(Circulation. 1999;100:2060-2066.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Early Dipyridamole 99mTc-Sestamibi Single Photon Emission Computed Tomographic Imaging 2 to 4 Days After Acute Myocardial Infarction Predicts In-Hospital and Postdischarge Cardiac Events
Comparison With Submaximal Exercise Imaging
Presented in part at the 70th Scientific Sessions of the American Heart Association, Orlando, Fla, November 9–12, 1997, and published in abstract form (Circulation. 1997;96[suppl I]:I-195–I-196).
From the Division of Cardiology, University of Vermont, Burlington, Vt (K.A.B.); Hartford Hospital, Hartford, Conn (G.V.H.); Northside Cardiology, Indianapolis, Ind (R.S.L.); Emory University, Atlanta, Ga (L.J.S.); Division of Cardiology, University of Virginia, Charlottesville, Va (G.A.B.); Christiana Hospital, Newark, Del (M.J.P.); and Dupont Pharmaceuticals Company, North Billerica, Mass (S.B.H.).
Correspondence to Kenneth A. Brown, MD, Medical Center Hospital of Vermont, Cardiology Division, 111 Colchester Ave, Burlington, VT 05401.
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionAppendix 1References |
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Background—Because of its brief hemodynamic effects and minor effect on determinants of myocardial oxygen demand, vasodilator stress myocardial perfusion imaging (MPI) can be applied very early after acute myocardial infarction (AMI) for risk stratification, allowing management decisions to be made earlier and thus potentially shortening hospitalization stays, reducing costs, and preventing early cardiac events. This multicenter randomized trial compared the prognostic value of early dipyridamole MPI and standard predischarge submaximal exercise MPI in patients who presented with AMI.
Methods and Results—Patients who presented with their first AMI (n=451) were randomized in a 3:1 ratio to undergo either both an early (day 2 to 4) dipyridamole 99mTc-sestamibi MPI study and a predischarge (day 6 to 12) submaximal exercise 99mTc-sestamibi MPI study or only the predischarge study. Multivariate predictors of in-hospital cardiac events included nuclear imaging summed stress and summed reversibility scores and peak creatine kinase. For postdischarge cardiac events, multivariate predictors in patients undergoing dipyridamole MPI included only the summed stress, reversibility, and rest imaging scores and anterior MI. For a given summed stress score, the interaction of reversibility score further improved the predictive value. Dipyridamole MPI showed better risk stratification than submaximal exercise MPI.
Conclusions—Dipyridamole MPI very early after MI predicts early and late cardiac events, with superior prognostic value compared with submaximal exercise imaging. The extent and severity of the stress defect and reversibility of the defect were the most important predictors of cardiac death and recurrent MI. This technique can allow management decisions to be made earlier with regard to AMI patients and could have important economic impact if applied widely.
Key Words: prognosis • myocardial infarction • perfusion • imaging • vasodilation • stress • coronary artery disease
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Noninvasive risk stratification after uncomplicated acute myocardial infarction (AMI) has been shown to be useful in guiding future patient management. Typically, this has involved low-level exercise testing 5 to 7 days after admission, with or without myocardial perfusion imaging (MPI).1 2 3 4 5 6 However, important cardiac events may occur before this testing time, and the end points of ST-segment depression and angina have a low sensitivity for identifying patients at risk for cardiac death or myocardial infarction (MI).7 Also, additional invasive procedures or hospital discharge is deferred for nearly a week, which prolongs hospitalization and increases costs. If the same or better prognostic information could be obtained at day 2 to 4, earlier management decisions could be made, which would reduce costs and potentially prevent early cardiac events.
