Use of a Pulmonary Artery Catheter in Patients With Cardiogenic Shock　― A Systematic Review and Meta-Analysis ―

Abstract

Background: A pulmonary artery catheter (PAC) provides detailed hemodynamic data, and managing a patient with cardiogenic shock (CS) using a PAC potentially improves patient outcomes. Therefore, in this systematic review and meta-analysis we aimed to evaluate whether a PAC is associated with better outcomes in patients with CS.

Methods and Results: Studies comparing PAC and non-PAC management in patients with CS were identified from the PubMed, Web of Science, and CENTRAL databases. There were no randomized controlled trials (RCTs). Of the 19 studies that met the inclusion criteria, 12 without a critical risk of bias were analyzed. PAC use was associated with lower in-hospital mortality when evaluated as a dichotomous outcome. Similar trends were observed in the time-to-event analyses. Substantial heterogeneity was observed across the studies. Subgroup analysis revealed better outcomes with PAC in patients with CS related to heart failure, but not in those with acute coronary syndrome. Sensitivity analyses, which included studies with a critical risk of bias, showed consistent trends favoring PAC use for crude in-hospital mortality. The overall certainty of the evidence was very low because of inconsistencies and biases.

Conclusions: The PAC-guided CS management was associated with better in-hospital mortality, particularly in patients with heart failure-related CS. However, RCTs that evaluated the efficacy of PAC use as a primary purpose were not included, necessitating further RCTs to confirm these findings.

Cardiogenic shock (CS) is a life-threatening condition in which reduced cardiac output causes insufficient perfusion of organs and tissues, leading to organ failure and death.^1–4 The mortality of CS remains high, and further advances in its management are desired.^1–3,5–8 A pulmonary artery catheter (PAC), which provides accurate and detailed hemodynamic information, is often used to manage patients with heart failure (HF) or CS. The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial examined the efficacy of PAC in patients hospitalized with severe HF, but failed to demonstrate a benefit, resulting in the less frequent use of PACs in clinical practice.^9–14 However, in the ESCAPE trial, because the enrolled patients had to be sufficiently stable to make crossover to a PAC for urgent management unlikely, fewer patients with CS may have been included in this trial. There is a rationale that in patients with CS, the placement of a PAC may improve outcomes because the measures obtained by the PAC help clinicians adjust drugs, including inotropes and vasodilators, guide fluid volume, and decide whether mechanical circulatory support should be provided. Therefore, in this study we aimed to clarify whether PAC use is associated with better outcomes than no PAC use in patients with CS.

Methods

Study Design

The Japan Resuscitation Council (JRC) CS Task Force for the 2025 JRC guidelines was established by the Japanese Circulation Society and Japanese Society of Internal Medicine. We examined the research question regarding the effect of PAC use on CS outcomes.

Based on discussions between the JRC CS Task Force and Guidelines Editorial Committee, the research question was posed using the Population, Intervention, Comparator, Outcome, Study Design, and Time frame format as follows: P (patients), patients aged 18 years or older with CS; I (intervention), implementation of PAC; C (comparator), no implementation of PAC or no evaluation; O (outcome), in-hospital mortality or 30-day mortality; and T (time frame), all published literature until July 16, 2023.

The study protocol was registered in PROSPERO (CRD42023423016). This systematic review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.¹⁵

Search Strategy

We conducted a comprehensive electronic search of PubMed, Web of Science Core Collection (Science Citation Index - Expanded Since 1973), and Cochrane Library (CENTRAL) databases using terms identified by the review team. The full search strategy is shown in the Supplementary Methods. The search strategy was modified from PROSPERO to accommodate different databases; however, the keywords were maintained. The search included all studies that compared management using PAC with not using PAC in patients with CS. The citation lists for the included studies were also reviewed, and relevant studies were included. English and Japanese articles were included, but Japanese articles without English abstracts were excluded.

Study Selection

Two reviewers (T.K. and T.N.) independently screened the study titles and abstracts for eligibility (first screening). After excluding case reports, case series, reviews, guidelines, animal studies, and studies that did not clearly report original human clinical data regarding the primary review question, the same 2 reviewers independently evaluated the full-text articles of potentially eligible studies to confirm the inclusion and exclusion criteria (second screening). Disagreements were discussed until consensus was reached.

