Guidelines for implantable cardioverter defibrillators (ICDs) - pacemaker perioperative management

Using surgical diathermy/electrocautery on patients with an implantable pacemaker or (ICD) can present additional risk of electrical interference and appropriate precautions need to be considered.

The guidance below summarises aspects that should be considered when pacemaker and ICD patients need to undergo unplanned emergency surgical procedures. It acknowledges the fact that in emergency situations, various risk/benefit analyses need to be undertaken when life is at risk.

A more detailed guidance document (140Kb) is also available for download.

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Guidelines for the perioperative management of patients with implantable pacemakers or implantable cardioverter defibrillators, where the use of surgical diathermy/electrocautery is anticipated.

Summary

Caution
Using surgical diathermy/electrocautery on patients with an implantable pacemaker or implantable cardioverter defibrillator (ICD) can present additional risk of electrical interference and appropriate precautions need to be considered.

Manufacturers either contraindicate or give strong warnings against its use, particularly the monopolar mode.

Where the risk/benefit analysis favours the use of surgical diathermy/electrocautery - particularly in emergency situations, the use of bipolar operating mode should first be considered. However, it should be noted that interference remains a possibility with bipolar mode.

Planned Surgical Procedures
Since all surgical procedures (except emergency) are planned in advance, patients with these implants can be identified through routine pre-admission screening – for guidelines refer to the main detailed document.

Emergency Procedures
Wherever possible, the guidance in MHRAs main document for planned surgical procedures should be considered.

• Ensure that cardio-pulmonary resuscitation, temporary external/transvenous pacing, and external defibrillation equipment are available.
• Where presence of a device is suspected but not confirmed use normal X-ray procedures to identify. Note that:
• • the majority of devices are implanted in the anterior left pectoral region (occasionally right)
  • older implants (minority) have been implanted abdominally
  • devices have X-ray identification symbols which can be used to identify the manufacturer (consult cardiac pacing clinic for manufacturer identification).
• Obtain pacemaker/ICD details from the patient’s device registration card/“passport”, which records pertinent details. Where possible obtain the following key information and alert cardiology for assistance:
• • device manufacturer, model number, serial number
  • implanting hospital, follow-up hospital
  • reason for implant
• Where possible, contact the cardiac pacing department to determine to what extent support may be required in pacemaker/ICD reprogramming. ICDs may need to be programmed to ‘monitor only’ mode to prevent inappropriate sensing and shock delivery. Securing a magnet over the ICD implant site may in many cases inhibit delivery of shock therapy. However, this cannot always be guaranteed (see main document below). Similarly, securing a magnet over the pacemaker implant site will not necessarily guarantee asynchronous (non-sensing) pacing. Magnet response may vary between manufacturers’ models and according to particular programmed settings.
• If an ICD is deactivated, consider connecting the patient to an external defibrillator using remote pads if access to the anterior chest wall will interfere with surgery or the sterile field.
• Monitor the patient’s ECG from the outset of surgery and before the induction of anaesthesia.
• Since some ECG monitors (having a “paced” mode) may misinterpret pacing spikes as the patient’s QRS complexes and incorrectly display a heart rate (when the patient is in asystole), an alternative method of detecting a patient’s pulse such as a pulse oximeter or an arterial line should be used.
• Monitoring systems that use thoracic impedance measurements can cause an increase in paced rate for pacemakers that use the minute ventilation system to determine patient exercise level. Where interaction is suspected consider using a patient monitoring system that does not employ thoracic impedance measurements.
• On detection of pacemaker inhibition or rate increase, inform the surgeon immediately and either use diathermy intermittently or not at all.
• Consider using an external pacemaker to overdrive and inhibit pacing from the implanted pacemaker (when necessary).
• Use monopolar diathermy/electrocautery as a last resort and –
• • use in short bursts
  • ensure that the return electrode is anatomically positioned to ensure that the current pathway is as far away from the pacemaker/defibrillator (and leads) as possible
  • keep all diathermy/electrocautery cables well away from the site of implant
  • consider alternative external/transvenous pacing where pacing from the implant is significantly affected during the use of monopolar diathermy.
• On completion of surgery, or as soon as possible, contact the cardiac pacing clinic to request a pacemaker/ICD check to ensure the correct functioning of the device.

Notes
Interference generated by monopolar surgical diathermy/electrocautery is more severe than bipolar and can be sufficient to temporarily inhibit pacemaker output, give rise to a temporary increase in pacing, or cause a loss of programmed settings.

For ICDs there is a possibility that noise/interference may be misinterpreted as ventricular tachycardia or ventricular fibrillation causing inappropriate initiation of therapy.

Where the implant’s internal power source is low, device operation may be uncertain during or after the application of monopolar surgical diathermy/electrocautery. 

This information together with the document below is intended to provide guidance when patients with implantable pacemaker and cardioverter defibrillators need to undergo surgical intervention and has been prepared at the request of MHRA’s Committee on the Safety of Devices (CSD) and in consultation with Heart Rhythm UK (HRUK).

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A more detailed guidance document (140Kb) is also available for download.

Contacts:
Enquiries to the MHRA should be addressed to:

Clinical aspects:	Technical aspects:
Dr Susanne Ludgate Medicines & Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Tel: 020 7084 3123 Fax: 020 7084 3111 E-mail: susanne.ludgate@mhra.gsi.gov.uk	Stephen Lee or Hazel Randall  Medicines & Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Tel: 020 7084 3309/3287 Fax: 020 7084 3106 E-mail: stephen.lee@mhra.gsi.gov.uk               hazel.randall@mhra.gsi.gov.uk