Standardized Catheterization Assessment for Pulmonary Vein Stenosis

Overseen By Jesse Esch, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Hemodynamic instability

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, single center study which applies a standardized, comprehensive catheterization assessment to patients with a known or suspected diagnosis of pulmonary vein stenosis (PVS) who are undergoing a cardiac catheterization at Boston Children's Hospital. As part of the assessment, each pulmonary vein will undergo angiography (pictures using moving x-rays and contrast dye), intravascular ultrasound (IVUS; pictures of the vein wall using a catheter inside the vein), pressure assessment and compliance testing. The status of each pulmonary vein will then be assessed 12 months after the catheterization (i.e. no disease, severe disease, etc.). Using statistics, the investigators will determine which patient and vein characteristics (obtained at the of catheterization) can predict whether or not a pulmonary vein will have disease. The investigators hypothesize that this comprehensive, standardized, invasive assessment of pediatric intraluminal PVS can predict vein outcome.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What safety data is available for standardized catheterization assessment for pulmonary vein stenosis?

The safety data for transcatheter pulmonary vein interventions, which may include standardized catheterization assessments, indicates that serious adverse events occur in 12% of cases, with the most common being pulmonary hemorrhage and arrhythmia. Severe or catastrophic adverse events, such as strokes and patient death, occur in 1.7% of cases. Factors like age under 6 months and low systemic arterial saturation increase the risk of adverse events. This data is based on a retrospective cohort analysis of 240 patients who underwent 841 catheterizations from 2014 to 2021. ^{1 2 3 4 5}

Is standardized catheterization assessment generally safe for humans?

Standardized catheterization procedures, like those used for pulmonary vein stenosis, have been associated with some risks. In a study of 841 procedures, serious adverse events occurred in 12% of cases, including pulmonary bleeding and irregular heartbeats, with severe events like strokes and one death in 1.7% of cases. ^{1 2 3 4 5}

Is the treatment 'Standardized catheterization assessment' a promising treatment for Pulmonary Vein Stenosis?

Yes, standardized catheterization assessment is a promising treatment because it helps doctors better understand heart and lung conditions by providing detailed measurements of heart pressures and blood flow. This can lead to more accurate diagnoses and improved treatment plans for conditions like pulmonary vein stenosis. ^{3 6 7 8 9}

How is the standardized catheterization assessment treatment different from other treatments for pulmonary vein stenosis?

The standardized catheterization assessment is unique because it provides a comprehensive evaluation of heart and lung pressures using a catheter, which helps in understanding the condition better and tailoring treatment. Unlike other treatments, it focuses on detailed hemodynamic measurements to guide therapy decisions, especially in complex cases like pulmonary vein stenosis. ^{3 6 7 8 9}

What data supports the idea that Standardized Catheterization Assessment for Pulmonary Vein Stenosis is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Standardized Catheterization Assessment for Pulmonary Vein Stenosis. The articles focus on the use of catheterization for other purposes, such as diagnosing heart conditions and improving quality in cardiac procedures, but do not directly address its effectiveness for treating Pulmonary Vein Stenosis. ^{6 8 9 10 11}

What data supports the effectiveness of the treatment Standardized catheterization assessment for Pulmonary Vein Stenosis?

The research highlights the importance of quality management and continuous quality improvement in cardiac catheterization, which can enhance patient safety and optimize outcomes. This suggests that a standardized approach to catheterization, as part of a quality improvement initiative, may improve the effectiveness of the treatment for conditions like pulmonary vein stenosis. ^{6 8 9 10 11}

Who Is on the Research Team?

Jesse Esch, MD

Principal Investigator

Boston Children's Hospital/Harvard Medical School

Are You a Good Fit for This Trial?

This trial is for pediatric patients who are suspected to have or are known to have pulmonary vein stenosis (PVS) and are stable enough to undergo a cardiac catheterization at Boston Children's Hospital.

Inclusion Criteria

My child is having a heart procedure to check for narrowed lung veins.

Exclusion Criteria

Hemodynamically unstable patients as determined by the patient care team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Catheterization Assessment

Participants undergo a comprehensive catheterization assessment including angiography, intravascular ultrasound, pressure assessment, and compliance testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pulmonary vein status and transplant-free survival

12 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Standardized catheterization assessment

Trial Overview The study tests a comprehensive catheterization assessment during cardiac catheterization, including angiography, intravascular ultrasound, pressure measurement, and compliance testing. The goal is to predict PVS outcomes in children.

