“We think about innovation as having to be this grand thing,” says Katie Bales. “But, to us, as patients and families, even small innovation makes a difference.”
And she’d know. Bales and her family have been through it.
The journey began at Bales’s 20-week ultrasound, when her unborn son was diagnosed with a complex congenital heart defect. As if the shock of the diagnosis wasn’t enough, Bales recalls being dumbfounded by the lack of clarity her family could get from their care team about the prognosis. They were desperate to know what kind of interventions and surgeries her son would need, but most importantly what his life would look like.
The care team could explain the various scenarios and surgeries on the horizon. The quality of life question? Not so much.
“So I really had questions around that and wanted to do everything I could to make sure we were on the right path to giving our son JJ the quality of life that we hoped for him,” Bales said, sharing her story at the 10th annual Virtual Human Twin Experience Symposium hosted by Dassault Systémes in 2024. “This drove me to get involved in the space.”
Getting home from the hospital, Bales dove in. All the fundamental questions she had that went unanswered? She wanted to make sure clinicians would be able to respond when other families had those same questions. So, she got involved with the Children’s Heart Foundation, which raises money and funds promising research around congenital heart defects.
As JJ got older, Katie, an engineer by training, was struck by the lack of innovation in the pediatric space. As an example, she described the 24-hour Holter monitor JJ undergoes as part of his normal care routine. At age 2, this meant a crude wire taped to his skin that led to tears from the boy and worries from his mother, who was nervous about him getting tangled while he slept. In contrast, if we fast-forward a few years, JJ now uses a small, wireless Holter that fits under his shirt and he can hide when he chooses.
“This small innovation that isn’t life-changing,” Bales says, “It isn’t saving his life, but it makes a big impact on the day-to-day experience of these patients.”
Fueled by a new passion for the importance of improving pediatric technology, Bales became a seed investor and led fundraising for a pediatric medical device development group. Soon, she saw a need for a patient- and parent-centric voice in other areas of care.
And, eventually, that’s what led Katie Bales into the orbit of The Living Heart Project, a research initiative using modeling and simulation to advance cardiovascular science. And through the Living Heart Project, she’d learn about the profound patient impact of virtual twins in life sciences and healthcare.
Virtual twins help families understand complex medical procedures
In early 2024, JJ needed another surgery, a highly specialized valve repair. Armed with her knowledge of the benefits of a virtual twin – a scientifically accurate model – of JJ’s heart, Katie sought out the team at Boston Children’s Hospital who would collaborate with JJ’s surgeon to simulate the procedure in advance to predict his outcome and plan the best surgery possible.
“I want to emphasize the impact this had on us as parents,” Katie Bales says. “We went into this knowing the amount of planning and precision that was done to generate this plan for the surgery. Words really can’t express how impactful this was for us.”
To make this happen, the Bales family decided to relocate temporarily from Chicago to Boston, where they’d have access to the technology and expertise at Boston Children’s for JJ’s care. Katie recalls sitting in a conference room, the day before surgery, watching and listening as the doctor pulled up a model of JJ’s heart that the team had used to plan the surgery, and showed the family exactly what they were going to do.
“In that moment, it felt very real, like, ‘This is happening tomorrow morning,’” she says. “I felt very overwhelmed and very scared and had this weird feeling of also feeling very confident and that’s what this did. It provided us as parents with the confidence that our surgeon knew exactly what he needed to do and what he was going to do to provide JJ with the best care as possible.
Bales recognizes how fortunate the family is to have the flexibility and resources to travel anywhere in the world for JJ’s care. But her hope for the future is to see virtual twin experiences transform patient and parent experiences for kids like JJ and families like hers. “I hope that one day we’ll be talking about this as the new standard of care and every congenital heart surgery is planned using this technology,” she said.
The team in Boston is now turning that dream into a reality.
Scaling modeling and simulation in surgeries
Dr. David Hoganson leads the team at Boston Children’s Hospital (BCH) that provided care for JJ Bales. They’re using patient-specific 3D modeling and simulation to redefine preoperative planning with virtual twin experiences. He’s been involved with the Living Heart Project since the initiative’s early days.
Over the years, Hoganson has hired more than a dozen of engineers to create patient-specific 3D models and run simulations in preparation for pediatric cardiac surgeries. Also speaking at the Symposium, he estimated the team would create over 400 patient-specific 3D models in 2024, accounting for almost 40% of their patients who had surgery that year an amazing static given the team performed the first surgery only five years ago.
Dealing with such young patients with congenital heart conditions, there’s little room for error. The costs of not getting it right the first time is substantial, even deadly. That’s why Hoganson and team have developed several surgical simulations to support the surgeons and their patients.
“It starts with a CT scan or an MRI,” Hoganson explained. “And then through a process called segmentation, we’re able to create a digital 3D model of the child’s heart. And then that 3D model can be used in several ways. It can be used for preoperative planning or intraoperative guidance. But it can also be used as a platform for advanced engineering work like virtual surgery or flow simulation.”
