We are there for the good of the patient, not for the good of the protocol, not for the good of the medical director, and not for the good of the company.

- Rogue Medic

The Silver Lining of Epi – Organ Donation – Part 1

 

Is there really a silver lining to giving epinephrine for cardiac arrest? Scott writes about organ donation as one possible silver lining.
 

The next time you bring one of those cardiac arrest patients in who when you follow up on them, you are told that they have “no brain activity” do not look at it as a complete loss. Ask that follow up question, “Are they going to be able to donate any organs?” You might be pleasantly surprised at what the answer is. Although it’s not exactly what we are looking for, a life might have been saved.[1]

 

That seems reasonable, except that it assumes that the treatment that will produce the best survival, a return to normal life, is produced with epinephrine.

Epinephrine may produce more organ donors, but that is not what we base our treatment on. We treat patients based on what is expected to produce the best outcome for them, not what is expected to produce the best/most organs for donation. Even looking at organ donation, there are many different considerations.

What produces the best organs?

What produces the most organs?

What produces the mixture of quality and quantity that seems to be best for patients?

If we want to improve organ donation rates, one thing we should consider is addressing organ donation directly – not advocating for things that might produce increased organ donation as a side effect. Changing the law from the current opt in to opt out.

With opt in – if I have not made a choice, or if anyone objects to my choice, it is presumed that I object to organ donation and my organs are discarded.

With opt out – if I have not made a choice, it is presumed that I do not object to organ donation and my organs are available to those on the organ transplant lists.

Currently, the license to drive is the indicator and there would be no reason to change that. We are asked to select this if you want to be an organ donor. We would change the question to select this if you do not want to be an organ donor.

Donations are more complex than opt in vs. opt out, but changing one thing may lead to changes in other things because of increased attention.

Here are changes in various rates of organ donation in Belgium before and after a change from opt in to opt out.
 


 

 

 

 

 

 

 

 

 

 

 

Presumed consent alone is unlikely to explain the variation in organ donation rates between different countries. A combination of legislation, availability of donors, transplantation system organisation and infrastructure, wealth and investment in health care, as well as underlying public attitudes to and awareness of organ donation and transplantation, may all play a role, although the relative importance of each is unclear.[2]

 

Should we assume that epinephrine really improves the likelihood of organ donation without decreasing survival from cardiac arrest? I will discuss that in Part 2.

-

Footnotes:

-

[1] The Silver Lining of Epi
February 3, 2014
EMS in the New Decade
Scott
Article

-

[2] A systematic review of presumed consent systems for deceased organ donation.
Rithalia A, McDaid C, Suekarran S, Norman G, Myers L, Sowden A.
Health Technol Assess. 2009 May;13(26):iii, ix-xi, 1-95. doi: 10.3310/hta13260. Review.
PMID: 19422754 [PubMed - indexed for MEDLINE]

Free Full Text from National Institute for Health Research.

.

In Defense of No Improvement by Medic Madness – Part IV

ResearchBlogging.org
 

Continuing from Part I, Part II, and Part III in response to what I wrote about the failure of the LUCAS,[1] Sean continues with -
 

Another issue I have with this data, is that it doesn’t address the following variables:

  • Down time
  • Whether or not bystander CPR was performed
  • Medications used
  • Whether or not an advanced airway was placed
  • Length of resuscitation

All of these things are important when looking at the effectiveness of the LUCAS. Had all of these cases been witnessed full-arrests with immediate intervention, then I might feel differently. Perhaps they did look at these things, but from the data that’s available to the general public, I can’t determine whether or not the LUCAS doesn’t “do any good”. From what we can see, at the very worst it keeps up with some of the best-trained responders out there. Not bad, if you ask me.[2]

 

Did you look at the paper?

Are you guessing at what the study shows based on intuition?

The information is there. This will be mostly a picture book response.

Down time?

Whether bystander CPR was performed?
 


Click on images to make them larger.[3]
 

Medications used?
 


Study design.[4]
 

In both groups, ventilation and drugs were given according to guidelines.16 [3]

 

There is no breakdown for medications.

Of course, medications have not been demonstrated to improve any outcome that matters.

The best way to determine this would be by –

Length of resuscitation or time to ROSC (Return Of Spontaneous Circulation).?
 


 

Whether an advanced airway was placed?
 


 

This may favor the LUCAS, since airways seem to interfere with survival.

Maybe manual compressions really are not the same during an intubation attempt. Maybe people back off on compressions. Therefore, maybe it is easier to intubate under those circumstances. We do not know. The LUCAS may make intubation more difficult.

Worse CPR may mean better intubation, but since intubation doesn’t improve anything, is that a good compromise?

Which is our no improvement device of choice? :oops:
 

Conclusion

We need to be looking at the whole picture here. If we can design a machine to do textbook-perfect CPR, and it doesn’t produce textbook results, then maybe we need to re-evaluate our textbook. Even if the studies do prove that the device isn’t improving survival rates, we still can’t discard the device as “worthless”. It has its place in situations with limited responders. And yes, the data supports that.[2]

 

Why assume that a textbook is right?

How often do I cite any textbook? The only textbook I regularly (and usually negatively) cite is ACLS.