Vasodilator stress in conjunction with MPI may have particular advantages for early risk stratification after MI. Data suggest it is more sensitive for coronary artery disease than submaximal exercise imaging.8 Vasodilator stress produces modest and brief hemodynamic changes and can be applied safely in conjunction with MPI 2 to 4 days after AMI.9 10 Limited data (50 patients) also suggest that very early postinfarction dipyridamole MPI predicts in-hospital and late cardiac events.9 The present multicenter study was undertaken to more definitively determine the prognostic value of dipyridamole 99mTc-sestamibi MPI performed 2 to 4 days after infarction compared with standard predischarge submaximal exercise 99mTc-sestamibi MPI performed 6 to 12 days after infarction.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Study Design
This multicenter (22 sites; see Appendix) randomized, controlled trial evaluated stable patients recovering from uncomplicated first AMI. Eligible patients were randomized to a dipyridamole or submaximal exercise group in a 3:1 ratio. Patients assigned to the dipyridamole group underwent intravenous dipyridamole 99mTc-sestamibi single photon emission computed tomographic (SPECT) MPI 48 to 96 hours after MI, followed by submaximal exercise 99mTc-sestamibi MPI 6 to 12 days after MI. Patients randomized to the submaximal exercise group underwent submaximal exercise MPI 6 to 12 days after infarction without early dipyridamole stress to allow assessment of any excess risk associated with administration of intravenous dipyridamole.10 A 3:1 randomization was used as a compromise between obtaining an adequate number of patients to assess such risk and maximizing the number of patients who would undergo dipyridamole imaging for prognosis.
Patient Population
Patients were excluded if they had chest pain beyond the initial
24 hours, cardiogenic shock, class III or IV heart failure,
coronary revascularization within 6 weeks
before randomization, cardiomyopathy,
contraindications to dipyridamole or theophylline,
inability to perform low-level exercise, or coexisting diseases that
would affect lifespan. The study was approved by the
institutional review committee at each center; subjects gave informed
consent.
Electrocardiographic Classification of MI
Standard 12-lead ECGs were obtained on the day of admission and
2 to 4 days later and were interpreted by 2 investigators blinded to
other patient data. MI was classified as Q-wave or non–Q-wave by
standard criteria. Infarct location was classified as anterior (leads
V1 through V4, I, and aVL),
inferior (II, III, and aVF), posterior
(V1), or indeterminate.
Myocardial Perfusion Imaging
A same-day rest-stress imaging protocol was used. Rest and
stress images were obtained 
1 hour after injection of 7.5 and 22.5
mCi 99mTc-sestamibi, respectively.
Dipyridamole (0.56 mg/kg) was infused
intravenously a mean of 3.3±0.7 days after onset of MI.
99mTc-sestamibi was injected 7 minutes after
initiation of the dipy- ridamole infusion; no
exercise was performed. Submaximal exercise was performed 6 to 12 days
after MI (mean 7.4±3.9 days) according to a modified Bruce protocol.
Exercise end points included completion of Bruce stage II or 75% of
maximum predicted heart rate, whichever came first. The exercise test
was discontinued early if any of the following signs occurred:
progressive moderate chest pain, dyspnea, fatigue, claudication,
10 mm Hg fall in systolic blood pressure, marked (0.3 mV)
ST-segment depression, or development of ventricular
tachycardia. 99mTc-sestamibi was
injected at peak stress, and exercise continued for 60 to 90 seconds
after injection. An ECG response was considered ischemic if
0.1 mV of horizontal or downsloping ST-segment depression occurred
compared with baseline. ECG responses were classified as indeterminate
for patients with left bundle-branch block, severe ST-segment
abnormalities, Wolf-Parkinson-White syndrome, or paced rhythms or if
the patient was taking digoxin. SPECT images were obtained with a
high-resolution collimator in a 64x64 matrix across 180° with 64
projections of 25 seconds each. Gated imaging was not performed for
this study.
