Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study

Abstract

Background: Outcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs.

Methods: This multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs.

Results: A total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, p < 0.001, n = 48) and pacemakers (42 v. 10, p < 0.001, n = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, p = 0.3, n = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% (n = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers.

Interpretation: This pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up.

Trial registration: ClinicalTrials.gov, no. NCT02585817.

Conflict of interest statement

Competing interests: For activities outside the work reported here, Jeff Healey has received personal fees from Boston Scientific, Medtronic, BMS/Pfizer and Cipher Pharma, as well as research grants from Abbott and ARCA Biopharma; Satish Raj has received personal fees from Lundbeck LLC, Theravance Biopharma, Spire Learning, Academy for Continued Healthcare Learning and Medscape; Evan Lockwood has received personal fees from Bayer, Pfizer and BMS; Samuel Sears has received research funding from Medtronic and Zoll Medical, as well as honoraria from Medtronic, Abbott/St. Jude Medical, Zoll Medical and Milestone Pharmaceutical; François Philippon and Anthony Tang have received research funding from Medtronic; and Ratika Parkash has received research funding from Novartis and Abbott. No other competing interests were declared.

© 2021 Joule Inc. or its licensors.

Figures

Figure 1:

Patient flow. The total number of patients approached to participate in the pilot study is not available because some of the centres did not keep a screening log. Of patients with pacemakers, 1 was removed from the study (because the device was replaced with an implantable cardioverter defibrillator), and 9 withdrew from the study for the following reasons: none given (n = 3), preferred in-clinic visits or already coming in for other appointments (n = 3), progressing cognitive impairment due to Alzheimer disease (n = 1), not comfortable with the technology (n = 1) and unable to be home for delivery of remote monitoring paddle (n = 1). Note: ICD = implantable cardioverter defibrillator, PM = pacemaker.

Figure 2:

In-clinic and remote visits before and after implementation of remote patient management. After implementation, in-clinic visits decreased (p < 0.001) and remote visits increased (p < 0.001) for patients with pacemakers (PMs; n = 51), whereas in-clinic visits decreased for patients with implantable cardioverter defibrillators (ICDs; n = 48; p < 0.001).