Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Preoperative optimization of cardiovascular hemodynamics improves outcome in peripheral vascular surgery. A prospective, randomized clinical trial. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. A randomized control trial of right-heart catheterization in critically ill patients. Ontario Intensive Care Study Group. A randomised, controlled trial of the pulmonary artery catheter in critically ill patients. The value of pulmonary artery and central venous monitoring in patients undergoing abdominal aortic reconstructive surgery: a comparative study of two selected, randomized groups. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Routine pulmonary artery catheterization does not reduce morbidity and mortality of elective vascular surgery: results of a prospective, randomized trial. Pulmonary-artery versus central venous catheter to guide treatment of acute lung injury. Effectiveness of pulmonary artery catheters in aortic surgery: a randomized trial. A cost/benefit analysis of randomized invasive monitoring for patients undergoing cardiac surgery. The role of central haemodynamic monitoring in abdominal aortic surgery. A prospective randomised study. Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome: a randomized controlled trial.
Over the past 30 years the pulmonary artery catheter (PAC) has become a widely used haemodynamic monitoring device in the management of critically ill patients, though doubts exist about its safety. Our aim was, therefore, to ascertain whether hospital mortality is reduced in critically ill patients when they are managed with a PAC.
                We did a randomised controlled trial to which we enrolled 1041 patients from 65 UK intensive care units. We assigned individuals to management with (n=519) or without (n=522) a PAC. The timing of insertion and subsequent clinical management were at the discretion of the treating clinician. Intensive care units decided a priori to have the option of using an alternative cardiac output-monitoring device in control patients.
                1014 patients were eligible for analysis. We noted no difference in hospital mortality between patients managed with or without a PAC (68% [346 of 506] vs 66% [333 of 507], p=0.39; adjusted hazard ratio 1.09, 95% CI 0.94-1.27). We noted complications associated with insertion of a PAC in 46 of 486 individuals in whom the device was placed, none of which was fatal.
                Our findings indicate no clear evidence of benefit or harm by managing critically ill patients with a PAC. Efficacy studies are needed to ascertain whether management protocols involving PAC use can result in improved outcomes in specific groups if these devices are not to become a redundant technology. The hypothesis that optimizing hemodynamics using pulmonary artery (PA) catheter (preoperative 'tune-up') would improve outcome in patients undergoing limb-salvage arterial surgery was tested. Eighty-nine patients were randomized to preoperative tune-up either in the surgical intensive care unit (SICU) (group 1) or the preinduction room (group 2) or to control (group 3). The tune-up consisted of fluid loading, afterload reduction, and/or inotropic support to achieve predetermined endpoints. Patients with a PA catheter had significantly fewer adverse intraoperative events (p less than 0.05), less postoperative cardiac morbidity (p less than 0.05), and less early graft thrombosis (p less than 0.05) than the control group. The overall study mortality rate was 3.4%, with a mortality rate of 9.5% in the control group and 1.5% in the PA catheter groups. There were no differences in ICU length of stay (LOS), hospital LOS, or total hospital costs, although the percentage of cost from complications was higher in group 3 (p greater than 0.05). In this group of patients, preoperative cardiac assessment and optimization is associated with improved outcome. Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality.
                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.
                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.
                We found no benefit to therapy directed by pulmonary-artery catheter over standard care in elderly, high-risk surgical patients requiring intensive care.
                Copyright 2003 Massachusetts Medical Society We investigated the impact of right-heart catheterization (RHC) on physiological status and stay in the intensive care unit. Thirty-three of 148 potentially eligible patients were randomized. Fifty-two otherwise eligible patients were excluded because the attending physician felt that RHC was ethically mandated. Ten of 16 (63%) patients randomized to RHC, and 9 of 17 (53%) to no RHC, died (difference: -10%; 95% confidence interval [CI], -43% to 24%). Mean number of days in the intensive care unit were 10.3 for RHC and 8.1 for no RHC (difference, -2.2; CI, -10.2 to 5.8). The lowest modified APACHE score achieved after randomization was 10.8 for RHC and 8.1 for no RHC (difference, -3.8; CI, -7.0 to -0.6), and the mean modified APACHE score was 14.4 for RHC and 11.1 for no RHC (difference, -3.3; CI, -6.47 to -0.2). Physiological measures in this trial showed statistically significant differences in favor of patients not receiving RHC. Confidence intervals around other outcomes include clinically important differences in favor of both RHC and control groups. Although other controlled trials of RHC are crucial, investigators face major practical difficulties. To compare the survival and clinical outcomes of critically ill patients treated with the use of a pulmonary artery catheter (PAC) to those treated without the use of a PAC.
