[HSF] Mitrofast

Ani Anyanwu anianyanwu at hotmail.com
Sun Apr 22 01:56:43 EDT 2007 

Well Prasanna show me the data - any data - that the Mitrofast works in Carpentier IIIA dysfunction, or indeed in any dysfunction. It is alright for us to theorize but maybe we should for now restrict ourselves to the advertised indication for Mitrofast (leaflet prolapse) and not putative and possible applications. I can understand the limitations Bojan and others face in publishing their clinical data, but how about animal data? There are none. Which again highlights the parody of Europe and the CE mark - how can we be placing a device in humans for which there are not even animal data showing efficacy? The existing data would not even get approval to run an investigational trial in the USA.

Tonight I did a literature search and found only one published paper on Mitrofast - it was a study of the device in FOUR sheep illustrating that the device can be used to treat P2 prolapse. No other dysfunction or lesion was mentioned in that animal paper. Indeed in the discussion the authors focus on a device that will help eliminate "time consuming" leaflet reconstruction (i.e. sliding plasty) stressing that it could be placed under 30 minutes compared to much longer time to do a complex valvuloplasty. The Manufacturers are marketing this device a treatment for prolapse and not for restriction. Anyone who suggests other than the indicated role should do the experimental work and show that it works. Somehow I suspect that if a rigid P3 does not coapt then replacing it with a rigid or semirigid shelf may not be the solution. 

Regardless how could surgeons ethically implant a device, outside the context of experimental study, when there is not a single clinical paper on its use or outcome and only one published experimental paper based on four animals, and where there is an effective existing therapy? I am not even sure there are enough data to ethically approve an investigational study in humans as while the concept may be appealing there are currently no data that it even works. The IRB (ethics committee) in my hospital would laugh if I proposed doing a study in humans, and all I had to back it up was four implants in sheep. Like Hal says in the implant I witnessed 17 months ago, MR was far from eliminated. 

It may well be that Mitrofast is indeed the future of mitral valve surgery but at present time we simply do not know that as there are no efficacy, effectiveness or durability data in either animals or in humans.

Ani

----- Original Message ----- 
  From: prasannasimha<mailto:prasannasimha at gmail.com> 
  To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com> 
  Sent: Saturday, April 21, 2007 9:56 PM
  Subject: Re: [HSF] FDA


  Ani, Acar's hemivalve is different from the Mitrofast. His Hemivalve was 
  AP and not posterior. The valve primarily degenerated.
  The Mitrofast concept is different giving an area of coaptation. 
  Conceptually very different.
  I also think as Hal say that it could have a potential use in extensive 
  irreparable posterior leaflet pathologies. As far as rheumatics I do 
  disagree - in young rheumatics - if the valve can be saved at times just 
  the P3 region just does not coapt despite various  maneuvers. The P3 
  area is the angle of sorrow and Yes I have gone through the cycle of 
  posterior leaflet augmentation etc etc but there are some valves with a 
  pliant AML where the PML just doesn't "behave" (if you get what I mean) 
  and I see a possible role specifically in these patients.
  The regular P2 prolapse is very repairable with conventional methods.
  I am curious about one thing - how many cardiac surgeons actually repair 
  the valves (though  people talk that repair is better than replacements ?)
  Prasanna
  Ani Anyanwu wrote:
  > Hal
  >
  > I think if the posterior leaflet is really irreparable then one should question whether there is any value in preserving the  valve. Acar's series of hemivalve posterior leaflet replacement (admittedly with homografts) did not have encouraging results. I suspect that in the rheumatic or calcified posterior annulus replacing calcified tissue with a rigid or semirigid surface will not necessarily result in an optimally functional valve with no stenosis or regurgitation. In endocarditis you can reconstruct the posterior leaflet with pericardium, gortex chords and sliding of the commisures (if so desired). I think such indications are rare and suspect that if you look at the mitrofast implants, most would have been done on reparable posterior leaflets (the one I saw in Leipzig could have been fixed with a simple ring). 
  >
  > There is a reason why this device has been very slow on uptake and why there have not been peer reviewed publications - I would still want to know if there is anyone on this forum who would have one placed in his heart. I agree with you that we should experiment and investigate new techniques - but this should be with appropriate informed consent. I doubt there are many IRBs that would give approval to an investigational study of the Mitrofast for the advertised indications.
  >
  > Ani
  >   ----- Original Message ----- 
  >   From: Hgrmd at aol.com<mailto:Hgrmd at aol.com<mailto:Hgrmd at aol.com<mailto:Hgrmd at aol.com>> 
  >   To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com>> 
  >   Sent: Saturday, April 21, 2007 10:22 AM
  >   Subject: Re: [HSF] FDA
  >
  >
  >   Bojan,
  >     Where I would potentially be interested in using Mitrofast (once  this FDA 
  >   problem is rectified) would be for mitrals where the posterior leaflet  isn't 
  >   repairable in my hands.  Unlike Carpentier, I haven't been able to  safely 
  >   decalcify and reconstruct heavily calcified posterior leaflets.   Another 
  >   potential application I could envision would be for extensive SBE  destruction of the 
  >   posterior leaflet.
  >    
  >   Hal
  >
  >
  >
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