CLINICAL RESEARCH: HEART RHYTHM DISORDER
Risk Stratification for Primary Implantation of a Cardioverter-Defibrillator in Patients With Ischemic Left Ventricular Dysfunction
Ilan Goldenberg, MD*,1,*,
Anant K. Vyas, MD, MPH ,1,
W. Jackson Hall, PhD ,1,
Arthur J. Moss, MD*,
Hongyue Wang, PhD,
Hua He, MA,
Wojciech Zareba, MD, PhD*,
Scott McNitt, MS*,
Mark L. Andrews, BBA* for the MADIT-II Investigators
* Cardiology Unit of the Department of Medicine, University of Rochester Medical Center, Rochester, New York
Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York
Cardiovascular Division of the Department of Medicine, University of Buffalo, Buffalo, New York.
Manuscript received May 31, 2007;
revised manuscript received July 27, 2007,
accepted August 20, 2007.
* Reprint requests and correspondence: Dr. Ilan Goldenberg, Heart Research Follow-up Program, Box 653, University of Rochester Medical Center, Rochester, New York 14642. (Email: Ilan.Goldenberg{at}heart.rochester.edu).
Objectives: The study was designed to develop a simple risk stratification score for primary therapy with an implantable cardioverter-defibrillator (ICD).
Background: Current guidelines recommend primary ICD therapy in patients with a low ejection fraction (EF). However, the benefit of the ICD in the low EF population may not be uniform.
Methods: Best-subset proportional-hazards regression analysis was used to develop a simple clinical risk score for the end point of all-cause mortality in patients allocated to the conventional therapy arm of MADIT (Multicenter Automatic Defibrillator Implantation Trial)-II after excluding a pre-specified subgroup of very high-risk (VHR) patients (defined by blood urea nitrogen [BUN]  50 mg/dl and/or serum creatinine 2.5 mg/dl). The benefit of the ICD was then assessed within risk score categories and separately in VHR patients.
Results: The selected risk score model comprised 5 clinical factors (New York Heart Association functional class >II, age >70 years, BUN >26 mg/dl, QRS duration >0.12 s, and atrial fibrillation). Crude mortality rates in the conventional group were 8% and 28% in patients with 0 and 1 risk factors, respectively, and 43% in VHR patients. Defibrillator therapy was associated with a 49% reduction in the risk of death (p < 0.001) among patients with 1 risk factors (n = 786), whereas no ICD benefit was identified in patients with 0 risk factors (n = 345; hazard ratio 0.96; p = 0.91) and in VHR patients (n = 60; hazard ratio 1.00; p > 0.99).
Conclusions: Our data suggest a U-shaped pattern for ICD efficacy in the low-EF population, with pronounced benefit in intermediate-risk patients and attenuated efficacy in lower- and higher-risk subsets.
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Abbreviations and Acronyms
| | BUN = blood urea nitrogen | | EF = ejection fraction | | ICD = implantable cardioverter-defibrillator | | LBBB = left bundle branch block | | MI = myocardial infarction | | NYHA = New York Heart Association | | VHR = very high risk |
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|
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|
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|
|
|
|
|
|
|
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March 2, 2010;
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712 - 718.
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|
|
|
|
|
|
|
H. Wieneke, S. Spencker, J. H. Svendsen, J. G. Martinez, B. Strohmer, L. Toivonen, H. Le Marec, J. Garcia, B. Kaup, O. Soykan, et al.
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12(3):
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|
|
|
|
|
|
|
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|
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|
|
|
|
|
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|
|
|
|
|
|
|
E. M. Kanoupakis, E. G. Manios, and P. E. Vardas
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11(11):
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[Full Text]
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|
|
|
|
|
|
|
W. C. Levy, K. L. Lee, A. S. Hellkamp, J. E. Poole, D. Mozaffarian, D. T. Linker, A. P. Maggioni, I. Anand, P. A. Poole-Wilson, D. P. Fishbein, et al.
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120(10):
835 - 842.
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|
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|
|
|
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R. Tung and C. D. Swerdlow
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September 8, 2009;
120(10):
825 - 827.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Brignole
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Europace,
September 1, 2009;
11(9):
1129 - 1133.
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Myerburg, V. Reddy, and A. Castellanos
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J. Am. Coll. Cardiol.,
August 25, 2009;
54(9):
747 - 763.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. M. Marcus, E. Keung, and M. M. Scheinman
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J. Am. Coll. Cardiol.,
August 25, 2009;
54(9):
777 - 787.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. W. Israel
Do some implant too many defibrillators or others too few?
Europace,
August 1, 2009;
11(8):
982 - 984.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. E. Epstein
Reply.
J. Am. Coll. Cardiol.,
March 31, 2009;
53(13):
1163 - 1163.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Rivero-Ayerza and B. Schaer
Device therapy in heart failure: do all treatment goals apply to all patients?
Europace,
March 1, 2009;
11(3):
280 - 282.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. N. DeMaria, O. Ben-Yehuda, J. J. Bax, G. K. Feld, B. H. Greenberg, W. Y.W. Lew, J. A.C. Lima, A. S. Maisel, S. M. Narayan, D. J. Sahn, et al.
Highlights of the Year in JACC 2008
J. Am. Coll. Cardiol.,
January 27, 2009;
53(4):
373 - 398.
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. S. Chan, B. K. Nallamothu, J. A. Spertus, F. A. Masoudi, C. Bartone, D. J. Kereiakes, and T. Chow
Impact of Age and Medical Comorbidity on the Effectiveness of Implantable Cardioverter-Defibrillators for Primary Prevention
Circ Cardiovasc Qual Outcomes,
January 1, 2009;
2(1):
16 - 24.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Goette, F. Cantu, L. van Erven, P. Geelen, F. Halimi, J. L. Merino, J. M. Morgan, and on behalf of the Scientific Initiative Committee o
Performance and survival of transvenous defibrillation leads: need for a European data registry
Europace,
January 1, 2009;
11(1):
31 - 34.
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|
|
|
|
|
|
|
C. N. Pellegrini, K. Lee, J. E. Olgin, M. P. Turakhia, Z. H. Tseng, R. Lee, N. Badhwar, B. Lee, and P. D. Varosy
Impact of advanced age on survival in patients with implantable cardioverter defibrillators
Europace,
November 1, 2008;
10(11):
1296 - 1301.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. A. Noseworthy and C. Newton-Cheh
Genetic Determinants of Sudden Cardiac Death
Circulation,
October 28, 2008;
118(18):
1854 - 1863.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. K. Triedman
Should patients with congenital heart disease and a systemic ventricular ejection fraction less than 30% undergo prophylactic implantation of an ICD?: Implantable Cardioverter Defibrillator Implantation Guidelines Based Solely on Left Ventricular Ejection Fraction Do Not Apply to Adults With Congenital Heart Disease
Circ Arrhythm Electrophysiol,
October 1, 2008;
1(4):
307 - 316.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. E. Epstein
Benefits of the Implantable Cardioverter-Defibrillator
J. Am. Coll. Cardiol.,
September 30, 2008;
52(14):
1122 - 1127.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. J. Moss
Life Versus Death
Circulation,
April 15, 2008;
117(15):
1912 - 1913.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Mittal
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J. Am. Coll. Cardiol.,
January 22, 2008;
51(3):
297 - 299.
[Full Text]
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|
|
|
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