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: Results vary; patient experience may not be comparable to that of Miller's, depending in part upon the condition of the patient prior to conduit failure.
To watch 13-year-old Miller and his family together at the health club or playing a friendly game of football in the living room, you would never imagine that he has been through so much in his young life. As a baby, Miller was diagnosed with subvalvular aortic stenosis, which causes the heart wall to thicken, and underwent his first open-heart surgery at 18 months. The surgery was a success and for many years Miller enjoyed a normal, active childhood.
When he was eight, Miller's aortic valve began to fail. Doctors performed a two-step procedure to replace his aortic valve with his own pulmonary valve and to put a valved conduit where his pulmonary valve had been. It took three months before Miller could play baseball and participate in gym class again. Everything seemed fine, and life in Miller's house went back to normal. So Miller's mom wasn't prepared to see him walk into the kitchen one morning, clutch his chest and collapse. Miller's father performed continuous chest compressions until paramedics arrived. At the hospital, staff quickly administered epinephrine, the adrenaline hormone, and Miller was revived. Doctors determined Miller had sudden cardiac arrest resulting from a condition called cardiomyopathy, in which the heart muscle is weakened and fast heart beats cause the heart to suddenly stop.
Miller received an implantable cardioverter defibrillator (ICD) to help prevent any future episodes of sudden cardiac arrest. While the device gave the family some peace of mind, Miller no longer had the strength or stamina to play sports or goof around with siblings.
As months passed, his health deteriorated, and he was unable to walk long distances without a wheelchair. One year after he received his ICD, Miller's cardiologist determined that Miller's pulmonary valve conduit, which was now several years old, was deteriorating and a replacement was needed. Miller's mom learned about a clinical trial for Medtronic's Melody™ Transcatheter Pulmonary Valve (TPV) Therapy, a less-invasive procedure designed to restore pulmonary valve function in failed conduits. 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, without the need to open the chest.
One of Miller's doctors was familiar with the Melody study, and recommended participating doctors in New York. The family made the trip to New York. Miller qualified for the clinical trial and soon had the procedure, which took about two hours.
"Immediately after Miller received his Melody valve, the color returned to his cheeks," said his mom. "While he had some nausea and vomiting from the anesthesia, and the access site on his leg was a little sore for a few days, it was nothing compared to how his personality changed right away," she said. "He was more animated and full of energy."
The day after his Melody procedure, Miller and his family took advantage of their time in New York by attending a Broadway play and shopping. When they returned home four days later, Miller was able to climb the stairs without resting part way up, and went ice skating for the first time.