How Is the Trial Designed?

Group I: Standardized catheterization assessment Experimental Treatment 1 Intervention

Assessment of pulmonary veins including angiography, intravascular ultrasound, pressure assessment and compliance testing.

Standardized catheterization assessment is already approved in United States for the following indications:

Approved in United States as Standardized catheterization assessment for:

• Diagnosis and assessment of pediatric pulmonary vein stenosis

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

Pulmonary artery catheterization is a valuable diagnostic tool that helps measure various heart pressures and cardiac output, providing insights into conditions like heart failure and pulmonary hypertension.

The review highlights the challenges in accurately assessing hemodynamic measurements due to varying techniques, which can affect clinical decisions and management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right heart catheterization in clinical practice: a review of basic physiology and important issues relevant to interpretation. Del Rio-Pertuz, G., Nugent, K., Argueta-Sosa, E.[2023]

Quality assurance (QA) and quality improvement (QI) initiatives in cardiac catheterization laboratories are essential for enhancing patient safety and optimizing interactions between patients and healthcare teams.

National registries and appropriate use criteria (AUC) for revascularization are key tools for benchmarking performance and ensuring that medical procedures are used effectively, especially in the context of value-based healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality management in the cardiac catheterization laboratory. Henien, S., Aronow, HD., Abbott, JD.[2020]

In a study of 513 patients with acute lung injury, physical examination findings like cool extremities and knee mottling were found to have high specificity but low sensitivity for predicting low cardiac index and mixed venous oxygen saturation, indicating they are not reliable indicators of ineffective circulation.

Central venous oxygen saturation levels below 70% were associated with low mixed venous oxygen saturation, but a level of 70% or higher could effectively rule out the risk of low mixed venous oxygen saturation, suggesting it may be a useful measure in clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of physical examination with pulmonary artery catheter parameters in acute lung injury. Grissom, CK., Morris, AH., Lanken, PN., et al.[2021]

In a study of 1043 patients with cardiogenic shock, those who received pulmonary artery catheters (PACs) had a lower in-hospital mortality rate (29.3%) compared to those who did not receive PACs (36.2%), particularly benefiting patients in more severe stages of shock (SCAI stages D and E).

Patients with PACs were more likely to receive advanced heart failure therapies, such as temporary mechanical circulatory support and durable ventricular assist devices, indicating that PACs may enhance treatment options and outcomes in severe cases of cardiogenic shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Artery Catheter Usage and Impact on Mortality in Patients with Cardiogenic Shock: Results from a Canadian, Single Centre Registry. Réa, ABBAC., Mihajlovic, V., Vishram-Nielsen, JKK., et al.[2023]

The Society for Cardiac Angiography and Interventions has established a structured quality improvement program for cardiac catheterization labs, emphasizing the importance of identifying risk-adjusted quality indicators to ensure valid comparisons of outcomes.

The program includes a comprehensive data collection and evaluation process to monitor patient outcomes and adverse events, followed by corrective actions and reassessment to enhance the quality of care in these medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for continuous quality improvement in the cardiac catheterization laboratory. Laboratory Performance Standards Committee of the Society for Cardiac Angiography & Interventions. Heupler, FA., al-Hani, AJ., Dear, WE.[2019]

In a review of 4454 pediatric cardiac catheterizations over 9 years, the overall incidence of adverse events was found to be 9.3%, indicating a higher risk compared to general pediatric anesthesia.

Infants under 1 year old experienced a significantly higher event rate of 13.9%, particularly during therapeutic interventions, highlighting the need for careful monitoring in this vulnerable age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidents and complications during pediatric cardiac catheterization. Bennett, D., Marcus, R., Stokes, M.[2012]

In a study of 240 patients with pulmonary vein stenosis who underwent 841 catheterizations, serious adverse events occurred in 12% of cases, with pulmonary hemorrhage and arrhythmia being the most common, while severe events like stroke and death were rare.

