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Chapter 58 - HEART FAILURE: MANAGEMENT AND PROGNOSIS fr...
1 de 3
http://remoto.dgb.uanl.mx:2065/das/book/body/108023714-4/0/1492/251...
Use of this content is subject to the Terms and Conditions
Goldman: Cecil Medicine, 23rd ed. Copyright © 2007 Saunders, An Imprint of Elsevier
Chapter 58 – HEART FAILURE: MANAGEMENT AND PROGNOSIS John J.V. McMurray Marc A. Pfeffer
EVALUATION AND MANAGEMENT OF HEART FAILURE Heart failure is an overarching term for a syndrome (i.e., a constellation of signs and symptoms) that encompasses a vast spectrum of cardiovascular disorders and is associated with a greatly heightened risk of death and nonfatal adverse cardiovascular events ( Chapter 57 ). Treatment is initially directed toward prevention of cardiac injury (e.g., due to hypertension or myocardial infarction) or toward limiting structural progression if cardiac damage has already occurred (e.g., left ventricular remodeling with declining left ventricular ejection fraction) and delaying the development of symptomatic heart failure. Once symptoms develop, treatments are also directed at improving functional status as well as prognosis. Approximately one in five adults will develop heart failure. In the United States, the nearly 1 million annual hospitalizations with a primary diagnosis of heart failure account for 5 million hospital days. The estimated cost of heart failure management ranges from $15 billion to $40 billion annually, depending on the formula used. Randomized controlled clinical trials (RCTs) supply the framework for quantifying what different therapeutic approaches can offer. Even when they are definitive, RCTs only generate data about average risks and benefits of the tested therapeutic option in a selected cohort. Because an individual patient's responses can only be implied from the overall estimated group responses, RCTs cannot definitively direct the approach of every patient or answer the myriad questions that confront the practitioner regarding the specific circumstances of the patient. Another major limitation of RCTs is the relatively narrow time frame of observation, generally only months to several years, compared with epidemiologic experiences during decades. Despite these limitations, RCTs are the premier tool of evidence-based medicine, and the field of heart failure has fortunately been the focus of relatively high quality RCTs that have provided robust evidence to improve clinical care and prognosis ( Table 58-1 ). Indeed, the implementation of evidence from RCTs into clinical practice has resulted in impressive temporal improvements in survival after discharge from a first hospital admission for heart failure. Moreover, the age at which symptomatic heart failure first becomes evident has increased. Despite these tangible advances, heart failure continues to be a leading cause of morbidity and mortality in the elderly. TABLE 58-1 -- CONTROLLED TRIALS [*] IN SYMPTOMATIC HEART FAILURE WITH REDUCED SYSTOLIC FUNCTION Events Prevented per 1000 Patients Treated [¶¶] Trial, Estimated Relative Treatment, and Year Published
N
Severity of First-Year Heart Placebo/Control Background Treatment Failure Group Mortality Treatment [†] Added
Trial Risk DEATH Duration Primary Reduction HF OR HF (years) End Point (%) [‡] DEATH HOSP. HOSP.
ACE INHIBITORS CONSENSUS, 253 1987 [a] SOLVD-T, 1991 [b]
End stage
52
Spironolactone Enalapril, 20 0.54 [‡] mg bid
2569 Mild-severe 15.7
—
Death
40
146
—
Enalapril, 20 3.5 mg bid
Death
16
45
96
— 108
β-BLOCKERS CIBIS-2, 1999 [c]
2647 Moderatesevere
13.2
ACE-I
Bisoprolol, 10 mg qd
1.3 [‡]
Death
34
55
56
MERIT-HF, 1999 [d]
3991 Mild-severe 11.0
ACE-I
Metoprolol CR/XL, 200 mg qd
1.0 [‡]
Death
34
36
46
63
ACE-I
Carvedilol, 25 mg bid
0.87 [‡]
Death
35
55
65
81
COPERNICUS, 2289 Severe 2001 [e]
19.7
—
ANGIOTENSIN RECEPTOR BLOCKERS Val-HeFT, 2001 [8]
5010 Mild-severe ~8.0
ACE-I
Valsartan, 160 mg bid
1.9
CV death or morbidity
13
0
35
33 [¶]
CHARMAlternative, 2003 [7]
2028 Mild-severe 12.6
BB
Candesartan, 2.8 32 mg qd
CV death or HF hosp.
23
30
31
60
21/10/2008 11:34 a.m.
Chapter 58 - HEART FAILURE: MANAGEMENT AND PROGNOSIS fr...
2 de 3
Trial, Treatment, and Year Published CHARMAdded, 2003 [9]
N
http://remoto.dgb.uanl.mx:2065/das/book/body/108023714-4/0/1492/251...
