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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using a Pulmonary Artery Catheter (PAC), a device that helps doctors monitor the heart more closely, can reduce the risk of in-hospital death for people with cardiogenic shock. Cardiogenic shock occurs when the heart suddenly can't pump enough blood, often due to severe heart failure. The trial compares early PAC use with usual care, which might involve using the device later or not at all. Individuals who have recently experienced heart failure and face severe heart issues, such as difficulty breathing or low blood pressure, might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance future heart failure treatments.

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 prior data suggests that the Pulmonary Artery Catheter is safe for patients with cardiogenic shock?

Research has shown that using a pulmonary artery catheter (PAC) in patients with heart problems might be safe. Studies have found that patients with heart issues who received a PAC had lower death rates, meaning fewer people died compared to those who did not receive a PAC.

Another study found similar results, showing a connection between PAC use and better survival rates within 30 days. However, not all studies agree. One large study found higher death rates with PAC use in patients with heart failure. These mixed results suggest that while PACs can be helpful, their safety might depend on the specific patient or situation.

Overall, PACs are generally considered safe, but it's important to consult doctors to determine the best option for each person. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Pulmonary Artery Catheter (PAC) for treating cardiogenic shock because it offers a precise method to monitor heart function in real-time. Unlike standard treatments, which often rely on medications like vasopressors and diuretics to manage symptoms, the PAC provides direct measurements of cardiac output and pressures inside the heart. This allows for more tailored treatment, potentially improving outcomes by enabling quicker and more accurate adjustments to therapy. Additionally, the PAC can be placed early, within 6 hours of randomization, offering a timely intervention that might better stabilize patients in critical condition.

What evidence suggests that the Pulmonary Artery Catheter is effective for cardiogenic shock?

Research has shown that using a pulmonary artery catheter (PAC) in patients with heart-related shock can be beneficial. Some studies suggest that PACs might reduce death rates by helping doctors better understand and manage heart function. In this trial, participants in the "Early Pulmonary Artery Catheter" arm will receive a PAC within 6 hours of randomization. PACs guide treatment decisions, especially in complex cases like heart failure. However, not all research agrees. Some studies found no clear effect on survival rates with PAC use. This mixed evidence underscores the need for more research to fully understand its benefits. Participants in the "No or Delayed Pulmonary Artery Catheter" arm will not receive a PAC during hospitalization or may have it placed 48 hours after randomization only in emergencies. ^{1 3 5 6 7}

Who Is on the Research Team?

Navin Kapur, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9069264/

Pulmonary Artery Catheter Monitoring in Patients with ... The use of the Swan-Ganz catheter could play a pivotal role in various phases of cardiogenic shock management, encompassing diagnosis and haemodynamic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34405356/

a systematic review and meta-analysis Very low-quality observational evidence suggests PAC use in patients with cardiogenic shock is associated with lower mortality.

3. jacc.org jacc.org/doi/10.1016/j.jchf.2023.05.022

Accepting the Pulmonary Artery Catheter for Cardiogenic ... PACs were used there for triage and stabilization of cardiogenic shock (CS) and reversal of pulmonary hypertension during transplant evaluation.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527324011318

The use of pulmonary artery catheter and clinical outcomes ... Higher hospital volume of CS was associated with both the use of PAC and lower patient mortality, which may suggest hospital-level confounding.

5. jtd.amegroups.org jtd.amegroups.org/article/view/72877/html

Effectiveness of pulmonary artery catheter monitoring for ... Our meta-analysis demonstrated no significant association between PAC monitoring and in-hospital mortality among patients managed for cardiogenic shock.

6. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)02181-0/fulltext

ASSOCIATION OF PULMONARY ARTERY CATHETER ... In this retrospective propensity-matched study, PAC placement was associated with lower 30-day mortality rates among cardiogenic shock patients.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213177923001932

Pulmonary Artery Catheter Use and Mortality in the ... PAC use was associated with higher survival in cardiac patients with shock presenting to CICUs. Randomized trials are needed to guide the appropriate use of ...