Textbooks tend to be the last to change, but textbooks do change. The change is because research demonstrates that the textbook is wrong and needs to be revised. Textbooks are expected to be revised as we learn more from research.

When you suggest that the research does not confirm the biases of the textbook writers as evidence of a problem with the research, there is the possibility that you are right. This research may be providing evidence that the assumptions of the textbook writers are wrong. The way we find out is by looking closely at the quality of the research and looking at similar research.

However, LINC is good research.
 

Experimental studies with the mechanical chest compression device used in this study have shown improved organ perfusion pressures, enhanced cerebral blood flow, and higher end-tidal CO2 compared with manual CPR, with the latter also supported by clinical data.9- 11 [3]

 

Why is it that improving these surrogate endpoints does not improve what matters – survival? What do we not understand?

We should be more interested in doing no harm.

We seem to be more interested in throwing the kitchen sink at the patient, because what if the arrest is due to a kitchen sink deficiency?
 

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

Peter Canning describes the failures of judgment in advocating for the LUCAS in Whup Kits and Chihuahuas.

-

Footnotes:

-

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

-

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

-

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed - indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

-

[4] The study protocol for the LINC (LUCAS in cardiac arrest) study: a study comparing conventional adult out-of-hospital cardiopulmonary resuscitation with a concept with mechanical chest compressions and simultaneous defibrillation.
Rubertsson S, Silfverstolpe J, Rehn L, Nyman T, Lichtveld R, Boomars R, Bruins W, Ahlstedt B, Puggioli H, Lindgren E, Smekal D, Skoog G, Kastberg R, Lindblad A, Halliwell D, Box M, Arnwald F, Hardig BM, Chamberlain D, Herlitz J, Karlsten R.
Scand J Trauma Resusc Emerg Med. 2013 Jan 25;21:5. doi: 10.1186/1757-7241-21-5.
PMID: 23351178 [PubMed - indexed for MEDLINE]

Free Full Text from PubMed Central.

-

Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, & Karlsten R (2014). Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA : the journal of the American Medical Association, 311 (1), 53-61 PMID: 24240611

-

Rubertsson S, Silfverstolpe J, Rehn L, Nyman T, Lichtveld R, Boomars R, Bruins W, Ahlstedt B, Puggioli H, Lindgren E, Smekal D, Skoog G, Kastberg R, Lindblad A, Halliwell D, Box M, Arnwald F, Hardig BM, Chamberlain D, Herlitz J, & Karlsten R (2013). The study protocol for the LINC (LUCAS in cardiac arrest) study: a study comparing conventional adult out-of-hospital cardiopulmonary resuscitation with a concept with mechanical chest compressions and simultaneous defibrillation. Scandinavian journal of trauma, resuscitation and emergency medicine, 21 PMID: 23351178
.

In Defense of No Improvement by Medic Madness – Part III

ResearchBlogging.org
 

Continuing from Part I and Part II, in response to what I wrote about the failure of the LUCAS,[1] Sean continues with -
 

So do these results reflect on a device that’s over-hyped, or are we missing something in our current CPR guidelines? Keep in mind that this study involved highly trained and prepared responders using the most up-to-date recommendations for CPR delivery. We developed a machine to do exactly what we tell it to. It follows the guidelines exactly as we want, and yet, it can’t produce the results we hoped for. Perhaps the machine isn’t the problem.[2]

 

Maybe the machine was never the answer.
 

In clinical practice, mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR.[3]

 

This is probably just a reflection of how little we understand of what we are doing.

Everything we do in EMS, and especially in resuscitation, is over-hyped.

If our worry is that we will look like we are not doing enough, then open heart cardiac massage can make it clear that we are doing a lot.[4]   :shock:
 

Image credit.
 

How many survival studies do we have that randomize patients between a placebo and a vasopressor treatment?

For epinephrine (Adrenaline), vasopressin, norepinephrine (Levophed), or phenylephrine (Neo-Synephrine)?[5]

Here is the evidence of of what happens to survival with epinephrine.[6] I added the two most recent studies.[7],[8] There are no positive epinephrine studies.
 

 

Epinephrine may turn out to be beneficial for some subset of patients, but it is unlikely that epinephrine is beneficial just because the patient remains dead long enough to be given a drug.

A mnemonic for teaching ACLS is – Everybody dead gets epi, because current ACLS (Advanced Cardiac Life Support) guidelines tell us to give epinephrine (or norepinephrine, or vasopressin, or phenylephrine) to all patients who remain dead long enough to be given a drug.

Got a dead patient and can’t think of what to do next? Give epi.

What are we going to do, poison them? Our first dose was so far above the therapeutic range, that it would be considered poisonous if the patient were not already dead.

Vasopressors produce just as much no improvement as a LUCAS.
 

How many survival studies do we have that randomize patients between a placebo and an antiarrhythmic active treatment in cardiac arrest?

Foe amiodarone (Cordarone), lidocaine (Xylocaine), procainamide (Procaine), and magnesium?[9]

In two studies of magnesium, there was no improvement in survival vs. placebo.[10],[11]

In one study of amiodarone, there was improvement in everything except survival to discharge – more patients were resuscitated, but they died in the hospital.[12]

Antiarrhythmics produce just as much no improvement as a LUCAS.
 

