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HEART RHYTHM
MANAGEMENT DEVICES
Guidance for Commissioners
National Heart Rhythm Management
Device Taskforce
CONTENTS
1.
2.
3.
Executive Summary
Introduction
Cardiac Pacing
4.
5.
6.
7.
Implantable Cardiover ter Defibrillators
Cardiac Resynchronisatioan Therapy
Implantable Loop Recorders
Remote Monitoring
Dr R G Charles
Dr R G Charles
Dr R G Charles
Professor J M Morgan
Dr N Linker
Dr J M McComb
Dr N Sulke
Dr C Plummer
Dr J M McComb
Ms M Tynan
Editors:
Dr R G Charles
Dr M D Gammage
NATIONAL HEART RHYTHM
MANAGEMENT DEVICE TASKFORCE
Adam Fitzpatrick
Mike Yates
Sue Armstrong
Richard Charles
Campbell Cowan
Dot Crone
David Cunningham
Mary Currie
Genevieve Dalton
Clare Felton
Michael Gammage
Ian Golton
Sue Hughes
Nick Linker
Trudie Lobban MBE
Janet McComb
Geraldine McParland
Judith McVey
Nicola Meldrum
John Morgan
Maria O’Brien
Chris Plummer
Neil Sulke
Manchester Hear t Centre Co-Chairman
Depar tment of Health Co-Chairman
Leicester
Chairman, Network Devices Survey Group
Hear t Improvement Programme
Greater Manchester & Cheshire Cardiac Network
CCAD
Director, SE London Cardiac Network
Manager, Anglia Cardiac Network
Manager, Thames Valley Cardiac Network
University of Birmingham
Hear t Improvement Programme
Liverpool
South Tees
Arrhythmia Alliance / STARS
Newcastle
Belfast
Manager, Beds and Her ts Cardiac Network
Oxford
Southampton
Director, NW London Cardiac Network
Newcastle
Eastbourne
1. EXECUTIVE SUMMARY
• Disorders of hear t rhy thm (cardiac arrhy thmias) are a major cause of
death and morbidity amongst patients with many types of hear t disease.
• Hear t failure, wi th or wi thou t cardiac ar r hy thmias, is a major
cause of dea th and mor bidity amongs t pa tients with hear t disease,
pr incipally coronar y hear t disease and dila ted cardiomyopa thy.
• Cardiac pacemakers, Implantable Cardiover ter Def ibrillators and Cardiac
Resy nchronisa tion Sys tems are scientif ically proven to be cos tef fec tive in reducing mor tali t y and mor bidi t y in appropr ia tely
s e l e c t e d p a t i e n t s w i t h ca r d i a c a r r hy t h mi a s a n d h e a r t failu r e .
• Implantation rates in the United Kingdom for all three therapeutic device
classes are low by international comparison and, as documented by the
Cardiac Networks Devices Sur vey (w w w.devicesur vey.com), inequitable
between localities within the UK, despite correction for demographic variables.
• Implantable Loop Recorder s and remote moni tor ing sys tems are
technologies which suppor t the eff icient identif ication and follow-up of
patients indicated for implantable cardiac rhy thm management devices.
• The National Service Framework, Chapter 8, sets out a broad strategy for
improving services to patients with cardiac arrhythmias. The strategy, suppor ted
by the National Heart Rhythm Management Taskforce, specifically includes increasing
the national low volume of provision of implantable devices. The annual repor ts
of the Networks Devices Survey Group (www.devicesurvey.com, and subsequent
repor ts) document regional inequities within the UK. These will only be
r e c t i f i e d b y c l o s e co l l a b o r a t i o n b e t w e e n Co m m i s s i o n e r s ,
Cardiac Networks and cardiac arrhythmia/hear t failure professionals, using the
best available scientific and demographic evidence.
• This guidance, derived from current national and international consensus guidelines,
is offered specifically to assist Commissioners responsible for the local provision
of implantable cardiac devices and their suppor ting services to cardiac patients.
Local commissioning decisions should be informed both by the current consensus
g u id e lin e s a n d b y t h e r e l a t i v e n e e d of t h e l o cal co m m u ni t y
as documented in the latest repor ts of the Networks Devices Sur vey.
2. INTRODUCTION
Hear t rhythm disorders are a major cause of sudden death and disability but for many
patients a modern implantable cardiac device can save lives and reduce symptoms
when implanted with a simple operation.
Pacemakers (PM), Implantable Cardiover ter Def ibrillators (ICD) and Cardiac
Resynchronization Systems (CRT) are amongst the most successful innovations of
modern biotechnology. A scientifically incontestable evidence base now documents
their ability to reduce mor tality and improve quality of life in appropriately selected
patients with symptomatic life threatening arrhythmias (PM and ICD) and advanced
hear t failure (CRT). Despite the irrefutable nature of the scientific evidence, which has
generated clear and increasingly consistent professional guidelines and cost-efficacy
analyses, the provision of these therapies to those who would benefit from them
remains strikingly inadequate.
Two recent events have finally thrust into proper prominence the importance of cardiac
arrhythmias, overshadowed in recent years by a perceived primacy of need for high
rates of coronary revascularisation, as a dominant cause of death and disability in
patients with hear t disease. Firstly, the publication in March 2005 of Chapter 8 of
the National Service Framework for Coronary Hear t Disease has served to focus
the attention of patients, clinicians and Cardiac Networks on the local provision of
implantable cardiac devices. Secondly, in 2006, the Network Devices Survey Group
made public the first systematic survey of the NHS in England and Wales in respect
of its level and equity of cardiac device provision compared to local relative need;
the second repor t for 2007 is also available (www.devicesurvey.com), whilst the 2008
repor t is currently in preparation.
The f indings continue to pose a major challenge to the NHS. Whilst increasing
numbers of patients are benefiting from these sophisticated devices, implantation
rates in the UK in 2005 and 2007 remained amongst the lowest in Western Europe
for all three device classes and there is continued evidence of real local inequity of
service provision. Implant rates for PM, corrected for demographic factors, varied
by over 100% between Cardiac Networks and over 300% between Primary Care
Trusts; analogous inequities occurred for ICD and CRT.
