Clinical Predictors of Fidelis Lead Failure

Birnie, David H.; Parkash, Ratika; Exner, Derek V.; Essebag, Vidal; Healey, Jeffrey S.; Verma, Atul; Coutu, Benoit; Kús, Teresa; Mangat, Iqwal; Ayala‐Paredes, F.; Nery, Pablo B.; Wells, George; Krahn, Andrew D.

doi:10.1161/circulationaha.111.053744

Cited by 103 publications

(44 citation statements)

References 28 publications

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“…In present analysis lead failure rate was 9% at 5 years, which is a relatively low value compared with other literature [6,7,12,15,16]. A relatively low lead failure rate was achieved with implantations which involved only double-coil lead in all patients.…”

Section: Lead Failurecontrasting

confidence: 53%

“…Most of them presented active fixation lead failure rate which was 9.1-16.4% in the 5-year follow-up [7,12,13]. By contrast, passive fixation lead failure ranges from 4.2% to 14.4% in the 5-year observation [6,7,10,14].…”

Section: Lead Failurementioning

confidence: 96%

“…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: Lead Failurecontrasting

confidence: 53%

Section: Lead Failurementioning

confidence: 96%

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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“…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. All transvenous leads are subjected to repetitive shoulder and cardiac motion.…”

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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“…Reports on the complications and negative aspects of ICDs include problems associated with the Sprint Fidelis ICD leads (119)(120)(121) and potential psychological impact and phobic anxiety among ICD recipients (122). In a study of 3253 patients from 117 Italian centres who underwent de novo implantation of a CRT-D device, investigators found that device related events were more frequent in patients who received CRT-D devices compared with those who received ICDs only (single or dual chamber), although these events were not associated with a worse clinical outcome (123).…”

Section: Implantable Cardioverter Defibrillatorsmentioning

confidence: 99%

Almanac 2013: cardiac arrhythmias and pacing

Liew¹

2013

Anadolu Kardiyol Derg

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Important advances have been made in the past few years in the fields of clinical cardiac electrophysiology and pacing. Researchers and clinicians have a greater understanding of the pathophysiological mechanisms underlying atrial fibrillation (AF), which has transpired into improved methods of detection, risk stratification, and treatments. The introduction of novel oral anticoagulants has provided clinicians with alternative options in managing patients with AF at moderate to high thromboembolic risk and further data has been emerging on the use of catheter ablation for the treatment of symptomatic AF. Another area of intense research in the field of cardiac arrhythmias and pacing is in the use of cardiac resynchronisation therapy (CRT) for the treatment of patients with heart failure. Following the publication of major landmark randomised controlled trials reporting that CRT confers a survival advantage in patients with severe heart failure and improves symptoms, many subsequent studies have been performed to further refine the selection of patients for CRT and determine the clinical characteristics associated with a favourable response. The field of sudden cardiac death and implantable cardioverter defibrillators also continues to be actively researched, with important new epidemiological and clinical data emerging on improved methods for patient selection, risk stratification, and management. This review covers the major recent advances in these areas related to cardiac arrhythmias and pacing. (Anadolu Kardiyol Derg 2013; 13: 739-50)

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Clinical Predictors of Fidelis Lead Failure

Cited by 103 publications

References 28 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

Almanac 2013: cardiac arrhythmias and pacing

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