perioperative management of pacemakers, defibrillators and

Perioperative management of pacemakers, defibrillators and cardiac resynchronisation therapy devices Anaesthetic Guideline Reference Number: DDCAna01(16) Version Number: 3 Issue Date: 12/12/2018 of 20

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Perioperative management of pacemakers,

defibrillators and cardiac resynchronisation therapy devices Anaesthetic Guideline:

Lead Author: Dr Jon Watt, Consultant anaesthetist

Additional author(s) Dr Alan Fitchet, Consultant cardiologist

Dr Kathy Teale, Consultant Anaesthetist.

Gill Woods, Cardiac Physiologist

Division/ Department:: Anaesthetic department

Applies to: Salford Royal Care Organisation

Date approved: 01/12/2018

Expiry date: December 2021

Contents

Contents

Section Page

Click here for the document summary sheet: 2

1 What is the policy about? 3

2 Where will this document be used? 3

3 Why is this document important? 3

4 What is new in this version? 3

5 Clinical Guideline – perioperative management of pacemakers 4

5.1 Preoperative assessment 5

5.2 Antibradycardia devices – Pacemakers (PM) 6

5.3 Implanted Cardiac Defibrillator (ICD) 7

5.4 Cardiac Resynchronisation Therapy (CRT-P; CRT-D) 8

5.5 Emergency Surgery 9

6 Roles and responsibilities 11

7 Monitoring document effectiveness 11

8 Abbreviations and definitions 11

9 References and Supporting Documents 11

10 Document Control Information 12

11 Equality Impact Assessment (EqIA) screening tool 13

12 Appendices 15

Appendix 1 Poster 15

Appendix 2 Pacemaker Codes 16

Appendix 3 Device Check reports - interpretation 17

Compliance checklist for authors (last page of this template) – Authors must complete this checklist prior to submission for approval.

Group arrangements:

Salford Royal NHS Foundation Trust (SRFT)

Pennine Acute Hospitals NHS Trust (PAT)

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Document Summary Sheet

Group arrangements:

Salford Royal NHS Foundation Trust (SRFT)

Pennine Acute Hospitals NHS Trust (PAT)

1. EMI is unlikely to affect the device unless the EMI source is within 6” (15cm) of the device or leads. 2. EMI will not damage the device, leads or myocardium. 3. Altering device function with magnet is safer than reprogramming

a. Function will return within 2 sec of removing magnet, b. Reprogramming errors are avoided.

4. Only request CRI team to reprogram the device if the device cannot be accessed during surgery. 5. ICDs cannot harm surgeon or scrub team if activated during surgery.

Standard management for surgery

a. Avoid EMI if possible (eg use bipolar or harmonic diathermy) b. Place monopolar diathermy earth plate away from the device and leads c. Use short bursts (less than 4 sec) of EMI source d. PM and CRT-P: Do not alter device settings, observe for EMI (inhibition or tracking)

i. Inform Surgeon if EMI occurs ii. Consider Magnet if EMI compromises CVS function. Caution with CRT-P

e. ICD and CRT-D: suggest turn off Defibrillator by securely sticking Magnet over device i. If VT or VF occur, remove magnet and allow device to treat

ii. Note: pacemaker (if present) continues to function as programmed

Sources of EMI in theatre

Monopolar diathermy Argon laser diathermy Nerve stimulators Radiofrequency devices Lithotripsy

MAGNETS ARE KEPT IN

RECOVERY

EMI = electromagnetic interference. Tracking – device interprets EMI as atrial pulse and paces ventricles at EMI rate. ICD response to VT or VF: ICDs will usually initiate ATP (anti-tachycardia pacing) before defibrillation.



1. What is this policy about? 1.1 This guide aims to help all staff safely manage patients with pacemakers, implanted

defibrillators or cardiac resynchronisation therapy devices when they require surgery or other invasive procedures at SRFT

If you have any concerns about the content of this document please contact the author or advise the Document Control Administrator.

