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Cardiology Homepage

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Study: Catheter-based TAVR heart procedure better than aortic valve surgery

Press releases may be edited for formatting or style
NEW ORLEANS – Many patients who need a new aortic heart valve can have it safely implanted through a catheter rather than open heart surgery, say study results announced today at the American College of Cardiology’s Annual Scientific Sessions in New Orleans.

“This isn’t just a paradigm shift; it’s a complete flip on its edge,” said Dr. Janet “Gigi” Wyman, nurse practitioner and manager of the Henry Ford Center for Structural Heart Disease. Dr. Wyman was part of the panel responding to Sunday’s announcement at the largest annual gathering of cardiologists in the world. The results were also published today in the New England Journal of Medicine.

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The Partner-3 trial results announced today compared transcatheter aortic valve replacement, or TAVR, in low-risk patients with symptomatic severe aortic stenosis to patients who underwent surgery. The trial involved 1,000 patients – including patients at Henry Ford Hospital – and was led by Columbia University cardiologist Martin B. Leon. The trial results showed TAVR was superior to SAVR at reducing death, stroke, or re-hospitalization at 1 year in low-risk patients.

Dr. William W. O’Neill, director of the Henry Ford Center for Structural Heart Disease, in 2005 was the first cardiologist to perform TAVR in the United States. The procedure – using a catheter through the groin to replace a defective aortic valve – was first performed in France in 2002.

The U.S. Food and Drug Administration, which regulates medical innovation in the United States, initially limited TAVR to high-risk patients who were too sick to undergo surgical aortic valve replacement, or SAVR. TAVR’s initial success led the FDA to commercially approve TAVR in high-risk patients in 2012 and allow studies to proceed in medium- and low-risk patients.

“When I saw news of the first TAVR ever, the medical skeptic in me thought ‘This will never work,’” Dr. Wyman said. “TAVR will now eventually become the first choice for aortic valve repair and replacement for the vast majority of patients. This is going to mean a seismic shift in our approach to discussions with patients, internal operations and future planning.”

Although the trial for low-risk patients is complete, FDA approval is still pending for TAVR to be commercially available for low-risk patients, she added.

Patients in the Partner-3 study had a mean age of 73 and were experiencing symptoms of advanced aortic stenosis, including shortness of breath, chest pain, fainting or palpitations. Those who underwent TAVR, which avoids a large chest incision, were suitable for access through a blood vessel in the groin and had a low risk for complications. Patients who were frail, had a bicuspid valve or left ventricular ejection fraction of less than 30%, recently experienced a heart attack or had other medical issues were excluded. The patients were randomized 1:1 for surgical or catheter-based valve replacement with a SAPIEN-3 valve manufactured by Edwards LifeSciences.
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