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Medical Forum / General / Cardiology / January 2006

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Heart-surgery drug risky, researchers find

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Roman Bystrianyk - 26 Jan 2006 16:47 GMT
Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
Jose Mercury News, January 26, 2006,
Link:
http://www.mercurynews.com/mld/mercurynews/living/health/13715800.htm

A drug widely used during heart surgery to control bleeding doubles the
risk of kidney damage, forcing an estimated 10,000 patients onto
dialysis each year, according to a new study from a group that is
calling for surgeons to abandon its use.

Known as aprotinin, the drug also increases the risk of heart attack 48
percent, heart failure 109 percent and stroke 181 percent, according to
a study among nearly 4,400 patients reported today in the New England
Journal of Medicine.

The researchers said the drug is not even needed in most cases because
there are two generic drugs that cost a tenth as much and are nearly as
good at stopping bleeding without increasing risks.

``I wonder how we can ethically prescribe aprotinin when there are
alternatives that are safer,'' said Dr. Dennis Mangano of the Ischemia
Research and Education Foundation, who led the study.

The drug, which is derived from the lung tissue of cows, was approved
by the Food and Drug Administration in 1993. It is used in a
significant number of the 1 million heart surgeries performed worldwide
each year.

An FDA official said the agency is aware of the study and is reviewing
the data.

Bayer, which manufactures the drug and sells it under the brand name
Trasylol, said in a statement that it had not yet analyzed the study,
but that the results were not consistent with its own experience.
Sue - 26 Jan 2006 22:18 GMT
> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
> Jose Mercury News, January 26, 2006,
[quoted text clipped - 30 lines]
> Trasylol, said in a statement that it had not yet analyzed the study,
> but that the results were not consistent with its own experience.

It is my understanding that aprotinin is administered following CABG,
in order to reverse the anticoagulant effects of heparin. Heparin (an
anticoagulant) inhibits the conversion of prothrombin to thrombin, the
step just preceding formation of fibrin and stable platelet clot
formation.

During CABG, fairly large cumulative doses of heparin are required to
prevent clot formation.

Since the on-pump procedure exposes the patient's blood to a plastic
reservior, pump filters and much tubing, the body's clotting cascade,
natural immune and inflammatory repsonses are activated.   All of these
reactions can result in red blood cell destruction and other
complications.

This is one reason why minimally invasive cardiac surgery "MICS"
(off-pump) is generally  favored over on-pump procedures,IMO (when
indicated).

Since the blood is not exposed to large surface areas of foreign
material, MISCS  eliminates the need for heparin administration.
Therefore heparin reversal is not required,  and the need for aprotonin
(or other similar drug) is avoided as well!

In addition, the body's natural yet undesirable responses (such as
complement activation, cytokine activation, activation of coagulation
factors etc.) are minimzed as well.

Just some additional thoughts.

-Sue (non doctor)
Sue - 27 Jan 2006 00:40 GMT
> > Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
> > Jose Mercury News, January 26, 2006,
[quoted text clipped - 62 lines]
>
> -Sue (non doctor)

Please excuse my post.  I was confusing protamine sulfate with
aprotinin.  Protamine suflate is used to reverse heparin effects in
CABG procedures, not aprotonin.

Please strike all of my comments that indicate aprotonin.  I was
referring to protamine sulfate.

My sincere apologies,

Sue (non doctor,  thank goodness!)
Hawki63@sbcglobal.net - 28 Jan 2006 21:07 GMT
>> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
>> Jose Mercury News, January 26, 2006,
[quoted text clipped - 49 lines]
> (off-pump) is generally  favored over on-pump procedures,IMO (when
> indicated).

you must be referring to MIDCAB....minimally invasive direct coronary bypass
sugery.....which is NOT always "off pump"

"off pump surgery" can be sternum splitting OR minimally invasive...

the two are not totally interchangeable

in MIDCAB the surgeons does NOT split the sternum...but works thru smaller
incisions..usually several...to sew bypass grafts onto diseased coronaries

"may be performed with or without use of the heart lung machine"

limitations to MIDCAB ...only can be used in a very small subset of
patients..usually those whose disease is limited to the LAD....

"beating heart" surgery..on the other hand...can be used on MOST
patients..as long as the surgeon involved is skilled at the
technique...approx 25% of bypass surgeries in the uS currently are off
pump....

a "stabilizer" similar to a suction cup thingie ..is applied to the
heart..and allows the immobilization of the area being operated on...it is
quite a fascinating surgery to watch...

recovery from any heart surgery NOT involving the bypass machine is quicker
and has less risks ..such as "pump head" and risks of emboli etc ...blood
flow thru the heart lung machine is VERY fast..and the blood cells can be
damaged

hubby had beating heart...tradiitional sternum splitting bypass...we even
have a videotape of the procedure...he was in recovery room ..fully awake
several hours after his surgery began (which took a tad less than 2
hours...3 grafts)...by 7pm night of surgery he was eating a turkey
sandwich..home in 72 hours...

