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Zoe's Story

This story recounts the experience of one patient who received a Melody Transcatheter Pulmonary Valve. Medtronic, Inc. invited her father to share her story candidly. Caution: results vary; and patient experience may not be comparable to that of Zoe's, depending in part upon the condition of the patient prior to conduit failure.

Seven-year-old Zoe is full of energy and loves to play tennis, swim and hang out with her friends. But unlike her friends, Zoe was born with an "owie" on her heart. Hours after her birth, she was diagnosed with a congenital heart condition called Tetralogy of Fallot, which causes reduced blood flow to the lungs, resulting in oxygen-poor blood.

Zoe's parents learned that Zoe would need open-heart surgery so that doctors could place a pulmonary valve conduit to create blood flow from her right ventricle to the pulmonary arteries with a donated, valved conduit. Since the average lifespan of pulmonary valve conduits is limited and children need different sized valves as they grow, Zoe would need several open-heart surgeries over her lifetime.

By the time she was five, Zoe had been through three open-heart procedures. When routine tests following her last open-heart surgery revealed her newly implanted pulmonary valve conduit was failing, Zoe's parents scoured the internet and medical journals in search of a less-invasive alternative. That's when they discovered 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) holding a specially designed heart valve is guided through a vein to the heart. The heart valve is attached to a wire frame that expands with the help of two balloons to deliver the valve, without the need to open the chest.

Zoe's condition began to quickly deteriorate. "She was listless – she had lost her energy and enthusiasm," explained her dad. So, in October 2008, Zoe underwent an emergency Melody TPV procedure.

"The Melody procedure was a relief. We were bracing ourselves for another open-heart surgery," her dad recalled. "Melody was a much simpler procedure. Instead of weeks in the hospital with drainage tubes, respirators, tons of medication and a large scar, Zoe spent one night in the hospital and came home with a bandage on her thigh."

"She did feel a bit sick for a short time after the procedure from the nausea but was saved from all the emotional challenges a six-year-old faces when she misses school and returns with a fresh scar visible above most of her shirts, dresses and bathing suits."

"It's been just over a year since the procedure, and Zoe continues to be in great health."

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 Zoe.

"Because of the Melody valve, we were able to delay Zoe's next open-heart surgery and spared her the trauma and stress that comes with each surgery," shared her dad.

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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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