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.

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