[The impact of closed system and 7 days intravascular administration set replacement on catheter related infections in a general intensive care unit: a before-after study]. / Efficacia della linea chiusa e sostituzione delle linee infusionali ogni 7 giorni sulle infezioni da catetere vascolare in una terapia intensiva polivalente: studio pre-post.

INTRODUCTION: The incidence of catheter related Bloodstream infections (BSI) is high in intensive care units (ICU). AIM: To evaluate the BSI rate in a population of patients admitted to a General ICU before and after the implementation of the 2011 CDC guidelines. METHODS: Retrospective observational study on patients admitted from January 2009 to December 2013. The infusion and monitoring lines were changed every 96 hours for the first 30 months, and every 7 days for the next 30. In all patients a closed infusion line with needle-free connectors pressure was used (Microclave). The following catheters were considered in the study: central venous catheter (CVC), arterial cannula (ART) and Swan Ganz catheter (SG). RESULTS: During the period with change every 96 hours 15 BSI were observed over 13395 catheters/days (C/D), 1.12 per 1000 C/D, while when lines where changed every 7 days 11 BSI were observed over 13120 C/D, 0.83 per 1000 C/D. A statistically significant reduction of BSI was observed in SG catheters (4.17 vs. no BSI p = 0.02), while the CVCS (1.12 vs 1.45 - p = 0.37) and ART (0.35 vs 0.36 - p = 0.61) infection rates remained unchanged. CONCLUSIONS: The replacement of infusion lines every 7 days in our sample did not increase the BSI, helping to reduce the costs.

Use of pulmonary artery catheter in coronary artery bypass graft. Costs and long-term outcomes.

BACKGROUND: Pulmonary artery catheters (PAC) are used widely to monitor hemodynamics in patients undergoing coronary bypass graft (CABG) surgery. However, recent studies have raised concerns regarding both the effectiveness and safety of PAC. Therefore, our aim was to determine the effects of the use of PAC on the short- and long-term health and economic outcomes of patients undergoing CABG. METHODS: 1361 Chinese patients who consecutively underwent isolated, primary CABG at the Cardiovascular Institute of Fuwai Hospital from June 1, 2012 to December 31, 2012 were included in this study. Of all the patients, 453 received PAC during operation (PAC group) and 908 received no PAC therapy (control group). Short-term and long-term mortality and major complications were analyzed with multivariate regression analysis and propensity score matched-pair analysis was used to yield two well-matched groups for further comparison. RESULTS: The patients who were managed with PAC more often received intraoperative vasoactive drugs dopamine (70.9% vs. 45.5%; P<0.001) and epinephrine (7.7% vs. 2.6%; P<0.001). In addition, costs for initial hospitalization were higher for PAC patients ($14,535 vs. $13,873, respectively, p = 0.004). PAC use was neither associated with the perioperative mortality or major complications, nor was it associated with long-term mortality and major adverse cardiac and cerebrovascular events. In addition, comparison between two well-matched groups showed no significant differences either in baseline characteristics or in short-term and long-term outcomes. CONCLUSIONS: There is no clear indication of any benefit or harm in managing CABG patients with PAC. However, use of PAC in CABG is more expensive. That is, PAC use increased costs without benefit and thus appears unjustified for routine use in CABG surgery.

Pulmonary artery catheters for adult patients in intensive care.

