Download Left ventricular ejection fraction measurements: accuracy and

Int J Cardiovasc Imaging
DOI 10.1007/s10554-008-9317-1
ORIGINAL PAPER
Left ventricular ejection fraction measurements: accuracy
and prognostic implications in a large population of patients
with known or suspected ischemic heart disease
Alessia Gimelli Æ Patrizia Landi Æ Paolo Marraccini Æ Rosa Sicari Æ
Paolo Frumento Æ Antonio L’Abbate Æ Daniele Rovai
Received: 16 January 2008 / Accepted: 5 May 2008
! Springer Science+Business Media, B.V. 2008
Abstract We sought to compare the reliability and
prognostic implications of left ventricular (LV) ejection
fraction (EF) measurements obtained in routine clinical
practice. We retrospectively selected from our clinical
database a group of 422 patients with known or
suspected ischemic heart disease, studied by twodimensional echocardiography, gated single-photon
emission computed tomography (SPECT) and left
ventriculography (LVG) for clinical purposes. In each
diagnostic procedure LVEF was measured as done
routinely. The LVEF values obtained by the three
methods were similar and closely related. The correlation coefficient r was equal to 0.83 between echocardiographic and LVG, to 0.75 between gated SPECT and
LVG and to 0.81 between echocardiographic and
SPECT. During follow-up (median 41 months), 31
patients died. The values of LVEF obtained by echocardiography, gated-SPECT and LVG were all
powerful predictors of all-cause mortality: v2 = 12.3
A. Gimelli (&) ! P. Landi ! P. Marraccini !
R. Sicari ! D. Rovai
CNR, Clinical Physiology Institute, San Cataldo Research
Area, Via Moruzzi 1, Pisa 56124, Italy
e-mail: [email protected]
for echocardiography, 14.4 for gated SPECT and 14.5
for LVG. However, including LVEF values into a
model based on patient age, sex, history of angina,
evidence of previous infarction and number of stenotic
coronary arteries, the ability to predict patient survival
significantly increased only including LVEF values
measured by gated SPECT (v2 = 40.6, P = 0.039).
Thus, in a large cohort of unselected patients with
known or suspected ischemic heart disease, the values
of LVEF routinely measured by echocardiography,
gated SPECT and LVG were closely correlated, and
provided a powerful prognostic information, that was
incremental to clinical variables for gated SPECT.
Keywords Ejection fraction ! Echocardiography !
Left ventriculography ! Single-photon emission
computed tomography
Abbreviations
EF
Ejection fraction
g-SPECT Gated single-photon emission
computed tomography
LV
Left ventricular
LVG
Left ventriculography
P. Frumento
Department of Statistics, University of Florence, Viale
Morgagni 59, Florence 50134, Italy
Introduction
A. L’Abbate
Scuola Superiore Sant’Anna, Piazza Martiri della Libertà
33, Pisa 56127, Italy
Measurements of left ventricular (LV) ejection fraction
(EF) have been widely utilized to assess the prognosis
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Int J Cardiovasc Imaging
of cardiac disease [1–4], as well as aid in reaching
therapeutic decisions [5, 6]. In clinical practice, noninvasive measurements of LVEF are usually obtained
by two-dimensional echocardiography; in addition,
non-invasive LVEF measurements are provided by
myocardial perfusion studies carried out using ECGgated single-photon emission computed tomography
(SPECT). The reliability of echocardiography and
gated SPECT in assessing LVEF has been tested in
numerous clinical trials [7–35]; however, the scenario
of clinical trials can sometimes diverge from that of
routine practice. Furthermore, although the number of
studies was large, the number of patients enrolled in
these trials has been limited: on average 59 patients in
the echocardiographic studies [7–27] and 36 patients in
the studies performed by gated SPECT [28–35].
Finally, although the impact of LVEF on the survival
of patients with ischemic heart disease is known since
more than two decades [1, 2], the prognostic power of
LVEF measurements obtained by different non-invasive and invasive methods has not been compared.
Thus, we sought to compare the reliability and prognostic implications of LVEF measurements obtained by
two-dimensional echocardiography, gated-SPECT and
contrast left ventriculography (LVG) in a group of 422
unselected patients with known or suspected ischemic
heart disease, followed up for a median of 41 months.
