Elsevier

Heart Rhythm

Volume 12, Issue 7, July 2015, Pages e69-e100
Heart Rhythm

HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices

https://doi.org/10.1016/j.hrthm.2015.05.008Get rights and content

Introduction

Cardiovascular implantable electronic devices (CIEDs) have evolved significantly since the publication of the 2008 Heart Rhythm Society (HRS) consensus statement1 outlining recommended monitoring strategies. Novel embedded technologies have created the ability of the devices to monitor their own function, record arrhythmias and other physiological parameters, and communicate this information to health care providers without the active participation of the patient. CIEDs with wireless remote monitoring (RM) capabilities stand at the forefront of a new class of medical devices that will unobtrusively acquire vital data beyond the walls of health care facilities and seamlessly transmit the information back to health care providers. This document focuses on implantable devices for managing heart rhythm disorders.

The 2008 recommendations were, by necessity, consensus driven, without objective evidence to inform clinical practice. The document recognized that contemporary CIED follow-up has been neglected and that many patients were not receiving the recommended follow-up care. This deficiency was subsequently confirmed; patient follow-up has been erratic, with almost a quarter of patients not seen in person in the year following implant.2 The 2008 document advocated for structured follow-up that employs a system of regular in-person evaluations (IPEs). Remote interrogation (RI) and RM technologies (defined below) were developed as complementary tools to replace some of the routine follow-up appointments during the long-term phase of CIED management while maintaining an IPE schedule of at least 6–12 months.3

Since 2008, randomized controlled trials have compared IPE and remote management strategies for follow-up care of patients with CIEDs. Various trials have also explored the ability of RM to detect problems early, thereby improving patient outcomes. The trials have employed a variety of proprietary technologies in various health care models and have collectively shown the superiority of RI and RM for achieving the follow-up goals of patient adherence to structured follow-up protocols and improvement in device clinic workflow efficiency. The advent of automatic wireless RM has been critical to these results, a change in paradigm that forms the basis of new recommendations.

The present document was developed from the foundations laid by the 2008 HRS consensus statement1 and the 2012 expert consensus statement on remote monitoring of CIEDs by the International Society for Holter and Noninvasive Electrocardiography and the European Heart Rhythm Association.4 The goals for follow-up, hardware definitions, and personnel remain the same and will not be covered in this document, except for cases in which remote technologies and responsibilities have evolved. The present document provides new recommendations based on data published since 2008, endorses the need to maintain consistent follow-up, and outlines the limitations of strictly in-person methods. We focus on the organizational changes required to most effectively implement RI and RM, from the occasional replacement of routine appointments (for patient and clinician convenience) to a system of nearly continuous monitoring, with most IPEs initiated in response to alert notifications communicated by RM, thereby improving the quality and efficiency of patient care.

The terms RI and RM are often used interchangeably, with RM being the colloquially accepted term for both. RI and RM, however, refer to different and complementary tools, which we will define below and address separately throughout the text.

RI refers to routine, scheduled, remote device interrogations structured to mirror in-office checkups.4, 5 Practically all information obtained during an in-office device checkup can now be obtained remotely. An important exception to this is the data for measuring the pacing capture threshold, which is available only for devices capable of automatically measuring the capture threshold.

RM refers to the automated transmission of data based on prespecified alerts related to device functionality and clinical events.4 This provides the ability for rapid detection of abnormal device function and/or arrhythmia events.6, 7

The writing group was comprised of content experts representing the following organizations: the HRS, the Latin American Society of Cardiac Pacing and Electrophysiology (SOLAECE), the American College of Cardiology (ACC), The American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Pediatric and Congenital Electrophysiology Society (PACES), and the Asia Pacific Heart Rhythm Society (APHRS). The members of the writing group performed a comprehensive literature search, developed a series of recommendations, and provided explanations for the reasoning and research used to make each recommendation outlined in the document text.* The recommendations were voted on, with the vote threshold for inclusion set at 80%. The classification of recommendation and the level of evidence follow the recently updated ACC/AHA standard.8 Class I is a strong recommendation, denoting a benefit greatly exceeding risk. Class IIa is a somewhat weaker recommendation, with a benefit probably exceeding risk, and class IIb denotes a benefit equivalent to or possibly exceeding risk. Class III is a recommendation against a specific treatment because either there is no net benefit or there is net harm. Level of evidence A denotes the highest level of evidence, usually from multiple randomized controlled trials or from a single randomized clinical trial and a high-quality registry. Level of evidence B indicates a moderate level, either from randomized trials or well-executed nonrandomized trials. Level of evidence C is from weaker studies with significant limitations, and level of evidence E is from consensus opinions in the absence of credible published evidence.

