Edwards to Begin U.S. Trial of SAPIEN 3 Valve for Intermediate Risk Patients

[Lynlw]

http://www.edwards.com/newsroom/Pages/NR20140113.aspx

January 13, 2014 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a single-arm, non-randomized clinical trial of the SAPIEN 3 transcatheter aortic heart valve in the treatment of intermediate risk patients with severe symptomatic aortic stenosis....

...The new U.S. trial of the SAPIEN 3 valve will enroll up to 1,000 patients with a Society of Thoracic Surgeons score of four to eight percent, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a SAPIEN 3 valve..."

 

[epstns]

Thanks, Lyn. This will be one to watch closely.

 

[Duffey]

Thanks Lyn.

I have a question. " . . . a Society of Thoracic Surgeons score of four to eight percent, which indicates the average predicted risk of operative mortality at 30 days..."

Any idea how a person such as those who come to VR before surgery would rank with this score? It says "intermediate risk" but is that the same, more, or less than what members of VR would expect to be ranked?

 

[Lynlw]

Thanks Lyn.

I have a question. " . . . a Society of Thoracic Surgeons score of four to eight percent, which indicates the average predicted risk of operative mortality at 30 days..."

Any idea how a person such as those who come to VR before surgery would rank with this score? It says "intermediate risk" but is that the same, more, or less than what members of VR would expect to be ranked?

You know I've been trying to figure out what these various scores really mean for a long time. , I know one of the problems w/ the Euro scores, and why people did much better than the predicted risk, was they hadnt updated their scores in a couple decades, as surgeries improved so much but the STS updates pretty frequently, so more realistic as far as chances of morality. I think they updated the Euro scores recently or are updating them now. I believe even tho the STS is closer to acual mortality, it still predicts higher mortality than actually happens. I don't know what the "baseline" would be

But I don't know and I really stink at math and stats and when I read studies on Math it is kind of like how the adults sound on charlie brown in my head. But My GUESS would be quite a few members would qualify as "intermediate" if it goes down to 4% risk. I would imagine, that depending on what surgery you are getting they start with a baseline, for each surgery like a Aortic valve would be a little higher than a CABG like 1-2 % then depending on a list of other things, comorbidities, age health it goes up or down for that patient.
I dont know if this helps
http://www.annalsthoracicsurgery.org/article/S0003-4975(09)00794-2/fulltext

 

[ottagal]

Thanks for this info, Lyn. As Steve said, it will be one we will be watching closely!

 

[ALLBETTERNOW!]

This is great news, really seems like edwards is making great strides with he sapien valve. As a 49 year old with a new tissue valve, this is great news and along the lines of what the surgeon was hinting at when we. Discussed uncertain but potentential for a valve in a valve next time around. Now we need a durable valve to go 20+ years! that evidence could be rolling in as there are a lot of edwards valves in circulation! I am hoping for 10 but praying for 20+ out of my edwards magna