Patients
We selected from our clinical database a group of inpatients, admitted from June 2000 to June 2006 for
known or suspected ischemic heart disease. The
inclusion criterion was having undergone two-dimensional echocardiography, gated SPECT and LVG for
clinical purposes. Patients who developed an acute
myocardial infarction and those who underwent
coronary revascularization between the different
procedures were excluded from the study. Patients
with atrial fibrillation or frequent premature contractions during the examinations were also excluded, as
well as patients with inadequate image quality. A
total of 422 subjects fulfilled the above criteria; their
characteristics are listed in Table 1. The study
complies with the Declaration of Helsinki. The
research protocol was approved by the local ethics
committee. Patients gave a written-informed consent
to collect and analyze their clinical data for research
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Table 1 Patient characteristics
Variable
Number (%)
Age (years)
65 ± 10
Male
337 (80%)
Angina on effort
Angina at rest
189 (45%)
158 (37%)
Previous myocardial infarction
228 (54%)
Diabetes mellitus
100 (24%)
Arterial hypertension
228 (54%)
Hypercholesterolemia
264 (63%)
Obesity
138 (32%)
Smoker within 1 year
215 (50%)
Single-vessel disease
123 (29%)
Double-vessel disease
87 (20%)
Triple-vessel disease
58 (14%)
Left main stenosis
26 (6%)
purposes. In each diagnostic procedure, LVEF was
measured as done routinely.
Two-dimensional echocardiography
The echocardiographic study was performed by seven
different cardiologists rotating in the echocardiography
laboratory. Ultrasound images were obtained using
three different scanners (Sonos 5500–7500, Philips
Ultrasound, Andover, MA, USA; Sequoia C256, Acuson Siemens, Mountain View, CA, USA and My Lab,
Esaote, Florence, Italy). The studies were carried out
following international guidelines [36], implemented
in the laboratory according its quality control program.
In case of any uncertainty in the interpretation, the
studies were reviewed by a senior physician. LVEF was
measured by single-plane Simpson’s rule; in case of
geometrically distorted ventricles and/or LV regional
wall motion abnormalities the EF was measured by the
biplane Simpson’s rule [9, 36]. The LVEF values, like
those of the other echocardiographic variables, were
stored in the database of the echo laboratory and in the
clinical database of the Institute.
Gated SPECT
Gated SPECT was performed to study myocardial
perfusion at rest and after stress. The scintigraphic study
Int J Cardiovasc Imaging
was performed by three physicians rotating in the nuclear
medicine laboratory. All the physicians were certified in
nuclear medicine, and one in cardiology as well. The
studies were performed by two double head gamma
cameras (E. Cam, Siemens Medical Solution, Hoffman
Estates, IL, USA and Millennium MC, GE Medical
System, Milwaukee, WI, USA) equipped with high
resolution collimator. A 64 9 64 matrix, 32-projection,
40-second projection, 8 frames/cycle protocol was
applied in association with appropriate energy photo
peaks. All studies were reconstructed using filtered back
projection without attenuation or scatter correction. The
studies were performed according to international
guidelines [38]. In each patient LVEF was calculated
using a previously validated software (QGS, Cedars
Sinai, Los Angeles, CA, USA) that provides measurements of LV volumes and EF. The LVEF value, like that
of other scintigraphic variables, was stored in the local
database and in the Institute’s clinical database.
Left ventriculography
Left ventriculography was performed to complete the
information provided by coronary arteriography and
cardiac catheterization. These procedures were performed by five rotating cardiologists using standard
Judkins’ or Sones’ technique. Single-plane LVG in
right anterior oblique view (30") was obtained by
injecting a non-ionic, low-osmolar contrast medium
into the LV cavity through a 6-Fr pig-tail catheter. The
volume and rate of contrast injection were optimized
according to the characteristics of each patient.
Radiological images were obtained by a flat panel
equipment (INNOVA2000, GE Healthcare, Milwaukee, WI, USA) and stored in a Dicom standard format.
From the digitally stored angiographic images, enddiastolic and end-systolic frames were selected,
excluding pre- and post-extrasystolic beats. In each
patient LV volumes and EF were computed by trained
technicians under the supervision of a physician using
commercial software (GE LVA 2.0, Emageon, Birmingham, AL, USA) and single plane Simpson’s rule.