There have been other studies of vasopressors and of antiarrhythmics against other unknowns, but does a positive outcome against a different unknown mean more beneficial than the other unknown or just less harmful than the other unknown?

We are aren’t even using Schrödinger’s treatments, because we don’t know if a good outcome means that the patient is surviving because of what we are doing or surviving in spite of what we are doing. We appear to be just happy to be doing something.

Still, we insist on giving these treatments, because we are afraid of doing too little.

We don’t know enough to know what too little is, but it is our fear of doing too little that keeps us from learning what works.

While this is not Sean’s fault, he is aggressively advocating for more of the status quo – the dramatic lack of improvement that we expect from EMS treatments.
 

The LUCAS failed – unless our idea of success is to make no difference in outcomes, because improving resuscitation outcomes is not really our goal.

EMS – we improve nothing more expensively, more dramatically, and more consistently than anyone else!
 

I look at the flawed claims of flaws in the paper in Part IV.

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

Peter Canning describes the failures of judgment in advocating for the LUCAS in Whup Kits and Chihuahuas.

-

Footnotes:

-

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

-

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

-

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed - indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

-

[4] A Resuscitation Question So Obvious That . . . .
Sun, 19 Jan 2014
Rogue Medic
Article

-

[5] Vasopressors
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
Part 8: Adult Advanced Cardiovascular Life Support
Part 8.2: Management of Cardiac Arrest
Medications for Arrest Rhythms
Free Full Text from Circulation with link to PDF Download

-

[6] Vasopressors in cardiac arrest: a systematic review.
Larabee TM, Liu KY, Campbell JA, Little CM.
Resuscitation. 2012 Aug;83(8):932-9. Epub 2012 Mar 15.
PMID: 22425731 [PubMed - in process]
 

CONCLUSION: There are few studies that compare vasopressors to placebo in resuscitation from cardiac arrest. Epinephrine is associated with improvement in short term survival outcomes as compared to placebo, but no long-term survival benefit has been demonstrated. Vasopressin is equivalent for use as an initial vasopressor when compared to epinephrine during resuscitation from cardiac arrest. There is a short-term, but no long-term, survival benefit when using high dose vs. standard dose epinephrine during resuscitation from cardiac arrest. There are no alternative vasopressors that provide a long-term survival benefit when compared to epinephrine. There is limited data on the use of vasopressors in the pediatric population.

-

[7] Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest.
Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, Miyazaki S.
JAMA. 2012 Mar 21;307(11):1161-8. doi: 10.1001/jama.2012.294.
PMID: 22436956 [PubMed - indexed for MEDLINE]

Free Full Text from JAMA.

-

[8] Impact of early intravenous epinephrine administration on outcomes following out-of-hospital cardiac arrest.
Hayashi Y, Iwami T, Kitamura T, Nishiuchi T, Kajino K, Sakai T, Nishiyama C, Nitta M, Hiraide A, Kai T.
Circ J. 2012;76(7):1639-45. Epub 2012 Apr 5.
PMID: 22481099 [PubMed - indexed for MEDLINE]

Free Full Text from Circulation Japan.

-

[9] Antiarrhythmics
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
Part 8: Adult Advanced Cardiovascular Life Support
Part 8.2: Management of Cardiac Arrest
Medications for Arrest Rhythms
Free Full Text from Circulation with link to PDF Download

-

[10] Randomised trial of magnesium in in-hospital cardiac arrest. Duke Internal Medicine Housestaff.
Thel MC, Armstrong AL, McNulty SE, Califf RM, O’Connor CM.
Lancet. 1997 Nov 1;350(9087):1272-6.
PMID: 9357406 [PubMed - indexed for MEDLINE]

-

[11] Magnesium sulfate in the treatment of refractory ventricular fibrillation in the prehospital setting.
Allegra J, Lavery R, Cody R, Birnbaum G, Brennan J, Hartman A, Horowitz M, Nashed A, Yablonski M.
Resuscitation. 2001 Jun;49(3):245-9.
PMID: 11719117 [PubMed - indexed for MEDLINE]

-

[12] Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation.
Kudenchuk PJ, Cobb LA, Copass MK, Cummins RO, Doherty AM, Fahrenbruch CE, Hallstrom AP, Murray WA, Olsufka M, Walsh T.
N Engl J Med. 1999 Sep 16;341(12):871-8.
PMID: 10486418 [PubMed - indexed for MEDLINE]

Free Full Text from New England Journal of Medicine.

