Document Detail


Multicenter Experience with Extraction of the Riata™/Riata™ ST ICD Lead.
MedLine Citation:
PMID:  24854215     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: In November 2011, the FDA issued a Class I Recall of Riata(™) and Riata(™) ST ICD leads. Management recommendations regarding the recall have remained controversial.
OBJECTIVE: Data regarding the safety and feasibility of extraction of Riata(™) ICD leads are limited.
METHODS: We performed a retrospective study of patients undergoing extraction of Riata(™)/ST leads at 11 centers.
RESULTS: Between July 2003-April 2013, 577 Riata(™)/ST leads were extracted from 577 patients (Riata(™) 84%, Riata(™) ST 16%). Complete procedural success achieved in 99.1%. Cohort was 78% male with mean age 60 years and mean LVEF of 34±14%. Average implant duration was 44.7 months (range, 0-124.6). The majority of leads extracted were for infection (53.0%); 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<0.0001). No difference in lead integrity was noted between Riata(™) and Riata(™) ST (11.7% v. 17.7% failure, p=0.23). Among leads in which cable externalization was noted, laser sheaths were employed more frequently (p=0.01). Major complications included 3 SVC/RV perforations requiring surgical intervention with one death 12 days post-procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%).
CONCLUSION: Extraction of the Riata(™)/ST leads can be challenging and leads with externalized cables may require specific extraction techniques. Extraction of the Riata(™)/ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.
Authors:
Melanie Maytin; Bruce L Wilkoff; Michael Brunner; Edmond Cronin; Charles J Love; Maria Grazia Bongiorni; Luca Segreti; Roger G Carrillo; Juan D Garisto; Steven Kutalek; Faiz Subzposh; Avi Fischer; James O Coffey; Sandeep R Gangireddy; Samir Saba; Suneet Mittal; Aysha Arshad; Ryan Michael O'Keefe; Charles A Henrikson; Peter Belott; Roy M John; Laurence M Epstein
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-5-19
Journal Detail:
Title:  Heart rhythm : the official journal of the Heart Rhythm Society     Volume:  -     ISSN:  1556-3871     ISO Abbreviation:  Heart Rhythm     Publication Date:  2014 May 
Date Detail:
Created Date:  2014-5-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101200317     Medline TA:  Heart Rhythm     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2014. Published by Elsevier Inc.
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