Download Outcome of Patients With Low Ejection Fraction

Outcome of Patients With Low Ejection Fraction
Undergoing Coronary Artery Bypass Grafting
Renal Function and Mortality After 3.8 Years
Graham S. Hillis, MBChB, PhD; Kenton J. Zehr, MD; Amy W. Williams, MD;
Hartzell V. Schaff, MD; Thomas A. Orzulak, MD; Richard C. Daly, MD; Charles J. Mullany, MD;
Richard J. Rodeheffer, MD; Jae K. Oh, MD
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Background—There are few data regarding medium-term outcome of coronary artery bypass grafting (CABG) in patients
with severe left ventricular (LV) systolic dysfunction, particularly in the modern era, and even less assessing
preoperative factors that might identify patients at highest risk.
Methods and Results—Three hundred seventy-nine consecutive patients with LV ejection fraction ⱕ35%, who underwent
isolated first CABG between 1995 and 1999 were studied. Potential preoperative and perioperative predictors of
outcome were recorded and patients followed-up for a median of 3.8 years. The primary study end-point was all-cause
mortality. The 30-day, 1-year, and 3-year survival rates were 94.5%, 88%, and 81%, respectively. The independent
predictors of mortality were preoperative estimated glomerular filtration rate (hazard ratio [HR], 0.98; 95% confidence
interval [CI], 0.97 to 0.99 per mL/min/1.73m2; P⬍0.001) and age (HR, 1.03; 95% CI, 1.01 to 1.06 per year; P⫽0.005).
Conclusions—Patients with significant LV systolic dysfunction undergoing isolated CABG using contemporary techniques have a good medium-term survival. Renal dysfunction is the strongest independent predictor of mortality.
(Circulation. 2006;114[suppl I]:I-414–I-419.)
Key Words: coronary disease 䡲 kidney 䡲 surgery 䡲 survival
M
ajor randomized control studies comparing medical
therapy with coronary artery bypass grafting (CABG)
did not recruit patients with a left ventricular (LV) ejection
fraction ⬍35%. They did, however, demonstrate improved
survival in surgically treated patients with milder degrees of
LV systolic dysfunction.1,2 Likewise, cohort studies and data
on nonrandomized patients from the Coronary Artery Surgery
Study registry have also favored surgical revascularization
over medical therapy.3,4 These data suggest that CABG may
improve prognosis in selected patients with coronary heart
disease and severely impaired systolic function, and it is
frequently performed on this patient population.5 It is, however, associated with a modest increase in risk compared with
patients with normal LV function,5–7 with some older publications reporting extreme variations in outcome. Nevertheless, previous studies have primarily addressed early (inhospital and/or 30-day) outcome, with limited contemporary
data regarding longer-term mortality and morbidity. Likewise, there are few data assessing the preoperative factors that
might identify patients who are at highest risk. To address
these issues, the current study reports the medium-term outcome
of a large cohort of consecutive patients with LV ejection
fraction ⱕ35%, who underwent isolated first CABG surgery
between 1995 and 1999, and the factors influencing this.
Methods
Patients
The study was approved by the Mayo Foundation Institutional
Review Board. All patients who underwent isolated first CABG at
the Mayo Clinic, Rochester, Minnesota between January 1, 1995 and
December 31, 1999, and whose preoperative LV ejection fraction
was ⱕ35%, were identified (n⫽379). In 195 patients (51%) this was
determined by echocardiography, in 169 (45%) left ventriculography
and in 15 (4%) by radionuclide scanning. Patients undergoing re-do
CABG, concomitant valvular surgery, cardioverter-defibrillator implantation, aneurysmectomy, or ventricular septal defect repair
were excluded.
Measures
Demographic and clinical data were recorded, including the preoperative Canadian Cardiovascular Society (CCS) angina class and the
New York Heart Association (NYHA) functional class. Preoperative
hemoglobin and creatinine and levels were documented (using the
sample taken immediately before surgery) and the glomerular
filtration rate estimated (eGFR) using the Modification of Diet in
Renal Disease equation.8 Using this equation the eGFR (mL/min/
1.73m2) ⫽ 186 ⫻ (serum creatinine level [mg per deciliter])⫺1.154⫻
(age [years])⫺0.203. The product of this equation was multiplied by a
correction factor of 0.742 for women and 1.212 for blacks.8 Patients
were categorized into 4 groups dependent on their eGFR (ⱖ75
mL/min/1.73m2, 60 to 74 mL/min/1.73m2, 45 to 59 mL/min/1.73m2,
⬍45 mL/min/1.73m2), as described by the US National Kidney
From the Divisions of Cardiovascular Disease (G.S.H., R.J.R, J.K.O.), Nephrology (A.W.W) and Cardiovascular Surgery (K.J.Z., H.V.S., T.A.O.,
R.C.D., C.J.M.), Mayo Clinic, Rochester, Minn.