Follow-up
According to the follow-up program of our Institute, patients underwent clinical examination and
12-lead ECG 1 year after hospitalization. In addition, follow-up data were obtained up to a maximum of 57 months using a scripted telephone
interview administered by trained personnel to the
patient or the patient’s family, or by mail questionnaires. In case of negative answers, the local
demographic registry was queried. Death was the
only considered event. No patient was lost to
follow up.
Statistical analysis
Quantitative data were expressed as mean, range
and standard deviation (SD), qualitative data as
percentage. The correlation between LVEF values
obtained by the different methods was determined
using the least squares linear regression analysis.
To assess the degree of agreement between techniques, the difference between the values of LVEF
was tested against their mean by Bland-Altman
analysis, and the 95% prediction intervals were
calculated. To evaluate the performance of echocardiography and gated SPECT in detecting
patients with and without LVEF \ 45%, the index
sensitivity, specificity, and Kappa concordance
index were utilized. To assess the association of
LVEF measured using the different methods with
patient survival, a Cox proportional-hazard regression analysis was performed. To investigate
weather LVEF measurements provided any incremental prognostic information after considering the
clinical variables, a model was built-up using Cox
proportional hazard regression analysis. The variables included into the prediction model were
patient age, sex, history of angina, evidence of
previous myocardial infarction, and number of
major coronary vessel showing a [ 75% luminal
diameter reduction at angiography ([ 50% diameter
reduction for the left main stem). The incremental
prognostic value of LVEF was tested by the
likelihood ratio test. The same analysis was
performed considering LVEF estimates as a categorical variable (\ 35%, between 35 and 49%
and C 50%). A P-value \ 0.05 was considered to
be statistically significant. All tests were two-tailed.
Statistical analysis was performed using JMP
statistical software, SAS Institute Inc, version 4.0.0.
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Results
Relationship between LVEF measurements
The LVEF values obtained by two-dimensional
echocardiography (50 ± 12%), gated SPECT
(49 ± 14%) and LVG (51 ± 16%) were similar,
and were closely related to each other. The correlation coefficient r was equal to 0.83 (P \ 0.0001)
between EF values measured by echocardiographic
and LVG (Fig. 1), r was equal to 0.75 (P \ 0.0001)
between the values obtained by gated SPECT and
LVG (Fig. 2), and was equal to 0.81 (P \ 0.0001)
between the measurements obtained by echocardiographic and gated SPECT (Fig. 3).
Agreement between LVEF measurements
The agreement between LVEF values obtained by
echocardiography, gated SPECT and LVG was fair,
as shown in Figs. 1–3. The values clustered around
the 458 line of equality.
The difference between echocardiographic and
angiographic values of LVEF tended to be positive at
the lowest EF values, but negative at the highest values
(Fig. 4). Thus, echocardiography overestimated angiographic measurements at the lowest values of EF, and
Fig. 2 Gated SPECT versus angiographic values of left
ventricular ejection fraction. The 458 line of equality is plotted
as a reference
Fig. 3 Echocardiographic versus Gated SPECT values of left
ventricular ejection fraction. The 458 line of equality is plotted
as a reference
Fig. 1 Echocardiographic versus angiographic values of left
ventricular ejection fraction. The 458 line of equality is plotted
as a reference
123
underestimated angiographic measurements at the
highest EF values. Considering the prediction interval,
which includes 95% of the values, if the angiographic
EF was 30%, echocardiographic EF value fell, in the
worst case, between 21 and 45%; if the angiographic
EF was 50%, the echocardiographic EF value fell
between 40 and 64%.
The difference between gated SPECT and angiographic EF values also tended to be positive at the
Int J Cardiovasc Imaging
422 patients, 134 (32%) had an LVEF by angiography \ 45%. Echocardiography was able to correctly
identify 90% of patients with or without an
LVEF \ 45% (j = 0.76), with a sensitivity of 80%
and a specificity of 94%. Gated SPECT was able to
correctly identify 88% of patients (j = 0.72), with a
sensitivity of 81% and specificity of 91%.
