Sprint Fidelis Defibrillation Lead: a Nine-Center Experience in Spain

Arias, Miguel Á.; Domínguez‐Pérez, Laura; Toquero, Jorge; Jiménez‐Candil, Javier; Olagüe, José; Dı́az-Infante, Ernesto; Tercedor, Luís; Valverde, Irene; Castro, Jorge; García-Fernández, Francisco Javier; Rodríguez‐Padial, Luis

doi:10.1016/j.rec.2010.10.033

Cited by 7 publications

(13 citation statements)

References 21 publications

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“…20 There are few contemporary data comparing these newer approaches with cephalic vein access. The 3 largest studies of ICD failure, Kleemann et al (990 patients), 13 Hauser et al (1023 patients), 7 and Ecksten et al (1317 patients) 21 did not report data on access vein. Two of the small single-center Fidelis publications did have data on access vein, and both studies did not find that vein was predictive.…”

Section: Circulation March 13 2012mentioning

confidence: 99%

Clinical Predictors of Fidelis Lead Failure

Birnie

Parkash²,

Exner³

et al. 2012

Circulation

104

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Background-Approximately 268 000 Fidelis leads were implanted worldwide until distribution was suspended because of a high rate of early failure. Careful analyses of predictors of increased lead failure hazard are required to help direct future lead design and also to inform decision making on lead replacement. We sought to perform a comprehensive analysis of all potential predictors in a multicenter study. Methods and Results-A total of 3169 Sprint Fidelis leads were implanted in 11 centers with a total of 251 failures. Lead failure rates at 3, 4, and 5 years were 5.3%, 10.6%, and 16.8%, respectively. The rate of lead failure continues to accelerate (PϽ0.001). There were 4 independent predictors of failure: center, sex, access vein, and previous lead failure. Women had a higher hazard of failure (hazard ratio 1.51; 95% confidence interval, 1.14 -2.04; Pϭ0.005). Both axillary and subclavian access increased the hazard of failure (Pϭ0.007); hazard ratio for axillary was 1.94, (95% confidence interval, 1.23-3.04) and for subclavian 1.63 (95% confidence interval, 1.08 -2.46). Previous lead failure increased the hazard of a subsequent Fidelis failure with a hazard ratio of 3.12 (95% confidence interval, 1.80 -5.41; PϽ0.001). Conclusions-The rate of Fidelis failure continues to increase over time, with failures approaching 17% at 5 years.Women, patients with leads inserted via the subclavian or axillary vein, and those with a previous lead fracture were at greatest risk of Fidelis failure. Our data suggest that Fidelis replacement should be strongly considered at the time of generator replacement. (Circulation. 2012;125:1217-1225.)

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Section: Circulation March 13 2012mentioning

confidence: 99%

Clinical Predictors of Fidelis Lead Failure

Birnie

Parkash²,

Exner³

et al. 2012

Circulation

104

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“…In the majority of papers published on SFL, only cumulative lead survival rate after 5 years is reported, the definition of failure is not consistent, and the lead type is mostly active. Reported lead survival ranges between 90% and 83%, mean/median follow‐up is less than 4 years, and the number of leads “at risk” at the time point 5 and 6 years is very low (e.g., less than 20% and 5%, respectively, in the paper by Cheung et al…”

Section: Discussionmentioning

confidence: 99%

“…More than 250,000 Sprint Fidelis® leads (SFL; Medtronic Inc., Minneapolis, MN, USA) have been implanted worldwide up to its withdrawal in 2007 after reports on elevated failure rates. Since then, many studies on the “long‐term” performance of the lead have been published. All of them showed a seriously impaired lead survival rate compared to other regularly used leads.…”

Section: Introductionmentioning

confidence: 99%

“…According to the most recent product performance report, for example, the Medtronic Sprint Quattro® lead has a 5‐year survival of 98.1%, whereas the SFL 5‐year survival varies between 90.3% and 94.3%, depending on lead model . The annual failure rate of the SFL varies considerably between 1.3% and 4.8% per year, depending on lead type, definition of lead failure, and population under study.…”

Section: Introductionmentioning

confidence: 99%

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Very Late Follow‐Up of a Passive Defibrillator Lead Under Recall: Do Failure Rates Increase during Long‐Term Observation

Frey

Sticherling

Kraus

et al. 2015

Pacing Clinical Electrophis

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“…A subcutaneous implantable cardioverter‐defibrillator (S‐ICD) does not require placement of leads directly into the heart, so use of these devices could avoid the complications related to the use of transvenous ICD leads. Moreover, since the incidence of lead injury increases over time after transvenous ICD implantation, use of S‐ICDs is expected to avoid troubles concerning cardiac leads, especially in younger patients without organic heart disease, such as patients with BrS, who do not usually need ventricular pacing . However, the eligibility of BrS patients for S‐ICD use is not well known, and data from a large cohort of this specific patient population have not been reported …”

Section: Introductionmentioning

confidence: 99%