[HSF] More Bad News About Trasylol

Michael Firstenberg msfirst at gmail.com
Mon Oct 2 17:13:26 EDT 2006 

Tea,
In the interest of full disclosure - coated or uncoated
   (and why not generic?   who is paying you off!)

michael

On Oct 1, 2006, at 11:28 PM, Tea Acuff wrote:

> Maybe we should recommend that all CABG be done "off pump" since  
> they clearly bleed less, and likely have less renal failure by  
> whatever criteria.
>
> On the other hand if aprotonin patients actually require say 25%  
> less transfusion ( I am sure Ben can come up with a "real" number)  
> does that follow that all patients of such class deserve  
> aprotonin?  Do all patients with an EF <35% need an ICD? Do all  
> patients with proximal LAD over 50% need a LIMA? Several years ago  
> I heard a talk by a MD/JD who said that all guidelines were for  
> lawyers, not patients and doctors. It is a rope that we give the  
> lawyers with instructions on how to hang us. I actually think that  
> guidelines are developed consciously with that factor in mind. I  
> know that I do think that way because that is how the game is now  
> played and why letting the ACC give the guidelines for surgeons and  
> the patients we see is totally inexcusable if we think surgeons  
> should be involved in any thinking whatsoever.
>
> The dissonance between evidence and practice is deafening in this  
> thread, and we need to come to real terms with this problem as we  
> as surgeons have a foot planted actually each in evidence and in  
> practice. This problem is not a religious or philosophical society  
> discussion. First we need to stop lying to ourselves with this  
> politically correct talk that we have true answers and guidelines  
> to protect all from harm. Then we need to stop promoting the  
> consequences of this lie to the public and our political bodies  
> that regulate us to seek their special dispensation. There are very  
> many consequences that we intuit but fail to formally examine and  
> act upon, eg the FDA, lawyers, credentials, etc. Lastly (and  
> perhaps also firstly) we need to get as real as possible with each  
> patient that we face, not to scare them, but to let them know their  
> options as best as the can from what we know.
>
> I know that I am hard to follow philosophically sometimes, but that  
> is not all my fault as we prefer to look right past these issues as  
> if they don't really exist. We do this at a great peril to  
> ourselves collectively and to our patients.
>
> Disclosure: I take a Bayer aspirin every day.
>
> Tea Acuff
>
>
>
> ----- Original Message ----
> From: Ben Bidstrup <benjamin.bidstrup at bigpond.com>
> To: OpenHeart-L at lists.hsforum.com
> Sent: Sunday, October 1, 2006 9:12:46 PM
> Subject: Re: [HSF] More Bad News About Trasylol
>
>
>> Hal
>>
>> I use aprotinin in almost all cases (especially circ arrest) given  
>> the
>> complexity of the cases I do and our incidence of renal failure
>> requiring dialysis
>> is no different. The incidence of "renal insufficiency" defined by  
>> a 50% rise
>> in creatinine is higher, however, what most people don't realize  
>> is that
>> aprotinin competes with creatinine for renal excretion and you will
>> see a  transient
>> rise in creatinine based on this competition.
>> Phil Hess is one of my partners that is currently studying  
>> aprotinin in a
>> variety of ways and he is much more eloquent at defending  
>> aprotinin than me.
>> According to Phil, an STS advisory committee found that 23 of 26
>> studies that they
>> reviewed on aprotinin showed no significant detrimental effects.  
>> The current
>> "study" that was in the NY Times, as I understand it has a lot  
>> more review to
>> be done.
>> Again, I still think the jury is still out and that in the end we  
>> will have a
>> different recommendation from the FDA.
>>
>> Tom Martin
>> U of Florida
>> Gainesville
>> _______________________________________________
>
> Out of every crisis can come some good.
> One thing this publicity is doing is making people look at their
> practice, not only wrt aprotinin but other things as well.
> Hal is quite prepared to use lots of blood products - that is his
> decision. Does Florida have a separate consent for use of blood
> products delineating the potential adverse effects, and the lack of
> data on efficacy?
> What are the true factors that determine renal insufficiency or
> failure or need for new dialysis (even fluid overload as a reason) ?
> How do we define renal problems? There are simple measures to
> estimate GFR which relate to body mass. Is this going to help us?
> Possibly.
> Maybe the patient (or his lawyer) should be asked to make the choice.
> The NNECVStudy group have a risk calculator which I believe can
> estimate the risk of renal problems after cardiac surgery.
>
> If you look at the paper by Cosgrove et al they showed an increase in
> creatinine clearance with aprotinin. How do you reconcile that with
> the discussion going on at present ?
> There is also a paper by Fauli Eur J Anesth 2005) and a subsequent
> comment by McBride in 2006 that suggests there is a possible
> protective effect of aprotinin on the renal tubule.
> Many years ago we measured urine output and found it was increased in
> 40 patients receiving aprotinin (high dose) for CABG when compared
> with a similar group receiving placebo for the period of 24 hours
> from induction of anaesthesia.
> -- 
> Ben Bidstrup FRACS FRCSEd FEBCTS
> Consultant Cardiothoracic Surgeon
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