Northwestern Medicine Bluhm Cardiovascular Institute Home to First Tiara Mitral Transcatheter Heart Valve Replacement in the Midwest, Second in the United States

CHICAGO, May 6, 2016 /PRNewswire-USNewswire/ -- Northwestern Medicine cardiologists and cardiac surgeons successfully replaced a mitral valve using an innovative procedure that avoided open-heart surgery in a high-risk patient.

Part of an elite group in an international clinical trial, Northwestern Medicine physicians placed the artificial valve through a small incision between the ribs before replacing the leaky mitral valve.

The patient receiving the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System, Orest Kozinczuk, 84, of Wheaton, Ill., said two days after the procedure "I already feel the difference."

Kozinczuk, an immigrant from Ukraine who has been married for 35 years, served in the U.S. Army in Korea and learned a series of calisthenics that, for decades, he practiced regularly. When his mitral valve started to leak and his heart became weak, he stopped exercising. Before the procedure, he had difficulty even taking short walks around his home.

"I get to start exercising again," Kozinczuk said, adding he also plans to resume gardening and traveling. He was discharged four days after the procedure.

Considered a high-risk patient for conventional open-heart surgery, Kozinczuk suffered from severe symptomatic mitral regurgitation, leakage of blood backward through the mitral valve each time the left ventricle contracts. As his condition worsened, his symptoms were no longer able to be treated with medication. Open-heart surgery carried, for him, a 10 percent mortality risk.  

Mark Ricciardi, director of the Cardiac Catheterization Center and interventional cardiology at Northwestern Memorial who was part of the team performing the mitral valve replacement, said he was pleased to offer the TIARA-I study as an option for Kozinczuk.

"He's a very motivated man, a fighter," said Ricciardi. "This procedure should get him back to where he was — a very viable octogenarian."

Though he was the first patient at Northwestern, and one of the first in the United States to receive the valve procedure, despite understanding the risks involved, Kozinczuk said he felt confident going into the hospital because he trusted his Northwestern physicians.

"I felt good about having this done at Northwestern," he said. "When I woke up in the recovery area, I congratulated everyone and said  'You did a great job.'"

Patrick McCarthy, MD, executive director of the Bluhm Cardiovascular Institute and the principal investigator at Northwestern for the TIARA-I study, said Northwestern Medicine continues to pioneer the use of less invasive valve replacements, building on the success of being the first heart center in Illinois to replace aortic valves with a transapical approach (TAVR).

Besides the Tiara transcatheter mitral valve replacement, in early 2016 cardiologists at Northwestern Memorial were the first in the Midwest and second in the United States to repair a "leaky" tricuspid heart valve using the Trialign system, an investigational device that allows patients to forgo open heart surgery while still repairing the malfunctioning valve. That procedure was also part of an investigational trial, called SCOUT.

"Part of our mission at the Bluhm Cardiovascular Institute is to be able to offer patients the most advanced, least-invasive options for life-saving valve replacement," said McCarthy, who is the Heller-Sacks professor of cardiothoracic surgery at Northwestern University Feinberg School of Medicine. "We are rapidly advancing the field of cardiovascular care through these new technologies and procedures."

The Neovasc Tiara Mitral Transcatheter Heart Valve is an investigational device and is not approved by the U.S. Food and Drug Administration.   As an investigational device, the Tiara Mitral Transcatheter Heart Valve can be provided for treatment only through participation in the clinical research study.  Northwestern Memorial is one of four sites in the United States, and the only one in the Midwest, investigating the Neovasc Tiara Mitral Transcatheter Heart Valve. The system is an alternative to open heart surgery for those with severe symptomatic mitral valve regurgitation.

The research study is looking to enroll up to 15 patients at the four sites in the United States. For more information about the TIARA study or other investigational studies at the Bluhm Cardiovascular Institute, visit www.feinberg.northwestern.edu/sites/bcvi-ctu.

Northwestern Medicine's Bluhm Cardiovascular Institute is one of the top 10 national programs for cardiology and heart surgery, according to U.S. News and World Report, and consistently ranked the top cardiovascular program in Chicago, Illinois and the surrounding states. For more information about Northwestern Medicine's top ranked cardiovascular care, go to heart.nm.org or call (312) NM-HEART.

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SOURCE Northwestern Medicine