Diagnostic and Device Monitoring Technologies
The optimal management of patients with cardiac arrhy thmias must obviously
include the accurate and efficient diagnosis of the underlying condition for which
an implantable device may be indicated, and the subsequent monitoring of both
the operational performance of that device and the natural history of the patient’s
underlying clinical condition. In parallel with the development of the therapeutic devices
described above has been the emergence of technology to enhance the efficiency
of diagnosis and follow-up.
Implantable Loop Recorders (ILR) allow prolonged monitoring of hear t rhythm and
may be more productive than traditional non-invasive testing in patients presenting
with intermittent, often infrequent, symptoms which may be due to impor tant cardiac
arrhythmias.
Device follow-up clinics based in hospital out-patient facilities consume major and
increasing resources in time and trained personnel. Remote or home monitoring
systems which allow the local acquisition of technical and sometimes clinical data
from the patient and their device, which can then be transmitted to the follow-up
centre, are sophisticated, widely used in comparable national healthcare systems,
and are now available in the UK.
It is appropriate that cardiac device commissioning guidance should include advice
about these integral and suppor tive technologies.
National Heart Rhythm Management Device (HRMD) Taskforce
Whilst Cardiac Networks and Commissioners will be at the front line of providing
adequate access to implantable cardiac device services for their local populations, they
will be suppor ted in their effor ts by the HRM-D Taskforce which was set up jointly
by the Hear t Team (Mr Mike Yates) and the Manchester Hear t Centre (Dr Adam
Fitzpatrick) in 2006. Its core mission is to facilitate an increase in the implantation
rates of HRM devices in England (and by extension the UK) to match Western
European average rates by 2016. It should immediately be appreciated that aiming
for an average performance is a modest target indeed, and that continuing European
growth in device provision will, in real terms, shift that modest target upwards. It
is under the aegis of the HRMD Taskforce that this Guidance for Commissioners is
offered.
The need for Guidance for Commissioners
Innovative and enlightened commissioning policies must play a decisive role in rectifying
the inequities and under provision identified in the Network Devices Survey Group
repor t, and to take forward the aims of the NSF Chapter 8. Commissioners require
a secure knowledge base to underpin their commissioning priorities and choices.
The aims of this Guidance are:
• to summarise briefly the operational principles and evidence base for the use of:
- Cardiac Pacemakers
- Implantable Cardiover ter Defibrillators
- Cardiac Resynchronisation Therapy
- Implantable Loop Recorders
- Remote Monitoring systems
• to indicate the health economics of commissioning the technology
• to indicate the manpower implications of providing target level commissioning
• to provide summary ‘key recommendations’ distilled from the above.
Sources of Evidence
The advice is drawn from the highest levels of published evidence available:
international clinical guidelines from professional bodies (European Society of
Cardiology, American College of Cardiology/American Hear t Association/Hear t
Rhythm Society), NICE guidance, large randomised controlled clinical trials and metaanalyses etc. However, it will rightly be the case that contemporary clinical practice
may step ahead of extant guidelines; thus indications which are based on current
clinical consensus will also be quoted.
3. CARDIAC PACING FOR BRADYCARDIA
What is a Cardiac Pacemaker?
A Cardiac Pacemaker is a device which delivers an electrical stimulus to the
hear t, via one or more pacing leads, initiating a hear t beat. Over the past 50
years cardiac pacing has become established, suppor ted by a mass of published
literature and both national and international guidelines, as the only indicated
treatment for a variety of conditions which are expressed by an abnormally low
hear t rate (bradycardia). As understanding of the physiology of bradycardias
has advanced, the technology of pacemakers has become more sophisticated
with the aim of simulating more closely the normal hear t function and avoiding
the adverse effects of ‘simple ventricular pacing’ such as pacemaker syndrome,
promotion of atrial fibrillation and long term deterioration of hear t pump (left
ventricular) function. Accordingly, various terms are in common use which describe
pacemaker function and which will be helpful for Commissioners to understand:
• Demand pacemaker: The pacemaker not only stimulates the heart but can sense a
normal heartbeat which then inhibits the electrical output of the pacemaker. Therefore
the pacemaker does not compete with the patient’s own hear tbeat but stimulates
the heart only when needed (on demand). All modern pacemakers operate in this way.
• Single chamber: The pacemaker senses and paces only one of the hear t
chambers; either atrium or ventricle. Inappropriate use of single chamber
ventricular pacing is associated with a range of adverse clinical effects.
• Dual chamber: The pacemaker can pace and sense in both a tr ium
and ventricle. This more closely emulates the sequence of the normal
hear tbeat and is thus sometimes called ‘physiological’ or ‘atrial-based’
pacing. In appropriately chosen patients it may improve quality of life, eliminate
pacemaker syndrome and reduce the chances of developing Atrial Fibrillation.
• Rate adaptive (responsive): The pacemaker incorporates a sensor which
detects the need for an increase in hear t rate, typically on physical effor t. Rate
adaptation is used when the patient’s heart is incapable of mounting an appropriate
spontaneous rise in heart rate in response to exercise (chronotropic incompetence).
• Mode: Describes the single or multiple pacing and sensing capabilities of
the pacemaker, and specifically the configuration of those capabilities chosen
for optimal pacing of the individual patient and their condition. Appropriate
pacemaker mode prescription is a fundamental choice in providing optimal pacing.
It has been the subject of guidelines from the British Pacing and Electrophysiology
Group (now Hear t Rhythm-UK) in 1991, largely endorsed by NICE TA88 (2005).
• Ventricular pacing avoidance: A substantial body of evidence now indicates that long
term, persistent pacing at the apex of the right ventricle (currently the standard
ventricular pacing site) can lead to a progressive deterioration in left ventricular function
and thus raise the risk of developing clinical hear t failure. Manufacturers are
now incorporating algorithms which reduce to the safest minimum the burden
of ventricular pacing.
• Pacing site: The evidence demonstrating that long term right ventricular apical pacing
may cause deterioration of left ventricular function has led to examination of alternative
pacing sites (alternate site or site-specific pacing). Accessing these sites requires specific
lead types and delivery systems which are available from a number of manufacturers.
