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

Hauser, Robert G.; Maisel, William H.; Friedman, Paul A.; Kallinen, Linda M.; Mugglin, Andrew S.; Kumar, Kapil; Hodge, David O.; Morrison, Thomas B.; Hayes, David L.

doi:10.1161/circulationaha.110.975219

Cited by 120 publications

(109 citation statements)

References 18 publications

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“…No single death could be categorized as associated with lead defect, which concurs with other studies [7,8,23,24,29]. In the literature, there are slightly lower mortality rates in SF recipients [6].…”

Section: Mortalitysupporting

confidence: 88%

“…Lead failure was diagnosed when one or more of the well established criteria [6][7][8][9] were fulfilled: (i) a sudden rise in long-term pacing or highvoltage impedance, (ii) electrical noise artefacts as manifested by non-physiological signals on the electrogram or by device diagnostics (e.g. nonphysiological short intervals and/or recurrent nonsustained ventricular tachycardia with intervals usually < 220 ms), (iii) failure to sense R-waves or ineffective electrical therapy due to an apparent structural lead defect.…”

Section: Patients Follow-upmentioning

confidence: 99%

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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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Section: Mortalitysupporting

confidence: 88%

Section: Patients Follow-upmentioning

confidence: 99%

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

et al. 2017

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“…Certain leads are even more prone to failure. The Medtronic Fidelis (Medtronic Inc, Minneapolis, MN) lead has failed at a rate of 2.8% a year, with a higher incidence in the younger individual 15. In a Canadian series the failure rate for the Fidelis lead at 5 years was 16.8% 16.…”

Section: Discussionmentioning

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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“…Previous studies have found that the risk factors for a Fidelis lead fracture include younger age, higher left ventricular ejection fraction, and noncephalic venous access. 11,12 No studies have been able to demonstrate the effect of CRT on lead fracture.…”

Section: Discussionmentioning

confidence: 99%

Sprint Fidelis Lead Fractures in Patients With Cardiac Resynchronization Therapy Devices

et al. 2012

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Background-Using data from the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) study, we examined whether Fidelis lead failure was more common in patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (ICD-CRT) than in patients with an ICD only. Methods and Results-All cases of patients who had a right ventricular defibrillation lead revision in the RAFT study were adjudicated for the presence of lead fracture. Criteria for fracture were at least 2 of the following: (1) Impedance rise (Ͼ50% or Ͼ500 ⍀ in 1 week), (2) short interval count Ͼ10 times per day or 300 times per month, or (3) inappropriate shock caused by noise, verified by stored electrogram. A total of 1798 patients were enrolled into the RAFT study, with a mean follow-up of 40Ϯ20 months. There were 818 patients (45.5%) who received a Fidelis lead at the original implantation, 405 with an ICD only and 413 with an ICD-CRT. There were 47 confirmed defibrillation lead fractures; 45 were Fidelis leads (5.5% of Fidelis leads). The overall rate of fracture in the ICD group was 3.2% compared with 7.8% in the ICD-CRT group (Pϭ0.006; hazard ratio, 2.42; 95% confidence interval, 1.27-4.61). Significant correlates of lead fracture in this population were undergoing an ICD-CRT implantation and having Ն2 leads. Conclusions-In this analysis of the RAFT study, patients with an ICD-CRT were found to have a significantly higher fracture rate than patients with an ICD. This finding needs to be considered when these patients are assessed for possible lead revision at the time of an elective generator replacement. (Circulation. 2012;126:2928-2934.)

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

Abstract: Background-Sprint

Cited by 120 publications

References 18 publications

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

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

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

Sprint Fidelis Lead Fractures in Patients With Cardiac Resynchronization Therapy Devices

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