The primary outcome was defined as in-hospital or 30-day mortality. For studies that evaluated several models, we chose the result from inverse probability weighting or propensity score-matching; if not available, the multivariable model adjusted for as many variables as possible was chosen.

Risk of Bias Assessment

The same 2 reviewers (T.K. and T.N.) independently evaluated the risk of bias in all the included studies according to the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I).¹⁶ All studies were assessed for bias in 7 domains, and the overall bias was judged as having being low, moderate, serious, or critical, or no information based on these results. Disagreements between reviewers regarding the risk of bias in particular studies were resolved by discussion, and studies judged to have a critical risk of bias were excluded from the meta-analysis.

Rating the Certainty of Evidence

The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool was used to rate the certainty of the evidence on the effect of PAC use.^17–19 The certainty of the evidence was assessed as “high”, “moderate”, “low” or “very low” by evaluating the risk of bias, inconsistency, indirectness, imprecision, and publication bias.

Statistical Analysis

We pooled the results after propensity score-matching, the results weighted by the inverse probability of treatment weighting, and adjusted results. The results were summarized using a random-effects model to estimate the association between PAC use and outcomes. Some studies evaluated in-hospital death as a dichotomous outcome and others as a time-to-event outcome; for dichotomous outcomes, odds ratios (ORs) with 95% confidence intervals (CIs) were used for the estimates, and for time-to-event, hazard ratios (HRs) were used for the estimates. These estimates were also obtained for subgroups according to the cause of CS. Statistical heterogeneity was assessed on the basis of the I² value: values >50% were considered indicative of substantial heterogeneity. The potential for publication bias was assessed using funnel plots. In the sensitivity analysis, the crude in-hospital or 30-day mortality was evaluated regardless of the risk of bias (i.e., studies with a critical risk of bias were included). Statistical analyses were performed using RevMan 5.4.1 (The Nordic Cochrane Centre, Copenhagen, Denmark), and statistical significance was set at P<0.05.

Results

Study Selection

After excluding duplicates, we identified 808 studies in the PubMed, Web of Science, and CENTRAL databases (Figure 1).^{12–14,20–35} After excluding 718 studies in the first screening and 71 studies in the second screening, a total of 19 studies remained, none of which was a randomized controlled trial (RCT). Therefore, we included the 19 studies in our meta-analysis.

Figure 1.

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram.

Risk of Bias

The authors’ judgments regarding each risk of bias item for each included study are shown in Figure 2: 6 studies were judged as having a moderate overall risk of bias;^{14,20,22–24,32} 6 had a serious overall risk of bias;^{12,13,25,29–31} and 7 had a critical overall risk of bias.^{21,26–28,33–35} After excluding studies with a critical overall risk of bias, a total of 12 studies (7 retrospective cohort studies, 4 prospective cohort studies, and 1 subanalysis of a RCT that did not evaluate the efficacy of PAC use as a primary purpose) were analyzed in this study.

Figure 2.

Risk of bias summary. (A) Traffic light plot. (B) Weighted summary plot for studies in which in-hospital death was evaluated using odds ratios. (C) Weighted summary plot of studies in which in-hospital death was evaluated using hazard ratios.

Study Characteristics

The characteristics of the analyzed studies are summarized in Table 1. The median or mean age of participants ranged from 58 to 75 years; patients treated with a PAC were younger than those who were not, except in the studies by Ruisi and Cohen. A total of 8 studies evaluated in-hospital deaths as a dichotomous outcome by ORs, and 4 studies evaluated it as time-to-event by HRs. The causes of CS were acute coronary syndrome (ACS) in 3 studies, HF in 3, and nonspecific causes in the remaining 6. The crude in-hospital mortality ranged from 21% to 78%.

Table 1.