Use of these pacing sites in selected patients is likely to reduce the burden of heart failure.
INDICATIONS
This is a summary of published UK/European guidelines that have been endorsed by
NICE and which have informed its published guidance.
The indications for bradycardia-treating pacemaker implants fall into two groups:
•
Prophylactic pacemaker implantation for patients known to be at
high risk of sudden death due to bradycardia mediated by Atrioventricular (AV) conduction disease. In this group, ECG diagnosis of cardiac
conduction abnormality indicates bradycardia risk. These ECG abnormalities
have been shown by a large and robust evidence base to be associated
with a likelihood of unpredictable progression to advanced conduction
abnormality which would be life-threatening. Pacemaker implantation is
known to protect against sudden death risk in this circumstance.
•
Patients requiring pacing therapy to ameliorate or abolish symptoms related
to bradycardia and correctable by atrial/ventricular pacing or both. Bradycardia
may be the consequence of sinus node disease, AV conduction disease or neurallymediated syndromes (carotid sinus syndrome and vasovagal syndrome) and
sometimes a combina tion of these conditions. It is impor tant to
under s tand tha t brad ycardia may be transient and may not
present with a typical history of syncope. Thus falls, exercise intolerance,
breathlessness and epileptiform fits may often be presenting clinical features.
Pacing for Symptomatic Bradycardia
•
Sinus node disease
Asymptomatic sinus node disease is not associated with sudden cardiac
death risk. Therefore, if a patient is genuinely asymptomatic there is
no indication for pacemaker implantation. There have been several
major well designed studies that have demonstrated the value of pacing
in patients with bradycardia related symptoms and sinus node disease.
•
Symptomatic Atrio-ventricular (A-V) block
Symptoma tic (usually syncope) abnor mality of the A-V Node or
the specialised conduction sys tem is a life-threa tening condition
and merits urgent pacemaker implantation, and again the value
of pacing is well characterised in substantial suppor ting literature.
•
Neurally mediated Syncope
Autonomic regulation of the sinus node and conduction systems can lead to
bradycardia and additional vasodepression (abnormal drop in blood pressure).
The value of cardiac pacing comes where bradycardia is a major clinical feature.
This has been par ticularly demonstrated for carotid sinus syncope for which
pacing is a long established and accepted clinical practice. If vasodepression is
the dominant mechanism for syncope pacing probably has a limited part to play.
Pacemaker Choice
There are a wide variety of pacemakers offering substantially different technologies to
service the needs of patients susceptible to bradycardias. It is impor tant to understand
that bradycardia and its underlying conditions are not “stand alone” abnormalities
but a complex interplay of various pathologies which can interact with other cardiac
disease processes/manifestations (e.g. Atrial Fibrillation/left ventricular dysfunction).
In their simplest form pacemakers deliver pacing pulses to the myocardium to initiate
a hear t beat. However, the precise nature of the pacing rhythm can determine a
variety of electrophysiological and clinical consequences. Thus the choice of pacemaker
mode and precise pacemaker type (manufacturer and version) may be governed
by a need to fulfil a treatment specification which manages not only the patient’s
bradycardia but related cardiac abnormalities independently influenced by pacemaker
proper ties. The ability of some devices to offer diagnostic information may also
influence pacemaker choice.
The simplest choice lies between single and dual chamber pacing. Major randomised
trials have looked at the benefits of single versus dual chamber pacing and it is clear
that the benefits differ depending on patient age, normality or impairment of left
ventricular function and susceptibility to atrial fibrillation. It is atrial fibrillation (and
related stroke risk) and hear t failure exacerbations that will par ticularly influence
clinicians’ choices of pacemaker modes and technologies. Some pacemakers are able
to influence the burden of unnecessary ventricular pacing in patients who experience
only intermittent abnormality of normal electrophysiological function and this is likely
(from the evidence base) to lead to preservation of ventricular systolic function,
par ticularly in those patients with already impaired left ventricular systolic function.
Others are able to influence the symptomatic burden and clinical consequences of
atrial fibrillation through specialised pacing manoeuvres.
There is also evidence that specific pacing site may optimise cardiac function in some
circumstances. It is necessary therefore for physicians to have access to a range of
single and dual chamber pacemaker and lead technologies so that they can match the
patient’s physiological needs with the most appropriate pacing therapy. Pacing choice
is also vital in neurally mediated syncope where inappropriate pacing technology
prescription can even exacerbate the underlying condition.
Commissioning and procurement choices must therefore allow for wide clinical
discretion in the range of devices available if optimal pacing is to be provided, a
principle espoused by NICE TA88.
Health Economics
Cardiac pacing is a highly effective therapy. Cardiac pacemakers (and the other
therapeutic devices considered in this guidance) cost signif icantly less in the UK
than in other West European and ‘western hemisphere’ countries, and vigorous
procurement arrangements serve fur ther to minimise hardware costs to individual
pacing services.
The principal economic discussion related to pacing has been the cost effectiveness
of dual chamber pacing compared to single chamber pacing. This issue is discussed
in detail by NICE TA88 (2005), which concludes that dual chamber pacing is cost
effective across the range of indications accepted by NICE, and by the literature and
professional guidelines which suppor ted the NICE conclusions.
Whilst accepting the cost effectiveness of optimal cardiac pacing as currently practiced,
Commissioners will need to take account of the national policy progressively to raise
the UK implantation rate from its current low levels to the European average rate, and
of the relative need to provide a given implantation rate according to the demographic
structure of their own client population, as demonstrated in the Networks Devices
Survey. In essence, a population with a higher average age will have a greater relative
need for pacing since the need for pacing increases exponentially with age.
Manpower implications
Pacemaker implantation is performed in the cardiac catheter laboratory or in
operating theatre facilities sometimes specified for cardiological device implants.
