Accuracy and Trending Ability of the Fourth-Generation FloTrac/EV1000 System in Patients With Severe Aortic Valve Stenosis Before and After Surgical Valve Replacement.

OBJECTIVE: Evaluate the accuracy and trending ability of the fourth-generation FloTrac/EV1000 (Edwards Lifesciences, Irvine, CA) system in patients with severe aortic valve stenosis by comparing FloTrac/EV1000-derived cardiac output (CCO-FT) with continuous thermodilution pulmonary artery catheter (CCO-PAC) measurements before and after surgical valve replacement. DESIGN: Prospective clinical study. SETTING: Anesthesia for cardiac surgery, operating room, single-center university hospital. PARTICIPANTS: Twenty-five patients were included. After exclusion, 20 patients undergoing elective aortic valve replacement were analyzed. INTERVENTIONS: After induction of general anesthesia, CCO-FT and CCO-PAC values were recorded every 30 seconds before and after aortic valve replacement with a bioprosthesis under cardiopulmonary bypass (CPB). MEASUREMENTS AND MAIN RESULTS: Data were analyzed separately from skin incision to last suture and before and after CPB. Regression analyses, Bland-Altman analyses, and trending analyses (4-quadrant plot, polar plot) were performed. The percentage errors of the FloTrac/EV1000 were 69.7% and 59.3% before and after CPB, respectively. The concordance rates (CRs) and angular CRs of the FloTrac/EV1000 were 50.9% and 57.1%, and 48.7% and 61.9% before and after CPB, respectively. CONCLUSION: This study revealed a low level of agreement and poor trending ability of the FloTrac/EV1000 system compared to continuous thermodilution pulmonary artery catheter in patients with severe aortic stenosis. Although there was a slight improvement after surgical valve replacement and CPB, the results were not within acceptable limits to replace CCO-PAC in this patient population.

Transpulmonary thermodilution: advantages and limits.

BACKGROUND: For complex patients in the intensive care unit or in the operating room, many questions regarding their haemodynamic management cannot be answered with simple clinical examination. In particular, arterial pressure allows only a rough estimation of cardiac output. Transpulmonary thermodilution is a technique that provides a full haemodynamic assessment through cardiac output and other indices. MAIN BODY: Through the analysis of the thermodilution curve recorded at the tip of an arterial catheter after the injection of a cold bolus in the venous circulation, transpulmonary thermodilution intermittently measures cardiac output. This measure allows the calibration of pulse contour analysis. This provides continuous and real time monitoring of cardiac output, which is not possible with the pulmonary artery catheter. Transpulmonary thermodilution provides several variables beyond cardiac output. It estimates the end-diastolic volume of the four cardiac cavities, which is a marker of cardiac preload. It provides an estimation of the systolic function of the combined ventricles. It is more direct than the pulmonary artery catheter, but does not allow the distinct estimation of right and left cardiac function. It is easier and faster to perform than echocardiography, but does not provide a full evaluation of the cardiac structure and function. Transpulmonary thermodilution has the unique advantage of being able to estimate at the bedside extravascular lung water, which quantifies the volume of pulmonary oedema, and pulmonary vascular permeability, which quantifies the degree of a pulmonary capillary leak. Both indices are helpful for guiding fluid strategy, especially in case of acute respiratory distress syndrome. CONCLUSIONS: Transpulmonary thermodilution provides a full cardiovascular evaluation that allows one to answer many questions regarding haemodynamic management. It belongs to the category of "advanced" devices that are indicated for the most critically ill and/or complex patients.

The Accuracy of Temperature Measurements Provided by the Edwards Lifesciences Pulmonary Artery Catheter.