-

Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, & Karlsten R (2014). Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial. JAMA : the journal of the American Medical Association, 311 (1), 53-61 PMID: 24240611

-

Larabee TM, Liu KY, Campbell JA, & Little CM (2012). Vasopressors in cardiac arrest: a systematic review. Resuscitation, 83 (8), 932-9 PMID: 22425731

-

Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, & Miyazaki S (2012). Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest. JAMA : the journal of the American Medical Association, 307 (11), 1161-8 PMID: 22436956

-

Hayashi Y, Iwami T, Kitamura T, Nishiuchi T, Kajino K, Sakai T, Nishiyama C, Nitta M, Hiraide A, & Kai T (2012). Impact of early intravenous epinephrine administration on outcomes following out-of-hospital cardiac arrest. Circulation journal : official journal of the Japanese Circulation Society, 76 (7), 1639-45 PMID: 22481099

-

Thel MC, Armstrong AL, McNulty SE, Califf RM, & O’Connor CM (1997). Randomised trial of magnesium in in-hospital cardiac arrest. Duke Internal Medicine Housestaff. Lancet, 350 (9087), 1272-6 PMID: 9357406

-

Allegra J, Lavery R, Cody R, Birnbaum G, Brennan J, Hartman A, Horowitz M, Nashed A, & Yablonski M (2001). Magnesium sulfate in the treatment of refractory ventricular fibrillation in the prehospital setting. Resuscitation, 49 (3), 245-9 PMID: 11719117

-

Kudenchuk PJ, Cobb LA, Copass MK, Cummins RO, Doherty AM, Fahrenbruch CE, Hallstrom AP, Murray WA, Olsufka M, & Walsh T (1999). Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation. The New England journal of medicine, 341 (12), 871-8 PMID: 10486418

.

$16M on EMS Stroke Trial? Dr. Rick Bukata Wants His Money Back!


 

FAST-MAG[1] actually has good methodology, so why is Dr. Rick Bukata so upset? Is this just USC vs. UCLA off the field/court?

Should the hypothesis being tested have received the Queen for a Decade treatment?

He wants his money back? Roughly 160 million tax payers in the US, so $0.10 per tax payer, but he makes more than the average schlub, so maybe as much as 50 cents for him. He can’t even buy enough caffeine to raise his blood pressure with that.
 

In a commentary regarding the IMAGES trial by Larry Goldstein of the Duke Center for Cerebrovascular Disease in the same issue of the Lancet in which the study was published, he noted that of more than 40 clinical trials of “neuroprotectants” involving over 11,000 patients, none has shown any evidence of benefit. Ten years later, the same is true.[2]

 

But look at the animal studies!

But look at the time being saved!

The authors actually like to repeat the term Golden Hour – as if that is new or valid.
 

So, if you are still a believer in the potential of magnesium, why not try and give magnesium in a pilot clinical study involving stroke patients in the ED? It would have been a relatively simple study to do. It could have been performed in selected EDs throughout the country and the answer would have been established in a fraction of eight years and at a very small fraction of $16 million.

Instead, the Fast-Mag investigators decide that giving magnesium in the field (probably about 10-20 minutes faster than could be given in the ED) would be a reasonable study.[2]

 

Gosh, when he brings reason into the argument, it just seems that the other side has none.

What could the money have been spent on?

Epinephrine vs. placebo in cardiac arrest? The number of lives affected is large and we are currently treating based on philosophy, not science.

IV (IntraVenous) bolus NTG (NiTroGlycerin – GTN GlycerylTriNitrate in Commonwealth countries) vs. SL (SubLingual) NTG for acute CHF (Congestive Heart Failure)? This affects even more patients than cardiac arrest and there is good evidence that IV bolus NTG dramatically improves outcomes, while SL NTG is not based on evidence.

Excited delirium treatment with various IM (IntraMuscular) medications to see what is safest and most effective and at what dose. A large trial would be necessary.

With no good reason to be optimistic about outcomes, why take this multimillion dollar long shot?

Maybe it has to do with tPA (tissue Plasminogen Activator) and the failure to get emergency physicians to accept the poor research on tPA – tPA showed harm, or no benefit, in 9 out of 11 studies.[3]

Ironically, if those studies used methodology similar to this study, that could be showed harm, or no benefit, in 11 out of 11 studies.

Dr. Jeffrey L. Saver, one of the authors, has a presentation on FAST-MAG that spends a lot of time on tPA, even prehospital tPA.

What does Dr. Sarver consider to be positive about FAST-MAG? Here are some of his slides.[4]
 


 

FAST-MAG means more tPA use.
 


 

FAST-MAG means doing a lot of things that have not been done before and expecting the outcome to be good.

This is the kind of person who starts turning all of the dials on a ventilator and then looks at the patient to see what the result is.

A reasonable approach to research is to limit variables, not brag about how much prudence has been abandoned.
 


 

FAST-MAG means time will be saved, but . . . .
 

Walter Koroshetz, MD, neurologist and deputy director of the National Institutes of Health’s (NIH’s) National Institute of Neurological Disorders and Stroke, sponsor of the FAST-MAG study, says that lessons can be learned from the trial.[5]

 

“The NIH have a new network to do more prehospital trials, but we need phase 2 studies first that demonstrate some biological effect before going into a large costly phase 3 trials.”[5]

 

This is a $16 million bet that time is the only factor that matters.

I hope these doctors do not drive the way they gamble.

What were the results?

The results were the same as all of the previous studies of magnesium – no improvement.

There is no Magnesium Golden Hour.
 

And, please, no – don’t even consider the idea of giving tPA in the field.[2]

 

Well, . . . .
 

