[HSF] More Bad News About Trasylol
Michael Firstenberg
msfirst at gmail.com
Mon Oct 2 16:52:30 EDT 2006
What about some of the other "benefits" of aprotinin. The Bayer
people are also promoting the reduced risk of neuro-cogn issues -
something that my former boss strongly believed in. The exactly
literature is escaping me, but I have seen presentations (usually
associated with a nice meal) and read some of the papers - but the
data and science look real.
The problem is not with aprotinin, but with the legal system. When
we discussed the NEJM article and the topic at a joint journal club
Surgery/Anesthesia (with Blackstone and Norman Starr in attendance)
the renal failure issues - "may exists" but contrary to this being
one of the most studied drugs/indications/outcomes combination in
medicine the data and strong science just is not there. The benefits
may be limited to bleeding (i.e. less chest tube drainage which we
all know is not always frank blood) but the increased in other
complications is hard to argue. Furthermore, the absence of
aproprotin (i.e. more bleeding) in many of these studies did not
result in a predictable increase in bleeding related complications
(transfusions, re-op for bleeding, prolonged ICU, morbidity/
mortality). The only real benefit of aprotinin may at the end be
decreased chest tube drainage - which at the end of the day means
less stress and better sleep for the surgeon.
michael
On Oct 2, 2006, at 1:18 PM, rsboova at comcast.net wrote:
> 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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