ACEP

Tintinalli Reviews ACEP’s Revised tPA Policy

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A review of the revised ACEP Clinical Policy – IV tPA downgraded to Level B evidence

Nothing seems to stir the emotions of an emergency physician more than a discussion of tPA for stroke: who, why, and when. Skeptics cite problems in the data, and conflicts of interest of the authors. Supporters trust the literature that passed peer review and became policy of emergency medicine and neurology professional societies around the world.

2012 and 2015
The 2012 ACEP Clinical Policy  on the use of tissue plasminogen activator for acute ischemic stroke [1] raised plenty of questions. It resulted in concerns about the effectiveness of the drug, the magnitude of its effectiveness, the risks of cerebral hemorrhage, effects of the drug on stroke mimics, legal implications of the policy, the policy’s impact in different practice settings, hospital differences in resources for stroke diagnosis and emergency care, and the lack of  tools for patient/family shared decision making [2,3,4,5]. The key question asked was ‘Is IV tPA safe and effective for acute ischemic stroke if given within 3, and within 3-4.5 hours after symptom onset? The level A recommendation stated: IVtPA should be offered …to patients who meet …(NINDS) inclusion/exclusion criteria and can be treated within 3 hours after symptom onset. The level B recommendation stated: IVtPA should be considered in patients who meet…(ECASS III) inclusion/exclusion criteria and can be treated between 3 to 4.5 hours after symptom onset.

Criticism of this policy was swift, in these pages and elsewhere. Level A recommendations imply generally accepted principles of care and as such seemed to ignore or shut down years of well-intentioned, well-reasoned debate on tPA’s safety and efficacy. Subsequently, ACEP took the unprecedented step of reconsidering their policy, which had been co-authored with the American Academy of Neurology.

In June 2015, the ACEP Board approved a revised clinical policy  on the use of tPA for ischemic stroke [6].  The question asked was the same as in 2012 – whether IV tPA is safe and effective within 3 hours of symptom onset, and within 3-4.5 hours of symptom onset.

2015 Recommendations
Is IV tPA safe and effective for patients with acute ischemic stroke if given within 3 hours, and within 3-4.5 hours  of symptom onset? Recommendations for ❤ and 3-4.5 hours are combined below for simplicity.

  • Level A recommendation: None.
    Note that the 2015 policy no longer provides level A recommendations for IVtPA.
  • Level B recommendation for ❤ hr administration: IV tPA should be offered and may be given …within 3 hours after symptom onset at institutions where systems are in place to safely administer the medication. Consider the increased risk of sICH.
  • Level B recommendation for 3-4.5 hr administration: despite the known risk of sICH and the variability in the degree of benefit in functional outcomes, IV tPA may be offered and may be given to carefully selected patients…within 3-4.5 hours after symptom onset at institutions where systems are in place to safely administer the medication.
  • Level C recommendation: When feasible, shared decisionmaking…should include a discussion of potential benefits and harms…

Risks and Benefits
Here are selected comments from Appendix D and text, using the most robust analyses that  were provided for risk-benefit analysis:

IVtPA given < 3 hrs

  • NNT = 8 (95% CI 4-31)  NINDS
  • NNH=17 (95% CI 12-34)  NINDS
  • sICH 5-7% sICH overall  (could be lower with adherence to protocol; sICH definitions also vary with study)
  • Proportion who improved: 13% achieving Rankin Scale 0-1 (NINDS 39% IVtPA vs 26% control)

IVtPA given 3-4.5 hrs

  • NNT = 14  (95% CI 7-244) ECASS III
  • NNH= 23 (95%  31-78)  ECASS III
  • sICH 3-8% and 2-6% depending on NINDS definition of sICH
  • Proportion who improved: 7% achieving Rankin Scale 0-1, ECASS III, 52% for IVtPA vs 45% for control)

Who benefits and when?
Published data is somewhat population-based and not at all individual-based, so we are still in the dark about the patients most likely to benefit from IVtPA. If only 13% benefit from IVtPA if given within 3 hours, or 7% in 3-4.5 hours, what about the rest? What about the cost and resources used?   Who exactly are the ‘carefully-selected’ patients who may receive IVtPA at 3-4.5 hours? The benefits of giving tPA in ❤ hours, or  ≤90 minutes also needs discussion [8].

Who is most at risk for sICH?
Several scoring systems for assessing the likelihood of sICH after IVtPA have been developed [9]. Predictive variables and scoring methods vary with the tool, but typically include early infarct signs on non-contrast CT scan; prestroke Rankin scale score; age;  antithrombotic therapy; hyperglycemia; and NIHSS on admission.

What about the ED, the hospital and the hospital system?
Stroke diagnosis and emergency management is not a one-man emergency physician show. It requires a team to make what is often a difficult diagnosis and treatment plan. All members of the team should use the same unified protocol: indications for activating Code Stroke; NIHSS reporting; imaging protocols; scoring systems for risk-benefit analysis; and well-articulated and well-presented information and consent forms.

What about tools for shared decision-making?
Involving patients and family in decision-making is more complex than asking ‘do you want the clot-buster’? Patients who elect a treatment, whether a stent for STEMI, or IVtPA for stroke, assume they will personally benefit from the treatment. This is not the case with IVtPA where most do not benefit. Only a few do. And a small number are harmed. Graphs and pictorial images are an excellent way to communicate a risk-benefit analysis, but are in various stages of development [10,11]. The challenge for tool developers is to convey information simply, clearly, and quickly given a variety of clinical scenarios.

