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Europace 2006 8(5):371-376; doi:10.1093/europace/eul023
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

ICD

Patient AlertTM to detect ICD lead failure: efficacy, limitations, and implications for future algorithms

Dirk Vollmann1,*, Ali Erdogan2, Ewald Himmrich3, Jörg Neuzner4, Daniel Becker5, Christina Unterberg-Buchwald1, Johannes Sperzel6 for the SAFE Study Investigators

1 Abteilung Kardiologie und Pneumologie, Herzzentrum, Georg-August-Universität Göttingen, Germany; 2 Justus-Liebig-Universität Gießen, Germany; 3 Johannes-Gutenberg-Universität Mainz, Germany; 4 Klinikum Kassel, Germany; 5 Medtronic Bakken Research Center, Maastricht, The Netherlands; 6 Kerckhoff-Klinik Bad Nauheim, Germany

Aims An algorithm that alerts implantable cardioverter-defibrillator (ICD) patients, in case of abnormal lead impedance (Patient AlertTM, Medtronic), may help to recognize lead dysfunction. We aimed to determine the utility of Patient Alert for ICD lead-failure detection in a prospective study.

Methods and results Three hundred and sixty ICD patients were followed for 22±14 months. Patient Alert was active for pacing impedance <200 and >2000–3000 {Omega}, and high-voltage conductor impedance <10–20 and >200 {Omega}. Ten alert events and a total of 29 severe system complications occurred. Patient Alert detected three of 10 ICD lead failures, with a positive predictive value (PPV) of 77.8% for any severe system complication. Retrospective analysis identified 23 patients with a sensing integrity counter (SIC) >300 and revealed an additional four prior undetected lead defects. SIC detected ICD lead failure with 92.9% sensitivity and a PPV of 59.1%. Eight of nine patients with a false-positive SIC had an integrated bipolar lead. Patient Alert combined with SIC detected all ICD lead failures and 71.4% of all severe lead complications.

Conclusions Patient Alert, based on daily lead-impedance measurement, detected one-third of all ICD lead failures. Combined use with continuous lead integrity monitoring (SIC) increased sensitivity to 100%. Integrated bipolar leads may yield a false-positive SIC. Incorporating SIC and automated pace/sense threshold measurement may improve Patient Alert sensitivity for severe lead complications.

Key Words: Implantable cardioverter-defibrillator, Lead failure, Impedance measurement, Oversensing, Complication

* Corresponding author. Tel: +49 551 39 9625; fax: +49 551 39 9628. E-mail address: dirkvollmann2000{at}aol.com


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