Multicenter experience with extraction of the Riata/Riata ST ICD lead

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Safety

Background:

• The Food and Drug Administration issued a class I recall for Riata and Riata ST implantable cardioverter-defibrillator leads in November 2011.
• Management recommendations for the Riata lead recall remain controversial, with limited data on extraction safety and feasibility.

Purpose of the Study:

• To evaluate the safety and feasibility of extracting Riata and Riata ST implantable cardioverter-defibrillator leads.
• To assess procedural success rates and complication profiles associated with Riata lead extraction.

Main Methods:

• A retrospective study was conducted across 11 centers, analyzing data from patients undergoing extraction of Riata/Riata ST leads.
• Data collected included lead type, implant duration, reasons for extraction, lead integrity findings, and procedural outcomes.

Main Results:

• 577 Riata/Riata ST leads were extracted from 577 patients between 2003 and 2013. Complete procedural success was achieved in 99.1%.
• The primary reasons for extraction were infection (53.0%) and lead malfunction (35.7%). Externalized cables were found in 34.9% of evaluated leads, with longer implant durations associated with externalization.
• Major complications occurred in 0.87% of cases, including perforations and pericardial effusion. Laser sheaths were more frequently used for leads with externalized cables.

Conclusions:

• Extraction of Riata/Riata ST leads can be challenging, especially when externalized cables are present, necessitating specific techniques.
• Experienced operators at high-volume centers can safely extract these leads, achieving complication rates comparable to existing literature.