All unprocessed data were submitted to a core laboratory (Hartford
Hospital) for processing. A low-pass Butterworth filter was used for
reconstruction. A 17-segment qualitative analysis was used for
regional tracer uptake (Figure 1
). All
analysis was performed as a blinded consensus of 3
investigators (K.A.B., G.V.H., and R.S.L.). Segmental uptake was graded
by use of a 5-point scoring system where 0 is normal, 1 is mild
reduction in activity, 2 is moderate reduction, 3 is severe reduction,
and 4 is absence of activity). The summed stress score (SSS) and summed
rest score (SRS) were determined by the sum of scores for each of the
17 segments on stress and rest images, respectively. A summed
difference (reversibility) score (SDS) was determined by the sum of the
difference between the SSS and SRS for each segment. SSS and SRS were
categorized as low (0 through 4), intermediate (5 through 8), or high
(>8). SDS was categorized as low (0 through 2), intermediate (3
through 7), or high (>7).
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Clinical Access to Imaging Data
By protocol, the imaging data from the early
dipyridamole MPI study were not available to treating
physicians. However, the predischarge submaximal exercise MPI results
were available, and management decisions were made at the discretion of
the treating physician.
Clinical Follow-Up
All patients were followed up throughout their hospitalization
and by telephone interview 3, 6, 12, 18, and 24 months after discharge
(mean 1.9±0.2 years). Significant changes in
cardiovascular status were confirmed by examination of
the patient’s hospital records and written follow-up from the
principal investigator from each center. Only 2 patients were lost to
follow-up, for an overall retention rate of 99.4%.
Study End Points
For in-hospital analysis, the primary outcome
events included cardiac death, recurrent MI, and coronary
revascularization with antecedent symptoms of
ischemia. For postdischarge analysis, the primary
outcome events were defined as cardiac death or recurrent MI.
Statistical Analysis
Continuous measures are given as mean±SD. Categorical
variables are given as percentages. Clinical,
hemodynamic, and nuclear variables (Table 1) for in-hospital cardiac events
were evaluated with logistic regression analysis, and
variables with P<0.20 on the univariate
assessment were entered into the multivariate model.
Variables were entered into the modeling process to mirror the
clinical scenario: clinical variables, followed by early
in-hospital measures, then nuclear test variables. Cox proportional
hazards analysis was used for postdischarge cardiac events, and
univariate estimators (P<0.20) were entered
into a multivariate model in steps: clinical
variables, in-hospital measures, and nuclear test variables.
The multivariate model was developed with consideration
of model overfitting procedures that allow assessment of 1 variable
for every 5 to 10 outcomes observed.
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To control for confounding risk markers, we developed a risk-adjusted multivariate model that adjusted for other important clinical estimators of outcome and evaluated any first-order interaction variables judged to influence the interpretation of the predictive value of the nuclear scan. The prognostic value of predischarge submaximal exercise imaging was evaluated as described above for dipyridamole 99mTc-sestamibi imaging.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Patient Characteristics
A total of 451 patients were enrolled in the study, 339 of whom were randomized to the dipyridamole plus submaximal exercise group and 112 to the submaximal exercise–only group. Of the 339 patients randomized to dipyridamole stress imaging, 284 patients received the infusion during the 48- to 96-hour time frame (mean 3.3±0.7 days). Fifty-five patients did not undergo dipyridamole stress because of clinical indications such as recurrent chest pain, heart failure, or cardiac death. Of the 284 patients who underwent early dipyridamole stress imaging, 226 went on to have submaximal exercise 99mTc-sestamibi imaging; 58 patients were excluded because of clinical indications. Of the 112 patients randomized to undergo only submaximal exercise, 83 underwent submaximal exercise MPI. Patients were excluded from either group at the discretion of the treating physicians. For analysis of prognostic value, all patients who underwent submaximal exercise 99mTc-sestamibi imaging were evaluated, including the 226 patients who had undergone dipyridamole stress imaging. Table 1
shows the clinical, stress test, MPI, and
outcome characteristics of each group. There were no significant
differences for any of the patient variables between those
randomized to dipyridamole and those randomized to
submaximal exercise stress alone.
