Applying the Evidence in Heart Failure….

Prof Ahmet Fuat PhD FRCGP FRCP PG Dip (Cardiology)

GP & GPSI Cardiology Darlington Professor of Primary Care Cardiology Durham

University Co-founder CVGP C.I.C

www.escardio.org

ESC CHF Guidelines, updated 2012 TA050516

ESC guidelines for the diagnosis and treatment of chronic heart failure – update 2012

Main changes in ESC Guidelines from 2008 : Treatment

1.  An expanded indication for mineralocorticoid(aldosterone) receptor antagonists (MRAs).

2.  A new indication for the sinus node inhibitorivabradine.

3.  An expanded indication for cardiac resynchronizationtherapy (CRT).

4.  New information on the role of coronaryrevascularization in systolic HF.

5.  Recognition of the growing use of ventricular assistdevices (VADs).

6.  The emergence of transcatheter valve interventions.

Initial pharmacological therapy

Zannad F et al. N Engl J Med. 2010 Nov 14. [Epub ahead of print]

*  

356 (25.9)

249 (18.3)

EMPHASIS-HF study PRIMARY ENDPOINT RESULTS

CV DEATH OR HOSPITALISATION FOR HF

EMPHASIS-HF Study SUMMARY

•  The addition of eplerenone to recommendedtreatment resulted in a –  37% reduction in the rate of the composite outcome of

death from cardiovascular causes or hospitalization forheart failure.

–  24% reduction in the rate of death from any cause–  23% reduction in the rate of hospitalization from any cause–  42% reduction in the rate of hospitalization for heart

failure

•  The effect of eplerenone on the primary outcomewas consistent across all prespecified subgroups.

Pharmacological therapy – next step

Swedberg K et al. Eur J Heart Fail. 2010;12:75-81.

Systolic Heart Failure treatment with the If Inhibitor Ivabradine Trial

HR and tolerability

Matching placebo, bid

Ivabradine 5 mg bid

D14 D28 D0 M4

Ivabradine 2.5, 5, or 7.5 mg bid according to Screening

7 to 30 days

Primary Endpoint a composite of: • Cardiovascular Death• Hospitalisation for worsening Heart Failure

• 677 centres in 37 countries• 6505 patients• Symptomatic CHF, NYHA Class II to IV• LV systolic dysfunction (EF ≤ 35%)• HR ≥ 70 bpm, sinus rhythm

• Admitted to hospital for HF in last 12 months• All aetiologies – 70% ischaemic• Followed 12 to 36 months, mean 22.9 months• On stable, guideline-based therapy for heart failure

Placebo n = 937 (29%, 17.7% PY) Ivabradine n = 793 (24%, 14.5% PY) HR = 0.82 p < 0.0001 NNT Y1 = 26

Primary endpoint

-18% Cumulative Frequency

(%)

Swedberg K, et al. Lancet. 2010; online August 29

0 6 12 18 24 30 Months

40

30

20

10

0

Ivabradine Placebo

Primary Endpoint a composite of: • Cardiovascular Death• Hospitalisation for worsening Heart Failure

Should be considered to reduce the risk of HF hospitalization in patients in sinus rhythm with an EF ≤ 35%, a heart rate remaining ≥70 beats per minute and persisting symptoms (NYHA class II–IV) despite treatment with an evidence-based dose of beta-blocker (or maximum tolerated dose below that), ACE inhibitor (or ARB) and an MRA (or ARB).

Ivabradine

Caveat about EMA labelling: ≥75 b.p.m.

Heart failure profile 2012/13: Darlington

CCG

September 2014

About the profiles

!  The aim of this slide set and associated data pack is to help assess achievement of the NICE Quality Standard for Heart Failure. It informs service improvement and planning, by gathering information and intelligence about: !  the current prevalence of heart failure; !  how effectively and accurately it is being diagnosed; !  whether evidence-based treatment guidelines are being

followed; !  how effective these treatments are in terms of patient

outcomes.

!  While some variation in healthcare is inevitable, unwarranted variation matters, as it can indicate that the right care is not being delivered to the right patients at the right time.

!  NICE Quality Standards are being used by NHS England to hold CCGs to account for improving outcomes under the NHS Outcomes Framework from 2012/13.

The NICE Quality Standard Statements (1)

Statement Description

QS1 People presenting in primary care with suspected heart failure and previous myocardial infarction are referred urgently, to have specialist assessment including echocardiography within 2 weeks.

