[HSF] Mitrofast

Ani Anyanwu anianyanwu at hotmail.com
Sun Apr 22 23:51:36 EDT 2007 

Dear Bojan,

Thank you for the clarifications. Just three points I would like to respond to
1. You have indeed declared at least two sources of individual or institutional conflict of interest. a) traveling support and b) provision of subsidized (actually free) products from the manufacturer. There is nothing wrong with having conflicts (most experts and academics do, and several have declared their conflicts on HSF), but for obvious reasons they must be declared. 

2. The quote I got was from the website of Dubrava University Department of Cardiac Surgery and not from Shelhigh. It was actually in English so I did not require a translator. Anyone interested can check it out for themselves on http://www.kbd.hr/kardkir/znanostE.htm#MF<http://www.kbd.hr/kardkir/znanostE.htm#MF> but below is exactly as the entry is on the website. 

Application of the "hemivalve concept" in mitral valve repair
Main investigator: B.Biočina
Short description: 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.
According to the dr Shlomo Gabbay (New Jersey Medical School, New Jersey, USA) and Shelhigh Company's original idea and patent, for the first time in the world usage an innovative hemivalve concept has been introduced in the practice of mitral valve repair..
The idea of this method is in covering the posterior cusp of a mitral valve with a special added piece of a reparation ring (so-called a mitral valve stent) and on that occasion the further valve function depends on/is built upon the function of an undamaged anterior cusp. Specially designed gauge provides a possibility of the complete verification of a valve function before activating a heart. Clinical implantation has been done within ten patients, with excellent clinical result. This method could considerably contribute to mitral valve repair techniques in cardiac surgery.

3. If your institution indeed did not get any financial recompense from Shelhigh for testing of this device then you were short-changed by that company and they are applying differing standards in Croatia as they would in the US. If indeed it was an investigational study then your institution was entitled to reasonable compensation to cover study and other costs - "revenue" from participation in industry sponsored research studies is one of the sources of funding of academic departments. 

Ani

  ----- Original Message ----- 
  From: bbiocina at kbd.hr<mailto:bbiocina at kbd.hr> 
  To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com> 
  Sent: Sunday, April 22, 2007 1:01 PM
  Subject: Re: [HSF] Mitrofast


  Ani ,

   as the isue is getting taft , point by point , quickly.

  1. I do not have any conflict of interest regarding Mitrofast  or
  Shelhigh ( I am not a consultant , I am not a shareholder , I do not 
  have ANY written agreement , especially financial, with Shelhigh , I am
  not a patent holder , I have no  share options. I have never received 
  ANY money  from Shelhigh or their distributors for my  involvement  in
  the project ( apart of  travel expenses). THIS CAN BE USED AS A
  DISCLOSURE STATEMENT. How many other "investigators" can do so?
  2.I have no connection  with marketing ,and I take no part in it .
  Marketing goals are exclusive responsability of Shelhigh. I repeatedly
  said that this concept can be used INSTEAD  OF CONVENTIONAL REPAIR OR
  WHEN  THE CONVENTIONAL REPAIR IS NOT POSSIBLE.THE PROOF FOR BOTH EXISTS.

  2.The quote from my institutional website
  http://www.kbd.hr/kardkir/<http://www.kbd.hr/kardkir/>  - Shelhigh is NOT my institutional website
  ( which quote , by the way , I was unable to  find) can be easily applied
   to the situation in US   previously described by Michael ( we are still
  missing your oppinion on that problem/ my last answer from the previous
  posting)

  One much more important point : as my institutional website is in
  Croatian , you either a) speak Croatian b.) had a translator . Please 
  provide  a link to  the  quote  to all of us , or  disclose the
  translator , if he/she does exist.

  3.Patient in Leipzig has not been done ( or indicated ) by  me , and I
  previously  stated many times that I have only ONE ( out of 27) ischemic
  MR in my series

  4. The ONLY patient  in my series with adittional arteficial chordae was
  done  during Prasanna's visit ( actually , Prasanna did  it , as he
  described  in his previous postings!).

  5. I do not know  where from you extracted a $ 4000 price tag?!!. In
  Zagreb , we do not  pay for the device  not  charge them to Croatian
  Health Insurence  either!!.If that price tag exists( please , tell us
  where) , it does not have  anything to do with me .

  6. "Testing " of new devices in humans , as YOU described in one of
  recent postings , is a common practice  of US companies in Europe ( and
  results lately  can be accepted by FDA).For an unknown reason , you
  think that Croatia is either not in Europe or is somehow different 
  BUT-----------
  Apart from my Ethical Committee , the usage  of the device has been
  cleared  by relevant  boards  in Aachen, Dortmund , Augsburg ,
  Regensburg (Germany ) , Szeged ( Hungary) , Leicester(UK) .Enough?
  And  your " hard to believe there is no gain from Shelhigh" question 
  should  be directed to them also ( or  you might have a proof!)

  4. Regarding your thesis of  unbiased peer review  , who  are right  not
  to accept  even valid data without "hypothesis or logic" ( and they
  decide , regardless  their possible involvement  with a COMPETING
  company, what is that) , I can only direct  you to one of the last
  Hal's postings about his  publishing experience  with cryo Maze ( you
  probably trust  him more than you trust me).

  Bojan


  On 4/22/2007, "Ani Anyanwu" <anianyanwu at hotmail.com<mailto:anianyanwu at hotmail.com>> wrote:

  >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<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: 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
  >
  >
  >
  >  ************************************** See what's free at http://www.aol.com<http://www.aol.com/<http://www.aol.com<http://www.aol.com/>>.
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