Cardionetics Ambulatory ECG Monitors

Clinical Trials

This article describes the clinical trials that Cardionetics has conducted to validate and demonstrate the performance of the C.Net5000 and C.Net2000+ ambulatory ECG monitors.

Comparison with Cardiologists

The analysis of ECG data performed by the C.Net2000+ has been validated against the performance of gold standard cardiology specialists in clinical trials sponsored by the British Heart Foundation and carried out at St. George's Hospital in London [1]. The C.Net2000+ achieved an accuracy level of 96%, which compares well with individual cardiologists, who averaged 91.4%. Moreover, the C.Net2000+ maintains a 100% consistency of diagnosis, eliminating human observer variability, which can be as high as 30%. The capability of the C.Net2000+ and C.Net5000 allows routine tests to be performed automatically and immediately at the primary care level prior to referral to a cardiologist.

Comparison with General Practitioners

A year-long planned, open, prospective study involving fifty-three GPs in 16 surgeries examined the practicality of carrying out 24-hour ambulatory ECG arrhythmia testing in primary care.

Interim results of the study were published in the British Journal of Cardiology [2], showing a 60% reduction in referrals to cardiology outpatients departments. Of the 26% who were referred, almost one third would not have been, had the GP not had access to a Cardionetics ECG monitor. The false negative rate for urgent referrals also improved when GPs used the C.Net2000+, only 15% of referrals being identified as urgent by the GP when not using the C.Net2000+, rising to 37% of referrals when using the equipment.

The results have positive implications for meeting the 18-week delivery target and Quality and Outcomes Framework (QOF) as well as improving patient care as a result of earlier diagnosis.

Use in General Practice

A clinical case-study paper has been published by Dr Kassianos, a general practitioner who uses the Cardionetics C.Net2000+ [3]. It describes two cases where use of the monitor resulted in early diagnosis and rapid treatment with satisfactory outcomes.

A follow-up study by Dr Kassianos examined records from 52 patients patients undergoing ECG monitoring in a primary care practice over a two-year period. The study showed that ambulatory ECG monitoring proved feasible and useful in primary care. Results were used as the basis of referrals for 50% of patients tested, and to inform initiation or changes of medication in a further 24% of patients [4].

Comparison with Holter Monitors

A further study is currently under way that compares diagnosis levels resulting from secondary care technicians using Holter recorder technology with automated analysis using the Cardionetics C.Net5000. The results obtained so far show comparable performance.

References

[1] L. Gamlyn, P. Needham, S. M. Sopher, T. J. Harris, The development of a neural network-based ambulatory ECG monitor, Neural Computing and Applications, 1999, Vol. 8, pp. 273–378.

[2] P. Standing, M. Dent, A. Craig, B. Glenville, Changes in referral patterns to cardiac outpatient clinics with ambulatory ECG monitoring in general practice, British Journal of Cardiology, 2001, Vol. 8 No. 6, pp. 394–398.

[3] A. K. J. Mandal, C. G. Missouris, G. G. Kassianos, Palpitations and syncope in primary care, British Journal of Cardiology, 2004, Vol. 11 No. 6, pp. 492–494. View

[4] G. Kassianos, Ambulatory ECG monitoring in primary care, Primary Care Cardiovascular Journal, July 2008, Vol. 1, No. 2. View