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Dan's Story

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; and patient experience may not be comparable to that of Dan's, depending in part upon the condition of the patient prior to conduit failure.

To see Dan spike a shot to the back corner of the volleyball court or perform a backside grab on his snowboard, you'd never know he grew up as a self-described "scrawny kid who wasn't allowed to participate in physical education classes."

Dan was born with a condition called Tetralogy of Fallot, which involves numerous defects within the heart structure. Together, these defects cause reduced blood flow to the lungs, resulting in oxygen-poor blood.

When Dan was just three months old, he had open-heart surgery to create flow from his right ventricle to the pulmonary arteries with a valved conduit. Since the average lifespan of a pulmonary valve conduit is limited and children need different sized conduits as they grow, Dan had five more open-heart surgeries by the time he was 18.

During Dan's last open-heart surgery, complications arose. There was excessive bleeding and Dan went into sudden cardiac arrest several times. His doctors didn't think he'd make it. In fact, they contacted his family to come say goodbye, including a sister who was asked to fly home from France.

Dan did pull through, but the experience haunted him so much that he delayed treatment when his conduit failed again. "The valve I received in 1990 was supposed to last about 10 years," he said. "My doctors kept telling me I needed to get it replaced, and I knew it too."

Dan was increasingly getting fatigued. "I could only play volleyball for 10 minutes and then had to sit out. Plus my heart would race for long periods of time. I was long overdue for a new conduit, but I was scared after my last near-death experience."

Then Dan received hope. He heard about Medtronic's Melody^® Transcatheter Pulmonary Valve (TPV) Therapy, which is designed to extend the life of failed pulmonary valve conduits using a less-invasive approach than open-heart surgery. With Melody TPV Therapy, a catheter (a thin, hollow tube) delivers the Melody valve to the heart through the body's cardiovascular system.

Seven years after doctors recommended replacement, Dan received a new pulmonary valve as part of the Melody clinical trial in the United States.

Dan compared his previous surgeries to Melody TPV Therapy. "Before, surgery took several hours, I was in the hospital for several weeks, and couldn't exercise for three to four months," he explained. "With the Melody procedure, I was in the cath lab for about two hours and out of the hospital the next day. I was back at work as a city planner within four days and played in a volleyball tournament at full strength within a week."

The Melody valve was approved under U.S. Food and Drug Administration Humanitarian Device Exemption status, which requires demonstration of safety and probable benefit to patients. While the effectiveness of Melody TPV Therapy hasn't been shown, and results differ for each patient, it has helped Dan.

To see Dan today, he's just another active family man. He snowboards with his daughter, does martial arts with his son, and goes horseback riding with his wife. "There weren't just physical benefits with Melody TPV Therapy," Dan said. "The psychological benefits are just as important. Now I feel at ease and can truly enjoy life."

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Important Risk Information

Potential procedural complications that may result from implantation of the Melody device include the following: Rupture of the RVOT conduit, compression of a coronary artery, perforation of a major blood vessel, embolization or migration of the device, perforation of a heart chamber, arrhythmias, allergic reaction to contrast media, cerebrovascular events (TIA, CVA), infection/sepsis, fever, hematoma, radiation-induced erythema, pain at the catheterization site.

Potential device-related adverse events that may occur following TPV implantation include the following: Stent fracture resulting in recurrent obstruction, endocarditis, embolization or migration of the device, valvular dysfunction (stenosis or regurgitation), paravalvular leak, valvular thrombosis, pulmonary thromboembolism, hemolysis.

For complete list of possible adverse events, see Important Safety Information.

Important Information About Stent Fracture

In some patients, the stent (wire frame) of the Melody TPV will break because of the forces it is exposed to in the body. The chance of the stent breaking may increase the longer the device is in the body. There is up to a 35 percent chance that the Melody TPV stent will break within one year of placement. In some cases, the broken stent does not require additional treatment. A doctor will determine the best treatment option.

However, a broken stent has the potential to become serious and could result in the need for another catheter intervention, an operation to replace the conduit, or could lead to death.

For the complete data set, additional information and Instructions for Use documentation, contact Medtronic LifeLine CardioVascular Technical Support at 877-526-7890.

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