This document provides information on diagnosing and managing congestive heart failure (CHF). It discusses: 1. Defining CHF and explaining how it develops. 2. Diagnostic methods including symptoms, signs, labs, echocardiogram and functional classification systems. 3. Treatment approaches including lifestyle changes, medications, and referral criteria. Optimal medical therapy for reduced ejection fraction CHF is outlined. 4. Considerations for managing preserved ejection fraction CHF are also briefly covered.

1. Michelle A. Hart MD CCFP M.Sc.C.H
Sid Feldman MD CCFP FCFP
Baycrest Health Sciences, Toronto, ON
Department of Family and Community Medicine,
University of Toronto

2. Faculty/Presenter Disclosure
• Faculty: Dr. Michelle Hart
• Program: 51st Annual Scientific Assembly
• Relationships with commercial interests:
None

3. Disclosure of Commercial
Support
• This program has not received financial support.
• This program has not received in-kind support.
• Potential for conflict(s) of interest: None

4. Mitigating Potential Bias
None

5. Faculty/Presenter Disclosure
• Faculty: Dr. Sid Feldman
• Program: 51st Annual Scientific Assembly
• Relationships with commercial interests:
None

6. Disclosure of Commercial
Support
• This program has not received financial support.
• This program has not received in-kind support.
• Potential for conflict(s) of interest: None

7. Mitigating Potential Bias
None

8.  Dr. Daphna Grossman

9. 1.
2.
3.
4.

10. By the end of this hour you will be able to:
1. Utilize best methods for accurate diagnosis
of congestive heart failure
2. Apply current evidence for effective
management of congestive heart failure and
delay progression of heart failure
3. Employ resources in the community to
support patients with strategies for self-
management

11. 1. Review on basics of heart failure
2. Diagnosing Heart Failure
3. Management of Heart Failure
4. Future Directions: What’s coming down the
pipeline for HF Management
5. Advanced Care Planning, Prognostication
and End-Of-Life
6. Summary of Heart Failure

13.  Definition of Heart Failure
 Why is it important?
 How does it happen?
 Types of Heart Failure
 Staging and Classes of Heart Failure

14.  Canadian Cardiovascular Society (CCS)
 “Complex syndrome in which abnormal heart
function results in, or increases risk of clinical
symptoms and signs of low cardiac output
and/or pulmonary or systemic congestion”

15.  In North America, it is the fastest growing
cardiac diagnosis for individuals > 65 years
 Average annual mortality rate of 10-35% in
Canada

16.  Myocardial injury or stress on heart initiates
the process of ventricular dysfunction
 Cardiac remodelling worsens function
 Progressive process
 Declining function exacerbates remodelling
 Neurohormonal activation: hemodynamic
stresses, cardiotoxicity, myocardial fibrosis –
ongoing remodelling and progression

17. Two Categories:
 Left ventricular systolic dysfunction with
Reduced Ejection Fraction (HF-REF)
 HF with preserved ejection fraction (HF-PEF)
◦ ½ the cases
◦ More often in older, female patients
◦ Often have hypertension, atrial fibrillation
◦ Less coronary artery disease
◦ Mortality less than for HF-REF
◦ Morbidity similar

18. American Heart Association
 Treatment linked to objective criteria
 Uses risk factor and cardiac structure
New York Heart Association (NYHA) Functional
Classification
 Based on subjective clinical evaluation
 Changes with treatment response and disease
progression
 Complementary with AHA
Canadian Cardiovascular Society (CCS) uses NYHA

20.  Fatigue
 Weakness
 Ankle edema
 Weight gain
 Exertional dyspnea
 Orthopnea
 Paroxysmal Nocturnal Dyspnea
 Cough

21.  Ascites/Abdominal Distension
 Enlarged liver
 Tachycardia
 Displaced, sustained apex beat
 3rd or 4th heart sound
 Left parasternal heave
 Murmurs of mitral and/or tricuspid regurgitation
 Increased JVP
 Pulmonary crackles
 Pleural effusion

22.  Renal failure
 Obesity
 COPD
 Depression/anxiety
 Severe anemia
 Pulmonary embolism
 Atrial Fibrillation
 Hypoalbuminemia
 Dependent edema
 Fluid retention 2˚ to calcium channel blocker or
non-steroidal anti-inflammatory drugs