Staffing requirements usually include, as a minimum, the implanting cardiologist, a
cardiac physiologist, a nurse and a radiographer. In recent years cardiac catheter
laboratories have opened in district general hospitals, whilst at the same time cardiac
pacing has largely devolved to similar hospitals and away from ter tiary centres,
accompanied by an increase in national pacemaker implantation rates. Clearly, a
national policy to increase pacemaker implantation rates will require local consideration
of both medical and non-medical staffing levels to suppor t the increase in the number
of procedures performed. A British Cardiovascular Society Working Group Repor t;
‘Non-medical catheter laboratory staffing’ (March 2007), highlights the scarcity of such
staff, notably cardiac physiologists. NICE TA88 recognises that the resources in time
and exper tise are greater for dual chamber than single chamber pacing but states
that it has insufficient data to quantify accurately the human resource implications.
Pacemaker follow-up is principally conducted by cardiac physiologists at a
high standard of training, who often possess fur ther qualif ications in the
f ield of cardiac arrhy thmias and device management. Adequate staff ing for
device follow-up must be planned for, it is here that potential savings may
be realised by the implementation of remote monitoring (see Section 7).
KEY RECOMMENDATIONS FOR COMMISSIONERS
•
Cardiac pacing is a highly clinically effective and cost-effective therapy with an
extensive supporting evidence base. UK implantation rates are low compared
to most comparable West European countries, despite a similar prevalence
of the conditions which require pacing, and evidence that countries with high
implantation rates are not over-implanting. There is major inequity in agecorrected pacemaker implantation rates between localities within the UK.
•
Recent guidelines on the indications for cardiac pacing and appropriate mode
prescription are in close agreement (NICE TA88, 2005; ESC, 2007), with dual
chamber pacing accepted as a cost effective strategy (NICE TA88, 2005).
•
Commissioners should work in close collaboration with their Cardiac
Networks and cardiac arrhy thmia professionals to plan a progressive
increase in pacemaker implantation rates to achieve the European
average rate by 2016, as targeted by the National Hear t Rhy thm
Management Device Task force of the Depar tment of Heal th.
•
Co m mi s s i o n e r s s h o u ld t a ke cl o s e a cco u n t of t h e r e l a t i v e
need for pacing of their local client population, as documented in
the mos t recent repor ts of the Networ k Devices Sur vey Group.
•
Increased pacemaker implant rates may entail the expansion of the capacity
of existing services and the commissioning of new pacing centres, generally
in suitably skilled secondary care settings. This will entail adequate medical
and non-medical workforce planning locally (with appropriate facilities for
implantation) to ensure a safe and effective implantation and follow-up service.
•
Device follow-up is expensive in time, personnel and exper tise. The
potential for savings and improved patient convenience offered by
remote monitoring systems (see section 7) should be carefully considered.
4. IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
What is an Implantable Cardioverter Defibrillator (ICD)?
Each year it is estimated that 50,000 people die in the UK as a result of sudden
cardiac death. The majority of these deaths are due to rapid and unstable hear t
rhythms (ventricular tachycardia and ventricular fibrillation). Some of these are
in the setting of a hear t attack, although the majority occur unexpectedly. An
Implantable Cardiover ter Defibrillator (ICD) is a device that is capable of recognising
these rapid arrhythmias when they occur and delivering life-saving therapy in terms
of a defibrillation “shock” to restore a normal rhythm. In the UK, most ICDs are
implanted in ter tiary centres although there are increasing numbers being implanted
in secondary care settings. Never theless, the UK has one of the lowest ICD implant
rates in Western Europe despite NICE guidance issued in 2000 and again in 2006.
Indications
Current NICE guidance, updated in 2006, recommends ICD implantation for patients
in the following categories:
Secondary prevention, that is, for patients who present, in the absence of a treatable
cause, with one of the following:
•
Having survived a cardiac arrest due to either ventricular tachycardia (VT)
or ventricular fibrillation (VF).
•
Spontaneous sustained VT causing syncope or significant haemodynamic
compromise.
•
Sustained VT without syncope or cardiac arrest and who have an associated
reduction in ejection fraction (LVEF) of less than 35% (no worse than class
III of the New York Hear t Association (NYHA) functional classification of
hear t failure).
Primary prevention, that is, for patients who have:
•
A history of previous (more than 4 weeks) myocardial infarction (MI) and:
either
-
left ventricular dysfunction with an LVEF of less than 35% (no
worse than NYHA class III)
and
-
non-sustained VT on Holter (24-hour electrocardiogram)
monitoring and
inducible VT on electrophysiology study
or
and
-
left ventricular dysfunction with an LVEF of less than 30% (no worse
than NYHA class III)
QRS duration of equal to or more than 120 ms.
•
A familial cardiac condition with a high risk of sudden death (e.g. congenital
long QT syndrome).
•
Following surgical repair of congenital hear t disease.
NICE guidance focuses primarily on patients with coronary hear t disease and does
not cover patients who have other conditions that result in poor left ventricular
function and an increased risk of sudden death, such as dilated cardiomyopathy. In
response to this, the British Cardiovascular Society (BCS) in conjunction with Hear t
Rhythm UK (HRUK) recommended that patients who have these other conditions
and who fulfil the NICE criteria in all other respects (for both primary and secondary
prevention) should be managed in the same way and offered ICD implantation. NICE
also recommends that patients who are being considered for cardiac resynchronisation
therapy (see elsewhere) who fulfil current criteria for this therapy but who also fulfil
the above ICD criteria should receive a bi-ventricular ICD (or CRT-D) device.
Health Economics
Several economic evaluations relating to use of ICDs have been performed. Based
on these evaluations NICE assessed the cost effectiveness of ICD implantation.
Analyses indicate that ICD therapy is cost effective for both primary and secondary
prevention of sudden cardiac death with an estimated cost/quality adjusted life year
(QALY) of < £30,000. In comparison to a number of therapies in various disease
areas also recommended by NICE cost/QALY estimates for ICDs are similar or lower.
A number of studies have been performed in relation to the numbers needed to
treat (NNT) to save one life. In comparison to other established cardiac therapies
(see figure 1) many more patients need treatment with medications to save one life
than with an ICD.
Figure 1: NNT to save one life for ICDs and various drugs. NNT is calculated for the specific
point in time shown under each study. NNT = 100/(% mor tality control group - % mor tality
group). NNT has been calculated using mor tality data from the Kaplan-Meiers curves for
each of the trials shown.
