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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for individuals with cardiogenic shock, a severe condition where the heart suddenly can't pump enough blood. Researchers are comparing two groups: one group will use a device called VA ECMO, which supports the heart and lungs, while the other group will use VA ECMO with an added device, an intra-aortic balloon pump (IABP, also known as intra-aortic counterpulsation), to determine if it aids heart recovery. This study targets those with cardiogenic shock who are not improving with current treatments. Participants will undergo monitoring through heart scans and blood work to evaluate which approach is most effective. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 this protocol is safe for patients with cardiogenic shock?

Research has shown that using an intra-aortic balloon pump (IABP) with veno-arterial extracorporeal membrane oxygenation (VA ECMO) is safe for patients with severe heart problems, such as cardiogenic shock. One study found that adding IABP to VA ECMO reduced the death rate in patients who had a heart attack complicated by cardiogenic shock. Specifically, the death rate decreased from 62.4% to 50.8% for those who received both treatments. This suggests that combining these treatments is generally well-tolerated and may improve survival chances in serious heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for cardiogenic shock focus on supporting the heart's pumping capability and maintaining blood flow. However, researchers are excited about using the Intra-aortic Balloon Pump (IABP) combined with VA ECMO because it offers a novel approach by potentially reducing the workload on the heart itself, a process known as "LV unloading." This technique could improve patient outcomes by minimizing heart muscle damage during critical periods. Unlike standard care that primarily focuses on stabilizing the patient, this innovative strategy might enhance recovery and survival rates by addressing the heart's underlying strain more directly.

What evidence suggests that this trial's treatments could be effective for cardiogenic shock?

This trial will compare the effectiveness of VA ECMO with and without LV unloading using IABP for patients with cardiogenic shock. Research has shown that combining VA ECMO and IABP can be more effective for patients with severe heart problems than using VA ECMO alone. Studies have found that this combination improves survival rates in the hospital. Specifically, adding IABP to VA ECMO has been linked to lower death rates in these patients. Large studies support these findings, showing much better results for patients who receive both treatments compared to those who only receive VA ECMO. The IABP reduces the strain on the heart, allowing it to recover more effectively. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9300857/

Comparison of the Efficacy of ECMO With or Without IABP in ... ECMO combined with IABP can improve in-hospital survival more effectively than ECMO alone in patients with CS.

2. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05129-1

Intra-aortic balloon pump after VA-ECMO reduces mortality in ... This study investigated the effect of applying IABP for left ventricle (LV) unloading after VA-ECMO on reducing mortality in patients with CS.

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.023713

Outcomes of Venoarterial Extracorporeal Membrane ... This large‐scale, nationwide study demonstrated that the combination of VA‐ECMO plus IABP support was associated with significantly lower mortality.

4. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1431875/full

Efficacy of venoarterial extracorporeal membrane ... In this study, we attempted to evaluate the association of the IABP approach on survival and vascular complication rates in adults with cardiogenic shock ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1109966624002094

ECMO versus IABP for patients with STEMI complicated by ... Among patients undergoing primary PCI for STEMI complicated by cardiogenic shock, ECMO was associated with better in-hospital survival than IABP.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9075437/

Outcomes of Venoarterial Extracorporeal Membrane ... Clinical outcomes of acute myocardial infarction complicated by cardiogenic shock remain poor with high in‐hospital mortality.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.006930

Concomitant Intra-Aortic Balloon Pump Use in Cardiogenic ... However, concomitant IABP with VA-ECMO was associated with lower mortality in patients with AMI (50.8% versus 62.4%; risk ratio, 0.56; 95% CI, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12042668/

Concurrent intra-aortic balloon pump and veno-arterial ... In conclusion, concurrent IABP and ECMO are independently associated with reduced short-term mortality in ACS-related CS patients, particularly in studies with ...

9. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(21)00282-3/fulltext

Prognostic significance of intra-aortic balloon pumping ... IABP use was associated with a lower risk of 30-day death in AMI cases with VA-ECMO.