Cited by 62Cardiac pacing and defibrillation studiesInfective Endocarditis Diagnosis and ManagementCardiac electrophysiology and arrhythmias

Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures

Kallinen, Linda M., Hauser, Robert G., Tang, Chuen, Melby, Daniel P., Almquist, Adrian K., Katsiyiannis, William T., Gornick, Charles C.·2010·Heart Rhythm

Abstract

Background The Medtronic Sprint Fidelis high-voltage implantable cardioverter-defibrillator (ICD) lead is prone to fracture. The majority of fractures involve the pace-sense (P/S) conductors and may result in multiple inappropriate shocks. The Medtronic lead integrity alert (LIA) algorithm was designed to improve early detection of transient P/S conductor fractures and to decrease the incidence and number of inappropriate shocks.Objective The purpose of this prospective single-center study was to assess the effectiveness of the LIA algorithm for warning patients of an impending Sprint Fidelis P/S conductor fracture and for decreasing the incidence and number of inappropriate shocks.Methods The study population included all patients who had Sprint Fidelis leads and Medtronic ICD pulse generators that were implanted and followed at the Minneapolis Heart Institute. Patients were evaluated in the clinic every 3 to 4 months or by remote monitoring using the Medtronic CareLink system. When the LIA algorithm was released in August 2008, the RAMware was downloaded to the pulse generator of all patients with the Sprint Fidelis lead. Patients and family members received educational materials and were given a demonstration of the audible alerts.Results Between October 2004 and January 2010, 52 (11.3%) of 461 Sprint Fidelis leads failed in the study population. Inappropriate shocks were the first sign of lead failure in 18 (69%) of the 26 patients who did not have the LIA compared to 4 (17%) of 23 patients who had the LIA (P = .0004). Patients who experienced inappropriate shocks without the LIA received an average of 13.2 +/- 13.6 inappropriate shocks (range 2-54) versus 3.0 +/- 2.0 inappropriate shocks (range 2-6) in patients who had the LIA (P = .017). The audible alert was effective in 70% (16/23) and 35% (6/17) of patients with and without the LIA, respectively, whose alerts were programmed ON (P = .053). Overall, 8 (32%) of 25 patients whose audible alerts were triggered did not immediately hear or recognize the tone.Conclusion The LIA appears to be an effective method for detecting most Sprint Fidelis lead fractures and for decreasing the incidence and number of inappropriate shocks. However, a better method for alerting patients and caregivers is needed.

Integrity signals

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Crossref · 10.1016/j.hrthm.2010.05.015

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  • Prospective although smaller studies have also demonstrated that lead integrity alerts decrease shocks.

    “Prospective although smaller studies have also demonstrated that lead integrity alerts decrease shocks.75”

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Authors
Kallinen, L. M., Hauser, R. G., Tang, C., Melby, D. P., Almquist, A. K., Katsiyiannis, W. T., & Gornick, C. C.
Affiliations
Minneapolis Heart Institute Foundation (US)
Corresponding author
Hauser, Robert G.
Venue
Heart Rhythm
Publisher
Elsevier BV
Published
2010-08
Volume
7
Issue
8
Pages
1048-1055
ISSN
1547-5271 (ISSN-L)
OpenAlex
W2011174551
Cited by
62
References
16
Citations by year
2025: 2 · 2024: 1 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 2 · 2018: 2 · 2017: 2 · 2016: 4 · 2015: 3 · 2014: 5 · 2013: 8 · 2012: 12
FWCI
7.68
Type
journal article
Language
en
Open access
closed
Locations
  • Heart Rhythm (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
  • Health Sciences › Medicine › Epidemiology › Infective Endocarditis Diagnosis and Management
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
Keywords
inappropriate shocks, implantable cardioverter-defibrillator, remote monitoring, patient education
MeSH terms
Adult, Aged, Algorithms, Cardiac Pacing, Artificial, Electrodes, Implanted, Equipment Failure, Female, Humans, Male, Middle Aged, Defibrillators, Implantable

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