Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

Conditions

Congestive Heart Failure

Keywords

implantable defibrillators, remote patient monitoring, patient-reported outcomes, cost-effectiveness

Brief summary

A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups. The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D). Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.

Gimon de Graaf, Ivy Timmermans, Mathias Meine, Marco Alings, Susanne S. Pedersen et al. (9 authors)

Journal of Telemedicine and Telecare2022-10-173 citations

10.1177/1357633x221129176

Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial

Cheyenne S L Chiu, Ivy Timmermans, Henneke Versteeg, Edgar Zitron, Philippe Mabo et al. (8 authors)

EP Europace2021-07-3039 citations

10.1093/europace/euab221

Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial

Henneke Versteeg, Ivy Timmermans, Jos Widdershoven, GEERT‐JAN P. KIMMAN, Sébastien Prévôt et al. (12 authors)

EP Europace2019-04-2435 citations

10.1093/europace/euz140

Interventions

DEVICERemote patient monitoring

Remote monitoring of ICD and heart failure data

OTHERIn-Clinic check-ups

Calender-based In-Clinic ICD check-up

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

* first time ICD/CRT-D implanted at one of the participating centers * left ventricular ejection fraction \<35% * NYHA functional class II or III symptoms * ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific

Exclusion criteria

* On the waiting list for heart transplantation * History of psychiatric illness others than affective/anxiety disorders * Cognitive impairments * Insufficient knowledge of the language to fill in the questionnaires

Design outcomes

Primary

Measure	Time frame	Description
Patient-reported health status	24 months	23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
Patient-reported device acceptance	24 months	12-item Florida Patient Acceptance Scale (FPAS)

Secondary

Measure	Time frame	Description
Patient-reported satisfaction with care	24 months	* Visual Analogue Scale ranging from 0-100 (with higher score representing more satisfaction with care) * 26-item self-made questionnaire to assess satisfaction with RPM
Cost-effectiveness	24 months	Data regarding health care utilization is gathered from hospitals and patients.

Countries

Netherlands

Outcome results

None listed