BACKGROUND: Since pulmonary artery balloon flotation catheterization was first introduced in 1970, by HJ Swan and W Ganz, it has been widely disseminated as a diagnostic tool without rigorous evaluation of its clinical utility and effectiveness in critically ill patients. A pulmonary artery catheter (PAC) is inserted through a central venous access into the right side of the heart and floated into the pulmonary artery. PAC is used to measure stroke volume, cardiac output, mixed venous oxygen saturation and intracardiac pressures with a variety of additional calculated variables to guide diagnosis and treatment. Complications of the procedure are mainly related to line insertion. Relatively uncommon complications include cardiac arrhythmias, pulmonary haemorrhage and infarct, and associated mortality from balloon tip rupture. OBJECTIVES: To provide an up-to-date assessment of the effectiveness of a PAC on mortality, length of stay (LOS) in intensive care unit (ICU) and hospital and cost of care in adult intensive care patients. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 12); MEDLINE (1954 to January 2012); EMBASE (1980 to January 2012); CINAHL (1982 to January 2012), and reference lists of articles. We contacted researchers in the field. We did a grey literature search for articles published until January 2012. SELECTION CRITERIA: We included all randomized controlled trials conducted in adults ICUs, comparing management with and without a PAC. DATA COLLECTION AND ANALYSIS: We screened the titles and abstracts and then the full text reports identified from our electronic search. Two authors (SR and MG) independently reviewed the titles, abstracts and then the full text reports for inclusion. We determined the final list of included studies by discussion among the group members (SR, ND, MG, AK and SC) with consensus agreement. We included all the studies that were in the original review. We assessed seven domains of potential risk of bias for the included studies. We examined the clinical, methodological and statistical heterogeneity and used random-effects model for meta-analysis. We calculated risk ratio for mortality across studies and mean days for LOS. MAIN RESULTS: We included 13 studies (5686 patients). We judged blinding of participants and personnel and blinding of outcome assessment to be at high risk in about 50% of the included studies and at low risk in 25% to 30% of the studies. Regardless of the high risk of performance bias these studies were included based on the low weight the studies had in the meta-analysis. We rated 75% of the studies as low risk for selection, attrition and reporting bias. All 13 studies reported some type of hospital mortality (28-day, 30-day, 60-day or ICU mortality). We considered studies of high-risk surgery patients (eight studies) and general intensive care patients (five studies) separately as subgroups for meta-analysis. The pooled risk ratio (RR) for mortality for the studies of general intensive care patients was 1.02 (95% confidence interval (CI) 0.96 to 1.09) and for the studies of high-risk surgery patients the RR was 0.98 (95% CI 0.74 to 1.29). Of the eight studies of high-risk surgery patients, five evaluated the effectiveness of pre-operative optimization but there was no difference in mortality when these studies were examined separately. PAC did not affect general ICU LOS (reported by four studies) or hospital LOS (reported by nine studies). Four studies, conducted in the United States (US), reported costs based on hospital charges billed, which on average were higher in the PAC groups. Two of these studies qualified for analysis and did not show a statistically significant hospital cost difference (mean difference USD 900, 95% CI -2620 to 4420, P = 0.62). AUTHORS' CONCLUSIONS: 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.

A matching method for improving covariate balance in cost-effectiveness analyses.

In cost-effectiveness analyses (CEA) that use randomized controlled trials (RCTs), covariates of prognostic importance may be imbalanced and warrant adjustment. In CEA that use non-randomized studies (NRS), the selection on observables assumption must hold for regression and matching methods to be unbiased. Even in restricted circumstances when this assumption is plausible, a key concern is how to adjust for imbalances in observed confounders. If the propensity score is misspecified, the covariates in the matched sample will be imbalanced, which can lead to conditional bias. To address covariate imbalance in CEA based on RCTs and NRS, this paper considers Genetic Matching. This matching method uses a search algorithm to directly maximize covariate balance. We compare Genetic and propensity score matching in Monte Carlo simulations and two case studies, CEA of pulmonary artery catheterization, based on an RCT and an NRS. The simulations show that Genetic Matching reduces the conditional bias and root mean squared error compared with propensity score matching. Genetic Matching achieves better covariate balance than the unadjusted analyses of the RCT data. In the NRS, Genetic Matching improves on the balance obtained from propensity score matching and gives substantively different estimates of incremental cost-effectiveness. We conclude that Genetic Matching can improve balance on measured covariates in CEA that use RCTs and NRS, but with NRS, this will be insufficient to reduce bias; the selection on observables assumption must also hold.

The effect of pulmonary artery catheter use on costs and long-term outcomes of acute lung injury.