                Prospective, randomised, controlled, clinical trial from October 1997 to February 1999.
                Adult intensive care unit at a large teaching hospital.
                Two hundred one critically ill patients were randomised either to a PAC group ( n=95) or the control group ( n=106). One patient in the control group was withdrawn from the study and five patients in the PAC group did not receive a PAC. All participants were available for follow-up.
                Participants were assigned to be managed either with the use of a PAC (PAC group) or without the use of a PAC (control group).
                Survival to 28 days, intensive care and hospital length of stay and organ dysfunction were compared on an intention-to-treat basis and also on a subgroup basis for those participants who successfully received a PAC. RESULTS There was no significant difference in mortality between the PAC group [46/95 (47.9%)] and the control group [50/106 (47.6)] (95% confidence intervals for the difference -13 to 14%, p>0.99). The mortality for participants who had management decisions based on information derived from a PAC was 41/91 (45%, 95% confidence intervals -11 to 16%, p=0.77). The PAC group had significantly more fluids in the first 24 h (4953 (3140, 7000) versus 4292 (2535, 6049) ml) and an increased incidence of renal failure (35 versus 20% of patients at day 3 post randomisation p<0.05) and thrombocytopenia ( p<0.03).
                These results suggest that the PAC is not associated with an increased mortality. One hundred two patients undergoing abdominal aortic reconstructive surgery were prospectively, randomly allocated to two groups, one of which was monitored with a central venous catheter and the other with a pulmonary artery catheter. Patients with uncompensated cardiopulmonary or renal disease were excluded from the study. General anesthesia was administered for the surgical procedure, and the patients were followed through hospital discharge. No statistically significant differences occurred between the two groups with regard to morbidity (perioperative cardiac, pulmonary or renal sequelae), mortality rate, duration of intensive care, postoperative hospital stay, or cost of hospitalization. The one statistically significant difference between groups was the professional fee charged for anesthetic care, which was higher for patients with pulmonary artery catheters than for those with central venous catheters. In conclusion, we prospectively gathered data from most patients presented for abdominal aortic reconstructive surgery. Our data seem to indicate that the choice of central venous catheter or pulmonary artery catheter monitoring makes little difference in outcome after abdominal aortic reconstructive surgery, and that for many patients pulmonary artery catheters are not necessary to give appropriate, adequate care. Because of the size of the sample, however, declarations of epidemiologic significance would be unfounded. Therefore large-scale, multicenter studies addressing such outcomes remain necessary. Survivors of high-risk surgical operations were previously observed to have significantly higher mean CI, DO2, and VO2 than nonsurvivors. The hypothesis was proposed that increased CI and DO2 are circulatory compensations for increased postoperative metabolism. We tested this hypothesis in two series. In series 1, prospectively allocated by services, mortality and morbidity of the control group were significantly greater than those of the protocol group. In series 2, patients who fulfilled previously defined high-risk criteria were preoperatively randomized to one of three monitoring/treatment groups: CVP-control group, PA-control group and PA-protocol group. Postoperative mortalities in the CVP-control and PA-control groups were not statistically significantly different, but PA-protocol group mortality was significantly reduced compared with its control group. The PA-protocol group had reduced complications, duration of hospitalization, duration in ICU, and mechanical ventilation, and reduced costs when the PA catheter was placed preoperatively and used to augment circulatory responses. The authors determined whether the preoperative placement of a pulmonary artery catheter (PAC) with optimization of hemodynamics results in outcome improvement after elective vascular surgery.
                The PAC commonly is used not only in patients who are critically ill, but also perioperatively in major elective surgery. Few prospective studies exist documenting its usefulness.
                One hundred four consecutive patients were randomized to have a PAC placed the morning of operation (group I) or to have a PAC placed only if clinically indicated (group II). Group I patients were resuscitated to preestablished endpoints before surgery and kept at these points both intraoperatively and postoperatively. Group II patients received standard care.
                There was one death in each group. An intraoperative or postoperative complication developed in 13 patients in group I versus 7 patients in group II (p = not significant). Group I patients received more fluid than did group II patients (5137 +/- 315 mL vs. 3789 +/- 306 mL; p < 0.003). There was no significant difference in either overall or surgical intensive care unit length of stay. Only one patient in group II required a postoperative PAC.
