Date of Meeting: Ratified Date: 11/03/2010

Transcription

1 Document Type: GUIDELINE Unique Identifier: CORP/GUID/086 Title: Implantable Cardioverter Defibrillator (ICD) Scope: Lancashire and Cumbria Cardiac and Stroke Network Lancashire and Cumbria wide Author/Originator and Title: Lauren Butler sevice development and improvement manager Angelic Delaney pacing and ICD manager `Replaces: Version 1, Implantable Cardioverter Defibrillator (ICD) Reprogramming Guidelines CORP/GUID/086 Description of amendments: Version Number: 2 Status: Ratified Classification: Organisational Responsibility: Cardiac Network Name of Committee: Divisional/Directorate/ Working Group: Cardiac Network Heart Failure Group Date of Meeting: 17/03/2010 Validated by: Sally Chisholm, Cardiac Network Programme Director Risk Assessment: Not Applicable Financial Implications Not Applicable Validation Date: March 2010 Ratified by: Clinical Governance Committee Review Dates: Review dates may alter if any significant changes are made Ratified Date: 11/03/2010 Date of Issue: 11/03/2010 Review Date: 01/03/ Does this document meet with the Race Relation Amendment Act (2000) Religious Discrimination Act, Age Discrimination Act, Disability Discrimination Act and Gender Equality Regulations? Not Applicable

2 1 PURPOSE To provide guidance to medical and clinical staff in acute and primary care trusts who are responsible for the management of patients in whom an Implantable Cardioverter Defibrillator has been implanted. This guidance outlines the situations in which reprogramming or withdrawal of Implantable Cardioverter Defibrillator therapy is required, the procedures to follow, personnel to contact and service availability is held within the guidance. 2 SCOPE Acute and Primary Care Trusts within Lancashire and Cumbria. These guidelines may also be valuable to staff working in the private sector including funeral homes, nursing homes and hospices. 3 GUIDELINE Clinical Requirement The clinical requirement for reprogramming an Implantable Cardioverter Defibrillator (ICD) should assess the clinical status of patients, underlying cardiac rhythm and whether detection and therapy is required or not and, if ICD therapy is delivered, whether it is appropriate. The clinical requirements include the following: (1) Routine reprogramming for optimisation of device settings (2) Switch off (withdrawal of therapy) during routine surgery/treatment (3) Switch off (withdrawal of therapy) device due to death of patient (4) Switch off (withdrawal of therapy) device due to end stage heart failure (5) Emergency reprogramming of detection or therapy parameters due to Ventricular Tachycardia (VT) (6) Emergency reprogramming/application of magnet during emergency surgery If the patient has an episode of Ventricular Fibrillation (VF) and the device fails to deliver therapy or if the shock therapy fails, immediate external Direct Current (DC) defibrillation should be delivered and this does not fall within the remit of this guidance. Routine Reprogramming For Optimisation of Device Settings This includes all reprogramming undertaken as part of follow up at ICD clinic which assesses therapies delivered, effectiveness of therapy, symptoms during arrhythmia and therapies and haemodynamic status of patient in relation to both ICD therapies and pacing modalities. Patients requiring follow up to assess ICD function and settings access the ICD clinic at the Lancashire Cardiac Centre. Clinics are held Monday to Friday, 9.00 am to 5 pm by pre-arranged appointment with the Cardiac Physiology Pacing Team. Contact details Lancashire Cardiac Centre Pacing Manager - Angelic Delaney Page 2 of 10

3 Once devolvement of ICD follow up to District General Hospitals occurs, routine reprogramming may take place at district general hospital level. Switch Off (Withdrawal of Therapy) During Routine Surgery/Treatment This involves programming the device to prevent detection of all incoming signals to the device. This ensures any noise entering the device from diathermy etc may not be considered an arrhythmia and prevents inappropriate shocks and collection of inappropriate data. However this does prevent the device from delivering any therapies and the device is effectively switched off. If during surgery the patient requires a shock due to an arrhythmia, the clinical condition and haemodynamic status of the patient should be considered and emergency external DC defibrillation delivered if required. If the patient is stable during the arrhythmia, consideration should be given to programming the device and allowing shocks/therapy to be delivered by the device itself. Reactivation of the device and the time taken for the cardiac physiologist to return to reprogram the device should be taken into consideration when scheduling any routine surgery/treatment. Reprogramming to original settings should take place as soon as possible post op. The Cardiac Physiologist at each District General Hospital should be contacted to perform the programming procedure and are currently available 9am 5pm Monday to Friday. As much notice as possible should be given to the Cardiac Physiology team when scheduling treatment preferably through pre-admission. Should you require support out or hours contact the local DGH cardiologist/physician on call. Contact details can be found at the end of this document. Switch Off (Withdrawal Of Therapy) Of Device Due To Death Of Patient When a patient dies with an active ICD the Specialist Cardiac Physiologist at each acute trust needs to be informed as the device requires deactivation before removal of the device by mortuary or undertaker staff. Relatives should be made aware that cremation is not possible with an ICD in situ. ICDs should always be deactivated in the event of the patient s death, as towards battery end of life it will emit an audible bleep every day. Switch Off (Withdrawal Of Therapy) Of Device Due End Stage Heart Failure Defibrillators are increasingly commonplace in the care of heart failure especially those combined with cardiac resynchronisation therapy pacing (CRT). Withdrawal or deactivating implantable defibrillators can be difficult for patients and their relatives and should be addressed on an individual patient basis. Patients often report a perceived dependence on the device. Not all deaths from heart failure result in tachyarrhythmia as final mode of death. Principles: Eventual withdrawal of ICD therapy should be discussed prior to initial implant, in all ICD recipients with heart failure. Patient information should be provided regarding the device activity, its function and its withdrawal prior to implantation. It is appropriate but not always essential to deactivate ICDs in patients with end stage heart failure. Page 3 of 10

