Proposed Protocol For The Shared Care Management Of Patients With
Implantable Cardiac Defibrillators (ICDs) And Cardiac Resynchronisation
Therapy (CRT) Devices Between Implanting And Non-Implanting Centres
Shared Care: Background
The continuing evolution of device technology has resulted in the production of a
range of devices capable of treating bradycardia, complex cardiac tachyarrhythmias,
and heart failure management. These devices have multiple modalities and
programmable features. The challenge of these treatments lies not only in the
implantation of the devices but also in comprehensive follow-up of the implanted
device as part of the lifelong management of the patient. As the number and variety
of implanted devices increase so does the burden of follow-up and the knowledge
required to optimise and troubleshoot their use. This is compounded by the
increasing volume of data provided by devices and the increasing sophistication of
programming therapy and detection algorithms. As a result of this increasing
complexity, inappropriate or incorrect use of these algorithms or other errors with
aspects of device programming may result in serious harm to the patient.
There are currently two principle implanting centres of ICD/CRT devices within the
North of England CardioVascular Network (NECVN), James Cook University
Hospital in Middlesbrough and Freeman Hospital in Newcastle-upon-Tyne.
Patients receive their ICD/CRT device follow-up via the implanting centre, by a
combination of direct contact and remote monitoring. Device follow-up remains the
clinical responsibility of the consultant cardiologist in charge of the device follow-up
service – although it is typically a cardiac physiologist run service. Cardiologists
providing such a service must have the required knowledge to do so. Ideally current
holders of (or working towards) a recognised pacing qualification such as certificate
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 1
of accreditation with Heart Rhythm UK (previously BPEG exam), European Heart
Rhythm Association (EHRA) or International Board of Heart Rhythm Examiners
(IBHRE, formerly North American Society of Pacing and Electrophysiology
Examination (NASPExAM)).
Most patients with a high energy device also have significant structural heart
disease, primarily heart failure. These patients are generally managed by the local
cardiology team and it is to their local hospital that they are likely to be admitted.
Separating device follow-up from the rest of these patients’ care can cause problems
for optimum care.
However, the device follow-up can be in isolation of the patient’s clinical cardiology
follow-up which remains with their local secondary or primary care provider. As
such, the proposal is to develop an agreed shared care pathway for patients
following ICD/CRT device implant, to receive their device follow-up at their preferred
hospital site, ideally integrated with any on-going clinical follow-up.
This document addresses the issue of patients undergoing device implantation at
one centre with subsequent repatriation for device follow up. The document should
be read in conjunction with Heart Rhythm UK “Standards for implantation and followup of cardiac rhythm management devices in adults,” January 2013 and in particular
section 7.2.3 - Additional requirements for ICD and CRT follow up (appendix 2).
The requirements for centres which both implant and follow up complex devices are
more extensive and are not covered by this document.
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 2
Aims of Shared Care in Patients with Implantable Devices

To provide out-patient care for patients with ICD and CRT devices to
nationally agreed standards. To minimise the need for patients to travel
excessively to access follow-up services.

To improve local expertise and community support.

Offer referral to supporting services (on site or in neighbouring centres):
including electrophysiology studies and catheter ablation, heart failure
management, percutaneous and surgical revascularisation and psychological
support.

Provide rolling audit and submission of data to CCAD/NICOR (it is the
responsibility of the follow up centre to record and submit 12 month post –
implant complication data to CCAD/NICOR).

Facilitate access to patient support groups.

