Study: Medtronic valve replacement tops surgery after two years

[March 16, 2015]  By Bill Berkrot

(Reuters) - Patients treated with Medtronic Plc's CoreValve non-invasive heart valve replacement system fared better two years after the procedure than those who underwent surgical valve replacement, according to data from a study presented on Sunday.

The data not only showed that results seen at one year were sustained a year later, but that there were greater differences favoring Medtronic's transcatheter aortic valve replacement (TAVR) compared with open heart surgery.

The rate of all-cause mortality or major stroke at two years was 24.2 percent for CoreValve versus 32.5 percent for surgery. The result was deemed highly statistically significant and was a greater difference than one-year rates of 16.2 percent and 22.5 percent.

The difference in all-cause mortality alone and for all strokes in the trial of 750 high-risk patients also favored TAVR by a wider margin at two years.

For all strokes, the rate after two years was 10.9 percent for CoreValve versus 16.6 percent for surgery.
 

"This data is strong enough that it should change our guidelines in the increased risk surgical population where TAVR is not just an alternative to surgery, but it should be the preferred option," said Dr. Michael Reardon, the study's primary investigator, who presented the data at the American College of Cardiology scientific meeting in San Diego.

TAVR systems are considered the most important future growth driver for Medtronic and rival Edwards Lifesciences Corp. Evidence of their long-term durability is seen as critical to advancing physician acceptance. The procedure involves threading the new valve into place in the heart through an artery as an alternative to open heart surgery.

It had been believed that TAVR would have a hard time competing with surgical results, Reardon said.

"We did really good surgery and at two years there was a survival advantage (for TAVR) that was highly statistically significant," said Reardon, a professor of cardio thoracic surgery at Houston Methodist Debakey Heart & Vascular Center.

Echocardiographic findings of how well the valves performed also favored CoreValve, researchers said.

Analyses of various patient subgroups, such older or younger than 80, by gender, severity of risk and whether patients had previously undergone coronary bypass procedures, all favored CoreValve, researchers found.

"When you look at the way the field is going, for me as a cardiac surgeon it may not be that great, but for our patients it's really groundbreaking," Reardon said.

(Reporting by Bill Berkrot in New York; Editing by Peter Galloway)

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