Hemodynamic Effects
Hemodynamic responses to
dipyridamole and submaximal exercise are shown in Table 2. Changes in heart rate, blood pressure,
and rate-pressure product were all significantly less during
dipyridamole infusion than with submaximal exercise
(P<0.05). There were no adverse events attributable to the
early dipyridamole infusion.10
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Nuclear Imaging Results
Results of early dipyridamole and submaximal
exercise MPI are shown in Table 2. The frequency of small/mild
stress defects (SSS 0 to 4) was greater in patients who underwent
submaximal exercise stress (74%) than in those who underwent
dipyridamole stress (58%; P<0.01). There
was no significant difference between the groups in the distribution of
rest or reversibility scores.
In-Hospital Cardiac Events and Predictors
During in-hospital follow-up (8±4 days after infarction), cardiac
events occurred in 29 patients: cardiac death in 2, recurrent nonfatal
MI in 3, and coronary revascularization
after antecedent ischemic symptoms in 24. The significant
univariate predictors of in-hospital cardiac events
included SSS, SDS, and a family history of coronary disease but
no dipyridamole stress end points, such as angina or
ECG changes (Table 3). SSS, SDS, and peak
creatine kinase (CK) were also found to be multivariate
predictors of events (Table 3). Compared with clinical data, the
incremental addition of nuclear imaging data significantly increased
the overall multivariate predictive model
2 from 4.0 to 12.5 (P<0.05).
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Postdischarge Follow-Up
Of 284 patients in the dipyridamole group, 29 had
in-hospital cardiac events, 24 had
revascularization within 90 days of hospital
discharge, and 1 patient was lost to follow-up. Posthospitalization
follow-up was obtained for the remaining 230
dipyridamole patients. For 309 patients who underwent
submaximal exercise, 24 had coronary
revascularization within 90 days of hospital
discharge and 2 were lost to follow-up, which left a cohort of 283
submaximal exercise patients with follow-up. Cardiac events are shown
in Table 1. Death or recurrent MI occurred in 37 patients in the
dipyridamole group and in 31 patients in the submaximal
exercise group.
Predictive Value of Early Dipyridamole
99mTc-Sestamibi Imaging for Postdischarge Cardiac
Events
Univariate predictors of postdischarge cardiac death
or reinfarction are shown in Table 4.
Among clinical variables, significant predictors included age,
diabetes, smoking, peak CK, peak CK-MB, anterior infarct location, and
Q-wave infarction. No dipyridamole stress variable
had significant predictive value. Among nuclear imaging variables,
both SDS and SSS were significant predictors.
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Multivariate predictors of postdischarge cardiac death
or infarction included only anterior location of MI and each of the
nuclear imaging variables (SDS, SSS and SRS) (Table 5). The reversibility index, SDS, had the
greatest relative risk for cardiac events. Nuclear imaging data
significantly (P<0.05) improved the overall predictive
model 2 when added to clinical data: global
2 increased from 6.1 (P=0.05) to
20.2 (P=0.0002). Cardiac event rates derived from the
risk-adjusted Cox survival curve as a function of SSS, SDS, and SRS are
depicted in Figure 2. The annual event
rate ranged from 2% in patients with a low SSS or SDS to 12% in
patients with a high SSS or SDS (P<0.05). The ability to
separate low- and high-risk subgroups by use of SSS was significantly
better for patients who received thrombolysis than for
those who did not (P=0.02) (Figure 3).
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Interaction of SSS and SDS
Patients in all SSS groups could be further risk stratified by use
of the degree and extent of reversibility (Figure 4). In the low and intermediate SSS
groups, the annual cardiac event rate was very low (0%) in patients
with low SDS. However, the event rate in the intermediate SSS group
increased to 6% and 17% in patients with intermediate and high SDS,
respectively. In patients with the highest SSS totals, the cardiac
event rate remained high even when the degree and extent of
reversibility were small.
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Predictive Value of Predischarge Submaximal Exercise
99mTc-Sestamibi Imaging for Postdischarge Cardiac
Events
Univariate predictors of postdischarge cardiac death
or recurrent MI are shown in Table 6.