QS2 People presenting in primary care with suspected heart failure without previous myocardial infarction have their serum natriuretic peptides measured.

QS3 People referred for specialist assessment including echocardiography, either because of suspected heart failure and previous myocardial infarction or suspected heart failure and high serum natriuretic peptide levels, are seen by a specialist and have an echocardiogram within 2 weeks of referral.

QS4 People referred for specialist assessment including echocardiography because ofsuspected heart failure and intermediate serum natriuretic peptide levels are seen by a specialist and have an echocardiogram within 6 weeks of referral.

QS5 People with chronic heart failure are offered personalised information, education, support and opportunities for discussion throughout their care to help them understand their condition and be involved in its management, if they wish.

QS6 People with chronic heart failure are cared for by a multidisciplinary heart failure team led by a specialist and consisting of professionals with appropriate competencies from primary and secondary care, and are given a single point of contact for the team.

The NICE Quality Standard Statements (2)

Statement Description

QS7 People with chronic heart failure due to left ventricular systolic dysfunction are offered angiotensin-converting enzyme inhibitors (or angiotensin II receptor antagonists licensed for heart failure if there are intolerable side effects with angiotensin-converting enzyme inhibitors) and beta-blockers licensed for heart failure, which are gradually increased up to the optimal tolerated or target dose with monitoring after each increase.

QS8 People with stable chronic heart failure and no precluding condition or device are offered a supervised group exercise-based cardiac rehabilitation programme that includes education and psychological support.

QS9 People with stable chronic heart failure receive a clinical assessment at least every 6 months, including a review of medication and measurement of renal function.

QS10 People admitted to hospital because of heart failure have a personalised management plan that is shared with them, their carer(s) and their GP.

QS11 People admitted to hospital because of heart failure receive input to their management plan from a multidisciplinary heart failure team.

QS12 People admitted to hospital because of heart failure are discharged only when stable and receive a clinical assessment from a member of the multidisciplinary heart failure team within 2 weeks of discharge.

QS13 People with moderate to severe chronic heart failure, and their carer(s), have access to a specialist in heart failure and a palliative care service.

Core dashboard summary

Link to quality statements Indicator

DarlingtonCCG 2012/13

CDDFT Darlington Memorial

2012/13

CDDFT University Hospital North Durham

2012/13 England 2012/13

1,2,3,4 % diagnosis confirmed (QOF HF02)

92.0% - - 90.8%

1,2,3,4 % unplanned hospital admissions for HF receiving echocardiogram (NHFA)

98.5% 97.3% 91.0%

7 % patients with HF prescribed ACE/ARB (QOF HF03)

85.6% - - 82.4%

7 % patients with HF prescribed ACE/ARB + BB (QOF HF04)

79.7% - - 63.7%

7 % patients receiving ACE/ARB on discharge following unplanned HF admission (NHFA)

- 88.3% 73.5% 85.0%

7 % patients receiving BB on discharge following unplanned HF admission (NHFA)

- 93.3% 74.8% 82.0%

Core dashboard summary

Link to quality statements Indicator

Darlington CCG 2012/13

CDDFT Darlington Memorial

2012/13

CDDFT University Hospital North Durham

2012/13 England 2012/13

5,6,9,10,11, 12,13

Referrals to HF liaison service following unplanned HF admission (NHFA)

- 65.5% 31.3% 59.0%

5,6,10,11,12,13

% Inpatients with HF that were cardiology inpatients (NHFA)

- 39.7% 71.8% 50.0%

12 HF readmissions within 30 days (HED)

- 23.0% 23.4%

8 Depression case finding (QOF DEP01)

86.5% - - 85.9%

9 Medication review all repeat medicines (QOF MEDICINES12)

all - -

13 Multidisciplinary case reviews (QOF PC02).

All current - -

13 Alert system around patients dying at home (QOF RECORDS13)

all - -

Prevalence – practice variation (context)

Fig 11a. HF prevalence, 2012/13

0.0

0.5

1.0

1.5

2.0

0 5000 10000 15000

% P

atie

nts

Persons on GP List

Darlington GP Practices National Average 2 standard errors limits 3 standard errors limits

5 (Less deprived) 4 3 2 1 (More

deprived)

Darlington Practices Deprivation Quintiles Colour KeyFig 11b. HF due to LVD prevalence, 2012/13

0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0

0 5000 10000 15000 %

Pat

ients

Persons on GP List

Darlington GP Practices National Average 2 standard errors limits 3 standard errors limits

5 (Less deprived) 4 3 2 1 (More

deprived)

Darlington Practices Deprivation Quintiles Colour Key

•   Wide variation in recorded prevalence of heart failure at practice level, ranging from 0.5% to 1.9%.