Dr. Saver explained that tPA cannot be given at present in a prehospital setting because hemorrhagic stroke has to be ruled out with computed tomography (CT). The use of ambulances with a CT scanner on board has been studied in Germany and is now starting to be tested in the United States.[5]

 

Be very afraid.

On the other hand, the authors did not rush this treatment into EMS protocols, as we recently have in EMS in so many places with therapeutic hypothermia, based entirely on research done in the ED (Emergency Department). It works in the ED, but not in the ambulance. :oops:

FAST-MAG was approved in 1999, several years after the EMS nifedipine (Procardia) for hypertensive crisis crisis. There was no study in the EMS setting of a treatment for the EMS setting. This involved treatment of the surrogate endpoint of blood pressure numbers, which makes for an easy win, such as a systolic drop of 250 -> 90 in ten minutes. :oops:

We need a balance between rushing to add the new cool treatment (and the predictable removal of the treatment decades later) and the inappropriate rush to a large scale trial of something that has repeatedly failed smaller studies.
 

Go read Dr. Bukata’s full article.

-

Footnotes:

-

[1] Methodology of the Field Administration of Stroke Therapy – Magnesium (FAST-MAG) phase 3 trial: Part 2 – prehospital study methods.
Saver JL, Starkman S, Eckstein M, Stratton S, Pratt F, Hamilton S, Conwit R, Liebeskind DS, Sung G, Sanossian N; FAST-MAG Investigators and Coordinators.
Int J Stroke. 2014 Feb;9(2):220-5. doi: 10.1111/ijs.12242.
PMID: 24444117 [PubMed - in process]

Methodology of the Field Administration of Stroke Therapy – Magnesium (FAST-MAG) phase 3 trial: Part 1 – rationale and general methods.
Saver JL, Starkman S, Eckstein M, Stratton S, Pratt F, Hamilton S, Conwit R, Liebeskind DS, Sung G, Sanossian N; FAST-MAG Investigators and Coordinators.
Int J Stroke. 2014 Feb;9(2):215-9. doi: 10.1111/ijs.12243. Epub 2014 Jan 13.
PMID: 24444116 [PubMed - in process]

-

[2] $16M on EMS Stroke Trial? I Want My Money Back!
by Rick Bukata, MD
March 24, 2014
Emergency Physicians monthly
Article

-

[3] The Guideline, The Science, and The Gap
Wednesday, April 17, 2013
Dr. David Newman
Smart EM
Article

-

[4] Treat Stroke in the Field:
Lessons from the NIH FAST-MAG Trial

Jeffrey L. Saver, MD, Professor of Neurology
UCLA Stroke Center
2012
Presentation Slides in PDF Downoad format.

-

[5] FAST-MAG: No Benefit of Prehospital Magnesium in Stroke
Sue Hughes
February 14, 2014
Medscape
Article

.

Valsalva the SVT or Shock the Monkey?


 

The Skeptics’ Guide to Emergency Medicine should be on your podcast list. The podcasts are short, so there is not much reason to avoid them. This one is 13 minutes.

Valsalva for SVT (SupraVentricular Tachycardia) is supposed to come before medication. At least that is the order of treatments of every EMS SVT protocol I have seen. Since medicine is expected to have more, and more serious, side effects, this is reasonable.

What medicines?

Adenosine has the side effects of -
 

Cardiovascular

Prolonged asystole, ventricular tachycardia, ventricular fibrillation, transient increase in blood pressure, bradycardia, atrial fibrillation, and Torsade de Pointes

Respiratory

Bronchospasm

Central Nervous System

Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness.[1]

 

It appears to be reasonable to try to avoid those side effects.

Too much of this could become more of a problem than an SVT.
 


Click on images to make them larger. Image credit.[2] This is not the actual strip, but a strip of an adenosine pause edited to produce more asystole, which I have seen.
 

The side effect becomes much more of a problem when someone decides to treat the side effect, rather than wait for it to wear off.

We SLAM adenosine in because it wears off quickly. A minute, or two, of asystole is not a problem.

Giving a dose of epinephrine to a patient who had an SVT a minute ago and now has adenosine quickly wearing off – that may be a fatal problem.

But how effective is the Valsalva maneuver (VM)?
 

The VM is a non-invasive way to convert patients from SVT to sinus.It increases myocardial refractory period by increasing intrathoracic pressure thus stimulating baroreceptors in the aortic arch and carotid bodies Increases vagal tone (parasympathetic).[3]

 

Here is a big problem with the use of the Valsalva maneuver. It is just one method of attempting to stimulate the vagus nerve.

There are many other methods and they may be more successful. Carotid sinus massage (after auscultation for bruits), facial immersion in ice water (assuring that the airway does not become a problem), bearing down, blowing through a straw (even better may be a swizzle stick), digital circumferential sweep of the anus, coughing, . . . .

There are many ways of activating the vagal nerve, but my favorite is to act as if I have not started an IV before, go very s l o w l y with the insertion of the largest IV catheter I think I can get in the vein, and this has almost always broken the rhythm.

Yes, that is anecdotal, but I have only rarely needed to follow that with medication.