It has been demonstrated that the NNT is dramatically dependent on the time window
over which the benefit is assessed. For example the NNT at 1 year in the MADIT II trial
was 133 patients but this dramatically decreased to 17 at 2 years of follow up then to
8 by the end of 3 years, indicating that for ICD therapy with high upfront costs (preimplant work up, device purchase and implant) the true cost can only be assessed over
several years. Recently published analyses show ICDs to be a cost effective therapy in
significantly increasing life expectancy in stable hear t failure patients with LVEF < 35%.
Cost/QALY estimates for ICDs are similar or lower than a number of therapies in
various disease areas, which have also been recommended by NICE. The costeffectiveness for a variety of cardiovascular disorders and treatment options has
also been evaluated. Using these categories, it appears that ICD therapy is a costeffective therapy, comparable to many widely accepted treatments. The table below
provides another comparison of incremental cost-effectiveness results, demonstrating
that ICD therapy is as cost-effective as other established cardiac therapies.
PTCA
–
CABG –
*LYS
–
percutaneous transluminal coronary angioplasty (same as PCI
percutaneous coronary intervention)
coronary ar tery bypass grafting;
life year saved
Potential savings to be offset against the cost of ICDs include; ambulance costs of
attending cardiac arrest, emergency admissions to hospital due to arrhy thmia,
hospitalisation leading to stays in high dependency areas such as coronary care
units and cardiac intensive care units and hospitalisation due to falls and fractures as
identified in the costing template and implementation tool developed by NICE.
Manpower Implications
A multi-disciplinary team (MDT) approach to providing adequate clinical services for
this patient group has proven to be effective in several centres across the UK. A
suggested MDT model based on practice in Middlesbrough and Manchester can be
found on the DH website. This model focuses on having the appropriate infrastructure
in place within the implanting centres enabling an effective hub and spoke approach
to be implemented. The teams consist of electrophysiologists, specialist registrars,
arrhythmia care co-ordinators, cardiac physiologists, specialist arrhythmia nurses
and catheter laboratory staff including nurses and radiographers. Each of these
disciplines has an essential role to play in providing comprehensive services for patients
with ICDs. Close links to rehabilitation, psychology and genetic services are also of
paramount impor tance. The number of staff needed within each discipline obviously
depends on implant rates.
Key Recommendations for Commissioners
•
ICD therapy is currently recommended by NICE for patients with coronary
hear t disease and haemodynamically impor tant ventricular arrhythmias.
•
ICD therapy is also currently recommended by NICE for primary prevention
in patients with coronary hear t disease at high risk of ventricular arrhythmias
or sudden death.
•
There is evidence that patients with poor left ventricular function due to other
mechanisms e.g. dilated cardiomyopathy should also be considered for ICD
implantation in the same manner as patients with coronary hear t disease.
•
Patients eligible for CRT who also meet guidelines for ICD implantation should
receive a CRT-D device.
5. CARDIAC RESYNCHRONISATION THERAPY
What is Cardiac Resynchronisation Therapy (CRT)?
Hear t failure is a major and growing public health problem in all Western countries
and is associated with high mor tality and morbidity despite optimal medical therapy.
Clinical trials of high scientific quality published in recent years have consistently
found that CRT improves symptoms, quality of life, exercise tolerance and survival
in appropriately chosen patients with advanced hear t failure and evidence of left
ventricular dyssynchrony who are refractory to optimal medical therapy.
CRT involves simultaneous pacing of the left and right ventricles (CRT-P), and may
be combined, in the same device, with a defibrillation function (CRT-D). Although
CRT involves pacing the hear t, it should not be confused with ‘classical’ pacing
for bradycardia – the vast majority of CRT recipients do not require pacing for
bradycardia. The function of pacing in CRT is to make the ventricles beat together
with improved coordination and hence efficiency (‘resynchronisation’).
In the UK, CRT is currently provided almost exclusively by ter tiary centres with a
special interest in device therapy. It is expected that the clinical demand for CRT will
continue to rise significantly in coming years, accompanied by an orderly devolution
of implanting services to include appropriately skilled, staffed and equipped secondary
centres.
Indications
NICE published guidance on CRT in 2007 as did the European Society of Cardiology
(ESC). The ESC guidance is more inclusive than NICE, although there is close agreement
between the guidelines. The NICE evidence is summarised in Technology Appraisal
Guidance No.120. CRT was also recommended in NICE Clinical Guidance No.5, Chronic
Hear t Failure, published in 2003, the ESC Guidelines for the Diagnosis and Treatment
of Chronic Hear t Failure (2005), and the American College of Cardiology/American
Hear t Association (ACC/AHA) Guideline Update for the Diagnosis and Management
of Chronic Hear t Failure in the Adult (2005).
In summary:
• Cardiac Resynchronisation Therapy with a Pacing device (CRT-P) is
recommended for people with hear t failure who fulfil all the following criteria.
•
They are currently experiencing or have recently experienced NYHA class
III–IV symptoms.
•
They are in sinus rhythm:
- either with a QRS duration of 150 ms or longer estimated by
standard electrocardiogram (ECG).
- or with a QRS duration of 120–149 ms estimated by ECG and
mechanical dyssynchrony that is confirmed by echocardiography.
•
They have a left ventricular ejection fraction of 35% or less.
•
They are receiving optimal pharmacological therapy.
The ESC guidelines allow QRS > 120ms without fur ther investigation. It includes
patients with atrial fibrillation and patients who fulfil the general selection criteria
and have a bradycardia pacing indication.
•
Cardiac Resynchronisation Therapy with a Defibrillator device (CRTD) is recommended for people who fulfil the criteria for implantation of a
CRT-P device above and who also separately fulfil the criteria for the use of
an ICD device as recommended in NICE technology appraisal guidance 95
(see Section 4 above).
The ESC recommends CRT-D is an acceptable option for patients who have
expectancy of survival with a good functional status for more than one year.
Health Economics
There are a variety of economic analyses of CRT. Taking account of these Peninsular
Technology Advisory Group (PenTAG), in its assessment repor t for NICE, estimates
the cost per life year saved for CRT-P at £16,598, and for CRT-D at £22,603. This
assessment is therefore compatible with the costs for other accepted cardiac
treatments (see Section 4, Table 1).