•   There is similar variation for heart failure due to LVD

Source: Quality and Outcomes Framework, HFPREV, 2012-13

Source: Quality and Outcomes Framework, LVDPREV, 2012-13

Darlington Health Centre has been removed from the charts as the practice had a very small number of patients and has ceased to operate. In addition, there were no patients on the heart failure register.

!   There are no routine data available to demonstrate achievement against the following quality standards: !   QS5 People with chronic heart failure are offered

personalised information, education, support and opportunities for discussion throughout their care to help them understand their condition and be involved in its management, if they wish.

!   QS8 People with stable chronic heart failure and no precluding condition or device are offered a supervised group exercise-based cardiac rehabilitation programme that includes education and psychological support.

Long term care – information, education, support and rehabilitation (QS 5,8)

Concluding comments – using available resources

!   NICE quality standards could be used in depth: !   within the service specification element of the

Standard Contract; !   as key performance indicators as part of a

commissioning process; !   to incentivise performance, e.g. through CQUINs; !   to measure and reward improvements;

!   to identify gaps in service provision.

!   The NICE commissioning guide and all relevant NICE implementation tools can further support CCGs in improving services for people with heart failure.

CRTP Patients with Heart

Failure and fill all criteria below

CRTD (CRT criteria met

and fulfil ICD criteria)

•   NYHA Class III-IV symptoms

•   QRS duration >150ms •   QRS duration 120 – 149

ms and dyssynnchrony confirmed by echo

•   LVEF < 35% •   OPT

CRT with Pacing Device

As CRTP Criteria Plus: •   No worse than NYHA Class III •   Recorded Non Sustained VT or Inducible

VT on EP Test OR: •   LVEF < 30% and QRS = > 120 ms For Secondary Prevention: •   Survival of cardiac arrest due to VT or VF •   Spontaneous sustained VT causing

syncope of haemodynamic compromise •   Sustained VT without syncope or cardiac

arrest and an LVEF of < 35%

Implantable Cardioverter Defibrillator

ICD’s For patients with arrhythmias

in the groups below

NICE guidance on cardiac resynchronisation therapy

(CRT) and implantable cardioverter defibrillators (ICDs)

2011 CRT EUROPEAN IMPLANT RATES 2011 ICD EUROPEAN IMPLANT RATES

Therapy PM ICD’s CRT

Actual 2011

525 77 113 Therapy PM ICD’s CRT

Target 700 100 130

Cardiac Rhythm Management UK National Clinical Audit Report

55 || MMDDTT CCoonnffideidennttialial

4 | MDT Confidential

Background to the Audit

Methods

Results !   Practice list size = 9890

!   Heart Failure prevalence 1.89% (National 0.7%) 187 patients

!   Mean age = 75 (range 51-94)

!   65% LVSD and 35% LVDD or HFPEF

!   ACEi/ARB use = 81%

!   Beta-blocker use = 78%

!   Few had LVEF recorded in notes and none coded

= 187 - 7

= 180 - 27

= 153 - 4

= 149 - 5

= 144 - 21

Results

21 Patients reviewed Carmel HF Clinic

!   All had routine bloods

!   2 needed ECG and echo

!   4 needed ECG and NHYA Class

!   1 died in interim (CVA)

!   10 too frail or ill (1 cancer 2 severe dementia etc)

!   4 refused to consider CRT despite meeting criteria

!   4 had AF and would not meet current NICE criteria (but possibly would ESC)

!   2 referred CRT-D (both fitted)

!   Overall 4 extra patients ended up with CRT-P 2 CRT-D 2 (subsequently 6 with 2 more CRT-D)

Additional Observations 82 NYHA found (46%) 36 NHYA coded (20%)

82 no ECG or Echo for 2 years (46%)

NICE CRT/ICD Guidance

In summary

!   Ejection fraction < 35% = Device

!   Broad QRS = CRT

Warning

!   Class I and II = less symptomatic

!   What can we do in Primary Care?

NICE CRT/ICD Guidance

What about HFPEF?

 

Diagnostic  group  

New  presentation  to  Heart  Failure  clinic?    