Younger patients (under 6 months) and those with low oxygen saturation or severely elevated pulmonary artery pressure were more likely to experience serious adverse events and require high-level cardiorespiratory support after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Serious Adverse Events and High-Level Cardiorespiratory Support in Patients Undergoing Transcatheter Pulmonary Vein Interventions. Barreto, JA., Gauvreau, K., Porras, D., et al.[2023]

In a study of 8111 cardiac catheterization procedures in children and young adults with pulmonary hypertension, the overall risk of catastrophic adverse events was found to be 1.4%, with a 5.2% risk of death before discharge, highlighting the high-risk nature of this population.

Factors such as being a prematurely born neonate, receiving inotropic treatment before the procedure, and having lower systemic arterial saturation were linked to increased risks of adverse events, while higher hospital experience with pulmonary hypertension procedures was associated with a reduced risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Major Early Adverse Events Related to Cardiac Catheterization in Children and Young Adults With Pulmonary Hypertension: An Analysis of Data From the IMPACT (Improving Adult and Congenital Treatment) Registry. O'Byrne, ML., Kennedy, KF., Kanter, JP., et al.[2020]

The pulmonary artery catheter has been linked to increased morbidity and mortality, prompting a workshop by the NHLBI and FDA to improve its safety and utility in clinical settings.

There is a strong need for standardized education for healthcare professionals on the use and interpretation of pulmonary artery catheters, with a focus on specific clinical scenarios like heart failure and sepsis, to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheterization and clinical outcomes: National Heart, Lung, and Blood Institute and Food and Drug Administration Workshop Report. Consensus Statement. Bernard, GR., Sopko, G., Cerra, F., et al.[2022]

In a review of 126 heart catheterization procedures performed on children, adverse events occurred in 13% of cases, with serious complications in 5.5%, indicating that while the procedure is generally safe, there are risks involved.

Factors such as being under one year old, having an unscheduled admission, and the use of inotropic drugs were associated with a higher likelihood of experiencing adverse events, highlighting the importance of thorough pre-procedure assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events during diagnostic and therapeutic pediatric cardiac catheterization]. Zepeda-Arámbula, A., Gutiérrez-Cobian, L., Villatoro-Fernández, JL., et al.[2019]

In a study of 4,401 children and young adults with pulmonary hypertension undergoing cardiac catheterization, the observed risk of serious adverse outcomes was 3.5%, indicating a significant risk associated with this invasive procedure.

Factors such as younger age, concurrent cardiac operations, and pre-procedural systemic vasodilator infusion increased the risk of adverse outcomes, while the use of pulmonary vasodilators before the procedure was linked to a reduced risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Catastrophic Adverse Outcomes in Children With Pulmonary Hypertension Undergoing Cardiac Catheterization: A Multi-Institutional Analysis From the Pediatric Health Information Systems Database. O'Byrne, ML., Glatz, AC., Hanna, BD., et al.[2018]

Citations

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

Right heart catheterization in clinical practice: a review of basic physiology and important issues relevant to interpretation. [2023]

2. China pubmed.ncbi.nlm.nih.gov

Quality management in the cardiac catheterization laboratory. [2020]

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

Association of physical examination with pulmonary artery catheter parameters in acute lung injury. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Pulmonary Artery Catheter Usage and Impact on Mortality in Patients with Cardiogenic Shock: Results from a Canadian, Single Centre Registry. [2023]

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

Guidelines for continuous quality improvement in the cardiac catheterization laboratory. Laboratory Performance Standards Committee of the Society for Cardiac Angiography & Interventions. [2019]

6. France pubmed.ncbi.nlm.nih.gov

Incidents and complications during pediatric cardiac catheterization. [2012]

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

Predictors of Serious Adverse Events and High-Level Cardiorespiratory Support in Patients Undergoing Transcatheter Pulmonary Vein Interventions. [2023]

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

Risk Factors for Major Early Adverse Events Related to Cardiac Catheterization in Children and Young Adults With Pulmonary Hypertension: An Analysis of Data From the IMPACT (Improving Adult and Congenital Treatment) Registry. [2020]

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

Pulmonary artery catheterization and clinical outcomes: National Heart, Lung, and Blood Institute and Food and Drug Administration Workshop Report. Consensus Statement. [2022]

10. Mexico pubmed.ncbi.nlm.nih.gov

[Adverse events during diagnostic and therapeutic pediatric cardiac catheterization]. [2019]

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

Predictors of Catastrophic Adverse Outcomes in Children With Pulmonary Hypertension Undergoing Cardiac Catheterization: A Multi-Institutional Analysis From the Pediatric Health Information Systems Database. [2018]