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Adverse events following implantable cardioverter defibrillator implantation: a systematic review

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Purpose

Implantable cardioverter defibrillators (ICDs) prevent sudden cardiac death, but patients need to be counseled about potential harms. We summarized the evidence on adverse events from ICDs with a focus on ICD use for primary prevention of sudden cardiac death.

Methods

We searched MEDLINE and Cochrane Central Register of Controlled Trials from 2002 through 2012 for reports of adverse events from ICDs implanted for primary prevention or mixed indications (primary and secondary prevention). Studies had to have ≥500 patients and specify patient numerators and denominators.

Results

Data from 35 independent cohorts reported in 53 articles were included. Reports from one registry provided high quality evidence on adverse events during hospitalization for ICD implantation. Adverse events ranged from 2.8 to 3.6 %. Serious adverse events ranged from 1.2 to 1.4 %. The most frequent serious adverse events were pneumothorax (0.4–0.5 %) and cardiac arrest (0.3 %). The quality of the evidence for long-term adverse events was low. Frequency of adverse events post-hospitalization was variable, as was follow-up: device-related complications <0.1–6.4 % (2–49 months), lead-related complications <0.1–3.9 % (1.5–40 months), infection 0.2–3.7 % (1.5–49 months), and thrombosis 0.2–2.9 % (1.5–49 months). Evidence for inappropriate shock was of moderate quality with 3–21 % of patients experiencing at least one inappropriate shock during 1 to 5 years of follow-up.

Limitations

The limitation of the evidence reviewed in this study is low quality evidence for adverse events post-hospitalization. Evidence is predominantly from mixed primary and secondary prevention populations.

Conclusions

In-hospital adverse events after ICD implantation are infrequent. The estimates for long-term adverse events are uncertain. Up to one-fifth of patients receive inappropriate shocks.

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Acknowledgments

We would like to thank Jenny Lamont MS, Minghua Chen MD MPH, and Michael Miligkos MD for their help in screening and data extraction and to Esther E. Avendano, B.A. for editorial assistance.

Funding sources

This report is based on research conducted under contract by the Agency for Healthcare Research and Quality to the Tufts Evidence-Based Practice Center (Contract No. 290 2007 10055 I).

Disclosures

No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this article. Dr Garlitski is a clinical electrophysiologist and performs ICD implantation.

Disclaimer

This report is based on research conducted by the Tufts Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290 2007 10055 I). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ.

Author information

Authors and Affiliations

  1. Center for Clinical Evidence Research, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA

    Rebecca Persson, Amy Earley, Ethan M. Balk & Katrin Uhlig

  2. Division of Cardiology, Department of Medicine, Tufts Medical Center, Boston, MA, USA

    Ann C. Garlitski

  3. Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA, USA

    Katrin Uhlig

  4. Tufts Medical Center, 800 Washington Street, #391, Boston, MA, 02111, USA

    Katrin Uhlig

Authors
  1. Rebecca Persson
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  2. Amy Earley
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  3. Ann C. Garlitski
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  4. Ethan M. Balk
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  5. Katrin Uhlig
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Corresponding author

Correspondence to Katrin Uhlig.

Appendix

Appendix

Table 3 Search strategy
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Table 4 P values for comparisons of adverse events across patient subgroups during hospitalization for ICD implantation
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Table 5 Any adverse events across patient subgroups during hospitalization for ICD implantation
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Table 6 P values for comparisons of adverse events post-hospitalization and inappropriate shock across patient subgroups
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Persson, R., Earley, A., Garlitski, A.C. et al. Adverse events following implantable cardioverter defibrillator implantation: a systematic review. J Interv Card Electrophysiol 40, 191–205 (2014). https://doi.org/10.1007/s10840-014-9913-z

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  • DOI: https://doi.org/10.1007/s10840-014-9913-z

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