Significant clinical predictors included age, diabetes, smoking, peak
CK, peak CK-MB, anterior MI, Q-wave MI, and
thrombolytic therapy. Significant stress test
variables included peak heart rate, peak systolic blood
pressure, and exercise-induced chest pain. Only SSS was a borderline
significant nuclear imaging variable (P=0.09). The
submaximal exercise ECG had no significant predictive value for cardiac
events (Figure 5).
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Multivariate predictors of postdischarge cardiac death
or recurrent MI are shown in Table 7. The
only significant predictor was SSS (P<0.02). Peak CK had a
borderline predictive value (P=0.08). The annual
Kaplan-Meier cardiac event rates as a function of SSS, SDS, and SRS are
shown in Figure 2. Nuclear imaging data significantly
(P<0.01) improved the global 2 of
the predictive model when all data were forced into the model,
increasing the 2 from 7.3 (P=0.03)
to 17.2 (P=0.007).
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Comparison of Dipyridamole Stress and Submaximal
Exercise MPI
The ability to stratify patients according to risk, separating
low- from high-risk patients, was significantly better with
dipyridamole imaging than with submaximal exercise
imaging for SSS (P<0.05), SDS (P<0.001), and
SRS (P<0.05) (Figure 2). This was manifested as
greater differences for event rates among low, intermediate, and
high-risk groups defined by the extent and severity of the stress
perfusion defect (SSS), reversibility (SDS), and rest perfusion (SRS)
defect (Figure 2).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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The present study demonstrates that dipyridamole 99mTc-sestamibi SPECT imaging has powerful prognostic value when performed as early as 2 days after an uncomplicated acute MI, which confirms an earlier pilot study.9 Our data are consistent with a larger body of literature that shows that peridischarge (day 5 to 21) stress nuclear imaging predicts early and late cardiac events after AMI.7 11 The present study is a multicenter affirmation that noninvasive risk stratification can be performed very early after MI without loss of predictive value compared with traditional predischarge exercise imaging, thereby potentially shortening hospitalization stays by allowing earlier management decisions to be made regarding whether invasive or interventional procedures are necessary. Earlier imaging information not only may reduce costs but may also potentially prevent early cardiac events by directing early intervention.
Nuclear Imaging Predictors of Cardiac Events
We found that the size and severity of both the stress defect and
reversibility of the defect observed with dipyridamole
99mTc-sestamibi imaging had significant
univariate and multivariate predictive
value for in-hospital and late cardiac events. These imaging
variables have been shown to have strong predictive value in many
prior studies involving a wide spectrum of coronary heart
disease.7 11
Our study suggests that the degree and extent of reversibility (SDS)
provide complimentary prognostic information to the stress defect
score. Regardless of the total stress defect score, the risk of cardiac
events was related to the extent and degree of reversibility. This
effect was greatest in the intermediate SSS group (Figure 4).
The overall annual cardiac event rate was 5% in this group but
decreased to 0% in patients with a low SDS and increased to 17% in
patients with a high SDS. Even in patients with small stress defects
(low SSS), the annual rate of cardiac events rose from 0% to 5% as
the reversibility index increased. The least effect was seen in the
group with the largest and most severe stress defects (high SSS), in
whom the cardiac event rate remained relatively high even with a low
SDS, which confirms previous data showing a high event rate in patients
with extensive infarction.2 12 13 14 15 16
Patients Receiving Thrombolysis
Our study confirms several recent studies demonstrating that
stress nuclear MPI retains its predictive value in AMI patients
receiving thrombolysis.6 9 17 18 19 20 Our
finding is in contrast to earlier reports that suggested that
201Tl imaging was not useful in such
patients,21 22 perhaps because these latter studies were
retrospective and potentially biased because imaging data were
available to treating physicians.
