Shunt vs Stent for Congenital Heart Disease

(COMPASS Trial)

Recruiting at 28 trial locations

Overseen By Rachna Kumar

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Carelon Research

Disqualifiers: Pulmonary atresia, Non-confluent arteries, Birth weight <2.0 kg, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for newborns with congenital heart disease who need assistance with blood flow. The treatments compared are a ductal artery stent (Ductal Arterial Stent or DAS), a small tube placed in the heart, and a systemic-to-pulmonary artery shunt, a surgical connection. Researchers aim to determine which treatment better maintains proper blood flow during the baby's first year. Babies 30 days old or younger with this specific heart condition, requiring only stable blood flow to the lungs, may qualify for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of the best treatment options for newborns with this condition.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the trial coordinators or your doctor for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both ductal artery stents and systemic-to-pulmonary artery shunts are generally well-tolerated treatments for congenital heart disease, particularly in newborns needing improved blood flow to the lungs.

Studies have found that ductal artery stents safely and effectively maintain proper blood flow in the heart. Being less invasive than surgery, they require fewer incisions, often resulting in fewer complications and quicker recovery times.

Conversely, a systemic-to-pulmonary artery shunt is a common surgical procedure used to increase blood flow to the lungs and has been safely used for many years. Some studies report that about 1.5% to 1.8% of patients may experience serious complications, often due to excessive blood flow to the lungs, which can be managed with careful monitoring.

Both treatments have been successfully used in young patients with similar conditions, indicating they are reasonably safe options for managing this type of heart issue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for congenital heart disease because they offer alternative methods to improve blood flow in infants with heart defects. The Ductal Arterial Stent is unique as it uses a transcatheter approach to place a drug-eluting coronary stent, which may reduce the need for open-heart surgery and provide a less invasive option than traditional surgical shunts. Meanwhile, the Systemic-to-Pulmonary Artery Shunt provides a surgical option where the diameter, length, and material can be tailored to the specific needs of the patient, potentially enhancing the customization of care. These innovations could lead to improved outcomes and recovery times compared to standard surgical shunts.

What evidence suggests that this trial's treatments could be effective for congenital heart disease?

In this trial, participants will receive either a Ductal Artery Stent or a Systemic-to-Pulmonary Artery Shunt. Previous studies have shown promising results for ductus arteriosus stenting in infants with congenital heart disease. The procedure succeeded 93% of the time, and patients generally experienced lower death rates and shorter hospital stays compared to other treatments. However, there is a slightly higher chance that additional procedures might be needed later. Conversely, using a shunt to connect the body’s main artery to the lung artery also improves survival rates and oxygen levels in infants. While some patients may face complications, the shunt can promote lung artery growth, benefiting overall heart health. Both treatments offer benefits, and the choice often depends on the specific needs and conditions of each patient. ^{3 6 7 8 9}

Who Is on the Research Team?

Christopher Petit, MD

Principal Investigator

Columbia University

Sara Pasquali, MD

Principal Investigator

University of Michigan

Jeffrey Zampi, MD

Principal Investigator

University of Michigan

Andrew Glatz, MD

Principal Investigator

Washington University School of Medicine

Jenna Romano, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

The COMPASS trial is for newborns with certain heart defects needing a stable blood flow to the lungs. It's open to babies 30 days old or younger, without severe additional health issues, genetic anomalies that affect survival, or those requiring other major interventions alongside the tested procedures.

Inclusion Criteria

I am 30 days old or younger at the time of my procedure.

My newborn has CHD and needs a stable blood flow to the lungs, decided by doctors to be treated with DAS or SPS.

Exclusion Criteria

My pulmonary arteries are not joined together and one comes from a duct.

I have a heart condition (PA/IVS) and need a procedure to relieve pressure in my heart.

You were born less than 34 weeks into the pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Ductal Arterial Stent
• Systemic-to-Pulmonary Artery Shunt

Trial Overview This study compares two ways to improve lung blood flow in newborns with heart defects: either placing a stent in the ductal artery or creating a shunt between systemic and pulmonary arteries. Babies will be randomly assigned to one of these treatments and tracked for their first year.

How Is the Trial Designed?

Group I: Systemic-to-Pulmonary Artery Shunt Experimental Treatment 1 Intervention

Surgical systemic-to-pulmonary artery shunt performed by the interventional team. SPS diameter, length, and material will be determined by the surgeon performing the intervention.

