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A meta-analysis indicates that use of a pulmonary artery catheter in
critically ill patients does not any add benefit.
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Hospitalized patients with severe congestive heart failure
did not experience a benefit from use of pulmonary artery
catheterization, but had more adverse events, according to a
study in the October 5 issue of JAMA.
Advances in medical therapy have improved outcomes for many
ambulatory patients with heart failure and low ejection fraction
(EF; a measure of how much blood the left ventricle of the heart
pumps out with each contraction), according to background
information in the article. However, each year an estimated
250,000 to 300,000 patients are hospitalized for heart failure
with low EF, and the 1-year survival rate after hospitalization
may be as low as 50 percent, even with recommended medical
therapies. Recent studies have indicated that pulmonary artery
catheters (PAC), a device used to monitor hemodynamic status and
guide therapy, may increase the risk of death for hospitalized
patients.
Lynne W. Stevenson, M.D., of Brigham and Women's Hospital,
Boston, and colleagues with the Evaluation Study of Congestive
Heart Failure and Pulmonary Artery Catheterization Effectiveness
(ESCAPE) trial, tested the hypothesis that for patients with
severe heart failure, therapy guided by PAC monitoring and
clinical assessment would lead to more days alive and fewer days
hospitalized during 6 months compared with therapy guided by
clinical assessment alone. The randomized controlled trial
included 433 patients at 26 sites and was conducted from January
18, 2000, to November 17, 2003. Patients were assigned to
receive clinical assessment and a PAC or clinical assessment
alone. The primary goal in both groups was resolution of
clinical congestion, with other targets based on levels of
pulmonary artery and right atrial pressures.
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The researchers found that therapy in both groups led to
substantial reduction in symptoms, jugular venous pressure, and
edema (swelling from fluid buildup). Use of the PAC did not
significantly affect the primary end point of days alive and out
of the hospital during the first 6 months (133 days vs. 135
days), death (43 patients [10 percent] vs. 38 patients [9
percent]), or the number of days hospitalized (8.7 vs. 8.3).
In-hospital adverse events were more common among patients in
the PAC group (47 [21.9 percent] vs. 25 [11.5 percent]). There
were no deaths related to PAC use, and no difference for
in-hospital plus 30-day mortality (10 [4.7 percent] vs. 11 [5.0
percent]). Exercise and quality of life end points improved in
both groups with a trend toward greater improvement with the
PAC, which reached significance for the time trade-off at all
time points after randomization.
"Based on ESCAPE, there is no indication for routine use of
PACs to adjust therapy during hospitalization for decompensation
of long-term heart failure. It seems probable that there are
some patients and some therapies that yield improved outcome
with PAC monitoring and others with counterbalancing deleterious
effects," the authors write. "For patients in whom signs and
symptoms of congestion do not resolve with initial therapy,
consideration of PAC monitoring at experienced sites appears
reasonable if the information may guide further choices of
therapy.
"The ESCAPE trial defined the most compromised patient
population to be studied in an National Heart Lung Blood
Institute heart failure trial with medical therapy, with 19
percent (83 patients) mortality at 6 months. No diagnostic test
by itself will improve outcomes. New strategies should be
developed to test both the interventions and the targets to
which they should be tailored. Although most trials in a
high-event population have focused on reducing mortality,
patients with advanced heart failure express willingness to
trade survival time for better health during the time remaining.
How patients value their daily lives should help guide both the
design and evaluation of new therapies," the authors conclude.
(JAMA.2005; 294:1625-1633).
Editor's Note: This research was supported by a contract from
the National Heart, Lung, and Blood Institute to Duke University
Medical Center.
Use of Pulmonary Artery Catheter in Critically Ill Patients
Has Neutral Effect
A meta-analysis of previous studies indicates that use of a
pulmonary artery catheter in critically ill patients neither
increases risk of death or hospital stay or adds benefit,
according to another article in this issue of JAMA.