Yes, pain is not a nice thing, but it is much nicer than the side effects listed above.
 

Bottom Line: There is no standardized methods to perform a VM to terminate uncomplicated SVT that are evidence based.

Clinical Application: VM is a viable technique that is poorly researched for the conversion of SVT and should not be considered essential to attempt prior to chemical cardioversion.[2]

 

We need better vagal maneuvers.

We need good evidence on what works.
 

Go read the article and listen to the podcast.
 

-

Footnotes:

-

[1] ADENOCARD (adenosine) solution
[Astellas Pharma US, Inc.]

DailyMed
FDA Label

-

[2] Atrioventricular Re-entrant Tachycardia
Thumbnail Guide to Congenital Heart Disease
edited version of their adenosine ECG strip
Article

-

[3] SGEM#67: Shock the Monkey Tonight (Valsalva Maneuver for SVT)
Podcast Link: SGEM67
Date: March 23, 2014
Skeptics’ Guide to Emergency Medicine
Article and link to podcast

.

In Defense of No Improvement by Medic Madness – Part II

 

Continuing from Part I, in response to what I wrote about the failure of the LUCAS,[1] Sean continues with -
 

No, there isn’t much data to suggest that using a LUCAS improves outcomes. Likewise, we aren’t discovering that it’s hurting people either. So at the very worst, it’s a luxury item.[2]

 

No.

I am critical of treatments that do not work. Once we start making excuses to use these treatments, we take decades to get rid of them.
 

No difference in survival or neurological outcome was seen for up to 6 months after the cardiac arrest as, by then, the vast majority of survivors had CPC scores of 1 or 2, and most patients with initial CPC scores of 3 or 4 had either improved or died. The numbers of serious adverse events and device-related adverse events were low.[3]

 

The LUCAS failed.

Unless your idea of success is to make no difference in outcomes, because improving resuscitation outcomes is not important.
 

Moving out of the big city and going to work in an area that utilizes volunteers as first-responders means that I often find myself working a resuscitation with just me and my partner. If – and I emphasize the word “if” – we happen to get first-responders to these calls, we still have no idea what kind of training or experience they have.[2]

 

The LUCAS as an excuse to tolerate incompetence.

Over, and over, and over, . . . this has been the main argument for the LUCAS.

We can’t expect EMS to perform high quality CPR.

We are too busy doing other things that do not improve outcomes to make sure that compressions are done well.

There are only two things that a paramedic needs to make sure are done well – compressions and defibrillation.

What do paramedics want to do?

We want to do things that do not improve outcomes, because we do not understand what we are doing and are easily distracted by shiny things. Maybe they can put a flashing light on the LUCAS, or give out badges with each use, and raise the price by $5,000 $10,000.
 


Rather than courage, we can award a LUCAS Save! medal – a shiny one.
 

If I am to take Sean seriously, perhaps it will be because he has taken the same argument against intubation and advocated for protecting patients from incompetent EMS by replacing endotracheal tubes with almost foolproof LMAs (Laryngeal Mask Airways).

More consistent, frees up a set of hands, probably less liability, . . . .

What?

Sean hasn’t applied the same logic to intubation in cardiac arrest?

I am shocked. :shock:
 

I too have been a volunteer and I know the value of the care they provide. Having said that, it’s hard to get strict on training when they are already going out of their way to provide service to their community.[2]

 

I don’t blame the volunteer for the quality of care they provide when working with a paramedic right there.

I blame the paramedic.

It is my job to make sure that what is going on is done well. Compressions and defibrillation are all that matter. If I can’t manage that, intubation is definitely beyond my capabilities.
 

What’s the harm of treatments that do not improve outcomes alternative medicine?

I look at the criticisms of the actual research in Part III and Part IV.

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

Peter Canning describes the failures of judgment in advocating for the LUCAS in Whup Kits and Chihuahuas.

-

Footnotes:

-

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

-

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

-

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed - indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

.

In Defense of No Improvement by Medic Madness – Part I

 

I wrote about treatment with the LUCAS CPR machine and stated that There is no price that justifies no improvement.[1]

There are plenty people who want to justify the use of placebo treatments – treatments that do not improve outcomes. Here is one –
 

Before writing this response, I took some time to examine the equipment I use on a daily basis. Needless to say, I was shocked to discover that we spend a lot of money of items that really don’t improve patient outcomes at all. One example is the Stryker Power Cot.[2]

 

The LUCAS is a treatment that is a potential substitute for manual chest compressions.

The selling point was supposed to be that the LUCAS improves outcomes – survival with a working brain – that is the whole purpose of the research I have been writing about.
 

Thus, in clinical practice, CPR with this mechanical device using the presented algorithm can be delivered without major complications but did not result in improved outcomes compared with manual chest compressions.[3]

 

The LUCAS failed.

However, Sean is taking my statement about the outcome of a treatment and applying it to the choice of equipment.

Does a power stretcher improve the survival of patients?
 


 

I do not know of any studies that examine this question, but the stretcher is not used as a treatment. The stretcher is used as a means of moving the patient.