                Routine PAC use in elective vascular surgery increases the volume of fluid given to patients without demonstrable improvement in morbidity or mortality. The balance between the benefits and the risks of pulmonary-artery catheters (PACs) has not been established.
                We evaluated the relationship of benefits and risks of PACs in 1000 patients with established acute lung injury in a randomized trial comparing hemodynamic management guided by a PAC with hemodynamic management guided by a central venous catheter (CVC) using an explicit management protocol. Mortality during the first 60 days before discharge home was the primary outcome.
                The groups had similar baseline characteristics. The rates of death during the first 60 days before discharge home were similar in the PAC and CVC groups (27.4 percent and 26.3 percent, respectively; P=0.69; absolute difference, 1.1 percent; 95 percent confidence interval, -4.4 to 6.6 percent), as were the mean (+/-SE) numbers of both ventilator-free days (13.2+/-0.5 and 13.5+/-0.5; P=0.58) and days not spent in the intensive care unit (12.0+/-0.4 and 12.5+/-0.5; P=0.40) to day 28. PAC-guided therapy did not improve these measures for patients in shock at the time of enrollment. There were no significant differences between groups in lung or kidney function, rates of hypotension, ventilator settings, or use of dialysis or vasopressors. Approximately 90 percent of protocol instructions were followed in both groups, with a 1 percent rate of crossover from CVC- to PAC-guided therapy. Fluid balance was similar in the two groups, as was the proportion of instructions given for fluid and diuretics. Dobutamine use was uncommon. The PAC group had approximately twice as many catheter-related complications (predominantly arrhythmias).
                PAC-guided therapy did not improve survival or organ function but was associated with more complications than CVC-guided therapy. These results, when considered with those of previous studies, suggest that the PAC should not be routinely used for the management of acute lung injury. (ClinicalTrials.gov number, NCT00281268.).
                Copyright 2006 Massachusetts Medical Society. To evaluate the routine use of pulmonary artery catheters (PAC) in patients who undergo aortic surgery.
                One hundred twenty patients were randomized to placement of PACs for perioperative monitoring and hemodynamic optimization (tune up) in the intensive care unit on the night before aortic operation, or to intravenous hydration in the ward and perioperative monitoring without PACs. Before randomization, all patients underwent routine adenosine thallium-201 scintigraphy.
                To meet predetermined endpoints, 30 PAC patients (50%) received nitrates, inotropic agents, or both. PAC patients received more fluid in the preoperative period (p < 0.001) and in the first 24 hours after operation (p = 0.002) than control subjects. Eleven PAC patients (18%) and three control subjects (5%) had adverse intraoperative events (p = 0.02). There were 20 adverse postoperative events in 15 PAC patients (25%; nine cardiac, seven pulmonary, four acute tubular necrosis), which was not different compared with 11 postoperative events in 10 control subjects (17%; five cardiac, five pulmonary, one acute tubular necrosis). There were also no differences in duration of mechanical ventilation, intensive care unit stay, or hospital stay between groups. Postoperative cardiac complications were more common among patients who had a history of congestive heart failure (p = 0.02; odds ratio, 3.75; confidence interval, 1.3 to 11) or reperfusion defects on adenosine thallium scintigraphy (p = 0.01; odds ratio, 3.4; confidence interval, 1.2 to 9.4), regardless of group.