Symptoms  or  signs  of  heart  failure  

 HFPEF  

Symptoms  or  signs  of  HF  

LVEF  ≥  50%  &  LV  <  97ml/m2)    

No  other  structural/functional  cause  for  HF  

Fulfils  echo  diastolic  dysfunction  criteria  

HF  and  no  NMSD  

Symptoms  or  signs  of  HF  

No  other  structural/functional  cause  

for  heart  failure  

Echo  measurements  not  diagnostic  of  HFREF/HFPEF  

At  least  one  marker  of  heart  disease  from  list  below  

Heart  Failure  due  to  another  cause  

Clinician  opinion  

E.g.  Significant  primary  valve  disease  

 

Non  Heart  Failure  

Symptoms  &  signs  not  in  keeping  with  heart  failure    

OR  

Normal  echo  &  BNP  &  ECG  

(BNP  <  35,  No  AF,  LVEF  >  50%,  LVEDV  <  76ml/m2),  E/e’  <  8,  e’  ≥  8  (septal),  e’  ≥  10  (lateral),  LAVI  <  29ml/m2,  Ard-­‐Ad  <  30ms,  LVMI  <  

96g/m2  (female),  <  116g/m2  (male))  

 

 

E/E’  >  15  

(Septal  or  lateral)  

 

Average  E/E’  8-­‐15    &  

LAVI  >40ml/m2      or  

Ard  –  Ad  >  30ms      or  

LVMI  >122g/m2  (female),  LVMI  >149g/m2  (male)    or  

E/A  <0.5  +  DT  >  280ms  (>50yrs)      or  

Atrial  fibrillation    or  

BNP  >  200pg/ml  

Abnormal  ECG  

Elevated  BNP  (>35pg/ml)  

Echo  abnormalities  suggestive  but  not  diagnostic  of  HFREF/HFPEF  or  poor                echo  subject    

Suspected  underlying  aetiology  

 

 

BNP  >  200pg/ml  &  

E/e’  >  8      or  

LAVI  >40ml/m2      or  

Ard  –  Ad  >  30ms      or  

LVMI  >122g/m2  (female),  LVMI  >149g/m2  (male)    or  

E/A  <0.5  +  DT  >  280ms  (>50yrs)      or  

Atrial  fibrillation  

HFREF  

Symptoms  or  signs  of  HF  

Dilated  LV  (LVED≥97ml/m2),  or  LVEF  <  50%  (≥  Mild  LV  

impairment)  

Managing HFPEF !   Control BP (systolic and diastolic)

!   Address all CAD risk factors

!   Restore SR in AF if possible

!   Control ventricular rate in permanent AF

!   Diuretics for pulmonary congestion or peripheral oedema

!   Coronary revascularisation in symptomatic patients or where myocardial ischaemia affecting diastolic function

!   No evidence base for ACEi/ARB/BB or AAs (use if other indications)

Potential Solutions

!   Accessible Multidisciplinary heart failure clinics and teams (for diagnosis and further care)

!   Standardised letter documenting evidence based management plans (including all investigations, diagnosis with NYHA Class, treatments, whether CRT-P or D considered, future review plan)

!   QOF to include more detailed evidence based treatment criteria, review and annual ECG

!   Clinician Education (HF, device therapies, BNP use)

!   Better patient information re CRT-P and D

!   Simplified audit plans to enable computerised review

Potential Solutions Dear Doctor,  

This patient has been seen and completed their diagnostic and management work up in the Darlington Integrated Heart Failure Service.

Diagnosis (mild, moderate or severe LVSD)/HFPEF/LVDD/VHD etc

NYHA Class:

Investigations Undertaken:

Relevant Bloods (BNP, Renal function) -

ECG -

Chest X-ray -

Echocardiogram -

Cardiac MRI -

Other –

Current Medications: (dose and reason maximum dose not achieved)

Diuretic -

Beta-blocker -

Ace inhibitor (or ARB) -

Mineralocorticoid antagonist (MRA) -

Other relevant drugs –

(Please remind patient that if diarrhoea, vomiting or any illness that may cause dehydration the patient should stop diuretic, ACEi, ARB and MRA until drinking and eating again. Restart at usual dose)

CRT and or ICD

Please see this patient every 3/6 months in your CHD/HF clinic

 

If deterioration in HF please refer back to specialist heart failure nurse in the community or the HF clinic urgently  

Aims: CVGP

!   Represent primary care CV health needs at policy level

!   Promote best practice in primary care CV health through education, training and service development

!   Support the development of primary care health professionals in CV medicine

!   Facilitate and lead primary care CV research

!   Influence and support commissioners

HF Prevention – or is it too late for this bunch of merry riders???

Any further questions...

ahmetfuat nhs.net