Pulmonary Artery Catheter for Cardiogenic Shock

(PACCS Trial)

Overseen By Karol Walec

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Myocardial infarction, Sepsis, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of hospitalization

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Pulmonary Artery Catheter for Cardiogenic Shock?

The research indicates that the effectiveness of using a pulmonary artery catheter (a device used to measure heart and lung pressures) in patients with cardiogenic shock is still debated, with studies exploring its impact on survival rates but not providing clear conclusions. ^{1 2 3 4 5}

Is the pulmonary artery catheter generally safe for use in humans?

The pulmonary artery catheter, also known as the Swan-Ganz catheter, can lead to complications such as hematoma (bruising), pneumothorax (collapsed lung), and in rare cases, serious vascular damage like pulmonary artery rupture. Careful insertion techniques and monitoring can help reduce these risks. ^{2 3 6 7 8}

How is the pulmonary artery catheter treatment different for cardiogenic shock?

The pulmonary artery catheter (PAC) is unique for treating cardiogenic shock because it allows doctors to directly measure heart and lung pressures, providing detailed information to guide treatment decisions. Unlike other treatments, it involves inserting a catheter (a thin tube) into the pulmonary artery to monitor heart function in real-time, which can be crucial for managing this severe condition. ^{2 3 4 6 9}

Research Team

Navin Kapur, MD

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for adults aged 18-90 with heart failure leading to cardiogenic shock, diagnosed within the last 24 hours. Participants must consent and meet specific criteria related to heart function and lactate levels. Exclusions include severe other conditions, recent COVID-19 hospitalization, certain prior treatments like ventricular assist devices or transplants, active infections, bleeding risks, and pregnancy.

Inclusion Criteria

You have a condition called cardiogenic shock, which is identified by specific test results showing high lactate levels and other specific measurements.

No identifiable data will be retained for subjects that are determined to be ineligible

A HIPAA waiver for screening is requested to identify potential subjects

Exclusion Criteria

I am on the waiting list for a heart transplant.

You have a "do not resuscitate" or "do not intubate" status.

Your blood tests show a high INR level, a low platelet count, or low hemoglobin levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Early invasive hemodynamic assessment with a PAC within 6 hours of randomization for the experimental group, or no/delayed PAC for the control group

Duration of hospitalization

Follow-up

Participants are monitored for in-hospital mortality and other outcomes

Until discharge

Treatment Details

Interventions

• Pulmonary Artery Catheter

Trial Overview The PACCS trial is testing if using a Pulmonary Artery Catheter (PAC) right away in patients with acute heart failure-induced cardiogenic shock can reduce the risk of dying in the hospital compared to standard care without immediate PAC use.

Participant Groups

Group I: Early Pulmonary Artery Catheter Experimental Treatment 1 Intervention

If you are in the experimental group a PAC will be placed within 6 hours of randomization and within 24 hours of presentation with ADHF-CS.

Group II: No or delayed Pulmonary Artery Catheter Active Control 1 Intervention

If you are in the control group, a PAC will not be placed during hospitalization or may be placed 48 hours after randomization into the study. Placement of a PAC within 48 hours is only permitted for emergencies.

Pulmonary Artery Catheter is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pulmonary Artery Catheter for:

• Cardiogenic shock
• Pulmonary hypertension
• Severe heart failure
• Complex heart attacks
• Unstable conditions before or after surgery
• Severe preeclampsia

Approved in European Union as Pulmonary Artery Catheter for:

• Cardiogenic shock
• Pulmonary hypertension
• Severe heart failure
• Complex heart attacks
• Unstable conditions before or after surgery
• Severe preeclampsia

Approved in Canada as Pulmonary Artery Catheter for:

• Cardiogenic shock
• Pulmonary hypertension
• Severe heart failure
• Complex heart attacks
• Unstable conditions before or after surgery
• Severe preeclampsia

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Findings from Research

In a review of six observational studies involving over 1.1 million patients with cardiogenic shock, the use of pulmonary artery catheter (PAC) monitoring was linked to a significant reduction in short-term mortality compared to those who did not use PAC, with mortality rates of 36% versus 47%.

Patients monitored with PAC also had a higher likelihood of receiving Mechanical Circulatory Support (MCS) devices, with 59% of the PAC group using MCS compared to 48% in the non-PAC group, suggesting that PAC may enhance treatment options in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. Bertaina, M., Galluzzo, A., Rossello, X., et al.[2022]

A systematic review of 19 observational studies involving over 2.7 million patients suggests that pulmonary artery catheterization (PAC) may improve survival rates in adults with cardiogenic shock, although the evidence quality is very low.