What Sean appears to be asking is – since I am going to use a stretcher (is there any state that does not require a stretcher in an ambulance), shouldn’t I use the cheapest stretcher that meets the requirements? Or am I going to base my decision on something other than outcomes?

Is the choice to pay more for a power stretcher based on the outcomes of patients?
 

Although I tried, I couldn’t find any studies that compared patient outcomes to those transported using a manual cot.[2]

 

It is not based on the outcomes of patients, but the choice is based on outcomes.

In a study comparing the injury rate among FTEs (Full-Time Employees), the rate of injury was cut in half after the introduction of a powered stretcher.[4]

Maybe EMS should not consider the outcomes for employees when making decisions?

What is Sean’s next gotcha?
 

Another major purchase was the LifePak 15 ECG monitor / defibrillator. Once again, I couldn’t find anything showing improved patient outcomes.[2]

 

Sean couldn’t find any evidence that waveform capnography improves outcomes for patients?[5] :sad:

Sean couldn’t find any evidence that an EMS 12 lead ECG (ElectroCardioGram) improves outcomes for patients?[6] :oops:

Sean couldn’t find any evidence that EMS defibrillation improve outcomes for patients?[7] :shock:

Perhaps Sean works in a state that does not require a defibrillator, 12 lead capability, and/or waveform capnography as minimum paramedic equipment and thinks these are just fun to have toys.

Sean appears to be suggesting that the choice of brand and options, except as mandated by EMS regulatory organizations, must be limited to the cheapest available item. Otherwise, I am misleading people by stating – There is no price that justifies no improvement.

Should I be worried at Sean’s failure to find the valid evidence, when I only provided a small sample of the valid evidence?

Does this affect Sean’s argument? The argument is really just a bait and switch – a logical fallacy known as a straw man.[8] I wrote about one thing and Sean represented my argument as something else, because he has an argument against the argument I did not make. However, his argument does not address the claim I actually did make.
 

That is not the only argument Sean makes. I address the rest in Part II, Part III, and Part IV.

Dr. Brooks Walsh also explains the failure of the LUCAS in this study in “We had a LUCAS save!” – No, you didn’t.

-

Footnotes:

-

[1] The Failure of LUCAS to Improve Outcomes in the LINC Trial
Wed, 05 Mar 2014
Rogue Medic
Article

The LUCAS, Research, and Wishful Thinking
Fri, 07 Mar 2014
Rogue Medic
Article

-

[2] In Defense of the LUCAS
March 12, 2014
by Sean Eddy
Medic Madness
Article

-

[3] Mechanical chest compressions and simultaneous defibrillation vs conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: the LINC randomized trial.
Rubertsson S, Lindgren E, Smekal D, Östlund O, Silfverstolpe J, Lichtveld RA, Boomars R, Ahlstedt B, Skoog G, Kastberg R, Halliwell D, Box M, Herlitz J, Karlsten R.
JAMA. 2014 Jan 1;311(1):53-61. doi: 10.1001/jama.2013.282538.
PMID: 24240611 [PubMed - indexed for MEDLINE]

Free Full Text in PDF Download format from PEHSC.org.

-

[4] Evaluation of occupational injuries in an urban emergency medical services system before and after implementation of electrically powered stretchers.
Studnek JR, Mac Crawford J, Fernandez AR.
Appl Ergon. 2012 Jan;43(1):198-202. doi: 10.1016/j.apergo.2011.05.001. Epub 2011 May 31.
PMID: 21632034 [PubMed - indexed for MEDLINE]

-

[5] The effectiveness of out-of-hospital use of continuous end-tidal carbon dioxide monitoring on the rate of unrecognized misplaced intubation within a regional emergency medical services system.
Silvestri S, Ralls GA, Krauss B, Thundiyil J, Rothrock SG, Senn A, Carter E, Falk J.
Ann Emerg Med. 2005 May;45(5):497-503.
PMID: 15855946 [PubMed - indexed for MEDLINE]

-

[6] Effect of prehospital triage on revascularization times, left ventricular function, and survival in patients with ST-elevation myocardial infarction.
Sivagangabalan G, Ong AT, Narayan A, Sadick N, Hansen PS, Nelson GC, Flynn M, Ross DL, Boyages SC, Kovoor P.
Am J Cardiol. 2009 Apr 1;103(7):907-12. doi: 10.1016/j.amjcard.2008.12.007. Epub 2009 Feb 7.
PMID: 19327414 [PubMed - indexed for MEDLINE]

-

[7] Treatment of out-of-hospital cardiac arrests with rapid defibrillation by emergency medical technicians.
Eisenberg MS, Copass MK, Hallstrom AP, Blake B, Bergner L, Short FA, Cobb LA.
N Engl J Med. 1980 Jun 19;302(25):1379-83.
PMID: 7374695 [PubMed - indexed for MEDLINE]

-

[8] Straw man
Wikipedia
Article

.

EMS Dinosaurs and the Slow Gazelles – EMS Office Hours

-
 

This week on EMS Office Hours, Jim Hoffman, Josh Knapp, and Dave Brenner discussed a couple of topics kind of related to dinosaurs before I got on the show. We ended up discussing what a dinosaur is (all of us) and what a problem dinosaur is (someone who refuses to learn).
 

