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Failure of implantable cardioverter-defibrillator leads: a matter of lead size?

Abstract：

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.

journal_name

Heart Rhythm

journal_title

Heart rhythm

authors

Rordorf R,Poggio L,Savastano S,Vicentini A,Petracci B,Chieffo E,Klersy C,Landolina M

doi

10.1016/j.hrthm.2012.10.017

subject

Has Abstract

pub_date

2013-02-01 00:00:00

pages

184-90

issue

2

eissn

1547-5271

issn

1556-3871

pii

S1547-5271(12)01206-4

journal_volume

10

pub_type

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