A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients.
BACKGROUND
Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality.


METHODS
We performed a randomized trial comparing goal-directed therapy guided by a pulmonary-artery catheter with standard care without the use of a pulmonary-artery catheter. The subjects were high-risk patients 60 years of age or older, with American Society of Anesthesiologists (ASA) class III or IV risk, who were scheduled for urgent or elective major surgery, followed by a stay in an intensive care unit. Outcomes were adjudicated by observers who were unaware of the treatment-group assignments. The primary outcome was in-hospital mortality from any cause.


RESULTS
Of 3803 eligible patients, 1994 (52.4 percent) underwent randomization. The base-line characteristics of the two treatment groups were similar. A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter (7.7 percent) died in the hospital, as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used (7.8 percent)--a difference of 0.1 percentage point (95 percent confidence interval, -2.3 to 2.5). There was a higher rate of pulmonary embolism in the catheter group than in the standard-care group (8 events vs. 0 events, P=0.004). The survival rates at 6 months among patients in the standard-care and catheter groups were 88.1 and 87.4 percent, respectively (difference, -0.7 percentage point [95 percent confidence interval, -3.6 to 2.2]; negative survival differences favor standard care); at 12 months, the rates were 83.9 and 83.0 percent, respectively (difference, -0.9 percentage point [95 percent confidence interval, -4.3 to 2.4]). The median hospital stay was 10 days in each group.


CONCLUSIONS
We found no benefit to therapy directed by pulmonary-artery catheter over standard care in elderly, high-risk surgical patients requiring intensive care.
Sandham
James Dean
JD
Faculty of Medicine, University of Calgary, Calgary, Alta, Canada. sandham@ucalgary.ca
Hull
Russell Douglas
RD
Brant
Rollin Frederick
RF
Knox
Linda
L
Pineo
Graham Frederick
GF
Doig
Christopher J
CJ
Laporta
Denny P
DP
Viner
Sidney
S
Passerini
Louise
L
Devitt
Hugh
H
Kirby
Ann
A
Jacka
Michael
M
D000368:Aged; D002407:Catheterization, Swan-Ganz / Q000009:adverse effects; D003422:Critical Care / Q000379:methods; D017558:Elective Surgical Procedures / Q000401:mortality; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods*; D011655:Pulmonary Embolism / Q000209:etiology; D012307:Risk Factors; D013514:Surgical Procedures, Operative / Q000401:mortality*; D015996:Survival Rate; D016896:Treatment Outcome