[HSF] More Bad News About Trasylol

rsboova at comcast.net rsboova at comcast.net
Mon Oct 2 18:18:34 EDT 2006 

Tea - part of my decision making process regarding Aprotinin is that all CABG's are done by OPCAB. I believe one of the  benefits of OPCAB is less bleeding and is why I have gone  this route .
Therefore the cases done with CPB are valves , valve + cab ( actually isolated CAB approx 30% overall OHS volume ) etc. For these cases I use full dose aprotinin routinely , including patients w/ elevated baseline creatinine .
There is definitely no increased incidence of morbidity, mortality,
  and definitely no ESRF requiring dialysis ( non - existent ) despite very advanced age and advanced risk patient population. 
The valve patienst are at higher risk for  end organ complications (CVA , renal fail , MI etc ) but this has not been my experience w/ aprotinin . Again anecdotal but has been a large experience
It seems that much of the discussion pertains to aprotinin w CAB
I too will not change my practice unless FDA mandates but will continue to monitor outomes carefully as in the past.
RSB

-------------- Original message -------------- 
From: Tea Acuff <tacuff at swbell.net> 

> 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 
> 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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