Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations

Niraj Varma, Justin Michalski, Bruce Stambler, Behzad B Pavri, TRUST Investigators, Niraj Varma, Justin Michalski, Bruce Stambler, Behzad B Pavri, TRUST Investigators

Abstract

Aims: To test recommended implantable cardioverter defibrillator (ICD) follow-up methods by 'in-person evaluations' (IPE) vs. 'remote Home Monitoring' (HM).

Methods and results: ICD patients were randomized 2:1 to automatic HM or to Conventional monitoring, with follow-up checks scheduled at 3, 6, 9, 12, and 15 months post-implant. Conventional patients were evaluated with IPE only. Home Monitoring patients were assessed remotely only for 1 year between 3 and 15 month evaluations. Adherence to follow-up was measured. HM and Conventional patients were similar (age 63 years, 72% male, left ventricular ejection fraction 29%, primary prevention 73%, DDD 57%). Conventional management suffered greater patient attrition during the trial (20.1 vs. 14.2% in HM, P = 0.007). Three month follow-up occurred in 84% in both groups. There was 100% adherence (5 of 5 checks) in 47.3% Conventional vs. 59.7% HM (P < 0.001). Between 3 and 15 months, HM exhibited superior (2.2×) adherence to scheduled follow-up [incidence of failed follow up was 146 of 2421 (6.0%) in HM vs. 145 of 1098 (13.2%) in Conventional, P < 0.001] and punctuality. In HM (daily transmission success rate median 91%), transmission loss caused only 22 of 2275 (0.97%) failed HM evaluations between 3 and 15 months; others resulted from clinic oversight. Overall IPE failure rate in Conventional [193 of 1841 (10.5%) exceeded that in HM [97 of 1484 (6.5%), P < 0.001] by 62%, i.e. HM patients remained more loyal to IPE when this was mandated.

Conclusion: Automatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE.

Clinical trial registration: NCT00336284.

Keywords: Defibrillators; Follow-up; Patient monitoring; Remote Monitoring' Guidelines.

© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
TRUST trial: post-implant follow-up scheme for 15 months. Three monthly (total 5) guideline-based evaluations were prescribed in both study arms. All were in-person (IPE) in Conventional. In Home Monitoring, evaluations were always remote, but at 3 and 15 months were followed by in-person, i.e. remote management was exercised solely for the interim 12 months.
Figure 2
Figure 2
Conventional vs. Home Monitoring success rates compared.
Figure 3
Figure 3
Rates of failed calendar-based evaluations in remote-only vs. conventional care between 3 and 15 months, i.e. at 3, 6, and 9 months, and total [right —146 of 2421 (6%) in Home Monitoring vs. 145 of 1098 (13.2%) with conventional].
Figure 4
Figure 4
(Top) Reasons for failed Home Monitoring checks during all vs. remote-only (6, 9, and 12 month) appointments. Clinic oversight was dominant. Transmission loss was infrequent, but when responsible for ‘unsuccessful follow-up’, (Bottom) last transmission available occurred a median of 36 days prior (left), and (right) after discovery corrected promptly (median 1 day).
Figure 5
Figure 5
Failure rate of mandated in person follow-up was 6.5% (97 of 1484 of 3 and 15 month time points) in Home Monitoring contrasting with 10.5% (193 of 1841) in Conventional (3, 6, 9, 12, and 15 months), i.e. 62% greater in Conventional.

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Source: PubMed

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