EMS Dinosaurs and the Slow Gazelles
 

I stated that dinosaurs, the problem people – those who refuse to learn, make excuses for the failure of their beliefs to be confirmed by reality (valid evidence of improved outcomes).

Here are some of the treatments that are routine in EMS, but are not supported by valid evidence of improved outcomes.

Backboards, a lot of saline for uncontrolled hemorrhage, ventilations for cardiac arrest, airways for cardiac arrest, drug for cardiac arrest, furosemide (Lasix, frusemide in Commonwealth countries) for acute CHF (Congestive Heart Failure), sodium bicarbonate is a good treatment for acidosis, high-flow oxygen in the absence of hypoxia, 50% dextrose for hypoglycemia, steroids for spinal injuries, et cetera.

All of these are based on an absence of evidence or on inadequate evidence. Most of them have evidence of more harm than benefit.

Why do we continue to add treatments to guidelines before there is evidence of benefit?

Because we believe that the treatments work because we are dangerous optimists. We refuse to learn that we harm patients by rushing treatments in to guidelines.

In the absence of evidence of benefit, we should assume that every treatment is harmful.

If reality does not agree with what we believe, then the problem is not reality, but our refusal to accept reality.
 

There was a discussion of prehospital therapeutic hypothermia with IV (IntraVenous) chilled saline, which has been clearly demonstrated to be not beneficial and possibly harmful. In-hospital therapeutic hypothermia does work, but having EMS start this was a bad idea and now needs to be removed from protocols.

There have been three studies of the effect of prehospital chilled saline for post-resuscitation therapeutic hypothermia. Dr. Bernard’s study showed no benefit and was stopped early because the results made it clear that there was no benefit.[1] Dr. Bernard talks with Dr. Scott Weingart on two EMCrit podcasts about the more recent studies.[2]
 


Click on images to make them larger. “Normal” temperature is 37°C and varies throughout the day, including when almost dead. The drop in the graph is not a temperature drop. It is the drop in survival for both groups.
 

After publication of the seminal trials of therapeutic hypothermia after cardiac arrest,2,3 this approach was recommended in international guidelines,4 despite arguments by some investigators that the evidence was weak, owing to the risk of bias and small samples.6,25 [3]

 

We are doing a lot to the patient that can cause complications with no expectation of any benefit.

This is a bad idea.

 


 

The intervention reduced core body temperature by hospital arrival, and patients reached the goal temperature about 1 hour sooner than in the control group. The intervention was associated with significantly increased incidence of rearrest during transport, time in the prehospital setting, pulmonary edema, and early diuretic use in the ED. Mortality in the out-of-hospital setting or ED and hospital length of stay did not differ significantly between the treatment groups.[4]

 

We need to wait for evidence of improved outcomes.

If we cannot provide evidence of improved outcomes, all we have is wishful thinking.

Wishful thinking kills.
 

Go listen to the podcast.
 

PS The story from Welcome to the Monkey House by Kurt Vonnegut is called Harrison Bergeron. It is only a couple of pages and beautifully written. The full text is on line for free here.
 

THE YEAR WAS 2081, and everybody was finally equal. They weren’t only equal before God and the law. They were equal every which way. Nobody was smarter than anybody else. Nobody was better looking than anybody else. Nobody was stronger or quicker than anybody else. All this equality was due to the 211th, 212th, and 213 th Amendments to the Constitution, and to the unceasing vigilance of agents of the United States Handicapper General.

. . . . .

 

Go read Harrison Bergeron.

-

Footnotes:

-

[1] Induction of therapeutic hypothermia by paramedics after resuscitation from out-of-hospital ventricular fibrillation cardiac arrest: a randomized controlled trial.
Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns (RICH) Investigators.
Circulation. 2010 Aug 17;122(7):737-42. doi: 10.1161/CIRCULATIONAHA.109.906859. Epub 2010 Aug 2.
PMID: 20679551 [PubMed - indexed for MEDLINE]

Free Full Text from Circulation.

-

[2] Podcast 113 – Post-Cardiac Arrest Care in 2013 with Stephen Bernard – Part I
EMCrit
Podcast page with links to research mentioned in the podcast.

Podcast 114 – Post-Arrest Care in 2013 with Stephen Bernard – Part II
EMCrit
Podcast page with links to research mentioned in the podcast.

-

[3] Targeted temperature management at 33°C versus 36°C after cardiac arrest.
Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Åneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Køber L, Langørgen J, Lilja G, Møller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators.
N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.
PMID:24237006[PubMed - indexed for MEDLINE]

-

[4] Effect of Prehospital Induction of Mild Hypothermia on Survival and Neurological Status Among Adults With Cardiac Arrest: A Randomized Clinical Trial.
Kim F, Nichol G, Maynard C, Hallstrom A, Kudenchuk PJ, Rea T, Copass MK, Carlbom D, Deem S, Longstreth WT Jr, Olsufka M, Cobb LA.
JAMA. 2013 Nov 17. doi: 10.1001/jama.2013.282173. [Epub ahead of print]
PMID: 24240712 [PubMed - as supplied by publisher]

.