Failure of implantable cardioverter-defibrillator leads: a matter of lead size?
BACKGROUND
Small-diameter implantable cardioverter-defibrillator (ICD) Sprint Fidelis and Riata leads have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue.


OBJECTIVE
To compare the incidence of failure of small-diameter (≤8 F) and standard-diameter (>8 F) ICD leads implanted in a single center.


METHODS
From January 2003 to December 2010, 190 Sprint Fidelis, 182 Riata/Riata ST, 99 Optim (Riata Optim/Durata), and 419 standard-diameter leads were implanted in our center.


RESULTS
During a median follow-up of 33 months, the overall failure rate was 6.3%. Follow-up duration was similar for Sprint Fidelis, Riata, and standard-diameter leads but shorter for the Optim group. The failure rate was significantly higher in Sprint Fidelis leads than in both standard-diameter (4.8%/year vs 0.8%/year; P<.001) and Riata/Riata ST (4.8%/year vs 2.6%/year; P = .03) leads. The incidence of lead failure in Riata/Riata ST leads proved significantly higher than in standard-diameter leads (2.6%/year vs 0.8%/year; P = .001). No cases of lead failure were recorded in the Optim group. On multivariable analyses, small-diameter (hazard ratio [HR] 5.03, 2.53-10.01, P<.001), Sprint Fidelis (HR 6.3, 3.1-13.3, P<.001), or Riata/Riata ST (HR 4.5, 1.9-10.5, P = .001) leads and age<60 years (HR 2.3, 1.3-4.3, P = .005) were found to independently increase the risk of lead failure.


CONCLUSIONS
Compared with standard-diameter leads, both Sprint Fidelis and Riata/Riata ST small-diameter ICD leads are at an increased risk of failure, although the incidence of events is significantly lower in the Riata than in the Sprint Fidelis group.
Department of Cardiology, IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy. r.rordorf@smatteo.pv.it
Roberto
R
Rordorf
Luca
L
Poggio
Simone
S
Savastano
Alessandro
A
Vicentini
Barbara
B
Petracci
Enrico
E
Chieffo
Catherine
C
Klersy
Maurizio
M
Landolina
D000328:Adult; D000704:Analysis of Variance; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D015331:Cohort Studies; D016001:Confidence Intervals; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004567:Electrodes, Implanted / Q000009:adverse effects; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome