Intraoperative Echocardiography for Heart Disease

Overseen By Emily MacKay, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Valve disease, Aortic intervention, Previous cardiac surgeries, Severe pulmonary hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to use a special type of ultrasound, called transesophageal echocardiography (TEE), during coronary artery bypass surgeries. It compares two groups: one using TEE continuously during surgery and another using it only if the surgeon needs extra heart images. Suitable participants are those scheduled for coronary artery bypass surgery at a UPenn hospital and who have undergone certain heart tests within the past year. As an unphased trial, this study allows participants to contribute to innovative research that could improve surgical outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

What prior data suggests that intraoperative echocardiography is safe for use during CABG surgeries?

Research has shown that using intraoperative transesophageal echocardiography (TEE) during heart surgeries is generally safe. In a study of 7,200 patients who underwent heart surgery, TEE safely monitored the heart during operations. Most patients experienced few side effects. Additionally, TEE has been linked to better outcomes in high-risk heart surgeries, indicating it can guide surgical decisions effectively.

In summary, evidence suggests that TEE is well-tolerated and can improve surgery outcomes, making it a promising option for those undergoing coronary artery bypass graft surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on intraoperative echocardiography for heart disease because it explores innovative ways to enhance surgical outcomes. Unlike standard heart monitoring methods during surgery, this technique uses a TEE (transesophageal echocardiography) probe to provide real-time images of the heart. This could help surgeons make more informed decisions during coronary artery bypass grafting (CABG) procedures. In one approach, the TEE probe stays throughout the surgery, offering continuous insights, while the other approach only uses it when specific heart images are needed. These strategies might improve surgical precision and patient safety, offering potential advancements over current practices.

What evidence suggests that intraoperative echocardiography is effective for heart disease?

Research shows that using a special heart ultrasound called intraoperative transesophageal echocardiography (TEE) during heart surgeries can lead to better outcomes. In this trial, participants will be randomized to receive either Default TEE, where the TEE probe remains in place throughout the surgery, or As-needed TEE, where the probe is used only when required by the surgeon. Studies have found that TEE guides decisions during surgery and links to improved results. For patients undergoing high-risk heart surgeries, TEE has been associated with lower death rates. Specifically, using TEE during surgeries like heart valve and aortic procedures has improved results. Overall, TEE provides important real-time images of the heart, helping surgeons make more informed choices during operations. ^{1 3 4 5 6}

Who Is on the Research Team?

Emily MacKay, DO, MS

Principal Investigator

University of Pennsylvania, Penn Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for low-risk isolated CABG surgery, have a good heart pump function (ejection fraction ≥50%), and recent heart tests. It's not for those with moderate or severe valve disease, planned aortic interventions, critical coronary disease, end-stage kidney disease on dialysis, certain esophageal conditions, or severe pulmonary hypertension.

Inclusion Criteria

Ejection fraction ≥50%

English language fluency

I am scheduled for a heart bypass surgery at PPMC.

Exclusion Criteria

Severe pulmonary hypertension defined as: Pulmonary arterial pressure ≥60 mmHg, Pulmonary vascular resistance (PVR) ≥3 Woods Units

I have moderate or severe heart valve disease.

I have had severe heart or blood pressure issues after a specific medical procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo coronary artery bypass graft (CABG) surgery with either default or as-needed intraoperative transesophageal echocardiography (TEE)

During surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of gastroesophageal and end-organ dysfunction, and incidence of cardiovascular re-intervention or mortality

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Echocardiography

Trial Overview The study aims to determine the usefulness of using an intraoperative TEE probe during CABG surgeries. The TEE probe is used to take detailed images of the heart from inside the esophagus during surgery to guide decisions and improve outcomes.

How Is the Trial Designed?

Group I: As-needed TEE Experimental Treatment 1 Intervention

The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Group II: Default TEE Active Control 1 Intervention

The TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840706

Surgical Volume and Outcomes of Intraoperative ... Among these patients, 61.8% received TEE and 39.0% did not receive TEE. Intraoperative TEE use (vs without TEE) was associated with a ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001342

Considerations of Intraoperative Transesophageal ... Recent data have shown the impact of improved outcomes in patients undergoing cardiac surgery and the use of intraoperative transesophageal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12576493/

Surgical Volume and Outcomes of Intraoperative ... Transesophageal echocardiography (TEE) is used during cardiac surgery to guide intraoperative decisions and is associated with improved outcomes ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788851

Intraoperative TEE and Clinical Outcomes After Open ... These findings suggest that intraoperative TEE may improve clinical outcomes after open cardiac valve (repair or replacement) and/or aortic surgery.

5. professional.heart.org professional.heart.org/en/science-news/considerations-of-intraoperative-transesophageal

Considerations of Intraoperative Transesophageal ... Intraoperative TEE use has been shown to improve outcomes and reduce mortality in high-risk cardiac surgery patients, particularly those ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11323333/

a case series of 7200 cardiac surgical patients These data suggest that intraoperative TEE is a relatively safe diagnostic monitor for the management of cardiac surgical patients.