> Since the blood is not exposed to large surface areas of foreign
> material, MISCS  eliminates the need for heparin administration.
[quoted text clipped - 8 lines]
>
> -Sue (non doctor)
Sue - 28 Jan 2006 21:58 GMT
> >> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
> >> Jose Mercury News, January 26, 2006,
[quoted text clipped - 97 lines]
> >
> > -Sue (non doctor)

Hi Hawke,

I am sorry that I lumped all minimally invasive procedures under one
umbrella. I was really thinking about the beating heart surgery.
Years ago I supported some of the preclinical research that was used to
bring this technology to premarket approval (our device is called the
Octopus, lol).

I was also involved in some CABG (pump devices) research (studying
various coatings, like heparin-bonded for tubing, filters etc.  These
coatings help to reduce potential clotting etc.

I am a little rusty in remembering the perfusion procedure now for
CABG!!  I think the beating heart surgery has fantastic advantages (but
I am obviously biased)

I am so happy to that your hubby has done well following the beating
heart surgery.

Best wishes,

Sue (nondoctor)
Hawki63@sbcglobal.net - 28 Jan 2006 22:54 GMT
>> >> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
>> >> Jose Mercury News, January 26, 2006,
[quoted text clipped - 115 lines]
> bring this technology to premarket approval (our device is called the
> Octopus, lol).

ah...a Medtronic gal!!

ours was by Guidant..and it was they who taped his surgery...for training
purposes..his surgeon does a lot of surgeon training for Guidant

> I was also involved in some CABG (pump devices) research (studying
> various coatings, like heparin-bonded for tubing, filters etc.  These
[quoted text clipped - 3 lines]
> CABG!!  I think the beating heart surgery has fantastic advantages (but
> I am obviously biased)

hubby's entire career was in medical devices..no..not your company...but he
knows lots of Medtronic folk...his devices all used in open heart
surgery..always said  "don't mind selling the stuff..but don't want to ever
need to use it"...

he was lucky that beating heart was available due to his grafting
sites..also that such a great surgeon was nearby...

> I am so happy to that your hubby has done well following the beating
> heart surgery.

thanks...he did great!!!  5 years post MI now..and failed stents...3 years
post CABG...looks and feels better than ever...age 66

> Best wishes,
>
> Sue (nondoctor)
Joe Doe - 29 Jan 2006 00:08 GMT
> thanks...he did great!!!  5 years post MI now..and failed stents...3 years
> post CABG...looks and feels better than ever...age 66

Was he very compliant with respect to diet, exercise and medication
after the stents?  

Just wondering because I just had some stents put in and am wondering
what the progression of the disease will be.

Roland
Andrew B. Chung, MD/PhD - 29 Jan 2006 10:33 GMT
> > thanks...he did great!!!  5 years post MI now..and failed stents...3 years
> > post CABG...looks and feels better than ever...age 66
[quoted text clipped - 4 lines]
> Just wondering because I just had some stents put in and am wondering
> what the progression of the disease will be.

It would be wise to become lean and trim if you wish to arrest the
progression of your coronary disease:

http://www.HeartMDPhD.com/wtloss.asp

Will be available to "glow" and chat about this and other things like
cardiology, diabetes, cooking and nutrition that interest those
following this thread here during the next on-line chat (02/02/06) from
6 to 7 pm EST:

http://tinyurl.com/cpayh

For those who are put off by the signature, my advance apologies for
how the LORD has reshaped me:

http://tinyurl.com/bgfqt

Prayerfully in Christ's love,

Andrew
http://tinyurl.com/8juld
Sue - 29 Jan 2006 15:27 GMT
> > thanks...he did great!!!  5 years post MI now..and failed stents...3 years
> > post CABG...looks and feels better than ever...age 66
[quoted text clipped - 6 lines]
>
> Roland

Roland,

I did not mean to scare anyone when I said reocclusion is common.  I
really have no stats about how common this is.   Keep in mind that I
work in research, so we are always trying to improve outcomes.  We are
alwasy eharing about the  failures.. not as much about the successes.

There is a lot that a patient can do.

>From what I hear, lifestyle changes are so important.  For example, if
a bad diet, smoking and other life choices speeded your CAD, a stent
may provide only a temporary grace period, if those habits are not
changed.

I do not know what your case is, but it seems that Dr. Chung's advice
is the best.  CAD can be slowed down in many cases.  Perhaps even
arrested.  

Best of luck to you.