BACKGROUND: The pulmonary artery catheter (PAC) remains widely used in acute lung injury (ALI) despite known complications and little evidence of improved short-term mortality. Concurrent with NHLBI ARDS Clinical Trials Network Fluid and Catheters Treatment Trial (FACTT), we conducted a prospectively-defined comparison of healthcare costs and long-term outcomes for care with a PAC vs. central venous catheter (CVC). We explored if use of the PAC in ALI is justified by a beneficial cost-effectiveness profile. METHODS: We obtained detailed bills for the initial hospitalization. We interviewed survivors using the Health Utilities Index Mark 2 questionnaire at 2, 6, 9 and 12 m to determine quality of life (QOL) and post-discharge resource use. Outcomes beyond 12 m were estimated from federal databases. Incremental costs and outcomes were generated using MonteCarlo simulation. RESULTS: Of 1001 subjects enrolled in FACTT, 774 (86%) were eligible for long-term follow-up and 655 (85%) consented. Hospital costs were similar for the PAC and CVC groups ($96.8k vs. $89.2k, p = 0.38). Post-discharge to 12 m costs were higher for PAC subjects ($61.1k vs. 45.4k, p = 0.03). One-year mortality and QOL among survivors were similar in PAC and CVC groups (mortality: 35.6% vs. 31.9%, p = 0.33; QOL [scale: 0-1]: 0.61 vs. 0.66, p = 0.49). MonteCarlo simulation showed PAC use had a 75.2% probability of being more expensive and less effective (mean cost increase of $14.4k and mean loss of 0.3 quality-adjusted life years (QALYs)) and a 94.2% probability of being higher than the $100k/QALY willingness-to-pay threshold. CONCLUSION: PAC use increased costs with no patient benefit and thus appears unjustified for routine use in ALI. TRIAL REGISTRATION: www.clinicaltrials.gov NCT00234767.

Improving costing methods in multicentre economic evaluation: the use of multiple imputation for unit costs.

Economic evaluations must use appropriate costing methods. However, in multicentre cost-effectiveness analyses (CEA) a fundamental issue of how best to measure and analyse unit costs has been neglected. Multicentre CEA commonly take the mean unit cost from a national database, such as NHS reference costs. This approach does not recognise that unit costs vary across centres and are unavailable in some centres. This paper proposes the use of multiple imputation (MI) to predict those centre-specific unit costs that are not available, while recognising the statistical uncertainty surrounding this imputation.We illustrate MI with a CEA of a multicentre randomised trial (1014 patients, 60 centres), implemented using multilevel modelling. We use MI to derive centre-specific unit costs, based on centre characteristics including average casemix, and compare this to using mean NHS reference costs. In this case study, using MI unit costs rather than mean reference costs led to less heterogeneity across centres, more precise estimates of incremental cost, but similar estimates of incremental cost-effectiveness.We conclude that using MI to predict unit costs can preserve correlations, maximise the use of available data, and, when combined with multilevel modelling is an appropriate method for recognising the statistical uncertainty in multicentre CEA.

Evidence-based review of the use of the pulmonary artery catheter: impact data and complications.

The pulmonary artery catheter (PAC) was introduced in 1971 for the assessment of heart function at the bedside. Since then it has generated much enthusiasm and controversy regarding the benefits and potential harms caused by this invasive form of hemodynamic monitoring. This review discusses all clinical studies conducted during the past 30 years, in intensive care unit settings or post mortem, on the impact of the PAC on outcomes and complications resulting from the procedure. Although most of the historical observational studies and randomized clinical trials also looked at PAC-related complications among their end-points, we opted to review the data under two main topics: the impact of PAC on clinical outcomes and cost-effectiveness, and the major complications related to the use of the PAC.

Efficiency of PA catheters in the ICU of a tertiary care hospital.

Existing randomized controlled trials on Pulmonary Artery Catheter (PAC)-guided strategies reveal a modest risk reduction that does reach statistical significance. An observational, prospective, controlled study was carried out in the ICU of a tertiary care hospital. Incidence, indications, complication rate and outcome of Pulmonary Artery (PA) catheter over a period of 3 months was looked at, comparing cases to matched controls. Despite being a limited study, it is obvious that the cost effectiveness and outcome of patients with the PA catheter seems ambiguous. In a developing country where resources are limited, thought must be given to the risk and benefit ratio of placing this invasive monitor and use of the information provided properly justified.

An evaluation of the clinical and cost-effectiveness of pulmonary artery catheters in patient management in intensive care: a systematic review and a randomised controlled trial.

