[HSF] Mitrofast

Sun Apr 22 12:46:17 EDT 2007

Well avoiding "time-consuming" reconstruction is indeed the essence of the Mitrofast. I think in this debate Bojan and others should declare any conflict of interests regarding the concept, product or the company so at least we know how objective the statements are. I personally do not have any conflict of interest and like I said Mitrofast may indeed be the future of mitral valve repair but at present time we simply do not know and need proper scientific evaluation.

Bojan's own institution website says of his Mitrofast Project.....        "Degenerative and ischemic mitral insufficiency take an increasing part in cardiac pathology today. On the other hand, the lack of the artificial valves, whether mechanical or biological, is leading to the higher necessity for the application of a valves reparation technique in such patients. The existing valves reparation techniques require a relatively long period of learning and they are characterized as having a bad reproducibility, which means that it is not possible to predict the results of a reparation before activating a heart again"

Clearly it is a procedure being marketed as an alternative to the difficult operation of mitral valve repair and not for those rare instances where repair fails. It is even being used for ischemic repairs as was in Liepzig (now is that a difficult repair to do?). I recall form previous debates on this subject Bojan had said his repair rate (for degenerative disease) was practically zero before he used Mitrofast, as he was not trained in mitral repair, but now over 50% with Mitrofast, and in more recent posts he has described using neochords for anterior leaflet to complement Mitrofast - whatever happened to the long period of training and bad reproducibility? If you can place chords on the anterior leaflet surely you can also do same on posterior in preference to using a $4,000 device?

In dissecting opinions on this forum it is important that we distinguish science and objectivity from individual biases that may be driven by conflicts of interest. Shelhigh - a US company - sought a center in Croatia to be its prime center for human 'testing' of Mitrofast - I find it hard to believe that the institution or individuals concerned have gained nothing (from Shelhigh), or have nothing to gain, from promoting Mitrofast. It is also not accurate that Mitrofast has not been given a forum - it is subject to the same peer review process that all of us are subject to but for some reason  our peers have felt the data are not worthy of presentation or publication. There are standards - scientific and ethical - that have to be met for human and animal research; if these are met it is unlikely that an abstract or paper will be continually rejected. I reject a lot of papers my self and generally it is because of inadequacy of the scientific method. The fact is that objectively hypothesis or logic driving Mitrofast as currently promoted is at best weak - without hypothesis or logic data are irrelevant. Unless the study is refined with specific rationale and device indications, it will be a very difficult sell to the unbiased mind.

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: Sunday, April 22, 2007 9:26 AM
  Subject: Re: [HSF] Mitrofast

  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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