While PAC appears to lower mortality risk, it is associated with a longer hospital stay by an average of 3.5 days, indicating a need for careful consideration of its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis. Chow, JY., Vadakken, ME., Whitlock, RP., et al.[2022]

In a study of 129 patients with cardiogenic shock, the use of pulmonary artery catheterization (PAC) was linked to significantly lower short-term mortality (hazard ratio of 0.55) and long-term mortality (hazard ratio of 0.63) after adjusting for age and gender.

The survival benefit from PAC was particularly notable in patients without acute coronary syndrome, where mortality was reduced from 82% to 49%, indicating that PAC may be more effective in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Pulmonary Artery Catheter Use on Short- and Long-Term Mortality in Patients with Cardiogenic Shock. Rossello, X., Vila, M., Rivas-Lasarte, M., et al.[2018]

A systematic review and meta-analysis of six studies involving 930,530 patients with cardiogenic shock found that the use of pulmonary artery catheters (PAC) is associated with a significantly lower risk of mortality compared to those who did not receive PAC guidance.

The analysis indicated that PAC-treated patients had a mortality rate ranging from 4.6% to 41.5%, while the control group had a higher mortality rate of 18.8% to 51.0%, suggesting that PAC may improve outcomes in this critical condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of pulmonary artery catheter in patients with cardiogenic shock: A systematic review and meta-analysis. Yoo, TK., Miyashita, S., Davoudi, F., et al.[2023]

In a study of 1043 patients with cardiogenic shock, those who received pulmonary artery catheters (PACs) had a lower in-hospital mortality rate (29.3%) compared to those who did not receive PACs (36.2%), particularly benefiting patients in more severe stages of shock (SCAI stages D and E).

Patients with PACs were more likely to receive advanced heart failure therapies, such as temporary mechanical circulatory support and durable ventricular assist devices, indicating that PACs may enhance treatment options and outcomes in severe cases of cardiogenic shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Artery Catheter Usage and Impact on Mortality in Patients with Cardiogenic Shock: Results from a Canadian, Single Centre Registry. Réa, ABBAC., Mihajlovic, V., Vishram-Nielsen, JKK., et al.[2023]

The Swan-Ganz catheter is crucial for monitoring heart diseases and hemodynamics during cardiac surgery and in the ICU, but its insertion requires a very careful technique to prevent serious complications.

Standardizing the insertion technique may help reduce the risk of complications such as hematoma, pneumothorax, and pulmonary artery rupture, and if complications occur, it may be necessary to reconsider proceeding with surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Insertion procedure of the Swan-Ganz catheter]. Narumiya, C., Isobe, F.[2010]

Iatrogenic pulmonary artery rupture (PAR) is a rare but serious complication of Swan-Ganz catheterization, occurring in less than 0.2% of cases, and requires immediate medical intervention.

In a study of 2 patients treated endovascularly for PAR, the use of different vascular devices (a coil and an Amplatzer Vascular Plug) successfully occluded the feeding artery, demonstrating that percutaneous embolization is a quick and effective alternative to surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary artery rupture as a complication of Swan-Ganz catheter application. Diagnosis and endovascular treatment: a single centre's experience. Rudziński, PN., Henzel, J., Dzielińska, Z., et al.[2022]

Pulmonary artery catheterization is commonly used for monitoring critically ill or high-risk surgical patients, but it can lead to complications such as catheter dysfunction and malposition, which may require intervention.

In this case, a Swan-Ganz catheter showed signs of mechanical fracture, highlighting the importance of thorough clinical and radiographic evaluation when a pulmonary artery catheter malfunctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The two-headed swan. Martin, GS., Horlander, KT.[2018]

Between 2000 and 2014, the use of pulmonary artery catheters (PAC) in patients with acute myocardial infarction-cardiogenic shock (AMI-CS) decreased by 75%, indicating a shift in clinical practice.

Patients who received PACs had higher in-hospital mortality rates and longer hospital stays compared to those who did not, although when adjusted for risk factors, in-hospital mortality rates were similar between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheter use in acute myocardial infarction-cardiogenic shock. Vallabhajosyula, S., Shankar, A., Patlolla, SH., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Pulmonary Artery Catheter Use on Short- and Long-Term Mortality in Patients with Cardiogenic Shock. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical impact of pulmonary artery catheter in patients with cardiogenic shock: A systematic review and meta-analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Pulmonary Artery Catheter Usage and Impact on Mortality in Patients with Cardiogenic Shock: Results from a Canadian, Single Centre Registry. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

[Insertion procedure of the Swan-Ganz catheter]. [2010]

7. Poland pubmed.ncbi.nlm.nih.gov

Pulmonary artery rupture as a complication of Swan-Ganz catheter application. Diagnosis and endovascular treatment: a single centre's experience. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The two-headed swan. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheter use in acute myocardial infarction-cardiogenic shock. [2021]