Summary of the Included Studies^{12–14,20,22–25,29–32}

Author	Year	n (%)*	Age, sex	Study design	Country	Population	Definition of CS	Cause of CS	In-hospital mortality†
Kanwar et al.20	2023	PAC: 834 (20.9%) No PAC: 221 (79.1%)	PAC: mean 60.4 years, male 73% No PAC: mean 67.3 years, male 57.5%	Retrospective cohort, IPTW, OR	USA	Retrospective registry of 15 institutes (2019–2021)	Sustained episode of ≥1 of the following: SBP <90 mm Hg for ≥30 min, use of vasoactive agents to maintain SBP, cardiac index <2.2 L/min/m2 in the absence of hypovolemia, each determined to be secondary to cardiac dysfunction, or use of a temporally MCS device for clinically suspected CS	HF	21.3% vs. 37.6%
Ranka et al.22	2021	PAC: 25,840 (9.9%) No PAC: 210,316 (89.1%)	PAC: mean 61.6 years, male 68.3% No PAC: mean 67.3 years, male 61.2%	Retrospective cohort, propensity score match, OR	USA	Nationwide Readmissions Database (2016–2017)	Patients with ICD-10-CM codes R57.0, T8111XA	Nonspecific	25.8% vs. 39.5%
Osman et al.23	2021	PAC: 62,565 (9.9%) No PAC: 332,070 (89.1%)	PAC: median 64 years, male 66.9% No PAC: median 68 years, male 61.4%	Retrospective cohort, propensity score match, OR	USA	National Inpatient Sample (2015–2018)	Patients with ICD-10-CM code R570	Nonspecific	24.1% vs. 35.8%
Sionis et al.24	2020	PAC: 82 (37.4%) No PAC: 137 (62.6%)	PAC: mean 65 years, male 78% No PAC: mean 68 years, male 72%	Prospective cohort, propensity score match, HR	8 countries in Europe	Prospective registry of 9 institutes (2010–2012)	Evident acute cardiac cause, and (1) SBP <90 mmHg (in the absence of hypovolemia and after adequate fluid challenge) for 30 min or need for vasopressor therapy to maintain SBP >90 mmHg, (2) symptoms and/or signs of systemic and/or pulmonary congestion, and (3) symptoms and/or signs of hypoperfusion (altered mental status/ confusion, cold periphery, oliguria [urine output <0.5 mL/kg/h for the previous 6 h], and blood lactate level >2 mmol/L)	Nonspecific Excluding patients after cardiac or noncardiac surgery or ongoing hemodynamically significant arrhythmia as the cause of hypotension	42% vs. 34%‡
Vallabhajosyula et al.14	2020	PAC: 29,609 (8.1%) No PAC: 334,392 (91.9%)	PAC: mean 68.3 years, male 62.3% No PAC: mean 70.1 years, male 59.0%	Retrospective cohort, propensity score match, OR	USA	National Inpatient Sample (2000–2014)	Patients with ICD-9CM code 785.51	AMI including STEMI and non-STEMI Excluding patients who underwent cardiac surgery	46.3% vs. 42.0%
Garan et al.25	2020	PAC: 598 (69.7%)§ No PAC: 260 (30.3%)	PAC: mean 58.5 years, male 69.6% No PAC: mean 62.4 years, male 73.4%	Retrospective cohort, adjusted, OR	USA	Cardiogenic Shock Working Group registry (2016–2019)	Sustained episode of SBP <90 mmHg for ≥30 min or use of vasoactive agents and/or a cardiac index value of <2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia; or use of an MCS device for clinically suspected CS	Nonspecific	Not provided
Hernandez et al.13	2019	PAC: 835,734 (91.3%) No PAC: 79,682 (8.7%)	PAC: mean 64.0 years, male 63.8% No PAC: mean 68.1 years, male 59.3%	Retrospective cohort, propensity score match, OR	USA	National Inpatient Sample (2004–2014)	Patients with ICD-9-CM codes 428.x, 402.01, 402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, and 404.93. Of them, patients with ICD-9CM code 785.51 were regarded as having CS	HF	35.1% vs. 39.2%
Doshi et al.12	2018	PAC: 71,452 (8.5%) No PAC: 770,917 (91.5%)	PAC: median 65 years, male 64.3% No PAC: median 69 years, male 59.5%	Retrospective cohort, adjusted, OR	USA	National Inpatient sample (2005–2014)	Patients with ICD-9CM code 785.51	Nonspecific	33.9% vs. 38.8%||
Rossello et al.29	2016	PAC: 83 (60.1%) No PAC: 55 (39.9%)	PAC: mean 66 years, male 65% No PAC: mean 71 years, male 65%	Prospective cohort, adjusted, HR	Spain	Single-center registry (2005–2009)	SBP <90 mmHg (in the absence of hypovolemia and after adequate fluid challenge) for 30 min or the need for vasopressor therapy to maintain adequate perfusion pressure and signs of hypoperfusion (≥2 of the following: altered mental status/ confusion, cold periphery, and oliguria)	Nonspecific	55% vs. 78%‡,¶
Sotomi et al.30	2014	Not provided	PAC: mean 66.1 years, male 63.7% No PAC: mean 74.4 years, male 57.0%	Prospective cohort, propensity score match, HR	Japan	ATTEND Registry enrolled patients (2007–2011)	Patients who met the modified Framingham criteria. Of them, those with inotrope were analyzed (n=120)	HF	Not provided
Ruisi et al.32	2009	Not provided	PAC: median 67.6 years, male 68.6% No PAC: median 66.2 years, male 67.3%	Prospective cohort, adjusted, OR	14 countries in North and South America	Multinational Global Registry of Acute Coronary Events (125 institutes) (2000–2007)	Patients with STEMI, non-STEMI, and unstable angina (n=58,970). Of them, those with Killip class IV (PAC: 5.2%, no PAC: 0.8%) were analyzed	ACS	51.4% vs. 47.6%
Cohen et al.31	2005	Not provided	PAC: median 67 years, male 66.8% No PAC: median 64 years, male 71.5%	Clinical trial data, adjusted, HR	20 countries in North and South America, Europe, and the Pacific region	Patients with ACS from the GUSTO IIb and GUSTO III trials	Patients with symptoms with ST-segment elevation or bundle-branch block, or ACS. Of them, those with shock were analyzed (numbers not available)	ACS Excluding patients who were referred for coronary artery bypass grafting	Not provided

