Management of Riata leads at time of generator change

MANAGEMENT OF RIATA LEADS AT TIME OF GENERATOR CHANGE

The St Jude Medical Riata ICD lead, is currently the  subject of a hazard alert. This is related to failure of the silicone insulation.

This is a guide to the management of the lead at time of generator change

  • If there is evidence of electrical failure ( in particular lead noise, variations in lead impedance, sensing or pacing thresholds) the lead should be replaced.
  • All leads should be screened  with fluoroscopy at time of generator change  looking for evidence of externalisation of conductors. If detected the lead should be replaced.
  • The pocket portion of the ICD lead should be visual inspected  for potential breaks in the insulation. If  detected the lead should be replaced
  • A high energy shock of (at least25 J) should be delivered to test the electrical integrity of the lead. It can be delivered via the old generator. If there is evidence of a problem the lead should be replaced
  • Lead alerts alarms should be activated on all new generators
  • Remote monitoring should be strongly considered in all patients during subsequent follow up.

Lead extraction can be considered as an alternative to lead replacement. The decision to extract the lead should be individualised and include a detailed discussion with the patient regards the potential benefits and risks of lead extraction. Lead extraction should occur at experienced centres only.

Routine lead fluoroscopy of Riata leads in the absence of suspected problems is not recommended during routine follow up