JACC Vol. 18 . No. 2
August 1991 :377-82
377
KEVIN W . JUDGE. MD,* YUDI PAWITAN . PIID, JAMES CALDWELL, MD,t
BERNARD J . GERSH, MB, CHB . PHI), FACC,7 J, WARD KENNEDY, MD. FACC,
CASS PARTICIPAraTS$
Seattle, Waahingtan
The dIIlral characteristics and long-term survival of 284 patients frown the Coronary Artery Surgery Study (CASS) registry data base who hod moderate to severe congestive heart failure syrup .
tams and a left ventricular ejection fracon 20,45 were studied . A control gyp consisting of registry patient, with an ejection fraction ?0.45 who did not have heart failure was used far comparison . Patients who had heart failure were older and more likely to be female end to have a higher incidence of hypertension, diabetes and chronic lung disease than registry patients who did out have heart failure . As a ;group, patients with heart failure had aware severe angina and were more likely to have had a prior myocardial infarction than were registry patients without heart fagum.
At 6 year follow-up, 82% of patients in the heart failure group survived compared with 91 % of patients in the control group (p <
0.0001). Multivariate analysis using the Cox proportional hazards model identified the following independent predictors of mortality: regional ventricular systolic dysfoocdon, number or diseased coronary arteries, advanced age, hypertension, lung disease, diabetes, ineressed left ventricular end-diastolic pressure and heart failure, symptoms. Among patients with heart failure, the
6-year survival rate of those who had three-vessel coronary artery disease was 60% compared with 92% for the group without coronary artery disease . However, the 6-year survival rate for patients with heart failure who underwent surgical revascularization of diseased coronary arteries was not slgntlcently improved compared with that of patients treated medically .
It appears from the" data that the presence of moderate to severe heart failure symptoms In patients with an ejection fraction
?0 .45 is a clinical marker for a distinct patient group characterized by increased age, a tore severe clinical coronary artery disease, hypertension and an increased Incidence of additional medical illnesses that have independent value In predicting longterm survival . As a result of the high incidence of concurrent
Manses, this patient group has a significantly reduced 6-year survival rate compared with a CASS registry patient group that did not have heart failure, and the additional presence of coronary artery disease dramatically reduces their survival. However, surgical treatment of coronary artery disease Is not associated with improved survival over a (year fohbw-up period in this
CASS registry subgroup.
(J Am CaU Cardrol 1991;18:377-82)
Until recently. congestive heart failure was considered to be primarily due to systolic dysfunction of the left ventricle . It is now increasingly recognized that left ventricular diastolic dysfunction is a less frequent but still common Ca :ISe of congestive heart failure symptoms (f-6) . Transient myocardial isehemia is known to cause profound alterations in !oft
ventricular relaxation (7-12) and clinically has been demonstrated to produce severe congestive heart failure symptoms in patients who have otherwise well preserved left ventricular systolic function (10 . 13,14) . This subgroup of patients
From the Division of Cardiology and the Department of 5iouatisbcs .
University of Washington, Seattle, Washington ; hhe Division of Cardiology .
Seattle Veterans Affairs Medical Conic,, Seattle : ttho Mayo Clinic. Rochester, Minnesota and the 4CASS Comdinaling Center, Seattle . (A complete list of CASS participants appears in Reference I61Cirrulation 1982 :66:562-81.
Manuscript received Septemher 25, 1990 : revised manuscript received
January 16.1991 . accepted February 12 . 1991.
'Cunenr address: Kevin W . lodge, MD. Virginia Mason Clinic South .
33501 First Way South. Federal Way.
Washington 98003 .
Address for reprints 1 . Ward Kennedy, MD. University of Washington
.
®1991 by the American College of Cardiology remains Poorly characterized with few longitudinal follow-up data available (15).
Previous reports from the Coronary Artery Surgery
Study (CASS) (16-18) and other studies (19,20) have demonstrated that patients with coronary artery disease and reduced ejection fraction have decreased survival compared with patients with preserved left ventricular function . For patients with coronary disease and symptoms of congestive heart failure despite well maintained left ventricular systolic function . the prognosis is less clear (15). Since congestive heart failure induced by ischemia is often reversible, it is important to assess the impact of medical and surgical interventions in patients with coronary artery disease, congestive heart failure and well maintained systolic function .
