David Kalfa, MD, Chief – Cardiovascular Surgery & Co-Medical Director – Heart Institute, Nicklaus Children’s Hospital / Professor of Surgery and Pediatrics, FIU Herbert Wertheim College of Medicine

Invest: spoke with Dr. David Kalfa, chief of cardiovascular surgery at Nicklaus Children’s Hospital and professor of surgery and pediatrics at FIU Herbert Wertheim College of Medicine, about how innovation at the Nicklaus Children’s Hospital Heart Institute is improving outcomes for children with congenital heart defects, from growing valves and minimally invasive approaches to virtual planning, AI, and translational research. “What drives us to innovate at Nicklaus Children’s Hospital’s Heart Institute is to improve outcomes for children and also adults with congenital heart disease,” Dr. Kalfa said.

What innovations are changing outcomes and recovery for pediatric patients?

What drives us to innovate at Nicklaus Children’s Hospital’s Heart Institute is to improve outcomes for children and also adults with congenital heart disease. One example is partial heart transplantation, where the idea is to use a living valve. Valves are important, and until now, there has been no good replacement option for children because the available valves degenerate with time, are not durable, or require blood thinners, which is a big issue for both children and adults.

Because those valves do not grow and tend to degenerate, they often require multiple reoperations. Each of those is an open-heart surgery with a significant amount of complications, morbidity, and mortality. The concept of using a living valve is based on the fact that this valve can grow with the child. That is completely disruptive and a game changer for children with congenital heart defects because it is the first time in the history of pediatric cardiac surgery that we are able to offer a growing valve to our patients. The impact in terms of outcomes, quality of life, and life expectancy is absolutely stunning.

Another example is minimally invasive surgery. The idea there is to reduce the trauma related to surgery as much as possible. Classically, we do open-heart surgery from the front using a sternotomy. Here, the idea is to use minimally invasive approaches. One major impact is cosmetic.

Avoiding a large incision in the front for a child who will keep that incision for the rest of their life is significant. Studies are showing the psychological impact of having a scar in the front that reminds a child every day of the disease. If you do a small incision, for example, below the arm, or even robotic heart surgery, where there is almost no scar, that is a game changer because patients can forget about it and have a better quality of life.

What distinguishes your surgical approach when cases are considered inoperable elsewhere?

We are pushing the boundaries in terms of what we can offer to repair a heart with a heart malformation. Some babies are born with a severe malformation where, instead of having two ventricles, they have only one. This is what we call single ventricle disease.

Nowadays, there are ways to either septate this single ventricle into two, or in patients who have a very large ventricle and then a tiny ventricle on the other side, we are offering techniques that help rehabilitate the small ventricle. We are doing things in the operating room that help make the small ventricle grow with time after birth. By promoting blood flow into a small chamber, that chamber actually grows, and because it grows, after that, you can use either two ventricles or at least one and a half ventricles.

We are doing biventricular repair, meaning two-ventricle repair, or one-and-a-half-ventricle repair, in patients who, in the vast majority of centers across the country and in the world, would have a single-ventricle repair. We try to avoid a single-ventricle repair because the midterm and long-term outcomes of a single-ventricle repair are far from optimal. It is not normal for a body to function with just one ventricle.

How are technologies such as robotics, virtual reality, and AI reshaping care?

These technologies, such as robotic pediatric cardiac surgery, virtual reality, and computational model-based personalized medicine, are reshaping the way we take care of patients. Every single child with a congenital heart malformation is unique, so we need to adapt our treatment and what we offer to each patient.

With virtual reality, we use advanced imaging and 3D segmentation and reconstruction of the heart to simulate different types of operations in advance and choose the best one for a specific patient, the one that fits the anatomy and physiology of the patient the most. It helps with decision-making and surgical planning because you are training on the specific operation in the virtual reality model. That is transforming the type of personalized care we are able to bring to each child.

We are also using computational model-based personalized medicine. We hired an engineer specialized in computational modeling and AI as part of the surgical team. At Nicklaus, we do not have surgeons only. We also have engineers who collaborate closely with surgeons, cardiologists, intensivists, imaging specialists, and the whole team to introduce new technologies, such as computational modeling and AI, to better serve patients. That is something transformative happening right now in Miami.

How does transparency around outcomes influence care?

We have been pioneers in terms of transparency in clinical outcomes. More importantly than our real-time data, what is key is the use of the STS Public Reporting System. STS means the Society of Thoracic Surgeons. They have the most advanced way to quantify outcomes of surgical pediatric care programs, and they have a public reporting system online that is accessible to everyone.

Through that system, people can see the quality of outcomes by level of complexity of the procedures we are doing in pediatric cardiac surgery across heart institutes around the country. The impact of this kind of public reporting is especially important for parents, who obviously want the best possible outcome for their child with congenital heart disease. They have a powerful tool at their disposal where they can see which center can offer fantastic outcomes. I am proud and grateful to be part of the Heart Institute, which has been pioneering and offering fantastic heart surgical outcomes in recent years for kids with congenital heart defects.

How do you design procedures that evolve with a child’s growth and long-term heart function?

Growth is something complex to understand. It has hemodynamic, mechanical, biological, and biochemical factors. When we take care of a child in the operating room, growth is an obsession in the sense that we are trained to do things that are sustainable and that are either growing or can be growth-accommodating for the years and decades to come.

When I operate on a 3-day-old child, every single step of the surgical procedure may have consequences 70 or 80 years later because these kids can have a normal life expectancy. That is something we always think about when we are doing clinical work in the operating room, and it is also something we always keep in mind when we do research and medical device development in our lab at Florida International University in collaboration with Nicklaus. We are working on different types of devices that are growth-accommodating.

How does the affiliation with FIU accelerate innovation in pediatric cardiovascular surgery?

This affiliation between Nicklaus Children’s Hospital, which is the leading pediatric health system in Florida, and Florida International University (FIU), one of Florida’s leading public research universities and part of the state’s elite “preeminent” group, is absolutely instrumental for us to do what we want to do, which is innovating and pushing the boundaries to better serve patients with congenital heart defects.

I am a surgeon-scientist, and I moved my lab to the FIU Herbert Wertheim College of Medicine while focusing on growth-accommodating medical devices, biomaterials, and new solutions based on computational modeling and AI for children with congenital heart defects. Having this collaboration between these two institutions is absolutely key.

Now we are thinking about the next steps by getting the leadership of both institutions on board to create a one-of-a-kind and transformative congenital heart defect research institute. We are building one center focusing on clinical outcomes and clinical trials applied to congenital heart defects, a center focusing on translational research that we can then apply directly to the patient at the bedside, and another center focused on basic science research in the field of congenital heart defects. We are also working now on attracting top talent, top researchers, and top physicians within this research institute. We are excited about that because it would be a huge differentiator and have a major impact on our patients.