Mizuho talks to Mel about giving tPA to a 14 year old stroke. It's never easy making life or death decisions when you have little or no evidence to guide you.
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Seriously? 1 1/2 hours into a dense CVA with an MRI confirmed visible clot in a healthy 14yo? Can you possibly get better - better risk/ benefit ratio? Why WOULDN'T you give it?
Just listened to this. Thank you for sharing, Dr. Spangler. Terrifying; for what it's worth, I would have done the same. I am not a strong tPA proponent, but given your work-up, consultation, and the buy-in from the parents, I think the care provided was excellent, and would have been even if a bad outcome were the result. I have heard the 'what would you do' question often and I answer it truthfully--if the case is not clear, I say I'm not sure because it's a balanced decision, but in this case, I would've said, 'yes, I would treat if it were my child'. Sometimes, as you said, our job is to give guidance. They can still disagree.
The longer I'm out of residency, the more I think our careers come down to a handful of cases, really. Glad there was a good outcome.
My hat is off to you but given all the data (including what your consultant said there is no way to tell if the good outcome was from TPA or just the natural history of CVA. Everyone prior to TPA and even now has those cases that progressed exactly like this one without TPA. The data from all the "positive Trials" is that there is no difference until 30-90 days between the two groups. The danger with this is any "positive" outcome is attributed to TPA or copper bracelets, or rain dance or whatever and this reinforces our desire to "do something". How may patients will tell you that "antibiotics" cured my URI last time. The danger is that I'm not sure giving TPA actually produces any benefit and that all we get is harm, just like antibiotics for viral illnesses. Sometimes the hardest thing to do is nothing (and the one for which you will get the most criticism. All that said I totally agree that we have to make life or death decisions with inadequate data.
Dr Spangler told the patient that there was a “fifty-fifty chance” the tPA may “make you better”. Please explain where this number came from. My understanding is that while 8 out of 18 stroke patients who receive tPA will recover by three months, 6 out of 18 stroke patients will recover substantially regardless of treatment. On the other hand, 1 out of 18 patients that receive tPA will bleed in the brain. Please see the AAEM tPA tool:
Mizuho, I have to agree with Kathleen - this is not in my opinion a very difficult decision. Calling TPA 'the devil' or suggesting heparin doesn't reflect objectivity or understanding of current literature. And I do like the (often false but oh so ego boosting) affirmation of the EP as the hero and protagonist of the story (full respec' to our neurologist colleagues) rather than an observer.
In the end we really have no idea if the tPA did anything to help this patient. This improvement could very well have been due to the natural history of the stroke syndrome. This is why we conduct RCT's with placebo arms to try to determine cause and effect. Many patients in the placebo arm demonstrate benefit. I.e. they get better with nothing more than good supportive care.
We need to be very cautious with case reports showing how tPA performs and I would not want people to listen to this podcast and think that the landscape has somehow changed regarding the evidence supporting stroke thrombolysis.
I made it a point to say 3 times that this outcome could/probably/may etc have NOTHING to do with TPA and could/probably/maybe from the natural course of the disease - so i agree with everyone else - the point is NOT about TPA in kids - the point is about what to do in a REAL situation with the data is not in!
Thank you all for your comments. Agreed, we are NOT suggesting this is the standard of care, as the reality stands there is no standard yet, and might not ever be for kids & tpa. And I do appreciate the fact that this very well likely could have been the natural progression of the disease, and as discussed with Mel, & not the tpa at all.
I do not see myself as the hero in this case. On the contrary, I was simply in the "right place, at the right time, with the right resources". I humbly & with great trepidation took the opportunity to make a decision based on what seemed to be in our favor; and by the grace of god did it thankfully have a fantastic outcome.
The discussion would have been very different if the boy had a terrible outcome…I would have been the "poster child" of what not to do! But in the end, the "learning point" remains the same…sometimes we don't have all the answers, and crazy decisions are demanded of ALL of us on the fly. We have to go with our gut, clinical gestalt, resources and fund of knowledge and hope that our well intended efforts don't cause more harm than good! I sincerely hope I never have to push tpa on a kid again! :) Thanks all for listening!!!
Dr. Spangler is to be commended in how she handled this case. Those who would Monday morning quarterback this one and declare the decision to give TPA as not a difficult one should be or even ask rhetorically "Why WOULDN'T you give it" should consider the following: 1) This therapy has significant risk of harm and death in adults. 2) It has not been studied adequately in the pediatric population. Any decision you make going forward to give it is essentially unsubstantiated in the literature.