The CASS registry contains baseline and long-term follow-up clinical, hemodynamic and angtogrophic data on
24,959 patients studied at 15 participating sites from 1975 to
1979 (16) . All patients who underwent coronary angiography for known or suspected coronary artery disease at the CASS sites d'ning this period were included in the CASS registry
0735-109719153 .50
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378 JUDGE ET AL .
HEART FAILURE WITH PRESERVED VENTRICULAR FUNCTION
JACC Vol. 18. No. 2
Augur 1991 :377-82 regardless of their final diagnosis or treatment . From this registry we retrospectively defined a clinical subset of patients with significant congestive heart failure and well preserved left ventricular systolic function and determined their long-term survival .
The goals ofthis CASS registry analysis are twofold: 1) to compare the clinical characteristics and long-term survival of patients with congestive heart failure and preserved ventricular function with those of patients without heart failure symptoms who also underwent coronary angiography ; and 2) to determine how the presence of coronary artery disease additionally affects survival in patients with heart failure and whether surgical revascularization offers a significant survival benefit over medical treatment alone .
Methods
Patient Selection. Patients in the CASS registry with a history of moderate to severe functional impairment from congestive heart failure as assessed by the enrolling physician were eligible for inclusion in this study . Congestive heart failure was considered to be present if the patient demonstrated two or more clinical symptoms of pulmonary congestion including orthopnea, paroxysmal nocturnal dyspnea and dyspnea on exertion s2 months before enrollment in CASS . Functional impairment from heart failure was assessed according to New York Heats Association classification . Only patients with class III or IV symptoms were included in this study . Physical signs of congestive heart failure including rates, third heart sound and peripheral edema were noted in a minority of patients chosen and these signs were not a part of the selection criteria . The degree of functional impairment from angina pectoris was considered separately from heart failure and was not one of the inclusion or exclusion criteria for this study .
Two hundred eighty-four patients met these criteria and were selected for study . Patients in the registry without symptoms of heart failure who met the exclusion ^.risen
used for the study group were included in the control broup .
The entire cohort of 13,071 patients who met the criteria was included in the control group .
Cardiac catheteriration data . The left ventricular ejection fraction, determined from a single-plane 45' right anterior oblique left ventricular angiogram at study entry, was required to be >0.45. Angiogmms obtained in this standardized view are the only ventriculographic data routinely available in the CASS registry data base . An assessment of regional wall motion was also made from the left ventricular angiogram . Each of five cardiac segments (anterobasal, anterolateral, apical, diaphragmatic and posterobasal) were graded on a scale of I to 6 as follows : I = normal ; 2 = moderately hypokinetic ; 3 = severely hypokinetic ; 4 = akinetic ; 5 = dyskinetic ; 6 = aneurysmal . The sum of the scores for each region is hereafter referred to as the left ventricular score . Thus, a score of 5 represents completely normal left ventricular systolic function . Patients with moderase to severe initial regurgitation, prior card . : c surgery, left main coronary artery disease or left ventricular aneurysm were excluded from analysis .
The number of diseased vessels in individual patients was determined by coronary angiography in the following manner. Stenosis >_70% in either the proximal or the distal portion of any of the three major coronary vessels was required by the CASS to classify a vessel as diseased .
Patients with left main stenosis w50% were excluded from further analysis in this study . In the case of left coronary dominance a diseased circumflex artery was classified twovessel disease . For the purpose of this study no distinction was made between proximal and distal lesions . In other words, a 701/c stenosis in the left anterior descending artery was classified as a single diseased vessel whether the stenosis occurred proximal to the first septal perforator or in the mid or distal portion of the artery .
Statistical methods . Comparisons of clinical characteristics between the two groups were performed with use of the chi-square and Student's t tests for categoric and continuous variables, respectively . Survival functions were computed with use of the Kaplan-Meier method and statistical comparisons between groups were made with use of the log-rank statistic . A p value <0.05 is considered statistically significant ; all p values are two-sided . Adjustments for differences in baseline variables were made with use of the Cox proportional hazards model . A stepwise procedure was used to screen the baseline factors that were significantly associated with mortality and then an adjusted p value was calculated in the model with use of those factors .