2. Where will this document be used?

2.1 Preoperative clinic 2.2 Theatres 2.3 Other areas where interventional procedures take place

3. Why is this document important?

Many patients with pacemakers are now presenting for surgery Devices used in surgery and other interventions can produce electromagnetic interference (EMI) that can interfere with the function of the pacemaker. Modern pacemakers are much less sensitive to Electro Magnetic Interference (EMI). Some devices are now MRI safe. Modern pacemakers can be classified into 4 types. Each type differs in its response to which differ the response to EMI and in its response to magnet application. The 4 types are:

Bradycardia (standard) Pacemaker (PM)

Implanted Cardiac Defibrillator (ICD)

Cardiac Resynchronisation Therapy Pacemaker (CRT-P)

Cardiac Resynchronisation Therapy with Defibrillator (CRT-D) It is important that the type of pacemaker is identified preoperatively and that there is a plan for the management of the pacemaker during the planned procedure.

4. What is new in this version?

4.1 No changes.

Acknowledgement

Dr Bewsher, Consultant Anaesthetist at MFT Central is the author of the MFT Central Pacemaker Guidelines from which this SRFT guideline is based.



Sources of EMI in theatre

Monopolar diathermy

Argon laser diathermy

Nerve stimulators

Radiofrequency devices

Lithotripsy

Device check time limits: PM 12months ICD 6 months CRT 3 months Need to know: Type Program mode Pacemaker dependency Magnet function

5. Perioperative Management of Pacemakers. Clinical Guideline

The rapid advance in ‘pacemaker’ technology over the last two decades has resulted in a bewildering number of cardiac device types with complex functionality. Expanding indications for such devices have resulted in an increasing number of patients being admitted to hospital for medical or surgical management of unrelated pathology. Anaesthetists and surgeons therefore need to keep up with current recommendations for management of patients with rhythm management devices in the perioperative period. Ideally the cardiorespiratory investigations (CRI) team will be notified of all patients admitted to SRFT, whatever the reason, who have an implanted device. It follows that the CRI team should be made aware of any such patient who is to be admitted to SRFT for future surgery. Consideration of the implications for a particular patient having particular surgery with a particular implanted device will allow the CRI team to prescribe device management for that patient episode. The CRI team is led by Dr Alan Fitchet, Consultant Cardiologist with Dr Peter Woolfson Consultant Cardiologist and the CRI team is contactable via ext 64748/64749 and answerphone 64726. Or referrals by email to Helen Kucyk, Gillian Woods and Sally Stead The following guidance is not fully comprehensive but provides a heavily abbreviated summary of device types in use and their perioperative management. For further information please discuss with the CRI team.

Perioperative management centres around the likelihood and consequences of electromagnetic interference (EMI) with the device. EMI from a diathermy source below the patient’s umbilicus is extremely unlikely although it is prudent to follow precautions as per surgery above the umbilicus. Device damage or programme interference are extremely rare unless the diathermy probe is applied directly to the device. EMI risk can be minimised by:

Use of alternative diathermy (eg bipolar, harmonic diathermy)

Place monopolar diathermy earth plate away from the device

Use EMI source in short bursts of less than 4 seconds

The safest way to override devices is with the use of a device Ring Magnet (available in both recovery areas)

Avoids reprogramming errors

Device will return to normal function within 2 sec of magnet removal Only request perioperative reprogramming if the surgical position makes access to the device difficult (eg prone position). If the device is reprogrammed, external defibrillator pads must be attached for external pacing or defibrillation if needed (note only the recovery defibrillator has pacemaker facility).



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5.1 Preoperative assessment

5.1.1 It is important that the type of device is identified a. When a patient is identified as having an implanted cardiac device in Pre-op, the Pre-op

nurse should obtain the device details. b. If the patient is supervised by SRFT cardioresp investigations team, there will be a record

with them. c. For patients supervised elsewhere, the Pre-op nurse should contact the patients

supervising unit and request a copy of the most recent device check. (do not rely on patient recall; patient passport does not carry enough information for decision making)

d. Once the device documents are obtained the Preop nurse may wish to discuss the patient with the SRFT CRI team (Gill, Helen or Sally 64748/64749)

e. The CRI team will need to know whether the device can be accessed during surgery and whether surgery will be near the device or leads