Group II: Ductal Artery Stent Experimental Treatment 1 Intervention

Transcatheter ductal artery shunt will be placed by the interventional team. Drug-eluting coronary stent brand, length, and diameter are determined by the interventional team.

Ductal Arterial Stent is already approved in United States, European Union for the following indications:

Approved in United States as Ductal Artery Stent for:

• Ductal-dependent pulmonary blood flow in neonates

Approved in European Union as Ductal Artery Stent for:

• Ductal-dependent pulmonary blood flow in neonates

Who Is Running the Clinical Trial?

Carelon Research

Lead Sponsor

Trials

76

Recruited

125,000+

HealthCore-NERI

Lead Sponsor

Trials

73

Recruited

111,000+

Pediatric Heart Network

Collaborator

Trials

11

Recruited

2,400+

Published Research Related to This Trial

In a study comparing 42 infants who underwent the modified Blalock-Taussig shunt to 13 infants who received ductal stenting, both procedures showed similar survival rates and need for reintervention to maintain pulmonary blood flow, indicating comparable efficacy.

However, ductal stenting was associated with fewer procedure-related complications and less incidence of distal branch pulmonary artery stenosis, suggesting it may be a safer alternative for selected infants with ductal-dependent pulmonary circulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Blalock-Taussig shunt versus ductal stenting for palliation of cardiac lesions with inadequate pulmonary blood flow. McMullan, DM., Permut, LC., Jones, TK., et al.[2013]

The ductus arteriosus stent (DAS) is increasingly being used as an alternative to the modified Blalock-Taussig-Thomas shunt for infants with ductal-dependent pulmonary blood flow, with a notable increase in its use over time (odds ratio 1.23 annually).

DAS is associated with shorter hospital stays and lower hospitalization costs compared to the traditional shunt, while showing similar rates of transplant-free survival and reintervention, and improved outcomes in terms of freedom from composite adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in Ductus Arteriosus Stent Versus Blalock-Taussig-Thomas Shunt Use and Comparison of Cost, Length of Stay, and Short-Term Outcomes in Neonates With Ductal-Dependent Pulmonary Blood Flow: An Observational Study Using the Pediatric Health Information Systems Database. Lemley, BA., Wu, L., Roberts, AL., et al.[2023]

Transcatheter ductus arteriosus stenting (DS) is a safe and feasible alternative to the modified Blalock-Taussig shunt (MBTS) for providing pulmonary blood flow in infants with cyanotic congenital heart disease, with no significant difference in post-procedural outcomes or overall mortality rates between the two methods.

However, infants with single ventricle morphology had a significantly higher mortality risk compared to those with biventricular morphology, highlighting the need for careful follow-up in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of duct stenting and modified Blalock-Taussig shunt in cyanotic congenital heart disease with duct-dependent pulmonary circulation. Lekchuensakul, S., Somanandana, R., Namchaisiri, J., et al.[2022]

In infants with ductal dependent pulmonary blood flow, PDA stenting significantly reduces the risk of mortality and complications compared to the Blalock-Taussig shunt, with a mortality risk reduction of 41% and a complication risk reduction of 48%.

PDA stenting also leads to better post-procedure outcomes, including higher oxygen saturation levels and improved Nakata index, indicating greater stability in circulation after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blalock-Taussig Shunt versus Ductal Stent in the Palliation of Duct Dependent Pulmonary Circulation; A Systematic Review and Metanalysis. Fakhry AbdelMassih, A., Menshawey, R., Menshawey, E., et al.[2022]

In a study of 22 infants with duct-dependent pulmonary circulation, ductal stenting (DS) provided adequate short-term palliation after balloon valvotomy for critical pulmonary stenosis or pulmonary atresia, allowing for sufficient oxygen saturation without the need for additional interventions.

The study found that DS was also effective for infants with univentricular hearts, enabling adequate growth before undergoing the Glenn shunt procedure, although there was an interstage mortality rate of 18%, highlighting the need for careful monitoring during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longevity of neonatal ductal stenting for congenital heart diseases with duct-dependent pulmonary circulation. Sivakumar, K., Bhagyavathy, A., Coelho, R., et al.[2012]

In a study of 27 neonates with congenital heart disease and duct-dependent pulmonary circulation, both arterial duct (AD) stenting and modified Blalock-Taussig shunt (MBTS) significantly increased pulmonary artery (PA) growth over approximately 10 months, indicating both methods are effective.

