Can we predict and prevent adverse events related to high-voltage implantable cardioverter defibrillator lead failure?
- 170 Downloads
In 2007, great concern arose regarding failure of implantable cardioverter defibrillator (ICD) leads from several manufacturers.
Of this analysis was to evaluate the incidence and predictors of Sprint Fidelis lead failure in order to find the best clinical strategy to prevent lead-related adverse events.
Four hundred fourteen patients (357 male, 67 ± 12 years) with ICD equipped with right ventricular Sprint Fidelis leads were followed up in our institution.
Over a median follow-up of 35 months (25th–75th percentile = 27–47 months) and a total follow-up of 1,231 patient-years, lead failures occurred in 40 of 414 (9.7%) patients. The annual rate was 3.2% per patient-year. Thirty-five (87.5%) failures were caused by pacing–sensing connector fracture. The risk of lead fracture was higher in patients younger than 70 years (odds ratio = 2.31; 95% confidence interval = 1.14–4.68, p = 0.02). Among 30 patients with pacing–sensing conductor failure and available device diagnostics for failure alerting, the diagnostic parameter which first responded to lead failure was the sensing integrity counter in 15 of 30 (50%), pacing impedance in 12 of 30 (40%), and non-sustained ventricular tachycardia in 3 of 30 (10%). The median time (25th–75th percentile) between diagnostics alert and lead failure-related adverse events or failure acknowledgment was 2.2 (0.3–13.0) days. Twenty-two patients suffered inappropriate shocks due to lead failure. In 50% of patients, daily monitoring by device diagnostics would have alerted physicians to impending lead failure at least 1 day in advance.
Automatic algorithms based on device diagnostics may detect impending lead failure in nearly 50% of cases. Remote monitoring may prevent failure-related adverse events.
KeywordsImplantable cardioverter defibrillator Lead Inappropriate shock Failure Remote monitoring Recall
- 1.Schoenfeld, M. H., Benditt, D. G., Fletcher, R. D., Furman, S., Goldschlager, N. F., Hayes, D. L., et al. (1992). NASPE policy statement. Recommendations for implementation of a North American multicenter arrhythmia device/lead database. Pacing Clin Electrophysiol, 15, 1632–1636.PubMedCrossRefGoogle Scholar
- 3.Carlson, M. D., Wilkoff, B. L., Maisel, W. H., Carlson, M. D., Ellenbogen, K. A., Saxon, L. A., et al. (2006). Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm, 3, 1250–1273.PubMedCrossRefGoogle Scholar
- 10.Krahn, A. D., Champagne, J., Healey, J. S., Cameron, D., Simpson, C. S., Thibault, B., et al. (2008). Canadian Heart Rhythm Society Device Advisory Committee. Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Device Advisory Committee. Heart Rhythm, 5(5), 639–642.PubMedCrossRefGoogle Scholar
- 11.Chun D, Keung E. Survival analysis of a high-voltage implantable cardioverter-defibrillator lead on United States food and drug administration recall. http://europace.oxfordjournals.org/content/11/suppl_1/i37.full.pdf (Abstract)
- 15.Swerdlow, C., & Shivkumar, K. (2004). Implantable cardioverter defibrillators: Clinical aspects. In D. P. Zipes & J. Jalife (Eds.), Cardiac electrophysiology: From cell to bedside (4th ed., pp. 980–993). Philadelphia: Saunders.Google Scholar
- 20.Kallinen, L. M., Hauser, R. G., Lee, K. W., Almquist, A. K., Katsiyiannis, W. T., Tang, C. Y., et al. (2008). Failure of impedance monitoring to prevent adverse clinical events caused by fracture of a recalled high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm, 5(6), 775–779.PubMedCrossRefGoogle Scholar
- 26.Ricci RP, Proclemer A, Accogli M, et al. AIAC Registro Avarie e Complicanze. http://www.aiac.it/registriaiac.asp