Estimated Severity of First-Year Heart Placebo/Control Background Treatment Failure Group Mortality Treatment [†] Added
2548 Moderatesevere
Events Prevented per 1000 Patients Treated [¶¶]
Relative DEATH Trial Risk HF OR HF Duration Primary Reduction DEATH HOSP. HOSP. (years) End Point (%) [‡]
10.6
ACE-I + BB
Candesartan, 3.4 32 mg qd
CV death or HF hosp.
15
28
47
39
~25
ACE-I
Spirolactone, 2.0 [‡] 25–50 mg qd
Death
30
113
95
—
Hydralazine, 2.3 75 mg tid-qid
Death
34
52
0
—
40
80
—
0
79
ALDOSTERONE BLOCKADE RALES, 1999 [11]
1663 Severe
HYDRALAZINE-ISDN V-HeFT-1, 1986 [f]
459
Mild-severe 26.4
—
ISDN, 40 mg qid A-HeFT, 2004 [14]
1050 Moderatesevere
~9.0
ACE-I + BB + Hydralazine, spironolactone 75 mg tid
0.83 [‡]
Composite
3.1
Death
—
ISDN, 40 mg tid DIGITALIS GLYCOSIDES DIG, 1997 [13]
6800 Mild-severe ~11.0
ACE-I
Digoxin
0
73
CRT COMPANION, 925 2004 [17]
Moderatesevere
19.0
ACE-I + BB + CRT spironolactone
1.35 [‡]
Death or 19 any hospital admission
38
813
Moderatesevere
12.6
ACE-I + BB + CRT spironolactone
2.45
Death or 37 CV hospital admission
97
COMPANION, 903 2004 [17]
Moderatesevere
19.0
ACE-I + BB + CRT-ICD spironolactone
1.35 [‡]
Death or 20 any hospital admission
74
ACE-I + BB
3.8
Death
23
129 End stage 75 ACE-I + LVAD 1.8 REMATCH, spironolactone 2001 [h] Modified from McMurray JJ, Pfeffer MA: Heart failure. Lancet 2005;365:1877–1889.
Death
48
CARE-HF, 2005 [g]
—
151
87
184
CRT-D —
114
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SCD-HeFT, 2005 [16]
1676 Mild-severe ~7.0
ICD
—
—
—
—
—
VENTRICULAR ASSIST DEVICE 282
ACE-I = ACE inhibitor; BB = β-blocker; CRT = cardiac resynchronization therapy (biventricular pacing); CRT-D = CRT device that also defibrillates; CV = cardiovascular; HF hosp. = patients with at least one hospital admission for worsening heart failure—some patients had multiple admissions; ICD = implantable cardioverter defibrillator; ISDN = isosorbide dinitrate; LVAD = left ventricular assist device.
*
Excluding active-controlled trials.
†
In more than one third of patients, ACE-I + BB means that ACE inhibitors were used in almost all patients and BB in the majority; most patients were also taking diuretics, and many digoxin (except in DIG). Spirono-lactone was used at baseline in 5% Val-HeFT, 8% MERIT-HF, 17% CHARM-Added, 19% SCD-HeFT, 20% COPERNICUS, and 24% CHARM-Alternative.
‡
Relative risk reduction in primary end point. §Stopped early for benefit.
¶¶ Individual trials may not have been designed or powered to evaluate effect of treatment on these outcomes. ¶
Primary end point that also included treatment of heart failure with intravenous drugs for 4 hours or more without admission and resuscitated cardiac arrest (both added small numbers).
21/10/2008 11:34 a.m.
Chapter 58 - HEART FAILURE: MANAGEMENT AND PROGNOSIS fr...
3 de 3
http://remoto.dgb.uanl.mx:2065/das/book/body/108023714-4/0/1492/251...
a
The CONSENSUS Trial Study Group: Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987;316:1429–1435.
b
The SOLVD Investigators: Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293–302.
c
The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): A randomised trial. Lancet 1999;353:9–13.
d
Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999;353:2001–2007.
e
Packer M, Coats AJ, Fowler MB, et al: Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001;344:1651–1658.
f
Cohn JN, Archibald DG, Ziesche S, et al: Effect of vasodilator therapy on mortality in chronic congestive heart failure. Results of a Veterans Administration Cooperative Study. N Engl J Med 1986;314:1547–1552.
g
Cleland JG, Daubert JC, Erdmann E, et al: The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005;352:1539–1549.
h
Rose EA, Gelijns AC, Moskowitz AJ, et al: Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001;345:1435–1443.
Copyright © 2008 Elsevier Inc. All rights reserved. - www.mdconsult.com
Bookmark URL: /das/book/0/view/1492/251.html
21/10/2008 11:34 a.m.
