IABP with VA ECMO for Cardiogenic Shock

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Disqualifiers: Metastatic cancer, Atrial septostomy, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

104 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for cardiogenic shock (CS). The main aims of the study are: 1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO 2. To determine the effects on myocardial function of adding LV unloading to ECMO 3. To test the effects on myocardial recovery of adding LV unloading to VA ECMO Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups.

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 Intra-aortic Balloon Pump (IABP) with VA ECMO for Cardiogenic Shock?

Research suggests that using an intra-aortic balloon pump (IABP) along with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) may reduce in-hospital deaths in patients with cardiogenic shock compared to using VA-ECMO alone. A study found that patients receiving both treatments had a lower death rate (58.4%) compared to those with only VA-ECMO (63.1%). ^{1 2 3 4 5}

Is the combination of IABP and VA-ECMO generally safe for humans?

The safety of using an intra-aortic balloon pump (IABP) with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for cardiogenic shock is not fully clear, as studies show mixed results. While IABP may help improve heart function, the risks and benefits in real-life settings have not been thoroughly evaluated. ^{1 2 4 6 7}

How does the treatment of IABP with VA ECMO for cardiogenic shock differ from other treatments?

This treatment combines two technologies: the intra-aortic balloon pump (IABP), which helps the heart pump more effectively, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO), which provides heart and lung support. This combination is unique because it aims to improve blood flow and reduce the heart's workload simultaneously, which is not typically achieved with standard treatments. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for patients with non-postoperative cardiogenic shock, a severe heart condition where the heart can't pump enough blood. Participants must be receiving veno-arterial extracorporeal membrane oxygenation (VA ECMO) treatment.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with acute heart failure.

My heart condition is worsening despite medical treatment.

Exclusion Criteria

My cancer has spread to other parts of my body.

Planned LV unloading on ECMO

Anticipated death <72 hours

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive VA ECMO with or without LV unloading, with measurements taken via lab work, echocardiography, and pulmonary artery catheter

Up to 6 months

Daily monitoring during ECMO, regular follow-ups until ICU discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of myocardial recovery and mortality

Up to 6 months

Regular follow-ups until hospital discharge

Treatment Details

Interventions

• Intra-aortic Balloon Pump

Trial Overview The study compares two approaches: one group receives VA ECMO alone, while the other gets VA ECMO plus left ventricular unloading using an intra-aortic balloon pump (IABP). The effects on heart and lung function will be measured through lab tests, echocardiography, and pulmonary artery catheter data.

Participant Groups

Group I: With LV Unloading Experimental Treatment 1 Intervention

Patients on VA ECMO who randomize to receive LV unloading

Group II: Without LV Unloading Active Control 1 Intervention

Patients on VA ECMO who randomize to receive no LV unloading

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Findings from Research

In a review of 22 studies involving 4653 patients, the use of an intra-aortic balloon pump (IABP) alongside veno-arterial extracorporeal membrane oxygenation (VA-ECMO) did not significantly affect short-term mortality in the overall cohort of cardiogenic shock patients.

However, in patients with acute myocardial infarction (AMI), the combination of IABP and VA-ECMO was associated with a significant reduction in mortality, showing an 18.5% lower death rate compared to those treated with VA-ECMO alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Intra-Aortic Balloon Pump Use in Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane Oxygenation. Vallabhajosyula, S., O'Horo, JC., Antharam, P., et al.[2022]

In a systematic review of 2251 patients, the combination of venoarterial extracorporeal membrane oxygenation (VA-ECMO) with intra-aortic balloon pump (IABP) did not significantly reduce in-hospital mortality compared to isolated VA-ECMO in patients experiencing postcardiotomy cardiogenic shock.

The study also found that using IABP alongside VA-ECMO did not improve the rate of weaning off VA-ECMO, suggesting that this combination may not provide additional benefits in managing these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venoarterial extracorporeal membrane oxygenation with intra-aortic balloon pump for postcardiotomy cardiogenic shock: A systematic review and meta-analysis. Huang, D., Xu, A., Guan, Q., et al.[2023]

In a case study of a 68-year-old man with cardiogenic shock, the use of an intra-aortic balloon pump (IABP) alongside veno-arterial extracorporeal membrane oxygenation (VA-ECMO) effectively improved left ventricular (LV) function by promoting aortic valve opening, demonstrating a potential mechanism for LV decompression.

