Shunt vs Stent for Congenital Heart Disease

(COMPASS Trial)

Recruiting at 26 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

Trial Summary

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.

What data supports the effectiveness of the treatment Ductal Arterial Stent (DAS) for congenital heart disease?

Research shows that using a ductal stent (a small tube placed in the ductus arteriosus to keep it open) for congenital heart disease with duct-dependent pulmonary circulation can reduce the risk of death and complications compared to the Blalock-Taussig shunt. Additionally, patients with stents had better oxygen levels after the procedure. ^{1 2 3 4 5}

Is the ductal stent or Blalock-Taussig shunt generally safe for humans?

Research shows that ductal stents are generally safe and may have fewer risks compared to the Blalock-Taussig shunt, including lower chances of death and complications. Stents also tend to result in better oxygen levels after the procedure. ^{1 2 3 6 7}

How does the Ductal Arterial Stent treatment differ from other treatments for congenital heart disease?

The Ductal Arterial Stent (DAS) is a less invasive alternative to the Blalock-Taussig shunt for managing congenital heart disease with duct-dependent pulmonary circulation. It is associated with a lower risk of complications and mortality, and it improves oxygen levels more effectively than the surgical shunt. ^{1 2 3 8 9}

What is the purpose of this trial?

COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.

Research Team

Christopher Petit, MD

Principal Investigator

Columbia University

Andrew Glatz, MD

Principal Investigator

Washington University School of Medicine

Sara Pasquali, MD

Principal Investigator

University of Michigan

Jenna Romano, MD

Principal Investigator

University of Michigan

Jeffrey Zampi, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

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]

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]

References

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

Longevity of neonatal ductal stenting for congenital heart diseases with duct-dependent pulmonary circulation. [2012]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Blalock-Taussig Shunt versus Ductal Stent in the Palliation of Duct Dependent Pulmonary Circulation; A Systematic Review and Metanalysis. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Outcomes of duct stenting and modified Blalock-Taussig shunt in cyanotic congenital heart disease with duct-dependent pulmonary circulation. [2022]

4. United States 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. [2020]

5. United States 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. [2021]

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

Modified Blalock-Taussig shunt versus ductal stenting for palliation of cardiac lesions with inadequate pulmonary blood flow. [2013]

7. England 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. [2023]

8. United States 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. [2012]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Duct Stenting vs. Modified Blalock-Taussig Shunt: New Insights Learned From High-Risk Patients With Duct-Dependent Pulmonary Circulation. [2022]