Comparison of Dipyridamole Versus Submaximal
Exercise Nuclear Imaging
We found that the ability to separate low- and high-risk patients
was greater with dipyridamole MPI than with submaximal
exercise MPI (Figure 2). This could reflect a greater
sensitivity for detecting myocardial ischemia, especially
outside the infarct zone.8 Of note, the frequency of large
and medium defects in our study was greater for patients who underwent
dipyridamole stress than for those who underwent only
submaximal exercise MPI, despite similar resting imaging scores (Table 2).
Limitations of the Study
Our study cohort was selected to include only patients with
uncomplicated first MI. Thus, it is unclear how our data would apply to
patients with prior MI. In general, however, risk stratification is
most valuable in intermediate-risk subgroups. Thus, early vasodilator
MPI would be expected to be most valuable in patients with prior MI who
do not have extensive areas of infarction and who have uncomplicated
early hospital courses.
Conclusions and Clinical Implications
Our study confirms earlier data suggesting that risk
stratification by use of vasodilator stress nuclear MPI can be
performed safely and can provide powerful prognostic data as early as 2
days after MI, a time frame generally not suitable for exercise or
ß-adrenergic stress. Not only was there no loss in predictive power
compared with submaximal exercise nuclear imaging performed later in
the hospitalization, but prognostic value was actually superior when
dipyridamole stress was used. With the current
increasing pressures to reduce hospital costs, the ability of risk
stratification with dipyridamole
99mTc-sestamibi imaging to allow management
decisions regarding discharge versus intervention to be made at day 2
rather than day 5 to 7 could have important economic impact if applied
widely. In addition, some in-hospital cardiac events may be prevented,
which would further reduce costs. Thus, patients identified to be at
low risk for cardiac events by dipyridamole
99mTc-sestamibi imaging could be considered for
early discharge, whereas patients at high risk could be referred for
early catheterization and possible
revascularization.
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Acknowledgments |
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This study was supported by a research grant from Dupont Pharmaceuticals Company, North Billerica, Mass. The authors thank Jeanne Kennedy for expert assistance in manuscript preparation, Paul Widner for guidance in the study design, and Debra Messinger for help in the imaging core laboratory.
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Appendix 1 |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Participating Centers and Principal Investigators
George A. Beller, MD, University of Virginia, Charlottesville, Va; Daniel S. Berman, MD, Cedars Sinai Medical Center, Los Angeles, Calif; Kenneth A. Brown, MD, University of Vermont, Burlington, Vt; James R. Corbett, MD, Parkland Memorial Hospital, Dallas, Tex; E. Gordon DePuey, MD, St. Luke’s/Roosevelt Medical Center, New York, NY; Douglas Eggli, MD, Hershey Medical Center, Hershey, Pa; Gary V. Heller, MD, PhD, Memorial Hospital, Pawtucket, RI; William M. Herndon, Jr, MD, Presbyterian Hospital, Charlotte, NC; Abdulmassih S. Iskandrian, MD, Philadelphia Heart Institute, Philadelphia, Pa; Robert Jaros, MD, Catholic Medical Center, Manchester, NH; Robert C. Kline, MD, Morton Plant Hospital, Clearwater, Fla; Ronald J. Landin, MD, Northside Cardiology, Indianapolis, Ind; Assad Movahed, MD, E. Carolina University, Greenville, NC; Judith E. Orie, MD, Allegheny General Hospital, Pittsburgh, Pa; Michael J. Pasquale, MD, Christiana Hospital, Newark, Del; Robert Quaife, MD, University of Colorado, Denver, Colo; Patrice Rehm, MD, Georgetown University, Washington, DC; Jason L. Stemmer, MD, Desert Cardiology of Tucson, Tucson, Ariz; James L. Tatum, MD, Medical College of Virginia, Richmond, Va; Mark I. Travin, MD, Roger Williams Medical Center, Providence, RI; John Wier, MD, Marshfield Clinic, Marshfield, Wis; Jack A. Ziffer, MD, Baptist Hospital, Miami, Fla.
Received January 12, 1999; revision received July 21, 1999; accepted July 21, 1999.
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References |
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