Conference Coverage

PARTNER outcomes hold firm over time

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TAVR is here to stay

There’s no question that TAVR is here to stay. In PARTNER and in registries from Europe, the valves have been shown to be durable. The 3-year outcomes are superb, compared with conventional AVR. We don’t know about years, 5, 6, 7, or 8; we still have to follow.

One of the questions here, as the valve gets better moving forward, is to define who is the best target for this. We’ve all seen the bar coming down from use in extremely high-risk patients, and now there are more and more trials in lower-risk patients.

On the other side of the fence, in very-high-risk patients, there is a time when people may be so high risk that we would be doing something futile. With such an expensive surgery, we have to "tune up" that a little bit. I hope that we refine those criteria in the future.

Aortic valve replacements frequently leak, and leaks can be mild, moderate, or severe. In the PARTNER trial, even a mild leak was associated with a higher risk of events over the follow-up period, which in the European registries doesn’t show up. That still remains a mystery. It may be a marker of something else that is going on with these patients.

Dr. Miguel A. Quiñones is a professor of medicine at Cornell University, New York, and chair of cardiology in the Methodist Hospital System, Houston, Tex. These were some of his comments at a press briefing after Dr. Thourani’s presentation. He had no disclosures.


 

AT ACC 13

Dr. Patrick T. O’Gara cautioned against generalizing results from the PARTNER cohort, which averaged 84 years in age. "We have durability information in the octogenarian group over 3 years of time. When we think about deploying this kind of technology in younger and healthier individuals, there remain concerns about durability and about paravalvular leaks," he said at a press briefing.

Concerns about some findings, such as the 44% mortality rate at 3 years, may amount to unnecessarily "throwing darts" at the TAVR results, he suggested. "Let’s remember that we’re dealing with a group of patients who are 84 years of age on average. Our expectations for their outcomes need to be tempered by the context in which these procedures are offered," said Dr. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

Each TAVR costs approximately $70,000-$75,000, Dr. Thourani estimated.

Edwards Lifesciences, which makes the transcatheter valve replacement systems, funded the PARTNER trial, and Dr. Thourani and some of his coinvestigators disclosed financial relationships with the company. He also disclosed relationships with St. Jude Medical, Marquet Medical, Sorin Medical, and Medtronic. Dr. O’Gara had nothing to disclose. Dr. Gersh disclosed financial relationships with St. Jude Medical and Boston Scientific.

sboschert@frontlinemedcom.com

Twitter @sherryboschert

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