AW: [HSF] The fallacy of surgical research

Thu Aug 2 12:18:26 EDT 2007

Ani,
Science in an art and science discipline (surgery) is very complicate, near
the theory of caos. Tell the clinical academics to come to  surgical
services and do science. They are not going to make it better than we
surgeons. 
Of course, we are not as good in biostatistics as they are. And the most
important factor, the surgeon itself is never included in the studies!

By the way, there are 2 Nobel Prize surgeons, Carrel and Forssmann (together
with Cournand).

Roberto

-----Ursprüngliche Nachricht-----
Von: openheart-l-bounces at lists.hsforum.com
[mailto:openheart-l-bounces at lists.hsforum.com] Im Auftrag von Ani Anyanwu
Gesendet: Mittwoch, 1. August 2007 22:14
An: openheart-l at lists.hsforum.com
Betreff: RE: [HSF] The fallacy of surgical research

The other issue the discussions on myocardial protection brings up is the
fallacy of surgical research and the poor understanding of research method
by surgeons.  This is what prompted the Lancet editor many years ago to
describe surgical research as 'comic opera'. The reality is that few in
academics or research takes us surgeons seriously. Look at the
representation of surgeons in key research bodies, funding of surgical
research by NIH or similar bodies, surgical influence in research groups,
surgical publications in key journals, guidelines committees, involvement in
key epidemiological efforts etc. The only Nobel prize received by a surgeon
in the recent era wasn't even for surgical research. The problem is we as
surgeons believe too much in our individual selves and individual methods
that we become blinkered as to the requirements of the scientific method.

Examples include

- there is evidence that such and such an additive to cardioplegia is of
benefit (this evidence comes from isolated animal hearts, animal experiments
and at best clinical measures of surrogate markers - these do not mean the
additive is benefit in the human, indeed it could be worse)

- it has worked well in my cases so it is okay (but as Dr Salerno and
Prasanna say the heart has great reserve - that nothing goes wrong does not
mean all is okay)

- i have had no deaths (the patient came to you alive; why is it an
achievement that he remains alive after surgery? (unless the aim of surgery
was to save life))

- Kirklin and Buckberg or Cleveland clinic demonstrated...(i.e. eminence
based medicine; but how many have ever read work of Kirklin or Buckberg? Do
they stand up to the requirements of scientific proof? Indeed did either
really show clinical benefit of the things we attribute to them? For example
the 'seminal' Cleveland clinic NEJM paper purpurtedly showing benefit of IMA
over SVG barely constitutes evidence of such)

- There was no enzyme rise (has anyone cared to show any relationship
between enzyme rise and any outcome of interest after surgery? Does the
patient really care what his CK, troponin or coronary sinus lactate are? Why
do we look at outcomes of no relevance to the patient?)

- Ventricular fibrillation means bad protection ( but has anyone shown so
scientifically? maybe fibrillation is intrinsic to some techniques and rare
with others and is a reflection of the technique rather than the degree of
protection; certainly a fibrillating heart in Salerno's beating heart
technique has different implications to an Arch done by Martin on DHCA)

- The patient was extubated the next day (and so what? Several times you go
back to ask what happened to the patient 2 months later and you hear a
different story. This outcome is of no relevance at all unless aim of
surgery was to allow extubation in patient previously ventilator dependent)

- My method of cold myocardial preservation works (but how do you know that
that is what is working? As Salerno says if you don't know the myocardial
temperature how do you know it is the hypothermia, and not some other
factor, that is in play?)

- Since I changed I use less inotropes (but you decide what you use- could
you not be just biased towards the success of your change? Maybe you should
compare two methos objectively)

- Multiple defibrillation harms the heart and leads to bad outcome (maybe
but could it be the condition requiring defibrillation that is resulting in
the bad outcome rather than the shock?)

- I have done it this way for 10 years and never had problems (how do you
know? Have you actually measured the outcomes on all your patients? Kocher
said the same about his thyroidectomies and was shocked when he recalled his
patients and found the majority had myxedema)

etc
The inability to critique within the scientific framework and a lack of
understanding of, or refusal to apply the research method, is a major
problem in surgery and is in part the reason why we are so diverse in
opinion and yet so opinionated and firm in our belief that what we do is
right (when yet examined there is often no evidence to support it). No
internist or scientist or epidemiologist would approve a drug based on any
of the criteria we list above yet we swear by what we do to the degree that
we suggest alternative approaches are inferior. 

Until we start thinking in a scientific and epidemiological manner, we as
surgeons will remain the laughing stock of academic medicine.

