Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.
- Lead extraction
- Lead management
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Physiology (medical)