Predictors of Fracture Risk of a Small Caliber Implantable Cardioverter Defibrillator Lead

Ha, Andrew C.T.; Vezi, Brian; Keren, Arieh; Alanazi, Haitham; Gollob, Michael H.; Green, Martin S.; Lemery, Robert; Nery, Pablo B.; Pósán, Emőke; Birnie, David H.

doi:10.1111/j.1540-8159.2009.02626.x

Cited by 30 publications

(27 citation statements)

References 13 publications

(29 reference statements)

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“…However, the pattern of Fidelis conductor fractures is consistent with a nonrandom time-dependent mechanical failure mode, and it is likely that young active adults with these inherited cardiac diseases mechanically stress Fidelis leads more vigorously than older sedentary patients who have severe ischemic cardiomyopathy and heart failure. The observation that patients who have higher left ventricular ejection fractions also experience higher Fidelis fracture rates 3,5,18 further supports the notion that the Fidelis conductors are vulnerable to normal physiological stresses. The influence of gender is less clear, but women have had a higher early complication rate after de novo ICD implantation than men, 19 and their vascular anatomy may subject leads to the aggressive bend conditions that have been shown to affect Fidelis more than Quattro leads.…”

Section: Discussion Principal Findingssupporting

confidence: 57%

Longevity of Sprint Fidelis Implantable Cardioverter-Defibrillator Leads and Risk Factors for Failure

et al. 2011

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Section: Discussion Principal Findingssupporting

confidence: 57%

Longevity of Sprint Fidelis Implantable Cardioverter-Defibrillator Leads and Risk Factors for Failure

et al. 2011

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“…This study has not confirmed previous findings [21][22][23][24] that patients with confirmed SF lead fracture have statistically significantly higher LVEF, the results obtained herein present contrary results -in our population patients with dysfunctional lead had lower LVEF. Additionally, no statistically significant correlation has been found according to gender www.cardiologyjournal.org [7,9,12,25] or age at implantation [23].…”

Section: Lead Failurecontrasting

confidence: 57%

“…Additionally, no statistically significant correlation has been found according to gender www.cardiologyjournal.org [7,9,12,25] or age at implantation [23]. Neither was any statistical correlation found between the type of prevention (primary vs. secondary), venous access [7,18,21,24,26,27] (cephalic vs. other), nor position of the lead tip in the right ventricle (apex vs. right ventricular outflow track). All parameters were analyzed and were found to be insignificant in multivariate analysis, as well in a univariate analysis.…”

Section: Lead Failurementioning

confidence: 75%

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study

et al. 2017

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. Patients were subjected to regular check-ups in 3 to 6 month intervals. Results: Patients were implanted at a median age of 66.5 years and majority of them had ischemic cardiomyopathy (72%). A majority of the studied population were men (72.2%). Predominantly dual-chamber ICD (ICD-DR) were implanted (50% ICD-DR vs. 47.2% ICD-VR). The guidelines for management of patients implanted with SF were fully implemented. During the follow-up 14 (38.9%) patients died.No deaths were noted that could be attributed to lead failure. In 5 cases lead failure was identified and of these 4 leads were replaced. Median time from implantation to the detection of lead dysfunction was 52 months (IQR 49; 83) (Cardiol J 2017; 24, 3: 259-265)

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“…This is particularly important because the Fidelis cohort is reaching elective generator replacement. Previous studies have suggested that younger age, 8 -9 female sex, 8 and higher 4,10 or preserved 8 left ventricular ejection fraction predispose to failure. However, previous studies had small sample sizes, incomplete data on potential predictors, or both.…”

Section: Clinical Perspective On P 1225mentioning

confidence: 99%

Clinical Predictors of Fidelis Lead Failure

Birnie

Parkash²,

Exner³

et al. 2012

Circulation

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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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Predictors of Fracture Risk of a Small Caliber Implantable Cardioverter Defibrillator Lead

Abstract: In this study, a higher LVEF was associated with a greater risk of lead fracture in patients with Sprint Fidelis 6949 ICD leads. Radiographic features did not predict subsequent risk of lead fracture in our population. (PACE 2010; 437-443).

Cited by 30 publications

References 13 publications

Longevity of Sprint Fidelis Implantable Cardioverter-Defibrillator Leads and Risk Factors for Failure

Longevity of Sprint Fidelis Implantable Cardioverter-Defibrillator Leads and Risk Factors for Failure

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study

Clinical Predictors of Fidelis Lead Failure

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