From left: Michael Hainstock, MD; Michael Shorofsky, MD; and John Saxon, MD
Pediatric and adult congenital heart specialists at UVA Health are committed to advancing transcatheter pulmonary valve technologies to deliver high-quality, less-invasive valve replacement options for children, adolescents, and adults with congenital heart disease. Innovative treatments using select investigational devices through national clinical trials are essential for improving treatment outcomes.
“Our goal is to match each patient with the right valve, at the right time, using the safest and most durable approach we can offer,” said Michael Hainstock, MD, associate professor of pediatrics in the Division of Pediatric Cardiology and director of the Pediatric Cardiac Catheterization Laboratory at UVA Health Children’s.
Dr. Hainstock was lead author for a study published in the American Heart Association Journal Circulation: Cardiovascular Interventions analyzing the five-year outcomes from the COMPASSION S3 trial in which UVA was the top enroller and national primary investigator. The trial evaluated the SAPIEN 3 transcatheter heart valve in patients with dysfunctional right ventricular outflow tract conduits, which demonstrated excellent durability and sustained hemodynamic performance.
“The results reinforce that transcatheter pulmonary valve replacement can provide long-lasting relief of obstruction and regurgitation with very low rates of reintervention or serious complications,” Dr. Hainstock said. “We’re proud that UVA played a role in generating this evidence for families worldwide.”
UVA is also one of the few centers in the United States with extensive experience using the Venus P-Valve system and is a leading enrollment site in the PROTEUS IDE pivotal trial. This investigational technology expands options for patients with dilated right ventricular outflow tracts who previously had limited catheter-based solutions.
“Being part of the PROTEUS study allows us to offer cutting-edge treatments to patients who might otherwise need repeat open-heart surgery,” noted Dr. Hainstock. “It reflects UVA’s commitment to bringing innovative devices to our patients as early and as safely as possible.”
At the heart of UVA’s program is a culture of innovation led by Michael Shorofsky, MD, associate chair of innovation and site primary investigator for the Harmony post-approval study, which focuses on advanced modeling to optimize complex procedures. “We can now virtually rehearse challenging cases, anticipate potential issues, and design a customized approach before a child ever enters the catheterization lab,” said Dr. Shorofsky. “That level of preparation translates into safer procedures, shorter procedure times, and better outcomes for our patients and their families.”
The advanced valve program at UVA is further strengthened by the leadership of John Saxon, MD, director of the Advanced Valve Center, whose expertise in pulmonary valve overexpansion techniques helps extend the life of transcatheter valves and preserve future treatment options.
“Patients with congenital heart disease often face multiple procedures over decades,” said Dr. Saxon. “Our responsibility is not only to fix the current problem, but to think several steps ahead so we maintain pathways for safe reintervention as patients grow and their needs change.
Together, Drs. Hainstock, Shorofsky, Saxon, and the multidisciplinary pediatric and congenital heart teams at UVA Health are advancing the field of transcatheter pulmonary valve replacement, while ensuring families throughout Virginia have access to the most advanced therapy options. The program’s integration with UVA’s broader heart valve and transplant initiatives allows patients with even the most complex conditions to receive comprehensive, lifelong care in one coordinated system.
Filed Under: Research