Prevalence and predictors of cable extrusion and loss of electrical integrity with the Riata defibrillator lead.
BACKGROUND
Recently, a medical advisory was issued regarding the Riata and Riata ST silicone endocardial defibrillator leads (St. Jude Medical, Sylmar, CA, USA) addressing the issue of conductor cables extruding in an "inside-out" fashion from the main body of the lead. However, little data exist to guide our management of patients with these leads.


RESULTS
A retrospective analysis was performed of 84 patients with a Riata lead who underwent cine-fluoroscopy and electrical evaluation as part of a screening program to assess for cable extrusion. All leads screened were dual-coil except for one single-coil lead. Of 84 patients, 23 patients (27.4%) had fluoroscopic evidence of cable extrusion. Multivariate analysis showed that the duration of time since lead implant and the presence of multiple right ventricular leads were significantly associated with cable extrusion. All 23 patients had normal electrical parameters on routine device interrogation. Fifteen of these 23 patients (65%) with extruded cables had high-voltage shocks within 12 months of lead screening; only one patient demonstrated postshock electrical abnormalities.


CONCLUSIONS
The prevalence of cable extrusion in dual-coil Riata leads is significantly higher at 27.4% than previously reported. The duration of time since implantation and the presence of multiple right ventricular leads are associated with cable extrusion. High-energy shocks did not reveal electrical abnormalities in most patients with cable extrusion.
Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Sharon
S
Shen
Prashant
P
Bhave
Evan
E
Giedrimas
Taral
T
Patel
Rishi
R
Arora
Alexandru B
AB
Chicos
Jeffrey J
JJ
Goldberger
Leonard
L
Ilkhanoff
Michael H
MH
Kim
Albert C
AC
Lin
Rod
R
Passman
Richard
R
Lee
Bradley P
BP
Knight
Susan S
SS
Kim
D000368:Aged; D002933:Cineradiography; D017147:Defibrillators, Implantable; D020878:Device Removal; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation*; D004699:Endocardium / Q000000981:diagnostic imaging; D005260:Female; D006352:Heart Ventricles / Q000000981:diagnostic imaging; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies; D012307:Risk Factors; D057053:Safety-Based Medical Device Withdrawals; D013997:Time Factors