Presented at the American Heart Association Scientific Sessions, Dallas, Tex, November 13–16, 2005.
Correspondence to Jae Oh, Division of Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. E-mail [email protected]
© 2006 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org
DOI: 10.1161/CIRCULATIONAHA.105.000661
I-414
Hillis et al
TABLE 1.
CABG and Low Ejection Fraction
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Clinical Characteristics
Characteristic
All Patients
(n⫽379)
Alive
(n⫽272)
Died
(n⫽107)
Hazard Ratio
(95% CI)
P
Age, years
69 (61–76)
68 (61–75)
73 (66–77)
1.05 (1.02–1.07)
⬍0.001
Risk factors and medical history
Male
286 (76%)
202 (74%)
84 (79%)
1.16 (0.73–1.84)
0.53
79 (21%)
61 (22%)
18 (17%)
0.76 (0.46–1.27)
0.30
Diabetes
150 (40%)
113 (42%)
37 (35%)
0.75 (0.50–1.12)
0.16
Hypertension
246 (65%)
174 (64%)
72 (67%)
1.06 (0.71–1.59)
0.78
Previous PCI
59 (16%)
41 (15%)
18 (17%)
1.15 (0.69–1.91)
0.60
Previous myocardial infarction
263 (69%)
191 (70%)
76 (71%)
1.06 (0.70–1.61)
0.78
Myocardial infarction in prior month
Current smoker
145 (38%)
104 (38%)
41 (38%)
1.00 (0.68–1.48)
1.00
Normal ECG
33 (9%)
25 (9%)
8 (7%)
0.75 (0.37–1.55)
0.44
Echocardiographic LVEF
28 (23–33)
28 (23–33)
28 (24–33)
1.01 (0.97–1.05)
0.68
Creatinine (mg/dL)
1.2 (1.0–1.4)
1.2 (1.0–1.4)
1.3 (1.1–1.8)
1.57 (1.29–1.92)
⬍0.001
Creatinine ⱖ1.5 mg/dL
93 (25%)
55 (20%)
38 (36%)
1.86 (1.25–2.76)
0.002
eGFR (mL/min/1.73m2)
59 (47–72)
63 (51–75)
53 (38–64)
0.97 (0.96–0.98)
⬍0.001
72 (67%)
2.01 (1.34–3.01)
0.001
0.90 (0.81–1.01)
0.07
Blood results
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eGFR ⬍60 mL/min/1.73m2
197 (52%)
125 (46%)
Hemoglobin (g/dL)
13.1 (12.1–14.2)
13.3 (12.2–14.3)
12.9 (11.9–14.0)
Therapy before CABG
ACE inhibitor/ARB
211 (56%)
158 (58%)
53 (50%)
0.82 (0.56–1.19)
0.29
␤ -blocker
156 (41%)
117 (43%)
39 (36%)
0.97 (0.65–1.44)
0.88
Statin
106 (28%)
86 (32%)
20 (19%)
0.66 (0.41–1.08)
0.10
Loop diuretic
145 (38%)
98 (36%)
47 (44%)
1.36 (0.92–1.98)
0.12
I or II
193 (51%)
146 (54%)
47 (44%)
III or IV
186 (49%)
126 (46%)
60 (56%)
1.37 (0.94–2.01)
0.10
I or II
176 (46%)
130 (48%)
46 (43%)
III or IV
201 (53%)
141 (52%)
60 (57%)
1.28 (0.87–1.88)
0.20
CCS angina status
NYHA functional class
ACE indicates angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; CABG, coronary artery bypass grafting; CCS,
Canadian Cardiovascular Society; CI, confidence interval; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; LVEF, left
ventricular ejection fraction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention.
NYHA functional class could not be determined in 2 cases.
Foundation.8 Angiographic data and operative details were recorded,
with an angiographic stenosis of ⱖ50% considered significant.
Follow-Up
Patients were followed-up between January and June 2002. Initially,
a review of Mayo Clinic records was performed. Patients were then
contacted by telephone to confirm the recorded data and ensure that
events treated at other institutions were documented. A scripted
telephone interview was used to determine symptom status (CCS
angina score and NYHA class). When telephone contact could not be
established, a mailed questionnaire was used. If necessary the
patient’s cardiologist or primary physician was contacted to acquire
missing information, confirm the data, and/or obtain updated contact
details. If the patient could not be contacted, vital status was
established using the Social Security Index.
