title: Transvenous Implantable Cardioverter-Defibrillator (ICD) Lead Performance: A Meta-Analysis of Observational Studies.
abstract: BACKGROUND
  Despite the widespread use of implantable cardioverter-defibrillators (ICDs) in clinical practice, concerns exist regarding ICD lead durability. The performance of specific lead designs and factors determining this in large populations need clarification.
  
  
  RESULTS
  The Medline, Embase, and Cochrane Collaboration databases were searched for studies including ≥2 of the most commonly implanted leads. The Mantel-Haenszel random-effects model was used. Seventeen studies were selected, including a total of 49 871 patients-5538 implanted with Durata (St. Jude Medical Inc), 10 605 with Endotak Reliance (Boston Scientific), 16 119 with Sprint Quattro (Medtronic Corp), 11 709 with Sprint Fidelis (Medtronic Corp), and 5900 with Riata (St. Jude Medical Inc)-with follow-up of 136 509 lead-years. Although the Durata lead presented a numerically higher rate, no statistically significant differences in the mean incidence of lead failure (0.29%-0.45% per year) were observed in comparison of the 3 nonrecalled leads. A higher event rate was documented with the Riata (1.0% per-year increase) and Sprint Fidelis (>2.0% per-year increase) leads compared with nonrecalled leads. An indication of increased incidence of Durata lead failure versus Sprint Quattro and Endotak Reliance leads was observed in 1 of 3 included studies, allowing for comparison of purely electrical lead failure, but this requires further evaluation.
  
  
  CONCLUSIONS
  Endotak Reliance (8F), Sprint Quattro (8F), and Durata (7F) leads displayed low annual incidence of failure; however, long-term follow-up data are still scarce. More data are needed to clarify the performance and safety of the Durata lead.
authors.affiliation: The Heart Hospital, University College of London Hospitals NHS Trust, London, United Kingdom (R.P., G.G.B., P.D.L.) Barts Heart Centre, Barts Health NHS Trust, London, United Kingdom (R.P., P.D.L.).
authors.forename: Rui
authors.initials: R
authors.lastname: Providência
authors.affiliation: Cardiac Electrophysiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D.B.K.).
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Kramer
authors.affiliation: University College of London Hospitals NHS Trust, London, United Kingdom (D.P.).
authors.forename: Dominic
authors.initials: D
authors.lastname: Pimenta
authors.affiliation: The Heart Hospital, University College of London Hospitals NHS Trust, London, United Kingdom (R.P., G.G.B., P.D.L.).
authors.forename: Girish G
authors.initials: GG
authors.lastname: Babu
authors.affiliation: Department of Health Care Policy, Harvard Medical School, Boston, MA (L.A.H.).
authors.forename: Laura A
authors.initials: LA
authors.lastname: Hatfield
authors.affiliation: University College of London, United Kingdom (A.I., P.D.L.).
authors.forename: Adam
authors.initials: A
authors.lastname: Ioannou
authors.affiliation: Solothurner Spitaeler AG, Solothurn, Switzerland (J.N.).
authors.forename: Jan
authors.initials: J
authors.lastname: Novak
authors.affiliation: Minneapolis Heart Institute Foundation, Minneapolis, MN (R.G.H.).
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hauser
authors.affiliation: The Heart Hospital, University College of London Hospitals NHS Trust, London, United Kingdom (R.P., G.G.B., P.D.L.) University College of London, United Kingdom (A.I., P.D.L.) Barts Heart Centre, Barts Health NHS Trust, London, United Kingdom (R.P., P.D.L.).
authors.forename: Pier D
authors.initials: PD
authors.lastname: Lambiase
mesh_terms: D016009:Chi-Square Distribution; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D004868:Equipment Failure; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D064887:Observational Studies as Topic; D016017:Odds Ratio; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: adverse event; complications; failure; fracture; implantable cardioverter‐defibrillator