Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial

doi:10.1016/S0140-6736(05)67061-4

The Lancet

Volume 366, Issue 9484, 6–12 August 2005, Pages 472-477

https://doi.org/10.1016/S0140-6736(05)67061-4 Get rights and content

Summary

Background

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.

Methods

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.

Findings

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.

Interpretation

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.

Introduction

No monitoring device has polarised opinion as much as the pulmonary artery catheter (PAC).1, 2, 3, 4, 5 Introduced 30 years ago, it is widely used in critically ill patients, yet there has been no formal assessment of either its clinical effectiveness or cost-effectiveness. Proponents4, 5 argue that its unique ability to allow accurate measurement of cardiac output and other haemodynamic variables enables improved diagnosis and management of circulatory instability. Critics, however, point to complications associated with its insertion and use,1, 2, 6, 7 inaccuracies in measurement, and difficulties with interpretation of data.8, 9, 10 Furthermore, a lack of positive outcome benefits in the critically ill and some suggestions of increased mortality from retrospective analyses11, 12 indicate potential problems with this device.

In 1996, a large, non-randomised, risk-adjusted study¹³ indicated an increased 30-day mortality associated with PAC use within the first 24 h after admission to intensive care. This fresh uncertainty encouraged governments in both Europe and North America to provide funding to enable large, randomised controlled trials of PAC use in intensive care. We designed the PAC-Man study as a pragmatic, randomised controlled trial to address the hypothesis that hospital mortality is reduced in critically ill patients managed with a PAC.

Section snippets

Patients

Between Oct 15, 2001, and March 29, 2004, we enrolled patients admitted to adult intensive care and identified by the treating clinician as someone who should be managed with a PAC. We invited all adult intensive care units (ICUs) in the UK to participate. Our only exclusion criteria were: age younger than 16 years; elective admission for preoperative optimisation; presence of a PAC on admission to intensive care; previous enrolment to the study; or haemodynamic optimisation before organ

Results

65 ICUs (from 13 university, eight university-affiliated, and 44 non-university hospitals) participated. 42 ICUs decided to join stratum B (option to use alternative cardiac output monitoring technologies in control group). A further five ICUs swapped to stratum B during recruitment; we considered patients randomly assigned after this point as stratum B patients.

Figure 1 shows the trial profile. We randomly assigned 1041 patients. Of the 522 patients allocated to the control group, 24 (5%) were

Discussion

Our results indicate no difference in hospital mortality between critically ill patients managed with or without a PAC. Similarly, length of stay in either intensive care or hospital, or organ-days of support did not differ between groups.

The pragmatic design of our study reflected the lack of consensus on a specific management protocol. Though some argue strongly for a structured approach, the lack of supportive data meant that no common strategy could be agreed with respect to timing or

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Cited by (858)