The writing committee believes that the problems faced by patients with heart rhythm disorders cannot be addressed if clinicians, scientists, and industry work in isolation and that the value of this document would be enhanced by a structured dialogue with industry to address technical questions and gain an understanding of the challenges faced by industry in advancing this technology. Because of the potential for actual or perceived bias, strict parameters had to be established for information sharing. It is the policy of the HRS that industry may participate in the development of clinical documents in an advisory capacity, but not in its authorship. To this end, manufacturers of cardiac rhythm management devices and related industries were invited to join the writing committee at a forum on emerging technologies. The forum provided a venue for sharing important research and innovation and helped inform the writing committee’s recommendations for future developments in the field.

Section snippets

Section 1: History and Description of Remote Monitoring Technology

The remote evaluation of CIEDs began with the transtelephonic monitoring (TTM) of pacemakers, which was first introduced in 1971. Soon after its adoption, the supplementation of in-office visits with TTM for pacemaker follow-up became common in North America. TTM is still in use, and its function remains essentially unchanged.1 The technology delivers limited data on pacemaker function via analog transmission over a telephone landline; the information includes sensing, capture, and battery

Section 2: Evidence Supporting Remote Interrogation and Monitoring

Most large-scale randomized trials of remote follow-up paradigms have employed both RI and RM as complementary tools; however, several important early studies have examined RI alone.

Section 3: Indications, Paradigms, Frequency, and Content of CIED Follow-Up

Technological advances in RI and RM are altering the relative value of IPEs vs remote CIED evaluations. Up to now, IPEs have served as the primary tool for evaluating device function and disease management, with RI and RM supplementing the evaluation when available. As noted in the Introduction, the rate of compliance with recommended follow-ups is low, with only 42% of eligible US patients who underwent CIED implantation between 2005 and 2009 actually participating in an initial IPE within the

Section 4: Roles and Responsibilities of the Remote Monitoring Team Members

The implementation of RM in clinical practice requires changes in the organizational model of CIED clinical follow-up and clearly defined roles and responsibilities of patients, physicians, allied professionals, and manufacturers.

Diversity of Data Repositories

The volume, granularity, and diversity of the repositories in which the device data are stored present opportunities and challenges for RM of CIEDs. These data repositories include manufacturer device registration databases, vendor device programmers, commercial manufacturer RM services, commercial CIED practice management software systems, practice and/or hospital medical records (which can include hardcopy and electronic records), and registries (including the American College of Cardiology

Reimbursement

Despite the scientific data supporting the cost-effectiveness of RI and RM, reimbursement for physician and practice expenses is lacking in many countries.33, 89 Payers have taken different approaches to this new model of health care delivery, with only the United States and Germany recognizing full reimbursement for services rendered remotely. Even in countries that do not provide reimbursement, many health care providers have adopted the technology because of the resulting efficiency. In this

Conclusions

This consensus document reflects the wealth of recent clinical data generated by large randomized prospective trials from around the world that included patients with pacemakers, ICDs, and CRT-Ds from various manufacturers. These consistently show meaningful patient benefits from the early detection capabilities of automatic RM. Incorporation of RM into follow-up practice, integrating this technology with a modified frequency of the conventional IPE ensures greater patient retention and

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    Developed in collaboration with and endorsed by the American College of Cardiology (ACC), Pediatric and Congenital Electrophysiology Society (PACES), the American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), the European Heart Rhythm Association (EHRA), and the Latin American Society of Cardiac Pacing and Electrophysiology (Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología [SOLAECE]).

    #

    These authors contributed equally to this work.

    *

    Representative for the Latin American Society of Cardiac Pacing and Electrophysiology (Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología [SOLAECE])

    Representative for the American Heart Association (AHA)

    Representative for the American College of Cardiology (ACC)

    §

    Representative for the European Heart Rhythm Association (EHRA)

    Representative for the Pediatric and Congenital Electrophysiology Society (PACES)

    Representative for the Asia Pacific Heart Rhythm Society (APHRS)

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