Risk Factors for Implantable Defibrillator Lead Fracture in a Recalled and a Nonrecalled Lead

Morrison, Thomas B.; Rea, Robert F.; Hodge, David O.; Crusan, B S Daniel; Koestler, R N Celeste; Asirvatham, Samuel J.; Bradley, David J.; Shen, Win Kuang; Munger, Thomas M.; Hammill, Stephen C.; Friedman, Paul A.

doi:10.1111/j.1540-8167.2009.01683.x

Cited by 55 publications

(41 citation statements)

References 33 publications

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“…The authors analyzed retrospective data from 2691 patients followed at 3 US centers with either Sprint Fidelis or Quattro leads; some may have been selected for inclusion in previous analyses of lead survival. 7,8 Not surprisingly, in this analysis, Fidelis leads failed significantly more frequently than Quattro leads. Between 2001 and 2009, the failure rate for Fidelis leads was 2.81%/y versus 0.43%/y for Quattro leads (PϽ0.0001); Fidelis lead survival was 87% at 4 years compared with 98.7% during the same period for the Quattro lead.…”

Section: Article See P 358mentioning

confidence: 86%

How Much Scrutiny and Stress Can the Fidelis Lead Withstand?

Fischer

2011

Circulation

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Section: Article See P 358mentioning

confidence: 86%

How Much Scrutiny and Stress Can the Fidelis Lead Withstand?

Fischer

2011

Circulation

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“…The risk of transvenous ICD lead failure increases over time and is related to age, activity level and specific lead. Lead failures occur more commonly in young active patients 5. Lead failure results in the potential for additional morbidity and mortality because of the need for additional transvenous leads, with or without lead extraction.…”

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confidence: 99%

Subcutaneous Implantable Cardioverter Defibrillator in Patients With Hypertrophic Cardiomyopathy: An Initial Experience

Weinstock

Bader

Maron

et al. 2016

JAHA

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BackgroundThe subcutaneous implantable cardioverter defibrillator (S‐ICD) has been developed to avert risks associated with transvenous defibrillator leads. The technology is attractive for younger patients, such as those with hypertrophic cardiomyopathy (HCM). However, there are limited data on S‐ICD use in HCM.Methods and Results HCM patients identified at risk for sudden death were considered for S‐ICD implantation. Patients were screened for potential oversensing by surface electrocardiography (ECG). At implant, defibrillation threshold (DFT) testing was performed at 65, 50, and 35 joules (J). Twenty‐seven patients were considered for S‐ICD implantation, and after screening, 23 (85%) remained eligible. The presence of a bundle branch block was associated with screening failure, whereas elevated body mass index (BMI) showed a trend toward association. One patient passed screening at rest, but failed with an ECG obtained after exercise. At implant, the S‐ICD terminated ventricular fibrillation (VF) with a 65J shock in all 15 implanted patients and a 50J shock was successful in 12 of 15. A 35J shock terminated VF in 10 of 12 patients. DFT failure at 50 J was associated with a higher BMI. There were no appropriate shocks after a median follow‐up of 17.5 (3–35) months, and 1 patient received an inappropriate shock attributable to a temporary reduction in QRS amplitude while bending forward, resulting in oversensing, despite successful screening.ConclusionsIn a high‐risk HCM cohort without a pacing indication referred for consideration of an ICD, the majority were eligible for S‐ICD. The S‐ICD is effective at recognizing and terminating VF at implant with a wide safety margin.

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“…1 The manufacturer voluntarily removed Fidelis leads from the market in 2007 after 268 000 were implanted worldwide. 2 Subsequently, the Fidelis fracture rate was observed to accelerate during the first 2 years after implantation, [3][4][5] and leads in younger 6 more active patients with less impairment of left ventricular function appeared to be more prone to failure. 3 …”

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confidence: 99%