Details of reduction in hospital admissions expected are given both in the PenTAG
assessment for NICE and in the NICE costing tool. NICE suggests that 748 hospital
admissions for hear t failure, 432 hospital admissions for arrhythmia, and 748 hospital
admissions for hear t attack will be avoided annually in England by CRT-P/D, leading
to an annual saving of £2,788,601.
Manpower implications
•
CRT is expensive in time, manpower and expertise. NICE, in its implementation
tool for CRT, estimates that 3,387 CRT-D devices will be required annually
(2,381 extra), and 1,133 (no change) CRT-P devices will be required annually
in the whole of England. This equates to:
- 2,619 lab sessions (allowing 10% lead displacement rate)
=
6.6 full time catheter laboratories, staffed with physiologists,
nurses, radiographers
- 16.5 implanting physicians - follow up
- One hour optimisation post implant
- 5 follow ups (30 minutes) per year
- 1 unscheduled follow up (30 minutes) per year
•
=
9,167 physiologist hours
=
230 extra full time experienced physiologists
Echocardiography - An increase in echocardiography services will be needed,
for:
- Dyssynchrony assessment, (45 minutes) prior to implantation
- Additional (~35%) ex tra will be needed, as not all those assessed
will be suitable
•
=
2,410 hours
Echo optimisation, post implantation
=
•
Follow up echocardiography (45 minutes), perhaps 1/patient/year
=
•
2,619 hours
1,785 hours
170 extra full time experienced physiologists
Key Recommendations for Commissioners
•
CRT is currently recommended by NICE in patients in sinus rhythm with
symptomatic hear t failure, (class III/IV) despite optimal medical therapy, with
EF <35% and QRS >120ms. ESC Guidelines (2007) include patients with atrial
fibrillation, and with a standard bradycardia indication, with impaired left
ventricular function.
•
There is increasing evidence that other groups of patients will derive
similar benefit
- Previous RV apical pacing, with impaired LV function
- Previous AV node ablation with impaired LV function
- Class II hear t failure patients with wide QRS complexes & EF<30%
(MADIT CRT Trial,2009)
- Patients with hear t failure, narrow QRS complexes & dyssynchrony
demonstrated on echocardiography
•
NICE, in its implementation tool for CRT, estimates that 3,387 CRT-D devices
will be required annually (2,381 extra), and 1,133 (no change) CRT-P devices
will be required annually in the whole of England.
•
Nationally, this equates to:
- 6.6 full time catheter laboratories, staffed with physiologists, nurses,
radiographers
- 16.5 implanting physicians
- 230 extra full time experienced pacing physiologists
- 170 extra full time experienced echo physiologists
•
The NICE cos ting tool allows local calcula tions to be made, (as
implantation rates required will depend on population demographics).
•
This will provide an excellent oppor tunity to improve patient care,
as existing hear t failure ser vices can be encouraged to work with
secondary/ter tiary care in selecting and following up patients.
6. IMPLANTABLE LOOP RECORDERS
What is an Implantable Loop Recorder (ILR)?
An ILR is an implantable device that continuously monitors heart rhythms automatically
or by using a patient activator. The device is implanted in a very quick and simple
outpatient procedure under local anaesthesia as a day case, and can remain implanted
just beneath the skin in the chest area for up to 36 months. It is principally used for
the diagnosis of unexplained syncope.
•
Syncope: Syncope, otherwise known as transient loss of consciousness (TLoC)
or fainting, is common and can be dangerous and disabling. It is a sudden loss
of consciousness that occurs when the blood pressure drops and not enough
oxygen reaches the brain. The episode can last for a brief amount of time
(usually a few seconds) and may look like a seizure. Syncope is difficult to
diagnose and thousands of pounds can be spent evaluating a patient with
syncope only to result in a series of negative test results and a patient who
continues to faint.
The estimated incidence of self-repor ted syncope is 6.2 per 1,000 person years in
the Framingham study. The overall incidence is approximately 3–6% over 10 years,
and in a select group of patients, the prevalence of syncope could reach almost 50%.
Of all syncopes, 10% are neurological and 28% cardiac in origin (4% organic hear t
disease and 14% arrhythmias).
Syncope is a symptom, not a disease. While some causes of fainting are benign,
others can be serious. Thus use of the term ‘fainting’ must never be taken to assume
a benign event – all ‘faints’ warrant careful clinical evaluation. Hear t-related causes
of syncope can be among the most serious and include different types of abnormal
hear t rhythms (also known as arrhythmias).
•
Impor tance of Diagnosis: The initial objective of management is to
distinguish between benign and life threatening causes of syncope.
•
Syncope and Mor tality: The incidence of death for syncope of a non-cardiac
cause is less than 5%. However, patients with cardiac syncope have a
poorer prognosis than other forms of syncope and cardiac syncope can
result in sudden death, up to 33% at 1 year. With early diagnosis the
underlying cause is often treatable. Early identification of cardiac causes
of syncope is therefore impor tant in order that treatment can be initiated.
•
Syncope and Falls: 30% of people over 65 living alone will fall each
year and between 2-6% of falls result in fractures. It is estimated that
falls cost the NHS over £1bn each year. It is estimated that 5% of
falls occur in older people as a result of syncope (NSF Older People).
•
Syncope Guidelines
The following guidelines and national targets cover the diagnosis of syncope:
•
NSF CHD: Chapter 8 Arrhy thmia and Sudden Cardiac Death Quality
requirement 2 of the NSF emphasises the need to create an effective
and lean diagnostic pathway for patients presenting with syncope.
•
NSF Older People Standard 6 highlights the need to create an effective
and treatment diagnostic pathway for syncope in order to prevent falls.
•
National Standards, Local Action It is stated that by 2008 no-one
should wait more than 18 weeks from GP referral to hospital treatment.
However, up to one half of syncopes are infrequent and remain
unexplained using conventional tests. The result is that the national 18
week waiting target can not be achieved for a large propor tion of patients.
