Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

2018 ACLS/PALS/NRP – AHA-ILCOR Guideline questions are being reviewed until 02-21-2017

AHA2015 - 2018
 

In preparation for the 2018 ACLS/PALS/NRP/CPR Guidelines (maybe 2017) the AHA (American Heart Association) and ILCOR (the International Liaison Committee On Resuscitation) are reviewing the questions they ask to examine the evidence, or the lack of evidence, on various interventions addressed by the guidelines for the:
 

First Aid Task Force (Public comment on PICO prioritization has recently closed. PICO categorization public comment period was open from October 10 to 24, 2016)

Advanced Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Basic Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Pediatric Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Education, Implementation and Teams Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)​

Neonatal Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 22nd, 2017!)[1]

 

Some questions are obvious and will be continued, such as 428. This is the review of antiarrhythmic drugs for cardiac arrest. Recent research shows no benefit to patients from amiodarone, or lidocaine.[2]

What do the 2015 ACLS Guidelines recommend?
 

Amiodarone may be considered for VF/pVT that is unresponsive to CPR, defibrillation, and a vasopressor therapy (Class IIb, LOE B-R).

Lidocaine may be considered as an alternative to amiodarone for VF/pVT that is unresponsive to CPR, defibrillation, and vasopressor therapy (Class IIb, LOE C-LD).[3]

 

Outside of controlled trials that are large enough to provide useful answers, amiodarone and lidocaine have no place in the treatment of cardiac arrest.
 

Much less obvious is 808, the suggestion that we should ventilate patients in the absence of evidence of benefit from ventilation – at least there is no evidence of benefit for the patient. Hands-only CPR seems to annoy doctors, nurses, paramedics, EMTs, . . . .

Why are we still ventilating adult cardiac arrest patients with cardiac causes of their cardiac arrest in the absence of evidence of safety and in the absence of evidence of benefit?
 

Why is there any question about 788? Results from Paramedic2 should be available next year. Is epinephrine in cardiac arrest better than a placebo?[4]

This is the first time we will have valid evidence to start to decide what to do with a treatment we have been using for over half a century based on the weakest of evidence. Paramedic2 is unlikely to answer many questions, such as which cardiac arrest patients should receive epinephrine and which should not, but it will be a start.
 

Then there is 464Drugs for monomorphic wide complex tachycardia. Considering the recent publication of PROCAMIO and the absence of discussion of tachycardia and bradycardia in the 2015 Guidelines, it is bizarre that this is among the questions recommended for elimination. Since there was no recommendation on treatment of ventricular tachycardia in the 2015 ACLS Guidelines, the recommendation from 2010 continues unchanged.

What did PROCAMIO show? If we give a high enough dose of amiodarone to actually try to treat the arrhythmia, major adverse cardiac events are more common than any benefit.[5]

Are we using amiodarone just to make stable ventricular tachycardia unstable?

Procainamide is safer and more effective.

Cardioversion is safer and more effective.

Adenosine is safer and probably more effective.[6]

Doing nothing is safer and only slightly less effective.

What about blood-letting for stable ventricular tachycardia?

Blood-letting is probably safer and maybe just as effective as amiodarone.[7]

Footnotes:

[1] ILCOR Continuous Evidence Evaluation
AHA (American Heart Association) and ILCOR (the International Liaison Committee On Resuscitation)
ILCOR 2016-2017 PICO categorization and prioritization public comment page

[2] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators..
N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204.
PMID: 27043165

Free Full Text from NEJM

[3] 2015 Recommendations—Updated
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
2015 Recommendations—Updated

[4] Paramedic2 – The Adrenaline Trial
Warwick Medical School
About

[5] Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study.
Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J; PROCAMIO Study Investigators.
Eur Heart J. 2016 Jun 28. pii: ehw230. [Epub ahead of print]
PMID: 27354046
 

The primary outcome, major adverse cardiac events within 40 minutes of infusion initiation, for procainamide vs. amiodarone, was 9% vs. 41%, p = 0.006. Severe hypotension or symptoms requiring immediate direct current cardioversion (DCCV) occurred in 6.3% vs. 31.0%. Results were similar in patients with structural heart disease (n = 49).