Results
Clinical Characteristics
Clinical features (Table 1) . The clinical characteristics of both the study and the control group at entry into the CASS registry are summarized in Table 1 . The two groups differ markedly across a wide range of clinical variables . Patients with congestive heart failure are older (56 vs . 52 years, p < 0.0001) and are more likely to be female (44% vs. 26%, p < 0.0001) than are patients without heart failure . Study patients also have a higher incidence of hypertension
(p = 0 .0003), diabetes (p < 0.0001) and chronic lung disease
(p < 0 .0001) . The incidence of smoking (40% vs . 35%, p = 0.06) and hypercholesterolemia (232 vs. 238 mg(dl) did not differ significantly between patients in the heart failure and nonheart failure groups . Canadian Cardiovascular Society class III or IV angina severity was present in 70% of the patients with heart failure compared with 43% of those without heart failure (p < 0.0001) . Patients with heart failure were also more likely to have had a prior myocardial infarction (53% Vs. 38%, p < 0 .0001) . The differential use of nitrates (75% vs. 61%, p < 0.0001) was higher in the heart failure group. However, the use of beta-adrenergic blocking agents (46% vs . 47%) was not significantly different . The use
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UACC YSII, 18, No. 2
A.gual 1991 .377_92
JUDGE ET AL .
HEART FAILURE WI roe PRESERVED VENTRICULAR FUNCTION
379
Table L Baseline Clinical Comparisons Between Groups With and Without Congestive Heaf Failure (CHF(
Namher of patients
Age (k'rl
Male gender
Smokers
Clateoeanl l,ny/dn
Diabeus
HypeneAltoa
Lung disc...
Add' Tonal ill
-se,
Ia2h
Prior myocardial aramliml
Anger clues 111 or IV)
Grd ;ecenl.4lea.ent
bledications
Digitalis
Diuretic
WRotdrcenn ael.-blacker
Wllh
CH
F-
84
!6
0 9
56
40
532 c 25
It
47
29
7
53
2)
46
55
75
46
Wnhoa
CIII
13,071
52 x 9
74
35
23a - 3)
10
75
39
13
0
3
19 l8
61
41
8 uRoto
0!1(01
.:0.1300l
5.5
Ns
<0 i
0 Wll
<ILIY05
<011001
10.0001
< 7.0001
NS
<OA00)
00 .0001
,dooill
NS
'All value represent a pereenl of the toW cnless otherwise irullcated .
tter;pheral vascular disease, renal disease or cerebroaascu)m disease, or
. Society danificasiunl of digitalis (4696vs .896,p <0 .0001)anddiuretic agents (55% vs . 18%, p < 0.0001) was predictably higher in the heart failure group.
Cardiac catheterization (Table 21 . The average number of diseased vessels was not different between patients to the heart failure and nonheart failure groups (L4 -_ 1 .2 in both groups) . The proportion of patients with name, one-, two- or three-vessel coronary artery disease was not significantly different between the two groups : however, slightly more patients without heart failure had three-vessel disease . Onethird of aft patients in the CASS registry demonstrated either normal coronary arteries or angiographically insignificant lesions, The group without heart failure symptoms demonstrated a slightly higher average ejection fraction than that of
Table 2 . Catheteaation Data
Eteeuan [-inn
No of diacaud-essela iaraut
Wdhuul CAD Ieh1
Oat -orlwo-vessel(iteasel11 .5
Three -sasseldmasel`Al
LVSCOR Irncani
LVEDP .taro Hgl
Wish
CHF without
0.62 5 0 .10 0 (4
12 .4 x 7.2
CHI'
011
14 7 .2
IA x 1 .2
33 35
43 37
24 29
7 .0 = 2.8
6.3 5 2.)