1 de 3
http://remoto.dgb.uanl.mx:2065/das/book/body/108023714-4/0/1492/251...
Use of this content is subject to the Terms and Conditions
Goldman: Cecil Medicine, 23rd ed. Copyright © 2007 Saunders, An Imprint of Elsevier
Chapter 58 – HEART FAILURE: MANAGEMENT AND PROGNOSIS John J.V. McMurray Marc A. Pfeffer
EVALUATION AND MANAGEMENT OF HEART FAILURE Heart failure is an overarching term for a syndrome (i.e., a constellation of signs and symptoms) that encompasses a vast spectrum of cardiovascular disorders and is associated with a greatly heightened risk of death and nonfatal adverse cardiovascular events ( Chapter 57 ). Treatment is initially directed toward prevention of cardiac injury (e.g., due to hypertension or myocardial infarction) or toward limiting structural progression if cardiac damage has already occurred (e.g., left ventricular remodeling with declining left ventricular ejection fraction) and delaying the development of symptomatic heart failure. Once symptoms develop, treatments are also directed at improving functional status as well as prognosis. Approximately one in five adults will develop heart failure. In the United States, the nearly 1 million annual hospitalizations with a primary diagnosis of heart failure account for 5 million hospital days. The estimated cost of heart failure management ranges from $15 billion to $40 billion annually, depending on the formula used. Randomized controlled clinical trials (RCTs) supply the framework for quantifying what different therapeutic approaches can offer. Even when they are definitive, RCTs only generate data about average risks and benefits of the tested therapeutic option in a selected cohort. Because an individual patient's responses can only be implied from the overall estimated group responses, RCTs cannot definitively direct the approach of every patient or answer the myriad questions that confront the practitioner regarding the specific circumstances of the patient. Another major limitation of RCTs is the relatively narrow time frame of observation, generally only months to several years, compared with epidemiologic experiences during decades. Despite these limitations, RCTs are the premier tool of evidence-based medicine, and the field of heart failure has fortunately been the focus of relatively high quality RCTs that have provided robust evidence to improve clinical care and prognosis ( Table 58-1 ). Indeed, the implementation of evidence from RCTs into clinical practice has resulted in impressive temporal improvements in survival after discharge from a first hospital admission for heart failure. Moreover, the age at which symptomatic heart failure first becomes evident has increased. Despite these tangible advances, heart failure continues to be a leading cause of morbidity and mortality in the elderly. TABLE 58-1 -- CONTROLLED TRIALS [*] IN SYMPTOMATIC HEART FAILURE WITH REDUCED SYSTOLIC FUNCTION Events Prevented per 1000 Patients Treated [¶¶] Trial, Estimated Relative Treatment, and Year Published
N
Severity of First-Year Heart Placebo/Control Background Treatment Failure Group Mortality Treatment [†] Added
Trial Risk DEATH Duration Primary Reduction HF OR HF (years) End Point (%) [‡] DEATH HOSP. HOSP.
ACE INHIBITORS CONSENSUS, 253 1987 [a] SOLVD-T, 1991 [b]
End stage
52
Spironolactone Enalapril, 20 0.54 [‡] mg bid
2569 Mild-severe 15.7
—
Death
40
146
—
Enalapril, 20 3.5 mg bid
Death
16
45
96
— 108
β-BLOCKERS CIBIS-2, 1999 [c]
2647 Moderatesevere
13.2
ACE-I
Bisoprolol, 10 mg qd
1.3 [‡]
Death
34
55
56
MERIT-HF, 1999 [d]
3991 Mild-severe 11.0
ACE-I
Metoprolol CR/XL, 200 mg qd
1.0 [‡]
Death
34
36
46
63
ACE-I
Carvedilol, 25 mg bid
0.87 [‡]
Death
35
55
65
81
COPERNICUS, 2289 Severe 2001 [e]
19.7
—
ANGIOTENSIN RECEPTOR BLOCKERS Val-HeFT, 2001 [8]
5010 Mild-severe ~8.0
ACE-I
Valsartan, 160 mg bid
1.9
CV death or morbidity
13
0
35
33 [¶]
CHARMAlternative, 2003 [7]
2028 Mild-severe 12.6
BB
Candesartan, 2.8 32 mg qd
CV death or HF hosp.
23
30
31
60
21/10/2008 11:34 a.m.
Chapter 58 - HEART FAILURE: MANAGEMENT AND PROGNOSIS fr...
2 de 3
Trial, Treatment, and Year Published CHARMAdded, 2003 [9]
N
http://remoto.dgb.uanl.mx:2065/das/book/body/108023714-4/0/1492/251...
