TY - JOUR
T1 - Multicenter experience with extraction of the Riata/Riata ST ICD lead
AU - Maytin, Melanie
AU - Wilkoff, Bruce L.
AU - Brunner, Michael
AU - Cronin, Edmond
AU - Love, Charles J.
AU - Grazia Bongiorni, Maria
AU - Segreti, Luca
AU - Carrillo, Roger G.
AU - Garisto, Juan D.
AU - Kutalek, Steven
AU - Subzposh, Faiz
AU - Fischer, Avi
AU - Coffey, James O.
AU - Gangireddy, Sandeep R.
AU - Saba, Samir
AU - Mittal, Suneet
AU - Arshad, Aysha
AU - O'Keefe, Ryan Michael
AU - Henrikson, Charles A.
AU - Belott, Peter
AU - John, Roy M.
AU - Epstein, Laurence M.
N1 - Funding Information:
Dr Maytin has received research grants from Medtronic and Spectranetics and is a consultant for St Jude Medical. Dr Wilkoff has received research grants from Biotronik, Boston Scientific, LifeWatch, Medtronic, Spectranetics, and St Jude Medical and is a consultant for Boston Scientific, LifeWatch, Medtronic, Spectranetics, and St Jude Medical. Dr Love has received research grants from Biotronik, Boston Scientific, Medtronic, and St Jude Medical and is a consultant for Biotronik, Boston Scientific, Cook Vascular, Medtronic, Sorin/ELA, St Jude Medical, Spectranetics, and TyRx. Dr Fischer is currently a paid employee of St Jude Medical. Dr Carrillo is a consultant for Medtronic, Sorin/ELA, Spectranetics, and St Jude Medical. Dr Mittal has received fellowship and research support from and is a consultant for Bard, Biosense Webster, Biotronik, Boehringer, Boston Scientific, Medtronic, Spectranetics, and St Jude Medical. Dr John participates in industry-sponsored research with Biosense Webster, Medtronic, and Thermedical and is a consultant for St Jude Medical. Dr Epstein has received research grants from and is a consultant for Boston Scientific, Medtronic, Spectranetics, and St Jude Medical; he has equity in and served as a board member for Carrot Medical.
PY - 2014/9
Y1 - 2014/9
N2 - 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.
AB - 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.
KW - ICD
KW - Lead extraction
KW - Lead management
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U2 - 10.1016/j.hrthm.2014.05.014
DO - 10.1016/j.hrthm.2014.05.014
M3 - Article
C2 - 24854215
AN - SCOPUS:84906716488
VL - 11
SP - 1613
EP - 1618
JO - Heart Rhythm
JF - Heart Rhythm
SN - 1547-5271
IS - 9
ER -