麻豆果冻传媒影音

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SAN FRANCISCO -- The FDA to replace failing bioprostheses in high surgical risk patients, a move based on good 1-year survival and safety results reported here from the PARTNER II valve-in-valve registry.

of St. Paul's Hospital in Vancouver, announced the approval at the end of his presentation of the results at the .

The registry showed a 13.4% mortality rate overall at 1 year for the Sapien XT valve, which dropped to 7.2% at 1 year in the more recent extended-registry data.

The cumulative stroke rate was 3.7% and rehospitalization 11.8% at 1 year in the overall valve-in-valve data.

The CoreValve device was approved for the same valve-in-valve indication earlier this year.

"Although there is no randomized data between redo surgery versus this, it's definitely standard of care at this stage for the high-risk patients," , director of the Sones Cardiac Catheterization Laboratory at the Cleveland Clinic, noted at a press conference where the findings were presented.

However, he cautioned, "the most important thing to understand are the exclusions... Remember this is up to 21 mm surgical valves, so we can't go below below 21 mm surgical valves in this particular registry."

That was the bone of contention for other panelists at the press conference as well.

The findings cannot be directly compared with CoreValve valve-in-valve because that device can be used in smaller diameters associated with higher risk, argued conference co-director , of New York-Presbyterian Hospital/Columbia University Medical Center in New York City.

Use of the Sapien aortic valve also had good outcomes through 1 year post-implant when used in high-risk surgical patients initially, , director of Penn Medicine's Interventional Cardiology Program in Philadelphia, reported at the conference.

One year results with the Sapien 3 valve in PARTNER II showed 87.3% survival in the high surgical risk cohort and 82.3% survival in the inoperable group.

Symptom status as indicated by New York Heart Association class showed no significant change from the initially-reported 30 day point to 1 year, which Herrmann said represented a durable benefit.

The PARTNER II valve-in-valve registry included 97 patients who got the Sapien XT device from June 2012 and April 2013, while the extended registry included another 100 patients getting the device from May 2013 through Dec. 2013.

The PARTNER II Sapien 3 study included 583 high surgical risk patients getting the device in a nonrandomized single arm with historical controls. One-year data for the other group of 1,076 intermediate surgical risk patients in the study is expected to be released at the American College of Cardiology meeting in 2016.