4 ICD patients should be encouraged to express their concerns especially in relation to their mode of death and shocks. Where the focus of care is more terminal, it should be explained: Deactivation of their ICD device does not mean that they will die imminently. The ICD may have been of value in prolonging their life in the past, it may no longer be in their best interest for them to receive painful and often traumatic shocks. Pacing functions including CRT should be left active with tachyarrhythmia therapies turned off. Should the patient change their mind at any stage re-activation can easily be performed. When anti-arrhythmic medical therapy is being withdrawn, patients should be aware that device activation is more likely and they may consider switching off shock therapy. Deactivation of the device in the community setting is problematic, it should be considered and discussed at the same time as do not resuscitate decisions are made; and ideally discussed if being discharged from hospital to palliative community care it is incompatible that a patient should have a active ICD but otherwise be not for resuscitation. The specialist cardiac physiologists and specialist nursing staff should be liaised with when deactivation is being considered. Immediate intervention from the Cardiac Physiologist may not be available and a suitable time convenient to all involved should be agreed within working hours. The Cardiac Physiologist at each District General Hospital should be contacted to perform the programming procedure and are currently available 9am 5pm Monday to Friday. As much notice as possible should be given to the Cardiac Physiology team. Emergency Reprogramming Of Detection or Therapy Parameters Due To Ventricular Tachycardia Clinical consideration should be given to the clinical and haemodynamic status of the patient and if emergency external defibrillation is required, this should be delivered. For patients with stable, incessant VT (VT storm) the device may be triggered to deliver multiple shocks, which may be ineffective and painful for the patient. Programming the device to inhibit delivery of shocks should be undertaken and medical management of the arrhythmia commenced. Initially, application of a magnet will deactivate the device temporarily until programming can take place and should only be used by emergency personnel. For patients with stable VT where the device is failing to deliver therapy, programming to ensure detection and termination of the arrhythmia should be undertaken under the guidance of consultant cardiologists. Referral to the tertiary centre may be required. The Cardiac Physiologist at each District General Hospital should be contacted to perform the programming procedure and are currently available 9am 5pm Monday to Friday. As much notice as possible should be given to the Cardiac Physiology team when scheduling treatment preferably through pre-admission. Page 4 of 10

5 Emergency Reprogramming/Application Of Magnet To Suspend Therapy During Emergency Surgery As recommended in the associated document Guidelines for the perioperative management of patients with implantable pacemakers or implantable cardioverter defibrillators, where the use of surgical diathermy/electrocautery is anticipated. (March 2006), it is recommended that if the ICD device cannot be programmed by available personnel, e.g. out of hours, then application of a magnet over the device will temporarily deactivate the device. In the event that the device is programmed to be unresponsive to magnet application, a follow up ICD check should be performed as soon as possible. The Cardiac Physiologist at each District General Hospital should be contacted to perform the programming procedure and are currently available 9am 5pm Monday to Friday. As much notice as possible should be given to the CP team when scheduling treatment preferably through pre-admission. Documentation Clear documentation of programming undertaken by the Cardiac Physiologist should be documented in any medical notes, heart failure notes, patient held records, GP notes or deactivation forms if available. All records available at the time should have an entry of the procedure undertaken and should be signed by the Cardiac Physiologist and accompanying health care professional. Lone working The Cardiac Physiologist should ensure another healthcare professional is present when attending a patient s home. Ideally this should be someone who knows the patient and should be discussed and arranged with the personnel requesting the programming procedure. Medical consent Agreement for the withdrawal of ICD device therapy has to be obtained from a clinician treating the patient, Consultant or General Practitioner. It is recommended that discussion with the Acute Trust Cardiologist be obtained if possible prior to deactivation. Tertiary Centre Support & Communication Support will always be available at the tertiary centre if any issues arise or if any follow up checks are required at the times listed. For all emergency out of hours care, the clinician at the District General Hospital should call the on-call cardiology registrar at Lancashire Cardiac Centre for advice/discussion regarding emergency transfer of the patient if required. Arrangements with the on-call cardiac physiologist at Lancashire Cardiac Centre will then be made. As recommended in the associated document Guidelines for the perioperative management of patients with implantable pacemakers or implantable cardioverter defibrillators, where the use of surgical diathermy/electrocautery is anticipated. (March 2006), it is recommended Page 5 of 10

