Research Article

Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology

Table 2

Diagnostic evaluation of the arrhythmia detection in parallel tests with ECG247 Smart Heart Sensor and conventional Holter technology.

Arrhythmia and ectopic beats, n = 150Diagnostic evaluationECG247 algorithm, 95% CIECG247 algorithm and physician review, 95% CIHolter algorithm, 95% CIHolter algorithm and physician review, 95% CI

Atrial fibrillationSensitivity8/9 = 89% (52–100)9/9 = 100% (66–100)7/9 = 78% (40–97)8/9 = 89% (52–100)
Specificity135/141 = 96% (91–98)141/141 = 100% (97–100)115/141 = 82% (74–88)141/141 = 100% (97–100)
Positive predictive value57% (37–75)100%21% (14–31)100%
Negative predictive value99% (96–100)100%98% (94–99)99% (96–100)
Diagnostic accuracy95% (91–98)100% (98–100)81% (74–87)99% (96–100)

Ventricular ectopic beatsSensitivity114/122 = 93% (87–97)114/122 = 93% (87–97)114/122 = 93% (88–97)118/122 = 97% (92–99)
Specificity8/28 = 29% (13–49)28/28 = 100% (88–100)16/28 = 57% (37–76)28/28 = 100% (88–100)
Positive predictive value85% (82–88)100%90% (86–94)100%
Negative predictive value50% (29–71)78% (64–87)67% (49–81)88% (73–95)
Diagnostic accuracy81% (74–87)95% (90–98)87% (80–92)97% (93–99)

Supraventricular ectopic beatsSensitivity130/135 = 96% (92–99)130/135 = 96% (92–99)131/135 = 97% (93–99)131/135 = 97% (93–99)
Specificity7/15 = 47% (21–73)15/15 = 100% (78–100)9/15 = 60% (32–84)15/15 = 100% (78–100)
Positive predictive value94% (91–96)100%96% (92–98)100%
Negative predictive value58% (34–79)75% (56–88)69% (44–87)79% (59–91)
Diagnostic accuracy91% (86–95)97% (92–99)93% (88–97)97% (93–99)