OBJECTIVES: To evaluate the clinical and cost-effectiveness of managing critically ill patients in adult, general intensive care with or without pulmonary artery catheters (PACs). DESIGN: An open, multi-centre, randomised controlled trial with economic evaluation (cost-utility and cost-effectiveness analysis). SETTING: The setting was general (mixed medical/surgical) intensive care units (ICUs) in the UK admitting adults. PARTICIPANTS: Adult patients in participating ICUs deemed by the responsible treating clinician to require management with a PAC. INTERVENTIONS: These were insertion of a PAC and subsequent clinical management, at the discretion of the responsible treating clinicians, using data derived from the PAC. The control group were managed without a PAC but with the option of using alternative cardiac output monitoring devices. MAIN OUTCOME MEASURES: The main outcome measure was hospital mortality. Secondary outcome measures were length of stay in the ICU, length of stay in an acute hospital and organ-days of support in the ICU. For the economic evaluation, the main outcome measure was quality-adjusted life-years (QALYs) and the secondary outcome measure was hospital mortality. RESULTS: Sixty-five ICUs in the UK participated. Of these, 43 (66%) used alternative cardiac output monitoring devices in control group patients. A total of 1263 patients were identified as being eligible for the trial. Of these, 1041 (82.4%) were randomised and allocated to management with (n = 519) or without (n = 522) a PAC. There were no losses to follow-up. However, 27 patients (13 in the PAC group and 14 in the control group) were withdrawn from the trial because either the patient withdrew consent on recovering mental competency or the relatives withdrew agreement following randomisation. Data on 1014 patients were included in the analysis. Participants in the two groups had similar baseline characteristics. There was no difference in hospital mortality for patients managed with (68.4%) or without (65.7%) a PAC. The adjusted hazard ratio (PAC versus no PAC) was 1.09 [95% confidence interval (CI) 0.94 to 1.27]. There was no difference in the median length of stay in ICU, the median length of stay in an acute hospital or mean organ-days of support in ICU between the two groups. The economic evaluation found that the expected cost per QALY gained from the withdrawal of PAC was 2985 pounds. The expected cost per life gained from the withdrawal of PAC was 22,038 pounds. CONCLUSIONS: Clinical management of critically ill patients with a PAC, as currently practised in the UK, neither improves hospital survival for adult, general intensive care patients nor reduces length of stay in hospital. The lack of demonstrable benefit from a device previously believed to be beneficial could be explained by statistical chance, by misinterpretation of PAC-derived data, by ineffective treatment strategies based on data correctly interpreted using the current paradigm or by subsequent inaction following insertion of the device. It is also possible that detailed data on haemodynamics, however used, cannot modify the disease process sufficiently to influence disease outcome. The economic evaluation, using decision analysis techniques rather than conventional hypothesis testing, suggests that the withdrawal of the PAC from routine clinical practice in the NHS would be considered cost-effective in the current decision-making climate, and might result in lives or life-years being saved at modest cost. With the declining use of PACs in the UK and the findings of this report indicating no overall benefit from management with a PAC, it should now be possible to examine protocolised management with a PAC in selected groups of critically ill patients against appropriate controls, something that was difficult while PACs were the considered standard of care.

Pulmonary artery catheters for adult patients in intensive care.