6 that if the ICD device cannot be programmed by available personnel, e.g. out of hours, then application of a magnet over the device will temporarily deactivate the device. In the event that the device is programmed to be unresponsive to magnet application, a follow up ICD check should be performed as soon as possible. Any changes made to implanted devices in the District General Hospital setting should be communicated to the Cardiac Physiology team at the tertiary centre. 4 ATTACHMENTS. Appendix 1 ICD Re Programming Guidelines, Contact Details 5 ELECTRONIC AND MANUAL RECORDING OF INFORMATION. Database for Policies, Procedures, Protocols and Guidelines Archive/Policy Co-ordinators office Archived at: Lancashire & Cumbria Cardiac and Stroke Network office, Room 176 Preston Business Centre, Watling Street Road, Preston PR2 8DY or via the Cardiac Network website 6 LOCATIONS THIS DOCUMENT ISSUED TO. Copy No Location Date Issued 1 Intranet 11/03/ Wards and departments 11/03/ OTHER RELEVANT /ASSOCIATED DOCUMENTS. Procedure No. Title Symptom Control Guidelines For Patients With End-Stage Heart Failure (March 2007) Blackpool Guidelines for the perioperative management of patients with implantable pacemakers or implantable cardioverter defibrillators, where the use of surgical diathermy/electrocautery is anticipated. (March 2006) British Heart Foundation Implantable cardioverter defibrillators in patients who are reaching the end of life (July 2007) East Lancashire End Stage HF Guidelines (2007) Website: and click on guidelines 9. CONSULTATION WITH STAFF AND PATIENTS Name N/A Designation Page 6 of 10

7 10. DEFINITIONS/GLOSSARY OF TERMS NAME DEFINITION N/A 11. AUTHOR/DIVISIONAL/DIRECTORATE MANAGER APPROVAL Issued By Job Title Lauren Butler Service Development and Improvement Manager Checked By Job Title Sally Chisholm Cardiac Network Programme Director Signature Signature Date March 2010 Date March 2010 Page 7 of 10

8 APPENDIX 1 ICD Re Programming Guidelines, Contact Details Acute Trust LCC ELHT LTH UHMBT Acute Trust Cardiac Physiologist Angelic Delaney Tracy Doherty Sarah Place Kay Smith Acute Trust Heart Failure Nurses Lesley Hutt Angela Graves Anna Adam None Page 8 of 10

9 PCT NHS BwD NHS Blackpool NHS Central Lancs NHS Cumbria (South) NHS East Lancs NHS North Lancs Acute Trust Cardiac Physiologist Tracy Doherty Angelic Delaney Sarah Place Kay Smith Tracy Doherty Angelic Delaney Kay Smith Heart Failure Nurses/Community Matrons Michaela Toms Angela Graves Sara Fisher Sara Trow Mandy Banks Sarah Gohil Chris Nicholson None Angela Graves Sue Leveridge/Robert Sharkey Kathy Clowes Page 9 of 10

10 Out of Hours (Lancashire Cardiac Centre): On call SpR Out of Network contact details for patients who had the device implanted at other tertiary centres and if information regarding manufacturer and model of device is required please contact:- Wythenshawe hospital, Manchester Monday - Friday 9am - 5pm Pacing/ICD Physiologists: ICD Nurse Specialists: Out of hours (Clinical Emergency only) On-call Cardiology SpR: Manchester Royal Infirmary Monday Friday 8.30am-5pm Ros Hirst (ros.hirst@cmmc.nhs.uk) Karen Toombs /7900 Out of hours CCU: CTC, Liverpool Monday Friday 9am - 5pm Sue Hughes Sandra Bellchambers Out of hours CCU: Pacing/EP SpR Leeds General Infirmary Monday Friday 9am 5pm Ann Nicholls or page 6389 via switch ( ) Out of hours CCU: Page 10 of 10