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

Disclosures

Eur Heart J. 2014;35(20):1345-1352. 

In This Article

Abstract and Introduction

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.

Introduction

Cardiac implantable electronic devices (CIEDs) are increasing in prevalence in response to widening indications. The implant—not an end goal in itself—initiates an indefinite commitment to manage both the device and patient condition being treated, and these needs may change with time. By definition, most CIED recipients constitute a high-risk population demanding close attention. Hence, post-implant monitoring is important. However, follow-up schedules vary according to facility, physician preference, and available resources.[1] Analysis of Medicare beneficiaries from 2005 to 2009 showed that most patients receiving a new CIED were not seen at all within 3 months, and almost a quarter of patients not reviewed in the year after implant.[2] The consequences of defaulting were vividly illustrated by the comparative survival advantage gained by those patients who did adhere to prescribed follow-up.[3] To address inconsistent clinical practice, professional organizations outlined a minimum frequency of follow-up, in the form of regular periodic 'in-person' or 'remote' assessments.[4] However, the efficacy of each of these methods, and their equivalency (implicit in this statement), had not been determined then. This has implications for patient security and clinic workflow organization, and for regulatory bodies seeking establishment and/or reimbursement for remote patient management.[5] Potential limitations exist. Patient-dependent follow-up is notoriously subject to non-compliance.[6] On the other hand, successful remote management may be determined by the technology (reliability and ease of use), and ability to reconfigure clinic workflows. Different operating characteristics among different proprietary technologies generate further complexity. Thus, although remote management is appealing, its role in clinical practice remains largely undefined, even more so as functional distinctions are drawn between remote follow-up and remote monitoring.[7] Prolonged remote management without scheduled in-person evaluations (IPEs) potentially arouses concern, and remains unevaluated. Lack of these data significantly impedes wider acceptance and adoption of this innovative technology.

The TRUST trial previously reported clinic efficiencies ensuing from remote patient management.[8] In the current analysis, we examined the comparative efficacy of in-person vs. remote management specifically regarding achievement of the core guideline objective of maintaining structured follow-up. Thus, we tested the trial hypothesis that remote management would more effectively achieve the key aims of patient retention, and adherence to and punctuality of regular periodic assessments.[9]

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