Pulmonary Artery Catheters: Old Dog With New Tricks?
2024, Canadian Journal of Cardiology
Pulmonary Artery Catheter Usage and Impact on Mortality in Patients With Cardiogenic Shock: Results From a Canadian Single-Centre Registry
2024, Canadian Journal of Cardiology
Hemodynamic assessment for cardiogenic shock (CS) phenotyping in patients has led to renewed interest in the use of pulmonary artery catheters (PACs).
We included patients admitted with CS from January 2014 to December 2020 and compared clinical outcomes among patients who received PACs and those who did not. The primary outcome was the rate of in-hospital mortality. Secondary outcomes included use of advanced heart failure therapies and coronary intensive care unit (CICU) and hospital lengths of stay.
A total of 1043 patients were analysed and 47% received PACs. Patients selected for PAC-guided management were younger and had lower left ventricular function. They also had higher use of vasopressor and inotropes, and 15.2% of them were already supported with temporary mechanical circulatory support (MCS). In-hospital mortality was lower in patients who received PACs (29.3% vs 36.2%; P = 0.02), mainly driven by a reduction in mortality among those in Society for Cardiovascular Angiography and Interventions (SCAI) stages D and E CS. Patients who received PACs were more likely to receive temporary MCS with Impella, durable ventricular assist devices (VADs), or orthotopic heart transplantation (OHT) (P < 0.001 for all analyses). CICU and hospital lengths of stay were longer in patients who used PACs.
Among patients with CS, the use of PACs was associated with lower in-hospital mortality, especially among those in SCAI stages D and E. Patients who received PACs were also more frequently rescued with temporary MCS or received advanced heart failure therapies, such as durable VADs or OHT.
L'évaluation hémodynamique pour le phénotypage du choc cardiogénique (CC) chez les patients a suscité un regain d'intérêt pour l'utilisation des cathéters artériels pulmonaires (CAP).
Nous avons inclus des patients admis pour CC de janvier 2014 à décembre 2020 et avons comparé les résultats cliniques entre les patients ayant reçu des CAP et ceux n'en ayant pas reçu. Le critère d'évaluation principal était le taux de mortalité hospitalière. Les critères d'évaluation secondaires comprenaient l'usage de thérapies avancées pour l'insuffisance cardiaque et la durée des séjours en unité de soins intensifs coronariens (USIC) et à l'hôpital.
Au total, 1043 patients ont fait partie de l'analyse et 47 % ont bénéficié de CAP. Les patients sélectionnés pour une prise en charge guidée par CAP étaient plus jeunes et avaient une fonction ventriculaire gauche plus faible. Ils utilisaient également davantage de vasopresseurs et d'inotropes, et 15,2 % d'entre eux bénéficiaient déjà d'une assistance circulatoire mécanique (ACM) temporaire. La mortalité hospitalière était plus faible chez les patients ayant reçu des CAP (29,3 % contre 36,2 %; P = 0,02), principalement due à une réduction de la mortalité parmi ceux aux stades D et E du CC selon la Society for Cardiovascular Angiography and Interventions (SCAI). Les patients ayant reçu des CAP étaient plus susceptibles de recevoir une ACM temporaire avec Impella, des dispositifs d'assistance ventriculaire (DAV) durables ou une transplantation cardiaque orthotopique (TCO) (P < 0,001 pour toutes les analyses). Les durées de séjour en USIC et à l'hôpital étaient plus longues chez les patients utilisant des CAP.
Chez les patients avec CC, l'utilisation de CAP était associée à une mortalité hospitalière plus faible, en particulier parmi ceux aux stades D et E selon les critères de la SCAI. Les patients ayant reçu des CAP étaient également plus fréquemment soutenus par ACM temporaire ou recevaient des thérapies avancées pour l'insuffisance cardiaque, telles que des DAV durables ou des TCO.
Use of the pulmonary artery catheter in the first postoperative hours of high-risk cardiovascular surgery
2024, Acta Colombiana de Cuidado Intensivo
La información de los fenómenos fisiológicos en el posoperatorio de cirugía cardiaca, uso del catéter de arteria pulmonar (CAP) y conductas médicas derivadas de su medición, es limitada.
Describir los patrones de uso del CAP y conductas terapéuticas derivadas de este en las primeras horas posoperatorias de cirugía cardiovascular de alto riesgo.
Estudio de cohorte retrospectiva de pacientes de cirugía cardiovascular de alto riesgo, imanejados con CAP en la Unidad de Cuidados Intensivos (UCI) del Hospital Universitario San Ignacio en Bogotá D.C., Colombia. Se evaluaron las intervenciones terapéuticas derivadas de la evaluación hemodinámica con este catéter, teniendo en cuenta los patrones de uso y conductas terapéuticas según el momento posoperatorio.
Se incluyeron 42 pacientes. Mediana de edad 65 años, 59,5% hombres, 57,1% con EuroSCORE ≥ 6. La mediana de tiempo de uso del CAP fue 63 horas (RIC 45-80). El número de mediciones con CAP por cada 12 horas se redujo de 2,16 ± 0,53 en las primeras 12 horas a 1,30 ± 0,82 después de 48 horas (p = 0,0003). El número de conductas tomadas a partir de cada medición bajó de 1,48 ± 0,45 a 0,71 ± 0,51 (p = 0,0001) en el mismo periodo. Hubo reducción significativa en número de conductas asociadas a administración de líquidos, vasoactivos y vasodilatadores con el tiempo.
Nuestros datos sugieren que con el paso de las horas el número de mediciones con el CAP es cada vez menor, al igual que el número de conductas que se toman con base en dichas mediciones. Dichos datos sugieren que muchos de los pacientes que mantuvieron el CAP hasta 48-72 horas ya no lo requerían. Serán necesarios nuevos estudios para aclarar cuáles pacientes se benefician del CAP más allá de 48 horas.
Information on physiological phenomena in the postoperative period of cardiac surgery, pulmonary artery catheter (PAC) use, and medical behaviors derived from its measurement, is limited.