In the operating room, the models are so valuable that they are used almost every day using whatever it takes to make it work. As Hoganson explained: the team will pull the model up on a screen in the operating room and use a reprogrammed Nintendo Switch inside a sterile bag to manipulate the model for intraoperative guidance. This is the state of the art for virtual surgery.
Hoganson also described workflows for patch design and intracardiac repair, which require understanding of complex 3D shapes, biomechanics and other variables, like how an aorta will grow over time after a patch is sewn into place. Then, he discussed the ability to use modeling and simulation to mitigate long-term complications associated with Fontan procedures in young patients.
Improving long-term patient impact using computational fluid dynamics (CFD)
The Fontan procedure is typically part of a multi-step approach to treating congenital heart defects where a young patient only has a single functional ventricle. The primary objective is redirecting systemic venous blood to the pulmonary arteries, bypassing the heart and allowing oxygen-poor blood to reach the lungs for oxygenation without having to circulate through the underdeveloped ventricle. This improves overall oxygen levels in the body.
However, Hoganson explained, the Fontan procedure is not without its challenges, including long-term complications like energy loss in the conduit and Fontan-associated liver disease.
The Fontan is considered to be the last operation unless a heart transplant is needed. But new learnings thanks to these advances have helped leaders like the team at Boston Children’s begin to understand how blood flow changes in these patients as they age and grow.
After a Fontan procedure, the balance of venous return shifts dramatically as patients grow. They’ll have roughly twice as much return from the upper body at age 4, which balances by age 8, and reverses by the teen years with twice as much return from the lower body.
“When we looked at these patients as they grew, we’re finding the energy loss across the Fontan conduit goes up dramatically as you get older, in part because the flow goes up, and in part because your distribution changes and completely flips,” Hoganson said. “This is creating a whole new paradigm for how we’re thinking about these Fontan patients as they age. We’re able to use CFD to model how to upsize these Fontan conduits for patients who need it.”
Increase the conduit size too much could also lead to increased energy loss due to swelling and inefficient flow. But, by using patient-specific models, performing virtual surgeries, adapting designs and approaches and modeling them under multiple physiologic conditions, the Boston Children’s team is better able to understand in the virtual world how treatments will work for real life.
“The central message is 3D modeling and simulation is really essential in planning and conducting complex reconstructions,” Hoganson said. “Surgical planning by experience alone is inadequate. Single ventricle patients with systemic abnormalities or AVMs really need CFD.”
Now, they’re looking to expand the access to virtual twins from children’s hospitals across the country to help more practitioners, patients and families.
Expanding patient impact with virtual twins
While the benefits are clear, innovation in healthcare can be a complex, expensive process. Hiring engineering teams to incorporate modeling and simulation into medicine requires significant investment. Without reimbursement, hospital take on the full costs which slows adoption. In recent years, the BCH team has been billing for the effort, an advance Hoganson says has “opened the door for other centers to start to take on this work at another level.”
As of fall 2024, there were around nine centers in the United States that had begun hiring engineers. The BCH team is teaching them how to bill for the modeling and simulation services.
“On a national level, we’ve submitted CPT Level Three codes to achieve durable billing for these processes,” Hoganson said. “It’s quite expensive, as you can imagine. I think this is going to be a super important aspect to make this care available to everybody.”
Another challenge: introducing the more advanced workflows into the clinical space. That’s where collaborations with the Living Heart Project, Dassault Systèmes and the ENRICHMENT Project make a difference.
The ENRICHMENT project, a 5-year collaboration led by Dassault Systèmes and the US Food and Drug Administration, culminated in 2024 with the development of a “playbook” that provides a methodology for in silico clinical trials. An in silico clinical trial uses virtual twins, like the ones Dr. Hoganson’s team builds at BCH, to safely predict the effects of a drug, disease, medicinal device or intervention, only on the scale of on an entire population.
Building on the findings from the ENRICHMENT Project, Hoganson is finalizing a joint manuscript with the FDA on regulatory validation of patient-specific surgical workflows by adapting the FDA’s credibility assessment for CFD into clinical settings.
Looking back, it was exactly this kind of challenge that sparked the creation of the Living Heart Project, making the progress shared all the more exciting and meaningful. The 10th annual Virtual Human Twin Experience Symposium was filled with stories like those of Bales’s and Hoganson.
This blog is part of a series on Dassault Systèmes’ 10th International Virtual Twin Human Experience Symposium.
Watch the symposium, learn more about out Virtual Human Twin Initiatives, and keep an eye out for the next blog in this series.
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Patrick BallPatrick is a Senior Communications Manager on the Corporate Publishing team here at Dassault Systèmes. An experienced journalist, marketer, speechwriter and storyteller, Patrick's words have appeared on pages and stages around the world.