Le Bonheur first in region to perform pulmonary valve replacement for tetralogy of Fallot via catheterization using newly FDA-approved Harmony valve

Published: Nov. 22, 2021 at 10:09 AM EST

MEMPHIS, Tenn., Nov. 22, 2021 /PRNewswire/ -- Tony and Karyn Tanner of Bossier City, La., knew that this day was coming sooner rather than later for their 17-year-old daughter Madi.

www.lebonheur.org (PRNewsFoto/Le Bonheur Children's Hospital)
www.lebonheur.org (PRNewsFoto/Le Bonheur Children's Hospital)

Born with tetralogy of Fallot (TOF), a congenital heart defect that changes the flow of blood through the heart, she needed a pulmonary valve replacement, a necessary intervention for TOF patients as they reach their teens.

Until recently, open-heart surgery for valve replacement was the only option for Madi and children like her. But thanks to a new device – the Harmony Transcatheter Pulmonary Valve (TPV) system – Le Bonheur Medical Director of the Interventional Catheterization Laboratory Shyam Sathanandam, MD, can conduct pulmonary valve replacement for TOF patients through a minimally-invasive catheterization procedure. Le Bonheur is the first hospital in the region to offer this device and procedure.

The TPV system is the first FDA-approved minimally-invasive therapy for pulmonary valve replacement for children with TOF who had transannular patch repair as an infant. Previous expandable valves did not fit the anatomy of patients with TOF repair. The new device functions by reestablishing efficient blood flow from the right ventricle to the lungs.

"This valve is a game changer for patients who need a pulmonary valve replacement as it will prevent TOF patients from needing multiple open-heart surgeries throughout their lives," said Sathanandam.

Madi was diagnosed with TOF at 2 days old. She had her first open-heart surgery for TOF repair at 4 months and at 4 years old had a stent placed in her left pulmonary artery. Since then, she has been able to live a full, fun and active life. Still, she and her parents knew that once her heart was fully grown she'd need another open-heart surgery for pulmonary valve replacement.

At an annual MRI appointment, her cardiologist in Shreveport, La., decided it was time for the valve replacement to take place. But he had a new suggestion: undergo a minimally-invasive catheterization procedure for a valve replacement at Le Bonheur's Heart Institute. Having trained at Le Bonheur, the cardiologist knew he could be continually involved in conversations with Sathanandam throughout Madi's procedure and recovery.

"We asked our cardiologist, 'If this was your child where would you have this procedure?'" said Karyn. "He told us to go to Le Bonheur where he trusted all the cardiologists, knew them all and had worked with them all. That sealed the deal for us."

Throughout October, Madi and her family made several journeys to Le Bonheur to have cath procedures to remove her existing stent and prepare for the new valve. She faced multiple complications – the original stent moving out of place, a balloon piece from the stent landing in her lungs – all of which were mitigated by Sathanandam's quick thinking in the cath lab.

Finally, on Oct. 25, Sathanandam conducted a cath procedure to put the new valve in place. During the procedure, blood flow was blocked to Madi's left lung, so he also placed a stent at the top of the valve – making Madi the only person in the world with a Harmony valve with a stent through it.

Less than a week later, Madi was at home in Louisiana celebrating Halloween with friends and family – something that would have been impossible with an open-heart procedure.

"Currently, open-heart surgical valve implantation is the primary treatment option for kids like Madi, but this new valve and its minimally-invasive procedure covers many TOF patients who have the initial TOF repair operation," said Sathanandam. "Typically, these patients have to have multiple heart surgeries throughout their lives for valve replacements. Now, there is a good chance they won't need any more operations beyond the initial repair surgery as a child."

Since her valve replacement, Madi has had two ECHOs that showed excellent blood flow in her heart. And her parents felt lighter knowing that she didn't have to face the risks associated with open-heart surgery.

Madi will continue to have follow-up close to home with her own cardiologist, who is in communication with Sathanandam on Madi's progress. In the meantime, she can go back to enjoying her junior year of high school as an honor student with a talent for art and theater.

"Madi can take any heavy situation, even a valve replacement, and find the fun in it," said Karyn. "We felt like Le Bonheur took us in – from nurses putting Madi at ease singing with her through needle sticks or staff offering to go shopping to get us necessities."

And Sathanandam is grateful to have another option to help this patient population who previously had to undergo risky open procedures for valve replacement. Because of these risks, valve replacement was put off as long as possible until the heart reached near failure.

"Now with this simple technique, we can replace the valve much earlier, before the heart fails," said Sathanandam. "This opens up a new frontier for future management of these patients – future percutaneous valves can be implanted within this valve."

About Le Bonheur Children's Hospital
Le Bonheur Children's Hospital in Memphis, Tenn., treats children each year through community programs, regional clinics and a 255 bed state-of-the-art hospital.  Le Bonheur serves as a primary teaching affiliate for the University Tennessee Health Science Center and trains more than 350 pediatricians and specialists each year. Nationally recognized, Le Bonheur is ranked by U.S. News & World Report as a Best Children's Hospital. 

For more information, please call (901) 287-6030 or visit lebonheur.org. Connect with us at facebook.com/lebonheurchildrens, twitter.com/lebonheurchild or on Instagram atlebonheurchildrens.

David Henson
(423) 304-9400
Alize' Prather
(615) 705-2971

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SOURCE Le Bonheur Children's Hospital

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