Risk factors for implantable defibrillator lead fracture in a recalled and a nonrecalled lead

T. Ben Morrison, Robert F. Rea, David O. Hodge, Daniel Crusan, Celeste Koestler, Samuel J Asirvatham, David John Bradley, Win K. Shen, Thomas M. Munger, Stephen C. Hammill, Paul Andrew Friedman

Research output: Contribution to journalArticle

46 Citations (Scopus)

Abstract

Risk Factors for ICD Lead Fracture. Introduction: The Medtronic Sprint Fidelis® implantable cardioverter defibrillator (ICD) lead was "recalled" in October 2007 after 268,000 implants worldwide due to increased failure risk. Manufacturer suggested monitoring has not been shown effective at preventing adverse events. Only limited data exist regarding clinical predictors of Fidelis® lead fracture. We sought to identify risk factors for Fidelis® fracture to guide clinical monitoring and compare its performance with a control lead. Methods: Fractured lead cases were retrospectively reviewed for demographic data, implant technique, radiographic appearance and clinical presentation was analyzed. Lead survival was compared using Kaplan-Meir curves. Results: Study patients (n = 1314) experienced 18 Fidelis® and 6 Quattro™ lead fractures. Patients with failed Fidelis® leads were younger than those with surviving leads (49.5 vs 64.6 years, P = 0.0066). Fidelis® lead fractures often occurred around the time of physical activity. No other measured demographic or technique related factors were associated with lead fracture. Fidelis® leads had significantly decreased survival compared with Quattro™ leads (89.3 vs 98.9% at 30 months). Patients less than 50 years old had significantly decreased lead survival compared with those older than 50 in both Fidelis® (79.6% vs 96.5% at 24 months) and Quattro™ (93.4 vs 99.8%, P < 0.001 at 24 months) leads. Conclusions: Patients under age 50, with either Fidelis® or Quattro™ ICD leads, are at increased risk of lead fracture compared with patients over 50, particularly around the time of intense physical activity. Aggressive monitoring and advisory programming appears warranted in patients with Fidelis® leads as well as especially in younger patients.

Original languageEnglish (US)
Pages (from-to)671-677
Number of pages7
JournalJournal of Cardiovascular Electrophysiology
Volume21
Issue number6
DOIs
StatePublished - 2010

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Implantable Defibrillators
Survival
Demography
Lead
Exercise

Keywords

  • Fidelis® lead
  • Implantable cardioverter defibrillator
  • Lead fracture
  • Syncope

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)
  • Medicine(all)

Cite this

Risk factors for implantable defibrillator lead fracture in a recalled and a nonrecalled lead. / Ben Morrison, T.; Rea, Robert F.; Hodge, David O.; Crusan, Daniel; Koestler, Celeste; Asirvatham, Samuel J; Bradley, David John; Shen, Win K.; Munger, Thomas M.; Hammill, Stephen C.; Friedman, Paul Andrew.

In: Journal of Cardiovascular Electrophysiology, Vol. 21, No. 6, 2010, p. 671-677.

Research output: Contribution to journalArticle

Ben Morrison, T. ; Rea, Robert F. ; Hodge, David O. ; Crusan, Daniel ; Koestler, Celeste ; Asirvatham, Samuel J ; Bradley, David John ; Shen, Win K. ; Munger, Thomas M. ; Hammill, Stephen C. ; Friedman, Paul Andrew. / Risk factors for implantable defibrillator lead fracture in a recalled and a nonrecalled lead. In: Journal of Cardiovascular Electrophysiology. 2010 ; Vol. 21, No. 6. pp. 671-677.
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T1 - Risk factors for implantable defibrillator lead fracture in a recalled and a nonrecalled lead

AU - Ben Morrison, T.

AU - Rea, Robert F.

AU - Hodge, David O.

AU - Crusan, Daniel

AU - Koestler, Celeste

AU - Asirvatham, Samuel J

AU - Bradley, David John

AU - Shen, Win K.

AU - Munger, Thomas M.

AU - Hammill, Stephen C.

AU - Friedman, Paul Andrew

PY - 2010

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N2 - Risk Factors for ICD Lead Fracture. Introduction: The Medtronic Sprint Fidelis® implantable cardioverter defibrillator (ICD) lead was "recalled" in October 2007 after 268,000 implants worldwide due to increased failure risk. Manufacturer suggested monitoring has not been shown effective at preventing adverse events. Only limited data exist regarding clinical predictors of Fidelis® lead fracture. We sought to identify risk factors for Fidelis® fracture to guide clinical monitoring and compare its performance with a control lead. Methods: Fractured lead cases were retrospectively reviewed for demographic data, implant technique, radiographic appearance and clinical presentation was analyzed. Lead survival was compared using Kaplan-Meir curves. Results: Study patients (n = 1314) experienced 18 Fidelis® and 6 Quattro™ lead fractures. Patients with failed Fidelis® leads were younger than those with surviving leads (49.5 vs 64.6 years, P = 0.0066). Fidelis® lead fractures often occurred around the time of physical activity. No other measured demographic or technique related factors were associated with lead fracture. Fidelis® leads had significantly decreased survival compared with Quattro™ leads (89.3 vs 98.9% at 30 months). Patients less than 50 years old had significantly decreased lead survival compared with those older than 50 in both Fidelis® (79.6% vs 96.5% at 24 months) and Quattro™ (93.4 vs 99.8%, P < 0.001 at 24 months) leads. Conclusions: Patients under age 50, with either Fidelis® or Quattro™ ICD leads, are at increased risk of lead fracture compared with patients over 50, particularly around the time of intense physical activity. Aggressive monitoring and advisory programming appears warranted in patients with Fidelis® leads as well as especially in younger patients.

AB - Risk Factors for ICD Lead Fracture. Introduction: The Medtronic Sprint Fidelis® implantable cardioverter defibrillator (ICD) lead was "recalled" in October 2007 after 268,000 implants worldwide due to increased failure risk. Manufacturer suggested monitoring has not been shown effective at preventing adverse events. Only limited data exist regarding clinical predictors of Fidelis® lead fracture. We sought to identify risk factors for Fidelis® fracture to guide clinical monitoring and compare its performance with a control lead. Methods: Fractured lead cases were retrospectively reviewed for demographic data, implant technique, radiographic appearance and clinical presentation was analyzed. Lead survival was compared using Kaplan-Meir curves. Results: Study patients (n = 1314) experienced 18 Fidelis® and 6 Quattro™ lead fractures. Patients with failed Fidelis® leads were younger than those with surviving leads (49.5 vs 64.6 years, P = 0.0066). Fidelis® lead fractures often occurred around the time of physical activity. No other measured demographic or technique related factors were associated with lead fracture. Fidelis® leads had significantly decreased survival compared with Quattro™ leads (89.3 vs 98.9% at 30 months). Patients less than 50 years old had significantly decreased lead survival compared with those older than 50 in both Fidelis® (79.6% vs 96.5% at 24 months) and Quattro™ (93.4 vs 99.8%, P < 0.001 at 24 months) leads. Conclusions: Patients under age 50, with either Fidelis® or Quattro™ ICD leads, are at increased risk of lead fracture compared with patients over 50, particularly around the time of intense physical activity. Aggressive monitoring and advisory programming appears warranted in patients with Fidelis® leads as well as especially in younger patients.

KW - Fidelis® lead

KW - Implantable cardioverter defibrillator

KW - Lead fracture

KW - Syncope

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