National Consultant in Cardiology Experts' Group Guidelines on dealing with patients implanted with some St. Jude Medical Riata and Riata ST leads

Abstract

In December 2010 St. Jude Medical informed about higher incidence of silicone insulation abrasion in implantable cardioverter-defibrillator leads Riata/Riata ST. The manifestation of this phenomenon is the externalisation of conductors outside the body of the lead, which is visible in a fluoroscopy. The abrasion could also involve an insulation under high-voltage coil and in the worst case could result in a short circuit within high voltage part of the system. The incidence of this phenomenon varies from part of to several dozen percent according to published papers and becomes higher in a longer follow-up. The highest probability of malfunction in 8 F single coil and the lowest in 7 F dual-coil leads is observed. For the needs of this guidelines all Riata/Riata ST leads were divided into: functioning, damaged but active (visible externalisation but electrically functioning), malfunctioning. In the last case the lead should be removed and a new one implanted (class of indication I) ,although only implantation of a new lead with abandoning malfunctioning one is allowed and should be considered (IIa). In patients with functioning lead extraction with a new lead implantation may be considered during elective replacement only in high risk patients (IIb). In case of damaged but active lead its extraction with the implantation of a new lead during elective replacement of the device should be considered in high risk population (IIa) and may be considered in other patients (IIb). The final decision related to Riata/Riata ST should be individualised and undertaken in co-operation with the patient after detailed assessment of the risk related to each treatment option.