Improve education of device indications within the local health care
community.
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 3
Scope
Agree a process for ensuring patients receive the highest quality of clinical care
following ICD/CRT implantation that is convenient for the patient and their
family/carers and ensures they remain within an integrated care management
pathway. It is envisaged that the decision regarding repatriation / shared care be
made at the first scheduled follow up visit post device implantation.
This process will include:
1. Multidisciplinary outpatient management – integrated heart failure (HF)
services and device services. This should include clearly defined links with
arrhythmia and heart failure specialist nurses. Specific problems to be
discussed with and/or referred to the implanting centres are outlined in
appendix 1.
2. Lines of clinical responsibility must be clearly defined within local trust policy.
All trusts delivering device follow-up services have a responsibility to ensure
appropriate arrangements are in place to cover clinic activity.
3. There must be arrangements in place for 24 hour, 7 days a week emergency
service to deal with patients admitted with multiple shock delivery, nondelivery of appropriate therapy or other device related issues. This is
particularly important for ICD patients where device-related and arrhythmic
complications occur frequently and can be life-threatening. Emergency care
arrangements need to be in line with recommendations as per the Heart
Rhythm UK “Standards for implantation and follow-up of cardiac rhythm
management devices in adults,” January 2013
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 4
4. Community care – liaising with community HF nurses, GPs and palliative care
teams to ensure device management is delivered at appropriate times and in
appropriate localities for the patient in line with Heart Rhythm UK document
“Standards for Implantation and Follow-Up of Cardiac Rhythm Management
Devices in Adults,” January 2013.
5. There must be a clearly defined protocol documenting the lines of
communication and support between the lead cardiac physiologist for the nonimplanting follow-up service and the consultant cardiologist (with specialist
interest in cardiac devices) responsible for the onsite service to ensure that
clinical governance requirements are met. The lead cardiac physiologist for
device follow-up services at non-implanting hospitals must also have strong
links with the lead cardiac physiologist and named consultant cardiologist at
the implant centre.
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 5
Outpatient Clinics
Organisation
Device implantation is only the start of treatment.
Patients with cardiac rhythm
management devices require life-long follow-up with specialised medical and
technical expertise and equipment.
Specialist cardiac physiologists running/supervising device follow-up clinics must
hold appropriately recognised accreditation (Heart Rhythm UK, IBHRE or EHRA).
The follow-up centre must have on-site cardiologists with sub-speciality interest in
implantable cardiac devices. Clinics should be run in accordance with published
Heart Rhythm UK document “Standards for Implantation and Follow-Up of Cardiac
Rhythm Management Devices in Adults” January 2013.
Device clinics should operate in an appropriate clinical environment with access to
full range of device programmers. The clinic should be manned with two staff, one of
who meets the lead role competencies.
The second staff member can be
undergoing training.
Follow-up should be performed at nationally accepted intervals. Patients should
have urgent follow-up if they report symptoms which may be associated with their
device. Access for rapid referral of any patient needing urgent admission should also
be available.
As outlined by Heart Rhythm UK document “Standards for Implantation and FollowUp of Cardiac Rhythm Management Devices in Adults” January 2013 the criteria to
be met by the Lead Cardiac Physiologist (CP) include:
•
A qualified cardiac physiologist (BSc Clinical Physiology or equivalent)
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 6
•
Evidence
of
post-graduate
training
in
cardiac
rhythm
management
techniques, e.g. holds appropriate Certification of Accreditation Heart Rhythm
UK, EHRA or IBHRE
•
Hold current ILS or ALS accreditation
•
Evidence of Continual Professional Development (CPD) in cardiac rhythm
management. All physiologists must undertake appropriate CPD in ICD/CRT
therapy including implications for driving.
•
Perform minimum of 150 ICD/CRT device system follow-up review
procedures per year.
•
Attend local implant centre regularly (to witness device implantation) and not
less than twice per annum to remain familiar with evolving technology (CPs
leading follow-up clinic at non implant hospitals).
•
Demonstrate high level of understanding and knowledge of the full range of
diagnostic cardiac investigations
In-clinic follow-up should include:
•
Wound review
•
Recorded patient rhythm data (including atrial fibrillation or ventricular
arrhythmias which may require medical input)
•
Device checks – battery, lead impedance, pacing thresholds, sensitivity
•
Access to specialised echocardiography services for CRT optimisation when
required
•
Access to specialised electrophysiology services for management of atrial and
ventricular arrhythmias when required
•
Psychological support and early identification of distress
•
Communication with cardiologists, heart failure team and general practitioners
as indicated
•
Given the complexity of high-voltage devices and the potential for patient risk