The combination of IABP and VA-ECMO may help prevent complications such as thrombus formation in the heart, although the overall benefits of this approach in patients on VA-ECMO require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left ventricular decompression on Veno-arterial extracorporeal membrane oxygenation with intra-aortic balloon Counterpulsation. Griffin, JM., Restaino, S., Takeda, K., et al.[2020]

In a study of 253 adult patients undergoing extracorporeal life support (ECLS) for cardiogenic shock, the use of intra-aortic balloon counterpulsation (IABP) significantly improved the rate of successful ECLS weaning (61.7% vs 42.0% in the control group).

Despite the increased weaning success with IABP, there was no significant difference in in-hospital mortality rates between the IABP group and the control group, suggesting that while IABP may aid in recovery, it does not necessarily improve overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal life support for cardiogenic shock: influence of concomitant intra-aortic balloon counterpulsation. Ro, SK., Kim, JB., Jung, SH., et al.[2014]

In a review of 29 studies involving 4576 patients with refractory cardiogenic shock, the combination of venoarterial extracorporeal membrane oxygenation (VA-ECMO) and intra-aortic balloon pump (IABP) was associated with a significant reduction in in-hospital deaths compared to VA-ECMO alone, with a risk ratio of 0.90.

The use of IABP alongside VA-ECMO also showed benefits in specific patient groups, including those undergoing extracorporeal cardiopulmonary resuscitation and those with ischemic heart disease, without increasing the risk of neurological, gastrointestinal, or limb-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an intra-aortic balloon pump with venoarterial extracorporeal membrane oxygenation on mortality of patients with cardiogenic shock: a systematic review and meta-analysis†. Li, Y., Yan, S., Gao, S., et al.[2020]

In a study of 88 patients treated with intra-aortic balloon pump (IABP) counterpulsation for cardiogenic shock in the emergency department, the procedure was found to be safe, with only 10% experiencing complications.

Younger age and lower serum lactate levels before IABP insertion were identified as independent predictors of 30-day survival, suggesting that these factors could help assess patient outcomes in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-aortic balloon counterpulsation in the emergency department: a 7-year review and analysis of predictors of survival. Bur, A., Bayegan, K., Holzer, M., et al.[2019]

The use of intra-aortic balloon pump (IABP) therapy for patients with cardiogenic shock has decreased by 24% since the European Society of Cardiology downgraded its recommendation in 2012, indicating a shift in clinical practice.

Before the guideline change, IABP was associated with improved clinical outcomes, including reduced mortality rates, but post-guideline, no significant benefits were observed, suggesting that IABP is now reserved for only the most severely affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Change in ESC Guidelines on Clinical Characteristics and Outcomes of Cardiogenic Shock Patients Receiving IABP Therapy. Nevzorov, R., Daum, A., Jafari, J., et al.[2020]

In patients with acute myocardial infarction and cardiogenic shock, the combination of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and intra-aortic balloon pump (IABP) significantly reduced in-hospital mortality compared to VA-ECMO alone and IABP alone, with odds ratios of 0.52 and 0.20, respectively.

The combination treatment also improved the likelihood of successfully weaning patients from VA-ECMO, with an odds ratio of 1.91, indicating that using both interventions together can enhance patient outcomes without increasing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intra-aortic balloon pump with veno-arterial extracorporeal membrane oxygenation in acute myocardial infarction with cardiogenic shock: A meta-analysis. Liu, Y., Zeng, M., Zhou, Y., et al.[2023]

References

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

Concomitant Intra-Aortic Balloon Pump Use in Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane Oxygenation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Venoarterial extracorporeal membrane oxygenation with intra-aortic balloon pump for postcardiotomy cardiogenic shock: A systematic review and meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Left ventricular decompression on Veno-arterial extracorporeal membrane oxygenation with intra-aortic balloon Counterpulsation. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Extracorporeal life support for cardiogenic shock: influence of concomitant intra-aortic balloon counterpulsation. [2014]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of an intra-aortic balloon pump with venoarterial extracorporeal membrane oxygenation on mortality of patients with cardiogenic shock: a systematic review and meta-analysis†. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

Intra-aortic balloon counterpulsation in the emergency department: a 7-year review and analysis of predictors of survival. [2019]

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

Impact of the Change in ESC Guidelines on Clinical Characteristics and Outcomes of Cardiogenic Shock Patients Receiving IABP Therapy. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effect of intra-aortic balloon pump with veno-arterial extracorporeal membrane oxygenation in acute myocardial infarction with cardiogenic shock: A meta-analysis. [2023]