5.1.2 The CRI team will identify: a. The type of device – PM, ICD, PM & ICD, CRT-P, CRT-D b. That the device is checked and functioning normally c. Whether the patient is ‘pacemaker dependent’ d. The response of the device to magnet application e. Recommend a management plan for the day of surgery 5.1.3 Consultant anaesthetic Preop assessment Patients with pacemaker devices will require a Doctor Preop Appointment and/or communication with the session anaesthetist. 5.1.4 Documentation and communication All communication should be documented within the Preoperative Assessment Document on EPR



Key points

Device check 12 months

Note pacemaker dependency – whether there is little or no underlying rhythm

Diathermy in short bursts (<4sec)

Monitor ECG/SpO2 and inform surgeon if EMI occurs.

If pacemaker dependent, use magnet to convert to asynchronous pacing mode.

Caution with IHD

5.2 Antibradycardia devices – Pacemakers (PM)

5.2.1 Indications In essence anybody with, or likely to develop, symptoms as a result of a slow heart rate (SA node disease, heart block, brady-related tachyarrhythmias, post AV node ablation, etc) 5.2.2 Pre-op Full anaesthetic assessment, as usual, with particular reference to cardiovascular disease and symptoms. Device check within last 12 months. Is the patient pacemaker dependent? This can be in a spectrum from 100% to virtually 0% paced. Is the patient medically optimised? Contact CRI team if unsure of device of management plan in advance of surgery. 5.2.3 Periop Small risk of inappropriate device inhibition leading to brief rhythm pauses/asystole during diathermy if patient is pacemaker dependent. Small risk of ‘tracking’ with DDD programming whereby EMI is interpreted as intrinsic atrial activity with possible rapid ventricular pacing (no higher than Upper Rate Limit – usually 135 BPM) with possible compromise. Both inhibition and tracking can be minimalised with brief periods of diathermy (less than 4 seconds) and ensuring the return pathway to the diathermy plate is as far from device/leads as is possible. Monitoring, with arterial line for major surgery or ECG monitor/pulse oximeter, and communication of EMI to surgeon as and when it occurs will likely be all that is required. Patients who are pacemaker dependent: converting to asynchronous pacing at a desired heart rate may be a safer option. This needs to be discussed with CRI team well in advance of surgery. This is best achieved by applying the magnet over the pulse generator. Only reprogram if the device will not be accessible. The magnet will produce asynchronous AV (or V if no atrial lead) pacing at a manufacturer-specific rate (usually 85bpm) independently of the underlying intrinsic cardiac rhythm. 5.2.4 Post-op The pacemaker will return to programme mode within 2 seconds of removal of the magnet. If reprogrammed, the CRI team will need to restore usual programme. Full monitoring in recovery until this has taken place.



Key points



Risk of triggering a cardioversion shock as device can misinterpret EMI as a ventricular arrhythmia

Temporarily disabling the defibrillation function with a magnet is safest

Prone patients require CRI team to switch off ICD with programmer – MUST be reprogrammed post op

5.3 Implanted Cardiac Defibrillator (ICD)

5.3.1 Indications NICE guidance has recently changed to keep up with worldwide evidence-based guidance whereby, in essence, anybody with a LV EF of less than 35% of any aetiology should be considered for ICD implant. All ICDs have full antibradycardia pacing programmability that will, usually, be set to provide some brief post-therapy pacing at 40 BPM unless an anti-bradycardia pacing requirement coexists. Clearly some patients will also have an indication for antibradycardia pacing and many will have an indication for CRT and hence, a CRT-D device. Device therapy is programmed firstly by rate ‘zones’ followed by more complex rhythm discriminators. This will then dictate therapy - antitachycardia pacing (ATP) for VT or defibrillation and a cardioversion shock for VT/other rates over about 220bpm188bpm. 5.3.2 Pre-op Full patient assessment and optimisation. Device check within last 6 months. (Appendix 1) Discuss plan with CRI team well in advance of surgery. 5.3.3 Peri-op ICD needs to have detection switched off to prevent inappropriate therapy in response to EMI. This is easily done with a cardiology ring magnet (the light blue doughnut found on theatre recovery) whilst the magnet is applied over the actual device. Medtronic ICDs will emit a 10 second audible alarm. Removal of the magnet will reactivate ICD detection allowing appropriate therapy in the event of rhythm disturbance or at the end of exposure to EMI. Note the magnet will not affect the pacemaker function (if present) – EMI can cause pacing inhibition or tracking (see pacemaker 5.2) Only request device reprogramming if the device will be inaccessible or the magnet cannot be applied during the procedure. Switching tachycardia therapies off via a programmer allows manipulation of all device functions immediately preoperatively but unless the programmer stays with you in theatre (unlikely!) defibrillation will have to be performed with pre-positioned external defibrillation pads. 5.3.4 Post-op Patient remains in a monitored environment until device is reverted to pre-op mode. If the device was reprogrammed, this requires the programmer to return and reactivate the ICD post surgery before discharge from recovery. It is well reported that this re-activation has on occasion been omitted in error resulting in patients being sent home with their ICD still inactive



