Verna Hoy knew something wasn't right; she was coughing a lot and running out of breath. Both her mother and a sister had heart murmurs — which doctors heard in Hoy's chest, too — so she wasn't surprised to be referred to a cardiologist.
What cardiologists found would not be so simple to fix, however. At least, it didn't use to be. Hoy had two problems: a leaky mitral valve in her heart, which caused blood to back up into her left atria, and something called hypertrophic cardiomyopathy (HCM) that obstructed blood flow in her heart. And the only way to fix it, before, was risky and invasive open heart surgery. But doctors didn't want to do that to the 87-year-old from Richfield.
Instead, her cardiologist turned to a just-approved device called a MitraClip that could be deployed via a catheter snaked up to her heart through a vein in her leg.
On Dec. 11, Hoy became the first patient in Minnesota to receive the MitraClip to repair a leaky mitral valve. Turns out, Hoy also is the first person in the world to also have her HCM treated with the same device.
"They decided they would try this procedure to see if it would work," Hoy said recently. Its seems to be working just fine. A week after her procedure, Hoy was washing clothes, running errands to the grocery store and drugstore and heading out to lunch.
"We're all very excited about it," said Dr. Paul Sorajja, an interventional cardiologist at the Minneapolis Heart Institute Foundation and Abbott Northwestern Hospital. "This is a new advance in the management of patients with HCM."
The combination of HCM and a faulty mitral valve affects 400,000 Americans. The MitraClip, developed by Abbott Laboratories, won approval from the Food and Drug Administration in October. It has been available in Europe for several years.
The MitraClip is the only commercially available mitral valve repair device that can be placed into the heart through a blood vessel, a much less-invasive process that speeds patient healing.
Sorajja and Dr. Wes Pedersen, director of the Transcatheter Valve Therapy Program at the Minneapolis Heart Institute, were investigators into the safety and effectiveness of the procedure during clinical trials.
"The device has proved its effectiveness in research studies and we are excited to see this device commercially available and improving and extending the lives of thousands of people," Sorajja said. "When we looked at how this device can be used to treat mitral regurgitation, we felt that it could also be used to simultaneously treat obstruction due to HCM."
HCM is a condition in which the walls of the heart thicken, interfering with the heart's activities. In Hoy's case, a thick wall in her left ventricle slowed the flow of blood out of the ventricle. At the same time, the thickening caused the mitral valve in her heart to leak blood into her left atrium — called mitral regurgitation. That combination was hurting Hoy.
For patients with HCM, doctors usually open the chest to remove part of the thickened heart wall. In some cases, they inject alcohol into the tissue to kill it, causing a small heart attack. But the MitraClip, which essentially clips the middle of the leaky mitral valve, also keeps that valve from further obstructing blood flow, Sorajja said. One device, two problems solved.
According to the FDA, repairing the valve during open heart surgery still is the preferred method. But MitraClip is now acceptable for patients who are not considered healthy enough for the surgery.
Sorajja, who came to Abbott Northwestern from the Mayo Clinic, said, "We had our suspicions that this would work. It was a great day. It was a really great day for us. We are so happy."
Hoy, who was discharged from the hospital just two days after the procedure, said she still gets a little breathless.
"I seem to be OK," she said. "I was told not to lift anything over 10 pounds and I watch it."
She said trying a new device didn't worry her. Besides, she likes the idea of maybe helping others with what doctors learn from her.
"There are a lot of people on this Earth," she said. "If it is my time, so be it. But I thought if it would help other people, I would take a shot."