Minimally Invasive Fetal Pacing for the Treatment of Congenital Heart Block

Dr. Christopher Breuer - Nationwide Children’s Hospital

The specific aim of this project is toEvaluate and compare the safety and efficacy of unseeded, prasugrel and losartan treated TEVGs to both seeded TEVGs and polytetrafluoroethylene (PTFE) vascular grafts using a juvenile ovine inferior vena cava (IVC) vascular interposition graft model. The broad, long-term goal of this ongoing project is to utilize a regenerative medicine approach to develop improved biomaterials designed specifically for use in infants and children with congenital heart disease.

Toward Imaging Criteria Diagnostic of Hepatocellular Carcinoma in Fontan-Associated Liver Disease 

Dr. Yuli Kim and Dr. Cara Morin - Children’s Hospital of Philadelphia/ University of Pennsylvania

Fontan-associated liver disease (FALD) is an inevitable consequence of the Fontan operation for single ventricle disease, worsening with age and often progressing to cirrhosis. Increasingly, liver cancer, or hepatocellular carcinoma (HCC), has been reported in this population, affecting up to 2% of young adults and represents a devastating late complication of an otherwise life-prolonging surgery.  Complicating the diagnosis of FALD-HCC is the coexistence of benign hyperplastic liver nodules, which share several key imaging features with FALD-HCC.3  Benign liver nodules are common in persons with FC, present in over half of CT/MR scans.4 The inability to clearly differentiate benign from malignant liver nodules in FALD leads to patient harm including underdiagnosis of HCC, overuse of invasive liver biopsy, repeated surveillance imaging, and psychological distress. Our overarching goal is to identify and validate an accurate imaging biomarker for FALD-HCC to obviate the need for liver biopsy and become the gold standard for diagnosis.

Minimally Invasive Fetal Pacing for the Treatment of Congenital Heart Block

Dr. Charles Berul - Children’s National Hospital

Congenital complete heart block (CCHB) is a rare but life-threatening cause of fetal morbidity and mortality, often resulting in hydrops fetalis and intrauterine demise. No prenatal therapy currently exists to restore cardiac rhythm once bradycardia and heart failure develop. Permanent pacing is curative postnatally, but there is currently no safe or effective method for pacemaker implantation before birth. This project proposes a minimally invasive, percutaneous fetal pacing system designed to safely restore physiologic rhythm in utero.

Over one year, the team will miniaturize and validate the PeriScope device, construct and test the simulator, and demonstrate procedural feasibility and pacing efficacy in a pregnant ewe model. This work will provide the first preclinical evidence that fetal pacing can be performed safely and reproducibly, establishing a translational pathway toward clinical use.

A prospective evaluation of lyophilized human milk fortification in infants with CHD: impact of growth, tolerance and clinical outcomes

Dr. Kimberly Mills - Boston Children’s Hospital

Gastrointestinal (GI) morbidities, including feeding intolerance, necrotizing enterocolitis (NEC), and malnutrition are common in infants with congenital heart disease (CHD) and contribute to increased resource utilization, poor clinical outcomes and high parental stress. Human milk is preferred in this population for its protective effects on gut integrity and immune function, yet fortification is often required to meet caloric needs. Standard bovine-based fortifiers (BBF) may worsen feeding intolerance and increase NEC risk. Lyophilized, or freeze-dried, human milk fortifier (FD-HMF) preserves the bioactive properties of human milk while allowing for increased caloric density.

This study investigates a novel human milk-based fortification strategy tailored to infants with CHD—a population uniquely vulnerable to gut ischemia, dysbiosis, and inflammation. The results of our study may have immediate impact at the bedside by proposing another means of nutrition provision, reduce feeding-related morbidity and support family-centered care by aligning nutritional strategy with parental goals. In addition, the study seeks to understand the mechanisms of feeding intolerance in infants with CHD. The intervention is scalable, parent-supported, and builds on prevailing literature.

VeraHeart: At Home Central Venous Pressure Monitor for Children with Heart Failure

Dr. Youseph Yazdi and Dr. Danielle Gotlieb-Sen - Johns Hopkins Children’s Hospital and Le Bonheur Children’s Hospital

Outpatient monitoring of heart failure in children with congenital heart disease (CHD) remains a critical unmet clinical need, as current management relies on subjective symptom assessment that often fails to detect deterioration before hospitalization becomes necessary1. While central venous pressure (CVP) provides essential information for heart failure management, current measurement requires invasive catheter placement associated with infection and thrombosis risk, as well as the consumption of precious peripheral venous access essential for future procedures and therapies. We aim to validate and optimize a novel non-invasive central venous pressure monitoring system specifically designed for children with congenital heart disease, enabling anticipatory outpatient heart failure management and reducing preventable hospitalizations.