11 .11 3 .6
p Valuc
00001
NS'
NS'
N5'
NS-
60 .0001
0 .001
'Ill do-ware test . CAD = w,00uey anew disease ; CHF= congestive heart failure : LV EDP = left ventneuhr end-diastolic pressure; LVSCOR is a conipnstle arsa;urclneM of regrenal avstolic funclsoe 50015 motion) leaned
Coitus in the Metha v section .
the study group (0 .65 vs. 0.62, p < 0 .0001). The control group also had fewer segmental wall motion abnormalities
(mean left ventricular score 6 .3 compared with 7.0 for the heart failure group, p < 0 .0001) and a lower mean left ventricular end-diastolic pressure (11 .2 ± 5 .6 vs- 12 .4 ± 7.2, p < 0.001). Thus, all indexes of left ventricular Function examined in this study were signfficanlly better in the control group than in the heart failure group, despite the selection of patients with an ejection fraction 20 .45 for both groups .
Although the patients with heart failure had relatively preserved global systolic function . significant abnormalities in regional function were noted in comparison with findings in the control patients .
Survival
A comparison of survival in the two groups is shown in
Figure L After 6 years, 82% of patients in The heart failure group were alive compared with 91% of patients in the control group (p < 0-0001) .
Variabiespredictiveofmortality (Table 3) . Stepwisemulmodel was perfumed for the combined study and control groups . The left ventricular score, the composite score for
90 a0
Figure IOverall survival by congestive heart failure
(CHF) status . The 6year survival of CASK registry patients with an ejection fraction 00.45 and congest heart failure (Iriangha) la compared wish chat of re8istry patients with en ejrrtion Fraulioo x0,45 with, vL congestive heart failure (circksl (p < 0 .00011 .
c e u a
70
60 r
L
GM
50 1
Yeacs R os„-3aik tag17071 170 eti263 100
Raek scat =
29 .9
2
12670 e7 x16
91 loo a~ h~~
_pay ----
I-n go
6o
70
60
9151
203
95
27
23V
97
50
5
91
02
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380 JUnGE ET AL .
HEART FAILURE WITH PRESERVED VENTRICULAR FUNCTION
JACC Val. 18, No.2
August 1991 :777-82
Table J. Independent Predictor, of yortality Istepwise multiple regression)
Variahle chi-gaaro pValue
LVSCOR
No . ofdiseased vexets
Ape
Hypenension
Lung disease
Diabetes
Additionulitinesse,
LVEDP
1024
17,8
71 .1
322
17.7
13.8
7,0
6.9
<0.0001
01401
%O.tlalll
<total
<0.m01
0.0002
0009
0.003
'Peripheral vascular disease, renal disease or cerebrovascular diseam . or combinnfmns. Ahbrcvintinru .,,a Table t.
segmental wail motion abnormalities, was the strongest independent predictor of mortality (chi-square (A) = 102 .4) .
Therefore, despite the selection of patients with an ejection fraction >_0 .45, the degree to which systolic dysfunction is present remains the single best predictor of outcome . Additional independent predictors of mortality include the number of diseased vessels
(,r
= 87.8)1, patient age (92 = 71 .3), hypertension (a^ = 33 .2), chronic lung disease (i = 17 .7) .
diabetes (9 = 13 .8) and left ventricular end-diastolic pressure (,2 = 6 .9) . The presence of other illnesses including renal disease, peripheral vasculardisease and cercl7rovascutar disease, alone or in combination, provided additional independent predictive value for mortality .
Role of congestive heart faanre, The presence of moderate to severe impairment from congestive heart failure was a significant univariate predictor of mortality (yn = 22 .68) in this study. However, after the stepwise multivariate analysis, the importance of congestive heart failure as an independent predictor of outcome was reduced to marginal significance (92 = 3,78, p = 0.05) . 11iis analysis suggests that although the presence of heart failure in a CA5S registry patient with preserved systolic function is associated with a decreased (,-year survival rate, it is the presence of associated clinical features and illnesses rather than the heart failure itself that primmily accounts for the decreased mortality. Nonetheless, in CASS registry patients the presence of heart failure appears to be an important and convenient marker for decreased long-term survival even among patients with preserved global systolic function .