*Crude number of patients. ^†Crude mortality. ^‡30-day mortality. ^§Complete assessment. ^||Survival status was missing for 529 patients. ^¶Survival status was missing for 56 patients. AMI, acute myocardial infarction; CS, cardiogenic shock; HF, heart failure; HR, hazard ratio; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification; IPTW, inverse probability treatment weighting; MCS, mechanical circulatory support; PAC, pulmonary artery catheter; OR, odds ratio; STEMI, ST-segment elevation myocardial infarction; USA, United States of America; SBP, systolic blood pressure.

Outcomes

Patients who received a PAC had better in-hospital mortality than those who did not receive a PAC in studies in which in-hospital deaths were evaluated as a dichotomous outcome by ORs (OR, 0.81 [95% CI 0.72–0.92]) (Figure 3A). There was a similar trend but not a significant difference in studies in which in-hospital deaths were evaluated as a time-to-event by HR (HR, 0.69 [95% CI 0.41–1.17]) (Figure 3B). Regardless of HR or OR, considerable heterogeneity was observed among the studies (I²=96% or 77%). Visual inspection of funnel plots suggested no publication bias (Supplementary Figure 1). There was considerable heterogeneity in PAC use and outcomes according to the etiology of CS (I²=86.7% or 76.1%). Patients receiving a PAC had comparable in-hospital mortality to those not receiving PAC if they had ACS, and those using PAC had better in-hospital mortality than those not using PAC if they had HF, although these subgroups included only 1–2 studies (Figure 4A,B). In studies that evaluated patients regardless of the etiology of CS, the in-hospital mortality was higher in patients who received a PAC than in those who did not (Figure 4A).

Figure 3.

Forest plots for in-hospital deaths. (A) Studies in which in-hospital death was evaluated as a dichotomous outcome by odds ratio. (B) Studies in which in-hospital death was evaluated as time-to-event by hazard ratio. Sionis, Rossello, and Cohen evaluated 30-day mortality. CI, confidence interval.

Figure 4.