BACKGROUND: Pulmonary artery catheters (PACs) are frequently used for monitoring patient temperatures in the intensive care unit. Nevertheless, data regarding the accuracy of these measurements are lacking, and few data testify to the accuracy of temperatures recorded after the PAC has been in place for several days. The absolute values of such measurements are relevant for critical care because patient temperatures are often used as diagnostic criteria for sepsis and antibiotic therapy. We thus hypothesized that the Edwards Lifesciences PAC would accurately measure blood temperature. To test our hypothesis, we compared temperature measurements obtained from PACs inserted in patients for different lengths of time with measurements of a reference platinum resistance thermometer (PRT). METHODS: PACs were removed and analyzed in 39 patients in whom PACs were inserted for 0 to 5 days. The PACs were placed in calibration baths, and 10 consecutive measurements at each of 7 different temperatures were obtained (36°C, 36.5°C, 37°C, 38°C, 38.3°C, 39°C, and 40°C). The temperature measurements obtained using PACs were compared with measurements obtained using a PRT. Bland-Altman statistical analyses were performed. Outliers, defined as PAC temperature measurements that varied more than ±0.3°C from PRT measurements, were identified. We considered a catheter unfit for clinical diagnostic or therapeutic use if ≥15% of data pairs were outliers. RESULTS: A total of 2730 data pairs were analyzed. Overall, the bias was -0.15°C; the precision was +0.13°C; and the limits of agreement were -0.45°C to +0.13°C. The bias and limits of agreement did not differ according to the age of the catheter or the temperature tested. One hundred fourteen data pairs (4.2% [95% confidence interval, 2.0%-6.4%]), involving 13 PACs and mostly from 4 PACs, were outliers. CONCLUSIONS: We conclude that temperature measurements obtained using the Edwards Lifesciences PACs are thus sufficiently accurate to be used for clinical temperature monitoring in critically ill patients.

Improved Performance of the Fourth-Generation FloTrac/Vigileo System for Tracking Cardiac Output Changes.

OBJECTIVES: The aims of this study were to compare cardiac output (CO) measured by the new fourth-generation FloTrac™/Vigileo™ system (Version 4.00) (COFVS) with that measured by a pulmonary artery catheter (COREF), and to investigate the ability of COFVS to track CO changes induced by increased peripheral resistance. DESIGN: Prospective study. SETTING: University Hospital. PARTICIPANTS: Twenty-three patients undergoing cardiac surgery. INTERVENTIONS: Phenylephrine (100 µg) was administered. MEASUREMENTS AND MAIN RESULTS: Hemodynamic variables, including CO(REF) and CO(FVS), were measured before and after phenylephrine administration. Bland-Altman analysis was used to assess the discrepancy between CO(REF) and CO(FVS). Four-quadrant plot and polar-plot analyses were utilized to evaluate the trending ability of CO(FVS) against CO(REF) after phenylephrine boluses. One hundred thirty-six hemodynamic interventions were performed. The bias shown by the Bland-Altman analysis was-0.66 L/min, and the percentage error was 55.4%. The bias was significantly correlated with the systemic vascular resistance index (SVRI) before phenylephrine administration (p<0.001, r(2) = 0.420). The concordance rate determined by four-quadrant plot analysis and the angular concordance rate calculated using polar-plot analysis were 87.0% and 83.0%, respectively. Additionally, this trending ability was not affected by SVRI state. CONCLUSIONS: The trending ability of the new fourth-generation FloTrac™/Vigileo™ system after increased vasomotor tone was greatly improved compared with previous versions; however, the discrepancy of the new system in CO measurement was not clinically acceptable, as in previous versions. For clinical application in critically ill patients, this vasomotor tone-dependent disagreement must be decreased.

The Precision of Pulmonary Artery Catheter Bolus Thermodilution Cardiac Output Measurements Varies With the Clinical Situation.

OBJECTIVE: To investigate the effects of ventilatory mode, injectate temperature, and clinical situation on the precision of cardiac output measurements. DESIGN: Randomized, prospective observational study. SETTING: Single university hospital. PARTICIPANTS: Forty patients undergoing planned cardiac surgery, receiving a pulmonary artery catheter according to institutional routine. INTERVENTIONS: Cardiac output was measured at 4 predefined time points during the perioperative patient course, twice during controlled and twice during spontaneous ventilation, using 2 blocks of 8 measurement replications with cold and tepid injectate in random order. MEASUREMENTS AND MAIN RESULTS: The data were analyzed using a hierarchical linear mixed model. Clinical precision was determined as half the width of the 95% confidence interval for the underlying true value. The single-measurement precision measured in 2 different clinical situations for each temperature/ventilation combination was 8% to 10%, 11% to 13%, 13% to 15%, and 23% to 24% in controlled ventilation with cold injectate, controlled ventilation with tepid injectate, spontaneous breathing with cold injectate, and spontaneous breathing with tepid injectate, respectively. Tables are provided for the number of replications needed to achieve a certain precision and for how to identify significant changes in cardiac output. CONCLUSIONS: Clinical precision of cardiac output measurements is reduced significantly during spontaneous relative to controlled ventilation. The differences in precision between repeated measurement series within the temperature/ventilation combinations indicate influence of other situation-specific factors not related to ventilatory mode. Compared with tepid injectate in patients breathing spontaneously, the precision is 3-fold better with cold injectate and controlled ventilation.

