In my book, “safe” translates to a lack of attributable harm. Therefore, going as fast as possible while still claiming safety – should mean no excess harms resulting from the rush.
There’s no way to precisely tell whether or not this is the case here in Helsinki, where the stroke neurologists have cut their door-to-needle time for thrombolysis to under 20 minutes. The results as described here, however, are not promising, and the authors agree with my impression:
“Our findings support the safety of highly optimized door-to-needle times.”
Ha ha! Of course they don’t.
This is a retrospective review of 1,015 stroke code patients arriving over a two-year period between 2013 and 2015. This institution, incorporating elements of pre-hospital assessment into their initial evaluation, have had door-to-needle times below 20 minutes since 2011. How do they perform?
Of the 1,015, there were 150 (14.8%) patients with misdiagnosis on the initial assessment. Of these, 90 were ultimately diagnosed with a stroke mimic, 59 were eventually diagnosed with a stroke or TIA, and one small basal ganglia hemorrhage was missed. These initial misdiagnoses led, as you might imagine, to both unnecessary treatment and delays to the correct treatment. The most profound effects of these delays were in the context of stroke mimics, whose median delay until a correct diagnosis was 39 hours. Thirteen stroke mimics received thrombolysis, and diagnostic inertia from the initial misdiagnosis led 13 more to have median delays of up to 56 hours for the initiation of condition-specific treatment.
Now, there are limitations here that likely tilt these statistics in favor of the institution. There is no described standard follow-up evaluation to confirm cerebral ischemia, and likely some of those with TIA (146 patients) or who received tPA (331 patients) and improved could further be lumped in with the stroke mimics based on their clinical evaluation and whether they ever underwent MRI. Conversely, even though these authors are speeding headlong in order to give tPA, we can’t actually attribute all these misdiagnoses to their rushed evaluation. It is likely some of these cases would remain clinically challenging, even with a few extra minutes of careful consideration.
However, if they are trying to prove their implementation is safe, this comparison group is exactly what is necessary. They’ve shown their protocol is results in a substantial number of misdiagnosis and documented patient harms; the onus is on this team to prove their pursuit of a handful fewer minutes to tPA is not a contributing factor. Finally, any possible advantage to shaving a handful of minutes off door-to0-needle times pales in comparison to these obvious misses.
“Diagnosing cerebral ischemia with door-to-thrombolysis times below 20 minutes”
http://n.neurology.org/content/early/2018/07/11/WNL.0000000000005954
We have a Teleneurolgy program at our hospital and there is a push to start giving tpa to pts in CT once it’s completed. In addition they want to order it under our name as the ER doc without completing the exclusion criteria.
We have already given the bolus to a patient who was thrombocytopenic because of the rush to get it on board.
Is there actual data to support the safety of quick administration prior to completing the exclusion criteria checklist. Also where do we as ER docs stand when the neurologist is telling us to order the meds and then there is a bad outcome?
It’s certainly a challenging predicament to be stuck with the specialist recommending tPA in an apparently unsafe fashion. It depends on the individual hospital system, but I would definitely encourage a configuration in which the neurologist is the ordering provider, or your group refuses to start the bolus until all relevant safety criteria are met.