Subgroup analysis results according to the etiology of cardiogenic shock. (A) Studies in which in-hospital death was evaluated as a dichotomous outcome by odds ratio. (B) Studies in which in-hospital death was evaluated as time-to-event by hazard ratio. Sionis, Rossello, and Cohen evaluated 30-day mortality. ACS, acute coronary syndrome; HF, heart failure; CI, confidence interval.

In the sensitivity analysis, patients receiving a PAC had better crude in-hospital mortality than those who did not (Supplementary Figure 2).

A summary of the evidence profile based on the assessment of the certainty of the evidence is presented in Table 2. For critical outcomes (i.e., in-hospital or 30-day mortality), the certainty of the evidence was rated as very low for the use of a PAC because of the very serious risk of bias and serious risk of inconsistency.

Table 2.

Evidence Profile

	Certainty assessment					Effect	Certainty	Importance
	Risk of bias	Inconsistency	Indirectness	Imprecision	Publication bias	Relative (95% CI)
In-hospital or 30-day mortality 11 observational studies and 1 subanalysis of an RCT (which did not examine the efficacy of PAC use as a primary purpose)	Very serious*	Serious	Not serious	Not serious	No effect	OR, 0.81 (95% CI, 0.72–0.92) HR, 0.69 (95% CI, 0.41–1.17)	⊕○○○ Very low	Critical

*6 studies had serious overall risk of bias. HR, hazard ratio; OR, odds ratio; RCT, randomized controlled trial.

Discussion

This systematic review and meta-analysis demonstrated that in patients with CS management with a PAC was associated with lower in-hospital mortality than management without a PAC (Central Figure). In the subgroup analysis based on CS etiology, the use of PAC was associated with better outcomes in patients with HF than in those without; however, this relationship was not observed in patients with ACS. No RCTs were included in the meta-analysis, and the certainty of the evidence was judged to be very low.

PAC provides a comprehensive hemodynamic profile, including cardiac output, mixed venous oxygen saturation, right atrial pressure, pulmonary arterial pressure, and pulmonary capillary wedge pressure. However, PAC placement is not a therapeutic intervention itself, but rather a tool to guide clinical decision-making. Thus, the impact of PAC placement on outcomes depends on how clinicians interpret the data and adjust treatment decisions accordingly, as well as on balancing the risks associated with PAC placement. The parameters obtained through PAC are included in the recently proposed Society for Cardiovascular Angiography & Interventions (SCAI) classification for assessing the risk stratification of CS.³⁶ Moreover, many recent algorithms for mechanical circulatory support selection have incorporated PAC parameters, and their use has been associated with improved outcomes.^26,37,38 Considering this, it is reasonable to assume that the use of a PAC for the management of patients with CS contributes to improving their prognosis. In our analysis, patients with CS managed with a PAC demonstrated lower in-hospital mortality than those without PAC when analyzed as binary outcomes, and showed a similar trend when analyzed as time-to-event outcomes. Although the decision to use a PAC in clinical practice often considers various confounding factors, the studies included in our primary analysis accounted for these confounders, and consistent results were observed for crude in-hospital mortality estimates, demonstrating robustness.

In the ESCAPE trial,⁹ 433 patients with HF were randomized to PAC or non-PAC management groups. The efficacy of PAC-guided therapy was neutral (days alive and out of the hospital during the first 6 months: 133 days vs. 135 days; HR, 1.00 [95% CI, 0.82–1.21]; P=0.99), with higher adverse events during hospitalization in the PAC group than in the non-PAC group (21.9% vs. 11.5%; P=0.04). However, there were few patients with CS included in the ESCAPE trial, limiting the generalizability of its findings to the CS population. Despite insufficient data on the role of PAC in CS, its use has declined not only for HF management but also for CS.^10–14 The association of PAC use with better outcomes in our study highlights that the ESCAPE trial findings may not apply to more critically ill patients with CS, in whom the benefits of PAC may outweigh the risks. Garan et al. reported that, the more severe CS, the more detailed PAC-guided hemodynamic assessments showed better outcomes,²⁵ which suggests that PAC-derived parameters may be more valuable in patients with severe CS than in those with less severe CS.