23.  Class 1 Recommendation, Level C Evidence
1. Clinical history
2. Physical Exam
3. Initial lab investigations
4. Transthoracic Echocardiography
5. Radionuclide Angiography
6. Coronary Angiography
7. Cardiac Magnetic Resonance
8. Assessment of Functional Capacity: NYHA

24. Figure 1
New York Heart Association Classification
Canadian Journal of
Cardiology 2013; 29:168-181)
Copyright © 2013 Canadian
Cardiovascular Society

25.  CCS Updated 2012 Guidelines
 Constellation of symptoms (eg, orthopnea
and shortness of breath on exertion) and
signs (eg, edema and respiratory crackles)
 Physical examination evaluates systemic
perfusion and presence of congestion (cold or
warm, wet or dry)

27.  Laboratory testing
 Electrocardiogram (ECG)
 Chest x-ray
 Echocardiogram

28. Taken from: The Radiology Assistant
http://www.radiologyassistant.nl/en/p4c132f36513d4

30. Taken from: The Radiology Assistant
http://www.radiologyassistant.nl/en/p4c132f36513d4
PCWP = Pulmonary
Capillary Wedge
Pressure

31.  A slight mild elevation of cardiac troponin is
not infrequently observed in acute
decompensation and not necessarily
indicative of myocardial infarction (MI).
 The utility of natriuretic peptide (NP) to
exclude (“rule out”) or confirm (“rule in”) the
diagnosis in the appropriate clinical scenario
is well established.
 NPs are best used when the diagnosis is
uncertain

32.  BNP and prohormone (NT-proBNP) are
synthesized and released from the heart in
response to end-diastolic volume and
pressure
 High negative predictive value
 BNP <100 pg/mL rules out HF in patients
presenting with dyspnea in the acute care
setting [level I-1 Evidence]
 BNP > 500 pg/mL confirms HF in patients
with dyspnea

33.  Several clinical scoring systems have been
derived and validated and combine commonly
used clinical features with NP values to
improve diagnosis and decision-making
 The most commonly used clinical scoring
system was developed by Baggish et al.

34. Predictor Possible score Your patient's score
Age > 75 y 1
Orthopnea present 2
Lack of cough 1
Current loop diuretic use
(before presentation)
1
Rales on lung exam 1
Lack of fever 2
Elevated NT-proBNP 4
Interstitial edema on
chest x-ray
2
14 Total =
Likelihood of heart failure Low 0-5
Intermediate 6-8
High 9-14
Elevated NT-proBNP was defined as > 450 pg/mL if age < 50 years and >
900 pg/mL if age > 50 years
Source: CCS Guidelines 2012
Table 1. A clinical scoring system for diagnosis of AHF

35.  Age
 Sex
 Weight
 Medications
 Pulmonary Disease
 Renal disease
 Routine use of BNP in evaluation, diagnosis
and management of HF in primary care awaits
more research

37. 1) Risk factor management
2) Patient education
3) Treatment: Non-pharmacological
4) Treatment: Pharmacological
5) When to refer?

38.  Cardiovascular risk factor targets
 National guidelines, lifestyle, pharmacologic
measures for patients with high risk of
developing HF and for those already
diagnosed with HF
[Class I Evidence, Level A Recommendation]

39.  Elderly Patients (>80 years) with sitting BP >
160/90 mmHg and standing systolic BP >
140 mmHg lower sitting BP to 150/80 mmHg
[Class I Evidence, Level A Recommendation]
 Patient with vascular disease or diabetes with
end-organ damage, prescribe target-dose
ACEi or ARB
 [Class IIa Evidence, Level B Recommendation]

40.  Critical for successful therapy
 Best way to maintain adherence/compliance
 Patient information/handouts
-Eg. Canadian Heart Failure Network (CHFN)
http://www.chfn.ca/patient-education-tools
 Self-management, meds (when applicable)
 Action plan – what to do if symptoms worsen
 Multidisciplinary interventions appear
beneficial (studies from academic centres
only)

41. 1) Physical activity and exercise training
2) Salt and fluid restriction & weight management
3) Reducing risk of serious respiratory infections

42. 1) Physical activity and exercise training
- Earlier studies: reduction in mortality
- Cochrane review (2010) >3500 patients:
Risk of death (mild-mod HF) ↔ [Level I-1 Evidence)
Hospital Admissions ↓
- All studies: health-related quality of life ↑
- Exercise programs mainly aerobic

