[HSF] More Bad News About Trasylol

[prasannasimha]

Ani,
Hal has a high "gut instinct" practice and probably has developed it 
from years in private practice where hands could get pretty badly burnt. 
I think his cautionary approach is based on "defensibility" in case 
something goes wrong. A sick patient may probably be "defended" as "but 
he was basically sick in the first place"  whereas giving a potentially 
litigatable drug opens a different can of worms were "impressions" play 
more of an unfavorable role wrt a jury rather than science.
Prasanna

Ani Anyanwu wrote:
> Hal
>
> Did we not all know you and your practice we would be thinking you are chickening away from complex problems because of lawyers! I bet you though that with the level of complexity of your cases, there are more than abundant sources of litigation for peri-op complications than aprotinin; yet that has never made you think twice about taking on high risk cases. So why this disproportionate reaction to aprotinin? I would be interested to know what you perceive as the risk of aprotinin. How many patients do you think you have to give aprotinin to end up with one on dialysis? 5 patients? 50? 500? 5000? 50,000? What risk do you consider acceptable? On the other hand you must have had a few patients having complex surgery die of hemorrhage - what do you perceive as an acceptable incidence of life threatening hemorrhage? I suppose the lawyers will not sue for not using aprotinin- death or morbidity from bleeding is fine but renal failure is not.
>
> I suggest to you that what is in operation in your views on aprotinin is a mix of selection and recall bias - we tend to remember the bad experience and forget all the good ones. I challenge you to give us the data - indeed you are best suited to do so given the exceptionally high case complexity and co-morbidity index in your practice (i.e. the very cases for which aprotinin is advanced). Why don't you check the incidence of ATN etc in patients of yours in your aprotinin era as compared to the current era? This will be a very publishable study>
>
> John Hunter, one of the founders of our discipline once said (on the importance of actually experimenting rather than making assumptions) "when I did the experiment, the results were different" which goes to say that when we actually go back and count we often find that our conceptions and assumptions are wrong. So the surgeon who says he has had one wound infection in 2 years is rarely being factual. Indeed it is interesting to note how high complication rates are when collection of outcome data is systematic and mandated (such as in New York where the stroke rate after mitral surgery is 1.5% on the Database - yet I bet most New York surgeons will insist they have never had a stroke after a mitral for many years). I suspect if you objectively looked at your data that you will suddenly start finding patients (who did not get aprotinin) on dialysis who you have long forgotten - for the type of cases you do ATN is an inevitable complication, aprotinin or no aprotinin. While aprotinin may contribute there are numerous other reasons in your practice why patients may get renal failure; for example did you know the pre-op creatinine clearance and renal ultrasound on the 85 year old?
>
> 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, October 01, 2006 9:43 PM
>   Subject: Re: [HSF] More Bad News About Trasylol
>
>
>   Tom,
>     Everything you say may be true, but until I get a green light from  the 
>   FDA, my use of aprotinin will probably be limited to circ arrest  cases and 
>   chronic dialysis patients.  I just don't need the  potential litagation hassles.
>   Hal
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