Top Docs 2016: Replacement Parts

A new type of replacement heart valve gets a trial at The Christ Hospital—and FDA approval.
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Dean Kereiakes, MD, Cardiologist
Medical Director of The Christ Hospital Heart and Vascular Center and The Lindner Research Center

—As told to Alyssa Brandt

“Aortic valve stenosis—narrowing of the aortic valve—prevents blood from flowing efficiently from the heart to the rest of the body, which can lead to fainting, chest pain, heart failure, and cardiac arrest. By the time a person is 80 there’s a 10 percent chance, plus or minus, that there is some aortic stenosis. Risk factors include things like high LDL cholesterol, high blood pressure, and smoking. Occurrence in men versus women is pretty evenly split, about 50–50. Once someone is symptomatic, life expectancy without treatment is less than two years; the heart is working so hard, it just gives out. Patients who are at a high risk for surgical valve replacement, due to age or previous cardiovascular surgeries, can be helped by trans-aortic valve replacement [TAVR], which uses a catheter to deliver the valve replacement, instead of open-heart surgery.

The Sapien 3 transcatheter heart valve [S3] is a significant improvement in technology for a few reasons. One, it’s smaller than the previous two generations by 66 percent. In terms of diameter change, think pencil versus baseball bat. The valve’s smaller diameter means the hole we make in the artery can be smaller. It’s more flexible. Think about a straight device going around a bend; it doesn’t work too well. In older people, the heart is often more horizontally positioned than vertically, so a smaller, more flexible valve can be delivered better, and precisely positioned more quickly and efficiently. The S3 has a skirt made out of a putty-like substance that creates a better seal, which significantly reduces blood leakage around the new valve. It also comes in a greater range of sizes.

The FDA approved the Sapien 3 valve for use, in part, because of clinical trials here at The Christ Hospital. We were second in the country to use the S3, and our clinical trial mortality rate was ranked number one out of 65 trial centers across the country, including Cedars [Sinai, in Los Angeles] and Mayo [Clinic, in Rochester, Minnesota]. We’ve also placed the S3 in the oldest patient. That was three years ago. He’s a World War II vet and is about to celebrate his 100th birthday. He’s amazing. Some people would ask why replace the aortic valve in a 97-year-old? My answer is, go meet the guy and talk to him. Then tell me we did something wrong.”

 

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