[Swan Ganz catheter. Experts opinion]. / Catéter de Swan Ganz. Opinión de expertos.

Investigators have raised doubts as to the safety of the Swan Ganz catheter (SGC). In order to define the point of view of cardiologists in our country, the Argentine Society of Cardiology's Emergency Council organized a meeting to analyze their views in different settings (non-cardiac surgery, cardiac surgery, acute coronary syndromes and heart failure) using the RAND-UCLA appropriateness method. A detailed review with the scientific evidence was sent to the experts in cardiology prior to the meeting in the SAC auditorium where the panellists selected the clinical variables create the specific situations. These hypothetic situations were resent to the panellists at a second stage for their individual evaluation, rating the benefit-to-harm ratio of the procedure on a scale of 1 to 9 (1 meant that the expected harms greatly outweighed the expected benefits, and 9 that the expected benefits greatly outweighed the expected harms, 5 could mean either that the harms and benefits were roughly equal). Two experts analyzed the results, describing the agreement/disagreement ratio. Finally, each indication was classified as "appropriate" "uncertain" or "inappropriate" ,for the procedure in accordance with the panelists' median score: median scores in the 1-3 range were classified as inappropriate, those in the 4-6 range as uncertain, and those in the 7-9 range as appropriate. We observed high disagreement rates in SGC indications between cardiologists. However, the panelists were in favor of SGC use when situations included shock and myocardial dysfunction, especially in the presence of organic dysfunction. There were some situations when panelists considered SGC not useful, in patients without organ failure.

Pulmonary artery catheter monitoring in 2011.

PURPOSE OF REVIEW: Hemodynamic monitoring has gained widespread acceptance in intensive care units. Despite ongoing debate regarding its safety and efficacy, monitoring with the pulmonary artery catheter (PAC) remains used for the management of severe heart failure and shock. RECENT FINDINGS: To reanalyze using the most recently published literature in the field, the role of the PAC to manage critically ill patients with right ventricular failure, pulmonary hypertension and weaning failure from cardiac origin. The role of PAC as a gold standard to validate new cardiac output monitoring devices was also reported. SUMMARY: Despite competition with less invasive hemodynamic monitoring devices or ultrasonic methods, the PAC remains a useful monitoring device in situations in which the knowledge of pulmonary artery pressure, pulmonary artery occlusion pressure and oxygenation parameters are needed. The proper use of PAC requires, however, a perfect knowledge of the numerous pitfalls and difficulties in interpretation of its measurements.

Pulse contour analysis: is it able to reliably detect changes in cardiac output in the haemodynamically unstable patient?

Three pulse contour systems for monitoring cardiac output - LiDCO Plus™, PiCCO Plus™ and FloTrac™ - were compared in postcardiac surgery patients. None of the three methods demonstrated good trending ability according to concordance analysis. Pulse contour systems remain unreliable in the haemodynamically unstable patient.

Comparison of calibrated and uncalibrated arterial pressure-based cardiac output monitors during orthotopic liver transplantation.

Arterial pressure-based cardiac output monitors (APCOs) are increasingly used as alternatives to thermodilution. Validation of these evolving technologies in high-risk surgery is still ongoing. In liver transplantation, FloTrac-Vigileo (Edwards Lifesciences) has limited correlation with thermodilution, whereas LiDCO Plus (LiDCO Ltd.) has not been tested intraoperatively. Our goal was to directly compare the 2 proprietary APCO algorithms as alternatives to pulmonary artery catheter thermodilution in orthotopic liver transplantation (OLT). The cardiac index (CI) was measured simultaneously in 20 OLT patients at prospectively defined surgical landmarks with the LiDCO Plus monitor (CI(L)) and the FloTrac-Vigileo monitor (CI(V)). LiDCO Plus was calibrated according to the manufacturer's instructions. FloTrac-Vigileo did not require calibration. The reference CI was derived from pulmonary artery catheter intermittent thermodilution (CI(TD)). CI(V)-CI(TD) bias ranged from -1.38 (95% confidence interval = -2.02 to -0.75 L/minute/m(2), P = 0.02) to -2.51 L/minute/m(2) (95% confidence interval = -3.36 to -1.65 L/minute/m(2), P < 0.001), and CI(L)-CI(TD) bias ranged from -0.65 (95% confidence interval = -1.29 to -0.01 L/minute/m(2), P = 0.047) to -1.48 L/minute/m(2) (95% confidence interval = -2.37 to -0.60 L/minute/m(2), P < 0.01). For both APCOs, bias to CI(TD) was correlated with the systemic vascular resistance index, with a stronger dependence for FloTrac-Vigileo. The capability of the APCOs for tracking changes in CI(TD) was assessed with a 4-quadrant plot for directional changes and with receiver operating characteristic curves for specificity and sensitivity. The performance of both APCOs was poor in detecting increases and fair in detecting decreases in CI(TD). In conclusion, the calibrated and uncalibrated APCOs perform differently during OLT. Although the calibrated APCO is less influenced by changes in the systemic vascular resistance, neither device can be used interchangeably with thermodilution to monitor cardiac output during liver transplantation.

