Author Affiliations: Department of Cardiology,
Columbia University Medical Center, New York, NY (Dr Shah); Biostatistics
and Bioinformatics, Duke Clinical Research Institute, Durham, NC (Dr Hasselblad);
Cardiovascular Division, Brigham and Women’s Hospital, Boston, Mass
(Dr Stevenson); Project Leadership, Duke Clinical Research Institute, Durham,
NC (Ms Binanay); Division of Cardiology, Duke University Medical Center, and
Duke Clinical Research Institute, Durham, NC (Drs O’Connor and Califf);
and Division of Heart and Vascular Diseases, National Heart, Lung, and Blood
Institute, National Institutes of Health, Bethesda, Md (Dr Sopko).
Context Randomized clinical trials (RCTs) evaluating the pulmonary artery catheter
(PAC) have been limited by small sample size. Some nonrandomized studies suggest
that PAC use is associated with increased morbidity and mortality.
Objective To estimate the impact of the PAC device in critically ill patients.
Data Sources MEDLINE (1985-2005), the Cochrane Controlled Trials Registry (1988-2005),
the National Institutes of Health ClinicalTrials.gov database, and the US
Food and Drug Administration Web site for RCTs in which patients were randomly
assigned to PAC or no PAC were searched. Results from the ESCAPE trial of
patients with severe heart failure were also included. Search terms included pulmonary artery catheter, right heart
catheter, catheter, and Swan-Ganz.
Study Selection Eligible studies included patients who were undergoing surgery, in the
intensive care unit (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.
Data Extraction Information on eligibility criteria, baseline characteristics, interventions,
outcomes, and methodological quality was extracted by 2 reviewers. Disagreements
were resolved by consensus.
Data Synthesis In 13 RCTs, 5051 patients were randomized. Hemodynamic goals and treatment
strategies varied among trials. A random-effects model was used to estimate
the odds ratios (ORs) for death, number of days hospitalized, and use of inotropes
and intravenous vasodilators. The combined OR for mortality was 1.04 (95%
confidence interval [CI], 0.90-1.20; P = .59).
The difference in the mean number of days hospitalized for PAC minus the mean
for no PAC was 0.11 (95% CI, −0.51 to 0.74; P = .73).
Use of the PAC was associated with a higher use of inotropes (OR, 1.58; 95%
CI, 1.19-2.12; P = .002) and intravenous
vasodilators (OR, 2.35; 95% CI, 1.75-3.15; P<.001).
Conclusions In critically ill patients, use of the PAC neither increased overall
mortality or days in hospital nor conferred benefit. Despite almost 20 years
of RCTs, a clear strategy leading to improved survival with the PAC has not
been devised. The neutrality of the PAC for clinical outcomes may result from
the absence of effective evidence-based treatments to use in combination with
PAC information across the spectrum of critically ill patients.
Shah MR, Hasselblad V, Stevenson LW, Binanay C, O’Connor CM, Sopko G, Califf RM. Impact of the Pulmonary Artery Catheter in Critically Ill PatientsMeta-analysis of Randomized Clinical Trials. JAMA. 2005;294(13):1664–1670. doi:10.1001/jama.294.13.1664