So the best you can do is try a shared decision making process which can be really difficult with tPA cases when you are trying to lay out the risk. Make sure you are communicating as best as you can with the patient and family and then let the chips fall where they may.
Not trying to start a fight, but to say, "Oh that's easy" is quite frankly a dangerous clinical posture to take in a case such as this.
Clearly many on EM rap agree with the ED doc in this case that TPA is "the devil." How are they approaching it? Are they not giving it? Do they offer it to patients but make it sound very dangerous and convince them to decline TPA? Do they wash their hands like Pontius Pilate and leave it to a consulting neurologist (if they are lucky enough to have one)?
I found the ED doctor's suggestion of heparin bizarre. I liked the neurologist.
TPA is safer when given earlier in the course of a stroke. This case illustrates the potential for antipathy to TPA to delay the administration of the drug (the ER doctor was certainly not speeding the process) which is not doing anybody any good.
I agree with Mel, commend Spangler for her handling of this difficult situation. I think some of the confusion here is justified. Though Mel repeatedly did attempt to intergect accurate statements about the situation, there were inaccurate statements made....such as the "50/50" chance Siamak questioned above, and Spanglers statements that clearly show she felt that the TPA definitely was the reason the kid did well....The jury is out LITERALLY....we just don't know enough which is why this is so difficult, and its certainly not "50/50" and the kid may well have recovered fully w/o Tpa and he may have been a vegetable, and those two outcomes could have occurred with the Tpa as well. The neurologists experience w 10 kids is hardly anything to base this decision on. I think what I would do in the case is tell the patient and the family the truth. That we really don't know, and that a relatively small percentage of people will be helped by Tpa and a smaller percentage harmed, that a sig number will recover sig w/o anything but a sig number won't. In the end "what would u do doc" is probably what we will be asked and telling the pt the truth there is probably our best option. In these cases the decision must be shared, We don't have enough data to say the onus is on us to guide the pt, since we really don't have the answer yet.
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Kathleen S., Md - March 4, 2014 11:44 AM
Seriously? 1 1/2 hours into a dense CVA with an MRI confirmed visible clot in a healthy 14yo? Can you possibly get better - better risk/ benefit ratio? Why WOULDN'T you give it?
Aaron A. - March 4, 2014 12:17 PM
Just listened to this. Thank you for sharing, Dr. Spangler. Terrifying; for what it's worth, I would have done the same. I am not a strong tPA proponent, but given your work-up, consultation, and the buy-in from the parents, I think the care provided was excellent, and would have been even if a bad outcome were the result. I have heard the 'what would you do' question often and I answer it truthfully--if the case is not clear, I say I'm not sure because it's a balanced decision, but in this case, I would've said, 'yes, I would treat if it were my child'. Sometimes, as you said, our job is to give guidance. They can still disagree.
The longer I'm out of residency, the more I think our careers come down to a handful of cases, really. Glad there was a good outcome.
Chuck S. - March 7, 2014 9:40 PM
My hat is off to you but given all the data (including what your consultant said there is no way to tell if the good outcome was from TPA or just the natural history of CVA. Everyone prior to TPA and even now has those cases that progressed exactly like this one without TPA. The data from all the "positive Trials" is that there is no difference until 30-90 days between the two groups. The danger with this is any "positive" outcome is attributed to TPA or copper bracelets, or rain dance or whatever and this reinforces our desire to "do something". How may patients will tell you that "antibiotics" cured my URI last time. The danger is that I'm not sure giving TPA actually produces any benefit and that all we get is harm, just like antibiotics for viral illnesses. Sometimes the hardest thing to do is nothing (and the one for which you will get the most criticism. All that said I totally agree that we have to make life or death decisions with inadequate data.
siamak m. - March 9, 2014 9:39 AM
Dr Spangler told the patient that there was a “fifty-fifty chance” the tPA may “make you better”. Please explain where this number came from. My understanding is that while 8 out of 18 stroke
patients who receive tPA will recover by three months, 6 out of 18 stroke patients will recover substantially regardless of treatment. On the other hand, 1 out of 18 patients that receive tPA will bleed in the brain. Please see the AAEM tPA tool:
http://www.aaem.org/UserFiles/file/tpaedtool-AAEM.pdf
Scott C., M.D. - March 9, 2014 3:26 PM
Mizuho, I have to agree with Kathleen - this is not in my opinion a very difficult decision. Calling TPA 'the devil' or suggesting heparin doesn't reflect objectivity or understanding of current literature. And I do like the (often false but oh so ego boosting) affirmation of the EP as the hero and protagonist of the story (full respec' to our neurologist colleagues) rather than an observer.
