Safety and compatibility of smart device heart rhythm monitoring in patients with cardiovascular implantable electronic devices

Anas A. Abudan, Ameesh Isath, James D. Ryan, Mark J. Henrich, Jennifer L. Dugan, Zachi I. Attia, Dorothy J. Ladewig, John J. Dillon, Paul Andrew Friedman

Research output: Contribution to journalArticle

Abstract

Introduction: Emerging medical technology has allowed for monitoring of heart rhythm abnormalities using smartphone compatible devices. The safety and utility of such devices have not been established in patients with cardiac implantable electronic devices (CIEDs). We sought to assess the safety and compatibility of the Food and Drug Administration-approved AliveCor Kardia device in patients with CIEDs. Methods and Results: We prospectively recruited patients with CIED for a Kardia recording during their routine device interrogation. A recording was obtained in paced and nonpaced states. Adverse clinical events were noted at the time of recording. Electrograms (EGMs) from the cardiac device were obtained at the time of recording to assess for any electromagnetic interference (EMI) introduced by Kardia. Recordings were analyzed for quality and given a score of 3 (interpretable rhythm, no noise), 2 (interpretable rhythm, significant noise) or 1 (uninterpretable). A total of 251 patients were recruited (59% with a pacemaker and 41% with ICD). There were no adverse clinical events noted at the time of recording and no changes to CIED settings. Review of all EGMs revealed no EMI introduced by Kardia. Recordings were correctly interpreted in 90% of paced recordings (183 had a score of 3, 43 of 2, and 25 of 1) and 94.7% of nonpaced recordings (147 of 3, 15 of 2, and 9 of 1). Conclusion: The AliveCor Kardia device has an excellent safety profile when used in conjunction with most CIEDs. The quality of recordings was preserved in this population. The device, therefore, can be considered for heart rhythm monitoring in patients with CIEDs.

Original languageEnglish (US)
JournalJournal of cardiovascular electrophysiology
DOIs
StatePublished - Jan 1 2019

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Physiologic Monitoring
Safety
Equipment and Supplies
Electromagnetic Phenomena
Noise
Congenital Heart Defects
United States Food and Drug Administration

Keywords

  • AliveCor
  • electrocardiogram
  • ICD
  • Kardia
  • pacemaker
  • safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Safety and compatibility of smart device heart rhythm monitoring in patients with cardiovascular implantable electronic devices. / Abudan, Anas A.; Isath, Ameesh; Ryan, James D.; Henrich, Mark J.; Dugan, Jennifer L.; Attia, Zachi I.; Ladewig, Dorothy J.; Dillon, John J.; Friedman, Paul Andrew.

In: Journal of cardiovascular electrophysiology, 01.01.2019.

Research output: Contribution to journalArticle

Abudan, Anas A. ; Isath, Ameesh ; Ryan, James D. ; Henrich, Mark J. ; Dugan, Jennifer L. ; Attia, Zachi I. ; Ladewig, Dorothy J. ; Dillon, John J. ; Friedman, Paul Andrew. / Safety and compatibility of smart device heart rhythm monitoring in patients with cardiovascular implantable electronic devices. In: Journal of cardiovascular electrophysiology. 2019.
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abstract = "Introduction: Emerging medical technology has allowed for monitoring of heart rhythm abnormalities using smartphone compatible devices. The safety and utility of such devices have not been established in patients with cardiac implantable electronic devices (CIEDs). We sought to assess the safety and compatibility of the Food and Drug Administration-approved AliveCor Kardia device in patients with CIEDs. Methods and Results: We prospectively recruited patients with CIED for a Kardia recording during their routine device interrogation. A recording was obtained in paced and nonpaced states. Adverse clinical events were noted at the time of recording. Electrograms (EGMs) from the cardiac device were obtained at the time of recording to assess for any electromagnetic interference (EMI) introduced by Kardia. Recordings were analyzed for quality and given a score of 3 (interpretable rhythm, no noise), 2 (interpretable rhythm, significant noise) or 1 (uninterpretable). A total of 251 patients were recruited (59{\%} with a pacemaker and 41{\%} with ICD). There were no adverse clinical events noted at the time of recording and no changes to CIED settings. Review of all EGMs revealed no EMI introduced by Kardia. Recordings were correctly interpreted in 90{\%} of paced recordings (183 had a score of 3, 43 of 2, and 25 of 1) and 94.7{\%} of nonpaced recordings (147 of 3, 15 of 2, and 9 of 1). Conclusion: The AliveCor Kardia device has an excellent safety profile when used in conjunction with most CIEDs. The quality of recordings was preserved in this population. The device, therefore, can be considered for heart rhythm monitoring in patients with CIEDs.",
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