Applying the Evidence in Heart Failure…. · An expanded indication for cardiac resynchronization...
Transcript of Applying the Evidence in Heart Failure…. · An expanded indication for cardiac resynchronization...
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