[HSF] FDA

[Ani Anyanwu]

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There is a reason why this device has been very slow on uptake and why there have not been peer reviewed publications - I would still want to know if there is anyone on this forum who would have one placed in his heart.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> 
  To: 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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