Cross-comparison of cardiac output trending accuracy of LiDCO, PiCCO, FloTrac and pulmonary artery catheters.

INTRODUCTION: Although less invasive than pulmonary artery catheters (PACs), arterial pulse pressure analysis techniques for estimating cardiac output (CO) have not been simultaneously compared to PAC bolus thermodilution CO (COtd) or continuous CO (CCO) devices. METHODS: We compared the accuracy, bias and trending ability of LiDCO™, PiCCO™ and FloTrac™ with PACs (COtd, CCO) to simultaneously track CO in a prospective observational study in 17 postoperative cardiac surgery patients for the first 4 hours following intensive care unit admission. Fifty-five paired simultaneous quadruple CO measurements were made before and after therapeutic interventions (volume, vasopressor/dilator, and inotrope). RESULTS: Mean CO values for PAC, LiDCO, PiCCO and FloTrac were similar (5.6 ± 1.5, 5.4 ± 1.6, 5.4 ± 1.5 and 6.1 ± 1.9 L/min, respectively). The mean CO bias by each paired method was -0.18 (PAC-LiDCO), 0.24 (PAC-PiCCO), -0.43 (PAC-FloTrac), 0.06 (LiDCO-PiCCO), -0.63 (LiDCO-FloTrac) and -0.67 L/min (PiCCO-FloTrac), with limits of agreement (1.96 standard deviation, 95% confidence interval) of ± 1.56, ± 2.22, ± 3.37, ± 2.03, ± 2.97 and ± 3.44 L/min, respectively. The instantaneous directional changes between any paired CO measurements displayed 74% (PAC-LiDCO), 72% (PAC-PiCCO), 59% (PAC-FloTrac), 70% (LiDCO-PiCCO), 71% (LiDCO-FloTrac) and 63% (PiCCO-FloTrac) concordance, but poor correlation (r(2) = 0.36, 0.11, 0.08, 0.20, 0.23 and 0.11, respectively). For mean CO < 5 L/min measured by each paired devices, the bias decreased slightly. CONCLUSIONS: Although PAC (COTD/CCO), FloTrac, LiDCO and PiCCO display similar mean CO values, they often trend differently in response to therapy and show different interdevice agreement. In the clinically relevant low CO range (< 5 L/min), agreement improved slightly. Thus, utility and validation studies using only one CO device may potentially not be extrapolated to equivalency of using another similar device.

Interventional Radiology Therapy: Inferior Vena Cava Filter and Catheter-based Therapies.

Endovascular management of pulmonary embolism can be divided into therapeutic and prophylactic treatments. Prophylactic treatment includes inferior vena cava filter placement, whereas endovascular therapeutic interventions include an array of catheter-directed therapies. The indications for both modalities have evolved over the last decade as new evidence has become available.

Cardiac output measurement in patients undergoing liver transplantation: pulmonary artery catheter versus uncalibrated arterial pressure waveform analysis.

BACKGROUND: Cardiac output (CO) and invasive hemodynamic measurements are useful during liver transplantation. The pulmonary artery catheter (PAC) is commonly used for these patients, despite the potential complications. Recently, a less invasive device (Vigileo/FloTrac) became available, which estimates CO using arterial pressure waveform analysis without external calibration. In this study, we compared CO obtained with a PAC using automatic thermodilution, instantaneous CO stat-mode (ICO(SM)), and CO obtained with the new device, arterial pressure waveform analysis (APCO) in patients undergoing liver transplantation. METHODS: Twenty sets of simultaneous measurements of APCO and ICO(SM) were determined in sedated and mechanically ventilated patients undergoing liver transplantation. Time points were as follows: after PAC insertion (T1-3), after portal clamping (T4-6), during anhepathy (T7-9), after graft reperfusion (T10-15), and in the postoperative period in the intensive care unit (T15-20). RESULTS: We enrolled 20 patients and 400 measurements were obtained. No data were rejected. Bias between ICO(SM) and APCO was 0.8 L/min, 95% limits of agreement were -1.8 to 3.5 L/min. The percentage error was 43%. Bias between ICO(SM) and APCO was correlated with systemic vascular resistance [r(2) = 0.55, P < 0.0001, y = 15.8-2.2 ln(x)] and subgroup analysis revealed an increase in the bias and in the percentage error in patients with low systemic vascular resistance (Child-Pugh grade B and C patients). There was no difference between the different surgical periods. CONCLUSIONS: Our results suggest that Vigileo/FloTrac CO monitoring data do not agree well with those of automatic thermodilution in patients undergoing liver transplantation, especially in Child-Pugh grade B and C patients with low systemic vascular resistance.