Prognostic implications of LVEF measurements
Fig. 4 Plot of the difference between echocardiographic and
angiographic values of left ventricular ejection fraction against
their mean using Bland-Altman analysis
Fig. 5 Plot of the difference between gated SPECT and
angiographic values of left ventricular ejection fraction against
their mean using Bland-Altman analysis
lowest values, and negative at the highest (Fig. 5).
Thus, gated SPECT also overestimated angiographic
EF at the lowest values, and underestimated it at the
highest values. Considering the prediction interval, if
the angiographic EF was 30%, 95% of EF values by
gated SPECT were included, in the worst case,
between 15 and 49%; if angiographic EF was 50%,
SPECT EF was included between 33 and 67%.
The difference between echocardiographic and
gated SPECT EF is illustrated in Fig. 6.
Accuracy of LVEF measurements
The accuracy of LVEF measurements obtained by
echocardiography and gated SPECT was similar. Of
During a median follow-up of 41 months, 31 patients
(7%) died (Fig. 7). The values of LVEF measured by
echocardiography, gated SPECT and LVG were all
powerful predictors of mortality at Cox proportional
hazard regression analysis (Table 2).
A model based on patient age, sex, history of angina,
evidence of previous myocardial infarction and number of major stenotic coronary arteries allowed to
accurately predict patient survival (global v2 = 35.7,
P \ 0.0001). Including into the model the values of
LVEF obtained by echocardiographic and by LVG
global v2 did not significantly increase. However,
including LVEF measured by gated SPECT, the ability
to predict patient survival increased (global v2 = 40.6,
P \ 0.0001) and the incremental prognostic information was statistically significant (P = 0.039 by
likelihood ratio test) (Table 3). Considering LVEF as
a categorical variable, the incremental prognostic
value was significant only for EF values obtained by
gated SPECT (P = 0.045), not by echocardiography
(P = 0.085) and LVG (P = 0.084).
Discussion
Correlation and agreement in LVEF
measurements
In this retrospective cohort study, LVEF values
measured by two-dimensional echocardiography,
gated SPECT and LVG showed a close correlation
and a fair agreement. A close correlation, expressed by
Table 2 Prediction of mortality
LVEF measurement
All-cause mortality
Echocardiography
Gated SPECT
Left Ventriculography
v2
P value
v2
P value
v2
P value
12.3
0.0005
14.4
0.0001
14.5
0.0001
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Table 3 Prediction of allcause mortality:
incremental prognostic
value of EF measurements
over clinical variables
Variables
Global v2
P value
Clinical variables
35.7
0.0000
Clinical variables + EF by Echocardiography
38.8
0.0000
0.107
Clinical variables + EF by VTG
39.9
0.0000
0.093
Clinical variables + EF gated SPECT
40.6
0.0000
0.039
a high correlation coefficient r, means that the values of
the variables are strictly associated, so that the value of
one variable can be derived by knowing that of the
other by means of the regression equation. A good
agreement means that the values of the variables are
close, as expressed by strict prediction intervals. In this
study, the correlation between the LVEF values
obtained by the different methods was close. As
already known, non-invasive methods over-estimated
angiographic EF at the lowest values, and underestimated angiographic EF at the highest. Furthermore,
the three methods showed a wide scatter of points
around the line of equality as indirectly confirmed by
the wide prediction limits. This data scattering likely
reflects the differences in physical principles and
image generation of the different methods. Ad a matter
of fact, echocardiography is a tomographic technique,
left ventriculography is a silhouette technique and
gated SPECT is a three-dimensional technique that
looks at the solid angle. The fair agreement between
measurements of LVEF obtained by the different
methods should be taken into account when making a
decision largely based on EF values, as in the case of
cardiac resynchronization therapy or implantable cardioverter defibrillators. For instance, if the
angiographic EF was 30%, echocardiographic EF
value fell, in the worst case, between 21 and 45%,
and gated SPECT EF fell between 15 and 49%. Such a
wide variability underscores the role of clinical
variables, in addition to LVEF measurements, in
decision-making (Figs. 6 and 7).
Echocardiographic assessment of LVEF
The accuracy of echocardiography in measuring
LVEF has been investigated in various studies
starting with M-mode echocardiography [7, 8].
