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“Home monitoring” for early detection of implantable cardioverter-defibrillator failure

A single-center prospective observational study

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Abstract

Background

Telemedical ICD monitoring has the potential to enhance patient safety. The “home-monitoring” (HM) feature transmits selected device-related data to a service-center via mobile phone network. In case of a potential emergency situation, event reports are generated automatically. This prospective observational study was designed to test whether HM is effective and reliable in early detection of device failure.

Methods

Consecutive patients receiving ICD, CRT-D or CRT pacemaker systems with HM feature were included. Regular follow-up visits were performed 1, 3, 6, 9 and 12 months after implantation in the first year, and every 6 months thereafter. All event reports transmitted by HM were analyzed and severe device-related events (serious lead or device dysfunction, hospitalization, death) were documented including timing, type and mode of detection.

Results

Sixty-nine patients were included and followed for 18 ± 9 months. A total of 206 event reports were transmitted, prompted by VF/VT-episodes (n = 193), ineffective ICD shocks (n = 7), abnormal pacing impedance (n = 4) or battery depletion (n = 2). 8 SAEs were observed (RV lead fracture; n = 5, connector defect; n = 1, sensing defect, n = 1, RV lead dislodgement, n = 1). There was no device-related death. 6 out of 8 SAEs were discovered by HM (sensitivity, 75%). Without HM, these events would have been detected with a theoretical delay of 1.9 ± 0.5 months in the first year (3 monthly FU) and 4.9 ± 0.5 months in the following years (6 monthly FU).

Conclusions

This pilot study demonstrates that HM enables early detection of ICD failure and appears to enhance patient safety.

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Abbreviations

CRT:

Cardiac resynchronisation therapy

CRT-D:

CRT-defibrillator system

EF:

Ejection fraction

ERI:

Elective replacement indicator

FU:

Follow up

HM:

Home monitoring

ICD:

Implantable cardioverter defibrillator

SAE:

Serious adverse event

VF:

Ventricular fibrillation

VT:

Ventricular tachycardia

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Authors and Affiliations

  1. Department of Cardiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany

    Melanie Hauck, Alexander Bauer, Frederik Voss, Slawomir Weretka, Hugo A. Katus & Ruediger Becker

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  1. Melanie Hauck
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  2. Alexander Bauer
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  3. Frederik Voss
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  4. Slawomir Weretka
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  5. Hugo A. Katus
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  6. Ruediger Becker
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Corresponding author

Correspondence to Melanie Hauck.

Additional information

Melanie Hauck, Alexander Bauer: both authors contributed equally to this work.

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Hauck, M., Bauer, A., Voss, F. et al. “Home monitoring” for early detection of implantable cardioverter-defibrillator failure. Clin Res Cardiol 98, 19–24 (2009). https://doi.org/10.1007/s00392-008-0712-3

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  • DOI: https://doi.org/10.1007/s00392-008-0712-3

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