open access

Vol 72, No 6 (2014)
Expert consensus statement
Published online: 2014-06-11
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National Consultant in Cardiology Experts' Group Guidelines on dealing with patients implanted with some St. Jude Medical Riata and Riata ST leads

Przemysław Mitkowski, Marcin Grabowski, Oskar Kowalski, Andrzej Kutarski, Włodzimierz Mojkowski, Andrzej Przybylski, Maciej Sterliński, Maria Trusz-Gluza, Grzegorz Opolski
DOI: 10.5603/KP.2014.0127
·
Kardiol Pol 2014;72(6):576-582.

open access

Vol 72, No 6 (2014)
Expert consensus statement
Published online: 2014-06-11

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.

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.
Get Citation

Keywords

Riata, Riata ST, implantable cardioverter-defibrillator, leads, malfunction

About this article
Title

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

Journal

Kardiologia Polska (Polish Heart Journal)

Issue

Vol 72, No 6 (2014)

Pages

576-582

Published online

2014-06-11

DOI

10.5603/KP.2014.0127

Bibliographic record

Kardiol Pol 2014;72(6):576-582.

Keywords

Riata
Riata ST
implantable cardioverter-defibrillator
leads
malfunction

Authors

Przemysław Mitkowski
Marcin Grabowski
Oskar Kowalski
Andrzej Kutarski
Włodzimierz Mojkowski
Andrzej Przybylski
Maciej Sterliński
Maria Trusz-Gluza
Grzegorz Opolski

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