R9k of eoronnry notary disease severity . The effect of coronary artery disease an the long-term survival of registry patients with heart failure was also examined, The survival curves for patients with heart failure without coronary disease were compared with survival curves for patients with one- or two-vessel disease and for those with threevessel coronary disease (Fig . 2) . Patients without coronary disease had a 6-year survival rate of 92%, compared with
93% in patients with one- or two-vessel disease and 68%
(p = 0,0001) in patients with three-vessel disease . Thus, in patients with preserved systolic function and heart failure, the severity of underlying coronary disease has a signifiant impact on long-term survival .
Role of surgical rerascularintion . Despite the important role of coronary ~!rtery disease in predicting adverse outcomes in patients with heart failure and preserved systolic function, surgical coronary revascularization did not confer a statistically significant survival advantage in this group by multivariate analysis (p = 0.26) . However, only a small number of patients were available in the study subset for comparison of results of medical and surgical treatment (n -
154) and only a small number of patients in the CASS registry data base were included in the randomized trial (17).
Therefore, the role of surgical revasculaeiration in the treatment of patients with coronary artery disease, symptoms of heart failure and preserved systolic function cannot be rigorously assessed from the CASS registry data base .
Discussion
Role of mynrardial ischewta. Reports of patients presenting with congestive heart failure symptoms and normal systolic function have appeared sporadically over the last 20
100~r+c,
„i---~~
---
-------------
80 a
60 u e
40
20 as Neon
-
3 v
:
° aeia l s awv~
0 -
Yeara
N 0 avrrival
100 190
97 109
66 109
Log sank nest - 19 .2
2
99 99
9e 93
57 86
100
4----q
60
40
20
O
4 6
96 93 37 92
74 99
45 75
27 83
23 69
Figure 2 . The impact of severity of coronary artery disease on the survivalof CASS registry patients with congestive heart failure and an ejection fraction
?0.45 . Six-year survival curves are shown for registry patients with no significant coronary disease (dr eks), patients with ane- and two-vessel coronary disease (filled triangles) and patients with three-vessel coronary disease (open triangles) (p < 0 .0001) .
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JACC Vol. 18 . No . 2
August 1991 :377-x2
JUDGE ET AL .
HEART FAILURE WITH PRESERVED VENTRICULAR FUNCTION
Sat years (I-5 .10,13,14) . In recent reported series in patients with coronary artery disease (7-9 .11,12), atrial pacing has been shown to produce marked changes in regional systolic function in association with significant increases in left ventrteutar end-diastolic pressure . More recently, in reported series of patients (1-4) with the diagnosis of congestive heart failure referred for radionuclide angiography or echocardiography, as many as 42% have had an ejection fraction >0.45 . A consistent clinical feature in these patients is the presence of hypertension or coronary disease .. or both .
Among patients with coronary disease and normal systolic function who present with pulmonary edema . reversible myocardial ischemia is frequently the precipitating event
(13,14) . In patients with coronary disease, atrial pacing has been shown to produce marked changes in regional systolic function in association with significant increases in left ventricular end-diastolic pressure (7-9 .11,12), Considerable evidence supports the existence of painless myocardial ischemia (21,22) . Given the demonstrated impact of ischemia on left ventricular end-diastolic pressure it is not surprising that myocardial ischemia can indeed manifest itself in many instances as severe dyspnea with or without concurrent angina, The clinical characteristics of patients with this form of symptomatic coronary disease and preserved systolic ventricular function have not been completely documented.
Whether the presence of heart failure symptoms in the absence of significantly depressed ventricular systolic function confers an increased mortality risk is not clear .
The current CASS registry study suggests that patients referred for angiography with suspected coronary artery disease and significant congestive heart failure symptoms in the absence of global left ventricular dysfunction are in fact quite different from patients without clinical heart failure .
Patients with heart failure are more likely to be female and older and to have more associated inedical illnesses including hypertension, diabetes and chronic lung disease . In addition, despite having the same number of diseased vessels at angiography, they have more severe angina, are more likely to have had a prior myocardial infarction and have significantly more ventricular wall motion abnormalities .
Therefore, despite an equivalent number of diseased vessels, the patients with congestive heart failure in this study have had a more active clinical course than have the patients without heart failure.
