J Korean Med Sci.  2017 Oct;32(10):1610-1615. 10.3346/jkms.2017.32.10.1610.

The Incidence of Riata Defibrillator Lead Failure: a Single-Center Experience

• Gwag HB
• Hwang JK
• Park KM
• Park SJ
• On YK
• Kim JS

• KMID: 2400432
• DOI: http://doi.org/10.3346/jkms.2017.32.10.1610

Abstract

Riata defibrillator leads were recalled due to a high failure rate. This study measured the incidence of externalized conductor (EC) and electrical dysfunction (ED) and sought to determine the predictors of ED with Riata defibrillator leads. We enrolled patients who received Riata® or Riata® ST silicone defibrillator leads at our center between January 2003 and December 2010. The presence of EC was evaluated with chest radiography. The incidence rates were measured at < 3 years, 3-5 years, and > 5 years after lead implantation. We also investigated the rates of ED and other clinical events during the follow-up period. A total of 44 patients were analyzed. The total cumulative incidence of EC was 27.3%. During the median dwell time (80 months), the incidence of ED was 22.7%. Patients with ED were younger (46.5 vs. 56.5 years, P = 0.018) and had a higher prevalence of cardiomyopathy than those without ED (60.0% vs. 20.6%, P = 0.043). ECs were most frequently detected in patients who underwent X-ray analysis 3-5 years after lead implantation (44.4%). In contrast, ED had a bimodal incidence pattern, with peaks at 5 years (7.0%) and 9 years (5.3%). There was no difference in ED-free survival rate between patients with and without EC (P = 0.628). Given the delayed occurrence of EC and ED after implantation of Riata defibrillator leads, long-term close monitoring is critically important.

Keyword

Implantable Cardioverter-Defibrillator; Device Failure; Device Safety

MeSH Terms

Cardiomyopathies
Defibrillators*
Defibrillators, Implantable
Equipment Failure
Equipment Safety
Follow-Up Studies
Humans
Incidence*
Prevalence
Radiography
Silicon
Silicones
Survival Rate
Thorax
Silicon
Silicones

Figure

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  Fig. 1 Location of conductor externalization on chest X-ray (posterior-anterior view). (A) Single coil lead. (B) Dual coil lead.A = distal to the SVC coil (dual coil lead) or distal to the SVC (single coil lead) (A1, proximal right ventricular coil to the tricuspid annulus; A2, tricuspid annulus; A3, tricuspid annulus to the SVC coil [dual coil lead] or right atrium [single coil lead]), B = distal to the clavicle including the SVC coil (dual coil lead) or SVC area (single coil lead), C = clavicular area, D = distal clavicle to the generator can, SVC = superior vena cava.

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  Fig. 2 Flow diagram of study patients.EC = externalized conductor, ED = electrical dysfunction.

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  Fig. 3 Incidence of EC of Riata leads on follow-up chest X-ray.EC = externalized conductor.

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  Fig. 4 The incidence of ED according to dwell time.ED = electrical dysfunction.

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  Fig. 5 Kaplan-Meier curve of cumulative probabilities of ED-free survival according to the EC of Riata leads.*P value refers to the result of the log-rank test between patients with and without ECs.EC = externalized conductor, ED = electrical dysfunction.

• 

  Fig. 6 Different types of electrical lead dysfunction.ED = electrical dysfunction.

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