The primary study end-point was all-cause mortality. In addition,
data were collected regarding nonfatal myocardial infarction (defined using standard criteria pertaining at the time it occurred9,10),
further myocardial revascularization, cardiac transplantation, and
symptom status at follow-up.
Statistical Analyses
Continuous data are expressed as median (interquartile range) and
categorical data as absolute values (percentage). Survival was plotted
using the Kaplan-Meier method and compared using the log-rank
statistic. Estimations of risk were performed using the Cox proportional hazard method. Potential independent predictors of outcome
were identified by univariable analyses. Univariable predictors were
entered in a stepwise manner into a multivariable model of survival,
with entry and retention set at a significance level of ⬍0.05. SPSS
version 9.0 (SPSS Inc, Chicago, Ill) was used for all analyses.
Results
Patient Population
The clinical characteristics of the study cohort are shown in
Table 1. At the time of surgery, 150 patients (40%) had CCS
class I angina, 43 (11%) class II, and 186 (49%) CCS class III
or IV. Sixty-eight of the 201 (34%) patients with NYHA
functional class III or IV symptoms had little or no angina
(CCS class I) at the time of surgery.
Fifty-nine patients had undergone 75 previous percutaneous coronary interventions. One patient was receiving renal
replacement therapy before surgery and 1 patient had a
pre-existing implantable cardioverter-defibrillator.
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Circulation
July 4, 2006
TABLE 2.
Angiographic and Operative Characteristics
Characteristic
All Patients
(n⫽379)
Alive
(n⫽272)
Died
(n⫽107)
Hazard Ratio
(95% CI)
P
Angiographic findings
Left main stem stenosis
121
84 (31%)
37 (35%)
1.17 (0.79–1.74)
0.44
Three vessel coronary artery disease
307
222 (82%)
85 (79%)
0.88 (0.55–1.40)
0.59
LV ejection fraction (%)
31 (25–33)
31 (25–33)
30 (25–33)
1.00 (0.95–1.05)
0.89
End diastolic pressure (mm Hg)
26 (19–32)
27 (20–33)
25 (17–28)
0.97 (0.94–1.00)
0.05
Operative details
IABP preoperatively
54
36 (13%)
18 (17%)
1.34 (0.81–2.23)
0.26
Three or more grafts
315
230 (85%)
85 (79%)
0.63 (0.39–1.00)
0.05
352
260 (96%)
Internal mammary graft used
92 (86%)
0.41 (0.23–0.70)
0.001
Bypass time (minutes)*
88 (66–114)
87 (65–112)
93 (69–118)
1.00 (1.00–1.01)
0.35
Cross-clamp time (minutes) *
50 (34–61)
50 (36–61)
49 (33–62)
1.00 (0.99–1.01)
0.76
0.75 (0.27–2.04)
0.57
⬘Off-pump⬘ CABG
16
12 (4%)
4 (4%)
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*Excludes surgery performed “off-pump” (n⫽16).
IABP indicates intra-aortic balloon pump.
Preoperative Investigations and Operative Details
Results of preoperative investigations are shown in Tables 1
and 2. Of the total cohort, 337 patients (89%) had either
significant (ⱖ50%) left main stem stenosis or 3-vessel
coronary artery disease or both (Table 2). Sixteen patients
(4%) underwent surgery without the use of cardiopulmonary
bypass (“off pump”). Total bypass and aortic cross-clamp
times for the remaining patients are shown in Table 2.
Follow-Up
Vital status data were obtained on all patients a median of 3.8
(2.5 to 5.3) years after surgery. The 30-day mortality rate was
5.5% (21/379). Four of these deaths occurred within 1-day of
surgery. There were 86 late (after 30-days) deaths. The 1- and
3-year survival rates were 88% and 81%, respectively.
Among the 272 survivors, 21 patients sustained a total of 22
nonfatal acute myocardial infarctions and 16 patients underwent further myocardial revascularization (15 percutaneous
coronary interventions and 1 re-do CABG). No patients
underwent cardiac transplantation during follow-up. Two
patients required renal replacement therapy within 7 days of
surgery. At follow-up, the CCS angina class was available in
235 patients (86% of survivors) and NYHA functional class
in 236 patients (87%). Only 12 surviving patients had a CCS
angina class ⬎II, in comparison to 105 of the same patients at
baseline. Thirty-nine survivors were in NHYA class III or IV,
compared with 122 of the same patients at baseline.
Univariable Predictors of Mortality
The most powerful predictors of mortality during long-term
follow-up were renal function and age (Table 1 and Figures 1
Figure 1. The effect of age on survival after coronary artery bypass grafting.
