MILLER'S STORY Melody™ Transcatheter Pulmonary Valve (TPV) Therapy

This story recounts the experience of one patient who received a Melody Transcatheter Pulmonary Valve. Medtronic, Inc. invited this person to share his story candidly. Caution: Experience, risks, outcomes, and results vary; patient experience may not be comparable to that of Miller's, depending in part upon the condition of the patient or with the techniques, facilities, or products used.

TODAY, THIS COLLEGE STUDENT LOVES HIS ‘NORMAL’ LIFE

Miller

At 21, Miller is a typical American college student. He’s working toward a business degree at a local community college. He enjoys exercise and being active, loves to eat, hangs out with friends and plays video games. Pretty normal young guy stuff. Except Miller’s childhood was anything but normal.

As a baby, he was diagnosed with subvalvular aortic stenosis, a rare congenital heart defect affecting his aortic valve, resulting in reduced blood flow from Miller’s heart. He underwent his first open-heart surgery at 18 months. Many years of active childhood followed until, at age 8, Miller’s aortic valve began to fail. Doctors replaced his aortic valve with his own pulmonary valve and put a valved conduit where his pulmonary valve had been.

From valves to pacing
Miller suffered another setback a few years later — a sudden cardiac arrest at home at age 11. His father did chest compressions on him until the paramedics arrived. Miller was without a pulse for 23 minutes. After miraculously being revived, “Miller’s short-term memory was shot,” says his mother Tracy. “He couldn’t recognize his siblings. He had to relearn how to walk. Miller fought his way back.” In the hospital, Miller received a Medtronic implantable cardiac defibrillator (ICD) to help prevent future episodes.

On the forefront of an innovative pulmonary solution
In the meantime, Miller’s pulmonary valve conduit—now several years old—was deteriorating. Miller no longer had the strength or stamina to play sports or goof around with his four siblings. He even had to rest just to walk upstairs to his bedroom. One year after receiving his ICD, Miller’s cardiologist said a replacement pulmonary valve was needed.

Eager to avoid a third open-heart surgery on her son’s 12-year-old body and the associated weeks of recovery and missed school, Miller's mom Tracy learned about a clinical trial for Medtronic's Melody™ Transcatheter Pulmonary Valve (TPV) Therapy, a less-invasive, catheter-based procedure to restore pulmonary valve function. During Melody TPV Therapy, a catheter (a thin, hollow tube) is used to deliver the Melody valve to the heart through the body's cardiovascular system, generally without the need to open the chest. There are both short-term and long-term risks for patients who receive the Melody TPV.

After qualifying for the trial and understanding the associated risks, Miller connected with a physician in New York to implant the Melody valve. Miller underwent the successful two-hour procedure.

"Immediately after Miller received his Melody valve, the color returned to his cheeks," says Tracy. "He was more animated and full of energy."

“I felt better instantly,” Miller says. "I’m still feeling great.”

Medtronic’s study data show that 81.5% of study patients haven’t had another surgery for this condition after 8 years.

Tracy says it’s remarkable that the Melody valve procedure involved just one overnight stay in the hospital. “Sort of miraculous,” she says, compared with Miller’s two previous open-heart surgeries. Miller is regularly followed by his doctor to monitor the function of his heart valve and keep an eye on long term risks associated with his Melody.

Tracy adds that at some point in the future when Miller needs to have his Melody replaced, it’s nice to know they have a local option. “When he received his first Melody valve, there were only a few clinical trial centers in the U.S. Now, we have local doctors and they have done so many Melody valves, which gives us so much confidence and peace of mind,” she says.

Loving his “normal” life
Shortly after his Melody valve procedure 9 years ago, Miller and his family attended a Broadway show similar to a typical family on a New York City vacation. Within a few days, he was back in school.

According to Tracy, prior to his Melody valve, Miller’s entire family had to adjust to his limited capabilities. “We would all have to wait for Miller to catch up to us if we were out walking or shopping,” says his Mom.

Tracy says this was frustrating for Miller, because he didn’t want to slow anyone down. He just wanted to be “normal” like everyone else. “Now, with the Melody valve, he can keep up with his family and his friends,” she says.

As a young adult today, Miller says he doesn’t even think about his Melody valve He feels like a normal person.