 

[6] Adenosine for wide-complex tachycardia – diagnostic?
Thu, 23 Aug 2012
Rogue Medic
Article

[7] Blood-Letting
Br Med J.
1871 March 18; 1(533): 283–291.
PMCID: PMC2260507
 

Physicians observed of old, and continued to observe for many centuries, the following facts concerning blood-letting.

1. It gave relief to pain. . . . .

2. It diminished swelling. . . . .

3. It diminished local redness or congestion. . . . .

4. For a short time after bleeding, either local or general, abnormal heat was sensibly diminished.

5. After bleeding, spasms ceased, . . . .

6. If the blood could be made to run, patients were roused up suddenly from the apparent death of coma. (This was puzzling to those who regarded spasm and paralysis as opposite states; but it showed the catholic applicability of the remedy.)

7. Natural (wrongly termed ” accidental”) hacmorrhages were observed sometimes to end disease. . . . .

8. . . . venesection would cause hamorrhages to cease.

 

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2015 In Review – Superstitious Standards of Care Suffer Small Losses, But Continue to be Favorites

 

What changed, or almost changed in 2015?

Withholding epinephrine (adrenaline in Commonwealth countries) in cardiac arrest is still heresy. This use of epinephrine is not based on evidence of improved outcomes that matter to patients – unless the patient is a pig/dog/rat with no heart disease having an artificially produced cardiac arrest.

The Jacobs trial ways sabotaged by politicians, the media, and other opponents of science claiming that depriving patients of the standard witchcraft is unethical.[1] Using inadequately tested hunches on uninformed patients, as long as everyone else is doing it, appears to be their idea of ethical behavior. However, the Paramedic2 trial has been underway for about a year and should provide results in 2018.[2]
 

paramedic2_logo
 

There probably is some benefit for cardiac arrest patients who are not having heart attacks, but we do not currently try to identify them. We also do not know what dose or frequency is best or when to give epinephrine. Paramedic2 will only be able to answer some of those questions.
 

Withholding ventilation is a less defended heresy, at least in Pennsylvania.
 

AVOID endotracheal intubation and patient packaging during initial 10 minutes

Ventilation Options6:

  • No Ventilation
  • 1 ventilation every 10-15 compressions8 (Monitor Perfusion with Capnography[3]
  •  

    However, the AHA (American Heart Association) and ILCOR (International Liaison Committee On Resuscitation) 2015 resuscitation guidelines double down on baseless fears –
     

    2015 Evidence Review
    There is concern that delivery of chest compressions without assisted ventilation for prolonged periods could be less effective than conventional CPR (compressions plus breaths) because the arterial oxygen content will decrease as CPR duration increases.
    [4]

     

    There is no evidence to support this fear, but using reason against irrational beliefs is often unsuccessful, since the irrational appeals to emotion and avoids reason.
     

    Medical directors have been recognizing that backboards were used because of irrational fear and assumptions of benefit that were based on hunches. Therefore many medical directors now recognize the absurdity of the use of this malpractice device and discourage the use of backboards.
     

    Pennsylvania has also removed chilled IV fluid from protocols following the failure of the treatment to improve outcomes for cardiac arrest patients, when given by EMS.

    Chilled IV fluid therapeutic hypothermia does work in the hospital, but not when provided by EMS.

    This is one of the reasons EMS should not automatically adopt treatments that work in the hospital. It is difficult for many in EMS to understand, but many in EMS still think that occasionally intubating a patient makes a paramedic as good as an anesthesiologist.
     

    In general, the state of EMS is best summed up by this statement by Prachi Sanghavi –

    Our current ambulance system is based on little scientific evidence.

    The scary thing for patients is that many in EMS are proud of our ignorance.
     

    Elsewhere in medicine in 2015.

