Small‐Caliber Lead Failure After Generator Exchange

Salgado, Ricardo; Martín, Javier Rodrigo; Martínez, José; Alzueta, Javier; Viñolas, Xavier; Fernández, J.; Molina, Manuel; Pérez, Lidia Sanz; Calvo, David; García, Jorge Alberto Osuna

doi:10.1111/jce.12994

Cited by 2 publications

(2 citation statements)

References 14 publications

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“…79 Two series of patients with Fidelis leads reported conflicting results associated with generator exchange (20.8% failure rate after generator exchange vs 2.54% in matched controls, P,.001 in one study, and in another study a 3.6% incidence of lead failure after generator exchange compared with 3.5% in controls, P5.962). 80,81 The lead failure rate did not increase in the first year after generator exchange in a series of patients with Riata leads (1.5% vs 2%, P5.32). 82…”

Section: Risk Of Lead Failure After Generator Exchangementioning

confidence: 88%

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

et al. 2017

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†Deceased (see In Memoriam at the end of this document) *Representative of the Pediatric and Congenital Electrophysiology Society (PACES) ‡Representative of the European Heart Rhythm Association (EHRA) xRepresentative of the Society of Thoracic Surgeons (STS) {Representative of the American College of Cardiology (ACC) #Representative of the Latin American Heart Rhythm Society (LAHRS) **Representative of the Infectious Diseases Society of America (IDSA) ‡ ‡Representative of the American Heart Association (AHA) xxRepresentative of the American Society of Anesthesiologists (ASA) {{Representative of the Asia Pacific Heart Rhythm Society (APHRS)

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Section: Risk Of Lead Failure After Generator Exchangementioning

confidence: 88%

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

et al. 2017

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“…Still, patients with a functioning SFL have a survival similar to patients with the nonadvisory Medtronic Quattro lead . In addition, Salgado et al demonstrated that the rate of failure after generator replacement was similar between functioning SF and other defibrillator leads (3.5 vs 3.6% after 1 year, P = .97), and insofar did not recommend preemptive lead replacement or removal.…”

Section: Discussionmentioning

confidence: 99%

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

Frey

Sticherling

Altmann

et al. 2019

Pacing Clinical Electrophis

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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.

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Small‐Caliber Lead Failure After Generator Exchange

Abstract: According to our results, the preventive removal/replacement of the Sprint Fidelis leads with normal function until GE is not a recommended practice since the rate of dysfunction after the procedure in this subgroup is no different compared with other defibrillator leads.

Cited by 2 publications

References 14 publications

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

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

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