Clinical Research Directory

Seeking for Perfected Aortic Arch Reconstruction Using a Graphically Designed Patient-specific Surgical Patch

Vascular Reconstruction is one of the most challenging areas of surgery, the surgeon has to create a completely watertight reconstruction without any narrowing or deformity that will restore normal flow characteristics, even at high pressures. Nowhere is this more challenging than in neonatal heart surgery where babies born with aortic arch narrowing or underdevelopment are one of the commonest life-threatening cardiovascular conditions. Reconstruction not only has to recreate normal anatomy but also allow for subsequent growth and development. Until now, surgical reconstruction depended on the surgeon's subjective assessment of the anatomy and a best estimate of patch shaping and design. New engineering techniques have enabled us to create 3D printed models of real hearts and then recreate the actual surgery on these models using a variety of engineered patches and different surgical techniques. These reconstructed models can now be placed in flow-testing rigs and undergo 4-dimensional flow imaging to provide high-fidelity velocity and shear force analysis that allow for precision design of the ideal geometry to give optimal flow. This project will combine the skills of the largest team of neonatal heart surgeons in Canada, working with cardiac imaging experts, physicists and biomechanical engineers who are recognized as the world leaders in 3D printing technologies for congenital heart disease. Using a series of rigorous repeated tests and different designs we will define the ideal techniques and patch shapes and then translate this to real cases where a precision-shaped personalized patch can be created for each individual. Following up these babies as they grow with precision 3D scanning will show how these vessels are growing. Our mathematics-driven approach will make the surgery easier, shorter and more efficient. It will also provide more consistent surgical results among surgeons.

National Collaborative to Improve Care of Children With Complex Congenital Heart Disease

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease

The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital mortality, and improving surgical prognosis compared with the traditional model of care. In addition, in neonates with CCHD associated with the right cardiac system, the investigators aim to further investigate whether early postnatal cardiac surgery has the potential advantage of obtaining a time window for myocardial regeneration and thus improving myocardial remodeling. The aim of this study is to improve the diagnostic and therapeutic capacity of critical congenital heart disease and to promote the integrated prenatal-postnatal treatment model for clinical use. This will ultimately improve the quality of healthcare services for patients with cardiovascular diseases and lay the foundation for exploring guidelines for the treatment of cardiovascular diseases suitable for China's national conditions. The project will be jointly implemented by Beijing Anzhen Hospital , Capital Pediatric Research Institute, and 307 PLA General Hospital. Starting from January 1, 2022, the hospitals will continue to collect hospitalized cases of newborns with CCHD. The integrated prenatal and postnatal model is defined as a definitive diagnosis of CCHD in the fetal period (22-26 weeks), documentation of intrauterine transfer in our obstetrics department, subsequent initiation of an intrapartum or postpartum surgical plan after multidisciplinary consultation, and transfer to the pediatric heart center at the first hour of life, where the child is treated with either postpartum immediate or elective surgery, depending on patient status. For neonates who meet the indications for emergency surgery, surgery is performed immediately after birth. For neonates with non-emergency surgical indications, surgery is performed after birth adjustment to optimal status. The traditional model was defined as postpartum transfer via an outside hospital with routine interventions. The investigators then evaluate surgical prognosis and myocardial regenerative capacity to compare the effects of the two treatment models. This project will validate the advantages of an integrated prenatal and postnatal model over traditional models through real-world research and will improve prognosis in neonates with CCHD.