BACKGROUND: Pulmonary artery catheterization was adopted about 30 years ago and widely disseminated without rigorous evaluation as to whether it benefited critically ill patients. The technique is used to measure cardiac output and pressures in the pulmonary circulation to guide diagnosis and treatment. Clinicians believe these data can improve patients' outcomes, even in the absence of consensus about the specific interpretation of the data. OBJECTIVES: To assess the effect of pulmonary artery catheterization on mortality and cost of care in adult intensive care patients. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2006); MEDLINE (all records to April 2006); EMBASE (all records to April 2006); CINAHL (all records to April 2006) and reference lists of articles. We contacted manufacturers and researchers in the field. SELECTION CRITERIA: We included all randomized controlled trials in adults, comparing management with and without a pulmonary artery catheter (PAC). DATA COLLECTION AND ANALYSIS: We screened the titles and abstracts of the electronic search results and obtained the full text of studies of possible relevance for independent review. We determined the final results of the literature search by consensus between the authors. We did not contact study authors for additional information. MAIN RESULTS: We identified 12 studies. Mortality was reported as hospital, 28-day, 30-day, or intensive care unit. We considered studies of high-risk surgery patients (eight studies) and general intensive care patients (four studies) separately for the meta-analysis. The pooled odds ratio for the studies of general intensive care patients was 1.05 (95% confidence interval (CI) 0.87 to 1.26) and for the studies of high-risk surgery patients 0.99 (95% CI 0.73 to 1.24). Of the eight studies of high-risk surgery patients, five evaluated the effectiveness of pre-operative optimization but there was no difference in mortality when these studies were examined separately. Pulmonary artery catheterization did not affect intensive care unit (reported by 10 studies) or hospital (reported by nine studies) length of stay. Four studies, conducted in the United States, measured costs based on hospital charges billed to patients, which on average were higher in the PAC groups. AUTHORS' CONCLUSIONS: To date, there have been two multi-centre trials of the effectiveness of PACs for managing critically ill patients admitted to intensive care, although only one was adequately powered. Efficacy studies are needed to determine optimal management protocols and patient groups who could benefit from management with a PAC.

The incremental cost effectiveness of withdrawing pulmonary artery catheters from routine use in critical care.

OBJECTIVE: The objective of this study was to conduct an economic evaluation to identify any differences in the expected costs and outcomes between patients treated with pulmonary artery catheters (PACs) and those without, in order to better inform healthcare decision makers. METHOD: The evaluation was carried out alongside a clinical trial investigating the use of PACs in intensive care units (ICUs) in the UK. It was conducted from the perspective of the UK NHS, in which PACs are an established intervention. Treating patients without using a PAC was characterised as the new intervention. The primary outcome measure was QALYs. The secondary outcome measure was hospital mortality. NHS costs per patient were calculated for the financial year 2002/03. The bootstrap method was used to characterise the uncertainty of the results and to construct cost-effectiveness acceptability curves. RESULTS: The cost per QALY and per life gained from the withdrawal of PACs were Pounds 2892 and Pounds 21,164, respectively. CONCLUSION: The results of this study indicate that withdrawal of PACs from routine clinical use in ICUs within the NHS would be considered cost effective in the current decision-making climate.

Evaluation of impedance cardiography as an alternative to pulmonary artery catheterization in critically ill patients.

Invasive pulmonary artery catheterization has historically been the method of choice for the evaluation of hemodynamic status. Impedance cardiography (ICG) is an accurate, noninvasive technique to obtain hemodynamic status information without the risk and cost associated with invasive methods. The purpose of this prospective, observational study was to determine whether the availability of ICG could decrease the need for placement of a pulmonary artery catheter in critically ill patients in coronary care units. After the need for hemodynamic data was determined, ICG parameters were provided to the attending physician who then decided whether pulmonary artery catheter insertion was still necessary. Of 107 subjects enrolled in the study, 14 (13%; 95% confidence interval, 7.3%-21.0%) were judged by the treating physicians to have indications for hemodynamic monitoring. In these subjects, the provision of ICG data allowed the physician to avoid placement of a pulmonary artery catheter in 10/14 patients (71%; 95% confidence interval, 41.9%-91.6%). When ICG was utilized, clinicians reported that the information was helpful in 10/10 patients (100%; 95% confidence interval, 74.1%-100.0%) and improved outcome in 6/10 patients (60%; 95% confidence interval, 26.2%-87.8%). ICG can replace the pulmonary artery catheter in coronary care unit patients, and clinicians utilizing ICG believe it aids medical decision making and improves patient outcomes.

[Hemodynamic surveillance: transesophageal echocardiography or Swan-Ganz catheter?]. / Surveillance hémodynamique: échocardiographie transoesophagienne ou catheter de Swan-Ganz?