To describe the patterns of PAC use and therapeutic behaviors derived from it in the first postoperative hours of high-risk cardiovascular surgery.
Retrospective cohort study of high-risk cardiovascular surgery patients, managed with PAC in the intensive care unit of the Hospital Universitario San Ignacio in Bogotá D.C. (Colombia). The therapeutic interventions derived from the hemodynamic evaluation with this catheter were evaluated, taking into account the patterns of use and therapeutic behaviors according to the postoperative moment.
Forty-two patients were included. Median age 65 years, 59.5% men, 57.1% with EuroSCORE≥6. Median time of PAC use was 63 h (RIC 45–80). The number of PAC measurements per 12 h decreased from 2.16 ± 0.53 in the first 12 h to 1.30 ± 0.82 after 48 h (p: 0.0003). The number of behaviors taken from each measurement decreased from 1.48 ± 0.45 to 0.71 ± 0.51 (p: 0.0001) in the same period. There was significant reduction in number of behaviors associated with fluid, vasoactive, and vasodilator administration over time.
Our data suggest that with the passage of hours the number of PAC measurements is decreasing, as well as the number of behaviors taken based on these measurements. These data suggest that many of the patients who maintained the pulmonary artery catheter for up to 48–72 h no longer required it. Further studies will be needed to clarify which patients benefit from pulmonary artery catheterization beyond 48 h.
Cardiogenic Shock: Pathogenesis, Classification, and Management
2024, Critical Care Clinics
Standardization of the Right Heart Catheterization and the Emerging Role of Advanced Hemodynamics in Heart Failure
2023, Journal of Cardiac Failure
The accurate assessment of hemodynamics is paramount to providing timely and efficacious care for patients presenting in cardiogenic shock. Recently, the regular use of the pulmonary artery catheter in cardiogenic shock has had a resurgence with emerging data indicating improved survival in the modern era. Optimal multidisciplinary management of advanced heart failure and cardiogenic shock relies on our ability to effectively communicate and understand the complete hemodynamic assessment. Standardization of data acquisition and a renewed focus on the physiological processes, and thresholds driving disease progression, including the coupling ratio and myocardial reserve, are needed to fully understand and interpret the hemodynamic assessment. This State-of-the-Art review discusses best practices in the cardiac catheterization laboratory as well as emerging data on the prognostic role of emerging advanced hemodynamic parameters.
Variation in Hemodynamic Assessment and Interpretation: A Call to Standardize the Right Heart Catheterization
2023, Journal of Cardiac Failure
Invasive hemodynamic measurement via right heart catheterization has shown divergent data in its role in the treatment of patients with heart failure (HF) and cardiogenic shock. We hypothesized that variation in data acquisition technique and interpretation might contribute to these observations. We sought to assess differences in hemodynamic acquisition and interpretation by operator subspecialty as well as level of experience.
Individual-level responses to how physicians both collect and interpret hemodynamic data at the time of right heart catheterization was solicited via a survey distributed to international professional societies in HF and interventional cardiology. Data were stratified both by operator subspecialty (HF specialists or interventional cardiologists [IC]) and operator experience (early career [≤10 years from training] or late career [>10 years from training]) to determine variations in clinical practice. For the sensitivity analysis, we also look at differences in each subgroup. A total of 261 responses were received. There were 141 clinicians (52%) who self-identified as HF specialists, 99 (38%) identified as IC, and 20 (8%) identified as other. There were 142 early career providers (54%) and late career providers (119 [46%]). When recording hemodynamic values, there was considerable variation in practice patterns, regardless of subspecialty or level of experience for the majority of the intracardiac variables. There was no agreement or mild agreement among HF and IC as to when to record right atrial pressures or pulmonary capillary wedge pressures. HF cardiologists were more likely to routinely measure both Fick and thermodilution cardiac output compared with IC (51% vs 29%, P < .001), something mirrored in early career vs later career cardiologists.
Significant variation exists between the acquisition and interpretation of right heart catheterization measurements between HF and IC, as well as those early and late in their careers. With the growth of the heart team approach to management of patients in cardiogenic shock, standardization of both assessment and management practices is needed.

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ArticlesAssessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial

Summary

Background

Methods

Findings

Interpretation

Introduction

Section snippets

Patients

Results

Discussion

Chest

Anesthesiol Clin North Am

Clin Chest Med

Chest

Chest

Lancet

Defenders of the pulmonary artery catheter

Chest

Is it time to pull the pulmonary artery catheter?

JAMA

Is the pulmonary artery catheter misused? A European view

Crit Care Med

Pulmonary Artery Catheter Consensus Conference: consensus statement

Crit Care Med

A multi-center study of physicians' knowledge of the pulmonary artery catheter

JAMA

Assessment of critical care nurses' knowledge of the pulmonary artery catheter

Crit Care Med

Intensive care physicians' insufficient knowledge of right-heart catherization at the bedside: time to act?

Crit Care Med

The effectiveness of right heart catheterization in the initial care of critically ill patients

JAMA

APACHE II: a severity of disease classification system

Crit Care Med

Articles
Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial