Nationwide Longitudinal Follow-Up of Riata Leads Under Advisory at 3 Annual Screenings: Report From the Netherlands Heart Rhythm Association Device Advisory Committee

JACC. Clinical Electrophysiology
Dominic A M J TheunsMathias Meine

Abstract

This study sought to determine prospectively the rate of conductor externalization (CE), and whether this was associated with electrical failure. The Riata family of defibrillator leads was placed under U.S. Food and Drug Administration advisory as of November 28, 2011 because of high rates of CE. A nationwide cohort established in 2012 of 1,029 patients with recalled Riata leads with 147 CE were followed until death, lead discontinuation, or 3 annual screenings with fluoroscopy and device interrogation. Follow-up of 882 patients with normal baseline fluoroscopy revealed incident overt CE in 95 leads (11%) after median risk time of 2.9 years, yielding an incidence rate of 4.9 (95% confidence interval [CI]: 3.9 to 5.9) per 100 patient-years. The incidence rate was significantly higher in 8-F Riata leads than in 7-F Riata ST leads (7.0 vs. 3.2 per 100 patient-years; p < 0.001). Electrical follow-up demonstrated electrical abnormality in 77 leads, resulting in an incidence rate of 4.0 (95% CI: 3.2 to 5.0) per 100 patient-years. The incidence rate of electrical abnormalities was not different between leads without CE and those with CE (3.9 vs. 5.2 per 100 patient-years; p = 0.39). The development of CE is progressive in nature with...Continue Reading

References

Aug 5, 2008·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Gabor Z DurayStefan H Hohnloser
Jan 15, 2010·Pacing and Clinical Electrophysiology : PACE·Suzanne ValkLuc Jordaens
Mar 30, 2010·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Martyn W RichardsMark H Anderson
Apr 5, 2011·Journal of Cardiovascular Electrophysiology·Damir ErkapicStefan H Hohnloser
Dec 2, 2011·Netherlands Heart Journal : Monthly Journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation·D A M J Theuns, L Jordaens
Jun 16, 2012·Journal of Cardiovascular Electrophysiology·Sharon ShenSusan S Kim
Oct 6, 2012·Pacing and Clinical Electrophysiology : PACE·Vivek N KodothMichael J D Roberts
Nov 7, 2012·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Raed H AbdelhadiRobert G Hauser
Feb 19, 2013·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Jacob M LarsenJens B Johansen
Sep 3, 2013·Heart Rhythm : the Official Journal of the Heart Rhythm Society·David HayesScott Beau
Sep 10, 2013·The American Journal of Cardiology·Jeffrey LiuSamir Saba
Sep 14, 2013·Journal of Cardiovascular Electrophysiology·Travis D RichardsonChristopher R Ellis
May 24, 2014·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Melanie MaytinLaurence M Epstein
Jul 11, 2014·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Jacob M LarsenSøren P Hjortshøj
Aug 2, 2014·Pacing and Clinical Electrophysiology : PACE·Nicholas A McKeagMichael J D Roberts
Dec 17, 2014·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Maria Grazia BongiorniEzio Soldati
May 24, 2015·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Emily P ZeitlerJonathan P Piccini

❮ Previous
Next ❯

Citations

Apr 17, 2020·Pacing and Clinical Electrophysiology : PACE·Vanessa CobbAnthony Chow

❮ Previous
Next ❯

Related Concepts

Related Feeds

Basal Ganglia

Basal Ganglia are a group of subcortical nuclei in the brain associated with control of voluntary motor movements, procedural and habit learning, emotion, and cognition. Here is the latest research.