[HSF] Re: Leipzig photopanorama (OT)

Fri Dec 21 06:41:23 EST 2007

Clearly this debate was played out in the 80's in general surgery. Although the details are different, the similarities are many.

tea

----- Original Message ----
From: Prasanna Simha M <prasannasimha at gmail.com>
To: OpenHeart-L at lists.hsforum.com
Sent: Thursday, December 20, 2007 11:38:00 PM
Subject: Re: [HSF] Re: Leipzig photopanorama (OT)

I am not saying that I agree to everything being done but then if we could
develop a really minimally invasive stapling system that would allow an
equally good anastomosis research in that direction would be worth it. I did
feel that  the anastomotic device was cumbersome (remember that I did not
advocate it) but if they can ensure that the tissue anastomotic area would
ensure least amount of foreign material then it would be worth it .If we get
a quicker way to get an equivalent anastomosis with similar patency would
you not adopt the faster lesser invasive technique ?
Prasanna

On Dec 21, 2007 10:30 AM, Ani Anyanwu <anianyanwu at hotmail.com> wrote:

> Prasanna
>
> That patients give informed consent does not mean all is okay. People can
> consent to the most bizarre of experiments which is why we have Nuremberg,
> IRBs and ethics committees. For example it is hard to see how a rationale 50
> yr old man will agree to have his LIMA attached to his LAD via *median
> sternotomy* using a stapling device when the alternative, hand suture with
> prolene has up to 95% patency at 20 years. What conceivably could he hope to
> gain with the new technique? What did the investigators tell him he could
> gain? A 5 minutes quicker operation? Surely not a more effective one.   That
> is why we have ethics committees to protect patients for they do not know
> better and can consent to anything. Up until the surgeon spoke to him about
> a stapling device the patient likely did not even know how the LIMA was
> attached to the LAD so how can such consent be informed.
>
> We all hate IRBs and ethics committee but their existence is necessary to
> help protect patients. The example you give of the total artificial heart
> and other such heroic experiments does not apply here because there was no
> alternative effective therapy. However for various reasons as outlined by Dr
> Novick even the greatest of surgeons and academics may perform unethical
> experiments on patients. I listened to a talk earlier this year at a meeting
> from a French group on use of donors aged 60 or above for heart
> transplantation - I stood up and asked the presenter if the patients were
> aware they were involved in such an experiment of older donor hearts and the
> presenter said no - its like the patients were lucky to be transplanted so
> they should accept what they are given.
>
> Surgical innovation such as described by Don for example is a different
> thing. We will modify our ways of doing things which is why we visited
> Leipzig and other such life meetings. Looking for solutions for existing
> problems requires innovation. However seeking alternatives to what are
> considered *effective* treatments requires ethically approved
> experimentation. As it stands now you could design a mitral ring shaped like
> a star and get it approved by FDA and implant it in humans without formal
> testing. I think the rule in innovation should be only do to the patient
> what you would not mind being done on you (for example if i had a diseased
> aorta i would not mind Don's technique used on me, or if i had mesothelioma
> i would not mind a drug tried on me that had never be tried on a human, on
> the other hand if i was having a LIMA, I would want it sewn with
> prolene...).
>
> Ani
>
>
>
>
>
> > Date: Thu, 20 Dec 2007 20:05:51 +0530> From: prasannasimha at gmail.com>
> To: OpenHeart-L at lists.hsforum.com> Subject: Re: [HSF] Re: Leipzig
> photopanorama (OT)> CC: > > They do not just chop up patients and they do
> have informed consent> ,disclosure etc and patients can agree to or withdraw
> from their> protocols.They have their local protocols and IRB etc.
> Remember that every> country has its own ethical guidelines and approaches
> to social problems.> The American view of things may not necessarily be the
> German or UK view or> that of the rest of the world from even the patients
> point of view.> I saw quite a lot of old people being operated there and
> when I said that> in my country they would just plain refuse surgery they
> said that if that> they wish it happened in Germany and if it happened their
> health budget> requirements would have halved. Patients expect , demand and
> get treatment.> Even in their 90's. My take on things may be very different
> from what I saw> but what is to be taken is their open mindedness and
> openness to> innovations and suggestions etc . For eg I was asked to give a
> talk on the> modifications that I have made etc and it was received well
> from a centre> which uses cutting edge technology. Dr Falk immediately
> fashioned a Goretex> steel ring to see how it was done etc. I was watching a
> patient with a> dysfunctional ventricle undergoing a David + Mitral repair +
> CABG by Dr Mohr> and I happened to ask him if he would consider an LV lead
> in view of his> preop dysfunction. He immediately did a trial pacing with a
> temporary lead> and seeing the improved function implanted the LV lead. I
> doubt many> surgeons with a lesser stature would have even bothered to hear
> or consider> my comment being a small unknown surgeon from some corner of
> the world and I> was impressed by his open minded approach to all
> suggestions and ideas. I> reiterate I would like to work in such an
> environment where thinking ,> discussion and ideas are given thoughtful
> address.> If you think that some companies in some countries ethically
> behave as a> realit check you should see how they try to "evaluate" their
> products in> third world countries under all sort of guises.> > Prasanna> >
> On Dec 20, 2007 7:41 PM, Ani Anyanwu <anianyanwu at hotmail.com> wrote:> > >
> Prasanna> >> > And where does the patient fit in all this?> >> > Would you
> also like to be the patient having one of those distal> > connectors in his
> LAD, or adjustable mitral rings for simple degenerative> > disease, or a
> Bentall at 82 yrs old for a 4cm aorta, or a mitrofast (Leipzig> > 2005) for
> ischemic MR?> >> > I think it was Westaby who once responded to a question
> on whether he had> > used a new device yet and replied that it had not yet
> been tested on the> > Germans... Ethics and IRB committees are a pain but
> they exist for a reason.> >> > Ani> >> >> >> > > Date: Thu, 20 Dec 2007
> 18:58:58 +0530> From: prasannasimha at gmail.com>> > To:
> OpenHeart-L at lists.hsforum.com> Subject: Re: [HSF] Re: Leipzig> >
> photopanorama (OT)> CC: > > I was talking with Falk and actually he thinks>
> > it may be better for actually> upsizing if you get SAM. He was also
> trying> > it out and trying to define> indications.> I wish I could work in
> an> > environment like the one Falk operates in.> Prasanna> > On Dec 20,
> 2007 6:12> > PM, <Hgrmd at aol.com> wrote:> > > Prasanna,> > Volkmar Falk's
> adjustable> > ring is ingenious, but I truthfully doubt I> > would have much
> need for it,> > since I usually get the correct size using> > the usual> >
> methods. The cool> > thing is that Volkmar operates in an environment> >
> (unlike> > the U.S.)> > where new methods like this can be tried without
> too much> > apparent> >> > hassle.> >> > Hal> >> >> >> >
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