    Thousands of Americans travel to regions with outbreaks of Ebola and help to stop the spread of infection. This was in spite of the panic being encouraged by the scientifically illiterate. We should have welcomed them home as we welcome home out military. Both of these groups of Americans risk their lives to protect others and should be treated better. They are far more ethical than our isolationist politicians.

    We learned that we need to add rats to the growing list of the non-human animals that exhibit empathy and will sacrifice to help others.[5] It appears that comparing those who opposed sending Americans to rats is unfair to the rats.
     

    Finally, 2015 was the 100th anniversary of Albert Einstein explaining that Isaac Newton was wrong about gravity, but that is the way science improves.
     

    PS – We also had push dose pressors added to the Pennsylvania protocols in 2015.

    Footnotes:

    [1] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
    Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
    Resuscitation. 2011 Sep;82(9):1138-43. Epub 2011 Jul 2.
    PMID: 21745533 [PubMed – in process]

    Free Full Text PDF Download of In Press Uncorrected Proof from xa.yming.com

     

    This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

     

    In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

     

    [2] Paramedic2 – The Adrenaline Trial
    Warwick Medical School
    About

    [3] General Cardiac Arrest – Adult
    3031A – ALS – Adult
    Pennsylvania Emergency Health Services Council
    PA ALS Protocols in PDF format

    [4] 2015 Evidence Review
    2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
    Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality
    Adult BLS Sequence—Updated
    2015 Evidence Review

    [5] Rats forsake chocolate to save a drowning companion
    Science Magazine
    By Emily Underwood
    12 May 2015
    Article

    .

    Our current ambulance system is based on little scientific evidence

     

    Our current ambulance system is based on little scientific evidence.

    This is one comment by Prachi Sanghavi that has some paramedics very upset.

    The video of her short speech at Harvard was posted on EMS1.com[1] and the responses suggested that there is something horribly wrong in the statement, or in any of what followed. There isn’t.
     


     

    The problem is with the attitude of those who think that they know everything.

    The problem is with the people who oppose finding out if treatments work.

    The problem is with people who oppose protecting our patients from harmful treatments.

    Prachi Sanghavi discusses the difference between BLS (Basic Life Support) treatment and ALS (Advanced Life Support) treatment. BLS includes all of the prehospital treatment that have evidence of benefit. All of them. ALS includes all of the cool things that paramedics and doctors do before getting to the hospital based on a wish and a prayer, but not on any valid evidence.
     


     

    This is a comparison of cardiac arrest outcomes between two similar counties looking at the lack of expected benefit with ALS. There are more variables than just ALS vs. BLS, but we do need to ask Why are these cardiac arrest outcomes so bad with ALS?

    Prachi Sanghavi is incorrect about a few things. Paramedics generally use a manual defibrillator, not a semi-automatic defibrillator. Taking longer at a cardiac arrest scene is probably not a problem. Those patients transported without pulses can be expected to end up in the morgue. Moving the patient with ineffective compressions, rather than staying on scene to do compressions well, is not recommended, because it is not supported by evidence. Rushing the patient to the hospital is just rushing the patient to ALS in a building. Yes, there is more ALS available at the hospital, but nothing that has good evidence of improving outcomes. Therapeutic hypothermia, is part of post-resuscitation treatment, not resuscitation treatment. That may change.[2]

    Prachi Sanghavi also looked at trauma, stroke, and heart attack. The results were the same. Patients had better outcomes with Basic Life Support.

    Our response should be to ask questions.

    Are we doing something wrong?

    What evidence do we have that ALS treatment improves outcomes?

    The problem is that we ignore evidence and make excuses for our willful ignorance.

    We are slow to adopt ALS treatments that have good evidence of improving outcomes and much, much slower to get rid of treatments that have only the weakest evidence of benefit – expert opinion. Expert opinion is the basis for all treatments that are later demonstrated to be harmful, so expert opinion isn’t worth bragging about. Real experts understand and learn from the evidence.