Estimated Severity of First-Year Heart Placebo/Control Background Treatment Failure Group Mortality Treatment [†] Added
2548 Moderatesevere
Events Prevented per 1000 Patients Treated [¶¶]
Relative DEATH Trial Risk HF OR HF Duration Primary Reduction DEATH HOSP. HOSP. (years) End Point (%) [‡]
10.6
ACE-I + BB
Candesartan, 3.4 32 mg qd
CV death or HF hosp.
15
28
47
39
~25
ACE-I
Spirolactone, 2.0 [‡] 25–50 mg qd
Death
30
113
95
—
Hydralazine, 2.3 75 mg tid-qid
Death
34
52
0
—
40
80
—
0
79
ALDOSTERONE BLOCKADE RALES, 1999 [11]
1663 Severe
HYDRALAZINE-ISDN V-HeFT-1, 1986 [f]
459
Mild-severe 26.4
—
ISDN, 40 mg qid A-HeFT, 2004 [14]
1050 Moderatesevere
~9.0
ACE-I + BB + Hydralazine, spironolactone 75 mg tid
0.83 [‡]
Composite
3.1
Death
—
ISDN, 40 mg tid DIGITALIS GLYCOSIDES DIG, 1997 [13]
6800 Mild-severe ~11.0
ACE-I
Digoxin
0
73
CRT COMPANION, 925 2004 [17]
Moderatesevere
19.0
ACE-I + BB + CRT spironolactone
1.35 [‡]
Death or 19 any hospital admission
38
813
Moderatesevere
12.6
ACE-I + BB + CRT spironolactone
2.45
Death or 37 CV hospital admission
97
COMPANION, 903 2004 [17]
Moderatesevere
19.0
ACE-I + BB + CRT-ICD spironolactone
1.35 [‡]
Death or 20 any hospital admission
74
ACE-I + BB
3.8
Death
23
129 End stage 75 ACE-I + LVAD 1.8 REMATCH, spironolactone 2001 [h] Modified from McMurray JJ, Pfeffer MA: Heart failure. Lancet 2005;365:1877–1889.
Death
48
CARE-HF, 2005 [g]
—
151
87
184
CRT-D —
114
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SCD-HeFT, 2005 [16]
1676 Mild-severe ~7.0
ICD
—
—
—
—
—
VENTRICULAR ASSIST DEVICE 282
ACE-I = ACE inhibitor; BB = β-blocker; CRT = cardiac resynchronization therapy (biventricular pacing); CRT-D = CRT device that also defibrillates; CV = cardiovascular; HF hosp. = patients with at least one hospital admission for worsening heart failure—some patients had multiple admissions; ICD = implantable cardioverter defibrillator; ISDN = isosorbide dinitrate; LVAD = left ventricular assist device.
*
Excluding active-controlled trials.
†
In more than one third of patients, ACE-I + BB means that ACE inhibitors were used in almost all patients and BB in the majority; most patients were also taking diuretics, and many digoxin (except in DIG). Spirono-lactone was used at baseline in 5% Val-HeFT, 8% MERIT-HF, 17% CHARM-Added, 19% SCD-HeFT, 20% COPERNICUS, and 24% CHARM-Alternative.
‡
Relative risk reduction in primary end point. §Stopped early for benefit.
¶¶ Individual trials may not have been designed or powered to evaluate effect of treatment on these outcomes. ¶
Primary end point that also included treatment of heart failure with intravenous drugs for 4 hours or more without admission and resuscitated cardiac arrest (both added small numbers).
21/10/2008 11:34 a.m.
Chapter 58 - HEART FAILURE: MANAGEMENT AND PROGNOSIS fr...
3 de 3
http://remoto.dgb.uanl.mx:2065/das/book/body/108023714-4/0/1492/251...
a
The CONSENSUS Trial Study Group: Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987;316:1429–1435.
b
The SOLVD Investigators: Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293–302.
c
The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): A randomised trial. Lancet 1999;353:9–13.
d
Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999;353:2001–2007.
e
Packer M, Coats AJ, Fowler MB, et al: Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001;344:1651–1658.
f
Cohn JN, Archibald DG, Ziesche S, et al: Effect of vasodilator therapy on mortality in chronic congestive heart failure. Results of a Veterans Administration Cooperative Study. N Engl J Med 1986;314:1547–1552.
g
Cleland JG, Daubert JC, Erdmann E, et al: The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005;352:1539–1549.
h
Rose EA, Gelijns AC, Moskowitz AJ, et al: Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001;345:1435–1443.
Copyright © 2008 Elsevier Inc. All rights reserved. - www.mdconsult.com
Bookmark URL: /das/book/0/view/1492/251.html
21/10/2008 11:34 a.m.
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