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

Frey, Simon; Sticherling, Christian; Kraus, Regula; Ammann, Peter; Kühne, Michael; Oßwald, Stefan; Schaer, Beat

doi:10.1111/pace.12578

Cited by 2 publications

(3 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Many of these earlier publications had a rather short follow‐up and data on long‐term follow‐up is scarce (except the Medtronic product performance report). In 2012, our group published that the passive SFL model had a better survival than the active fixation model and that also the 5‐year survival rate was better than assumed …”

Section: Introductionmentioning

confidence: 99%

“…In 2012, our group published that the passive SFL model had a better survival than the active fixation model 10 and that also the 5-year survival rate was better than assumed. 15 Pacing Clin Electrophysiol. Due to lack of a universal definition of lead failure, we used two different definitions of lead failure, as previously described 15 :…”

Section: Introductionmentioning

confidence: 99%

“…15 Pacing Clin Electrophysiol. Due to lack of a universal definition of lead failure, we used two different definitions of lead failure, as previously described 15 :…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

The Medtronic Sprint Fidelis® lead history revisited—Extended follow‐up of passive leads

Frey

Sticherling

Altmann

et al. 2019

Pacing Clinical Electrophis

Self Cite

View full text Add to dashboard Cite

Background Due to high failure rates, Medtronic withdrew the Sprint Fidelis lead (SFL) from the market. Passive fixation lead models exhibited better survival than active models, but most studies have limited follow‐up. Aim of this study was to give insights into passive lead survival with a follow‐up of 10 years. Methods In two large Swiss centers, patients with passive SFLs were identified and data from routine implantable cardioverter defibrillator (ICD) follow‐ups were collected. Patients were censored at time of death, last device interrogation (if lost to follow‐up), time of lead revision (in non‐SFL‐related problems), or at database closure (31th December 2017). We defined lead failure as any of the following: lead fracture with inappropriate discharge; sudden increase in low‐voltage impedance to >1500 or high‐voltage impedance to >100 Ω; >300 nonphysiological short VV‐intervals. Results We identified 145 patients. Age at implant was 60 ± 12 years with a median follow‐up of 10.2 (interquartile range [IQR]: 5.0‐11.2) years. Thirty‐five percent of patients died after 5.4 ± 2.7 years. A total of 19 leads (13%) failed after 6.7 ± 3.2 years (range: 1.2‐12.0). Overt malfunction with shocks existed in four patients (3%). Cumulative lead survival was 93.1% at 6, 88.2% at 8, 83.8% at 10, and 77.6% at 11 years, respectively, with 35% of implanted leads under monitoring at 10 years. Lead survival fits best a Weibull distribution with accelerating failure rates (k = 1.95, 95% CI 1.32‐2.87, P < 0.001). Conclusions During very long‐term follow‐up, failure rate of the passive SFL shows an increase resulting in an impaired lead survival of 84% at 10 years.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The Medtronic Sprint Fidelis® lead history revisited—Extended follow‐up of passive leads

Frey

Sticherling

Altmann

et al. 2019

Pacing Clinical Electrophis

Self Cite

View full text Add to dashboard Cite

show abstract

Cardiac Resynchronization Therapy With or Without Defibrillation: A Long-Standing Debate

Golzio

Bocchino²,

Bissolino³

et al. 2021

Cardiology in Review

View full text Add to dashboard Cite

Please indicate in-training status and name of institution. Institutional rates apply to libraries, hospitals, corporations, and partnerships of three or more individuals. Prices subject to change without notice. Subscriptions will begin with currently available issue unless otherwise requested. Copies will be replaced without charge if the publisher receives a request within 90 days of the mailing date.Individual and in-training subscription rates include print and access to the online version. Institutional rates are for print only; online subscriptions are available via Ovid. Please contact the Ovid Regional Sales Office near you for more information on institutional online access.

show abstract

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

Abstract: In this population with passive SFLs, 5-year lead survival is impaired with 94.2% based on 74% of leads "at risk" at this time point.

Cited by 2 publications

References 18 publications

The Medtronic Sprint Fidelis® lead history revisited—Extended follow‐up of passive leads

The Medtronic Sprint Fidelis® lead history revisited—Extended follow‐up of passive leads

Cardiac Resynchronization Therapy With or Without Defibrillation: A Long-Standing Debate

Contact Info

Product

Resources

About