Re: [½ðɽ¶¾°Ôʶ±ð´ËÓʼþΪÀ¬»øÓʼþ]Re: [HSF] Mitrofast

[陈鑫]

Dear Ben:  

have you get my e-mail, Ben.  Steve 


----- Original Message ----- 
From: "Ben Bidstrup" <benjamin.bidstrup at bigpond.com>
To: <OpenHeart-L at lists.hsforum.com>
Sent: Monday, April 23, 2007 5:43 AM
Subject: [½ðɽ¶¾°Ôʶ±ð´ËÓʼþΪÀ¬»øÓʼþ]Re: [HSF] Mitrofast


> This raises a few more points.
> 1. I recall Guyton's review of DES vs Surgery past year. 'I'll be 
> able to fix your heart with a little prick in the groin rather than a 
> big cut in your chest." Gruentzig. Same now will apply to MV Repair. 
> Omitting of course " If it fails either soon(er) or later, you can 
> have the valve replaced." No discussion of the pros and cons of valve 
> replacement!
> 2. Many reviewers and even editors have a very selective approach to 
> what is published. So a new device may have some trouble getting a 
> look in for many reasons. It sometimes needs to be in a journal that 
> specialises in new technology at first. Here the science is proof of 
> concept, not an RCT. IMHO this often needs a slightly different 
> method of presentation to that seen say in a mainstream journal. 
> Often the conclusions are ramped up a lot and unjustified by the 
> data. I have seen that when a valve repair device was published in a 
> cardiology journall and the criterion for success was as noted below 
> a reduction of 2 grades. To us - absolutely unsustainable. A bit like 
> reduction of luminal diameter from x to y, RReduction of 50%, but 
> still leaving a 45% lesion!
> 
>>Ani,
>>   That was a fairly thorough dismantling of the indications for  Mitrofast! 
>>"Time consuming" reconstruction of the posterior leaflet is  highly effective
>>and should not be an excuse for substituting a device with no  long term data.
>>  It's the same logic that makes me crazy when I hear  interventional
>>cardiologists like Ted Feldman shilling for E-Valve (check his 
>>website).  For those
>>who may not know, this is the catheter delivered clip  that produces the
>>equivalent of an unsupported Alfieri.  The patients he  recruits for 
>>his EVEREST
>>study are those with myxomatous P2 prolapse.  I  believe the minimum 
>>age for the
>>study is 18.  A "successful" deployment of  the E-valve is when it produces a
>>reduction of 2 grades in the severity of MR  (i.e., 4+ to 2+).  If that was my
>>criterion for a successful repair, I  would be out of the mitral repair
>>business. Even moderate MR adversely  impacts the long term 
>>survival. It is well
>>documented in the literature that an  unsupported Alfieri (no ring) done by
>>Alfieri himself has moderate or worse MR  after 3 years.  Why should 
>>E-Valve be
>>any different?  In addition, the  clip produces intense scarring and eventual
>>calcification that will make  eventual open repair difficult, if not 
>>impossible.
>>  For example, they would  be willing to implant an E-valve in a 25 yo woman. 
>>If it failed 5 years  later, she would likely need a mechanical replacement. 
>>The odds of her  making Medicare would probably be less than 20-30%. The
>>logic of these doctors  in comparing E-Valve to conventional mitral 
>>repair is that
>>the overall results  of mitral repair in the literature are not uniformly
>>good.  Though I  haven't seen what sources they cite, I would bet 
>>that they are
>>mixing in repairs  for other etiologies, such as ischemic.
>>   Believe it or not, I still think Mitrofast might have some use for  the
>>indications I previously cited (calcified posterior annulus, severe 
>>SBE).  The
>>fact remains that mitral replacement increases operative  mortality and
>>shortens life as compared to repair. However, I would want to  see Mitrofast
>>successfully used for these indications in significant  numbers. 
>>Surgeons like Bojan
>>and those in Germany with Mitrofast  experience will hopefully get their
>>results in print in the near future.
>>
>>Hal
>>
>>
>>
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> 
> 
> -- 
> Ben Bidstrup FRACS FRCSEd FEBCTS
> Consultant Cardiothoracic Surgeon
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