43. [Class IIa Recommendation, Level B Evidence]
1) Regular daily physical activity that does not
induce symptoms, for all patients with stable
HF symptoms and impaired LV systolic
function; to prevent muscle deconditioning

44. [Class IIa Recommendation, Level B Evidence]
2) All patients should have a graded exercise
stress test to assess functional capacity,
identify angina or ischemia, and determine
optimal target HR for exercise training
3) Exercise training should be considered when
symptoms have stabilized and patient is
euvolemic

45. [Class IIa Recommendation, Level B Evidence]
4) Referral to cardiac rehabilitation program
should be considered for all stable NYHA I to II
HF patients
5) Moderate-intensity aerobic (30-45 mins)
and resistance training, 3-5 x/wk for NYHA II
to III, with LVEF < 40% can be considered

46. 2) Salt and fluid restriction & weight management
Symptomatic patients: No-salt-added diet (total
2-3g daily)
Patients with fluid retention: low-salt diet (1-2 g
total daily)
[Class I Recommendation, Level C Evidence]

47. 2) Salt and fluid restriction & weight management
Significant renal dysfunction/fluid retention not
easily controlled with diuretics:
 Monitor daily morning weight
 Fluid restriction 1.5-2 L per day
[Class I Recommendation, Level C Evidence)

48. 2) Salt and fluid restriction & weight management
 Patients with recurrent fluid retention who are
able to follow instructions can be taught to
adjust their diuretic dose based on symptoms
and changes in daily body weight

49. 3) Reducing risk of serious respiratory infections
 Pneumococcal vaccination
 Annual influenza vaccination
[Class I Recommendation, Level C Evidence]

50.  Some differences between how to
(pharmacologically) manage HF with reduced
EF vs. preserved EF
 Treat probable HF
◦ Eg. Echocardiography results unavailable
◦ Use diuretic and nitrates for symptoms relief
◦ Consider ACEi and ß-blocker in the long-term

51. 1. Type of heart failure: systolic or diastolic or mixed HF
2. NYHA class of symptoms
3. Renal function
4. Co-morbidities (e.g., COPD, anemia)
5. Life expectancy
6. Time needed to produce an effect
7. Goals of care or target symptom improvement including
patient preferences
8. Goals of pulse and blood pressure reduction with HF
medications
9. Common drug interactions (increase or decrease
concentration) and side effects
Drugs Aging (2013) 30:765–782

52. Heart Failure with Reduced Ejection Fraction
(HF-REF)
-Diuretic
-ACEi (or ARB) and ß-blocker
-Aldosterone antagonists
-Digoxin
-Nitrates/Vasodilators
-Omega-3 Polyunsaturated Fatty Acids
-Ivabradine
-What about ASA/Antiplatelets?

53. Diuretic
 Loop diuretic (eg. Furosemide) for congestive
symptoms
 When symptoms clear, use lowest possible
dose [Class I, Level C]
 If volume overload persists, despite
optimisation of dose: add a second diuretic
(eg. Metolazone or a Thiazide diuretic)
[Class IIb, Level B]

54. ACEi (or ARB) and ß-blocker
 All patients with HF and LVEF < 40% should
receive target-dose combination therapy with
an ACEi and ß-blocker
[Class I, Level A]
 Asymptomatic patients with LVEF < 35%
should receive an ACEi
[Class I, Level A]

55. ACEi (or ARB) and ß-blocker
 If cannot tolerate ACEi, substitute with ARB
[Class I, Level A]
 Monitor serum Creatinine

56.  Patients optimally treated with ACEi and ß-
blocker with persistent HF symptoms, ↑
hospitalization
 Add ARB  consult cardiologist/internist

57.  Addition of an ARB to ACE inhibitor and β-
blockade therapy modestly improves clinical
outcome predominantly by reducing HF
hospitalizations
 Monitor BP, K+, Renal function: use with
caution!
 ONTARGET hypertension trial: 13% increased
risk of renal dysfunction [Level I-1 Evidence]

58. Aldosterone Antagonists/Mineralocorticoid
Receptor Antagonists (MRAs)
 Spironolactone for patients with LVEF < 30%
and severe HF symptoms HF symptoms
despite optimal medical therapy
 Monitor renal function and electrolyte status
[Class I, Level B]

59.  Aldosterone Antagonists/Mineralocorticoid
Receptor Antagonists (MRAs)
 Eplerenone: up to 50 g reduces
hospitalization and death in HF patients
(NYHA II, LVEF < 30%) (EMPASIS-HF Trial)