                Routine use of PACs for perioperative monitoring with the above protocol during aortic surgery is not beneficial and may be associated with a higher rate of intraoperative complications. Preoperative tune up does not prevent postoperative cardiac, renal, and other complications. Variables such as cardiac risk factors and adenosine thallium scintigraphy may be more important predictors of cardiac events in patients who undergo aortic operations. The aim of this study was to determine the effect of choice of invasive monitoring on cost, morbidity, and mortality in cardiac surgery. Two hundred and twenty-six adults undergoing elective cardiac surgery were initially assigned at random to receive either a central venous pressure monitoring catheter (group I), a conventional pulmonary artery (PA) catheter (group II), or a mixed venous oxygen saturation (SvO2) measuring PA catheter (group III). If the attending anesthesiologist believed that the patient initially randomized to group I should have a PA catheter, that patient was then reassigned to receive either a conventional PA catheter (group IV) or SvO2 measuring PA catheter (group V). The total costs were defined as the total amount billed to the patient for the catheter used; the professional cost of its insertion; and the determinations of cardiac output, arterial blood gas tensions, hemoglobin level, and hematocrit. Mean total monitoring and laboratory costs in Group I ($591 +/- 67) were statistically significantly (P less than 0.05) less than costs in Group II ($856 +/- 231). Further, mean monitoring and laboratory costs in Group II were statistically significantly (P less than 0.05) less than those in Group III ($1128 +/- 759). Patients in group IV incurred mean total costs of $986 +/- 578, while those in group V had mean total costs of $1126 +/- 382 (NS). There were no significant differences between any of the groups with respect to length of stay in the intensive care unit, morbidity, or mortality.(ABSTRACT TRUNCATED AT 250 WORDS) To test the hypothesis that central haemodynamic monitoring is not necessary in all patients undergoing abdominal aortic surgery, a prospective randomised study in 40 consecutive patients undergoing elective abdominal aortic surgery was carried out. Patients with unstable angina, recent myocardial infarction (less than or equal to 6 months), and left ventricular ejection fraction (LVEF) less than 0.50 were excluded. Twenty-one patients had perioperative central haemodynamic monitoring while 19 patients had central venous pressure monitoring alone. Parameters studied included, perioperative haemodynamics and fluid balance, perioperative cardiac drug administration, operation time and clamp time, postoperative renal function, incidence of postoperative ventilation and line complications, duration of hospital and ICU stay, and 30 day postoperative outcome. Results obtained were compared with a high risk group of patients (LVEF less than 0.50) undergoing similar surgery. Statistical analysis failed to show any difference in outcome for any variable measured in either low risk group. All serious postoperative cardiac complications occurred in patients with LVEF less than 0.50 (P less than 0.0001). These data suggest that patients with LVEF greater than or equal to 0.50 are at low risk of developing postoperative cardiac complications and can be successfully managed perioperatively without the added potential risks and costs of central haemodynamic monitoring. Many physicians believe that the pulmonary artery catheter (PAC) is useful for the diagnosis and treatment of cardiopulmonary disturbances; however, observational studies suggest that its use may be harmful.
                To determine the effects on outcome of the early use of a PAC in patients with shock mainly of septic origin, acute respiratory distress syndrome (ARDS), or both.
                A multicenter randomized controlled study of 676 patients aged 18 years or older who fulfilled the standard criteria for shock, ARDS, or both conducted in 36 intensive care units in France from January 30, 1999, to June 29, 2001.
                Patients were randomly assigned to either receive a PAC (n = 335) or not (n = 341). The treatment was left to the discretion of each individual physician.
                The primary end point was mortality at 28 days. The principal secondary end points were day 14 and 90 mortality; day 14 organ system, renal support, and vasoactive agents-free days; hospital, intensive care unit, and mechanical ventilation-free days at day 28.
                The 2 groups were similar at baseline. There were no significant differences in mortality with or without the PAC at day 14: 49.9% vs 51.3% (mortality relative risk [RR], 0.97; 95% confidence interval [CI], 0.84-1.13; P =.70); day 28: 59.4% vs 61.0% (RR, 0.97; 95% CI, 0.86-1.10; P =.67); or day 90: 70.7% vs 72.0% (RR, 0.98; 95% CI, 0.89-1.08; P =.71). At day 14, the mean (SD) number of days free of organ system failures with or without the PAC (2.3 [3.6] vs 2.4 [3.5]), renal support (7.4 [6.0] vs 7.5 [5.9]), and vasoactive agents (3.8 [4.8] vs 3.9 [4.9]) did not differ. At day 28, mean (SD) days in hospital with or without the PAC (0.9 [3.6] vs 0.9 [3.3]), in the intensive care unit (3.4 [6.8] vs 3.3 [6.9]), or mechanical ventilation use (5.2 [8.5] vs 5.0 [8.5]) did not differ.
                Clinical management involving the early use of a PAC in patients with shock, ARDS, or both did not significantly affect mortality and morbidity.
PAC is a diagnostic and haemodynamic monitoring tool but not a therapeutic intervention. Our review concluded that use of a PAC did not alter the mortality, general ICU or hospital LOS, or cost for adult patients in intensive care. The quality of evidence was high for mortality and LOS but low for cost analysis. Efficacy studies are needed to determine if there are optimal PAC-guided management protocols, which when applied to specific patient groups in ICUs could result in benefits such as shock reversal, improved organ function and less vasopressor use. Newer, less-invasive haemodynamic monitoring tools need to be validated against PAC prior to clinical use in critically ill patients.