Revolutionizing Care: Texas Children’s Celebrates Research Breakthrough to Raise Awareness for American Heart Month

Texas Children’s is proud to announce that Iki Adachi, MD, and his research team have been awarded a Single Ventricle Research Fund (SVRF) grant to develop “ReVolution,” a novel implantable device intended to transform care for infants with congenital heart disease who have undergone the Fontan procedure. 

Led by Dr. Adachi, Surgical Director of Heart Transplant and Mechanical Circulatory Support at Texas Children’s, the research team includes experts Dr. Nobuyuki Kurita and Dr. Christopher Broda from Baylor College of Medicine/Texas Children’s Hospital, Dr. Yaxin Wang and Dr. Chris Chan from the Texas Heart Institute and Dr. Huang Chen from the University of Nevada, Las Vegas. 

Driving the need

For infants born with single ventricle congenital heart defects, the Fontan procedure is the final of 3 surgeries, creating a system in which the single ventricle supports systemic circulation while pulmonary circulation relies on elevated venous pressure. This allows blood to pass from the veins instead of the ventricle to the pulmonary artery and then the lungs, successfully creating a new blood-flow configuration. While effective initially, the Fontan circulation eventually fails due to chronic venous hypertension. Adults with Fontan circulation may develop complications later in life, including blood clots, heart rhythm disorders, heart failure and liver disease. 

“It works well, for a while — 10 to 40 years,” said Dr. Adachi. “But all Fontans will fail at some point.”

Read about Laurel, a Texas Children’s patient who had a Fontan procedure and a subsequent stroke at 9 years old, and who bravely shared her story to raise awareness for World Thrombosis Day. 

When the Fontan circulation fails, many patients will require a heart transplant. Unfortunately, donor hearts are scarce. 

“In the United States alone, 900 Fontan procedures are performed each year and only 400 hearts become available for transplant,” Dr. Adachi said. “The number of patients who need a heart far exceeds the number available. As single ventricle care and surgical outcomes continue to improve, we have more children surviving longer than ever before such that their Fontan will eventually fail.”

Although Texas Children’s boasts the largest pediatric mechanical support program in the world, existing mechanical circulatory support devices aren’t suitable for Fontan patients due to anatomical differences. 

“The traditional design doesn’t work for Fontan patients because they have one inlet instead of two,” Dr. Adachi explained. “We’ll use this grant to work on a device that’s specifically designed for failing Fontan procedures.”

Revolutionizing care

The ReVolution device uses a maglev centrifugal blood pump, establishing a “biventricular” circulation adaptable to various anatomies — unlike traditional approaches that only support the failing Fontan circulation. The pump’s placement post-Fontan allows for lower venous pressure, addressing the fundamental issue of chronic venous hypertension. 

“With our device design, the pump is in the middle, which means venous pressure can be lower,” said Dr. Adachi.

The grant will fund the next phases of development, including motor testing and casing design, as well as the initial testing phases. The team’s goal is to complete the pump casing design and move into in vivo testing in 2025, to see how the pump behaves with fluid. By the end of the three-year grant, the goal is to begin testing in animal models.

Initially, the goal for the device is to offer a bridge to heart transplant, helping patients circulate blood effectively until a heart becomes available. However, the successful integration of the ReVolution pump holds the potential to dramatically reduce or even eliminate the need for heart transplants among Fontan patients by providing a long-term solution.

“Initially, we aim for the device to be a bridge to heart transplant,” Dr. Adachi said. “We need to test durability. If it works well, then we will evaluate it for potential long-term or permanent support to avoid a heart transplant altogether.”

This groundbreaking research has the potential to significantly improve not only quality of life for Fontan patients, but also reduce healthcare costs associated with managing chronic complications and catalyze further research and innovation in the field.

The Difference is Life-Changing

For more than 60 years, Texas Children’s Heart Center has combined cutting-edge technology with a compassionate and family-centered approach to care. More than 1,000 surgeries and 1,600 cardiac catheterization procedures are performed annually in the Lester and Sue Smith Legacy Tower, home of the Heart Center, where an integrated, multidisciplinary approach to care brings to the bedside a comprehensive team of experts who specialize in every aspect of cardiac treatment. For eight years in a row, U. S. News & World Report has named Texas Children’s the best hospital in the country for children in need of pediatric cardiology and heart surgery care.

Dr. Adachi’s groundbreaking research is continuing a long tradition of life-changing care at Texas Children’s. In November 2024, the Texas Children’s Heart Transplant Program celebrated its 40th anniversary.

"Our heart transplant program is truly exceptional because of our clinical expertise and depth of experience," Dr. Adachi shared at the time. "As we celebrate 40 years of saving children’s lives, we are dedicated to leading research and providing the very best specialized care to our patients.”

This February, Texas Children’s is proud to celebrate Dr. Adachi’s research to raise awareness for American Heart Month. 

Learn more about Texas Children’s Single Ventricle Program.