Indications
Guidelines describe the following indications for implantable loop recorders:
•
ESC: Class 1 indication for ILR. ILR Monitoring is indicated in an early phase
of evaluation in patients with recurrent syncope of uncer tain origin with a
recurrence frequency ≥ 4 weeks head of Holter monitoring and tilt table testing.
•
18 Week Guidance, ILR’s are directly mentioned as a technology enabler
to be used in achieving the 18 week guidance for TLoC (Syncope).
•
Patients indicated for ambulatory ECG with infrequent symptoms - ACC/AHA.
•
To assess the contribution of bradycardia, before embarking on cardiac pacing,
in patients with suspected or cer tain neurally mediated syncope presenting
with frequent or traumatic syncopal episodes. Class II evidence – ESC.
•
Any severe syncope i.e. very frequent and affecting quality of life OR recurrent
and unpredictable, predisposing the patient to trauma or risk from activities
such as driving, machine operation and spor t. (Multiple publications/
guidelines).
Diagnostic Yield and Clinical Effectiveness of ILRs
•
Syncope is by na ture per iodic, unpredic table and may have a
diversity of underlying causes. Conventional diagnos tic pathways
may var y according to the speciality of f irs t referral (cardiology,
neurology etc) resulting in often protracted and excessive investigation.
•
Published data indicate that ILRs have a relatively high diagnostic
yield compared to conventional inves tiga tive pa thways. From
reviewing the currently available literature the diagnostic yield for
the ILR was 43%-82% compared to 20% with conventional testing.
•
Several s tudies have demons tra ted the ef fec tiveness of ILR in
detecting potentially fatal cardiac conditions in patients mis-diagnosed
with epilepsy, or concomitant with a diagnosis of epilepsy. ILR has
also been shown ef fective in identif ying the cause of previously
undiagnosed syncope in both young and elderly patient groups.
Health Economics
Based on an assumption from published work that 28% of patients with unexplained
syncope have an indication for ILR, the need for ILR implantation is 130 implants
per million population per year. The currently available ILR devices in the UK cost
approximately £1,550. However, numerous published studies have indicated that
ILRs:
•
Cost less per diagnosis than conventional testing.
•
Deliver savings against ongoing investigations and possibly overall
hospitalisation costs.
•
Reduce the cost of unnecessary work up.
•
Reduce the cost of unnecessary treatment for epilepsy.
•
Reduce the cost of falls by older people.
•
Reduce the cost of injury caused by undiagnosed syncope.
Manpower implications
ILRs are implanted by a simple procedure taking only a few minutes and are both
quick and simple to interrogate; efficiency can be optimised by using the remote
capabilities of some ILR’s. Manpower implications are negligible for any existing
cardiac service.
Key recommendations for Commissioners
•
ILRs are demonstrated to result in shor ter waits to treatment and
resolution of symptoms, reduced risk of falls, reduced risk from misdiagnosis and unnecessar y treatment, reduced number of steps in
the diagnostic work up and reduced risk of sudden cardiac death.
•
ILRs can result in improvement in per formance against the 18 week
waiting target, compliance with National Ser vice Frameworks for
Coronar y Hear t Disease and Older People, improved treatment
outcomes (as a result of improved patient selection), improvement in
performance against health gain targets (extended life expectancy and
reduced mor tality), increased capacity in the cardiac catheter laboratory,
compliance with national standards on clinical and cost effectiveness,
more efficient diagnostic pathways and savings on inappropriate drugs.
7. REMOTE MONITORING
What is Remote Monitoring?
Introduction
Implantation of a device is only the star t of a patient’s investigation or treatment.
Follow-up is an integral par t of this process and is required to maintain patient safety
and optimise device performance. Device follow-up has become increasingly complex
and time-consuming with the increasing numbers and functionality of implanted
systems.
The concept of “Telemedicine” is not new and is recognised in The NHS Improvement
Plan and in the Depar tment of Health’s Information for Health strategy as an
impor tant par t of the development of electronic health records and the fast and
convenient access to care through on-line services. The technology for the remote
monitoring of patients with implanted devices has developed rapidly in recent years
and will develop fur ther in the near future. Current technology allows not only
increased time efficiency for patients and NHS staff, but a paradigm shift in device
follow-up: We are now able to move from regular clinic attendance to frequent
unobtrusive device and patient disease monitoring. This will allow us for the first time
to see patients only when they need to be seen and to intervene before the onset of
symptoms to prevent clinical decompensation (sudden development of severe hear t
failure) and emergency hospital admissions.
If we are to achieve the goal of improving access to evidence-based and NICEapproved CRM device therapy in the UK, it is essential that the development and
implementation of these telemedicine services is encouraged and financially suppor ted
within the NHS.
Follow-up of implanted devices
Device follow-up practice has developed over many years. In the UK, usual practice
is to follow-up patients with pacemakers soon after implant then annually until they
are nearing the end of battery life, and defibrillator and CRT patients six monthly. A
new generation of implanted hear t rhythm and haemodynamic monitors are now
available which can be incorporated into a rhythm management device or implanted
separately where indicated.
Conventional device follow-up is per formed in a booked out-patient clinic,
interrogating the device using radio-frequency telemetry (shown below). Most clinic
visits are scheduled and do not result in changes in clinical care. Most unscheduled
visits occur when the patient has symptoms which could be attributable to device
malfunction.
Remote monitoring of implanted devices
Remote device monitoring has a long history in the USA: large geographical distances
led to the development of trans-telephonic monitoring with the transmission of very
limited ECG and pacemaker battery information over standard telephone lines. In
recent years, this technology has developed to more sophisticated telemetry with
on- or off-line analysis. This has the advantage that patient travelling is reduced,
clinic time is reduced and patients can transmit data at a time convenient for them
allowing data to be reviewed off-line in a “vir tual clinic” at an efficient time. This
process requires the patient to initiate the remote follow-up either because of
symptoms or on a planned date.