Hillis et al
CABG and Low Ejection Fraction
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Figure 2. The effect of creatinine on survival after coronary artery bypass grafting.
to 3). Receipt of an internal mammary artery graft was also
associated with improved survival.
When patients who had sustained an acute myocardial
infarction in the month before their index CABG (n⫽145,
38%) were excluded, the univariable predictors of mortality
were age (hazard ratio [HR], 1.05 per year; 95% confidence
interval [CI], 1.02 to 1.08; P⫽0.001), creatinine (HR, 1.56
per mg/dL; 95% CI, 1.20 to 2.04; P⫽0.001), eGFR (HR, 0.97
per mL/min/1.73m2; 95% CI, 0.96 to 0.99; P⬍0.001), eGFR
⬍60 mL/min/1.73m2 (HR, 1.76; 95% CI, 1.06 to 2.90;
P⫽0.03), CCS class 3 or 4 angina (HR, 1.65; 95% CI, 1.02 to
2.68; P⫽0.04), and receipt of an internal mammary artery
graft (HR, 0.32; 95% CI, 0.14 to 0.75; P⫽0.008).
Multivariable Predictors of Mortality
Serum creatinine and eGFR are mathematically related. In
this cohort, however, eGFR was a stronger univariable
predictor of mortality (␹2 25.9 versus 20.6; P⫽0.02), and
Figure 3. The effect of estimated glomerular filtration rate on survival after coronary artery bypass grafting.
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Circulation
TABLE 3.
Multivariable Predictors of Mortality
Characteristic
July 4, 2006
Wald ␹
2
Hazard ratio
95% CI
eGFR
0.98*
0.97–0.99
17.57
⬍0.001
Age
1.03†
1.01–1.06
8.01
0.005
1.82
0.18
IMA graft
P
2
*Hazard ratio per mL/min/1.73m .
†Hazard ratio per year.
IMA indicates internal mammary artery.
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when this was used creatinine provided no additional prognostic information. Estimated GFR was, therefore, used in a
stepwise multivariable model that included other univariable
predictors of outcome (P⬍0.05: age and receipt of an internal
mammary artery graft). The independent predictors of mortality were eGFR and age (Table 3 and Figures 1 and 3).
Patients with an eGFR of ⬍45 mL/min/1.73m2 were at
particularly high risk (Table 4 and Figure 3).
When the 145 patients who had sustained an acute myocardial infarction in the month before their index CABG were
excluded, the independent predictors of mortality were eGFR
(HR, 0.98 per mL/min/1.73m2; 95% CI, 0.96 to 0.99; ␹2 9.2;
P⫽0.002), age (HR, 1.04 per year; 95% CI, 1.01 to 1.07; ␹2
6.0; P⫽0.01), and receipt of an internal mammary artery graft
(HR, 0.41; 95% CI, 0.17 to 0.97; ␹2 4.2; P⫽0.04).
Discussion
Although patients with advanced LV systolic dysfunction
frequently undergo CABG there are few contemporary data
assessing the outcome of such individuals beyond the early
postoperative period. Likewise, the predictors of mediumterm outcome are poorly documented, as are the symptomatic
benefits of such therapy. The main findings of the current
study were that during a median of 3.8 years of follow-up
28% of patients had died, with a 30-day mortality rate of
5.5%. The independent predictors of mortality were increasing age and impaired renal function. The most powerful
predictor was the preoperative eGFR.
Patient Characteristics, Preoperative Therapy,
and Investigation
The cohort were elderly, with a high prevalence of cardiovascular
risk factors. The majority of patients had significant limiting angina
and/or a pattern of coronary artery disease, whereby CABG would
be recommended in current guidelines.11 Likewise, the majority of
patients were in NYHA functional class III or IV. Use of angiotensin-converting enzyme inhibitors and/or angiotensin II receptor
blockers, ␤-blockers, and statins was lower than optimal, but higher
than reported in other comparable cohorts12 and in large contemporary North American databases.13,14 Use of all of these agents was
significantly higher during the second half of the study period (data
not shown).
Predictors of Mortality
The increasing perioperative risks associated with CABG in
elderly patients have been well-documented11 and some
previous data suggest that the risks are particularly high in
those with reduced LV ejection fraction.5,15,16 Others, however, have failed to demonstrate an independent relationship
between age and outcome in this setting.12,17–20 Our data
suggest it is an important determinant, with those dying
within 30 days having a median age of 76 years compared
with 69 years among survivors. In this cohort, patients 75
years of age and older had a 5-year survival of ⬍30%.