-Sue
Hawki63@sbcglobal.net - 29 Jan 2006 18:24 GMT
>> thanks...he did great!!!  5 years post MI now..and failed stents...3
>> years
>> post CABG...looks and feels better than ever...age 66
>
> Was he very compliant with respect to diet, exercise and medication
> after the stents?

yes....

statistically about 40% of stents will re occlude...usually within 6
months...

"unfortunately" if that is the right word..hubby NEVER had any angina..at
any time..before or after ...yeah the MI was pain bigtime..but once the
thrombylitic kicked it..all pain went away...he sorta thought he could go
home!!  stents were placed the next day...

we feel it may have been the location and placement of the stents that
contributed to their re occluding...3 placed nearly stem to stern...at the
LAD right at the bifurcation.....

> Just wondering because I just had some stents put in and am wondering
> what the progression of the disease will be.
>
> Roland
Sue - 29 Jan 2006 15:11 GMT
> >> >> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
> >> >> Jose Mercury News, January 26, 2006,
[quoted text clipped - 146 lines]
> >
> > Sue (nondoctor)

LOL. We are all in this together, I say. :-)

I will bet your husband loved his job.  I love working for a company
like this (providing medical devices).

Unfortunatley it seems stents have always had issues (reocclusion is so
common).  But my statement is just a broad sweeping generalization
based upon "talk" I hear.  I have no true stats on reocclusion rates.

Hawke,  I love hearing success stories. Thanks for sharing.

I wish you and your husband many more years of health and prosperity!

-Sue (non doctor)
William Wagner - 28 Jan 2006 22:31 GMT
> >> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
> >> Jose Mercury News, January 26, 2006,
[quoted text clipped - 97 lines]
> >
> > -Sue (non doctor)

Guess my guys were not the best.  Had a 4 way that took 7 hours on the
pump.  I got out of  hospital  in 2 days.  Lots of drugs and had my
wires for monitoring backwards.  I was yelled at for  jumping  about two
times.  Leads were not right....remember that.  Noticed the night folks  
and low level employes were not happy campers.  Missed most of my
doctor's who came to see me visits as I was out and about.  Got
chastised for walking up and down steps in the solarium for which I gave
a censored response.

Surgery guy gave me a teddy bear and a few weeks latter said you are
doing fine. He hinted that the cardio follow up may be extensive.  It
was  and obstinate me said  obscenity  this after four years. I can't
handle statin's   help due to muscle loss.

Sucks

Bill still about.

Signature

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This article is posted under fair use rules in accordance with
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Sue - 29 Jan 2006 15:44 GMT
> > >> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find", San
> > >> Jose Mercury News, January 26, 2006,
[quoted text clipped - 122 lines]
>  and informative purposes. This material is distributed without profit.
> Vision Problems?  Look at http://www.ocutech.com/ ~us$1500

Bill,

You made it through 7 hours on-pump.  You are a tough dude.  I am not
sure why but I have this feeling that you were a premie... came out
early.. kicking and screaming.

Now you are still about, kicking and screaming.  Keep it up :-)

Look for the positives and keep moving forward.

Best wishes,
Sue
PS Hey- You are not one of the night shift low level employess at the
hospital.  They might be in your shoes one day.. how would they take
it? Woudl they keep kicking and fighting?

You can be happy again Bill.  You have the guts for it.,,, You have the
guts for living, not just existing.  Go for any gold ring you can find,
and grab it.
Hawki63@sbcglobal.net - 29 Jan 2006 18:34 GMT
>> > >> Thomas H. Maugh II, "Heart-surgery drug risky, researchers find",
>> > >> San
[quoted text clipped - 166 lines]
> guts for living, not just existing.  Go for any gold ring you can find,
> and grab it.

hmmm...one of the advantages of being a nurse   ....nurses always know the
best surgeons..and the best places...no kidding..

my sister works in cardiac rehab...and hubby's ex worked in the OR at the
hospital he had his surgery...plus the surgeon's "nurse " was an old friend
of over 20 years!!...yeah..it does pay to have inside info...

just an example..hubby was determined to have his leg vein "harvested" via
an endoscope...not the awful down the leg incisions,,,two days pre op..when
we went in to the surgeon..same day he agreed to and met the guys who would
videotape his procedure...we asked about getting the endoscopic harvest(we
knew that hospital had the equipment)...nurse told us.."we have the
scope,,,but the guy who used to run it has retired"...hmmm we said.."can't
you find someone else to do the harvest??"....now..remember..we were doing
this surgeon a favor by allowing the videotaping ...by late afternoon..the
nurse called back ...she had "found a PA that worked with this surgeon at
ANOTHER hospital"...and he was making a special trip to harvest hubby's vein
using the endoscope...!!!  "pulling strings??"...yep...

ALL of the staff at this hospital were superb!!!  being a nurse it is easy
to evaluate excellent care (have had less than optimal care myself when
hyster was done)....
 
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