The next technological development is automatic monitoring – the device wirelessly
up-loads data to a monitor either routinely (e.g. each night) or as soon as a
problem is detected. The clinical team have access to these data at any time but
are specifically aler ted by any data outside pre-specified limits.This has a number of
immediate advantages and has the capacity to change the paradigm of follow-up
– from monitoring the device to monitoring the patient. Studies with this technology
have shown significantly earlier detection of not only device problems but the onset
of arrhythmias such as atrial fibrillation, allowing early initiation of hear t rate control
and anticoagulation, thereby reducing subsequent admissions with hear t failure
or stroke. Hear t failure devices (CRT-P and CRT-D) are now available which can
monitor patients’ activity, fluid status and/or haemodynamic parameters allowing
early intervention in hear t failure and reducing emergency admissions. There are
also new implantable devices for patients without rhythm management indications
which can monitor these parameters in the same way. The data available suggest
that patients prefer routine remote monitoring with visits to the clinic limited to the
occurrence of clinical or device problems.
At present, there is no commercially available system which allows remote reprogramming of devices. However, the technology exists to do this and safety
evaluations are underway. This has the potential
to reduce in-clinic follow-up fur ther by limiting it
to wound and other physical problems.
Indications
This technology is applicable to all new
and many alread y implanted devices
al t h o u g h w ir e l e s s co m m u ni ca t i o n i s
possible only with wire-less-enabled models.
The patients with most to gain are those whose visits can be reduced to “as required”.
For example, an elderly immobile patient living far from the clinic with a pacemaker
implanted for bradycardia, and those who would benefit from closer monitoring
e.g. a hear t failure bi-ventricular defibrillator (CRT-D) patient with difficult to control
symptoms or frequent arrhythmias. Other patient groups with clear benefit are
younger working patients where taking time off work is problematic and older
patients who need either ambulance transpor t or transpor t from a relative to
attend the clinic.
Advantages
of Remote Monitoring
Disadvantages
Reduced number of clinic
attendances without reduction
in monitoring (patient safety)
Unable to review wound –
not appropriate for 1st
follow-up appointment
after intervention
Reduced routine follow-up time
(routine remote follow-up can
be achieved in approximately
1/3 the time of conventional
clinic follow-up).
No remote programming
possible (at present)
Reduced patient travel time
and costs
Limited data review (at
present)
Reduced patient waiting time
Increased patient/device
monitoring possible when
indicated
Earlier detection of device
malfunction or disease states
e.g. atrial fibrillation allowing
early treatment to avoid
emergency hospital admission
and long-term morbidity
Health economics
The UK has a chronic shor tage of highly trained cardiac physiologists capable of
complex device follow-up. Remote monitoring has the potential to use their time more
efficiently. Each of these remote monitoring systems has the potential to improve the
efficiency of device follow-up – reducing follow-up in those who do not require it and
thereby allowing increased follow-up of patients who will benefit in safety, symptoms
and reduced emergency hospital admissions.
Cost effectiveness analyses have been performed (Fauchier, 2005) and there is an
on-going multi-centre cost-effectiveness study (EuroEco) which should provide fur ther
European data in the next two years. Exact cost modelling is limited by its sensitivity
to the different financial models used by the manufacturers. Some are currently
charging a monthly fee per device but manufacturers are moving towards building
the cost in to the purchase price of the device.
The development of remote device follow-up requires an appropriate tariff. In the UK,
follow-up is performed almost exclusively by highly trained NHS cardiac physiologists
suppor ted by cardiologists (electrophysiologists). The service is currently funded by
the cardiology follow-up the outpatient tariff - £82 for adult clinic follow-up visits.
Scheduled periodic follow-ups performed remotely will therefore attract the same
cardiology outpatient tariff as conventional in-clinic follow-up and no significant cost
changes would be anticipated – an additional tariff would not be charged if the
remote follow-up showed the need for a physical clinic attendance. Unscheduled
follow-up would attract a standard tariff as at present. Patients under continuous or
continual (daily) monitoring will undergo formal data review at conventional intervals
incurring a payment equivalent to conventional follow-up schedule of the device (e.g.
annual for bradycardia pacemakers = £82pa, 6 monthly for ICDs/CRT = £164pa)
with additional follow-up requiring action charged as an additional follow-up tariff
(£82). This, again, will be broadly cost-neutral.
Disease management – the anticipation of patient decompensation by remote
monitoring from an implanted CRM or monitoring-only device – has the potential
to avoid emergency admissions. This will improve patient safety and reduce costs
to the NHS.
Manpower implications
There is a severe shor tage of appropriately trained physiologists in the UK. There
are active training programmes but because of the considerable time required, it is
not possible for these to produce sufficient physiologists in the next few years.
Remote follow-up has the potential to allow physiologists and cardiologists to use
the time available for follow-up more eff iciently and f lexibly, reviewing patient
records faster and at an efficient time which does not need to be pre-arranged.
More impor tantly, it has the capacity to focus the most highly trained physiologists’
follow-up capacity on patients with problems while the automatic nature of data
review in other patients may allow others to review patient and device data safely
and efficiently.
Remote monitoring is therefore an essential component of the delivery of evidencebased, NICE-approved device therapy in the NHS for the UK.
Key recommendations for commissioners
•
Remote device follow-up is an impor tant new technology which has the
potential to improve patient care and safety while at the same time increasing
the efficiency of device services without significant additional cost. It also allows
a paradigm shift from device follow-up to disease monitoring – facilitating
early interventions which prevent decompensation and emergency hospital
admission.
•
Adoption of this technology is essential to the delivery of improved
CRM device ser vices in the UK which would other wise be limited
by the low numbers of appropriately trained cardiac physiologists.
•
We recommend that adoption of these technologies should be suppor ted
by the cardiology out-patient PbR tariff. This is expected to be broadly cost
neutral although it must be recognised that as the number and complexity of
devices increases, the overall number of follow-up appointments will continue
to rise.
Endorsed by
www.heartrhythmcharity.org.uk
Registered Charity No. 1107496 ©2007
Arrhythmia Alliance
PO Box 3697 Stratford upon Avon
Warwickshire CV37 8YL
Tel: 01789 450 787
e-mail: [email protected]
www.heartrhythmcharity.org.uk
Please remember these are general guidelines and individuals
should always discuss their condition with their own doctor.
Published 2009