Study Calls for a Digital-First Approach to Patient Monitoring

BIOTRONIK has today announced an important online symposium hosting the principal investigator of the TRUST Trial¹, the latest study calling for a reform to the current clinical standards for in-person patient evaluations (IPE), as part of this year’s European Society of Cardiology Congress. The study assessed incidence and timing of actionable clinic work during post-implant implantable cardioverter defibrillator (ICD) management.

Prof. Niraj Varma will present his findings at the ‘Future Direction of Remote Cardiac Monitoring’ symposium. The study’s model of digitally driven remote patient monitoring aims to reduce non-actionable patient follow-ups, which causes undue strain on clinics and hospitals globally.

As part of the current standard, clinicians perform IPEs every three months irrespective of patient condition and device status. This means that before seeing a patient who requires attention, clinicians and healthcare systems are over-burdened with multiple non-actionable visits. This approach also places undue burden on patients, who must travel to the hospital – particularly strenuous and stressful for some patients – and can cause patients and their caregivers to lose workdays.

“Using alert-based monitoring, clinics can perform fewer but more meaningful in-clinic evaluations,” said Prof. Niraj Varma, principal investigator, TRUST Trial, Cleveland Clinic, United States. “Alert-based remote monitoring also has advantages for patients because at-risk patients gain from earlier identification of changes in device or disease conditions and this might enable interventional therapies.”

The randomized trial followed up its 1,450 patients for 15 months, with a 2:1 ratio of remote patient (RPM) to conventional follow-up. Conventional device interrogations were performed quarterly, as is standard; the RPM group was followed up at three then at 15 months.

A reduction in non-actionable visits can allow clinicians to have more time for patients who most need their care and it will significantly reduce the burden on patients, boosting patient satisfaction and compliance with treatment. Importantly, an alert-based system will notify clinics of clinically relevant patient events in between in-person visits, enabling earlier diagnosis or detection of worsening in patient condition, supporting improved clinical outcomes^2,3.

Key findings from the study:

• Non-actionable clinic visits were reduced by 81%.
• Number of in-person evaluation needed per actionable visit was 8.2 with conventional and 4.9 in RPM follow-ups, which was further reduced to 2.1 with alert-based follow-ups.
• Proven daily transmission success rate is essential for effective remote patient follow-up.

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References:

1. TRUST Trial. Varma, N., Love, C. J., Michalski, J., Epstein, A. E. Alert-Based ICD Follow-Up: A Model of Digitally Driven Remote Patient Monitoring. JACC: Clinical Electrophysiology. 2021. doi: 10.1016/j.jacep.2021.01.008
2. COMPAS Study. Mabo et al., European Heart Journal (2012), 33: 1105.
3. ECOST Study. Guedon-Moreau et al., European Heart Journal (2013), 34: 605-614.