60. Digoxin
 Relieves symptoms
 Decreases hospitalizations
 In patients in sinus rhythm who have
moderate-severe symptoms despite optimal
medical therapy
[Class I, Level A Evidence]

61. Nitrates/Vasodilators
 Isosorbide Dinitrate plus Hydralazine added
to standard therapy for African-American
patients who have HF with reduced EF
 A-HeFT (African-American Heart Failure Trial)
[Class IIa, Level A]
 Consider this combination for other HF
patients who cannot tolerate recommended
standard therapy [Class IIb, Level B]

62. Source: Canadian Journal of Cardiology 2013; 29:168-181
(DOI:10.1016/j.cjca.2012.10.007 )
Copyright © 2013 Canadian Cardiovascular Society

63. Omega-3 Polyunsaturated Fatty Acids
 Recent study in patients with NYHA class II-IV
symptoms and ejection fraction (EF) ≤ 40%
 Use of omega-3 polyunsaturated fatty acids
(1 g daily)
 Modest reduction in cardiovascular mortality
and hospitalization

64. Ivabradine
 Inhibits the If channel
 Not yet approved
 Might be considered in patients who remain
symptomatic with a heart rate > 70 bpm
(despite optimal medical therapy eg.β-
blockers) to reduce hospitalizations and
deaths because of HF
 On basis that resting HR independently
predicts CV events, including HF
hospitalization

65.  Antiplatelet agents such as aspirin should be
administered ONLY to patients with HF who
have a documented history of coronary artery
disease and stroke or who are deemed high
risk for CV events

66.  Treatment trials have been inconclusive,
limited evidence-based recommendations
 Best available data is for ACEi and ARB
therapy.
 Combo therapy for most patients (add ARB)
[Class IIa, Level B]
 If HR is high, ß-blockers may be useful to
prolong diastolic filling time and relieve
pulmonary congestions

67.  Diuretics : for symptom control
 Once acute congestion cleared, use lowest
dose compatible with stable weight and
symptoms
 [Class I, Level C]

68.  Emphasis on management of comorbidities
◦ Diabetes
◦ Hypertension : Control diastolic and systolic as per
Hypertension guidelines [Class I, Level A]
◦ Coronary Revascularization: CABG for patients
whose ischemia affects cardiac function
[Class IIa, Level C]

69.  Emphasis on management of comorbidities:
◦ Atrial Fibrillation: 50% of patients
-ß-blocker or Digoxin to control ventricular rate
-Restoration of sinus rhythm

70.  Thiazolidinediones
 Nonsteroidal anti-inflammatory agents
 Cyclooxygenase-2 inhibitors

71.  Common arrhythmia in HF
 Associated with higher rates of adverse clinical
events
 Increased risk of thromboembolism including
stroke
 Manage and classify according to current AF
guidelines

72.  General approach : control rate
 Limited data to support a specific upper heart
rate target
 Current CCS AF guidelines target rate < 100
bpm
 β-Blockers are preferred over digoxin for rate
control
 Rate-lowering CCBs are acceptable alternatives
in patients with HF-PEF

73.  Combination of β-blocker and digoxin is
more effective than β-blocker alone
 When rhythm control is required because of
symptoms, Amiodarone is preferred
 Unless contraindicated, oral anticoagulants
should be initiated in patients deemed high
risk for stroke as per current AF guidelines

74.  Primary Implantable Cardioverter-Defibrillator
(ICD) therapy improves survival in patients
with NYHA II-III ischemic and non-ischemic
HF with EF ≤ 35% and in patients with a
previous MI with EF ≤ 30%.91
 ICD therapy does not provide any survival
benefit early after an MI

75.  Cardiac Resynchronisation Therapy (CRT)
Devices (aka Biventricular pacing)
 In combination with Implantable
Cardioverter-Defibrillator (ICD) in less
symptomatic HF patients [Level I-1 Evidence]
 CCS recommends combination for HF patients
on optimal therapy with:
NYHA II symptoms
LVEF < 30%
QRS duration > 150 msec [Level I, Class A]

76. CCS recommendation:
 At initial HF diagnosis
 After HF hospitalization
 HF associated with any of the following:
◦ Ischemia
◦ Hypertension
◦ Valvular disease
◦ Syncope
◦ Renal Dysfunction
◦ Other comorbidities
◦ Unknown etiology
◦ Treatment intolerance
◦ Poor compliance [Class I, Level C]