Thank you however for discussing the case.
Brian D. - March 10, 2014 9:08 PM
Yes, I would reitterate what Chuck has said.
In the end we really have no idea if the tPA did anything to help this patient. This improvement could very well have been due to the natural history of the stroke syndrome. This is why we conduct RCT's with placebo arms to try to determine cause and effect. Many patients in the placebo arm demonstrate benefit. I.e. they get better with nothing more than good supportive care.
We need to be very cautious with case reports showing how tPA performs and I would not want people to listen to this podcast and think that the landscape has somehow changed regarding the evidence supporting stroke thrombolysis.
Mel H. - March 10, 2014 9:31 PM
I made it a point to say 3 times that this outcome could/probably/may etc have NOTHING to do with TPA and could/probably/maybe from the natural course of the disease - so i agree with everyone else - the point is NOT about TPA in kids - the point is about what to do in a REAL situation with the data is not in!
Mizuho M. - March 13, 2014 9:38 AM
Thank you all for your comments. Agreed, we are NOT suggesting this is the standard of care, as the reality stands there is no standard yet, and might not ever be for kids & tpa. And I do appreciate the fact that this very well likely could have been the natural progression of the disease, and as discussed with Mel, & not the tpa at all.
I do not see myself as the hero in this case. On the contrary, I was simply in the "right place, at the right time, with the right resources". I humbly & with great trepidation took the opportunity to make a decision based on what seemed to be in our favor; and by the grace of god did it thankfully have a fantastic outcome.
The discussion would have been very different if the boy had a terrible outcome…I would have been the "poster child" of what not to do! But in the end, the "learning point" remains the same…sometimes we don't have all the answers, and crazy decisions are demanded of ALL of us on the fly. We have to go with our gut, clinical gestalt, resources and fund of knowledge and hope that our well intended efforts don't cause more harm than good! I sincerely hope I never have to push tpa on a kid again! :)
Thanks all for listening!!!
Sid W - March 13, 2014 6:01 PM
Dr. Spangler is to be commended in how she handled this case. Those who would Monday morning quarterback this one and declare the decision to give TPA as not a difficult one should be or even ask rhetorically "Why WOULDN'T you give it" should consider the following: 1) This therapy has significant risk of harm and death in adults. 2) It has not been studied adequately in the pediatric population. Any decision you make going forward to give it is essentially unsubstantiated in the literature.
So the best you can do is try a shared decision making process which can be really difficult with tPA cases when you are trying to lay out the risk. Make sure you are communicating as best as you can with the patient and family and then let the chips fall where they may.
Not trying to start a fight, but to say, "Oh that's easy" is quite frankly a dangerous clinical posture to take in a case such as this.
Thank you, Dr. Spangler, for sharing this case.
Tor K. - March 13, 2014 7:57 PM
Clearly many on EM rap agree with the ED doc in this case that TPA is "the devil." How are they approaching it? Are they not giving it? Do they offer it to patients but make it sound very dangerous and convince them to decline TPA? Do they wash their hands like Pontius Pilate and leave it to a consulting neurologist (if they are lucky enough to have one)?
I found the ED doctor's suggestion of heparin bizarre. I liked the neurologist.
TPA is safer when given earlier in the course of a stroke. This case illustrates the potential for antipathy to TPA to delay the administration of the drug (the ER doctor was certainly not speeding the process) which is not doing anybody any good.
Sean G., M.D. - March 31, 2014 10:45 AM
I agree with Mel, commend Spangler for her handling of this difficult situation. I think some of the confusion here is justified. Though Mel repeatedly did attempt to intergect accurate statements about the situation, there were inaccurate statements made....such as the "50/50" chance Siamak questioned above, and Spanglers statements that clearly show she felt that the TPA definitely was the reason the kid did well....The jury is out LITERALLY....we just don't know enough which is why this is so difficult, and its certainly not "50/50" and the kid may well have recovered fully w/o Tpa and he may have been a vegetable, and those two outcomes could have occurred with the Tpa as well. The neurologists experience w 10 kids is hardly anything to base this decision on. I think what I would do in the case is tell the patient and the family the truth. That we really don't know, and that a relatively small percentage of people will be helped by Tpa and a smaller percentage harmed, that a sig number will recover sig w/o anything but a sig number won't. In the end "what would u do doc" is probably what we will be asked and telling the pt the truth there is probably our best option. In these cases the decision must be shared, We don't have enough data to say the onus is on us to guide the pt, since we really don't have the answer yet.