Ani

> Date: Thu, 2 Aug 2007 04:52:48 +1000> To: OpenHeart-L at lists.hsforum.com>
From: benjamin.bidstrup at bigpond.com> Subject: Re: [HSF] Inotropes,
ventricular fibrillation and myocardial protection> CC: > > What this does
is once again ask the question, how do we measure > myocardial
preservation?> > We can look at the highly sensitive markers such as
Troponin which > indicate some element of damage to components of the
myofibrils. and > so on. Echo - RWMA ECG and the list goes on.> We need to
look at use of inotropes, IABP, survival. Khuri published > on his
intramyocardiall pH device stating that poor preservation as > reflected by
pH changes resulted in altered long term survival.> > Much of the cocktails'
components have been determined by isolated > rat heart experiments. They
have translated well to the human, but it > is very hard to measure total
water content of an intact heart or > regional blood flow distribution in a
human model.> > Why is it that there is no universal cocktail. Put 100
cardiac teams > in a room and you will have 120 different ways of preserving
the > myocardium.> I review papers that look at different methods of
preservation and > they use markers such as inotrope use to determine
improvement. How > variable that is is a whole new debate.> > > > > >Tomas,>
>> > A fibrillating heart is a dying heart? Is this an edict of some >
>sort? I've seen plenty of hearts that fibrillated during some part > >of
their open heart operation only to have a completely, and I mean >
>completely, normal EF on remote echo. Speaking in absolutes serves > >no
purpose.> >> >> >> >Hal> >> >> >-----Original Message-----> >From: Salerno,
Tomas <TSalerno at med.miami.edu>> >To: OpenHeart-L at lists.hsforum.com> >Sent:
Wed, 1 Aug 2007 11:19 am> >Subject: Re: [HSF] Inotropes, ventricular
fibrillation and > >myocardial protection> >> >> >> >> >A fibrillating heart
is. "Dying" heart.> >The brain does not have seizure during CPB; neither
should the heart > >fibrillate.> >Tomas> >> >----- Original Message ----->
>rom: openheart-l-bounces at lists.hsforum.com >
><openheart-l-bounces at lists.hsforum.com>> >o: OpenHeart-L at lists.hsforum.com
<OpenHeart-L at lists.hsforum.com>> >ent: Wed Aug 01 10:45:53 2007> >ubject:
Re: [HSF] Inotropes,ventricular fibrillation and myocardial > >rotection>
>Ani,> >aving graduated from voodoo homemade cocktails to blood and its>
>ariants, you would easily be able to see that the bad cardioplegia's> >id
have a higher (more accurately uniform) incidence of fibrillation> >hich
came down with better modifications of cardioplegia's. That does> >ake us
wary and anyway fibrillation is not something by any stretch>
>ormal.Transient defibrillation may appear innocuous but then it has> >een
shown that such hearts have indeed been improperly preserved (from> >orks of
Buckberg and Kirklin).Remember that sometimes speed etc etc may> >ompensate
but this may become an issue in longer case.> >rasanna> >ni Anyanwu wrote:>
> I still do not understand why we are alarmed about transient ventricular>
>ibrillation on reperfusion and why using drugs to suppress it will have
any> >mpact on outcome.> >> > Ani> >> >> >> > > >> Date: Wed, 1 Aug 2007
11:51:47 +0530> From: prasannasimha at gmail.com> To:>
>penHeart-L at lists.hsforum.com> Subject: Re: [HSF] Inotropes, ventricular>
>ibrillation and myocardial protection> CC: > > I am not saying that the>
>rocaine or lignocaine is still acting. What I> meant is that since the>
>ibrillation is occurring with the hotshot delivery> with high local
lignocaine> >hanging the drug class may be beneficial.> Prasanna> > On
8/1/07, Ben Bidstrup> >benjamin.bidstrup at bigpond.com> wrote:> >> > I beg
respectfully to differ. The> >idocaine (a fast Na channel> > blocker) is all
but gone after a short while in> >he cardioplegia> > scenario. Getting a
suitable level back into the > >circulation> >nd thus> > the heart at
release of the clamp is what is > >needed.> >> > Perhaps a> >andomised study
is in the offing.> >> > >
>http://circ.ahajournals.org/cgi/content/abstract/79/5/1106>> >> > This
reference relates to defib energy levels but i think you will> > see> >here
I am coming from.> >> > At James Cook, I was involved in the development> >f
a non> > depolarising cardioplegia solution, which is slowly > >working its
way>> > up the development path. The main components are lidocaine and> >
adenosine.>> >> >> >> >> > >Ben,> > >I use Amiadorone in the pump for all
emazes > >>(and postop)> >nd> > >Amiadorone in the pump for all aortic
valves. Since the St Thomas> >> >Cardioplegia (which we mix in blood)
already has procaine > >adding> > >Lignocaine> >ould be
redundant.(Incidentally Amiadorone is very cheap> > >in India !!)> >>
>Prasanna> > >Ben Bidstrup wrote:> > >>Why the amiodarone. Surely with some>
>erfusion, the electrolyte> > >>imbalances within the myocardium would
correct> >nd SR ensue. If> > >>anything use lidocaine. Less toxic and
cheaper, not a> >egative> > >>inotrope. It is what Yacoub taught me many
years ago, and I have>> > >>used it to good effect (infrequently I might >
>add).> > >>> > >>>Tohru,> > >>>> > did an AVR on an 87 yo man as a 2nd case
just a couple of> > >>>hours ago.> >gain, no LV vent, only a sump. While
closing the> > >>>aortotomy, I began the>> > >>>continuous warm retrograde
blood. The heart began fibrillating> > >>>after> > couple of> > >>>minutes.
I gave amio and then cardioverted. The > >heart had a> >> >>>slow
junctional> > >>>rhythm until the clamp was released. A sinus rhythm>
>eveloped shortly> > >>>afterwards. He came off with no inotropes. It's
much> >asier on> > >>>the heart and> > >>>your nerves to cardiovert a >
>clamped, flaccid> >eart rather than> > >>>trying to do it> > >>>after the
clamp has been> >eleased.> > >>> I look forward to your visit at the STS. As
I said before,> >'ll> > try to> > >>>have a couple of interesting cases for
you and other> >nterested> > >>>members of HSF> > >>>to watch and criticize
to your heart's> >ontent.> > >>>> > >>>Hal> > >>>> > >>>> > >>>> >
>>>**************************************> >et a sneak peek of the> >
>>>all-new AOL > >at> > >>>http://discover.aol.com/memed/aolcom30tour>> >
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