However, in the great majority of these studies LVEF
was measured in the context of a clinical trial [7–25].
In this scenario, patients are selected according to
strict inclusion and exclusion criteria, physicians are
very motivated and scanners representing the state of
123
Likelihood ratio test
Fig. 6 Plot of the difference between echocardiographic and
gated SPECT values of left ventricular ejection fraction against
their mean using Bland-Altman analysis
Fig. 7 Survival curve of the studied patient population
the art of ultrasound technology are generally
utilized. In our study patients were unselected, the
data were generated in routine clinical practice, and
LVEF measurements were obtained by rotating
personnel who utilized a variety of different scanners.
Finally, the patient population evaluated in this study
was large. Thus, the present study shows the
reliability achieved by echocardiography in measuring LVEF in current clinical practice.
An exception to the above considerations is seen in a
study by Habash-Bseiso et al., where the accuracy of
LVEF measurement by echocardiography and gated
SPECT was evaluated in a large community-based
Int J Cardiovasc Imaging
clinic [37]. Patient data were registered in the American College of Cardiology Data Registry. At variance
with the present study, echocardiographic values of
LVEF were significantly higher than angiographic
ones, and correlation with angiographic EF was lower
(r = 0.70).
SPECT assessment of LVEF
For many years nuclear cardiology, particularly gated
blood pool scintigraphy, has been considered a gold
standard for measuring LVEF [38]. However, with
technical advances and the wide availability of
echocardiography, fewer and fewer patients undergo
gated blood pool scintigraphy to measure LVEF.
Conversely, a consistent number of patients with
known or suspected ischemic heart disease undergo
gated SPECT to study myocardial perfusion at rest
and after stress. In these patients, the value of LVEF
is a kind of byproduct, routinely obtained, whose
accuracy has been previously demonstrated [28–35,
37]. For these reasons, we chose gated SPECT
instead of gated blood pool scintigraphy to evaluate
the reliability and prognostic implications of LVEF
measurements obtained by nuclear cardiology.
Limitations
This study was focused on the reliability and prognostic implications of the methods currently utilized to
measure LVEF. However, LVEF is only a piece of the
information provided by both non-invasive and invasive methods. In clinical practice, the utilization of the
different technologies is largely influenced by additional factors, including their availability, feasibility,
safety, reproducibility, repeatability and added value
of the information provided, that were not explored in
this study. In addition, single plane Simpson’s rule was
utilized to calculate LVEF by LVG and by echo, and a
more accurate biplane approach was utilized only in
case of geometrically distorted ventricles or regional
wall motion abnormalities. Furthermore, to compare
the non-invasive data with those obtained by LVG,
only hospitalized patients were recruited, so that the
results of this study cannot be extrapolated to a wider
outpatient population. In addition, no data were
collected on intra- and inter-observer variability.
Finally, even though different physicians interpreted
the echocardiographic, scintigraphic and angiographic
studies, it cannot be assured that they were blinded to
the results obtained by the other physicians.
Prognostic impact of EF measurements
For several years LVG has been considered the gold
standard for measuring LVEF. Due to the advancements of echocardiography and nuclear cardiology,
and since a single plane angiographic view was utilized
in this study, we decided not to chose a pre-defined
gold standard. For this reason, the three different
methods were compared to each other and were all
tested against variable not based on cardiac imaging,
i.e., patient outcome. Thus, the well-known impact of
LVEF on the survival of patients with ischemic heart
disease was utilized to test which of the three methods
provided the best prognostic information. The results
show that LVEF values obtained by the three methods
provide a similar information on patient survival.
However, after considering the clinical predictors of
patient survival, LVEF values measured by gated
SPECT provided a significant incremental prognostic
information, that was not the case for the EF measured
by echocardiography and LVG. Thus, LVEF by gated
SPECT was the best predictor of patient survival after
considering the clinical variables.
Conclusion
This observational study on a large cohort of unselected patients shows a close correlation between the
values of LVEF measured by echocardiography, gated
SPECT and LVG. The fair agreement between the
measurements should be taken into account in medical
decision-making. The non-invasive measurement of
LVEF obtained by gated SPECT yield powerful
information on patient outcome that was significant
also after considering the clinical variables.
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