Diagnostic Accuracy of a Novel Wireless, Bluetooth-Enabled Simultaneous 12-Lead Portable ECG Device Compared with Standard ECG in Preoperative Patient Population

Background and Objectives: Significant proportion of patients undergoing various surgeries have abnormal ECG findings and it is known to have prognostic value. Recently, portable ECG with Bluetooth technology with smartphone have been gaining popularity. One such novel device, Wellnest (R) is a Bluetooth enabled portable ECG machine, can capture simultaneous 12 lead ECG on smartphone application. This is probably only such device available device in India. The objective of this study was to test diagnostic accuracy of Wellnest 12L ECG device compared to standard 12 lead ECG. Methods and Material: This was a Prospective, observational, diagnostic accuracy study conducted at a tertiary care level hospital. During, pre-anaesthesia check-up visit of 109 patients undergoing cardiac and non-cardiac surgeries, whenever indicated, a preoperative 12 lead ECG was done. The Wellnest 12 lead ECG was done within 24 hours of standard ECG. Matching was done between Minnesota codes assigned to ECG findings of Wellnest and standard 12 lead ECG. Also, grading of Wellnest ECG quality was done as excellent, good, bad and poor. Results: In all, 216 various Minnesota codes were assigned to 109 patients undergoing various surgeries. The primary endpoint of Wellnest ECG in comparison to standard ECG were- sensitivity of 96.51% (CI 90.14- 99.27%); specificity of 86.96% (CI 66.41- 97.22%); positive likelihood ratio of 7.4 (CI 2.57- 21.27) and negative likelihood ratio of 0.04 (CI 0.01- 0.12).Performance of Wellnest ECG as per individual Minnesota Codes compared to standard ECG was also acceptable. Wellnest ECG was graded as excellent in 55(50%) patients, good in 51(47%) patients and only 3 (3%) patients were graded as bad. Conclusions: Wellnest ECG had satisfactory performance in comparison with standard 12 lead ECG in preoperative patient population. It is easy to use, portable and can give simultaneous 12 leads ECG and its use in preoperative population can be recommended.