[HSF] Aprotinin

Wed Nov 7 21:48:26 EST 2007

One of my patients (died) had ischemia in all four limbs and would have needed at least 3 amputations to survive. Factor VII always given centrally here. Difficult to isolate effect of factor VII as critically ill patient on BiVAD etc but it is most unusual to see a patient with multiple limb ischemia. Had another patient on ECMO who received factor VII and all four limbs were ischemic requiring bilateral below knee amputations and bilateral below elbow amputations (although weaned successfully off ECMO we withdrew support in preference to such mutilative surgery). Autopsy showed multiple intravascular thrombi. HIT was negative. 

I have however also seen patients whom I believe would not be alive today if we had not given factor VII. As I said this is not a convenience drug and I suspect if we don't control its use it will end up the way of aprotinin when the lawyers get into the picture. It is important therefore that rampant use of this agent outside the context of true life threatening haemorrhage or clinical trials is discouraged. I have certainly seen it abused being used so the surgeon can go home early (rather than spend hours drying up) or to treat post-operative bleeding (without first recourse to re-exploration).

Ani

> To: OpenHeart-L at lists.hsforum.com> Subject: Re: [HSF] Aprotinin> From: zzhoumd at pol.net> Date: Wed, 7 Nov 2007 21:07:18 +0000> CC: > > People have limb loss from factor 7 is caused by peripheral infusing> > > > Sent via BlackBerry by AT&T> > -----Original Message-----> From: Ben Bidstrup <benjamin.bidstrup at bigpond.com>> > Date: Thu, 8 Nov 2007 06:29:45 > To:OpenHeart-L at lists.hsforum.com> Subject: Re: [HSF] Aprotinin> > > Peripheral administration of which drug ?> > >I do not think you can use aprotinin in US anymore. I do not know if > >there is any point to debat this issue. People have limb loss is > >caused by peripheral administration which is not recommanded.> >> >Z Zhou> >> >Sent via BlackBerry by AT&T> >> >-----Original Message-----> >From: Ani Anyanwu <anianyanwu at hotmail.com>> >> >Date: Wed, 7 Nov 2007 16:23:19> >To:<openheart-l at lists.hsforum.com>> >Subject: RE: [HSF] Aprotinin> >> >> >My reservations about factor seven were really the flawed logic (as > >Michael highlighted) that one does not use aprotinin which is > >licensed for blood conservation but choses to use factor VII which > >is not. Also concerned about adverse events as have seen three > >patients who got this drug have limb loss and also colleagues have > >experienced unexplained thrombotic deaths. This is certainly one > >that must not be a convinience drug but on the other hand is a drug > >that can be life-saving when used appropriately. The cost is > >relatively cheap considering all else we do and the cost of > >morbidity from bleeding.> >> >Ani> >> >> >> >> To: OpenHeart-L at lists.hsforum.com> Subject: Re: [HSF] Aprotinin> > >>Date: Wed, 7 Nov 2007 09:47:02 -0500> From: hgrmd at aol.com> CC: > > > >>Z,> I've used Factor 7 successfully as well on a few cases with > >>stubborn coagulopathy. We discussed its use a few months back, and > >>I recall that Ani wasn't too keen on using it due to it being > >>extremely expensive as well as off label. However, it has saved me > >>a couple of sure trips back to the OR for bleeding.> > Hal> > > > >>-----Original Message-----> From: zzhoumd at pol.net> To: > >>OpenHeart-L at lists.hsforum.com> Sent: Wed, 7 Nov 2007 9:12 am> > >>Subject: Re: [HSF] Aprotinin> > > > > ry Factor 7, I did a Bentall > >>couple months ago for 4th time redo. The patient > led after > >>surgery. Due to concern of cirulation arrest, (our perfusionist > > >>eluctant to use aprotinin in circ arrest) I did not use it. Patient > >>bled a lot. > inally I used a vial of Novo 7, bleeding stopped in a > >>few minutes. > Z Zhou> > ent via BlackBerry by AT&T> -----Original > >>Message-----> rom: hgrmd at aol.com> Date: Wed, 07 Nov 2007 08:51:02 > > >>o:OpenHeart-L at lists.hsforum.com> ubject: Re: [HSF] Aprotinin> > > >>Ani,> Sixth time reop MVR? My god, I've only done as far as 4 > >>times. That must > ave been hell.> Again, my concern with > >>aprotinin lies mainly with its potential legal > iability. Indeed, > >>I like the drug for circulatory arrest and dialysis > atients. It > >>may not be fair, but it's medical life in America.