Key points


Sicker patients


Monitor ECG/SpO2 and inform surgeon if EMI occurs.

Do not use a magnet on CRT-P unless pacing dependent

Magnet will turn off defib of CRT-D

5.4 Cardiac Resynchronisation Therapy (CRT-P is pacemaker only; CRT-D is pacemaker with defibrillator)

5.4.1 Indications CRT pacing (Biventricular pacing) has been recommended for patients with poor LV performance, broad QRS complexes (enhanced benefit with broader complexes) and NYHA class 3 to 4 symptoms. CRT may benefit some AF patients and some with class 1 or 2 symptoms. Many patients will be functionally dependent upon their CRT and should ideally have at least 90% pacing activity to provide benefit. The device is therefore programmed to pace the ventricles as much as possible unlike the demand only pacing mode used in bradycardia pacemakers. If in sinus rhythm the device will be programmed to track intrinsic atrial activity with mandatory V-pacing after a programmed short AV delay. 5.4.2 Pre-op More significant cardiac disease Require consultant anaesthetic assessment and medical optimisation. Device check within past 3 months. (Appendix 1) Discuss with CRI team and cardiology well in advance of surgery. 5.4.3 Peri-op Most patients will require no action but close monitoring (arterial access, certainly for major surgery) and management of electrosurgery issues. As most (not all) of these patients have normal SA node activity and respond to surgical stimulation in a normal physiological way fixed asynchronous pacing (either by magnet or programming) is likely to cause competitive rhythms with serious haemodynamic compromise and therefore should be avoided. However, some ablated or bradycardic patients will require both a paced rhythm as well as biventricular ventricular pacing and may be safely converted to asynchronous pacing. This should only be arranged after discussion with CRI team well in advance of surgery. CRT-P The use of a magnet will result in fixed asynchronous pacing with CRT-P devices that can be detrimental or dangerous for the patient with normal atrial activity. CRT-D is combined CRT and ICD. The use of a magnet will switch off ICD detection but will have no effect on the CRT pacing mode of the device. It is appropriate to use a magnet to switch off the defibrillator during surgery. 5.4.4 Post-op No specific post-op precautions required Request ‘devices’ to restore usual programme if altered prior to surgery.



Key points

Identify the type of pacemaker

Insert arterial line

Consider placing defibrillator or external pacemaker pads

If defibrillator coils present, use magnet to disable ICD

Bipolar or harmonic diathermy is safest


Monitor ECG/SPO2 trace and inform surgeon if EMI occurs.

Consider magnet if EMI causes asystole

5.5 Emergency Surgery

Attempts to identify the device should be made. i) The patient may have a device passport with some basic information such as device type, programmed modes, details and date of last check. ii) EPR may have a device check in Documents > Cardiorespiratory Dept. or scanned print outs in Scanned Records > Scanned Results > Tests & Investigations. (see Appendix 1) iii) Chest X-ray appearance can be highly informative. (see next page)

Pacing RA and RV leads are usually obvious (X-ray 1).

The thickened appearance of an ICD coil is usually obvious and will be seen distally on the RV lead. An additional coil may be seen within the SVC on the same or different lead (X-ray 2).

