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9/Auditing the clinical accuracy of Reveal Linq Interpretation via external analysis provider Focus On™

Published Online: October 9th 2012 European Journal of Arrhythmia & Electrophysiology. 2022;8(Suppl. 1):abstr9
Authors: D Walker (Presenting Author) – The Royal Wolverhampton NHS Trust, Wolverhampton; S Petkar – The Royal Wolverhampton NHS Trust, Wolverhampton; S Velu – The Royal Wolverhampton NHS Trust, Wolverhampton; N Sunni – Walsall Healthcare NHS Trust, Walsall; C Barr – The Dudley Group NHS Foundation Trust, Dudley; G Leventogiannis – The Dudley Group NHS Foundation Trust, Dudley; J Kelly – The Royal Wolverhampton NHS Trust, Wolverhampton; E Painter – The Royal Wolverhampton NHS Trust, Wolverhampton; L Bradley – The Royal Wolverhampton NHS Trust, Wolverhampton
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Introduction: With the ever-increasing importance of home monitoring for the follow-up of cardiac implanted electronic devices (CIED), emphasised during the COVID pandemic, the workload for CIED follow-up clinics has grown exponentially. The demand on services is exceeding resource, with innovative solutions needed to maximise efficiency, safety and quality. One potential solution has been offered by Medtronic in the form of a third-party triage/interpretation service called Focus On™. This service is linked to the clinic’s Carelink™ server, and they receive home monitoring downloads from the entirety or subset of Medtronic devices that are remotely monitored. They triage and interpret this information based on clinical significance. The information is returned to the follow-up clinic, classified as Green, Amber or Red based on clinical relevance, with email and/or telephone alerts to the clinic for Amber and Red alerts. Green alerts are those deemed to have no clinical relevance, with a recommendation that no extra clinic time is spent reviewing these reports. The service is promoted as not only a significant time saver, but also ensuring timely review and actioning of clinically significant data. Articles have been published confirming the same, although, to this author’s knowledge, no data have been published regarding the clinical accuracy of the Focus On™ service reports.

Aims: To assess the diagnostic accuracy of the Green alerts labelled as such by FocusOn™.

Methods: This was a retrospective 6-month audit of Reveal Linq Green alert downloads, which would normally have no secondary review from the device clinic. As all Amber and Red alerts receive clinic review, they were not included in our audit. Within that period, 6750 Green alert downloads were received (out of a total of 7780 transmissions), although only 3537 of those downloads had interpretable data (other alerts received for device battery RRT/atrial arrhythmia burden/patient downloads with no episodes etc.). A total of 500 downloads were then selected by randomly choosing 2 downloads with data from each patient page (2 out of 25). These downloads were initially reviewed by a highly specialised, IBHRE CCDS accredited cardiac physiologist. Any downloads for which the Focus On™ interpretation accuracy was queried were then anonymised and forwarded to 3 CRM and EP consultants, who were blinded to the audit, for analysis. These analyses were collated and discussed at a wider EP meeting, which involved 2 further EP consultants and EP/CRM physiologists, for a consensus opinion.

Results: Of the downloads reviewed, the accuracy of 17 interpretations (3.4%) were disputed by a consensus opinion from consultants and physiologists. A total of 12 of the 17 EGMs showed atrial tachycardia and/or fibrillation, which had been interpreted as sinus rhythm with ectopy; 3 showed junctional rhythm (1 with short sinus arrest), interpreted as sinus bradycardia; 1 showed second degree AV block Mobitz type I, interpreted as sinus bradycardia; 1 showed second-degree AV block type II, interpreted as second-degree AV block type I.

Conclusion: The findings of this audit show that the percentage of patients with an abnormal trace among the Green alerts is not inconsequential and can have a bearing on optimal patient management. NHS Trusts already using such services or planning on using this service in future should consider performing their own audit or have mechanisms in place to do so when the service is up and running, to ensure quality of patient care is maintained. 

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