FDA perspective on assessing the clinical benefit of cardiac resynchronization and implantable cardioverter-defibrillator devices

被引:0
作者
Selzman, Kimberly A. [1 ]
机构
[1] US FDA, Div Cardiovasc Devices, Off Device Evaluat, Ctr Devices & Radiol Hlth, White Oak Campus,Bldg 66,10903 New Hampshire Ave, Silver Spring, MD 20903 USA
关键词
HEART-FAILURE; THERAPY;
D O I
10.1016/j.jelectrocard.2018.08.024
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页码:S22 / S24
页数:3
相关论文
共 15 条
  • [1] Cardiac resynchronization in chronic heart failure
    Abraham, WT
    Fisher, WG
    Smith, AL
    Delurgio, DB
    Leon, AR
    Loh, E
    Kocovic, DZ
    Packer, M
    Clavell, AL
    Hayes, DL
    Ellestad, M
    Messenger, J
    Trupp, RJ
    Underwood, J
    Pickering, F
    Truex, C
    McAtee, P
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2002, 346 (24) : 1845 - 1853
  • [2] Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure
    Bristow, MR
    Saxon, LA
    Boehmer, J
    Krueger, S
    Kass, DA
    De Marco, T
    Carson, P
    DiCarlo, L
    DeMets, D
    White, BG
    DeVries, DW
    Feldman, AM
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2004, 350 (21) : 2140 - 2150
  • [3] Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay.
    Cazeau, S
    Leclercq, C
    Lavergne, T
    Walker, S
    Varma, C
    Linde, C
    Garrigue, S
    Kappenberger, L
    Haywood, GA
    Santini, M
    Bailleul, C
    Daubert, JC
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (12) : 873 - 880
  • [4] The effect of cardiac resynchronization on morbidity and mortality in heart failure
    Cleland, JGF
    Daubert, J
    Erdmann, E
    Freemantle, N
    Gras, D
    Kappenberger, L
    Tavazzi, L
    Cleland, JGF
    Daubert, JC
    Erdmann, E
    Gras, D
    Kappenberger, L
    Klein, W
    Tavazzi, L
    Poole-Wilson, PA
    Rydén, L
    Wedel, H
    Wellens, HJJ
    Uretsky, B
    Thygesen, K
    Böcker, D
    Marijianowski, MMH
    Freemantle, N
    Calvert, MJ
    Christ, G
    Fruhwald, F
    Hofmann, R
    Krypta, A
    Leisch, F
    Pacher, R
    Rauscha, F
    Tavernier, R
    Thomsen, PEB
    Boesgaard, S
    Eiskjær, H
    Esperen, GT
    Haarbo, J
    Hagemann, A
    Korup, E
    Moller, M
    Mortensen, P
    Sogaard, P
    Vesterlund, T
    Huikuri, H
    Niemelä, KI
    Toivonen, L
    Bauer, F
    Cohen-Solal, A
    Crocq, C
    Djiane, P
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2005, 352 (15) : 1539 - 1549
  • [5] Curtis AB, 2013, NEW ENGL J MED, V369, P579, DOI [10.1056/NEJMc1306998, 10.1056/NEJMoa1210356]
  • [6] Faris Owen, 2005, Congest Heart Fail, V11, P207, DOI 10.1111/j.1527-5299.2005.04620.x
  • [7] Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms
    Linde, Cecilia
    Abraham, William T.
    Gold, Michael R.
    Sutton, Martin St. John
    Ghio, Stefano
    Daubert, Claude
    [J]. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2008, 52 (23) : 1834 - 1843
  • [8] Medtronic CRT-P and CRT-D devices, SUMM SAF EFF
  • [9] Medtronic InSync, SUMM SAF EFF
  • [10] Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia
    Moss, AJ
    Hall, WJ
    Cannom, DS
    Daubert, JP
    Higgins, SL
    Klein, H
    Levine, JH
    Saksena, S
    Waldo, AL
    Wilber, D
    Brown, MW
    Heo, M
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1996, 335 (26) : 1933 - 1940