CRT-P has an additional LV lead (X-ray 3). A lateral film will demonstrate the RA lead anteriorly in RA appendage and the LV lead posteriorly in the coronary sinus.

CRT-D as for CRT-P and will additionally have defibrillator coil(s). iv) ECG the presence of pacing spikes with either all atrial or all ventricular complexes is highly suggestive of pacemaker dependency. v) Magnet test While monitoring ECG

Pacemaker and CRT-P will convert to asynchronous mode at approximately 85bpm.

ICD and CRT-D may emit a 10sec alarm (continuous = defib working; alternating = pacemaker check due). ECG rhythm will not change.

This method, however, is not entirely predictable as the magnet rate may be close to the intrinsic rate. The ECG pacing artefact is not always obvious with bipolar leads (usual pacing configuration) and may be missed. All precautions should be undertaken in emergency surgery as for elective surgery if the device is known. Arterial line placement is advisable. If the device remains unidentified or is known to be a defibrillator then pacing defibrillator pads should always be positioned on the patient prior to surgery starting. A magnet must be available for use in the event of unavoidable and compromising pacing inhibition/tracking or unexpected ICD therapy. In the presence of an ICD a magnet should be applied (stuck down) over the device for the duration of surgery, which may be removed in the event of rhythm disturbance.



6. Roles and responsibilities

6.1 Preop will assess all patients with pacemakers and will identify the type of pacemaker. A

plan will be developed for the management of the pacemaker during the upcoming surgical procedure. This will be developed with the CRI team if necessary

6.2 The CRI team will be available for advice 6.3 Theatre recovery will ensure the ring magnet is stored safely

7. Monitoring document effectiveness

This is a Clinical Guideline, designed to provide relevant information to clinicians. It is not a policy and does not require monitoring.

.

8. Abbreviations and definitions

All identified in the text

9. References and Supporting Documents

9.1 References

1. Guidelines for the perioperative management of patients with implantable

pacemakers or implantable cardioverter defibrillators, where the use of surgical

diathermy/electrocautery is anticipated. MRHA. March 2006

2. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA)

Expert Consensus Statement on the Perioperative Management of Patients with

Implantable Defibrillators, Pacemakers and Arrhythmia Monitors: Facilities and

Patient Management Heart Rhythm, Vol 8, No 7, July 2011

3. PACEMAKERS, CARDIAC RESYNCHRONISATION THERAPY, ICDS PERIOPERATIVE MANAGEMENT. CMFT Guideline Dr M S Bewsher 2015



10. Document Control Information

It is the author’s responsibility to ensure that all sections below are completed in relation to this version of

the document prior to submission for upload.

Nominated Lead author:

Dr Jon Watt Consultant anaesthetist

Lead author contact details:

0161 2060642 0729552911 [email protected]

Lead Author’s Manager:

Dr Glyn Smurthwaite Clinical Director

Applies to: Please indicate which Care Organisation(s) this document applies to:

Salford

CO X

Oldham CO North Manchester CO

Bury & Rochdale CO

Northern Care Alliance Group (NCA)

Document developed in consultation with :

Department of Anaesthesia Department of Cardiology Cardio Respiratory Investigation team

Keywords/ phrases:

PM, ICD, CRT, CRT-P, CRT-D, pacemaker, defibrillator, defib, cardiac, resynchronisation, device, therapy, anaesthesia, anaesthetic, preop, pre-op, surgery, procedure, operation, diathermy, magnet, peri-op, post-op, recovery

Communication plan:

Clinical governance. Email to all anaesthetic consultants. Lead nurses and ODPs to cascade down to preop, scrub teams, anaesthetic teams, recovery teams. Poster in theatre

Document review arrangements:

This document will be reviewed by the author, or a nominated person, at least once every three years or earlier should a change in legislation, best practice or other change in circumstance dictate.

