Cleveland Clinic no longer using CE Magna aortic valve replacements?

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G

Grey

Member
Joined
Mar 4, 2011
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13
Location
USA
I just saw Dr Lars Svensson at the CC and he mentioned that they had taken the Edwards Magna and Magna Ease (he called it Magna "plus") aortic valves off the shelves and are no longer using them. He said they did this just recently. I asked if anyone was using them at the CC and he said no, they're no longer available there. They felt they were having too many problems with occlusions of the coronary arteries.

This is the first I've heard of this...is anyone else aware of this?


Grey
 
Grey said:
I just saw Dr Lars Svensson at the CC and he mentioned that they had taken the Edwards Magna and Magna Ease (he called it Magna "plus") aortic valves off the shelves and are no longer using them. He said they did this just recently. I asked if anyone was using them at the CC and he said no, they're no longer available there. They felt they were having too many problems with occlusions of the coronary arteries.

This is the first I've heard of this...is anyone else aware of this?


Grey
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This is news to me. I have an older model, the Edwards Perimount which has been around for some time. It didn't check the Edward's site to see if they have any info on this.
Thanks for sharing,
 
This is the valve I have - I wonder along with Steve how this valve causes occlusions of the coronary arteries.

Doing some Internet searching I found a report from the FDA involving this valve - but it states that a death occurred to a patient due to an implant error and not due to a product error. - I'm not sure if an occlusion of the coronary ostia is the same as an occlusion of the coronary arteries.

"Conclusion: partial or total occlusion of the coronary ostia is a recognized complication of an aortic valve replacement. It is typically the result of a technical error during valve implant and not related to a product malfunction."

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2487725
 
pellicle said:
um, reading that I see:
The patient expired on (b)(6) 2012.

does that mean died?
Click to expand...

Yes, I think so - that's what I thought anyway when I posted

Rachel said:
I found a report from the FDA involving this valve - but it states that a death occurred to a patient due to an implant error and not due to a product error. - I'm not sure if an occlusion of the coronary ostia is the same as an occlusion of the coronary arteries.
Click to expand...
 
I also find it strange that CCF would pull the Edwards valves off the shelf, as I somewhere remember that there was some connection between the clinic and the research that developed the current generation of Edwards valve. It would seem that a member of the development team would be the last to stop using a product that they helped to design.
 
"It would seem that a member of the development team would be the last to stop using a product that they helped to design."

Not if they stopped getting royalties or had a tiff with the company.

From my surgeon, I got the impression that much of valve selection is not "right vs. wrong" but what the surgeon likes and is used to.
 
I know, I found it strange as well. I've emailed Edwards but have not heard back from them yet. Dr Svensson replaced my bicuspid aortic valve 2 years ago with a CE PERIMOUNT 2700, despite the fact I asked specifically for the 3300 Magna for the better hemodynamics. Since then my gradients have been persistently elevated and I've had a bout of prosthetic valve endocarditis. When I asked about my gradients and reminded him of our pre-op valve discussion he told me they had pulled the Magna's "off the shelf". I asked him several times to make sure we were talking about the same thing, and it seems we were. I have not had any other confirmation of that decision, though, and it seems it would be a major development, given the CC's relationship with Edwards, and the number of these valves that have been implanted. I'll let you all know if I hear anything else.
 
If you requested a specific valve and it was agreed to in preliminary discussions, then you have cause to sue if he did not do as requrested. Therefore he needs a reason for not implanting the 3300 Magna. He might have told you that Magna's were pulled off the shelf to stave off problems due to his failure to implant the requested valve.

IIRC in my discussions and signed consent form, choice of valve (valve type in my case not manufacturer and model) and need for additional work (e.g. bypass, anuerysm repair, etc.) if deemed necessary by the surgeon were all covered.
 
I had read this thread and asked my surgeon yesterday about CC and the valves off the shelf. He told me it was a licensing/cost debate, that CE was charging more for certain valves than the research proved as higher value. Not sure it was more than this, not a product quality issue it seems. Hope this helps to worry less.

Eleanor
 
Eleanor said:
I had read this thread and asked my surgeon yesterday about CC and the valves off the shelf. He told me it was a licensing/cost debate, that CE was charging more for certain valves than the research proved as higher value. Not sure it was more than this, not a product quality issue it seems. Hope this helps to worry less.

Eleanor
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That is most interesting information! Thanks for the clarification, Eleanor.
 
ottagal said:


That is most interesting information! Thanks for the clarification, Eleanor.
Click to expand...

Thank you. I believe this is the value added of new folks, who have the opportunity to ask questions about things they have heard or read. I was so relieved that first my surgeon knew what I was talking about, knew about the issue personally from conversations with the director at CC, and most of all that it was a pricing decision, nothing to do with valve problems or anything. It also made me feel more confident in his own decisions, going forward, as I will next see him for AVR on July 14th!

Eleanor
 
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