, Gabriel C. ;
Lee, Byron K. ;
Rao, Rajni ;
Lin, Feng ;
Morin, Daniel P. ;
Zweibel, Steven L. ;
Buxton, Alfred E. ;
Pletcher, Mark J. ;
Vittinghoff, Eric ;
Olgin, Jeffrey E. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2016, 67 (10) :1186-1196
[9]   A randomized study of the prevention of sudden death in patients with coronary artery disease [J].
Buxton, AE ;
Lee, KL ;
Fisher, JD ;
Josephson, ME ;
Prystowsky, EN ;
Hafley, G .
NEW ENGLAND JOURNAL OF MEDICINE, 1999, 341 (25) :1882-1890
[10]   Aggregate National Experience With the Wearable Cardioverter-Defibrillator Event Rates, Compliance, and Survival [J].
Chung, Mina K. ;
Szymkiewicz, Steven J. ;
Shao, Mingyuan ;
Zishiri, Edwin ;
Niebauer, Mark J. ;
Lindsay, Bruce D. ;
Tchou, Patrick J. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2010, 56 (03) :194-203