Summary
The 2015 ACEP clinical policy discussion is detailed. Study deficiencies are noted, the discussion uses updated data, and methodology, case definitions, heterogeneity and outcome differences are noted. IVtPA was lowered from a level A to level B recommendation, and qualifications on the proper environment for drug administration were added. However, these qualifications were not spelled out in any detail and key issues relative to decision-making remain unaddressed. The revised policy reminds us that data on risks and  benefits are still a moving target. What is clear is that the pressure is on for emergency physicians who must be the initiators and leaders of the emergency stroke care team.

REFERENCES

  1. Clinical Policy: Use of Intravenous tPA for the Management of Acute Ischemic Stroke in the Emergency Department . Annals of Emergency Medicine, 61:2, February 2013, 225- 243
  2. Ellison D, ‘The Lytic Lottery’ Annals of Emergency Medicine, 62:5, October 2013, 432-33
  3. Newman, David, ‘Thrombolytics for Acute Ischemic Stroke’ ,theNNT.com, March 25, 2013 accessed Aug 7, 2015
  4. Hoffman JR and Schriger DL ‘A Graphic Reanalysis of the NINDS Trial’ Annals of Emergency Medicine 54:3 September 2009, 329-336
  5. Klauer, K ‘tPA and the Problems of ‘Indication Creep. Emergency Physicians Monthly, May 29, 2013.
  6. Clinical Policy: Use of Intravenous Tissue Plasminogen Activator for the Management of Acute Ischemic Stroke in the Emergency Department. http://www.acep.org/workarea/DownloadAsset.aspx?id=102373
  7. Zinsser, William. On Writing Well. The Classic Guide to Writing Nonfiction’. 7e, 2006, HarperCollins, New York.
  8. Miller JB, Heitsch L, Siket M, et al ‘The Emergency Medicine Debate on tPA for Stroke: What is Best for our Patients? Efficacy in the First Three Hours’ Acad Emerg Med 2015 July; 22(7):852-5
  9. Asuzu D, Nystrom K, Amin H et al ‘Comparison of 8 scores for predicting symptomatic intracerebral hemorhage after IV thrombolysis’ NeurocritCare 2015 Apr; 22 (2):229-33. PMID 25168743
  10. Gadhia J, Starkman S, Ovbiagele B, et al ‘Assessment and Immprovement of Figures to Visually Convey Benefit and Risk of Stroke Thrombolysis’ Stroke 2010 February; 41 (2): 300-306
  11. Flynn D, Ford GA, Stobbart L et al ‘A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers. BMC Health Services Research 2013, 13:225

Choosing Wisely: ACEP Lists 5 Tests to Question

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The American College of Emergency Physicians (ACEP) issued a list of 5 tests and procedures that may not be cost-effective in some situations. The ACEP announced this list, which reflects its participation in the ABIM Foundation‘s Choosing Wisely campaign, at the opening session of their annual meeting in Seattle, Washington.

To lower healthcare costs and improve patient care, ACEP recommends that clinicians avoid these interventions when appropriate, after discussing that decision with patients and educating them regarding the rationale.

“ACEP needed a strategy to determine what emergency physicians could do to improve efficiency and reduce cost without affecting the quality of care we deliver,” ACEP Cost Effectiveness Task Force Chair David Ross, MD, an emergency physician in Colorado and medical director for more than 50 emergency medical services agencies in Colorado Springs, said in a news release. “The challenge also was to identify real cost savings, but also to develop consensus among emergency physicians.”

The ACEP board of directors approved the following 5 Choosing Wisely recommendations for patients seen in the emergency department:

1.      For patients with minor head injury who are deemed to be at low risk for skull fractures or hemorrhage, based on validated decision rules, clinicians should avoid head computed tomography scans. The majority of minor head injuries do not result in brain hemorrhage.

2.      For stable patients who can urinate on their own, clinicians should avoid placing indwelling urinary catheters for either urine output monitoring or patient or staff convenience.

3.      For patients likely to benefit from palliative and hospice care services, clinicians should not delay in engaging such services when available. Early referral from the emergency department can improve quality, as well as quantity, of life.

4.      For patients with uncomplicated skin and soft tissue abscesses successfully treated with incision and drainage, clinicians should provide adequate medical follow-up but avoid antibiotics and wound cultures.

5.      For children with mild to moderate, uncomplicated dehydration, clinicians should avoid giving intravenous fluids before a trial of oral rehydration therapy.

“Emergency physicians are dedicated to improving emergency care and to reducing health care costs,” ACEP President Alex Rosenau, DO, said in a news release. “These recommendations are evidence-based and developed with significant input from experts.”

An expert panel of emergency physicians and the ACEP board of directors reviewed pertinent research and input, including a survey of all ACEP members, before developing the recommendations.

In its Choosing Wisely campaign, the ABIM Foundation aims to facilitate discussion among physicians and patients about appropriate use of tests and treatments and avoidance of these interventions when the harms may outweigh the benefits.

More than 80 national, regional, and state medical specialty societies and consumer groups have joined Choosing Wisely since the campaign began in April 2012, but ACEP held off until February 2013. The delay resulted from potential conflicts of the Choosing Wisely strategy with the unique goals of emergency medicine and from concerns that the campaign does not advocate for medical liability reform.

“Overuse of medical tests is a serious problem, and health care reform is incomplete without medical liability reform,” said Dr. Rosenau. “Millions of dollars in defensive medicine are driving up the costs of health care for everyone. We will continue to encourage the ABIM Foundation and its many partners in this campaign to lend their influential voices to the need for medical liability reform.”

Source: American College of Emergency Physicians.