Interestingly, consistent with the findings of Lee et al., our study revealed heterogeneity in the association between PAC use and outcomes based on the etiology of CS. PAC use was associated with better outcomes in HF but not in ACS.³⁹ Lee et al. proposed an explanation for this heterogeneity. Among the parameters obtained via right heart catheterization (RHC), those modifiable by treatment, such as right atrial pressure, are key prognostic factors in HF, whereas in ACS, less modifiable parameters, such as cardiac output, are more predictive of prognosis. However, a subsequent study by Berg et al., using data from the Critical Care Cardiology Trials Network, demonstrated that the associations between RHC parameters and outcomes were consistent in HF and ACS, suggesting that the explanation may not fully account for the observed heterogeneity.⁴⁰ In ACS, parameters derived from RHC might affect clinicians’ decision-making, but this influence on outcomes may be outweighed by factors such as reperfusion, infarct size, comorbidities, and the development of mechanical complications. Nonetheless, the number of studies on HF or ACS subgroups in our analysis was limited; thus, further detailed investigations are warranted.

Recent meta-analyses evaluating the association between PAC and outcomes have mixed dichotomous in-hospital mortality estimated as ORs with time-to-in-hospital mortality estimated as HRs into a single overall estimate, which is not recommended.^39,41–43 Our meta-analysis addressed this issue by constructing distinct models. Moreover, we adhered to a prespecified protocol, applied high methodological standards, and incorporated additional recent observational studies, providing more granular results. Nonetheless, as in previous meta-analyses, no RCTs were included, and the certainty of evidence was judged to be very low. Although current guidelines do not distinguish between CS phenotypes in their PAC recommendations,^44–46 our findings provide valuable insights into PAC use in CS.

Study Limitations

There are some limitations to note. First, as mentioned earlier, no RCT examining the efficacy of PAC use as a primary purpose was included. Although estimates adjusted for confounding factors were used, individual-level data were not included, resulting in a lack of standardization in the adjustment of confounding factors across studies. Further prospective RCTs are necessary to provide robust evidence to support our findings. Currently, the PACCS, a multicenter randomized trial examining whether early invasive hemodynamic management with PAC reduces in-hospital mortality of patients with CS due to HF, is ongoing (NCT05485376). Second, many studies included in this analysis were based on data from the Nationwide Inpatient Sample.^12–14,23 Although the sampling periods varied between studies, there was an overlap in the timeframes of many studies, raising the possibility of duplicate patient data. Third, the diagnosis of CS varied across studies and encompassed a mixture of severity levels. It was challenging to determine where the study populations of each study fell within the SCAI classification of CS severity, making it somewhat difficult to interpret the findings in a modern clinical context.³⁶ Finally, this analysis considered only the use of a PAC, without accounting for detailed data on pharmacological and therapeutic management. Consequently, deeper insight into the effects of PAC use is lacking. Variations in how PAC data are interpreted by clinicians, as well as differences in treatment strategies, may have led to differing patient prognoses.

Conclusions

This analysis supports the potential role of PAC in improving in-hospital mortality among patients with CS, particularly in those with HF-related CS. However, the findings were limited by low evidence certainty and substantial heterogeneity. Nevertheless, the results suggested that PAC-guided management may offer clinical benefits to select patient populations, but its routine use should be informed by further high-quality evidence, including ongoing RCTs.

Acknowledgments

This work was supported by the Japan Resuscitation Council, Japan Circulation Society, and JSPS KAKENHI Grant Number JP23K08454. The authors thank Mr. Shunya Suzuki and Ms. Tomoko Nagaoka, librarians at Dokkyo Medical University, Tochigi, Japan for their assistance in searching for articles.

Disclosures

T.M. is a member of Circulation Reports’ Editorial Team. Toru Kondo received lecture fees from Abbott Japan LLC, AstraZeneca K.K., Boehringer Ingelheim, Ono Pharmaceutical Co., Ltd., Kowa Company, Ltd., and Kyowa Kirin Co., Ltd., and Novartis Pharma K.K.

IRB Information

Not applicable.

Data Availability

All data used in this analysis are available from PubMed, Web of Science Core Collection (Science Citation Index - Expanded Since 1973), and Cochrane Library (CENTRAL) databases.

Supplementary Files

Please find supplementary file(s);

https://doi.org/10.1253/circrep.CR-25-0088

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