in the event of malfunction, remote monitoring should be considered the
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 7
standard of care in the UK and should be available to all services providing
ICD/CRT-D follow-up
An agreed process for highlighting device interactions, change in rhythm/pacing
status and alteration in clinical and symptomatic status must be available to staff
running the clinics to ensure clinicians are aware and enable to initiate management
changes.
A copy of the report or a letter is sent to the patient’s general practitioner and the
patients named cardiologist where appropriate.
A copy of the report and any
information such as programming changes should also be given to the patient if
desired. The implant centre need only be contacted when seeking additional advice
or when making a referral to the implanting physician.
Remote monitoring should be offered to patients to ensure alerts or alterations in
device status are rapidly identified and arrangements made for patients to be seen if
appropriate.
End of Patient Life Management
Device implantation and follow up centres are strongly encouraged to follow a local
policy for the management of end of patient life.
Device therapy termination should be a consensus between the clinician with clinical
responsibility for the patient (e.g. cardiologist, elderly care physician, general
practitioner), device physiologist, the patient and where possible representative for
the patient (e.g. a relative).
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 8
Different levels of device therapy termination should be considered specific to the
individual case and informed consent must be documented as outlined in the
NECVN device deactivation policy.
Investigations
Access to cardiac physiology testing to include echocardiography must be available
along with clinic access to radiology for CXR as appropriate. It is preferable to have
an assessment protocol in place for CRT non-responders.
Communication
Communication pathways with community CHD/HF teams, palliative care teams,
rehabilitation and psychological support must be established if not already in place.
Communication with the implanting centres in case of wound problems, device
problems requiring intervention or general clinical advice must be maintained (see
appendix 1).
Process
Following ICD/CRT implantation, patient returns to the implanting centre for 4-6
week wound review and assessment of any early device complications. If no further
intervention or clinical follow-up is planned at the implanting centre at that point all
patients should then be offered local follow-up of their ICD/CRT devices in
conjunction with their medical follow-up. Existing patients should also be offered
follow-up at their geographically closest follow-up centre.
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 9
Ultimately the decision of where ongoing device follow up takes place is the
patient’s
decision
and
this
should
be
respected
and
appropriately
documented.
Implanting centres should have a list of local ICD/CRT follow-up centres that have
met the Heart Rhythm UK standards for device follow-up (NECVN benchmark
assessment).
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 10
Appendix 1:
Specific Problems to be Discussed with or Referred to the
implanting Centres
ICDs
Lead alerts and MHRA recommendation for lead screening e.g. Riata Leads
Lead extraction
Patients presenting with VT storm
CRT
Issues with LV lead: high thresholds, phrenic stimulation, consideration for transseptal LV lead or epicardial LV lead
AF patients: Protocol for AV node ablation
Device Upgrades/Revisions
These should be discussed with the implanting centre
Device Infections
All cases should be discussed with the implanting centre
The above problems could be discussed either in person or via a regular MDT. The
MDT process should not only include patients for consideration of implantation but
discussion of existing patients with device/rhythm related problems. It is essential
that there is wide participation at these forums from implanting and follow-up centres.
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 11
Appendix 2: Standards For Implantation And Follow-Up Of Cardiac Rhythm
Management Devices In Adults. Heart Rhythm UK, January 2013
Section 7.2.3 - Additional requirements for ICD and CRT follow up
http://heartrhythmuk.org.uk/standards
“There must be a clearly defined protocol documenting the lines of communication
and support between the lead physiologist for the ICD and CRT device follow up
service and the consultant cardiologist responsible for the on-site service to ensure
that clinical governance requirements are met. ICD and CRT follow-up clinics should
not be undertaken without a designated cardiologist available onsite.
There must be a 24 hour service available to deal with patients admitted with
multiple shock delivery, non-delivery of appropriate therapy or other device related
issues. This should consist of an appropriately trained cardiac physiologist (as
outlined in the above section) and an appropriately trained cardiologist, either on site
or with clearly defined, documented and agreed protocols with other implanting
centres.
The lines of clinical responsibility must be clearly defined in the local Trust policy.
Trusts delivering ICD and CRT device follow-up services have a responsibility to
ensure appropriate arrangements are in place to cover clinic activity (elective or
urgent).”
Andrew Turley, Consultant Cardiologist South Tees Hospitals, NHS Foundation Trust
Jane Curry, Consultant Cardiologist, County Durham and Darlington Acute Hospital NHS
Trust
Review Date: August 2017
Page 12