AW: [HSF] Valve Dysfunction - Faulty technique

Nasser F. Abou'Seada nfaabouseada at gmail.com
Fri Dec 15 10:38:04 EST 2006 

well ....
if we put apart the insinuation behind the thoughts .... then .. I would
totally agree with Ani's experience .... !!

I have seen surgeons doing the same .... testing for the valve leaflet
mobility using "Pick ups" ... rotating a valve after insertion with
"Robert's" ..... -Monocuspid Valves- .... the wonderful thing is that IMH
Experience, I have seen no valve-related complications in these particular
patients ..... yet ... this is just an unfounded observation. 

I would seriously question the old practice of rotating a valve not using
its rotator .... but a "Robert's" ...  for sure putting an extra stress on
the valve axis that is not designed to be submitted to such stress, is a
serious faulty technique .... however ... I have not seen any cases of strut
fractures in these cases .... a divine action I suppose ... still .... a
random observation ...!!

Nonetheless .... I can't see how testing the leaflet mobility -touching with
the tip of a pick up- would affect leaflet mobility ...... may be can damage
the carbon cover of the leaflet ... may be related to thrombogenic
complications !!!! ... I don't know .... sure it is a faulty technique ...
yet can not be incriminated in the failure of closure dysfunction .... ...!!
.. simple mechanics ... !!!! ...... different issues .... 

Implications that a surgeon can be the cause of the failure .... -no
personal offense- ..... can for sure be valid, IMHO may account for the
majority of problems seen .... however these are more likely to appear
immediately once valve is functioning .... or likely to appear late due to
dehiscence or rupture ..... . or the least .... a surgeon would not go
complaining while he knows where the fault is .... is he knows from the
start ......  yet for sure ..... can not be implicated in totally unrelated
mechanical issues ... 
I do wonder whether inserting a non-well spaced stitches resulting in
crumbling of the valve annulus, would result in application of a force of 2
pound's to the annulus ..!!

trying to implicate faulty surgical technique is certainly to be taken into
account .... however ... one can not use that as a non-specific defensive
shield against all other non-related faults ..... -no personal offense- 

Still .... I think the discussion has gone so far beyond the purpose of the
thread .... I do agree vigorously with Bob that putting the legitimate
aspect first before the scientific one ... is a serious  concept .... both
ways .... 
Still .... I believe that Keeping the Valve in a safe custody is a must-
practice ... -if it is retrieved from the heart- .... as it is likely to be
lost and never to appear should it be asked for in a court of investigations
....

Still .... I do believe that using such blackmailing concepts .... such as
waving with a "faulty technique" ... though I'm sure it is a reality in many
cases .... should not blind our eyes of the fact which is very well
apparent. 

> Of course this should not be a witch hunt - but will be if we chose to be
cagey and less
> open with the industry; it becomes them versus us. If the industry has to
fight to view
> or inspect the damaged good then it will look like we have something to
hide or gain
> by holding on to the product. I agree that industry is often less
forthcoming about
> failures  but we should not sink to their depths, else it will be the
patient that
> ultimately suffers.

your thoughts are mine .... 


NFA

> From: Ani Anyanwu
> There is another reason to hide the valve in the vault in your hospital -
if it is sent to
> the valve company, the engineers may well find out that the surgeon was
the cause of
> the failure. I have seen on several occasions surgeons using metallic
instruments to
> test leaflets or rotate valves, instruments that were not designed for
that purpose. If
> analysis of the valve finds dents or scratches on a valve then guess who
will get the
> 'blame' for inappropriate handling of the product?
> 
> Of course this should not be a witch hunt - but will be if we chose to be
cagey and less
> open with the industry; it becomes them versus us. If the industry has to
fight to view
> or inspect the damaged good then it will look like we have something to
hide or gain
> by holding on to the product. I agree that industry is often less
forthcoming about
> failures (I had recent experience with ABIOMED regarding hemolysis on
AB5000
> pumps) but we should not sink to their depths, else it will be the patient
that
> ultimately suffers.
> 
> Ani
> 
> ----- Original Message -----
>   From: Ben Bidstrup<mailto:benjamin.bidstrup at bigpond.com>
>   To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com>
>   Sent: Friday, December 15, 2006 7:57 AM
>   Subject: Re: AW: [HSF] Valve Dysfunction
> 
> 
>   To support what Bob has stated, each valve has a history. The serial
>   number can usually be retrieved by Xraying the valve and the audit
>   trail looked at. This gives the tolerances of the leaflet fit etc
>   etc. Now, with the pressure from regulatory bodies any funny business
>   is likely to be more damaging than describing a problem.
>   After all, we are replacing what is essentially a well designed valve
>   that has degenerated be it by disease or dint of time with a man made
>   device.
>   We, like our patients expect perfection, but man ain't perfect. We go
>   close but we also err.
>   How does 1 failure in say 100,000 implants compare with the
>   multitudes of stents that have failed with withdrawal of ADP receptor
>   blockade.
>   We are also responsible for our own actions, so putting a high
>   profile valve of any description into a small LV cavity must be
>   viewed with suspicion. We learnt that with early versions of tissue
>   valves and in some cases with the Starr-Edwards.
> 
> 
>   >Nasser,
>   >
>   >(who would have thought that I do hear from you so soon after
>   >Damascus?)  I think a lot has been said already (as Alvarez`quoted
>   >nicely) and the discussion jumped from the  tragedy with a blocked
>   >valve over emergency EC to LV rupture with tissue valves.
>   >
>   >I think we have to separate the problem and I want to comment only
>   >your  initial sad experience: as you have heard personally,  I have
>   >presented the 10yrs data on the ON-X valve and have never ever seen
>   >a blocked valve in aortic position,  which is impossible due to the
>   >ingenious design of that valve. You know that the leaflets are in
>   >what I call a tube and there is nothing like a hinge mechanism like
>   >the opening of a door, but the leaflet slide on a ramp up and down
>   >the housing and simultaneously clean it. I am not aware of anybody
>   >who had this sort of complication with an  ON-X valve.
>   >
>   >Also the ingrowth of pannus (as discussed some weeks before) is
>   >impossible, at least not in aortic position.
>   >
>   >So one should simply look at different valves at the same time and
>   >decide. Same is true for biological valves and the height and
>   >morphology of the struts; but I am not going in to details here. I
>   >do believe nearly all of the postings on this matter. Maybe we
>   >surgeons should rethink the position of the struts, when more
>   >colleagues have seen LV rupture at the 10 o'clock position?
>   >
>   >I would also repeat John Fleges comment in never giving any  valve
>   >out of your hands; I do have negative experiences with 2 companies
>   >some 10 years ago. One valve is not on the market anymore.  Let
>   >somebody inspect the valves in your presence and let also somebody
>   >else have a look to have several opinions and make up your mind. A
>   >cooperation with the Technical University in Cairo and its
>   >department for material testing would be great, if there are
>   >interested engineers?
>   >
>   >Marhaba, Axel
>   >( Laczkovics, Germany)
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> 
>   --
>   Ben Bidstrup FRACS FRCSEd FEBCTS
>   Consultant Cardiothoracic Surgeon
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