78.  Vasopressin Antagonists: improve volume
overload and hyponatremia
Eg. Tolvapatan is approved by the US FDA
for hospitalized hypervolemic and
euvolemic hyponatremia in HF
 Adenosine A1 Receptor Antagonists: arteriolar
vasodilatation, improved renal function,
natriuresis without activation of
tubuloglomerular feedback Eg. Rolofylline

79.  Selective Phosphodiesterase Type 5
Inhibitors: vascular smooth muscle dilatation,
role in the reversal of ventricular hypertrophy
(inhibiting downstream hypertrophy signaling
and improving ventricular function)
 Eg. Sildenafil

80.  Patients with HF-REF: Ryanodine receptor
stabilizers, Sarcoplasmic Reticulum Calcium
ATPase isoform (SERCA) activators, blockers of
the RAAS (direct renin inhibitors, aldosterone
synthase inhibitors)
 Patients with HF-PEF: strategies target specific
structural and functional abnormalities that lead
to increased myocardial stiffness.
◦ Eg. Dicarbonyl-breaking compounds reverse advanced
glycation-induced cross-linking of collagen and improve
the compliance of aged and/or diabetic myocardium.

82.  Patient-centred decision making
 Open communication with patients and their
families: critical concepts in high quality care

83.  Description of underlying condition +
prognosis
 Exploration patient’s values, needs, goals
+ expectations of treatment.
 Discussion must take into account the
psychosocial, cultural and spiritual and/or
informational needs by patient or proxy
 Options for treatment and expected
outcome - benefit vs. harm
 Explanation of conclusion of holding or
withdrawing treatment
 Explain that patient will not be abandoned -
palliative care

84.  Likely to Benefit - reasonable likelihood that
life support will restore/maintain organ
function or likelihood of returning to pre-
arrest status is moderate
 Unlikely to Benefit - there is almost certainly
no chance that the person will benefit from
CPR either because the underlying illness
makes recovery or improvement
unprecedented. Person unlikely to
experience permanent benefit.
 Good End of Life care includes ongoing
communication between the health care
providers and the patient/POA

85. What are we addressing?
 Code status
 Aggressiveness of management “along the
way”
 Admissions to acute care vs. care at home
and end-of-life planning

86.  When is the right time to have the discussion?
 Exploring end-of-life preferences,
expectations
 Quality of life as a valuable goal of therapy
 Treatment modality:
Improve symptom + prognosis
vs.
Symptom relief (at expense of survival)

87. Brunner-La Rocca et al (2012) “End-of-Life
preferences of elderly patients with chronic
heart failure”
 ~75% not willing to trade survival time for
excellent health
 25%: equal groups willing to trade up to 6
months, >6 mo-1yr, >1yr
 Patients ≥ 75 slightly more willing to trade
than younger patients
 During follow-up, patients willing to trade
any survival time decreased

88. Brunner-La Rocca et al (2012) continued:
Who were the patients willing to trade survival
time for symptom-free living?
 Older
 More females
 Lived alone
 Not married
 More signs and symptoms of CHF and poorer
quality of life

89. The next slides have some tools that may help
with prognostication, and informing your
discussions with patients and families

90. Medical Care of the Dying 2006

91.  No clear “transition point”
 When do you start PC?
 Costly and invasive therapies
 When do you say “no”?
 Sudden death (50%)
 Poor patient understanding of illness

92. Reviewed 38,702 consecutive patients with
first time admissions for heart failure
Overall:
30 day fatality rate – 12%
1 year fatality rate – 33%
If >75 y.o. and co-morbidities:
30 day fatality rate – 24%
1 year fatality rate – 60%
Jong et al Arch Int Med (2002)

93. EFFECT Score (http://www.ccort.ca/CHFriskmodel.aspx)
 Prediction score to stratify the risk of death in
heart failure patients
 Enter age in years, RR and Systolic BP at hospital
presentation, BUN, Sodium and list of co-
morbidities including: CVA, Dementia, COPD,
Cirrhosis, Cancer and Anemia.
 Calculate

94. Mortality risk at 30 days:
30-Day Score 30-Day Mortality Rate (%)
< 60 0.4
61-90 3.4
91-120 12.2
121-150 32.7
> 150 59.0
Mortality risk at one year:
One-Year Score One-Year Mortality Rate
(%)
< 60 7.8
61-90 12.9
91-120 32.5
121-150 59.3
> 150 78.8
EFFECT Score: http://www.ccort.ca/CHFriskmodel.aspx