The PAC is used to diagnose various diseases and
physiological states, monitor the progress of critically ill
patients, and guide the selection and adjustment of medical
therapy, according to background information in the article. The
PAC is often considered a cornerstone of critical care and a
hallmark of the intensive care unit (ICU). Approximately 1
million PACs are used annually in the United States. However,
despite widespread use of these devices, there is conflicting
data about their effectiveness, and whether they increase risk
of illness and death. Since the mid-1980s, randomized clinical
trials (RCTs) have been conducted to evaluate the efficacy of
the PAC. However, none of these trials have been persuasive
individually, because they are limited by small sample sizes in
heterogeneous populations. Despite the overwhelmingly negative
outcomes of the literature, clinicians continue to use the PAC
in ICUs based on personal experience and the belief that careful
monitoring will improve decision making and clinical outcomes.
Monica R. Shah, M.D., M.H.S., of Columbia University Medical
Center, New York, and colleagues performed a meta-analysis of
recently published clinical trials testing the safety and
efficacy of the PAC. The researchers located the RCTs, in which
patients were randomly assigned to PAC or no PAC, from several
databases. Eligible studies included patients who were
undergoing surgery, in the ICU, admitted with advanced heart
failure, or diagnosed with acute respiratory distress syndrome
and/or sepsis; and studies that reported death and the number of
days hospitalized or the number of days in the ICU as outcome
measures. The researchers found 13 RCTs that included 5,051
patients.
"Our meta-analysis of 13 RCTs evaluating the safety and
efficacy of the PAC demonstrates that use of the catheter
neither improves outcomes in critically ill patients nor
increases mortality or days in hospital. This provides a broader
confirmation of the recent results of the ESCAPE trial, which
showed that the routine use of the PAC in patients with advanced
heart failure did not reduce or increase death or days in
hospital," the authors write.
"During the past 60 years, the PAC has evolved from a simple
diagnostic tool to a device that is used for monitoring and
determining goal-directed therapy. Our meta-analysis shows that
despite the widespread acceptance of the PAC, use of this device
across a variety of clinical circumstances in critically ill
patients does not improve survival or decrease the number of
days hospitalized. … These results suggest that the PAC should
not be used for the routine treatment of patients in the ICU,
patients with decompensated heart failure, or patients
undergoing surgery until or unless effective therapies can be
found that improve outcomes when coupled with this diagnostic
tool," the authors conclude.
(JAMA.2005; 294:1664-1670).
Editor's Note: This meta-analysis was funded by the Duke
Clinical Research Institute.
Editorial: Searching for Evidence to Support Pulmonary
Artery Catheter Use in Critically Ill Patients
In an accompanying editorial, Jesse B. Hall, M.D., of the
University of Chicago, comments on the articles in this week's
JAMA on PAC.
"What is the evidence for the broader issue of PAC use in the
ICU and perioperative setting? The data collected to date
certainly do not support routine use of the catheter in any
patient group, and the currently available information could be
viewed as justifying 'pulling the pulmonary artery catheter'
from routine use, a suggestion made almost 10 years ago. One
important additional trial is nearing completion and evaluates
the use of PAC in patients with adult respiratory distress
syndrome."
"Should there be a positive result attributable to PAC in
this trial, a specific niche for this technology may remain in
critical care. If the results of this soon-to-be-completed trial
show no benefit of PAC monitoring, it is likely that the
available data will indicate that it is time to remove the
catheter from widespread use, or at the very least relegate this
former common monitoring tool to salvage therapy of an extremely
small and select number of patients. The need to question the
routine use of this monitoring modality was quite real and the
results of the last 5 years of study most valuable. Once again
the community of critical care physicians has been edified by
the approach of 'Don't just do something, stand there! And then
think about it. …'" Dr. Hall concludes.
(JAMA.2005; 294:1694-1695.
| Article reviewed by: |
Dr. Tamer Fouad, M.D.
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