Pulmonary artery catheter (PAC) and transoesophageal echocardiography (TOE) are two different windows on haemodynamics. PAC observes mainly right heart and pulmonary circulation; it measures pressures and outputs. Its contribution is essential to the management of situations accompanied by hypervolemia, pulmonary stasis, and severe pulmonary pathology, whereas it has little impact on diagnosis of hypovolemia and ventricular function. TOE offers a dynamic vision of the four heart chambers and their valves; it measures flows, surfaces and volumes. It allows quantification of systolic and diastolic functions for each ventricle. It is particularly adapted to the evaluation of hypovolemia and to the differential diagnosis of intractable hypotension. Its applications in cardiac surgery are numerous. The cost/benefice ratio of each technique is dependent of their indications and of their impact on therapy. Both require specific knowledge and learning time in order to have an major clinical impact.

Clinical and economic effects of pulmonary artery catheterization in nonemergent coronary artery bypass graft surgery.

OBJECTIVE: To examine the association between use of pulmonary artery catheterization with hospital outcomes and costs in nonemergent coronary artery bypass graft (CABG) surgery. DESIGN: Retrospective cohort study. SETTING: Fifty-six community-based hospitals in 26 states. PARTICIPANTS: A total of 13,907 patients undergoing nonemergent CABG surgery between January 1, 1997, and December 31, 1997. MEASUREMENTS AND MAIN RESULTS: Discharge abstracts for each patient were examined. Stratified and multivariate analyses were used to assess the impact of pulmonary artery catheters (PACs) on in-hospital mortality, length of stay in the intensive care unit, total length of stay, and hospital costs. Outcomes were adjusted for patient demographic factors, hospital characteristics, and hospital volume of PAC use in the year of analysis. Fifty-eight percent of the patients received a PAC. After adjustment, the relative risk of in-hospital mortality was 2.10 for the PAC group compared with the patients who did not receive a PAC (95% confidence interval [CI], 1.40 to 3.14; p < 0.001). The mortality risk was significantly higher in hospitals with the lowest third of PAC use (odds ratio, 3.35; 95% CI, 1.74 to 6.47; p < 0.001) and not significantly increased in the highest two thirds of users (odds ratio, 1.62; 95% CI, 0.99 to 2.66; p = 0.09). Days spent in critical care were similar; however, total length of hospital stay was 0.26 days longer in the PAC group (p < 0.001). Hospital costs were $1,402 higher in the PAC group. CONCLUSION: In the setting of nonemergent CABG surgery, pulmonary artery catheterization was associated with an increased risk of in-hospital mortality, greater length of stay, and higher total costs, particularly in hospitals with low volume of PAC use.

Semicontinuous cardiac output monitoring using a neural network.

OBJECTIVES: This study compared 2-mL bolus thermodilution cardiac output measurements with standard 10-mL bolus measurements. DESIGN: Cardiac output was measured with the new 2-mL bolus technique and the 10-mL standard thermodilution technique in a perspective series. We describe a system that automatically cools and injects 2-mL boluses of saline into a standard pulmonary artery catheter. It uses a Peltier effect solid-state cooler and pneumatically driven syringe injector to measure cardiac output once per minute. SETTING: Animal laboratory. ANIMALS: Eight adult Duroc swine weighing between 38.0 and 57.5 kg. INTERVENTIONS: Once each minute, 2 mL of cooled 5% dextrose was injected through the pulmonary catheter. Once every 8 mins, four sequential measurements of cardiac output were made using 10-mL injections. MEASUREMENTS AND MAIN RESULTS: A total of 1249 paired waveforms were processed with both a conventional algorithm and with a neural network. For the conventional algorithm, the correlation coefficient was r2 = .92 and the SD of the difference was 1.30 L/min. For the neural network, the correlation coefficient was r2 = .94 and the SD of the difference was 0.88 L/min. Output filtering improved the results in both cases. CONCLUSION: Neural networks accurately derive cardiac output from 2-mL bolus thermodilution injections, allowing cardiac output to be monitored automatically once per minute in many patients. The technique is convenient and uses standard low-cost catheters.

Cost-effectiveness of noninvasive hemodynamic monitoring.

Costs for hemodynamic monitoring can comprise a large segment of an institution's budget. Noninvasive monitoring with thoracic electrical bioimpedance is a cost-effective alternative to invasive monitoring. It can decrease not only materials costs but also costs related to patient complications.