Multicenter experience with extraction of the Riata/Riata ST ICD lead.
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%).


CONCLUSIONS
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.
Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: mmaytin@partners.org.
Melanie
M
Maytin
Cleveland Clinic, Cleveland, Ohio.
Bruce L
BL
Wilkoff
Cleveland Clinic, Cleveland, Ohio.
Michael
M
Brunner
Cleveland Clinic, Cleveland, Ohio.
Edmond
E
Cronin
Ohio State University Medical Center, Columbus, Ohio.
Charles J
CJ
Love
University Hospital, Pisa, Italy.
Maria
M
Grazia Bongiorni
University Hospital, Pisa, Italy.
Luca
L
Segreti
University of Miami Miller School of Medicine, Miami, Florida.
Roger G
RG
Carrillo
University of Miami Miller School of Medicine, Miami, Florida.
Juan D
JD
Garisto
Drexel University College of Medicine, Philadelphia, Pennsylvania.
Steven
S
Kutalek
Drexel University College of Medicine, Philadelphia, Pennsylvania.
Faiz
F
Subzposh
Mount Sinai School of Medicine, New York, New York.
Avi
A
Fischer
Mount Sinai School of Medicine, New York, New York.
James O
JO
Coffey
Mount Sinai School of Medicine, New York, New York.
Sandeep R
SR
Gangireddy
University of Pittsburgh Medical College, Pittsburgh, Pennsylvania.
Samir
S
Saba
The Valley Health System and Columbia University College of Physicians and Surgeons, New York, New York.
Suneet
S
Mittal
The Valley Health System and Columbia University College of Physicians and Surgeons, New York, New York.
Aysha
A
Arshad
The Valley Health System and Columbia University College of Physicians and Surgeons, New York, New York.
Ryan Michael
RM
O'Keefe
Oregon Health & Science University, Portland, Oregon.
Charles A
CA
Henrikson
Scripps Green Hospital, El Cajon, California.
Peter
P
Belott
Brigham and Women's Hospital, Boston, Massachusetts.
Roy M
RM
John
Brigham and Women's Hospital, Boston, Massachusetts.
Laurence M
LM
Epstein
D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal / Q000379:methods*; D004867:Equipment Design; D004868:Equipment Failure; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010490:Pericardial Effusion / Q000209:etiology / Q000601:surgery*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
ICD; Lead extraction; Lead management