95. http://depts.washington.edu/shfm/index.php
 Insert age, gender, weight, EF, systolic BP,
NYHA class level, medications and lab data
 Graph will appear showing mortality risk over
1,2, and 5 years

97.  SOB
 Pain (>70%!)
 Depression (60%)
 Myopathy
 Cachexia
 Cognitive impairment
Goodlin J Am Coll Cardiology (2009)

98.  Consensus panels advocate provision of
palliative care concurrent with efforts to
prolong life in heart failure
ACC/AHA Practice Guidelines

99.  Sudden death
 Arrhythmia
 Progressive Heart Failure
 Importance of communication with patient
early in the disease: prognosis, advanced
medical directives (living will), resuscitation
wishes, identifying a substitute decision
maker/power of attorney

101. 1.
2.
3.
4.

102.  A clinical syndrome: impaired cardiac output
and/or volume overload, concurrent cardiac
dysfunction
 Progressive
 Associated with poor quality of life – frequent
hospitalizations, poor survival

103.  Educate patients: communication,
communication, communication!
 Teach patients to:
-weigh themselves daily
-recognize worsening symptoms
-adjust diuretic dose, in appropriate patients
-monitor salt and fluid intake

104.  Monitor clinical status of all patients with HF
 Monitor renal function, electrolytes
 Monitor BP, HR
 Perform medication reviews
-q6months (minimum)
-If status change, qfew days-2 weeks

105.  Delayed progression/prolong survival
through early diagnosis, optimized
pharmacotherapy, non-pharmacological
treatments
 Manage side-effects
 Adherence, self-management strategies
 Complex cases – manage with support of
cardiology consultation, specialty heart
failure clinics

106.  Titrate doses slowly
-ß-blocker increases slowly – double the
dose every 2-4 weeks
-ACEi increases slowly – double the dose
every 1-2 weeks
 Optimize ß-blocker and ACEi
-Decrease doses of diuretics, nitrates and
other antihypertensives

107.  Refer to an interprofessional HF clinic for
patient education and management
 Refer to a cardiac rehab program for
individualized exercise training for all stable
NYHA I to III HF patients

108.  Advanced care planning is an important part
of patient care
 Disease trajectory difficult to follow
 Prognostication tools can be helpful
 Quality of life and exploration of patient
preferences and expectations important part
of high quality care

110. Drug Start Dose Target Dose
ACE Inhibitors
Captopril 6.25-12.5 mg TID 25-50 mg TID
Enalapril 1.25-2.5 mg BID 10 mg BID
Lisinopril 2.5-5 mg OD 20-35 mg OD
Perindopril 2-4 mg OD 4-8 mg OD
Ramipril 1.25-2.5 mg BID 5 mg BID
Trandolapril 1-2 mg OD 4 mg OD
Beta-blockers
Bisoprolol 1.25 mg OD 10 mg OD
Carvedilol 3.125 mg BID 25 mg BID*
Metoprolol CR/XL** 12.5-25 mg OD 200 mg OD
* 50 mg BID if weight is >85 kg
** Not available in Canada

111. Drug Start Dose Target Dose
ARBs
Candesartan 4 mg OD 32 mg OD
Valsartan 40 mg BID 160 mg BID
Aldosterone Antagonists
Spironolactone 12.5 mg OD 50 mg OD
Eplerenone 25 mg OD 50 mg OD
Vasodilatators
Hydralazine 37.5 mg TID 75 mg TID
Isorbide dinitrate 20 mg TID 40 mg TID
* 50 mg BID if weight is >85 kg
** Not available in Canada

112. Class and Definition
I Evidence or general agreement that a given
procedure or treatment is beneficial, useful and effective
II Conflicting evidence or a divergence of opinion about the
usefulness or efficacy of the procedure or treatment
IIa Weight of evidence is in favour of usefulness or efficacy
IIb Usefulness or efficacy is less well established by evidence or opinion
III Evidence or general agreement that the procedure or treatment is not
useful or effective and in some cases may be harmful.

113. Level and Definition
A Data derived from multiple randomized
clinical trials or meta-analysis
B Data derived from a single randomized
clinical trial or non-randomized studies
C Consensus of opinion or experts and/or
small studies.