Approval: Department of Anaesthesia – Clinical Governance

Department of Cardiology – Clinical Governance

Preop clinic

Insert full approval date: 01/12/2018

How approved: Chair’s actions Formal Committee decision



11. Equality Impact Assessment (EqIA) screening tool Legislation requires that our documents consider the potential to affect groups differently, and eliminate or minimise this where possible. This process helps to reduce health inequalities by identifying where steps can be taken to ensure the same access, experience and outcomes are achieved across all groups of people. This may require you to do things differently for some groups to reduce any potential differences.

1a) Have you undertaken any consultation/ involvement with service users, staff or other groups in relation to this document? If yes, specify what.

Department of Anaesthesia Department of Cardiology Cardio Respiratory Investigation team

1b) Have any amendments been made as a result? If yes, specify what.

No

2) Does this policy have the potential to affect any of the groups listed below differently? Place an X in the appropriate box: Yes, No or Unsure This may be linked to access, how the process/procedure is experienced, and/or intended outcomes. Prompts for consideration are provided, but are not an exhaustive list.

Protected Group Yes No Unsure

Age (e.g. are specific age groups excluded? Would the same process affect

age groups in different ways?) X

Sex (e.g. is gender neutral language used in the way the policy or

information leaflet is written?) X

Race (e.g. any specific needs identified for certain groups such as dress, diet, individual care needs? Are interpretation and translation services required and do staff know how to book these?)

X

Religion & Belief (e.g. Jehovah Witness stance on blood transfusions;

dietary needs that may conflict with medication offered.) X

Sexual orientation (e.g. is inclusive language used? Are there different

access/prevalence rates?) X

Pregnancy & Maternity (e.g. are procedures suitable for pregnant and/or

breastfeeding women?) X

Marital status/civil partnership (e.g. would there be any difference

because the individual is/is not married/in a civil partnership?) X

Gender Reassignment (e.g. are there particular tests related to gender? Is

confidentiality of the patient or staff member maintained?) X

Human Rights (e.g. does it uphold the principles of Fairness, Respect,

Equality, Dignity and Autonomy?) X

Carers (e.g. is sufficient notice built in so can take time off work to attend

appointment?) X

Socio/economic (e.g. would there be any requirement or expectation that

may not be able to be met by those on low or limited income, such as costs incurred?)

X

Disability (e.g. are information/questionnaires/consent forms available in

different formats upon request? Are waiting areas suitable?) Includes hearing and/or visual impairments, physical disability, neurodevelopmental impairments e.g. autism, mental health conditions, and long term conditions e.g. cancer.

X



Are there any adjustments that need to be made to ensure that people with disabilities have the same access to and outcomes from the service or employment activities as those without disabilities? (e.g. allow extra time for appointments, allow advocates to be

present in the room, having access to visual aids, removing requirement to wait in unsuitable environments, etc.)

X

3) Where you have identified that there are potential differences, what steps have you taken to mitigate these? Not applicable

4) Where you have identified adjustments would need to be made for those with disabilities, what action has been taken? Not applicable

Will this policy require a full impact assessment? No Author: Type/sign: Jon Watt Date: 01/12/2018 Sign off from Equality Champion: Jules Wall Date: 11/12/18



12. Appendices

Appendix 1 Anaesthetic room poster



Appendix 2 Pacemaker codes, British Pacing and Electrophysiology Group (BPEG) 2002

Common codes

AOO Asynchronous atrial pacing AAI Atrial paced, atrial sensed, sensed activity will inhibit pace VOO Asynchronous ventricular pacing VVI Ventricle paced, ventricle sensed, sensed activity will inhibit pace DOO Asynchronous atrial and ventricular pacing DVI Atrial and ventricular pacing, ventricle sensed, sensed activity will inhibit

ventricular pace DDD does everything – 4 faces: AP VP. AP VS. AS VP. AS VS.

DDDR does everything and varies heart rate



Appendix 3 Understanding Pacemaker Device Checks Device checks by Cardio-Respiratory Investigations at SRFT are found in Scanned Records > Scanned Results > Tests & Investigations. Open the most recent and read the first (summary) page. Examples below:

1. Pacemaker summary page



2 Implanted cardiac defibrillator summary page



3 Cardiac Resynchronisation Therapy device (CRT-P) summary page.



4 Cardiac Resynchronisation Therapy with defibrillator (CRT-D)