Right heart catheterisation: best practice and pitfalls in pulmonary hypertension.

Right heart catheterisation (RHC) plays a central role in identifying pulmonary hypertension (PH) disorders, and is required to definitively diagnose pulmonary arterial hypertension (PAH). Despite widespread acceptance, there is a lack of guidance regarding the best practice for performing RHC in clinical practice. In order to ensure the correct evaluation of haemodynamic parameters directly measured or calculated from RHC, attention should be drawn to standardising procedures such as the position of the pressure transducer and catheter balloon inflation volume. Measurement of pulmonary arterial wedge pressure, in particular, is vulnerable to over- or under-wedging, which can give rise to false readings. In turn, errors in RHC measurement and data interpretation can complicate the differentiation of PAH from other PH disorders and lead to misdiagnosis. In addition to diagnosis, the role of RHC in conjunction with noninvasive tests is widening rapidly to encompass monitoring of treatment response and establishing prognosis of patients diagnosed with PAH. However, further standardisation of RHC is warranted to ensure optimal use in routine clinical practice.

Is routine preoperative hemodynamic evaluation of nonagenarians necessary?

An Incidence of co-morbid cardiac disease in the elderly surgical patient as high as 66% has been previously reported. Even in the absence of clinically significant cardiac disease, advanced age alone is often considered sufficient indication for Swan-Ganz placement, hemodynamic evaluation, adjustment of fluid states, and inotropic support. Yet data clearly documenting the need for this evaluation and therapy are difficult to obtain. All major general surgical and orthopedic operations in non-agenarians were reviewed in our institution from July 1, 1987 through December 31, 1988. Fifty-one procedures were performed on 46 patients. None of these patients had preoperative Swan-Ganz catheterization or hemodynamic evaluation. Eighteen general surgical, 30 orthopedic, 2 neurosurgical, and 1 gynecological procedures were performed. Forty-three were performed under general anesthesia, 7 under spinal anesthesia, and 1 with local anesthesia. Seven out of 51 patients (14%) experienced major complications, and 16 out of 51 (31%) experienced minor complications. Thirty-day mortality was 0%, and 6-month survival was 92%. Only one complication occurred within 48 hours of surgery that might possibly have been prevented with hemodynamic evaluation, adjustment of fluid status, inotropic support, and intensive care unit monitoring.

Monitoring of central venous oxygen saturation versus mixed venous oxygen saturation in critically ill patients.

Continuous monitoring of mixed venous (SvO2) and central venous (ScO2) oxygen saturation was compared in 7 critically-ill patients (Apache II score: 19 +/- 2.1) to determine whether or not information derived from ScO2 were reliable in clinical practice. Patients were catheterized with both a pulmonary artery (PA) and a central venous (CV) catheter, each of them mounted with fiberoptic sensors (Opticath PA Catheter P7110 and Opticath CV Catheter U440, Abbott). A total of 580 comparative measurements were obtained during periods without and with therapeutic interventions (drug-titration, bronchial suction, use of PEEP, changes in FiO2 ...). The systematic error between the 2 measurement techniques was 0.6% and 0.3% in periods with and without therapeutic interventions, respectively. The variability between the 2 techniques was 10% for both periods. Differences between the values were greater than or equal to 5% in 49% of values during periods of stability and in 50% of values during periods with therapeutic interventions. There were poor correlations between the values during periods without (r = 0.48) and with therapeutic interventions (r = 0.62). Better, but still less than ideal, correlations were obtained with changes in SvO2 and ScO2 during periods without (r = 0.70) and with therapeutic interventions (r = 0.77). Although there is a need to develop a simple technique to monitor mixed venous oxygen saturation, the present study indicates that ScO2 monitoring was not reliable in the study patients.