> Hal> > > >>----Original Message-----> rom: Ani Anyanwu > >><anianyanwu at hotmail.com>> o: openheart-l at lists.hsforum.com> ent: > >>Wed, 7 Nov 2007 8:00 am> ubject: RE: [HSF] Aprotinin> > > al> here > >>is no mounting evidence that aprotinin is dangerous - the > >>overwhelming > idence by far is that it is safe. What is mounting > >>is the perception that it > unsafe. Remember that aprotinin is 20 > >>years old. There are numerous studies > the literature, many > >>randomized, on aprotinin the majority of which have not > und any > >>adverse effects. A metaanalysis in JTCVS few years ago confirmed > > >>tient benefit. All the present feelings on the drug are prompted > >>not by > idence (as it overwhelmingly suggests benefit) but by the > >>results of two > udies, one of which is very questionable, the > >>other we are awaiting. The > alogy is if a paper is published today > >>showing you are more likely to die in 5 > ars if you have a mitral > >>repair and based on that we all stop repairing > lves. It reminds > >>me of the two flawed lancet papers few years ago linking the > R > >>vaccine to autism which received all the press and reduced uptake > >>of the MMR > 50% sporadic outbreaks of measles. All the lay media, > >>lawyers and many > ctors caught on with this. Now the papers have > >>all been discredited and > tracted by the lancet for flaws that > >>were very evident on the first read. All > t 3 of the original > >>authors wrote a retraction acknowledging the paper was > accurate > >>and misleading. The three remaining authors are facing the UK > >>medical > uncil for scientific fraud. The lead author, who like the > >>aprotinin killers, > d questionable motive fors lancet papers, now > >>makes a living in the USA > rking with autism groups - a celebrity > >>made by what is now accepted to be > ped up fabrication. > >>Unfortunately like with aprotinin the damage was already > ne, > >>people have suffered and people remain skeptical. My understanding > >>is thus > r the Mangano group have not allowed others independent > >>access to their data, > t it wont surprise me if that one is also > >>withdrawrn too. I for one will await > is new paper but suspect it > >>will turn out to be no evidence on which > thdrawal of a drug will > >>be based. > ind you Hal, we ALL agree on the benefits of the drug - > >>it is the risks we > nder about. Even yourself used it in selected > >>patients like circulatory > rest. Why? I do not think tranexamic > >>acid and EACA are the solution and > spect that if given enough in > >>a like for like dosage, it is antifibrinolysis > ther than > >>aprotinin that is potentially harmful.> am afraid though that this > >>discussion is now academic. Regardless of the truth > rotinin will > >>likely be a historical drug. We had no problems administering > > >>rotinin in the past but this week all patients furnished with the > >>information > at the company has stopped marketing it have refused > >>use of the drug. If the > mpany choses to stop marketing either > >>they know something we don't (i.e. drug > really dangerous) or they > >>are scared FDA will mandate a withdrawal (thus > e-empting) or they > >>are scared of lawyers. Neither is good and I cannot see how > e > >>confidence of patients and doctors can be restored.> e will have a > >>meeting next week to decide on alternatives to aprotinin - we > ve > >>no choice than to accept the reality and move on. Having said that > >>I did a > xth time reop MVR yesterday with no aprotinin and she is > >>doing fine. So maybe > is after all a convenience drug which we can > >>do without.> ni> > > From: Hgrmd at aol.com> Date: Wed, 7 Nov 2007 > >>07:24:54 -0500> Subject: Re: [HSF] > rotinin> To: > >>OpenHeart-L at lists.hsforum.com> CC: > > Tony,> I'll be happy to > it > >>for the "final analysis". If aprotinin is truly > vindicated and > >>re > leased on the market, I will consider using it for certain > > >>cases. However, I > lieve all of this breast beating bluster on HSF > >>by some > aprotinin believers, > spite of mounting evidence of it's > >>potential danger, > may cause some regret > the near future. I > >>certainly hope not, but I do think > one is definitely > king a > >>chance in persisting in using a drug with well > publicized > >>questions > out its safety. > > Hal> > > > > >>************************************** See > at's new at > >>http://www.aol.com>_______________________________________________> > > >>penHeart-L mailing list> > Send postings to:> > >>OpenHeart-L at lists.hsforum.com> > > UNSUBSCRIBE, to CHANGE email > >>address, or to view archives:> > > >>tp://mmp.cjp.com/mailman/listinfo/openheart-l> > All messages > >>transmitted by > e OpenHeart-L are subject to the policies and > > >>disclaimers posted at:> > tp://www.hsforum.com/listdisclaim> > >>----------------------------------------->_______________________________________________________________> > >>0's of Music vouchers to be won with MSN Music> > >>tps://www.musicmashup.co.uk_______________________________________________> > >>enHeart-L mailing list> end postings to:> > >>penHeart-L at lists.hsforum.com> o UNSUBSCRIBE, to CHANGE email > >>address, or to view archives:> > >>tp://mmp.cjp.com/mailman/listinfo/openheart-l> ll messages > >>transmitted by the OpenHeart-L are subject to the policies and > > >>sclaimers posted at:> tp://www.hsforum.com/listdisclaim> > >>---------------------------------------> >_______________________________________________________________________> > >>mail and AIM finally together. 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