Higher NYHA functional class was not associated with
increased mortality. This is contrast to the findings from the
Coronary Artery Bypass Grafting Patch Trial database.12 However, in this study, the excess risk was observed only when
comparing an absence of heart failure symptoms with any
degree of limitation and the increased risk was similar regardless
of the severity of heart failure, with mortality among patients
with grade IV symptoms slightly lower than those in class I, II,
or III. Although other groups have reported an increased perioperative mortality among patients with severe symptoms of
heart failure undergoing CABG,21 there is considerable variation
between centers and several studies assessing long-term outcome have failed to find any such relationship.16,18,19
Several other notable clinical factors did not influence mortality. These included patient gender, diabetes mellitus, hypertension, use of an intra-aortic balloon pump preoperatively, and
recent acute myocardial infarction. The preoperative LV ejection
fraction (measured either by left ventriculography or echocardiography) was also of no prognostic significance. This may
reflect a declining influence on perioperative mortality22 but may
also be caused by the relative homogeneity of the cohort in this
respect. Certainly, LV ejection fraction is an important prognostic factor in less selected populations.11
Renal Function and Outcome
Mortality rates after CABG in patients with end-stage renal disease
are know to be higher.11 In addition, the importance of milder
degrees of renal dysfunction is increasingly recognized.23,24 Nevertheless, the particular importance of renal impairment in the outcome of patients with depressed LV systolic function has not been
well-documented. One previous study of 80 patients with a LV
ejection fraction ⱕ30% followed for a mean of 15 months demon-
TABLE 4. Relative Unadjusted and Adjusted Risk for Mortality Stratified by Estimated
Glomerular Filtration Rate
Unadjusted
Hazard Ratio
(95% CI)
Characteristic
Hazard Ratio
(95% CI) Adjusted
for Age and Gender
Hazard Ratio
(95% CI) With
Mutivariable Adjustment*
eGFR ⱖ75 mL/min/1.73m2 (n⫽78)
1
1
1
eGFR 60–74 mL/min/1.73m2 (n⫽104)
1.81(0.87–3.78)
1.72(0.82–3.58)
1.71(0.82–3.58)
eGFR 45–59 mL/min/1.73m2 (n⫽120)
2.13(1.05–4.33)
1.90(0.92–3.89)
1.65(0.80–3.41)
eGFR ⬍45 mL/min/1.73m2 (n⫽77)
4.43(2.21–8.88)
3.59(1.76–7.32)
2.66(1.14–6.20)
*Adjusted for age, creatinine, and use of an internal mammary artery graft.
Hillis et al
strated that a creatinine of ⱖ180 ␮mol/L (2 mg/dL) was associated
with a higher cardiac mortality,17 whereas others have reported a
considerable increase in risk among patients with low ejection
fraction requiring dialysis before CABG.5 The importance of renal
dysfunction has not, however, been replicated in all studies.16,18–20
This is surprising, particularly because impaired renal function
increases cardiovascular risk and is a powerful predictor of a poor
prognosis in patients with LV systolic dysfunction.25 Certainly, the
current data suggest that, among patients with significant LV
systolic dysfunction undergoing CABG, renal function, measured
using either serum creatinine or eGFR, is the single most powerful
predictor of medium-term outcome. Further work is required to
assess whether measures to improve renal function and correct
associated abnormalities might improve surgical prognosis in this
high-risk group.
7.
8.
9.
10.
11.
Strengths and Limitations of the Current Study
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The large cohort of consecutive patients ensures that total
mortality can be used as the primary end-point. In addition,
symptomatic status at follow-up is available in a large number of
patients. However, the lack of data regarding myocardial function after surgery is a weakness and the study has the limitations
inherent in a retrospective cohort design. Finally, the study
cannot address the relative benefits of medical therapy alone
versus a combination of medical therapy plus surgical revascularization in patients with severe ischemic LV dysfunction. This
can only be adequately evaluated in a prospective study.
12.
13.
14.
Conclusions
The current study demonstrates that patients with significant LV
systolic dysfunction undergoing isolated first CABG using contemporary techniques have a good early and medium-term survival. In
addition, the majority of survivors derive considerable symptomatic
benefit. Renal dysfunction portends a very poor prognosis in this
setting. Further work is required to determine strategies that can
improve the outcome of these individuals at high risk.
15.
16.
17.
18.
Source of Funding
Dr Hillis was supported by the British Heart Foundation.
Disclosures
19.
None.
20.
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Circulation. 2006;114:I-414-I-419
doi: 10.1161/CIRCULATIONAHA.105.000661
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