Mitral Valve Replacement Restores 82-Year-Old Womans Energy

An estimated four million people in the U.S. suffer from mitral regurgitation (MR), a condition in which mitral valve leaflets in the heart become damaged or stretched and they don’t close properly. This allows blood to flow backward in the heart. MR can cause symptoms like shortness of breath, fatigue, heart palpitations and swelling. If left untreated, MR may lead to chronic heart failure, the leading cause of hospitalization in the U.S. After a diagnosis of heart failure, approximately 50 percent of patients will die within five years.

The APOLLO Trial evaluates the safety and effectiveness of an investigative treatment for patients with MR: the Intrepid™ transcatheter mitral valve replacement system. This system is currently used only as part of the clinical trial and is not approved by the FDA. University Hospitals Harrington Heart & Vascular Institute is the only hospital in Northeast Ohio participating in the trial.

“We have other options for treatment of MR, but they have some limitations,” said Guilherme Attizzani, MD, interventional cardiologist and Co-Director of the Valve and Structural Heart Disease Center at UH Harrington Heart & Vascular Institute. “Some patients with MR whose mitral valve also happens to be narrow (stenosis) sometimes do not do well when treated with the only FDA approved technology to date because it can make their valves too small. The APOLLO Trial is important because it allows us to replace the mitral valve in these patients in a minimally invasive fashion.”

Jean Mirossay of Concord, Ohio was one of those patients.

At 82 years old, she underwent a procedure for a mitral valve clip to treat her MR, but it didn’t work well because her valve became too small.

“I take care of myself,” said Mirossay. “I keep up with my house. I shop, cook, clean and pull weeds. But because of my heart I felt so tired all the time. Even trying to pick up a pot felt heavy. I was drained of all my strength. I was starting to feel hopeless.”

“We don’t give up on patients just because they have advanced age,” said Dr. Attizzani. “Though in her eighties, Jean had a lot of zest for life and we wanted to explore other options to try to help her.”

Mirossay learned she qualified for the APOLLO Trial and eagerly signed on as a participant.

“Jean’s procedure went well and we could tell immediately that it was a success,” said Dr. Attizzani. “It’s a minimally invasive procedure where we go in through the femoral vein and up to the heart through a blood vessel. We don’t make a big incision. This leaves patients with less pain and a quicker recovery.”

“It was over in no time,” said Mirossay. “I had no pain whatsoever and I was home the next day. It was amazing.”

As part of the trial, Jean’s progress will be followed for 10 years. Shortly after the procedure she reported improved energy and stamina.

“I don’t think I would be here without being a part of this trial,” said Mirossay. “I’m so grateful my doctors didn’t give up on me. I have an extended quality of life now.”

For now, use of the Intrepid™ transcatheter mitral valve replacement system is limited to clinical trial sites, but if it proves safe and effective it could receive FDA approval and be available at hospitals across the country.

“UH Harrington Heart & Vascular Institute is at the forefront of innovation with the ultimate goal of providing hope and a better quality of life for our patients,” said Dr. Attizzani. “We’re proud to be involved in clinical trials investigating new approaches for patients with few or no other options.”

Related Links

The physician scientists at University Hospitals Harrington Heart & Vascular Institute are involved in ongoing research to perfect methods of treating heart disease in patients of all ages. To learn more about research and clinical trials at University Hospitals, visit UHhospitals.org/UHResearch.