However, AD stenting resulted in a more uniform distribution of pulmonary blood flow compared to MBTS, which caused uneven growth in the pulmonary arteries, suggesting that AD stenting may be a better option for promoting balanced pulmonary vascular development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary artery growth after palliation of congenital heart disease with duct-dependent pulmonary circulation: arterial duct stenting versus surgical shunt. Santoro, G., Capozzi, G., Caianiello, G., et al.[2012]

Duct stenting in infants with duct-dependent pulmonary flow showed lower medium-term mortality and fewer procedural complications compared to the modified Blalock-Taussig shunt, based on a systematic review of six studies.

While duct stenting resulted in shorter hospital stays and intensive care unit lengths, it also had a higher risk of unplanned reinterventions, indicating a trade-off between benefits and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duct stenting versus modified Blalock-Taussig shunt in neonates and infants with duct-dependent pulmonary blood flow: A systematic review and meta-analysis. Alsagheir, A., Koziarz, A., Makhdoum, A., et al.[2021]

In a study of 127 patients with duct-dependent pulmonary circulation, modified Blalock-Taussig shunts (MBTs) and duct-stenting (DS) showed similar primary outcomes, but MBTs had higher rates of hospital deaths and complications, indicating potential safety concerns.

For patients with a high ductal curvature index (DCI >0.45), MBTs were more effective than DS, achieving a primary outcome in 64% of cases, while DS only succeeded in 20%, suggesting that MBTs may be preferable for those with more tortuous ducts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duct Stenting vs. Modified Blalock-Taussig Shunt: New Insights Learned From High-Risk Patients With Duct-Dependent Pulmonary Circulation. Mini, N., Schneider, MBE., Asfour, B., et al.[2022]

In a study of 171 infants with single ventricle anatomy, both ductus arteriosus stent (DAS) and modified Blalock-Taussig shunt (BTS) showed similar interstage outcomes, with no significant difference in unplanned reinterventions, deaths, or transplants.

However, the DAS group had a higher rate of planned reinterventions and demonstrated better growth of the right pulmonary artery, suggesting that DAS can be a viable initial palliative option for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Outcomes at Time of Superior Cavopulmonary Connection Between Single Ventricle Patients With Ductal-Dependent Pulmonary Blood Flow Initially Palliated With Either Blalock-Taussig Shunt or Ductus Arteriosus Stent: Results From the Congenital Catheterization Research Collaborative. Meadows, JJ., Qureshi, AM., Goldstein, BH., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8452800/

Outcome of ductus arteriosus stenting including vertical ... We attempted to stent the PDA in 43 patients, with a success rate of 93% (40 patients) and only one procedural mortality. There was also one ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030528

Transcatheter Ductal Stents Versus Surgical Systemic ... Ductal stenting is associated with decreased length of hospital stay and reduced overall cost for the index hospitalization but with a greater reintervention ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0019483225001701

Institutional experience with ductus arteriosus stenting in ... Primary outcomes included procedural success, defined as achieving post-procedural oxygen saturation (SpO2) ≥85%, and survival to planned ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39681751/

PDA Stenting for Ductal-Dependent Cyanotic Congenital ... This article provides a historical review and a current perspective on the procedures used to palliate cyanosis in ductal-dependent infants.

5. jscai.org jscai.org/article/S2772-9303(23)00543-4/fulltext

Stenting of the Patent Ductus Arteriosus: A Meta-analysis ... Meta-analysis showed lower mortality rates and a shorter hospital LOS for patients who received palliation via PDA stent as opposed to systemic- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2840730/

Stenting the ductus arteriosus: Case selection, technique and ... Ductal stenting is a reasonable, less invasive alternative to BT shunt as first-stage palliation in neonates with duct-dependant cyanotic CHD.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.120.009520

Patent Ductus Arteriosus Stenting for All Ductal-Dependent ... PDA stenting for almost all ductal dependent cyanotic newborns can be safe and effective and may have lower morbidity than selective PDA stenting.

8. revespcardiol.org revespcardiol.org/en-ductal-stenting-in-congenital-heart-dise-articulo-S188558572030181X

Ductal stenting in congenital heart disease with duct ... Stenting of ductus arteriosus in patients with congenital heart disease and duct-dependent pulmonary flow has a long history and validated outcomes.

9. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-020-01817-2

Arterial duct stent versus surgical shunt for patients with duct ... Arterial duct stent appears to have not inferior outcomes of procedural complications, mortality, hospital and ICU stay, and pulmonary artery growth in ...