Alerts during automatic remote monitoring (RM) offer early event detection but risk data overload. Criteria for transmission vary and programming is inconsistent, reflecting lack of guidelines. What is unknown is a transmission schedule that captures important events but minimizes volume while maintaining patient safety. This was tested in the TRUST trial (the Lumos-T Reduces Routine Office Device Follow-Up Study; primary results reported previously
1), which randomized follow-up (1:2) of 1450 patients (mean age 63 ± 13 years; 72% (1042/1450) male; New York Heart Association class I/II 67% (976/1450); left ventricular ejection fraction 29% ± 11%; coronary artery disease 67% (973/1450); 1° prevention indication 72% (1048/1450); DDD mode 57% (820/1450)) receiving implantable cardioverter-defibrillators to conventional care (evaluated in-office every 3 months) or to RM (Biotronik Home Monitoring) using a prespecified set of alert notifications with a high predictive value
- Varma N.
- Epstein A.
- Irimpen A.
- et al.
Efficacy and safety of automatic remote monitoring for ICD follow-up: the TRUST trial.
Circulation. 2010; 122: 325-332
2(Figure 1). Safety, a primary end point, was evaluated by the incidence of major adverse cardiovascular events including death, stroke, and cardiac surgical interventions. All patients gave written informed consent in this institutional review board–approved study conducted according to the Helsinki Declaration.
- Ricci R.
- Morichelli L.
- D’Onofrio A.
- et al.
Home monitoring manpower, sensitivity and positive predictive value of adverse event detection: preliminary results from the Home Guide registry.
Eur Heart J. 2011; 32: 54
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- Efficacy and safety of automatic remote monitoring for ICD follow-up: the TRUST trial.Circulation. 2010; 122: 325-332
- Home monitoring manpower, sensitivity and positive predictive value of adverse event detection: preliminary results from the Home Guide registry.Eur Heart J. 2011; 32: 54
- Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial.J Cardiovasc Electrophysiol. 2014; 25: 763-770
- Remote monitoring of cardiovascular devices—a time and activity analysis.Heart Rhythm. 2012; 9: 1947-1951
- Optimizing implantable cardioverter-defibrillator remote monitoring: a practical guide.JACC Clin Electrophysiol. 2017; 3: 315-328
Published online: November 29, 2022
Funding Sources: This trial was sponsored by Biotronik.
Disclosures: Dr Varma serves as a consultant to Biotronik. Mr Michalski is an employee of Biotronik.
Trial Registration: ClinicalTrials.gov identifier NCT00336284
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