Effects of concurrent illnesses on survival . The CASS registry patients with congestive heart failure have a significantly higher mortality rate over a 6-year follow-up period than that of registry patients without failure. Stepwise multiple regression analysis revealed that the higher mortality was largely accounted far by the presence of additional significant covariates, including segmental wall motion abnormalities, hypertension, the number of diseased vessels, age, diabetes and chronic lung disease. Therefore, the presence of heart failure appears to be a useful marker for a patient with an adverse prognosis despite well preserved systolic function . Given the number of important covariates associated with the presence of heart failure in determining prognosis, the mechanism by which heart failure occurs in these patients is not likely to be due to a single cause .
Hypertension (5 .23,24), previous myocardial infarction (25) and increased age (26,27) have all been demonstrated to be associated with altered patterns of left ventricular diastolic filling.
Barrow et al. (28) demonstrated a high incidence of abnormal diastolic left ventricular filling patterns in patients with coronary artery disease who have entirely normal systolic function . Transient, reversible myocardial ischemia can also dramatically decrease left ventricular compliance to the point of causing pulmonary congestion . This effect is likely to he must severe in patients who have baseline abnormalities in diastolic function (for example, in patients with left ventricular hypertrophy due to hypertension or patients with prior myocardial infarction) . Specific data regarding left ventricular filling patterns and left ventricular compliance are not available in the CASS registry . By inference . however, it is likely that significant abnormalities in diastolic function are present in this study's elderly, hypertensive patients with advanced coronary artery disease .
Impact of coronary artery disease on survival . The presence of coronary artery disease had a particularly marked effect on survival in patients with heart failure and preserved systolic ventricular function in the current study . Ninetytwo percent of the patients who had heart failure without coronary artery disease were alive at 6 years in contrast to only 68% of the patients with three-vessel disease .
A recent report (29) from the V-HeFT study documented the 5-year survival of patients with heart failure, cardiac enlargement and an ejection fraction x0 .45 . The investigators compared findings in 83 patients with heart failure and an ejection fraction ?0 .45 with those in 540 patients with an ejection fraction <0 .45. The former group had a higher incidence of hypertension but a lower incidence of coronary artery disease and an annual mortality rate of 8% compared with 19l for the low ejection fraction group . Although the present CASS study and the V-HeFT study are drawn from dissimilar patient groups, the greater age and increased incide nee of hypertension among patients with heart failure symptoms and preserved systolic function are observed in both studies . Previous observational studies (1-5) have also demonstrated an association between hypertension and putative abnormalities in diastolic function. However, as demonstrated in the current study, the additional presence of coronary artery disease dramatically reduces survival rates .
Effect of revascularizatian on survival . Given the significant impact of coronary artery disease on survival of patients in the study group, the results of surgical revascularization were of particular interest. Multivariate analysis failed to show a statistically significant benefit to long-term survival associated with surgical treatment in this study group . The negative result obtained must be cautiously considered given the small number of patients available for
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382 JUDGE ET AL .
HEART FAILURE WITH PRESERVED VENTRICULAR FUNCTION
JACC Vol. 18. No. 2
August 1991 .377-82 comparison and the retrospective nature of the analysis .
Previous CASS reports, including the randomized trial (17), have also failed to show a survival advantage for surgical revoscularieatian over medical treatment alone among patients with intact left ventricular systolic function . except in those wish left main coronary artery disease . A previous
CASS registry study (]D) of patients with severe angina and threc-vessel disease . however. demonstrated an improved
6-year survival rate with surgical treatment . Seventy percent of the patients in the present study had Canadian Cardiovascular Society class III or I V angina . On this basis a reasonable clinical argument could be made for s-crgical revascularizalion in patients with multivessel coronary disease and severe angina, heart failure and preserved Sys(olic VenIricularfunetion . Whether coronary revasculadzalier procedures including coronary angioplasty, would improve survival is not yet known. As the median age ofthe general Population continues to rise, an increasing number of patients with heart failure symptoms, advanced coronary disease and preserved systolic function will likely be seen . The appropriate management of there patients will require careful consideration of the concurrent physiologic abnormalities that predispose them to reduced long-term survival .
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