    Should we trust the people criticizing the message that Maybe more is not better, or should we examine what we have been doing to find out what works?

    Why are we opposed to providing the best care we can?

    Footnotes:

    [1] Researcher: Is BLS better than ALS?
    EMS1.com
    November 13, 2015
    Article

    [1] Refractory cardiac arrest treated with mechanical CPR, hypothermia, ECMO and early reperfusion (the CHEER trial).
    Stub D, Bernard S, Pellegrino V, Smith K, Walker T, Sheldrake J, Hockings L, Shaw J, Duffy SJ, Burrell A, Cameron P, Smit de V, Kaye DM.
    Resuscitation. 2015 Jan;86:88-94. doi: 10.1016/j.resuscitation.2014.09.010. Epub 2014 Oct 2.
    PMID: 25281189

    Free Full Text from Resuscitation.

    This is a tiny study that suggests a grouping of treatments that may work (or that may include a treatment, or two, that may lead to improved outcomes. The results are good, but it is just one tiny study that needs replication and each of the treatments should be studied individually.

    .

    How Bad is the Evidence for the New 2015 ACLS Guidelines?

    ResearchBlogging.org
     
        The new ACLS guidelines are out. How bad is the evidence?

        The short answer – The Advanced Cardiac Life Support guidelines could be worse.

    How does the American Heart Association determine that a recommendation is not beneficial?
     

    Class III: No Benefit, is a moderate recommendation, generally reserved for therapies or tests that have been shown in high-level studies (generally LOE A or B) to provide no benefit when tested against a placebo or control.[1]

     

    The tobacco enema has been used successfully as a treatment for cardiac arrest, so the evidence of lack of benefit is poor.[2] Clearly, the Advanced Cardiac Life Support guidelines cannot claim that the tobacco enema is Class III. Successfully? The treatment was used and a dead person was no longer dead. In other words, just as successfully as most of the ACLS treatments.
     

    From Eisenberg, MS. Life in the balance: emergency medicine and the quest to reverse sudden death. 1997; Oxford University Press. [betterworldbooks][3]

     

    This is one way to make excuses for justify doing something just because of ideology. In the absence of good evidence of benefit, we should not harm our patients to protect our ideology. We used to do this with blood-letting, which was defended even after there was clear evidence of harm. That is just the best known example, but this dishonesty continues and continues to be defended.

    Why don’t we hold anyone accountable, when we have the evidence that our treatments are harmful? Because we all seem to go along to get along.

    The 2015 ACLS guidelines are not all bad, but they clearly do not encourage withholding harmful treatments until we have obvious evidence of harm. Should we assume that a treatment works just because the explanation appeals to some experts as much as the explanation for blood-letting appealed to the experts when that was in vogue?

    This is not medicine. This is a fashion show. Our patients are the ones harmed.
     

    Footnotes:

    [1] 2015 AHA Classes of Recommendation
    2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
    Part 2: Evidence Evaluation and Management of Conflicts of Interest
    Development of the 2015 Guidelines Update
    Circulation.
    2015; 132: S368-S382
    Free Full Text from Circulation.

    [2] Tobacco smoke enemas
    Ghislaine Lawrence
    Volume 359, No. 9315, p1442,
    20 April 2002
    Lancet
    Abstract with link to Full Text PDF download.

    [3] Ever tried smoking?
    by Chris Nickson
    Life in the Fast Lane
    Article

    Morrison LJ, Gent LM, Lang E, Nunnally ME, Parker MJ, Callaway CW, Nadkarni VM, Fernandez AR, Billi JE, Egan JR, Griffin RE, Shuster M, & Hazinski MF (2015). Part 2: Evidence Evaluation and Management of Conflicts of Interest: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation, 132 (18 Suppl 2) PMID: 26472990
     

    Lawrence, G. (2002). Tobacco smoke enemas The Lancet, 359 (9315) DOI: 10.1016/S0140-6736(02)08339-3

    .