Diagnostic Tests

What Physicians Need to Know

KardiaMobile for ECG Monitoring and Arrhythmia Diagnosis

 

Am Fam Physician. 2020 Nov 1;102(9):563-564.

KardiaMobile is a mobile, single-lead electrocardiogram (ECG) device that has been approved by the U.S. Food and Drug Administration for detection of atrial fibrillation (AF), bradycardia, and tachycardia.1 It connects wirelessly to a smartphone application to provide the ECG tracing and automated interpretation. KardiaMobile may be used by health care professionals, adults with known or suspected heart conditions, and health-conscious individuals to record, store, and display single-channel ECG rhythms.

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TestIndicationPopulationCost*

KardiaMobile

Detection of atrial fibrillation, bradycardia, and tachycardia

Adult patients with known or suspected heart conditions

$99


*—Payment rate according to Healthcare Bluebook. Accessed May 14, 2020 (zip code: 66211).

TestIndicationPopulationCost*

KardiaMobile

Detection of atrial fibrillation, bradycardia, and tachycardia

Adult patients with known or suspected heart conditions

$99


*—Payment rate according to Healthcare Bluebook. Accessed May 14, 2020 (zip code: 66211).

Accuracy

A study conducted in a single outpatient cardiology clinic compared KardiaMobile with a standard 12-lead ECG read by a cardiologist. The study included 233 patients with a mean age of 58 years. Most patients presented with paroxysmal AF, palpitations of unknown origin, or episodes of near collapse. The sensitivity and specificity of KardiaMobile were 92% and 95%, respectively, for AF; 85% and 83% for normal sinus rhythm (without premature atrial or ventricular contractions); and 84% and 91% for any form of sinus rhythm (with or without premature atrial or ventricular contractions).2

Another study involving 55 patients who underwent AF ablation found a sensitivity of 100% and specificity of 97% for AF or flutter.3 A third study of 381 university athletes, nonathlete university students, and patients in a cardiology clinic reported 94% sensitivity and specificity for AF.4

In 42 patients with a mean age of 69 years who had paroxysmal AF after cardiac surgery but were discharged home in sinus rhythm, KardiaMobile was used to identify AF recurrence within four weeks of discharge. In the participants with recurrent AF, sensitivity was 94.6% and specificity was 92.9%.5

Benefit

Address correspondence to Madhavi Singh, MD, at msingh1@pennstatehealth.psu.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. U.S. Food and Drug Administration. Indications for use. Kardia Band System. November 16, 2017. Accessed September 19, 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171816.pdf...

2. Selder JL, Breukel L, Blok S, et al. A mobile one-lead ECG device incorporated in a symptom-driven remote arrhythmia monitoring program. The first 5,982 Hartwacht ECGs [published correction appears in Neth Heart J. 2019;27(3):165]. Neth Heart J. 2019;27(1):38–45.

3. Tarakji KG, Wazni OM, Callahan T, et al. Using a novel wireless system for monitoring patients after the atrial fibrillation ablation procedure: the iTransmit study. Heart Rhythm. 2015;12(3):554–559.

4. Haberman ZC, Jahn RT, Bose R, et al. Wireless smartphone ECG enables large-scale screening in diverse populations. J Cardiovasc Electrophysiol. 2015;26(5):520–526.

5. Lowres N, Mulcahy G, Gallagher R, et al. Self-monitoring for atrial fibrillation recurrence in the discharge period post-cardiac surgery using an iPhone electrocardiogram. Eur J Cardiothorac Surg. 2016;50(1):44–51.

6. Mandrola J, Foy A. Downsides of detecting atrial fibrillation in asymptomatic patients. Am Fam Physician. 2019;99(6):354–355. Accessed September 19, 2020. https://www.aafp.org/afp/2019/0315/p354.html

7. Curry SJ, U.S. Preventive Services Task Force. Atrial fibrillation: screening with electrocardiography. Final recommendation statement. August 7, 2018. Accessed September 19, 2020. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/atrial-fibrillation-screening-with-electrocardiography

8. Perez MV, Mahaffey KW, Hedlin H, et al.; Apple Heart Study Investigators. Large-scale assessment of a smartwatch to identify atrial fibrillation. N Engl J Med. 2019;381(20):1909–1917.

9. Benezet-Mazuecos J, García-Talavera CS, Rubio JM. Smart devices for a smart detection of atrial fibrillation. J Thorac Dis. 2018;10(suppl 33):S3824–S3827.

10. Healthcare Bluebook. Electrocardiogram (24 hour study). Accessed May 14, 2020 (zip code: 66211). https://www.healthcarebluebook.com/ui/proceduredetails/192

This series is coordinated by Kenny Lin, MD, MPH, deputy editor.

A collection of Diagnostic Tests published in AFP is available at https://www.aafp.org/afp/diagnostic.

 

 

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