Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads

Giovanni B. Forleo, Luigi Di Biase, Germana Panattoni, Alessandro Politano, Giulia Magliano, Luca Santini, Andrea Natale, Francesco Romeo

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Aims Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients. Methods and Results Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant. Conclusion This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.

Original languageEnglish (US)
Pages (from-to)265-270
Number of pages6
JournalEuropace
Volume16
Issue number2
DOIs
StatePublished - Feb 2014

Fingerprint

Polyurethanes
Implantable Defibrillators
Silicones
Fluoroscopy
Lead
Noise
Incidence

Keywords

  • Durata
  • Fluoroscopy
  • Implantable cardioverter-defibrillator
  • Insulation breach
  • Lead failure
  • Riata

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads. / Forleo, Giovanni B.; Di Biase, Luigi; Panattoni, Germana; Politano, Alessandro; Magliano, Giulia; Santini, Luca; Natale, Andrea; Romeo, Francesco.

In: Europace, Vol. 16, No. 2, 02.2014, p. 265-270.

Research output: Contribution to journalArticle

Forleo, Giovanni B. ; Di Biase, Luigi ; Panattoni, Germana ; Politano, Alessandro ; Magliano, Giulia ; Santini, Luca ; Natale, Andrea ; Romeo, Francesco. / Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads. In: Europace. 2014 ; Vol. 16, No. 2. pp. 265-270.
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